Code of Colorado Regulations — Department of Labor and Employment

1101 Division of Unemployment Insurance

7 CCR 1101-2 Regulations Concerning Employment Security {#sec-7-ccr-1101-2 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-2}

DEPARTMENT OF LABOR AND EMPLOYMENT

REGULATIONS CONCERNING EMPLOYMENT SECURITY

7 CCR 1101-2 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

PART I GENERAL PROVISIONS

1.1 PREAMBLE

Pursuant to the provisions of 8-72-102, C.R.S., and other provisions of the Colorado Employment Security Act, the industrial commission of Colorado, ex officio, unemployment compensation commission of Colorado hereby adopts and promulgates the following regulations.

1.2 PURPOSE AND SCOPE

The purpose of these regulations effective March 3, 1980, is to implement the procedural and substantive provisions of the Colorado Employment Security Act. 1.2.1 Basis and Purpose for the 1983 Amendments. - The amendments and reenactments and renumbering of the regulations effective August 30, 1983, are caused by requirements of legislative enactments that require conformity in the implementing regulations, and the necessities for clarifications and elaborations in the regulations to ensure continuing fairness in administration and adjudication of claims for benefits and appeals from adjudications; and in just determination of appeals and petitions at a reasonable expense to parties and the administering agencies. 1.2.2 Basis and Purpose for the 1984 Amendments. - The amendments effective October 30, 1984, are promulgated by the commission pursuant to 8-72-102 and 24-4-103, C.R.S., for the purpose of clarifying and defining more fully the procedural rights and duties of claimants for unemployment benefits, employers, and other interested parties, and are calculated to implement the Colorado Employment Security Act, C.R.S. title 8, articles 70 to 82 as amended, more fairly and efficiently, and to further its stated purposes; and to implement the purpose of harmony in state administration with federal statutes and regulations; and the requirements for effective appeals or petitions for review of administrative determinations; and the duties and liabilities of parties in communications with the administrative authorities in matters of claims for benefits and notices and determinations related thereto.

These amendments to rules and regulations result from recent legislative enactments upon employment security; from a public hearing held in accordance with 24-4-103, C.R.S., and the entire record connected thereto; and from comments and advice offered during proceedings of the legal affairs committee within the Colorado Department of Labor and Employment that is concerned, as is the commission, with just and efficient administrative practices and response to the needs for changes and prospective improvements in procedure, including the areas of claims, hearing, and appeals. 1.2.3 Basis and Purpose for the 1985 Amendments. - The amendments effective September 30, 1985, are adopted pursuant to 8-72-102, C.R.S., for the purpose of conformity with new legislation, clarification of the substantive and procedural rights and responsibilities of interested parties, and increased efficiency and effectiveness in the fair administration of the Colorado Employment Security Act, including the appeal process. 1.2.4 Basis and Purpose for the 1987 Amendments. - The amendments effective January 1, 1988, are adopted pursuant to 8-72-102, C.R.S., for the purpose of conformity with new legislation, clarification of the substantive and procedural rights and responsibilities of interested parties, and increased efficiency and effectiveness in the fair administration of the Colorado Employment Security Act, including the appeal process. 1.2.5 Basis and Purpose for the 1991 Amendments. - The amendments effective October 1, 1991, are adopted pursuant to 8-72-102, C.R.S., for the purposes of conformity with new legislation, facilitating the reorganization of the division and its operations, and removing obsolete language from the regulations. 1.2.6 Basis and Purpose for the 1992 Amendments. - The amendments effective August 3, 1992, are adopted pursuant to 8-72-102, C.R.S., for the purpose of transferring to the industrial claim appeals office certain procedural responsibilities concerning appeals from referees' decisions, to facilitate increased efficiency and effectiveness in the administration of the appeals process, and to effectuate the 1992 amendments to 8-74-104(3), C.R.S., and enactment of 8-74-104 (4), 1.2.7 Basis and Purpose for the 1994 Amendments. - The amendments effective July 1, 1994, are adopted pursuant to 8-72-102, C.R.S., for the purpose of more fully describing claim-filing requirements, clarifying administrative-appeals procedures, and removing obsolete provisions from the regulations. 1.2.8 Effective Date for the 1994 Amendments. - The rules adopted on May 4, 1994, are effective on July 1, 1994. 1.2.9 Basis and Purpose for the 1997 Amendments. - The amendments effective January 1, 1998, are adopted pursuant to 8-72-102, C.R.S., for the purpose of modifying statutory citations, clarifying eligibility requirements, removing obsolete provisions concerning the Head Start Program, conforming quarterly tax and wage reporting to federal-law requirements, modifying hearing-document exchange and good-cause provisions, and outlining criteria for the write-off of recovery and the waiver of recovery of benefit overpayments. 1.2.10 Effective Date for the 1997 Amendments. - The rules adopted on November 6, 1997, are effective on January 1, 1998. 1.2.11 Basis and Purpose for the 1998 Amendments. - The amendments effective January 1, 1999, are adopted pursuant to 8-72-102, C.R.S., for the purpose of making technical corrections, modifying provisions concerning claims for benefits, promoting increased effectiveness in the administration of the appeals process, and conforming interstate provisions to arrangements with other states. 1.2.12 Effective Date for the 1998 Amendments. - The rules adopted on November 6, 1998, are effective on January 1, 1999. 1.2.13 Basis and Purpose for the 2000 Amendments. - The amendments effective January 1, 2001, are adopted pursuant to 8-72-102, C.R.S., for the purpose of modifying provisions concerning approved training and improving clarity and uniformity in the regulations. 1.2.14 Effective date for the 2000 Amendments. - The rules adopted on November 1, 2000, are effective on January 1, 2001. 1.2.15 Basis and Purpose for the 2002 Amendments. - The amendments effective January 1, 2003, are adopted pursuant to 8-72-102, C.R.S., for the purpose of expanding the methods for the division, the panel, and their customers to conduct business through use of technology and harmonizing the regulations with the provisions of 8-76-101(3), C.R.S., concerning quarterly taxes due that are less than five dollars. 1.2.16 Effective Date for the 2002 Amendments. - The rules adopted on October 30, 2002, are effective on January 1, 2003. 1.2.17 Basis and Purpose for the 2008 Amendments. - The amendments effective February 1, 2009, are adopted pursuant to 8-72-102, C.R.S., for the purpose of modifying provisions required by legislative enactments to facilitate increased efficiency and effectiveness in the administration of the appeals process, to include the employee -leasing company requirements, and to remove obsolete language from the regulations concerning employment security. 1.2.18 Effective Date for the 2008 Amendments. - The rules adopted on November 12, 2008, are effective on February 1, 2009. 1.2.19 Effective Date for the 2009 Amendments. - The rules adopted on August 14, 2009, are effective on October 30, 2009. 1.2.20 Basis and Purpose for the 2009 Amendments. - The amendments effective October 30, 2009, are adopted pursuant to 8-72-102, C.R.S, to: .1 Reflect the changes in the reporting requirements for employee-leasing companies in

part xvi. .2 Create processes related to employee misclassification by adding new Part XVII. .3 Modify provisions required by legislative enactments to add a definition for remuneration in part I. .4 Reflect statutory amendments in part ii, by allowing for a work-search waiver for an individual who has a qualifying job separation under 8-73-108 (4) (t) C.R.S, and; .5 Extend the waiver of the requirements to register for work and report to an employment office as a condition of being eligible to receive unemployment insurance benefits for a claimant who is job-attached. 1.2.21 Effective Date for the 2009 Amendments. The rules adopted on October 30, 2009, are effective on December 30, 2009. 1.2.22 Basis and Purpose for the 2009 Amendments. The amendments effective December 30, 2009, are adopted pursuant to 8-72-102, C.R.S., for the purpose of modifying provisions required by legislative enactments to facilitate increased efficiency and effectiveness in the administration of the appeals process, and to include House Bill 09-1363, Unemployment Compensation Enterprise requirements to the Regulations Concerning Employment Security. 1.2.23 Basis and Purpose of the 2011 Amendments. - The rules adopted on November 14, 2011, are effective January 1, 2012 for the purpose of: .1 Improving communication with claimants in regards to what defines an active work search. .2 Amending the rules related to actively seeking work to add clear definitions of what represents a work search. Additionally, adding further explanation that a tangible record of contacts is required, what a tangible record is, and the length of time the record must be maintained by a claimant. .3 Adding new rules allowing the Division to issue a formal warning, at its discretion, to a claimant who unintentionally fails to meet the work-search requirements. 1.2.24 Basis and Purpose of the 2012 Amendments. - The rules adopted on November 22, 2011, are effective April 1, 2012 for the purpose of: .1 Amending the rules related to unemployment insurance appeals and redeterminations for clarity. .2 Amending the rules related to good cause for clarity. .3 Adopting rules allowing the Division to fine an employer who is found to have willfully disregarded the law when misclassifying an employee as an independent contractor. 1.2.25 Basis and Purpose of the 2012 Amendments. - The rules adopted on January 18, 2012, are effective April 1, 2012 for the purpose of: .1 Amend the rules regarding employer reports, specifically a wage or separation report on a specific worker to include a statement that good cause is automatically found when the separation report is received after the deadline but before a decision is issued. As appropriate, add the new reference on good cause to other rules within this Part. .2 Repeal a portion of the rule regarding a decision of the hearing officer that no longer applies. .3 Amend the rules regarding good cause procedure to allow Unemployment Insurance Appeals to make a determination of good cause without specifically requesting a goodcause statement from the appellant if the file material contains the necessary information. 1.2.26 Basis and Purpose of the May 2012 Amendments. – The rules adopted on April 2, 2012, are effective May 30, 2012 for the purpose of amending the rules to allow the Division to take the postmark date into account when determining the timeliness of the receipt of a premium payment and quarterly report. 1.2.27 Basis and Purpose of the May 2012 Amendments. – The rules adopted on June 4, 2012 are effective July 30, 2012. The Division of Unemployment Insurance reviewed all rules currently in effect. The review found rules that are redundant to statute and/or outdated. The following amendments are proposed to simplify the Division’s rules: .1 Repeal rules that repeat statute and renumber the remaining Definitions in Part I. .2 Amend rules to clarify that an employer is not required to pay premiums that are less than $5 as long as the quarterly reports are submitted timely in Part VI, Premiums and Assessments. .3 Repeal reporting methods that cannot be accepted for employer quarterly reports in Part VII, Employer Records and Reports. .4 Repeal a portion of the employee-leasing companies rules that is no longer applicable in

Part XVI, Employee-Leasing Companies. .5 Repeal rules that repeat statute and renumber the remaining rules in Part XVII, Work Share. 1.2.28 The rules adopted on July 18, 2012, are effective September 14, 2012. The Division of Unemployment Insurance amended the following rules to address legislative changes made during the 2012 Colorado General Assembly. .1 Amend references to the Unemployment Insurance Program to be the Division. .2 Amend the definition of the division to conform to statute creating the Division of Unemployment Insurance. .3 Amend references to the Unemployment Insurance Program to be the Division and extend the date by which enhanced benefits can be paid to June 30, 2014, to conform to the law. .4 Amend rules on the application of delinquent payments to include nonprincipal-related bond payments. 1.2.29 The rules adopted on March 13, 2013, are effective May 15, 2013. The Unemployment Insurance Division reviewed all rules currently in effect. The review found rules that are redundant to statute and/or outdated. The following amendments are proposed to simplify the Unemployment Insurance Program’s rules.

1. Repeal rules regarding emergency rules that were later promulgated into permanent rules, and the effective date of the permanent rules are included in the details of that promulgation.

2. Repeal a rule that is no longer applicable, and clarify income derived from investmentinterest payments.

3. Clarify that a spousal relationship is defined by Colorado law.

4. Amend rules regarding the timelines for requesting redeterminations to extend the time from fifteen (15) days to twenty (20) days.

5. Amend rules for clarity, and repeal sections that are no longer applicable. Renumber remaining sections.

6. Repeal a rule that is no longer applicable.

1.3 DEFINITIONS

As used in these regulations, the following words shall have the following meanings: .1 Commission. - The word “commission” shall mean the Industrial Commission of Colorado, ex officio, Unemployment Compensation Commission of Colorado as it existed prior to July 1, 1986. .2 Division. - The word “division” shall mean the Division of Unemployment Insurance of the Department of Labor and Employment of the State of Colorado. .3 Act. - The word “act” shall mean the Colorado Employment Security Act, articles 70 to 82 of title 8, C.R.S., unless the context clearly indicates otherwise. .4 Benefits. - The word “benefits” shall mean unemployment compensation benefits payable to claimants under the act. .5 Calendar Week. - The term “calendar week” shall mean a period of seven consecutive days beginning at 12:01 a.m. on Sunday and ending at midnight on the following Saturday. .6 Public Employment Office. - The term “public employment office” shall mean any workforce center, itinerant service point, or representative thereof. .7 Panel. - The word “panel” shall mean the industrial claim appeals panel that conducts administrative appellate review of any decision entered pursuant to article 74 of title 8, C.R.S. .8 Examiner. - The word “examiner” shall mean one of the industrial claim appeals examiners appointed to the panel. .9 Attendance. - The term “attendance” shall mean participation in hearings before a hearing officer by telephonic means or in person. .10 Written, in Writing. - The terms “written” and “in writing” shall mean: .1 Decisions, determinations, notices, account statements, and documents provided by the division or the panel to an interested party, or their authorized representative, if any, in person, by mail, by facsimile machine, or by electronic means. .2 Appeals, applications, documents, elections, forms, notices, protests, reports, and requests submitted to the division or the panel by an interested party, or their authorized representative, if any, when handwritten or typed, transmitted using division-approved electronic means and formats, or panel-approved electronic means, or provided using a division interactive voice response system when this method is expressly permitted by

regulation. .11 Signed, Signature. - When information submitted to the division is required to be signed, the personal identification number (PIN) shall be considered the same as a signature when a claimant, an employer, or authorized representative thereof uses division-approved electronic means or uses a division interactive voice response system. .12 Personal Identification Number (PIN). - The term “personal identification number (PIN)” shall mean a confidential number or other electronic method of verification unique to a claimant, an employer, or authorized representative thereof that shall be required for such persons to perform certain transactions with the division by electronic means or by a division interactive voice response system. .13 Electronic. - The term “electronic” shall have the meaning set forth in 8-70-103 (8.5), C.R.S., and, for purposes of these regulations, said meaning shall include the Internet and any other technology the division in its discretion may approve, or when appropriate, the panel may approve. .14 Facsimile Machine. - The term “facsimile machine” shall mean a device that electronically or telephonically receives and transmits reproductions or facsimiles of documents. .15 Transmit. - The term “transmit,” or any derivative thereof, shall mean by facsimile machine, by electronic means, or by a division interactive voice response system unless the context clearly indicates otherwise. .16 Mail. - The term “mail” shall mean delivery through the United States Postal Service or by other commercial carrier, but not by electronic or telephonic means. .17 Interactive Voice Response System. - The term “interactive voice response system” means the division's automated interface between a caller using a telephone and a division computer. .18 By Telephone. - The term “by telephone” means verbal communication using a telephone instrument or communication using a telephone device for the deaf (TDD). Said term does not include information transmitted by “electronic” means pursuant to regulation 1.3.14 or information transmitted using an “interactive voice response system” pursuant to regulation 1.3.18. .19 Corrected Decision. - The term “corrected decision” shall refer to a decision issued by a deputy or a hearing officer or the panel, within 30 days subsequent to the date of his decision, to correct typographical or clerical or other minor errors. A “corrected decision” is not a reconsidered decision as provided by 8-74-105, C.R.S. Notice of a corrected decision shall promptly be given to all interested parties. .20 The term “remuneration,” - as used in §8-73-110, C.R.S., shall mean any payment the individual receives from the employer which the individual would not have received had he or she not separated from employment. .21 Negative Excess Employer. - The term “negative excess employer” shall mean an employer who has more in unemployment benefits charged to his or her account as compared to unemployment premiums paid and credited to his or her account. .22 Fringe Benefits. - The term “fringe benefits” shall mean health insurance, retirement benefits received under a pension plan, paid vacation days, paid holidays, paid sick leave, and any other similar employee benefit that is provided by an employer. .23 Work Share Benefits. - The term “work share benefits” shall mean the unemployment benefits payable to employees in an affected unit under an approved work share plan as distinguished from the unemployment benefits otherwise payable under the conventional unemployment compensation provisions of the Colorado Employment Security Act. .24 Participating Employer. - The term “participating employer” shall mean an employer who has a work share plan in effect. .25 Participating Employee. - The term “participating employee” shall mean an employee who works a reduced number of hours under a work share plan. .26 “Federal Program” means any federal- and state-extended benefits program under federal law that provides benefits to exhaustees of regular benefits during times of high unemployment or economic downturn and any program that pays benefits under federal law, including but not limited to, Disaster Unemployment Assistance.

1.4 USE OF PRONOUNS

As used in these regulations, “he,” “his,” and “him” shall refer to individuals of either gender, and also, where appropriate, to entities and organizations.

1.5 REPEAL

All rules and regulations enacted previous to March 3, 1980, relating to employment security are hereby repealed.

1.6 SUBSTITUTION OF THE WORD “PREMIUM” FOR THE WORD “TAX”.

Wherever the word “tax(es)” appears in these rules said word(s) shall be replaced by the word “premium(s)”.

1.7 AMENDMENT OF REGULATIONS CONCERNING EMPLOYMENT SECURITY BY

EMERGENCY RULE MADE PERMANENT 1.7.1 Statement of Basis and Purpose as to Emergency Rule Made Permanent. - The emergency

rule, adding a new subsubsection .11 to regulation 11.2.15 of part XI of the Regulations Concerning Employment Security, was promulgated and made permanent to comply with 8-74- 104(1), C.R.S. (1985 Cum. Supp.), that required the commission to promulgate a rule regarding briefing schedules on first appeal to the commission. The rule establishes a simultaneous briefing schedule for such appeals and codifies existing division procedure for processing such appeals. 1.7.2 Authority. - The emergency rule was promulgated effective January 2, 1986, pursuant to the industrial commission's authority in 8-72-102 and 24-4-103(6), C.R.S., having to do with promulgation of emergency rules. The commission found that said adoption and promulgation as an emergency rule was imperatively necessary for the preservation of health, safety, and welfare, and of substantive and procedural rights of parties to unemployment compensation appeals, and that compliance with the ordinary provisions and requirements for notice and prior public hearing, as provided by 24-4-103, C.R.S., would be contrary to the public interest; and such finding by the commission has been duly set forth in the commission resolution adopting the emergency rule dated January 2, 1986. 1.7.3 Permanency of Emergency Rule. - The commission, pursuant to said section 24-4-103, C.R.S., and after duly published notice and public hearing, now promulgates said rule as a permanent

rule, adding a new subsubsection .11 to existing regulation 11.2.15 of existing part XI of the Regulations Concerning Employment Security, 7 C.C.R. 1101-2. 1.7.4 Effective Date of Rule. - This rule shall be effective 20 days after publication. 1.7.5 Repealed 1.8 DATE OF FILING.

Where part II, part V, part VI, part VII, part X, part XI, part XII, part XIII, or part XV of these regulations provides for the filing of documents, the date of filing shall be the date received, if mailed or filed in person, the receipt date encoded on a facsimile document, or the receipt date recorded by the division's automated systems if filed using division-approved electronic means or a division interactive voice response system unless the regulation specifically provides otherwise.

1.9 DIVISION OR PANEL COMMUNICATIONS.

The division or panel may request information from an interested party and their authorized representative, if any, by personal delivery, by mail to their last known address as shown in the division’s or panel’s records, by telephone, by facsimile machine, or by division approved electronic means. Any decision, determination, notice, or statement that conveys protest or appeal rights shall be provided in accordance with articles 70 to 82 of title 8, C.R.S., and these regulations.

1.10 USE OF PERSONAL IDENTIFICATION NUMBER (PIN).

It is the responsibility of a claimant, an employer, or authorized representative thereof who uses a PIN to keep that information confidential. Use of said PIN by any third party to obtain, increase, delay, prevent, or reduce benefit payments shall be subject to the provisions of 8-81-101, C.R.S., and the regulations pursuant thereto.

1.11 MAILING ADDRESS OF PARTIES.

It is the responsibility of a claimant, an employer, or authorized representative thereof to keep the division promptly and directly informed of the party’s current and correct mailing address. Parties may notify the division of a change of address by providing a written, signed statement in person, by mail, by facsimile machine, by division-approved electronic means, or via cubline, the division's interactive voice response system.

PART II CLAIMS FOR BENEFITS

2.1 REGISTRATION AND FILING CLAIMS 2.1.1 Statutory References. 8-70-111 (2)(a), 8-70-112, 8-73-107 (1)(a)(b)(e)(h), and 8-74-101 (1), 2.1.2 Work Registration. To qualify for benefits, an unemployed worker must register for work when instructed by the division. Failure to register for work when so instructed may result in a disallowance of benefits pursuant to regulation 2.1.67. 2.1.3 Filing an Initial, Additional, or Reopened Claim. The claimant may file an initial, additional, or reopened claim by division-approved electronic means, by telephone, by mail, or in person at the discretion of the division. Unless otherwise determined by the division, filing claims by divisionapproved electronic means and by telephone shall be the preferred methods of filing. .1 If the division determines that the claimant's interests would be better served by an alternative method of claim filing, an individual may be permitted to file a claim by mail or in person. The division shall determine which alternative method of claims filing the claimant may use. .2 If the division determines that an individual may file by mail, the following criteria shall be used in addition to the criteria contained in regulation 2.3.5 in determining the effective date of the claim: .1 The claimant must fill out the prescribed claim form completely and correctly in order to establish a valid claim. .2 The effective date of the claim may not be established until the claim form is correctly completed by the claimant and received by the division. If the information on the form is not complete, it may be returned to the claimant for correction. The time the corrected claim is received by the division may establish the effective date. .3 to establish the validity of an initial, additional, or reopened claim, the division may require the claimant to provide documentation or other evidence to establish their identity.

Failure to provide such information shall result in a disallowance of benefits. such information must be provided by the claimant by methods prescribed by the division director, which may include the submission of the information through a third-party administrator. Failure to submit such information by the method prescribed by the division director shall be considered in the same manner and shall be subject to the same disallowance of benefits as if the claimant had failed to submit the information. .1 no claim for benefits shall be considered valid as defined in 8-70-111(2)(a) until this requirement has been met. .2 An individual’s identity may not be established by any method other than those prescribed by the division director. .3 Good cause may not be established, and no waiver may be granted for the failure to complete this requirement and under no circumstances, including on appeal, shall benefits be paid until this requirement has been completed. 2.1.4 Completion of the Required Forms. After filing an initial, additional, or reopened claim, the claimant will be issued the necessary forms that must be completed and returned to the division.

At the discretion of the division, completed forms may be returned to the division in person, by mail, by facsimile machine, or by division-approved electronic means. Failure to return the completed forms could result in a disallowance of benefits. 2.1.5 Reporting in Person. The division may, at its discretion, require a claimant to report in person to a public employment office to comply with such requirements as deemed necessary to demonstrate eligibility for benefits. 2.1.6 Failure to Report. Failure by the claimant to comply with a request to report in person, by telephone, by mail, by facsimile machine, or by division-approved electronic means as directed by the division or to provide the division with necessary information or documentation when so requested could result in a disallowance of benefits, unless good cause is shown. 2.1.6.1 [Emergency rule expired 08/12/2020] 2.1.7 Filing a Continued Claim. A continued claim is a request filed for waiting-period credit or payment for one or more weeks of unemployment. Claimants must file for continued claims by interactive voice response system or by division-approved electronic means. the division may permit a claimant to file a continued claim by mail or in person if filing by interactive voice response system or by division-approved electronic means would cause undue hardship for an individual. .1 filing period. continued claims must be filed on a weekly basis, as directed by the division, and must be filed no later than the seventh day after the last day of the week for which the claimant is requesting a benefit payment. .2 continued Claims Filed by Interactive Voice Response System. The term “interactive voice response system” means the division's automated interface between a caller using a telephone and a division computer. .3 continued Claims Filed by Division-Approved Electronic Means. Division approved electronic means include the internet and any other technology the division in its discretion, may approve, or when appropriate, the panel may approve. The transmittal date recorded by the division’s automated systems shall determine the date of filing. .4 continued Claims Filed by Mail. “mail” means delivery through the united states postal service or by other commercial carrier, but not by electronic or telephonic means. in the event that the division permits filing a continued claim by mail, the claimant must complete and sign the document. the division must receive the document at the central office of the division no later than the last day of the filing period. .5 continued claims filed in person. in the event that the division permits filing an in-person continued claim, he or she must file in person, a completed claim form, signed by the claimant at a public employment office or at the central office of the division. the claimant must complete this action no later than the last day of the filing period. 2.1.8 Temporary Absence From State. Claimants who reside in Colorado and temporarily leave the state to seek employment and, while absent from the state, satisfy the eligibility requirements set forth in 8-73-107, C.R.S., and the regulations pursuant thereto will be allowed to file continued claims from out-of-state. Upon a claimant's relocation to another state, the provisions of

regulation 13.1 shall apply. 2.1.9 Nonreceipt of Forms. If prescribed continued-claim forms are not received by the claimant by mail, the claimant must request such forms from the division. 2.1.10 Exceptions to Time Limits. Acts under this section 2.1 may be permitted out of time only under limited circumstances, but regardless of whether an individual has met the requirements of this

section 2.1.10, no act under this section 2.1 shall be permitted more than 180 days beyond the last day of the applicable time period. Exceptions for untimely act that occur within the allotted 180 days may be granted only if the following standards apply. .1 Work Registration and Requested Reports. The division may, for good cause shown, permit an individual to register for work or provide requested reports to the division outside the required time period without loss of eligibility. For the purposes of this subsection, good cause shall have the meaning set forth in regulation 12.1.8. 2.1.10.2 Continued Claims. The division may permit filing a continued claim out of time as set forth in regulation 2.1.7 only if the individual establishes to the satisfaction of the division that he or she exercised no control over the circumstances of the untimely filing.

Being unaware of the need to timely file is not considered a factor outside an individual’s control. .3 Initial, Additional, Reopened Claims. When an initial, additional, or reopen claim is filed, the first week of that claim shall be determined in accordance with regulation 2.3.5.

The division may permit a change in the first week of an initial, additional, or reopened claim only if the individual establishes to the satisfaction of the division that he or she exercised no control over the circumstances of the untimely filing. Being unaware of the need to timely file shall not be considered a factor outside the individual’s control. 2.1.11 Cancellation of Initial Claim. When a benefit year is established as a result of a valid initial claim, such claim may be cancelled only when: .1 Part XIII of the regulations concerning interstate and combined-wage claimants applies, or .2 The claimant requests cancellation in person, by mail, by facsimile machine, by divisionapproved electronic means, or by telephone within twelve calendar days from the date of such filing. Requests to cancel a valid initial claim made after the twelve-day period shall be denied without consideration of good cause or whether the individual exercised any control over the circumstances of the untimely request. 2.1.12 Tax-Withholding Option for Federal Programs. Claimants may choose a tax-withholding option upon initially applying for a federal program, as defined in Regulation 1.3.31, for which claimants receive a notice of monetary determination.

2.2 BENEFITS RIGHTS OF PART-TIME WORKERS 2.2.1 Statutory References: 8-73-103, 8-73-104 (1), 8-73-105, 8-73-106 (1), and 8-73-107, C.R.S. 2.2.2 Eligibility. An unemployed part-time worker as defined in 8-73-105 (1), C.R.S., who worked parttime for the majority of weeks of work in his or her base period for one or more employers and whose availability is restricted to part-time work shall be eligible for benefits pursuant to this

section. 2.2.3 Able, Available, and Actively Seeking Work. Any unemployed part-time worker shall be deemed to have met the requirements of 8-73-107 (1)(c) and (g), C.R.S., if: .1 Said worker is able to work, available for work, and actively seeking his or her customary

part-time work or other part-time work for which he or she is qualified; and .2 Such part-time work exists in the labor-market area. 2.2.4 Totally Unemployed Part-Time Seasonal Worker. Benefit rights of an unemployed part-time worker who is also a seasonal worker shall be determined pursuant to 8-73-104 (1), C.R.S. 2.2.5 Partially Unemployed Part-Time Worker. Benefit rights of partially unemployed part-time workers who meet the requirements of regulation 2.2.2 and who receive a reduction in customary work hours shall be determined in accordance with 8-73-103, C.R.S. 2.2.6 Regular Part-Time Worker. Regular part-time employment is defined to be that part-time baseperiod employment from which a claimant has not separated at the time of filing a valid initial claim and that was present with other full-time or part-time base-period employment. Benefits are not payable with respect to wages from regular part-time employment until a claimant becomes separated from such employment and then only for those weeks occurring after said separation.

2.3 WEEK OF UNEMPLOYMENT 2.3.1 Statutory References: 8-70-103 (19)(28)(30), 8-70-112, 8-73-107 (1)(d)(f)(h), 8-73-108 and 8- 74-101, C.R.S. 2.3.2 Week of Unemployment. Except as provided in regulations 2.3.4 and 2.3.5, a week of unemployment shall be the calendar week in which the individual files an initial, additional, or reopened claim with the division and each calendar week immediately following any such week for which said individual has filed a continued claim as provided by regulation or has failed to do so and has established to the satisfaction of the division that he or she exercised no control over that failure. However, no week is a week of unemployment unless the individual has worked less than thirty-two hours during such week, earned less than his or her weekly benefit amount, and has filed an initial, additional, or reopened claim not later than Wednesday of that week or has filed a continued claim pursuant to regulation 2.1.7. 2.3.3 Area Served by Itinerant Service Point. A week of unemployment for an individual who resides in an area served only by an itinerant service point of the division shall be the calendar week in which such individual became unemployed, if such individual files an initial, additional, or reopened claim at such itinerant service point at the first opportunity thereafter, and each calendar week immediately following such week for which such individual has filed a continued claim as provided by regulation or has failed to do so and has established to the satisfaction of the division that he or she exercised no control over that failure. However, no week shall be considered a week of unemployment unless the individual has worked less than thirty-two hours during such week and earned less than his or her weekly benefit amount. 2.3.4 Failure to Meet Requirements. A week of unemployment for an individual who has failed to timely file an initial, additional, or reopened claim for benefits as provided in these regulations shall be the earliest calendar week in which the individual established to the satisfaction of the division that he or she exercised no control over the circumstances of the failure to act timely.

Thereafter, weeks of unemployment shall be the calendar weeks immediately following any such week for which the individual has filed a continued claim as provided by regulation, or has failed to do so and has established to the satisfaction of the division that he or she exercised no control over that failure. However, no week shall be considered a week of unemployment unless the individual has worked less than thirty-two hours during such week and earned less than his or her weekly benefit amount. 2.3.5 First Week for Claims. To begin a claims series by reason of an initial, additional, or reopened claim, an individual's first week in the claims series shall be determined as follows: .1 If the individual files a claim on Monday, Tuesday, or Wednesday, the first day of the first week in the claims series shall begin on the Sunday immediately preceding the day on which said claim was filed. .2 If the individual files a claim on Thursday, Friday, or Saturday, the first day of the first week in the claims series shall begin on the Sunday immediately following the day on which said claim was filed.

2.4 JOB ATTACHMENT. 2.4.1 Statutory References: - 8-73-107 and 8-73-108 (5)(a)(b)(c), C.R.S. 2.4.2 Job Attachment to an Employer. - A claimant is considered to be job-attached and is presumed to be following a course of action reasonably designed to result in prompt reemployment in suitable work, as contemplated by 8-73-107 (1)(g), C.R.S., when an understanding exists between the claimant and his or her employer that the claimant will return to his or her old job or other suitable work with such employer within the period set forth in regulation 2.4.5 and the requirements of this section 2.4 of the regulations are met. This presumption may be rebutted by competent evidence in an individual case. Job attachment to an employer shall commence with the week in which the claimant last separated from said employer. 2.4.3 Job Attachment by Virtue of Union Hiring Hall. - A claimant who is properly registered for employment through a union hiring hall is presumed to be following a course of action reasonably designed to result in prompt reemployment in suitable work, as contemplated by 8-73-107 (1)(g), C.R.S., and shall be considered job-attached to the extent permitted by regulation 2.4.5. This presumption may be rebutted by competent evidence in an individual case. Job attachment shall commence with the effective date of a valid initial, additional, or reopened claim filing. 2.4.4 Job Attachment by Promise of New Work. - A claimant who has an assurance of new work shall be considered job-attached to the extent permitted by regulation 2.4.5, and such period shall commence with the week in which the offer of new work was accepted. “New work” for the purposes of this section 2.4 shall mean a job offer that has no known termination date made by any employer other than the employer from whom the claimant most recently separated. 2.4.5 Duration of Job Attachment. - Claimants who are job-attached to an employer or who are jobattached by virtue of a union hiring hall arrangement will be presumed to meet the requirements of 8-73-107 (1)(g), C.R.S., for a period of up to sixteen weeks unless it can be shown that said job-attached status is not reasonably designed to result in prompt reemployment in suitable work.

Job-attached status may be granted for a period of no more than two weeks to a claimant with a promise of new work. .1 The division, at its discretion during times of economic recession, may extend the period of job attachment for up to twenty-six weeks for claimants who are job-attached to an employer or who are job-attached by virtue of a union hiring hall arrangement. 2.4.6 Duties of Claimant. - During the period of job attachment set forth in regulation 2.4.5, a jobattached claimant must be able to work and be available for suitable work with the employer to whom he or she is job-attached or be able to work and be available for referral to a job by his or her hiring hall. The claimant shall not be required to search for work elsewhere and shall, by means of his or her job attachment, be presumed to have met these requirements. Nothing in this

regulation 2.4 shall permit a claimant to refuse an offer of suitable work as defined in 8-73-108 (5)(b), C.R.S. 2.4.7 Expiration of Job Attachment. - When the job-attached period set forth in regulation 2.4.5 has expired or when a claimant's understanding with the employer as provided in regulation 2.4.2 no longer exists or when a claimant's registration with a union hiring hall ceases or when an offer of new work is withdrawn or if, in the judgement of the division, job-attached status is not reasonably designed to result in prompt reemployment in suitable work, the claimant must comply with the provisions of 8-73-107, C.R.S., or his or her compensability shall cease.

2.5 SELF-EMPLOYMENT 2.5.1 Statutory Reference: 8-73-107, C.R.S. 2.5.2 Effect of Self-Employment Activities. A claimant may be disqualified from receipt of benefits due to self-employment activities where such activities result in the claimant restricting his or her availability for work or limiting his or her search for work. 2.5.3 Self-Employment Activities. For the purposes of this section, “self-employment activities” shall include all activities of a claimant that relate to the formulation, development, or operation of any business or income-producing undertaking. 2.5.4 Matters to be Considered. In determining whether or not a claimant's availability for suitable work is restricted or a claimant's search for work is limited by means of his or her selfemployment activities, the division may consider, in addition to other relevant factors, the following: .1 The nature of the claimant's self-employment activities; .2 The nature of the claimant's previous employment; .3 The amount of time required for the claimant's self-employment activities; .4 Whether the claimant's self-employment activities occur at the normal time the claimant would be employed or seeking employment; .5 Whether the nature of the claimant's self-employment activities require regular hours of work; .6 Whether the nature of the claimant's previous employment required regular hours of work; .7 The extent to which the claimant's self-employment activities coexisted with the claimant's previous employment; .8 The extent of the claimant's financial commitment to the self-employment activities; .9 Whether the claimant has rented or purchased space to be used for self-employment activities; .10 Whether the claimant has arranged for or obtained a business telephone; .11 Whether the claimant has obtained any required licenses or permits; .12 Whether the claimant has advertised for customers; .13 The extent to which the claimant's self-employment activities required him or her to supervise or direct other individuals. 2.5.5 All Requirements Must be Met. Notwithstanding any provision of this section, a self-employed claimant, in order to qualify for benefits, must satisfy all of the eligibility conditions enumerated in 8-73-107, C.R.S. 2.5.6 Reporting Earnings. A self-employed claimant must report all monies earned during the week(s) for which benefits are claimed regardless of whether or not such earnings have been received.

Where earnings have not been received, the claimant must provide an estimate of monies earned and, thereafter, must report actual earnings, when received, if the estimate was incorrect.

2.6 APPROVED-TRAINING COURSE 2.6.1 Statutory Reference: 8-73-107 (4), C.R.S. 2.6.2 Approved Training. The claimant must produce evidence of continued attendance and satisfactory progress in an approved-training course when requested by the division. In determining whether or not a training course will be approved for an individual claiming benefits under the provisions of 8-73-107 (4), C.R.S., the division shall consider, among other factors, the following: .1 Whether the claimant's skills are such that reasonable employment opportunities do not exist or have substantially diminished in the labor-market area of the claimant to the extent that, in the judgement of the division, the individual has little or no prospect of obtaining suitable employment; .2 Whether the claimant possesses the qualifications and aptitudes to successfully complete the program of training; .3 Whether there is a reasonable expectation that the claimant will complete the training course; .4 Whether the training relates to an occupation or skill for which there are, or are expected to be, reasonable employment opportunities for the claimant; and .5 Whether the training course is reasonably designed to result in the claimant's prompt reemployment in suitable work. 2.6.3 Effect of Participation in Approved Training. With respect to any week in which a claimant is participating in a training program with the approval of the division and meets the requirements of this section, he or she shall not be denied benefits for the reason that he or she is not actively searching for work or that he or she has failed to apply for or refused to accept suitable work. 2.6.4 Enhanced Unemployment Insurance Compensation Benefits. (Repealed) 2.6.5 Approved Training for Industries In Crisis. In the event of a localized or state-wide downturn in a particular industry, such as unexpected mass layoffs or other triggers that threaten the economic stability of the regional or state economy, the division may, at the discretion of the division director, waive consideration of any of the factors set forth in regulation 2.6.2.

2.7 (RESERVED)

2.8 ELIGIBILITY REQUIREMENTS 2.8.1 Statutory References: - 8-73-107, 8-73-108 (5)(a)(b)(c), and 8-73-113, C.R.S. 2.8.2 Able to Work. - In general, a claimant must be physically and mentally capable of performing the usual duties of his or her customary occupation or the usual duties of other suitable work for which he or she is reasonably qualified. The burden of establishing ability to work is on the claimant. However, there shall be no presumption that the claimant is not able to work. In determining whether the claimant is able to work, the division shall consider the relevant facts and circumstances of the claimant's individual situation. .1 The division may request the claimant to furnish, at his or her own expense, a competent written statement from a licensed practicing physician or a licensed mental-health-care professional when the claimant's ability to work is in doubt. .2 The claimant must be able to work all shifts that are customary for his or her usual occupation or be able to perform other suitable work for which he or she is reasonably qualified. .3 A part-time worker's ability to work shall be determined in accordance with regulation 2.2. .4 A claimant engaged in self-employment activities shall have his or her ability to work determined in accordance with regulation 2.5. 2.8.3 Available for Work. - In general, a claimant shall be considered available for work only if he or she is ready and willing to accept suitable work. There must be no restrictions, either selfimposed or created by other circumstances, that prevent accepting suitable work. The claimant must accept referral to suitable work or accept an offer of suitable work to avoid being disqualified from receiving benefits in accordance with 8-73-108 (5), C.R.S. .1 Labor-Market Area. A claimant must offer his or her services without restriction to the labor-market area to be considered available for work. For the purposes of this regulation 2.8, the term “labor-market area” shall mean the geographic area where the claimant can reasonably be expected to seek and find employment. .2 Absence From State. A claimant who is temporarily absent from the state for reasons other than to seek work pursuant to regulation 2.1.8 is presumed to be not available for work. This presumption may be rebutted by competent evidence in an individual case. .3 Change of Labor-Market Area. A claimant who relocates to a new labor-market area may be required to expand his or her work search to include other occupations for which he or she is reasonably qualified when, in the opinion of the division, opportunities for securing work in his or her customary occupation are significantly limited. .4 Referral to Job Opening. A claimant who cannot be reached for referral to a job opening, after reasonable efforts to contact the person have been made, shall be considered unavailable for work unless good cause for failure to be reachable is shown.

For purposes of this regulation 2.8, good cause shall have the meaning set forth in

regulation 12.1.8. .5 Length of Unemployment. As a claimant's duration of unemployment lengthens, prospects for obtaining employment in his or her customary occupation or other work in a reasonable time may change. Therefore, work that is unsuitable at one point in time may become suitable at another point. To be available for work, a claimant must be ready and willing to accept other work that becomes suitable as his or her prospects for customary work change. Thus, a claimant may be required to broaden the geographic area where he or she will accept work, accept counseling for possible retraining or change in occupation, or seek and accept employment at the prevailing wage in a new occupation. .6 Incarceration. A claimant who is incarcerated and unable to accept employment under a work-release program is not available for work. .7 Seasonal Worker. A seasonal worker who, outside the seasonal period, is not willing to accept suitable work in a nonseasonal occupation is not available for work. .8 Self-Employment. A claimant engaged in self-employment activities shall have his or her availability determined in accordance with regulation 2.5. .9 Time or Shift Restriction. A claimant who is unwilling to work the hours of the day or the days of the week that are customary for his or her usual occupation or other suitable work for which he or she is reasonably qualified is not available for work. .10 Transportation. Transportation is the responsibility of the worker. A claimant who is unable to seek or accept suitable work in the labor-market area due to a lack of transportation is not available for work. .11 Dependent Care. A claimant who elects not to seek or accept suitable work because he or she must care for a dependent person is not available for work. .12 School or Training. Except as provided by 8-73-107 (4)(a) and 8-73-113, C.R.S., and

regulation 2.6, a claimant who elects not to seek or accept suitable work because of participation in or attendance at school or training is not available for work. .13 Wage Restriction. A claimant who is unwilling to accept the prevailing wage for the type of work he or she is seeking in the labor-market area is not available for work. .14 Part-Time Worker. A part-time worker's availability for work shall be determined in accordance with regulation 2.2. 2.8.4 Actively Seeking Work. In general, a claimant shall be considered to be actively seeking work if he or she is following a course of action reasonably designed to result in prompt reemployment in suitable work. Failure to establish to the satisfaction of the Division that the work-search activities in which the claimant engages are reasonably designed to result in prompt reemployment may result in a disallowance of benefits. .1 Evidence Of Work Search. A claimant shall, upon request by the Division, provide verifiable information of his or her work-search activities. Such activities may include, but are not limited to:

1. Applying for a job for which the claimant is reasonably qualified.

2. Interviewing for a job for which the claimant is reasonably qualified.

3. Taking an exam required as part of the application process for a new job for which the claimant is reasonably qualified.

4. Contacting an employer, who the claimant reasonably believes may have available suitable work, to inquire as to whether the employer is hiring.

5. Being referred to a job by a state workforce center or other entity which provides similar services.

6. Adding a resume to an online job board.

7. Engaging in documented use of online career tools.

8. Participation in reemployment services at a state workforce center or other location where such similar services are provided.

9. Participation in state-sponsored or other professional job-related education or skills development.

10. Creating a user profile on a professional networking website.

11. Participating in networking events related to a job or occupation for which the claimant is reasonably qualified.

12. Timely reporting to a union hiring hall when you are a registered member of that union. .2 Number of Work-Search Activities. The acceptable number of work-search activities that the claimant engages in each week shall be determined by the Division or the Division’s designee. .3 Reasonably Designed to Result in Prompt Reemployment. In determining the adequacy of an individual’s work-search activities, the Division shall consider the totality of the efforts made by the claimant to become reemployed. In addition, the Division, or the Division’s designee shall consider, but not be limited to, the employment opportunities in the claimant’s labor market area, the skills and qualifications of the claimant, and the normal practices and customary methods for obtaining work. .4 Warning Letter. The Director or the Director’s designee, at his or her discretion, may elect to issue a warning letter to any claimant who has failed to meet the work-search requirements. This authority shall, in no way, limit the authority of the Division to issue a disallowance of benefits when it is determined that a claimant has not met the worksearch requirements. If a claimant has been issued a warning letter for failing to meet the work-search requirements and is again determined to have failed to meet the requirements, another warning letter shall not be issued. Instead, a disallowance of benefits shall be issued for the weeks in which a second and any subsequent failure occurred unless the circumstances of that failure were outside the claimant’s control. .1 Penalties. If a claimant is issued a warning letter, pursuant to this section, it shall be considered in determining whether a claimant made a false representation or willfully failed to disclose a material fact for the purpose of determining whether monetary or weekly penalties should be imposed pursuant to 8-81-101 (4)(a)(II), .5 Verifiable Information. Verifiable information, as used in section 2.8.4.1, is the date an activity is completed and may include:

13. Employer contact information, including business name, address, phone number, email address 2. Name and title of person contacted 3. Documentation of use of an online career tool 4. Confirmation of an online job board submission 5. Networking event name and location 6. Specifics of job-related education or other skills development activity 7. Reemployment service in which you participated .6 Seasonal Worker. A claimant who is seasonally employed is not relieved of the responsibility to engage in work-search activities. .7 Incarcerated Worker. A claimant who is incarcerated and who is unable to seek work is not actively seeking work. .8 Limited Job Opportunities. If, due to economic conditions within the labor-market area, the division determines that any effort to search for work would be fruitless for the claimant and burdensome to employers, then registering for work as directed by the division shall constitute an active search for work. .9 Part-Time Worker. Whether a part-time worker is actively seeking work shall be determined in accordance with regulation 2.2. .10 Self-Employment. Whether an individual engaged in self-employment activities is actively seeking work shall be determined in accordance with regulation 2.5. .11 [Repealed eff. 10/30/2020] .13 under circumstances in which provisions have been made for the payment of benefits to individuals separated from work not classified as employment under article 70 of this title 8, and when such individuals are required to comply with the requirements of section 8- 73-107(1)(g)(i) regarding an active work search. .1 the following actions by the individual shall be considered in determining whether the individual has followed a course of action designed to result in a prompt return to work. consideration of the following work-search activities shall not preclude the division from also considering other relevant activities or factors.

14. documented efforts to obtain new or additional clients for the individual’s business;

15. documented efforts to expand the individual’s business beyond the services typically performed;

16. documented efforts to market the individual’s business to new, reasonably available customers;

17. if the individual performs work for an online platform, establishing an account with another similar online platform for the purpose of seeking work with that platform;

18. if the individual performs work for an online platform, seeking work with another online platform for which the individual may reasonably be qualified;

19. any activity which demonstrates an active search for covered employment including, but not limited to, the activities listed in section 2.8.4.1. .2 a determination under this section shall be applicable only to the eligibility of the individual claiming benefits and shall not prevent the division from later determining that the individual was engaged in covered employment pursuant to

article 70 of title 8 of the act. .4a Repealed 2.8.5 Reemployment Services. - A claimant who fails to participate in reemployment services, after having been determined likely to exhaust regular benefits and to need such services pursuant to a profiling system established by the director of the division, shall be ineligible to receive benefits with respect to any week unless it is determined that: .1 The individual has completed such services; or .2 There is justifiable cause for the claimant's failure to participate in such services. 2.8.6 The Waiting Week. Any unemployed individual shall be eligible to receive benefits with respect to any week only if the division finds that the individual has been either totally or partially unemployed for a waiting period of one week.

2.9 DISQUALIFYING PAYMENTS 2.9.1 Statutory References: 8-70-103 (28), 8-73-102 (4), 8-73-107 (1) and (4), and 8-73-110 (1), 2.9.2 Gross Wages/Earnings Reportable During a Week of Unemployment. For the purposes of determining weekly benefits, “wages/earnings” is defined as any income or remuneration received in exchange for services performed, including amounts that have been deducted under a plan for tax exemption or deferral. .1 Wages/earnings do not include payments for reimbursements for out-of-pocket expenses by volunteer workers. .2 Wages/earnings do not include income derived from investment-interest payments, dividend payments, or rent receipts from rental property, except if the income is earned through a business owned or operated by the individual requesting payment for a week of unemployment.

PART III WAGES

3.1 REMUNERATION PAYABLE IN ANY MEDIUM OTHER THAN CASH 3.1.1 Statutory References: 8-70-141, 8-70-142, 8-73-102, and 8-76-102 (2), C.R.S. 3.1.2 Value of Remuneration. If board, lodging, payments in kind, and/or other benefits are given as compensation for services performed by employees, and where a cash value of such benefits is agreed upon in a contract of hire or otherwise, the amounts agreed upon shall be deemed a reasonable value of such benefits. The division may, after investigation, determine in individual cases the amounts to be included as reasonable value of all such remuneration payable in any medium other than cash for the purpose of computing contributions due under the act.

3.2 TIPS, GRATUITIES, AND SERVICE CHARGES 3.2.1 Statutory References: 8-70-141, 8-73-102, and 8-76-102 (1), C.R.S. 3.2.2 Tips, Gratuities, and Service Charges as Wages. Tips, gratuities, and service charges shall be considered to be wages for the purposes of the act when the employer exercises significant control over the amount and distribution of money received by an employee as a tip, gratuity, or service charge. 3.2.3 Significant Control. An employer is considered to have significant control over tips, gratuities, or service charges when they are collected by the employer and then redistributed to employees. 3.2.4 Minimum-Wage Requirements. Notwithstanding any other provision of this section, any tips, gratuities, and service charges that are used by the employer in order to conform to the minimumwage requirements of federal or state law shall be deemed to be wages for the purposes of the act, to the extent of such use. 3.2.5 Use of Credit Card. For the purposes of this section, the inclusion, for the convenience of the customer, of a tip or gratuity in an amount charged by a customer through the use of a credit card shall not, by itself, be deemed to constitute significant control. 3.2.6 Requirement to Report Tips. For the purposes of this section, a requirement by an employer that an employee report or account for tips and gratuities shall not, by itself, be deemed to constitute significant control. 3.2.7 Tips Reported to Employer. In addition to the foregoing provisions of this section, on and after January 1, 1986, wages shall also include tips that are received while performing services that constitute employment and that are made known to the employer through a written statement furnished by the employee.

PART IV JOB SEPARATIONS

4.1 SEPARATIONS RELATED TO RELOCATION

4.1.1 STATUTORY REFERENCE: 8-73-108 (4), C.R.S 4.1.2 SPOUSE’S EMPLOYMENT LOCATION CHANGED. If a claimant separates from his or her employment due to a change in location of the employment of the claimant’s spouse, the Division shall consider in determining benefit entitlement whether the claimant has demonstrated all the required elements of 8-73-108 (4)(s) or 8-73-108 (4)(u), C.R.S. The Division may, at its discretion, request from the claimant additional documentation related to any or all of the following: .1 The claimant has established a spousal relationship, as defined under Colorado law, with the individual whose employment necessitates a new place of residence. .2 The claimant has established that his or her spouse secured employment prior to the claimant separating from his or her job. .3 The claimant has established that the change in his or her spouse’s employment requires a new place of residence. .4 The claimant has established that it is impractical to commute to his or her place of employment from the new place of residence. .5 The claimant has established that, upon arrival to the new location, he or she is available for suitable work as described in section 8-73-108(5)(b) C.R.S. 4.2 Separations Related To Domestic Violence 4.2.1 Statutory Reference: 8-73-108 (4)(r), c.r.s 4.2.2 Domestic Violence. “Domestic violence” means an act or threatened act of violence, or any other act of aggression, abuse, coercion, or intimidation committed against the worker or a member of the worker’s immediate family, as defined in § 8-73-108 (4)(r)(v), by a person with whom the worker or immediate family member is or has been involved in an intimate relationship, and that would cause a reasonable worker to believe his or her continued employment would jeopardize the safety of the worker or an immediate family member. .1 “Intimate relationship” means a relationship between past or present spouses, past or present unmarried couples, past or present household members, or parents of the same child, regardless of whether they have been married or have lived together. .2 “Separating from a job” as used in § 8-73-108(4)(r)(I) C.R.S includes a partial separation. 4.2.3 In determining whether a worker reasonably believes that their continued employment would jeopardize the safety of the worker or any member of the worker’s immediate family, the Division may consider whether it is reasonably necessary for the worker to refrain from working to engage in certain activities necessary to ensure their own safety or the safety of their immediate family member, including but not limited to:

1. Making arrangements for alternative housing or transportation.

2. Appearance in scheduled court proceedings related to the domestic violence.

3. Medical appointments reasonably related to the domestic violence.

4. Meeting with an attorney and/or law enforcement officer related to ensuring the safety of the worker or the worker’s immediate family.

5. Any other activity which, as determined by the division, is necessary to ensure the safety of the worker or the worker’s immediate family.

PART V BENEFIT CHARGING

5.1 BENEFIT CHARGE-BACKS IN CASES OF TWO OR MORE EMPLOYERS 5.1.1 Statutory Reference: 8-76-103 (1), C.R.S. 5.1.2 Benefit Charge-Backs. In the event it is administratively impracticable for the division to determine the chronological order of employment because two or more employers have submitted wage reports covering the same calendar quarter, periods of employment within such calendar quarter shall be chargeable without regard to chronological order by the division in a manner determined to be fair and equitable for all affected employers. The order of charges shall stand unless an affected employer makes a timely request for redetermination pursuant to

regulation 11.1.

PART VI PREMIUMS AND ASSESSMENTS

6.1 EMPLOYER PREMIUMS 6.1.1 Statutory References: 8-76-101 (1) (3), 8-76-102, 8-79-101, 8-79-102, 8-79-104, and 8-79-107, 6.1.2 Due Date of Premiums. Except as otherwise provided by this rule 6.1, premiums shall become due and be paid no later than the last day of the month immediately following the end of the calendar quarter for which the premiums have accrued. For purposes of this rule 6.1, payment will be considered timely if postmarked or received in person or electronically on or before the due date. If the due date of premiums falls on a Saturday, Sunday, or legal holiday, payment will be considered timely if postmarked or received in person or electronically on the next business day that is not a Saturday, Sunday, or legal holiday. .1 Quarterly payment shall not be required when the total amount of any premiums due, including any penalties and interest accrued for an untimely or incorrect report, is less than five dollars. 6.1.3 Payment to Another Jurisdiction. An employer who has erroneously paid to another jurisdiction an amount as premiums properly payable to Colorado shall not be delinquent if premiums properly payable to Colorado are paid within thirty days of the date on which the division determines that such premiums are payable to Colorado. 6.1.4 Erroneous Rate Notice. If, as a result of an incorrect notification or computation of rate by the division, an employer is required to make an additional payment of premiums, such additional payment shall not accrue interest until thirty days after notification by the division that such additional payments are due. 6.1.5 Payments. Quarterly payments shall include all premiums with respect to wages paid for employment in all payroll periods that end within the quarter. .1 Quarterly payment shall not be required when the total amount of any premiums due, including any penalties and interest accrued for an untimely or incorrect report, is less than five dollars. 6.1.6 First Payment of New Employer. The first premium payment of any employing unit that becomes an employer at any time during a calendar year shall become due and be paid on or before the last day of the month immediately following the calendar quarter in which such employing unit becomes an employer. Said payment shall include premiums with respect to wages paid for employment occurring on and from the first day of the calendar year through all payroll periods that end within the calendar quarter in which the employing unit becomes an employer. 6.1.7 Application of Payments on Delinquent Accounts. Whenever a delinquency exists in the account of an employer and payment is submitted to the division upon said account, the division shall apply such payment in the following order of priority: .1 Unpaid interest assessments from federal trust fund advances, starting with the earliest quarter in which premiums are due; .2 Unpaid nonprincipal-related bond repayment assessments, starting with the earliest quarter in which premiums are due .3 Penalties owed, starting with the earliest quarter in which such penalty was incurred; .4 Interest already charged, commencing with the earliest quarter in which such interest is due; .5 Interest accrued on unpaid premiums as of the date of the payment, commencing with the earliest quarter in which premiums are due; .6 Unpaid premiums or unpaid regular unemployment insurance benefits charged, starting with the earliest quarter in which premiums or reimbursements are due. .7 Unpaid reimbursements for extended benefits charged, starting with the earliest quarter in which amounts are due.

6.2 ASSESSMENTS AND RECOMPUTATIONS 6.2.1 Statutory References: 8-72-101 (1), 8-72-108, 8-79-104, and 8-79-107, C.R.S. 6.2.2 Obtaining Information. If, in the judgment of the division or upon its information and knowledge, the report of wages included in an employer’s report is incomplete or in error, the division may require a further report, examine the employer’s relevant books and records, or use other reasonable measures to the extent necessary to obtain an accurate report. 6.2.3 Summary Methods. If a contributing employer is delinquent in filing a wage report within the time prescribed by the division or if a reimbursing employer whose records are needed to make a proper determination of an amount of indebtedness or other matter declines to make its records available, the division may, in its discretion: .1 Use the information and knowledge available to the division to estimate the amount of chargeable wages paid by a contributing employer during the premium period or periods.

The amount of chargeable wages so determined shall be deemed to have been paid by the employer and shall be used to determine the annual payroll; .2 Assess the employer for premiums calculated on the basis of the estimated wages; and .3 Issue a subpoena duces tecum to compel an employer to release books and records to the division for use in obtaining the required information. 6.2.4 Notification. A contributing employer who is delinquent in filing reports or paying premiums shall be promptly notified of the assessment computed under rule 6.2.3. 6.2.5 Recomputations. Notwithstanding the provisions of rule 11.1, the division may correct errors of computation whenever such erroneous computations are found or brought to the division's attention. 6.2.6 Notice of Recomputation. Every interested party shall be promptly notified of any recomputation made hereunder that affects an employer's liability for premiums. 6.2.7 Recomputation Not a Redetermination. An initial recomputation issued hereunder shall not be deemed to be a redetermination decision under rule 11.1. 6.2.8 Redetermination Rights. Assessments and recomputations made hereunder are subject to redetermination pursuant to the provisions of rule 11.1.

PART VII EMPLOYER RECORDS AND REPORTS

7.1 RECORDS 7.1.1 Statutory Reference: 8-72-107(1), C.R.S. 7.1.2 Work Records. Each employing unit shall keep true and accurate work records in accordance with the requirements of this section. 7.1.3 Payroll Information. For each payroll period, the employing unit's records shall show: .1 Beginning and ending dates. .2 Total wages payable for employment during such period and the date on which such wages were paid. .3 The date in each calendar week on which the largest number of workers was employed and the number of such workers. .4 A reporting pay period of not to exceed one month, if any established payroll period be longer than one month. 7.1.4 Employee Information. For each worker, the employing unit's records shall show: .1 Name. .2 State of residence. .3 Social security account number. If a worker has no account number, the employer shall require the worker to produce a receipt of application therefor within seven days of entering upon employment. .4 Date of hire, rehire, or return to work after temporary layoff. .5 Date and reason separated from employment. .6 State or states where services are performed. .7 If services are performed outside of Colorado, the worker's base of operations, and, if there is no base of operations, then the place from which such services are directed or controlled. .8 If such worker is paid: .1 On a salary basis, the wage rate and period covered. .2 On a fixed hourly basis, the hourly rate and the customary scheduled days per week prevailing in the establishment for the occupation. .3 On a fixed daily basis, the daily rate and the customary scheduled days per week in the establishment for the occupation. .4 On a piece rate or other variable pay basis, the method by which the wages are computed. .5 By tips, gratuities, or service charges as defined in regulation 3.2, whether in whole or in part. .9 If, during any payroll period, such worker shall work less than his or her customary fulltime hours: .1 The specific amount of time lost; and .2 The specific reason or reasons, including his or her nonavailability for work, and, if there be more than one reason, the amount of time attributable to each. .10 Wages paid during each payroll period and the date of payment thereof, with separate entries for: .1 Money wages; .2 The reasonable cash value of wages paid in any medium other than money as defined in regulation 3.1; .3 Amounts paid to a worker that exceed travel and other business expenses actually incurred or accounted for; and .4 Tips, gratuities, and service charges that meet the requirements of regulation 3.2.

7.2 REPORTS 7.2.1 Statutory References: 8-70-103 (17), 8-72-101 (1), 8-73-107 (1) (h), 8-74-102 (1), 8-76-104 (3)(g), 8-76-106 (4), 8-79-103 (1), and 8-79-104, C.R.S. 7.2.2 Duty to Submit Reports. Each employing unit shall make such reports as required by the division using such reporting methods as the division allows. 7.2.3 Social Security Number and Worker Name. An employer shall include a worker's social security number and name in all reports required by the division with respect to such worker. If the worker has no social security number, the employer shall report the date of issue of the application receipt therefor, its termination date, the address of the issuing Social Security Administration office, and the name and address of the worker as shown on the receipt. 7.2.4 Unemployment Insurance Quarterly Reports. Every employer subject to the act shall furnish to the division a quarterly report of total covered wages paid and a report of covered wages paid to all workers in his or her employ, except that no such reports shall be required with respect to an employee of a state or local agency performing intelligence or counterintelligence functions if the head of such agency has determined that filing such reports could endanger the safety of the employee or compromise an ongoing investigation or intelligence mission. These reports are due, and any premiums due thereon are payable no later than the last day of the month immediately following the end of each calendar quarter, regardless of whether covered wages were paid during such quarter, and shall be filed in accordance with the methods specified in rule 7.2.5.

Quarterly wage reports will be considered timely if received electronically on or before the due date. If an employer has received a waiver of the requirement to file quarterly reports by electronic means, the report shall be considered timely if it is postmarked or received prior to the due date. If the due date for filing timely quarterly wage reports falls on a Saturday, Sunday, or legal holiday, the due date will be extended to the next business day that is not a Saturday, Sunday, or legal holiday.

Must include the report period, Colorado employer account number assigned by the division, employer's current name and address, worker's social security number, worker's name and total quarterly covered wages paid. 7.2.5 Reporting Methods. Quarterly reports of wages paid to workers must be submitted by divisionapproved electronic means unless a waiver to submit such reports in person, by mail, or by facsimile machine has been granted by the division. .1 Waiver of the requirement to file quarterly reports of wages paid to workers by divisionapproved electronic means will be granted only if the employer can demonstrate to the satisfaction of the division that such a means of reporting creates an undue burden on the employer. .2 Waiver of the requirement to file quarterly reports of wages paid to workers by divisionapproved electronic means will be valid only for a one-year period commencing with the date of issue of said waiver. 7.2.6 Request for Report. The division may request a wage and/or separation report concerning a particular worker for the purpose of confirming a report previously submitted or obtaining information necessary to enable the division to make a determination of benefit rights. Such report shall be furnished to the division by division approved electronic means except that the Division, at its discretion, may waive this requirement. The report shall be received by the division within seven calendar days after the date on which the division requests such information, except that the division may accept information out of time if it determines good cause exists for the untimely action, as referenced in 7.2.8 or 12.1.8. If the initial report is not provided within the required seven days, the Division may make a follow up request by telephone or electronic means. A response to such a follow up request must be received within the time period provided by the Division at the time the request is made. In the event that the requested report is received late but before the initial adjudication of the matter for which the report was requested, there is a presumptive showing of good cause. 7.2.7 Cessation or Transfer of Business. Any employer that ceases doing business, that in any manner transfers all or part of the trade and business, or that changes the trade name or address of said business shall: .1 Within ten days thereof, give notice in writing to the division in accordance with rule 1.3.11; and .2 In accordance with rule 1.3.11 and rule 7.2.4, file with the division a final Employer's Unemployment Insurance Quarterly Report and Report of Worker's Wages when due for the calendar quarter in which the change or cessation occurred and for any quarter for which a report was due but not previously filed. 7.2.8 Loss of Right to Protest. An employer who fails to comply with the provisions of the preceding paragraphs of this section 7.2 without good cause as referenced in 7.2.6 or 12.1.8 shall be deemed not to be an interested party as defined in 8-70-103 (17) and 8-73-107 (1)(h), C.R.S., and shall be barred from protesting either: .1 The payment of benefits to workers for whom wage and separation information was not furnished within the required time; or .2 The charging of the employer's account for experience-rating purposes with benefits paid such workers or the amount due as payments in lieu of contributions for benefits paid such workers. 7.2.9 Incorrect or Incomplete Report or failure to follow approved method of submission of report. An incorrect or incomplete report not in substantial compliance with the provisions of this

part VII of the rules or the failure to submit a report by the approved electronic method of submission, pursuant to 7.2.6 may, at the division's discretion, be considered in the same manner and subject to the same penalties and loss of rights as if the employer had failed to submit a report. For the purposes of this paragraph, the Report of worker's wages required by rule. 7.2.10 Labor Dispute. When workers become unemployed or separated from an employer because of a labor dispute, the employer shall furnish the division with such relevant information about each worker as the division may require. 7.2.11 Penalties Remain in Force. Nothing contained in these rules shall be construed as reason to relieve an employer from: .1 The responsibility for the submission of quarterly wage reports or from the liability for payment of penalties incurred for failure to timely submit such reports, as provided by 8- 79-104 (1), C.R.S., or .2 The responsibility to provide separation reports or the liability for the payment of penalties incurred for failure to timely submit such information as provided by 8-73-107(1)(h), C.R.S., unless .3 The division finds that the employer had good cause, as defined at rule 12.1.8, for failing to timely submit required documents. 7.2.12 [Emergency rule expired 08/12/2020]

7.3 POSTING NOTICES TO WORKERS 7.3.1 Statutory References: 8-72-101(1) and 8-74-101(2), C.R.S. 7.3.2 Posting Notices. Every employer shall post and maintain notices that inform employees that the employer is subject to the act and has been so registered by the division. .1 Posted Notice To Workers Of Availability Of Unemployment Insurance. Every employer shall post and maintain notices that inform workers of the availability of unemployment insurance. .2 Notice Provided To Employee Upon Separation. The employer must also provide such notice to every worker upon separation from employment. This notice must include: .1 A statement that unemployment insurance benefits are available to unemployed workers who meet the eligibility requirements of colorado law; .2 Contact information to file a claim; .3 Information the worker will need to file a claim; .4 Contact information to inquire about the status of their claim after it is filed. 7.3.3 Form and Design. Such notices shall be of such form and design and posted in such numbers as the division may determine to be necessary. 7.3.4 Post in Work Locations. Such notices shall be conspicuously posted at or near work locations. 7.3.5 Assignment of Account Number. An employer shall not be required to post notices until an employer's account number has been assigned by the division. 7.3.6 [Emergency rule expired 08/12/2020]

7.4 PATTERN OF FAILING TO RESPOND 7.4.1 Statutory References: 8-79-102(5)(a), C.R.S. 7.4.2 Definitions .1 TIMELY. As used in this section means, those acts completed by the employer within the time period permitted by law. .2 ADEQUATE. As used in the section, refers to that information provided by an employer to a division request which is sufficient to support a determination on the issue. .3 Fault. As used in §8-79-102(5)(a)(i), C.R.S., an employer shall not be considered at fault for failing to respond timely or adequately to a request of the division for information if that failure occurred for any reason outside the employer’s control such as administrative error by the division or a natural or other such similar disaster. 7.4.3 Pattern of Failing to Respond. A “pattern of failing to respond timely or adequately” as referenced under §8-79-102(5)(A)(II) C.R.S. refers to a repeated, documented failure on the part of the employer or the agent of the employer to respond timely or adequately to initial requests for information from the division, taking into consideration the number of instances of failure in relation to the total volume of requests. The determination of whether such a pattern has been shown shall be at the discretion of the division except that: .1 An employer or its agent shall not be determined to have engaged in a “pattern of failing to respond timely or adequately” if the number of such failures during the year prior to such request is fewer than three or less than three percent of such requests, whichever is greater. .2 An agent, representing two or more employers, shall not be determined to have engaged in a pattern of failing to respond timely or adequately in relation to the total volume of requests collectively sent to the agent. Instead, each specific employer account shall be subject to the determination.. 7.4.4 APPEALS. Determinations by the division under this section shall be subject to appeal in the same manner as other determinations of the division.

PART VIII EMPLOYER BOND REQUIREMENTS

8.1 BONDING REQUIREMENTS 8.1.1 Statutory Reference: 8-70-114 and 8-76-110, C.R.S. 8.1.2 Bond Requirements. A surety bond, deposit of money, or securities, specified in 8-70-114 (2)(g)(III) AND 8-76-110 (4), C.R.S., shall be required only if the amount of the bond, deposit of money, or securities computed as provided in said sections is one hundred dollars or more. 8.1.3 Bond Calculation, Employee Leasing. The bond calculation required in section 8-70-114 (2)(g)(III)(a), shall be based on the total premiums assessed under the employee-leasing company’s unemployment insurance account, including premiums assessed for work-site employers required to report under the employee-leasing company’s account. If in the prior year, the work-site employer reported under a separate unemployment insurance account, the premiums assessed for the work-site employer in the separate account shall be included in the bond calculation for the current year.

PART IX COVERED EMPLOYMENT (RESERVED)

PART X SEASONAL INDUSTRY

10.1 SEASONAL DETERMINATIONS 10.1.1 Statutory References: 8-73-104(1), 8-73-106, and 8-76-113, C.R.S. 10.1.2 Seasonal Periods Considered. As used in 8-73-106(1), C.R.S., the words “a regularly recurring period or periods of less than twenty-six weeks in a calendar year” are deemed to include periods in those years during which an employing unit was not subject to the provisions of the act, or during which a predecessor employer was subject to the act, and records of such predecessor are available to support such periods. 10.1.3 Seasonal Operation. No industry or functionally distinct occupation within an industry shall be deemed a seasonal industry as defined in 8-73-106 (1), C.R.S., unless the employer certifies in the application for seasonal determination required by regulation 10.1.5 that the employer will fulfill the requirements set forth in regulation 10.1.4 and certifies such other information as may be required by the division to determine eligibility for designation as a seasonal employer under this

part X of the regulations. 10.1.4 Seasonal Employer. An employer shall be determined to be a seasonal employer as to a particular industry or functionally-distinct occupation within an industry only if: .1 The employer customarily employs workers in such industry or functionally-distinct occupation only during a regularly-recurring period or period of less than twenty-six weeks in a calendar year, and .2 The employer does not employ more than twenty-five percent of the total number of workers in such functionally-distinct occupation outside the seasonal period that were employed in such occupation during the previous seasonal period, and .3 The employer does not employ any workers in such functionally-distinct occupation for a period of forty-five consecutive days following the seasonal period. For the purposes of this part X of the regulations, no employment shall be determined to be a functionallydistinct occupation unless its assigned duties or activities, as a whole, are identifiably distinct under the usual and customary practice of the industry. 10.1.5 Application for Determination. An employer who wishes designation as a seasonal employer or determination or redetermination of a seasonal period or periods shall make application with the division upon such forms and using such filing methods as may be prescribed by the division. 10.1.6 Notice of Application. The division shall require the employer to post a Notice of Application for Seasonal Status on such forms as the division may require and shall require the employer to notify the unions representing any of its workers that an application for seasonal status has been filed. 10.1.7 Seasonal Determination. Upon review of the matters set forth in the application and such other information as it may require, the division shall issue a determination as to the employer's seasonal status, the seasonal period, the functionally-distinct occupations determined to be seasonal, and the functionally-distinct occupations determined to be nonseasonal. 10.1.8 Seasonal Workers. A worker may not be determined to be a seasonal worker if: .1 The worker performs services for a seasonal employer outside the employer's designated seasonal period or periods; or .2 The worker performs services for a seasonal employer for twenty-six weeks or more in a calendar year. 10.1.9 Appeal From Determination. Any employer who wishes to protest a determination made under the provisions of this part X of the regulations shall file a notice of appeal with the division. Such notice of appeal must be received by the division within twenty calendar days after the date the seasonal determination was mailed. A hearing may be obtained in accordance with 8-76-113, C.R.S., and regulation 11.2. 10.1.10 Notice of Operation Outside Season. Each seasonal employer shall give written notice, in accordance with regulation 1.3.11, to the division within thirty days when the seasonal industry or functionally-distinct occupation is operated for twenty-six weeks or more in a calendar year and, for a functionally-distinct occupation, when more than twenty-five percent of the total number of workers who were employed in any such functionally-distinct occupation during the designated season are employed in such occupation outside the seasonal period or there is not a forty-five consecutive-day period outside the seasonal period, during which no workers are employed in such functionally-distinct occupation. 10.1.11 Annual Report. In addition to the notice required in regulation 10.1.10, every employer who has been designated a seasonal employer must file a written report on prescribed forms and using such filing methods as may be prescribed by the division on or before the last day of February, which report shall inform the division of the beginning and ending dates of the previous calendar year's seasonal operations and such other information as may be required by the division to show compliance with this part X of the regulations. 10.1.12 Notification. Each seasonal employer shall notify each seasonal worker in writing at the time of hire of the worker's seasonal status and the beginning and ending dates of the seasonal period for which the worker is to be employed. 10.1.13 Loss of Seasonal Status. If an employer, subsequent to the date on which he or she was designated as a seasonal employer, fails to fulfill the requirements of regulation 10.1.4 or fails, without good cause, to comply with the reporting or notification requirements of this part X of the regulations during a calendar year, such employer shall lose his or her seasonal status. Any determination by the division that an employer has lost his or her seasonal status shall be made in writing and provided to the employer in accordance with regulation 1.3.11.1. Said determination shall be subject to appeal pursuant to regulation 10.1.9. 10.1.14 Reinstatement of Seasonal Status. .1 An employer who has lost his or her designation as a seasonal employer, and who wishes reinstatement as such, may make application with the division for reinstatement in any calendar year subsequent to the year in which the employer lost the designation as a seasonal employer, provided such employer has met the requirements of regulation 10.1.4 in the calendar year immediately preceding application for reinstatement. .2 A worker who has performed services for a seasonal employer outside the employer's designated seasonal period or periods, and thereby lost his or her status as a seasonal worker, shall regain his or her status as a seasonal worker if he or she is not thereafter employed by such employer between any two following designated seasonal periods and he or she is subsequently reemployed by the employer in a seasonal industry or occupation. 10.1.15 Filing Methods. For purposes of this part X of the regulations, applications, notices, and reports may be made in person, by mail, by facsimile machine, by division-approved electronic means, or by a division interactive voice response system.

PART XI REDETERMINATIONS AND APPEALS

11.1 REDETERMINATIONS 11.1.1 Statutory References: 8-73-102 (3), 8-74-102 (2), 8-76-103 (4), 8-76-110 (3) (e), and 8-76-113, 11.1.2 Redetermination of Assessments. An employer who wishes to protest a notice of assessment of premiums shall file a written request for redetermination of said assessment or to file a correct report of chargeable wages paid during the premium period or periods. The written request for redetermination must be received by the Division within twenty calendar days of the date the assessment was issued. 11.1.3 Redetermination of Quarterly Statement of Benefits Charged to Employer's Account. An employer who wishes to protest a quarterly statement of benefits charged to his or her account shall have sixty calendar days after the date notification was provided to file a written notice for redetermination of the accuracy of the statement. 11.1.4 Redetermination of Premium Rates. An employer who wishes to protest a notice of his or her premium rate shall file a written request for redetermination of the premium rate. The written request for redetermination must be received by the Division within twenty calendar days of the date the rate notice was issued. 11.1.5 Redetermination of Recomputations. Any interested party who wishes to protest a recomputation made by the division shall file a written request for redetermination of the matters corrected. The written request for redetermination must be received by the Division within twenty calendar days of the date the recomputation was issued. 11.1.6 Monetary Determinations. Any interested party who wishes to protest a monetary determination made by the division on a claim for benefits shall file a written request for redetermination with the division within the benefit year or extended-benefit period for such claim. 11.1.7 Reimbursement Bill. Any employer who wishes to protest a bill for payments in lieu of premiums shall file a written request for redetermination of the amount due. The written request for redetermination must be received by the Division within twenty calendar days of the date the bill was issued. 11.1.8 Timeliness of Request for Review. Any determination made by the division that is subject to redetermination under this section shall be deemed final, and any information contained in any document or notice issued by the division that is subject to redetermination under this section shall be deemed correct unless the party files a timely request for redetermination in accordance with this regulation or establishes to the satisfaction of the division that said party had good cause for the failure to do so. Good cause for failure to file a timely request for redetermination shall have the meaning set forth in regulation 12.1.8. 11.1.9 Form of Request. Each request for redetermination filed pursuant to this section shall specify in detail the errors, omissions, or other grounds upon which the party relies. 11.1.10 Redetermination Decision. Upon receipt of a request for redetermination, the division shall review the request, investigate the matters specified, and give the parties notice of its redetermination decision in accordance with regulation 1.3.11.1. 11.1.11 Appeals From Redeterminations. Any party who wishes to appeal from a redetermination decision shall file a written notice of appeal with the division in accordance with regulation 11.2.

Such notice of appeal must be received by the division within twenty calendar days of the date the redetermination decision was mailed. Appeals shall be filed and heard pursuant to 8-74-103 to 8-74-109 and 8-76-113, C.R.S., and regulation 11.2. 11.1.12 Benefit Claims Not Covered. Except for monetary eligibility questions subject to redetermination pursuant to regulation 11.1.6, this regulation 11.1 does not authorize the adjudication in the redetermination process of the merits of claims for benefits, which are subject to the appeal process established in 8-74-101 to 8-74-109, C.R.S., and regulation 11.2. 11.1.13 Limitation on Review. Review and redetermination by the division under this section shall be limited to the matters covered by the document protested. No protest by an employer under rule 11.1.4 of a notice of the employer's premium rate shall permit inquiry into the validity of any assessment of premiums subject to review and redetermination under rule 11.1.2 nor of any benefit charge to the employer's account subject to review and redetermination under rule 11.1.3, unless the employer has first protested the assessment or charge pursuant to rules 11.1.2 or 11.1.3. 11.1.14 Written Notices, Reports, and Requests. For purposes of this regulation 11.1, written notices, reports, and requests shall have the meaning set forth in regulation 1.3.11.1.

11.2 APPEALS PROCEDURE 11.2.1 Statutory References: 8-72-108, 8-74-101 to 8-74-109, 8-76-103 (4), 8-76-113, and 8-80-102, 11.2.2 Scope of Section. The procedures described herein deal with appeals on disputed claims under 8-74-101, et. seq., C.R.S.; appeals from determinations of liability, determinations of coverage, and seasonality determinations under 8-76-113 (1), C.R.S.; appeals from redeterminations regarding quarterly statements of benefits charged to an employer's account under 8-76-103 (4), C.R.S.; appeals from redeterminations as to an assessment of taxes, rate of tax, recomputation of rate, or correction of any such matter under 8-76-113 (2), C.R.S.; redeterminations of reimbursement billings under 8-76-110 (3)(e), C.R.S.; appeals from redeterminations of monetary eligibility under 8-74-102 (2), C.R.S.; and appeals from eligibility determinations regarding enhanced unemployment insurance compensation under 8-73-114, C.R.S., as defined in

regulation 2.6.4. 11.2.3 Procedure for Filing Appeals to Hearing Officer. Appeals from decisions of a deputy on a claim for benefits, from premium liability and coverage determinations, from seasonality determinations, and from redeterminations shall be by written notice of appeal that should state specific reasons. However, any written statement expressing disagreement with a determination or the party’s desire for review shall be accepted as an appeal. An appeal that does not state specific reasons must be supplemented prior to the appeal hearing and provided to the other interested parties in time to be received before the date of the hearing, as required by rule 11.2.9.4, or the specific factual issues may be excluded from the hearing. An appeal shall be filed by mail at the address designated in the notice of decision, or may be filed in person, by facsimile machine, or by division-approved electronic means. For purposes of this rule 11.2.3, the term “written” shall have the meaning set forth in rule 1.3.11. The notices of appeal in matters involving a disputed claim may also be filed with a public employment office. The division shall provide a copy of such notice of appeal to each interested party. When an appeal of a deputy’s decision on a claim for benefits is received, the division shall provide to interested parties and their authorized representatives, if any, copies of relevant separation information in the claim file submitted by the parties. The division shall also provide to interested parties and their authorized representatives, if any, a copy of the form(s) used to document additional fact-finding information and to reflect those issues considered in rendering the decision. 11.2.4 Notice of Hearing. Notices specifying the time and date of the hearing as well as instructions for the proper method of participation shall be mailed, transmitted by facsimile machine, or transmitted by electronic means to each party to the appeal at least ten calendar days before the scheduled hearing date. If participants are required to register for their hearing, the notice shall contain instructions regarding the method of registration. 11.2.5 Disqualification of a Hearing Officer. Challenges to the interest of a hearing officer in an appeal scheduled to be heard by said hearing officer shall be heard and decided by that hearing officer or, in his or her discretion, referred to the panel. 11.2.6 Prehearing Conference. The chief hearing officer or designee may, upon the application of any party or on his or her own motion, convene a prehearing conference to discuss the issues on appeal, the evidence to be presented, and any other relevant matters that may simplify further proceedings. 11.2.7 Prehearing Discovery in Premium Cases. In cases arising under 8-76-110 (3)(e) and 8-76-113, C.R.S., the chief hearing officer or designee may permit the parties to engage in prehearing discovery, insofar as practicable, in accordance with the Colorado Rules of Civil Procedure and, in connection therewith, shorten or extend any applicable response time. 11.2.8 Limitation on Discovery. No party to an appeal proceeding may seek discovery without having first obtained an order of the chief hearing officer or designee and only upon a showing of necessity for such discovery. 11.2.9 Conduct of Hearing. Hearings shall be conducted informally with as few technical requirements as possible. The hearing officer shall control the evidence taken during a hearing in a manner best suited to develop, fully and fairly the relevant evidence, safeguard the rights of all parties, and ascertain the substantive rights of the parties based on the merits of the issue(s) to be decided. The appealing party shall be required to present evidence that supports the party’s position on the issues raised by the appeal. Parties to the appeal may present any relevant evidence. However, the hearing officer is charged with ensuring that the record is fully developed to the extent practicable based on the evidence reasonably available at the time of the hearing, whether or not a party is represented. Therefore, the hearing officer should oversee the development of the evidence and participate in the interrogation process to the extent necessary to fully develop the record. .1 Parties and witnesses shall ordinarily participate by telephone. However, based on the individual circumstances of a case or if a party would be disadvantaged by telephone participation, the chief hearing officer or designee shall have the discretion to determine another method of participation and to order the parties to participate in that manner to best achieve the purposes of this rule 11.2. .2 Parties may be required to register for their hearing prior to the scheduled date and time of the hearing. Registration shall be considered part of the hearing process and failure to register for a scheduled hearing shall constitute a failure to appear pursuant to regulation 11.2.13. .3 An interested party to a hearing must submit to the hearing officer any documents, subpoenaed documents, and any physical exhibits that can be reproduced that he or she intends to introduce at the hearing. Such materials must be submitted in time to ensure that the hearing officer receives them before the date of the scheduled hearing. Such party must also provide copies of all documents and physical exhibits sent to the hearing officer to any other interested party to the hearing or to that interested party's representative as shown on the hearing notice, in time to ensure the materials are received prior to the date of the scheduled hearing. Failure to timely submit such materials to the hearing officer, or to timely send the materials to the opposing party or such party’s representative may result in their exclusion from the record. However, if a party has made a good faith effort to provide documents or physical exhibits in time to be received prior to the hearing, such materials shall not be excluded due to the failure of the hearing officer, the other interested party, or an interested party’s representative to receive the materials. In any appropriate case where documents have been timely sent but not received in advance, an adjournment of the hearing may be permitted by the hearing officer pursuant to rule 11.2.11 unless waived on the record by both parties. .4 Hearing Procedure. Prior to taking evidence, the hearing officer shall state the issues and the order in which evidence will be received. The hearing officer also shall inform the parties of any written documents or other tangible materials that have been received and explain the procedure for introducing the materials and offering them into evidence. The sequence of receiving testimony shall be in the hearing officer’s discretion. Computer records of the division concerning continued weeks claimed or payment for continued weeks claimed are admissible as evidence and may be filed in the record as evidence without formal identification if relevant to the issues raised by the appeal. The hearing officer also may consider any other relevant division file documents without a formal request or identification. However, parties shall be advised during the hearing of the division records and documents to be considered. All physical materials offered into the record shall be clearly identified and marked. Further, materials admitted shall be expressly received for the record. The hearing officer shall permit the parties to testify on their own behalf and present witnesses, and opposing parties may cross-examine each other and the others’ witnesses. The hearing officer shall examine the parties and witnesses as necessary and, after notice to the parties, may hear such additional evidence as deemed necessary. All testimony shall be presented under oath and the hearing shall be timed. At the conclusion of the hearing, the hearing officer shall inform the parties of the time consumed by the hearing and the approximate cost of the preparation of the transcript of the hearing, if any, and shall instruct the parties that a decision will be promptly issued as to the issues brought forth at the hearing. The hearing officer shall also instruct the parties that such decision may be appealed and, if applicable, that the appellant must bear the cost of preparation of a transcript. The sum paid may, be reimbursed at a later date by the panel without interest, if such appeal results in a decision favorable to the appellant. It shall also be stated to the parties that the cost of preparation of the transcript may be waived pursuant to rule 11.2.15. .5 New Issues. Parties are entitled to advance notice of the factual issues that may be considered at a hearing. The hearing officer shall not permit an interested party to present factual issues at a hearing that have not been disclosed to the other interested party(ies) in writing, as shown by the claim file. If good cause, as set forth in rule 12.1.8, is found for a party not providing proper notice of the factual issues it intends to present, the hearing officer may adjourn the hearing. If good cause is not found, the hearing shall proceed as scheduled, and those new factual issues raised shall not be considered. In determining whether there is good cause for permitting a new factual issue, the hearing officer shall give substantial weight to an absence of prejudice to the other interested party and to the overall interests of an accurate and fair resolution. An interested party, at the hearing, may waive the requirement that they be provided with proper notice. 11.2.10 Stipulations of Fact. With the consent of the hearing officer, parties to an appeal may stipulate to the facts in writing. Parties may also stipulate to facts on the record at the hearing before the hearing officer. The hearing officer may decide the case on the facts stipulated or, in his or her discretion, set the appeal for hearing and take such additional evidence as is deemed necessary. 11.2.11 Adjournment of Hearings. The hearing officer may grant requests for further hearing when, in his or her own best judgment, such further hearing will result in adducing all necessary evidence and be equitable to the parties. 11.2.12 Postponements of Hearings. Postponements of hearings shall not be granted without the showing of necessity therefor by the requesting party. 11.2.13 Failure to Appear. .1 Appealing Party. If the appealing party fails to register for their hearing of fails to participate in the hearing after registering, the appeal shall be dismissed and the decision that was the subject of the appeal shall become final. Written notice that the appeal has been dismissed shall be provided to the interested parties named in the caption. The appealing party may request that the appeal be reinstated and the hearing be rescheduled pursuant to the procedures set forth in part XII of the regulations. The request must be received by the division within twenty calendar days after the date the dismissal notice was mailed by the division. An untimely request that a hearing be rescheduled may be permitted by the division for good cause shown, pursuant to the procedure set forth in part XII of the regulations. .2 Nonappealing Party. If any other interested party fails to register for their hearing of fails to participate in the hearing, and a decision is issued by a hearing officer on the merits of the appeal, the party who failed to participate as directed may request that a new hearing be scheduled either by filing a written request with the panel or filing a written appeal from the hearing officer's decision. The written statement shall include details, pursuant to part XII of the regulations, to establish that he or she had good cause for the failure to participate in the appeal hearing. The request for a new hearing shall be filed with the panel in person, by mail, by facsimile machine, by panel-approved electronic means, or at a public employment office, the central office of the division, the office where the hearing officer is located, or by division-approved electronic means and shall be received by the panel within twenty calendar days after the date mailed on the hearing officer’s decision. An untimely request for a new hearing may be permitted by the panel for good cause shown, pursuant to the procedure set forth in part XII of the regulations. If it is determined that the party has shown good cause for the failure to participate, the hearing officer's decision that was issued on the merits of the appeal shall be vacated and a new hearing scheduled forthwith. .3 Representative of a Party. When an interested party's attorney or other designated representative appears for and participates in the scheduled hearing on the party's behalf, the party shall be deemed to have appeared for the hearing, for the purposes of this part XI of the regulations. 11.2.14 Decision of the Hearing Officer. The hearing officer shall announce, in written form, findings of fact, decision, and reasons therefor, as soon as practicable after a hearing, and a copy thereof shall be provided to all parties to the appeal. 11.2.15 Procedure for Appeal to the Panel. .1 An appeal from a decision of a hearing officer shall be by written notice of appeal that shall be in any form that signifies an intent to appeal and shall be filed with the panel in person, by mail, by facsimile machine or by panel-approved electronic means, or at a public employment office or the central office of the division or the office where the hearing officer is located or by division-approved electronic means. An appeal from a decision of a hearing officer shall be filed within the time limits provided by 8-74-104 (1), C.R.S., and regulation 1.8. When an appeal has been received, the appeal file and record shall be transmitted to the panel. The panel shall notify the interested parties named in the caption of the hearing officer's decision that an appeal has been filed and shall provide a copy of the written appeal to the other-named parties. 2 The appeal shall be filed in the manner provided by 8-74-106 (1), C.R.S. The panel shall provide each interested party or the party's representative with an audio copy of the recorded hearing testimony or, at the panel’s discretion, a written transcript. Any interested party may obtain a transcript of the hearing testimony for purposes of the appeal by tendering payment for the approximate cost of the transcript. If a transcript is reasonably necessary for an interested party or the party's representative for purposes of the appeal due to a disability of the party or the representative, the party or representative may provide a written statement of disability on a form prescribed by the panel, requesting that the transcript cost be waived. In determining whether a transcript is reasonably necessary to accommodate a disability, the panel may require the requesting party to provide written documentation of the disability from a treating health-care professional. If a transcript is reasonably necessary for an interested party or the party's representative for other reasons and the party is unable to pay the cost of the transcript due to financial hardship, the party may provide a written statement of necessity and indigency on a form prescribed by the panel, requesting that such cost be waived. The appealing party shall submit the payment or completed waiver request form with the appeal. Any other interested party shall submit the payment or completed waiver request form within ten business days of the date the notice of appeal is issued. In determining whether payment would cause undue financial hardship, any relevant factors may be considered, including but not limited to the party's household income and available money and existing expenses; the approximate cost of the transcript; and whether payment of this cost would deprive the party or his or her family of basic necessities. If any interested party or representative receives a transcript of the hearing testimony, the panel shall provide a copy of the transcript to the other interested party or the party's representative. .3 The panel shall issue a written procedural decision on a completed waiver request, based upon the information contained in the statement of indigency, written documentation from a treating health-care professional, or other relevant information contained in the record, within fifteen calendar days after the completed prescribed request has been received by the panel. .4 In ruling on a waiver request, the panel shall have the discretion to request or accept additional reliable evidence by such means as shall be deemed appropriate for resolution of the issue. If the panel requests additional information, the time period for issuing a decision on the waiver request shall be tolled until the information is received by the panel or the time limit imposed for providing the information has expired, whichever occurs sooner. .5 The cost of the preparation of the transcript of a hearing that occurs as a result of a remand order by the panel may be assigned to be borne by the division, if expressly so assigned by panel order, but otherwise shall be borne by the appealing party as provided in these regulations. .6 If the payment of the approximate cost of the transcript tendered by the requesting party exceeds the actual cost of the transcript, the excess payment shall be refunded without interest to the payer. If the actual cost of the transcript exceeds the payment received, the requesting party shall be assessed a charge for such excess cost that must be paid within fifteen days after the date notice of such charge was provided to the party by the panel. If this charge for excess cost is not timely paid, the appeal shall proceed with audio copies of the testimony and the division shall retain all monies previously submitted by the requesting party unless the time for payment is extended for good cause shown as provided in rule 12.1. .7 If a party withdraws his or her appeal after the panel has received payment or payments for the transcript, the panel may retain such payments in whole or in part according to the panel's assessment of its own costs in administrative time and expense in preparation of the transcript. .8 Any act required by this regulation 11.2.15, except regulation 11.2.15.5, may be permitted outside the time periods set forth herein for good cause shown. .9 Briefing Schedule. A “brief” for purposes of this rule, shall be any document apparently intended by an interested party to be a written argument. Copies of the audio recording or the transcript of the hearing testimony shall be provided to the interested parties named in the caption of the hearing officer's decision with a notice that the parties may submit a brief. Each named interested party may submit one brief within twelve calendar days after the date the notice was provided to the party by the panel. The panel may, in its discretion, permit the non-appealing party to file a brief in response to the brief filed by the appealing party. Such response brief must be filed with the panel within ten calendar days of the date of the panel's notification, which shall be accompanied by a copy of the appealing party's brief. Requests for extensions of time for the filing of briefs must be in writing as defined in rule 1.3.11.2 and will be granted only on a specific showing of inability to submit a brief within the time limits set forth herein. When a party files an appeal of a hearing officer's decision in circumstances in which no hearing has been held, the appealing party shall submit its written argument, if any, with the appeal. 11.2.16 Decision of the Panel. The panel may affirm, modify, reverse, or set aside a hearing officer’s decision on the basis of the evidence in the record previously submitted in the case, which shall include any relevant materials in the case file at the time of the hearing. In addition, the majority of the members of entire panel may remand a case for the taking of further evidence where there has been a compelling demonstration that such evidence, if credited, would establish that a miscarriage of justice has occurred. Prior to determining whether such a remand is appropriate, the panel shall provide written notice of the issue to the interested parties and afford them at least seven (7) calendar days to provide a written response. In determining the issue, the panel members shall consider the following factors: whether the party offering the additional evidence knew or should have known of the existence of the evidence at the time of the hearing; whether the party requested the hearing officer to continue the hearing to allow additional evidence and the hearing officer denied the party’s request; whether there is a substantial likelihood that the offer of proof pertaining to the additional evidence would have compelled a substantially different decision by the hearing officer; and whether there is a substantial likelihood that the additional evidence would show that the evidence presented at the hearing was false and that the false evidence had an effect on the outcome of the hearing. The neglect or error of a party’s designated representative shall be imputed to the party and shall not constitute a basis for a remand to consider additional evidence under this section. Decisions shall identify those members of the panel who consider an appeal and copies thereof shall be provided to all interested parties or their representatives of record. The decision of the majority shall control, provided, however, that a dissent stating reasons therefor may be filed by the minority. .1 Precedential Decisions. Upon a unanimous vote of the members of the entire panel, a panel decision may be designated as precedential to be followed by the hearing officers and deputies of the division. Precedential decisions shall meet at least one of the following criteria: 1) The decision interprets a statute, rule, or 2) The decision resolves an apparent conflict of authority. Precedential decisions shall be promptly provided to the hearing officers and deputies of the division. In addition, precedential decisions shall be published and made available to the public in a manner that does not reveal confidential identifying information prohibited by 8-72-107(1), C.R.S. 11.2.17 Disqualification of Examiner. Challenges to the interest of an examiner shall be heard and decided by the panel. 11.2.18 Evidence From Another State. The division may, after notice to the parties, request an agency that administers the employment security law for another state to take evidence in that state for use by the division. Such agency, after notice to the parties, may follow the procedure prescribed by the law and regulations of that state for conducting hearings. 11.2.19 Subpoenas. The division may issue subpoenas to compel attendance of witnesses and production of records for a hearing before a hearing officer. A subpoena shall be served by delivering a copy of the subpoena to the person named therein no later than forty-eight hours before the time for appearance set forth in said subpoena. A subpoena may be served by an interested party, and proof of service shall be made by affidavit setting forth the date, place, and manner of service. .1 A party that submits a request for a subpoena shall show: .1 The name of the witness and the address where the witness can be served the subpoena; .2 That the testimony of the witness is material; and .3 That the testimony of the witness is not repetitive. .2 If the requesting party wishes the witness to produce books, records, documents, or other physical evidence, the party shall also show: .1 The name or a detailed description of the specific books, records, documents, or other physical evidence the witness should bring to the hearing; .2 That such evidence is material; .3 That such evidence is not repetitive; and .4 That such evidence does not cause an undue burden on the party to whom it is directed. .3 If the subpoena or subpoena duces tecum is denied, the aggrieved party may object at the hearing. The hearing officer will consider all objections and responses and supporting evidence, if any, and will grant or deny the request for issuance of the subpoena. If denied, the hearing will proceed on the merits of the issue in dispute. If granted, the hearing shall be adjourned pursuant to regulation 11.2.11. 11.2.20 Appearance of Parties. In a proceeding before a hearing officer or the panel, an individual may appear for himself or herself; a partnership may be represented by any partner or a duly authorized representative; and a corporation or association may be represented by an officer or duly authorized representative. 11.2.21 Designation of Representative. In addition to representatives under regulation 11.2.20, any party may designate another person as an authorized representative in an appeal proceeding before the division or panel. 11.2.22 Preserving Records of Decisions. Decisions of hearing officers and the panel shall be kept in such format as may be determined by the division in the main administrative office of the division in Denver, Colorado for a period of two years after the last decision. Copies of such decisions may be obtained by the interested parties upon written request and the payment of a reasonable fee therefor.

PART XII GOOD CAUSE

12.1 DETERMINATION OF GOOD CAUSE 12.1.1 Statutory References: 8-73-107 (1)(h), 8-73-108 (5)(e)(XVIII)(XIX), 8-74-102, 8-74-106, 8-76- 110 (2)(g), 8-76-110 (4)(e), 8-76-113, and 8-79-104 (1)(d), C.R.S. 12.1.2 Purpose. The purpose of this part XII of the regulations is to provide procedures and substantive guidelines for the determination of good cause only when a particular section of the act or regulations other than this part XII of the regulations specifically permits an untimely action or excuses the failure to act as required for good cause shown. 12.1.3 Procedure. .1 Whenever an interested party files an untimely appeal from a deputy’s decision, a rebuttable presumption of good cause shall be established and a hearing shall be scheduled unless the appeal was received more than 180 days beyond the expiration of the timely filing period. The notice of hearing shall contain a statement indicating that the appeal was filed beyond the expiration of the timely filing period and that the nonappealing party may object to the hearing being granted at the time of the new hearing. If the nonappealing party fails at the time of the hearing to object to the hearing proceeding, that party waives the opportunity to object to the hearing going forward. If the nonappealing party objects at the time of the hearing to the matter being scheduled, the hearing officer shall determine whether good cause has been shown, pursuant to section 12.1.8, for permitting the untimely appeal. If the hearing officer determines that good cause has been shown for permitting the untimely appeal, the hearing shall proceed. If the hearing officer determines that good cause has not been shown for permitting the untimely appeal, the appeal shall be dismissed. .2 In the event an interested party files an untimely appeal from a deputy’s decision or makes a request for a new hearing and the appeal or hearing request is received more than 180 days beyond the expiration of the timely filing period, good cause may not be established, a hearing shall not be scheduled, the appeal shall be dismissed, and the deputy’s decision shall become final. .3 Whenever an interested party files an untimely appeal from a hearing officer’s decision, or fails to participate as directed in a hearing held on an appeal from a deputy’s decision and has filed a request for a new hearing, the panel shall determine if good cause has been shown, pursuant to section 12.1.8, for permitting the untimely appeal or excusing the failure to participate in the hearing as directed. The panel shall make a determination of good cause only if the untimely appeal or request for new hearing contains a statement of the reasons for which the party failed to act in a timely manner or if information within the appeal file supports a determination of good cause. If the party’s untimely appeal or request for a new hearing does not establish good cause, the panel may request an explanation in writing, by postal mail, by approved electronic means, or by telephone.

The party shall respond to any such request within ten days. .4 Whenever an appeal from a deputy’s decision has been dismissed because the appealing party failed to participate as directed in a scheduled hearing before a hearing officer and the appealing party requests that a new hearing be scheduled, a rebuttable presumption of good cause shall be established and a new hearing shall be scheduled.

The notice of the new hearing shall contain a statement indicating that the hearing is being rescheduled because the appealing party did not participate in the prior hearing as directed and that the nonappealing party may object at the beginning of the new hearing to the matter being rescheduled. If, at the time of the new hearing, the nonappealing party objects to the matter being rescheduled, the hearing officer shall determine whether good cause has been shown, pursuant to section 12.1.8, to excuse the failure to participate in the hearing as directed. If, at the time of the hearing, the nonappealing party fails to object to the hearing proceeding, that party waives the opportunity to object to the hearing going forward. If the hearing officer determines that good cause has been shown to excuse the failure to participate in the hearing as directed, the hearing on the deputy’s decision shall proceed. If the hearing officer determines that good cause has not been shown to excuse the failure to participate in the hearing as directed, the appeal shall be dismissed. .5 Notwithstanding these provisions, good cause may not be established for the failure of an appealing party to participate in a second hearing as directed which was set because that party failed to participate as directed in the first hearing. In the event that the appealing party fails to participate as directed in the first setting of a hearing on a deputy’s decision and then subsequently fails to participate as directed in the second setting of a hearing, the appeal shall be dismissed and the deputy’s decision shall become final. Under such circumstances, the division shall issue a notice to all interested parties that the appeal has been dismissed and that no further rescheduled hearings shall be granted. 12.1.4 Written Statement. All statements provided for the purpose of part XII of these regulations shall be in writing and identify the person submitting the statement. The statement may be submitted in person, by postal mail, by facsimile machine, by telephone, by division-approved electronic means, or if submitted to the panel, by panel-approved electronic means. 12.1.5 Determination by Panel. Upon receipt of the statement, the panel shall determine whether good cause has been shown for permitting an untimely appeal from a hearing officer's decision or for excusing the failure of a nonappealing party to appear for a hearing. Such determination shall be in writing with supporting findings of fact and shall be provided to all interested parties in person, by mail, by facsimile machine, or by electronic means. If the panel determines that good cause exists for permitting a late appeal, the decision shall contain a written notification that the othernamed interested parties may object to the good-cause determination by raising their objections in their written arguments as permitted by regulation 12.1.3. The panel shall consider any objections and conduct further appropriate proceedings to reconsider the good-cause determination. 12.1.6 Additional Evidence. In making a determination of whether good cause has been shown for permitting an untimely appeal from a hearing officer's decision or for excusing the failure to appear for a hearing, the panel may request or accept additional written evidence, may obtain additional evidence by other reliable means as shall be deemed appropriate, or may order that a hearing be conducted by a hearing officer to obtain such evidence and to make findings of fact deemed necessary to resolve this issue. 12.1.7 Appeals. If any interested party objects to a determination of the chief hearing officer or designee that a rebuttable presumption of good cause exists for an untimely appeal from a deputy's decision; or objects to a determination of the panel based solely on written documents that there is good cause for an untimely appeal, that excuses the failure to appear for a hearing or determines that good cause exists for an untimely request for a new hearing, that interested party may present its objections at the hearing scheduled on the issues in dispute. .1 The hearing officer shall consider all information in support of or in opposition to the good cause determination presented by the interested parties, including all objections and responses and supporting evidence. The hearing officer shall determine if good cause exists for permitting the untimely appeal or excusing the failure to appear or excusing the untimely request for a new hearing based on the evidence presented. .2 However, if the hearing officer does not find the facts to be different than those already considered, the hearing officer shall not disturb the prior determination of good cause, and the hearing will proceed on the merits of the issues in dispute. If good cause is overturned, the hearing will be terminated and any previously vacated hearing officer's decision on the merits of the appeal shall be reinstated. 12.1.8 Substantive Guidelines. In determining whether good cause has been shown for permitting an untimely action or excusing the failure to act as required, the division or the panel consider: .1 whether the party acted in the manner that a reasonably prudent individual would have acted under the same or similar circumstances; .2 whether there was administrative error by the division; .3 whether the party exercised control over the untimely action, except that the acts and omissions of a party's authorized representative are considered the acts and omissions of the party and are not considered to be a factor outside the party's control as intended by this rule; .4 the length of time the action was untimely; .5 whether any other interested party has been prejudiced by the failure to act or untimely action, “prejudiced,” as used in this section, means that an interested party will be prevented from presenting of substantially hindered from presenting probative evidence in support of the interested party’s position or in the ability to refute the position of the opposing party; and .6 whether denying good cause would lead to a result that in inconsistent with the law. .7 Good cause cannot be established to accept or permit an untimely action or to excuse the failure to act, as required, that was caused by the party's failure to keep the division directly and promptly informed by a written, signed statement of his or her current and correct mailing address in person, by mail, by facsimile machine, or by other divisionapproved electronic means. This provision shall not apply if the party establishes that he or she reasonably believed that the division would not have any need for his or her new address under the circumstances. .8 A written decision concerning the existence of good cause need not contain findings of fact on every relevant factor, but the basis for the decision must be apparent from the order. .9 Unless otherwise provided by law, no act subject to this section shall be permitted more than 180 days beyond the applicable timely date.

PART XIII INTERSTATE ARRANGEMENTS

13.1 PAYMENT OF BENEFITS TO INTERSTATE CLAIMANTS 13.1.1 Statutory References: 8-72-109 and 8-72-110, C.R.S. 13.1.2 Cooperation With Other States. This section of the regulations shall govern the division in its administrative cooperation with other states that adopt similar regulations for the payment of benefits to interstate claimants. 13.1.3 Definitions. The following definitions shall apply to this section unless the context clearly requires otherwise. .1 Interstate Benefit Payment Plan. The plan approved by the Interstate Conference of Employment Security Agencies (ICESA) under which benefits shall be payable to unemployed individuals absent from the state or states in which benefit credits have been accumulated. .2 Interstate Claimant. An individual who claims benefits under the unemployment insurance law of one or more liable states through the facilities of an agent state or directly with the liable state. The term shall not include an individual who customarily commutes from a residence in any agent state to work in a liable state unless the division determines that such an exclusion would create undue hardship upon claimants in designated areas. .3 State. Any state of the United States, the District of Columbia, Puerto Rico, the Virgin Islands, and the provinces of Canada. .4 Agent State. Any state from or through which an individual files a claim for benefits against another state. .5 Liable State. Any state against which an individual files, from or through another state, a claim for benefits. .6 Benefits. The unemployment compensation payable to an individual under the unemployment insurance law of any state. .7 Week of Unemployment. Any week of unemployment as defined in the law of the liable state from which benefits with respect to such week are claimed. 13.1.4 Registration for Work. .1 Each interstate claimant who files through the agent state or directly with the liable state shall register for work as required by the law, regulations, and procedures of the agent state. Such registration shall be deemed to meet the registration requirements of the liable state. .2 The agent state shall duly report to the liable state each interstate claimant who fails to meet the registration or reemployment-assistance-reporting requirements of the agent 13.1.5 Benefit Rights of Interstate Claimants. If an interstate claimant files a claim against a state and such state determines that benefit credits are available to the claimant in that state, claims may be filed only against that state and no other state so long as such benefit credits are available.

Thereafter, the claimant may file claims against any other state in which he or she has available benefit credits. Benefit credits, for the purposes of this section, shall be deemed to be unavailable whenever benefits are affected by the application of a seasonal restriction or have been exhausted, terminated, or postponed for an indefinite period or for the entire period during which benefits would otherwise be payable. 13.1.6 Claims for Benefits. .1 Interstate claims for benefits and waiting periods filed by interstate claimants through the agent state shall be filed in compliance with the uniform procedures developed pursuant to the Interstate Benefit Payment Plan. Such claims filed directly with the liable state shall be filed in accordance with the liable state's procedures. Claims shall be filed to conform to the type of week in effect in the agent state. The liable state shall make required adjustments on the basis of consecutive claims. .2 Agent-state regulations for filing intrastate claims with public employment offices or itinerant service points or representative therefor or by mail or by telephone shall apply to interstate claims. .3 With respect to weeks of unemployment during which an individual is attached to his or her regular employer, the liable state shall accept as timely any claim that is filed through the agent state within the time limit applicable to such claims under the law of the agent 13.1.7 Determination of Claims. .1 When an interstate claim is filed, the agent state shall identify to the liable state any potential issue relating to the claimant's availability for work and eligibility for benefits detected by the agent state. .2 The agent state's authority and responsibility with respect to the determination of interstate claims shall be limited to the identification of potential issues identified in connection with initial claims or weeks claimed that are filed through the agent state and to the reporting of relevant facts pertaining to the claimant's failure to register for work or report for reemployment assistance as required by the agent state. .3 The agent state shall not refuse to accept an interstate claim. 13.1.8 Providing Assistance to Interstate Claimants. Each agent state, upon request by an interstate claimant, shall assist the individual with the understanding and filing of necessary notices and documents. The liable state shall provide interstate claimants with access to information concerning the status of their claims during normal business hours. 13.1.9 Eligibility Review Program. The liable state may schedule and conduct eligibility-review interviews for interstate claimants. 13.1.10 Notification of Interstate Claim. The liable state shall notify the agent state of each initial claim, reopened claim, claim transferred to interstate status, and each week claimed filed from the agent state using uniform procedures and record formats pursuant to the Interstate Benefit Payment Plan. 13.1.11 Appellate Procedure. .1 The agent state shall give all reasonable cooperation in conducting hearings and taking evidence in connection with disputed benefit determinations when so requested by a liable state. .2 The time limit imposed by the liable state for filing an appeal in connection with a disputed benefit determination shall control, provided, however, that a claimant's appeal shall be deemed to have been made and communicated to the liable state on the date on which it is received by an employee of the agent state. .3 The liable state shall conduct hearings in connection with appealed interstate benefit claims. The liable state may contact the agent state for assistance in special circumstances.

13.2 COMBINING EMPLOYMENT AND WAGES 13.2.1 Statutory Reference: 8-72-110 (2), C.R.S. 13.2.2 Purpose of Arrangement. This arrangement is approved by the Secretary of Labor of the United States (Secretary) under the provisions of section 3304 (a)(9)(B) of the Federal Unemployment Tax Act to establish a system whereby an unemployed worker, with covered employment or wages in more than one state, may combine all such employment and wages in one state, in order to qualify for benefits or to receive more benefits. 13.2.3 Consultation With the State Agencies. As required by section 3304 (a)(9)(B) of the Federal Unemployment Tax Act, this arrangement has been developed in consultation with the state unemployment compensation agencies. For purposes of such consultation, in its formulation and any future amendment, the Secretary recognizes, as agents of the state agencies, the duly designated representatives of the Interstate Conference of Employment Security Agencies (ICESA). 13.2.4 Interstate Cooperation. Each state agency will cooperate with every other state agency by implementing such rules, regulations, and procedures as may be prescribed for the operation of this arrangement. Each state agency shall identify the paying and the transferring state with respect to combined-wage claims filed in its state. 13.2.5 Rules, Regulations, Procedures, Forms - Resolution of Disagreements. All state agencies shall operate in accordance with such rules, regulations, and procedures and shall use such forms as shall be prescribed by the Secretary in consultation with the state unemployment compensation agencies. All rules, regulations, and standards prescribed by the Secretary with respect to intrastate claims will apply to claims filed under this arrangement unless they are clearly inconsistent with the arrangement. The Secretary will resolve any disagreement between state agencies concerning the operation of the arrangement, with the advice of the duly designated representatives of the state agencies. 13.2.6 Effective Date. This arrangement shall apply to all new claims (to establish a benefit year) filed under it after December 31, 1971. 13.2.7 Definitions. These definitions apply for the purpose of this arrangement and the procedures issued to effectuate it. .1 State. “State” includes the states of the United States, the District of Columbia, the Commonwealth of Puerto Rico, and the Virgin Islands. .2 State Agency. The agency that administers the unemployment compensation law of a .3 Combined-Wage Claim. A claim filed under this arrangement. .4 Combined-Wage Claimant. A claimant who has covered wages under the unemployment compensation law of more than one state and who has filed a claim under this arrangement. .5 Paying State. .1 The state where a combined-wage claimant files a combined-wage claim, if the claimant qualifies for unemployment benefits in that state on the basis of combined employment and wages. .2 If the state where a combined-wage claimant files a combined-wage claim is not the paying state under the criterion set forth in regulation 13.2.7.5.1, or if the combined-wage claim is filed in Canada, then the paying state shall be that state where the combined-wage claimant was last employed in covered employment among the states where the claimant qualifies for unemployment benefits on the

basis of combined employment and wages. .6 Transferring State. A state where a combined-wage claimant had covered employment and wages in the base period of a paying state and that transfers such employment and wages to the paying state for its use in determining the benefit rights of such claimant under its law. .7 Employment and Wages. “Employment” refers to all services that are covered under the unemployment compensation law of a state, whether expressed in terms of weeks or work or otherwise. “Wages” refers to all remuneration for such employment. .8 Secretary. The Secretary of Labor of the United States. .9 Base Period and Benefit Year. The base period and benefit year applicable under the unemployment compensation law of the paying state. 13.2.8 Election to File a Combined-Wage Claim. .1 Any unemployed individual who has had employment covered under the unemployment compensation law of two or more states, whether or not he or she is monetarily qualified under one or more of them, may elect to file a combined-wage claim. Said individual may not so elect, however, if he or she has established a benefit year under any state or federal unemployment compensation law and: .1 The benefit year has not ended; and .2 He or she still has unused benefit rights based on such benefit year. .2 For the purpose of this arrangement, a claimant will not be considered to have unused benefit rights based on a benefit year that he or she has established under a state or federal unemployment compensation law if: .1 The claimant has exhausted his or her rights to all benefits based on such benefit year; or .2 The claimant's rights to such benefits have been postponed for an indefinite period or for the entire period in which benefits would otherwise be payable; or .3 Benefits are affected by the application of a seasonal restriction. .3 If an individual elects to file a combined-wage claim, all employment and wages in all states in which he or she worked during the base period of the paying state must be included in such combining, except employment and wages that are not transferable under the provisions of regulation 13.2.10.2. .4 A combined-wage claimant may withdraw his or her combined-wage claim within the period prescribed by the law of the paying state for filing an appeal, protest, or request for redetermination (as the case may be) from the monetary determination of the combinedwage claim, provided the claimant either: .1 Repays in full any benefits paid to him or her thereunder; or .2 Authorizes the state(s) against which he or she files a substitute claim(s) for benefits to withhold and forward to the paying state a sum sufficient to repay such benefits. .5 If the combined-wage claimant files his or her claim in a state other than the paying state, he or she shall do so pursuant to the Interstate Benefit Payment Plan. 13.2.9 Responsibilities of the Paying State. .1 Transfer of Employment and Wages - Payment of Benefits. The paying state shall request the transfer of a combined-wage claimant's employment and wages in all states during its base period and shall determine his or her entitlement to benefits (including additional benefits, extended benefits, and dependents' allowances, when applicable) under the provisions of its law based on employment and wages in the paying state, if any, and all such employment and wages transferred to it hereunder. The paying state shall apply all the provisions of its law to each determination made hereunder, even if the combined-wage claimant has no earnings in covered employment in that state, except that the paying state may not determine an issue that has previously been adjudicated by a transferring state. Such exception shall not apply, however, if the transferring state's determination of the issue resulted in making the combined-wage claim possible under

regulation 13.2.8.2.2. If the paying state fails to establish a benefit year for the combinedwage claimant, or if the claimant withdraws his or her claim as provided herein, the paying state shall return to each transferring state all employment and wages thus unused. .2 Notices of Determination. The paying state shall give to the claimant a notice of each of its determinations on his or her combined-wage claim that he or she is required to receive under the Secretary's claim-determinations standard, and the contents of such notice shall meet such standard. When the claimant is filing his or her combined-wage claims in a state other than the paying state, the paying state shall send a copy of each such notice to the local office where the claimant filed such claims. .3 Redeterminations. Redeterminations may be made by the paying state in accordance with its law based on additional or corrected information received from any source, including a transferring state, except that such information shall not be used as a basis for charging the paying state if benefits have been paid under the combined-wage claim. .4 Appeals. .1 Except as provided in regulation 13.2.9.4.3 where the claimant files his or her combined-wage claim in the paying state, any protest, request for redetermination, or appeal shall be in accordance with the law of such state. .2 Where the claimant files his or her combined-wage claim in a state other than the paying state or under the circumstances described in regulation 13.2.9.4.3, any protest, request for redetermination, or appeal shall be in accordance with the Interstate Benefit Payment Plan. .3 To the extent that any protest, request for redetermination, or appeal involves a dispute as to the coverage of the employing unit or services in a transferring state or otherwise involves the amount of employment and wages subject to transfer, the protest, request for redetermination, or appeal shall be decided by the transferring state in accordance with its law. .5 Recovery of Prior Overpayments. If there is an overpayment outstanding in a transferring state and such transferring state so requests, the overpayment shall be deducted from any benefits the paying state would otherwise pay to the claimant on his or her combined-wage claim, except to the extent prohibited by the law of the paying state. The paying state shall transmit the amount deducted to the transferring state or credit the deduction against the transferring state's required reimbursement under this arrangement. This subsection shall apply to overpayments only if the transferring state certifies to the paying state that the determination of overpayment was made within three years before the combined-wage claim was filed and that repayment by the claimant is legally required and enforceable against the claimant under the law of the transferring .6 Statement of Benefit Charges. .1 At the close of each calendar quarter, the paying state shall send each transferring state a statement of benefits charged during such quarter to such state for each combined wage claimant. .2 Each such charge shall bear the same ratio to the total benefits paid to the combined-wage claimant by the paying state as his or her wages transferred by the transferring state bear to the total wages used in such determination. The paying state shall express the ratio as a percentage, of three or more decimal places. .3 With respect to new claims establishing a benefit year effective on and after July 1, 1977, the United States shall be charged directly by the paying state in the same manner as provided in regulations 13.2.9.6.1 and 13.2.9.6.2 of this section 13.2 in regard to federal-civilian service and wages and federal-military service and wages assigned or transferred to the paying state and included in combinedwage claims in accordance with the Code of Federal Regulations, 20 C.F.R., parts 609, 614, and 616. 13.2.10 Responsibilities of Transferring States. .1 Transfer of Employment and Wages. Each transferring state shall promptly transfer to the paying state the employment and wages the combined-wage claimant had in covered employment during the base period of the paying state. Any employment and wages so transferred shall be transferred without restriction as to their use for determination and benefit payments under the provisions of the paying state's law. .2 Employment and Wages Not Transferable. Employment and wages transferred to the paying state by a transferring state shall not include: .1 Any employment and wages that have been transferred to any other paying state and not returned unused or that have been used in the transferring state as the

basis of a monetary determination that established a benefit year. .2 Any employment and wages that have been canceled or are otherwise unavailable to the claimant as a result of a determination by the transferring state made prior to its receipt of the request for transfer, if such determination has become final or is in the process of appeal but is still pending. If the appeal is finally decided in favor of the combined-wage claimant, any employment and wages involved in the appeal shall forthwith be transferred to the paying state, and any necessary redetermination shall be made by such paying state. .3 Any employment and wages that would be canceled under the law of the transferring state, if its law does not permit noncharging of benefits paid thereon, except that this subsection shall not apply to requests for transfer made after June 30, 1973, or after amendment of the law to provide for noncharging, whichever is earlier. .3 Reimbursement of Paying State. Each transferring state shall, as soon as practicable after receipt of a quarterly statement of charges described herein, reimburse the paying state accordingly. 13.2.11 Reuse of Employment and Wages. Employment and wages that have been used under this arrangement for a determination of benefits that establishes a benefit year shall not thereafter be used by any state as the basis for another monetary determination of benefits. 13.2.12 Amendment of Arrangement. Periodically, the Secretary shall review the operation of this arrangement and shall propose such amendments to the arrangement as he or she believes are necessary or appropriate. Any state unemployment compensation agency or the ICESA may propose amendments to the arrangement. Any proposal shall constitute an amendment to the arrangement upon approval by the Secretary in consultation with the state unemployment compensation agencies. Any such amendment shall specify when the change shall take effect and to which claims it shall apply.

13.3 EMPLOYER ELECTIONS TO COVER WORKERS PERFORMING SERVICES IN MORE THAN

ONE STATE 13.3.1 Statutory Reference: 8-72-110(3), C.R.S. 13.3.2 Definitions. The following definitions shall apply to this section unless the context otherwise clearly requires: .1 Arrangement. The Interstate Reciprocal Coverage Arrangement. .2 Jurisdiction. Any state of the United States, the District of Columbia, Puerto Rico, the Virgin Islands, and Canada or the federal government, with respect to coverage under a federal unemployment compensation law. .3 Participating Jurisdiction. A jurisdiction whose agency has subscribed to and has not terminated participation in the arrangement. .4 Agency. Any officer, board, commission, or other authority charged with the administration of the unemployment compensation law of a participating jurisdiction. .5 Electing Unit. An employing unit that requests that the services customarily performed for it by any individual in more than one participating jurisdiction be covered under the law of a single participating jurisdiction. .6 Election. The request of an electing unit for permission to cover under the law of a single participating jurisdiction all of the services customarily performed for such unit by any individual who customarily works in more than one participating jurisdiction. .7 Elected Jurisdiction. The participating jurisdiction selected by an employing unit to cover under its law any individual who customarily performs services for such unit in more than one participating jurisdiction. .8 Interested Jurisdiction. Any participating jurisdiction where the elected jurisdiction submits an election for approval. .9 Interested Agency. The agency of the interested jurisdiction. .10 Services Customarily Performed. Services performed by an individual over a reasonable period of time, the nature of which is such that it can be expected that they will continue in more than one jurisdiction; services required or expected to be performed in more than one jurisdiction. .11 Multistate Worker. An individual who customarily performs services for the same employing unit in more than one jurisdiction. 13.3.3 Procedure. .1 An electing unit shall use the prescribed form (Form RC-1) or other methods as may be permitted or required by the Interstate Benefit Payment Plan to file an election to cover multistate workers under the unemployment compensation law of a participating jurisdiction. .2 An election may be filed with any participating jurisdiction where: .1 Any part of an individual's services are performed. .2 An individual maintains his or her residence. .3 The employing unit maintains a place of business to which the individual's services bear a reasonable relation. .3 The agency of the elected jurisdiction shall approve or disapprove the election. If such election is approved, the agency shall forward a copy thereof to each interested agency (as specified on the election form) under whose unemployment compensation law the electing unit's employee might be covered in the absence of such election. .4 Each interested agency shall approve or disapprove such election, as soon as practicable, and notify the elected jurisdiction. If the law of the interested jurisdiction so requires, an interested agency may, before taking action, require the electing unit to furnish satisfactory evidence that it has notified affected employees of the election and they have agreed thereto. .5 If the agency of the elected jurisdiction disapproves the election, the agency shall notify the electing unit stating reasons therefor. .6 An interested agency that disapproves the election shall notify the elected jurisdiction and electing unit, stating reasons therefor. .7 The election shall become effective only upon approval of the agency of the elected jurisdiction and one or more interested agencies. .8 An interested agency that disapproves the election shall not be bound by such election. .9 If the election is not approved by the agencies of all participating jurisdictions, the electing unit may withdraw such election within ten days of notification thereof. .10 If the services for which an employer is requesting reciprocal coverage is determined to be employment as defined in the Colorado Employment Security Act, such request shall not be granted. 13.3.4 Effective Period. .1 An election, duly approved under this regulation, shall become effective at the beginning of the calendar quarter during which such election is submitted unless such election, as approved, specifies a different calendar quarter. An electing unit may request an effective date for a calendar quarter earlier than the calendar quarter during which the election is submitted, provided, however, that such earlier date may be approved solely as to those interested jurisdictions in which the electing unit had no liability to pay contributions during such earlier calendar quarter. .2 The application of an election to an individual shall terminate if the agency of the elected jurisdiction finds that the services of such individual are no longer performed in more than one participating jurisdiction. The termination date shall be the last day of the calendar quarter in which notice of termination is mailed to all affected parties. Except as provided in the forgoing paragraph, each election approved under this section shall be in effect through the end of the calendar year in which such election was filed and, thereafter, through the end of the calendar quarter during which the electing unit gives written notice of termination to the agencies of the elected and interested jurisdictions. .3 The electing unit shall notify each affected individual when an election under this section ceases to apply to that individual. 13.3.5 Required Reports and Notices. .1 The electing unit shall promptly notify each affected individual when an election is approved. Prescribed form Notice to Employee as to Unemployment Compensation Coverage (Form RC-2) shall be used, and a copy thereof shall be forwarded to the elected jurisdiction. .2 Whenever an individual affected by an election is separated from employment with the electing unit, such unit shall forthwith again notify said individual of the elected jurisdiction under whose law his or her services have been covered. If the individual is not in the elected jurisdiction when he or she is separated from his or her employment, the electing unit shall give the individual information concerning procedures to follow in filing interstate claims. .3 The electing unit shall immediately notify the elected jurisdiction of any changes that are applicable to and affect its election, as when an individual's services will no longer be customarily performed in more than one participating jurisdiction or when a change in an individual's work assignment requires him or her customarily to perform services in an additional participating jurisdiction. .4 Notification to the elected jurisdiction pursuant to this regulation 13.3.5 shall be made as permitted or required by the Interstate Benefit Payment Plan.

13.4 INTERSTATE RECIPROCAL OVERPAYMENT RECOVERY 13.4.1 Statutory References: 8-72-109(1), 8-72-110, and 8-79-102(1), C.R.S. 13.4.2 Definitions. The following definitions shall apply to this section unless the context clearly requires otherwise. .1 State. Any state of the United States, the District of Columbia, Puerto Rico, and the Virgin Islands. .2 Offset. The withholding of the overpaid amount against benefits that would otherwise be payable for a compensable week of unemployment. .3 Overpayment. An improper payment of benefits from a state or federal unemployment compensation fund that has been determined recoverable under the requesting state's law. .4 Participating State. A state that has subscribed to the interstate reciprocal overpayment arrangement. .5 Paying State. The state under whose law a claim for unemployment benefits has been established on the basis of combining wages and employment covered in more than one .6 Recovering State. The state that has received a request for assistance from a requesting state. .7 Requesting State. The state that has issued a final determination of overpayment and is requesting another state to assist it in recovering the outstanding balance from the overpaid individual. .8 Transferring State. A state in which a combined-wage claimant had covered employment and wages in the base period of a paying state and that transfers such employment and wages to the paying state for its use in determining the benefit rights of such claimant under its law. .9 Liable State. Any state against which an individual files, through another state, a claim for benefits. 13.4.3 Recovery of State or Federal Benefit Overpayments. .1 Duties of Requesting State. The requesting state shall: .1 Send the recovering state a written request for overpayment-recovery assistance that includes certification that the overpayment is legally collectable under the requesting state's law, certification that the determination is final and that any rights to postponement of recoupment have been exhausted or have expired, a statement as to whether the state is participating in cross-program offset by agreement with the U.S. Secretary of Labor, a copy of the initial overpayment determination, and a statement of the outstanding balance; .2 Send notice of the request to the claimant; and .3 Send to the recovering state a new outstanding overpayment balance whenever the requesting state receives any amount of repayment from a source other than the recovering state such as by interception of tax refund. .2 Duties of Recovering State. The recovering state shall: .1 Issue to the claimant an overpayment-recovery determination that includes the statutory authority for the offset, the name of the state requesting recoupment, the date of the original overpayment determination, the type of overpayment (fraud or nonfraud), program type, total amount to be offset, the amount to be offset weekly, and the right to request determination and appeal of the determination to recover the overpayment by offset. .2 Offset benefits payable for each week claimed in the amount determined under state law. .3 Provide the claimant with a notice of the amount offset. .4 Prepare and forward, no less than once a month, payment representing the amount recovered made payable to the requesting state except as provided in

regulation 13.4.4.1.2. .5 Retain a record of the overpayment balance no later than the exhaustion of benefits, end of the benefit year, exhaustion or end of an additional or extended benefits period, or other extensions of benefits, whichever is latest. .6 Not redetermine the original overpayment determination. 13.4.4 Combined-Wage Claims. .1 Recovery of Outstanding Overpayment in Transferring State. The paying state shall: .1 Offset any outstanding overpayment in a transferring state(s) prior to honoring a request from any other participating state. .2 Credit the deductions against the statement of benefits paid to combined-wage claimants, Form IB-6, or forward payment to the transferring state as described in

regulation 13.4.3.2.4. .2 Withdrawal of Combined-Wage Claim After Benefits Have Been Paid. .1 Withdrawal of a combined-wage claim after benefits have been paid shall be honored only if the combined-wage claimant has repaid any benefits paid or authorizes the new liable state to offset the overpayment pursuant to regulation 13.2.8.4. .2 The paying state shall issue an overpayment determination and forward a copy, with an overpayment-recovery request and an authorization to offset, with the initial claim to the liable state. .3 The recovering state shall: .1 Offset the total amount of any overpayment resulting from the withdrawal of a combined-wage claim prior to the release of any payments to the claimant; .2 Offset the total amount of any overpayment resulting from the withdrawal of a combined-wage claim prior to honoring a request from any other participating state; .3 Provide the claimant with a notice for the amount offset; and .4 Prepare and forward payment representing the amount recovered to the requesting state as described in regulation 13.4.3.2.4. 13.4.5 Cross-Program Offset. The recovering state shall offset benefits payable under a state unemployment compensation program to recover any benefits overpaid under a federal unemployment compensation program, as described in the recovering state's agreement with the U.S. Secretary of Labor, and vice versa, in the same manner as required under regulation 13.4.3 and regulation 13.4.4 when both the recovering state and requesting state have entered into an agreement with the U.S. Secretary of Labor to implement section 303(a) of the federal Social Security Act.

PART XIV (RESERVED)

PART XV BENEFIT OVERPAYMENTS 15.0 Coordination of benefits. 15.0.1 Statutory References: 8-70-101 et seq., and 8-13.3-513, C.R.S. 15.0.2 Concurrency of Benefits.

1. Benefits under the FAMLI Act and its implementing regulations do not run concurrently with benefits under the Colorado Employment Security Act, C.R.S. § 8-70-101 et seq. or its implementing regulations (“CESA”), including Workshare.

15.1 WRITE-OFF OF RECOVERY 15.1.1 Statutory References: 8-74-109, 8-79-102, and 8-81-101(4)(b)(c)(d), C.R.S. 15.1.2 Purpose. The division may write off the recovery of all or part of the amount of overpaid benefits that it finds non-collectible or the recovery of which it finds to be administratively impracticable. 15.1.3 Criteria for Write-Off. In determining whether overpaid benefits are non-collectible or whether the recovery of such benefits would be administratively impracticable, the division shall consider all relevant factors including, but not limited to, the following: .1 That the claimant has died. .2 That the claimant is totally and permanently disabled. .3 That the claimant has retired from the labor force, including consideration of the claimant's age, the likelihood of the claimant's reentering the labor force, the claimant's physical condition, and the claimant's financial status. .4 That the claimant has been adjudicated bankrupt. .5 That the division determines the costs of collection to exceed the amount of overpayment. .6 That the overpaid amount, if not due to false representation or willful failure to disclose a material fact, has remained uncollected for more than five years. .7 That the overpaid amount, if due to false representation or willful failure to disclose a material fact, has remained uncollected for more than seven years.

15.2 WAIVER OF RECOVERY 15.2.1 Statutory References: 8-79-102, 8-81-101 (4)(a)(I)(II), and 8-81-101 (4)(c)(d)(e), C.R.S. 15.2.2 Request for Waiver. When a determination establishing an overpayment is final, the overpaid claimant shall be notified of the overpayment and advised that a written request for waiver of recovery may be submitted to the division. Such request shall be submitted in accordance with

regulation 1.3.11. Upon receipt of such request, the division shall suspend recovery of the overpayment until the waiver determination is final. .1 If the final waiver determination denies said request, subsequent requests for waiver may be submitted upon a showing by the claimant of a significant change in financial conditions affecting his or her ability to repay the overpaid amount, such as catastrophic illness or loss of employment. .2 A final determination that approves a waiver request shall apply only to the overpaid balance at the time the request was made, as evidenced by the date received, if mailed or filed in person, the receipt date encoded on a facsimile document, or the receipt date recorded by the division's automated systems if filed using division-approved electronic means and shall not be retroactive to any part of the overpaid amount already recovered. except that, if the division has failed to timely notify the individual of the right to request a waiver as required, the waiver shall then be retroactive to the date of the overpayment determination. 15.2.3 Requests for Information by the Division. Financial and other relevant information that, in the opinion of the division, is necessary to render a waiver determination may be requested from the claimant by the division in writing. Failure by the claimant to provide the requested information, in writing, to the division within fifteen calendar days of said request shall cause the claimant's request for waiver to be determined based on available information. Information may be submitted to the division in person, by mail, by facsimile machine, or by division approved electronic means. 15.2.4 Criteria for Waiver. A person who is overpaid any amount of benefits is liable for the amount overpaid. The division may waive the recovery of all or any part of an overpaid amount only when: .1 The overpayment did not result from false representation or willful failure to disclose a material fact by the claimant; and .2 Requiring repayment would be inequitable. 15.2.5 False Representation. For purposes of part XV of the regulations, the term “false representation” means any representation made by an individual that he or she knew to be false or any representation made by an individual with an awareness that he or she did not know whether the representation was true or false. 15.2.6 Willful Failure to Disclose a Material Fact. For purposes of part XV of the regulations, the term “willful failure to disclose a material fact” means knowingly withholding material information from the division.

15.3 FRAUDULENT CLAIMS 15.3.1 Statutory References: 8-81-101(1)(a), 8-81-101(4)(a)(I) AND (II) C.R.S. 15.3.2 False Statements. The terms “false statement” and “false representation” include, but are not limited to, the following actions: .1 Filing a claim for benefits knowingly using a social security number or other identifying information belonging to another or which is otherwise not properly assigned to the individual filing the claim for the purpose of improperly obtaining unemployment benefits. .2 Accessing the benefit claim of another by knowingly using the social security number or other identifying information properly belonging to that other individual for the purpose of improperly obtaining unemployment benefits. .3 Knowingly using false or fictitious employer information to either establish a false employer account or add fictitious wages to an employer account for the purpose of improperly obtaining unemployment benefits. 15.3.3 A claim filed by using such false statements or false representations is not a valid claim. 15.3.4 Any benefits obtained using such methods are overpaid and shall be repaid to the Division. 15.3.5 Nothing in this section shall be construed to infringe upon the rights of any individual who, as determined by the Division, is properly making a claim for benefits using their own social security number or other identifying information properly belonging to that individual.

PART XVI EMPLOYEE-LEASING COMPANIES

16.1 EMPLOYEE-LEASING COMPANY CERTIFICATIONS 16.1.1 Statutory Reference: 8-70-114, C.R.S. 16.1.2 Employee-Leasing Company Certification Considered. An employer who meets the definition of an employee-leasing company as described in 8-70-114 (2)(a)(V), C.R.S., shall be certified only if: .1 The employer completes and submits an initial and annual employee-leasing company application and work-site employer and employee list as required by regulation 16.1.3., and .2 Upon filing the application and work-site employer and employee list, the employer submits a nonrefundable fee of $500, and .3 In conjunction with the application, the employer provides evidence of securitization of unemployment premiums as set forth in 8-70-114 (2)(g)(III) and rules part VIII, and .4 The employer completes and submits a quarterly report of all terminated and activated employee-leasing company contracts in the previous calendar quarter using such filing methods as may be prescribed by the division. Quarterly reports are to be submitted no later than the last day of the month following the completion of a calendar quarter. 16.1.3 Application for Certification. An employer seeking to be a certified employee-leasing company shall make application with the division upon such forms and using such filing methods as may be prescribed by the division. Such application shall include a complete list of all coemployer clients as follows: .1 A list of all work-site employers with whom a coemployment relationship exists that shall include name of each business, the work-site address(es) for each business, actual initiation dates and termination dates of each employee-leasing company contract, gross wages for each business per quarter, the federal employer identification number of each business, and the name, social security number, and quarterly wages of each employee performing work for each coemployer client. 16.1.4 [Emergency Rule expired 05/06/2009]. 16.1.5 Certification Determination. Upon review of the matters set forth in the application and such other information as it may require, the division shall issue a determination as to the employeeleasing company’s certification. Such certification shall be valid until the end of the state’s first fiscal year that is more than one year after the effective date of the initial certification. 16.1.6 Appeal From Determination. Any employer who wishes to protest a determination made under the provisions of 8-70-114, C.R.S, or this part XVI of the regulations shall file a notice of appeal with the division. Such notice of appeal must be received by the division within twenty calendar days after the date the certification determination was mailed. A hearing may be obtained in accordance with 8-73-113, C.R.S., and regulation 11.2. 16.1.7 Annual Certification. Subsequent to the initial certification, every employer who has been certified as an employee-leasing company shall file a certification on prescribed forms and using such filing methods as may be prescribed by the division on or before the last day of June of each year, except as set forth in regulation 16.1.4. An employee-leasing company shall retain its certification only if all requirements defined in 16.1.2 are met. 16.1.8 Notification. An employee-leasing company or the work-site employer shall notify each covered employee in writing at the time of hire of the coemployment relationship. The employee-leasing company contract shall specify whether the responsibility for making written notice belongs to the employee-leasing company or the work-site employer. 16.1.9 Loss of Employee-Leasing Company Certification. If an employer, subsequent to the date on which he or she was designated as an employee-leasing company, fails to fulfill the requirements of 8-70-114, C.R.S, or this part XVI of the regulations without good cause, such employer shall lose his or her employee-leasing company certification. Any determination by the division that an employer has lost his or her employee-leasing company certification shall be made in writing and provided to the employer in accordance with regulation 1.3.11.1 said determination shall be subject to appeal pursuant to regulation 16.1.6.

16.2 EMPLOYEE-LEASING COMPANY STATUS 16.2.1 Statutory Reference: 8-70-114 16.2.2 Employee-Leasing Company Reporting Election. At the time of application for certification, an employee-leasing company shall elect to report and pay unemployment insurance taxes under its own account or under the respective work-site employer’s account. 16.2.3 Effect of Agency Relationship Upon Status as Employee Leasing Company. - If an entity, or any portion of its business, meets the requirements under section 8-70-114 (2) C.R.S., that entity shall be determined to be an employee leasing company and not an agent, for the purposes of

section 8-70-114 C.R.S.

16.3 PROVISION OF BOND OR OTHER SECURITY. 16.3.1 Statutory Reference: 8-70-114 (2)(g)(III), C.R.S. 16.3.2 Holding a Deposit of Money or Security. Any deposit of money or securities in accordance with

section 8-70-114 (2)(g)(III)(A) C.R.S. shall be retained by the division in an escrow account until liability under section 8-70-114 C.R.S. is terminated, at which time it shall be returned to the organization, less any deductions pursuant to regulation 16.3.3. 16.3.3 Deduction From a Deposit Of Money or Security. The division may deduct from the money deposited by an employee-leasing company pursuant to rule 16.3.2 or sell the securities an employee-leasing company has so deposited to the extent necessary to satisfy any due and unpaid premiums and any applicable interest and penalties.

16.4 QUALIFIED ASSURANCE ORGANIZATION 16.4.1 Statutory Reference: 8-70-114 (2)(g)(III) 16.4.2 Application to be an Approved Assurance Organization. Any assurance organization seeking to be an approved, qualified assurance organization in accordance with 8-70-114 (2)(g)(III)(C), C.R.S., shall make application with the division using such filing methods as may be prescribed by the division. Such application shall include evidence of securitization of unemployment premiums as set forth in 8-70-114 (2)(g)(III), C.R.S. 16.4.3 Assurance-Organization Approval. Upon approval, each assurance organization shall receive written notification from the division director. Such approval shall be valid for three years unless the assurance organization fails to comply with any provision of the law. 16.4.4 Subsequent Approval. An approved assurance organization shall make subsequent application with the division at least ninety days prior to the expiration date specified in the written approval notice.

PART XVII WORKER CLASSIFICATION

17.1 CLASSIFICATION GUIDANCE AND CLARIFICATION 17.1.1 Statutory Reference: 8-70-115, C.R.S. 17.1.2 Factors to Consider. In determining whether a worker is an employee or independent contractor, the Deputy, Hearing Officer, or Panel considers the nine factors enumerated under § 8-70-115, C.R.S., as well as any other relevant factors, including but not limited to: .1 The relationship between the company for whom services are performed and the worker. .2 The totality of the circumstances of the relationship between the company for whom services are performed and the worker. .3 The degree of direction and control exercised by the company over the worker performing the service, except the division will not consider direction and control exercised pursuant to the requirements of any state or federal statute or regulation. 17.1.3 Customarily Engaged in an Independent Trade, Occupation, Profession, or Business.

Whether a worker is customarily engaged in an independent trade, occupation, profession or business is dependent upon whether the worker engages in a business that is separate and distinct from the company for whom services are performed. Whether a worker could or does perform services for multiple businesses may be considered in the Division’s determination regarding the worker as an employee or an independent contractor, but it is not solely dispositive in that determination.

In reaching its determination, the Division considers each working relationship individually. The Division does not rely on any single factor, but rather the totality of the circumstances and all relevant factors in accordance with applicable law. While these factors may represent consideration as to the status of the working relationship, the circumstances differ from case to case and additional factors not listed may be considered. No single set of factors is exclusive.

When determining whether an employment relationship exists under the Colorado Employment Security Act, the Division considers factors, which may include but are not limited to: .1 The date the worker’s business started and whether the company required the worker to start the business in order to perform services for the company. .2 If the worker markets his or her own business and the means used for marketing. .3 If the worker has a business that is viable beyond the scope of the agreement between the worker and the company for whom the services are currently being performed, including whether: .1 The worker is economically independent from or is substantially dependent upon continued work with the company for whom services are performed. .2 There is a permanent or continuous working relationship between the worker and the company, and any industry-specific conditions relevant to the permanency. .4 If the worker has a business investment such that there is a risk of suffering a loss on the project. .5 If the company for whom services are performed provides tools to the worker, except as allowed by 8-70-115 (1)(c)(VI), while on the project. .6 If the rate and method of payment is negotiated by the parties, is established by the worker, is established by the company for whom services are performed, or is established as part of a contract awarded through a bidding process. .7 If the worker may employ or does employ others to complete the work. .8 If the worker carries his or her own liability insurance, as well as other types of insurance relevant to sustaining the worker’s business. .9 The number of hours per week that the worker performs services for the company. .10 If the worker seeks other work for the worker’s own business in the same field as he or she performs for the company. .11 If the worker has the ability to accept or reject work being offered. .12 If the service provided by the worker is an integral part of the company’s business. 17.1.4 Worker-Business Relationship. .1 The evidence and circumstances must demonstrate that the worker in question is an independent contractor. .2 A worker could still be determined to be in covered employment, even if the worker signs a contract or an agreement, if the facts of the relationship establish that an employment relationship exists. .3 The existence of an agreement between the worker and the company for the workers’ compensation coverage is not determinative of the worker-business relationship for unemployment insurance purposes. 17.1.5 Burden of Proof. The company for whom services are performed has the burden of establishing, by a preponderance of the evidence, that a worker is, in fact, free from control and direction in the performance of the work and is customarily engaged in an independent trade, occupation, or profession related to that work. A written document may establish a rebuttable presumption of independent contractor status only if it includes the applicable factors set forth in § 8-70-115 (1)(c), C.R.S., and the disclosure set forth in § 8-70-115 (2), C.R.S. While an agreement that meets the requirements of § 8-70-115 (1) (c) may shift the burden of proof to the worker or the Division, such an agreement is not, in itself, conclusive of whether the worker is, in fact, an employee or an independent contractor. 17.1.6 Compliance Assistance. A business may request that the Division provide educational information as it relates to proper worker classification. A business has further opportunity to request a nonbinding advisory opinion in accordance with Regulation 17.2. 17.1.7. Industry-Specific Guidelines. The Division may adopt industry-specific guidance in collaboration with industry representatives to address unique factors and situations in that industry. When applicable, the Division considers such guidance, in addition to the applicable law and the regulations in this Part XVII when determining whether an individual is an employee or an independent contractor.

17.2 NONBINDING ADVISORY OPINION 17.2.1 Statutory Reference: 8-72-114 (4), C.R.S. 17.2.2 Issuance of Advisory Opinion. An advisory opinion, described in 8-72-114 (4)(a), C.R.S., shall be issued only if: .1 The employer completes and submits a request for a written advisory opinion using such filing methods as may be prescribed by the division; and .2 Upon submitting the request for a written advisory opinion, the employer must submit a nonrefundable fee of $100; and .3 In conjunction with the request, as solicited by the division, the employer must provide information and evidence as described in 8-70-115, C.R.S. 17.2.3 The Director shall not use an advisory opinion previously issued pursuant to section 8-72-114 (4), C.R.S. for the purposes of initiating an unemployment insurance audit.

17.3 WORKER CLASSIFICATION INVESTIGATIONS AND FINES 17.3.1 Statutory Reference: 8-72-114 (3), C.R.S. 17.3.2 Written Order. Upon conclusion of a requested investigation of misclassification, the division shall issue a written order in conjunction with an audit report including any determination of the existence of an employment relationship. 17.3.3 Appeal From Determination. Any employer who wishes to appeal a determination made under the provisions of this part XVII of the regulations shall file a notice of appeal with the division. A hearing may be obtained in accordance with 8-76- 113, C.R.S., and regulation 11.2. 17.3.4 The Division, prior to committing department resources to a full audit under the provision of this

article, shall take into consideration whether the purported acts of misclassification are inconsistent with section 8-70-115 (1) (b), C.R.S. 17.3.5 Fine. As described in 8-72-114 (3)(e)(III), C.R.S., a fine may be imposed on an employer who misclassified an employee with willful disregard for the law. Such fine shall be imposed in the following manner: .1 For the first instance of such misclassification, an employer shall be fined a minimum of one hundred dollars or one hundred dollars for each day that an employee was misclassified, whichever is greater, but the fine shall not exceed five thousand dollars per misclassified employee. .2 For the second and any subsequent instance of such misclassification, an employer shall be fined a minimum of one thousand dollars or five hundred dollars for each day that an employee was misclassified, whichever is greater, but the fine shall not exceed twentyfive thousand dollars per misclassified employee.

PART XVIII SPECIAL PROGRAMS

18.1 WORK SHARE

18.1.1 STATUTORY REFERENCE: 8-75-203, C.R.S. 18.1.2 criteria for work share plan .1 The director shall deny a work share plan if the employer has seasonal status with the division and any portion of the work share period is during the employer’s off-season. .2 The provisions of section 8-75-203 (1)(b)(i) notwithstanding, the division, at its discretion during an economic crisis or declared state of emergency, may accept a work share plan submitted by a negative excess employer. .3 an employer who has been approved for a workshare plan must reduce hours and earnings for the employees identified on the work share plan by at least ten percent and no more than 50 percent of the employees' regular work hours. any reduction in pay under this section must be proportional to the reduction in hours." 18.1.3.1 work share plan modification an employer can submit a plan modification for a maximum of one new modification every 7 days or no earlier than 7 days after the submission of a plan or plan modification 18.1.4 Work Share Plan Revocation. The director may revoke approval of a work share plan for good cause. A decision of revocation is final and the employer’s re-enrollment is subject to a waiting period pursuant to 18.1.4.1. The revocation order shall be in writing and shall specify the date the revocation is effective and the reasons. Good cause shall include, but not be limited to, violation of any criteria upon which approval of the plan was based, unreasonable revision of productivity standards for the affected unit, or other conduct by the employer that may compromise the

purpose, intent, and effective operation of the plan. 18.1.4.1 Waiting Period After Revocation. An employer that has had a Workshare plan revoked for an affected unit under an approved Workshare plan may not reapply for a new Workshare plan for the affected unit or any employee included in that affected unit for a period of six weeks from the effective date of such revocation. 18.1.4.2 Early Termination of Workshare Plan. An employer that terminates a Workshare plan for any employment unit under an approved Workshare plan shall not be eligible to reapply for a new Workshare plan for the affected unit or to include any employee of that unit for a period of six weeks following the Division’s receipt of the employers notice of intent to terminate the Workshare plan. 18.1.6 Employee Eligibility Under The Work Share Plan .1 An individual who has received all of the work share benefits and regular unemployment compensation benefits available to him or her in a benefit year is an exhaustee for purposes of 8-75-101 C.R.S. and is entitled to receive extended benefits under such sections, provided the claimant is otherwise eligible for such benefits. .2 If an individual who is eligible to receive work share benefits has a prior overpayment, which is still outstanding, the director shall offset such overpayment from work share benefits in accordance with 8-81-101 C.R.S .3 If an individual who is eligible to receive work share benefits has been identified as having outstanding child support obligations, the director shall reduce the work share benefits in accordance with 8-73-102 C.R.S. .4 Wages earned from other part-time work will not reduce benefits and are not reportable. .5 No individual shall be eligible to receive a work share benefit payment for a given week if their work hours in that week are such that their overall reduction in hours from normal would be less than ten percent. In no case shall an individual be eligible to receive a work share benefit payment for a week if their hours of work in that week exceeds thirty-six. 18.1.7 Work Share Program Administration. The administration of the work share program shall be as follows: .1 A work share plan shall be effective on the date it is approved by the director or the first week specified by the employer, whichever is later. .2 A work share plan shall expire twelve months or less after the effective date of the plan. .3 An employer’s chargeability under a work share plan is subject to the provisions of 8-73- 108 (3)(e)(i) C.R.S. .4 An individual who does not work during a week for the work share employer and who is otherwise eligible for benefits shall be paid regular unemployment benefits and the week shall not be counted as a week for which work share benefits were received.

PART XIX OPERATIONS DURING OTHER THAN NORMAL CONDITIONS

19.1 ECONOMIC CRISIS OR DECLARED STATE OF EMERGENCY 19.1.2 Statutory References. 8-70-102, 8-72-109 (1)(A), 8-72-109(2), AND 8-74-101, C.R.S. 19.1.3 Definitions. .1 Executive Orders. The president or the governor or both may use executive orders to trigger emergency powers during natural disasters, energy crises, and other emergency situations requiring immediate attention. .2 Emergency Declarations. The president or the governor or both may declare an emergency in anticipation of or in the event of a natural or man-made disaster; an epidemic, pandemic, or other health emergency; or other emergency situation. 19.1.4 Actions. Notwithstanding other sections of colorado law that may require otherwise, this part XIX shall be implemented at the discretion of the division director in accordance with federal law allowances or at the direction of the governor pursuant to an executive order or in the event of a declared state of emergency as described in section 19.1.3, with the direction being consistent with federal law, the division may: 1 Waive the waiting week as described in regulation 2.8.6. 2 Expand the definition of when an individual is able to work as described by regulation 2.8.2 to comply with orders of an emergency declaration as described in this section 19.1.3. 3 Expand the definition of when an individual is available to work as described by

regulation 2.8.3 to comply with orders of an emergency declaration as described in this

section 19.1.3. 4 Waive, modify, or broaden the work-search requirement as described in 2.8.4. 5 Require that a claimant register for work with the online job database as described by

regulation 2.1.2 and 13.1.4 when the work-search requirement is waived. 6 Extend the period of job attachment as described by regulation 2.4 to a period no longer than the closure required by the crisis or emergency order or declaration. 7 Waive any charges to an employer’s account and experience rate; instead, charge the unemployment insurance compensation fund or another fund established for the purpose of paying benefits for the period of the crisis or emergency. 8 Extend reporting deadlines for employer’s quarterly reports and premium payments when businesses are unable to meet those because: 1 A declared emergency, as described in this section 19.1.3, caused the employer to close their place of business or severely curtail operations. 2 The employer or an immediate family member received a request from a medical professional, local official, or state department to be isolated or quarantined or relocated because of a declared emergency as described in this section 19.1.3. 9 Require a claimant or an employer to submit reports or other correspondence in a preferred manner as dictated by the nature of the crisis or emergency. 10 Extend the protest period for employer’s quarterly statement of benefits charged as described by regulation 11.1.3. 11 Extend the protest period for employer’s notice of premium rate as described by

regulation 11.1.4 12 Extend the protest period for employer’s quarterly bill for benefits charged as described by regulation 11.1.7. _________________________________________________________________________ Editor’s Notes

History Rules 1.2, 1.3, 1.9, 2.1., 7.2, 8, 10.1, 11.1, 11.2.13, 11.2.15, 12.1, 16 eff. 02/01/2009.

Rule 16.1.4 emer. rule eff. 02/06/2009; expired 05/06/2009.

Rules 2.4.5(.1), 2.8.4, 2.8.4(.8) emer. rules eff. 05/29/2009.

Rules 2.4.5(.1), 2.8.4, 2.8.4(.8) emer. rules eff. 08/27/2009.

Rule 2.2.2 eff. 08/30/2009.

Rules 1.2.19-1.2.20, 1.3.22, 1.7.5, 2.4.5.1, 2.8.4, 2.8.4.8, 16.2.2, XVII eff. 10/30/2009.

Rules 1.2.19-1.2.20, 1.6, 1.11, VI, 7.2, VIII, XI, XII, XVI eff. 12/30/2009.

Rules 2.6; IV; 11.2.2 emer. rules eff. 12/31/2009; expired 03/31/2010.

Rules 2.6; IV; 11.2.2 emer. rules eff. 04/02/2010.

Rules 1.2.21-1.2.22; 2.6, IV, 11.2.2, 17.1.4-17.1.5 eff. 05/31/2010.

Rules 1.3.23-1.3.30; Part XVIII emer. rules eff. 06/09/2010.

Rules 1.3.23-1.3.30; Part XVIII eff. 09/30/2010.

Rules 1.3.31, 2.1.12, 6.1.7 emer. rules eff. 11/30/2010.

Rules 1.3.31, 1.8, 2.1.12, 6.1.2, 6.1.7, 7.2.4, 15.2.2 eff. 03/31/2011.

Rules 1.2.23, 2.8.4 eff. 01/01/2012.

Rules 6.1.2, 7.2.4 emer. rules eff. 01/25/2012; expired 05/24/2012.

Rules 1.2.24, 1.2.25, 7.2.6, 7.2.8, 7.2.11, 11.2.9, 11.2.14, 11.2.15, 12.1.3, 12.1.7, 12.1.8, 17 eff. 04/01/2012.

Rules 1.2.26, 6.1.2, 7.2.4 eff. 05/30/2012.

Rules 1.2.27, 1.3.10-1.3.26, 6.1.2, 6.1.5, 7.2.5, 16.2.2, 18.1 eff. 07/30/2012.

Rules 1.2.23-1.2.24, 1.2.26, 1.2.28, 1.3.2, 2.6.4, 6.1.7 eff. 09/14/2012.

Rules 1.2.29, 2.9, 4.1.2, 11.1, 11.2.9, 11.2.15 eff. 05/15/2013. Rules 1.7.5, 15.2.7.7 repealed eff. 05/15/2013.

Rules 4.2, 15.2.7.7 eff. 08/01/2014.

Rule 2.8.4.4 a emer. rule eff. 01/19/2016.

Rule 2.8.4.4 a eff. 05/15/2016.

Rule 2.6.5 emer. rule eff. 09/01/2016.

Rules 2.1.10-2.1.11, 2.3.2-2.3.4, 2.6.1, 2.6.5 eff. 12/15/2016. Rule 2.6.4 repealed eff. 12/15/2016.

Rules 17.1, 17.3 emer. rules eff. 01/09/2017; expired 05/09/2017.

Part XVII eff. 07/01/2017.

Rules 11.2.13, 12.1.3-12.1.6 emer. rules eff. 09/05/2017; expired 12/12/2017.

Rules 11.2.13, 12.1.3-12.1.7 eff. 12/30/2017.

Rule 2.8.4 eff. 06/03/2018.

Rules 2.1.10, 7.2.4, 7.2.5, 7.4, 12.1.7, 12.1.8 eff. 09/14/2018.

Rules 2.3.2.1, 2.3.2.2, 2.9.3, 15.3 emer. rules eff. 01/17/2019; expired 05/17/2019.

Rules 11.2.9, 11.2.13, 12.1.3 eff. 04/15/2019.

Rules 2.1.7.5, 2.4.5.2, 2.8.4.12, 2.8.5, 4.3, 6.1.2.2, 7.2.4.2 emer. rules eff. 03/20/2020.

Rules 1.9, 7.2.6, 11.2.4, 11.2.9, 11.2.13, 12.1.7, 13.2.9.6 eff. 04/14/2020. Rules 2.1.6.1, 7.2.12, 7.3.6, 18.1.1, 18.1.2.2, 18.1.3, 18.1.7.2-.3,.5 emer. rules eff. 04/14/2020; expired 08/12/2020.

Rule 4.3.2 emer. rule eff. 04/27/2020.

Rules 4.3.2.1.4, 4.4.1-4.4.3.2.2 emer. rules eff. 05/06/2020; expired 09/03/2020.

Rule 18.1.7 emer. rule eff. 05/08/2020.

Rules 2.1.7.5, 2.4.5.2, 2.8.4.12, 2.8.4.13, 2.8.6, 4.3, 4.3.1.2, 4.3.1.3, 6.1.2.2, 7.2.4.2 emer. rules eff. 06/03/2020; expired 10/01/2020.

Rules 18.1.1, 18.1.2, 18.1.3.1, 18.1.6.4-.6, 18.1.7.2-.3 emer. rules eff. 09/15/2020.

Rules 2.8.6, 7.3.2, 7.4.2.3, Part XIX eff. 10/30/2020. Rule 2.8.4.11 repealed eff. 10/30/2020.

Rules 18.1.1, 18.1.2, 18.1.3.1, 18.1.6.4-.6, 18.1.7.2-.3 emer. rules eff. 01/05/2021; expired 05/05/2021.

Rules 1.3.27, 2.10 emer. rules eff. 05/04/2021; expired 09/01/2021.

Rules 2.8.4.13, 18.1.1, 18.1.2, 18.1.3.1, 18.1.6.4-.6, 18.1.7.2-.3, 19.1.4.4, 19.1.4.10-.12 eff. 06/30/2021.

Rules 2.1.7, 2.1.10.2, 2.3.2, 6.2.2, 6.2.3, 7.2.4-7.2.6, 7.2.11, 13.2.9.5, 15.1, 15.2, 18.1.2.3, 18.1.3.1, 18.1.7 eff. 10/01/2023. Rules 15.2.7, 18.1.6.6 repealed eff. 10/01/2023.

Rules 4.2.2, 4.2.3, 7.2.4, 7.2.6, 7.2.9, 7.4.3, 15.0-15.02, 15.3-15.3.5, 18.1.4, 18.1.4.1, 18.1.4.2 eff. 09/30/2024. Rule 18.1.5 repealed eff. 09/30/2024.

Rules 2.1.1-2.1.3.3.2 emer. rules eff. 01/25/2025; expired 04/22/2025.

Rules 2.1.1-2.1.3.3.3 eff. 05/20/2025.

1101 Division of Labor Standards and Statistics (Includes 1103 Series)

7 CCR 1101-1 Labor Peace and Industrial Relations (lpir) Rules {#sec-7-ccr-1101-1 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-1}

DEPARTMENT OF LABOR AND EMPLOYMENT

LABOR PEACE AND INDUSTRIAL RELATIONS (LPIR) RULES

7 CCR 1101-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted May 11, 2023; effective July 1, 2023.

Rule 1. Statement of Purpose and Authority 1.1 The general purpose of these Labor Peace and Industrial Relations Rules is to exercise the

authority of the Department of Labor and Employment and the Division of Labor Standards and Statistics to administer and enforce the provisions of the Industrial Relations Act (“IRA”), Colorado Revised Statutes (C.R.S.) Title 8, Article 1 (2023), C.R.S. § 8-1-101 et seq., and the Labor Peace Act (“LPA”), C.R.S. Title 8, Article 3 (2023), C.R.S. § 8-3-101 et seq. These rules are intended to be consistent with the rulemaking requirements of the State Administrative Procedure Act, C.R.S. § 24-4-103. 1.2 The Director of the Division of Labor Standards and Statistics in the Department of Labor and Employment has authority to enforce, interpret, apply, and administer the provisions of C.R.S.

Title 8, Articles 1 and 3 and these rules. 1.3 Incorporations by Reference. The Industrial Relations Act, C.R.S. § 8-1-101 et seq., and the Labor Peace Act, C.R.S. § 8-3-101 et seq., are hereby incorporated by reference into these rules.

Earlier versions of such laws may apply to events that occurred in prior years. Such incorporation excludes later amendments to or editions of the statutes. These statutes are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, 633 17th Street, Denver CO 80202. Copies may be obtained from the Division of Labor Standards & Statistics at a reasonable charge. Electronic access is available from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of the statutes incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Division rules are available to the public at www.coloradolaborlaw.gov. Where these rules have provisions different from or contrary to any incorporated or referenced material, the provisions of these rules govern so long as they are consistent with Colorado statutory and constitutional provisions. Where these rules reference another rule, the reference shall be deemed to include all subparts of the referenced rule. 1.4 Separability. These rules are intended to remain in effect to the maximum extent possible. If any

part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the rule remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form.

Rule 2. Definitions and Clarifications 2.1 “All-union agreement” (“AUA”) means a contractual provision between an employer or group of employers, and a collective bargaining unit representing some or all employees, providing for any type of union security and compelling an employee’s financial support or allegiance to a labor organization as described in C.R.S. § 8-3-104(1.5). 2.2 “Authorized representative” means a person designated by a party to any labor-management dispute, unfair labor practice complaint, election petition, or other Division administrative proceeding to represent the party. A party may designate an authorized representative by filing the Division-approved form or by a signed written notice to the Division that the authorized representative will represent the party. Authority of the authorized representative may be revoked by the designating party upon written notice to the Division. 2.3 “Collective bargaining agreement” (“CBA”) is a contract or agreement between an employer or group of employers and a collective bargaining unit representing some or all employees. 2.4 “Collective bargaining unit” (“CBU”) or “bargaining unit” has the meaning as defined in C.R.S. § 8- 3-104(4). 2.5 “Director” means the Director of the Division of Labor Standards and Statistics, and includes a designee or agent the Director selects to perform any delegable functions of the Director under

authority granted by any applicable law, including but not limited to C.R.S. § 8-1-103(1). 2.6 “Division” means the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment. 2.7 “Employee” has the following definitions: 2.7.1 Under the Industrial Relations Act, C.R.S. § 8-1-101(6), an “employee” means every person in the service of an employer, under any contract of hire, express or implied, not including an elective official of the state, or of any county, city, town, irrigation, drainage, or school district thereof, and not including any officers or enlisted men of the National Guard of the state of Colorado. 2.7.2 Under the Labor Peace Act:

(A) “Employee” means any person working for another for hire in the state of Colorado in a non-executive or non-supervisory capacity and is not limited to the employees of a particular employer under C.R.S. § 8-3-104(11)(a). The analysis of “non-executive” is guided by the definition of “managerial” under the policies of the National Labor Relations Board (“NLRB”) and the analysis of “nonsupervisory” is guided by the definition of “supervisor” under the National Labor Relations Act (“NLRA”), 29 U.S.C. § 152(11).

(B) “Employee” includes any individual whose work has ceased solely as a consequence of or in connection with any current labor dispute or because of any unfair labor practice on the part of an employer and who otherwise meets the conditions of C.R.S. § 8-3-104(11)(a)(II).

(C) An “employee” does not include an independent contractor (as defined and applied by the Colorado Wage Act, C.R.S. § 8-4-101(5)), an individual employed by the individual’s parent or spouse, or domestic servants employed in and about private homes.

(D) With respect to agricultural workers, “employee” includes an employee of an agricultural employer under C.R.S. §§ 8-3-104(1)(a) and 104(12)(a)(II)(B), as amended by the Agricultural Labor Rights and Responsibilities Act, Colorado SB 21-087. An employee of a marijuana licensee is an agricultural worker when the employee is a farm laborer at a site (e.g., farm, plantation, ranch, nursery, range, greenhouse, orchard, or other structure) used for the raising of agricultural or horticultural commodities, as long as the structure is utilized for at least 50% of the total output produced, as defined by the Colorado Marijuana Code, C.R.S. § 44-10-105. “Employee” does not include a parent, spouse, or child of an agricultural employer’s immediate family. 2.8 “Employer” has the following definitions: 2.8.1 Under the Industrial Relations Act, C.R.S. § 8-1-101(7), an “employer” means:

(A) the state, and each county, city, town, irrigation, and school district therein, and all public institutions and administrative boards thereof having four or more employees; and (B) every person, association of persons, firm, and private corporation, including any public service corporation, manager, personal representative, assignee, trustee, and receiver, who has four or more persons regularly engaged in the same business or employment, except as otherwise expressly provided by the IRA, in service under any contract of hire, expressed or implied.

(C) The IRA is not intended to apply to employers of private domestic servants or farm and ranch labor; nor to employers who employ less than four employees regularly in the same business, or in or about the same place of employment. 2.8.2 Under the Labor Peace Act:

(A) An “employer” means, under C.R.S. § 8-3-104(12), a person who regularly engages the services of eight or more employees, other than persons within the classes expressly exempted in section 104(11), and includes:

(i) Any person acting on behalf of an employer within the scope of the employer’s authority, express or implied; and (ii) An agricultural employer.

(iii) “Employer” does not include any labor organization or anyone acting on behalf of that organization other than when the labor organization is acting as an employer-in-fact.

(B) An “agricultural employer” means, under C.R.S. § 8-3-104(1)(a), a person that:

(i) Regularly engages the services of one or more employees or contracts with any person who recruits, solicits, hires, employs, furnishes, or transports employees; and (ii) Is engaged in any service or activity included in section 203(f) of the federal “Fair Labor Standards Act of 1938,” 29 U.S.C. § 201 et seq., as amended, or engaged in “agricultural labor” as defined in section 3121(g) of the federal “Internal Revenue Code of 1986,” as amended. 2.9 “Exclusive representative” means the labor organization certified as the representative of employees in a collective bargaining unit under the Labor Peace Act. 2.10 “Mail” refers to first-class mail sent through the United States Postal Service, postage prepaid. 2.11 “Order” means any decision, rule, regulation, requirement, or standard promulgated by the Director, as defined by C.R.S. § 8-1-101(11). 2.12 “Person” refers to one or more individuals, an employee, a labor organization, partnerships, associations, corporations, legal representatives, trustees, or receivers.

Rule 3. Notices by Employers 3.1 Whenever notice is required to be given to employees by these rules, notice shall mean the posting and distribution of required information. 3.2 Posting means to display in conspicuous places frequented by employees on the employer’s premises, at places customarily used for the posting of employee notices, and where such notice may be easily read during the workday, such as in break rooms, on employee bulletin boards, and/or adjacent to time clocks, department entrances, and/or facility entrances, and on any electronic bulletin boards or other means of electronic notice used by the employer. 3.3 Notice must be provided electronically to any employees with whom the employer customarily communicates through electronic means. 3.4 In all employment situations where employees are engaged in their duties away from the employer’s principal or permanent place of business, notice shall be given in writing by such methods as shall reasonably be calculated to apprise all affected employees of such notice. This may include posting of the notice at remote sites, such as on construction sites, and distributing individual written or electronic copies of the notice to employees. 3.5 If posting and distribution in the manner set forth in Rules 3.2-3.4 cannot reasonably be effectuated to reach all employees, the Director may order any other reasonable means of giving notice, e.g., providing employees with individual written or electronic copies of the notice.

Rule 4. Filing, Service, and Deadlines 4.1 Documents shall be filed electronically, on a Division-approved form if one is available, pursuant to these rules and any orders, instructions, and deadlines provided or published by the Division. If the Division does not publish an applicable form or provide one when the party intends to file, or if a party cannot readily use such means for filing, the party may file documents by any other means that provide the filing to the Division, including but not limited to email, other electronic means, or mailing or hand-delivering paper copies. A document is considered “filed” when received by the Division; any document received after 11:59 p.m. Mountain Time is considered “filed” the next business day. 4.1.1 Any submission is considered “signed” or to have a “signature” if it has either an ink, scanned, or electronically drawn or generated signature, or a typed name entered by the party or their authorized representative in the signature area. By signing in any such manner, the individual is deemed to have agreed and assented that the document is signed by them. 4.1.2 Handwritten signatures verifying identification and voter eligibility are required on envelopes for mail ballot elections. Typed or electronically drawn or generated signatures will not be accepted. 4.2 Except as otherwise provided by these rules, or by the Director, whenever service of a document is required, service is made to a person or party by hand-delivery, mail, or transmission by facsimile, or other electronic means. The email address or facsimile number on file with the Division or furnished by the person or party shall be used for service. The current address on file with the Division or the last known address of the person or party shall be used for mailing. 4.3 The calculation of any period of time prescribed or allowed by these rules shall be done in accordance with C.R.S. § 2-4-108. 4.4 Deadlines and schedules under these rules shall generally be set considering the goals of the LPA and IRA, including, but not limited to: effective enforcement of all rights and responsibilities provided by the LPA and IRA; providing all parties notice and opportunity to be heard; and conducting elections as soon as practicable. Deadlines may be extended for “good cause” if the request is made three days before the deadline, absent emergencies or exigent circumstances. In considering whether good cause exists under these rules or applicable statutes for extensions of deadlines, the Director will determine whether the reason is substantial and reasonable, based on all the available information and circumstances pertaining to the matter.

Rule 5. Elections 5.1 Types of Elections. 5.1.1 Collective Bargaining Unit Election. A collective bargaining unit or representation election determines whether a labor organization shall be certified (or decertified) as the exclusive representative of all employees in a bargaining unit.

(A) Certification. The labor organization shall be selected as the exclusive representative for the proposed collective bargaining unit if a majority (over 50%) of all eligible employees cast ballots (the majority turnout requirement of C.R.S. § 8-3-107(1)), and a majority of those votes are cast in favor of representation (the majority rules requirement of C.R.S. § 8-3-104(4)). If both majorities are attained, the Division shall certify the labor organization as the exclusive representative.

(B) Decertification. The same procedures for certification apply to decertification of an existing labor organization.

(C) Collective bargaining units selected pursuant to C.R.S. § 8-3-107 and certified by the Director may be clarified or modified, as follows:

(1) Questions of interpretation as to coverage of particular employees or positions in an existing unit may be submitted to the Director. Notice of the clarification request shall be provided to the employer, the exclusive representative of the certified unit with the coverage question, and any employees whose coverage is in question. Any parties notified of the request may respond within 14 days, absent an extension for good cause shown. The Director’s clarification is a final agency action under C.R.S. § 24-4-106.

(2) Requests to modify the scope of a unit (e.g., to add additional employees not already covered, or to subtract already-covered employees) will be determined by secret ballot election following the procedures for representation elections. 5.1.2 All-Union Agreement Election. An all-union agreement election determines whether an employer and labor organization are authorized to negotiate an all-union agreement, or union security clause, during collective bargaining.

(A) Authorization for an all-union agreement is approved by an affirmative vote of at least a majority of all employees eligible to vote, or three-quarters or more of employees who actually vote, whichever is greater. The election results shall be construed as granting or denying authorization to the employer and labor organization to enter any form of all-union agreement, except as provided in C.R.S. § 8-3-109(3), in initial and subsequent collective bargaining agreements between the same parties.

(B) Revocation of an All-Union Agreement.

(1) Petitions to revoke an all-union agreement may be filed by the employer or 20% of the covered employees. Petitions shall be filed between 105 and 120 days prior to the end or third anniversary of the collective bargaining agreement. The Director shall verify the petition’s sufficiency, including petitioners’ employment, status, and eligibility without disclosing the identity of the petitioning employees.

(2) The Director may conduct an election for revocation of an all-union agreement within a collective bargaining unit only once during the term of a collective bargaining agreement or once every three years in the case of agreements for a term of over three years.

(3) Revocation of an all-union agreement is approved by an election following the same procedures as an all-union agreement election, with all employees covered by the all-union agreement eligible to vote. The Division must complete the election within 60 days prior to the end or third anniversary of the collective bargaining agreement.

(C) Construction Industry. Certification and ratification of all-union agreements in the construction industry.

(1) A request for certification of an all-union agreement, entered into by an employer and a labor organization, and limited to employees engaged in the building and construction industry, may be filed by an employer, employee, or labor organization, or their authorized representative, as provided in C.R.S. §§ 8-3-108(1)(c)(II)(B) and 8-3-109(3).

(2) A request for certification shall include a copy of the signed all-union agreement or, if a signed copy is unavailable, an unsigned copy with a declaration under penalty of perjury that the parties executed the agreement.

(3) In the case of an all-union agreement, including multi-employer groups or associations, the request for certification shall include a list of the members of the group or association that delegated their bargaining rights, and/or the names of employers that, although they have not delegated bargaining rights to a group or association, individually signed such agreements, together with the addresses of such employers.

(D) If the all-union agreement complies with the provisions of C.R.S. § 8-3-109(3), the Director will certify the agreement and furnish written notice to the requesting party and all other parties of interest. The original certification of the all-union agreement shall be retained by the Division.

(E) If the Director does not certify the all-union agreement, the Director shall give written notice to the requesting party, signatories to the agreement, and all other parties of interest stating the reasons for not certifying, or set the matter for hearing prior to issuing such determination.

(F) Within two weeks of the date of certification by the Director, the employer, or in the case of multi-employer associations, each member or signatory employer, shall post and distribute written notice to all employees covered by the certified all-union agreement indicating that the agreement has been ratified and certified pursuant to the provisions of the Labor Peace Act. Under C.R.S. § 8-3- 108(1)(c)(II)(D), the notice shall explicitly state that 20% of the covered employees may demand an all-union agreement election within 45 days of the Director’s certification following the same procedures for an all-union agreement election. Proof that notice was given shall be filed with the Director within 20 days. 5.2 Election Petitions. 5.2.1 Election petitions shall be filed with the Division using the approved form(s) and in compliance with any instructions specified by the Division. For an all-union agreement election, certification of the collective bargaining unit by the NLRB or the Division, or other written evidence of voluntary recognition, shall be submitted with the petition. 5.2.2 Unless otherwise specified, election petitions may be filed by a single employee, a group of employees, an employer, or any person or organization with permission from one or more employees to file a petition on their behalf. 5.2.3 The Division shall not disclose the names of any employees who sign or file election petitions themselves or through another person or entity. 5.2.4 The fact that one election has been held shall not prevent the holding of another election of the same type among the same group of employees, if it appears to the Director that sufficient reasons exist (except for an election to revoke an all-union agreement, as provided in Rule 5.1.2(B)). The Director will presume that sufficient reasons exist if all the following apply:

(A) One year or more has passed since the conclusion of balloting and voting in a prior election of the same type;

(B) The proposed election is not during the term of a CBA with a term of under three years or within the first three years of a longer CBA; and (C) The petitioner is not a party to the CBA currently in effect. 5.3 Processing Election Petitions and Issuing Notice of Petition for Election. 5.3.1 Upon filing of an election petition, the Director will determine whether the Division has

authority to conduct the election and evaluate the sufficiency of the petition including any supporting documentation (e.g., NLRB certification). The Director may request additional information or documentation in support of the petition. The determination of the sufficiency of an election petition under this rule is an administrative determination, not a final agency action, and therefore is not subject to appeal until after final certification of an election, pursuant to Rule 5.8.4. 5.3.2 When the election petition is deemed sufficient, the Director shall:

(A) Issue a notice of petition identifying the bargaining unit and the petitioner, unless confidential; explaining the election process; and advising employees of their rights under the LPA. The employer shall post and distribute such notice in accordance with Rule 3.

(B) Schedule a pre-election conference with the parties for the purpose of setting the election date(s) and time(s); determining election procedures; and identifying the employees eligible to vote. In the event the parties are unable to agree, the Director shall set the date(s) and time(s) of election and determine the election procedures. Elections may be conducted in-person, by mail, and/or by other means the Director determines to be appropriate.

(C) Direct the employer to furnish a tentative poll list of the employees eligible to vote in the election to the Division, the labor organization, and any other interested party before the pre-election conference. The employee list shall include full employee names, work locations, shifts, job titles or classifications, home addresses, personal email addresses, home telephone numbers, and personal cell phone numbers (in spreadsheet format) as of the last date of the payroll period immediately preceding the date the petition was filed, unless otherwise directed by the Director. 5.3.3 In the event the employer or other party fails or refuses to furnish requested information for purposes of determining the employees eligible to vote, or for finalizing a proper poll list, the Director may demand a voter list based on an employer’s or other party’s obligation to furnish information under the IRA. 5.4 Challenges to Election, Collective Bargaining Unit, or Qualified Voters. 5.4.1 Within one week after posting and distributing the notice of petition, employees shall notify the Division of their desires to be included or excluded from the bargaining unit proposed, or their requests for a separate bargaining unit by craft, division, department, or plant. 5.4.2 Any party challenging an election petition, the proposed bargaining unit, or the employees eligible to vote as shown on the tentative poll list shall file a position statement with the Division, and serve a copy to all other parties, at least three business days prior to the pre-election conference. The Director may:

(A) resolve the challenge and proceed with the pre-election conference; or (B) reschedule the pre-election conference if any other party requests to file a written response or if additional information is necessary to resolve the challenge. 5.4.3 The resolution of a challenge under this rule is an administrative determination, not a final agency action, and therefore is not subject to appeal until after final certification of an election, pursuant to Rule 5.8.4. 5.5 Notice of Election and Qualified Voters. 5.5.1 At least one week before the established election date, the Director shall issue a notice of election with the tentative poll list. The employer shall post and distribute the notice of election with the tentative poll list in accordance with Rule 3. 5.5.2 The notice of election shall describe the election to be conducted (i.e., CBU or AUA); identify the petitioner, unless confidential; specify when (i.e., dates and times), where, and how the secret ballot election will be conducted; specify the bargaining unit and the employees eligible to vote; and advise employees of their rights under the LPA and these rules.

(A) For collective bargaining unit (representation) elections, the notice of election shall include a description of the proposed bargaining unit or units to be formed (e.g., included and excluded unit classifications).

(B) For an all-union agreement election, all employees in the unit proposed to be covered by an all-union agreement shall be eligible to vote. 5.5.3 At least 72 hours before the election, or as ordered by the Director, the employer shall, and other parties may, furnish any updates to the tentative poll list reflecting the employees eligible to vote in the election to the Division, the labor organization, and any other interested party. 5.5.4 The Director shall certify a final poll list of qualified voters not later than 24 hours nor earlier than 48 hours preceding the time of balloting (or the mailing of ballots). The certified poll list shall then be posted with the notice of election and shall be available in the office of the Director and to any interested party. 5.5.5 At any time prior to certification of a final poll list, the Director may order any party to provide further information the Director deems relevant to finalizing the poll list. 5.6 Conduct of Elections. 5.6.1 The Director shall prepare suitable notices and ballots for any election held under these rules.

(A) For a representation election, the secret ballot shall contain the name of any eligible labor organization(s) seeking to be the exclusive representative, and a choice of “no representation” for employees who do not desire representation.

(B) Notices and ballots for any election shall be in English and Spanish if any party or eligible voter credibly indicates, at or before the pre-election conference, that any voters need Spanish-language ballots. Any party or eligible voter may request ballots in any other language, and the Director shall endeavor to so provide, if possible, in the time provided. 5.6.2 The Director may establish more than one suitable polling place for the same election, and may either provide a separate suitable ballot box and election officials for each place, or establish different times for reception of ballots by the same election officials at different places. In either event, the notice posted at each polling place shall specify the day and hours when ballots may be cast. The Director will establish sufficient safeguards to ensure that multiple ballots will not be cast by the same voter. 5.6.3 Each eligible labor organization and each employer may designate one election observer; additional observers may be permitted upon good cause shown to the Director at least three days before the election. The Director, the Director’s designees or agents, and the designated observers shall be the only individuals allowed to observe the check-in of qualified voters as compared to the certified poll list and remain at the polling place during balloting. Supervisors, management, and paid union officials shall not serve as election observers but may be present for counting of ballots. 5.6.4 Copies of the certified polling list shall be in the possession of the Director during balloting. Only employees named on the certified poll list and currently employed shall be entitled to vote at the election. 5.6.5 If any employee is unable to prepare the ballot due to insufficient literacy or familiarity with the language(s) of the ballots, or for any other reason, the employee may be assisted in preparing the ballot by the Director. 5.6.6 Electioneering shall not be permitted within 50 feet of the polling place for in-person balloting and is defined as: (1) any communication, whether verbal, written, electronic, or in any other format, (2) which unambiguously refers to a candidate, and is disseminated to the members of the eligible voting electorate in a representation or decertification election conducted under these rules. 5.6.7 For in-person balloting, at the time specified in the election notice for the closing of balloting, the Director shall receive the ballots of those employees present at the polling place, and no others. 5.7 Challenges to Ballots. 5.7.1 Designated election observers may challenge the right of any person to vote upon the grounds of either: identity (i.e., whether they are or are not a person on the certified poll list); or ineligibility due to separation from employment (other than an unlawful termination) or other job change. If the validity of a challenge cannot be resolved at the time of balloting, then the challenged ballot may be cast. 5.7.2 Any challenged ballot will be retained by the Director in a sealed envelope. After securing all ballots to ensure election integrity and secrecy of the votes, the Director shall receive evidence as to voter eligibility from the parties and attempt to resolve any challenges.

(A) The Director need not resolve whether the challenged ballots should be counted under this rule if the challenged ballots are insufficient in number to affect the results of the election.

(B) If insufficient evidence is presented for the Director to determine whether to count the challenged ballots, all ballots cast will be sealed in the ballot box and secured by the Director, and the parties will have one week to submit any additional evidence that may assist the Director in resolving challenged ballots.

(C) If no decision is reached after consideration of the parties’ submissions, the Director shall cause the matter to be heard at a hearing for resolution.

(D) Challenged ballots determined by the Director to be invalid shall be declared void and disregarded. Challenged ballots determined by the Director to be valid shall be mixed with unchallenged ballots for counting. 5.7.3 The resolution of a challenge under this rule is an administrative determination, not a final agency action, and therefore is not subject to appeal until after final certification of an election, pursuant to Rule 5.8.4. 5.8 Counting of Ballots and Certification of Results. 5.8.1 At the pre-election conference or before the conclusion of balloting, the Director shall determine and notify the parties of a time and place at which the ballots will be counted.

Each eligible labor organization and each employer may designate one observer for the ballot count; additional observers may be permitted upon good cause shown to the Director at least three days before the ballot counting. 5.8.2 The Director shall disregard, and record as a void ballot, any ballot (A) on which the vote(s) cast cannot be reliably determined (e.g., blank ballots, conflicting marks, inconsistent votes, and/or lack of clear indication of voter intent), or (B) that the Director finds to be spurious or otherwise legally invalid. 5.8.3 After the counting of ballots, the Director shall prepare election certificates containing a tabulation of the ballots cast and certifying the results of the election, which shall be served on all parties. Ballots will be maintained in a sealed container at the Division until one month after: (A) expiration of the deadline to file and serve any appeal or other legal challenge to the outcome or any aspect of the election; or (B) final judgment has been rendered on the merits in any appeal or other legal challenge to the election and all appeal rights have been exhausted, whichever is later. 5.8.4 Within one week after certification of the election results, any party may file an appeal in writing with the Director to review the certification based on error or fraud with regard to the results certified therein. The Director will serve a copy of the appeal on all interested parties, giving the non-filing parties one week to file and serve written responses. The Director may extend these deadlines for good cause shown in accordance with Rule 4.4.

The Director may set the matter for hearing, require additional submissions and/or evidence from any party, or issue a final decision without a hearing based on the filings.

Absent timely modification by the Director, the certification shall constitute final agency action, and the final decision of the Director, subject to judicial review pursuant to C.R.S. § 24-4-106.

Rule 6. Unfair Labor Practices 6.1 Filing an Unfair Labor Practice Complaint. Complaints may be filed in the Division or in court; the Division will not exercise jurisdiction over complaints that were or are being adjudicated in court. 6.1.1 Unfair labor practice complaints shall be filed on the designated form provided by the Division, and shall comply with any other Division instructions as to the information and/or documentation required by the Division.

(A) The aggrieved party filing an unfair labor practice complaint shall be designated the charging party. The party against whom an unfair labor practice complaint is filed shall be designated the respondent(s).

(B) Either party may designate an authorized representative to act on their behalf in the Division’s complaint and/or appeal process in accordance with Rule 2.2.

(C) An unfair labor practice complaint (or charge) must be received by the Division within six months after the date on which the charging party knew or reasonably should have known of the alleged unfair labor practice.

(D) The charging party shall set forth a clear and concise statement of the facts constituting the unfair labor practice and the statutes allegedly violated.

(E) Failure to respond in a timely manner to requests from the Division for additional supporting information and/or documentation may result in dismissal of the unfair labor practice complaint.

(F) The Director may initiate, file, and investigate any such complaint on their own initiative, or at the request of any interested party. The name or interest of any such party shall not be disclosed. Decisions under this rule are within the discretion of the Director’s authority to enforce and administer the LPA, these rules, and other applicable statutes and rules. 6.1.2 The Division will evaluate unfair labor practice complaints to determine if the Division has jurisdiction over the alleged conduct and if sufficient allegations and evidence has been shown from which an unfair labor practice may be reasonably inferred. 6.1.3 If the unfair labor practice complaint provides insufficient evidence, the Division will notify the charging party and may request additional information and/or documentation. The date the charging party provides all the information and/or documentation necessary to support the complaint will be used to calculate the time prescribed in C.R.S. § 8-3-110(2) for the hearing, if any. 6.1.4 A charging party may withdraw an unfair labor practice complaint at any time prior to issuance of a determination. 6.2 Notice of Unfair Labor Practice Complaint to Respondent(s). 6.2.1 After determining that a charging party’s unfair labor practice complaint contains sufficient allegations and evidence that, if proven true, would state a claim of an unfair labor practice, the Division shall give notice of the allegations and request an answer be filed by each respondent. 6.2.2 The respondent shall file an answer responding to each allegation in the complaint and attach any documentation or evidence the respondent wishes the Division to consider in reviewing the complaint, within 21 days of the date the Division sends a copy of the complaint to the respondent. The Division may exercise discretion to shorten the response deadline. 6.2.3 Upon receiving a request in writing stating the reason an extension is required, the Division may, at its discretion, extend the period for the respondent to file an answer to the complaint for good cause in accordance with Rule 4.4. 6.2.4 Upon written request, at the Division’s discretion, other parties or entities may be designated as intervenors or may be joined as charging parties or respondents. 6.3 Investigation and Initial Determination of Unfair Labor Practice Complaints. 6.3.1 Upon receipt of the unfair labor practice complaint, the answer, and any supplemental information or documentation, the Director shall determine whether additional investigation is required. In the event further investigation is required, investigatory methods used by the Division may include, but are not limited to:

(A) Interviews of the employer, employee(s), and other parties;

(B) Information gathering, fact-finding, and reviews of written submissions; and (C) Any other lawful techniques that enable the Division to assess whether an unfair labor practice occurred. 6.3.2 During the investigation, if information is provided to the Division by a source requesting confidentiality, and that information is used only as a basis for procuring other evidence, but not offered as evidence itself, then the source shall remain confidential. 6.3.3 The Director may exercise discretion to adjourn the hearing prescribed in C.R.S. § 8-3- 110(2) to permit additional time for submissions by the parties; extensions for good cause or by consent; evaluation of the submissions and supporting information and/or documentation; and to issue orders disposing of the complaint without a hearing. 6.3.4 Where a complaint or investigation for violation of these rules or the statutes they enforce has been filed or commenced, all parties shall preserve all relevant documents until final disposition and until the expiration of the statutory period within which a person aggrieved may bring a civil action. 6.3.5 The Division may exercise its discretion to have an investigation sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations and/or phases of the investigation. 6.3.6 The burden of proof to establish an unfair labor practice is on the charging party, who must establish by a preponderance of the evidence that an unfair labor practice has been committed. 6.3.7 The Division shall make a determination as to whether an unfair labor practice has been committed and report its recommended findings and proposed orders to the Director, which shall be sent to all parties. 6.3.8 Absent a request for a hearing within 35 days of the determination, the recommended findings of fact and conclusions of law, and proposed orders of the Division, shall be deemed those of the Director and shall constitute final agency action. A party may seek judicial review of the final agency decision pursuant to C.R.S. § 24-4-106. 6.3.9 Determinations by the Division may include the following proposed remedies, as supported by the recommended findings:

(A) order(s) to cease the unfair labor practice, effectuate compliance by modifying or rescinding existing policies, practices, or agreements, and/or otherwise redress direct or indirect consequences of unfair labor practices, as authorized by the LPA, the IRA, and/or other statutes on Division investigative and enforcement

authority;

(B) periodic reports showing compliance with the orders;

(C) suspension of rights, immunities, privileges, or remedies granted or afforded by the LPA for one year pursuant to C.R.S. § 8-3-110(7);

(D) termination of an AUA agreement pursuant to C.R.S. § 8-3-108(1)(c)(III)(A);

(E) reinstatement of employee(s) with or without pay, as deemed appropriate; and (F) any other remedies or relief authorized by law, including but not limited to C.R.S.

Title 8, Articles 1, 3, 4, 6, and 13.5. 6.4 Unfair Labor Practice Hearing. 6.4.1 Either the charging party or respondent may request a hearing within 35 days after the Division’s initial determination of an unfair labor practice complaint. A valid hearing request is a written statement that is timely filed with and received within 35 days by the Division, explains the basis for the request, and has been signed by a party or authorized representative. 6.4.2 The hearing officer (including an Administrative Law Judge) shall have the power and

authority to:

(A) review the recommendations and proposed orders in the initial determination de novo;

(B) call, preside at, and conduct hearings, which may be held by phone or other remote means;

(C) certify to official acts, administer oaths and affirmations, order and take depositions, or otherwise question witnesses;

(D) issue subpoenas to compel the attendance of witnesses and the production of books, papers, correspondence, memoranda, and other records deemed necessary as evidence;

(E) sequence and/or divide the hearing into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more hearings, decisions, and/or phases of the hearing; and (F) issue interim orders requiring the parties to identify or narrow the disputed issues requiring a hearing. 6.4.3 Upon receipt of the hearing request, the Division will notify the parties of the date of the hearing and any interim deadlines, and send a copy of the request and a copy of the record of its investigation to the parties by mail or email. All evidence submitted to the Division during the investigation is part of the record and need not be resubmitted. 6.4.4 The parties may submit new testimonial evidence, which is defined as any evidence that is elicited through the statements of individual witnesses, to the hearing officer in accordance with deadlines imposed by the Division. New evidence must be provided to all other parties to the unfair labor practice claim. New evidence that is not provided to all other parties may be excluded from the record under consideration at the hearing. The parties may submit new documentary or other non-testimonial evidence in accordance with deadlines imposed by the Division and upon showing “good cause,” which may be assessed based on any relevant factors, including but not limited to:

(A) That the new evidence was previously not known or obtainable, despite diligent evidence gathering efforts by the party offering the new evidence;

(B) That the party failed to receive fair notice of the investigation or of a key filing by another party or by the Division to which the new evidence is responsive;

(C) That factors outside the control of the party prevented a timely action or interfered with the opportunity to act, except that the acts and omissions of a party’s authorized representative are considered the acts and omissions of the party and are not considered to be a factor outside the party’s control as intended by this rule;

(D) That the initial determination raised a new issue or argument that cannot be responded to adequately without the new evidence;

(E) That, at the investigation stage, the party offering new evidence requested more time to submit evidence, yet was denied, and in the hearing officer’s judgment (1) the need for more time was legitimate and did not reflect neglect by the party, (2) the denial of the request for more time was unwarranted, and (3) exclusion of the evidence would cause substantial injustice to the party; and/or (F) That failure to admit the new evidence otherwise would cause substantial injustice and did not arise from neglect by the party. 6.4.5 After the hearing, a decision shall be issued, and served to all parties, on each relevant issue raised, including findings of fact, conclusions of law, and orders. Absent timely modification by the Director, the decision shall constitute final agency action, and the final decision of the Director, subject to judicial review pursuant to C.R.S. § 24-4-106.

Rule 7. Notices of Intent to Strike Required by the Labor Peace Act 7.1 NLRA-Covered Employers. Bargaining units recognized by, and subject to the notification provisions of the National Labor Relations Act shall simultaneously submit to the Division a copy of any form F-7 they submit to the Federal Mediation and Conciliation Service (FMCS). 7.2 Coverage and Timeframes for Strike Notices. Under statutory timeframes the Division cannot waive or extend, a Notice of Intent to Strike (a “Strike Notice”) shall be served on the Division and all parties to the dispute before a strike as follows:

(A) 40 days in advance of a strike against a public “Authority” (as defined by C.R.S. § 8-3-104);

(B) 30 days in advance of a strike against an agricultural employer (as defined by C.R.S. § 8-3-113(2) — any employer in “production, harvesting, or initial processing (after leaving the farm), of any farm or dairy product,” including marijuana, produced in the state); and (C) 20 days in advance of a strike against any other employer that is both (1) covered by the Labor Peace Act and (2) not covered by the National Labor Relations Act. 7.3 Contents of Strike Notices. A Strike Notice shall be submitted on any form provided by the Division at www.coloradolaborlaw.gov. If a party cannot submit any such form, it may submit a Strike Notice in any other form, on paper or electronic, that will be received by (not sent to) the Division the required number of days before a strike, and that contains the following information (with “none available” entered for any information a party lacks, and “not applicable” entered for any item that is not applicable to the dispute or strike at issue):

(A) The name, address, telephone number, and email address where each party to the labor dispute may be contacted;

(B) The date of the expiration of the most recent collective bargaining agreement between the parties; and (C) The status of negotiation to resolve the dispute, including the date of the last conference or negotiation between the parties.

(D) For a strike against a public “Authority” (as defined by C.R.S. § 8-3-104) — (1) “whether or not such strike would interfere with the preservation of the public peace, health, and safety” (C.R.S. § 8-3-113(3));

(2) whether a strike or binding arbitration of the labor dispute is preferable; and (3) if a strike is not allowed, what arbitration procedures or processes are preferable. 7.4 Employer Response to a Strike Notice. An employer shall serve the Division and all other parties a written response within five days of receiving a Strike Notice, detailing any information the employer knows that is missing from the Strike Notice, as well as the extent to which the employer disagrees with any facts, opinions or other contents in the Strike Notice. 7.5 Further Submissions and/or Proceedings on a Strike Notice. The Director may request, allow, or order parties to a Strike Notice:

(A) to submit further information in addition to that in the Strike Notice and initial employer response; and (B) to the extent possible to achieve progress from doing so, to meet and discuss effectuating dispute resolution methods to resolve the dispute, including mediation and arbitration. 7.6 Updates after Mediation or Other Non-Binding Dispute Resolution. 7.6.1 The parties shall, unless ordered otherwise by the Director, file a written status report every 30 days from the date of consent to mediate, or periodically as the Director may order, until the conclusion of the mediation. 7.6.2 If the parties reach impasse or otherwise fail to resolve their dispute with mediation or other non-binding dispute resolution, then:

(A) the Director may request, allow, or order the parties to meet to discuss voluntary arbitration or other dispute resolution; and (B) if the parties consent to arbitration, they shall file with the Division a signed written agreement to arbitrate, which may, at their option, include requests or proposals for the Director to conduct the arbitration, appoint one or more arbitrators, or otherwise facilitate arbitration to resolve the dispute. 7.7 Decisions on a Strike Notice as to a Public Authority. 7.7.1 Within 20 days of a Notice of Intent to Strike, the Director “shall enter an order allowing or denying the strike based on the grounds of whether or not such strike would interfere with the preservation of the public peace, health, and safety in accordance with rules and regulations of the division” (C.R.S. § 8-3-113(3)) and the legislative declarations as to the purposes and construction of the Labor Peace Act (C.R.S. §§ 8-3-102, 8-3-103). 7.7.2 If permission to strike is denied, the “order denying a strike ... shall include an order to arbitrate,” providing as follows:

(A) that “[s]uch arbitration shall be entered into not later than 100 days from the filing of the notice of intent to strike” (C.R.S. § 8-3-113(3));

(B) that the Director may either serve as the arbitrator or name one or more arbitrators (C.R.S. § 8-3-112(1)); and (C) that the Director may request, permit, or order submissions from the parties as to the arbitration schedule, arbitration process, and selection of arbitrators.

Rule 8. Intervention in Labor Disputes (Industrial Relations Act, C.R.S. § 8-1-125) 8.1 Coverage of Intervention Rule. This rule applies to employers that:

(A) are covered by the Industrial Relations Act (Article 1 of C.R.S. Title 8); and (B) are not covered by the NLRA or any other federal or state statute governing strikes, lockouts, or similar labor stoppages as to that employer. 8.2 Requests for Intervention. 8.2.1 Grounds for Intervention. Under C.R.S. § 8-1-125, the Director may intervene in a dispute affecting wages, hours, or other conditions of employment if either (A) both parties to a dispute request intervention, or (B) the dispute affects the public interest. 8.2.2 Requests for Intervention. A party to a labor dispute requesting intervention shall do so by completing, and serving on the Division and all other parties to the dispute (in conformity with Rule 4), a Division-approved form if one is available, or in any other written form if none is available, providing the following information:

(A) The name, address, telephone number, and email address where each party to the labor dispute may be contacted;

(B) The date of the expiration of the most recent collective bargaining agreement between the parties;

(C) The status of negotiation to resolve the dispute, including the date of the last conference or negotiation between the parties;

(D) Whether, and if so how, the dispute affects the public interest; and (E) Whether, and if so what type of, intervention would help resolve the dispute. 8.2.3 Responses to Requests. Upon request for intervention by only one party to a dispute, any other parties shall respond within ten days, providing all information required by Rule 8.2.2. 8.3 Decisions on Intervention. 8.3.1 In considering whether to intervene, the Director may:

(A) meet with the parties to discuss the use of mediation, arbitration, or other dispute resolution; and/or (B) investigate to determine the extent to which the dispute affects the public interest and whether the Director should assert jurisdiction. 8.3.2 Jurisdiction shall not be deemed to have been exercised until and unless a written decision to intervene is issued. 8.3.3 The parties shall be notified of the decision to either assert or decline jurisdiction in a written decision that shall advise the parties that:

(A) the relation of the employer and employee shall continue uninterrupted by the dispute or anything arising out of the dispute until the final determination of any aspects of the dispute that the Director may address; and (B) neither the employer nor any employee affected by any such dispute shall either:

(1) alter wages, hours, or other conditions of employment; or (2) on account of such dispute, directly or indirectly engage in anything in the nature of a lockout, strike, or suspension or discontinuation of work or employment. 8.3.4 In intervening, the Director may investigate, hold hearings, and issue temporary orders to authorize and encourage mediation, voluntary arbitration, or other similar dispute resolution prior to issuing any final orders. 8.3.5 The Director shall issue a final order terminating jurisdiction within 180 days after the Director’s decision to assert jurisdiction.. _________________________________________________________________________ Editor’s Notes

History Entire rule eff. 09/01/2017.

Entire rule eff. 07/01/2023.

7 CCR 1101-13 GENERAL REGULATION NO. 1 REGULAR PUBLIC MEETINGS [Repealed eff. 01/01/2013] {#sec-7-ccr-1101-13 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-13}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Labor GENERAL REGULATION NO. 1 REGULAR PUBLIC MEETINGS - Repealed eff. 01/01/2013 7 CCR 1101-13 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes

History Entire rule repealed eff. 01/01/2013.

7 CCR 1103-1 Colorado Overtime and Minimum Pay Standards Order (comps Order) #40 {#sec-7-ccr-1103-1 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-1}

DEPARTMENT OF LABOR AND EMPLOYMENT

COLORADO OVERTIME AND MINIMUM PAY STANDARDS ORDER (COMPS

ORDER) #40

7 CCR 1103-1 [Editor's Notes follow the text of the rules at the end of this CCR Document.]

Adopted December 8, 2025; effective February 1, 2026.

Rule 1. Authority and Definitions. 1.1 Authority, application, and relation to prior orders. Colorado Overtime and Minimum Pay Standards Order (COMPS Order) #40 replaces COMPS Order #39 (2024) and prior orders, except that the provisions of prior orders still govern as to events occurring while they were in effect. The COMPS Order is issued under the authority of, and as enforcement of, Colorado Revised Statutes (C.R.S.) Title 8, Articles 1, 4, 6, 12, 13.3, and 13.5, and is intended to be consistent with the requirements of the State Administrative Procedure Act, C.R.S. § 24-4-101, et seq. Unless otherwise noted, in these Rules: all statutes cited apply the most recent versions of the Colorado Revised Statutes; all rules cited apply the most recent versions adopted as of the adoption of these Rules. See Appendix A for citations. Where these Rules have provisions different from or contrary to any referenced material, the provisions of these Rules govern, so long as they are consistent with Colorado statutory and constitutional provisions. Earlier versions of such laws and rules may apply to events that occurred in prior years. The effective date of COMPS Order #40 is February 1, 2026. 1.2 Incorporation by reference. The COMPS Order incorporates by reference only the following rules stated in Subpart G of Part 541 within Title 29 of the Code of Federal Regulations: 29 C.F.R. §§ 541.600(d), except for references to salary amounts; 541.601(b), except for references to salary amounts; and 541.602 – 541.604. These rules are available to the public in electronic form at https://www.ecfr.gov/current/title-29/part-541/subpart-G, as adopted by the United States Department of Labor’s Wage and Hour Division, located at 200 Constitution Ave NW, Washington, DC 20210. All incorporated rules refer to the date and edition in effect as of the effective date of this COMPS Order, February 1, 2026, and exclude later amendments to or editions of the rules incorporated by reference. The Publication And Yearly Calculation of Adjusted Labor Compensation Order (PAY CALC Order), 7 CCR 1103-14, states the periodically-adjusted dollar amounts of the minimum wages and minimum pay and income levels for exemptions required in the COMPS Order. All sources cited or incorporated by reference are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, 707 17th Street, Denver, CO 80202. Copies may be obtained from the Division of Labor Standards & Statistics at a reasonable charge. They can be accessed electronically from the website of the Colorado Secretary of State.

Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of them at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing them. All Division Rules are available to the public at www.coloradolaborlaw.gov. 1.3 “Director” means the Director of the Division of Labor Standards and Statistics. 1.4 “Division” means the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment. 1.5 “Employee,” as used in the COMPS Order and the PAY CALC Order, has the following definitions.

(A) Under the Colorado Wage Act (CWA), as defined by C.R.S. § 8-4-101(5):

“Employee” means any person, including a migratory laborer, performing labor or services for the benefit of an employer. For the purpose of the COMPS Order, relevant factors in determining whether a person is an employee include the degree of control the employer may or does exercise over the person and the degree to which the person performs work that is the primary work of the employer; except that an individual primarily free from control and direction in the performance of the service, both under their contract for the performance of service and in fact, and who is customarily engaged in an independent trade, occupation, profession, or business related to the service performed is not an “employee.”

(B) Under the Healthy Families and Workplaces Act (HFWA), as defined by C.R.S. § 8-13.3-402(4): “Employee” has the meaning set forth in section 8-4-101(5) but does not include an “employee” as defined in 45 U.S.C. sec 351(d) who is subject to the federal “Railroad Unemployment Insurance Act”, 45 U.S.C. sec. 351 et seq.

(C) Under the Agricultural Labor Rights and Responsibilities Act, Colorado Senate Bill 21-87, as defined by C.R.S. § 8-6-101.5(3): “agricultural employee” or “agricultural worker” has the “same meaning as under C.R.S. § 8-13.5-201(3)” (“A worker engaged in any service or activity included in section 203(f) of the federal ‘Fair Labor Standards Act of 1938’,...as amended...or section 3121(g) of the federal ‘Internal Revenue Code of 1986’, as amended”). 1.6 “Employer,” as used in the COMPS Order and the PAY CALC Order, has the following definitions.

(A) Under the CWA, C.R.S. § 8-4-101(6): “Employer” has the same meaning as set forth in the federal “Fair Labor Standards Act,” 29 U.S.C. sec 203(d), and includes a foreign labor contractor, a migratory field labor contractor or crew leader, and each individual who owns or controls at least 25 percent of the ownership interests in an employer; except that the provisions of the COMPS Order do not apply to a minority owner of an employer that demonstrates full delegation of its authority to control dayto-day operations of the employer; the state or its agencies or entities, counties, cities and counties, municipal corporations, quasi-municipal corporations, school districts, and irrigation, reservoir, or drainage conservation companies or districts organized and existing under the laws of Colorado.

(B) Under HFWA, as defined by C.R.S. § 8-13.3-402(5): “Employer” has the meaning set forth in section 8-4-101(6); except that the term includes the state and its agencies or entities, counties, cities and counties, municipalities, school districts, and any political subdivisions of the state but does not include the federal government.

(C) Under the Agricultural Labor Rights and Responsibilities Act, Colorado Senate Bill 21-87, as defined by C.R.S. § 8-2-206(1)(c): “agricultural employer” has the “same meaning provided in C.R.S. § 8-3-104(1)” (“a person that is engaged in any service or activity included in section 203(f) of the federal ‘Fair Labor Standards Act of 1938’, ... as amended,” or engaged in “agricultural labor, as defined in section 3121 of the federal ‘Internal Revenue Code of 1986’,” that either (1) contracts with any person who recruits, solicits, hires, employs, furnishes, or transports agricultural employees, or (2) regularly engages the services of one or more agricultural employees). 1.7 “Minor,” for purposes of minimum wage provisions specific to minors, means a person under 18 years of age. “Emancipated minor” means any individual less than eighteen years of age who meets the definition provided by C.R.S. § 8-6- 108.5. 1.8 “Regular rate of pay” means the hourly rate actually paid to employees for a standard, non-overtime workweek. Employers need not pay employees on an hourly basis. If pay is on a piece-rate, salary, commission, or other non-hourly

basis, any overtime compensation is based on an hourly regular rate calculated from the employee’s pay. 1.8.1 Pay included in regular rate. The regular rate includes all compensation paid to an employee, including set hourly rates, shift differentials, minimum wage tip credits, non-discretionary bonuses, production bonuses, and commissions used for calculating hourly overtime rates for non-exempt employees. Business expenses, bona fide gifts, discretionary bonuses, tips, employer investment contributions, vacation pay, holiday pay, sick leave, jury duty, or other pay for non-work hours may be excluded from regular rates. 1.8.2 Regular rate for employees paid a weekly salary or other non-hourly basis.

(A) A weekly salary or other non-hourly pay may be paid as straight time pay for all work hours, and the regular rate each workweek will be the total paid divided by hours worked, if the parties have a clear mutual understanding that the salary is:

(1) compensation (apart from any overtime premium) for all hours each workweek;

(2) at least the applicable minimum wage for all hours in workweeks with the greatest hours;

(3) supplemented by extra pay for all overtime hours (in addition to the salary that covers the regular rate) of an extra ½ of the regular rate; and (4) paid for whatever hours the employee works in a workweek.

(B) Where the requirements of (1)-(4) are not carried out, there is not the required “clear mutual understanding” that the non-hourly pay provides the regular rate for all hours with extra pay added for overtime hours. Absent such an understanding, the hourly regular rate is the applicable weekly pay divided by 40, the number of hours presumed to be in a workweek for an employee paid no overtime premium. 1.8.3 The regular rate for an employee working two or more non-exempt jobs at different hourly pay rates for the same employer within a specific workweek shall be calculated as follows:

(A) Rate based on a weighted average: The employee’s regular rate for the particular workweek is determined by adding together all the wages earned performing each job, then dividing that amount by the total number of hours worked in all jobs, consistent with the federal Fair Labor Standards Act (FLSA) and resulting in a weighted average rate of pay, or (B) Rate based on the job actually performed during overtime hours:

The employee’s regular rate is the regular rate of hourly pay for the job being performed during the actual overtime hours.

If there is no written agreement between the employee and the employer as to the method of calculating the regular rate of pay in advance of performing the work, the employee’s regular rate shall be calculated using the “weighted average” method described above in 1.8.3(A). 1.9 “Time worked” means time during which an employee is performing labor or services for the benefit of an employer, including all time they are suffered or permitted to work, whether or not required to do so. 1.9.1 Requiring or permitting employees to be on the employer’s premises, on duty, or at a prescribed workplace (but not merely permitting an employee completely relieved from duty to arrive or remain on-premises) — including but not limited to putting on or removing required work clothes or gear (but not a uniform worn outside work as well), receiving or sharing work-related information, security or safety screening, remaining at the place of employment awaiting a decision on job assignment or when to begin work, performing clean-up or other duties “off the clock,” clocking or checking in or out, or waiting for any of the preceding — shall be considered time worked that must be compensated; except that whether an employer must compensate an activity (or combination of multiple activities consecutively) of less than one minute depends on the balance of the following factors, as shown by the employer: (A) the difficulty of recording the time, or alternatively of reasonably estimating the time; (B) the aggregate amount of compensable time, for each employee as well as for all employees combined; and (C) whether the activity was performed on a regular basis. 1.9.2 “ Travel time” means time spent on travel for the benefit of an employer, excluding normal home to work travel, and shall be considered time worked. At the start or end of the workday, travel to or from a work station, entirely within the employer's premises and/or with employer-provided transportation, shall not be considered time worked, except that such travel is compensable if it is:

(A) time worked under Rule 1.9 – 1.9.1;

(B) after compensable time starts or before compensable time ends under Rule 1.9 – 1.9.1; or (C) travel in employer-mandated transportation (1) that materially prolongs commute time or (2) in which employees are subjected to heightened physical risk compared to an ordinary commute. 1.9.3 “Sleep time” means time an employee may sleep, which is compensable as follows. Where an employee’s shift is 24 hours or longer, up to 8 hours of sleeping time may be excluded from overtime compensation, if:

(A) an express agreement excluding sleeping time exists;

(B) adequate sleeping facilities for an uninterrupted night’s sleep are provided;

(C) at least 5 hours of sleep are possible during the scheduled sleep period; and (D) interruptions to perform duties are considered time worked.

When an employee’s shift is less than 24 hours, periods when they are permitted to sleep are compensable work time, as long as they are on duty and must work when required. Only actual sleep time may be excluded, up to a maximum of 8 hours per workday. When work-related interruptions prevent 5 hours of sleep, the employee shall be compensated for the entire workday. 1.10 “Tipped employee” means any employee who regularly receives more than $1.64 per hour in tips (averaged over any pay period permitted by C.R.S. § 8-4-103).

Tips include amounts designated as a tip by credit card customers on their charge slips.

(A) Nothing in this rule prevents an employer from requiring employees to share or allocate such tips or gratuities on a pre-established basis among other tipped employees who perform significant customer-service functions in contact with patrons — which includes employees with duties typical of the following occupations, whether or not customers tip them directly: servers; bussers (i.e., server helpers); counter personnel who serve customers; sushi or teppanyaki chefs who are similar to counter personnel because they have direct contact and interact with customers, and prepare and serve meals to customers (in bar areas or at tables); service bartenders; bartender assistants or barbacks who are similar to bussers because they learn bartending under the tutelage of a bartender they support and from whom they receive their tips while working in the bar area and interacting with customers; sommeliers who explain the wine list to, bring the selected wine bottle to, and serve wine to customers; and bellhops.

(B) Employer-required sharing of tips with management, or with employees who do not have such duties, or deduction of credit card processing fees from tipped employees, shall nullify allowable tip credits towards the minimum wage. 1.11 “‘Wages’ or ‘compensation’” has the meaning provided by C.R.S. § 8-4-101(14) and includes paid sick leave under the Healthy Families and Workplaces Act, C.R.S. § 8-13.3-402(8)(b). 1.12 “Workday” means any consecutive 24-hour period starting with the same hour each day and the same hour as the beginning of the workweek. The workday is set by the employer and may accommodate flexible shift scheduling. 1.13 “Workweek” means any consecutive set period of 168 hours (7 days) starting with the same calendar day and hour each week.

Rule 2. Coverage and Exemptions. 2.1 Scope of coverage. The COMPS Order regulates wages, hours, working conditions, and procedures for all employers and employees for work performed within Colorado, with the exceptions and exemptions contained within Rule 2. 2.2 Exemption from all except Rules 1, 2, and 8. The following are exempt from the COMPS Order except Rules 1 (Authority and Definitions), 2 (Coverage and Exemptions), and 8 (Administration and Interpretation). 2.2.1 Administrative employees. This exemption covers a salaried employee, paid at least the applicable salary in Rule 2.5 as specified for the applicable year in the PAY CALC Order, who directly serves an executive, and regularly performs duties important to the decision-making process of that executive. The executive and employee who serves the executive must regularly exercise independent judgment and discretion in matters of significance, with a primary duty that is non-manual in nature and directly related to management policies or general business operations. 2.2.2 Executives or supervisors. This exemption covers a salaried employee, paid at least the applicable salary in Rule 2.5 as specified for the applicable year in the PAY CALC Order, who supervises the work of at least two full-time employees and has the authority to hire and fire, or to effectively recommend such action. The employee must spend a minimum of 50% of the workweek in duties directly related to supervision. 2.2.3 Professional employees. This exemption covers a salaried employee, paid at least the applicable salary in Rule 2.5 as specified for the applicable year in the PAY CALC Order, employed in a field of endeavor whose primary duty is work that requires (A) the consistent exercise of discretion and judgment, as distinguished from routine work that is mental, manual, mechanical or physical, and (B) either (1) knowledge of an advanced type in a field of science or learning customarily acquired by a prolonged course of specialized intellectual instruction and study, or (2) invention, imagination, originality or talent in a recognized field of artistic or creative endeavor (as opposed to routine mental, manual, mechanical or physical work, or work that primarily depends on intelligence, diligence and accuracy). The professional employee must be employed in the field in which they were trained. 2.2.4 Outside salespersons. This exemption covers an employee working primarily away from the employer’s place of business or enterprise for the

purpose of making sales or obtaining orders or contracts for any commodities, articles, goods, real estate, wares, merchandise, or services. The employee must spend a minimum of 80% of the workweek in activities directly related to their own outside sales. 2.2.5 Owners or proprietors. This exemption covers a full-time employee actively engaged in management of the employer who either:

(A) owns at least a bona fide 20% equity interest in the employer; or (B) for a non-profit employer, is the highest-ranked and highest-paid employee, and is paid at least the salary threshold in Rule 2.5 as specified for the applicable year in the PAY CALC Order. 2.2.6 Taxi cab drivers employed by a taxi service provider licensed by a state or local government. 2.2.7 In-residence workers. This exemption covers the below-listed in-residence employees.

(A) Casual babysitters employed in private residences directly by households, or directly by family members of the individual(s) receiving care from the babysitter.

(B) Property managers residing on-premises at the property they manage.

(C) Student residence workers working in premises where they reside for sororities, fraternities, college clubs, or dormitories.

(D) Laundry workers who (a) are inmates, patients, or residents of charitable institutions, and (b) perform laundry services, (c) in institutions where they reside.

(E) Field staff of seasonal camps or seasonal outdoor education programs who primarily provide supervision or education of minors, or education of adults; are required to reside on-premises or in the field; are provided adequate lodging and all meals free of charge and without deduction from wages; and as of January 1, 2021, are paid the amount required by subpart (1) below (with no minimum pay required before January 1, 2021).

(1) This exemption requires that field staff be paid either (a) the applicable Colorado minimum wage for all hours worked, or (b) a salary (i) equivalent to at least 42 hours per week at the Colorado minimum wage (with the 15% hourly wage reduction that Rule 3.3 permits for unemancipated minors), (ii) with hourly wage reduced one-sixth (⅙) for non-profit employers with annual total gross revenue of $25 million or less, and (iii) reduced $200 per week as a credit for facilities provided (lodging, meals, and other facilities), as specified for the applicable year in the PAY CALC Order.

(2) “Seasonal” in this Rule means a camp or program that either (a) does not operate for more than seven months in a year, or (b) during the preceding calendar year had average receipts for any six months of not more than one-third (⅓) of its average receipts for the other six months. 2.2.8 Bona fide volunteers and work-study students. This exemption covers those who need not be compensated under the federal Fair Labor Standards Act (29 U.S.C. §§ 201 et seq.) as either: (A) enrolled students receiving credit for an unpaid work-study program or internship; or (B) bona fide volunteers for non-profit organizations. 2.2.9 Elected officials and their staff. This exemption covers individuals elected to public office and members of their staff. 2.2.10 Employees in highly technical computer-related occupations. This exemption covers an employee paid a salary, or hourly compensation, in accord with Rule 2.5, and as specified for the applicable year in the PAY CALC Order, who:

(A) is a skilled worker employed as a computer systems analyst, computer programmer, software engineer, or other similarly highly technical computer employee;

(B) who has knowledge of an advanced type, customarily acquired by a prolonged course of specialized formal or informal study; and (C) spends a minimum of 50% of the workweek in any combination of the following duties — (1) the application of systems analysis techniques and procedures, including consulting with users, to determine hardware, software, or system functional specifications, (2) the design, development, documentation, analysis, creation, testing, or modification of computer systems or programs, including prototypes, based on and related to user or system design specifications, or (3) the design, documentation, testing, creation, or modification of computer programs related to machine operating systems. 2.2.11 Highly compensated employees. This exemption covers an employee who:

(A) is paid annual wages of at least — (1) weekly, the weekly salary for the executive, professional, or administrative exemption, as specified for the applicable year in the PAY CALC Order, and (2) annually, two and one-quarter times the rounded annual salary for the executive, professional, or administrative exemption, as specified for the applicable year in the PAY CALC Order;

(B) customarily and regularly performs any one or more of the exempt duties or responsibilities of an executive, administrative or professional employee (as described in Rules 2.2.1-2.2.3); and (C) whose primary duty is office or non-manual work — for example, non-management production-line workers and non-management employees in maintenance, construction and similar occupations such as carpenters, electricians, mechanics, plumbers, iron workers, craftsmen, operating engineers, longshoremen, construction workers, laborers and other employees who perform work involving repetitive operations with their hands, physical skill and energy are not exempt under this section no matter how highly paid they might be. 2.2.12 National Western Stock Show. This exemption covers temporary employees employed directly by the Western Stock Show Association for the annual National Western Stock Show. 2.3 Agriculture. 2.3.1 Minimum Wages. All minimum wage laws and rules apply to all employees of all agricultural employers, except as otherwise provided for “range workers” in Rule 2.4.9. 2.3.2 Overtime and Maximum Hours Protections.

(A) Agricultural employees of agricultural employers are exempt from both the 40-hour weekly and the 12-hour daily overtime pay requirements in Rule 4.1.1, provided that such employees receive the following.

(1) Weekly overtime pay, at one and one-half times their regular rate of pay, after 60 hours worked per workweek from November 1, 2022, through December 31, 2023, and thereafter as follows, and as listed in the summary table below:

(a) at a highly seasonal agricultural employer (defined in

Rule 2.3.2(C)), (i) after 56 hours worked per workweek during any up to 22-workweek period, or any two or three periods of at least four workweeks each totaling up to 22 weeks, that the employer designates as its peak labor period(s), and (ii) otherwise after 48 hours worked per week; and (b) at an agricultural employer that is not highly seasonal, (i) after 54 hours worked per workweek in 2024, and (ii) after 48 hours worked per workweek as of January 1, 2025; except (c) at a small agricultural employer (defined in Rule 2.3.2(B) below), whether or not highly seasonal, after 56 hours worked per workweek in 2024, then whichever of (a) or (b) applies as of January 1, 2025.

Summary Table: Weekly Overtime Requirements for Agricultural Employers Time Period (a) Highly Seasonal Employers (b) Non-Highly Seasonal Employers (c) Small Employers (seasonal or not)

Until 11/1/22 [ No requirements ] 11/1/22- 12/31/2 60 hours 56 hours for up to 22 peak weeks; 48 hours otherwise 54 hours 56 hours 2025 - 48 hours [No separate rule for small employers; apply (a) or (b)]

(2) Beginning November 1, 2022:

(a) in lieu of 12-hour daily overtime pay under Rule 4.1.1, 30 minutes for the third Rule 5.2 paid rest period (rather than 10 minutes or any other duration under 30 minutes otherwise applicable to that rest period) — except that if the employer had no reason to believe an employee would exceed 12 hours until the twelfth hour worked, then the additional break time may be provided on the employee’s next workday; and (b) for a workday with more than 15 hours of work, or for more than 15 consecutive hours of work (as provided by Rule 4.1.5) without regard to the start and end time of the workday, an additional lump-sum payment equal to one hour of the Colorado minimum wage, as specified for the applicable year in the PAY CALC Order.

(B) “Small agricultural employer” means an agricultural employer that:

(1) employed fewer than four employees on average over the three prior calendar years (or as many complete prior calendar years as they have been in operation); and (2) had average adjusted gross income, over the three prior complete taxable years preceding 2024 (the year that small agricultural employers have a different overtime standard), of no more than $1,000,000. Employers in operation fewer than three complete taxable years shall use as many complete taxable years as they have been in operation; employers not yet in operation for any complete taxable years shall be considered below the threshold.

(C) “Highly seasonal agricultural employer” means an agricultural employer that, in any up to 22-workweek period (or any two or three periods , of at least four workweeks each, totaling up to 22 weeks) in the prior calendar year, had at least twice as many employees as the rest of the year, and provides the following to those it would pay weekly overtime after 56 rather than 48 hours in peak weeks.

(1) An initial disclosure, at least annually, (a) weekly overtime pay will be after 56 rather than 48 hours for up to 22 peak weeks, (b) whether those peak weeks will be divided into one, two, or three periods (of four weeks or more), and (c) a good-faith estimate of the months in which the peak weeks will occur.

The initial disclosure must be provided to employees at least 30 days in advance of the first expected peak week (or upon hiring for those start work fewer than 30 days in advance), except for those employed under, and in compliance with federal requirements for, temporary work visas, no later than the date of the worker’s visa application, contemporaneous with required federal pre-employment written disclosures to visa workers ordinarily due by the date of the worker’s visa application.

(2) Written notice, at least annually, of which weeks will be the peak weeks, no later than the seventh day before the first peak week (or upon hiring for those starting work after the seventh day). The employer may change which are the peak weeks after that notice if:

(a) it provides at least one week’s written notice of any week being added or removed as a peak week;

(b) the initial disclosure was the employer’s good-faith, reasonable expectation of which weeks would be the peak weeks; and (c) the changes are based on circumstances not foreseeable at the time of the initial disclosure (for example, a late frost).

(3) All required notices and disclosures related to peak weeks in English and any language that is the first language spoken by at least five percent of the employer’s workforce at any point during the year.

(D) An agricultural employee is exempt from all overtime pay requirements in the COMPS Order if (by blood, adoption, or marriage) they are the child, sibling, spouse, parent, aunt, uncle, nephew, niece, first cousin, grandchild, or grandparent of a family owner of an employer. For this exemption, a “family owner” is an individual with an ownership interest in an agricultural employer that is either (a) a majority interest or (b) an at least 10% interest that combines with those of other family members of that owner (of any type of relative listed in the prior sentence) to form a majority interest. If a family owner is also an “employee” of the agricultural employer, they also are exempt from all overtime pay requirements in the COMPS Order.

(E) How many employees an agricultural employer has, for purposes of the above definitions of “small agricultural employer” in (B), and “highly seasonal agricultural employer” in (C), shall be determined as follows.

(1) Employees shall be counted at the worksite for which the definition is being assessed, and shall count proportionally as follows, based on their average hours worked in all weeks in the preceding year with at least one hour worked:

(a) 35 hours per week or more, 1.0;

(b) between 15 and 35 hours per week, 0.5; and (c) under 15 hours per week, 0.

(2) Employers need not rely on prior staffing levels to qualify for the “small agricultural” or “highly seasonal” employee thresholds if they (a) have been in operation for less than one calendar year, or (b) did not qualify based on their prior staffing levels, but have a good-faith, objectively reasonable belief that they will qualify for the present year. If their belief that they will qualify for the threshold proves incorrect, they must pay affected employees back pay for any additional overtime owed, plus 5%, by 30 days from the date the employer has notice that it will not qualify for the threshold for the year, or (if they lacked notice until the end of the year) by 30 days from the end of that calendar year.

(F) The Rule 2.3.2 exemption does not apply if an employer draws at least 50% of its annual dollar volume of business from sales to the consuming public (rather than for resale) of any services, commodities, articles, goods, wares, or merchandise; prior Orders for decades have covered any such employer, in any industry. E.g., Order #35, Rule 2(A) (covering any employer “that sells or offers for sale, any service, commodity, article, good, ... wares, or merchandise to the consuming public” and draws “50% or more of its annual dollar volume ... from such sales,” rather than from sales to other businesses “for resale”). 2.3.3 Meal and Rest Periods.

(A) In addition to the meal and rest periods required by Rule 5, an agricultural employer shall provide agricultural employees engaged in hand-weeding and hand-thinning an additional, five-minute rest period, which, insofar as is practicable, must be in the middle of each work period.

(B) The requirement of meal and rest periods in Rule 2.3.3 and Rule 5 does not apply to a truck driver whose sole and principal duty is to haul livestock or to a combine or harvester operator while harvesting. 2.4 Exemptions from Overtime Requirements of the COMPS Order. The following employees are exempt from Rule 4 (Overtime) unless otherwise specified. 2.4.1 Certain Salespersons and Mechanics. Salespersons, parts-persons, and mechanics employed by automobile, truck, or farm implement (retail) dealers; and salespersons employed by trailer, aircraft, and boat (retail) dealers are exempt from Rule 4 (Overtime). 2.4.2 Commission Sales. Sales employees of retail or service industries paid on a commission basis, provided that at least 50% of their total earnings in the pay period is derived from commission sales, and their regular rate of pay is at least one and one-half times the minimum wage, are exempt from Rule 4 (Overtime). This exemption is applicable for only employees of retail or service employers who receive over 75% of their annual dollar volume from retail or service sales. 2.4.3 Ski Industry. Employees of the ski industry performing duties directly related to ski area operations for downhill skiing or snowboarding, and those employees engaged in providing food and beverage services at onmountain locations, are exempt from (within Rule 4) the 40-hour overtime requirement but not the requirement of overtime pay for over 12 hours that are consecutive or are within a workday. This partial overtime exemption does not apply to ski area employees performing duties related to lodging. 2.4.4 Medical Transportation. Employees of the medical transportation industry who work 24-hour shifts are exempt from the Rule 4.1.1(B)-(C) daily (12hour) overtime rules if they receive the required Rule 4.1.1(A) weekly (40hour) overtime pay. 2.4.5 Eight and Eighty Rule. A hospital or nursing home may seek an agreement with individual employees to pay overtime pursuant to the provisions of the federal Fair Labor Standards Act “8 and 80 rule” whereby employees are paid time and one-half their regular rate of pay for any work performed in excess of 80 hours in a 14 consecutive day period and for any work in excess of 8 hours per day. 2.4.6 Drivers, and Driver’s Helpers, Subject to the Federal Motor Carrier Act (MCA). Drivers and their driver’s helpers are exempt from Rule 4 (overtime) and Rule 5 (rest and meal periods) while and to the extent that they are:

(A) subject to the federal MCA and exempt from overtime requirements of the FLSA pursuant to 29 U.S.C. § 213(b)(1) and regulations promulgated thereunder;

(B) working on MCA-covered non-passenger vehicles, or on MCAcovered passenger vehicles qualifying as commercial motor vehicles requiring a commercial driver’s license (CDL) — but not on vehicles that transport workers to and from manual work jobs (e.g., landscaping or lawn care, construction or roofing, cleaning or janitorial, or other manual labor) and do not require a CDL; and (C) paid compensation equivalent to at least 50 hours at the Colorado minimum wage with overtime, as specified for the applicable year in the PAY CALC Order, regardless of whether the pay is hourly, salaried, piece rate, or on another basis. 2.4.7 Direct Support and Care. The Rule 4.1.1(B)-(C) daily (12-hour) overtime

rule does not apply to companions designated as direct support professionals/direct care workers who are scheduled for, and work, shifts of at least 24 hours providing residential or respite services and who are employed by service providers and agencies that receive at least 75% of their total revenue from Medicaid or other governmental sources, and who provide services within Medicaid home- and community-based service waivers. 2.4.8 Decision-Making Managers at Livestock Employers. The Rule 2.3.2 and

Rule 4 overtime rules do not apply to decision-making managers at livestock employers, defined as follows.

(A) A “decision-making manager” (for purposes of this exemption) is an employee primarily engaged in livestock work:

(1) who is paid at least the applicable salary in Rule 2.5, as specified for the applicable year in the PAY CALC Order;

(2) who is not employed in the position on a seasonal or temporary basis (i.e., not expected to remain in the position for less than 12 months); and (3) whose primary duties require routine exercise of independent judgment and discretion in matters of significance, and who either (a) supervises two or more full-time employees, or (b) reports directly to an owner (majority or minority), or to an executive-level employee who reports directly to such an owner, who routinely exercises independent judgment and discretion in matters of significance, whether in manual or non-manual labor (e.g., the owner’s second-in-command, or the head of the site where the exempt employee works).

(B) A “livestock employer” (for purposes of this exemption) is an agricultural employer with significant responsibilities for “livestock”

(as defined under the FLSA) care and health — a dairy, cattle ranch, feedlot, or similar employer — that does not qualify as a “highly seasonal” employer under Rule 2.3.2. 2.4.9 Range workers. The Rule 2.3.2 and Rule 4 overtime rules do not apply to range workers who are paid at least the minimum range worker salary (as specified in the PAY CALC Order for the applicable year) during periods when they are “principally engaged in the range production of livestock . . . on the open range” (as defined by C.R.S. § 8-6-101.5(1)(b)), and are provided without cost or deduction any housing, food, transport, and equipment required for H-2A visa range workers by federal regulations. 2.4.10 Voluntary shift trades by employees of interstate air carriers. Hours worked by an employee of a carrier by air engaged in interstate or foreign commerce shall not count toward the number of hours worked for the purposes of Rule 4 when such hours are voluntarily worked by the employee pursuant to a shift-trading practice under which the employee has the opportunity in the same or in other workweeks to reduce hours worked by voluntarily offering a shift for trade or reassignment. 2.5 Salary Thresholds for Certain Exemptions. 2.5.1 For COMPS Order exemptions requiring a salary, the “Salary Requirement” rules of the federal Fair Labor Standards Act in 29 C.F.R.

Part 541 Subpart G, as identified as incorporated by reference and made available to the public for review in Rule 1.2, apply, except that under the COMPS Order, the salary must be at least the level specified for the applicable year in the PAY CALC Order and sufficient for the minimum wage for all hours in a workweek (with the exception of certain professionals listed in Rule 2.5.2). Except as provided in Rule 2.2.11, the weekly salary from July 1, 2020, through December 31, 2020, was $684 ($35,568 per year); $778.85 for 2021 ($40,500 per year); $865.38 for 2022 ($45,000 per year); $961.54 for 2023 ($50,000 per year); is $1,057.69 for 2024 ($55,000 per year); and after 2024 shall be indexed every January 1 by the same Consumer Price Index (CPI) as the Colorado minimum wage, as stated in the PAY CALC Order; except that the 2020 salary did not apply to the following two categories of employers, for whom the above salary schedule applied only as of January 1, 2021 — (A) non-profit employers with annual total gross revenue of under $50 million, and (B) for-profit employers with annual total gross revenue of under $1 million.

Annual equivalents are based on 2080 hours over 52 weeks of 40 hours, as under the federal Fair Labor Standards Act, and are rounded to the nearest dollar.

For any employer that was not subject to the $684 per week salary under this

Rule 2.5.1 for all or part of 2020, the required salary was the equivalent of the Colorado $12.00 minimum wage, less any applicable lawful credits, for all hours worked in a workweek; this salary requirement of minimum wage for all hours work applied under Minimum Wage Order #35 (2019) and prior Minimum Wage Orders. 2.5.2 Exemption for Certain Professionals Exempt from the Salary Requirement under Federal Wage Law. The Rule 2.5.1 salaries do not apply to the following professionals who are exempt from the requirement of a salary under federal wage law.

(A) Doctors, lawyers, and teachers who qualify as exempt Rule 2.2.3 professional employees need not receive any particular salary or hourly pay to be exempt.

(B) Employees in highly technical computer-related occupations, as defined by Rule 2.2.10, must receive at least the lesser of (1) the applicable salary in Rule 2.5.1, or (2) hourly pay that was at least $28.38 in 2021, adjusted annually by CPI thereafter, as specified for the applicable year in the PAY CALC Order.

Rule 3. Minimum Wages. 3.1 Statewide Minimum Wage. Under the minimum wage requirements of Article XVIII, Section 15, of the Colorado Constitution, all employees (with the exception detailed in Rule 3.3), whether employed on an hourly, piecework, commission, time, task, or other basis, shall be paid not less than the Colorado minimum wage, as specified for the applicable year in the PAY CALC Order, less any applicable lawful credits or exceptions noted, for all hours worked, if the employee is covered by either:

(A) Rule 2 (Coverage and Exemptions) of the COMPS Order; or (B) the minimum wage provisions of the federal Fair Labor Standards Act (29 U.S.C. § 201 et seq.). 3.2 Minimum and Overtime Wage Requirements of Other Applicable Jurisdictions. In addition to these requirements, federal, local, or other state laws or regulations may apply minimum, base, overtime, or other wage requirements to some or all Colorado employers and employees. If an employee is covered by multiple wage requirements, the requirement providing a higher wage, or otherwise setting a higher standard, shall apply. The Division accepts state law complaints by employees who claim entitlement to state, federal, or local minimum, base, or overtime wages under the C.R.S. § 8-4-101(14) definition that the “unpaid wages” recoverable in a state-law claim include “[a]ll amounts for labor or service performed by employees,” as long as such amounts are “earned, vested, and determinable, at which time such amount shall be payable to the employee pursuant to this article.” 3.3 Reduced Minimum for Minors. The minimum wage may be reduced by 15% for non-emancipated minors, as specified for the applicable year in the PAY CALC Order, and subject to the limitations in 7 CCR 1103-20, the Colorado Youth Employment Standards Rules (YES Rules), Rule 11.

Rule 4. Overtime. 4.1 Overtime Wages. 4.1.1 Employees shall be paid time and one-half of the regular rate of pay for any work in excess of any of the following, except as provided in exemptions or variances in Rule 2:

(A) 40 hours per workweek;

(B) 12 hours per workday; or (C) consecutive hours without regard to the start and end time of the workday. 4.1.2 Whichever of the three calculations in Rule 4.1.1 results in the greater payment of wages shall apply in any particular situation. 4.1.3 Hours worked in two or more workweeks shall not be averaged for computing overtime. 4.1.4 Performance of work in two or more positions, at different pay rates, for the same employer, shall be computed at the overtime rate based on the regular rate of pay as described in Rule 1.8.3. 4.1.5 In calculating when 12 consecutive hours are worked for purposes of the

Rule 4.1.1 requirement of overtime after 12 hours, meal periods may be subtracted, but only if the meal periods comply with the Rule 5.1 requirements for meal periods. 4.2 Effect of Daily Overtime on Workday and Workweek. The requirement to pay overtime for work in excess of 12 consecutive hours will not alter the employee's established workday or workweek, as previously defined. 4.3 Overtime for Minors. Nothing in Rule 4 modifies the provisions on work hours for minors, as defined by C.R.S. § 8-12-103, contained in C.R.S. § 8-12-105.

Rule 5. Meal and Rest Periods. 5.1 Meal Periods. Employees shall be entitled to an uninterrupted and duty-free meal period of at least a 30-minute duration when the shift exceeds 5 consecutive hours. Such meal periods, to the extent practical, shall be at least one hour after the start, and one hour before the end, of the shift. Employees must be completely relieved of all duties and permitted to pursue personal activities for a period to qualify as non-work, uncompensated time. When the nature of the business activity or other circumstances make an uninterrupted meal period impractical, the employee shall be permitted to consume an on-duty meal while performing duties. Employees shall be permitted to fully consume a meal of choice on the job and be fully compensated for the on-duty meal period without any loss of time or compensation. 5.2 Rest Periods. Every employer shall authorize and permit a compensated 10minute rest period for each 4 hours of work, or major fractions thereof, for all employees, as follows, except as provided in exemptions or variances in Rule 2:

Work Hours Rest Periods Required 2 or fewer 0 Over 2, and up to 6 1 Over 6, and up to 10 2 Over 10, and up to Over 14, and up to Over 18, and up to Over 22 6 5.2.1 Rest periods shall be 10 minutes unless, (A) on a given workday, or in a writing covering up to a one-year period that is signed by both parties, the employee and the employer agree, voluntarily and without coercion, to have two 5-minute breaks, as long as 5 minutes is sufficient, in the work setting, to allow the employee to go back and forth to a bathroom or other location where a bona fide break would be taken; or (B) if the below conditions are met, rest periods need not be 10 minutes every 4 hours for any employees (i) governed by a collective bargaining agreement at any employer, or (ii) during time they are providing Medicaid-funded services for a service provider or agency receiving at least 75% of its annual total gross revenue from Medicaid or other governmental funds for providing such services within Medicaid home- and community-based services waivers, and the services provided require continuous supervision of the service recipient, or providing a rest period would interfere with ensuring the service recipient’s health, safety, and welfare.

Employees in category (i) or (ii) must receive:

(1) rest periods that average, over the workday, at least 10 minutes per 4 hours worked; and (2) at least 5 minutes of rest in every 4 hours worked.

Such an agreement does not change an employee’s right to pay for rest periods under Rule 5.2.4. Additionally, when (B)(ii) above applies: When direct support professionals or direct care workers serving individuals with disabilities spend time in community outings with those individuals with disabilities — as part of day programs, supported living services, or oneto-one respite or personal care — time in such outings does not require rest breaks or pay for rest breaks. 5.2.2 Rest periods, to the extent practical, shall be in the middle of each 4-hour work period. It is not necessary that the employee leave the premises for a rest period. 5.2.3 Required rest periods are time worked for the purposes of calculating minimum wage and overtime obligations. 5.2.4 When an employee is not authorized and permitted a required 10-minute rest period, their shift is effectively extended by 10 minutes without compensation. Because a rest period requires 10 minutes of pay without work being performed, work during a rest period is additional work for which additional pay is not provided. Therefore, a failure by an employer to authorize and permit a 10-minute compensated rest period is a failure to pay 10 minutes of wages at the employee’s agreed-upon or legally required (whichever is higher) rate of pay. This Rule 5.2.4 applies equally to any required rest period time not provided (e.g., rest periods that are incomplete, or for non-hourly-paid employees, or under any other rule or statute providing rest periods of different durations).

Rule 6. Deductions, Credits, and Charges. 6.1 Tips or Gratuities. It shall be unlawful for an employer to assert a claim to, right of ownership in, or control over tips or gratuities intended for employees in violation of the Colorado Wage Act, including C.R.S. § 8-4-103(6). 6.2 Credits Toward Minimum Wages. The only allowable credits an employer may take toward the minimum wage are those in Rules 6.2.1 - 6.2.3 below. 6.2.1 Lodging Credit. A lodging credit for housing furnished by the employer and used by the employee may be considered part of the minimum wage if it is:

(A) no greater than the smaller of (1) the reasonable and actual cost to the employer of providing the housing, (2) the fair market value of the housing, or (3) $25 per week for a room (in a shared residence, dormitory, or hotel) or $100 per week for a private residence (an apartment or a house);

(B) accepted voluntarily and without coercion, and primarily for the benefit or convenience of the employee, rather than of the employer; and (C) recorded in a written agreement (electronic form is acceptable) that states the fact and amount of the credit (but need not be a lease). 6.2.2 Meal Credit. A meal credit, equal to the reasonable cost or fair market value of meals provided to the employee, may be used as part of the minimum hourly wage. No profits to the employer may be included in the reasonable cost or fair market value of such meals furnished. Employee acceptance of a meal must be voluntary and uncoerced. 6.2.3 Tip Credit. Employers must always pay at least the statewide tipped minimum wage (as a direct or cash wage), but may be able to apply a greater tip credit based on the laws of the local government, as explained in (B).

(A) Statewide Tip Credit. A statewide tip credit no greater than $3.02 per hour may be used to offset direct wages for employers of tipped employees. An employer must pay a direct wage of at least the amount specified for the applicable year in the PAY CALC Order if it claims a tip credit against its minimum hourly wage obligation; if an employee’s tips combined with the direct wage of at least the amount specified for the applicable year in the PAY CALC Order

Rule 1.2.1(B) do not equal the applicable minimum hourly wage, the employer must make up the difference in direct wages.

(B) Local Tip Credit. In local governments that have enacted a higher local minimum wage, a tip credit of at least $3.02 per hour may be used to offset direct wages for employers of tipped employees.

Such local governments may adopt tip credits over $3.02 per hour, so long as the direct wage is at least the amount specified for the applicable year in the PAY CALC Order Rule 1.2.1(B). If an employee’s tips combined with the direct wage do not equal the local minimum hourly wage, the employer must make up the difference in direct wages. 6.3 Uniforms. 6.3.1 Where wearing a particular uniform or special apparel is a condition of employment, the employer shall pay the cost of purchases, maintenance, and cleaning of the uniforms or special apparel, with the following exceptions:

(A) if the uniform furnished by the employer is plain and washable, and does not need or require special care such as ironing, dry cleaning, pressing, etc., the employer need not maintain or pay for cleaning; and (B) clothing that is ordinary, plain, and washable that is prescribed as a uniform need not be furnished by the employer unless a special color, make, pattern, logo, or material is required. 6.3.2 The cost of ordinary wear and tear of a uniform or special apparel shall not be deducted from an employee's wages.

Rule 7. Employer Record-Keeping and Posting Requirements. 7.1 Employee Records. Every employer shall keep at the place of employment, or at the employer's principal place of business in Colorado, a true and accurate record for each employee which contains the following information:

(A) name, address, occupation, and date of hire of the employee;

(B) date of birth, if the employee is under 18 years of age;

(C) daily record of all hours worked;

(D) record of credits claimed and of tips;

(E) regular rates of pay, gross wages earned, withholdings made, and net amounts paid each pay period;

(F) all vacation pay hours accrued, used, and available for use during the current benefit year, if any; and (G) all HFWA or sick leave hours accrued, used, and available for use during the current benefit year (to the extent these hours are tracked separately from vacation hours).

“Vacation pay” has the same meaning as the definition set forth in Wage Protection Rule 2.17, 7 CCR 1103-7. 7.2 Issuance of Earnings Statement and Information. 7.2.1 An itemized earnings statement of the information in Rule 7.1(D)-(E) and the total hours worked in the pay period, with the employee’s and the employer’s names, shall be provided to each employee each pay period. 7.2.2 Nothing in Rule 7.2.1 shall prevent an employer from providing to an employee information related to Rule 7.1(F). Upon an employee’s request, an employer must provide, in writing or electronically, documents sufficient to show, or a dated statement containing, the information in Rule 7.1(F).

Employees may make such requests no more than once per month, or more frequently as provided by an employer policy. Employers may choose a reasonable system for fulfilling such requests, including but not limited to listing such information on each pay stub, using an electronic system where employees can access their own information, or providing the necessary information in a letter or electronic communication. 7.2.3 Nothing in Rule 7.2.1 shall impede an employee’s right to request information related to Rule 7.1(G) or concerning paid sick leave, as authorized by Wage Protection Rule 3.5.7, 7 CCR 1103-7. 7.3 Maintenance of Earnings Statement Information. An employer shall retain records reflecting the information contained in an employee’s itemized earnings statement as described in this rule for at least 3 years after the wages or compensation were due, and for the duration of any pending wage claim pertaining to the employee. Each employer shall provide each employee access to the information in Rules 7.1(A) and (C) in any of the following forms it chooses:

(A) provide the information with the regular earnings statements;

(B) provide each employee with access to a functioning electronic portal that shows the information – but this method is permissible only if the employer knows an email address of the employee; or (C) provide each employee the information for the entire calendar year by January 31st the following year and, in addition, provide the information to an employee upon a request that an employee may make once per year. 7.4 Posting and Distribution Requirements. 7.4.1 Posting. Every employer subject to the COMPS Order must display a COMPS Order poster for the current year, with applicable dollar figures as stated in the PAY CALC Order for that year, published by the Division in an area frequented by employees where it may be easily read during the workday. If the work site or other conditions make a physical posting impractical (including private residences employing only one worker, and certain entirely outdoor work sites lacking an indoor area), the employer shall provide a copy of the COMPS Order or poster to each employee within their first month of employment, and shall make it available to employees upon request. Employers shall be deemed noncompliant if they attempt to minimize the effect of posters or notices required by statute or these Rules, such as by communicating positions contrary to, or discouraging the exercise of rights covered in, the required poster or notice. An employer that does not comply with the above requirements of this paragraph shall be ineligible for any employee-specific credits, deductions, or exemptions in the COMPS Order, but shall remain eligible for employer- or industry-wide exemptions, such as exempting an entire employer or industry from any overtime or meal/rest period requirements in Rules 4 – 5. 7.4.2 Distribution. Every employer publishing or distributing to employees any handbook, manual, or written or posted policies shall include a copy of the COMPS Order, or a COMPS Order poster published by the Division, with any such handbook, manual, or policies. Every employer that requires employees to sign any handbook, manual, or policy shall, at the same time or promptly thereafter, include a copy of the COMPS Order, or a COMPS Order poster published by the Division, and have the employee sign an acknowledgement of being provided the COMPS Order or the COMPS Order poster. 7.4.3 Translation. Employers with any employees with limited English language ability shall:

(A) use a Spanish-language version of the COMPS Order and poster published by the Division, if the employee(s) in question speak Spanish; or (B) contact the Division to request that the Division, if possible, provide a version of the COMPS Order and poster in another language that any employee(s) need.

Rule 8 Administration and Interpretation. 8.1 Recovery of Wages.

(A) Availability of court action or Division administrative complaint. An employee receiving less than the full wages or other compensation owed is entitled to recover in a civil action the unpaid balance of the full amount owed, together with reasonable attorney fees and court costs, notwithstanding any agreement to work for a lesser wage, pursuant to C.R.S. §§ 8-4-121, 8-6-118. Alternatively, an employee may elect to pursue a complaint through the Division’s administrative procedure as described in the Colorado Wage Act, C.R.S. § 8-4-101, et seq.

(B) No minimum claim size. There is no minimum size of a wage claim, and thus no claim too minimal (“de minimis”) for recovery (subject to Rule 1.9.1 as to certain activities of less than one minute), because Article 4 requires paying “[a]ll wages or compensation” (C.R.S. § 8-4-103(1)(a)), and authorizes civil actions “to recover any amount of wages or compensation”

(C.R.S. § 8-4-110(1)) and Division complaints “for any violation” (C.R.S. § 8-4-111(1)(a)). 8.2 Complaints. Any person may register with the Division a written complaint that alleges a violation of the COMPS Order within 2 years of the alleged violation(s), except that actions brought for a willful violation shall be commenced within 3 years. 8.3 Investigations. The Director or a designated agent shall investigate and take all proceedings necessary to enforce the payment of the minimum wage and other provisions of the COMPS Order, pursuant to these Rules and C.R.S. Title 8, Articles 1, 4, 6, and 13.3. Violations may be subject to the administrative procedure as described in the Colorado Wage Act, C.R.S. § 8-4-101, et seq. 8.4 Violations. It is theft under the Criminal Code (C.R.S. § 18-4-401) if an employer or agent:

(A) willfully refuses to pay wages or compensation, or falsely denies the amount of a wage claim, or the validity thereof, or that the same is due, with intent to secure for themself, or another person any discount upon such indebtedness or any underpayment of such indebtedness or with intent to annoy, harass, oppress, hinder, coerce, delay, or defraud the person to whom such indebtedness is due (C.R.S. § 8-4-114); or (B) intentionally pays or causes to be paid to any such employee a wage less than the minimum (C.R.S. § 8-6-116). 8.5 Reprisals. Employers shall not threaten, coerce, or discriminate against any person for the purpose of reprisal, interference, or obstruction as to any actual or anticipated investigation, hearing, complaint, or other process or proceeding relating to a wage claim, right, or rule. Violators may be subject to penalties under C.R.S. §§ 8-1-116, 8-1-140, 8-4-120, and/or 8-6-115. 8.6 Division and Dual Jurisdiction. The Division shall have jurisdiction over all questions arising with respect to the administration and interpretation of the COMPS Order. Whenever employers are subjected to Colorado law as well as federal and/or local law, the law providing greater protection or setting the higher standard shall apply. For information on federal law, contact the U.S. Department of Labor, Wage and Hour Division. 8.7 Construction.

(A) Liberal construction of the COMPS Order, narrow construction of exceptions/ exemptions. Under the C.R.S. § 8-6-102 “Construction” provision (“Whenever this article or any part thereof is interpreted by any court, it shall be liberally construed by such court”), applicable to rules on “wages which are inadequate to supply the necessary cost of living” (§ 8- 6- 104), on “conditions of labor detrimental to [worker] health or morals” (§ 8-6-104), on “conditions of labor and hours of employment not detrimental to health or morals for workers” (§ 8-6-106), on “what are unreasonably long hours” (§ 8-6-106), on what requirements are “necessary to carry out the provisions of this article” (§ 8-6-108.5), on minimum and overtime wages (§§ 8-6-109, -111, -116, -117), and on who qualifies as an “agricultural employer” (§ 8-6-120 (incorporating §§ 8-13.5-201(1); 8-3- 104(1)(b))): The provisions of the COMPS Order shall be liberally construed, with exceptions and exemptions accordingly narrowly construed.

(B) Subpart included in cross-references. Where any Division rule references another rule, the reference shall be deemed to include all subparts of the referenced rule.

(C) Minimum Wage Order references. References to the Colorado “Minimum Wage Order” shall be deemed to reference the COMPS Order, as the successor to the Colorado Minimum Wage Order. 8.8 Separability. The COMPS Order is intended to remain in effect to the maximum extent possible. If any part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the COMPS Order remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form. 8.9 Basis for Calculation. Calculations in the PAY CALC and COMPS Orders are based on Section 15 of Article XVIII of the Colorado Constitution (Section 15)

(“Colorado’s minimum wage is . . . adjusted annually for cost of living increases, as measured by the . . . Consumer Price Index used for Colorado”); C.R.S.

Article 8, Title 6; and the COMPS Order. All inflation-adjusted values applicable to the COMPS and PAY CALC Orders are based on the CPI used for Colorado, the Denver-Aurora-Lakewood CPI published by the federal Bureau of Labor Statistics. To effectuate the above provisions that employees must be paid not less than the prior year’s minimum wage adjusted for inflation, Division rules and practice must round up, to the nearest cent, any fractional cents yielded by the inflation adjustment. Other than in the annual minimum wage calculation, Division rules and practice round fractional cents of at least 0.5 up, and of under 0.5 down.

Appendix A. Statutory Authority.

• C.R.S. §§ 8-1-101 (“‘General order’ means an order of the director applying generally throughout the state to all persons, employments, or places of employment under the jurisdiction of the division”);

• 8-1-103 (“[P]owers, duties, and functions of the director ... , includ[e] ... promulgation of rules, rates, regulations, and standards, and the rendering of findings, orders, and adjudications”);

• 8-1-107 (“[T]he director has the duty and the power to ... [a]dopt reasonable and proper rules and regulations relative to the exercise of his powers and proper rules and regulations to govern the proceedings of the division and to regulate the manner of investigations and hearings.”)

• 8-1-108 (“[G]eneral orders shall be effective ... after they are adopted by the director and posted”; “All orders of the division shall be ... in force and prima facie reasonable and lawful until ... found otherwise.”);

• 8-1-111 (“The director is vested with the power and jurisdiction to have such supervision of every employment and place of employment ... [to] determine the conditions under which the employees labor ... , to enforce all provisions of law relating thereto ... to administer all provisions of this article with respect to the relations between employer and employee and to do all other acts and things convenient and necessary to accomplish the purposes of this article.”);

• 8-1-130 (“The director has full power to hear and determine all questions within his[, her, or their] jurisdiction, and his[, her, or their] findings, award, and order issued thereon shall be final agency action.”);

• 8-4-111 (“It is the duty of the director ... to enforce generally the provisions of this

article.”);

• 8-6-101.5 (“[T]he minimum wage requirements of section 15 of article xviii of the state constitution, and any minimum wage laws enacted pursuant to this article 6, apply to agricultural employers employing agricultural workers. ...The Colorado minimum wage that an agricultural employer must pay to an agricultural worker who is principally engaged in the range production of livestock ... on the open range is: (i) beginning January 1, 2022, ... five hundred fifteen dollars per week; and (ii) beginning January 1, 2023, the minimum wage required in the prior calendar year adjusted annually ... . The director may set a higher minimum wage than is required ... consistent with the director’s authority and duties[.]”);

• 8-6-101.5 (“An agricultural worker is entitled to an uninterrupted and duty-free meal period of at least a thirty-minute duration when the agricultural worker's shift exceeds five consecutive hours. ...An agricultural worker is entitled to an uninterrupted and duty-free rest period of at least ten minutes within each four hours of work.”); 8-13.5-203(3) (“An agricultural employer shall provide agricultural workers engaged in hand weeding and hand thinning an additional five minute rest period, which, insofar as is practicable, must be in the middle of each work period. The authorized rest period must be based on the total hours worked daily at the rate of fifteen minutes net rest time per four hours worked, or a major fraction thereof. The agricultural employer shall count the authorized rest period as hours worked and not deduct the rest period from the agricultural worker’s wages.”);

• 8-6-102 (“Whenever this article or any part thereof is interpreted by any court, it shall be liberally construed.”);

• 8-6-104 (“It is unlawful to employ workers in any occupation ... for wages which are inadequate to supply the necessary cost of living and to maintain the health of the workers .... It is unlawful to employ workers in any occupation ... under conditions of labor detrimental to their health or morals.”);

• 8-6-105 (“It is the duty of the director to inquire into the wages paid to employees and into the conditions of labor ... in any occupation ... if the director has reason to believe ... conditions of labor are detrimental to the health or morals of said employees or that the wages paid to a substantial number of employees are inadequate to supply the necessary cost of living and to maintain such employees in health.”);

• 8-6-106 (“The director shall determine the minimum wages sufficient for living wages ... ; standards of conditions of labor and hours ... not detrimental to health or morals for workers; and what are unreasonably long hours.”);

• 8-6-108 (“[F]or the purpose of investigating any of the matters [s/]he[/they] is authorized to investigate by this article ... [t]he director has power to make reasonable and proper rules and procedure and to enforce said rules and procedure.”);

• 8-6-109 (“If after investigation the director is of the opinion that the conditions of employment surrounding said employees are detrimental to the health or morals or that a substantial number of workers in any occupation are receiving wages ... inadequate to supply the necessary costs of living and to maintain the workers in health, the director shall proceed to establish minimum wage rates.”);

• 8-6-111 (“Overtime, at a rate of one and one-half times the regular rate of pay, may be permitted by the director under conditions and rules and for increased minimum wages which the director, after investigation, determines and prescribes by order and which shall apply equally to all employers in such industry or occupation.”);

• 8-6-116 (“The minimum wages fixed by the director, as provided in this article, shall be the minimum wages paid to the employees, and the payment ... of a wage less than the minimum ... is unlawful”);

• 8-6-117 (“In every prosecution ... of this article, the minimum wage established by the director shall be prima facie presumed to be reasonable and lawful and the wage required to be paid. The findings of fact made by the director acting within prescribed powers, in the absence of fraud, shall be conclusive.”);

• 8-6-120 (“The director shall promulgate rules providing meaningful overtime and maximum hours protections to agricultural employees. ... In promulgating such rules, the director shall consider the inequity and racist origins of the exclusion of agricultural employees from overtime and maximum hours protections available to other employees, the fundamental right of all employees to overtime and maximum hours standards that protect the health and welfare of employees, and the unique difficulties agricultural employees have obtaining workplace conditions equal to those provided to other employees.”);

• 8-12-115 (“The director shall enforce ... this article” and “shall promulgate rules and regulations more specifically defining the occupations and types of equipment permitted or prohibited by this article.”);

• 8-13.3-403 (“The division shall promulgate rules regarding compensation and accrual of paid sick leave for employees employed and compensated on a feefor-service basis.”);

• 8-13.3-407 (“Determinations made by the division under this section [as to paid sick leave] are appealable pursuant to section 8-4-111.5 and rules promulgated by the department regarding appeals and strategic enforcement.”);

• 8-13.3-408 (“Each employer shall notify its employees that they are entitled to paid sick leave, pursuant to rules promulgated by the division.”);

• 8-13.3-410 (“The director may coordinate implementation and enforcement of this part and adopt rules as necessary for such purposes.”);

• 8-13.5-202(1)(c)(I) (“To ensure that agricultural workers have meaningful access to services, the director of the division may adopt rules regarding additional times during which an employer may not interfere with an agricultural worker’s reasonable access to key service providers at any location other than the employer’s property, including periods during which the agricultural worker is performing compensable work, especially during periods when the agricultural worker is required to work in excess of forty hours per week and may have difficulty accessing such services outside of work hours.”);

• 8-13.5-203 (“The director of the division shall promulgate rules that require agricultural employers to protect agricultural workers from heat-related stress illnesses and injuries when the outside temperatures reach eighty degrees or higher, with discretion to adjust requirements based on environmental factors, exposure time, acclimatization, and metabolic demands of the job as set forth in the federal Department of Health and Human Services Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 2016 Revised Publication: Criteria for a Recommended Standard, Occupational Exposure to Heat and Hot Environments.”); and • the Administrative Procedure Act, C.R.S. § 24-4-103. ______________________________________________________________________

Editor's Notes

History Entire rule eff. 01/01/2008.

Entire rule eff. 01/01/2009.

Entire rule eff. 01/01/2010.

Entire rule eff. 01/01/2011.

Entire rule eff. 01/01/2012.

Entire rule eff. 01/01/2013.

Entire rule eff. 01/01/2014.

Entire rule eff. 12/30/2014.

Entire rule eff. 01/01/2016.

Entire rule eff. 01/01/2017.

Entire rule eff. 01/01/2018.

Entire rule eff. 01/01/2019.

Entire rule emer. rule eff. 01/01/2020.

Entire rule eff. 03/16/2020.

Rules 1.6, 2.2.7 (G), 5.2.1, 7.2, 7.3 emer. rules eff. 03/16/2020.

Rules 1.6, 2.2.7 (G), 5.2.1, 7.2, 7.3 eff. 07/15/2020.

Entire rule eff. 01/01/2021.

Entire rule eff. 01/01/2022.

Entire rule eff. 01/01/2024.

Entire rule eff. 02/01/2026.

7 CCR 1103-2 Colorado Works Program Act Grievance Procedure Rules {#sec-7-ccr-1103-2 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-2}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Labor COLORADO WORKS PROGRAM ACT GRIEVANCE PROCEDURE RULES 7 CCR 1103-2 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

Section 1 Basis, Purpose, and Statutory Authority The purpose of the following rules is to establish a grievance procedure for use by the employment community in matters related to welfare reform in compliance with sections 26-2-716 (3)(a) (IV), (b) of the Colorado Works Program Act, (CWPA) and provisions of the Personal Responsibility and Work Opportunity Reconciliation Act, (PRWORA) of 1996, as amended. The director of the division of labor has the power to adopt, amend, or rescind, in accordance with section 24-4-103, and 8-1-107 (2)(r)

C.R.S., as amended reasonable and necessary rules relating to the administration of the grievance procedure of the Colorado Works Program Act.

Section 2 Powers and Duties The labor standards unit in the division of labor is responsible for administering the provisions of these rules. In carrying out the provisions of these rules, the director of the division of labor has all applicable duties and powers as outlined in Title 8, Article 1 of Colorado Revised Statutes, as amended.

Section 3 Definitions 3.1 - Definitions THE FOLLOWING DEFINITIONS APPLY TO THESE RULES ONLY: 3.1.1 Administrator: the administrator of the labor standards unit in the division of labor. 3.1.2 Administrative Law Judge (ALJ): an administrative law judge appointed pursuant to section 24-30-1003, C.R.S., as amended. 3.1.3 Adult: the head of a household, including an emancipated minor or an individual over the age of 18. 3.1.4 Complaint: a completed complaint form, or other document containing essentially the same information, received by the division of labor, with regard to a potential violation of the provisions of the Colorado Works Program Act, or these rules. 3.1.5 Complainant: a person who has filed a complaint with the division of labor. 3.1.6 Director: the director of the division of labor. 3.1.7 Displacement of a regular employee by a participant: includes but is not limited to:

(a) A reduction of hours (regular or overtime), compensation, or fringe benefits, (b) A failure to restore a regular employee to the same or equivalent position after the conclusion of approved leave of absence, including but not limited to vacation, sick, maternity, family/medical leave, military reserve training or a Workers'

Compensation related temporary disability, (c) Replacement while on a strike, lockout or other organized labor dispute, (d) Terminations, suspensions, reductions in workforce, or layoffs for the purpose of displacement, (e) Other displacements as determined by the director or administrative law judge at any proceedings conducted under the provisions of these rules. 3.1.8 Division: the division of labor in the Colorado Department of Labor and Employment established by section, 24-1-121 (3)(a)(l), C.R.S, as amended. 3.1.9 Employee: any adult, performing labor or services for the benefit of and subject to the direction and control of an employer. 3.1.10 Employer: any individual, limited liability company, partnership, corporation, association, county, and public or private organization of any character employing any Temporary Assistance for Needy Families (JANF) welfare to work participant in Colorado. 3.1.11 Executive Director: the executive director of the department of labor and employment. 3.1.12 Final Determination: the decision of the director at Step II - Director’s Hearing unless appealed to Step III - Administrative Law Judge. In such cases the final determination is the decision of the administrative law judge. 3.1.13 Final Investigative Report: the final investigative report released by a division investigator at step I of the grievance process. The report shall contain findings, recommendations, and appropriate material responses from interested parties. 3.1.14 Finding: a summary of a condition, in a preliminary or final investigative report, which is substantially out of compliance, or may have a material impact on an employer’s positive participation in programs authorized by the Colorado Works Program Act. 3.1.15 Full time: performing work for the benefit of an employer for a minimum of 32 hours per work 3.1.16 Hearing: a hearing as described in the Section 7 - Grievance Procedure of these rules. 3.1.17 Investigator: an investigator of the division of labor. 3.1.18 Investigator’s Determination: the initial findings and recommendations made by the investigator in the final investigative report. 3.1.19 Participant: an adult participating in a Welfare-to-Work component of the CWPA or Subtitle A, (TANF Block Grant) of the Personal Responsibility and Work Opportunity Act of 1996, as amended. A participant becomes a regular employee when he/she attains permanent employment, and is no longer receiving public assistance under the TANF programs referenced in section 3.1.26. 3.1.20 Person: any individual, corporation, government, or governmental subdivision or agency, business trust, estate, trust, limited liability company, partnership, association, or other legal entity. 3.1.21 Preliminary Report: the initial report prepared by a division investigator in step I of the grievance process, and is intended to inform interested parties of the likely content of the final investigative report, and to prompt written responses to the findings and recommendations contained in the report. 3.1.22 Program: refers to organized strategical plans, with regard to welfare reform, as referenced and authorized in the Colorado Works Program Act (CWPA), or the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), as amended. 3.1.23 Recommendation: an official suggestion, in a preliminary or final investigative report, regarding the actions an employer might take to bring an outlined condition into compliance, or interested parties might take to bring resolution to an outlined dispute. 3.1.24 Re-determination: the review conducted by the administrator of the labor standards unit in the division of labor. 3.1.25 Regular Employee: an employee who is not a participant, and who was working for an employer during the period relevant to any complaint filed under these rules. 3.1.26 Temporary Assistance for Needy Families (TANF): Refers to the implementation of federal block grants assistance under the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA).

Section 4 Employer Records Each employer participating in any welfare reform program, at any level, shall maintain true and accurate work records containing such information as the division may prescribe. Such records shall be maintained for a period of not less than five years and shall be open for inspection and be subject to copying in accordance with section 8-1-117, C.R.S., as amended.

Information obtained, pursuant to an investigation conducted under these rules, shall be confidential and shall not be open to public inspection. In the administration of the Colorado Works Program Act and the rules promulgated in accordance with that act, the division shall cooperate with the county governments of the State of Colorado, the Colorado Department of Human Services, the United States Department of Labor, and the United States Department of Health and Human Services to the fullest extent consistent with the provisions of these rules.

Section 5 Grievance Process This section documents the steps of the grievance process. For the Grievance Procedure see Section 7. 5.1 Step I - Complaint (a) Complaint (b) Investigation (c) Preliminary report (d) Final report (determination)

(e) Protest findings and recommendations in the final investigative report (f) Administrator’s review (re-determination)

(g) Administrator’s settlement conference (h) Appeal to Step II - Director’s Hearing within fifteen (15) calendar days of the date of the administrator’s decision (I) If no such appeal is filed, the decision of the administrator becomes final 5.2 Step II - Director’s Hearing (a) Hearing (b) Issuance of decision (final order). Such order shall represent the agency’s final determination (c) Appeal to Step III- Administrative Law Judge within thirty (30) calendar days (d) If no such appeal if filed, the decision (order) of the director shall become final 5.3 Step III - Administrative Law Judge Appeal (a) Review conducted at the division of administrative hearings in the department of personnel (b) The administrative law judge shall render a decision within one hundred twenty (120) days of the receipt of an appeal (c) Appeal to Step IV - Judicial Review within thirty (30) calendar days of the decision of the administrative law judge (d) If no such appeal is filed, the decision of the administrative law judge becomes final 5.4 Step IV - Judicial Review - Courts (a) Judicial review in accordance with the provisions of 24-4-106: C.R.S., as amended.

Section 6 Remedies 6.1 Remedies Authorized (a) For the purposes of these rules, remedies authorized may include, but are not limited to:

1. Back pay 2. Reinstatement (with or without back pay)

2. Restoration of benefit packages, including but not limited to;

• vacation leave accrual - sick leave accrual - employer’s contribution to retirement plans 4. Restoration of service credit (anniversary or hire date)

5. Suspension or termination of payments from funds under the Colorado Works Program Act 6. Suspension or termination of future placement of participants with an employer who has knowingly violated any protections provided under these rules 7. The director may order other equitable relief where appropriate (b) Nothing in this rule shall be construed to limit the ability or right of any individual or his or her exclusive bargaining representative from pursuing available procedures and remedies under any applicable collective bargaining agreement.

(c) In the event the application of these remedies changes the placement status of a participant, such application should not be deemed to prejudice the participant’s eligibility for benefits under any welfare reform program.

Section 7 Grievance Procedure 7.1 Step I 7.1.1 - Complaint (a) Any party who believes they have been displaced from employment in violation of the Colorado Works Program Act, can file a complaint with the division of labor - labor standards unit in the Colorado Department of Labor and Employment.

(b) Complaints must be filed in writing, and contain: 1.) The name, address, telephone number, and social security number of the complainant. 2.) The name, address and telephone number of the employer. 3.) A summary of the complaint including the position last held by the complainant, the hire date of the complainant, the termination date of the complainant, and any information available on the person believed to have replaced the complainant. 4.) Any other evidence that supports the validity of the complaint. 7.1.2 -Investigation (a) Upon receipt of a complaint the division will: 1.) Review the complaint to determine if it has jurisdiction to handle the complaint. 2.) Assign the case to an investigator and conduct an investigation to gather and review evidence. 3.) At the conclusion of the investigation the investigator shall issue a preliminary report. Such report will contain findings and recommendations; a copy of which will be made available to the complainant and employer. 4.) Both parties will have fourteen (14) calendar days to provide comments, responses, or additional information for consideration. 5.) The investigator incorporates responses and other appropriate information into the report and issues a final investigative report.

(b) If both parties agree with the findings and recommendations the parties shall submit evidence documenting the affirmative actions taken or agreed upon to settle the dispute. The investigator may assist in documenting such affirmative actions or agreement.

(c) A complainant may not waive any rights, or accept a settlement amount of less than that recommended in the final investigative report except as agreed upon in a settlement conference before the administrator of the labor standards unit as provided for in section 7.1.3 (d) (3) and (4) of these rules.

(d) Either party who wishes to protest the findings and recommendations in the final investigative report may request an administrator’s review.

(e) The request for an administrator’s review shall be filed with the administrator of the labor standards unit of the division of labor, within fifteen (15) calendar days from the release date of the final investigative report.

(f) If no protest, as provided for in subsection (d) of this section 7.1.2 is filed, the determination of the investigator in the final investigative report shall become final. 7.1.3 - Administrator’s Review (a) Upon timely receipt of a request for an administrator’s review from either party, the administrator shall; 1.) Review the investigative report to determine that;

• the investigative report was prepared in accordance with unit policy and procedure, - findings are reasonable and supported by substantial evidence, - recommendations are appropriate and reasonable. 2.) If the administrator finds a material problem with the report, it may be returned to the investigation’s unit for further follow-up work. 3.) If the administrator finds no material problem with the report, both parties are notified of such decision and the parties are invited to participate in a settlement conference. 4.) If all parties agree, the administrator schedules the settlement conference, and notifies all parties of the time and date of the conference. 5.) If any interested party refuses to participate in a settlement conference, the grievance can be appealed to Step II - Director’s Hearing within fifteen (15) calendar days of the administrator’s decision. 6.) The administrator shall within thirty (30) calendar days of the receipt of a request for settlement conference issue a re-determination decision. 7.) The parties shall not request an appeal of the administrator’s decision if a settlement conference as provided for in subsection 4 of this section 7.1.2 (a) has been scheduled. The time limit for requesting an appeal to Step II of the grievance process will start at the conclusion of such settlement conference.

(b) Any party wishing to appeal an adverse decision of the administrator may request a hearing before the director of the division of labor at Step II - Director’s Hearing of the grievance process. Such appeal shall be filed with the director of the division of labor at the department of labor and employment within fifteen (15) calendar days of the date of the administrator’s re-determination decision.

(c) If no such request is filed, the decision of the administrator becomes final. 7.2 Step II - Director’s Hearing (a) Upon receipt of a request for hearing to appeal the administrator’s decision, the director of the division of labor shall schedule a hearing. Such proceeding shall be conducted in accordance with the State Administrative Procedures Act.

(b) The director shall issue a decision within ten (10) calendar days of the conclusion of a hearing as provided for in sub-section (a) of this section 7.2. Such decision which shall be an order upon the parties.

(c) Any party wishing to appeal an adverse decision of the director may appeal to Step III - Administrative Law Judge, by filing such appeal with the division of administrative hearings, and the division of labor within thirty (30) calendar days of the date of the director’s decision (order).

(d) If no such appeal is filed as outlined in subsection (c) of this section 7.2, the decision (order) of the director shall become final. Such decision shall represent a final determination, or final agency action.

(e) The director may obtain a decree of the district court for the enforcement of such order upon showing that a party is subject to the jurisdiction of the division, and resides or transacts business within the county in which the petition for enforcement is brought. 7.3 Step III - Administrative Law Judge Appeal (a) An aggrieved complainant can file an appeal with the division of administrative hearings. A request for appeal can be filed by mailing or delivering the request to the offices of the Director of the Division of Labor, and the offices of the Chief Administrative Law Judge at the Division of Administrative Hearings. The request must be filed at both offices.

(b) A copy of the appeal must also be mailed or delivered to all interested parties. The appeal should include reasons (exceptions) for why the decision of the director was not correct. The request for an appeal review should contain a mailing date and the parties notified should file a response to the exceptions within thirty days of that date The response should be filed with the chief administrative law judge at the division of administrative hearings (c) If any interested party intends to have a part, or specific parts, of *e audio recording of the director’s hearing transcribed, such request, formally referred to as a “designation of record”, should be filed with the division of labor within twenty days of the date of the director’s decision. A copy of the designate shall be mailed or delivered to all interested parties. 1.) Upon receipt of a designation of records, or a request for appeal from any interested party, or the division of administrative hearings, the division of labor will forward the entire record to the division of administrative hearings along with any request for portions of the record to be transcribed. The division of administrative hearings shall cause the requested portions of the audio recording to be transcribed. 2.)The cost of transcribing all or part of an audio tape of a proceeding shall be paid by the requestor. The division of administrative hearings may require the estimated cost of such transcript be paid in advance. 3.) The entire record shall include, an audio tape of the Director’s Hearing, along with all pleadings, applications, evidence, exhibits, and other papers> presented or considered, matters officially noticed, rulings upon exceptions, any findings of fact and conclusions of law proposed by any party, and any written brief filed.

(d) The administrative law judge shall review the record, and issue a decision within one hundred twenty (120) days of the receipt of the request for appeal.

(e) Any party wishing to appeal an adverse decision of the administrative law judge may appeal to Step IV- Judicial Review by filing an appeal within thirty (30) calendar days of the date of the decision of the administrative law judge in accordance with the provisions of section 24-4-106 C.R.S., as amended.

Processes at this step are intended to comply with the State Administrative Procedures Act, specifically, 24-4-105, (14), (15), and (16), C.R.S., as amended. In the event of a conflict between the information contained in this section and an official printing of the State Administrative Procedures Act, the official printing will be the controlling document.

(f) If no such appeal is filed, the decision of the administrative law judge becomes final. Such decision shall represent a final determination, or final agency action. 7.4 Step IV - Judicial Review - Courts Judicial Review (a) Any appeal for judicial review of the decision of the administrative law judge, shall be brought in the appropriate district court for the district where the complainant resides by utilizing appropriate proceedings under section 24-4-106, C. R. S., as amended.

(b) Such appeal proceeding shall be initiated by the filing of a petition in the appropriate district court and the service of a copy thereof upon the agency whose decision is the subject of the appeal, and upon all parties who appeared before the division of labor, or the division of administrative hearings. Thereafter such proceeding shall be processed under the rules of procedure of that court.

Section 8 Good Cause Good Cause 8.1 - Request for good cause consideration - An interested party who files an untimely request at Steps 1 -2 of the grievance process, or fails to appear at any conference, hearing, or appeal of those steps, may request the director to consider whether there was good cause for failing to meet a filing deadline, or appearance dates.

1. Any party requesting good cause consideration should file a statement, with the division, containing the reasons for why the filing deadline, or appearance date was missed. The requesting party shall notify all interested parties of such request.

2. Any supporting evidence, which shall include documents outlining the method used to notify the parties, should be submitted as an attachment to such statement.

3. The requirements in both subsections 1 and 2 of this section 8.1 shall be met before a good cause consideration can be conducted. 8.2 - Good cause consideration - steps 1 - 2 The director will review such statement and supporting evidence and issue a decision on the good cause request. All interested parties shall be notified of such decision. If the director determines the requesting party had good cause for failing to meet the filing deadline, or appear, the grievance process shall continue as if the deadline had not been missed. If the director determines that good cause is not demonstrated, the determination, re-determination, or decision just prior to the request for good cause consideration shall become final. 8.3 - Good cause consideration - step 3 - The determination of good cause at step three of the grievance process shall be made by the division of administrative hearings.

Section 9 Deadlines 9.1 For the purpose of these rules, wherever a response, protest or filing deadline falls on a weekend or official State holiday, the last day to file shall be the next business day.

Section 10 Interventions 10.1 Any person may intervene in any proceeding by filing a motion to intervene demonstrating a substantial interest the person has that may be impacted by the proceeding.

Section 11 Severability 11.1 If any section, sentence, clause or phrase of this rule is for any reason held to be invalid, such decision shall not affect the validity of the remaining portions of the rule. _________________________________________________________________________ Editor’s Notes

History

7 CCR 1103-3 EMPLOYMENT VERIFICATION LAW RULES [Repealed eff. 01/01/2017] {#sec-7-ccr-1103-3 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-3}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Labor Standards and Statistics EMPLOYMENT VERIFICATION LAW RULES - Repealed eff. 01/01/2017 7 CCR 1103-3 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes

History Entire rule eff. 10/30/2009.

Entire rule eff. 10/01/2012.

Entire rule repealed eff. 01/01/2017.

7 CCR 1103-4 EMPLOYMENT OPPORTUNITY ACT RULES [Recodified as 7 CCR 1103-18 eff. 07/01/2024] {#sec-7-ccr-1103-4 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-4}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Labor Standards and Statistics EMPLOYMENT OPPORTUNITY ACT RULES [Recodified as 7 CCR 1103-18 eff. 07/01/2024]

7 CCR 1103-4 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes

History Entire rule eff. 07/15/2014.

Rules 1.1, 2.4, 2.6, 8-11 eff. 09/01/2017.

Entire rule recodified as 7 CCR 1103-18 eff. 07/01/2024.

7 CCR 1103-5 SOCIAL MEDIA AND THE WORKPLACE LAW RULES [Recodified as 7 CCR 1103-18 eff. 07/01/2024] {#sec-7-ccr-1103-5 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-5}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Labor Standards and Statistics SOCIAL MEDIA AND THE WORKPLACE LAW RULES [Recodified as 7 CCR 1103-18 eff. 07/01/2024]

7 CCR 1103-5 [Editor's Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

Editor's Notes

History Entire rule eff. 01/01/2014.

Rules 1.1, 2.4, 9-12 eff. 09/01/2017.

Entire rule recodified as 7 CCR 1103-18 eff. 07/01/2024.

7 CCR 1103-6 Prevailing Wage and Residency (pwr) Rules {#sec-7-ccr-1103-6 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-6}

DEPARTMENT OF LABOR AND EMPLOYMENT

PREVAILING WAGE AND RESIDENCY (PWR) RULES

7 CCR 1103-6 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted November 9, 2023, effective January 1, 2024.

Rule 1. Statement of Purpose; Dual Jurisdiction; Separability 1.1 The general purpose of these Prevailing Wage and Residency (PWR) Rules, 7 CCR 1103-6, is to exercise the authority of this Division to administer and enforce the Keep Jobs in Colorado Act (KJICA), C.R.S. Title 8, Article 17, C.R.S. § 8-17-101 et seq., the Colorado Quality Apprenticeship Training Act of 2019, C.R.S. Title 24, Article 92, Part 2, C.R.S. § 24-92-201 et seq. (Prevailing Wage Act), the Colorado Energy Sector Public Works Project Craft Labor Requirements Act, C.R.S. Title 24, Article 92, Part 3, C.R.S. § 24-92-301 et seq., and the Thermal Energy Act, C.R.S. Title 40, Article 3.2, Part 1 C.R.S. § 40-3.2-105.7. These rules are issued under the

authority and as enforcement of Articles 1, 4, 6, 17 of C.R.S. Title 8 (2023); C.R.S. § 24-92- 209(7); and are intended to be consistent with the State Administrative Procedure Act, C.R.S. § 24-4-101, et seq. 1.2 Incorporations by Reference. Hereby incorporated by reference into these PWR Rules are Title 8, Articles 1, 4, 6, and 17 of the Colorado Revised Statutes (C.R.S.) (2023); Title 24, Article 92, of the C.R.S. (2023); Title 40, Article 3.2, Part 1 of the C.R.S. (2023); the Wage Protection Rules, 7 CCR 1103-7 (2023); the Colorado WARNING Rules, 7 CCR 1103-11 (2023); and the Davis Bacon Act and its implementing regulations, 40 U.S.C. § 3141 et seq (2023). Earlier versions of such laws and rules may apply to events that occurred in prior years. Incorporation excludes later amendments to or editions of the constitution, statutes, and rules; all cited laws are incorporated in the forms that are in effect as of the effective date of these Rules. Where these Rules reference another rule, the reference shall be deemed to include all subparts of the referenced

rule. Where these Rules have provisions different from or contrary to any incorporated or referenced material, the provisions of these Rules govern, so long as they are consistent with Colorado statutory and constitutional provisions. Except where any of these Rules, or any other Colorado rules or statutes, provide otherwise, these Rules, as well as the Acts that these rules implement and enforce should be interpreted consistently with the federal Davis-Bacon Act and its implementing regulations, 40 U.S.C. § 3141 et seq. All sources cited or incorporated by reference are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, 633 17th Street, Denver CO 80202.

Copies may be obtained from the Division at a reasonable charge or can be accessed from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of them at cost upon request or provide the requestor information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing them. All Division rules are publicly available at www.coloradolaborlaw.gov. 1.3 Administration and Dual Jurisdiction. The Division shall have jurisdiction over all questions arising with respect to the administration and interpretation of these Rules. Pursuant to C.R.S. § 24-92- 202(3), the Department of Personnel and Administration (DPA) may promulgate additional rules applicable to rights under C.R.S. Title 24, Article 92, Part 2. Given the remedial purposes of the Prevailing Wage Act, in the event of any conflict between the DPA’s rules and these Rules, the

rule(s) providing greater protection for the rights of employees shall govern. Whenever employers are subject to both Colorado and federal and/or local law, the law providing the greater protection or setting the higher standard shall apply. For information on federal law, contact the U.S.

Department of Labor, Wage and Hour Division. 1.4 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any

part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rules remain valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form.

Rule 2. Definitions 2.1 “Agency of government” as used in the Prevailing Wage Act, C.R.S. § 24-92-201(1) means any agency, department, division, board, bureau, commission, institution, or section of the state, which is a budgetary unit exercising construction contracting authority or discretion. “Agency of government” does not include any county, city and county, city, municipality, town, school district, special district, or any other political subdivision of the state. 2.1.1 “Contracting Agency” is the specific agency of government with which a contractor or subcontractor has a contract for a public project. 2.2 “Authorized representative” means a person who is designated by a party to a complaint to represent the party during the Division’s complaint and/or appeal process. 2.3 “Colorado labor” as used in KJICA, C.R.S. § 8-17-101(2)(a), means labor that is performed on a public project by any person who is a resident of the state of Colorado, without discrimination as to race, color, creed, sex, sexual orientation, marital status, national origin, ancestry, age, or religion, except when sex or age is a bona fide occupational qualification. 2.3.1 A resident of the state of Colorado is a person who can provide a valid Colorado driver’s license, a valid Colorado state-issued photo identification, or other documentation showing that the person has resided in Colorado for the last thirty days. 2.4 “Contractor” as used in the Prevailing Wage Act, C.R.S. § 24-92-201(2), means any employer, person, entity, individual, partnership, association, corporation, business trust, legal representative, or any organized group of persons that has a contract for a public project with a Contracting Agency. 2.5 “Davis Bacon Act” refers to the Davis-Bacon and Related Acts (DBRA), 40 U.S.C. § 3141 et seq. 2.6 “Director” means the Director of the Colorado Division of Labor Standards and Statistics, or his or her designee. 2.7 “Division” means the Division of Labor Standards and Statistics within the Colorado Department of Labor and Employment. 2.8 “Employees” and/or “workers” under KJICA and Prevailing Wage Act. 2.8.1 Under KJICA, C.R.S. § 8-17-105, a “worker” is defined pursuant to the Davis Bacon Act, 29 C.F.R. § 5.2. Workers are those whose duties are manual or physical in nature (including those workers who use tools or who are performing the work of a trade), as distinguished from mental or managerial. The term does not apply to workers whose duties are primarily administrative, executive, or clerical, rather than manual. 2.8.2 Under the Prevailing Wage Act, C.R.S. § 24-92-201(4), “employees” are workers who are employees pursuant to the Colorado Wage Act, C.R.S. § 8-4-101(5), and who are engaged by contractors or subcontractors to perform jobs on various types of public projects, including as mechanics, laborers, or other construction workers. 2.9 “Fringe benefit”, as used in KJICA, C.R.S. § 8-17-105, is defined pursuant to the Davis Bacon Act, 29 C.F.R. § 5.23. Fringe benefit includes the rate of costs to the contractor or subcontractor which may be reasonably anticipated in providing benefits to workers pursuant to an enforceable commitment to carry out a financially responsible plan or program which was communicated in writing to the workers affected, for medical or hospital care, pensions on retirement or death, compensation for injuries or illness resulting from occupational activity, or insurance to provide any of the foregoing, for unemployment benefits, life insurance, disability and sickness insurance, or accident insurance, for vacation and holiday pay, for defraying costs of apprenticeship or other similar programs, or for other bona fide fringe benefits. 2.10 "Public works project" or “public project” have the following definitions: 2.10.1 Under KJICA, C.R.S. § 8-17-101(2)(b), C.R.S. § 24-103-908(1), and C.R.S. § 24-92- 102(8), “public works project” has the same meaning as “public project,” and is defined as:

(A) any public project as defined in C.R.S. § 24-92-102(8), including any construction, alteration, repair, demolition, or improvement of any land, building, structure, facility, road, highway, bridge, or other public improvement suitable for and intended for use in the promotion of the public health, welfare, or safety and any maintenance programs for the upkeep of such projects, including any such project awarded by any county, including any home rule county, municipality, as defined in C.R.S. § 31-1-101(6), school district, special district, or other political subdivision of the state. It does not include any project:

(1) for which appropriation or expenditure of moneys may be reasonably expected not to exceed five hundred thousand dollars in the aggregate for any fiscal year;

(2) under the supervision of the department of transportation for which appropriation or expenditure of funds may be reasonably expected not to exceed two hundred fifty thousand dollars in the aggregate of any fiscal year; or (3) that is financed with any amount of federal money.

(B) any publicly funded contract for construction entered into by a governmental body of the executive branch of the state of Colorado which is subject to the “Procurement Code,” articles 101 to 112 of title 24, C.R.S.; and (C) any highway or bridge construction, whether undertaken by the department of transportation or by any political subdivision of the state of Colorado, in which the expenditure of funds may be reasonably expected to exceed fifty thousand dollars. 2.10.2 Under the Prevailing Wage Act, C.R.S. § 24-92-201, “public project”:

(A) means any construction, alteration, repair, demolition, or improvement of any land, building, structure, facility, road, highway, bridge, or other public improvement suitable for and intended for use in the promotion of public health, welfare, or safety and any operation or maintenance programs for the operation and upkeep of such projects. “Public project” includes any work, construction, or repair performed by a private party through a contract to rent, lease, or purchase at least fifty percent of the project by one or more agencies of government, and may include projects undertaken pursuant to contracts awarded under Title 24,

Article 92, Part 1, C.R.S., or under Title 24, Article 93, C.R.S. It does not include any project:

(1) that receives federal funding; or (2) for which the contracting agency is the Department of Transportation.

(B) includes an “energy sector public works project,” as defined by C.R.S. § 24-92- 303(5), and may include thermal energy network or thermal energy system projects, as defined by C.R.S. § 40-3.2-108. It does not include any project:

(1) for which a public utility or cooperative electric association invitation for bids or proposals was issued before January 1, 2024; or (2) listed under C.R.S. § 24-92-304(1)(c). 2.11 “Site of the project” as used in KJICA, C.R.S. § 8-17-105, is defined pursuant to the Davis Bacon Act definition of “site of the work,” 29 C.F.R. § 5.2. Site of the project is the physical place or places where the building or work called for in the contract will remain; and any other site where a significant portion of the building or work is constructed, provided that such site is either established specifically for the performance of the contract or project or dedicated exclusively, or nearly so, to the performance of the contract or project for a specific period of time. 2.11.1 Not included in the site of the project are permanent home offices, branch plant establishments, fabrication plants, tool yards, etc., of a contractor or subcontractor whose location and continuance in operation are determined wholly without regard to a particular public works contract or project. 2.12 A “wage determination” as defined by the Prevailing Wage Act, C.R.S. § 24-92-205(1), is the determination made by the Colorado Department of Personnel and Administration establishing prevailing wage rates for the applicable trade or occupation and the particular geographical locality of the public project. A “wage determination” includes the original decision and any subsequent decisions modifying, superseding, correcting, or otherwise changing the provisions of the original decision. 2.13 “Wages,” “scale of wages,” “wage rates,” “minimum wages,” and “prevailing wages” as defined by the Prevailing Wage Act, C.R.S. § 24-92-201(6), means:

(A) The employee’s basic hourly rate of pay;

(B) Any contribution irrevocably made by a contractor or subcontractor to a trustee or to a third person pursuant to a bona fide fringe benefit fund, plan, or program; and (C) The rate of costs to the contractor or subcontractor which may be reasonably anticipated in providing bona fide fringe benefits to laborers, mechanics, and other construction workers pursuant to an enforceable commitment to carry out a financially responsible plan or program, which was communicated in writing to the workers affected in advance.

Unless otherwise noted, when used herein, the term “wages” includes fringe benefits, except where it is used to refer to wages as defined in the Colorado Wage Act, C.R.S. § 8-4-101(14). 2.14 A “willful violation,” as defined by the Prevailing Wage Act, C.R.S. § 24-92-209(2)(b), includes an intentional violation and a violation made with reckless disregard or deliberate ignorance of the law. A contractor or subcontractor acts with “reckless disregard” of the requirements of the law if, for example, it should have inquired further into whether its conduct was in compliance with the law and failed to make adequate further inquiry. Whether employees accepted or agreed to accept less than the required rate of wages or voluntarily made refunds is not a defense to willfulness.

Rule 3. KJICA: The “Colorado Labor” Requirement and Contractor Obligations 3.1 Under C.R.S. § 8-17-101(1), workers meeting the Rule 2.3 definition of “Colorado labor” are required to perform at least eighty percent of the work on public projects undertaken in the state of Colorado and financed in whole or in part by funds of the state of Colorado or its counties, school districts, or municipalities, unless the requirement is waived by the governmental body financing the public works project. 3.2 Compliance with Rule 3.1 is measured over the entirety of the completed project, and is determined using the total taxable wages and fringe benefits paid to workers meeting the Rule 2.3 definition of “Colorado labor,” minus any per diem payments made to such workers. 3.3 In order to meet the Rule 2.3 definition of “Colorado labor,” workers must provide contractors with adequate proof of residency. 3.3.1 Each contractor shall retain the documentation required under the law for at least ninety days after the completion of the project. 3.3.2 Workers who establish residency during the course of the project also qualify as “Colorado labor” under Rule 2.3. 3.3.3 The Division assesses the acceptability and validity of residency documentation on a case-by-case basis. The Division examines the totality of the circumstances and the evidence provided for each covered worker in the reviewing of residency documentation.

Examples of potentially acceptable residency documentation may include, but are not limited to:

(A) valid Colorado’s driver’s license or state-issued photo identification;

(B) Colorado voter registration;

(C) utility or water bill;

(D) rental lease;

(E) state income tax returns; and/or (F) documentation reflecting ownership of residential real property in Colorado. 3.3.4 The following documentation must be provided by the contractor to the Division in the event of an investigation:

(A) documentation reflecting the taxable wages and fringe benefits for each covered worker on the public works project; and (B) the required residency documentation for each covered worker on the public works project. 3.4 The governmental body financing a public works project shall waive the eighty percent requirement if there is reasonable evidence to demonstrate insufficient Colorado labor to perform the work of the project and if compliance with the law would create an undue burden that would substantially prevent a project from proceeding to completion. 3.4.1 A governmental body that allows a waiver shall post notice of the waiver and a justification for the waiver on its website. 3.4.2 A governmental body shall not impose contractual damages on a contractor for a delay in work due to the waiver process. 3.5 All contracts let for public works financed in whole or in part by funds of the state, counties, school districts, or municipalities of the state of Colorado shall contain provisions for the preference in employment of Colorado labor.

Rule 4. Prevailing Wage Act: Contractor Payment Obligations 4.1 A contractor or subcontractor is required to pay all laborers, mechanics, and other construction workers all wages owed under the Prevailing Wage Act, C.R.S. § 24-92-202, no less frequently than once every seven calendar days (not workdays), regardless of any contractual relationship which may be alleged to exist between the contractor or subcontractor and such employees. 4.2 A contractor or subcontractor may discharge its minimum obligation for the payment of wages as contained in a wage determination by paying all employees the full amount unconditionally and at least once per week, the prevailing wage as defined in Rule 2.13. 4.3 An employee performing multiple positions with differing prevailing wage rates or classifications must be paid the appropriate wages on the wage determination for the classification(s) of work actually performed, without regard to skill.

Rule 5. Prevailing Wage Act: Coverage of Energy Projects 5.1 Contracts between lead contractors and the owners of an energy sector public works project, as defined in C.R.S. § 24-92-303(5), must include provisions expressly requiring that all work performed under the contract comply with the apprenticeship requirements of C.R.S. § 24-92- 115(7) and prevailing wage requirements in C.R.S. § 24-92-201 et seq. if:

(A) the energy sector public works project (1) is either (a) a power generation project with a nameplate generation capacity of one megawatt or higher, or (b) an energy storage system as defined by C.R.S. § 40-2-202 with an energy rating of one megawatt of power capacity or four megawatt hours of useable energy capacity or higher, and (2) has aggregated public assistance from the state of five hundred thousand dollars or more (C.R.S. § 24-92-304(1)(b)(I)); or (B) the energy sector public works project (1) is included under C.R.S. § 24-92-303(5)(b)(II), (2) has a total project cost of one million dollars or more, and (3) has aggregated public assistance from the state, funding from a public utility, or funding from a cooperative electric association of five hundred thousand dollars or more (C.R.S. § 24-92- 304(1)(b)(II)). 5.2 Owners of energy sector public works projects must either (A) provide quarterly copies of “craft labor certifications” to the Division, or (B) require by contract that lead contractors do so. C.R.S. § 24-92-305(4). This Rule does not apply to an energy sector public works project where all construction work is covered by a “project labor agreement” as defined in C.R.S. § 24-92-303(9).

C.R.S. § 24-92-306(2). 5.2.1 Craft labor certifications are “all documentation and certification of payroll required for an energy sector public works project in accordance with the requirements of section[s] 24- 92-115(7)” and 24-92-201 et seq. C.R.S. § 24-92-303(4). 5.2.2 Craft labor certifications must include (A) a sworn attestation that the lead contractor is fully compliant with these requirements, and (B) identical, equivalent craft labor certifications for all subcontractors participating in the energy sector public works project, C.R.S. § 24-92-305(3), and are additionally required as reports to the Division pursuant to C.R.S. §§ 8-1-114, 8-1-117. 5.2.3 Craft labor certifications should be submitted to the Division quarterly, by the end of the month following the close of each calendar quarter (January-March, etc.), pursuant to instructions posted at www.coloradolaborlaw.gov. 5.3 Any thermal energy network project or thermal energy system project that an agency of government or a state institution of higher education procures, and that is a public project, must comply with:

(A) the prevailing wage requirements of C.R.S. § 24-92-201 et seq. if the estimated contract cost of the project is five hundred thousand dollars or more (C.R.S. § 40-3.2-105.7(1)(b)); and (B) the apprenticeship requirements of C.R.S. § 24-92-115 if the estimated contract cost of the project is one million dollars or more (C.R.S. § 40-3.2-105.7(1)(a)).

Rule 6. Filing and Investigation of Complaints 6.1 KJICA Complaints 6.1.1 A person who alleges a potential violation of KJICA may file a complaint with the Division within ninety days after the date the public project was completed (not the date that the work was performed).

(A) Anonymous complaints are not accepted by the Division.

(B) Complaints shall be filed using the Division-approved form, and the complaint shall include the complainant’s signature, contact information, and the basis for the complaint. Failure to include this information on the complaint form may result in administrative dismissal of the complaint. 6.1.2 Upon the receipt of a KJICA complaint, the Division shall notify the contractor of the complaint. 6.1.3 Either party may designate an authorized representative to act on its behalf in filing a complaint with the Division. The party may designate an authorized representative by filing the Division-approved form with the Division. The party may revoke the authorized representative’s authority by contacting the Division in writing. 6.1.4 The Division commences the investigation only after completion of the project. 6.1.5 The Division investigates KJICA complaints pursuant to the Wage Protection Rules, 7 CCR 1103-7, to the extent not inconsistent with those Rules. 6.2 Prevailing Wage Act Complaints 6.2.1 An employee, former employee, or contracting agency (“complainant”) may file a complaint with the contracting agency for a public project regarding any perceived violation of the prevailing wage requirements of Title 24, Article 92, Part 2 or Rule 4 of these Rules.

(A) A complainant may, but is not required to, use the Division’s public project prevailing wage complaint form to file a complaint with the contracting agency.

(B) Upon receipt of a complaint, the contracting agency shall report the perceived violation to the contractor of the project, and, if applicable, the subcontractor which is the subject of the complaint within 48 hours of being made aware of the alleged violation.

(C) If, within fifteen days of being notified of the alleged violation, the contractor or subcontractor (1) demonstrates to the contracting agency that no violation occurred or that any violation was the result of legitimate administrative error and (2) remedies any violation, the complaint shall be dismissed.

(D) If the contracting agency determines that a “willful violation” occurred or the contractor or subcontractor fails to remedy any alleged violation within fifteen days of being notified, the contracting agency shall report the violation to the Division. Upon receiving a report of an alleged violation from a contracting agency, the Division will treat the report as a complaint and investigate it pursuant to the Wage Protection Rules, 7 CCR 1103-7, to the extent not inconsistent with those Rules, to determine if the perceived violation was conducted in a willful manner, as defined in Rule 2.18 of these Rules. 6.2.2 If a complaint is not resolved by either the contracting agency, or the Division, the complaining employee or former employee may file a civil action in court within 120 days from the later of: (A) the employee’s complaint to the contracting agency, if it is not resolved under Rule 6.2.1(C) or reported to the Division under Rule 6.2.1(D) of these Rules in that time; or (B) the Division’s determination pursuant to Rule 5 of the Wage Protection Rules, 7 CCR 1103-7.

(A) Such civil action may be brought in the district court for the county where the alleged violation occurred, the county where the complainant resides, or the county where the person against whom in the civil complaint is filed resides or has their principal place of business, and must be brought within three years after the occurrence of the alleged violation.

(B) Such civil action may be brought for appropriate injunctive relief, actual damages, or both, and may be brought by one or more employees or former employees on behalf of him or herself or themselves and other employees similarly situated.

Rule 7. Remedies and Fines 7.1 KJICA Remedies and Fines 7.1.1 If the Division determines that a contractor has knowingly violated Rule 3, it shall subject the contractor to the following fines:

(A) for the first violation, either five thousand dollars or an amount equal to one percent of the cost of the contract, whichever is less;

(B) for the second violation, either ten thousand dollars or an amount equal to one percent of the cost of the contract, whichever is less; or (C) for the third violation and any subsequent violation thereafter, either twenty-five thousand dollars or an amount equal to one percent of the cost of the contract, whichever is less.

If the Division has imposed three or more KJICA fines on a contractor within the past five years and finds the violations to be egregious, the Division may initiate the process to debar the contractor pursuant to C.R.S. § 24-109-105. 7.2 Prevailing Wage Act Remedies and Fines 7.2.1 If the Division reaches a determination pursuant to Rule 5 of the Wage Protection Rules, 7 CCR 1103-7, that a willful violation of Rule 4 of these Rules occurred, the Division may order any remedies permitted by law, including but not limited to that the Division:

(A) shall order restitution of applicable back pay for the impacted employees, including damages in an amount equal to the amount of unpaid wages or benefits owed, and any penalties that may be awarded under the Colorado Wage Act (unpaid fringe benefit contributions owed shall be paid to the appropriate benefit fund, except that in the absence of an appropriate fund the benefit shall be paid directly to the individuals), and (B) shall subject the contractor to the following fines:

(1) for the first violation, five thousand dollars;

(2) for the second violation, ten thousand dollars; and (3) for the third violation and all subsequent violations thereafter, twenty-five thousand dollars.

Rule 8. Retaliation Prohibited 8.1 It is unlawful to retaliate for filing any complaint, or instituting or causing to be instituted any proceeding, under any law or rule related to wages or hours, including but not limited to these Rules and the statutes they implement, under C.R.S. §§ 8-4-120, 8-6-115, Rules 4.7 – 4.8 of the Wage Protection Rules, 7 CCR 1103-7, and the Colorado WARNING Rules, 7 CCR 1103-11.

Rule 9. Appeals 9.1 A complainant or respondent may appeal a Division determination pursuant to Rule 6 of the Wage Protection Rules, 7 CCR 1103-7, to the maximum extent consistent with the Colorado Administrative Procedure Act, C.R.S. §§ 24-4-105, 24-4-106. _________________________________________________________________________ Editor’s Notes

History Entire rule eff. 04/30/2014.

Entire rule eff. 09/01/2017.

Entire rule eff. 01/01/2023.

Entire rule eff. 01/01/2024.

7 CCR 1103-7 Wage Protection Rules {#sec-7-ccr-1103-7 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-7}

DEPARTMENT OF LABOR AND EMPLOYMENT

WAGE PROTECTION RULES

7 CCR 1103-7 [Editor’s Notes follow the text of the rules at the end of this CCR Document.]

Adopted December 8, 2025; effective February 1, 2026.

Rule 1. Statement of Purpose and Authority 1.1 Authority and relation to other orders. The general purpose of these Wage Protection Rules (Rules) is to implement labor laws within the jurisdiction of the Division, including but not limited to the Colorado Wage Act (CWA) as amended by the Wage Protection Act (WPA) of 2014, C.R.S. § 8-4-101 et seq.; the Healthy Families and Workplaces Act (HFWA) of 2020, C.R.S. § 8-13.3-401 et seq.; the Agricultural Labor Rights and Responsibilities Act, as codified in relevant part at C.R.S. §§ 8-6-101.5, 8-6-120, and 8-13.5-201 et seq.; the Equal Pay for Equal Work Act (EPEWA), C.R.S. Title 8, Article 5 (C.R.S. §§ 8-5-101 et seq.); the Colorado Employment Opportunity Act, C.R.S. § 8-2-126; the Social Media and the Workplace Law, § 8-2-127; the Chance to Compete Act, C.R.S. § 8-2-130; and the Job Application Fairness Act, C.R.S. § 8-2-131. These rules are adopted pursuant to the Division’s authority in, and as enforcement of, Articles 1, 2, 4-6, 12, 13.3, and 13.5 of Title 8, C.R.S., and are intended to be consistent with the requirements of the State Administrative Procedure Act, C.R.S. § 24-4-103, and provisions of these Articles. Unless otherwise noted, in these Rules: all statutes cited apply the most recent versions of the Colorado Revised Statutes; all rules cited apply the most recent versions adopted as of the adoption of these Rules. 1.2 Incorporation by reference. The Wage Protection Rules incorporate by reference only the following rules stated in Part 578 within Title 29 of the Code of Federal Regulations: 29 C.F.R. § 578.3(c), except as identified in Wage Protection Rule 2.18. These rules are available to the public in electronic form at https://www.ecfr.gov/current/title-29/subtitle-B/chapter-V/subchapter-A/part- 578/section-578.3, as adopted by the United States Department of Labor’s Wage and Hour Division, located at 200 Constitution Ave NW, Washington, DC 20210.

All incorporated rules refer to the date and edition of those rules in effect as of the effective date of these Wage Protection Rules, February 1, 2026, and exclude later amendments to or editions of the rules incorporated by reference.

All sources cited or incorporated by reference are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, 707 17th Street, Denver, CO 80202. Copies may be obtained from the Division of Labor Standards & Statistics at a reasonable charge. They can be accessed electronically from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of them at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing them. All Division Rules are available to the public at www.coloradolaborlaw.gov. 1.3 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any part of a rule (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the rule remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form. 1.4 The Director of the Division of Labor Standards and Statistics in the Department of Labor and Employment (Director) has the authority to enforce the statutes cited in Rule 1.1 above and these Rules.

Rule 2. Definitions and Clarifications 2.1 “Administrative procedure” means the process used by the Division to investigate wage complaints in accordance with C.R.S. § 8-4-111 and C.R.S. §§ 8-13.3- 407(4), -410, and -411. 2.2 “Authorized representative” means a person designated by a party to a wage complaint to represent the party during the Division’s administrative procedure.

To designate an authorized representative, the party must comply with the requirements of Rule 4.3. 2.3 “Average daily earnings,” as formerly used in C.R.S. § 8-4-109(3)(b), will be calculated as follows, unless the Division identifies a legitimate reason to use a different method of calculation: 2.3.1 The most recent typical workweek or pay period will generally be used to calculate the average daily earnings. The total gross amount of wages and compensation will be divided by the number of days worked. 2.3.2 If an employee is entitled to and has been paid less than the Colorado minimum wage, and has not earned more than the Colorado minimum wage, then the Colorado minimum wage will be used to calculate average daily earnings. 2.3.3 All compensation paid to employees, including the hourly rate, shift differential, minimum wage tip credit, regularly occurring non-discretionary bonuses, commissions, and overtime may be included in the average daily earnings calculation. 2.4 “Certified copy,” as used in C.R.S. § 8-4-113, means a copy of a Division decision issued and signed by the Director of the Division, or his or her designee (including any Division staff designated to issue such decision), certifying that the document is a true and accurate copy of the decision. A certified copy must be requested in writing or may be issued by the Division on its own initiative. A Division decision (issued by investigative or hearing staff) will not be filed in court unless two weeks have passed since the appeal deadline and either (1) no appeal has been filed or (2) if an appeal or other legal challenge was timely filed, the decision was not superseded on appeal nor subject to any order barring the filing or enforcement of a certified copy. A certified copy will not be issued in the event of termination pursuant to C.R.S. § 8-4-111(3). 2.5 “Determination” means a decision issued by investigative staff upon the conclusion of a wage complaint investigation. “Determination” includes: Citation and Notice of Assessment, Determination of Compliance, and Notice of Administrative Dismissal, if that Notice of Administrative Dismissal is issued after the Division initiated the administrative procedure as described in Rule 4.4. 2.6 “Employee” has the following definitions: 2.6.1 Under the CWA, C.R.S. § 8-4-101(5), an “employee” means any person, including a migratory laborer, performing labor or services for the benefit of an employer. For the purpose of these Rules, relevant factors in determining whether a person is an employee include the degree of control the employer may or does exercise over the person and the degree to which the person performs work that is the primary work of the employer; except that an individual primarily free from control and direction in the performance of the service, both under his or her contract for the performance of service and in fact, and who is customarily engaged in an independent trade, occupation, profession, or business related to the service performed is not an “employee”. 2.6.2 Under the HFWA, C.R.S. § 8-13.3-402(4), “employee” has the same meaning as in C.R.S. § 8-4-101(5), but does not include an “employee” as defined in 45 U.S.C. § 351(d), who is subject to the federal “Railroad Unemployment Insurance Act,” 45 U.S.C. § 351 et seq. An employee’s “family member” means (1) an employee’s immediate family member, as defined in C.R.S. § 2-4-401(3.7); (2) a child to whom the employee stands in loco parentis or a person who stood in loco parentis to the employee when the employee was a minor; or (3) a person for whom the employee is responsible for providing or arranging health- or safety-related care.

C.R.S. § 8-13.3-402(6). 2.7 “Employer” has the following definitions: 2.7.1 Under the CWA, C.R.S. § 8-4-101(6), and as applied by the COMPS Order, “employer” has the same meaning as in the federal Fair Labor Standards Act, 29 U.S.C. § 203(d), and includes a foreign labor contractor, a migratory field labor contractor or crew leader, and each individual who owns or controls at least 25 percent of the ownership interests in an employer; except for a minority owner of the employer that demonstrates full delegation of its authority to control day-to-day operations of the employer; the state or its agencies or entities, counties, cities and counties, municipal corporations, quasi-municipal corporations, school districts, and irrigation, reservoir, or drainage conservation companies or districts organized and existing under the laws of Colorado.

“Foreign labor contractor” and “field labor contractor” have the definitions in C.R.S. § 8-4-101(7), (8.5). 2.7.2 Under the HFWA, C.R.S. § 8-13.3-402(5), “employer” has the same meaning as in C.R.S. § 8-4-101(6), except that an “employer” also includes the state and its agencies or entities, counties, cities and counties, municipalities, school districts, and any political subdivisions of the state, but does not include the federal government. 2.7.3 Under the HFWA, C.R.S. § 8-13.3-402(12), “successor employer” is “an employing unit, whether or not an employing unit at the time of acquisition, that . . . acquires all of an organization, a trade, or a business, or substantially all of the assets, of one or more employers subject to”

HFWA. A “successor employer” is responsible for an acquired employer’s HFWA obligations, including but not limited to accrued, requested, or inprogress leave.

(A) Acquiring “substantially all of the assets” of an employer is the acquisition by one corporation, in exchange solely for all or a part of its voting stock, or in exchange solely for all or part of the voting stock of a corporation which is in control of the acquiring corporation, of substantially all of the properties of another corporation, but in determining whether the exchange is solely for stock the assumption by the acquiring corporation of a liability of the other shall be disregarded;

(B) “Substantially all,” as used in Rule 2.7.3(A), is satisfied if there is a transfer of assets representing at least 90 percent of the fair market value of the net assets and at least 70 percent of the fair market value of the gross assets held by the corporation immediately preceding the transfer and which are part of the plan of reorganization will be considered as assets held by the corporation immediately prior to the transfer;

(C) A “trade” or a “business,” as used in C.R.S. § 8-13.3-402(12), includes an employer’s work force. 2.8 A “correct address” for a party, including but not limited to as used in C.R.S. § 8- 4- 101(15) and these or other applicable Division rules, can include, but is not limited to (unless defined otherwise by statute, rule, or order): a physical or email address the party used, or provided to the Division, in the investigation (unless the party notifies the Division to use an alternate valid address instead); the party’s email address; the address on file with the Colorado Secretary of State for the party or their registered agent; or an address actually used, or publicly posted as a current address for mail or deliveries, by the party. 2.9 When considering whether there is “good cause” for an extension of time, including as used in C.R.S. § 8-4-113(1)(b), the Division will determine whether the reason is substantial and reasonable and must take into account all available information and circumstances pertaining to the specific complaint. 2.10 “Post,” including as used in C.R.S. § 8-4-107, may include electronic posting in a place readily accessible to all employees. 2.11 “Public health emergency” is defined as in C.R.S. § 8-13.3-402. A public health emergency is “declared” by any initial, amended, extended, restated, or prolonged declaration of an emergency that meets the statutory definition. During a public health emergency, employees have a right to use up to 80 hours of paid sick leave, that the employer must supplement to an employee who lacks enough previously accrued sick leave. Employees can use up to 80 hours of leave for reasons listed in C.R.S. § 8-13.3-405(3) only once during the entirety of a public health emergency even if such public health emergency is amended, extended, restated, or prolonged. 2.12 “Records reflecting the information contained in an employee’s itemized pay statement,” as used in C.R.S. § 8-4-103(4.5), may be kept electronically. The records are not required to be copies of the pay statements but must reflect all information contained in the pay statements. 2.13 “Terminated employee,” as used in C.R.S. § 8-4-105(1)(e)(I), includes any employee separated from employment, whether the separation occurs by volition of the employer or the employee. 2.14 The Division may enforce the gratuity provisions described in C.R.S. § 8-4-103(6) through the administrative procedure described in C.R.S. § 8-4-111. The legal treatment of “tips,” “ gratuities,” or other monies paid on a similar basis, in any source of law, is identical regardless of the terminology used. 2.15 “‘Wages’ or ‘compensation’” has the same meaning as in C.R.S. § 8-4-101(14).

“Paid sick leave” required by HFWA constitutes “wages” under C.R.S. § 8-4- 101(14); is covered by the provisions of C.R.S. Title 8, Article 4, and these Rules; is defined as paid time off from work that is provided by an employer for one of the qualifying reasons described in C.R.S. §§ 8-13.3-404 to -406. C.R.S. § 8- 13.3-402(8)(a), (b). 2.16 A “written demand,” including as used in C.R.S. § 8-4-101(15), can be sent to the employer by electronic means, including but not limited to email and text message. Wages must be owed and past due at the time of sending for the written demand to be considered valid. The penalty provisions in C.R.S. § 8-4- 109(3)(b) effective on January 1, 2023, shall apply if the 14-day deadline for payment after the sending of a written demand without penalties passes on or after January 1, 2023, unless a prior written demand was sent more than 14 days before January 1, 2023. Notwithstanding the foregoing, when a Division Notice of Complaint (or other Division-issued document satisfying the requirements of a written demand) is sent where the 14-day deadline for payment is on or after January 1, 2023, the passing of that deadline triggers those penalty provisions, regardless of whether a prior written demand was sent before the Division’s. 2.17 Vacation Pay. 2.17.1 C.R.S. § 8-4-101(14)(a)(III), includes in the definition of “‘wages’ or ‘compensation’”: “Vacation pay earned in accordance with the terms of any agreement. If an employer provides paid vacation for an employee, the employer shall pay upon separation from employment all vacation pay earned and determinable in accordance with the terms of any agreement between the employer and the employee.” “Vacation pay” is pay for leave, regardless of its label, that is usable at the employee’s discretion (other than procedural requirements such as notice and approval of particular dates), rather than leave usable only upon occurrence of a qualifying event (for example, a medical need, caretaking requirement, bereavement, or holiday). 2.17.2 The “earned and determinable in accordance with the terms” provision does not allow a forfeiture of any earned (accrued) vacation pay, but does allow agreements on matters such as: (1) whether there is any vacation pay at all; (2) the amount of vacation pay per year or other period; (3) whether vacation pay accrues all at once, proportionally each week, month, or other period; and (4) whether there is a cap of one year’s worth (or more) of vacation pay. Thus, employers may have policies that cap employees at a year’s worth of vacation pay, but that do not forfeit any of that year’s worth.

For example, an agreement for ten paid vacation days per year:

(A) may provide that employees can accrue more than ten days, by allowing carryover of vacation from year to year;

(B) may cap employees at ten days; but (C) may not diminish an employee’s number of days (other than due to use by the employee). 2.18 “Willful,” in Articles within C.R.S., Title 8, that this Division enforces or administers, has the same meaning as under 29 C.F.R. § 578.3(c), implementing the Fair Labor Standards Act, 29 U.S.C. § 255(a), which is incorporated by reference and available to the public for review as stated in Rule 1.2, except that as incorporated:

(A) all references to the Fair Labor Standards Act shall include Articles within C.R.S., Title 8, that this Division enforces or administers; and (B) the reference to “a responsible official of the Wage and Hour Division” shall include any official of the Division. 2.19 C.R.S. § 8-4-103(1)(b) describes circumstances under which employers are “subject to the penalties specified in section 8-4-113(1).” Despite use of the word “penalties” in this section, this language does refer to the fine described in C.R.S. § 8-4-113(1) and is payable to the Division. 2.20 A complaint, appeal, or other submission to the Division is considered “filed” with the Division when it is received by the Division via mail, fax, email, online submission, or personal delivery. Any complaint, appeal, or other submission to the Division received after 11:59 p.m. Mountain Time is considered filed the next business day. Any such submission is considered “signed,” or to have a “signature,” if it has either an ink signature, a scanned signature, an electronically drawn or generated signature, or a typed name entered by the party or their authorized representative in the signature area; by signing in any such fashion, the individual is deemed to have agreed and assented that the document is signed by them. 2.21 For purposes of Rules 8 and 9, “Division debtor” means any employer, or any other person or entity, who owes wages, fines, or penalties determined by the Division to be due to any employee(s), the Division, or any other party. 2.22 These Rules are to be read in conjunction with other rules promulgated and enforced by the Division with additional requirements, including but not limited to the Colorado Overtime and Minimum Pay Standards Order (COMPS Order), 7 CCR 1103-1, the Colorado Whistleblower, Anti-Retaliation, Non-Interference, and Notice-Giving Rules (Colorado WARNING Rules), 7 CCR 1103-11, and the Publication and Yearly Calculation of Adjusted Labor Compensation (PAY CALC Order), 7 CCR 1103-14.

Rule 3. Filing a Wage Complaint 3.1 An employee who wishes to file a wage complaint with the Division shall use the Division-approved form(s), and shall comply with any other Division instructions as to information or submissions required by the Division. 3.1.1 A wage complaint may only be filed by the employee who did not receive his or her wages or compensation. 3.1.2 A wage complaint shall include the employee’s signature, employee’s contact information, employer’s contact information, and basis for the wage complaint. Failure to include this information on the wage complaint form may result in dismissal of the wage complaint. 3.1.3 The failure of an employee to respond in a timely manner to informational or investigatory requests by the Division may result in dismissal of the wage complaint. 3.1.4 If a wage complaint is dismissed before a Notice of Complaint is sent to the employer because the employee failed to respond to a Division request for information, the complaint may be reopened if the employee provides the requested information or documentation to the Division within 35 days of the Division’s request for information. Employees may be required to file a new complaint if the employee’s response is received more than 35 days after the Division’s request for information. 3.1.5 The Division shall accept wage complaints for amounts of $7,500 or less, per employee, for claims filed through June 30, 2026, and $13,000 or less, per employee, for claims filed from July 1, 2026, through December 31, 2027. As of January 1, 2028, this amount will be increased every other year for inflation based on the consumer price index or $1,000, whichever is greater, as provided in the annual PAY CALC Order. The Division may investigate any amounts shown to be owed in an investigation, including in investigations the Division initiates without a wage complaint. 3.1.6 An anonymous complaint is not a “wage complaint” within the meaning of C.R.S. § 8-4-111 and C.R.S. §§ 8-13.3-402(8)(a)(I)-(II), - 407, -410, -411 and will not be investigated using the Division’s administrative procedure.

The Division may choose to address an anonymous complaint outside of the administrative procedure. 3.2 An employee may pursue a wage complaint through either the court system or the Division’s administrative procedure. 3.2.1 Employees are not required to use the Division’s administrative procedure in order to pursue a wage complaint in court. 3.2.2 The Division may dismiss or stay an investigation decided by, or pending in, a court or other Labor Department with jurisdiction, based on the Division’s judgment as to whether Division involvement would be productive rather than duplicative. 3.2.3 As provided by C.R.S. § 8-4-113(2), a certified copy of any citation, notice of assessment, or order imposing wages due, fines, or penalties pursuant to this article may be filed with the clerk of any court having jurisdiction over the parties at any time after the entry of the order. Such a filing can be in a county or district court, and will thereby have the effect of a judgment from which execution may issue. 3.3 The employee may withdraw the wage complaint, or their participation in a complaint filed on their behalf as a similarly situated employee, at any time prior to issuance of a determination by notifying the Division in writing. 3.4 The Division may exercise its discretion to consolidate complaints, or to have an investigation sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations and/or phases of the investigation. 3.5 Accrual, use, and other matters relating to paid leave under HFWA. 3.5.1 Accrual of HFWA leave. Paid leave begins to accrue at the commencement of employment or on January 1, 2021, whichever is later.

(A) For the minimum HFWA accrual rate of one hour of leave for every 30 hours worked, up to cap of 48 hours per benefits year (C.R.S. § 8-13.3-403(2)(a)), accrual is based on all “time worked” under

Rule 1.9 of the COMPS Order, 7 CCR 1103-1, with regular and overtime hours counting equally; except under C.R.S. § 8-13.3- 403(2)(c), an overtime-exempt employee accrues paid leave based on their normal hours worked up to a maximum of forty per week.

Once employees have accrued 48 hours of paid leave during the benefit year, they do not accrue more, except if an employer chooses to provide paid leave in a greater amount. C.R.S. §§ 8- 13.3-403(2)(a), -413.

(B) For hours accrual for purposes of C.R.S. § 8-13.3-403(2)(a), the best available, reasonable estimate shall be used for employees paid on a fee-for-service basis for which hours are not ordinarily tracked and cannot feasibly be tracked, except that higher education adjunct faculty paid on a per-credit or per-course basis shall be deemed to work three hours total for each in-class hour.

(C) On the day a public health emergency is declared within the definition of Rule 2.11, employers are required to immediately provide each employee with additional hours of paid leave, usable as of the date of the declaration, January 1, 2021, or the employee’s first date of employment, whichever is later — whatever the employee has accrued prior to the declaration of the public health emergency at the regular HFWA rate (i.e., one hour per 30 worked, up to a maximum of 48 per benefit year), and a one-time supplement with the number of hours needed for:

(1) employees who normally work forty or more hours in a week to have access to 80 hours of total paid leave; and (2) employees who normally work under forty hours in a week to have access to paid leave hours that are at least the greater of the number of hours the employee (a) is scheduled for work or paid leave in the 14-day period after the leave request, or (b) actually worked in the 14-day period prior to the declaration of the public health emergency or the leave request, whichever is later.

(D) During the entire duration of a public health emergency (i.e., during the time between the date on which the emergency is declared and four weeks after the date of the official termination or suspension of the emergency declaration), employers:

(1) are required to permit employees to take both (a) the paid leave they have accrued prior to the declaration date of the public health emergency pursuant to C.R.S. § 8-13.3- 403(2)(a), for any of the qualifying reasons provided in C.R.S. § 8-13.3-404(1), and (b) the amount of supplemental paid leave that was provided to the employee on the date of the declaration of a public health emergency, for any of the qualifying reasons provided in C.R.S. § 8-13.3-405(3);

(2) remain subject to the minimum accrual requirements of C.R.S. § 8-13.3-403(2)(a), and employees continue to accrue paid leave (up to 48 hours per benefit year); and (3) must permit an employee to use the full amount of supplementary leave provided under C.R.S. § 8-13.3-405(1) and this rule, prior to using any of the employee’s previouslyaccrued leave under C.R.S. § 8-13.3-403(2)(a), if an employee required leave in circumstances that qualify under both C.R.S. § 8-13.3-404(1) and C.R.S. § 8-13.3-405(3)

(e.g., an employee is experiencing symptoms of a communicable illness that was the subject of the declaration of a public health emergency and needs to obtain testing and treatment).

(E) Yearly Basis for HFWA leave.

(1) Carryover. Pursuant to C.R.S. § 8-13.3-403(3)(b), “up to forty-eight hours of paid sick leave that an employee accrues in a year but does not use carries forward to, and may be used in, a subsequent year.” For purposes of C.R.S. § 8- 13.3-403(3)(b), “year” means “a regular and consecutive twelve-month period as determined by an employer.” C.R.S. § 8-13.3-402(13). The employer shall not be required to, but may, permit an employee to carry forward more than fortyeight (48) hours of unused paid leave from one benefit year to the next. C.R.S. §§ 8-13.3-403(3)(b), -413.

(2) “Benefit year” definition. The applicable "benefit year" is the period of 12 consecutive months established by an employer in which an employee shall accrue earned sick leave for use.

Unless otherwise established by an employer in a written policy, a “benefit year” is the calendar year. If an employer transitions from one type of year to another, the employer must ensure that the transition process maintains all HFWA rights, and must notify employees in writing of any such changes. 3.5.2 Pay rate and amount of HFWA leave. Under C.R.S. § 8-13.3-402(8), leave must be paid at the same rate and with the same benefits, including health benefits, as the employee normally earns during hours worked, not including overtime premiums, bonuses, or holiday leave pay. Leave must be paid on the same schedule as regular wages.

(A) Employees shall be paid for leave the same wages that the employee would have earned if the employee had worked, excluding bonuses and overtime premiums. The pay rate for leave must be at least the applicable minimum wage.

(1) If use of leave does not reduce an employee’s pay (e.g., if the employee is paid solely on a salary, commission, or piece rate basis, and the leave does not impact total salary, commissions, or piece pay), then the employee does not earn additional compensation solely for using leave.

(2) If an employee receives a wage in addition to commissions, commissions are not included in the pay rate for sick leave.

(3) If an employee works at multiple rates, including shift differentials and separate jobs for the same employer, the employee shall be paid the rate they would have earned during the period of leave.

(4) If the pay rate for the period of leave is unknown, the pay rate shall be calculated based upon the employee’s pay over a “lookback” period of (i) the 30 calendar days preceding the leave, or (ii) at the employer’s option, the most recent full pay period(s) or work weeks totaling 28 to 31 days. Earnings in the pay rate calculation shall include hourly or salary rates, shift differentials, tip credits, and commissions (if applicable, see Rule 3.5.2(A)(2) above); and shall not include overtime premiums, bonuses, or holiday leave pay.

(a) If an employee has not yet worked a full lookback period as noted above, then the period will consist of all days worked prior to the leave.

(b) The HFWA pay rate for employees covered by Rule 3.5.1(B) shall be calculated in accordance with that

Rule.

(B) The number of hours of paid HFWA leave an employee can take is the number of hours the employer reasonably anticipated they would have worked during the period of the leave, based on: (1) their regular schedule of hours actually worked; (2) or, if leave is during a period the employee was anticipated to depart from a regular schedule, then hours anticipated for that period; (3) or, if the number of hours the employee would have worked during the period cannot be reasonably anticipated, then their average hours worked during their most recent 30 calendar days of work (or, at the employer’s option, the most recent of any full pay period, or consecutive full pay periods or work weeks, totaling 28 to 31 days).

If an employee has not yet been employed for the full 30-day duration (or other duration from 28 to 31 days) noted above, their entitlement must be determined under 3.5.2(B)(1) or (2).

(C) Indeterminate shifts. If an employee uses paid leave for a shift of indeterminate length (for example, a shift that is defined by business needs rather than a previously specified number of hours), an employer may determine the number of paid leave hours used by the employee based on the number of hours actually worked by a replacement employee in the same shift. If there is no replacement employee for the indeterminate shift, an employer may determine the number of paid leave hours used by the employee based on the number of hours actually worked by the employee for their most similar shift in the past.

(D) On-call employees are entitled to use paid leave during any hours they have been scheduled to work, including hours among the employee’s on-call time that the employer actually requests the employee to work, or any other hours that would qualify as “time worked” as defined by Rule 1.9 of the COMPS Order, 7 CCR 1103- 1. Otherwise, being “scheduled to work” does not include shifts for which an employee has been asked to be available or on-call.

However, if an on-call employee has an agreement with an employer to be paid for a scheduled shift regardless of whether the employee actually works the shift, the employer must provide paid leave to a qualifying employee for that shift. 3.5.3 Use of HFWA leave.

(A) Because an employee “may use accrued paid sick leave as it is accrued,” C.R.S. § 8-13.3-403(3)(a), HFWA leave may be used immediately upon accrual, but an employer may, in the ordinary course of business and in good faith, verify employee hours within a month after work is performed and adjust accrued leave to correct any inaccuracy, provided that the employee is so notified in writing.

(B) An employer may require use of HFWA leave in hourly increments, or may require or allow smaller minimum increments; if an employer does not specify the minimum increment in writing, employees nevertheless may not use increments smaller than a tenth of an hour (i.e., six-minute increments).

(C) An employer cannot apply an absence or attendance policy to an employee’s HFWA-qualifying leave use if it could result in adverse action against the employee, including discipline, as defined in C.R.S. § 8 13.3 407(2)(b). However, after an employee has exhausted all leave required by HFWA, an employer can apply an absence or attendance policy to any absences taken by the employee. 3.5.4 Applicability of a general paid time off (PTO) policy to HFWA leave. HFWA does not require additional leave if an employer policy provides fully paid leave for both HFWA and non-HFWA purposes (e.g., sick time and vacation) and makes clear to employees, in a writing distributed in advance of an actual or anticipated leave request, that:

(A) its leave policy provides PTO — (1) in at least an amount of hours and with pay sufficient to satisfy HFWA and applicable rules (including, if a public health emergency is declared, a supplemental amount of leave required to satisfy C.R.S. § 8-13.3-405(1) and Rule 3.5.1(C), (2) for all the same purposes covered by HFWA and applicable rules, not a narrower set of purposes, and (3) under all the same conditions as under HFWA and applicable rules, not stricter or more onerous conditions (including but not limited to matters such as accrual, use, payment, annual carryover of unused accrued leave, notice and documentation requirements, and anti-retaliation and anti-interference rights); and (B) additional HFWA leave need not be provided when employees use all of their available PTO for non-HFWA-qualifying reasons (e.g., vacation). C.R.S. § 8-13.3-403(4), except if a public health emergency is declared after an employee uses some or all available PTO for the applicable benefit year, the employer must supplement the employee’s current total of accrued, unused leave pursuant to Rule 3.5.1(C). 3.5.5 Notice by employees of HFWA-qualifying leave.

(A) An employee may request leave orally or in writing, including electronically (for example, by email or text message). An employer may choose additional methods of receiving requests or notifications that it deems acceptable, but shall not restrict employees from using any method that notifies the employer effectively. C.R.S. § 8-13.3-404(2).

(B) For HFWA leave for any health-related or safety-related reason within C.R.S. § 8-13.3-404, if the employee’s need for leave is “foreseeable,” (1) an employee shall make a good-faith effort to provide advance notice and a reasonable effort to schedule the leave in a manner that does not unduly disrupt employer operations, and (2) an employer may by written policy require reasonable procedures to provide notice of foreseeable leave, but shall not deny paid sick leave based on noncompliance with such a policy. C.R.S. § 8-13.3-404(2), (5).

(C) For HFWA leave that is “related to public health emergency” under C.R.S. § 8-13.3-405(3): An employee shall notify their employer of their need for leave as soon as practicable if (1) the need for leave is foreseeable and (2) the employer’s place of business is not closed. C.R.S. § 8-13.3-405(4). 3.5.6 An employer may require “reasonable documentation” that leave is for a HFWA-qualifying purpose only if the leave requested or taken is for “four or more consecutive work days,” C.R.S. § 8-13.3-404(6), defined as four consecutive days on which the employee would have ordinarily worked absent the leave-qualifying condition, not four consecutive calendar days.

An employer may not require an employee to provide documentation that leave is for a qualifying reason “related to [a] public health emergency” under C.R.S. § 8-13.3-405(3) – (4).

(A) When documentation is required, an employer may request only “reasonable” documentation, which is defined as not more documentation than needed to show a HFWA-qualifying reason for leave, as described in subparts (B), (C), and (D) below, and an employer shall not require disclosure of “details” regarding the employee’s or family member’s “health information” or the “domestic violence, sexual assault, or stalking” that is the basis for HFWA leave (C.R.S. § 8-13.3-412(1)).

(B) To document leave for a health-related need under C.R.S. § 8- 13.3-404(1)(a), (b):

(1) If the employee received any services (including remote services) from a health or social services provider for the HFWA-qualifying condition or need, a document from that provider, indicating a HFWA-qualifying purpose for the leave, will suffice.

(2) An employee who did not receive services from a provider for the HFWA-qualifying leave, or who cannot obtain a document from their provider in reasonable time or without added expense, can provide their own writing indicating that they took leave for a HFWA-qualifying purpose.

(C) To document leave for a safety-related need covered by C.R.S. § 8- 13.3-404(1)(c) (i.e., domestic abuse, sexual assault, or criminal harassment): A document under subpart (B)(1) (from a health provider or a non-health provider of legal services, shelter services, social work, or other similar services) or an employee writing under (B)(2) will suffice, as will a legal document indicating a safety need that was the reason for the leave (e.g., a restraining order, other court order, or police report).

(D) Submission of documentation to an employer may be provided (1) by any reasonable method, including but not limited to electronic transmission, (2) at any time until whichever is sooner of an employee’s return from leave (or termination of employment, if the employee does not return), (3) without a requirement of the employee’s signature, notarization, or any other particular document format.

(E) Confidentiality of leave-related information and documentation. Any information an employer possesses regarding the health of an employee or the employee’s family member, or regarding domestic abuse, sexual assault, or criminal harassment affecting an employee or employee's family member, shall be treated as confidential and may not be disclosed to any other individual except the affected employee, unless the affected employee provides written permission prior to such disclosure. C.R.S. § 8-13.3- 412(2)(c). If the information is in writing, it shall be maintained on a separate form and in a separate file from other personnel information, and shall be treated as a confidential medical record by the employer. C.R.S. § 8-13.3-412(2)(a)-(b).

(F) If an employer reasonably deems an employee’s documentation deficient, without imposing a requirement of providing more documentation than HFWA or applicable rules permit, prior to denying leave, the employer must: (1) notify the employee within seven days of either receiving the documentation or the employee’s return to work (or termination of employment, if the employee does not return), and (2) provide the employee the minimum of seven days to cure the deficiency after the employee is notified that the employer deems the existing documentation inadequate. 3.5.7 Employer records of accrued and used paid leave hours. An employer “shall retain records for each employee for a two-year period, documenting hours worked, paid sick leave accrued, and paid sick leave used” (C.R.S. § 8-13.3-409(1)), except that two-year limit does not diminish the obligation to retain pay statement records for three years (C.R.S. § 8-4-103(4.5)). Upon an employee’s request, an employer must provide, in writing or electronically, documents sufficient to show, or a dated statement containing, the then-current amount of paid leave the employee has (1) available for use, and (2) already used during the current benefit year, including information as to any accrued leave provided and used subject to C.R.S. § 8-13.3-403 and any supplemental public health emergency-related leave provided and used subject to C.R.S. § 8-13.3-405(3). Employees may make such requests no more than once per month, except they may make an additional request when any need for HFWA leave arises. Employers may choose a reasonable system for fulfilling such requests, including but not limited to listing such information on each pay stub, using an electronic system where employees can access their own information, or providing the necessary information in a letter or electronic communication. 3.5.8 Collective bargaining agreements that provide for equivalent or more generous paid sick leave.

(A) If a bona fide collective bargaining agreement (CBA) “provides for equivalent or more generous paid sick leave for the employees covered” (C.R.S. § 8-13.3-415(2), (3)), then:

(1) HFWA does not apply additional requirements (e.g. it does not require an additional 48 hours of leave when a CBA provides the same amount of leave); and (2) HFWA does not invalidate the CBA or require its re-opening.

(B) A CBA “provides for equivalent or more generous paid sick leave”

(C.R.S. §§ 8-13.3-415(2), (3)) if the CBA does not diminish any employee protections under HFWA and rules promulgated thereunder, including but not limited to the requirements in Rule 3.5.4(A) and:

(1) accrual and carryover;

(2) use and its conditions (e.g., documentation and notice to employers); and (3) protection and effectuation of paid sick leave rights through notice to employees and prohibitions against retaliation based on, or interference with, protected activity.

(C) This Rule applies to a CBA that is either:

(1) “in effect on the effective date” of HFWA, July 14, 2020; or (2) “initially negotiated or negotiated for the next collective bargaining agreement after that effective date . . . if the requirements of this Part 4 are expressly waived in the CBA.” (C.R.S. § 8 13.3 415(2), (3).)

Rule 4. Investigation and Mediation 4.1 Wage complaints shall be assigned to Division investigative staff. Investigatory methods used by the Division may include:

(A) Interviews of the employer, employee, and other parties;

(B) Information gathering, fact-finding, and reviews of written submissions; and (C) Any other lawful techniques that enable the Division to assess the employer’s compliance. 4.2 The Division will evaluate wage complaints under the following burden of proof structure: 4.2.1 To initiate a wage complaint, an employee must provide an explanation of the basis for the complaint that is clear, specific, and shows the employee is entitled to relief. The employee must provide sufficient evidence from which both a violation of Colorado wage and hour laws and an estimate of wages due may be reasonably inferred. 4.2.2 The Division may investigate a wage complaint on behalf of a group of employees if (A) the claimant so requests and (B) it may be reasonably inferred that other employees are similarly situated. If the Division declines to investigate a wage complaint on behalf of a group of employees, it shall investigate on behalf of the individual claimant, and others similarly situated may consent in writing to participate as parties, pursuant to any Division instructions as to information or submissions required by the Division. Nothing in this Rule 4 limits the Division’s authority for direct investigations under the Direct Investigations Rules, 7 CCR 1103-8. 4.2.3 The burden then shifts to the employer to prove, by a preponderance of the evidence, that the employee is not entitled to the claimed relief. If the employer fails to meet its burden, the Division may award wages and/or penalties to the employee based on the employee’s evidence. 4.2.4 If the Division concludes that wages are owed to the employee, but cannot calculate the precise amount of wages due, then the Division may award a reasonable estimate of wages due. 4.3 Any party to a wage complaint may designate an authorized representative to represent the party during the Division’s administrative procedure. 4.3.1 The party may designate an authorized representative by filing the Division-approved form with the Division. 4.3.2 If not using the Division-approved form, and the authorized representative is a licensed attorney or accountant, the party or the authorized representative must provide written notice to the Division that the authorized representative will represent the party during the Division’s administrative procedure. 4.3.3 If not using the Division-approved form, and the authorized representative is not a licensed attorney or accountant, the party must provide a signed written notice to the Division that the authorized representative will represent the party during the Division’s administrative procedure. 4.3.4 The party may revoke the authorized representative’s authority by contacting the Division in writing. 4.4 After receipt of a wage complaint that states a claim for relief, the Division will initiate the administrative procedure by sending a Notice of Complaint to a correct address of the employer, along with any relevant supporting documentation submitted by the employee, via U.S. postal mail, electronic means, or personal delivery. 4.4.1 If the Notice of Complaint cannot be delivered, and is not otherwise served to or received by the employer, the administrative procedure has not been initiated, but the Division may resend the Notice of Complaint to a correct address, with the response deadline calculated from the date when that notice was sent. Any competent evidence may establish that a party was served; conclusive proof of service includes proof of delivery to any correct address as defined in Rule 2. Proper service is effective regardless of whether the party reads or opens the material served. 4.4.2 If the Division cannot determine the employer’s correct address, it may contact the employee to request the employer’s address. The Division may dismiss the wage complaint if neither the employee nor the Division can determine the employer’s correct address. 4.4.3 The employer’s response to the Notice of Complaint must include the completed Division Employer Response Form, as well as any additional information or documentation requested by the Division. An insufficient response from the employer may be considered a failure to respond under C.R.S. § 8-4-113(1)(b). 4.4.4 If an employer obtains a good cause extension to respond under C.R.S. § 8-4-113(1)(b), the extension does not waive or reduce penalties owed to the employee pursuant to C.R.S. § 8-4-109(3)(b) if the employer fails to pay the employee’s wages within 14 days after the Notice of Complaint is sent. 4.4.5 Where a claim, complaint, or investigation for violation of these Rules or the statutes they enforce has been filed or commenced, the employer shall preserve all relevant documents until final disposition and until the expiration of the statutory period within which a person aggrieved may bring a civil action. 4.5 After receipt and review of the employer’s response, the Division may contact the employee for additional documentation or information. If the employer denies, in whole or in part, the allegations in the Notice of Complaint, and the Division determines further investigation would be beneficial, the Division shall send to the employee any relevant supporting documentation submitted by the employer.

If the employee does not respond to the request for additional documentation or information by the deadline given, the Division will make a determination based on the information in the record. 4.6 All parties to a wage complaint are responsible for ensuring the Division has current contact information. 4.6.1 All parties must promptly notify the Division of any change in contact information, including mailing address, email address, and phone number. 4.6.2 Parties should not rely on the U.S. Postal Service to forward mail. Failure to respond to a notice because mail was not forwarded to a new address will not be excused. 4.7 In any stage of any Division investigation, proceeding, or other action, if information is provided to the Division by a source requesting or otherwise warranting confidentiality, then the source shall remain confidential if that information is used: (1) as a basis for procuring other evidence, not offered as evidence itself; (2) as evidence of liability, but not to establish individual relief for the source of the information; or (3) in other circumstances in which confidentiality is necessary and appropriate. Any such confidential source is unlawful to disclose (unless the source consents) in any administrative or judicial proceeding, in response to any records or information request, or in any other manner, in order to effectuate statutory requirements including but not limited to the following:

(A) If information is properly treated as confidential, the Division “shall provide a physical environment and establish policies and procedures to ensure confidentiality for all information regarding any employer, employee, or person pertaining to any action pursuant to articles 1 to 13” (C.R.S. § 8-1-115);

(B) “An employer, or any other person that is regularly engaged in business or commercial activity that has contracted with an employer or worker, directly or indirectly, for labor from which such person is the beneficiary shall not intimidate, threaten, restrain, coerce, blacklist, discharge, or in any manner discriminate or retaliate against any employee who has: (a) filed a complaint or instituted or caused to be instituted a proceeding under this article 4 or any other law or rule related to wages, hours, or employment of minors; (b) testified or provided other evidence, or may testify or provide other evidence in a proceeding on behalf of the employee or another person regarding afforded protections under this article 4 or under any other law or rule related to wages, hours, or the employment of minors; or (c) raised concerns in good faith about compliance with or otherwise provided information as to legal rights and remedies available under this article 4 or any other law or rule related to wages or hours to any person.” (C.R.S. § 8-4-120(1));

(C) It is unlawful to “discharge or threaten to discharge, or in any other way discriminate against an employee” because s/he “may testify in any investigation or proceeding relative to enforcement of this

article” (C.R.S. § 8-6-115); and (D) It is unlawful to take adverse action based on “participating in an investigation, hearing, or proceeding or cooperating with or assisting the Division in its investigations of alleged violations” of HFWA (C.R.S. §§ 8-13.3-402(10), -407). 4.8 Immigration status is irrelevant to labor rights and responsibilities, and the Division shall assure that labor rights and responsibilities apply regardless of immigration status, including but not limited to as follows. 4.8.1 The Division will not voluntarily provide any person or entity information concerning the immigration status of (a) a party to a wage claim, (b) a person offering information concerning a wage claim, or (c) a person with a relationship with anyone in categories (a) or (b). 4.8.2 Any effort to use a person’s immigration status to negatively impact the labor law rights, responsibilities, or proceedings of any person or entity is an unlawful act of obstruction, retaliation, and/or extortion, based on statutory or rule provisions including but not limited to the following that make it unlawful:

(A) For “any person” to “hinder or obstruct the director or any such person authorized by the director in the exercise of any power conferred by this article,” including but not limited to wage investigations, rulemakings, or adjudicative or judicial proceedings (C.R.S. § 8-1-116(2));

(B) For an employer to in any manner discriminate or retaliate against a person for exercising labor rights, including but not limited to acts that “intimidate, threaten, restrain, coerce, blacklist, discharge, or in any manner discriminate or retaliate against any employee who has: (a) filed a complaint or instituted or caused to be instituted a proceeding under this article 4 or any other law or rule related to wages, hours, or employment of minors; (b) testified or provided other evidence, or may testify or provide other evidence, in a proceeding on behalf of himself, herself, or another regarding afforded protections under this article 4 or under any other law or

rule related to wages, hours; or the employment of minors; or (c) raised concerns in good faith about compliance with or otherwise provided information as to legal rights and remedies available under this article 4 or any other law or rule related to wages or hours to any person” (C.R.S. § 8 4-120(1));

(C) For any person to “threaten to report to law enforcement officials the immigration status of the threatened person or another person” to “induce another person” to give up money “or another item of value” (C.R.S. § 18 3 207(1.5)), including inducing the surrender of any “tangible and intangible personal property, contract rights, choses in action, or services . . . , and any rights of use or enjoyment connected therewith” (C.R.S. § 18-1-901); and (D) For an employer to deny “any right guaranteed under” HFWA, or to take “any adverse action against an employee for exercising any right guaranteed” by HFWA (C.R.S. §§ 8-13.3-402(10), -407). 4.9 Mediation 4.9.1 The Division may invite or order parties to a complaint to meet to mediate or otherwise attempt to resolve the complaint at any stage of the administrative procedure or other applicable process. 4.9.2 No statements, actions, evidence, or other submissions during or for mediation shall be disclosed by any party or used as evidence in any subsequent proceeding unless the parties agree otherwise. 4.9.3 Upon request, parties shall provide the Division copies of settlement agreements entered through mediation or private settlement negotiation.

To the extent that an agreement requires confidentiality, the Division shall, in conformity with the Colorado Dispute Resolution Act (C.R.S. § 13-22- 301, et seq.) and other applicable law (e.g., C.R.S. § 8-1-115), maintain that confidentiality, subject to any legal restrictions on confidentiality.

Rule 5. Determination 5.1 Upon conclusion of the investigation of a wage complaint, the Division will issue a determination. 5.1.1 The Division shall send the determination to all parties via U.S. postal mail, electronic means, or personal delivery on the date the determination is issued by the Division. The Division shall notify the parties of their termination and any appeal rights pursuant to C.R.S. § 8-4-111(3) and C.R.S. § 8-4-111.5(1). 5.1.2 The date of “issuance” of the Division’s determination, as used in C.R.S. § 8-4-111(3), is the date the Division’s determination is “sent,” as used in C.R.S. § 8-4-111.5(1). Both the termination and appeal deadlines are calculated from the date the Division’s determination is originally issued and sent to the parties. 5.1.3 If any copies of the decision are sent to the parties after the date the Division’s determination is originally issued and sent to the parties, those copies are provided only as a courtesy and do not change the 35-day appeal and termination deadlines. 5.1.4 Determinations by the Division may include the following remedies, depending on which, if any, the Division’s findings support:

(A) monetary or other relief authorized by the statute(s) under which the wage complaint was filed, including but not limited to, where applicable — (1) any unpaid wages, penalties, and/or fines under C.R.S. Title 8, Articles 1, 4, 6, and 13.3;

(2) if a claim under C.R.S. Title 8, Article 13.3 (HFWA) cost the employee a job or pay, back pay plus either reinstatement or (if reinstatement is infeasible) front pay for a reasonable period; and/or (3) other fines or penalties authorized by statutes applicable to the complaint;

(B) fines or penalties authorized by the statutes on Division investigative and enforcement authority in C.R.S. Title 8, Articles 1, 4, 6, and 13.3; and/or (C) order(s) to cease non-compliance and/or effectuate compliance, as authorized by the statute(s) under which the complaint was filed and statutes on Division investigative and enforcement authority in C.R.S. Title 8, Articles 1, 4, 6, and 13.3.

Rule 6. Appeal 6.1 Any party to the claim may appeal the Division’s determination. 6.1.1 Parties are encouraged, though not required, to use the Division’s appeal form. A valid appeal is a written statement that is timely filed with the Division, explains the clear error in the determination that is the basis for the appeal, is not frivolous, and has been signed by the party or the party’s authorized representative. An appeal is frivolous if it fails to allege an error that could result in the reversal or modification of the determination or otherwise is manifestly insufficient or futile. 6.1.2 No appeal will be heard and no hearing will be held unless the appeal is received by the Division within 35 calendar days of the date the determination is sent. It is the responsibility of the party filing the appeal to ensure the appeal is received by the Division within the 35-day filing deadline. 6.1.3 Upon receipt of the appeal, the Division will notify the parties of the date of the hearing and any interim deadlines via U.S. postal mail, electronic means, or personal delivery. 6.1.4 Upon receipt of the appeal, the Division will send a copy of the appeal and a copy of the record of its investigation to the parties via U.S. postal mail, electronic means, or personal delivery. All evidence submitted to the Division as part of the investigation is part of the record on appeal and need not be resubmitted. 6.1.5 The filing of an appeal does not, except to the extent that a stay is granted, toll any deadlines applicable under, or triggered by the issuance of, the determination, decision, or order being appealed. 6.2 Parties who timely file a valid appeal of the Division's determination will be afforded an administrative appeal hearing before a Division hearing officer, unless the hearing officer finds, based on pre-hearing submissions, that the appeal presents no issues warranting a live hearing, and gives the parties notice and opportunity to be heard as to whether a hearing is warranted. Parties may appear by telephone. 6.3 The parties may submit new testimonial evidence to the hearing officer in accordance with deadlines imposed by the Division. The parties may submit new documentary or other non-testimonial evidence in accordance with deadlines imposed by the Division and upon showing “good cause,” which may be assessed based on any relevant factors, including but not limited to: 6.3.1 That the new evidence was previously not known or obtainable, despite diligent evidence-gathering efforts by the party offering the new evidence; 6.3.2 That the party failed to receive fair notice of the investigation or of a key filing by another party or by the Division to which the new evidence is responsive; 6.3.3 That factors outside the control of the party prevented a timely action or interfered with the opportunity to act, except that the acts and omissions of a party's authorized representative are considered the acts and omissions of the party and are not considered to be a factor outside the party's control as intended by this rule; 6.3.4 That a determination raised a new issue or argument that cannot be responded to adequately without the new evidence; 6.3.5 That, at the investigation stage, the party offering new evidence requested more time to submit evidence, yet was denied, and in the hearing officer’s judgment (a) the need for more time was legitimate and did not reflect neglect by the party, (b) the denial of the request for more time was unwarranted, and (c) exclusion of the evidence would cause substantial injustice to the party; and/or 6.3.6 That failure to admit the evidence otherwise would cause substantial injustice and did not arise from neglect by the party. 6.4 New evidence must be sent to all other parties to the appeal. Failure to send all new evidence to all other parties to the appeal may result in the evidence being excluded from the record. 6.5 If the party who filed the appeal does not participate in the hearing, the appeal may be dismissed. 6.6 All testimony at a hearing must be recorded by the Division but need not be transcribed unless the hearing officer’s decision is appealed. 6.7 The hearing officer may, upon the application of any party or on his or her own motion, convene a prehearing conference to discuss the issues on appeal, the evidence to be presented, and any other relevant matters that may simplify further proceedings. 6.8 The hearing officer will decide whether the Division’s determination is based on a clear error of fact or law. Clear error means that either the correct facts were not known at the time the determination was made, or the law was applied incorrectly. 6.9 The hearing officer shall not engage in ex parte communication with any party to an appeal. 6.10 An appeal may, in the discretion of the hearing officer, be sequenced and/or divided into two or more stages on discrete questions of liability and/or relief (e.g., bifurcation), yielding two or more decisions and/or phases of the appeal. 6.11 The hearing officer’s decision constitutes a final agency action pursuant to C.R.S. § 24-4-106. The Division shall promptly provide all parties with a copy of the hearing officer’s decision via U.S. postal mail, electronic means, or personal delivery, as consistent with applicable law. The Division shall notify the parties of their appeal rights pursuant to C.R.S. § 8-4-111.5(5). 6.12 This Rule 6 applies to all Division wage claims adjudicated under these rules by the person designated by the Division to serve as the hearing officer for a claim, and for any other Division proceedings, to the maximum extent consistent with the Colorado Administrative Procedure Act, C.R.S. §§ 24-4-105, -106.

Rule 7. Attorney Fees and Costs 7.1 Where permitted by law, employees, or other applicable claimants or complainants, may apply for an award of reasonable attorney fees or costs within the timeframe ordered by the Division, and pursuant to orders and instructions provided by the Division. 7.2 After an application for attorney fees or costs is filed, the Division will send any other parties a copy of the application, any supporting documents, and any other relevant orders or requests from the Division. Other parties may respond to the application, within the timeframe ordered, as to the reasonableness, amount, or recoverability of any attorney fees or costs claimed. The Division will send any responses it receives to the applicant, who may optionally reply to any points, or may be ordered to reply, as directed by the Division. The Division may extend deadlines for good cause as described in Rule 2.9. 7.3 An award of attorney fees or costs may be appealed pursuant to orders and instructions on appeal rights provided by the Division pursuant to Rule 6. 7.4 For unpaid wage claims, this Rule 7 applies to only claims filed on or after January 1, 2023.

Rule 8. Administrative Liens and Levies 8.1 The Division may issue a notice of administrative lien and levy if an employer or other Division debtor fails to pay wages, fines, or penalties determined to be due in an order that is not the subject of an order staying the enforceability of the order, that has not been superseded on appeal, or that is not subject to any order barring such action.

(A) Notice shall be provided to the Division debtor, as well as to any other known co-owner or any person or entity with possession, custody, or control of any of the assets at issue, including a financial institution as applicable.

(B) Upon an employee’s written request, the Division will inform the employee within 60 calendar days whether it will issue such notice, subject to the Division’s discretion to issue such notices on its own initiative at any later time.

(C) An administrative lien placed on any and all types of jointly owned or shared account(s), including multiple-party accounts as defined in C.R.S. § 15-15-201 (collectively, “joint account(s)”) shall require the financial institution to freeze 100% of the assets on deposit as of the date of the notice of the administrative lien and levy. 8.2 A notice of administrative lien and levy may be opposed in whole or in part, for the reasons detailed in this Rule 8.2, and under the procedures detailed in Rule 8.3 below. 8.2.1 An exemption shall be granted for any of the following reasons:

(A) the notice contained a misidentification of the owner of some or all of the assets, and these assets are wholly owned by some person other than the employer or other Division debtor;

(B) the notice identified assets within a custodial account created pursuant to the “Colorado Uniform Transfers to Minors Act”, Article 50 of Title 11, C.R.S., or a trust account of moneys held in trust for a third party;

(C) the notice would apply to assets in an amount of “disposal earnings,” as defined in C.R.S. § 13-54-104(1)(a), that would exceed the maximum allowable percentage amount of “disposable earnings” that can be seized to enforce an order under C.R.S. § 13- 54-104(3) based upon the documentation provided by the employer or some other Division debtor; or (D) the notice identified assets that are exempted by law from execution, levy, attachment, garnishment, or other legal process. 8.2.2 A notice of administrative lien and levy shall be rescinded if:

(A) the Division has failed to follow the procedures in C.R.S. § 8-4- 113(4) or these Rules for issuance of a notice of administrative lien and levy; and (B) the failure either deprived a party of notice or opportunity to be heard, or otherwise had a prejudicial effect upon a party. 8.2.3 An exception may be granted to a Division debtor when the Division debtor is a natural person who is terminally ill. For purposes of this rule, “natural person” means a human, and does not include any kind of corporation, company, limited liability company, partnership, form, association, organization, agency, or any other kind of entity. 8.2.4 An appeal may be granted on the basis that there is proof that the notice would apply to assets in a joint account and some or all of those assets include up to 100% of a non-debtor account holder’s net contribution of the funds on deposit, as governed by C.R.S. § 15-15-211, as of the date the person served with the notice was in receipt of the notice. 8.3 Within 21 calendar days from the date of the notice of administrative lien and levy, a Division debtor, any other person or entity claiming ownership or joint ownership of any of the asset(s), or any other person or entity with possession, custody or control any of the asset(s) (collectively, “Filer(s)”), may file any applicable opposition to the notice of administrative lien and levy for the reasons detailed in Rule 8.2 and in accordance with the procedures detailed in this Rule 8.3 and/or described in orders and instructions provided by the Division and/or published by the Division on its website. 8.3.1 The Filer has the burden, pursuant to any policies or instructions included with any notice of administrative lien and levy, of claiming with specificity, producing evidence to support, and proving entitlement to, any exceptions or exemptions, or in the case of a non-debtor joint account holder, of making such showing as to their contribution of an identifiable portion of the funds. 8.3.2 A Division hearing officer shall review the claim and document the decision whether to approve or deny the requested relief. The Division shall provide an initial decision within seven calendar days of receipt, or the next business day thereafter.

(A) An initial grant may be subject to further review by the Division, based on information from the Filer or other information obtained by the Division.

(B) An initial denial may include permission or a request to submit further information, based on which the claim for exception or exemption may be re-reviewed by the Division.

(C) An initial denial will be deemed an appealable final administrative lien and levy order (1) if the Filer chooses not to provide further information within seven calendar days, on the eighth calendar day; or (2) if the Division does not issue a new decision within seven calendar days of any new information provided by the Filer, on the eighth calendar day after the new information is provided. 8.3.3 Notice of an order on a filing opposing a notice of administrative lien and levy.

(A) If the claim is approved, in whole or in part, the decision shall indicate the scope of asset(s) released, and the extent to which a notice of administrative lien and levy may be re-issued; and the Division shall notify, and issue a release of the administrative lien and levy to:

(1) the Filer and (to the extent different) the Division debtor and any other applicable owner of any of the assets(s); and (2) any other applicable persons or entity (including but not limited to a financial institution) with possession, custody or control of the asset(s).

(B) If the claim is denied, the Division:

(1) shall notify the Filer and (to the extent different) the employer or other Division debtor and any other applicable owner of any of the assets(s); and (2) may, where appropriate and applicable, notify any person or entity (including, but not limited to, a financial institution) with possession, custody or control of the asset(s). 8.3.4 A hearing officer’s appealable, final administrative lien and levy order pursuant to Rule 8.3.2 and 8.3.3 constitutes a final agency action pursuant to C.R.S. § 24-4-106. The Division shall promptly provide all parties with a copy of the hearing officer’s decision via U.S. postal mail, electronic means, or personal delivery. The Division shall notify the parties of their appeal rights pursuant to C.R.S. § 8-4-111.5(5).

Rule 9. Wage Theft Enforcement Fund 9.1 When the Division, pursuant to Title 8, Articles 4, 6, or 12 of the Colorado Revised Statutes, or a hearing officer, pursuant to C.R.S. § 8-4-111.5, determines that an employer owes wages, compensation, or other monetary relief to an employee, if the employer fails to pay an employee the determined amount of wages, compensation, or other monetary relief owed the employee within 120 days after the Division’s determination, or hearing officer’s decision, or the expiration of an order from the Division, the hearing officer, or a court staying or postponing the employer’s payment obligation, whichever is later, the Division may disburse payment for the amount of wages, compensation, or other monetary relief determined to be owed the employee from the wage theft enforcement fund (the “fund”) to the employee.

(A) Any disbursement from the fund shall be subject to the Division’s prioritization and the available resources in the fund.

(B) Pursuant to C.R.S. § 8-4-113(3)(a), (c)(II), and 5(a), the Division may disburse amounts from the fund to make payments to employees for part or all of the unpaid amount of wages, compensation, or other monetary relief, which include statutorily mandated penalties, determined to be owed to an employee.

(C) The Division may, based both on its own discretion and its consideration of the criteria identified in Rule 9.3, make a disbursement from the fund to an employee to pay wages, compensation, or other monetary relief owed to the employee without receiving an employee’s request for such disbursement. 9.2 After 120 days following the Division determination or hearing officer decision that an employer owes wages, compensation, or other monetary relief to an employee, or the expiration of an order from the Division, a hearing officer, or a court staying or postponing the employer’s payment obligation, whichever is later, if the employer has still failed to pay the determined wages, compensation, or other monetary relief owed the employee, the employee may submit a written request seeking payment from the fund pursuant to C.R.S. § 8-4-113(5) (“fund request”). 9.2.1 An employee who submits a fund request to the Division must comply with orders and instructions posted or otherwise provided by the Division:

(A) as to the method and timeframe to submit a fund request; and (B) requiring information on any relevant matters, including but not limited to the determination or decision awarding relief, any collections efforts by or for the employee, and any up to date personal information from the employee. 9.2.2 The Division will inform the employee in writing (e.g., letter or electronic communication) as to its decision on the fund request. If the Division determines that it will not grant a fund request, it may, in its discretion, inform the employee that it will retain the request on file for future consideration, without need for a further submission by the employee. 9.2.3 If, pursuant to an employee’s fund request, the Division determines that it will disburse from the fund any amounts related to the unpaid wages, compensation, or other monetary relief described in the employee’s fund request (“disbursement amount”), the Division:

(A) shall notify the employee in writing (e.g., letter or electronic communication) of the payment to the employee (“fund payment”);

(B) may inform the employee that such fund payment may be conditioned on confirmation of the employee’s current contact information and/or preferred method of payment;

(C) may require the employee to sign an acknowledgement of the following conditions prior to issuing any payment to the employee — (1) once the employee has deposited or cashed the fund payment, they may not recover payment in the disbursement amount from the employer;

(2) the Division replaces the employee as the creditor of the employer for the disbursement amount;

(3) the Division shall credit any payment it obtains from the employer toward the disbursement amount to the fund; and (4) if the employee does not deposit or cash the fund payment within three months of transmission, the Division may cancel the fund payment.

(D) shall, upon Division confirmation of both reliable payment transmission information and compliance with all requirements, transmit payment to the employee. 9.2.4 Nothing in Rule 9.2 shall be construed to reduce or otherwise alter the amount of an employer’s or other Division debtor’s unpaid liabilities for wages, compensation, or other monetary relief owed to an employee based on a fund payment. 9.2.5 Pursuant to C.R.S. § 8-4-113(5)(a), because the Division’s authority to disburse payments from the fund is a discretionary use of Division funds, an employee cannot appeal any Division determination concerning a fund request. 9.3 The Division shall review, evaluate, and resolve an employee’s fund request based on the following criteria, to the extent that any or all are appropriate and relevant to a particular request:

(A) enforcement priorities of the Division;

(B) available resources in the fund;

(C) length of time that the unpaid liabilities for wage law violations have been outstanding;

(D) the employee's degree of need for payment from the fund;

(E) the employer’s prospects of paying their debt, including any risk of asset depletion;

(F) the employer’s degree of compliance or non-compliance in relation to either the employee, other employees, or the Division;

(G) the extent of any past, current, or impending collection efforts by the employee or the Division; and (H) any other considerations relevant to the merits of the fund request. ______________________________________________________________________ Editor’s Notes

History Entire rule eff. 12/30/2014.

Entire rule eff. 09/01/2017.

Rules 1.2, 2.12, 2.15, 3.2.3, 4.7, 4.8 emer. rules eff. 08/20/2019.

Rules 1.2, 2.12, 2.15, 3.2.3, 4.7, 4.8 eff. 12/15/2019.

Rules 2.6-2.17 emer. rules eff. 03/16/2020.

Rules 2.6-2.17, 6.3-6.10 eff. 07/15/2020.

Entire rule eff. 01/01/2021. Rules 2.11, 3.5.1(C) emer. rules eff. 01/01/2021.

Entire rule eff. 04/14/2021.

Entire rule eff. 01/01/2022.

Entire rule eff. 01/01/2023.

Entire rule eff. 04/01/2024.

Entire rule eff. 01/01/2025.

Entire rule eff. 02/01/2026.

7 CCR 1103-8 Direct Investigation Rules {#sec-7-ccr-1103-8 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-8}

DEPARTMENT OF LABOR AND EMPLOYMENT

DIRECT INVESTIGATION RULES

7 CCR 1103-8 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted February 9, 2024; effective April 1, 2024.

Rule 1. Statement of Purpose and Authority 1.1 Authority and relation to prior orders. The general purpose of these Direct Investigation Rules is to implement the Division of Labor Standards and Statistics’s authority to conduct direct investigations of potential violations of labor standards law contained in C.R.S. Title 8, Articles 1, 2, 4-6, 12, 13.3, 13.5, and 14.4. These rules are adopted pursuant to the Division’s authority in, and as enforcement of, these Articles, and are intended to be consistent with the requirements of the State Administrative Procedure Act, C.R.S. § 24-4-101, et seq. Unless otherwise noted, in these Rules: all statutes cited apply the most recent 2023 versions of the Colorado Revised Statutes, all rules cited apply the most recent versions adopted as of the adoption of these Rules. 1.2 These Rules are intended to remain in effect to the maximum extent possible. If any part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rules remain valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form. 1.3 Incorporation by reference. Colo. Const. art. XVIII, § 15 (2023); Title 8, Articles 1, 2, 4-6, 12, 13.3, 13.5, and 14.4 of the Colorado Revised Statutes, including the Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq. (2024); 7 CCR 1103-1; 7 CCR 1103-7; 7 CCR 1103-11, 7 CCR 1103-13, and 7 CCR 1103-15, are hereby incorporated by reference into this rule, except where these Rules differ. Such incorporation excludes later amendments to or editions of the constitution, statutes, and rules. They are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, 633 17th Street, Denver, CO 80202.

Copies may be obtained from the Division of Labor Standards & Statistics at a reasonable charge. They can be accessed electronically from the website of the Colorado Secretary of State.

Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of them at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing them. All Division Rules are available to the public at www.coloradolaborlaw.gov. Where these Rules have provisions different from or contrary to any incorporated or referenced material, the provisions of these Rules govern so long as they are consistent with Colorado statutory and constitutional provisions.

Rule 2. Definitions 2.1 “Division” means the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment; “Director” means the Director of the Division. 2.2 “Employee” has the meaning provided by C.R.S. § 8-4-101(5), except as follows, or as otherwise required by statute:

(A) under the Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq., “employee” has the meaning provided by C.R.S. § 8-5-101(4);

(B) under the Healthy Families and Workplaces Act, “employee” has the meaning provided by C.R.S. § 8-13.3-402(4);

(B) under the Public Health Emergencies Whistleblower Act, C.R.S. § 8-14.4-101, et seq.

“employee” and “worker” have the meaning provided by C.R.S. § 8-14.4-101(5), and where that Act applies, provisions of these Rules applicable to an “employee” shall apply equally to a non-employee “worker”; and (D) under the Agricultural Labor Rights and Responsibilities Act, as codified in relevant part at C.R.S. §§ 8-6-101.5, 8-6-120, and 8-13.5-201 et seq., “employee” has the meaning provided by C.R.S. §§ 8-13.5-201 and 8-2-206(1)(b), as applicable. 2.3 “Employer” has the meaning provided by C.R.S. § 8-4-101(6), except as follows, or as otherwise required by statute:

(A) under the Healthy Families and Workplaces Act, C.R.S. § 8-13.3-401 et seq., “employer” has the meaning provided by C.R.S. § 8-13.3-402(4);

(B) under the Chance to Compete Act, C.R.S. § 8-2-130 et seq., “employer” has the meaning provided by C.R.S. § 8-2-130(2)(c);

(C) under the Colorado Public Health Emergencies Whistleblower Act, C.R.S. § 8-14.4-101, et seq., “employer” and “principal” have the meaning provided by C.R.S. § 8-14.4-101(3), and where that Act applies, provisions of these Rules applicable to an “employer” shall apply equally to a non-employer “principal”;

(D) under the Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq., “employer” has the meaning provided by C.R.S. § 8-5-101(5); and (E) under the Agricultural Labor Rights and Responsibilities Act, as codified in relevant part at C.R.S. §§ 8-6-101.5, 8-6-120, and 8-13.5-201 et seq., “employer” has the meaning provided by C.R.S. § 8-3-104(1). 2.4 A “correct address” for a party, including but not limited to as used in C.R.S. § 8-4-101(15) and these or other applicable Division rules, can include, but is not limited to (unless defined otherwise by statute, rule, or order): a physical or email address the party used, or provided to the Division, in the investigation (unless the party notifies the Division to use an alternate valid address instead); the party’s email address; the address on file with the Colorado Secretary of State for the party or their registered agent; or an address actually used, or publicly posted as a current address for mail or deliveries, by the party. 2.5 “Fine” means any monetary amount assessed against an employer and payable to the Division. 2.6 “Notice of Investigation” means a notice to an employer that identifies potential violations under investigation and includes initial demands for documentation and records. 2.7 “Notice of Investigation Termination” means a notice to an employer that no further action is contemplated by Direct Investigations regarding the potential violations described in the Notice of Investigation. 2.8 “Place of employment” is defined at C.R.S. § 8-1-101(12). 2.9 “Labor Standards law” is defined as laws within, and rules promulgated pursuant to, C.R.S., Title 8, Articles 1, 2, 4-6, 12, 13.3, 13.5, and 14.4, and includes Colo. Const. art. XVIII, § 15; 7 CCR 1103-1, 1103-4, 1103-5, 1103-7, 1103-9, 1103-11; and any other Rules promulgated pursuant to the Division’s authority in the foregoing statutes. 2.10 “Witness” means any person or entity ordered to provide, or volunteering to provide, documents, information, or other evidence in a direct investigation. 2.11 A “written demand,” including as used in C.R.S. § 8-4-101(15), can be sent to the employer by electronic means, including but not limited to email and text message. Wages must be owed at the time of sending for the written demand to be considered valid. The penalty provisions in C.R.S. § 8-4-109(3)(b) effective on January 1, 2023, shall apply if the 14-day deadline for payment after the sending of a written demand without penalties passes on or after January 1, 2023, unless a prior written demand was sent more than 14 days before January 1, 2023.

Notwithstanding the foregoing, when a Division Notice of Investigation, Citation, Notice of Assessment, or other Division-issued document satisfying the requirements of a written demand, is sent where the 14-day deadline for payment is on or after January 1, 2023, the passing of that deadline triggers those penalty provisions, regardless of whether a prior written demand was sent before the Division’s. A Citation and Notice of Assessment will constitute a written demand for the payment of any wages described therein, in accordance with C.R.S. § 8-4-101(15), and will be treated as such pursuant to C.R.S. § 8-4-109(3).

Rule 3. Investigations 3.1 The Division may initiate a direct investigation of any potential violations of any labor standards law it has authority to enforce or investigate. The scope of an investigation may include all impacted individuals, including all of an employer’s employees or contractors, or any subset or combination thereof. 3.2 The Division shall initiate the direct investigation by sending a Notice of Investigation to a correct address of the employer. The direct investigation is not limited to the time period or potential violations identified in the Notice of Investigation. The Division may, at its discretion, expand the direct investigation beyond the scope of the Notice of Investigation. 3.3 The employer and any witness may designate an authorized representative to represent it during the investigation. 3.4 In the course of a direct investigation, the Division may utilize all information-gathering powers authorized by statute through orders to the employer or any witness, and may issue fines pursuant to this same authority for failure or refusal to comply with these orders. See, e.g., C.R.S. §§ 8-1-114, -116, -117, -120; 8-4-111(1)(c), -118, -120; 8-5-103(1)(b). 3.5 During a direct investigation, the Division may issue directives, instructions, protocols, and procedures to an employer and witnesses, and may establish protocols or procedures governing an investigation. Such directives, instructions, protocols, and procedures are presumed to be “lawful order[s]” within the meaning of C.R.S. § 8-1-140(2). Failure to comply with a lawful order may subject the noncompliant individual or entity to fines. Id. 3.6 The employer is responsible for ensuring the Division has its current contact information and correct address as defined in Rule 2. Conclusive proof of service includes proof of delivery to any correct address as defined in Rule 2. Proper service is effective regardless of whether the party reads or opens the material served.

Rule 4. Determination 4.1 Upon completing the investigation, the Division may issue a determination detailing its conclusions. 4.1.1 The Division may issue a Citation against an employer that the Division determines by a preponderance of evidence has violated labor standards law. 4.1.2 The Division may issue to the employer a Notice of Assessment for one or more employee(s) whom the Division determines by a preponderance of the evidence has suffered a violation of labor standards law and who is owed any remedies. 4.1.3 Determinations by the Division may include all remedies authorized by law, that are supported by the Division’s findings, including:

(A) monetary or other relief authorized by the statute(s) under which the investigation was conducted, including but not limited to, where applicable — (1) any unpaid wages, penalties, and/or fines under C.R.S. Title 8, Article 4, (2) if a violation of C.R.S. Title 8, Articles 13.3 (HFWA) or 14.4 (PHEW) cost an employee or worker a job or pay, back pay plus either reinstatement or (if reinstatement is infeasible) front pay for a reasonable period, and/or (3) other fines or penalties authorized by statutes applicable to the investigation;

(B) fines or penalties authorized by the statutes on Division investigative and enforcement authority in C.R.S. Title 8, Articles 1, 4, and 5; and/or (C) order(s) to cease non-compliance and/or effectuate compliance, as authorized by the statute(s) under which the investigation was conducted and statutes on Division investigative and enforcement authority in C.R.S. Title 8, Article 1, 4, 5, and 6. 4.1.4 The Division may issue to the employer a Notice of Assessment inclusive of all wages, penalties, fines and/or other remedies assessed upon the employer. 4.1.5 The Citation and Notice of Assessment will identify the violation, any wages, penalties, and/or other remedies owed to the employee(s), and any fines owed to the Division. If the Division concludes that wages and/or other sums are owed to the employee, but cannot calculate the precise amount due, then the Division may award a reasonable estimate. 4.1.6 For cases in which a valid written demand was sent prior to the issuance of the Citation and Notice of Assessment, to encourage compliance by the employer, if the employer pays the employee(s) all wages and compensation owed within 14 days after a Citation and Notice of Assessment is sent to the employer, the Division may reduce by up to fifty percent any penalties imposed pursuant to C.R.S. § 8-4-109, and may waive or reduce any fines imposed. 4.1.7 If the Division does not determine that an employee suffered a violation of labor standards law, the Division may issue a Notice of Investigation Termination. 4.2 The Division shall send the determination via U.S. postal mail, electronic means, or personal delivery to a correct address of the employer on the date the determination is issued. 4.3 The appeal deadline is calculated from the date the Division’s determination is originally issued and sent to the employer. 4.4 If any copies of the Division’s determination are sent to the employer after the date of its issuance, those copies are only courtesy copies and do not change the 35-day appeal and termination deadlines.

Rule 5. Appeal 5.1 The employer may appeal a Citation and one or more Notices of Assessment. 5.1.1 A valid appeal is a written statement that is timely filed with the Division, explains the clear error in the determination or other grounds that are the basis for the appeal, and has been signed by the employer or the employer’s authorized representative. The employer is encouraged to use the Division’s appeal form. 5.1.2 No appeal will be heard and no hearing will be held unless the appeal is received by the Division within 35 calendar days of the date the determination is sent. It is the responsibility of the employer filing the appeal to ensure the appeal is received by the Division within the 35-day filing deadline. 5.1.3 Upon receipt of the appeal, the Division will notify the parties of the date of the hearing and any interim deadlines via U.S. postal mail, electronic means, or personal delivery. 5.1.4 Upon receipt of the appeal, the Division will send a copy of the record of its investigation to the parties via U.S. postal mail, electronic means, or personal delivery. All evidence submitted to the Division as part of the investigation is part of the record on appeal and need not be resubmitted. 5.1.5 The filing of an appeal does not, except to the extent that a stay is granted, toll any deadlines applicable under, or triggered by the issuance of, the determination, decision, or order being appealed. 5.2 Parties to the appeal will be the employer and the Division Direct Investigations program. Notices to the Division as a party, including disclosure of new evidence pursuant to Rule 5.6, should be sent via email to cdle_ls_direct_investigations@state.co.us. 5.3 An employer that timely files a valid appeal of the Division’s determination will be afforded an administrative appeal hearing before a Division hearing officer. Parties may appear by telephone. 5.4 Consistent with C.R.S. § 8-4-111.5, the hearing officer shall have the power and authority to call, preside at, and conduct hearings. The hearing officer has the power to administer oaths and affirmations, take depositions, certify official acts, and issue subpoenas to compel the attendance of witnesses and the production of books, papers, correspondence, memoranda, and other records deemed necessary as evidence in connection with a disputed determination. 5.4.1 The provisions of C.R.S. § 8-4-111.5(2)(b) and (c), and of (3)(b), are applicable to an appeal filed pursuant to Rule 5.1 to the maximum extent allowable by law. 5.5 The parties may submit new testimonial evidence to the hearing officer in accordance with deadlines imposed by the Division. The parties may submit new documentary or other nontestimonial evidence in accordance with deadlines imposed by the Division and upon showing “good cause,” which may be assessed based on any relevant factors, including but not limited to: 5.5.1 That the new evidence was previously not known or obtainable, despite diligent evidence-gathering efforts by the party offering the new evidence; 5.5.2 That the party failed to receive fair notice of the investigation or of a key filing by another party or by the Division to which the new evidence is responsive; 5.5.3 That factors outside the control of the party prevented a timely action or interfered with the opportunity to act, except that the acts and omissions of a party’s authorized representative are considered the acts and omissions of the party and are not considered to be a factor outside the party’s control as intended by this rule; 5.5.4 That a determination raised a new issue or argument that cannot be responded to adequately without the new evidence; 5.5.5 That, at the investigation stage, the party offering new evidence requested more time to submit evidence, yet was denied, and in the hearing officer’s judgment (a) the need for more time was legitimate and did not reflect neglect by the party, (b) the denial of the request for more time was unwarranted, and (c) exclusion of the evidence would cause substantial injustice to the party; and/or 5.5.6 That failure to admit the evidence otherwise would cause substantial injustice and did not arise from neglect by the party. 5.6 New evidence must be sent to all other parties to the appeal. Failure to send all new evidence to all other parties to the appeal may result in the evidence being excluded from the record. 5.7 If the employer that filed the appeal does not participate in the hearing, the appeal may be dismissed. 5.8 The Division shall keep a full and complete record of all proceedings in connection with the investigation. All testimony at a hearing must be recorded by the Division but need not be transcribed unless the hearing officer’s Decision is appealed. 5.9 The hearing officer may, upon the application of any party or on his or her own motion, convene a prehearing conference to discuss the issues on appeal, the evidence to be presented, and any other relevant matters that may simplify further proceedings. 5.10 The hearing officer shall make a decision on each relevant issue raised, including findings of fact, conclusions of law, and an order. The hearing officer will decide whether the Division’s determination is based on a clear error of fact or law. 5.11 The hearing officer shall not engage in ex parte communication with any party to an appeal. 5.12 The Division shall promptly provide all parties with a copy of the hearing officer’s decision via U.S. postal mail, electronic means, or personal delivery, as consistent with applicable law. 5.13 Any party to the administrative proceeding may appeal the hearing officer’s decision only by commencing an action for judicial review in the district court of competent jurisdiction within 35 days after the date of mailing of the decision by the Division. A respondent may appeal a Division determination in accordance with Rule 6 of the Wage Protection Rules, 7 CCR 1103-7. This rule applies to the maximum extent consistent with the Colorado Administrative Procedures Act, C.R.S. §§ 24-4-105, -106. Judicial review is limited to appeal briefs and the record designated on appeal. 5.14 An appeal may, at the discretion of the hearing officer, be sequenced and/or divided into two or more stages on discrete questions of liability and/or relief (i.e., bifurcation), yielding two or more decisions and/or phases of the appeal..

Rule 6. Certified Copy 6.1 The Division shall issue and file a certified copy of the Division’s final decision in accordance with C.R.S. § 8-4-113(2); 7 CCR 1103-7, Rule 2.4; and any other applicable statute or rule.

Rule 7. Preservation of Actions 7.1 No Citation, Notice of Assessment, or Notice of Investigation Termination issued by the Division is intended to preclude an employee from initiating or pursuing a civil action or other administrative proceeding. Evidence obtained by the Division in the course of a direct investigation may be considered in determining whether an employee has initiated a wage complaint pursuant to 7 CCR 1103-7, Rule 4.2.1.

Rule 8. Discrimination and Reprisal Prohibited 8.1 The provisions against retaliation, interference, and discrimination for protected activity in labor standards law (including but not limited to C.R.S. §§ 8-1-116, 8-1-140, 8-4-120, 8-6-115, 8-13.3- 407, 8-14.4-102; 7 CCR 1103-11; and 7 CCR 1103-1) apply to individuals who assist or otherwise participate in the Division’s investigations. 8.1.1 Unlawful “interference” with a Division investigation or proceeding, at any stage (e.g., from anticipated investigations through appeals or post-decision enforcement) includes any act (whether an affirmative act, an omission, or a statement) that:

(A) tends to mislead or intimidate actual or potential witnesses, or discourage actual or potential witnesses from providing evidence or information to the Division;

(B) conceals relevant evidence or information from the Division, or knowingly or recklessly furnishes false or misleading evidence or information to the Division; or (C) otherwise inhibits the provision of accurate evidence or information to the Division. _________________________________________________________________________ Editor’s Notes

History New rule eff. 02/14/2019.

Rules 1.4, 2.2, 2.3, 3.5 eff. 12/15/2019.

Rules 5.1.6-5.1.8, 6.5-6.13 eff. 07/15/2020. Rule 4.3 repealed eff. 07/15/2020.

Entire rule emer. rule eff. 09/21/2020.

Entire rule eff. 01/01/2021.

Entire rule eff. 04/01/2024.

7 CCR 1103-9 COLORADO CHANCE TO COMPETE ACT RULES [Recodified as 7 CCR 1103-18 eff. 07/01/2024] {#sec-7-ccr-1103-9 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-9}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Labor Standards and Statistics COLORADO CHANCE TO COMPETE ACT RULES [Recodified as 7 CCR 1103-18 eff. 07/01/2024]

7 CCR 1103-9 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes

History New rule emer. rule eff. 08/20/2019.

Entire rule eff. 12/15/2019.

Entire rule recodified as 7 CCR 1103-18 eff. 07/01/2024.

7 CCR 1103-10 COLORADO HEALTH EMERGENCY LEAVE WITH PAY (“COLORADO HELP”) RULES [Emergency rule expired 11/11/2020] {#sec-7-ccr-1103-10 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-10}

COLORADO DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Labor Standards and Statistics COLORADO HEALTH EMERGENCY LEAVE WITH PAY (“COLORADO HELP”) RULES - Emergency rules expired 11/11/2020 7 CCR 1103-10 _________________________________________________________________________ Editor’s Notes

History New rule emer. rule eff. 03/11/2020.

Entire rule emer. rule eff. 04/03/2020.

Entire rule emer. rule eff. 04/27/2020.

Entire rule emer. rule eff. 07/14/2020; expired 11/11/2020.

7 CCR 1103-11 Colorado Whistleblower, Anti-Retaliation, Non-Interference, and Notice-Giving Rules (colorado Warning Rules) {#sec-7-ccr-1103-11 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-11}

DEPARTMENT OF LABOR AND EMPLOYMENT

COLORADO WHISTLEBLOWER, ANTI-RETALIATION, NON-INTERFERENCE, AND

NOTICE-GIVING RULES (COLORADO WARNING RULES)

7 CCR 1103-11 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] ______________________________________________________________________ Adopted December 8, 2025; effective February 1, 2026.

Rule 1. Statement of Purpose, Authority, and Construction 1.1 The general purpose of these Colorado Whistleblower, Anti-Retaliation, Non- Interference, and Notice-Giving Rules (WARNING Rules) is to exercise the

authority of this Division to enforce and implement Colorado legislative enactments and accompanying rules protecting against retaliation for, or interference with, the exercise of protected rights, and requiring that employees and other workers receive various forms of notification of their rights, including but not limited to the Healthy Family and Workplaces Act of 2020 (HFWA, C.R.S.

Title 8, Article 13.3, Part 4), the Public Health Emergency Whistleblower Act of 2020 and the Protected Health/Safety Expression and Whistleblowing Act (PHEW, C.R.S. Title 8, Article 14.4), the Equal Pay for Equal Work Act of 2019 (EPEWA, C.R.S. Title 8, Article 5), the Agricultural Labor Rights and Responsibilities Act of 2021, Colorado Senate Bill 21-87 (ALRRA) as amended by Colorado House Bill 22-1313, amendments to the Colorado Wage Act (C.R.S.

Title 8, Article 4), and rules promulgated under the foregoing statutes. These Rules are adopted pursuant to Division authority in C.R.S. §§ 8-1-103(3), - 107(2), -111, -116, -117; §§ 8-2-130, -206(3)(c)(II); §§ 8-4-111, -113(4)(d), -120; § 8 5 203; §§ 8-6-105, -106, -108, -117; §§ 8-13.3-403(9), -407(6), -408(1)-(2), - 409, -410; § 8-13.5-204(1)(b); and §§ 8-14.4-103(2), -104, -105(4), -108. Every

rule herein applies to all statutes and rules referenced in Rule 1.1, unless a specific rule states otherwise. 1.2 Authority and Application. The Colorado WARNING Rules are issued under the

authority and as enforcement of Articles 1-6, 13.3, 13.5, and 14.4 of C.R.S. Title 8 (2025) and are intended to be consistent with these statutory provisions as well as the State Administrative Procedure Act, C.R.S. § 24-4-101, et seq. Where these Rules reference another rule, the reference shall be deemed to include all subparts of the referenced rule. Where these Rules have provisions different from or contrary to any referenced material, the provisions of these Rules govern so long as they are consistent with Colorado statutory and constitutional provisions. 1.3 Incorporation by Reference. These Rules incorporate by reference only those specific federal and Colorado rules identified as incorporated by reference below in these Rules. As referenced below, these WARNING Rules incorporate by reference the following federal rules stated in Part 578 within Title 29 of the Code of Federal Regulations: 29 C.F.R. § 578.3(c), except as identified in WARNING

Rule 2.13. These rules are available to the public in electronic form at https://www.ecfr.gov/current/title-29/subtitle-B/chapter-V/subchapter-A/part- 578/section-578.3, as adopted by the United States Department of Labor’s Wage and Hour Division, located at 200 Constitution Ave NW, Washington, DC 20210.

These WARNING Rules also incorporate by reference Colorado rules, as identified below, from the Wage Protection Rules, 7 CCR 1103-7, and the Direct Investigations Rules, 7 CCR 1103-8, as adopted by the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics. These incorporated Division rules are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, located at 707 17th Street, Denver, CO 80202. Copies may be obtained from the Division of Labor Standards & Statistics at a reasonable charge. These incorporated Division rules can be accessed electronically from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of the rules incorporated by reference at cost upon request. All incorporated Division Rules are available to the public at www.coloradolaborlaw.gov. All such incorporated rules refer to the date and edition of those rules in effect as of the effective date of these WARNING Rules, February 1, 2026, and exclude later amendments to or editions of these rules incorporated by reference. 1.4 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rules remain valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form.

Rule 2. Definitions and Clarifications 2.1 “Administrative Procedure” means the process used by the Division to investigate Complaints arising under any rule or statute cited in Rule 1.1. 2.2 “Authorized representative” means a person designated by a party to a Complaint to represent the party during the Division’s administrative procedure.

To designate an authorized representative, the party must comply with the requirements for authorizing a representative in the Wage Protection Rules, 7 CCR 1103-7, Rule 4.3, which is incorporated by reference as stated in Rule 3.1 and available to the public for review as stated in 1.3. 2.3 “Complaint” or “Claim” interchangeably mean a Complaint or Claim alleging violation of any retaliation, interference, or notice requirements of any statute or

rule cited in Rule 1.1. “Complainant” means an employee, worker, whistleblower, key service provider, or other protected party with a Complaint or Claim. 2.4 Rule 2.4 incorporates by reference Wage Protection Rule 2.4, 7 CCR 1103-7, 1.3, except that as incorporated, “certified copy” also includes a copy of a Division decision issued under these Rules and/or laws they implement and enforce. 2.5 “Correct address” can include, but is not limited to, an email address reported to the Division or posted on a party’s website, an address on file with the Colorado Secretary of State, the address of a registered agent on file with the Colorado Secretary of State, or an address provided to the Division by the party. A notice is deemed sent to a party when placed in the U.S. mail; sent by electronic means; or personally delivered to a party or a party’s representative, or a party’s correct address. 2.6 “Determination” means a decision issued by a compliance investigator upon the conclusion of an investigation. “Determination” includes: Citation and Notice of Assessment, Determination of Compliance, and Notice of Dismissal, if that Notice of Dismissal is issued after the Division initiated the administrative procedure. A notice that the Division declines to investigate a Complaint is not a Determination. 2.7 “Division” means the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment. 2.8 “Employee” and “Employer” have the same meaning as in C.R.S. §§ 8-4- 101(5),(6), except as to rights or responsibilities under C.R.S. Title 8, (A) Article 13.3, “Employee” and “Employer” have the same meaning as in C.R.S. §§ 8- 13.3-402(4),(5); and (B) Article 5, “Employee” and “Employer” have the same meaning as in C.R.S. §§ 8-5-101(4),(5). As used in these rules, the term “Employee” includes an agricultural employee as defined in C.R.S. § 8-2- 206(1)(b) and an agricultural worker as defined in C.R.S. § 8-13.5-201(3), and the term “Employer” includes an agricultural employer as defined in C.R.S. § 8 2 206(1)(c), except as otherwise provided. 2.9 “Notice of Right to Sue” means a notice from the Division stating that the Complainant has exhausted administrative remedies pursuant to C.R.S. § 8- 14.4-105, and/or that the Division has received and declined to investigate a Complaint for purposes of C.R.S. §§ 8 2-206(3)(c)(II), 8-13.3-411(4)(d), or 8- 13.5-204(1)(b). 2.10 “Respondent” means an employer or principal that is alleged in a Complaint or Claim to have, or that is the subject of an investigation into whether they have, committed an unlawful practice. 2.11 In “retaliation” or “interference” claims or investigations, the following definitions apply: 2.11.1 “ Protected activity” means, as to any right under these Rules or any statute or rule to which these Rules apply:

(A) asserting, seeking, or exercising any right or remedy;

(B) opposing a possible or perceived violation;

(C) participating in a formal or informal investigation, hearing, complaint, or other process or proceeding that relates to any possible or perceived violation, or that relates to any relevant claim, right, or rule; and/or (D) engaging in any other activity authorized or protected thereby.

With respect to rights under PHEW, “protected activity” is further defined in Rule 5 herein. 2.11.2 “ Retaliation” means, and is synonymous with, discrimination based on or for protected activity, and it encompasses any act (whether an affirmative act, an omission, or a statement) that is intended to, and could, deter a reasonable person from engaging in, or impose consequences for, protected activity. Examples of retaliation include:

(A) using the assertion or exercise of any right protected by these Rules, or any statute or rule to which these Rules apply, as a negative factor in any employment action;

(B) acts that may not affect employment status but that may dissuade, deter, or interfere with engaging in protected activity, such as acts prohibited by Rule 4.8.2 of the Wage Protection Rules (7 CCR 1103-7), or acts that interfere or threaten to interfere with the receipt of public benefits. 2.11.3 “ Interference” means any act (whether an affirmative act, an omission, or a statement) that, regardless of intent, interferes with any protected activity or any right under these Rules or any statute or rule to which these Rules apply, including any act that deters any protected activity. Examples of acts that may constitute interference include:

(A) failing to authorize the exercise of a right, imposing stricter conditions upon exercising a right (e.g., as to documentation or notice) than the applicable statute or rule permits, or altering employment conditions, rules, or procedures to limit coverage;

(B) failing to effectively provide a required notice or notification as to an employee’s rights;

(C) inducing or attempting to induce an employee, worker, whistleblower, key service provider, or other protected party to prospectively waive a right;

(D) imposing consequences (whether or not employment-related) for or discouraging the exercise of any such right, such as by counting paid sick leave taken by an employee pursuant to HFWA as an absence that may lead to negative consequences;

(E) “access interference” with an agricultural employee’s rights to reasonable access (as defined by C.R.S. § 8-13.5-202 and the Agricultural Labor Conditions Rules, 7 CCR 1103-15, Rule 4) to visitors at employer-provided housing, to employee residence access and egress, to remote access to key service providers, or to required transportation; except an agricultural employer may apply generally applicable hazard or safety protocols to work site visitors;

(F) any act (whether an affirmative act, an omission, or a statement) that interferes with a Division investigation or proceeding, at any stage (e.g., from anticipated investigations through appeals or postdecision enforcement). Investigation interference includes acts that:

(I) tend to mislead or intimidate actual or potential witnesses, or discourage actual or potential witnesses from providing evidence or information to the Division;

(II) conceal relevant evidence or information from the Division, or knowingly or recklessly furnish false or misleading evidence or information to the Division; or (III) otherwise inhibit the provision of accurate evidence or information to the Division. 2.12 “Wage Protection Rules” refer to the rules contained in 7 CCR 1103-7. 2.13 “Willful,” in Articles within C.R.S. Title 8 that this Division enforces or administers, has the same meaning as under 29 C.F.R. § 578.3(c), implementing the Fair Labor Standards Act, 29 U.S.C. § 255(a), which is incorporated by reference and available to the public for review as stated in Rule 1.3, except that as incorporated:

(A) all references to the Fair Labor Standards Act shall include Articles within C.R.S., Title 8, that this Division enforces or administers; and (B) the reference to “a responsible official of the Wage and Hour Division” shall include any official of the Division. 2.14 “Worker” and “principal,” as to rights or responsibilities under C.R.S. Title 8,

Article 14.4, have the same meaning as in C.R.S. § 8-14.4-101(3), (5). 2.15 Any other terms defined in statutes enforced through these Rules and that appear in these Rules will have the same meaning as defined by those statutes, except where terms are defined differently in these Rules. 2.16 Under the ALRRA and PHEW, a “whistleblower” is defined as follows, and need not have personally experienced the relevant violation:

(A) under the ALRRA, an agricultural employee “with knowledge of an alleged violation of Part 2 [of Article 13.5 of C.R.S. Title 8] or the agricultural worker’s representative” (as defined in C.R.S. § 8-13.5-201(4)); and (B) under PHEW, a worker with knowledge of an alleged violation of Article 14.4 of C.R.S. Title 8 or the “worker's representative” (as defined in C.R.S. § 8-14.4-107). 2.17 Under the ALRRA, the definitions of the following parties apply. 2.17.1 “ Agricultural employee” and “agricultural worker,” as to rights and responsibilities under C.R.S. § 8-2-206 of the ALRRA, identically mean a person employed by an agricultural employer. As to other rights and responsibilities under the ALRRA, “agricultural employee” and “agricultural worker” identically mean an employee engaged in any service or activity included in 29 U.S.C. § 203(f) or 26 U.S.C. § 3121(g). 2.17.2 “ Agricultural employer,” as to rights and responsibilities under the ALRRA, means a person engaged in any service or activity included in 29 U.S.C. § 203(f) or 26 U.S.C. § 3121(g) who either (1) contracts with any person who recruits, solicits, hires, employs, furnishes, or transports agricultural employees, or (2) regularly engages the services of one or more agricultural employees. Under C.R.S. § 8 3 104(1)(b) of the ALRRA, “[t]he meaning of ‘agricultural employer’ must be liberally construed for the protection of persons providing services to an employer.” 2.17.3 “ Other protected party,” as to rights and responsibilities under the ALRRA, means a person who has, or is perceived as having, any of the following relationships protected against retaliation by C.R.S. § 8-2-206 of the ALRRA:

(A) a “familial . . . relationship” with an agricultural employee (C.R.S. § 8 2 206(3)(c)), which encompasses (1) a spousal relationship (including a common-law marriage, civil union, or domestic partner), (2) any of the following relationships by blood, marriage, or adoption: parent, grandparent, child, grandchild, sibling, stepparent, stepsibling, stepchild, uncle, aunt, niece, nephew, or cousin, or (3) another person with whom the employee similarly has a significant personal bond regardless of biological or legal relationship.

(B) a “workplace relationship” with an agricultural employee (C.R.S. § 8 2 206(3)(c)), which encompasses any person with whom the employee has interacted repeatedly in the scope of their employment, regardless of the person’s employer or employment status.

(C) a “person with whom the agricultural employee exchanges care or support” (C.R.S. § 8-2-206(3)(c)), which encompasses any relationship in which the employee or the person, outside of their scope of employment, provides care or support to the other with (1) health, family care, transportation, or similarly important personal needs, or (2) any other needs that the individual lacks capacity to perform on their own, such as hygiene, financial or similar paperwork, or home tasks (basic cleaning, shopping, cooking, maintenance, etc.). 2.18 For the purposes of the C.R.S. § 8-4-120 provisions against retaliation as to rights under “any . . . law or rule related to wages or hours”: 2.18.1 “ Filed a complaint” includes formal or informal complaints, written or oral, whether to a court; a governmental labor agency; an employer or principal; or another relevant entity or person, public or private. 2.18.2 “ Proceeding” includes any procedure, process, or action by a court; a governmental labor agency; an employer or principal; or another relevant entity or person, public or private. 2.18.3 All rules that apply or refer to an “employer” shall also apply to any other person that is regularly engaged in business or commercial activity that has contracted with an employer or worker, directly or indirectly, for labor from which such person is the beneficiary. 2.19 As referenced by C.R.S. § 8-14.4-102(3)(b), “public health agency” means agencies or authorities of the United States, states or political subdivisions thereof with jurisdiction over the worker’s workplace; or an individual or entity performing public health functions under a grant of authority from such a public health agency. 2.20 Under C.R.S. § 8-5-102(2), “prospective employee” includes individuals applying for an employment position, being considered for an employment position, or who have been extended an offer for an employment position.

Rule 3. Complaint, Investigation, and Appeal Procedures 3.1 Rule 3.1 incorporates by reference Wage Protection Rules, 7 CCR 1103-7, Rules 4.1 and 4.3 through 4.9, adopted by the Division and available to the public for review as stated in Rule 1.3, except that as incorporated:

(A) all references to “wage” or “wage and hour” Complaints, Claims, rights, responsibilities, or proceedings shall include other labor rights or responsibilities within these Rules;

(B) in Rule 4.4.3 “C.R.S. § 8-4-113(1)(b)” is replaced with “C.R.S. § 8-1- 140(2)”;

(C) for Claims under PHEW and the ALRRA, references to “employers” or “employees” shall include “principals” and “workers,” respectively, as defined by PHEW and these Rules, and “agricultural employers” and “agricultural employees,” respectively, as defined by the ALRRA and these Rules; and (D) for Claims under C.R.S. § 8-4-120, references to an “employer” shall include “any other person that is regularly engaged in business or commercial activity that has contracted with an employer or worker, directly or indirectly, for labor from which such person is the beneficiary.” 3.2 Complaint filings. 3.2.1 An employee, worker, whistleblower, key service provider, or other protected party who wishes to file a Complaint shall use a Divisionapproved form(s) and shall include the Complainant’s signature, the Complainant’s contact information, the Respondent’s contact information, and basis for the Complaint. If the Division does not have an applicable form publicly posted when the Complainant intends to file, then a Complainant may file a Complaint in any form, by mail or electronic mail, with the Division, and the Division may later require the Complainant to complete the Division's Complaint form, but the filing date will remain the date of the Complainant’s original filing. 3.2.2 A Complainant shall respond in a timely manner to informational or investigatory requests by the Division. Failure to comply with this Rule may result in dismissal of the Complaint. If a Complaint is dismissed before a Notice of Complaint is sent to the Respondent due to failure to respond to a Division request for information, the Complaint may be reopened if the Complainant provides the requested information or documentation to the Division within 35 days of the request. A Complainant may be required to file a new Complaint if the response is received more than 35 days after the request. 3.2.3 Anonymous complaints will be accepted, but will not be investigated using the Division’s administrative procedure, and will be investigated only at the discretion of the Division. 3.3 Filing, service, and deadlines. 3.3.1 A Complaint or appeal is considered “filed” with the Division when it is received by the Division via mail, fax, email, online submission, or personal delivery. Any Complaint, appeal, or termination received after 11:59pm Mountain Time is considered filed the next business day. 3.3.2 Deadlines in these Rules may be extended for good cause. In considering whether good cause exists, under these Rules or applicable statutes allowing good-cause extensions of deadlines, the Division will determine whether the reason is substantial and reasonable, and must take into account all available information and circumstances pertaining to the specific Complaint. 3.3.3 Within 90 days of receipt of a Complaint (or within 90 days of the effective date of these Rules, whichever is later), the Division will (A) assess whether it will exercise its discretion to investigate the Complaint, and (B) inform the Complainant of the decision, including sending the Complainant a Notice of Right to Sue if the Complaint is subject to C.R.S. §§ 8-14.4- 105(2)(b), 8-2-206(3)(c)(II), 8 13.3 411(4)(d), 8-13.5-204(1)(b) and the Division declines to exercise its discretion to investigate the Complaint.

Under this Rule 3.3.3, the Division’s decision whether to investigate the Complaint is not required until 90 days after the Complainant has provided all information and documents needed to complete, process, and evaluate the Complaint. 3.3.4 In a Complaint investigation, the Division will send the Respondent a Notice of Complaint, along with any relevant supporting documentation submitted by the Complainant, via U.S. mail, electronic means, or personal delivery. A Respondent must respond within four weeks after a Complaint is sent to them, unless an extension is granted. 3.3.5 Where a retaliation or interference Complaint or investigation governed by these Rules is filed or commenced, the Respondent shall preserve all personnel records relevant to the Complaint or investigation until final disposition of the Complaint or investigation. For purposes of retaliation or interference Claims, relevant personnel records include but are not limited to:

(A) requests or statements by the individual that are claimed to be protected activity;

(B) responses to, or analyses of, such request(s) or statement(s);

(C) policies or decisions, formal or informal, that may apply to such request(s) or statements(s); and (D) to the extent relevant to the Complaint or investigation (e.g., if the possible violation includes disparate treatment based on protected activity), the contents of personnel files of the Complainant and others holding positions similar to that held or sought by the aggrieved person and application forms or test papers completed by an unsuccessful applicant and by all other candidates for the same position as that for which the aggrieved person applied and was rejected. 3.3.6 A Complainant may withdraw a Complaint at any time before issuance of a determination by notifying the Division in writing. Additionally, for a Complaint under PHEW, HFWA, or the ALRRA:

(A) whether or not a Complainant requests Complaint withdrawal or a Notice of Right to Sue, the Division may exercise its discretion to terminate an investigation at any time, in which case it will promptly send a Notice of Right to Sue; and (B) if a Determination has not been sent by 180 days after the date the Division notifies the Claimant of its decision to investigate, the Complainant may request a Notice of Right to Sue, and the Division will respond within 30 days by sending either (1) the determination or (2) a Notice of Right to Sue indicating that the Division has terminated the investigation and that the Complainant has exhausted administrative remedies if required to do so. 3.4 Burdens of proof and production. 3.4.1 Complaints of retaliation are analyzed as follows, with the preponderance of the evidence standard applying to all burdens of proof.

(A) The Complainant has the burden of proving all elements of a Claim, including that unlawful retaliation occurred. The Respondent must explain which, if any, allegations it disputes. Any evidence probative of a relevant issue may be submitted or considered.

(1) In determining whether there has been retaliation as prohibited by C.R.S. § 8-4-120(1), a period of 90 or fewer days between the exercise of a protected activity and the adverse action may, without more, be sufficient to find retaliatory intent. Adverse action occurring more than 90 days after the exercise of a protected activity may also constitute retaliation.

(2) If an agricultural employer takes an “adverse action” (as defined in C.R.S. § 8-2-206(1)(a)) against an agricultural employee within 90 days of protected activity, under C.R.S. § 8-2-206(3)(b), that creates a rebuttable presumption of retaliation, shifting the burden of proof to the Respondent to offer any such rebuttal.

(B) If the Complainant proves unlawful retaliation or discrimination was a motivating factor for the complained-of practice, then a violation is proven. However, if a violation is proven but the Respondent proves that the complained-of practice would have occurred for another lawful reason, then the Division shall not award reinstatement, back pay, or front pay as of the date the practice would have occurred. 3.4.2 Complaints of interference or failure to provide any required notice are analyzed as follows, with the preponderance of the evidence standard applying to all burdens of proof.

(A) The Complainant has the burden of proving all elements of a Claim, including that unlawful interference or failure to provide required notice occurred. The Respondent must explain which, if any, allegations it disputes. Any evidence probative of a relevant issue may be submitted or considered.

(B) If the Complainant meets its burden of proof, then a violation is proven. However, if a violation is proven but the Respondent proves that the complained-of practice would have occurred for another lawful reason, then the Division shall not award reinstatement, back pay, or front pay as of the date the practice would have occurred. 3.5 Determinations. 3.5.1 Upon conclusion of the investigation of a Complaint, the Division will issue a determination. The Division shall notify the parties on the date the determination is issued by the Division’s compliance investigator by sending (a) a copy of the determination; and (b) notice of the parties’ termination and appeal rights. 3.5.2 The date of “issuance” of the Division’s determination is the date the Division’s determination is “sent.” Both the termination and appeal deadlines are calculated from the date the Division’s determination is originally issued and sent to the parties. 3.5.3 Determinations by the Division may include the following remedies and orders, depending on which, if any, the Division’s findings support:

(A) monetary or other relief authorized by the statute(s) under which the Complaint was filed, including but not limited to, where applicable — (1) any unpaid wages, penalties, fines, and/or other remedies under C.R.S. Title 8, Article 4, (2) if a violation of C.R.S. Title 8, Articles 13.3 (HFWA) or 14.4 (PHEW) cost an employee or worker a job or pay, back pay plus either reinstatement or (if reinstatement is infeasible) front pay for a reasonable period, (3) the greater of actual damages or ten thousand dollars for each violation of the ALRRA, as stated in C.R.S. §§ 8-2-206 and 8-13.5-204, and/or (4) other fines or penalties authorized by statutes applicable to the Complaint;

(B) fines or penalties authorized by the statutes on Division investigative and enforcement authority in C.R.S. Title 8, Articles 1 and 4; and/or (C) order(s) to cease non-compliance, effectuate compliance, and/or otherwise redress direct or indirect consequences of violations, as authorized by the statute(s) under which the Complaint was filed and statutes on Division investigative and enforcement authority, including but not limited to C.R.S. Title 8, Article 1, § 8-2- 206(3)(c)(I), Articles 4-6, and § 8-13.5-204(1)(b), (2)(a)(I); and/or (D) for any award under C.R.S. § 8-13.5-204 of the ALRRA, the Division’s determination must order that any amounts recovered by a whistleblower or key service provider pursuant to the award must be distributed to agricultural workers affected by the violation who can be located, insofar as such disbursement is economically feasible. 3.6 The Division may exercise its discretion to have an investigation sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations and/or phases of the investigation. 3.7 Appeals. 3.7.1 Any party to a Claim or determination may appeal the Division’s determination. 3.7.2 Rule 3.7.2 incorporates by reference Wage Protection Rule 6, 7 CCR 1103-7, adopted by the Division and available to the public for review as stated in Rule 1.3, which shall govern and apply to Claims or determinations under these Rules, except for determinations for direct investigations. 3.7.3 Rule 3.7.3 incorporates by reference Direct Investigations Rule 6, 7 CCR 1103-8, adopted by the Division and available to the public for review as stated in Rule 1.3, which shall govern and apply to determinations for direct investigations made under these Rules. 3.7.4 Parties may not appeal the Division’s discretionary decisions as to whether or not to investigate a Complaint. 3.7.5 An appeal may, in the discretion of the hearing officer, be sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more decisions and/or phases of the appeal. 3.7.6 From the time of the filing of an appeal throughout the appeal, a party or other participant in an appeal must send complete copies of all appeal submissions to the contact information and in the manner designated (a) in the determination and/or any accompanying notices from the Division, and (b) in any subsequent orders or notices from the Division. 3.8 A certified copy of any citation, notice of assessment, or order imposing relief or remedies may be filed with the clerk of any court having jurisdiction over the parties at any time after the entry of the order. Such a filing can be in a county or district court, and will thereby have the effect of a judgment from which execution may issue. 3.9 Rule 3.9 incorporates by reference Wage Protection Rule 7, 7 CCR 1103-7, 1.3. 3.10 Rule 3.10 incorporates by reference Wage Protection Rule 8, 7 CCR 1103-7, 1.3.

Rule 4. Notice and Posting Rights and Responsibilities 4.1 Poster requirements. A poster informing all employees and workers of their rights under HFWA and PHEW must be posted, displayed, or otherwise provided by employers and principals, as required by C.R.S. § 8-13.3-408 (HFWA), and C.R.S. § 8-14.4-103 (PHEW). All agricultural employers must post a notice of agricultural employees’ rights under Part 2 of Article 13.5 of Title 8, C.R.S., as required by C.R.S. § 8-13.5-202. 4.1.1 The poster(s) must specify:

(A) for those covered by HFWA, (1) the amount of paid sick leave to which employees are entitled, and (2) the terms of its use;

(B) for those covered by PHEW, (1) the right to raise reasonable concerns about workplace violations of government health or safety rules, or otherwise significant workplace health or safety threats, and (2) the right to wear one’s own personal protective equipment, such as a mask, faceguard, or gloves, if it provides a higher level of protection than already-provided equipment, is recommended by a governmental public health agency with jurisdiction over the workplace, and does not render the worker incapable of performing the job duties;

(C) for those covered by either HFWA or PHEW, (1) that it is unlawful to retaliate for or interfere with HFWA or PHEW rights, and (2) that a complaint may be filed if retaliation, interference, or another denial of HFWA or PHEW rights occurs; and (D) for those covered by the ALRRA, all rights under Part 2 of Article 13.5 of Title 8, C.R.S., and rules issued pursuant to and as implementation of those provisions, including: (1) § 202 of Part 2 (access to key service providers, visitors, and employee residences); (2) § 203 of Part 2 (protections from heat illness and injury; restrictions on short-handled hoe and other short-handled tool use; and for hand-weeding/thinning, additional rest as well as gloves and knee pads); and (3) § 204 of Part 2 (procedures and remedies for enforcement of Part 2 rights); and (4) the Agricultural Labor Conditions Rules, 7 CCR 1103-15. 4.1.2 Employers and principals may use the latest version of the “Colorado Workplace Public Health Rights Poster” (provided by the Division at www.coloradolaborlaw.gov) to satisfy the poster requirements of both HFWA and PHEW. Agricultural employers may use an up-to-date “Agricultural Labor Rights and Responsibilities Poster” published by the Division or, at any time such a poster is unavailable, an up-to-date version of an Interpretive Notice and Formal Opinion on agricultural labor rights and responsibilities published by the Division, to satisfy the poster requirements of the ALRRA. Employers and principals may comply by using another poster that contains all substantive information in the “Colorado Workplace Public Health Rights Poster,” and if applicable, in an “Agricultural Labor Rights and Responsibilities Poster,” and otherwise satisfies all statutory and rule requirements. 4.1.3 The poster(s) shall be displayed in each establishment where employees or workers work, in a conspicuous location frequented by employees or workers where it may be easily read during the workday, and in all places where notices concerning the rights and safety of employees or workers are customarily posted — such as in break rooms, on employee bulletin boards, and/or adjacent to time clocks, department entrances, and/or facility entrances. In addition:

(A) Agricultural employers must post an “Agricultural Labor Rights and Responsibilities Poster” or equivalent posting at any employerprovided housing, and must post it electronically, including by email and on an intranet or internet site, if the agricultural employer customarily communicates with agricultural employees by these means.

(B) If the work site or other conditions make a physical posting of the “Colorado Workplace Public Health Rights Poster” impractical (including remote work, private residences employing only one worker, and certain entirely outdoor work sites lacking an indoor area), the employer or principal shall provide a copy of the poster to each employee or worker within their first month of work, including through (if information is customarily disseminated to the employees or workers through these means) either electronic communication or conspicuous posting in a web-based platform. 4.2 Notice and Guidance Requirements. 4.2.1 A written HFWA notice shall be provided to each employee, in addition to the poster requirement.

(A) The written HFWA notice to each employee shall specify the same information specified in Rule 4.1.1 for those covered by HFWA.

(B) Employers may use the latest version of the “Colorado Workplace Public Health Rights Poster” (provided by the Division at www.coloradolaborlaw.gov) to satisfy the written notice requirements of HFWA. Employers may comply by using another written notice that contains all substantive information in the “Colorado Workplace Public Health Rights Poster” and otherwise satisfies all statutory and rule requirements.

(C) Including the written HFWA notice among other employmentrelated documents (such as a handbook, a manual, or other written or posted policies) complies with this written notice requirement, as long as the documents are provided either:

(1) in hard copies given to each employee; or (2) in electronic form, if the employee -- (a) can easily access the documents electronically, and (b) is provided actual notice that the documents contain information regarding their terms of employment, not just a link that fails to so notify the employee. 4.2.2 Under C.R.S. § 8-14.4-109 of the ALRRA, during a public health emergency, as defined in C.R.S. § 8-14.4-109(2), a principal engaged in agricultural employment (as defined in C.R.S. § 8-13.5-201(2)) must also provide resources to agricultural employees as follows.

(A) Employers must “provide informational and educational materials through posters and pamphlets written in English and Spanish and any other relevant languages [...as defined in Rule 4.3, that (1)] lists the contact information for the migrant farm worker division of Colorado Legal Services, or its successor organization, where a worker may receive free and confidential legal services; and [...(2)] informs the workers regarding federal and state guidance concerning [...the] public health emergency.”

(B) These materials must be provided “in employer-provided housing, work sites, and other places where the principal usually posts information for the workers[.]” If materials are damaged or removed, they must be replaced within 48 hours of damage or removal.

(C) An employer may comply with the public health emergency guidance portion of these requirements by providing a copy (including an electronic copy, if the employer customarily communicates to the employees in this form) of up-to-date guidance by the Occupational Safety and Health Administration (OSHA) as to workplace conditions in a public health emergency (as of the publication of these rules, available at https://www.osha.gov/coronavirus/safework) and by the Colorado Department of Public Health and Environment (CDPHE) (as of publication of these rules, available at https://covid19.colorado.gov/guidance-for-businessescommunities).

(D) Employers must also “provide training to workers concerning safety precautions and protections during [...the] public health emergency.” An employer may comply with these requirements by training workers in accordance with federal OSHA or CDPHE recommendations. 4.3 Posters and notices required by these Rules shall be in English and any language that is the first language spoken by at least five percent of the employer’s or principal’s workforce. The “Colorado Workplace Public Health Rights Poster” (provided by the Division at www.coloradolaborlaw.gov) is available in multiple languages. The “Agricultural Labor Rights and Responsibilities Poster” will also be made available in multiple languages. If an employer or principal needs the poster in a language not already provided, it has 30 days to procure a translation, and may ask the Division for a translation, which the Division will endeavor to provide if feasible. 4.4 Employers or principals shall be deemed noncompliant if they attempt to minimize the effect of posters or notices required by statute or these Rules, such as by communicating positions contrary to, or discouraging the exercise of rights covered in, the required poster or notice. 4.5 The poster and written notice rights and responsibilities of PHEW, C.R.S. § 8- 14.4-103, HFWA, C.R.S. § 8-13.3-408, and ALRRA, C.R.S. § 8-13.5-202, have applied since each statute took effect on July 11, 2020, July 14, 2020, and June 25, 2021, respectively, and will be interpreted in conformity with these Rules.

Employers and principals will be deemed compliant if they executed required posting(s) and/or notice(s) within 30 days of the applicable statutory effective date. 4.6 Violation of these poster or notice requirements may subject the violator to:

(A) fines pursuant to C.R.S. § 8-1-140;

(B) additional fines for willful violations pursuant to C.R.S. § 8-13.3-408(4); and/or (C) in the event that the violator also committed another violation of HFWA or PHEW, fines in the maximum amount available for that violation under HFWA (pursuant to C.R.S. §§ 8-4-111, 8-4-113, 8-13.3-407(5)) or PHEW (pursuant to C.R.S. § 8 14.4 105(3)).

Rule 5. Protected Activity under PHEW 5.1 For the PHEW provision that raising a “concern about workplace violations of government health or safety rules, or about an otherwise significant workplace threat to health or safety” is protected against retaliation if the worker’s belief as to a violation or threat is, whether or not correct, was “reasonable” and “in good faith” (C.R.S. § 8-14.4-102(1)): 5.1.1 relevant evidence includes a recommendation, research, guidance, or other information from or provided by a public health agency (federal, state, or local), a major medical association, a major industry-specific trade association, a major public health organization, or another similarly reliable source; and 5.1.2 the worker, whether or not citing a specific rule or guideline, must state what action, condition, or situation they believe constitutes a qualifying violation of a rule regarding, or significant threat to, workplace health or safety. 5.2 For protected use of a worker’s own personal protective equipment (PPE) under PHEW, the requirements of C.R.S. §§ 8-14.4-102(a)-(c) are conjunctive: PHEW protection for PPE use applies only if the PPE provides a higher level of protection as required by 102(a), is recommended by an applicable public health agency as required by 102(b), and does not render the worker incapable of performing as required by 102(c). 5.2.1 For the C.R.S. § 8-14.4-102(3)(a) requirement that a worker’s PPE “provides a higher level of protection than the equipment provided by the principal”:

(A) the provisions of Rule 5.1.1 as to relevant information apply;

(B) information may not be relied on if, before the worker either brought the PPE to work or communicated about the PPE with the principal, the information was repealed or otherwise repudiated by the person or entity who provided it, but information may still be relied on if, though no longer publicly published, it was not repealed or repudiated;

(C) if principal-provided PPE of the same type is either cleaned or replaced, the worker’s own PPE must also be either cleaned or replaced; and (D) the requirement is not met if the PPE is more protective of the worker yet less protective of others (e.g., a mask with a vent releasing air that, even if highly protective for the wearer, is less protective for others). 5.2.2 For the C.R.S. § 8-14.4-102(3)(b) requirement that PPE is “recommended by a federal, state, or local public health agency with jurisdiction over the worker's workplace,” the provisions of Rule 5.2.1(B) as to relevant information apply. 5.2.3 Special cases as to the requirements of C.R.S. §§ 8-14.4-102(3)(a) (that the PPE “provides a higher level of protection than the equipment provided by the principal”) and 8-14.4-102(3)(b) (that the PPE “is recommended by a federal, state, or local public health agency with jurisdiction over the worker's workplace”).

(A) If a principal provides a worker no face covering during (1) a public health emergency related to an airborne pathogen, or (2) a governmental public health recommendation of a face covering for those in the worker’s occupation, then (3) a worker using their own face covering presumptively meets the C.R.S. §§ 8-14.4-102(3)(a)- (b) requirements (“higher level of protection” and “recommended”), without need for further evidence or inquiry, unless the principal proves that the worker’s face covering is worse than none at all.

(B) If a principal (1) provides a form of PPE (e.g., a mask) that is compliant with all applicable recommendations by federal, state, and local public health agencies with jurisdiction over the workplace, and (2) procures that PPE from a provider it knows to provide reliable PPE (from experience prior to obtaining the particular item it is providing to a worker wishing to use their own PPE), then (3) a worker may use their own PPE of the same type (e.g., a different mask) only if it was obtained from a reliable provider, whether or not the principal’s provider. 5.2.4 An unlawful decision to disallow a worker from wearing PPE that they are permitted to use under C.R.S. §§ 8-14.4-102(3)(a)-(c) is an adverse action, and may qualify as a constructive discharge if all of the following apply:

(A) the principal fails to remedy the unlawful decision immediately;

(B) working without the PPE would increase a substantial threat to health or safety for any person; and (C) the worker terminates the work for the principal because of unwillingness to work without the PPE.

Rule 6. Retaliation and Interference Prohibited 6.1 Retaliation related to, or interference with, rights and protections under the Colorado laws enforced by the Division is prohibited, and violations may be subject to fines under C.R.S. § 8-1-140 or as otherwise provided by law. These rights and protections against retaliation, interference, and discrimination in Colorado labor law include but are not limited to those under C.R.S. §§ 8-1-116, 8-1-140, 8-4-120, 8-5-102, 8-6-115, 8-13.3-407, 8-14.4-102; 7 CCR 1103-11; and 7 CCR 1103-1. The provisions against investigation interference and retaliation or discrimination for protected activity apply to individuals who assist or otherwise participate in the Division’s investigations. 6.2 Except as otherwise provided by applicable rules or statutes, when the same conduct violates multiple provisions in rules or statutes, or violates the same provision as to multiple individuals, the conduct constitutes multiple violations for purposes of remedies. ______________________________________________________________________ Editor’s Notes

History New rule emer. rule eff. 09/21/2020.

Entire rule eff. 01/01/2021.

Rules 1.2, 2.11.1, 2.17.3(A), 3.3.3, 3.7.3, 4.2.2(C) eff. 03/02/2022.

Entire rule eff. 01/01/2023.

Entire rule eff. 02/01/2026.

7 CCR 1103-12 Colorado State Labor Relations Rules {#sec-7-ccr-1103-12 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-12}

COLORADO DEPARTMENT OF LABOR AND EMPLOYMENT

STATE LABOR RELATIONS RULES

7 CCR 1103-12 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted February 9, 2024; effective April 1, 2024.

Rule 1. Authority. 1.1 These Rules are issued under the authority of, and as enforcement of, Colorado Revised Statutes (“C.R.S.”) Title 24, Article 50 (2022) (the “Colorado Partnership for Quality Jobs and Services Act,” C.R.S. § 24-50-1101 et seq.), as well as the general labor law implementation and enforcement authority of C.R.S. Title 8, Articles 1 and 3 (2022), and are intended to be consistent with the rulemaking requirements of the Administrative Procedure Act, C.R.S. § 24-4-103. These Rules are promulgated pursuant to the Division’s authority in C.R.S. §§ 24-50-1103, -1106(4), and C.R.S. § 8-3-105. 1.2 The Director of the Division of Labor Standards and Statistics in the Department of Labor and Employment has the authority to enforce C.R.S. § 24-50-1101 et seq. and these Rules. 1.3 Incorporations by Reference. C.R.S. § 24-50-1101 et seq. is hereby incorporated by reference into these Rules. Copies are available for public inspection and a reasonable charge at the Colorado Department of Labor and Employment, Division of Labor Standards and Statistics, 633 17th Street, Denver CO 80202. Electronic access is available from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of them at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing them. All Division Rules are available to the public at www.coloradolaborlaw.gov. Where these Rules have provisions different from or contrary to any incorporated or referenced material, the provisions of these Rules govern so long as they are consistent with Colorado statutory and constitutional provisions. 1.4 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any

part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rule remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form.

Rule 2. Definitions. 2.1 “Authorized representative” means a person designated by a party to an unfair labor practice complaint to represent the party during the Division’s complaint and/or appeal process. To designate an authorized representative, the party must comply with the requirements of Rule 4.1.1. 2.2 A “covered employee” is defined as “an employee who is employed in the personnel system of the state established in Section 13 of Article XII of the State Constitution,” unless the individual is not covered for one of the reasons provided in C.R.S. § 24-50-1102(3)(a)-(h). 2.3 “Director” refers to the Director of the Division of Labor Standards and Statistics and his or her designee, unless otherwise specified in these Rules. 2.4 An “employee organization” has the same meaning as in C.R.S. § 24-50-1102(7), and a “certified employee organization” has the same meaning as in C.R.S. § 24-50-1102(1). 2.5 “Division” refers to the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment. 2.6 “Electronic mail” (“email”) refers to the electronic transmission of messages, including documents, via the Internet. 2.7 “Mail” refers to first-class mail, sent through the United States Postal Service, postage prepaid. 2.8 “Unfair labor practice” is defined as in C.R.S. §§ 24-50-1107, -1108, -1109, -1111, and -1112, but does not include disputes over the interpretation, application, and enforcement of any provision of the partnership agreement.

Rule 3. Filing. 3.1 Documents may be filed with the Division by electronic mail, facsimile, or other electronic means when possible; U.S. mail is also an acceptable filing method. A document is considered “filed” with the Division when it is received by the Division; any document received after 11:59 p.m.

Mountain Time is considered “filed” the next business day.

Rule 4. Unfair Labor Practices. 4.1 Unfair Labor Practice Complaints 4.1.1 The party filing an unfair labor practice complaint shall be designated the charging party.

The party against whom a complaint is filed shall be designated the respondent. Either party may designate an authorized representative to act on its behalf in filing a complaint with the Division. The party may designate an authorized representative by filing the Division-approved form with the Division. The party may revoke the authorized representative’s authority by contacting the Division in writing. 4.1.2 An unfair labor practice complaint must be received by the Division no later than six months after the date that the alleged unfair labor practice occurred. 4.1.3 Unfair labor practice complaints shall be filed on the designated form provided by the Division. The charging party shall set forth a clear and concise statement of the facts constituting the unfair labor practice. 4.1.4 The Division will evaluate unfair labor practice complaints to determine if the Division has jurisdiction over the alleged conduct and if sufficient evidence has been shown from which an unfair labor practice may be reasonably inferred. 4.1.5 If the unfair labor practice complaint provides insufficient evidence, the Division will notify the charging party and may request additional information. 4.1.6 Failure to respond in a timely manner to requests from the Division for additional supporting information and/or documentation may result in dismissal of the unfair labor practice complaint. 4.1.7 After determining that a charging party’s unfair labor practice complaint contains sufficient allegations and evidence that, if proven true, would state a claim of an unfair labor practice, the Division shall give notice of the allegations and request an answer be filed by the respondent. 4.1.8 The respondent shall file an answer responding to each allegation in the complaint, and attach any documentation or evidence the respondent wishes the Division to consider in reviewing the complaint, within 21 calendar days of the date the Division sends a copy of the complaint to the respondent. 4.1.9 In any stage of any Division investigation, proceeding, or other action, if information is provided to the Division by a source requesting or otherwise warranting confidentiality, then the source shall remain confidential if that information is used: (1) as a basis for procuring other evidence, not offered as evidence itself; (2) as evidence of liability, but not to establish individual relief for the source of the information; or (3) in other circumstances in which confidentiality is necessary and appropriate. Any such confidential source is unlawful to disclose (unless the source consents) in any administrative or judicial proceeding, in response to any records or information request, or in any other manner, in order to effectuate statutory requirements. To the extent applicable, the provisions and practices regarding confidential sources stated in the Wage Protection Rules, 7 CCR 1103-7 (as amended and modified) are incorporated by reference. 4.1.10 Upon receiving a request in writing to the Division stating the reason required for an extension, the Division may, in its discretion, extend the period for the respondent to file an answer to the complaint for good cause. 4.1.11 Upon written request, other parties or entities may be designated as intervenors or may be joined as charging parties or respondents, at the Division’s discretion. 4.1.12 Upon receipt of the complaint, answer, and any supplemental documents, the Division shall make a determination as to whether an unfair labor practice has been committed and issue findings and orders. 4.1.13 The burden of proof for establishing an unfair labor practice is on the charging party. 4.1.14 The Division may exercise its discretion to have an investigation sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations and/or phases of the investigation. 4.1.15 A charging party may withdraw an unfair labor practice complaint at any time prior to issuance of a determination. 4.2 Unfair Labor Practice Appeals 4.2.1 An appellant, either the charging party or respondent, may file an appeal within 35 calendar days from the date of the Division’s determination. A valid appeal is a written statement that is timely filed with the Division, explains the basis for the appeal, and has been signed by the appellant or the appellant’s authorized representative. 4.2.2 On appeal, questions of fact are reviewable for clear error, while questions of law are reviewable de novo. 4.2.3 Upon receipt of the appeal, the Division will notify the parties of the date of the hearing and any interim deadlines, and send a copy of the appeal and a copy of the record of its investigation to the parties by mail or electronic mail. All evidence submitted to the Division as part of the investigation is part of the record on appeal and need not be resubmitted. 4.2.4 The hearing officer shall have the power and authority to call, preside at, and conduct hearings on the appeal, including the power to administer oaths and affirmations, order and take depositions, certify to official acts, and issue subpoenas to compel the attendance of witnesses and the production of books, papers, correspondence, memoranda, and other records deemed necessary as evidence in connection with a disputed determination. The hearing officer shall make a decision on each relevant issue raised, including findings of fact, conclusions of law, and an order. 4.2.5 Parties who timely file a valid appeal of the Division’s determination will be afforded an administrative appeal hearing before a Division hearing officer. Parties may be required to appear by telephone. 4.2.6 The parties may submit new testimonial evidence, which is defined as any evidence that is elicited through the statements of individual witnesses, to the hearing officer in accordance with deadlines imposed by the Division. New evidence must be sent to all other parties to the appeal. Failure to send all new evidence to all other parties to the appeal may result in the evidence being excluded from the record. The parties may submit new documentary or other non-testimonial evidence in accordance with deadlines imposed by the Division and upon showing “good cause,” which may be assessed based on any relevant factors, including but not limited to:

(A) That the new evidence was previously not known or obtainable, despite diligent evidence gathering efforts by the party offering the new evidence;

(B) That the party failed to receive fair notice of the investigation or of a key filing by another party or by the Division to which the new evidence is responsive;

(C) That factors outside the control of the party prevented a timely action or interfered with the opportunity to act, except that the acts and omissions of a party's authorized representative are considered the acts and omissions of the party and are not considered to be a factor outside the party's control as intended by this rule;

(D) That a determination raised a new issue or argument that cannot be responded to adequately without the new designate;

(E) That, at the investigation stage, the party offering new evidence requested more time to submit evidence, yet was denied, and in the hearing officer’s judgment (1) the need for more time was legitimate and did not reflect neglect by the party, (2) the denial of the request for more time was unwarranted, and (3) exclusion of the evidence would cause substantial injustice to the party; and/or (F) That failure to admit the evidence otherwise would cause substantial injustice and did not arise from neglect by the party. 4.2.7 An appeal may, at the discretion of the hearing officer, be sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more decisions and/or phases of the appeal. 4.2.8 After the hearing, a decision shall be issued on each relevant issue raised, including findings of fact, conclusions of law, and orders, and shall be served on all parties by mail, or electronic mail, as consistent with applicable law. Absent timely modification by the Director, the decision shall constitute final agency action, and the final decision of the Division. A party may seek judicial review of the decision pursuant to C.R.S. § 24-50- 1115(1).

Rule 5. Appeals of Coverage Decisions by the State Personnel Director. 5.1 Appeals of a decision by the State Personnel Director regarding whether an employee or group of employees are appropriately classified as “covered employees” may be filed with the Division on the Notice of Appeal form provided by the Division. The hearing officer will review the State Personnel Director decision de novo. 5.2 A certified employee organization or the State may file a Notice of Appeal with the Division within 35 calendar days from the date of the decision of the State Personnel Director. A valid appeal is a written statement that is timely filed with the Division, explains the basis for the appeal, and has been signed by the appellant or the appellant’s authorized representative. 5.3 The appellant shall provide the State Personnel Director (SPD) with a copy of the Notice of Appeal at the time of filing with the Division. The SPD shall have 21 calendar days to file a Response, after which the appellant shall have 21 calendar days to file a Reply. 5.4 The State Personnel Director (SPD) may authorize another official, department, division, agency, or other person to respond to the Notice of Appeal, provide information or evidence regarding the Notice of Appeal, or otherwise participate in the appeal. The SPD may so authorize in writing, or a state official may represent that they have been so authorized in a submission that is also copied to the SPD. 5.5 Upon receipt of the Notice of Appeal, the Response, and the Reply, the Division shall assign a hearing officer, who may set the matter for hearing or make a decision on the existing record. The hearing officer shall have the power and authority to call, preside at, and conduct hearings on the appeal, including the power to administer oaths and affirmations, order and take depositions, certify to official acts, and issue subpoenas to compel the attendance of witnesses and the production of books, papers, correspondence, memoranda, and other records deemed necessary as evidence in connection with a disputed ruling of the State Personnel Director. 5.6 The hearing officer shall make a decision on each relevant issue raised, including findings of fact, conclusions of law, and an order sustaining, overruling or modifying the ruling of the State Personnel Director. Testimony and further evidence may be allowed at the hearing, at the discretion of the hearing officer. Parties may be required to appear by telephone. 5.7 The hearing officer’s decision constitutes a final agency action pursuant to C.R.S. § 24-4-106, unless written exceptions to that decision are filed in accordance with the State Administrative Procedure Act (C.R.S. § 24-4-101 et seq.) and any Division filing instructions accompanying the hearing officer’s decision. If timely exceptions are filed, the decision on the exceptions constitutes the final agency action. The Division shall promptly provide all parties with a copy of the hearing officer’s decision by mail or electronic mail, as consistent with applicable law. A party may seek judicial review of the decision pursuant to C.R.S. § 24-50-1115(1) and in accordance with the State Administrative Procedure Act. _________________________________________________________________________ Editor’s Notes

History New rule eff. 01/01/2021.

Rules 1.1, 4.1.2 eff. 03/02/2022.

Entire rule eff. 04/01/2024.

7 CCR 1103-13 EQUAL PAY TRANSPARENCY RULES (“EPT RULES”) [Recodified as 7 CCR 1103-18 eff. 07/01/2024] {#sec-7-ccr-1103-13 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-13}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Labor Standards and Statistics EQUAL PAY TRANSPARENCY RULES (“EPT Rules”) [Recodified as 7 CCR 1103-18 eff. 07/01/2024]

7 CCR 1103-13 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes

History New rule eff. 01/01/2021.

Entire rule eff. 01/01/2024.

Entire rule recodified as 7 CCR 1103-18 eff. 07/01/2024.

7 CCR 1103-14 2026 Publication and Yearly Calculation of Adjusted Labor Compensation (2026 Pay Calc) Order {#sec-7-ccr-1103-14 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-14}

DEPARTMENT OF LABOR AND EMPLOYMENT

2026 PUBLICATION AND YEARLY CALCULATION OF ADJUSTED LABOR

COMPENSATION (2026 PAY CALC) ORDER

7 CCR 1103-14 [Editor’s Notes follow the text of the rules at the end of this CCR Document.]

Adopted December 8, 2025; effective February 1, 2026.

Rule 1. Statement of Purpose, Requirements, and Calculations 1.1 This Publication And Yearly Calculation of Adjusted Labor Compensation Order (PAY CALC Order), 7 CCR 1103-14, publishes values that adjust periodically under the Colorado Wage Act, C.R.S. § 8-4-101 et seq., Colorado Overtime and Minimum Pay Standards Order (COMPS Order), 7 CCR 1103-1, Wage Protection Rules, 7 CCR 1103 7, or other laws. 1.2 Coverage and Application. 1.2.1 Following are the 2026 minimum pay and income levels and future adjustments in each cited COMPS Order rule, and/or mandated by constitutional, statutory, or rule provisions the COMPS Order implements, or from which it derives.

Minimum Pay Level in COMPS Order Rule 2026 Level (Yearly Calculation)

Future Annual Adjustments (A)Full Colorado minimum wage (R. 3.1) $15.16 per hour Last year’s minimum adjusted by CPI (Consumer Price Index) for Colorado (B)Amount of Colorado minimum wage that employers must pay to tipped employees (R. 1.10, 6.2.3) $12.14 per hour to the extent that adding tips raises total pay to full minimum wage $3.02 per hour below full Colorado minimum wage to the extent that adding tips raises total pay to full Colorado minimum wage (C)Minimum wage for nonemancipated minors (R. 3.3) $12.89 per hour 15% below full minimum wage Minimum Pay Level in COMPS Order Rule 2026 Level (Yearly Calculation)

Future Annual Adjustments (D) Minimum pay for agricultural range workers (R. 2.4.9) $620.52 per week Prior year’s level adjusted by inflation (E) Executive/supervisor, administrative, or professional employees (EAP) (R. 2.5.1); certain owners or proprietors of non-profit employers (R. 2.2.5); decision-making managers at livestock employers (R. 2.4.8) $1,111.23 per week ($57,784 rounded annual equivalent); and sufficient for the minimum wage for all hours worked in a workweek Prior year’s level adjusted by inflation (F) Highly technical computer employees (R. 2.5.2, 2.2.10) $34.85 per hour or the EAP salary above (row E)

Prior year’s hourly wage adjusted by inflation, or the EAP salary above (G) Highly compensated employees (R. 2.2.11) $130,014 annually, and the EAP salary (row E) weekly The annual EAP salary (row E) multiplied by 2.25 (H) Certain drivers and driver’s helpers (R. 2.4.6) $833.80 per week Based on Colorado minimum wage each year (I) Certain seasonal camp or outdoor education field staff (R. 2.2.7(E))

Full minimum wage or, per week: $436.72 (adults) or $341.38 (minors); except at non-profits with up to $25 million in revenue, $330.60 (adults) or $251.15 (minors)

Based on Colorado minimum wage each year 1.2.2 The following amounts in the Colorado Wage Act, C.R.S. § 8-4-101 et seq., must also be periodically adjusted. The table below describes these amounts, any related rules, the dates that each amount applies during, and the future adjustments to these amounts.

Inflation or Otherwise Adjusted Wage Act Amounts Amounts and Dates Future Adjustments (A) The Division shall accept wage claims for the following per-employee amounts, pursuant to C.R.S. § 8-4- 111(2)(a)(I) and as stated in Wage Protection Rule 3.1.5 Through June 30, 2026: $7,500 per employee From July 1, 2026 through December 31, 2027: $13,000.00 per employee On January 1, 2028, and then every other year thereafter, the rate will increase by either $1,000 or a higher amount if necessary to adjust for inflation, as based on the CPI-U for Denver-Aurora- Lakewood 1.3 Additional Requirements. Many of the referenced COMPS Order rules have other requirements aside from a minimum pay level, including but not limited to: an employee having duties that qualify for exemption; an employee receiving sufficient tips to allow for a tip credit to be taken; and an employer paying any higher applicable federal, local, or minimum wage.

Rule 2. Authority, Construction, and Definitions 2.1 Authority and Application. This PAY CALC Order is issued under the authority and as enforcement of Section 15 of Article XVIII of the Colorado Constitution and Articles 1, 4, 6, 12, and 13.3 of C.R.S. Title 8, and is intended to be consistent with these provisions as well as the State Administrative Procedure Act, C.R.S. § 24-4-101, et seq. Where these Rules reference another rule, the reference shall be deemed to include all subparts of the referenced rule. Where these Rules have provisions different from or contrary to any referenced material, the provisions of these Rules govern, so long as they are consistent with Colorado statutory and constitutional provisions. Unless otherwise noted, in these Rules: all statutes cited apply the most recent versions of the Colorado Revised Statutes; all rules cited apply the most recent versions adopted as of the adoption of these Rules. Earlier versions of such laws and rules may apply to events that occurred in prior years. 2.2 Administration and Dual Jurisdiction. The Division shall have jurisdiction over all questions arising with respect to the administration and interpretation of this PAY CALC Order. Whenever employers are subjected to Colorado law as well as federal and/or local law, the law providing greater protection or setting the higher standard shall apply. For information on federal law, contact the U.S. Department of Labor, Wage and Hour Division; find local minimum wages, industry-specific base wages, and other wage requirements in Colorado at www.coloradolaborlaw.gov, or contact the relevant local government for more details. 2.3 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rules remain valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form. 2.4 “Division” means the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment. _____________________________________________________________________ Editor’s Notes

History New rule eff. 01/01/2022.

Entire rule eff. 01/01/2023.

Entire rule eff. 01/01/2024.

Entire rule eff. 01/01/2025.

Entire rule eff. 01/01/2026.

Entire rule eff. 02/01/2026.

7 CCR 1103-15 Agricultural Labor Conditions Rules {#sec-7-ccr-1103-15 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-15}

DEPARTMENT OF LABOR AND EMPLOYMENT

AGRICULTURAL LABOR CONDITIONS RULES

7 CCR 1103-15 [Editor’s Notes follow the text of the rules at the end of this CCR Document.]

Adopted December 8, 2025; effective February 1, 2026.

Rule 1. Statement of Purpose, Authority, and Construction 1.1 The general purpose of these Agricultural Labor Conditions Rules is to exercise the authority of this Division to enforce and implement the Agricultural Labor Rights and Responsibilities Act, Colorado Senate Bill 21-087 (ALRRA, enacted June 25, 2021), including but not limited to Part 2, “Labor Conditions for Agricultural Workers,” of Article 13.5 of Colorado Revised Statutes (C.R.S.) Title 8, and other existing Title 8 provisions and authority, including but not limited to C.R.S §§ 8-1-103(3), -107(2), -111; 8-2-206; 8 3 104; 8-6-101.5, -105, -106, - 108, -117; and 8-13.5-201 to -204. The Rules shall be interpreted in accordance with the ALRRA. The Rules are intended to be consistent with the State Administrative Procedure Act, C.R.S. § 24-4-101, et seq. 1.2 Incorporation by Reference. These Rules incorporate by reference only those specific Colorado rules, as identified below, from the Colorado Whistleblower, Anti-Retaliation, Non-Interference, and Notice-Giving (WARNING) Rules, 7 CCR 1103-11, as adopted by the Colorado Department of Labor and Employment, Division of Labor Standards and Statistics. These incorporated Division rules are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, located at 707 17th Street, Denver, CO 80202. Copies may be obtained from the Division of Labor Standards & Statistics at a reasonable charge. These incorporated Division rules can be accessed electronically from the website of the Colorado Secretary of State, and are available to the public at www.coloradolaborlaw.gov. Pursuant to C.R.S. § 24 4 103(12.5)(b), the agency shall provide certified copies of the rules incorporated by reference at cost upon request. All such incorporated rules refer to the date and edition of those rules in effect as of the effective date of these Agricultural Labor Conditions Rules, February 1, 2026, and exclude later amendments to or editions of these rules incorporated by reference. 1.3 Application. Where these Rules have provisions different from or contrary to any referenced material, the provisions of these Rules govern so long as consistent with Colorado statutory and constitutional provisions. Where these Rules reference another rule, the reference shall be deemed to include all subparts of the referenced rule. Unless otherwise noted, in these Rules: all statutes cited apply the most recent versions of the Colorado Revised Statutes; all rules cited apply the most recent versions adopted as of the adoption of these Rules. Earlier versions of such laws and rules may apply to events that occurred in prior years. 1.4 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rules remain valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form. 1.5 Other Requirements for Agricultural Labor. In addition to these rules on certain labor conditions for which the ALRRA requires rules from this Division: (A) the ALRRA put into effect other agricultural labor requirements that do not require any rules; (B) other ALRRA requirements are covered in other rules, such as the Colorado Overtime and Minimum Pay Standards (COMPS) Order, 7 CCR 1103-1 (wage and hour matters); Labor Peace Act Rules and Industrial Relations Act Rules, 7 CCR 1101-1 (labor management relations); and Colorado Whistleblower, Anti-Retaliation, Non-Interference, and Notice Giving (Colorado WARNING) Rules, 7 CCR 1103-11 (retaliation, interference, and notice); and (C) other rules cover other labor requirements not specific to, but applicable to, agriculture.

Rule 2. Definitions Applicable to These Rules 2.1 “Division” is the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment. 2.2 “Employee” is as defined by C.R.S. § 8-6-101.5(3): “agricultural employee” or “agricultural worker” has the “same meaning as under C.R.S. § 8-13.5-201(3)”

(“ A worker engaged in any service or activity included in section 203(f) of the federal ‘Fair Labor Standards Act of 1938’, . . . as amended . . . or section 3121(g) of the federal ‘Internal Revenue Code of 1986’, as amended”). As to rights and remedies under C.R.S. § 8-2-206, “agricultural worker” means “a person employed by an agricultural employer.” Unless otherwise noted, references to “employees” in these rules mean “agricultural employees.” 2.3 “Employer” is as defined by C.R.S. § 8-2-206(1)(c): “agricultural employer” has the “same meaning provided in C.R.S. § 8-3-104(1)” (“a person that is engaged in any service or activity included in section 203(f) of the federal ‘Fair Labor Standards Act of 1938’, . . . as amended,” or engaged in “agricultural labor, as defined in section 3121 of the federal ‘Internal Revenue Code of 1986’,” that either (1) contracts with any person who recruits, solicits, hires, employees, furnishes, or transports agricultural employees, or (2) regularly engages the services of one or more agricultural employees). Unless otherwise noted, references to “employers” in these rules mean “agricultural employers.” 2.4 “Locality” includes a county, city, town, village, other municipality, unincorporated local area, or other government unit or subdivision smaller than the state of Colorado. 2.5 “Meal period” and “rest period” are defined by and apply as stated in COMPS Order Rules 5.1-5.2 unless otherwise provided in these Rules, and are synonymous with “meal break” or “rest break,” respectively. 2.6 “Potable water” means drinkable water safe for human consumption, and in compliance with Colorado Primary Drinking Water Regulations, 5 CCR 1002-11, if provided from a supply system subject to those rules. 2.7 “Provide” (or in any other form such as “provides,” “ provided,” or “providing”) means the item, service, or permission must be given at no cost, with no additional conditions, and with no deductions from compensation, except that references to “employer-provided” housing are not limited to housing provided at no cost. 2.8 “Range worker” is as defined by C.R.S. § 8-6-101.5(1)(b) and, as used to define agricultural employees to whom different rights and responsibilities within these rules apply, means an agricultural employee who is paid at least the minimum salary for range workers (as specified in the Publication And Yearly Calculation of Adjusted Labor Compensation (PAY CALC) Order, 7 CCR 1103-14, for the applicable year) during periods when they are “principally engaged in the range production of livestock . . . on the open range” (as defined by C.R.S. § 8-6- 101.5(b)), and who is provided without cost or deduction any housing, food, transport, and equipment required for H-2A visa range workers by federal regulations. 2.9 Temperatures in or applicable to these rules are all on the Fahrenheit temperature scale. 2.10 “Workday” means any consecutive 24-hour period starting with the same hour each day and the same hour as the beginning of the workweek. The workday is set by the employer and may accommodate flexible shift scheduling. 2.11 “Workweek” means any consecutive set period of 168 hours (7 days) starting with the same calendar day and hour each week.

Rule 3. Heat Illness and Injury Protection 3.1 Application of heat illness and injury protection rules. This Rule 3 applies on days when the temperature at a worksite for agricultural work is, or is forecast to be, at least 80 degrees, except:

(A) Rule 3.4 applies additional requirements only under the “increased risk conditions” defined in that Rule;

(B) Rule 3 does not apply to employees working no more than fifteen minutes in any sixty-minute period in conditions that otherwise trigger Rule 3 requirements;

(C) Rule 3 does not apply to a workday if conditions are forecasted to trigger

Rule 3 requirements, but employees work only at times when conditions are not forecasted to, and do not actually, trigger those requirements — for example, if employees finish work by 11:30 a.m. on a day when the temperature is not forecasted to, and does not actually, reach 80 degrees until 12:00 p.m.; and (D) Rules 3.5 and 3.6 apply if, at any point in the calendar year, a worksite temperature of at least 80 degrees is reasonably expected (as defined in

Rule 3.1.6), even if particular work occurs, or workdays are, under 80 degrees, or are exempt under (B) or (C) above. 3.1.1 Temperature and increased risk conditions shall be assessed on a day-today basis.

(A) For outdoor worksites of agricultural work, the employer shall rely on a forecasted high temperature for the day. For indoor worksites of agricultural work, the employer shall measure the worksite temperature during the workday, and shall apply the relevant Rule 3 requirements (1) on any day when the measured temperature exceeds a Rule 3 threshold, or (2) regardless of measured temperature, on any day when the employer has reason to expect the temperature to exceed the relevant Rule 3 threshold. This includes when (a) the employer intends to cause the indoor temperature to meet the threshold, (b) outdoor weather conditions give the employer reason to expect that the indoor temperature will meet the threshold, or (c) in one of the last three workdays the indoor worksite had a high temperature that met the threshold.

(B) The employer may rely on any forecast, from no earlier than noon the prior day, for any locality that includes the worksite (or if no such forecast is available, the nearest locality with a forecast), from any reliable daily forecast source, such as a professional weather service, mass media source, or government entity.

(C) If it is not possible for an employer to determine whether outdoor temperatures meet a Rule 3 threshold, or to inform employees when a threshold is met (e.g., to inform range workers whose location is unknown or who lack reliable reception), then it shall rely on the prior year’s monthly average temperature for the same month in which employees are currently working (applying Rule 3.1 standards for choosing a locality and reliable forecast), to comply with:

(1) Rule 3 heat illness and injury prevention requirements for all days in a month with at least a 76-degree average high temperature (i.e., 95% of the 80-degree threshold); and (2) Rule 3.4 increased risk conditions requirements for all days in a month with at least a 90-degree average high temperature (i.e., 95% of the 95-degree threshold). 3.1.2 For outdoor worksites of agricultural work, an employer shall monitor conditions throughout the workday for heat protection triggers under this

Rule 3.1 and 3.4. An employer shall monitor the current temperature by:

(A) Measuring the temperature of the location where employees perform work that day as frequently as required by conditions;

(B) Providing a means for employees to measure the temperature at least once per hour, and to report weather conditions triggering heat protections; or (C) Using or permitting employees to use a reliable weather report for the exact location where the work is being performed.

An employer shall accurately measure the temperature of the worksite under 3.1.2(A) or (B). Accurate measuring requires the dry bulb temperature to be measured in sunlight and as near as possible to the location of workers in a location that experiences similar conditions to the workers but no more than one half mile away. 3.1.3 If an employer learns of conditions that do or are expected to trigger Rule 3 requirements only after a workday starts (e.g., if a temperature exceeding a Rule 3 threshold, or any Rule 3.4 increased risk condition, appears after not being forecast), then the employer shall comply with applicable Rule 3 requirements to the maximum extent, and as soon as, possible. 3.1.4 An employer does not have an obligation to monitor the conditions if it assumes the Rule 3.1 temperature threshold and/or Rule 3.4 increasedrisk conditions are met and follows the requirements of these rules. An employer may choose to assume Rule 3.1 applies and monitor only for increased risk conditions under Rule 3.4. 3.1.5 If complying with any Rule 3 requirement(s) is not possible or would make employees more unsafe, then an employer must (A) comply to the maximum extent possible, and (B) implement equivalent protective measures, recording in writing their nature and reasons. 3.1.6 Where a rule is based on whether a certain temperature (e.g., 80 or 95 degrees) is “reasonably expected” in a current year, that condition is satisfied if either: (A) any days had at least that temperature in the prior year; or (B) any day in the current year is forecasted to have, or actually has, at least that temperature. Prior year temperature data may be from any reliable source for a locality that includes the worksite (or, if data for the locality is not available, for the nearest locality to the worksite), such as a professional weather service, mass media source, or government entity, including the National Weather Service (NWS) [as of publication of these rules: at www.weather.gov, select “Past Weather,” and a region, to reach the “Climate” page; then select “Monthly Summarized Data” and “Max Temp” for the relevant location and time period]. 3.2 Drinking Water. Employers shall provide employees with potable water, and the opportunity to drink it, as follows:

(A) at least 32 ounces of water per hour per employee, kept 60 degrees or cooler, by any means the employer chooses, such as providing (1) a tap or fountain supplying water in that temperature range, or (2) a supply of water kept within that temperature range as much as possible (e.g., in a refrigerator or enclosed cooler in the shade) and, if the temperature would rise out of the range, is replenished or re-cooled (e.g., by adding ice);

(B) from a sanitary source, whether a fountain, tap, or individual cup or container;

(C) with employees permitted time to drink water and use restrooms during shifts as needed, including by providing water where it is available during shifts and breaks; and (D) located as close as practicable to the worksite, no further than 0.25 miles from the worksite for employees accessing the water source by foot, and not otherwise too far for employees to reasonably access. 3.2.1 If it is not possible to comply with any portion of Rule 3.2 for a range worker or ranch worker during periods when they spend the majority of their workday mobile (for example, riding a horse or ATV) and too distant from any fixed or mobile source of water compliant with Rule 3, then the employer shall comply to the maximum extent possible, including but not limited to by: (A) re-supplying potable water to the worker whenever the employer re-supplies or otherwise visits a location near the worker; and (B) providing equipment or resources to permit the employee to carry potable water, and to the extent that it is not possible to carry enough potable water, providing equipment or resources to permit the worker to obtain potable water from non-potable sources, such as water purification containers or other devices that render water potable. 3.3 Shade. For employee use during rest, meal, cool-down, and other breaks, employers shall provide access to adequate shade located as close as practicable to the worksite, which may be artificial or natural, but does not qualify if:

(A) any source yields additional heat in the shaded area, such as exhaust, running machinery, heat-radiating structures, or heat in a non-air conditioned vehicle;

(B) the shaded area is located further than 0.25 miles from the worksite for employees accessing the shade by foot, or otherwise too far to reasonably access during rest and meal periods;

(C) the shaded area is too small for employees to sit fully shaded in normal posture, without touching one another;

(D) the shaded area is neither ventilated nor open to the air; or (E) the area has unsafe, unhealthy, unsanitary, or other conditions (e.g., noxious odor from rot or garbage) that deter or discourage accessing or using the shade. 3.3.1 If an employer can demonstrate that providing access to adequate shade is not safe or possible (e.g., during high wind), then, during at least the times when Rule 3.3 requires access to shade, it shall provide equivalent protection by alternate measures, such as an air-conditioned site (e.g., a vehicle or structure), and/or an individualized cooling item (e.g., vest, bandana, or towel) that contains or is made from material that retains a cool temperature.

An employer may provide cooling with an indoor air-conditioned space as an alternative to outdoor shade, without demonstrating that providing access to adequate shade is not safe or possible, provided the space meets the requirements of 3.3(B), (C), and (E). 3.3.2 Range workers shall be authorized and permitted to seek and use shade during rest and meal periods, and otherwise limit the impact of heat and sun exposure. 3.4 Increased Risk Conditions. 3.4.1 “ Increased risk conditions” means one or more of the following conditions occur in the day, in addition to Rule 3.1 heat conditions (i.e., a temperature of at least 80 degrees), applying standards in Rule 3.1 and below for choosing a locality and a reliable forecast.

(A) Temperature: A daily high forecast or measured worksite temperature is at least 95 degrees.

(B) Unhealthy Air Quality: A Colorado Department of Public Health and Environment (CDPHE) Air Quality Advisory (AQA) or Action Day is in effect (for the State or a locality or other area that includes the worksite), with the exception in (1) below. [As of publication of these rules: AQA and Action Day information is available from CDPHE (888-4-THE AIR or www.colorado.gov/airquality, with signup for email updates), or federal agencies relying on CDPHE data (the National Weather Service (NWS) at www.weather.gov, or the Environmental Protection Agency at www.airnow.gov).]

(1) For Action Days based solely on ozone, this increased risk condition does not apply if an employer shows that the Air Quality Index (AQI) for its worksite location is rated “moderate” or “good” (i.e., AQI of 100 or less) based on: (a) current or forecasted AQI ozone data from NWS “Air Quality Forecast Guidance” (as of publication of these rules, at www.airquality.weather.gov); or (b) the nearest available CDPHE monitoring site, as long as it is within 50 miles of the worksite.

(C) Long Days: An employee (other than a range worker) is scheduled or reasonably expected to work over 12 hours in the workday or shift.

(D) Heavy Clothing or Gear Required: The employee is required, by the employer or safety protocols for their equipment or work, to wear vapor barrier clothes (i.e., clothes significantly inhibiting sweat from evaporating into outside air, such as various chemical resistant or encapsulating suits), or personal protective equipment (such as protective jackets, suits, or coveralls) requiring an additional layer over regular clothes or covering all or almost all of the head and face.

(E) Acclimatization: The employee is in their first four workdays for the employer during which the Rule 3 requirements are triggered. The requirements of this rule apply when the employee is newly exposed to heat in the workplace and after an employee spends 30 days away from the workplace. 3.4.2 Under increased risk condition, employers shall ensure that no more than two hours of work are performed before at least 10 minutes of rest are provided, by any mix of spacing out any breaks already required by these or other Rules, and/or providing additional breaks meeting the rest or meal period standards of Rule 5 of the COMPS Order; except that for range workers, employers shall encourage spacing the rest breaks provided in the COMPS Order, and other rest opportunities, to include rest every two hours to the maximum extent possible. 3.4.3 Before a workday or shift starts (or as soon as possible during a shift, if the employer only later learns of an increased risk condition), employers shall notify employees, by any effective means, of their rights to (1) all

Rule 3 heat protections, including additional Rule 3.4 breaks, and (2) additional preventative cool-down rest under Rule 3.5.5 when needed. If an employer cannot contact an employee to provide this information, or cannot assess possible increased risk conditions, it shall provide this information if any such conditions are anticipated or forecasted to be present during that week (or lesser time period when an employee is inaccessible). 3.4.4 If at any point in a calendar year a worksite temperature of at least 95 degrees is reasonably expected (as defined in Rule 3.1.6), or actually occurs, then an employer shall provide employees with fans sufficient to circulate air in all sleeping quarters in employer-provided housing (e.g., bedrooms or multi-bed dormitory rooms). Qualifying fans can include air conditioning or other devices that circulate cooled air. Qualifying fans shall be able to run continuously. 3.5 Safety Procedures. If at any point in the calendar year a worksite temperature of at least 80 degrees is reasonably expected (as defined in Rule 3.1.6), then an employer shall implement the following. 3.5.1 Communication availability. Employers shall maintain effective communication means for employees by voice, observation, or (if area reception is reliable) electronic means, so that when necessary for health or safety, employees can contact a supervisor, other designated individual, or emergency medical services. If an employer cannot regularly communicate with employees (e.g., range workers in an area lacking reliable reception), then it shall identify and implement (including by training employees as needed) means (A) to make contact with employees to monitor their well-being, and (B) for employees to obtain medical care in emergencies, such as those detailed in federal regulations for range worker visas (which include: providing satellite or cell phones, wireless devices, or radio transmitters; arranging for employees to be located, on a regular basis, in a geographic area where electronic communication devices operate effectively; or arranging for regular, prescheduled, in-person employer-employee visits). 3.5.2 Monitoring and receiving reports of heat illness or injury. Employers shall monitor, and receive reports of, signs or symptoms of heat illness or injury, by any of the following:

(A) observation of up to 20 employees by a designated individual;

(B) a mandatory buddy system assigning each employee to observe, at periodic intervals, one or more other employees;

(C) regular communication with any employee working outside the presence of others, such as by radio or phone; or (D) any other effective means of monitoring and receiving reports. 3.5.3 Response to possible heat illness or injury. Employers shall respond to signs and symptoms of heat illness or injury, when reported by anyone or when observed by a supervisor or other designated individual, promptly and appropriately to the severity, by:

(A) promptly relieving from duty an employee showing, or reported to have, such signs or symptoms (or, for an employee outside the presence of others, permitting them to relieve themselves from duty);

(B) monitoring those signs or symptoms (or for employees outside the presence of others, checking in as frequently as weather, environmental, or other circumstances warrant to monitor employee health and safety) and, when warranted, ensuring that such employees are not left alone or sent home without being offered onsite first aid and/or emergency services; and (C) implementing a Rule 3.5.4 emergency response for severe signs or symptoms, e.g., decreased consciousness, staggering, vomiting, disorientation, irrational behavior, convulsions, or (even after resting) an increased heart rate. 3.5.4 Emergency response. Employers shall:

(A) designate at least one person at each worksite to contact emergency medical services when needed, and permit others to if that person is unavailable; and (B) ensure, in an emergency, that emergency medical services are contacted, and provided all necessary information, as immediately as possible (including contact information and directions to reach the employee(s)), and that (if necessary and appropriate) employees are transported to where responders can reach them. 3.5.5 Preventative measures. An employer shall allow and facilitate employee preventative measures, including by reminding employees of the availability of water, shade for use during breaks, and (if an employee believes it is needed to avoid or remedy overheating) cool-down rest in shade. Preventative cool-down rest may be satisfied with rest or meal periods already required by the COMPS Order or Rule 3 (and otherwise qualifies as additional rest period time under those Rules), as long as other requirements of this Rule 3.5.5 are followed, and no preventative cool-down rest is denied or delayed based on the scheduling or use of other rest or meal periods. An employee taking a preventative cool-down rest shall:

(A) be monitored (or if outside of the presence of others, communicated with as frequently as weather, environmental, or other circumstances warrant to monitor employee health and safety) and asked if they have signs or symptoms of heat illness or injury, and if symptoms persist after resting, the employer shall respond as these Rules require; and (B) not be sent back to work until any such signs or symptoms have abated, but in no event in less than 10 minutes after the employee reaches the shade. 3.6 Training. If at any point in the calendar year a worksite temperature of at least 80 degrees is reasonably expected (as defined in Rule 3.1.6), then an employer shall implement the following training measures by April 20th of each year, and upon hiring for new employees hired after those training measures. 3.6.1 Training shall be provided to all employees on the following:

(A) environmental and personal risk factors for heat illness, including the added burden of heat on the body from exertion, clothing, and gear;

(B) the importance of acclimatization in the first days of work in heat, drinking water, and promptly reporting their or others’ signs or symptoms of heat illness or injury;

(C) different types, signs, and symptoms of heat illness, including selfmonitoring, and how signs or symptoms can progress from mild to serious or life-threatening;

(D) basic first aid (including by the employees themselves), and the available emergency responses to heat illness; and (E) the requirements of Rule 3 (Heat Illness and Injury Protection) and

Rule 5.1 (Retaliation and Interference Prohibited), which may be satisfied by providing a document that satisfies the Rule 5.2 requirement of posted notice of rights, as well as how the employer is complying with Rule 3 (e.g., how it is providing required water, shade, and break time, as well as its safety procedures). 3.6.2 Supervisors and others designated to have any roles or responsibilities to implement any requirements in these Rules shall be trained on those roles or responsibilities. 3.6.3 An employer may comply with this Rule 3.6 by providing site-specific information on the topics in Rules 3.6.1(E) and 3.6.2, and for the non-sitespecific topics in Rule 3.6.1(A)-(D), by providing training based on any one of the following heat safety programs, or another program with comparable information: ● “Heat Illness Prevention Training Guide, A Lesson Plan for Employers,” published by the federal Occupational Safety and Health Administration (as of publication of these rules, available in English at www.osha.gov/index.php/heat-exposure/resources); ● “Heat Education and Awareness Tools (HEAT) Facilitator’s Guide,” published by the University of Washington Pacific Northwest Agricultural Safety and Health Center (as of publication of these rules, available in English and Spanish at www.deohs.washington.edu/pnash/heat-toolkit); or ● “Heat Illness Prevention Employer Training Discussion Guides and Visual Aids,” published by the University of California Davis Western Center for Agricultural Health and Safety (as of publication of these rules, available in English and Spanish at aghealth.ucdavis.edu/training/heat-illness). 3.6.4 For any employees not fluent in English, the employer shall provide, in the employee’s primary language for any written or verbal content, either training, printed, or online materials accessible to the employee, covering the training content. The employer may ask the Division for help procuring materials in that language.

Rule 4. Access to Key Service Providers 4.1 Purpose. In addition to access to key service providers at any location other than the employer’s property; for housed employees, access to visitors and to offsite services required by statute, C.R.S. § 8-13.5-202, this Rule 4 provides “additional times during which an employer may not interfere with an agricultural worker’s reasonable access to key service providers, including periods during which the agricultural worker is performing compensable work, especially during periods when the agricultural worker is required to work in excess of forty hours per week and may have difficulty accessing such services outside of work hours” (C.R.S. § 8- 13.5-202(1)(c)), including difficulty planning appointments with, communicating with, following up with, and reviewing information from key service providers. 4.2 Communication access to off-site providers. 4.2.1 An employer shall not interfere with an agricultural worker’s reasonable access to key service providers at any location other than the employer’s property during any time in which the agricultural worker is not performing compensable work or during paid or unpaid rest and meal breaks. An employer shall not interfere with an agricultural worker’s reasonable access to key service providers through remote channels, including telehealth appointments, on the employer’s property. 4.2.2 Communication with off-site providers shall be permitted during all rest and meal periods, required breaks under these Rules and any other statute or rule, and any other time when the worker is not performing compensable work. 4.2.3 Employees shall be provided and permitted to use a location with phone service and internet access that allows as much privacy and quiet as possible.

(A) If an employee living in employer-provided housing lacks a device for phone or internet access, then the employer shall provide a device when the employee needs to use one.

(B) If the worksite lacks phone or internet service, then the employer (1) shall permit an employee with their own transportation (as described in C.R.S. § 8-13.5-202(1)(f)) to travel to such a site with service, or (2) shall, for an employee living in employer-provided housing without transportation of their own, provide transportation to a site with service within 24 hours of the employee’s request (which may be the same transportation that satisfies the requirements of C.R.S. § 8-13.5-202(1)(e) to provide workers transportation for service provider access, if the employee is provided adequate time for the activities identified in § 202(1)(e)).

(C) If an employer cannot provide an employee with the communication access detailed in (A) and (B), then it shall provide meaningful access to key service providers by alternate means. 4.2.4 In any workweek of over 40 hours, an employee who requests at least 24 hours in advance shall be permitted, at least once per week, to extend a meal period or other 30-minute break to up to 60 minutes (the extra time may be unpaid) to communicate with a key service provider of their choice during the provider’s hours of operation. For range workers, an employer may require 72 hours’ notice (except for health emergency needs) before permitting up to 60 minutes for such communication with a key service provider. If an employer denies a request made less than 24 hours in advance (or less than 72 hours in advance for a range worker), the employer must allow the employee to extend a different break during that workweek or any break during the next workweek (in addition to other breaks to which the employee may be entitled). 4.2.5 An employer shall promptly provide an employee all mail or other communications (written, electronic, or verbal) it receives that were sent to or left for the employee. 4.3 Additional break time to facilitate service provider access during long workweeks.

An employer shall provide (in addition to other rest, meal, or other breaks provided by these Rules, the COMPS Order, or other statutes or rules) to employees other than range workers one additional paid break of 60 minutes in any workweek of over 60 hours worked, and two such paid breaks in any workweek of over 70 hours. 4.3.1 If an employer had no reason to believe an employee would exceed 60 or 70 hours until the last day of the week, it may instead provide the additional break time the following week. 4.3.2 During this additional break time, employees shall be permitted to leave the worksite and to use the time either to directly support their access to a key service provider’s hours of operation, or as indirect support by using the time for other needs (meals, rest, other services, etc.) that may facilitate their access to key service providers at other times. 4.3.3 Paid break time under this rule shall be compensated at the same rate as time worked and is governed by the COMPS Order provisions applicable to paid rest periods. 4.4 Visitors at Employer-provided Housing. 4.4.1 An employer shall not interfere with an agricultural worker’s reasonable access to visitors at the agricultural worker’s employer-provided housing during any time when the agricultural worker is present at such housing. 4.4.2 An agricultural employer that provides housing and transportation for agricultural workers shall, at least one day per week, provide transportation to the agricultural workers to a location where the workers can access basic necessities, conduct financial transactions, and meet with key service providers; except that transportation must be provided not less than one day every three weeks for range workers who are actively engaged in the production of livestock on the open range. 4.5 Right to Exit. No person other than the agricultural worker may prohibit, bar, or interfere with, or attempt to prohibit, bar, or interfere with, the access to or egress from the residence of any agricultural worker by any person, either by the erection or maintenance of any physical barrier, by physical force or violence, or by the threat of physical force or violence, or by any order or notice given in any manner. 4.6 Emergency Access. An employer shall allow access to its property in the event of necessity to the maximum extent of law.

Rule 5. Enforcement 5.1 Retaliation and Interference Prohibited. Retaliation for or interference with any protected activity or right under the ALRRA or these Rules is prohibited.

Retaliation and interference have the same meaning as defined by C.R.S. § 8-2- 206 and Colorado WARNING Rule 2.11, 7 CCR 1103-11, which is incorporated by reference and available to the public for review as stated in Rule 1.2. 5.2 Notice of Rights. Employers “shall post notice of an agricultural worker’s rights under [C.R.S. Title 8, Article 13.5] Part 2” (C.R.S. § 8-13.5-202(3)), in conformity with Colorado WARNING Rules 4.1, 4.3 through 4.4, and 4.6(A), 7 CCR 1103- 11, which are incorporated by reference and available to the public for review as stated in Rule 1.2. This Rule 5.2 may be satisfied with (A) an up-to-date Agricultural Labor Rights and Responsibilities Poster published by the Division;

(B) at any time such a poster is unavailable, an up-to-date version of an Interpretive Notice and Formal Opinion on agricultural labor rights and responsibilities published by the Division; or (C) another document with the required information. Division publications are available at www.ColoradoLaborLaw.gov. 5.3 Complaints and Investigations. The Division may investigate possible violations of these Rules. Complaints within the scope of C.R.S. §§ 8-2-206 or 8-13.5-204 of the ALRRA may be filed in court. Complaints of any violations of the ALRRA or of these Rules may be filed with the Division and shall be governed by the Colorado WARNING Rules, 7 CCR 1103-11, and any other Division rules that may apply based on the type of complaint or investigation. The Division will consider any showing by the employer of good-faith effort to comply to the maximum extent possible in exercising discretion as to whether to investigate certain types of claims under these Rules or the ALRRA, and as to appropriate remedies for violations in such investigations. _____________________________________________________________________ Editor’s Notes

History New rule eff. 05/01/2022.

Entire rule eff. 02/01/2026.

7 CCR 1103-16 County Collective Bargaining (cobca) Rules {#sec-7-ccr-1103-16 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-16}

DEPARTMENT OF LABOR AND EMPLOYMENT

COUNTY COLLECTIVE BARGAINING (COBCA) RULES

7 CCR 1103-16 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted May 11, 2023; effective July 1, 2023.

Rule 1. Statement of Purpose and Authority 1.1 The general purpose of these County Collective Bargaining Rules is to exercise the authority of the Director, through the Division, to administer and enforce the provisions of the Collective Bargaining by County Employees Act (“COBCA”), Colorado Revised Statutes (C.R.S.) Title 8,

Article 3.3 (2023), C.R.S. § 8-3.3-101 et seq. These rules are intended to be consistent with the rulemaking requirements of the State Administrative Procedure Act, C.R.S. § 24-4-103. 1.2 The Director of the Division of Labor Standards and Statistics in the Department of Labor and Employment has authority to enforce, interpret, apply, and administer the provisions of C.R.S.

Title 8, Article 3.3 and these rules. 1.3 Incorporations by Reference. The Collective Bargaining by County Employees Act, C.R.S. § 8- 3.3-101 et seq., is hereby incorporated by reference into these rules. Such incorporation excludes later amendments to or editions of the statutes. These statutes are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, 633 17th Street, Denver CO 80202. Copies may be obtained from the Division of Labor Standards & Statistics at a reasonable charge. Electronic access is available from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of the statutes incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Division rules are available to the public at www.coloradolaborlaw.gov. Where these rules have provisions different from or contrary to any incorporated or referenced material, the provisions of these rules govern so long as they are consistent with Colorado statutory and constitutional provisions. Where these rules reference another rule, the reference shall be deemed to include all subparts of the referenced rule. 1.4 Separability. These rules are intended to remain in effect to the maximum extent possible. If any

part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rule remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form.

Rule 2. Definitions 2.1 “Authorized representative” means a person designated by a party to any labor-management dispute, unfair labor practice complaint, election petition, or other Division administrative proceeding to represent the party. A party may designate an authorized representative by filing the Division-approved form or by a signed written notice to the Division that the authorized representative will represent the party. Authority of the authorized representative may be revoked by the designating party upon written notice to the Division. 2.2 “Bargaining unit” means a group of county employees in a unit deemed appropriate for the

purpose of collective bargaining in accordance with C.R.S. § 8-3.3-110, except that a bargaining unit does not include a confidential employee as defined by C.R.S. § 8-3.3-102(5); an executive employee as defined by C.R.S. § 8-3.3-102(14); a managerial employee as defined by C.R.S. § 8-3.3-102(18); or temporary, intermittent, or seasonal employees who work less than 90 days in a 365-day period. 2.3 “COBCA” means the Collective Bargaining by County Employees Act as contained in Title 8,

Article 3.3 of the Colorado Revised Statutes, enacted on May 27, 2022. 2.4 “Collective bargaining” or “collectively bargain” has the meaning as defined by C.R.S. § 8-3.3- 102(2). 2.5 “Collective Bargaining Agreement” (“CBA”) has the meaning as defined by C.R.S. § 8-3.3-102(3). 2.6 “County” has the meaning as defined in C.R.S. § 8-3.3-102(6) and includes a county in the state of Colorado, but does not include: (1) A city and county; (2) A county with a population of less than 7,500 people pursuant to the official figures of the most recent United States decennial census; (3) The state or any political subdivision of the state where the state or political subdivision of the state acquires or operates a mass transportation system, or any carrier by railroad, express company, or sleeping car company subject to the Railway Labor Act, 45 U.S.C. § 151 et seq., as amended; (4) A municipality; (5) A school district, a district charter school pursuant to Part 1, Article 30.5, Title 22, or an institute charter school pursuant to Part 5, Article 30.5,Title 22; (6) Any district, business improvement district, special district created pursuant to Title 32, authority, or other political subdivision of the state; or (7) A public hospital established by a county pursuant to Part 3, Article 3, Title 25. 2.7 “County employee” has the meaning as defined by C.R.S. § 8-3.3-102(7): “a person employed by a county, including a person whose employment with the county has ceased due to an unfair labor practice or a discharge, if such discharge is subject to appeal under an applicable appeals process.” 2.8 “Director” means the Director of the Division of Labor Standards and Statistics, and includes a designee or agent selected by the Director to perform any delegable functions of the Director pursuant to authority granted by any applicable provision of law, including but not limited to C.R.S. § 8-1-103(1). 2.9 “Division” means the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment. 2.10 “Employee organization” has the meaning as defined in C.R.S. § 8-3.3-102(12), includes any organization of persons or entities that is not operated or organized for profit, and is synonymous with “labor organization.” 2.11 “Exclusive representative” means the employee organization certified or recognized as the representative of employees in a bargaining unit under COBCA. 2.12 “Mail” refers to first-class mail sent through the United States Postal Service, postage prepaid. 2.13 “Order” means any decision, rule, regulation, requirement, or standard promulgated by the Director, as defined by C.R.S. § 8-1-101(11). 2.14 “Organizations,” for purposes of regulating deductions under C.R.S. § 8-3.3-104(4), include only the exclusive representative and related entities. Charitable organizations unaffiliated with the exclusive representative are not regulated by C.R.S. § 8-3.3-104(4). 2.15 “Person” refers to one or more individuals, an employee, an employee organization, partnerships, associations, corporations, legal representatives, trustees, or receivers. 2.16 “Post” means to display in conspicuous places frequented by employees on the employer’s premises, at places customarily used for posting of employee notices, and where such notice may be easily read during the workday, such as in break rooms, on employee bulletin boards, and/or adjacent to time clocks, department entrances, and/or facility entrances, and on any electronic bulletin boards or other means of electronic notice used by the employer. 2.17 “Showing of interest” means written or electronic documentation that provides evidence of county employee membership or support for an employee organization for purposes of exclusive representation. For a “showing of interest,” county employees may submit an ink signature, a scanned signature, an electronically drawn or generated signature, or their typed name personally entered in the designated signature area. Any electronic signature acceptable under the “Uniform Electronic Transactions Act,” Article 71.3 of Title 24, is sufficient for a “showing of interest.” 2.18 “Unfair labor practices” are defined in C.R.S. § 8-3.3-115(1)-(6).

Rule 3. Filing, Service, and Deadlines 3.1 Documents shall be filed electronically, on a Division-approved form if one is available, pursuant to these rules and any orders, instructions, and deadlines provided or published by the Division. If the Division does not publish an applicable form or provide one to a party when the party intends to file, or if a party cannot readily use such means for filing, the party may file documents by any other means that provide the filing to the Division, including but not limited to email, other electronic means, or mailing or hand-delivering paper copies. A document is considered “filed” when received by the Division; any document received after 11:59 p.m. Mountain Time is considered “filed” the next business day. 3.1.1 Any submission is considered “signed” or to have a “signature” if it has either an ink, scanned, or electronically drawn or generated signature, or a typed name entered by the party or their authorized representative in the signature area. By signing in any such manner, the individual is deemed to have agreed and assented that the document is signed by them. 3.1.2 Handwritten signatures verifying identification and voter eligibility are required on envelopes in mail ballot elections. Typed or electronically drawn or generated signatures will not be accepted. 3.2 Except as otherwise provided by these rules, or by the Director, whenever service of a document is required, service is made to a person or party by hand-delivery, mail, or transmission by facsimile, or other electronic means. The email address or facsimile number on file with the Division or furnished by the person or party shall be used for service. The current address on file with the Division or the last known address of the person or party shall be used for mailing. 3.3 The calculation of any period of time prescribed or allowed by these rules shall be done in accordance with C.R.S. § 2-4-108. 3.4 Deadlines and schedules under these rules shall generally be set considering the goals of COBCA, including, but not limited to: effective enforcement of all rights and responsibilities provided by COBCA; providing all parties notice and opportunity to be heard; and conducting elections as soon as practicable. Deadlines may be extended for “good cause” if the request is made three days before the deadline, absent emergencies or exigent circumstances. In considering whether good cause exists under these rules or applicable statutes for extensions of deadlines, the Director will determine whether the reason is substantial and reasonable, based on all the available information and circumstances pertaining to the matter.

Rule 4. Certification or Decertification of Exclusive Representative 4.1 Certification of Exclusive Representative. 4.1.1 Petitions for the selection of an exclusive representative for a proposed bargaining unit shall be filed with the Division using the approved form(s) and in compliance with any instructions specified by the Division. 4.1.2 Petitions for the selection of an exclusive representative shall contain a showing of interest of at least 30% of the county employees in the proposed bargaining unit. 4.1.3 Petitions may be filed by an employee organization seeking exclusive recognition, or by a single employee, a group of employees, or the representative of either of them. 4.1.4 Upon receipt of a petition for selection of an exclusive representative, the Director shall issue a notice identifying the petitioner and the proposed bargaining unit, explaining the election process, and advising county employees of their rights under C.R.S. § 8-3.3- 103(1)-(3). The county shall distribute the notice to the county employees in the proposed bargaining unit and shall post the notice in the manner described in Rule 2.16. 4.1.5 An employee organization voluntarily recognized by a county prior to July 1, 2023, may obtain certification from the Division using forms approved by the Division, if any, and in accordance with C.R.S. § 8-3.3-108(2)(a)-(c). An employee organization that does not obtain such a certification shall nevertheless continue as the voluntarily recognized exclusive representative for the duration of a CBA in effect as of July 1, 2023. 4.2 Intervention. 4.2.1 Within 10 days after the date the notice in Rule 4.1.4 is first distributed, other employee organizations may seek to intervene in the certification process by filing a petition for intervention with the Division using the approved form(s) and in compliance with any instructions specified by the Division. 4.2.2 Petitions for intervention shall contain a showing of interest of at least 30% of the county employees in the proposed bargaining unit. Disputes regarding the composition of the bargaining unit will be resolved in accordance with Rule 4.4. 4.3 Decertification of Exclusive Representative. 4.3.1 A county employee or an employee organization may initiate decertification of the exclusive representative. 4.3.2 A petition for decertification shall be filed with the Division using the approved form(s) and in compliance with any instructions specified by the Division. 4.3.3 The decertification petition shall contain a showing of interest demonstrating that at least 30% of the county employees in the appropriate bargaining unit either:

(A) request decertification of the existing exclusive representative, or (B) authorize an employee organization other than the exclusive representative to represent them for purposes of collective bargaining. 4.3.4 If a collective bargaining agreement is in effect, the petition for decertification may be filed no earlier than 90 days and no later than 60 days prior to the expiration of the collective bargaining agreement; except that a petition for decertification may be filed any time after the third year of a collective bargaining agreement that has a term of more than three years. 4.3.5 If a collective bargaining agreement is not in effect, no action shall be taken on a petition for decertification earlier than 12 months after the certification of an employee organization as the exclusive representative. 4.4 Appropriate Bargaining Unit Determination. 4.4.1 Objections to bargaining unit composition shall be raised by a party or intervenor within 10 days after the county posts the notice of the petition as required in Rule 4.1.4, by submitting a position statement that shall include any relevant arguments and supporting evidence. 4.4.2 In any dispute regarding the determination of the appropriate bargaining unit based on the factors listed in C.R.S. § 8-3.3-110, the parties may address, among other considerations, (A) the community of interest and right to effective representation of the petitioned-for employees, (B) the efficiency of county operations, and/or (C) the promotion of harmonious, peaceful, and cooperative employment relations. 4.4.3 After receiving a position statement objecting under Rule 4.4.1, the Director may: invite or order other parties to submit responses; order an investigation, and/or the exchange of discovery; order parties to appear at any hearing(s); and/or issue findings of fact or law prior to holding a hearing to determine the appropriate bargaining unit. 4.4.4 In the event of a hearing to determine the appropriate bargaining unit, the Director will accept evidence on the factors listed in C.R.S. § 8-3.3-110, and Rule 4.4.2, and issue a written determination of the appropriate bargaining unit, including findings of fact, conclusions of law, and an order. 4.4.5 The Director may determine a unit to be an appropriate unit in a particular case, even though some other unit might also be appropriate. 4.4.6 The Director’s decision regarding an appropriate bargaining unit is an administrative determination rather than a final agency action, and therefore is not subject to appeal until final certification of an election. 4.5 Showing of Interest Determination. 4.5.1 After composition of the bargaining unit has been deemed appropriate, either by consent of the parties or by decision of the Director, the sufficiency of the showing of interest of each petitioner shall be determined without disclosing the identity of any county employee who participated in the showing of interest. 4.5.2 In determining the sufficiency of the showing of interest, the Director may request a list of the employees in the bargaining unit from the county employer for comparison. 4.5.3 If any petition lacks sufficient showing of interest, the Director, in accordance with C.R.S. § 8-3.3-109(3), shall permit a 10-day opportunity for the petitioner to demonstrate a sufficient showing of interest in the bargaining unit. 4.5.4 The sufficiency of the showing of interest in a representation election for exclusive representation is an administrative determination made by the Director and is not subject to challenge by any person. 4.6 Representation Elections (Certification or Decertification). 4.6.1 Within 10 days after the Director’s determination that a sufficient showing of interest has been provided, the Director shall:

(A) Order the county to provide to the petitioning employee organization(s) and the Division, by three business days before the pre-election conference, unless the Director orders an earlier date, a list of employees as required by C.R.S. § 8-3.3- 109(4)(a) and the Labor Peace and Industrial Relations (“LPIR”) Rules, 7 CCR 1101-1, Rules 5.3.2(C) and 5.3.3, and consistent with the requirements of those statutory and rule provisions, unless the Director orders different procedures based on the circumstances;

(B) Establish procedures for a secret ballot election, conducted in-person, by mail, and/or other means the Director determines to be appropriate, either by consent or by order, after soliciting input from the parties at a pre-election conference or otherwise; and (C) Order the county to distribute the election notice to all county employees in the appropriate bargaining unit and to post the election notice in the manner described in Rule 2.16. 4.6.2 Notices and ballots for any election shall be in English and Spanish if any party or eligible voter credibly indicates, at or before the pre-election conference, that any voters need Spanish-language ballots. Any party or eligible voter may request ballots in any other language, and the Director shall endeavor to so provide if possible in the time provided. 4.6.3 The ballot for the secret ballot election shall contain:

(A) The name of any employee organization submitting a petition with a sufficient showing of interest as determined by the Director in accordance with Rule 4.5; and (B) A choice of “no representation” for county employees to indicate they do not desire to be represented by an employee organization. 4.6.4 Representation elections shall follow the procedures of LPIR Rules 5.3.2(C)–5.3.3, 5.5.3– 5.5.5, and 5.6.2–5.8.3, unless the Director orders different procedures based on the circumstances. 4.6.5 The Director shall notify, or cause notice to be provided to, all parties and all covered employees of the certified results of the secret ballot election. 4.6.6 In order to prevail in an election, a choice on the ballot must receive a majority of the valid ballots cast, except:

(A) In a certification election in which only the petitioning employee organization and “no representation” appear on the ballot, “no representation” prevails in the event of a tie vote.

(B) In a decertification election in which only the incumbent employee organization and “no representation” appear on the ballot, the incumbent employee organization prevails in the event of a tie vote. 4.6.7 Within 28 days after a secret ballot election with multiple employee organizations on the ballot, a runoff election shall be held if there is no majority of ballots cast for any employee organization and the “no representation” choice did not achieve a majority.

(A) A runoff election shall be between the two employee organizations that received the most ballots cast in the initial representation election. “No representation” will not be a choice in the runoff election.

(B) A runoff election shall be held no later than 28 days after the initial representation election and shall be conducted as a second balloting limited to the two runoff options.

(C) Only if an employee organization receives a majority of the ballots cast in the runoff election will the Director certify the employee organization as the exclusive representative of all county employees in the appropriate bargaining unit. In the event of a tie, neither employee organization has achieved a majority and neither employee organization will be certified as the exclusive representative. 4.6.8 Within seven days after certification of the results of an election, any party may file objections to the conduct of the election or to conduct affecting the results of the election.

Absent timely objections, the certification shall constitute final agency action subject to judicial review pursuant to C.R.S. § 24-4-106.

(A) The objections must contain a short statement of the reasons for the objections and be accompanied by a written offer of proof identifying:

(i) each witness the party would call to testify concerning the issue; and (ii) a summary of each witness’s testimony.

(B) Upon a showing of good cause, the Director may extend the time for filing the offer(s) of proof. Objections without supporting evidence may be dismissed.

(C) The party filing objections shall serve a copy of the objections, but not the offer(s) of proof, on the other parties. The objecting party shall file a signed statement with the Division affirming that the objections have been served on the other parties and stating the date and method of service. The other parties shall have 10 days from the date of service to respond to any objection. Responses shall be served on all other parties and filed with the Division. The Division filing must be accompanied by the same offer of proof required by subsection (A) of this rule.

(D) The Division will only investigate challenged ballots if the challenged ballots are sufficient in number to affect an election’s outcome.

(E) If the Director or a designated hearing officer finds that misconduct affected the outcome of the election, the Director shall invalidate the election and order a subsequent election for the county employees in the appropriate bargaining unit within 28 days after the finding. This order is an administrative determination, rather than a final agency action, and therefore is not subject to appeal until after final certification of the subsequent election.

Rule 5. Unfair Labor Practices 5.1 Unfair Labor Practice Complaints. 5.1.1 Unfair labor practice complaints shall be filed on the designated form provided by the Division, and shall comply with any other Division instructions as to the information and/or documentation required by the Division.

(A) The aggrieved party filing an unfair labor practice complaint shall be designated the charging party. The party against whom a complaint is filed shall be designated the respondent(s).

(B) Either party may designate an authorized representative to act on their behalf in the Division’s complaint and/or appeal process in accordance with Rule 2.1.

(C) An unfair labor practice complaint (or charge) must be received by the Division within six months after the date on which the charging party knew or reasonably should have known of the alleged unfair labor practice.

(D) The charging party shall set forth a clear and concise statement of the facts constituting the unfair labor practice and the statutes allegedly violated.

(E) Failure to respond in a timely manner to requests from the Division for additional supporting information and/or documentation may result in dismissal of the unfair labor practice complaint. 5.1.2 The Division will evaluate unfair labor practice complaints to determine if the Division has jurisdiction over the alleged conduct and if sufficient allegations and evidence has been shown from which an unfair labor practice may be reasonably inferred. 5.1.3 If the unfair labor practice complaint provides insufficient evidence, the Division will notify the charging party and may request additional information and/or documentation. 5.1.4 A charging party may withdraw an unfair labor practice complaint at any time prior to issuance of a determination. 5.2 Notice of Unfair Labor Practice Complaint to Respondent(s). 5.2.1 After determining that a charging party’s unfair labor practice complaint contains sufficient allegations and evidence that, if proven true, would state a claim of an unfair labor practice, the Division shall give notice of the allegations and request an answer be filed by each respondent. 5.2.2 The respondent shall file an answer responding to each allegation in the complaint, and attach any documentation or evidence the respondent wishes the Division to consider in reviewing the complaint, within 21 days of the date the Division sends a copy of the complaint to the respondent. The Division may exercise discretion to shorten the response deadline. 5.2.3 Upon receiving a request in writing to the Division stating the reason an extension is required, the Division may, at its discretion, extend the period for the respondent to file an answer to the complaint for good cause in accordance with Rule 3.4. 5.2.4 Upon written request, at the Division’s discretion, other parties or entities may be designated as intervenors or may be joined as charging parties or respondents. 5.3 Investigation and Determination of Unfair Labor Practice Complaints. 5.3.1 Upon receipt of the unfair labor practice complaint, the answer, and any supplemental information or documentation, the Division shall determine whether additional investigation is required. In the event further investigation is required, investigatory methods used by the Division may include, but are not limited to:

(A) Interviews of the employer, employee(s), and other parties;

(B) Information gathering, fact-finding, and reviews of written submissions; and (C) Any other lawful techniques that enable the Division to assess whether an unfair labor practice occurred. 5.3.2 During the investigation, if information is provided to the Division by a source requesting confidentiality, and that information is used only as a basis for procuring other evidence, but not offered as evidence itself, then the source shall remain confidential. 5.3.3 The Division may exercise its discretion to have an investigation sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations and/or phases of the investigation. 5.3.4 Where a complaint or investigation for violation of these rules or the statutes they enforce has been filed or commenced, all parties shall preserve all relevant documents until final disposition and until the expiration of the statutory period within which a person aggrieved may bring a civil action. 5.3.5 The burden of proof for establishing an unfair labor practice is on the charging party, who must establish by a preponderance of the evidence that an unfair labor practice has been committed. 5.3.6 The Division shall make a determination as to whether an unfair labor practice has been committed and issue written findings and orders, which shall be sent to all parties. Absent a timely administrative appeal, the determination shall constitute final agency action, and the final decision of the Director, subject to judicial review pursuant to C.R.S. § 24-4-106. 5.3.7 Determinations by the Division may include the following remedies, as the findings of the determination warrant, and pursuant to the Division’s investigative and enforcement

authority as authorized by COBCA and/or other statutes:

(A) appropriate administrative remedies;

(B) actual damages related to employee organization dues;

(C) back pay, including benefits;

(D) reinstatement of the county employee with the same seniority status the employee would have had but for the unfair labor practice violation;

(E) other remedies to address any loss suffered by a county employee or a group of county employees from unlawful conduct by a county;

(F) declarative or injunctive relief or provisional remedies, including temporary restraining orders or preliminary injunctions; and (G) any other remedies or relief authorized by law, including but not limited to C.R.S.

Title 8, Articles 1, 4, 6, and 13.5. 5.4 Unfair Labor Practice Appeals. 5.4.1 Either the charging party or respondent may file an administrative appeal within 35 days from the date of the Division’s determination. A valid appeal is a written statement explaining the basis for the appeal that is timely filed with the Division, is not frivolous, and has been signed by the appellant or the appellant’s authorized representative. An appeal is frivolous if it fails to allege an error that could result in the reversal or modification of the determination or otherwise is manifestly insufficient or futile. The Division’s initial determination remains operative during the appeal, unless an appeal filing requests, and then is granted, any stay. 5.4.2 On appeal, findings of fact are reviewable for clear error, while findings of law are reviewable de novo. 5.4.3 Upon receipt of the appeal, the Division will notify the parties of the date of the hearing and any interim deadlines, and send a copy of the appeal and a copy of the record of its investigation to the parties by mail or email. All evidence submitted to the Division during the investigation is part of the record on appeal and need not be resubmitted. 5.4.4 The hearing officer (including an Administrative Law Judge) shall have the power and

authority to call, preside at, and conduct hearings on the appeal, including the power to administer oaths and affirmations, order and take depositions, certify to official acts, and issue subpoenas to compel the attendance of witnesses and the production of books, papers, correspondence, memoranda, and other records deemed necessary as evidence in connection with a disputed determination. The hearing officer shall make a decision on each relevant issue raised, including findings of fact, conclusions of law, and an order. 5.4.5 Parties who timely file a valid appeal of the Division’s determination will be afforded an administrative appeal hearing before a Division hearing officer. Parties may be required to appear by telephone or other remote means. 5.4.6 The parties may submit new testimonial evidence, which is defined as any evidence that is elicited through the statements of individual witnesses, to the hearing officer in accordance with deadlines imposed by the Division. New evidence must be sent to all other parties to the appeal. Failure to send all new evidence to all other parties to the appeal may result in the evidence being excluded from the record. The parties may submit new documentary or other non-testimonial evidence in accordance with deadlines imposed by the Division and upon showing “good cause,” which may be assessed based on any relevant factors, including but not limited to:

(A) That the new evidence was previously not known or obtainable, despite diligent evidence gathering efforts by the party offering the new evidence;

(B) That the party failed to receive fair notice of the investigation or of a key filing by another party or by the Division to which the new evidence is responsive;

(C) That factors outside the control of the party prevented a timely action or interfered with the opportunity to act, except that the acts and omissions of a party’s authorized representative are considered the acts and omissions of the party and are not considered to be a factor outside the party’s control as intended by this rule;

(D) That a determination raised a new issue or argument that cannot be responded to adequately without the new evidence;

(E) That, at the investigation stage, the party offering new evidence requested more time to submit evidence, yet was denied, and in the hearing officer’s judgment (1) the need for more time was legitimate and did not reflect neglect by the party, (2) the denial of the request for more time was unwarranted, and (3) exclusion of the evidence would cause substantial injustice to the party; and/or (F) That failure to admit the new evidence otherwise would cause substantial injustice and did not arise from neglect by the party. 5.4.7 An appeal may, at the discretion of the hearing officer, be sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more decisions and/or phases of the appeal.

Rule 6. Judicial Review 6.1 The certification of an election or the determination of a ULP complaint by the Director, a hearing officer, or an Administrative Law Judge (“ALJ”) constitutes a final agency action subject to judicial review pursuant to C.R.S. § 24-4-106. The Division shall promptly provide all parties with a copy of the decision of the Director, hearing officer, or ALJ by mail or email. _________________________________________________________________________ Editor’s Notes

History New rule eff. 07/01/2023.

7 CCR 1103-17 Protections for Public Workers Act (propwa) Rules {#sec-7-ccr-1103-17 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-17}

DEPARTMENT OF LABOR AND EMPLOYMENT

PROTECTIONS FOR PUBLIC WORKERS ACT (PROPWA) RULES

7 CCR 1103-17 [Editor's Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted October 10, 2024; effective December 1, 2024.

Rule 1. Statement of Purpose and Authority. 1.1 Authority and relation to other orders. The general purpose of these Protections for Public Workers Act (“PROPWA”) Rules is to exercise the authority of the Director, through the Division, to administer and enforce the provisions of the Protections for Public Workers Act, Colorado Revised Statutes (C.R.S.) Title 29, Article 33 (2023), C.R.S. § 29-33-101 et seq. These Rules are intended to be consistent with the rulemaking requirements of the State Administrative Procedure Act, C.R.S. § 24-4-103. 1.2 The Director of the Division has authority to enforce, interpret, apply, and administer the provisions of C.R.S. Title 29, Article 33 and these Rules. 1.3 [Expired 05/15/2025 per Senate Bill 25-125] 1.4 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any

part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rule remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form.

Rule 2. Definitions and Clarifications. 2.1 “Authorized representative” means a person designated by a party to any unfair labor practice complaint or other Division administrative proceeding to represent the party. A party may designate an authorized representative by filing the Division-approved form or a signed written notice to the Division that the authorized representative will represent the party. Authority of the authorized representative may be revoked by the party upon written notice to the Division. 2.2 “Director” means the Director of the Division of Labor Standards and Statistics, and includes a designee or agent to perform any delegable functions of the Director pursuant to authority granted by any applicable provision of law, including but not limited to C.R.S. § 8-1-103(1). 2.3 “Division” means the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment. 2.4 “Employee organization” means an organization independent of the employer in which public employees may participate and that exists for the purpose, in whole or in part, of acting on behalf of and for the benefit of the public employees concerning public employee grievances, labor disputes, wages, hours, and other terms and conditions of employment. “Employee organization” includes any agents or representatives of the employee organization designated by the employee organization. “Employee organization” does not include an organization, including a committee, advisory council, or other similar group, that includes public employees but is created by a public employee’s employer. 2.5 “Order” means any decision, rule, regulation, requirement, or standard promulgated by the Director, as defined by C.R.S. § 8-1-101(11). 2.6 “Person” refers to one or more individuals, an employee, an employee organization, partnerships, associations, corporations, legal representatives, trustees, or receivers. 2.7 “Public employee” means an individual employed by a public employer; except those employees employed in the personnel system of the state established in Section 13 of Article XII of the state Constitution, or employees employed by an employer, as defined in C.R.S. § 8-3-104(12). “Public employee” includes two types of employees as follows: 2.7.1 “Confidential public employee” means a public employee who: (A) develops or presents the positions of the employer with respect to employer-employee relations, contributes significantly to the employer’s decision-making in connection with such positions, or accesses confidential information, including the employer’s non-public planning or strategy information, in connection with the development, presentation, or decisionmaking of the employer’s positions with respect to employer-employee relations; or (B) provides legal advice to the employer as the employer’s attorney related to this Article 33 or other labor relations matters. 2.7.2 “Managerial public employee” means an executive-level public employee with significant decision-making authority including the authority to develop employer policies or programs or administer an agency or other subdivision of the employer. “Managerial employee” does not include a non-policymaking employee even if the employee oversees, manages, or directs other employees; except that a firefighter who is a “supervisor,” as defined in C.R.S. § 29-5-203(15) (“the chief and all officers in the rank or position immediately below the chief who report directly to the chief”), is a “managerial employee” for purposes of this Article 33. 2.8 “Public employer” means a county or municipality; a district, business improvement district, special district created pursuant to Title 32, authority, or other political subdivision of the state, a county, or a municipality; the Colorado School for the Deaf and Blind established in Article 80 of Title 22; a state institution of higher education as defined in section 23-18-102(10)(a), and a local district college operating pursuant to Article 71 of Title 23; the Office of State Public Defender created in section 21-1-101; the University of Colorado Hospital Authority created in section 23- 21-503; the Denver Health and Hospital Authority created in section 25-29-103; the Joint Budget Committee staff, the Legislative Council staff, the Office of Legislative Legal Services, the staff of the Office of the Chief Clerk of the House of Representatives, and the Senate Services staff; the majority and minority caucus staff of the House of Representatives and the Senate; a board of cooperative services established pursuant to the “Boards of Cooperative Services Act of 1965,”

Article 5 of Title 22; any school district as defined in section 22-7-1003(20); a district charter school pursuant to part 1 of Article 30.5 of Title 22; or an institute charter school which means a charter school authorized by the State Charter School Institute pursuant to part 5 of Article 30.5 of Title 22. Counties covered by the Collective Bargaining by County Employees Act (“COBCA”) are not “public employers” for purposes of these rules. 2.9 “Retaliation” and “interference” (or other forms of those words) are as defined in the Colorado Whistleblower, Anti-Retaliation, Non-Interference, and Notice-Giving Rules, 7 CCR 1103-11. 2.10 “Unfair labor practice” means a violation of any rights or obligations in PROPWA or these Rules.

Rule 3. Filing, Service, and Deadlines. 3.1 Documents shall be filed electronically, on a Division-approved form if one is available, pursuant to these Rules and any orders, instructions, and deadlines provided or published by the Division.

If the Division does not publish an applicable form or provide one to a party when the party intends to file, or if a party cannot readily use such means, the party may file by any means that provides the filing to the Division, including but not limited to email, other electronic means, or mailing or hand-delivering copies. A document is considered “filed” when received by the Division; a document received after 11:59 p.m. Mountain Time is considered “filed” the next business day. 3.2 Any submission is considered “signed” or to have a “signature” if it has either an ink, scanned, or electronically drawn or generated signature, or a typed name entered by the party or their authorized representative in the signature area. By signing in any such manner, the individual is deemed to have agreed and assented that the document is signed by them. 3.3 Except as otherwise provided by these Rules, or by the Director, whenever service of a document or information is required, service is made to a person or party by hand-delivery, mail, or transmission by facsimile, or other electronic means. The email address or facsimile number on file with the Division or furnished by the person or party shall be used for service. The current address on file with the Division or the last known address of the person or party shall be used for mailing. 3.4 Calculations of any prescribed or allowed time periods shall be in accordance with C.R.S. § 2-4- 108. 3.5 Deadlines and schedules under these Rules shall generally be set in light of the goals of PROPWA, including but not limited to: effective enforcement of PROPWA rights and responsibilities; providing all parties notice and opportunity to be heard; and timely protection of public employees from retaliation for engaging in protected concerted activity. 3.6 Deadlines may be extended for “good cause” if the request is made three days before the deadline, absent emergencies or exigent circumstances. In considering whether good cause exists under these Rules or applicable statutes for extensions of deadlines, the Director will determine whether the reason is substantial and reasonable, based on all the available information and circumstances, and the above-listed goals of PROPWA.

Rule 4. Scope of Rights and Responsibilities under PROPWA. 4.1 Protected Activity under PROPWA. 4.1.1 Types of Activities Protected. PROPWA protects public employee rights to engage in the following activities in C.R.S. §§ 29-33-104(1)(a)–(d) and -104(3) (“Section 104 activity”):

(A) speech on employee representation, workplace issues, or PROPWA rights (“Section 104(1)(a) activity”);

(B) concerted activity for mutual aid or protection (“Section 104(1)(b) activity”);

(C) political participation while off duty and not in uniform, including (i) speech with the public employer’s governing body (or any of its members) on work terms and conditions or matters of public concern, and (ii) political activity of other kinds in the same manner as other Coloradans (“Section 104(1)(c) activity”);

(D) organizing, forming, joining, or assisting an employee organization, or refraining from doing so (“Section 104(1)(d) activity”); and (E) exercising any rights under PROPWA, including but not limited to complaining, testifying or otherwise submitting evidence or information about, or opposing (verbally or in writing) what the employee believes, reasonably and in good faith, to be a violation of PROPWA (“Section 104(3) activity”).

Section 104(1)(a) and 104(1)(c) activities collectively are “PROPWA expressive activity”;

Section 104(1)(b) and 104(1)(d) activities collectively are “PROPWA concerted activity.” 4.1.2 When Multiple Sections Apply. If activity may or is alleged to qualify under multiple of Sections 104(1)(a)–(d) or 104(3), or any other section of any applicable law (constitutional, statutory, or regulatory), then it shall be analyzed separately under each

section as to scope of protection, defenses, and other matters. 4.1.3 Applicability of Other Law. Any enumeration in PROPWA or in these Rules of rights, responsibilities, or limits thereupon is not intended to deny, modify, or limit other rights or responsibilities under any other source of law (constitutional, statutory, or regulatory) that may apply to situations also covered by PROPWA. 4.2 PROPWA Expressive Activity: Scope and limits (Section 104(1)(a) and (c) activity). 4.2.1 Expressive activity is protected unless the employer shows that an exception in Rules 4.2 or 4.4 applies. 4.2.2 Official Duties. PROPWA expressive activity shall not be protected if it is pursuant to or

part of duties that the public employee either:

(A) is paid by their public employer to perform; or (B) otherwise has a responsibility to perform under a directive from their public employer. 4.2.3 Restrictions on the Time, Place, and Manner of Expressive Activity.

(A) In a place that qualifies as a public forum. A place qualifies as a “public forum” open for expressive activity by the public, including by public employees, if it has been traditionally open to such activity, or was opened for such activity by a public entity. In a public forum, expressive activity is unprotected if the activity is contrary to a limitation on the time, place, or manner of such activity:

(1) that is set and enforced on a content-neutral and viewpoint-neutral basis;

(2) that is narrowly tailored to serve a significant governmental interest; and (3) that leaves open ample alternative channels for the activity that are known and available to the public employee.

(B) In other places. Expressive activity in places other than a public forum is unprotected if it is contrary to a limitation on the time, place, or manner of such activity:

(1) that is reasonable in light of the purposes of the forum; and (2) that is viewpoint-neutral. 4.3 PROPWA Concerted Activity: Scope and Limits (Section 104(1)(b) and (d) activity). 4.3.1 Scope of Concerted Activity Protected. “Concerted activity” is activity by one or more public employees for the purpose of mutual aid or protection (irrespective of any subjective motivations of the employee), among employees of the same or another employer, and includes the protected rights of employees set forth in 29 U.S.C. § 157; except that “protected, concerted activity for the purpose of mutual aid and protection” does not include the right or obligation to recognize or negotiate a collective bargaining agreement. 4.3.2 Limits on Protection. Concerted activity is protected unless the employer shows that an exception in Rules 4.3 or 4.4 applies.

(A) Protected concerted activity does not include the activities of a confidential public employee or a managerial public employee, as defined in C.R.S. § 29-33- 103(5)(b).

(B) Concerted activity of solicitation, or distribution of written materials, related to an employee organization may be restricted during any working time (e.g., interacting directly with customers) if the restriction does not discriminate or retaliate against, or interfere with, the activity (as set forth in Rules 4.4.1–4.4.2). 4.4 Management Rights: Scope and Limits. 4.4.1 Permissible Employer Actions. Even if a public employee did or may engage in PROPWA protected activity, adverse action — termination, discipline, or other action that may deter protected activity — is not unlawful under PROPWA if it is not imposed (or disproportionately imposed) in whole or in part to discriminate against, interfere with, or otherwise deter protected activity. 4.4.2 Impermissible Interference or Retaliation. A public employer rule, policy, or action shall not:

(A) impermissibly interfere with or retaliate against protected activity, including if it was enacted or enforced in response to protected activity as a way to interfere with or retaliate against such activity; or (B) be overly broad or vague in a way that may be reasonably understood as impermissibly interfering with or retaliating against protected activity, when read by a public employee dependent upon their job who acts reasonably, and in good faith, in interpreting the potential restriction in light of factors such as past practice, the nature of the workplace, and the field of work. 4.4.3 Employer Expressive Activity. Public employers may express views, including engaging in conversations, with public employees about the advantages and disadvantages of employee organizations and collective bargaining. In doing so, such expression:

(A) may include general views on employee organizations, or predictions of the effects of unionization on the employer, to the extent such predictions have a

basis in objective fact as demonstrably probable consequences beyond employer control; but (B) may not include or be accompanied by actions reasonably tending to discriminate against, interfere with, or otherwise deter protected activity, such as an economic (or other) threat of the employer’s own volition, a promise of a benefit for foregoing or causing others to forego protected activity, or creating an impression of surveillance — whether or not protected activity is actually interfered with, deterred, or surveilled. 4.4.4 Activity that results in material disruption of a public employee’s duties, a public employer’s operations, or the delivery of public services is not protected activity; except that an employer’s or other individual’s disagreement with the content or viewpoint expressed through an employee’s activity or a strike by employees does not constitute material disruption. 4.4.5 A public employer may limit the rights of a public employee to the extent necessary to maintain the nonpartisan role of the employer’s nonpartisan legislative, judicial, or election-related staff.

Rule 5. Unfair Labor Practice Filings and Proceedings. 5.1 Unfair Labor Practice Complaints. 5.1.1 Unfair labor practice complaints (“complaints” as used in this Rule 5) shall be filed on the designated form provided by the Division, and shall comply with any other Division instructions as to the information and/or documentation required by the Division.

(A) An aggrieved party filing a complaint is designated a “charging party.” A party against whom a complaint is filed is designated a “respondent.”

(B) Either party may designate an authorized representative to act on their behalf in the Division’s complaint and/or appeal process in accordance with these Rules.

(C) A complaint must be received by the Division within six months after the date on which the charging party knew or reasonably should have known of the alleged unfair labor practice.

(D) The charging party shall set forth a clear and concise statement of the facts constituting the unfair labor practice and (to the extent that the party is able) the statutes allegedly violated.

(E) Failure to respond in a timely manner to Division requests for additional supporting information and/or documentation may result in dismissal of the complaint.

(F) The Director may initiate, file, and investigate any such complaint on their own initiative, or at the request of any interested party. The name or interest of any such party shall not be disclosed if not necessary to resolution of the complaint.

Decisions under this Rule are within the discretion of the Director’s authority to enforce and administer PROPWA, these Rules, and other applicable statutes and rules. 5.1.2 The Division will evaluate complaints to determine if the Division has jurisdiction over the alleged conduct, if sufficient allegations and evidence have been shown from which an unfair labor practice may be reasonably inferred, and if, in the Director’s good faith discretion and judgment, the complaint warrants investigation.

(A) In exercising its discretion, the Division may decline to investigate, or may defer action on, a complaint if evidence shows the dispute is within the scope of a dispute resolution process, established by a collective bargaining agreement applicable to both parties, with a neutral third-party arbiter authorized to issue a binding decision. 5.1.3 If a complaint provides insufficient evidence, the Division will notify the charging party and may request additional information and/or documentation. 5.1.4 A charging party may withdraw a complaint at any time prior to issuance of a determination. 5.2 Notice of Unfair Labor Practice Complaints to Respondents. 5.2.1 After determining that a complaint offers sufficient allegations and evidence that, if proven true, would state a claim of an unfair labor practice, the Division shall give notice of the allegations, and request that an answer be filed by each respondent. 5.2.2 The respondent shall file an answer responding to each allegation in the complaint, and attach any documentation or evidence the respondent wishes the Division to consider in reviewing the complaint, within 21 days of the date the Division sends a copy of the complaint to the respondent. The Division may exercise discretion to shorten the response deadline. 5.2.3 Upon receiving a written request for an extension that states the reason an extension is required, and that otherwise complies with Rule 3.6, the Division may, at its discretion, extend the period for the respondent to file an answer for good cause in accord with these Rules. 5.2.4 Upon written request, at the Division’s discretion, other parties or entities may be joined as charging parties or respondents. 5.3 Investigation and Determination of Unfair Labor Practice Complaints. 5.3.1 Upon receipt of a complaint, the answer, and any supplemental information or documentation, the Division shall determine whether additional investigation is required, which may include, but is not limited to:

(A) interviews of the employer(s), employee(s), and/or other parties;

(B) information gathering, fact-finding, and reviews of written submissions; and (C) any other methods that may help assess whether an unfair labor practice occurred. 5.3.2 During the investigation, if information is provided to the Division by a source requesting or otherwise warranting confidentiality, and that information is used as a basis for procuring other evidence but not offered as evidence itself, or as evidence of liability, but not to establish individual relief for the source of the information, or in other circumstances in which confidentiality is necessary and appropriate, then the source shall remain confidential. 5.3.3 The Director may exercise discretion to adjourn hearings; to permit additional time for submissions; to extend ordered deadlines for good cause or by consent; and to issue orders disposing of a complaint without a hearing. 5.3.4 Where a complaint or investigation for violation of these Rules or the statutes they enforce has been filed or commenced, all parties shall preserve all relevant documents until final disposition and until the expiration of the statutory period within which a person aggrieved may bring a civil action. 5.3.5 The Division may exercise its discretion to have an investigation sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations and/or phases of the investigation. 5.3.6 The Division may exercise its discretion to terminate an investigation at any time. 5.3.7 The burden of proof to establish an unfair labor practice is on the charging party, who must establish by a preponderance of the evidence that an unfair labor practice occurred. 5.3.8 The Division shall make a determination as to whether an unfair labor practice occurred, and issue written findings and orders to all parties. Absent a timely request for a hearing pursuant to Rule 5.3.9, the determination shall constitute final agency action, and the final decision of the Director, subject to judicial review pursuant to C.R.S. §§ 24-4-106 and 29- 33-105(4),(5). 5.3.9 A hearing may be requested within 35 days after the Division’s determination of a complaint, and conducted in accord with Rule 6.4 of the Labor Peace and Industrial Relations Rules, 7 CCR 1101-1, which is incorporated herein by reference. Absent timely modification, the decision rendered after the hearing shall constitute final agency action and the final decision of the Director subject to judicial review pursuant to C.R.S. §§ 24-4- 106 and 29-33-105(4)–(5). 5.4 Remedies for Unfair Labor Practices. 5.4.1 The Division shall consider the unique circumstances of rural counties as defined in C.R.S. § 29-33-103(1)(b) in assigning remedies. 5.4.2 Remedies for unfair labor practices may include any of the following, pursuant to investigative and enforcement authority under applicable statutes the Division enforces or administers.

(A) Damages to compensate losses caused by an unfair labor practice, including but not limited to, where applicable: back pay with benefits; lost dues for an employee organization; and other direct or foreseeable pecuniary harm.

(B) Reinstatement or instatement with the same seniority status the employee would have without the violation, or (if (re)instatement is not feasible) front pay with benefits.

(C) Orders to cease and remedy violations and effects thereof; effectuate compliance by modifying or rescinding policies, practices, or agreements; otherwise redress direct or indirect consequences of violations; and provide notice of any such changes.

(D) Any other relief authorized by applicable statutes the Division enforces or administers. _________________________________________________________________________ Editor’s Notes

History New rule eff. 07/01/2024.

Rule 6 emer. rule eff. 08/07/2024.

Entire rule eff. 12/01/2024.

Annotations

Rule 1.3 (adopted 10/10/2024) was not extended by Senate Bill 25-125 and therefore expired 05/15/2025.

7 CCR 1103-18 Posting, Screening, and Transparency Rules (“post Rules”) {#sec-7-ccr-1103-18 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-18}

DEPARTMENT OF LABOR AND EMPLOYMENT

POSTING, SCREENING, AND TRANSPARENCY RULES (“POST Rules”)

7 CCR 1103-18 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted May 3, 2024; effective July 1, 2024.

Rule 1. Statement of Purpose and Authority. 1.1 The general purpose of these Posting, Screening, and Transparency Rules (“POST Rules”) is to exercise the authority of the Director, through the Division of Labor Standards and Statistics, to administer and enforce the provisions of C.R.S. §§ 8-2-126, 8-2-127, 8-2-130, 8-2-131, and 8-5- 201 et seq. (2024). These rules are adopted pursuant to the Division’s authority in C.R.S. §§ 8-1- 107(2)(p), 8-1-103(3), 8-1-111, 8-2-126, 8-2-127, 8-2-130(5)(e), 8-2-131(5)(f), 8-5-103, and 8-5- 203. These rules are intended to be consistent with the rulemaking requirements of the State Administrative Procedure Act, C.R.S. § 24-4-103. Unless otherwise noted, in these Rules: all statutes cited apply the most recent 2023 versions of the Colorado Revised Statutes; all rules cited apply the most recent versions adopted as of the adoption of these Rules. 1.2 These POST Rules replace the Employment Opportunity Act Rules (7 CCR 1103-4), the Social Media and the Workplace Law Rules (7 CCR 1103-5), the Colorado Chance To Compete Act Rules (7 CCR 1103-9), and the Equal Pay Transparency Rules (“EPT Rules”) (7 CCR 1103-13). 1.3 The Director of the Division of Labor Standards and Statistics in the Department of Labor and Employment has the authority to enforce, interpret, apply, and administer the statutes cited in

Rule 1.1 above and these rules. 1.4 Incorporation by reference. The Employment Opportunity Act, C.R.S. §§ 8-2-126; the Social Media and the Workplace Law, C.R.S. § 8-2-127; the Colorado Chance to Compete Act, C.R.S. § 8-2-130; the Job Application Fairness Act, C.R.S. § 8-2-131; and the Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq. (2024) (together referred to as the “POST Acts”) are hereby incorporated by reference into this rule. Such incorporation excludes later amendments to or editions of these statutes. These statutes are available for public inspection at the Colorado Department of Labor and Employment, 633 17th Street, Denver CO 80202. Copies may be obtained from the Department of Labor and Employment at a reasonable charge. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of them at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Division rules are available to the public at www.coloradolaborlaw.gov. Where these rules have provisions different from or contrary to any incorporated or referenced material, the provisions of these rules govern so long as they are consistent with Colorado statutory and constitutional provisions. Where these rules reference another rule, the reference shall be deemed to include all subparts of the referenced rule. 1.5 Severability. If any part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rule remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form. 1.6 Deadlines. Deadlines in these Rules may be extended for good cause. In considering whether good cause exists, the Division will determine whether the reason is substantial and reasonable, and must take into account all available information and circumstances pertaining to the specific Complaint.

Rule 2. Definitions. 2.1 “Adverse action” means termination, discipline, failure to hire or promote, lower compensation, or other action that may deter activity protected by any of the POST Acts. 2.2 “Aggrieved by” means a possible or perceived violation witnessed by, suffered by, or injured by. 2.3 “Career development” means “a change to an employee’s terms of compensation, benefits, fulltime or part-time status, duties, or access to further advancement in order to update the employee’s job title or compensate the employee to reflect work performed or contributions already made by the employee[,]” C.R.S. § 8-5-101(1.3), which means that such existing work or contributions:

(A) were part of the employee’s existing job; and (B) were not within a position with a current or anticipated “vacancy” as defined in C.R.S. § 8- 5-101(8.5) and these Rules. 2.4 “Career progression” means “a regular or automatic movement from one position to another based on time in a specific role or other objective metrics.” C.R.S. § 8-5-101(1.5). 2.5 “Complaint” or “Claim” interchangeably mean a Complaint or Claim alleging a violation of one of the POST Acts. “Complainant” means a person with a Complaint or Claim. 2.6 “Consumer credit information” means a written, oral, or other communication of information bearing on a consumer’s creditworthiness, credit standing, credit capacity, or credit history.

“Consumer credit information” includes a credit score but does not include the address, name, or date of birth of an employee associated with a social security number. “Consumer credit information” does not include income or work history verification. 2.7 “Credit score” means an attempted numerical quantification of a person’s creditworthiness or credit history. 2.8 “Division” means the Division of Labor Standards and Statistics within the Department of Labor and Employment. 2.9 “Electronic communications device” means a device that uses electronic signals to create, transmit, and receive information, including computers, telephones, personal digital assistants, and other similar devices. 2.10 “Employee” has the meaning provided in C.R.S. § 8-4-101(5), and includes every person who may be permitted, required, or directed by any employer in consideration of direct or indirect gain or profit, to engage in any employment, and includes an applicant for employment. 2.11 “Employer” has the meaning provided in C.R.S. § 8-4-101(6), except where a different meaning is otherwise required by statute, including:

(A) Under the Employment Opportunity Act, “employer” has the meaning provided by C.R.S. § 8-2-126(2)(e);

(B) Under the Social Media and the Workplace Law, “employer” has the meaning provided by C.R.S. § 8-2-127(1)(c);

(C) Under the Colorado Chance to Compete Act, “employer” has the meaning provided by C.R.S. § 8-2-130(2)(c);

(D) Under the Job Application Fairness Act, “employer” has the meaning provided by C.R.S. § 8-2-131(2)(b); and (E) Under the Equal Pay for Equal Work Act, “employer” has the meaning provided by C.R.S. § 8-5-101(5). 2.12 “Employment purposes” means evaluating a person for employment, hiring, promotion, demotion, reassignment, adjustment in compensation level, or retention as an employee. 2.13 “Initial employment application” or “initial written or electronic application form” includes all items the employer requires in order for an applicant to submit complete application materials for a position. 2.14 A “job opportunity” means “a current or anticipated vacancy for which the employer is considering a candidate or candidates or interviewing a candidate or candidates or that the employer externally posts.” C.R.S. § 8-5-101(5.5)(a). A job opportunity “does not include career development or career progression.” C.R.S. § 8-5-101(5.5)(b). 2.15 A “posting” and a “notice” of a job opportunity are interchangeable terms in these Rules; any “posting” qualifies as a “notice,” and any “notice” qualifies as a “posting.” A “notification of ... [a] job opportunity” (interchangeably termed a “job opportunity notice”) that must include compensation and benefits includes both a notice to current employees required by C.R.S. § 8-5- 201(1) and a posting an employer “externally posts” to others outside the employer. C.R.S. § 8-5- 101(5.5)(a). 2.16 “POST Acts” refer to the Employment Opportunity Act, C.R.S. § 8-2-126; the Social Media and the Workplace Law, § 8-2-127; the Colorado Chance to Compete Act, § 8-2-130; the Job Application Fairness Act, § 8-2-131; and the Equal Pay for Equal Work Act, § 8-5-201 et seq. 2.17 “Prevailing party” means a claimant or employer who successfully achieves a favorable outcome. 2.18 “Substantially related to the employee’s current or potential job” means the information contained in a credit report is related to the position for which the employee who is the subject of the report is being evaluated because the position: 2.18.1 Constitutes executive or management personnel or officers or employees who constitute professional staff to executive and management personnel, and the position involves one or more of the following — (A) Setting the direction or control of a business, division, unit, or an agency of a business, (B) A fiduciary responsibility to the employer, (C) Access to customers’, employees’, or the employer’s personal or financial information other than information customarily provided in a retail transaction, or (D) The authority to issue payments, collect debts, or enter into contracts; 2.18.2 Involves contracts with defense, intelligence, national security, or space agencies of the federal government; or 2.18.3 Is with a bank or financial institution. 2.19 A “vacancy” means “an open position, whether as a result of a newly created position or a vacated position.” C.R.S. § 8-5-101(8.5). 2.20 Any other definitions set forth in the POST Acts are hereby incorporated by reference, except where terms are defined differently in these Rules.

Rule 3. Complaints. 3.1 A person who is aggrieved by a violation of the POST Acts, or a representative of an aggrieved person, may file a complaint with the Division. 3.2 The Division will not accept complaints of violations of the Colorado Chance to Compete Act, C.R.S. § 8-2-130, or the Job Application Fairness Act, C.R.S. § 8-2-131, that occurred more than 12 months prior to the date of the complaint, and will not accept complaints of violations of the Equal Pay for Equal Work Act, Part II, C.R.S. § 8-5-201, that occurred before January 1, 2021. 3.3 Complaints shall be filed using a Division-approved form. A complaint or appeal is considered “filed” with the Division when it is received by the Division via mail, fax, email, online submission, or personal delivery. Any Complaint, appeal, or termination received after 11:59pm Mountain Time is considered filed the next business day. If a complaint is filed without using a Divisionapproved form, the date the complaint is received will be the date of the complaint, then the complainant will have 14 days to submit a Division-approved form to avoid dismissal of the complaint without prejudice. The 14 days runs from the date the Division requests completion of the Division-approved form, unless the deadline is extended by the Division. 3.4 The complaint shall include the complainant’s signature, contact information, and basis for the complaint. Failure to include this information on the complaint form may result in administrative dismissal of the complaint. Any such submission is considered “signed,” or to have a “signature,” if it has either an ink signature, a scanned signature, an electronically drawn or generated signature, or a typed name entered by the party or their authorized representative in the signature area; by signing in any such fashion, the individual is deemed to have agreed and assented that the document is signed by them. 3.5 The complaint shall include a short and plain statement of its grounds. A complaint concerning an employment application should also include or attach whichever the complainant is able to provide among the following: a link to, copy of, screen capture of, or other image of the application. The employer must explain which, if any, allegations it disputes. Any evidence probative of a relevant issue may be submitted or considered. The Division will cease investigating a complaint that, upon review, fails to raise a reasonable inference of a violation of any of the POST Acts. 3.6 Anonymous complaints will be accepted, but will not be investigated using the Division’s administrative procedure, do not trigger any notice or participation rights for the Complainant, and will be investigated only at the discretion of the Division. 3.6.1 Anonymous complaints submitted on the Division’s complaint form are considered tips or leads, and will be handled accordingly. 3.7 A complainant may withdraw a complaint at any time before the issuance of a determination by notifying the Division in writing. 3.8 A complainant shall respond in a timely manner to informational or investigatory requests by the Division. Failure to comply with this Rule may result in dismissal of the complaint. If a complaint is dismissed before a Notice of Complaint is sent to the employer due to failure to respond to a Division request for information, the complaint may be reopened if the complainant provides the requested information or documentation to the Division within 35 days of the request. A complainant may be required to file a new complaint if the response is received more than 35 days after the request.

Rule 4. Investigations. 4.1 The Division will investigate complaints that provide sufficient evidence from which a violation of one or more of the POST Acts may be reasonably inferred (subject to Rule 3.6 as to anonymous complaints), as provided for wage complaints in the Wage Protection Rules (“WPR”), 7 CCR 1103-7, Rules 4.1 and 4.2.1. 4.2 WPR 4.1, and 4.3–4.8, regarding investigation procedures and protections, are incorporated by reference, except that as incorporated:

(A) All references to a “wage claim” or “wage complaint” shall include a claim or complaint alleging a violation of a POST Act;

(B) All references to “wage,” “wage and hour,” or “labor” law, rights, responsibilities, investigations or proceedings shall include labor rights or responsibilities within these Rules;

(C) All references to “HFWA” shall include other labor rights or responsibilities within these Rules; and (D) in WPR Rule 4.4.3 “C.R.S. § 8-4-113(1)(b)” is replaced with “C.R.S. §§ 8-4-113(1)(b) and 8-1-140(2).” 4.3 After receipt of a qualifying complaint, the Division will initiate the investigation by notifying the employer with a Notice of Complaint, along with any relevant supporting documentation the Complainant submitted, via U.S. mail, electronic means, or personal delivery. The employer must respond within 14 days after a complaint is sent, unless the Division grants an extension. 4.4 The Division may exercise its discretion to have an investigation sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations and/or phases of the investigation.

Rule 5. Determinations and Remedies. 5.1 After investigating the complaint and assessing the employer’s compliance, the Division investigator will issue a determination in writing. 5.1.1 The determination will be provided to the employer and complainant in writing via U.S. postal mail, electronic means or personal delivery. 5.1.2 The determination will contain information on the extent of the employer’s compliance with the law, and will describe:

(A) what provisions of the law were adhered to and/or violated; and (B) if a violation of a POST Act has occurred, steps the employer must take to cure the violation. 5.1.3 Determinations by the Division may include the following remedies, depending on which, if any, the Division’s findings support:

(A) order(s) to cease non-compliance and/or effectuate compliance, as authorized by the POST Acts and statutes on Division investigative and enforcement authority in C.R.S. Title 8, Article 1; and (B) fines pursuant to C.R.S. § 8-1-140(2) and/or the relevant POST Act. 5.1.4 The determination will contain information on appeal rights and appeal procedures. 5.1.5 The date of issuance of the Division’s determination is the date the Division’s determination is sent. Both the termination and appeal deadlines are calculated from the date the Division’s determination is originally issued and sent to the parties. 5.1.6 A certified copy of any citation, notice of assessment, or order imposing relief or remedies may be filed with the clerk of any court having jurisdiction over the parties at any time after the entry of the order. Such a filing can be in a county or district court, and will thereby have the effect of a judgment from which execution may issue. 5.2 Each distinct violative job posting constitutes a separate violation for purposes of remedies, regardless of whether each posting references the same external publication or site with the violative content. Each instance of an individual responding to a job posting does not constitute a separate violation for purposes of remedies.

Rule 6. Recordkeeping Requirements. 6.1 If any application, instruction, or advisement (written or electronic) for an employment position includes any question, inquiry, or request as to any aspect of a “criminal history” (as defined by C.R.S. § 8-2-130), or concerning the applicant’s age, date of birth, or dates of attendance at or date of graduation from an educational institution, then the employer shall maintain copies of all such documents for two years after such material was made available, or throughout an investigation under these rules, whichever is longer. 6.2 Where a claim, complaint, or investigation for violation of Part 2 of the Equal Pay for Equal Work Act, C.R.S. §§ 8-5-201 or 8-5-202, has been filed or commenced, the employer shall preserve all relevant documents throughout the duration and until the expiration of the statutory period within which a person aggrieved may bring a civil action.

Rule 7. Appeals. 7.1 The determination issued by the investigator may be appealed to the Division. 7.2 A party to the claim who appeals the determination is entitled to an appeal hearing and final agency decision in conformity with the Colorado Administrative Procedure Act, C.R.S. § 24-4- 105. 7.3 A Division hearing officer will preside over the hearing and issue an initial decision. 7.4 Any party to the claim may appeal the initial decision by filing written exceptions with the Division director within 30 calendar days of the initial decision under C.R.S. § 24-4-105(14)(a)(II). 7.4.1 Written exceptions shall be filed in conformity with instructions stated in the decision or order to which exceptions are being filed, as well as instructions posted on the Division website. 7.4.2 If no party files written exceptions with the director of the Division within 30 calendar days of the initial decision, the initial decision shall become the final agency decision. 7.5 The record on appeal to the director is the Division’s record of its investigation unless the appealing party files a designation of the record with the division within 20 calendar days of the initial decision in accordance with C.R.S. § 24-4-105(15)(a). 7.6 The director’s decision, after review of any exceptions, is the final agency decision. Any party to the claim may seek judicial review of this decision in accordance with C.R.S. § 24-4-106. 7.7 Failure to file exceptions in accordance with Rule 7.4 shall result in a waiver of the right to judicial review of the final agency decision in accordance with C.R.S. § 24-4-105(14)(c).

Rule 8. Rules as to the Employment Opportunity Act. 8.1 Nothing in the Employment Opportunity Act or these rules imposes any liability on a person, including a consumer reporting agency, as that term is defined in C.R.S. § 12-14.3-102(4), for providing an employer with consumer credit information.

Rule 9. Rules as to the Social Media and the Workplace Law. 9.1 An employer may access information about employees that is publicly available online.

Rule 10. Rules as to the Colorado Chance to Compete Act. 10.1 An employer may obtain publicly available criminal background reports at any time.

Rule 11. Rules as to the Equal Pay for Equal Work Act. 11.1 Job opportunity notices. Notices of job opportunities, including both those an employer “externally posts” (C.R.S. § 8-5-101(5.5)(a)) and those to notify current employees (C.R.S. § 8-5-201(1)), must include information on compensation, benefits, and application processes, as specified in Rules 11.1.1–3. Employers must make reasonable efforts to notify current employees, as specified in Rule 11.1.4. 11.1.1 Contents. Employers must include the following information in each posting (C.R.S. § 8- 5-201(2)):

(A) the hourly rate or salary compensation (or a range thereof) that the employer is offering for the position (subject to Rule 11.1.2);

(B) a general description of any bonuses, commissions, or other forms of compensation that are being offered for the job;

(C) a general description of all employment benefits the employer is offering for the position, including health care benefits, retirement benefits, any benefits permitting paid days off (including sick leave, parental leave, and paid time off or vacation benefits), and any other benefits that must be reported for federal tax purposes, but not benefits in the form of minor perks;

(D) the application deadline (subject to Rule 11.1.3); and (E) how to apply for the job opportunity. 11.1.2 Pay ranges. A posted compensation range may extend from the lowest to the highest pay the employer in good faith believes it might pay for the particular job, depending on the circumstances. An employer may ultimately pay more or less than the posted range, if the posted range was the employer’s good-faith and reasonable estimate of the range of possible compensation at the time of the posting. 11.1.3 Deadlines. Postings must include the deadline to apply, but:

(A) if there is no deadline because the employer accepts applications on an ongoing

basis, the posting must say so, and a deadline need not be included; and (B) a deadline may be extended as long as (1) the original deadline was a good-faith expectation or estimate of what the deadline would be, and (2) the posting is promptly updated when the deadline is extended. 11.1.4 Duties to notify employees. An employer is required to make “reasonable efforts” to “announce, post or otherwise make known each job opportunity to all employees on the same calendar day and prior to the date on which the employer makes a selection decision[.]” C.R.S. § 8-5-201(1).

(A) Exceptions and limitations on the duty to provide job opportunity notices:

(1) Career developments and career progressions are not “job opportunities” and therefore do not require job opportunity notices.

(2) Confidentiality. A job opportunity need not be posted to all employees if the employer has a compelling need to keep a particular opening confidential because the position is still held by an incumbent employee who, for reasons other than avoiding job posting requirements, the employer has not yet made aware they will be separated. If any employees are told of the opportunity, all employees must be told who either (a) meet the minimum qualifications or (b) have a job “substantially similar” (within the meaning of C.R.S. § 8-5-102 in the Equal Pay for Equal Work Act) to any employees being told of the opportunity. If the need for confidentiality ends before any deadline to apply for the job, the employer must then promptly comply with applicable posting requirements in the Act.

(3) Automatic promotion after trial period. No job opportunity posting to other employees is required for a promotion within one year of an employee being hired with a written representation (whether in an offer letter; in an agreement; or in a policy the employer publishes to employees) that the employer will automatically consider the employee for promotion to a specific position within one year based solely on their own performance and/or employer needs.

(4) Acting, interim, or temporary (“AINT”) hires. No immediate job opportunity posting is required to fill a position on an AINT basis for up to nine months where:

(a) the AINT hiring is not expected to be permanent, and if the hire may become permanent, the required job opportunity posting must be made in time for employees to apply for the permanent position; and (b) the same or a substantially similar position was not held anytime in 7 or more of the preceding 12 months by another AINT hire for which there was no job opportunity posting, except that if an AINT hire separates after more than 7 months, from a position expected to last up to 9 months, then a posting is not required for a replacement to finish their term.

(5) If an employer is only physically located outside of Colorado and has fewer than 15 employees working in Colorado, all of whom work only remotely, then, through July 1, 2029, the employer is only required to provide notice of remote job opportunities.

(B) Methods. An employer makes “reasonable efforts” with any method(s) by which all covered employees (1) can access within their regular workplace, either online or in hard copy, and (2) are told where to find required postings or announcements. If a particular method reaches some but not all employees, such as an online posting not accessible to those lacking internet access, an alternative method shall be used for such employees.

(C) Qualifications. Employers must notify all employees of all job opportunities, and may not limit notice to those employees it deems qualified for the position, but may state that applications are open to only those with certain qualifications, and may screen or reject candidates based on such qualifications. 11.2 Post-selection notice. After a candidate is selected for a job opportunity, employers must provide information described in Rule 11.2.1, by the processes described in Rule 11.2.2, to employees with whom the employer intends the selected candidate to regularly work. 11.2.1 Contents. Employers must include the following information:

(A) the name of the candidate selected for the job opportunity;

(B) the selected candidate’s former job title if selected while already employed by the employer;

(C) the selected candidate’s new job title; and (D) information on how employees may demonstrate interest in similar job opportunities in the future, including identifying individuals or departments to whom the employees can express interest in similar job opportunities. 11.2.2 Duties to notify employees. Within 30 calendar days after a candidate who is selected to fill a job opportunity begins working in the position, employers must make “reasonable efforts” (as defined in Rule 11.1.4(B)) to notify the employees with whom the employer intends the selected candidate to work with regularly of the information in Rule 11.2.1.

(A) “Work with regularly” means employees who, as part of their job responsibilities, either (1) collaborate or communicate about their work at least monthly, or (2) have a reporting relationship (i.e., supervisor or supervisee). Employers may comply by providing notice to a broader range of, or all, employees.

(B) Employers may comply with this Rule by providing post-selection notice either (1) of each individual selection, or (2) of multiple selections, as long as the notice is provided no later than 30 days after any selection(s) in the notice. 11.2.3 Non-disclosure rights.

(A) An employer shall not disclose a selected candidate’s name and/or prior job title if:

(1) any applicable law (including an applicable, legally binding statute, rule, or order) requires not disclosing either (or both) of those items; or (2) a selected candidate informs the employer (a) in writing, (b) on their own initiative (but employers may inform candidates of non-disclosure rights under this Rule), and (c) voluntarily (i.e., without pressure or coercion), that they believe disclosure of either (or both) of those items would put their health or safety at risk (but need not detail the health or safety risk).

(B) An employer shall still provide all other required post-selection information, even if under this rule it does not disclose a candidate’s name or prior job title. 11.3 Career progression notices. 11.3.1 For positions with “career progression,” an employer shall disclose and make available to all eligible employees (consistent with the methods for reasonable efforts in Rule 11.1.4(B)) the requirements for career progression, in addition to each position’s terms of compensation, benefits, full-time or part-time status, duties, and access to further advancement. 11.3.2 “Eligible employees” are those in the position that, when the requirements in the notice are satisfied, would move from their position to another position listed in the notice as a “career progression.”

Rule 12. Rules as to the Job Application Fairness Act. 12.1 Initial Application Requirements. 12.1.1 An employer may request or require additional application materials, such as resumes, CVs, transcripts, or certifications, during an initial employment application, provided that the employer notifies the applicant that the applicant may redact or remove information that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution. 12.1.2 Employers may request an individual to verify compliance with age requirements imposed by law or regulation, or enrollment or membership in a program or organization required for the position, so long as the individual is not required to disclose their “specific age, date of birth, or dates of attendance at or date of graduation from an educational institution on an initial employment application.” This includes that an employer may ask:

(A) if an applicant is at least an age legally required to perform the job; or (B) whether an applicant is enrolled in a school or education program for a position that requires such enrollment. 12.2 Bona Fide Occupational Qualifications. 12.2.1 If an employer claims that it is or was required to verify compliance with age requirements imposed pursuant to or required by a bona fide occupational qualification pertaining to public or occupational safety, it must establish that the challenged practice does indeed effectuate that goal and that there is no acceptable alternative which would better advance it or equally advance it with less discriminatory impact. 12.2.2 If an employer claims that it is or was required to verify compliance with age requirements imposed pursuant to or required by a federal, state, or local law or regulation based on a bona fide occupational qualification, it must establish that the age limit imposed by the law or requirement is reasonably necessary to the essence of the business, and either that:

(A) all or substantially all individuals excluded from the job involved are in fact disqualified; or (B) some of the individuals so excluded possess a disqualifying trait that cannot be ascertained except by reference to age. 12.2.3 Whether occupational qualifications will be deemed to be “bona fide” to a specific job will be determined on the basis of all the pertinent facts surrounding each particular situation.

It is anticipated that inquiries based on a bona fide occupational qualification will be limited in scope and application.

Rule 13. Geographic Limits. 13.1 The compensation and benefits disclosure requirements (§ 8-5-201(2)) and the requirements of § 8-2-126, § 8-2-127, § 8-2-130, and § 8-2-131 do not apply to postings or applications (1) for jobs to be performed entirely outside Colorado, or (2) physically located entirely outside Colorado. 13.2 Under the Equal Pay for Equal Work Act, the job opportunity notice, post-selection notice, and career progression notice requirements (C.R.S. § 8-5-201(1), (3), and (4), respectively) do not require notice to employees entirely outside Colorado. _________________________________________________________________________ Editor’s Notes

History New rule eff. 07/01/2024.

7 CCR 1103-19 Delivery Network Company (dnc) and Transportation Network Company (tnc) Acts Labor Rules (data Labor Rules) {#sec-7-ccr-1103-19 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-19}

DEPARTMENT OF LABOR AND EMPLOYMENT

DELIVERY NETWORK COMPANY (DNC) AND TRANSPORTATION NETWORK COMPANY (TNC)

ACTS LABOR RULES (DATA LABOR RULES)

7 CCR 1103-19 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted November 13, 2024, effective January 1, 2025.

Rule 1. Statement of Purpose and Authority 1.1 Authority and relation to other orders. The general purpose of these Delivery Network Company (DNC) And Transportation Network Company (TNC) Acts Labor Rules (DATA Labor Rules) is to exercise the authority of the Director, through the Division, to administer and enforce the provisions of the Protections for Delivery Network Company Drivers Act (DNC Act), C.R.S. § 8-4- 126, and the Transportation Network Company Transparency Act (TNC Act), C.R.S. § 8-4-127.

These Rules are intended to be consistent with the rulemaking requirements of the State Administrative Procedure Act, C.R.S. § 24-4-103. 1.2 The Director of the Division has authority to enforce, interpret, apply, and administer the provisions of C.R.S. Title 8, Articles 1 and 4 and these Rules. 1.3 Incorporation by Reference. The DNC Act and TNC Act are hereby incorporated by reference into these Rules. Such incorporation excludes later amendments to or editions of the statutes. Unless otherwise noted, in these Rules: all statutes cited apply the most recent 2024 versions of the Colorado Revised Statutes; all rules cited apply the most recent versions adopted as of the adoption of these Rules. These statutes are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, 633 17th Street, Denver, CO 80202. Copies may be obtained from the Division at a reasonable charge. Electronic access is available from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24- 4-103(12.5)(b), the agency shall provide certified copies of the statutes incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Division rules are available to the public at www.coloradolaborlaw.gov. Where these Rules have provisions different from or contrary to any incorporated or referenced material, the provisions of these Rules govern so long as they are consistent with Colorado statutory and constitutional provisions. Where these Rules reference another rule, the reference shall be deemed to include all subparts of the referenced rule. 1.4 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any

part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rule remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form.

Rule 2. Definitions and Clarifications 2.1 “Authorized representative” means a person designated by a party to a complaint to represent the party during the Division’s administrative procedure. To designate an authorized representative the party shall comply with the requirements for authorizing a representative in the Wage Protection Rules, 7 CCR 1103-7, Rule 4.3. 2.2 “Complaint” or “claim” interchangeably mean a complaint or claim alleging a violation of the DNC Act or TNC Act. “Complainant” means a person who files a complaint or claim. “Respondent” means a party against whom a complaint or claim is filed. 2.3 “Deactivation” and “suspension” mean conduct that a DNC or TNC engages in to restrict or block a driver’s access to the digital platform, including by changing a driver’s status from eligible to ineligible, for a period of less than 72 hours for suspension, and for deactivation, for a period of 72 hours or more under the TNC Act or more than 72 hours under the DNC Act.

(A) If, at the time that it restricts a driver’s access to its digital platform, a DNC or TNC knows or reasonably expects that the restriction could last 72 hours or more under the TNC Act or more than 72 hours under the DNC Act , the DNC or TNC is considered to have “deactivated” the driver and shall comply with the deactivation requirements of the DNC Act or TNC Act, respectively.

(B) “Deactivation” or “suspension” does not include a DNC’s or TNC’s restriction of a prospective driver’s access to its digital platform prior to that prospective driver having performed any delivery tasks using the DNC’s digital platform or any transportation tasks using the TNC’s digital platform. 2.4 “Delivery Network Company” or “DNC” has the meaning provided in C.R.S. § 8-4-126(1)(c), except DNC does not include a motor carrier of towed motor vehicles regulated by the Public Utilities Commission pursuant to Part 4 of Article 10.1 of Title 40, or a motor carrier of household goods regulated by the Public Utilities Commission pursuant to Part 5 of Article 10.1 of Title 40. 2.5 “Disclosure” as used in these Rules means any document, information, or data that a DNC, TNC, or Driver Support Organization (“DSO”) shall provide or make available to a driver, a consumer, a TNC, a Driver Support Organization, the Division, or the public. 2.6 “Division” means the Division of Labor Standards and Statistics in the Colorado Department of Labor and Employment. 2.7 “Driver” has the meaning provided in C.R.S. § 8-4-126(1)(f) for purposes of the DNC Act, and the meaning provided in C.R.S. § 8-4-127(1)(h) for purposes of the TNC Act. For purposes of this definition, a “personal vehicle” includes any vehicle that a DNC or TNC allows for performing services through its digital platform. 2.8 “Task” means and includes:

(A) As to the DNC Act, “task” refers to a “delivery task” and is defined in C.R.S. § 8-4- 126(1)(d) as the time spent, distance traveled, and route followed by a driver to provide delivery services to a consumer through a delivery network company, including traveling to a merchant’s business; picking up food, beverages, or other goods for delivery; and taking and depositing the delivery at a different location, as requested. A delivery task may encompass multiple transactions. Task “time,” pursuant to C.R.S. § 8-4-126(1)(d), (3)(a)(V), and 3(c)(II), begins when the driver accepts a delivery task and lasts until the driver drops off the goods.

(B) As to the TNC Act, “task” refers to a “transportation task” and is defined in C.R.S. § 8-4- 127(1)(s) as a driver’s provision of transportation services to a consumer or to one or more riders for whom a consumer orders transportation services through a TNC’s digital platform. 2.9 “Transportation Network Company” or “TNC” has the meaning provided in C.R.S. § 40-10.1- 602(3); except that the term does not include a TNC that meets the requirements of C.R.S. § 8-4- 127(1)(q). 2.10 Any other definitions provided in the DNC and TNC Acts are hereby incorporated by reference, except where terms are defined differently in these Rules.

Rule 3. Filing, Service, and Deadlines 3.1 Except as otherwise provided, documents, complaints, and disclosures shall be filed or submitted electronically, on a Division-approved form if one is available, pursuant to these Rules and any orders, instructions, and deadlines provided or published by the Division; payments required shall be by means, and by deadlines, required by applicable statutes, rules, or instructions from the Division. If the Division does not publish an applicable form or provide one to a party when the party intends to file, or if a party cannot readily use such means, the party may file by any means that provides the filing to the Division, including but not limited to email, other electronic means, or mailing or hand-delivering copies. A document is considered “filed” when received by the Division; a document received after 11:59 p.m. Mountain Time is considered “filed” the next business day. 3.2 Any submission is considered “signed” or to have a “signature” if it has an ink, scanned, or electronically drawn or generated signature, or a typed name entered by the party or their authorized representative in the signature area. By signing in any such manner, the individual is deemed to have agreed and assented that the document is signed by them. 3.3 Except as otherwise provided, calculations of any prescribed or allowed time periods shall be in accordance with C.R.S. § 2-4-108. 3.4 Upon receiving a written request for an extension that states the reason an extension is required, and that otherwise complies with these Rules, the Division may, at its discretion, extend the deadline for “good cause” shown. In considering whether good cause exists, the Division will determine whether the reason is substantial and reasonable, based on all the available information and the circumstances.

Rule 4. Complaints, Investigations, and Determinations 4.1 Complaints. 4.1.1 A person who is aggrieved by a violation of the DNC or TNC Acts, or their authorized representative, may file a complaint with the Division.

(A) The complaint shall include the complainant’s signature and contact information, and a short, plain statement of its grounds.

(B) Failure to respond timely to Division requests for additional supporting information or documentation may result in dismissal of the complaint.

(C) The Director may initiate, file, and investigate alleged violations in response to complaints filed or at its discretion. Decisions under this Rule are within the discretion of the Director’s authority to enforce and administer the DNC and TNC Acts, these Rules, and other applicable statutes and rules. 4.1.2 The Division will evaluate complaints to determine if the Division has jurisdiction over the alleged conduct, if sufficient allegations and evidence have been shown from which a violation of applicable law may be reasonably inferred, and if, in the Director’s good faith discretion and judgment, the complaint warrants investigation. 4.1.3 A complainant may withdraw a complaint at any time prior to issuance of a determination. 4.2 Notices of Investigation to respondents. 4.2.1 If the Division exercises its discretion to investigate, it shall give notice of the allegations, and request that an answer be filed by the respondent. 4.2.2 The respondent shall file an answer responding to each allegation, and attach any documentation or evidence the respondent wishes the Division to consider, within 21 days of the date of the Division’s notice. The Division may exercise discretion to shorten the response deadline. 4.2.3 Upon written request, at the Division’s discretion, other parties or entities may be joined as complainants. 4.3 Investigation and determination of complaints. 4.3.1 Upon receipt of a complaint, the answer, and any supplemental information or documentation, the Division shall determine what if any additional investigation is required. 4.3.2 During the investigation, if information is provided to the Division by a source requesting or otherwise warranting confidentiality, and that information is used as a basis for procuring other evidence but not offered as evidence itself, or as evidence of liability, but not to establish individual relief for the source of the information, or in other circumstances in which confidentiality is necessary and appropriate, then the source shall remain confidential. 4.3.3 The Director may exercise discretion to adjourn hearings; to permit additional time for submissions; to extend ordered deadlines for good cause or by consent; and to issue orders disposing of a complaint without a hearing. 4.3.4 Where a complaint or investigation for violation of these Rules or the statutes they enforce has been filed or commenced, all parties shall preserve all relevant documents until final disposition and until the expiration of the statutory period within which a person aggrieved may bring a civil action. 4.3.5 The Division may exercise its discretion to have an investigation sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations and/or phases of the investigation. 4.3.6 The Division may exercise its discretion to terminate an investigation at any time. 4.3.7 Upon completing an investigation that has not been terminated, the Division shall issue all parties a determination as to whether a violation of applicable law occurred. Upon completion of any further internal review by the Division, or absent a request for such review, the determination shall constitute final agency action, and final decision of the Director, subject to judicial review pursuant to C.R.S. § 24-4-106. 4.4 Remedies for violations. 4.4.1 Remedies for violations of applicable law may include any of the following, depending on which, if any, the Division’s findings support:

(A) Monetary damages in the amount of $1,000, as determined by the Director, on a per-consumer or per-driver basis, which amount a TNC respondent shall pay to the affected consumer or driver;

(B) Fines in the amount of $100 per violation, as determined by the Director on a per-consumer or per-driver basis, which a TNC respondent or DNC respondent shall pay to the Division;

(C) Any other relief authorized by applicable statutes the Division enforces or administers. 4.4.2 Monetary remedies are calculated on a per-consumer or per-driver basis regardless of the degree of similarity of the challenged disclosures or other conduct at issue.

Rule 5. Requirements as to DNCs 5.1 Wage transparency disclosures to drivers. As to disclosures under C.R.S. § 8-4-126(3): 5.1.1 When a DNC makes a disclosure pursuant to C.R.S. § 8-4-126(3)(b)(I)–(II) for a delivery task involving multiple transactions, the DNC shall provide the required amounts disaggregated by transaction, if such amounts are determined on a transaction basis. 5.1.2 To comply with the requirement that DNCs disclose information regarding the pick-up and delivery locations contained in C.R.S. 8-4-126(3)(a)(IV), DNCs may disclose to the driver on a smartphone or similar screen a map showing the location of each, as long as all requirements in C.R.S. 8-4-126(3)(e) are otherwise met. 5.1.3 Disclosures pursuant to C.R.S. § 8-4-126(3)(b), (d) and (e) may be in machine-readable, downloadable data (e.g., a .csv file) that:

(A) may include prior data listed separately (e.g., a file listing a recent task or summary, followed by prior tasks or summaries), and (B) so long as legible, shall be deemed compliant with the C.R.S. § 8-4-126(3)(f) display requirements. 5.2 Task acceptance time. 5.2.1 The requirement that DNCs ensure all drivers have at least sixty seconds to decide whether or not to accept an offered delivery task applies to all task offers, including an offer to compensate a driver for a block of time for multiple deliveries. 5.2.2 A DNC is considered to “encourage the driver to respond to a delivery task offer in a period of less than sixty seconds after displaying the offer on the driver’s smartphone or similar screen” within the meaning of C.R.S. § 8-4-126(7)(b) if the DNC rewards, or has a policy of rewarding, drivers for responding to a delivery task offer in less than sixty seconds, whether the driver’s response time is the entire basis of the reward or only one factor. “Rewards” or “rewarding” for purposes of this Rule include:

(A) Paying or offering to pay a higher amount for one or more delivery tasks;

(B) Giving a driver selective or preferential access to delivery task offers; or (C) Any other incentive provided or offered by a DNC to a driver. 5.3 Disclosures to consumers. 5.3.1 For the purpose of complying with the driver safety consumer prompting requirements under C.R.S. § 8-4-126(6):

(A) A DNC is considered to “connect” a consumer to a driver only once. That one instance shall occur at a time that provides the consumer with sufficient time to review and act upon the prompt before the driver arrives at the consumer’s location.

(B) If a delivery task includes transactions involving more than one consumer, a DNC shall prompt each individual consumer. 5.3.2 For consumer payment disclosures made pursuant to C.R.S. § 8-4-126(2), the “amount that the consumer paid or will pay for the transaction” does not include membership fees or dues paid by a consumer to a DNC.

Rule 6. Requirements as to TNCs 6.1 TNC disclosures to drivers. 6.1.1 Deactivation and suspension policy disclosures. As to the deactivation and suspension policy required under C.R.S. § 8-4-127(3):

(A) Any “range of days” for deactivation or suspension shall be estimated in good faith by the TNC as a likely duration for the deactivation or suspension.

(B) The policy shall be made available to drivers, posted by the TNC, and sent to the Division, on or before May 1, 2025, in accordance with C.R.S. § 8-4-127(3).

(C) On and after June 1, 2025, TNCs shall comply with all requirements of C.R.S. § 8-4-127(3), and shall not deactivate or suspend a driver unless the deactivation or suspension is consistent with the TNC’s deactivation and suspension policy, or amended deactivation and suspension policy, as written and distributed in accordance with C.R.S. § 8-4-127(3). 6.1.2 Suspension and deactivation disclosures. As to the written disclosure provided to drivers within 24 hours of a deactivation or suspension under C.R.S. § 8-4-127(4): A description of steps to take, if any, to remedy an alleged violation include, if available to the TNC, any remedial steps required by, or related to, regulations or orders promulgated by the Public Utilities Commission or other regulatory agency. 6.1.3 Task and pay disclosures. As to disclosures to drivers under C.R.S. § 8-4-127(11), effective February 1, 2025:

(A) Pursuant to C.R.S. § 8-4-127(11)(b), if a driver completes multiple transportation tasks before resuming available platform time, a TNC shall provide the required disclosure for each completed task when the driver resumes available platform time. The required disclosure for each task shall be displayed separately, on a single screen, for each completed task.

(B) Disclosures made pursuant to C.R.S. § 8-4-127(11)(f) shall be made by the last day of the month following the month for which the disclosure is required, or if provided on a more frequent basis than monthly, by the end of the last day of the period following the relevant reporting period.

(C) Disclosures made pursuant to C.R.S. § 8-4-127(11)(c) and (f) may be in machine-readable, downloadable data (e.g., a .csv file), and those under (c):

(1) may include prior data listed separately (e.g., a file listing a recent task or summary, followed by prior tasks or summaries), and (2) so long as legible, shall be deemed compliant with the C.R.S. § 8-4- 127(11)(e) display requirements.

(D) To comply with the requirement that TNCs disclose information regarding the driver’s location and consumer’s or rider’s destination contained in C.R.S. § 8-4- 127(11)(a)(I), TNCs may disclose to the driver on a smartphone or similar screen a map showing the location of each, as long as all requirements in C.R.S. § 8-4- 127(11)(e) are otherwise met.

(E) To comply with the requirement that TNCs disclose the total amount that a driver may be entitled to deduct from income pursuant to C.R.S. § 8-4-127(11)(f)(V), TNCs may disclose a single amount based on aggregated miles driven during available platform time, dispatch platform time, and consumer platform time. 6.1.4 Disclosures to drivers regarding the Driver Support Organization (DSO). As to disclosures required under C.R.S. § 8-4-127(6)(b):

(A) Contact information for the certified DSO need not be provided at any time during which there is not a certified DSO.

(B) On and after October 31, 2025, pursuant to C.R.S. § 8-4-127(6)(b)(II), TNCs are required to disclose the information required under C.R.S. § 8-4-127(6)(b)(I) to each new driver only once, before that driver engages in any transportation task for the TNC, and to any driver upon deactivation or suspension. 6.2 TNC disclosures to the Division. 6.2.1 As to TNC disclosures to the Division of the annual number of transportation tasks under C.R.S. § 8-4-127(6)(a)(VIII), following the initial disclosure of annual transportation tasks completed in 2023 by November 5, 2024, each disclosure made by January 15 shall be of the annual number of tasks for the prior calendar year (e.g., disclosing by January 15, 2025 the number of tasks completed in 2024). 6.2.2 As to TNC disclosures to the Division of deactivation and reconsideration information under C.R.S. § 8-4-127(9):

(A) The reporting period is the prior January 1 through June 30 for the disclosure due by August 1, beginning August 1, 2026, and the prior July 1 through December 31 for the disclosure due by February 1, beginning February 1, 2027.

(B) “Demographic information” means information that a TNC collects or possesses regarding a driver’s personal characteristics and includes a driver’s: driver’s license number or other unique numerical identifier associated with the driver; race or ethnicity; age; gender and gender identity; and the default language selected by the driver in the TNC’s digital platform. This Rule does not create a requirement that TNCs collect any demographic information; rather, TNCs shall disclose all demographic information that it does collect or possess in any disclosure made pursuant to the requirements of C.R.S. § 8-4-127(9)(c). 6.3 Annual DSO budget and quarterly remittance by TNCs. 6.3.1 DSOs shall submit a proposed annual budget when applying for certification, and once certified, before each subsequent year of the certified DSO’s three-year term. Each proposed annual budget shall cover the upcoming period of October 1 through September 30 of the following year. 6.3.2 The number of tasks used for the calculation of the annual budget shall be based on the total transportation tasks in the prior calendar year, as submitted by TNCs no later than January 15 of each year pursuant to C.R.S. § 8-4-127(6)(a)(VIII). The annual budget may increase based on the number of tasks in the prior year and the extent of services provided to drivers. 6.3.3 The DSO’s annual budget shall not exceed seven cents per transportation task based on the prior year’s total transportation tasks, with future inflation adjustments published in the Publication And Yearly Calculation of Adjusted Labor Compensation (PAY CALC)

Order, 7 CCR 1103-14. 6.3.4 Following each three-year certification period, the Division may increase the maximum per-transportation task rate amount that a TNC may be required to pay pursuant to C.R.S. § 8-4-127(6)(a)(II)(C) by an amount not exceeding the rate of inflation during the prior three-year certification period if the Division determines that the increase is necessary to cover the DSO’s costs. 6.3.5 A TNC’s quarterly share of the DSO’s approved annual budget, which shall be paid by the 15th day after the end of each calendar quarter, shall be calculated as one-quarter of the annual DSO budget multiplied by the TNC’s fraction of the total number of TNC tasks in the state in the prior year. A TNC’s first quarterly share shall be paid no later than 15 days following the end of the calendar quarter during which the Division approves the certified DSO’s proposed annual budget.

Rule 7. Requirements as to Both DNCs and TNCs 7.1 Translations. The languages into which translations from English are required shall be Spanish, Arabic, Amharic, Swahili, and Nepalese for:

(A) Disclosures of DNC driver contracts under C.R.S. § 8-4-126(4) and DNC account deactivation policies under C.R.S. § 8-4-126(5).

(B) Disclosures of TNC deactivation and suspension policies under C.R.S. § 8-4-127(3). 7.2 If, at the time required for any disclosure, a DNC or TNC lacks and cannot obtain any of the information required by that disclosure, then it shall:

(A) make the disclosure as completely as possible; and (B) notify the recipient of any such required information as soon as possible. _________________________________________________________________________ Editor’s Notes

History New rule eff. 01/01/2025.

7 CCR 1103-20 Colorado Youth Employment Standards Rules {#sec-7-ccr-1103-20 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-20}

DEPARTMENT OF LABOR AND EMPLOYMENT

COLORADO YOUTH EMPLOYMENT STANDARDS RULES

7 CCR 1103-20 [Editor’s Notes follow the text of the rules at the end of this CCR Document.]

Adopted December 8, 2025; effective February 1, 2026.

Rule 1. Statement of Purpose and Authority 1.1 The general purpose of these Colorado Youth Employment Standards Rules (YES Rules) is to exercise the authority of the Director, through the Division of Labor Standards and Statistics, to administer and enforce the provisions of the Colorado Youth Employment Opportunity Act (CYEOA), including C.R.S. §§ 8- 12-105, 8-12-110, 8-12-113(4), 8 12 116, 8-12-117 and these rules shall be interpreted in accordance with the CYEOA. These rules are adopted pursuant to the Division’s authority in C.R.S. §§ 8-1-103(3), 8 1 107(2)(p), 8-1-111, 8-6- 108.5, 8-12-110(3), 8-12-113(4), and -115. These rules are intended to be consistent with the rulemaking requirements of the State Administrative Procedure Act, C.R.S. § 24-4-103. Unless otherwise noted, in these Rules: all statutes cited apply the most recent 2025 versions of the Colorado Revised Statutes; all rules cited apply the most recent versions adopted as of the adoption of these Rules. 1.2 The Director of the Division of Labor Standards and Statistics in the Department of Labor and Employment has the authority to enforce, interpret, apply, and administer the statutes cited in Rule 1.1 above and these rules. 1.3 Incorporation by Reference. The YES Rules incorporate by reference only those specific federal and Colorado rules identified as incorporated by reference in these Rules. As referenced below, the YES Rules incorporate by reference the following federal rules: the following regulations in Subparts E and E-1 of Part 570 within Title 29 of the Code of Federal Regulations, 29 C.F.R. §§ 570.33(b)– (i),(l),(n)(1),(n)(3); 570.50–570.51; 570.53–570.72, as adopted by the United States Department of Labor’s Wage and Hour Division, located at 200 Constitution Ave NW, Washington, DC 20210 and available to the public in electronic form at https://www.ecfr.gov/current/title-29/part-570; and all regulations in Part 1910 within Title 29 of the Code of Federal Regulations (available to the public in electronic form at https://www.ecfr.gov/current/title- 29/part-1910), the following regulations in Part 1926 within Title 29 of the Code of Federal Regulations, Subparts C through O, W, and X (available to the public in electronic form at https://www.ecfr.gov/current/title-29/part-1926), and the following regulations in Part 1928 within Title 29 of the Code of Federal Regulations, Subparts C through D (available to the public in electronic form at https://www.ecfr.gov/current/title-29/part-1928) as adopted by the United States Department of Labor, Occupational Safety and Health Administration, located at 200 Constitution Ave NW, Washington, DC 20210. The YES Rules also incorporate by reference specific rules, as identified below, from the Colorado Wage Protection Rules, 7 CCR 1103-7, and the Agricultural Labor Conditions Rules, 7 CCR 1103-15, as adopted by the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics. These incorporated Division rules can be accessed electronically from the website of the Colorado Secretary of State and are available to the public at www.coloradolaborlaw.gov.

All incorporated rules are available for public inspection at the Colorado Department of Labor and Employment, Division of Labor Standards & Statistics, which is located at 707 17th Street, Denver, CO 80202. Pursuant to C.R.S. § 24 4 103(12.5)(b), the agency shall provide certified copies of the rules incorporated by reference at cost upon request. All such incorporated rules refer to the date and edition of those rules in effect as of the effective date of these YES Rules, February 1, 2026, and exclude later amendments to or editions of these rules incorporated by reference. 1.4 Where these rules have provisions different from or contrary to any referenced material, the provisions of these rules govern so long as they are consistent with Colorado statutory and constitutional provisions. Where these rules reference another rule, the reference shall be deemed to include all subparts of the referenced rule. 1.5 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any part (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the Rule remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form. 1.6 Deadlines in these Rules may be extended for good cause. In considering whether good cause exists, the Division will determine whether the reason is substantial and reasonable, and must take into account all available information and circumstances pertaining to the specific Complaint.

Rule 2. Definitions 2.1 “Complaint” or “Claim” interchangeably mean a Complaint or Claim alleging a violation of the CYEOA. “Complainant” means a person with a Complaint or Claim. “Complainant” includes any authorized representative of the minor. 2.2 “Division” means the Division of Labor Standards and Statistics within the Department of Labor and Employment. 2.3 “Employer” means any individual or entity engaged in the “employment” of a minor that pays compensation or other valuable consideration in exchange for the minor’s work. “Employer” under the CYEOA and these rules includes both contractors and “employers,” as defined by C.R.S. § 8-4-101(6). This definition does not apply to Rule 11. 2.4 “Employment” has the same definition as C.R.S. § 8-12-103(4). This definition does not apply to Rule 11. 2.5 “Includes” means including but not limited to. 2.6 “Minor” has the same definition as C.R.S. § 8-12-103(5). This definition does not apply to Rule 11. 2.7 Temperatures in or applicable to these rules are all on the Fahrenheit temperature scale.

Rule 3. Complaints 3.1 A minor or a representative of a minor may file a complaint with the Division.

Complaints shall be filed using a Division-approved form. 3.2 A complaint or appeal is considered “filed” with the Division when it is received by the Division via mail, fax, email, online submission, or personal delivery. Any Complaint, appeal, or termination received after 11:59 p.m. Mountain Time is considered filed the next business day. If a complaint is filed without using a Division-approved form, the date the complaint is received will be the date of the complaint, then the complainant will have 14 days to submit a Division-approved form to avoid dismissal of the complaint without prejudice. The 14 days runs from the date the Division requests completion of the Division-approved form, unless the deadline is extended by the Division. 3.3 The complaint shall include the complainant’s signature, contact information, and

basis for the complaint. Failure to include this information on the complaint form may result in administrative dismissal of the complaint. Any such submission is considered “signed,” or to have a “signature,” if it has either an ink signature, a scanned signature, an electronically drawn or generated signature, or a typed name entered by the party or their authorized representative in the signature area; by signing in any such fashion, the individual is deemed to have agreed and assented that the document is signed by them. 3.4 The complaint shall include a short and plain statement of its grounds. Any evidence probative of a relevant issue may be submitted or considered. The Division will cease investigating a complaint that, upon review, fails to raise a reasonable inference of a violation of the CYEOA. 3.5 Any party to the complaint may designate an authorized representative using the procedures of Wage Protection Rule 4.3, 7 CCR 1103-7. 3.6 If the complaint is filed by someone other than a minor (a third-party filer), the Division will contact the third-party filer. The third-party filer will have 14 days to be designated as an authorized representative, using the procedures of Wage Protection Rule 4.3, 7 CCR 1103-7. If the third-party filer is not an authorized representative or does not meet the requirements, the complaint will be dismissed or, at the sole and total discretion of the Division, investigated. 3.6.1 If the Division, in its discretion, proceeds with the investigation, the complaint will be converted to a direct investigation subject to the Direct Investigation Rules, 7 CCR 1103-8, and the third-party filer will be removed as a party to the investigation. The Division shall issue a Notice of Conversion to the third-party filer, notifying them that they are no longer a party. The Notice of Conversion shall inform the third-party filer that they:

(A) have been removed as a party;

(B) will have no involvement with the further investigation of the claim, except at the request of the Division;

(C) will receive no further updates or have rights to updates;

(D) will have no rights to withdraw the claim; and, (E) have no right to appeal the conversion or the outcome of the investigation. 3.7 A complainant may withdraw a complaint at any time before the issuance of a determination by notifying the Division in writing. 3.8 A complainant shall respond in a timely manner to informational or investigatory requests by the Division. Failure to comply with this Rule may result in dismissal of the complaint. If a complaint is dismissed before a Notice of Complaint is sent to the employer due to failure to respond to a Division request for information, the complaint may be reopened if the complainant provides the requested information or documentation to the Division within 35 days of the request. A complainant may be required to file a new complaint if the response is received more than 35 days after the request.

Rule 4. Investigations 4.1 The Division will investigate complaints that provide sufficient evidence from which a violation of the CYEOA may be reasonably inferred (subject to Rule 3.6 as to third-party complaints). 4.2 Rule 4.2 incorporates by reference Wage Protection Rules 4.1, 4.2.1, and 4.3 through 4.9, 7 CCR 1103-7, as adopted by the Division, except that as incorporated:

(A) all references to a “wage claim” or “wage complaint” shall include a claim or complaint alleging a violation of the CYEOA;

(B) all references to “wage,” “ wage and hour,” or “labor” law, rights, responsibilities, investigations or proceedings shall include labor rights or responsibilities within these Rules;

(C) all references to “HFWA” shall include other labor rights or responsibilities within these Rules; and (D) in Rule 4.4.3, “C.R.S. § 8-4-113(1)(b)” is replaced with “C.R.S. §§ 8-4- 113(1)(b); 8-1-114; 8-1-116; 8-1-117; and 8-1-140(2).” 4.3 The Division may exercise its discretion to have an investigation sequenced or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations or phases of the investigation.

Rule 5. Determinations and Remedies 5.1 After investigating the complaint and assessing the employer’s compliance, the Division will issue a written determination. 5.1.1 The determination will be provided to the employer and complainant in writing via U.S. postal mail, electronic means, or personal delivery. 5.1.2 The determination will contain information on the extent of the employer’s compliance with the law, and will describe:

(A) what provisions of the law were adhered to or violated; and, (B) if a violation of the CYEOA has occurred, steps the employer must take to cure the violation. 5.1.3 Determinations by the Division may include the following remedies, depending on which, if any, the Division’s findings support:

(A) order(s) to cease non-compliance or effectuate compliance, as authorized by the CYEOA and statutes on Division investigative and enforcement authority in C.R.S. Title 8, Article 1;

(B) fines pursuant to C.R.S. § 8-1-140(2) or the CYEOA, C.R.S. § 8-12- 116(1);

(C) damages payable to the aggrieved minor under C.R.S. § 8-12- 116(3); and, (D) any other remedies authorized by law. 5.1.4 The determination will contain information on appeal rights and appeal procedures. 5.1.5 The date of issuance of the Division’s determination is the date the Division’s determination is sent. Both the termination and appeal deadlines are calculated from the date the Division’s determination is originally issued and sent to the parties. 5.1.6 A certified copy of any citation, notice of assessment, or order imposing relief or remedies may be filed with the clerk of any court having jurisdiction over the parties at any time after the entry of the order. Such a filing can be in a county or district court, and will thereby have the effect of a judgment from which execution may issue. 5.2 Pursuant to C.R.S. § 8-12-115(4)(b), the Division may issue an additional determination that orders penalties for each offense without sending an additional Notice of Complaint. Any resulting determination shall follow Rule 5.1, and any appeal shall follow Rule 6.

Rule 6. Appeals 6.1 Any party to the claim may appeal the Division’s determination(s). 6.2 Rule 6.2 incorporates by reference Wage Protection Rule 6, 7 CCR 1103-7, as adopted by the Division, which shall govern and apply to Claims filed or determinations made under these Rules.

Rule 7. Recordkeeping Requirements 7.1 An employer must retain a true and accurate record for each minor, including the date of birth for minors under 18 years of age, as already required separately by the Colorado Overtime and Minimum Pay Standards (COMPS) Order Rule 7.1, 7 CCR 1103-1. 7.2 An employer must retain a copy of these records for three years after the minor’s eighteenth birthday or three years after the termination of employment, whichever is sooner:

(A) Any exemption under C.R.S. § 8-12-104;

(B) Any documents supporting use of the C.R.S. § 8-12-110(1) exception, including proof of completion of or enrollment in a qualifying program;

(C) Any age certificate and any other documents under C.R.S. § 8-12- 111;

(D) Any proof of a high school diploma, a passing score on the general educational development examination, completion of a career and technical education program, or any other documents under C.R.S. § 8-12-112; and, (E) Any school release permit and other documents under C.R.S. § 8- 12-113. 7.3 All documents described in Rules 7.1 and 7.2 must be made available to the Division upon request. Nothing in this rule shall be construed to limit the Division’s authority to obtain documents and information from any employer. 7.4 Where a claim, complaint, or investigation under the CYEOA has been filed or commenced, the employer shall preserve all relevant documents throughout the duration of the investigation and until the expiration of the statutory period within which a person aggrieved may bring a civil action.

Rule 8. Hazardous Occupations Prohibited for All Minors Under C.R.S. § 8- 12-110 8.1 Operation of any high-pressure steam boiler or high-temperature water boiler. 8.1.1 An employer shall not permit a minor to perform any job duty that involves the operation of any high-pressure steam boiler or high-temperature water boiler. 8.1.2 “ High-pressure steam boiler” means any boiler that operates at a pressure in excess of 15 pounds per square inch (psi). 8.1.3 “ High-temperature water boiler” means a water boiler that operates at greater than 160 psi water pressure or over 250°F. 8.2 Risk of falling. 8.2.1 A minor shall not be permitted to perform any job duty that involves the risk of falling from any elevated place located 10 feet or more above the ground for non-agricultural employment and 20 feet or more above the ground for agricultural employment. 8.2.2 For heights below the applicable limit, an employer must ensure compliance with 29 C.F.R. §§ 1910 Subparts D, F, and I, and 1926 Subparts E, G, H, L, M, N, R, and X, which are incorporated by reference and available to the public for review as stated in Rule 1.3. 8.3 Manufacturing, transporting, or storing of explosives. 8.3.1 An employer engaged in manufacturing, transporting, using, or storing explosives may not employ minors. 8.3.2 An employer shall not permit a minor to access explosives. 8.3.3 An employer shall not permit a minor to perform any job duties that involve the manufacture, transport, use, or storage of explosives. 8.3.4 “Explosives” means and includes ammunition, black powder, blasting caps or agents, detonators, igniters, fireworks, high explosives, primers, smokeless powder, and any chemical compound mixture, or device, the primary or common purpose of which is to function by explosion.

Explosives include all goods identified in the “2025 Annual List of Explosive Materials,” published by the Bureau of Alcohol, Tobacco, Firearms, and Explosives, 90 Federal Register 25077, 25077 — 79, available for public review at: https://www.federalregister.gov/documents/2025/06/13/2025- 10659/commerce-in-explosives-2025-annual-list-of-explosive-materials. 8.4 Mining, logging, oil drilling, or quarrying. 8.4.1 An employer engaged in mining, logging, oil drilling, or quarrying may not employ minors. 8.4.2 An employer shall not permit a minor to enter or work in close proximity to a mine or quarry, sawmill, logging operation, or oil rig. 8.4.3 An employer shall not permit a minor to perform any job duties related to mining or quarrying, logging, or oil drilling. 8.4.4 Mining or quarrying includes all work performed underground in mines and quarries; on the surface at underground mines and underground quarries; in or about open-cut mines, open quarries, clay pits, and sand and gravel operations; at or about placer mining operations; at or about dredging operations for clay, sand or gravel; at or about bore-hole mining operations; in or about all metal mills, washer plants, or grinding mills reducing the bulk of the extracted minerals; and at or about any other crushing, grinding, screening, sizing, washing or cleaning operations performed upon the extracted minerals except where such operations are performed as a part of a manufacturing process permitted by these rules. 8.4.5 Logging includes all work performed in forest fire fighting and forest fire prevention, in timber tracts, in forestry services, timber operations, transportation or processing of wood products, and the operation of any sawmill, lathe mill, shingle mill, or cooperage stock mill. 8.4.6 Oil drilling includes the physical drilling of a well, the operation of an oil drill, and the testing, completing, or equipping of an oil well for production. 8.5 Any occupation involving exposure to radioactive substances or ionizing radiation. 8.5.1 An employer shall not permit a minor to perform any work in any area subject to exposure to radioactive substances or ionizing radiation. An area is not subject to exposure if an employer demonstrates that all areas where a minor is able to access are protected from exposure to radioactive substances or ionizing radiation. 8.5.2 An employer shall not permit a minor to be exposed to radioactive substances or ionizing radiation. 8.5.3 Ionizing radiation includes alpha and beta particles, electrons, protons, neutrons, gamma and x-rays, and all other radiations that produce ionizations directly or indirectly, excluding electromagnetic radiations other than gamma and x-rays. 8.5.4 Radioactive substances include:

(A) Radium;

(B) Any mixture of phosphorescent material and radium, mesothorium, or other radioactive element compounds;

(C) Incandescent mantles made from fabric and solutions containing thorium salts; and, (D) any material which emits, by spontaneous nuclear disintegration, corpuscular or electromagnetic emanations. 8.6 Operation of power-driven machinery. 8.6.1 Definitions.

(A) “Power-driven machinery” means all machines driven by power, without regard for the power source. Sources of power include electrical, gas, hydraulic, or air.

(B) “Duties related to operation of power-driven machinery” means operating or assisting in the operation of power machinery, and any work that either (i) creates a foreseeable risk that a minor will operate the machinery due to proximity or nature of the work; or (ii) subjects a minor to the same safety risks as operation, e.g., within the area where one could be struck or injured by the prohibited machine. This definition applies even when machines are not operated. 8.6.2 An employer shall not permit a minor to perform any duties related to operating power-driven woodworking machinery.

(A) Power-driven woodworking machines include all fixed or portable machines or tools driven by power and used or designed for cutting, shaping, forming, surfacing, nailing, stapling, wire stitching, fastening or otherwise assembling, pressing or printing wood, veneer, trees, logs, or lumber.

(B) Examples of machinery prohibited by this rule include power-driven circular saws, band saws, guillotine shears, chain saws, reciprocating saws, wood chippers, planers, drill presses, sanders, nailers, abrasive cutting discs, shapers, molders, heel turners, lathes, tenoners, mortisers, stickers, drills, boring machines, hole cutters, chuckers, wire stitchers, berry-basket machines, and bushel-tub machines. 8.6.3 An employer may not permit a minor to perform any duties related to operating power-driven metal forming, punching, or shearing machines.

(A) Power-driven metal forming, punching, or shearing machines include power-driven metalworking machines that change the shape of or cut metal by means of tools, such as dies, rolls, knives mounted on rams, plungers, and other moving parts.

(B) Examples of machinery prohibited by this rule include rolling machines, pressing or punching machines, bending machines, hammering machines, and shearing machines. 8.6.4 An employer may not permit a minor to perform any duties related to operating power-driven bakery machines.

(A) Bakery machines include all power-driven machines used in baking and the preparation of baked goods, but does not include (i) lightweight, small capacity, portable counter-top power-driven food mixers and (ii) pizza-dough rollers, as defined by 29 C.F.R. § 570.62, which is incorporated by reference and available to the public for review as stated in Rule 1.3.

(B) Examples of machinery prohibited by this rule include walk-in ovens, horizontal or vertical dough mixers, batter mixers, bread dividing, rounding, or molding machines, dough brakes, dough sheeters; combination bread slicing and wrapping machines, or cake cutting band saws. 8.6.5 An employer may not permit a minor to perform any duties related to operating power-driven paper products machines.

(A) Paper products machines include all power-driven machines used in the remanufacture or conversion of paper or pulp into finished product (including recycling) or the preparation of material for disposal.

(B) Examples of machinery prohibited by this rule include arm-type wire stitchers or staplers, circular or band saws, corner cutter or mitering machines, corrugating and single-or-double facing machines, envelope die-cutting presses, guillotine paper cutters or shears, horizontal bar scorers, laminating or combining machines, sheeting machines, scrap paper balers, paper box compactors, or vertical slotters. 8.6.6 An employer may not permit a minor to perform any duties related to operating power-driven shears.

(A) Shears include power-driven machinery for cutting material, including metal, paper, coal, or other things, by shearing, which utilize a fixed blade(s) and non-rotary moving blade(s).

(B) Examples of machinery prohibited by this rule include guillotine shears, alligator shears, circular shears, rotary shears, and squaring shears. 8.6.7 An employer may not permit a minor to perform any duties related to operating power-driven automatic pin-setting machines.

(A) An employer may not permit a minor to go into the area where an automatic pin-setting machine operates.

(B) “Operating” an automatic pin-setting machine does not include operating it remotely through software or a control panel, nor does it include bowling down the aisle. 8.6.8 An employer may not permit a minor to perform any duties related to operating power-driven food processing equipment.

(A) Power-driven food processing equipment includes equipment used in processing food, food slicers, food grinders, food choppers, food processors, food cutters, and food mixers (B) Examples of machinery prohibited by this rule include meat patty forming machines, meat and bone cutting saws, poultry scissors or shears; meat slicers, knives, headsplitters, and guillotine cutters; snoutpullers and jawpullers; skinning machines; horizontal rotary washing machines; casing-cleaning machines such as crushing, stripping, and finishing machines; grinding, mixing, chopping, and hashing machines; and presses. 8.6.9 An employer may not permit a minor to perform any duties related to operating power-driven balers and compactors.

(A) Power-driven balers and compactors include any powered machine designed or used to compress, compact, or bind materials into bales for storage, handling or transportation, including scrap paper balers or any baler that is designed or used to process materials other than paper.

(B) Examples of machinery prohibited by this rule include hay balers, metal balers, plastic balers, textile balers, mixed waste balers, and industrial balers. 8.6.10 An employer may not permit a minor to perform any duties related to operating power-driven construction and industrial machines.

(A) Power-driven construction and industrial machines include all machines used in the alteration, repair, painting, demolition, and maintenance of buildings, bridges, and other structures.

(B) Examples of machinery prohibited by this rule include bulldozers, excavators, loaders, compactors, pavers, cranes, derricks, hoists, high-lift trucks, graders, earth compactors, backhoes, and tractors. 8.6.11 An employer may not permit a minor to perform any duties related to operating power-driven grinding, abrasive, polishing, or buffing machines that use emery, tripoli, rouge, corundum, stone, silicon carbide, or any other abrasive. 8.6.12 An employer may not permit a minor to perform any duties related to operating power-driven welding machines, including stick, MIG, TIG, and Arc machines, as well as gas-only welding machines and blowtorches. 8.6.13 An employer may not permit a minor to perform any duties related to operating power-driven rolling and shaping machines, regardless of the substance rolled or shaped, including corrugating, crimping or embossing machines, milling machines, turning machines, and boring machines. 8.6.14 An employer may not permit a minor to perform any duties related to operating power-driven dry cleaning and commercial laundry machinery. 8.6.15 An employer may not permit a minor to perform any duties related to operating power-driven hoisting machines, including elevators, cranes, derricks, hoists, or high-lift trucks, except that a minor may be permitted to operate or ride inside an unattended automatic operation passenger elevator. 8.6.16 An employer may not permit a minor to perform any duties related to operating power-driven conveyors. 8.6.17 An employer may not permit a minor to perform any duties related to operating any power-driven machinery declared to be hazardous by the United States Department of Labor in 29 C.F.R. §§ 570.53 through 570.68, which are incorporated by reference and available to the public for review as stated in Rule 1.3. 8.7 Slaughter of livestock and rendering and packaging of meat. 8.7.1 An employer engaged in the slaughter of livestock or poultry, or rendering and packaging of meat may not employ a minor. 8.7.2 An employer may not permit a minor to enter any areas where the slaughter of livestock or poultry is performed, including the killing rooms, curing rooms, or hide rooms. 8.7.3 An employer may not permit a minor to perform duties related to:

(A) Slaughtering of livestock or poultry, including immobilizing, shackling, or killing of livestock or poultry; grading; trimming, salting, or curing of hides, and preserving and flavoring of meat by curing materials;

(B) Packaging and rendering of meat, including: (i) cutting or slicing, whether using power-driven machines related to meat, (ii) recovery of lard or oils and the operation of lard-roll machines, and (iii) tankage or rendering of dead animals, animal offal, animal fats, scrap meats, blood, and bones into stock feeds, tallow, inedible greases, fertilizer ingredients, and similar products;

(C) Boning operations;

(D) Handling of any carcass or partial carcass; and, (E) Cleaning or maintenance of any areas where duties prohibited by this rule are performed. 8.8 Occupations directly involved in the manufacture of brick or other clay construction products or of silica refractory products. 8.8.1 An employer engaged in manufacturing clay construction products or silica refractory products shall not employ minors. 8.8.2 An employer shall not permit a minor to work in or about areas where clay construction products or silica refractory products are manufactured or packaged. 8.8.3 Clay construction products include brick, hollow structural tile, sewer pipe and kindred products, refractories, and other clay products such as architectural terra cotta, glazed structural tile, roofing tile, stove lining, chimney pipes and tops, wall coping, and drain tile. 8.8.4 Silica refractory products include refractory products produced from raw materials containing free silica as their main constituent. 8.9 Wrecking or demolition, but not including manual auto wrecking. 8.9.1 An employer engaged in wrecking or demolition may not employ a minor, except an employer engaged in only manual dismantling of automobiles without the use of power-driven equipment may employ a minor. 8.9.2 “ Wrecking or demolition” includes all work, including clean-up and salvage work, performed at the site of the total or partial razing, demolishing, or dismantling of a building, bridge, steeple, tower, chimney, other structure, ship, or other vessel. 8.10 Roofing. 8.10.1 An employer engaged in roofing may not employ a minor. 8.10.2 An employer may not permit a minor to work on or about a roof or area where roofing is occurring. 8.10.3 An employer may not permit a minor to perform any roofing. 8.10.4 Roofing includes all work performed in connection with the installation of roofs, including related metal work such as flashing, and applying weatherproofing materials and substances (such as waterproof membranes, tar, slag or pitch, asphalt prepared paper, tile, composite roofing materials, slate, metal, translucent materials, and shingles of asbestos, asphalt, wood or other materials) to roofs of buildings or other structures. The term also includes all jobs on the ground related to roofing operations such as roofing laborer, roofing helper, materials handler and tending a tar heater. 8.11 Occupations in excavation operations. 8.11.1 An employer engaged in excavation operations may not employ a minor. 8.11.2 Excavation operations include all excavating, working in, or backfilling trenches; excavating for buildings or other structures or working in excavations; and working within tunnels or shafts. Excavation operations do not include manual excavation that is less than four feet in depth. 8.12 Office and retail exception. 8.12.1 If an employer is prohibited from employing a minor under Rules 8.3.1, 8.4.1, 8.7.1, 8.8.1, 8.9.1, 8.10.1, or 8.11.1, it may employ a minor sixteen years or older to perform office, clerical, or retail work if it demonstrates that the minor is not exposed to any hazards. 8.12.2 The minor may not be employed on the same property or location where the hazardous activities are conducted. A minor may not perform any work on the same property or location where the following have occurred and the hazards have not been mitigated, occur on an ongoing basis, or are occurring:

(A) Use or manufacture of explosives or firearms;

(B) Mining, logging, oil drilling, or quarrying;

(C) Slaughter of livestock or poultry;

(D) Manufacture of clay construction products or silica refractory products;

(E) Wrecking or demolition, but not including manual auto wrecking;

(F) Roofing; or (G) Excavation operations. 8.12.3 An employer must demonstrate that it prevents minors from physically accessing any areas prohibited by the CYEOA, areas where duties prohibited by the CYEOA are performed, or areas exposed to the risks of prohibited areas or duties. 8.12.4 This exception must be narrowly construed. There is a presumption that it is hazardous for employers engaged in prohibited work to employ minors.

Nothing in this exception shall be construed to permit a minor to perform duties or access an area prohibited by the CYEOA or these Rules. 8.12.5 This exception does not require an exemption from the Division under C.R.S. § 8 12-104, but an employer may request an exemption.

Rule 9. Prohibited Duties and Occupations 9.1 Minors may only be employed as permitted by C.R.S. § 8-12-106 to -109 and these Rules. An employer has the burden to demonstrate that employment of a minor is permissible under the CYEOA and these Rules. For occupations not specifically permitted by the CYEOA or identified in Division rules or guidance as “similar to those enumerated in” C.R.S. § 8-12-106 to -109, employers may submit an exemption request in accordance with Rule 10 and Division procedures established for such requests. Employers may be notified through the exemption request process if the work is an allowed “similar” occupation under C.R.S. § 8-12-106 to -109. 9.2 An employer shall not permit any minor: 9.2.1 To perform any occupation prohibited as hazardous by the United States Department of Labor in 29 C.F.R. §§ 570.50, 570.51, and 570.53 through 570.72, which are incorporated by reference and available to the public for review as stated in Rule 1.3; 9.2.2 To perform job duties or employment in:

(A) Liquor stores;

(B) Marijuana dispensaries;

(C) Tobacco, nicotine, or other store where the primary activity is the sale or use of age-restricted substances;

(D) Adult entertainment venues or strip clubs;

(E) Casinos or other gambling establishments, except as permitted by C.R.S. § 44-30-103(14) and 1 CCR 207-1-1;

(F) Locations where the primary activity is illegal, such as brothels or illegal gambling operations; or (G) Any other locations that local, Colorado, or federal law prohibits minors from entering without an adult. 9.2.3 To be exposed to toxic or hazardous substances. Toxic or hazardous substances are substances regulated by 29 C.F.R. Part 1910 Subparts H and Z, as well as carcinogens, pesticides, and chemicals or fumes that are known to be dangerous to humans; 9.2.4 To lift excessive weight; 9.2.5 To work in confined spaces that by design or construction have limited openings for entry and egress, have unfavorable natural ventilation, and are not intended for human occupancy; 9.2.6 To use power-driven lawn equipment, unless:

(A) The minor is adequately trained to operate the equipment safely, including review of the operator’s manual and all warnings and precautions, review and demonstration of all controls of the equipment, and review of hazards, including hazards associated with mowing up and down steep slopes;

(B) The power-driven equipment and its use comply with 29 C.F.R. §§ 1910 Subparts D, E, G, I, O through S; 1926 Subparts C through O, W, and X; and 1928 Subparts C through D, which are incorporated by reference and available to the public for review as stated in Rule 1.3;

(C) The power-driven equipment is not prohibited by Rule 8.6 (e.g., chainsaws); and (D) The minor does not perform any maintenance or repair of the power-driven equipment. 9.2.7 To violate, be injured by, or be at risk of injury by a violation of any occupational safety and health standards set forth in: Part 1910 within title 29 of the Code of Federal Regulations; 29 C.F.R. § 1926, Subparts C through O, W, and X; and 29 C.F.R. § 1928, Subparts C through D — which are incorporated by reference and available to the public for review as stated in Rule 1.3; or, 9.2.8 To perform occupations other than those authorized by the CYEOA. 9.3 An employer shall not permit a minor under sixteen: 9.3.1 To be employed in any occupation prohibited by the United States Department of Labor as oppressive child labor in 29 C.F.R. § 570.33(b)– (i), (l), (n)(1), (n)(3), which are incorporated by reference and available to the public for review as stated in Rule 1.3. 9.3.2 In restaurants, retail food service, and related occupations, to:

(A) Cook or bake, including using an open-flame, electric or conductive cooktop, grill, pressure cooker, rotisserie cooker, or fryer, except that cooking is permitted with deep fryers that are equipped with and utilize a device that automatically lowers the baskets into the hot oil or grease and automatically raises the baskets from the hot oil or grease;

(B) Handle liquids or oils over 100°F;

(C) Heat foods over 140°F;

(D) Use power-driven kitchen equipment, including pizza dough rollers and lightweight, small-capacity, portable counter-top power-driven food mixers; or, (E) Use knives or other sharp blades unless the minor uses cut-proof gloves rated at least ANSI A7 or higher. 9.3.3 To perform any job duties that involve operating, tending to, setting up, adjusting, cleaning, oiling, or repairing any power-driven lawn equipment, including lawn mowers, riding equipment (including riding mowers, golf carts, and all-terrain vehicles), trimmers, cutters, weed-eaters, edgers, except lawn equipment permitted 9.4.1. 9.3.4 To perform job duties other than those authorized by C.R.S. §§ 8-12-106 to -108. 9.4 An employer shall not permit a minor under fourteen: 9.4.1 To use power-driven lawn equipment, unless the requirements of Rule 9.2.6 are satisfied and the power-driven lawn equipment is of the type approved by the Division. The Division approves:

(A) Hand-held leaf blowers, if electric-powered, and the minor wears face and ear protection;

(B) Weed trimmers, if electric-powered and a string-type trimmer, and the minor wears eye protection;

(C) Snowblowers and throwers with a “deadman” mechanism as required by 29 C.F.R. § 1910.243(e)(4)(vi), which is incorporated by reference and available to the public for review as stated in Rule 1.3; and (D) Any other equipment the Division may approve through informal guidance. 9.4.2 To perform the job duties permitted by C.R.S. §§ 8-12-106 and -107 unless:

(A) The employer ensures that the work is adequately supervised by an adult, as required by the nature and location of the work, the individual minor employee, hazards of the work or circumstances, and any other relevant factors; and (B) The minor has received appropriate first aid and safety training.

(C) If an employer does not directly provide the required supervision and training, the employer must prove that it had a reasonable, good-faith belief that the required supervision and training were provided. 9.4.3 To perform job duties other than those authorized by C.R.S. §§ 8-12-106 and -107. 9.5 An employer shall not permit a minor under twelve to perform any job duties other than those authorized by C.R.S. § 8-12-106. 9.6 Rule 9.6 incorporates by reference Agricultural Labor Conditions Rule 3, 7 CCR 1103-15, as identified and made available to the public for review in Rule 1.3, except that as incorporated, an employer shall provide the heat protections contained in Agricultural Labor Conditions Rule 3 to all minors when the Agricultural Labor Conditions Rules 3.1 and 3.4 thresholds are triggered.

Rule 10. Exemptions, Exceptions, and Criteria 10.1 The Division may grant exemptions from any provision of the CYEOA concerning restrictions on work hours and occupations “for an individual minor if . . . such an exemption would be in the best interests of the minor involved.” C.R.S. § 8-12- 104(3). 10.1.1 Requests for exemptions must be submitted on forms provided by the Division, in accordance with procedures set by the Division. These forms and procedures may require information and documentation to demonstrate that the request is in the “best interest of the minor involved.” 10.1.2 The request may be submitted by any employer, minor, minor’s parent or guardian, school official, or youth employment specialist. A request from an employer, school official, or youth employment specialist will not be approved without agreement by the minor and, if appropriate, the minor’s parent or guardian. 10.1.3 When considering whether an exemption is in the best interest of the minor, the Division shall consider the totality of the circumstances. The relevant factors and weight of each factor are determined by the Division on a case-by-case basis. The Division will always consider the following, but may also consider other factors:

(A) the minor’s training and knowledge of safety practices related to the work;

(B) relative degree of safety, and any safety measures proposed by the employer;

(C) educational impact, including the work’s impact on the minor’s ability to attend school and educational benefits of the work itself;

(D) overall impact on the health and well-being of the minor; and (E) benefits to the minor, including career growth potential and whether the minor is fairly compensated for the work performed. 10.1.4 When evaluating the exemption, the Division may use all informationgathering authority it is granted by law and may visit the proposed workplace or require the minor to complete a test of proficiency. 10.2 A minor fourteen or older may perform hazardous duties as listed in Rule 8 as

part of their employment, without an exemption if the minor meets the requirements of C.R.S. § 8-12-110(1). 10.2.1 Apprenticeship training, as used in C.R.S. § 8-12-110(1), means apprenticeship training that is approved by, and registered with, Colorado’s State Apprenticeship Agency or the United States Department of Labor.

Rule 11. Minimum Wage for Minors 11.1 Definitions. For the purposes of this Rule 11 and only this Rule 11: 11.1.1 “ Minor” means any individual who is under eighteen years of age and is not an “emancipated minor.” 11.1.2 “ Emancipated minor” means any individual who is less than eighteen years of age who (A) has the sole or primary responsibility for their own support; (B) is married and living away from parents or guardian; or (C) is able to show that their well-being is substantially dependent upon being gainfully employed. 11.1.3 “ Employee” has the same meaning as C.R.S. § 8-4-101(5). 11.1.4 “ Employer” has the same meaning as C.R.S. § 8-4-101(6). 11.2 Pursuant to C.R.S. § 8-6-108.5, “the minimum wage for minors may be fifteen percent below the minimum wage for other workers; except that the full minimum wage shall be paid to any emancipated minor.” 11.2.1 The reduced minimum wage may only be paid if, after diligent inquiry, the employer determines that a minor is not emancipated. The employer must keep records of this inquiry, including the information considered and the final determination. 11.2.2 The reduced minimum wage may only be paid to individuals employed as minors in compliance with Colorado law. Minors who are employed in violation of the CYEOA or these Rules are entitled to the full minimum wage. ______________________________________________________________________ Editor’s Notes

History New rule eff. 02/01/2026.

7 CCR 1103-21 Appeals' Standing Order For Administrative Procedure Act Review {#sec-7-ccr-1103-21 omnilex-key=us-co-regs-official--department-10--7 CCR 1103-21}

DEPARTMENT OF LABOR AND EMPLOYMENT

APPEALS' STANDING ORDER FOR ADMINISTRATIVE PROCEDURE ACT REVIEW

7 CCR 1103-21 [Editor’s Notes follow the text of the rules at the end of this CCR Document.]

Adopted December 8, 2025; effective February 1, 2026.

Rule 1. Statement of Purpose and Authority 1.1 Authority and relation to other orders. The Appeals’ Standing Order for Administrative Procedure Act (APA) Review (SOAR) is issued under the general labor law implementation and authority and as enforcement of C.R.S. Title 8, Articles 1 and 3 (2025), and are intended to be consistent with the rulemaking and hearing and determination requirements of the State Administrative Procedure Act (APA), C.R.S. §§ 24-4-103 and 105. These SOAR Rules are promulgated pursuant to express authority including, but not limited to, C.R.S. §§ 8-1-107, -118, and 24-4-105 (“Any agency conducting a hearing, any administrative law judge, and any hearing officers shall have the authority to . . . regulate the course of the hearing, set the time and place for continued hearings, and fix the time for the filing of briefs and other documents . . . and take any other action authorized by agency rule consistent with this article 4 or in accordance, to the extent practicable, with the procedure in the district courts.”). These Rules supplement the procedures set forth in the APA, specifically C.R.S. § 24-4-105, as applied to requests for the agency to review determinations under statutes to which the APA applies, including, but not limited to, the Equal Pay for Equal Work Act (EPEWA), C.R.S. §§ 8-5-101 et seq.; the Employment Opportunity Act, C.R.S. § 8-2-126; the Social Media and the Workplace Law, C.R.S. § 8 2 127; the Colorado Chance to Compete Act, C.R.S. § 8-2-130; the Job Application Fairness Act (JAFA), C.R.S. § 8-2-131; and the Keep Jobs in Colorado Act, C.R.S. § 8 17 101 et seq. 1.2 Separability. These Rules are intended to remain in effect to the maximum extent possible. If any part of a rule (including any section, sentence, clause, phrase, word, or number) is held invalid, (A) the remainder of the rule remains valid, and (B) if the provision is held not wholly invalid, but merely in need of narrowing, the provision should be retained in narrowed form. 1.3 The Director of the Division of Labor Standards and Statistics in the Department of Labor and Employment has the authority to enforce the statutes cited in Rule 1.1 and other statutes under the Division’s purview subject to the APA § 24-4- 105 and has the authority to enforce these Rules.

Rule 2. Appeal Filings 2.1 Appeals of the Division determinations of claims governed by the APA’s hearing and decision provision, C.R.S. § 24-4-105, are subject to these rules. Any party to the claim may appeal the Division’s determination to a hearing officer in the Appeals Unit. No appeal will be heard and no hearing will be held unless the appeal is received by the Division within 35 calendar days of the date the determination is sent. It is the responsibility of the party filing the appeal to ensure the appeal is received by the Division within the 35-day filing deadline. If no request is received by the Division within the 35-day period, the Division’s determination is final.

Rule 3. Form of Appeal 3.1 Valid Appeals. Parties are encouraged, though not required, to use the Division’s appeal form. A valid appeal is a written statement that is timely filed with the Division, explains the clear error in the determination that is the basis for the appeal, is not frivolous, and has been signed by the party or the party’s authorized representative. 3.2 No Frivolous Appeals. An appeal is frivolous if it fails to allege an error that could result in the reversal or modification of the determination or otherwise is manifestly insufficient or futile.

Rule 4. Standard of Review on Appeal 4.1 The hearing officer will decide whether the Division’s determination was based on a clear error of fact or law. Clear error means that either the correct facts were not known at the time the determination was made, or the law was applied incorrectly. ______________________________________________________________________ Editor’s Notes

History New rule eff. 02/01/2026.

1101 Division of Oil and Public Safety

7 CCR 1101-5 Boiler and Pressure Vessel Regulations {#sec-7-ccr-1101-5 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-5}

DEPARTMENT OF LABOR AND EMPLOYMENT

BOILER AND PRESSURE VESSEL REGULATIONS

7 CCR 1101-5 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Basis and Purpose The basis and purpose of these regulations are to establish construction, installation, inspection, maintenance, and repair requirements for boilers and pressure vessels, establish inspection and certificate of inspection fees, adopt nationally recognized codes and standards, add or clarify terminology and add or clarify the duties of owners, users, installers and inspectors in order to ensure the safe operation of boilers and pressure vessels in Colorado.

Section 1-2 Technical Rationale The technical requirements of these regulations are generally accepted as national and international standards governing the minimum levels of acceptability for the initial design, fabrication and certification, as well as in-service inspection rating, repair, alteration, and re-rating of boilers and pressure vessels.

The adoption of these consistent standards is necessary for the preservation of the public health, safety, and welfare of the citizens of Colorado.

Section 1-3 Statutory Authority The amendments to these regulations are created pursuant to §§8-20-101, 9-4-103 and 9-4-109(1)(a) of the Colorado Revised Statutes (CRS).

Section 1-4 Effective Date These amended regulations shall be effective on January 1, 2026, and supersede all prior editions.

Section 1-5 Codes Incorporated by Reference (a) The following codes are incorporated by reference. This rule does not include any later amendments or editions of the standards and codes listed below.

(1) For the construction of new boilers and pressure vessels, the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code, Sections I, IV, V, VIII Divisions 1 and 2 and 3, IX, and X, 2023 edition. Exemptions from the scope of ASME

Section VIII Division 1 remain as listed in the 2023 edition. Copies of these documents from the ASME are available at the ASME’s website, www.asme.org, Two Park Avenue, Suite 1600, New York, NY 10016-5990.

(2) For the installation, in-service inspection, repairs, and alterations of boilers, pressure vessels and pressure-retaining items, the National Board Inspection Code (NBIC), 2023 edition. . Copies of these documents from the National Board Inspection Code (NBIC) are available at the National Board of Boiler and Pressure Vessel’s website, www.nationalboard.org, 1055 Crupper Avenue Columbus, OH 43229.

(3) For the design, materials, fabrication, erection, test, inspection, operation, and maintenance of boiler external piping, ASME B31.1, Power Piping, 2024 edition. Copies of these documents from the ASME are available at the ASME’s website, www.asme.org, Two Park Avenue, Suite 1600, New York, NY 10016-5990.

(4) For the installation, inspection, repairs, alterations, rating and re-rating of pressure vessels and piping used in the petroleum and chemical processing industries:

(A) For pressure vessels, the API/ASME 510, 10th edition, addenda 1-3. Copies of these documents from the API are available at the API’s website, www.api.org.

(B) For pressure piping, the API/ASME 570, 4th edition, addenda 1-4. Copies of these documents from the API are available at the API’s website, www.api.org.

(5) For the assembly, installation, maintenance, and operation of controls and safety devices, ASME CSD-1, 2021 edition. Copies of these documents from the ASME are available at the ASME’s website, www.asme.org, Two Park Avenue, Suite 1600, New York, NY 10016-5990.

(A) ASME CSD-1 applies to all boilers installed, relocated, or returned to service on or after January 1, 1993. The pertinent edition of ASME CSD-1 is the one adopted by the Colorado Boiler and Pressure Vessel Regulations at the installation, re-location, or return to service date. Copies of these documents from the ASME are available at the ASME’s website, www.asme.org, Two Park Avenue, Suite 1600, New York, NY 10016-5990.

(6) NFPA 85, Boiler and Combustion Systems Hazards Code, 2023 edition. Copies of these documents from the NFPA are available at the NFPAs website, www.nfpa.org, 1 Batterymarch Park, Quincy, Massachusetts U.S. 02169-7471 (7) NB-371, Accreditation of Owner-User Inspection Organizations (OUIO), Rev 10. Copies of these documents from the National Board Inspection Code (NBIC) are available at the National Board of Boiler and Pressure Vessel’s website, www.nationalboard.org, 1055 Crupper Avenue Columbus, OH 43229.

(b) Interested parties may review the referenced incorporated materials by contacting the Program Manager, Boiler Inspection Program 707 7th Street, Suite 2400, in Denver, Colorado 80202..

(c) This rule does not include later amendments to or editions of the incorporated material.

(d) Code cases approved for use by ASME are allowed to be used in the design, fabrication and testing of boilers and pressure vessels provided acceptance is first obtained from the Director.

(e) The application for a variance to the codes and standards listed above or to these regulations shall be made on the form provided by the Director.

Section 1-6 Definitions Terms in these regulations shall have the same meaning as those found in Title 4 Article 9 of the Colorado Revised Statutes. In addition, unless the context otherwise requires:

Alteration - Any change in the item described on the original Manufacturers' Data Report that affects the pressure-containing capability of the boiler or pressure vessel. Non-physical changes, such as an increase in the maximum allowable working pressure (internal or external) or design temperature of a boiler or pressure vessel shall be considered an alteration. A reduction in minimum temperature, such that additional mechanical tests are required, shall also be considered an alteration.

Apartment house - A building with multiple family dwelling units, including condominiums and townhouses, where boilers are located in a common area outside of the individual dwelling units, such as a boiler room. The exemption for apartment houses with fewer than six units refers to the number of units, not the number of units served by a boiler. Individual dwelling units are considered residences, such that any boiler located inside an individual dwelling unit is exempt.

ANSI - The American National Standards Institute.

API - The American Petroleum Institute.

API-certified inspector - An inspector who is certified by the American Petroleum Institute to perform functions specified in API-510 or API-570.

API-510, Pressure Vessel Inspection Code - The code for maintenance inspection, repair, alteration and re-rating procedures for pressure vessels used by the petroleum and chemical process industries. API- 510 is published by the American Petroleum Institute and is an approved ANSI standard.

API-570, Piping Inspection Code - The code for maintenance inspection, repair, alteration and re-rating procedures for process piping used by the petroleum and chemical process industries. API-570 is published by the American Petroleum Institute and is an approved ANSI standard.

ASME CSD-1 - The national standard entitled Controls and Safety Devices for Automatically Fired Boilers published by ASME.

Boiler - A closed pressure vessel in which a fluid is heated, steam or vapor generated, steam or vapor superheated, or any combination thereof, under pressure for use external to itself by the direct application of energy resulting from the combustion of fuel, solid, liquid, or gaseous, or by the use of electricity or nuclear energy.

Boiler, ASME Section I - A boiler falling under the scope of Section I of the ASME Boiler and Pressure Vessel Code. These are boilers in which steam or vapor is generated at a pressure more than 15 psig for use external to itself; or high temperature water boiler intended for operation at pressures exceeding 160 psig and/or temperatures exceeding 250 degrees Fahrenheit.

Boiler, ASME Section IV - A boiler falling under the scope of Section IV of the ASME Boiler and Pressure Vessel Code. These are steam boilers for operation at pressures not exceeding 15 psi, or hot water heating / hot water supply boilers for operation at pressures not exceeding 160 psi or temperatures not exceeding 250 degrees Fahrenheit.

Boiler, electric - A boiler whose source of heat is electricity.

Boiler external piping – Piping for boilers in which steam or vapor is generated at a pressure more than 15 psig for use external to itself, or a high temperature water boiler intended for operation at pressures exceeding 160 psig and/or temperatures exceeding 250 degrees Fahrenheit. This piping begins at the termination of the boiler proper and ends at:

(1) the first circumferential joint for welding and connections; or (2) the face of the first flange in bolted flanged connections; or (3) the first threaded joint in that type of connection; and that extends up to and including the valve or valves as required in ASME B31.1.

Boiler, forced circulation - A boiler requiring forced circulation to prevent overheating and failure of the tubes or coils.

Boiler, high temperature - A boiler in which water is heated and operates at pressures in excess of 160 psig or temperature in excess of 250 degrees Fahrenheit.

Boiler, hot water heating - A boiler in which no steam is generated and from which hot water is circulated for heating purposes, then returned to the boiler operating at pressure less than or equal to 160 psig or a temperature less than or equal to 250 degrees Fahrenheit.

Boiler, hot water supply - A boiler that furnishes hot water to be used externally to itself at a pressure less than or equal to 160 psig or at temperature less than or equal to 250 degrees Fahrenheit and not returned to the boiler.

Boiler, miniature - Any power boiler that does not exceed any of the following: ● 16 inches inside diameter of shell ● 20 square feet of heating surface ● Five cubic feet of gross volume exclusive of casing and insulation ● 100 psig maximum allowable working pressure Boiler, portable or moveable - A boiler permanently affixed to a trailer with wheels or skid-mounted that is totally self-contained while operating and not attached to any other object for any reason either by pipe, hose or wire while operating.

Boiler, power - A boiler in which steam or other vapor is generated at pressures in excess of 15 psig for use external to itself.

Boiler, unfired - A steam or other vapor generating system using heat external from itself, usually from the operation of a processing system or other indirect heat source.

Btu - British thermal unit.

Certificate inspection - An inspection performed by an authorized State or Special Inspector, the report of which is used as justification for issuing, withholding or revoking the certificate of inspection.

Certificate inspection, initial - The certificate inspection conducted by a State Inspector when a new or relocated boiler is being placed in service.

Certificate of inspection - A certificate of inspection, also known as a certificate of boiler operation, an inspection certificate or an operations certificate, is the certificate issued by the Director authorizing the operation of a boiler until a specific date.

Condemned - A boiler or pressure vessel determined by an Inspector to be so unsafe that further use is prohibited until it is satisfactorily repaired or replaced.

Director - The Director of the Colorado Department of Labor and Employment, Division of Oil and Public Safety or his or her designee.

Existing installation - Any boiler or pressure vessel that has received its initial certificate of inspection.

Grace period - The time when a boiler may legally be operated without a valid certificate of inspection.

Hot water storage tank - A closed vessel connected to a regulated boiler or water heater. When heated by steam or any other indirect means, these storage tanks shall comply with ASME construction requirements if any of the following limitations are exceeded: ● Heat input of 200,000 Btu/hr ● Water temperature of 210° F ● Nominal water-containing capacity of 120 gal Inspector, State - A person who is employed and authorized by the Director to perform certificate inspections.

Inspector, Owner-User - A person who holds a valid National Board Owner-User Commission and has passed the examination prescribed by the National Board or is an API-Certified Inspector under a jurisdictionally-approved Owner-User Inspection Organization.

Inspector, Special - A person employed by an insurance company licensed to sell or provide insurance for boilers or pressure vessels in Colorado who holds a valid commission as inspector issued by the National Board of Boiler and Pressure Vessel Inspectors and is authorized by the Director to inspect boilers insured by his or her employer.

Installer - A person or company responsible for setting up for use any regulated boiler or pressure vessel.

Jacketed steam kettle - A pressure vessel with inner and outer walls that is subject to steam pressure and stress, is used to boil or heat liquids or to cook food, and falls under the scope of ASME Section VIII

Appendix 9 (Jacketed Vessels) or Appendix 19 (Electrically Heated or Gas Fired Jacketed Steam Kettles).

(a) A direct-fired jacketed steam kettle is a jacketed steam kettle having its own independent source of energy, such as gas or electricity, for generating the steam within the jacket’s walls.

(b) An indirect-fired jacketed steam kettle is one where the steam within the jacket’s walls is generated external to itself, such as from a boiler.

NBIC - The National Board Inspection Code, also known as ANSI/NB-23.

National Board - The National Board of Boiler and Pressure Vessel Inspectors.

New installation - Any boiler or pressure vessel that has not received its initial certificate of inspection at its current location.

NFPA - The National Fire Protection Association.

Non-boiler external piping - Piping outside of the boundary for boiler external piping.

Operations certificate - See certification of inspection.

Out of service - A boiler that has been removed from service in accordance with Section 1-8 of these regulations. A certificate of inspection is not required for an out-of-service boiler or pressure vessel.

Owner-User Inspection Organization - An owner or user of pressure-retaining items who maintains a regularly established inspection department, and whose organization and inspection procedures meet the requirements of the National Board rules or API-510/570 and are acceptable to the Director.

Pressure-retaining item (PRI) - Any boiler, pressure vessel, piping or material used for the containment of pressure, either internal or external. The pressure may be obtained from an external source, by the application of heat from a direct source, or any combination thereof.

Pressure Vessel - A container other than a boiler or piping used for the containment of pressure. See also Section VIII vessel.

PSI - Pounds per square inch.

PSIG - Pounds per square inch gage.

Repair - Work necessary to restore pressure-retaining items to a safe and satisfactory operating condition.

Re-rate - A change in the temperature rating, the maximum allowable working pressure rating, or both, of a boiler, pressure vessel, or piping that shall be considered an alteration.

Scrapped - A boiler that has been cut into pieces or damaged to the point it cannot be returned to service, or has been removed from the location.

Section VIII vessel - A pressure vessel falling under the scope of Section VIII of the ASME Boiler and Pressure Vessel Code.

Stand-by status - A boiler or pressure vessel not in use, but its fuel supply or source of pressure remains connected. A current certificate of inspection is required for a boiler or pressure vessel in stand-by status.

Water heater, ASME - A closed vessel constructed to ASME Section IV designed to supply potable hot water which is heated by the combustion of fuels, electricity or any other source and withdrawn for use external to the system and shall include all controls and devices necessary to prevent pressures greater than 160 psig and water temperatures greater than 210 degrees Fahrenheit. This system operates at an input rating that exceeds 200,000 BTUs per hour or has a nominal capacity exceeding 120 gallons. .

Water Heater, forced circulation - A water heater requiring forced circulation to prevent overheating and failure of the tubes or coils.

Section 1-7 Scope These regulations apply to all boilers and water heaters as listed in Section 1-7(a), as defined in Section 1- 6, except those listed in Section 1-7(b).

(a) Boilers and pressure vessels as listed in the scope of ASME Sections I, IV and VIII.

(b) The following are not included in the scope of these regulations:

(1) Boilers owned or operated by the federal government.

(2) Locomotive boilers of carriers subject to the Federal Locomotive Inspection Act.

(3) Boilers located in private residences.

(4) Boilers located in apartment houses having less than six family units.

(5) Boilers in any city where city boiler inspectors, record-keeping, and inspection codes are comparable to the State program where the program has been reviewed and recommended by the National Board and approved by the Director upon application to the Director with submission of proof of such comparability.

(6) Water Heaters that do not exceed any of the following:

(A) An input rating of 200,000 BTUs per hour.

(B) A nominal capacity of 120 gallons.

(C) A design temperature of 210 degrees Fahrenheit.

(7) A hot-water storage tank heated by steam or other indirect means meeting the parameters listed in (6) of this Section.

Section 1-8 Removing a Boiler from Service (a) Boilers removed from service must be done so in a safe manner. This may be accomplished by scrapping the boiler or by putting the boiler into out-of-service status. To safely put a boiler into out-of-service status, physically sever all sources of energy (water, gas, electricity, etc.), cap all fuel lines and disconnect or remove all electrical lines.

(b) Prior to placing a boiler back in service, or when a boiler is moved and reinstalled, the boiler shall:

(1) Comply with currently-adopted codes and standards in these regulations or be upgraded as determined by the Director.

(2) Comply with rules and regulations for new installations.

(3) Successfully pass an inspection conducted by a State boiler inspector.

Section 1-9 Registration Requirements (a) All boilers, including reinstalled and second-hand boilers, regardless of code of construction, shall be registered with the National Board (excluding cast iron boilers and non-standard boilers).

(b) All fired and unfired pressure vessels, regardless of code of construction, shall be registered with the National Board, except for the following:

(1) Vessels installed or re-installed before April 30, 1999.

(2) Vessels built to Section VIII, Division 1 of the ASME Boiler and Pressure Vessel Code bearing the “UM” symbol before January 1, 2003.

(3) Vessels exempted by these Regulations or adopted codes of construction.

Section 1-10 Notification Requirements (a) The owner, user or installer shall report to the Director the location of previously unreported, newly-installed or relocated boilers by completing the application form supplied by the Director and submitting it prior to operation. This application form will ensure vital information is obtained, proper codes are utilized and timely inspections are scheduled. No fee will be charged for completing this application form.

(b) The owner, user or insurer of any existing boiler or pressure vessel shall report to the Director any boiler that is taken out of service or scrapped within 30 days in the format required by the Director.

Section 1-11 Repairs (a) Repairs to pressure relief valves shall be made only by an organization that holds a valid Certificate of Authorization for use of the National Board Pressure Relief Valve Repair “VR” symbol stamp in accordance with the regulations set forth in the National Board Inspection Code.

The initial installation testing and adjustments of a new pressure relief valve on a boiler or pressure vessel are not considered a repair if made by the manufacturer or assembler of the valve.

(b) Welded repairs and alterations to boilers and pressure vessels shall be made only by an organization that holds a valid Certificate of Authorization for use of the National Board Repair “R” symbol stamp in accordance with the regulations set forth in the National Board Inspection Code or the API Pressure Vessel Inspection Code (API-510), as applicable.

(c) The Director recommends that repairs to non-boiler external piping be made only by an organization with a written quality system manual enlisting the features of a quality system described within the NBIC.

Section 1-12 Boilers and Water Heaters (a) Newly installed or replacement boilers and water heaters installed after January 1, 2026, shall have the following:

(1) Manually-operated remote shutdown switch(es) or circuit breaker which shall be located just outside the equipment water heater room door(s) and marked for easy identification.

If the potential for tampering exists, the switch(es) shall be located just inside the door. If there is more than one door to the equipment water heater room, there shall be a switch located at each door. The emergency shutdown switch(s) or circuit breaker shall immediately shut off the fuel or energy supply.

(2) Carbon monoxide detection with an audible alarm in equipment rooms containing fuel fired boilers or water heaters.

(3) A method of controlling the pH of the condensate prior to its discharge into a sewer system on applicable equipment.

(4) A manually operated fuel shut off valve within six feet of the unit that is readily accessible from the floor.

Section 1-13 Forced-Circulation Water Heaters (a) All water tube or coil-type water heaters requiring forced circulation shall have the following: a n accepted safety control to prevent burner operation at a flow rate inadequate to protect the water heater unit against overheating, at all allowable firing rates. This safety control shall shut down the burner and prevent restarting until an adequate flow is restored. Positive means shall be provided to determine, during testing, that the accepted safety control has functioned upon an inadequate flow condition.

ARTICLE 200 INSPECTIONS

Section 2-1 Inspection Schedule (a) All new and reinstalled boilers shall receive an initial certificate inspection by a State Inspector.

Upon successful installation, completion of inspection and payment of fees, the Director shall issue a certificate of boiler and pressure vessel inspection.

(b) Pursuant to 9-4-108 CRS, all owners or responsible parties of regulated boilers shall allow access for inspection of a boiler as requested by a State or Special Inspector.

(c) Except as permitted in (c)(1) of this Section, power boilers and high-temperature water boilers shall receive a certificate inspection annually, which shall be an internal inspection where construction permits; otherwise, it shall be as complete an inspection as possible. Such boilers shall also be inspected externally on an annual frequency while under normal operating conditions.

(1) Alternative internal inspection requirements (A) The inspection frequency for fully-attended power boilers and high-temperature boilers may be extended to 36 months if the following requirements are met and approved by the Director:

(1) Continuous boiler water treatment under the direct supervision of persons trained and experienced in water treatment for the purpose of controlling and limiting corrosion and deposits.

(2) Record-keeping available for review, showing:

(i) The date and time the boiler is out of service and the reason therefore.

(ii) Daily analysis of water samples that adequately show the conditions of the water and elements or characteristics that are capable of producing corrosion or other deterioration to the boiler or its parts.

(3) Controls, safety devices, instrumentation and other equipment necessary for safe operation are up-to-date, in service, calibrated and meet the requirements of an appropriate safety code for that size boiler, such as NFPA 85, ASME CSD-1, National Board Inspection Code ANSI/NB-23 or jurisdictional requirements and are not compromised.

(B) Inspection intervals greater than 36 months may be granted at the discretion of the Director.

(d) ASME Section IV boilers covered by these rules and regulations shall receive a certificate inspection every two years, with an internal inspection at the discretion of a State or Special Inspector, where construction permits.

(1) Steam or vapor boilers shall have an external inspection or an internal inspection every two years.

(2) Hot water heating and hot water supply boilers shall have an external inspection every two years and, where construction permits, an internal inspection at the discretion of the State or Special Inspector.

(3) Water heaters, including hot water storage tanks, shall have an external inspection every two years which shall include an inspection of the function of all controls and devices.

(4) Indirect-fired jacketed steam kettles shall be inspected when the boiler providing steam to the kettle is inspected, although no certificate of inspection shall be issued by the Director.

(5) Hot water storage tanks shall be inspected when the hot water heating boiler or hot water supply boiler is inspected, although no separate certificate of inspection will be issued by the Director.

(e) Based upon documentation of such actual service conditions by the owner or user of the operating equipment, the Director may, at his/her discretion, permit variations in the inspection frequency requirements as provided in the Act.

(f) Historical boilers, defined as steam boilers of riveted construction that are preserved, restored or maintained for hobby or demonstration use, shall be subjected to an initial certificate inspection followed by a certificate inspection every three years thereafter if stored inside a shelter and annually if stored outdoors. The initial inspection shall include ultrasonic thickness testing of all pressure boundaries provided by an authorized non-destructive examination testing entity as defined in NBIC. All thinned areas shall be monitored and recorded on the inspection report both to the owner and Director’s electronic copy in the comments section.

(g) When a boiler, water heater, or direct-fired jacketed steam kettle that is required to have an operating certificate has a noted deficiency or a requirement for repair from an inspector authorized to inspect boilers or pressure vessels in the State of Colorado, the Inspector shall reinspect the pressure-retaining item within 90 days from the date the requirement or deficiency was first noted. The Inspector may omit this re-inspection at his/her discretion.

Section 2-2 Condemning a Boiler (a) Conditions which a State or Special Inspector may determine to be unsafe include: bypassed safety controls, inoperative safety valves, an excessive gas leak and any other condition that, in the Inspector’s judgment, means the boiler should be condemned.

(b) The owner or user must shut down the condemned boiler or pressure vessel as directed by the Inspector. If neither the owner nor user is available, the Inspector will cause the boiler to be shut down.

(c) The Inspector will affix to a condemned boiler or pressure vessel a notice that it has been condemned and may not be used until satisfactory repairs are made, as determined by a reinspection by an authorized State or Special Inspector.

Section 2-3 Inspections of Exempt Vessels State or Special Inspectors may perform inspections of exempt boilers or pressure vessels, upon receiving a written request from the boiler owner and based upon inspector availability. The inspector will notify the boiler owner of any safety code violations. An inspection fee and a certificate fee will be charged according to the schedule established by Article 4 of these regulations.

Section 2-4 Inspection of Insured Vessels by a State Inspector If an insurance company has not submitted to the Director an inspection report of an insured boiler or pressure vessel by 90 days after the expiration date of the certificate of inspection, the Director may send a State Inspector to perform the certificate inspection. Such an inspection by a State Inspector becomes the certificate inspection, regardless of whether the Special Inspector also performs the inspection and will be invoiced at the State inspection rate.

Section 2-5 Submission of Inspection Reports by Special Inspectors Special Inspectors shall file their inspection reports either by entering data into the web-based inspection entry form approved by the Director or by electronic transfer of data between the insurance company and the Director. If the electronic transfer of data option is selected, the insurance company is responsible for all costs to develop and implement this functionality.

Section 2-6 Inspections Required before Shipment to Colorado Before a new power boiler or a used/secondhand boiler or pressure vessel may be shipped for installation in the Director’s jurisdiction, an inspection must be made by an Inspector authorized by the Director or by any Inspector holding a valid National Board Commission. The purpose of this inspection is to assess the integrity of the vessel and ensure it meets the original design specification. Prior to installation, an application shall be filed by the owner or user of the boiler or pressure vessel with the Director for approval.

ARTICLE 3 CERTIFICATE OF INSPECTION

Section 3-1 Requirement of Certificates A valid certificate of inspection is required for all boilers that are included in the inspection fee schedule established by these regulations and that are in operational or stand-by status. A certificate of inspection is not required for a boiler that is out of service or scrapped as defined by these regulations.

Section 3-2 Grace Periods (a) A boiler may legally be operated without a current, valid certificate of inspection in the following situations:

(1) A new or existing boiler has received its initial inspection by a State Inspector, and:

(A) No violations were noted or proper notice has been made that all noted violations have been corrected.

(B) An enforcement document has not been issued for non-payment of invoiced inspection fees.

(2) An existing boiler has an expired certificate because the boiler was not inspected in a timely manner, provided the owner/owner’s representative has not hindered the performance of that inspection.

(b) The Director may extend the grace period provided there is no undue risk to public safety.

(c) No grace period applies for any boiler when the certificate of inspection has been suspended for non-compliance with safety requirements of these regulations.

ARTICLE 4 INSPECTION AND CERTIFICATE FEES

Table 4-1: Boiler Inspection and Certificate Fees Boiler type Inspection type BTU input Frequency Issued?

Fee- State fee- Insurance Fee All Boilers and Water Heaters Initial internal/external inspection Initial after installation Yes $100 N/A $25 Internal (water-side) inspection ≥ 5,000,000 btu/hr input Annual Yes $100 $15 $25 Annual Yes $85 $15 $25 < 1,000,000 btu/hr input Annual Yes $70 $15 $25 External (fire-side) inspection following the internal certificate inspection All capacities Annual No $50 $15 N/A External (fire-side) inspection where construction does not permit internal inspection ≥ 5,000,000 btu/hr input Annual Yes $85 $15 $25 Annual Yes $75 $15 $25 < 1,000,000 btu/hr input Annual Yes $65 $15 $25 ASME Sec IV Boiler or Non-Atmospheric Water Heater External (fire-side) inspection ≥ 5,000,000 btu/hr input Yes $75 $15 $25 < 1,000,000 btu/hr input Yes $65 $15 $25 Table 4-1: Boiler Inspection and Certificate Fees Boiler type Inspection type BTU input Frequency Issued?

Fee- State fee- Insurance Fee Storage Tank Water Heaters with Atmospheric Burners Yes $35 $15 $25 Direct-fired Jacketed Steam Kettles Yes $35 $15 $25 Exempt boilers and pressure vessels Upon request No $85 $0 $0 Historical boiler Every 3 Historical boiler Internal inspection Every 3

ARTICLE 5 OWNER-USER INSPECTION ORGANIZATIONS

Section 5-1 Requirement (a) Any person, firm, partnership, or corporation operating boilers or pressure vessels in Colorado may seek approval and registration as an owner-user inspection organization by filing an application with the Director on the prescribed forms.

(b) The applicant shall show the name of the organization, its principal address in the jurisdiction and the name and address of the person or persons having supervision over inspections made by said organization on the application and registration. The applicant shall report changes in supervisory personnel to the director within 30 days after any such change.

(c) Each owner-user inspection organization shall:

(1) Conduct inspections of its non-exempt boilers, utilizing only qualified owner-user inspectors.

(2) Retain on file at the location where equipment is inspected a true record or copy of the report of each inspection signed by the owner-user inspector who performed the inspection.

(3) Promptly notify the Director of any boiler or pressure vessel that does not meet the requirements for safe operation.

(4) Maintain inspection records that include a list of non-exempt boilers, showing the serial number and such abbreviated description as may be necessary for identification, the date of the last inspection of each unit, the approximate date of the next inspection and documentation of all repairs. Such inspection records shall be readily available for examination by the Director during business hours.

(5) Transmit a statement annually to the Director, on a date mutually agreed upon. Such statement shall be signed by the individual having supervision over the inspections made during the period covered. The statement shall include the number of boilers inspected during the year and shall certify that each inspection was conducted in accordance with the inspection requirements provided by these regulations.

(d) A state-issued certificate of inspection is required for boilers inspected by an owner-user inspection organization when all of the requirements in this Section are met.

(e) An individual or organization performing an inspection pursuant to this Section shall have liability insurance appropriate for the size and scope of the relevant inspection.

ARTICLE 6 ACCIDENT REPORTS AND INVESTIGATIONS

Section 6-1 Reporting Accidents (a) The owner or user shall notify the Director within 24 hours of the explosion of any boiler or pressure vessel, or of any accident involving a boiler, pressure vessel or boiler external piping that involves bodily injury or death to any person. The initial accident report may be by telephone (303-514-2140 ) or email (cdle_boiler@state.co.us).

(b) If the initial report is not on the form required by the State Boiler Section, that form must be completed and submitted within seven days of the explosion.

Section 6-2 Prohibition against Removal of Boiler or Pressure Vessel In the event of an explosion, personal injury or death, the boiler, pressure vessel, power piping and any associated parts shall not be removed or disturbed before permission has been given by the Director, except for the purpose of saving human life or limiting consequential damage.

Section 6-3 Investigation of Accidents The Director shall investigate any reported accident or explosion to determine the cause, if possible, and shall maintain a record of all such reports and investigations.

ARTICLE 7 ENFORCEMENT

Section 7-1 Enforcement Program The Director provides these regulations to assist the regulated community with maintaining safe and proper operation of regulated boilers and pressure vessels. When a regulated boiler or pressure vessel is found to be out of compliance with these regulations, the Director will pursue enforcement actions. The enforcement process will include requiring the boiler owner to make repairs and other actions to bring the boiler or pressure vessel back into compliance. During and following the enforcement process, the Director will continue to assist the boiler owner to remain in compliance. The enforcement process may include monetary penalties up to $1,000 per boiler or pressure vessel per day of violation according to §8- 20-104 CRS if the enforcement obligations are not implemented according to the required schedule.

Section 7-1-1 Notice of Violation (a) A Notice of Violation (NOV) may be issued when a boiler or pressure vessel is found to be out of compliance with these regulations or §8-20 and 9-4 CRS.

(b) Pursuant to §9-4-105(3) CRS, the NOV may include condemnation of a boiler or pressure vessel that has been determined to be unsafe, and the NOV shall constitute sufficient notice to cease and desist operation of the boiler or pressure vessel such that no further notice by the Director is required. In the case of a condemned boiler or pressure vessel, a re-inspection by a State or Special Inspector must be performed to document that satisfactory repairs were completed before the boiler or pressure vessel may be operated.

(c) Within 10 working days after an NOV has been issued, the person issued the NOV may file a written request with the Director for an informal conference regarding the NOV. If the person issued the NOV does not request an informal conference within this time frame, all provisions of the NOV shall become final and not subject to further discussion. If the NOV is not resolved within the prescribed time frame, the Director may then seek judicial enforcement of the NOV, or an Enforcement Order may be issued.

Section 7-1-2 Enforcement Order (a) An Enforcement Order may be issued when the violations included within an NOV are not resolved within the prescribed time frame. The Enforcement Order may include increased fines up to $1,000 per boiler or pressure vessel for each day of violation pursuant to §8-20-104(4)(a)

CRS. In addition, the Enforcement Order may include a cease and desist order per §9-4-108 CRS to discontinue use of the boiler or pressure vessel. The Director shall not issue a cease and desist order for a boiler operated without a valid certificate of inspection if the sole reason for failure to have the certificate of inspection is that the boiler was not inspected in a timely manner.

(b) Within 10 working days after an Enforcement Order has been issued, the boiler owner may file a written request with the Executive Director for an informal conference regarding the Enforcement Order. If the boiler owner does not request an informal conference within this time frame, all provisions of the Enforcement Order shall become final and not subject to further discussion. If the Enforcement Order is not resolved within the prescribed time frame, the Director may seek judicial enforcement of the Enforcement Order.

Section 7-1-3 Informal Conference (a) Upon receipt of the request, the Director shall provide the boiler owner with notice of the date, time and place of the informal conference. The Director shall preside at the informal conference, during which the boiler owner and Division personnel may present information and arguments regarding the allegations and requirements of the NOV or the Enforcement Order.

(b) Within 20 days after the informal conference, the Director shall issue a Settlement Agreement in which the violations from the NOV or Enforcement Order will be upheld, modified or stricken. The Settlement Agreement will include a schedule of required activity for resolution of the violations. If the terms or schedule in the Settlement Agreement are not satisfied, either an Enforcement Order will be issued or the Director may seek judicial enforcement of the previously-issued Enforcement Order. _________________________________________________________________________ Editor’s Notes

History Sections 1-4, 1-5-1, 2-1(c), 3-4 (d) and (e) eff. 12/01/2008.

Section 3-4 (d) and (e) emer. rule eff. 07/05/2010; expired 11/02/2010.

Sections 1-4, 1-5-1(a), 1-5-1(b)(1), 1-5-1(c), 1-5-2, 2-1(a), 2-1(c), 2-1(f), 3-3(b), 3-4(b), 3-4(d), 3-4(e), 3-5, 6- 1(a) emer. rule eff. 12/13/2010.

Sections 1-4, 1-5-1(a), 1-5-1(b)(1), 1-5-1(c), 1-5-2, 2-1(a), 2-1(c), 2-1(f), 3-3(b), 3-4(b), 3-4(d), 3-4(e), 3-5, 6- 1(a) emer. rule eff. 03/11/2011.

Sections 1-4, 1-5-1(a), 1-5-1(b)(1), 1-5-1(c), 1-5-2, 2-1(a), 2-1(c), 2-1(f), 3-3(b), 3-4(b), 3-4(d), 3-4(e), 3-5, 6- 1(a) eff. 04/14/2011.

Section 3-4 emer. rule eff. 11/30/2011.

Section 3-4 emer. rule eff.11/30/2011; expired 03/29/2012.

Sections 1-4, 1-5-1(a), 1-5-1(b)(1), 3-4(d) eff. 03/30/2012.

Sections 1-4, 1-5-1(c)-(e), 1-7-1(b), 1-9, 3-4(d), 5-1, 6-1(a) eff. 06/15/2013.

Entire rule eff. 07/01/2017.

Article 1, Sections 2-1(d)(5), 2-4, 2-6, Article 4, Sections 6-1, 6-3 eff. 01/01/2026.

Annotations Rules 1-7-1(b), 1-9, and 5-1 (adopted 06/01/2006) were not extended by House Bill 07-1167 and therefore expired 05/15/2007.

7 CCR 1101-7 Standards for Public School Buildings and Structures {#sec-7-ccr-1101-7 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-7}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Oil and Public Safety STANDARDS FOR PUBLIC SCHOOL BUILDINGS AND STRUCTURES 7 CCR 1101-7 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Statement of Basis and Purpose These regulations are promulgated by the Division of Oil and Public Safety (OPS) to establish uniform rules for the construction and inspection of public school buildings and structures, in the interest, safety and welfare of the general public.

The main purpose of these regulations is to ensure that public school buildings or structures are constructed and inspected in conformity with these rules and adopted building and fire codes, thereby protecting the health, safety, and welfare of the general public by creating better buildings and safer communities.

These regulations establish minimum requirements to safeguard the public health, safety, and general welfare through structural strength, means of egress facilities, stability, sanitation, adequate light and ventilation, energy conservation, and safety to life and property from fire and other hazards attributed to the built environment and to provide safety to fire fighters and emergency responders during emergency operations.

Section 1-2 Technical Rationale The technical requirements of these regulations are supported primarily by codes developed by the International Code Council, a membership association dedicated to building safety and fire prevention.

These regulations establish minimum requirements for building systems using prescriptive and performance related provisions which are widely used to construct residential and commercial buildings, including homes and schools.

Section 1-3 Statutory Authority The amendments to these regulations have been created pursuant to Title 8 Article 20.5 Sections (202) and (302) of the Colorado Revised Statutes sections Title 22 Article 32-124 and Title 23 Article -122 and Title 8 Article 107 as amended

Section 1-4 Effective Date These amended regulations shall be effective on December 1, 2008. The prior editions of the regulations were published July 20, 2007, April 24, 2008, and July 24, 2008.

Section 1-5 Definitions Terms in these regulations shall have the same definitions as those found in Articles of the Colorado Revised Statutes. In addition, unless the context otherwise requires:

Appropriate Building Department: Means the building department of a county, town, city, or city and county and includes a building department within a fire department.

Board: Means a Board of education, state charter school institute, charter school, or a junior college or their authorized representative subject to these regulations.

Building Permit: An official document issued by OPS or the prequalified building department which authorizes performance of the erection, alteration, demolition and/or moving of buildings and structures.

Certificate of Compliance: Means a certificate stating that materials and products meet specified standards, or that work was done in compliance with approved construction documents.

Certificate of Occupancy: An official document issued by OPS or the prequalified building department which authorizes a building or structure to be used or occupied.

Core and Shell Permit: An official document issued by OPS or the prequalified building department which is limited to authorizing the construction of foundation, columns, floor slabs, roof structure, exterior walls, and exterior glazing to the point of the building being weather tight.

Demolition Only Permit: An official document issued by OPS or the prequalified building department which is limited to authorizing the demolition of all or part of a building or structure.

Foundation: Work related to building footings, piers, foundation walls, slabs on grade, under slab and underground building services.

Foundation Only Permit: An official document issued by OPS or the prequalified building department which is limited to authorizing the construction of foundations.

Local Fire Department: A fire department providing fire protection service for the buildings and structures of the Board.

Qualified Fire Department: A fire department providing fire protection service for the buildings and structures of the Board that has certified fire inspectors, as defined by C.R.S. 24-33.5-1202(2.5), at the appropriate level for the task being performed.

Qualified Tradesperson: Means an employee of the Board who has satisfactorily demonstrated to OPS that they either hold a current building inspector certification from ICC or other similar national organization, or have at least five years of demonstrated education, training, and experience in commercial building construction or inspection.

Small Construction Project: Includes, installation of one or more new security gate, new window: interior/exterior, new door: fire rated, new door: non-fire rated, magnetic hold open device, wall: non-load bearing, skylight, new playground, partition over 5'-9", new operable partition, recreational equipment supported by structure, occupational therapy hook, dugout (fence), dugout (CMU), shop/vocational instruction equipment, shade structure, one or more portable modular buildings, re-roofing, roof penetrations, alteration of door: adding window/glazing in door, alteration of door hardware: panic hardware, or area that changes in use and occupancy. NOTE See separate small projects form, reroofing, and modular application form.

Temporary Certificate of Occupancy: An official document issued by OPS or the prequalified building department which authorizes a building or structure to be temporarily used or occupied for a period not to exceed 90 days, unless an extension has been granted by the Director of OPS or the prequalified building

Section 1-6 Codes, Documents or Standards incorporated by reference The following codes, have been adopted and promulgated as Colorado standards for erection and for purposes of inspection, of public school buildings and structures:

(1) International Building Code - 2003 Edition, First Printing: December 2002 (Copyright 2002 by International Code Council, Inc. - Falls Church, Virginia)

(2) International Fire Code - 2003 Edition, First Printing: December 2002 (Copyright 2002 by International Code Council, Inc. - Falls Church, Virginia)

(3) International Mechanical Code - 2003 Edition, Second Printing: May 2003 (Copyright 2003 by International Code Council, Inc. - Falls Church, Virginia)

The adoption of these codes expires on December 31, 2008.

Effective January 1, 2009 the Colorado Division of Oil and Public Safety will adopt the 2006 editions of the following codes:

(1) International Building Code - 2006 Edition, Third Printing: March 2007 (Copyright 2006 by International Code Council, Inc. Washington, D.C.)

(2) International Fire Code - 2006 Edition, Third Printing: April 2007 (Copyright 2006 by International Code Council, Inc. - Washington, D.C.), including Appendices B and C.

(3) International Mechanical Code - 2006 Edition, Second Printing: December 2007 (Copyright 2006 by (4) International Energy Conservation Code - 2006 Edition, First Printing: January 2007 (Copyright 2006 by International Code Council, Inc. - Washington, D.C.)

(5) International Existing Building Code - 2006 Edition, First Printing: January 2007 (Copyright 2006 by (6) International Residential Code – 2006 Edition, Second Printing: November 2006 (Copyright 2006 by In the event that a new edition of the code is adopted after a permit has been issued, the edition of the code current at the time of permit application shall remain in effect throughout the work authorized by the permit.

Section 1-7 Inspection of incorporated codes OPS shall maintain copies of the complete texts of the codes hereinabove, adopted as said codes, which copies shall be available for public inspection during regular business hours.

Interested parties may inspect the referenced incorporated materials by contacting the Program Manager, Public School Construction Program, 633 17th Street, Suite 500, Denver, CO 80202 and/or The State Depository Libraries.

Section 1-8 Later amendments not included This rule does not include later amendments to or editions of the incorporated material.

ARTICLE 2 FEES FOR PLAN REVIEW, PERMITTING AND INSPECTIONS

Section 2-1 Plan review, construction permit and inspection fees.

The Director of the Division shall charge a fee for plan review and issuance of a construction permit to cover the actual, reasonable, and necessary expenses of both OPS in the Department of Labor and Employment and the Division of Fire Safety in the Department of Public Safety for those expenses related to the Public School Construction Program.

The plan review, construction permit and inspection fees will be calculated based on the project valuation.

The inspection component of this fee only includes an oversight (interim) inspection and a final inspection conducted by OPS prior to the issuance of a certificate of occupancy. OPS inspection fees do not include costs associated with inspections conducted by the Division of Fire Safety, or third-party inspectors.

Effective August 6, 2008, the Director of the Division of Fire Safety shall charge a fee for inspections to cover the actual, reasonable, and necessary expenses of the Division of Fire Safety for those expenses related to conducting inspections as required by the Public School Construction Program. Refer to 8 C.C.R. 1507-30 for information about fees established by the Division of Fire Safety.

Section 2-2 Current OPS Fee Schedule The following table lists the current fee schedule which has been in effect since October 2007. The current fee schedule is also posted on the OPS website.

Plan Review, Permit and Inspection Fees Total Valuation Fee $1.00 to $2,000 $50 $2,001 to $25,000 $51 to $647 $25,001 to $50,000 $648 to $1,064 $50,001 to $100,000 $1,065 to $1,598 $100,001 to $500,000 $1,599 to $4,337 $500,001 to $1,000,000 $4,338 to $6,532 $1,000,001 to $2,000,000 $6,533 to $9,345 $2,000,001 to $4,000,000 $9,346 to $12,952 $4,000,001 to $8,000,000 $12,593 to $17,577 $8,000,001 to $16,000,000 $17,578 to $23,505 $16,000,001 to $32,000,000 $23,506 to $31,105 $32,000,001 to $64,000,000 $31,106 to $40,848 $64,000,001 + $40,849 + Portable/Modular Building Fees per site: $800.00 for the first unit, each additional portable/modular is $100.00, up to 10 units.

Re-Roof: Use fee schedule above, $800.00 minimum Boiler/Chiller/Furnace/Air Handling Unit: Use fee schedule above, $800.00 minimum Annual Permit: $500 A fee calculator also posted on the OPS website, enables determination of total fees (plan review and construction permit fees, including inspection fees) prior to submittal of a project. The fee schedule applied to a project will be the fee schedule in effect on the date of application submittal.

The Director of the Division will review the fund balance periodically and may reduce or increase the amount of the fee, if necessary, pursuant to section 24-75-402 (3) and 24-75-402 (4), C.R.S.

Section 2-3 Re-inspection fees OPS shall assess a $200 re-inspection fee for each inspection or reinspection when such portion of work for which inspection is called is not complete or when corrections called for are not made. This section is not to be interpreted as requiring reinspection fees the first time a job is rejected for failure to comply with the requirements of this code, but as controlling the practice of calling for inspections before the job is ready for such inspection or reinspection.

ARTICLE 3 CERTIFICATION AND PREQUALIFICATION PROGRAMS

Section 3-1 Third-Party Inspector Certification OPS will certify qualified persons to perform third-party inspection on public school construction projects.

A completed OPS Inspector Certification application form shall be used to apply for such certification.

Applications are available on the OPS website. Applicants seeking such certification from OPS shall have the following minimum qualifications:

1. Hold current appropriate building inspector certifications from ICC or other similar national organization, and have demonstrated education, training, and experience, or 2) Have at least five years of demonstrated education, training, and experience in commercial building inspections and receive national certification within one year after the date of OPS certification.

Qualified applicants that are currently certified by ICC or other similar national organization, as appropriate building inspectors will be issued OPS certifications for three years. Inspectors certified by OPS shall ensure that their ICC inspector certifications are renewed and continue to remain active throughout the duration of their OPS inspector certification.

Qualified applicants that have at least five years of demonstrated education, training, and experience in appropriate building inspections will be issued OPS certifications for one year.

Certification renewal will be contingent on the applicant obtaining commercial building inspector certification from ICC or other similar national organization, prior to the expiration date of the applicant’s OPS inspector certification. 3-1-1 Duties of Third–Party Inspectors (a) Certified third party inspectors contracted by the Board shall conduct the required inspections, and take enforcement action to ensure that a building or structure is constructed in conformity with the building and fire codes adopted by OPS.

(b) Certified third party inspectors contracted by the Board shall not take enforcement action other than in relation to the building and fire codes adopted by OPS.

(c) Certified third party inspectors contracted by the Board shall only use inspectors that have been certified by OPS to work on Public School Construction projects.

(d) Certified third party inspectors contracted by the Board shall cause copies of their inspection reports to be sent to OPS.

(e) If all inspections are not completed and the Board requires immediate occupancy, and if the Board has passed the appropriate inspections that indicate there are no life safety issues, the certified third party inspectors contracted by the Board shall notify OPS of the same so that OPS may issue a Temporary Certificate of Occupancy to allow the Board to occupy the buildings and structures.

(f) Certified third party inspectors contracted by the Board shall attest that inspections are complete and all violations are corrected before OPS issues the Board a certificate of occupancy. Inspection records shall be retained by the certified third party inspectors contracted by the Board for two years after the certificate of occupancy is issued. 3-1-2 Criteria for the Revocation of Third-Party Inspector Certifications If OPS finds any non-compliance with these regulations or the codes adopted therein, any intentional or known falsification of information, or that inspections are not complete, or that all violations are not corrected, OPS shall take enforcement action against the third-party inspector pursuant to section 8-20- 104, C.R.S.

Enforcement actions may include assessing penalties of up to $1,000 per violation for each day of violation as well as revocation of the third party inspector certification.

Section 3-2 Prequalification of Appropriate Building Departments OPS may prequalify an Appropriate Building Department to conduct the necessary plan reviews, issue building permits, conduct inspections, issue certificates of occupancy, issue temporary certificates of occupancy, and take enforcement action to ensure that a building or structure has been constructed in conformity with these regulations. In lieu of applying for a building permit through OPS, an affected Board may, at its own discretion, opt to use a building department that has been prequalified by OPS to conduct plan reviews, inspections and issue certificates of occupancy. 3-2-1 Prequalification Process (a) Application Form: In order to be considered for prequalification, OPS requires a completed application be submitted by the Appropriate Building Department, and by each qualified applicant seeking certification as a plan reviewer or inspector on a public school construction project. Qualified applicants shall have the following minimum qualifications:

1. Hold current appropriate plan reviewer and/or building inspector certifications from ICC or other similar national organization, and have demonstrated education, training, and experience, or 2) If an applicant is not certified in his or her respective field, the applicant shall have at least five years of demonstrated education, training, and experience in commercial building inspections and receive national certification within one year after the date of certification by OPS.

Plan reviewer and Inspector certifications issued by OPS to applicants holding ICC or national certifications will be valid for three years, whereas certifications issued to applicants on the basis of demonstrated education, training, and experience will be valid for one year, and will require ICC or national certification prior to renewal.

(b) Memorandum of Understanding: After OPS has reviewed the application and determined that the Appropriate Building Department has plan reviewers and inspectors that have the necessary education, training, and experience; OPS may issue and execute a Memorandum of Understanding (MOU) between the local jurisdiction and OPS. Pursuant to this MOU, OPS may prequalify an Appropriate Building Department to conduct the necessary plan reviews, issue building permits, conduct inspections, issue certificates of occupancy, and issue temporary certificates of occupancy to ensure that a building or structure has been constructed in conformity with the adopted building and fire codes, and take enforcement action. Nothing in the MOU shall be construed to allow the building department to take enforcement action other than in relation to the building and fire codes adopted by OPS.

In lieu of applying for a building permit through OPS, an affected Board may, at its own discretion, opt to use a prequalified building department that has entered into a MOU with OPS as the delegated authority. 3-2-2 Duties of Prequalified Building Departments (a) The prequalified building department shall conduct the necessary plan reviews, issue building permits, conduct inspections, issue certificates of occupancy, and issue temporary certificates of occupancy, and take enforcement action to ensure that a building or structure constructed in conformity with the building and fire codes adopted by OPS.

(b) The prequalified building department shall not take enforcement action other than in relation to the building and fire codes adopted by OPS.

(c) The prequalified building department shall only use plan reviewers and inspectors within their building department that have been certified by OPS to work on Public School Construction projects.

(d) The prequalified building department shall cause copies of the building plans to be sent to the appropriate fire department and the Division of Fire Safety for review of fire safety issues.

(e) If the building or structure is in conformity with the adopted building and fire codes, and if the Qualified Fire Department or the Division of Fire Safety certifies that the building or structure is in compliance with the adopted fire code, the prequalified building department shall issue the necessary certificate of occupancy prior to use of the building or structure by the permit applicant.

(f) If all inspections are not completed and the Board requires immediate occupancy, and if the Board has passed the appropriate inspections that indicate there are no life safety issues, the prequalified building department may issue a Temporary Certificate of Occupancy to allow the Board to occupy the buildings and structures.

(g) The prequalified building department shall attest that inspections are complete and all violations are corrected before the Board is issued a certificate of occupancy. Inspection records shall be retained by the prequalified building department for two years after the certificate of occupancy is issued.

(h) The prequalified building department may set reasonable fees and collect these fees to offset the cost of plan review and inspection of Public School construction projects. Public School Boards shall be notified of any adjustment of fees a minimum of thirty (30) days prior to the effective date of the change

ARTICLE 4 BUILDING PERMIT APPLICATION

Section 4-1 Building Construction Notification The Board must notify OPS within five days of initiating a project. Notification to OPS is only required when serving notice to OPS that the Board will be delegating plan review and inspections to the prequalified building department. Notification should include:

(a) Name of project (including district);

(b) Location of project;

(c) Scope of work;

(d) Projected cost;

(e) Planned construction start and end dates;

(f) Selection of delegation for fire review (Qualified Fire Department or Division of Fire Safety)

(g) Selection of delegation for plan review (prequalified local building department).

Section 4-2 Building Permit Application Process 4-2-1 Preliminary Application Package Review (a) For any construction project, the Board may hold a preliminary review meeting with either OPS or the prequalified building department, and the local fire department or the Division of Fire Safety at the appropriate design stage of document preparation.

(b) If a preliminary review meeting is requested, the following items should be included in the preliminary review package:

(1) A key plan or site plan as applicable, showing the property address(s) (or legal description), boundaries, existing buildings, proposed buildings and/or additions, parking lots, fenced areas, fire hydrants, fire equipment access, water supply and topography.

(2) Sufficient documentation to illustrate and describe the design of the project, establishing the scope, relationships, forms, size and appearance of the project by means of plans, sections and elevations, typical construction details, and equipment layouts. The documents shall include outline specifications that identify major materials and systems and establish in general their quality levels.

(3) A code plan that includes the following minimum information, (A) Calculation of the allowable and actual square footage of the new construction;

(B) The floor plan of all new construction, existing to remain, and remodel areas;

(C) The proposed occupancy group(s) of the building. Include daytime use and afterhours use occupancy groups where applicable;

(D) All fire and smoke rated construction (including rated exit corridors, fire walls, fire barriers, fire partitions, smoke barriers), and construction capable of resisting the passage of smoke; and (E) All exits and all stairways.

(c) OPS, the local fire department, the Division of Fire Safety, and the Board may request a meeting or teleconference, in a timely manner, at any time during the preliminary review. OPS shall make reasonable accommodations for such meeting or teleconference. 4-2-2 Building Permit Application Submittal (a) For all construction projects not covered under an annual building permit as defined in code, the Board must submit a complete plan review application package to OPS, the local fire department, and the Division of Fire Safety not less than 30 days prior to beginning construction. The Board may request from OPS an exemption to the 30 day minimum submittal time frame which will be considered on a case by case basis.

(b) The plan review application package must contain the following items listed below, except for small construction projects as defined in Section 1-5 (1) A fully completed plan review application, signed by the applicant, on the form provided by OPS (available on OPS website); http://oil.cdle.state.co.us/Public%20Safety/Schools/schoolconstruction.sp (2) A site plan or key plan as applicable.

(3) A code plan and analysis as required by IBC Section 106;

(4) Two full sets of construction documents (Both full size or one full and one half size), signed and wet stamped by the design professional in responsible charge, and by all design professionals in each of the design disciplines represented in the project;

(5) Two full sets of construction specifications (full size), signed and wet stamped by the design professional in responsible charge, and by all design professionals in each of the design disciplines represented in the project;

(6) Soils report (when required by IBC Section 1802.2).

(7) A statement of special inspections, as required by IBC Section 1704.1.1; and (8) Documentation of design compliance with the International Energy Conservation Code.

(9) Structural calculations (when applicable).

(c) The building permit application package shall be concurrently submitted to the Division of Fire Safety and to the Local Fire Department. The submittal will be reviewed by either the Qualified Fire Department or the Division of Fire Safety. Permit issuance is contingent upon the review and approval of the submittal by the Fire Code Official. Refer to 8 C.C.R 1507-30 for additional information pertaining to Fire Code review. 4-2-3 Plan Review and Permitting (a) OPS will notify the Board upon receipt of a complete Building Permit Application Submittal or of incomplete Building Permit Application Submittals.

(b) The Qualified Fire Department and/or the Division of Fire Safety have twenty (20) business days to submit the completed fire review to OPS. The Local Fire Department and/or the Division of Fire Safety may request in writing, an extension from OPS on the basis of the complexity of the building plans.

(c) Upon completion of the review, and after receipt of the fire review from the Qualified Fire Department and/or the Division of Fire Safety, OPS will provide to the Board a comprehensive list of corrections from both building and fire code reviews to be addressed prior to the issuance of a Building Permit. This list of corrections shall not be considered as all inclusive, and may not be considered as approval of any condition in violation of applicable code.

(d) OPS, Local Fire Department and/or the Division of Fire Safety, and the Board may request a meeting or teleconference, in a timely manner, at any time during the final review. OPS shall make reasonable accommodations for such meeting or teleconference. 4-2-4 Phased Permitting Upon request by the Board, OPS may issue phased permits for demolition, construction of foundations, and construction of core and shell, provided that construction documents for the whole building or structure have been submitted per section 4-2-2. The holder of such permit for demolition, or the construction of foundations or vertical construction shall proceed at the holder’s own risk with building operation and without assurance that a permit for the entire structure will be granted. Issuance of this permit shall not be considered all inclusive and may not be considered as approval of any condition in violation of applicable codes. 4-2-5 Annual Permits In lieu of an individual permit for each alteration to an already approved mechanical or building installation, OPS or prequalified building departments (PBD) may issue an annual permit upon application to any school district regularly employing one or more Qualified Tradespersons in the building, structure or on the premises owned or operated by the school district. Annual permits shall remain valid for a period of 12 months from the issuance date. The school district shall notify the Division of Fire Safety and the Local Fire Department prior to the commencement of work conducted under an annual permit. A PBD may require notification prior to commencement of projects conducted under an annual permit.

(a) Annual Permit Scope: The annual permit will be limited to the following scope of work:

(1) Replacement of already approved mechanical equipment.

(2) Installation of new non-fire rated door(s), in a non-bearing wall or partition.

(3) Adding window/glazing to an existing door.

(4) Repair of existing panic hardware.

(5) Installation of skylight(s) greater than ten feet away from a firewall.

(6) Installation involving roof penetration(s) greater than ten feet away from a firewall.

(7) Installation of one or more occupational therapy hooks.

(8) Installation of fence dugout(s) greater than six feet in height.

(9) Installation of shop/vocational instruction equipment.

(10) Demolition or removal of portable modular units.

(b) Annual Permit Records: The school district to whom an annual permit is issued shall keep a detailed record, including stamped engineered drawings (if applicable), of all replacements made under such annual permit. All work completed under an annual permit shall be inspected by a third party inspector or a Qualified Tradesperson within 10 days of completion of a project, and such inspections shall be recorded on an inspection log. OPS or PBD that chooses to issue annual permits shall have access to all inspection logs at all times and such records shall be submitted to OPS or the PBD within 30 days of the expiration date of annual permit. If the inspection logs associated with the annual permit demonstrate compliance with the annual permit requirements, OPS or the PBD may issue a Certificate of Compliance for projects completed under that permit.

ARTICLE 5 INSPECTIONS

Section 5-1 Required Inspections OPS shall require a sufficient number of third-party inspection reports to be submitted by the inspector based upon the scope and cost of the project to ensure quality inspections are performed. Concurrent with the building permit approval, OPS shall issue an Inspection Card specifying the applicable required inspections as set forth in Sections 109.3.1 through 109.3.10 of the IBC. The required inspections may include footing and foundation inspection, concrete slab and under-floor inspection, lowest floor elevation, frame inspection, lath and gypsum Board inspection, fire-resistant penetrations, energy efficiency inspections, other inspections, special inspections, and final inspection. The final inspection shall be conducted only by OPS or a prequalified local building department after all work required by the building permit is completed.

Construction or work for which a permit is required shall be subject to inspection by OPS, a third party inspector contracted by the Board, or the prequalified local jurisdiction and such construction or work shall remain accessible and exposed for inspection purposes until approved. Neither OPS, a third party inspector contracted by the Board, nor the prequalified local jurisdiction shall be liable for expense entailed in the removal or replacement of any material required to allow inspection.

Results of all inspections shall be documented on the job site inspection card and in the official records of the inspecting entity, including type of inspection, date of inspection, identification of the responsible individual making the inspection, and comments regarding approval or disapproval of the inspection.

Inspection records shall be retained by the inspecting entity for two years after the certificate of occupancy is issued.

Section 5-2 Inspection Request Notification OPS shall be provided with notification in writing at least 5 days prior to any requested inspection. It shall be the duty of the permit holder to provide access to and means for inspections of such work that are required by this code.

Work shall not be done beyond the point indicated in each successive inspection without first obtaining the approval from OPS, a third party inspector contracted by the Board, or the prequalified local jurisdiction. OPS, a third party inspector contracted by the Board, or the prequalified local jurisdiction, upon notification, shall make the requested inspections and shall either indicate the portion of the construction that is satisfactory as completed, or notify the permit holder or his or her agent wherein the same fails to comply with the codes adopted in these regulations. Any portions that do not comply shall be corrected and such portion shall not be covered or concealed until authorized by OPS, a third party inspector contracted by the Board, or the prequalified local jurisdiction.

Section 5-3 Third-party Inspections For all building permit applications received by OPS on and after August 6, 2008, the affected Board shall hire and compensate third-party inspectors certified by OPS to perform inspections. A listing of certified third party inspectors will be posted on the OPS website. If the Board is unable to obtain a third-party inspector, an Appropriate Building Department that has been prequalified by OPS shall oversee the project. If the Board is unable to obtain a third-party inspector and no building department has been prequalified, OPS shall conduct or contract with a third party inspector to perform the required inspections, and the Board shall compensate OPS or the contracted third-party inspectors for all associated inspection costs.

Prior to commencement of construction on projects requiring third party inspections, the Board shall notify OPS of the designated third party inspector for the permitted project. The notification shall be made in writing using a form provided by OPS. OPS may request a preconstruction meeting with the Board, the contractor hired to perform the work, and the certified third party inspector.

Section 5-4 Violation of Third-Party Inspection Requirement If OPS finds that inspections are not completed satisfactorily, or that all violations are not corrected, OPS shall take enforcement action against the appropriate Board pursuant to section 8-20-104, C.R.S., and shall require that the next project undertaken by the Board be delegated to the prequalified building

ARTICLE 6 CERTIFICATE OF OCCUPANCY

The Board shall not occupy or use a public school building or structure until a certificate of occupancy, or a temporary certificate of occupancy has been issued by OPS.

OPS or the prequalified building department may issue a temporary certificate of occupancy if a Board requires immediate occupancy, and if the Board has passed the appropriate inspections that indicate there are no life safety issues. The temporary certificate of occupancy shall expire ninety days after the date of issuance. If no renewal of the temporary certificate of occupancy is issued or a permanent certificate of occupancy is not issued, the building shall be vacated upon expiration of the temporary certificate of occupancy. OPS shall enforce this requirement pursuant to section 8-20-104, C.R.S.

ARTICLE 7 BOARD OF APPEALS

Section 7-1 General A board of appeals shall be created in accordance with section 22-32-124.5 C.R.S in order to hear and decide appeals of orders, decisions or determinations made by an inspecting entity relative to the application and interpretation of this code. The board of appeals shall be appointed by the Executive Director of the Department of Labor and Employment and shall hold office at its pleasure. The board of appeals shall adopt rules of procedure for conducting its business. If the inspecting entity and the board of appeals disagree on the interpretation of adopted codes or referenced standards, OPS shall set a date for a hearing as soon as practicable before the board of appeals.

Section 7-2 Limitations on authority An application for appeal shall be based on a claim that the true intent of this code or the rules legally adopted therein have been incorrectly interpreted, the provisions of this code do not fully apply or an equally good or better form of construction is proposed. The board of appeals shall have no authority to waive any requirements of the codes or standards. The board of appeals may recommend alternative materials as provided in the codes or standards. The final written decision of the board is final agency action for purposes of section 24-4-106, C.R.S.

Section 7-3 Qualifications The board of appeals shall consist of members who are qualified by experience and training to pass on matters pertaining to building construction and are not employees of OPS or a prequalified building

ARTICLE 8 ENFORCEMENT

If OPS finds any violation, of these regulations and the codes adopted therein, by the Board, a certified third party inspector or a prequalified building department, OPS shall take enforcement action against the offender pursuant to section 8-20-104, C.R.S. Besides penalties of up to $1,000 per day for each day of violation, OPS may revoke the certification of an offending third party inspector, or the prequalification status of an offending building department. _________________________________________________________________________ Editor’s Notes

History

Article 4 eff. 4/30/2007

Article 4-4, 405 emer. rule eff. 07/20/2007

Article 5 emer. rule eff. 8/6/2007 Articles 4-4, 4-5 eff. 10/30/2007

Article 5 eff. 11/30/2007 Entire rule emer. rule eff. 4/24/2008 Entire rule emer. rule eff. 07/24/2008 Entire rule emer. rule eff. 10/23/2008; expired 01/23/2009 Entire rule eff. 01/30/2009.

7 CCR 1101-8 Conveyance Regulations {#sec-7-ccr-1101-8 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-8}

DEPARTMENT OF LABOR AND EMPLOYMENT

CONVEYANCE REGULATIONS

7 CCR 1101-8 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] ______________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Statement of Basis and Purpose These regulations are promulgated to establish rules for the design, installation, registration, construction, operation, maintenance, testing and inspection of conveyances, and for the licensing of Conveyance Mechanics, Contractors and Inspectors. The purpose of these regulations is to ensure that elevators and other automated conveyances, accessible to the general public, are correctly and safely installed and operated within the state. The Conveyance Owner should communicate with Local Jurisdictions regarding more stringent requirements that may be in place, such as the required operation of the conveyance.

Section 1-2 Statutory Authority These regulations have been created pursuant to the Elevator and Escalator Certification Act, Title 9 Article 5.5 Section 116 of the Colorado Revised Statutes (C.R.S.).

Section 1-3 Effective Date These amended regulations shall be effective on January 1, 2026, and supersede all prior editions.

Section 1-4 Definitions Terms in these regulations shall have the same definitions as those found in Article 5.5 of Title 9 of the C.R.S. or as defined below.

ACCEPTANCE TEST. The testing, conducted by a Conveyance Mechanic, of a new or altered conveyance to verify compliance with standards as defined in these ADMINISTRATOR. The Director of the Division of Oil and Public Safety within the Department of Labor and Employment or the Director’s designee.

AFFILIATED. An employment or subsidiary relationship between two entities.

ALTERATION. As defined in American Society of Mechanical Engineers (ASME) A17.1: any change to equipment, including its parts, components, and/or subsystems, other than maintenance, repair, or replacement or as otherwise defined by the Administrator. This activity requires an Alteration permit, as defined in Section 2- 4- 1 of these regulations.

ALTERATION, EMERGENCY. An alteration that is limited to minor alteration activities and to those facilities where the building is dependent on the conveyance as the sole means of access and no other conveyance is available. The Conveyance Contractor performing such alteration shall submit a minor alteration permit application to the Administrator or Approved AHJ by the next working day.

ALTERATION, MAJOR. An alteration that is extensive in scope such that it warrants a complete witnessed Acceptance Inspection and applicable tests.

ALTERATION, MINOR. An alteration that is minor in scope, such that it only warrants the specific component(s) being altered to be tested and inspected.

ALTERATION, SUBSTANTIAL. An alteration that includes one of the following:

(a) The change in the Type of Service of an elevator (b) The change in the type of Operation Control or Motion Control (c) The installation of a controller The Substantial Alteration Permit must also include any scope necessary to comply with the currently adopted edition of ASME A17.3, which in turn requires compliance with any more stringent requirements listed in the currently adopted ALTERNATE MATERIALS AND METHODS REQUEST. The submittal of documentation to the Administrator or Approved AHJ by a Conveyance Owner or Conveyance Contractor that justifies the use of alternate methods or materials for the implementation of standards adopted pursuant to these regulations.

ANSI. American National Standards Institute.

ANSI/ASSE A10.4. Safety Requirements for Personnel Hoists and Employee Elevators on Construction and Demolition Sites.

ASCE. American Society of Civil Engineers.

ASCE 21. Automated People Mover Standards published as ASCE 21 Parts 1-4, as amended by ASCE. ASME. American Society of Mechanical Engineers.

ASME A17.1. Safety Code for Elevators and Escalators.

ASME A17.2. Guide for Inspection of Elevators, Escalators, and Moving Walks. ASME A17.3. Safety Code for Existing Elevators and Escalators.

ASME A18.1. Safety Standard for Platform Lifts and Stairway Chairlifts. ASSE.

American Society of Safety Engineers.

AUTHORITY HAVING JURISDICTION (AHJ). A Local Jurisdiction (including a fire department, fire district or fire authority) that is responsible for enforcing the requirements of a code or standard or for approving equipment, materials, an installation or a procedure.

AUTHORITY HAVING JURISDICTION (AHJ), APPROVED. A Local Jurisdiction or any agent thereof that has been approved by the Administrator pursuant to Section 3- 1 of these regulations.

AUTOMATED PEOPLE MOVER (APM). As defined in ASCE 21:a guided transit mode with fully automated operation, featuring vehicles that operate on guideways with exclusive right-of-way.

AUTOMATED PEOPLE MOVER ALTERATION. Any change to equipment, including its parts, components and/or subsystems other than maintenance, repair or replacement that does not materially affect the APM integrity, operation or control.

CERTIFICATE OF OPERATION (CO). A document issued by the Administrator or an Approved AHJ indicating that the conveyance has had the required safety inspection and tests and that fees have been paid as set forth in these CERTIFICATE OF OPERATION, CONSTRUCTION (CCO). A document issued by the Administrator or an Approved AHJ that allows the temporary operation of a conveyance for the support of construction activities without permitting conveyance access to the public.

CERTIFICATE OF OPERATION, TEMPORARY (TCO). A document issued by the Administrator or an Approved AHJ that allows the temporary operation of a conveyance for public use if life safety issues have not been identified following the inspection of the conveyance by a Conveyance Inspector.

CERTIFICATE OF SUBSTANTIAL COMPLETION. A document issued by the owner of an APM system stating that work relating to a product has progressed to the point that the owner can beneficially occupy or utilize the product for the purpose for which it is intended and that the work and product comply with all applicable codes and regulations.

COMPLIANCE MONTH. The month of the year in which the Certificate of Operation expires. The annual inspection is completed during this month for the issuance of subsequent Certificates of Operation.

CONVEYANCE. A mechanical device to which these regulations apply pursuant to

Section 1-5 of these regulations.

CONVEYANCE, PRIVATE RESIDENCE. A power passenger conveyance that is limited in size, capacity, rise, and speed and is designed to be installed in a private residence or in a multiple dwelling as a means of access to a private residence.

CONVEYANCE APPRENTICE. A person who is not licensed by the Administrator, is employed by a Conveyance Contractor, and is being trained by a Conveyance Mechanic on erecting, constructing, installing, altering, replacing, maintaining, removing or dismantling a conveyance.

CONVEYANCE CONTRACTOR. A person who holds a current Conveyance Contractor License issued by the Administrator.

CONVEYANCE MECHANIC. A person who holds a current Conveyance Mechanic, Temporary Conveyance Mechanic or Emergency Conveyance Mechanic License issued by the Administrator and who is employed by a Conveyance Contractor.

CONVEYANCE OWNER. The owner of the conveyance or assigned Managing Agent responsible for maintaining the conveyance.

DOOR RESTRICTORS. As described in the currently-adopted edition of ASME A17.1.

ELEVATOR. As defined in ASME A17.1: a hoisting or lowering mechanism, equipped with a car that moves within guides and serves two or more landings.

ELEVATOR, ELECTRIC. As defined in ASME A17.1: a power elevator in which the energy is applied, by means of an electric driving machine.

ELEVATOR, HYDRAULIC. As defined in ASME A17.1: a power elevator in which the energy is applied, by means of a liquid under pressure, in a hydraulic jack.

ELEVATOR, PRIVATE RESIDENCE. A power passenger elevator that is limited in size, capacity, speed and rise (as listed below), and is installed in a private residence or in a multiple dwelling as a means of access to a private residence.

(1) The inside net platform area shall not exceed 15 square feet (2) The minimum rated load shall be not less than the following:

(a) For net platform areas up to and including 12 square feet, the rated load shall be not less than 40 pounds per square foot or 350 pounds, whichever is greater (b) For net platform areas greater than 12 square feet, the rated load shall be based upon 62.5 pounds per square foot (3) The rated speed shall not exceed 40 feet per minute (4) The rise shall not exceed 50 feet ELEVATOR, SPECIAL PURPOSE PERSONNEL (SPPE). As defined in ASME A17.1: an elevator that is limited in size, capacity, and speed, and permanently installed in structures, such as grain elevators, radio antennae, bridge towers, underground facilities, power plants and similar structures to provide vertical transportation of Authorized Personnel and their tools and equipment only. An SPPE shall not exceed the following specifications:

(1) Capacity: 1,000 pounds (2) Size: 13 square feet (3) Speed: 150 feet per minute ELEVATOR, WIND TURBINE TOWER. As defined in ASME A17.1: a hoisting and lowering mechanism equipped with a car located within a wind turbine tower.

ESCALATOR. As defined in ASME A17.1: a power-driven inclined, continuous stairway used for raising or lowering passengers.

FIREFIGHTERS’ EMERGENCY OPERATION. As described in the currently-adopted HOISTWAY. An opening through a building or structure for the travel of a conveyance in which car rails have been installed.

INJURY. An injury that results in death or requires medical treatment (other than first aid) administered by a physician or by registered professional personnel under the standing orders of a physician. Medical treatment does not include first aid treatment or one-time treatment and subsequent observation of minor scratches, cuts, burns, splinters, and any other minor injuries that do not ordinarily require medical care even though treatment is provided by a physician or by registered professional personnel.

INSPECTION, ACCEPTANCE. The initial inspection and witnessing of acceptance testing, conducted by a licensed Conveyance Inspector, of a new or altered conveyance to verify compliance with standards as defined in these regulations.

INSPECTION, PERIODIC. The inspection of an existing conveyance conducted by a Conveyance Inspector to verify compliance with standards as defined in these INSPECTOR, AHJ. A Conveyance Inspector who holds a current Conveyance Inspector License issued by the Administrator, is employed by an Approved AHJ to inspect a conveyance and is not Affiliated with the Conveyance Mechanic whose Repair, Alteration or Installation is being inspected.

INSPECTOR, AHJ-APPOINTED. A Conveyance Inspector who holds a current Conveyance Inspector License issued by the Administrator, is employed by a non-profit entity, voluntary association or other council of governments that has been appointed or designated by an Approved AHJ to provide conveyance plan review and/or inspection services and is not Affiliated with the Conveyance Mechanic whose Repair, Alteration or installation is being inspected.

INSPECTOR, CONVEYANCE. A person who meets the definition of AHJ Inspector, AHJ-Appointed Inspector or Private Inspector.

INSPECTOR, PRIVATE. A Conveyance Inspector who holds a current Conveyance Inspector License issued by the Administrator, is not an Approved AHJ or Approved AHJ-appointed Conveyance Inspector, is retained by the Conveyance Owner to inspect a conveyance, and is not Affiliated with the Conveyance Owner, general contractor or Conveyance Contractor who is performing work on the conveyance or with the Conveyance Mechanic whose Repair, Alteration or installation is being inspected.

LICENSE. A written license, duly issued by the Administrator, authorizing a person, sole proprietor, firm or company to carry on the business of erecting, constructing, installing, altering, servicing, repairing, maintaining or performing inspections of conveyances covered by these regulations.

LOCAL JURISDICTION. A city, county, city and county or any agent thereof.

MAINTENANCE CONTROL PROGRAM (MCP). A documented set of maintenance tasks, maintenance procedures, examinations, and tests designed to ensure that equipment is maintained in compliance with the requirements of the currentlyadopted edition of ASME A17.1.

MANAGING AGENT. A person or company that is hired by the building owner or lessee to be responsible for maintenance of the conveyance(s).

MATERIAL RISK. A risk to public safety as determined by the Administrator in cooperation with Local Jurisdictions.

MOTION CONTROL. As defined in ASME A17.1: that portion of a control system that governs the acceleration, speed, retardation, and stopping of the moving member.

MOVING WALK. As defined in ASME A17.1: a type of passenger-carrying device on which passengers stand or walk and in which the passenger-carrying surface remains parallel to its direction of motion and is uninterrupted.

NFPA. National Fire Protection Association.

NFPA 13. Standard for the Installation of Sprinkler Systems.

OPERATION CONTROL. As defined in ASME A17.1: that portion of a control system that initiates the starting, stopping, and direction of motion, in response to a signal from an operating device.

PERSONNEL HOIST. A mechanism and its Hoistway for use in connection with the construction, Alteration, ongoing maintenance or demolition of a building, structure or other work. It is used for hoisting and lowering workers and/or materials and is equipped with a car that moves vertically on guide members. For the purpose of these regulations, a personnel hoist is only regulated if it is accessible to or used by members of the general public.

PERSONNEL, AUTHORIZED. As defined in ASME A17.1 and as amended in this definition: persons who have been instructed in the operation of the equipment and designated by the Conveyance Owner to use the equipment.

PERSONNEL, ELEVATOR. As defined in ASME A17.1: persons who have been trained in the construction, maintenance, repair, inspection, or testing of equipment.

PERSONNEL, EMERGENCY. As defined in ASME A17.1 Section 8.1.4 and as amended in this definition: persons who have been trained in the operation of emergency or standby power and Firefighters’ Emergency Operation or emergency evacuation. This category includes firefighters and other trained emergency personnel.

PLATFORM LIFT. As defined in ASME A18.1: a powered hoisting and lowering mechanism designed to transport mobility impaired persons on a guided platform that travels vertically or on an incline.

REPAIR. As defined in ASME A17.1: reconditioning or renewal of parts, components, and/or subsystems necessary to keep equipment in compliance with applicable Code requirements.

REPLACEMENT. As defined in ASME A17.1: the substitution of a device or component and/or subsystems, in its entirety, with a unit that is basically the same as the original for the purpose of ensuring performance in accordance with applicable Code requirements.

SYSTEM VERIFICATION. Activities with a set of minimum standards by which an APM system application shall be verified to meet the currently adopted edition of ASCE 21 and which shall include the elements of design review, analysis, qualification test, Acceptance Test, inspection, demonstration, and previous experience as listed in this document.

TYPE OF SERVICE. The passenger or freight classification for the use of an elevator.

Section 1-5 Scope These conveyance regulations apply to all conveyances listed below and as defined in

Section 1-4 of these regulations, except as provided in Section 1-5(4) of these (1) Hoisting and lowering mechanisms equipped with a car or platform for carrying persons between two or more landings.

(2) Power-driven stairways and walkways for carrying persons between landings.

Such equipment includes, but is not limited to:

(a) Escalators (b) Moving Walks (3) Automated people movers (APMs) as defined in ASCE 21.

(4) The following are not included in the scope of these regulations.

(a) Material hoists within the scope of ANSI A10.5 (b) Manlifts within the scope of ASME A90.1 (c) Mobile scaffolds, towers, and platforms within the scope of ANSI A92 (d) Powered platforms and equipment for exterior and interior maintenance within the scope of ASME A120.1 (e) Conveyors and related equipment within the scope of ASME B20.1 (f) Cranes, derricks, hoists, hooks, jacks, and slings within the scope of ASME B30.10 (g) Industrial trucks within the scope of ASME B56 (h) Items of portable equipment that are not portable escalators (i) Tiering or piling machines used to move materials between storage locations that operate entirely within one story (j) Equipment for feeding or positioning materials at machine tools, printing presses, and other similar equipment (k) Skip or furnace hoists (l) Wharf ramps (m) Railroad car lifts or dumpers (n) Line jacks, false cars, shafters, moving platforms, and similar equipment used by a certified Conveyance Contractor for installing a conveyance (o) Conveyances at facilities regulated by the Mine Safety and Health Administration in the United States Department of Labor, or its successor, pursuant to the “Federal Mine Safety and Health Act of 1977,” Pub.L. 91- 173, codified at 30 U.S.C. sec. 801 et seq., as amended (p) Elevators within the facilities of gas or electric utilities that are not accessible to the public (q) A passenger tramway defined in §25-5-702, C.R.S.

(r) Conveyances in a single-family residence (s) Stairway chairlifts as defined in ASME A18.1 (t) Special Purpose Personnel Elevators and Wind Turbine Tower Elevators that are used by Authorized Personnel, but are not accessible to or used by customers or members of the general public (u) Dumbwaiters within the scope of the currently adopted edition of ASME A17.1 (v) Type A material lifts within the scope of the currently adopted edition of ASME A17.1

ARTICLE 2 ADMINISTRATION

Section 2-1 Registration (1) The Conveyance Owner shall register the conveyance with the Administrator.

(2) The registration notice shall include:

(a) A complete conveyance registration form, which is provided on the Administrator’s website.

(b) The registration fee of $200 per conveyance.

(3) Upon the Administrator’s approval of the registration, the Administrator will assign a unique number to each conveyance and to the facility at which each conveyance is located. This number shall be known as the CP number.

(4) The CP number assigned by the Administrator to all conveyances subject to these regulations shall be permanently displayed on the controller cabinet or on the mainline electrical disconnecting means for the applicable conveyance. This number shall be verified during annual testing. The means for display shall be legible and withstand fading or removal. The means shall be replaced if it is deemed illegible during inspection.

(5) Conveyances installed after July 1, 2008, shall be registered with the Administrator before they are placed into service.

(6) The Conveyance Owner shall be responsible for notifying the Administrator of any change in ownership or management contact information within 30 days of the change.

Section 2-2 Adoption of Nationally-Recognized Safety Standards (1) Within these regulations, the Administrator adopts standards and codes as listed below except as amended by the Administrator. This rule does not include any later amendments or editions of the standards and codes listed below.

(a) American Society of Mechanical Engineers (ASME), Two Park Avenue New York, NY 10016-5990; www.ASME.org (i) ASME A17.1 – 2022; Safety Code for Elevators and Escalators (ii) ASME A18.1 – 2020; Safety Standard for Platform Lifts and Stairway Chairlifts (iii) ASME A17.3 – 2023; Safety Code for Existing Elevators and Escalators (b) American Society of Civil Engineers (ASCE), 1801 Alexander Bell Drive, Reston, VA 20191; www.ASCE.org (i) ASCE 21 – 2021; Automated People Mover Standards (2) Nothing in these regulations prohibits a Local Jurisdiction from adopting and enforcing standards which are more stringent than the minimum requirements included herein.

(3) Following the initial adoption of standards described in (1) of this Section, the Approved AHJ will remain current in adoption of future standard editions as they are adopted by the Administrator within the timeframe stated in the Memorandum of Agreement (MOA) or as determined by the Administrator.

(4) The Administrator, in collaboration with stakeholders, shall review the latest edition of a standard listed in (1) of this Section and shall determine whether any or all portions of the edition of the standard will be modified or deleted as it pertains to these regulations. Any deviation from the adopted standards will be incorporated into these regulations according to the regulation promulgation process as described in Title 24 Article 4 Section 103 C.R.S. Deviations from the adopted standards are listed in Section 2-7 of these regulations.

(5) The standards listed in (1) of this Section may be examined by contacting the Conveyance Program manager at the office of the Administrator located at 707 17th Street, Suite 2400 in Denver, Colorado.

Section 2-3 Inspections, Tests and Maintenance

Section 2-3-1 Periodic Inspections and Certificates of Operation

Section 2-3-1-1 Periodic Inspection (1) The Conveyance Owner shall arrange for a Periodic Inspection of an existing conveyance on an annual frequency or on a frequency as determined by the (2) The Periodic Inspection shall be completed by a Conveyance Inspector not Affiliated with the Conveyance Owner or Conveyance Contractor.

(3) The Conveyance Owner shall provide access at all times to all keys necessary for licensed personnel to conduct maintenance and inspections, for the Administrator to conduct inspections and for Emergency Personnel during an emergency. These keys shall include all keys listed in Section 8.1 of the currently adopted edition of ASME A17.1, as applicable. Such keys shall include, but not be limited to:

(a) Machine room, control room, or machine or control space (b) Hoistway access and Hoistway enable switch (c) Phase I and Phase II Firefighters’ Emergency Operation switch (d) Emergency or standby power emergency access selector switch (e) Pit access, if applicable (f) Equipment access panels (4) The Conveyance Inspector shall:

(a) Obtain the permission of the Conveyance Owner to conduct the Periodic Inspection, Acceptance Inspection or test witness inspection, prior to commencing inspection activities.

(b) Inspect the conveyance to the applicable code using either of the following criteria:

(i) The code edition adopted by the AHJ at the time of original installation and/or Alteration (ii) The code edition that was in effect at the time of original installation and/or Alteration if no code edition was adopted by the AHJ.

(c) Conduct the Periodic Inspection using the latest edition of ASME A17.2, manufacturers’ recommendation or the appropriate code based on the type of equipment as guidance.

(d) Witness all applicable tests in accordance with Section 2-3-2 of these (e) Document all deficiencies and the results of the Periodic Inspection on an inspection report form provided on the Administrator’s website. All applicable portions of the inspection report shall be completed.

(f) Submit the completed inspection report(s) to the Conveyance Owner.

(5) The Conveyance Owner shall submit the passing inspection report(s) and the required fee of $30 per conveyance to the office of the Administrator.

(6) All Periodic Inspections must be completed prior to the expiration date of the current Certificate of Operation. The Administrator may commence enforcement actions on the Conveyance Owner for operating the conveyance without a current Certificate of Operation.

(7) The expiration date for the ensuing Certificate of Operation will be set at the last day of the Compliance Month.

Section 2-3-1-2 Certificate of Operation (1) A conveyance shall not operate unless the Conveyance Owner maintains a current Certificate of Operation for the conveyance. The Certificate of Operation must be available for review as part of the Maintenance Control Program at the property where the conveyance is located.

(2) Following the Administrator’s review of the Periodic Inspection report described in Section 2-3-1-1 of these regulations and determination that the conveyance is in compliance with the applicable standards listed in Section 2-2(1) of these regulations or the standard under which the conveyance was installed or altered and the conveyance is registered according to Section 2-1 of these regulations, the Administrator will issue the Certificate of Operation for the conveyance to the Conveyance Owner.

(3) The Administrator may not issue the Certificate of Operation for the conveyance unless all deficiencies identified during previous Periodic Inspections have been corrected.

(4) The Certificate of Operation shall expire on the last day of the Compliance Month every year, or on a date as determined by the Administrator.

Section 2-3-1-3 Temporary Certificate of Operation (1) The Administrator may issue a Temporary Certificate of Operation (TCO) for a conveyance if the temporary operation of the conveyance for public use is necessary and a Conveyance Inspector or the Administrator has not identified imminent life safety issues.

(2) The TCO shall be valid for 60 days or a period as determined by the (3) Violations identified on an inspection report that warrant the issuance of a TCO must be mitigated prior to the Administrator issuing a Certificate of Operation that is valid through the last day of the Compliance Month. Following completion of the appropriate repairs and prior to the expiration of the TCO, the Conveyance Contractor must submit verification to the Conveyance Owner and the Administrator that the violations have been mitigated using one of the following documents:

(a) The TCO Affidavit attached to the TCO, signed by the owner, Conveyance Contractor or Mechanic performing the work. The signed affidavit must identify the Licensed Mechanic, or other person as allowed in these regulations, who completed the work.

(b) An inspection report indicating that an inspection occurred following the repairs and that the violations were mitigated (c) When a TCO is issued for the replacement of suspension means, compensation means or, governor rope an inspection shall be required to verify the replacement was completed in accordance with the applicable code. A TCO Affidavit will not be issued or accepted as verification.

(4) Violations identified by Conveyance Inspectors that warrant issuance of a TCO or shutdown of a conveyance are listed in Tables 2-3-1-3a and 2-3-1-3b of these regulations or as determined by the Administrator.

(5) Licensed personnel who recommend shutdown of a conveyance for any reason must notify the Administrator.

Table 2-3-1-3a: Violations Warranting TCO or Shutdown for Elevators Failure of witnessed Acceptance Tests for a new Installation or alteration.

Failure of components tested with full load (or via alternative testing) during a witnessed Category 5 test (see

Section 2-3-2 of these regulations), such as, brakes, car and counterweight safeties, governor, buffer, or overspeed valve.

Electrical protective safety device missing or inoperable (stop switch, door interlock, final terminal stop, car top exit device, etc.).

The installation or presence of any oversized fuse X Any past due safety tests as listed in Table 2-3-2 of these Violations (other than those listed in this table) that are not mitigated prior to the next annual Periodic Inspection.

Maintenance Control Program (MCP) is missing or is not complete.

Failure of Category 1 (see Section 2-3-2 of these regulations) test items listed on the Administrator’s test form except for the items listed in rows below which may warrant a TCO instead of a shutdown.

Governor rope nominal size is: ● Less than 8mm and is undersized, the wire break criteria is not met, or there is evidence of rouging. ● Greater than 8mm and is undersized or the wire Table 2-3-1-3a: Violations Warranting TCO or Shutdown for Elevators break criteria is not met. (Reinspection required)

Wire suspension means are undersized or have breaks not meeting code requirements. (Reinspection required)

Suspension means monitoring devices are missing or inoperable. (Reinspection required)

Door restrictors are missing or inoperable for elevators: ● Installed between January 1,1990 to present ● Altered between January 1,1990 and present, where the Alteration required the installation of door restrictors (i.e., Alteration of hoistway openings or change in Type of Service) ● Where there is evidence that door restrictors have been previously installed on the elevator Top and/or bottom hoistway door retainers are missing.

Any of the required hoistway door bottom guides are missing Door closing force exceeds 30 foot-pounds (lbf). X Firefighters’ emergency operation components are inoperable (not including signage).

Two-way communication is missing or inoperable. X Keys described in Section 2-3-1-1(3) of these regulations are not made available.

Table 2-3-1-3b: Violations Warranting TCO or Shutdown for Escalators and Moving Walks Failure of witnessed Acceptance Test (new or altered). X Electrical protective safety device missing or inoperable (stop switches, broken chain switch or floor access plate switch).

The installation or presence of any oversized fuse X Any past due safety tests as listed in Table 2-3-2 of these Violations (other than those listed in this table) that are not mitigated prior to the next annual Periodic Inspection.

MCP is missing or is not complete. X Failure of Category 1 test items listed on the Administrator’s test form except for the items listed in rows below which may warrant a TCO.

Comb plates with two or more adjacent broken teeth. X Comb plates with one broken tooth not adjacent to another broken tooth.

Failure of a step-skirt indexing test. X

Section 2-3-1-4 Construction Certificate of Operation (1) The Administrator may issue a Construction Certificate of Operation for an elevator that shall be valid for a period of 90 days if the temporary operation of the elevator is necessary to support building construction activities. The operation of the elevator shall conform to the following:

(a) The elevator shall be registered with the Administrator prior to the elevator being placed into service.

(b) The Administrator or Approved AHJ has issued an installation or Alteration permit.

(c) A full passing Acceptance Inspection and a completed conveyance inspection form shall be submitted to the Administrator or Approved AHJ.

Fire service operation and fire rating of the Hoistway and machine room do not need to be completed for a passing Acceptance Inspection for a Construction Certificate of Operation.

(d) The following items are required during construction use of the conveyance.

(i) The elevator shall conform to the requirements of the currentlyadopted edition of ASME A17.1.

(ii) All testing shall be completed by a Conveyance Mechanic and witnessed by a Conveyance Inspector.

(iii) The elevator shall have a designated attendant for operation.

(iv) The elevator shall be run on independent service only.

(v) A means of two-way communication shall be provided. Cell phones shall not be accepted as a means of two-way communication.

(vi) The machine room shall be enclosed and have a lockable door to prevent entry.

(vii) The hall call stations, if installed, shall be inactive.

(viii) Penetrations that allow an object to be inserted in the hoistway while the elevator is in motion shall not be allowed.

(ix) Substantially-flush floor surface shall be used in front of the entrances.

(x) Adequate lighting shall be used in front of the entrances and in the machine room.

(xi) The Construction Certificate of Operation shall be posted inside the elevator and shall be visible to riders at all times.

(e) If the finished cab interior was not installed when the initial tests were performed for a Construction Certificate of Operation, all tests shall be performed again before a Certificate of Operation is issued.

(2) The Construction Certificate of Operation can be renewed following the inspection by a Conveyance Inspector and approval of the inspection report by the Administrator or Approved AHJ. A Certificate of Operation for public use will be issued by the Administrator or Approved AHJ only after re-inspection and approval of the inspection report by the Administrator.

Section 2-3-2 Periodic and Acceptance Tests (1) An Acceptance Test shall be conducted following the completion of the new Installation or Alteration in accordance with the currently-adopted edition of the appropriate code based on the type of equipment before the conveyance is placed into service.

(a) For new installations, Major Alterations and Substantial Alterations, Acceptance Tests shall be completed in accordance with the applicable provisions of the currently-adopted edition of the appropriate code.

(b) For Minor Alterations, only the portion or component that was altered must be tested and inspected in accordance with the applicable provisions of the currently-adopted edition of the appropriate code.

(2) Tests referred to as Category 1and Category 5 in ASME A17.1 shall be performed by a Conveyance Mechanic employed by a Conveyance Contractor on all existing conveyances, except for an APM, at the frequencies listed in Table 2-3-2 of these regulations.

(3) The Conveyance Owner shall ensure that conveyance testing and inspection are aligned as follows:

(a) The Certificate of Operation (CO) will expire on the last day of the Compliance Month, and the Compliance Month will not change in future years, except as approved by the Administrator.

(b) The non-witnessed annual safety test shall be conducted within the two months prior to the Compliance Month. The annual safety test may be conducted during the Compliance Month as long as it occurs prior to or during the Periodic Inspection.

(c) The Periodic Inspection shall be conducted during the Compliance Month, and during or following the annual test to verify the completion of the test.

(d) During the year that the witnessed Category 1 and/or Category 5 tests are due, all testing shall be conducted during the Compliance Month and the Periodic Inspection shall be conducted concurrently with the witnessing of these tests.

(e) If a TCO has been issued because of a non-compliant test, the previously established Compliance Month shall not change.

(4) The requirements listed in Section 2-3-2 (3) do not apply to an Approved AHJ that conducts the Periodic Inspections and controls the testing within its territory or to other entities that have demonstrated to the Administrator that processes are in place allowing for the verification by the Administrator of Category 1 and 5 testing and witnessing.

(5) Tests referred to as One-Year and Five-Year in ASME A18.1 shall be performed by a Conveyance Mechanic employed by a Conveyance Contractor on all existing Platform Lifts at the frequencies listed in Table 2-3-2 of these regulations. These tests shall be aligned with the Periodic Inspection as described in Section 2-3-2 (3).

(6) The results of all tests discussed in this Section shall be recorded on the applicable conveyance test report form that is provided on the Administrator’s website. Test reports for tests not required to be witnessed shall be retained for a minimum of 5 years from the date of the test and shall be submitted to the Administrator upon request by the firm performing the test. The test report must be signed by the Conveyance Mechanic performing the test. When a Witness Test is required, the test form signed by the Conveyance Mechanic performing the test and the Conveyance Inspector witnessing shall be submitted to the Administrator by the firm performing the test. The completed test form shall be submitted no later than 7 days after the completion of the test.

(7) A Conveyance Inspector shall witness the performance of tests at frequencies as listed in Table 2-3-2 of these regulations.

(8) Upon completion of a periodic test or an Acceptance Test, a metal test tag made of metal or other durable material designed to last the life of the equipment shall be permanently mounted to the controller, in a readily visible location, in accordance with currently-adopted code. Periodic test tags shall remain in place for 5 years from the date of the test. Acceptance Test tags shall remain in place permanently.

(9) If Category 5 testing without load via alternative test methodologies will be utilized, the Conveyance Owner or Conveyance Contractor must notify the Administrator prior to development of the base-line and alternative testing procedures and must have approval from the Administrator prior to implementation of the alternative testing.

(10) The frequency of test performance and witnessing shall be on the frequency listed in Table 2-3-2 of these regulations or as determined by the Administrator.

Table 2-3-2: Frequency of Periodic Tests Conveyance Type Category 1 Category 5 Perform Witness Perform Witness Traction Elevators Annually 5 years 5 years 5 years Hydraulic Elevators Annually 5 years 5 years 5 years Other Elevators Annually 5 years 5 years 5 years Escalators & Moving Walks Annually Annually Not required Not requ ired Private Residence Elevators installed in commercial buildings 5 years 5 years 5 years 5 years Platform Lifts (A18.1 One-Year) (A18.1 Five-Year)

Indoor Platform Lifts 5 years 5 years 5 years 5 years Outdoor Platform Lifts 3 years 6 years 3 years 6 years A category 5 test is only required to be conducted and witnessed on a hydraulic elevator if the elevator is equipped with safeties, a plunger gripper, a governor, an oil buffer, or an over-speed valve.

Includes roped-hydraulic elevators, winding-drum, type B material lifts and Limited-Use/Limited-Application (LU/LA) elevators.

Private Residence Elevators shall not be installed in commercial settings after January 1, 2008, per section 2-4-2(5) of these regulations. For requirements of approved Installations, refer to Section 2-7(5) of these regulations.

Section 2-3-3 Maintenance Control Program (1) A Maintenance Control Program (MCP) shall comply with this section and be in place to maintain regulated conveyance equipment in compliance with currentlyadopted codes.

(2) The MCP shall consist of the following components.

(a) General Maintenance Requirements: The General Maintenance Requirements component shall include, but not be limited to, the following:

(i) If the conveyance equipment was installed before January 1, 2000 and did not undergo a Major or Substantial Alteration after this date, a version specific to the conveyance type (traction, hydraulic, etc.) will satisfy this requirement (ii) If the conveyance equipment was installed or underwent a Major or Substantial Alteration on or after January 1, 2000, a version applicable to the equipment model will satisfy this requirement (iii) Required maintenance tasks, such as cleaning, lubricating and adjusting the equipment (iv) Code-required examination and tests listed in the currently-adopted (v) Specified scheduled maintenance intervals (vi) Procedures for tests, Periodic Inspections, maintenance, Replacements, adjustments, and any other procedures included in On-site Documentation (b) On-site Documentation: The On-site Documentation component shall include items listed in the currently-adopted edition of ASME A17.1.

(i) Up-to-date wiring diagram detailing circuits of all electrical protective devices for:

(A) Conveyances installed or altered on or after January 1, 2000 (B) Conveyances installed prior to January 1, 2000, if the diagrams exist.

(ii) Written check-out procedures (iii) Unique procedures for all maintenance, inspections and tests not described in ASME A17.2; such as, Repairs of the detection means and related circuits for traction-loss, broken-suspension- member and residual-strength as listed the currently-adopted edition of ASME A17.1.

(iv) Written procedures for evacuation by Emergency Personnel (v) Written procedures for cleaning the exterior of cars and interior of hoistways which have transparent enclosures (c) Maintenance and Inspection Records: The Maintenance Records component shall include items listed in the currently-adopted edition of ASME A17.1 and as summarized below.

(i) Description of maintenance tasks performed, including dates of service (ii) Description and dates of examinations, tests (completed reports), adjustments, Repairs and Replacements (iii) Written record of required oil level verification. The manufacturer’s required oil level shall be verified and logged during maintenance visits and testing. Entries are required regardless of the need to add oil or not.

(iv) Findings of activities conducted by Authorized Personnel:

(A) Monthly Firefighter’s Service Emergency Operation check according to the applicable edition of ASME A17.1 (B) Quarterly verification of operation of the elevator car emergency two-way communication according to a process provided by the Administrator.

(v) A minimum of the last 5 years of Periodic Inspection reports (vi) Current Certificate of Operation (vii) Maintenance records shall be retained for 5 years. A record of Acceptance Tests (completed reports) and test tags, required in these regulations, shall be retained permanently.

(viii) List of Authorized Personnel per Section 4-1(4)(b).

(3) All components of the MCP shall be:

(a) Provided by the contractor responsible for maintenance of the conveyance or by the Conveyance Owner and owned by the Conveyance Owner.

When a maintenance contractor is no longer retained by the Conveyance Owner to maintain the conveyance, the Conveyance Contractor must leave the entire document at the facility in the location described in (3)(b) of this Section, with the exception of maintenance frequencies as determined in the contract between the Conveyance Owner and contractor. The maintenance frequencies provided by the Conveyance Contractor that is subsequently retained by the Conveyance Owner shall provide this documentation as described in (2)(a) of this Section.

(b) Kept on-site outside of the hoistway in the machine or control room, machinery or control space, Escalator or Moving Walk pit area, or another on-site location with proper signage according to the currently-adopted edition of ASME A17.1. For those conveyances listed in ASME A18.1, the MCP shall be maintained on-site at a location with proper signage according to the currently-adopted edition of ASME A17.1. This requirement does not apply to call-back documents as described in (4) of this Section.

(c) Presented in hard-copy or electronic form, unless specified by these regulations as written. The Conveyance Contractor or Conveyance Owner shall ensure that the mode of presentation is viewable by Conveyance Contractors, Mechanics, Inspectors, and the Administrator at all times from the time of the Acceptance Inspection and test or from the time of equipment installation or Alteration.

(d) Updated when any items listed in the MCP have been altered.

(4) Call-backs (trouble calls): The description, dates and associated corrective actions of all call- backs are required to be maintained and made available to licensed personnel, Conveyance Owner and Administrator personnel as required in the currently-adopted edition of ASME A17.1. These records are not required to be kept on-site.

Section 2-4 Alteration and New Installation

Section 2-4-1 Alteration (1) The Conveyance Owner or Conveyance Contractor who intends to complete an Alteration on an existing conveyance shall submit a permit application and a fee of $150 per conveyance to the Administrator at least 30 days prior to commencing construction. The permit application shall be accompanied by all applicable documents describing the complete proposed scope of work to be permitted, including but not limited to construction drawings, equipment specifications and information determined to be relevant by the Administrator.

(2) Prior to the Alteration of the conveyance, the permit application shall be reviewed and documentation approved by the Administrator. If all documentation in (1) of this Section is not complete and accurate, the application will not be approved and the applicant will be notified of the deficiencies. If approved, the permit issued by the Administrator shall be available to be viewed by the Administrator and/or Elevator Personnel on-site where the conveyance is to be installed.

(3) Alteration activities shall commence prior to the expiration date of the permit issued from the office of the Administrator. When Alteration activities fail to begin prior to the expiration date of the permit issued from the Administrator, the permit is invalid and a new permit must be issued by the Administrator prior to work beginning.

(4) Alteration activities regarding elevators which require a permit application to be submitted to the Administrator are items listed in ASME A17.1 and include but are not limited to the following:

(a) Minor Alterations (i) Addition of power operation to door systems (ii) Change or Replacement of a car door operating system (iii) Changes to the guide rails, supports, or fastenings (iv) Changes to car or counterweight buffers (v) Increase or decrease of the dead weight of the car that is sufficient to increase or decrease the sum of the dead weight and rated load, as originally installed, by more than 5%. Where this Alteration increases the original building design reactions by more than 5%, the permit application shall also include documentation that the adequacy of the affected building structure has been verified by a licensed professional engineer.

(vi) Installation of new car or counterweight safeties or Alteration to existing safeties. If new car safeties are added to an existing conveyance, the permit application shall also include documentation that the adequacy of the affected building structure, guide rails, supports and fastenings has been verified by a licensed professional engineer.

(vii) Installation (other than Replacement) or Alteration to a speed governor (viii) Alteration to the terminal stopping device (ix) Alteration to the standby or emergency power system (x) Alteration to Firefighters’ Emergency Operation (xi) Addition of a hoistway entrance (xii) Controller Replacement for a hoistway door, car door, or car gate (xiii) Increase in working pressure by more than 5% (xiv) Change to or Replacement of a plunger or cylinder (to include the installation of a plunger gripper)

(xv) Replacement of an existing control valve with a valve of another type (xvi) Replacement of a hydraulic tank (xvii) Replacement of a hydraulic tank and valve (power unit)

(xviii) Any work within a cab other than that specified in Section 2-4-1-1 (1) of these regulations (xix) Addition of access control to elevators.

(b) Major Alteration Types (i) Increase of rated load (ii) Installation or Alteration to driving machine, driving machine brake or driving machine sheaves. This includes moving a driving machine.

(iii) Increase to the rated speed (iv) Increase or decrease in rise (v) Any Alteration to a Platform Lift (c) Substantial Alteration (i) The change in the Type of Service (ii) The change in the type of Operation or Motion Control (iii) The installation of a controller The Substantial Alteration permit must also include any scope necessary to comply with the currently-adopted edition of ASME A17.3, which in turn requires compliance with any more stringent requirements listed in the currently-adopted edition of ASME A17.1. Refer to Section 2-7(1) of these regulations for further requirements.

(5) Alteration activities regarding Escalators and Moving Walks which require a permit application and processing fee of $150 per conveyance to be submitted to the Administrator are listed below.

(a) Minor Alteration Types (i) Installation of skirt deflector device or adjustment of the skirt (ii) Alteration or Replacement of handrails or handrail system (iii) Alterations that involve the trusses, girders or supporting structures (iv) Any Alteration to or addition of operating and/or safety devices (v) Alteration or addition to lighting, access or electrical work (vi) Alteration to entrance or egress (b) Major Alteration Types (i) Change in angle of inclination or geometry of balustrades (ii) Alteration to step system or treadway system (iii) Alteration to the step wheel tracks or track system (iv) Changes in rated load or speed (v) Installation or Replacement of the controller (6) The Administrator or Approved AHJ may allow a Conveyance Contractor to perform emergency work on a conveyance that normally requires a permit if the emergency Alteration activity is as defined in Section 1-4 of these regulations.

(7) Following any Alteration of a conveyance, where a permit is required from the Administrator or the Approved AHJ according to this Section, the Conveyance Owner shall arrange for an Acceptance Test and inspection of the conveyance in accordance with Section 2-3-2 of these regulations. The Acceptance Inspection and issuance of a Certificate of Operation shall be processed by the Administrator in accordance with Section 2-3-1 of these regulations.

Section 2-4-1-1 Elevator Cab Interiors (1) A Conveyance Owner may conduct the following type of work within the interior of an elevator cab without notification to or obtaining a permit from the (a) Change light lamps, not to include Replacement of the luminaire (fixture)

(b) Repair or refinish existing floor, wall or ceiling materials limited to in-place work such that it does not require the removal of the cab ceiling or wall panels, does not include any change in the type of materials of the existing cab interior, does not add or subtract weight to the existing cab, and the new materials meet the requirements of the currently- adopted (c) Replacement of flooring materials with materials of the same type (i.e. ceramic, carpet, wood, metal) and weight, and the new materials meet the required critical radiant flux measurement of the currently-adopted edition of ASME A17.1.

(2) A Conveyance Owner or a Conveyance Contractor shall first obtain a permit from the Administrator as described in Section 2-4-1 of these regulations for work within an elevator cab that involves the installation or Alteration of cab components. A Conveyance Mechanic shall conduct this work or maintain on-site direction of the execution of this work by a Conveyance Apprentice or another contractor.

Section 2-4-2 New Installation (1) The Conveyance Owner or Conveyance Contractor who intends to install a conveyance shall submit a permit application and a fee of $300 per conveyance to the Administrator at least 30 days prior to commencing construction. The permit application shall be accompanied by all applicable documents describing the complete proposed scope of work to be permitted, including but not limited to construction drawings, equipment specifications and information determined to be relevant by the Administrator.

(2) Prior to the installation of the conveyance, the permit application shall be reviewed and documentation approved by the Administrator. If all documentation in (1) of this Section is not complete and accurate, the application will not be approved and the applicant will be notified of the deficiencies. If approved, the permit issued by the Administrator shall be available to be viewed by the Administrator and/or Elevator Personnel on-site where the conveyance is to be installed.

(3) Installation activities shall commence prior to the expiration date of the permit issued from the office of the Administrator. When Installation activities fail to begin prior to the expiration date of the permit issued from the Administrator, the permit is invalid and a new permit must be issued by the Administrator prior to work beginning.

(4) Following the installation, where a permit is required from the Administrator or Approved AHJ according to Section 2-4-2 of these regulations, the Conveyance Owner shall arrange for an Acceptance Test and Inspection of the conveyance in accordance with Section 2-3-2 of these regulations. The Acceptance Inspection and issuance of a Certificate of Operation shall be processed by the Administrator in accordance with Section 2-3-1 of these regulations.

(5) After January 1, 2008, the Administrator shall not allow the installation of a Private Residence Conveyance in any commercial setting where the public or multiple private residences have access to the conveyance.

Section 2-4-3 Alternate Materials and Methods Request (1) The Administrator and Approved AHJ may grant the use of alternate materials and methods on a case-specific basis for the implementation requirements of the adopted codes or standards listed in Section 2-2 of these regulations. An Approved AHJ shall notify the Administrator of an alternate materials and methods request approved by the AHJ prior to implementation.

(2) Requests for the use of alternate materials and methods where a conveyance is not located within the area of an Approved AHJ shall be submitted to the Administrator and be completed on the alternate materials and methods request form provided on the Administrator’s website. This request will not be reviewed unless the appropriate form and required documentation are complete.

(3) A submitted alternate materials and methods request shall not relieve a person from complying with the applicable standards adopted in these regulations unless the Administrator or the Approved AHJ expressly approve the use of alternate materials and methods.

Section 2-5 Automated People Movers (1) The Conveyance Contractor who intends to install an APM or perform an APM Alteration shall conform to the requirements in either Section 2-4-1 or 2-4-2 of (2) The Conveyance Owner or Managing Agent where the APM system is located shall arrange for inspection of verification testing of the installed or altered APM system by a Conveyance Inspector and shall submit the following items to the (a) Report documenting System Verification completed at the factory (b) Report documenting on-site system verification (c) Certificate of Substantial Completion (3) A Conveyance Inspector shall witness the testing of the APM system as defined in the currently- adopted edition of ASCE 21 (Annual Internal Audit Responsibilities) on an annual frequency. The results of the testing shall be submitted to the Administrator.

(4) Following the Administrator’s determination that the documentation listed in (2) or (3) of this Section indicates that the conveyance conforms to standards listed in

Section 2-2 (1)(b) of these regulations, the Administrator will issue the Certificate of Operation for the APM system.

Section 2-6 Accident Reporting (1) Any accident involving a conveyance that caused or could have caused Injury to a person should be investigated by the Conveyance Owner or Managing Agent to determine if maintenance or repairs are needed to ensure proper operation of the conveyance and that the conveyance is in compliance with these regulations.

(2) Following any accident involving a conveyance that causes Injury to any person, the Conveyance Owner or Managing Agent shall:

(a) Arrange for a Licensed Mechanic or Inspector to conduct a preliminary investigation to determine whether the accident was the result of a component of the conveyance that malfunctioned or was not in compliance with these regulations.

(b) Report this information to the Administrator or Approved AHJ via phone or email within 24 hours of the accident. This report shall include the following items:

(i) Caller’s first and last name, phone number and organization.

(ii) Accident location with conveyance description, facility name, facility address and conveyance registration number assigned by the Administrator (iii) Description of the accident and the preliminary determination of whether the accident was a result of a component of the conveyance that malfunctioned or is not in compliance with these regulations (3) Based on results of the preliminary accident investigation, the following activities shall be conducted.

(a) If the accident is not the result of the malfunction of a component of the conveyance and the conveyance is in compliance with these regulations, the Conveyance Owner may make the conveyance accessible to the public and shall complete and submit to the Administrator or Approved AHJ an accident investigation report as described in (3)(b)(iii) of this

Section.

(b) If the accident is the result of a component of the conveyance that malfunctioned or is not in compliance with these regulations, the Administrator or Approved AHJ will suspend or revoke the Certificate of Operation for the conveyance and the Conveyance Owner shall do the following:

(i) Immediately shut down the conveyance and arrange for an inspection of the conveyance to verify the cause of the accident prior to a Conveyance Contractor performing any modifications or repairs to the conveyance.

(ii) Arrange for a full Inspection of the conveyance following any modifications or repairs.

(iii) Complete and submit to the Administrator or Approved AHJ an accident investigation report, using the form that is provided on the Administrator’s website, within 30 days of the accident or as approved by the Administrator. This report shall include a description of the actions taken to investigate the cause of the accident, corrective actions taken to repair and test the performance of the conveyance and any inspection reports.

The conveyance shall not be made accessible to the public without a current Certificate of Operation issued by the Administrator or Approved AHJ.

(4) When the Approved AHJ becomes aware of an accident associated with a conveyance, the Approved AHJ will report this accident to the Administrator within 24 hours from notification.

Section 2-7 Implementation of Adopted Standards (1) All conveyances installed prior to July 1, 2008 are exempt from complying with the currently- adopted edition of ASME A17.3 unless one of the following conditions exists:

(a) Substantial Alteration of a conveyance (b) An elevator presents a Material Risk Any Alteration that is a result of the conditions listed above shall conform to the currently-adopted edition of ASME A17.1.

(2) Material Risk related to Firefighters’ Emergency Operation is present unless any of the following conditions apply:

(a) The elevator complies with ASME A17.1 - 1981 Rules 211.1 and 211.3.

(b) The elevator travels less than 75 feet above or below the Emergency Personnel access.

(c) The building is equipped with an automatic sprinkling system according to the NFPA 13.

Any elevator that does not meet one or more of the conditions listed above shall comply with Firefighters’ Emergency Operation requirements as described in the currently-adopted version of ASME A17.1. An AHJ may require and enforce more stringent standards than these minimum requirements regarding Firefighters’ Emergency Operation, including full compliance with ASME A17.3.

Contact the AHJ for local requirements.

(3) Regarding Door Restrictors, the following shall apply.

(a) Door restrictors shall be installed and operational on all elevators installed on or after January 1, 1990.

(b) Where there is evidence that door restrictors have been previously installed and not properly maintained, regardless of original installation date, the door restrictors shall be repaired to operate as intended.

(c) Door restrictors shall be installed in accordance with ASME A17.1-2013,

Section 2.14.5.7 where an Alteration permit is issued that includes a change in the type of Motion Control or Operation Control.

(d) Following review of additional information regarding door restrictors, the Administrator will determine whether door restrictors shall be required on elevators installed prior to January 1, 1990.

(4) The Administrator will allow continued operation of a hydraulic elevator that has a hydraulic cylinder buried in the ground and is not provided with a safety bulkhead (typically installed prior to 1973) after January 1, 2012, if the Conveyance Owner completes one of the following actions in conformance with ASME A17.3 – 2005:

(a) The hydraulic cylinder shall be provided with a safety bulkhead.

(b) The elevator shall be provided with car safeties, guide rails, guide-rail supports, and fastenings conforming to the currently-adopted edition of ASME A17.1.

(c) The elevator shall be provided with a plunger gripper that shall grip the plunger when the applicable maximum governor tripping speed is achieved.

(5) The Administrator will allow continued operation of a Private Residence Conveyance installed in any building other than in a single-family residence if the following conditions are met:

(a) The conveyance was installed prior to January 1, 2008.

(b) The conveyance is registered with the Administrator on a form that is provided on the Administrator’s website.

(c) The conveyance shall conform to inspection requirements included in

Article 2 of these regulations, and testing frequency listed in Table 2-3-2 of (d) An Alteration of an existing Private Residence Elevator shall include bringing the elevator into compliance with the currently-adopted edition of ASME A17.1 or replacing the elevator with a conveyance that is in compliance with the currently-adopted edition of ASME A18.1.

(6) The Administrator will only require a code data plate (as required by ASME A17.1) on an existing conveyance if the conveyance was installed on or after July 1, 1997. For conveyances installed prior to July 1, 1997, the absence of a code data plate is not a violation of these regulations, and the edition of ASME A17.1 that will be referenced for inspection purposes will be the applicable code edition in effect, or adopted by a Local Jurisdiction, on the date of installation.

(7) The Administrator may allow deviations to specific code requirements for elevators located in law enforcement facilities, mental hospitals or similar facilities that are used to transport prisoners or other detainees. These elevators are still required to comply with the inspection, testing and maintenance requirements of Section 2-3 of these regulations.

(8) ASME A17.1 2022 Sections 8.6.4.24 and 8.6.5.19 require that all automatic passenger and freight elevators comply with Section 2.26.5, which requires that these elevators be provided with a system to monitor and prevent automatic operation of the elevator with faulty door circuits. Automatic passenger and freight elevators are exempt from complying with ASME A17.1 2022 Sections 8.6.4.24 and 8.6.5.19 unless one of the following conditions exists:

(a) Substantial Alteration of a Conveyance (b) The elevator presents a Material Risk as determined by the Administrator (c) The elevator is permitted to be installed after the effective date of these regulations (9) Elevators required to meet ASME A17.1 2022 Section 3 shall be provided with hoistway lighting equivalent to the requirements of ASME A17.1 2022 Section 2.1.7.

Section 2-8 Shut-down of a Dangerous Conveyance (1) If a Conveyance Inspector determines that a conveyance poses imminent danger to passengers or inspection/maintenance personnel or equipment, the Conveyance Inspector shall immediately notify the Administrator or the Approved AHJ and the Conveyance Owner of the condition of the conveyance and shall follow the procedures of the Approved AHJ or as listed in the policy on the Administrator’s website to shut down the dangerous conveyance.

(2) If a Conveyance Mechanic determines that a conveyance poses imminent danger to passengers or inspection/maintenance personnel, the Conveyance Mechanic shall notify his/her employing Conveyance Contractor. Upon this notification, the Conveyance Contractor shall immediately notify the Administrator or the Approved AHJ and the Conveyance Owner of the condition of the conveyance and follow the procedures of the Approved AHJ or as listed in the policy on the Administrator’s website to shut down the dangerous conveyance.

(3) Any conveyance that has been shut down shall not be placed back into service without first obtaining approval from the Administrator or the Approved AHJ.

(4) Upon shut-down of a conveyance, the Conveyance Owner shall have the necessary repairs completed within 6 months from the date of shut-down or place the conveyance in either a dormant or removed from service state.

Section 2-9 Conveyances Made Dormant (1) A conveyance is considered dormant based on the following conditions.

(a) The traction (electric) elevator car is parked at the top of the Hoistway and the counterweights are parked at the bottom of the Hoistway, or the hydraulic elevator is parked at the bottom of the Hoistway.

(i) The Hoistway doors are latched in the closed position.

(ii) The fuses are removed from the main line disconnect (if applicable).

(iii) The mainline disconnect is locked in the “off ” position with a wire seal or a red tag provided by the Administrator placed on the disconnect switch (b) The Escalators/Moving Walk has been adjusted in the following manner:

(i) The mainline disconnect is locked in the “off ” position with a wire seal or a red tag provided by the Administrator placed on the disconnect switch.

(ii) Entrances are permanently barricaded. Escalators that have been made dormant cannot be used as a stairway.

(2) A Conveyance Inspector or the Administrator shall verify the status of the conveyance as dormant, place a wire seal on the mainline disconnect switch, document the activities on an inspection report and submit the inspection report to the Conveyance Owner, who shall then submit the report to the Administrator without fee.

(3) A conveyance shall not be made dormant for more than 5 years in total. At the end of 5 years, the Conveyance Owner shall obtain a valid Certificate of Operation or remove the conveyance from service pursuant to Section 2-10 of (4) To place a dormant conveyance back in service, the following conditions shall be met.

(a) All applicable tests according to Section 2-3-2 of these regulations must be current, or if the applicable testing schedule was not maintained during dormancy, the applicable Category 1 and Category 5 tests must be completed and witnessed by a Conveyance Inspector.

(b) If the applicable testing schedule was maintained, a Conveyance Inspector must perform a Periodic Inspection on the conveyance.

(c) Prior to conveyance operation, the Conveyance Owner must mitigate all violations identified on the inspection report and obtain a valid Certificate of Operation from the Administrator or Approved AHJ.

(d) A Temporary Certificate of Operation will not be issued when placing a dormant conveyance back in operation.

Section 2-10 Conveyances Removed From Service (1) A conveyance is removed from service per the following items as listed in the currently-adopted edition of ASME A17.1.

(a) Traction (electric) Elevators (i) Remove the power feed line from the mainline disconnect switch.

(ii) Suspension ropes are removed.

(iii) Car and counterweights are parked at the bottom of the Hoistway.

(iv) The Hoistway doors are permanently barricaded or sealed in the closed position on the Hoistway side. The lowest landing Hoistway door may be sealed on the lobby side.

(b) Hydraulic Elevators (i) Remove the power feed line from the mainline disconnect switch;

(ii) The hydraulic elevator car is parked at the bottom of the Hoistway;

(iii) If provided, suspension means are removed and counterweight is parked at the bottom of the hoistway;

(iv) Pressure piping has been disassembled and a section removed from the premises;

(v) The Hoistway doors are permanently barricaded or sealed in the closed position on the Hoistway side. The lowest landing Hoistway door may be sealed on the lobby side.

(c) Escalators/Moving Walks (i) Remove the power feed line from the mainline disconnect switch.

(ii) Entrances are permanently barricaded. Escalators that have been removed from service cannot be used as a stairway.

(2) A Conveyance Inspector shall verify the status of the conveyance as out of service, place a wire seal on the mainline disconnect switch, document the activities on an inspection report and submit the inspection report to the Conveyance Owner, who shall then submit the report to the Administrator without fee.

(3) If a Conveyance Owner has removed a conveyance from service and intends to place the conveyance back into operation, the conveyance shall conform to all of the provisions of the applicable standard listed in Section 2-2 of these (4) All applicable tests must be performed and witnessed according to Section 2-3-2 of these regulations.

Section 2-11 Removal of a Conveyance from a Facility (1) The Conveyance Owner must notify the Administrator when a conveyance is removed from a facility.

ARTICLE 3 AUTHORITY HAVING JURISDICTION

Section 3-1 Authority Having Jurisdiction Requirements (1) A municipality or county (an authority having jurisdiction), or any agent thereof, may enter into a memorandum of agreement (MOA) with the Administrator under which the Administrator may delegate to the AHJ the authority to regulate conveyances located within the territory of the AHJ, provided that the AHJ program has standards that are equal to or more stringent than the minimum standards listed in Sections 2-2 through 2-11 of these regulations. The Administrator will maintain registration activities described in Section 2-1 of these (2) If an MOA as described above is executed, the AHJ will become an Approved AHJ and will be responsible for enforcing the applicable provisions of these regulations. If the Approved AHJ does not satisfy all requirements listed in Sections 2-2 through 2-11 of these regulations per the executed MOA, the Administrator may terminate the MOA. The Approved AHJ may also terminate the MOA per directions in the MOA.

(3) The Approved AHJ will submit to the Administrator all requested information regarding new or existing conveyances as determined by the Administrator and listed in the MOA.

(4) The Approved AHJ may set fees and collect or contract the collection of those fees to offset the cost of conducting activities described in Section 2-3 of these regulations for conveyances located within the Approved AHJ territory. Fee amounts will be determined by the Approved AHJ or agreed upon by the Approved AHJ and the contracted inspection organization.

(5) Inspections of public school conveyances in Approved AHJ territories shall be conducted by the Approved AHJ or, with prior consent of the Administrator or Approved AHJ, by a Conveyance Inspector contracted by the public school district.

(6) An Approved AHJ shall make readily available to the general public, Licensed Conveyance Contractors and, Licensed Conveyance Inspectors any and all Approved AHJ program requirements that differ and are considered to be more stringent and/or restrictive than the requirements found in these regulations.

ARTICLE 4 LICENSING

Section 4-1 General Requirements This section describes the requirements for the licensing of Conveyance Contractors, Conveyance Mechanics and Conveyance Inspectors.

(1) Each License allows the licensee to perform the applicable duties of installation, Alteration, Replacement, maintenance, removal, dismantling, or inspection of a conveyance as listed on the License.

(2) A Conveyance Apprentice shall not be licensed by the Administrator and shall conduct activities listed in Section 4-1 (1) only under the supervision of a Licensed Conveyance Mechanic, except as follows:

(a) Deliver and stage conveyance components, not to include hoisting or assembly.

(b) Access the Hoistway and operate and position the elevator car via the cartop inspection station.

(c) Re-lamp, Replace or Repair light fixtures.

(d) Clean or paint a Hoistway, pit, machine room or equipment.

(e) Oil or grease equipment.

(f) Replace Escalator and Moving Walk combplate teeth.

(3) Personnel employed by the Administrator or an Approved AHJ, and designated as Elevator Personnel, may access the elevator Hoistway or any other conveyance component at any time in the performance of their duties, although not including activities as described in Section 4-1 (1).

(4) Other personnel may access the elevator Hoistway to conduct activities other than those described in Section 4-1 (1) as follows:

(a) Emergency Personnel in the performance of emergency evacuation or training activities.

(b) Personnel employed by a Conveyance Contractor and designated as Elevator Personnel.

(c) Personnel authorized by the Conveyance Owner or Conveyance Contractor to conduct other work only under the following conditions:

(i) When elevator equipment operation is necessary, a Conveyance Mechanic or Inspector shall operate the equipment.

(ii) When elevator equipment operation is not necessary, a Conveyance Mechanic shall ensure that the elevator and all related equipment has been positioned safely, proper disconnect lockout/tagout procedures have been followed, and the conveyance has been physically secured from movement prior to the person accessing the Hoistway. The Conveyance Mechanic is then permitted to leave the building. Following completion of the work, only a Conveyance Mechanic shall release the equipment for operation.

(5) The Administrator may request documentation in addition to that described in the following sections to verify the accuracy of information provided with a License application.

(6) Fees to obtain a License are listed in Table 4-1.

Table 4-1: Licensing Fees License Type License Fee Mechanic $125.00 Temporary Mechanic $25.00 Contractor $500.00 Inspector $175.00 Replacement License $25.00

Section 4-1-1 Conveyance Mechanic License (1) The Administrator may issue a Conveyance Mechanic License to the applicant if the applicant has provided documentation required in this Section. The Conveyance Mechanic License will indicate the type(s) of conveyance(s) on which the licensee is allowed to conduct work per these regulations. The types of Conveyance Mechanic Licenses are as follows:

(a) Type 1: All conveyances with the exception of APMs, which would include elevators, Escalators, Moving Walks and Platform Lifts, as described in ASME A17.1 and A18.

(i) If the initial training program or continuing education does not include training for Escalators and Moving Walks, an exclusion will be applied to the License that will not allow the Conveyance Mechanic to work on that type of equipment (b) Type 2: Platform Lifts only, as described in ASME A18.1 (c) Type 3: APM as described in ASCE 21 (d) Type 4: All conveyances listed in (1)(a) and (c) of this Section (2) A person applying for a Conveyance Mechanic License shall submit to the Administrator a completed Conveyance Mechanic License application using the form that is provided on the Administrator’s website, the License fee, listed in Table 4-1 of these regulations and documentation that, as determined by the Administrator, indicates the applicant is qualified under one of the following scenarios:

(a) The applicant submits documentation that proves that the applicant has successfully completed a Conveyance Mechanic training program. This program will be subject to audit by the Administrator. Evaluation criteria for Administrator audit may include, but is not limited to, review of course materials, required classroom and field hours, classroom activities, and test materials and procedures. Based on evaluation of the Conveyance Mechanic License training curriculum, the Administrator may set limitations on the License issued. To be approved, the training program shall either:

(i) Be registered with the United States Department of Labor Office of Apprenticeship (USDOL) under specific apprentice occupation categories assigned by the USDOL to License types listed in (1) of this Section, and shall include classroom and field training according to the USDOL requirements on the actual equipment listed in the License types (ii) Be approved by the Administrator. Applicants seeking licensure under programs approved solely by the Administrator shall submit to the Administrator an executed affidavit on a form that is provided by the Administrator and signed by the applicant which states that during the applicant’s participation in the approved program, the applicant’s work experience consisted of at least 1,700 hours per year performing activities listed in the work process schedule attached to the affidavit.

(iii) For a Type 2 Mechanic License only, the candidate must successfully complete a conveyance mechanic training program for ASME A18.1 related conveyances, such as a CAT certification from NAEC or another nationally recognized program as approved by the Administrator.

(b) In lieu of qualifying pursuant to (2)(a) of this Section, the applicant may qualify if the applicant submits to the Administrator one of the following types of documentation:

(i) Documentation that the applicant holds a current and valid license from another state whose standards, as determined by the Administrator, meet or exceed those of these regulations. This documentation will consist of:

(A) A copy of the icense.

(B) Contact name, phone number and name of the issuing department of the state in which the license was obtained.

(ii) Documentation that the applicant has obtained both of the following items:

(A) Three years of work experience as a Conveyance Mechanic on non- residential conveyances without supervision. One year of work experience will equal 1,700 hours.

Documentation of work experience will consist of:

(I) A statement on the employer’s letterhead and signed by the personnel administrator or other person of

authority affirming that the condition in (A) is true; and (II) Personnel records that indicate the timeframe and listing of hours for completion of the experience described in (A); or (III) An affidavit on a form that is provided by the Administrator and signed by the applicant which states that the work experience indicated in personnel records submitted consists of unsupervised mechanic activities listed in the work process schedule attached to the affidavit.

(B) A passing score on an examination provided by the Administrator, or on a similar exam as determined by the Administrator, on the codes and standards that relate to the type of Conveyance Mechanic License applied for, as described in (1) of this Section.

(3) A person who obtains a Conveyance Mechanic License shall also complete 8 hours of continuing education that has been approved by the Administrator every 2 years.

(4) Following review of the application, the Administrator will notify the applicant of the approval or disapproval of the application. If the applicant is approved, the notification will include the Conveyance Mechanic License number, the type(s) of conveyance(s) on which the Conveyance Mechanic may perform work, a License card and a payment receipt. If the applicant is not approved, the notification will include a description of the deficiencies in the application.

(5) The Conveyance Mechanic License issued by the Administrator shall be valid for one year. The Administrator may renew a License, provided the applicant submits the following:

(a) A completed Conveyance Mechanic License application form (b) License renewal fee, listed in Table 4-1 of these regulations (c) A copy of certification indicating that the applicant completed continuing education required in this Section

Section 4-1-2 Emergency and Temporary Conveyance Mechanic License (1) When an emergency exists, as defined in § 9-5.5-108 (2) C.R.S., the Administrator may issue an Emergency Conveyance Mechanic License. This License will be issued to a person who, based on the judgment of a Conveyance Contractor, has acceptable documented experience and education to perform work on specific types of conveyances identified in Section 1-5 of these regulations. Within 5 business days after commencing work, the applicant will complete and submit the Conveyance Mechanic License application to the Administrator. There will be no License fee for an Emergency Conveyance Mechanic License.

(2) Upon notification to the Administrator from a Conveyance Contractor that there are no Conveyance Mechanics available to perform conveyance work, the Administrator may issue a Temporary Conveyance Mechanic License.

(a) This License will be issued to a person who is:

(i) Enrolled in and progressing through a mechanic training program as described in Section 4-1-1(2) of these regulations, and (ii) Based on the judgment of a Conveyance Contractor, has acceptable documented experience and education to perform work on specific types of conveyances identified in Section 4-1-1(1) of (b) At least 5 working days prior to commencing work, the Conveyance Contractor who will employ the Temporary Conveyance Mechanic shall submit the following documentation to the Administrator.

(i) A completed Temporary Conveyance Mechanic License application on the form that is provided on the Administrator’s website.

(ii) The License fee, listed in Table 4-1 of these regulations.

(3) Following review of the application, the Administrator will notify the Conveyance Contractor and Temporary Conveyance Mechanic applicant of the approval or disapproval of the application. If the applicant is approved, the notification will include the Temporary Conveyance Mechanic License number and the type of conveyance on which the Temporary Conveyance Mechanic may perform work.

If the applicant is not approved, the notification will describe the deficiencies in the application.

(4) The Emergency Conveyance Mechanic License will be valid for 60 days and the Temporary Conveyance Mechanic License will be valid for 30 days. The Administrator may renew a Temporary Mechanic License, provided the Conveyance Contractor submits the License fee and notification to the Administrator that renewal is requested for a License issued the prior month. This documentation may include multiple License renewal requests for Temporary Conveyance Mechanics.

Section 4-1-3 Conveyance Contractor License (1) The Administrator will consider issuing a Conveyance Contractor License to a company if the applicant submits to the Administrator a completed Conveyance Contractor License application using the form provided on the Administrator’s website, the License fee, listed in Table 4-1 of these regulations and:

(a) The applicant employs, at a minimum, one Conveyance Mechanic licensed with the Administrator, as indicated on the License application.

The employment of Temporary or Emergency Conveyance Mechanics does not satisfy this requirement.

(b) A certificate of insurance, declaration page or insurance policy indicating that the applying company possesses insurance coverage according to § 9- 5.5-115 (1) C.R.S.

(2) The Conveyance Contractor License issued by the Administrator shall be valid for one year. The Administrator may renew a License, provided the applicant maintains current insurance according to (1)(b) of this Section and submits the following:

(a) A completed Conveyance Contractor License application form (b) Documentation as described in (1)(a) of this Section (c) License renewal fee, listed in Table 4-1 of these regulations (3) Licensed Conveyance Contractors shall notify the Administrator in writing within 7 days of receiving notification from Conveyance Manufacturers or manufacturers of conveyance systems, subsystems, components or devices of product recalls, safety alerts and any information that could potentially affect the safe operation of a conveyance or the safety of the riding public.

Section 4-1-4 Conveyance Inspector License (1) The Administrator may issue a Conveyance Inspector License to the applicant if the applicant has provided documentation required in this Section. The Conveyance Inspector License will indicate the type of conveyance for which the licensee is allowed to inspect per these regulations. The types of Conveyance Inspector Licenses are as follows:

(a) Type 1: All conveyances, with the exception of APMs, which would include Elevators, Escalators, Personnel Hoists, Moving Walks and Platform Lifts, as described in ASME A17.1 and A18.1 (b) Type 2: APM as defined in ASCE 21 (c) Type 3: All conveyances listed in (a) and (b) of this Section (2) A person applying for a Conveyance Inspector License shall submit to the Administrator a completed Conveyance Inspector License application using the form that is provided on the Administrator’s website, the License fee, listed in Table 4-1 of these regulations and documentation that, as determined by the Administrator, indicates that the applicant is qualified under one of the following scenarios.

(a) Private Conveyance Inspector.

(i) To obtain a Type 1 Conveyance Inspector License, the applicant shall submit to the Administrator documentation that, as determined by the Administrator, proves one of the following:

(A) The applicant is certified to inspect conveyances by a nationally- recognized conveyance association, which will consist of a copy of the front and back of a current certification card from the issuing association, or (B) The applicant qualifies as Elevator Personnel as defined in ASME A17.1 and has been approved to take the certification exam offered by a nationally-recognized conveyance association as determined by the Administrator. The applicant shall attend the first available exam offered by a nationally-recognized conveyance association and obtain certification within 6 months of licensure. If the applicant fails the exam, the Administrator may suspend the applicant’s License until proof of certification is submitted to the (ii) To obtain a Type 2 Conveyance Inspector License, the applicant will submit to the Administrator documentation that, as determined by the Administrator, indicates one of the following:

(A) The applicant possesses a current Professional Engineer license, or (B) The applicant has, at a minimum, three years of experience participating in APM inspections and audits.

(b) AHJ Conveyance Inspector or AHJ-appointed Conveyance Inspector (i) To obtain a Type 1 Conveyance Inspector License, the applicant shall comply with (2)(a)(i)(A) of this section, or (ii) The applicant submits the following items to the Administrator.

(A) Documentation that the applicant intends to obtain certification within one year following the completion of the requirement listed in (2)(b)(ii)(B) of this section.

(B) Documentation showing that the applicant has completed at least 8 weeks of conveyance inspection activities under the direct supervision of a Conveyance Inspector prior to conducting conveyance inspection activities without direct supervision. During this supervised period, the licensee shall be trained on the inspection of any type of conveyance which the licensee will encounter in the inspection territory.

This documentation shall be submitted to and approved by the Administrator and should indicate that the applicant has received the required supervision prior to conducting unsupervised conveyance inspection activities.

(3) If a licensee qualifies by (2)(a)(i)(B) or (2)(b)(ii) of this Section and the licensee fails to obtain certification as required, the Administrator may suspend or revoke the licensee’s Conveyance Inspector License.

(4) New applicants shall successfully pass a test that will be administered by the Administrator on these regulations, policies and guidance documents which are available on the Administrator’s website.

(a) New applicants shall successfully pass the test administered by the Administrator before a License will be issued.

(b) Applicants shall obtain a passing score of not less than 90%.

(c) This exam requirement does not apply to those applying for a Type 2 Inspector License or Inspectors employed by the Administrator.

(d) The Administrator may waive or alter this exam requirement as necessary.

(5) Any Private or AHJ-appointed Conveyance Inspector applicant shall also submit to the Administrator a certificate of insurance or insurance policy indicating that the applicant possesses insurance coverage according to § 9-5.5-115 (2) C.R.S.

(6) An AHJ Conveyance Inspector applicant is exempt from the requirement to provide insurance, pursuant to § 9-5.5-115 (2) C.R.S., while performing Approved AHJ official duties.

(7) If a licensee receives a Type 1 Conveyance Inspector License and will be conducting inspection activities on Escalators or Moving Walks, the licensee shall complete at least 8 hours of inspection training on this equipment prior to conducting unsupervised inspection activities on this equipment. This training shall consist of direct supervision under a Conveyance Inspector who has at least 8 hours of experience inspecting, installing or maintaining this type of equipment. This requirement shall not apply to a licensee who has received training on this type of equipment through an Administrator-approved training program.

(8) The Conveyance Inspector License issued by the Administrator shall be valid for one year. The Administrator may renew a License, provided the applicant submits the following:

(a) A completed Conveyance Inspector License application form.

(b) Documentation that the applicant is certified by a nationally-recognized conveyance association.

(c) Certification through the Administrator indicating completion of continuing education as approved by the Administrator. A Type 2 Conveyance Inspector is exempt from this requirement.

(d) A certificate of insurance, declaration page or insurance policy indicating that the applicant possesses insurance coverage according to § 9-5.5-115 (2) C.R.S.

(e) License renewal fee, listed in Table 4-1 of these regulations.

(9) A Licensed Conveyance Inspector who has been retained for the purpose of consulting for an installation or Alteration of a conveyance shall not perform the Acceptance inspection when the permitted activities have been completed.

Section 4-2 Suspension or Revocation of a License If a Licensed person or company is in violation of these regulations, the Administrator may pursue suspension or revocation of the License per Article 5 of these regulations.

ARTICLE 5 ENFORCEMENT

Section 5-1 Enforcement Program The Administrator provides these regulations to assist the regulated community with maintaining safe and proper operation of regulated conveyances. When a regulated conveyance or Conveyance Mechanic, Contractor or Inspector is found to be out of compliance with these regulations, or if the Administrator finds that a conveyance poses a danger to the public, the Administrator will pursue enforcement actions against the regulated party.

The enforcement process will include requiring the regulated party to make repairs and/or upgrades, perform system tests, keep records, maintain current Licenses, and other actions to bring the conveyance or licensee back into compliance. During and following the enforcement process, the Administrator will continue to assist the regulated party to remain in compliance. The enforcement process may include monetary penalties up to $1,000 per conveyance per day of violation according to statute (8-20-104 C.R.S.) if the enforcement obligations are not implemented according to the required schedule.

Section 5-1-1 Notice of Violation (1) A Notice of Violation (NOV) may be issued when a conveyance is found to be out of compliance with these regulations and/or statutes. The NOV may include fines and/or an order to cease and desist operation of the specific conveyance until all violations are satisfactorily corrected. A NOV may also be issued if a Conveyance Contractor, Mechanic or Inspector has violated any part of these regulations or any applicable statutes.

(2) Within 10 working days after an NOV has been issued, the person issued the NOV may file a written request with the Administrator for an informal conference regarding the NOV. Upon receipt of the request, the Administrator shall provide the alleged violator with notice of the date, time and place of the informal conference. During the conference, the alleged violator and Administrator personnel may present information and arguments regarding the allegations and requirements of the NOV.

Section 5-1-2 Enforcement Order (1) An Enforcement Order may be issued when the violations included within an NOV are not resolved within the prescribed time frame.

(2) An Enforcement Order may include increased fines up to $1,000.00 per violation for each day of violation. In addition, the Enforcement Order may include shutdown of the conveyance, and suspension and/or revocation of a conveyance License.

(3) An alleged violator may appeal the enforcement order to the Administrator for a hearing under 24- 4-105 C.R.S. The Administrator shall then issue a final decision which is subject to judicial review under 24-4-106 C.R.S.

Section 5-1-3 Suspension or Revocation of a License (1) In any case where the Administrator denies a License or the licensee is subject to suspension or revocation for a violation of these regulations, the Administrator shall follow the procedures provided in 24-4-104 and 24-4-105 C.R.S.

(2) The period of suspension or revocation shall be within the sound discretion of the (3) Any person aggrieved by a decision after a hearing may seek judicial review pursuant to the provisions of 24-4-106 C.R.S.

(4) Any person who has had a License revoked may not reapply to the Administrator for a License within 2 years of the decision, unless an exception is made by the Administrator and the applicant establishes a substantial change in circumstances to indicate fitness to hold a License in accordance with the requirements of these regulations.

(5) In case of revocation or suspension of a License, the Administrator shall notify any issuer of certifications required during licensing of such revocation or suspension. ______________________________________________________________________ Editor’s Notes

History New rule emer. rule eff. 04/03/2008.

Entire rule emer. rule eff. 07/02/2008; expired 10/02/2008.

Entire rule eff. 01/01/2009.

Section 3-1-1 emer. rule eff. 06/11/2009.

Section 3-1-1 (3)-(7) emer. rule eff. 09/11/2009; expired eff. 12/11/2009.

Entire rule eff. 01/01/2010.

Entire rule eff. 01/01/2011.

Entire rule eff. 02/01/2013.

Entire rule eff. 01/01/2015.

Entire rule eff. 04/01/2017.

Entire rule eff. 01/01/2020.

Entire rule eff. 01/01/2021.

Entire rule eff. 01/01/2023.

Entire rule eff. 01/01/2026.

7 CCR 1101-9 Explosives Regulations {#sec-7-ccr-1101-9 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-9}

DEPARTMENT OF LABOR AND EMPLOYMENT

EXPLOSIVES REGULATIONS

7 CCR 1101-9 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Basis and Purpose These regulations are promulgated to establish rules for the use, manufacture, possession, sale, storage, transport, or disposal of explosives materials or blasting agents in the interest of the life, health, and safety of employees and the general public, as well as the protection of property.

To this end, a procedure for the granting of explosives permits is contained herein whereby the opportunity to use, manufacture, possess, sell, store, transport, or dispose of explosives materials is restricted to such permittees and conditioned upon satisfactory continued compliance with these rules and regulations. Failure to comply with these rules and regulations subjects the permittee to suspension, denial, or revocation of the permit.

Adoption of these rules and regulations is intended to greatly clarify the Division of Oil and Public Safety requirements pertaining to the use of explosive materials, to ease the burden on the permittee where interpretation has been necessary, and to better incorporate the numerous requirements from other governmental agencies. These rules and regulations provide for uniformity of compliance and elimination of numerous areas of confusion and duplication in an effort to better serve and protect the public.

Section 1-2 Statutory Authority The amendments to these regulations are created pursuant to Section 9-7-105, C.R.S. (2004) of the Colorado Revised Statutes. All prior rules for explosive materials are hereby repealed.

Section 1-3 Effective Date These amended regulations shall be effective on May 1, 2019. The previous versions of these regulations were effective on December 1, 2018, March 10, 2015, and January 1, 2009.

Section 1-4 Scope These rules and regulations shall apply to the use, manufacture, purchase, possession, sale, storage, transportation, and disposal of explosive materials in the State of Colorado by any individual, corporation, company, firm, partnership, association, or state or local government agency.

These rules and regulations shall not apply to:

(A) The shipment, transportation, and handling of military explosives by the Armed Forces of the United States or the State Militia.

(B) The normal and emergency operations of any government law enforcement agency including all departments, and divisions thereof, provided they are acting in their official capacity and in the proper performance of their duties and functions.

(C) Explosives in the forms prescribed by the official United States Pharmacopoeia or the National Formulary and used in medicines and medicinal agents.

(D) Explosive materials while in the course of transportation by for-hire commercial carriers via railroad, water, highway, or air when the explosive materials are moving under the jurisdiction of, and in conformity with, regulations adopted by any Federal Department or Agency.

(E) The components for hand loading rifle, pistol, and shotgun ammunition and/or rifle, pistol, and shotgun ammunition.

(F) The manufacture, sale and use (public display) of pyrotechnics commonly known as fireworks, including signaling devices such as flares, fuses, and torpedoes.

(G) Gasoline, fertilizers, installed propellant/powder-actuated safety devices or propellant/powderactuated power tools.

(H) The use and storage of model rocket motors containing a propellant weight of 62.5 grams or less and which produce less than 17.92 pound seconds of total impulse.

No permit shall be required for the occasional purchase of explosives by a person for normal agricultural purposes where such person is known by the seller of such explosives, and a record is kept of such transactions by the seller, including the specific purpose for which such explosives will be used, the location of the purposed use, the signature of the purchaser, and the certification of the seller as to his personal knowledge of the purchaser. Violation of this record requirement shall cause the seller’s permit to be canceled. A permit is required for any manufacturing, storage, dealing, or non-agricultural use of explosives as outlined in Article 3 of this regulation.

No person, firm, partnership, or corporation whose possession of explosive materials is for the purpose of underground mining, surface or underground metal mining, or surface or underground coal mining and whose use and storage is subject to regulation by the provisions of 30 Code of Federal Regulations (CFR) - Parts 56, 57, 75 or 77 shall be subject to the provisions of the Explosives Act, Sections 9-7-101, et seq., Colorado Revised Statutes (C.R.S.).

No person, firm, partnership, or corporation whose possession, use, or storage of explosive materials is subject to regulation by the provisions of Colorado Mining Law, Sections 34-21-104 and 34-21-110, C.R.S. shall be subject to the provisions of the Explosives Act, Sections 9-7-101, et seq., C.R.S.

A permit issued by the Division of Oil and Public Safety shall be required for the possession, use, or storage of explosives in mining operations whose use and storage is not subject to the provisions of 30 CFR - Parts 56, 57, 75 or 77 or Colorado Mining Law, Sections 34-21-104 and 34-21-110, C.R.S.

Except as noted in the foregoing, the Division of Oil and Public Safety may approve or disapprove the location for, and limit the quantity of, explosives or blasting agents which may be loaded, unloaded, reloaded, stored, or temporarily retained at any facility within the State of Colorado.

The Division of Oil and Public Safety may issue an explosive permit for continued use for a period of time not to exceed 36 months.

Section 1-5 Definitions The following publications and codes are hereby incorporated by this reference:

• Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), U.S. Department of Justice, Publication ATF P 5400.7, ATF- Explosives Law and Regulations (2012) – Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), 99 New York Avenue, NE; Washington, DC 20226. https://www.atf.gov • Title 49 CFR - Parts 100-177 (inclusive) https://www.govinfo.gov Parts 390-397 U.S. Department of Transportation (Revised September 27, 2012) – US DOT FMCSA, 1200 New Jersey Avenue, SE; Washington, DC 80590. https://www.fmcsa.dot.gov • National Electric Code (NEC), 2017 Edition, National Fire Protection Association (NFPA) – NFPA (NEC), 1 Batterymarch Park, Quincy, MA 02169. https://catalog.nfpa.org • Institute of Makers of Explosives (IME) Safety Library Publication No. 22 (February 2007) – IME, 1212 New York Avenue, NW, Suite 650; Washington, DC 20005. https://www.ime.org • Institute Of Makers Of Explosives (IME) Safety Library Publication No. 20 (December 2011) - IME, 1212 New York Avenue, NW, Suite 650; Washington, DC 20005. https://www.ime.org • The Avalanche Artillery Users of North America Committee (AAUNAC) Training Standard (Revised May 16, 2012) – AAUNAC, PO Box 8095, 8920 South Collins Road; Alta, UT 84092 These rules incorporate the editions and revisions specified. Subsequent editions and revisions have not been incorporated by this reference. The publications incorporated by this reference may be examined and a copy of them may be obtained upon request and payment of the cost of reproduction during regular business hours from the Colorado Department of Labor and Employment, Division of Oil and Public Safety, 633 17th Street, Suite 500, Denver, CO 80202, and may also be inspected at the state depository libraries.

The following words when used in these rules and regulations shall mean:

AIR OVERPRESSURE, OVERPRESSURE: The airborne shock wave or acoustic transient generated by an explosive.

AMERICAN TABLE OF DISTANCES: A quantity-distance table prepared and approved by the Institute of the Makers of Explosives, for storage of explosive materials to determine safe distances from inhabited buildings, public highways, passenger railways, and other stored explosive materials.

See Section 4.6 of these regulations.

AMMONIUM NITRATE: The ammonium salt of nitric acid represented by the formula NH4NO3.

APPROVED STORAGE FACILITY (APPROVED MAGAZINE): A facility for the storage of explosives materials conforming to the requirements of these rules and regulations.

ATTEND(ED): The physical presence of an authorized person within the field of vision of explosives or the use of explosives.

AUTHORIZED, APPROVED, OR APPROVAL: Terms which mean approved, approval, or authorized by the Division.

AUTHORIZED PERSON: A person approved or assigned by the management to perform a specific type of duty or duties or to be at a specific location or locations at the job site.

ARMED CHARGE: An explosive cartridge that contains a detonator.

ARTIFICIAL BARRICADE: An artificial mound, berm, or wall of earth of a minimum thickness of 3 feet, or any other approved barricade that offers equivalent protection.

AVALAUNCHER: A compressed gas explosives delivery system designed for avalanche hazard mitigation.

BARRICADED: The effective screening of a building or magazine containing explosive materials from another magazine or building, railway, or highway by a natural or artificial barrier. A straight line from the top of any sidewall of the building or magazine containing explosives materials to the eave line of any magazine or building or to a point 12 feet above the center of a railway or highway shall pass through the barrier.

BINARY (TWO-COMPONENT) EXPLOSIVE: A blasting explosive formed by the mixing or combining of two precursor chemicals, (e.g., ammonium nitrate and nitromethane).

BLACK POWDER: A deflagrating or low explosive compound of an intimate mixture of sulfur, charcoal and an alkali nitrate (usually potassium or sodium nitrate).

BLAST AREA: Area of the blast within the influence of flying rock missiles, gases, vibration, and concussion.

BLASTER: A Type I permitted individual who is permitted by the Division to possess and control the use of explosives.

BLASTER IN CHARGE: A Type I permittee who is in charge of and responsible for the loading or preparing of the explosives charges, and either physically initiates the charge or is physically present when the charge is initiated at a specific job site. This individual is in charge of the planning of the blast at a specific job site, the supervision of all persons assisting on the blast and all persons in training, and is responsible for the inventory, inventory records, and blast records for the blast.

BLASTING AGENT: An explosive material which meets prescribed criteria for insensitivity to initiation.

For storage, Title 27, CFR, Section 55.11, defines a blasting agent as any material or mixture consisting of fuel and oxidizer intended for blasting, not otherwise defined as an explosive provided that the finished product, as mixed for use or shipment, cannot be detonated by means of a No. 8 Blasting Cap when unconfined (Bureau of Alcohol, Tobacco, Firearms, and Explosives

Regulation).

For transportation, Title 49 CFR defines a blasting agent as a material designed for blasting which has been tested and found to be so insensitive that there is very little probability of accidental initiation to explosion or transition from deflagration to detonation (US Department of Transportation Regulation).

BLASTING MAT: A mat of woven steel, wire, rope, scrap tires, or other suitable material or construction to cover blast holes for the purpose of preventing flying rock missiles.

BLAST PATTERN, DRILL PATTERN: The plan of the drill holes laid out for blasting; an expression of the burden distance, the spacing distance and their relationship to each other.

BLAST SITE: Area where explosive material is handled during blasting operations, including the perimeter of blast holes and a distance of 50 feet in all directions from explosive charges, loaded boreholes or boreholes to be loaded.

BOOSTER: An explosive charge, usually of high detonation velocity and detonation pressure, designed to be used in the initiation sequence between an initiator or primer and the main charge.

BOREHOLE, BLAST HOLE, DRILL HOLE: A hole drilled in the material to be blasted, for the purpose of containing an explosive charge.

BULK MIX: A mass of explosive material prepared for use in bulk form without packaging.

BULK MIX DELIVERY EQUIPMENT: Equipment (usually a motor vehicle with or without a mechanical delivery device) which transports explosive material in bulk form for mixing and/or loading directly into blast holes.

BULLET-RESISTANT: Magazine walls or doors of construction resistant to penetration of a bullet of 150grain M2 ball ammunition having a nominal muzzle velocity of 2,700 feet per second fired from a .30 caliber rifle from a distance of 100 feet perpendicular to the wall or door.

When a magazine ceiling or roof is required to be bullet-resistant, the ceiling or roof shall be constructed of materials comparable to the side walls or of other materials which will withstand penetration of the bullet described above when fired at an angle of 45 degrees from perpendicular.

Tests to determine bullet resistance shall be conducted on test panels or empty magazines which shall resist penetration of 5 out of 5 shots placed independently of each other in an area of at least 3 feet by 3 feet. Examples of construction that meet this definition are given in Article 4 as alternate construction standards for Type 1 and Type 2 magazines.

BULLET-SENSITIVE EXPLOSIVE MATERIAL: Explosive material that can be detonated by 150 grain M2 ball ammunition having a nominal muzzle velocity of 2,700 feet per second when the bullet is fired from a .30 caliber rifle at a distance of not more than 100 feet and the test material, at a temperature of 70-75 degrees Fahrenheit, is placed against a backing material of 2 inch steel plate.

BURDEN: The distance from the borehole and the nearest free face, or the distance between boreholes measured perpendicular to the spacing. Also, the total amount to be blasted by a given hole, which is usually measured in cubic yards or tons.

BUS WIRE: Expendable heavy gauge bare copper wire used to connect detonators or series of detonators in parallel.

CHARGE-PER-DELAY: Any charges firing within any 8-millisecond time period are considered to have a cumulative effect on vibration and air over-pressure effects. Therefore, the maximum charge-perdelay (w) is the maximum weight of all charges firing within any 8-millisecond (ms) time period from the time a blast starts until the time it ends. For example, if two 10-lb charges fire at 100 ms and one 15-lb charge fires at 105 ms, the maximum charge-per-delay (w) for this time period would be 35 lbs.

COLLAR: The mouth or opening of a borehole.

CONNECTING WIRE: Wire used to extend the firing line or leg wires in the electric blasting circuit.

CONTROL: To directly exercise authority or dominating influence over the use, manufacture, acquisition, purchase, sale, distribution, storage, transportation, or disposal of explosive materials.

CORNICE: An overhanging mass of windblown snow or ice, usually located near a sharp terrain break.

DATE-SHIFT CODE: A code, required by federal regulation (ATF), applied by manufacturers to the outside shipping containers, and, in many instances, to the immediate containers of explosive materials to aid in their identification and tracing. The code indicates the date, work shift and plant of manufacture.

DAY BOX: A portable magazine for the temporary and attended storage of explosives. Day boxes shall meet construction requirements of a Type 3 magazine.

DEALER: Any person engaged in the business of distributing explosive material at wholesale or retail.

DECK: An explosive charge that is separated from other charges in the blast hole by stemming or an air cushion.

DEFLAGRATION: An explosive reaction, such as rapid combustion, that moves through an explosive material at a velocity less than the speed of sound in the material.

DENSITY: The mass of an explosive per unit volume, usually expressed in grams per cubic centimeter or pounds per cubic foot.

DETONATING CORD: A flexible cord containing a center core of high explosives, which may be used to initiate other high explosives.

DETONATION: An explosive reaction that moves through an explosive material at a velocity greater than the speed of sound in the material.

DETONATOR: Any device containing any initiating or primary explosive that is used for initiating detonation. A detonator may not contain more than 10 grams of total explosives by weight, excluding ignition or delay charges. The term includes, but is not limited to, electric blasting caps of instantaneous and delay types, electronic detonators, blasting caps for use with safety fuses, detonating cord delay connectors, and non-electric instantaneous and delay blasting caps which use detonating cord, shock tube, or any other replacement for electric leg wires.

DIVISION: The Director of the Division of Oil and Public Safety of the Department of Labor and Employment or any designees thereof which may include certain employees of the Division of Oil and Public Safety or other persons.

DOWN LINE: A line of detonating cord or plastic tubing in a blast hole which transmits detonation from the trunkline or surface delay system down the hole to the primer.

ELECTRIC DETONATOR: A detonator designed for and capable of initiation by means of an electric current.

ELECTRONIC DETONATORS: A detonator that utilizes stored electrical energy as a means of powering an electronic timing delay element/module and that provides initiation energy for firing the base charge.

EMULSION: An explosive material containing substantial amounts of oxidizers dissolved in water droplets surrounded by an immiscible fuel, or droplets of an immiscible fuel surrounded by water containing substantial amounts of oxidizer.

EXPLOSIVE: Any chemical compound, mixture or device, the primary or common purpose of which is to function by explosion; the term includes, but is not limited to, dynamite and other high explosives, black powder, pellet powder, initiating explosives, detonators, safety fuses, squibs, detonating cord, igniter cord and igniters.

EXPLOSIVE MATERIALS: These include explosives, blasting agents, and detonators. The term includes but is not limited to dynamite and other high explosives; slurries, emulsions, and water gels, black powder, initiating explosives, propellant rockbreaking cartridges (such as Rockrackers™), detonators (blasting caps), safety fuses, squibs, detonating cord, igniter cord, and igniters. Binary explosives (such as Kinepak™ or Execon™), sold in two or more components, are considered an explosive material requiring a Division explosives permit.

EXPLOSIVE OILS: Liquid explosive sensitizers for explosive materials (.e.g., nitroglycerin, ethylene glycol dinitrate and metriol trinitrate).

EXTRANEOUS ELECTRICITY: Electrical energy, other than actual firing current or the test current from a blasting galvanometer, that is present at a blast site and that could enter a blasting circuit. It includes stray current, static electricity, electromagnetic waves, and time varying electric and magnetic fields.

FIRE EXTINGUISHER RATING: A rating set forth in the National Fire Code which may be identified on an extinguisher by a number (5, 20, 70, etc.) indicating the extinguisher’s relative effectiveness, followed by a letter (A, B, C, etc.) indicating the class or classes of fires for which the extinguisher has been found to be effective.

FIRE-RESISTANT: Construction designed to provide reasonable protection against fire. For exterior walls or magazine constructed of wood, this shall mean fire resistance equivalency provided by sheet metal of not less than #26 gauge.

FIRING LINE: The wire(s) connecting the electrical power source with the electric or electronic blasting circuit.

FLYROCK: Dirt, mud, stone, fragmented rock or other material that is propelled from the blast site by the force of an explosion.

FREE FACE: A rock surface exposed to air or water which provides room for expansion upon fragmentation.

FUSE (SAFETY): A flexible cord containing an internal burning medium by which fire or flame is conveyed at a continuous and uniform rate from the point of ignition to a cut end. A fuse detonator is usually attached to that end, although safety fuse may be used without a detonator to ignite material such as deflagrating explosives.

FUSE DETONATOR, BLASTING CAP: A detonator which is initiated by a safety fuse or used in an avalauncher round; also referred to as an ordinary blasting cap. Also see detonator.

FUSE LIGHTERS: Pyrotechnic devices for the rapid and certain lighting of safety fuse.

FUEL: A substance which may react with oxygen to produce combustion.

GRAINS: In the avoirdupois system of weight measurement, 7,000 7000 grains are equivalent to one standard, 16-ounce pound (0.45 kg). A grain is 0.0648 grams in both the avoirdupois and troy systems.

GROUND VIBRATION: Shaking the ground by elastic waves emanating from a blast; usually measured in inches per second of particle velocity.

HARDWOOD: Red Oak, White Oak, Hard Maple, Ash, or Hickory, free from loose knots, wind shakes, or similar defects.

HIGH EXPLOSIVES: Explosives which are characterized by a very high rate of reaction, high pressure development and the presence of a detonation wave, including, but not limited to, dynamite, detonating cord, cast boosters, detonators, cap-sensitive slurry, emulsion, or water gels, and mixed binaries.

HOWITZER: A military cannon that delivers projectiles at medium muzzle velocity at low or high trajectories.

INHABITED AREA OR BUILDING: A building regularly occupied in whole or in part as a habitation for human beings, or any church, schoolhouse, railroad station, store, or other structure where people are accustomed to assemble, except any building or structure occupied in connection with the manufacture, transportation, storage, and use of explosive materials.

INSPECTOR: An Inspector of the Division.

INITIATION: The start of deflagration or detonation in an explosive material.

INITIATION SYSTEM: Combination of explosive devices and accessories (detonators, wire, cord, etc.) designed to convey a signal and initiate an explosive charge.

LAWFUL POSSESSOR: A Type II permittee who has legally purchased or acquired explosive materials.

LOADING DENSITY: The weight of explosive, expressed as pounds per foot or kilograms per meter of borehole.

LOW EXPLOSIVES: Explosives which are characterized by deflagration or a low rate of reaction and the development of low pressure.

MAGAZINE: Any building, structure, or container, other than an explosives manufacturing building, approved for the storage of explosive materials.

MAGAZINE DISTANCE: Shall mean the minimum distance permitted between any two storage magazines which is expected to prevent propagation of an explosion from one magazine to another from a blast.

MAKE-UP ROOM: A room located inside an uninhabited building which shall be used for the assembly of cap and fuse or for the arming of explosive charges used in avalanche mitigation work.

MANUFACTURER: Any individual, corporation, company, firm, partnership, association, or state or local government agency engaged in the business of manufacturing explosive materials for the

purpose of sale, distribution or for his own use.

MASS DETONATION: When a unit or any part or quantity of explosive material detonates and causes all or a substantial part of the remaining material to detonate.

MISFIRE: A blast that fails to detonate completely after an attempt at initiation. This term is also used to describe the explosive material itself that has failed to detonate as planned.

MOTOR VEHICLE: A vehicle, machine, tractor, semi-trailer or other conveyance propelled or drawn by mechanical power. Does not include vehicles operated exclusively on rail.

NATURAL BARRICADE: Natural features of the ground, such as hills, or timber of sufficient density that the surrounding exposures which require protection cannot be seen from the magazine when the trees are bare of leaves.

NON-ELECTRIC DETONATOR: A detonator that does not require the use of electric energy to function.

OXIDIZER OR OXIDIZING MATERIAL: A substance, such as nitrite, that readily yields oxygen or other oxidizing substances to promote the combustion of organic matter or other fuel.

PERMANENT STORAGE MAGAZINE: Type 1 magazines or Type 2, Type 4, or Type 5 magazines that have been at the same location for longer than 90 days.

PARTICLE BOARD: A composition board made of small pieces of wood that have been bonded together.

PARTICLE VELOCITY: A measure of the intensity of ground vibration, specifically the velocity of motion of the ground particles as they are excited by the wave energy.

PERMITTEE: Any user, purchaser, manufacturer, dealer, storer, disposer, or transporter of explosives for a lawful purpose, who has obtained a permit from the Division.

PERSON: Any individual, corporation, company, firm, partnership, association, or state or local government agency.

PETN: Pentaerythritol tetranitrate.

PLACARDS: Division of Transportation Approved Title 49 CFR signs placed on vehicles transporting hazardous materials (including explosive materials) indicating the nature of the cargo.

PLYWOOD: Exterior construction-grade plywood.

POSSESS: The physical possession of explosives on one’s person, or in the person’s vehicle, magazine or building.

POWDER: A common synonym for explosive materials.

POWDER FACTOR: The amount of explosives used per unit of blasted material (see Loading Density).

PRIMER: A unit, package, or cartridge of explosives used to initiate other explosives or blasting agents, which contains either a detonator or a detonating cord to which a detonator designed to initiate the detonating cord is attached.

PROPELLANT/POWDER-ACTUATED POWER DEVICE: Any tool or special mechanized device or gas generator system which is actuated by a propellant or which releases and directs work through a propellant charge.

PUBLIC CONVEYANCE: Any railroad car, streetcar, ferry, cab, bus, aircraft, or other vehicle carrying passengers for hire.

PUBLIC HIGHWAY: Shall mean any public street, alley, or road.

PUBLIC HIGHWAY DISTANCE: Shall mean the minimum distance permitted between a public highway and an explosives magazine.

PUBLIC PLACE: A place which the public or a substantial number of the public has access, and includes but is not limited to, highways, transportation facilities, schools, places of amusement, parks, playgrounds, and the common areas of public and private buildings and facilities.

PURCHASER: A Type II permittee who acquires explosives.

PYROTECHNICS, FIREWORKS: Any combustible or explosive compositions or manufactured articles designed and prepared for the purpose of producing audible or visible effects.

RAILWAY: Any steam, electric, or other type of railroad or railway.

RESPONSIBLE PERSON: A Type I permitted individual who is directly responsible for a Type II permittee’s compliance with the provisions of the Explosives Act, 9-7, C.R.S., and any rules and regulations promulgated thereunder.

SAFETY FUSE: A flexible cord containing an internal burning medium by which fire or flame is conveyed at a continuous and uniform rate from the point of ignition to a cut end. A fuse detonator is usually attached to that end, although safety fuse may be used without a detonator to ignite material such as deflagrating explosives.

SCALED DISTANCE (D

S ): A factor relating similar blast effects from various weight charges of explosive material at various distances. Scaled Distances referring to blasting effects are obtained by dividing the distance of concern by a fractional power of the charge weight per delay of the SECURED STORAGE: An area which is protected from weather and is theft-resistant and in compliance with the uniform fire code.

SEISMOGRAPH: An instrument that is useful in monitoring blasting operations for recording records ground vibration. Particle velocity, displacement or acceleration is generally measured and recorded in three mutually-perpendicular directions.

SEMI-CONDUCTIVE HOSE: A hose used for pneumatic conveying of explosive materials, having an electrical resistance high enough to limit flow of stray electric currents to safe levels yet not so high as to prevent drainage of static electric charges to ground. A hose of not more than 2 megohms resistance over its entire length and of not less than 1,000 ohms per foot (3280 ohms per meter) meets this requirement.

SENSITIVITY: A physical characteristic of an explosive material classifying its ability to be initiated upon receiving an external impulse, such as heat impact, shock, friction, static electricity, stray current or other influence which can cause explosive decomposition.

SHALL: Means that the rule establishes a minimum standard which is mandatory.

SHOCK TUBE: A small diameter plastic tube containing reactive material used for initiating detonators. It contains only a limited amount of reactive material such that the energy that is transmitted through the tube by means of a detonation wave is guided through and confined within the walls of the tube.

SITE: Area where active blasting is taking place or the location of explosives storage magazines.

SLURRY/WATER GEL: An explosive material containing substantial portions of a liquid, oxidizers, and fuel, plus a thickener.

SMALL ARMS AMMUNITION: Any cartridge for a shotgun, rifle, pistol, or revolver, and cartridges for propellant-actuated power device and industrial guns. Military-type ammunition containing explosive bursting charges, or any incendiary, tracer, spotting, or pyrotechnic projectile is excluded from this definition.

SOFTWOOD: Douglas Fir, or other wood of equal bullet-resistance, free of loose knots, wind shakes, or similar defects.

SPACING: The distance between boreholes. In bench blasting, the distance is measured parallel to the free face and perpendicular to the burden.

STATIC ELECTRICITY: Electric charge at rest on a person or object. It is most often produced by the contact and separation of dissimilar insulating materials.

STEMMING: Inert material placed in a borehole on top of or between separate charges of explosive material, used for the purpose of confining explosive materials or to separate charges of explosive material in the same borehole.

STEEL: General purpose (hot or cold rolled) low carbon steel, such as specification ASTM A366 or equivalent.

STORAGE: The safekeeping of explosives in unattended magazines.

TEMPORARY STORAGE MAGAZINE: A Type 1, Type 2, Type 4, or Type 5 magazine that is at a location for a period not to exceed 90 days.

THEFT-RESISTANT: Construction designed to deter illegal entry into facilities used for the storage of explosive material.

TWO-COMPONENT: See binary explosive.

TRANSPORTATION: The conveyance or carrying of explosives from one place to another by means of a motorized vehicle or device.

TYPE I EXPLOSIVES PERMIT: A permit issued by the Division to individuals who possess and control explosive materials during the use, manufacture, acquisition, purchase, sale, distribution, storage, transportation, or disposal of explosives materials.

TYPE II EXPLOSIVES PERMIT: A permit issued by the Division to corporations, companies, partnerships, firms, individuals operating a business, associations, or state or local government agencies involved in the use, purchase, sale, manufacture, transportation, acquisition, distribution or disposal of explosives materials.

TYPE III EXPLOSIVES PERMIT: A permit issued by the Division to corporations, companies, partnerships, firms, individuals operating a business, associations, or state or local government agencies for the storage of explosives in approved magazines.

WEATHER-RESISTANT: Construction designed to offer reasonable protection against weather.

U.S. DEPARTMENT OF TRANSPORTATION EXPLOSIVE CLASSIFICATIONS FOR THE

TRANSPORTATION OF EXPLOSIVES:

Division 1.1: Explosives that have a mass explosion hazard Division 1.2: Explosives that have a projection hazard but not a mass explosion hazard Division 1.3: Explosives that have a fire hazard and either a minor blast hazard or minor projection hazard or both, but not a mass explosion hazard Division 1.4: Explosives that present minor explosion hazard Division 1.5: Very insensitive explosives that have a mass explosion hazard, but are so insensitive that there is little probability of initiation or of transition from burning to detonation under normal conditions of transport (Blasting Agents)

ARTICLE 2 GENERAL REQUIREMENTS

Section 2-1 Miscellaneous Requirements (A) No person shall sell, display, or expose for sale an explosive or blasting agent on any public way or public place.

(B) No person shall sell, deliver, or give possession and control of explosives materials to any person not in possession of a valid permit except an authorized for-hire commercial carrier transporting between two valid permittees.

(C) No person shall sell, purchase, store, transport, use or otherwise possess or control any explosive material without the authorization of the lawful possessor of the explosive material. The lawful possessor shall file a written list of authorized Type I permittees with the Division and shall notify the Division of any changes in writing.

(D) Any theft or loss of explosives or blasting agents, whether from a storage magazine or area, a vehicle in which they are being transported, or from a site where they are being used, or from any other location, shall immediately (but in no event later than 24 hours) be reported by the person having control of such explosives or blasting agents to the local sheriff or local police, the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF), and the Division.

(E) All individuals, corporations, companies, firms, partnerships, associations, or state or local government agencies conducting an operation or activity requiring the use, possession, purchase, sale, manufacturing, storage, acquisition, distribution, transportation or disposal of any explosive materials shall:

(1) Obtain a permit from the Division prior to conducting such operation or activity and shall be responsible for the results and any other consequences of any loading and firing of the explosive materials; and (2) NOT delegate either performance of the blast or accountability for such performance to another person(s).

(F) The Division, Public Safety Section and local law enforcement authority shall be notified immediately by the permittee of any accident, explosion, fire, or misuse of explosives which occurs in connection with the use, manufacture, possession, sale, transportation, storage or disposal of explosives that results in the loss of life, personal injury, or damage to any property.

(G) The Division may inspect the site where any accident, explosion, fire, misuse, theft or loss of explosives occurred.

(H) A Division representative may enter during normal business hours, without advance notice, the premises of any permittee, including places of storage or use, for the purpose of inspecting or examining any records or documents required under these regulations and any explosives material used or stored at the premises.

(I) All corporations, companies, partnerships, firms, individuals operating a business, associations, or state or local government agencies conducting blasting operations shall have a certificate of liability insurance, be named as an also insured on another liability insurance policy, or shall have obtained a signed release of liability for damages from blasting operations from all parties who may be potentially affected by blasting operations. The U.S. Forest Service (USFS) should be notified prior to all blasting activities that occur on USFS land.

ARTICLE 3 EXPLOSIVES PERMIT

Section 3-1 Basic Legal Obligations (A) Except as specifically allowed by these regulations, it is unlawful for any person to use, possess and control, manufacture, purchase, sell, store, transport, or dispose of any explosive material without possessing a valid permit from the Division (18-12-109 (2) and 9-7-101, et seq., C.R.S.).

Section 3-2 General Requirements (A) Permits issued under these rules and regulations shall be dated and numbered. Each permit will indicate class of permit, and shall be valid for up to 36 months after the date of issue unless revoked or suspended by the Division, and shall be renewed on or before the expiration date. The application for renewal of permits shall be made to the Division prior to the renewal date to avoid possible lapse of said permit. The Division shall send a notice a minimum of 60 days prior to the expiration date. The failure of the permittee to receive timely notice from the Division shall not excuse the permittee’s requirement to submit a renewal application not less than 30 days prior to the expiration date.

(B) Upon notice from the Division or any law enforcement agency having jurisdiction, a person using, manufacturing, purchasing, selling, storing, transporting, disposing, or otherwise in possession and control of any explosives without a permit shall immediately surrender any and all such explosives to the Division or to the law enforcement agency designated by the Division.

(C) The Division shall require, as a condition precedent to the original issuance of any explosives permit, fingerprinting and criminal history record checks for every individual applicant.

Fingerprints shall be submitted on forms provided to the applicant by the Division. If a Type I permit holder submits a complete application for renewal, fingerprint cards are not required unless requested by the Division. As a condition precedent to renewal of any explosives permit for an individual, a criminal background check is required.

(D) No person shall withhold information or make any false statement or fictitious oral or written statement or furnish or exhibit any false, fictitious, or misrepresented identification, intended or likely to deceive for the purpose of obtaining or retaining an explosives permit.

(E) No person shall knowingly make any false entry in any record that a permittee is required to keep pursuant to these regulations.

(F) When a permit has expired and has not been renewed, the applicable County Sheriff’s Department shall be notified by the Division, and the Type II permittee must turn over any remaining explosives which the permittee is in possession of directly to the Division or the law enforcement agency designated by the Division, or in the presence of the Division or the law enforcement agency designated by the Division, surrender control of all remaining explosives which the permittee is in possession of to a valid Type II permittee.

(G) All permittees shall take every reasonable precaution to protect their permits from loss, theft, defacement, destruction, or unauthorized duplication. The loss or theft of any permit shall be reported immediately to the local law enforcement agency and to the Division.

Section 3-3 Revocation, Suspension, or Denial of Explosives Permits (A) The Division shall not issue a permit to any person who:

(1) Is under 21 years of age;

(2) Has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;

(3) Is currently charged with, or has a charge pending for a crime punishable by imprisonment for a term exceeding 1 year;

(4) Is a fugitive from justice;

(5) Has been convicted of a crime involving the illegal distribution of marijuana, any depressant or stimulant drug, or narcotic drug, perjury, fraud, false swearing, or bomb threats;

(6) Has been adjudicated developmentally disabled, mentally unstable, mentally ill or insane, or to be incompetent due to any mental disability or disease;

(7) Has been discharged from the armed forces under dishonorable conditions;

(8) Is an alien, other than an alien who is lawfully admitted for permanent residence or an alien who has obtained either a letter of clearance or letter of restoration of explosives privileges from the ATF; or (9) Having been a citizen of the United States, has renounced citizenship.

(B) The Division shall deny or revoke and not renew the permit of any person who is currently charged with, has a charge pending or has been convicted of any of the following offenses:

(1) A crime punishable by imprisonment for a term exceeding 1 year;

(2) A crime involving the illegal distribution of marijuana, any depressant or stimulant drug, or narcotic drug, bomb threats, perjury, fraud, or false swearing, including making a false affidavit or statement under oath to the Division in an application or report; or (3) A crime relating to use, manufacturing, sale, transportation, possession, or disposal of (C) The Division may revoke and not renew the permit of any person when the violation of any law or

regulation relating to explosive material or the misuse of explosive materials results in loss of life or serious injury to any person.

(D) A permit may be denied, suspended, or revoked by the Division because of, but not limited to the (1) Unlawful use of, or addiction to, alcohol, narcotics or illegal drugs;

(2) Failure to exercise reasonable safeguards resulting in hazard to life, health, or property;

(3) Failure to show legitimate use for a permit;

(4) Failure to show sufficient proof of training or prior experience with explosives;

(5) Non-compliance with an order issued by the Division within the time specified in such order;

(6) Proof that the permittee or applicant advocates, or knowingly belongs to any organization or group that advocates the violent overthrow of, or violent action against any federal, state, or local government or institution;

(7) Failure to comply with the Colorado Explosives Act, these regulations and Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), U.S. Department of Justice, Publication ATF P 5400.7, ATF- Explosives Law and Regulations (2012);

(8) Giving false information or a misrepresentation being willfully made to the Division and its investigators or inspectors to obtain or maintain a permit;

(9) Making a false affidavit or statement under oath to the Division in an application or report; or (10) Other factors which, at the discretion of the Division, indicate an unfitness to hold an explosive permit in compliance with state and federal law and these regulations.

(E) The Division shall revoke the permit of any person adjudicated to be mentally unstable, mentally ill or insane, or to be incompetent due to any mental disability or disease. The Division shall not renew the permit until the person has been legally restored to competency.

Section 3-4 Procedure on Revocation, Suspension, or Denial of Explosives Permit (A) [Expired 05/15/2020 per House Bill 20-1179]

(B) [Expired 05/15/2019 per Senate Bill 19-168]

(C) The period of denial, suspension, or revocation shall be within the sound discretion of the (D) [Expired 05/15/2020 per House Bill 20-1179]

(E) Any person aggrieved by a decision after a hearing may seek judicial review pursuant to the provisions of 24-4-106 C.R.S.

(F) Any person who has been denied a permit may not reapply to the Division for an explosives permit within one year of the decision, unless exception is made by the Division and the applicant establishes a substantial change in circumstances to indicate fitness to hold an explosive permit in accordance with the requirements of these regulations, State and Federal law.

(G) In case of revocation or suspension of a permit, the Division shall notify all vendors of explosives of such revocation or suspension.

Section 3-5 Permit Types and Classifications Permits are separated according to type. A permit may have more than one designated classification; however, for each and every classification requested, the applicant must show legitimate use and qualifications. 3-5-1 Type I Explosives Permit (A) All individuals who possess and control explosive materials shall have a valid Type I Explosives Permit issued by the Division.

(B) The requirements of permitting a Type I permittee shall be:

(1) An individual who possesses and controls explosive materials during the use, transportation, storage, distribution, manufacturing, sale, acquisition, or purchase of (2) An individual who makes any or all of the following decisions:

(i) Decides total quantity of explosives used;

(ii) Decides borehole size, spacing, or depth;

(iii) Decides quantity of explosives in each borehole or charge;

(iv) Decides initiation system to be used;

(v) Decides timing delays to be used.

(3) An individual who directly supervises all personnel assisting in the use of explosives and supervises all personnel in training.

(4) An individual who shall also be physically present during the use of explosives, at the point of initiation when a charge is detonated and either initiates the detonation or gives the order to initiate the detonation of the charge.

(C) The classification of permits the applicant may apply for shall be:

(1) Construction (i) Applicant must also apply for a Type I transporter permit, or provide to the Division a written plan documenting the manner in which explosives shall be legally transported to and from construction sites.

(2) Construction Limited (i) Applicant may use or possess class 1.4 or 1.5 explosives or binary products only.

(3) Possession (i) An individual who possesses explosive materials during the storage, distribution, component assembly, manufacturing, sale, acquisition or purchase of explosive materials. This endorsement does not allow an individual to exercise responsibilities as described in 3-5-1 (B) (2) through (4).

(ii) The requirement listed in 3-5-1(D)(3) does not apply to this classification.

(4) Quarry Operations (5) Avalanche Mitigation (6) Geophysical Research (7) Transporter (i) Applicant must submit a copy of his/her Commercial Driver’s License with the Hazardous Material Endorsement included on it.

(ii) Required for the transportation of explosive materials and blasting agents in quantities required to be placarded across or over roads within the state.

(8) Well Perforation (9) Manufacturer (10) Special (special use or possession and control as described on the permit, including but not limited to fabrication, research and development, rock-breaker cartridges, demolition, law enforcement, unexploded ordnance disposal, purchasing agent, sales agent,.)

(D) Type I permittee qualifications (1) The Type I permittee shall be able to understand and give written and oral orders.

(2) The Type I permittee shall be qualified by reason of training, knowledge, and experience in the field of using, transporting, possessing, storing and handling of explosives, and have a working knowledge of state, federal and local laws and regulations which pertain to explosives.

(3) The Type I permit applicant shall be required to submit proof of not less than one year of explosives experience or on the job training in explosives specific to at least one classification of permit. Avalanche mitigation applicants must meet training requirements as defined in Section 7-2.

(4) The Type I permit applicant shall be required to submit proof of not less than six months of explosive experience or on-the-job training in explosives specific to each additional classification of permit applied for.

(5) The Type I permittee shall be knowledgeable and competent in the use of each type of blasting method and initiation system used.

(6) A Type I permit applicant for a transportation classification permit only shall have a valid commercial driver’s license with a hazardous materials endorsement and experience in the transportation of explosive materials for a period of not less than ninety days.

(E) Type I permit limitations (1) A Type I permit shall be limited to possession and control of explosives while authorized by the Type II permittee(s) for whom the Type I permittee is employed or otherwise associated.

(2) The Type I permit shall be placed on inactive status by the Division upon notification in accordance with Section 3-9(D) that the Type I permittee is no longer authorized to possess and control explosives for a Type II permittee.

(3) Upon receipt of written notification by a Type II permittee of authorization and the return of the original Type I permit card, the Division shall return the Type I permit to active status and issue an updated permit card reflecting the change in employment or association.

(4) An active status Type I permit card shall be carried by the Type I permittee at all times when using, transporting, or possessing explosives. 3-5-2 Type II Explosives Permit (A) Corporations, companies, partnerships, firms, individuals operating a business, associations, or state or local government agencies involved in the use, purchase, sale, manufacture, transportation, or disposal of explosives shall have a valid Type II Explosives Permit.

(B) Only one Type II permit shall be required of any corporation, company, partnership, firm, individual operating a business, association, or state or local government agency, and may be issued for all or any of the following classifications:

(1) CLASSIFICATION AS A MANUFACTURER OF EXPLOSIVES authorizes the possession, manufacture, and purchase of materials required in the process of manufacturing the finished product. A corporation, company, partnership, firm, individual operating a business, association, or state or local government agency that combines compounds to manufacture an explosive is engaged in the business of manufacturing explosives and shall be responsible for compliance with the provisions of 9-6-105 C.R.S., the Explosives Act, 9-7-101, et seq. C.R.S., and any rules and regulations promulgated thereunder.

(2) CLASSIFICATION AS A DEALER OF EXPLOSIVES authorizes the purchase, possession, and resale of explosives or blasting agents. A dealer permit is required of jobbers, wholesalers, distributors, dealers, and retailers, whether or not they physically handle, store, or have possession of the explosives or blasting agents. This permit is also required for all nonresidents who desire to sell explosives within the State of Colorado.

(3) CLASSIFICATION AS A PURCHASER OF EXPLOSIVES authorizes the purchase or acquisition and possession of explosives and blasting agents.

(4) CLASSIFICATION AS A PURCHASER LIMITED authorizes the purchase or acquisition and possession of 1.4 and 1.5 classes of explosives and binary products.

(5) CLASSIFICATION AS A USER OF EXPLOSIVES authorizes the possession and use of explosives and blasting agents by a corporation, company, partnership, firm, individual operating a business, association, or state or local government agency conducting an operation or activity which requires the use of such materials. User permits shall be issued for the following types of operations:

(i) Construction (a) Applicant must also apply for a Type II transportation permit, or provide to the Division a written plan documenting the manner in which explosives shall be legally transported to and from construction sites.

(ii) Construction Limited (a) Applicant’s use and possession of explosives is limited to 1.4 and 1.5 classes of explosives and binary products.

(iii) Quarry Operations (iv) Avalanche Mitigation (v) Geophysical Research (vi) Well Perforation (vii) Manufacturer (viii) Special (special use or possession and control as described on the permit, including but not limited to fabrication, research and development, rock-breaker cartridges, demolition, law enforcement, unexploded ordnance disposal, purchasing agent, , sales agent, etc.)

(6) A TRANSPORTATION permit authorizes the transportation of explosive materials and blasting agents in quantities that are required to be placarded across or over roads within the state when such transportation is in compliance with federal, state and local transportation laws and regulations.

(i) A copy of a Hazardous Materials Transport Permit issued by the Public Utilities Commission (PUC) shall be submitted with the application. 3-5-3 Type III Storage Permit (A) Corporations, companies, partnerships, firms, individuals operating a business, associations, or state or local government agencies that store explosives shall have a valid Type III permit.

(B) Storage permits shall be issued to those persons who have approved storage magazine sites.

(C) Approval by the Division of a permanent storage magazine site shall include a site inspection by a Division representative. Written notification of the location of the permanent storage magazine site shall be made to the applicable fire district or department.

(D) Approval by the Division of temporary magazine sites shall be made for a period not to exceed 90 days upon written notification to the Division as to the location of the magazine site, the type(s) and supplier of the magazines being utilized, the type and quantity of explosives being stored and proof of written notification of the location of the storage magazine to the applicable fire district or department and county sheriff.

(E) An inspection shall be required at each permanent storage magazine site, including any added permanent storage magazine sites, prior to the renewal of the Type III permit.

Section 3-6 Permit Application (A) Application for each type of original permit or renewal shall be made on forms available from the Division and shall provide the following information:

(1) The name and address of the applicant (2) Front and reverse side copies of applicant’s driver’s license (3) The reason for desiring to use, purchase, sell, store, manufacture, transport or dispose of explosives (4) The applicant’s citizenship, if the applicant is an individual (5) If the Type II applicant is a partnership, the names and addresses of the Type I permitted partners and their citizenship (6) If the Type II or Type III permit applicant is a corporation, company, firm, association or state or local government agency, the names and addresses of the Type I permitted owner(s), manager(s) or other designated individual thereof, and their citizenship (7) Where application for a Type II explosives permit is made in the name of a corporation, company, partnership, association, state or local government agency or firm, the application shall be signed by the permitted owner(s), partner(s), manager(s) or other designated individual(s) who will have access to explosive materials and be directly responsible for compliance with the provisions of the Explosives Act, 9-7-101, et seq.

C.R.S., and any rules and regulations promulgated thereunder (8) The name(s) of the valid Type II permittee the Type I permit applicant is employed by or associated with, and for whom the applicant will possess and control explosive materials (9) Evidence that the Type I applicant is sufficiently trained and experienced in the use, transportation, storage, purchase, sale, disposal or manufacturing of explosives (10) Such other pertinent information as the Division shall require to effectuate the purpose of these regulations (B) Application forms may be obtained from the Division.

(C) The submission of an application shall be a certification by the Type I permit applicant that the applicant, or Type I permittee acting as the responsible person for the Type II or Type III permit applicant, has read, understands and accepts these regulations and shall comply with all requirements of these regulations.

(D) Payment of the application fee for a period of 36 months, according to the following list, must accompany each application for a permit.

Type I Explosives Permit: $110.00 Type II Explosives Permit: $225.00 Type III Explosives Permit: $375.00 (E) A check or money order for the fee shall be made payable to the Division and submitted to the address provided on the application.

(F) The applicant may be asked to supply additional information requested by the Division in order to verify statements in an application or in order to facilitate a Division inquiry prior to the issuance or renewal of a permit.

(G) Each Type II application for a manufacturer or dealer permit shall be accompanied by a copy of the applicant’s current federal license issued by The Bureau of Alcohol, Tobacco, Firearms and Explosives.

(H) The Type II application for a manufacturer or dealer permit shall list the location(s) in Colorado where explosives will be manufactured or from where explosives will be sold. This shall not be required for the manufacturers of binary explosives.

(I) A valid Type I permit shall be held by at least one of the individual owners, partners, managers or other designated individual for each classification of use requested on the Type II Explosives Permit application.

(J) Each application for an original Type II permit or a renewal permit shall be accompanied by a list of valid Type I permittees authorized to possess and control explosives on behalf of the Type II permittee. The Division shall be notified of any changes of such Type I permittees.

(K) An application for a Type III storage permit shall include the location of all storage facilities and types of magazines to be utilized.

(L) Each application for a Type II permit to purchase shall have a list of Type I permittees authorized to order and receive explosives on behalf of the purchaser. The list of Type I permittees authorized to order and receive explosives on behalf of the purchaser shall be provided to dealers prior to the purchase of explosives.

(M) In addition to the application form, all new Type I applicants, all Type I applicants requesting a change in classification of their permit, and all Type I applicants who have not renewed their permit within 60 days after expiration will be required to obtain a score of not less than 90% on a written examination prepared and administered by the Division. A Type I applicant failing the examination may retake the examination at any time. A Type I applicant failing the examination a second time must wait for a period of at least 14 days before retaking the exam.

(N) All Type I applicants renewing their permits are required to obtain a score of not less than 90% on a written examination prepared and administered by the Division every 3 years or provide proof of 16 hours attendance during the previous 3 years in a training course approved by the Division.

(O) The Division shall obtain a photograph of Type I permit applicants.

(P) Upon receipt of an incomplete application or an application requiring additional information, the applicant will be notified of the deficiency or additional requirements. If the deficiency is not corrected or if the Division does not receive the additional information within 180 days following the date of notification, the application shall be considered abandoned and the Division shall not retain the application.

(Q) Upon receipt of a completed Type I application the applicant will be sent an exam notification. If the Type I permit applicant fails to complete the exam within 180 days of the exam notification, the application shall be considered abandoned and the Division shall not retain the application.

(R) A Type I renewal applicant must complete the exam, if required, within 180 days of the date of the renewal notification letter sent by the Division. Should the renewal applicant fail to complete the exam within 180 days of the date of the renewal letter, the application shall be considered abandoned and the Division shall not retain the application.

Section 3-7 Protection and Exhibition of Permits Permittees shall take every reasonable precaution to protect their permits from loss, theft, defacement, destruction or unauthorized duplication.

The loss or theft of any permit shall be reported immediately to the local law enforcement agency and to the Division.

Permits, or copies thereof, shall be exhibited in conformity with the following provisions:

(A) Manufacturer - the permit shall be posted at the facility where explosives or blasting agents are manufactured. Manufacturing permits for bulk mix trucks shall be posted in the office of the permittee.

(B) Dealer- the permit shall be posted in the office at the location where explosives or blasting agents are sold.

(C) Purchaser - the permit or a copy of the permit must be displayed at magazine/warehouse where explosives or blasting agents are received and stored.

(D) User - the permit shall be posted in the main office of explosives operations.

(E) Storage - a copy of the permit must be displayed at the office, warehouse, or in at least one magazine where explosives or blasting agents are received for storage.

(F) A Type I permit card shall be carried by the Type I permittee at all times when using, transporting, or possessing explosives and presented to representatives of the Division and law enforcement officials, upon request, along with valid personal identification.

Section 3-8 Records of Transactions All permittees shall keep a complete record of all transactions in, or operations involving explosives for five years following the year in which the transactions or operations involving explosives or blasting agents occurred. The permittees must retain copies thereof and furnish such copies to the Division during normal business hours upon request. When the permittee is employed by another person who holds a valid permit, the records of the employer shall be deemed to satisfy these record-keeping requirements. 3-8-1 Manufacturer The records of a person having a permit to manufacture explosives or blasting agents shall include the following information:

(A) Amount and kinds manufactured.

(B) Amounts and kinds acquired for manufacture.

(C) Names and addresses of the persons from whom acquired and dates on which acquired.

(D) Amount and kinds sold or otherwise disposed of.

(E) Names, addresses and permit numbers of persons to whom sold or otherwise disposed of and dates of the sales or other dispositions.

(F) Amounts and kinds on hand at each location at the end of each day on which there are transactions or operations.

(G) The records kept in accordance with Section 6-1(U) shall meet the record requirements for the manufacture of binary products. 3-8-2 Dealer The records of a person having a permit for dealer shall include the following information:

(A) Amounts and kinds acquired.

(B) Names and addresses of persons from whom acquired and dates on which acquired.

(C) Amounts and kinds sold or otherwise disposed of.

(D) Names, addresses, and permit numbers of persons to whom sold or otherwise disposed of and the dates of sales or other dispositions. This requirement shall not apply to the sale of smokeless powder. 3-8-3 Type II Permit A person holding a Type II permit to use explosives or blasting agents shall maintain a record of all explosive material transactions including a daily inventory record of all explosives received, removed from, or returned to each storage magazine in accordance with Section 4-1(F)(6) of these regulations, and records completed by Type I permittees in accordance with Section 6-1(U) and Section 7-4(B)(11). 3-8-4 Type I Permit Type I permittees shall complete and sign records of explosives used in accordance with Section 6-1(U) or Section 7-4(B)(11) of these regulations.

Section 3-9 Permit Changes The Division shall be notified immediately when:

(A) There is a change in the permittee’s permanent address.

(B) There is a change in the name of a permittee, or a change in the Type I permitted owner(s), manager(s), or other designated individual(s) acting as the responsible person of any Type II or Type III permittee.

(C) The location of an explosives storage facility is changed or added and the address of the new location shall be provided.

(D) There is a change in the Type II permitted employer or association for whom the Type I permittee will possess and control explosive materials.

(E) There is a change in the Type I permitted individuals authorized to possess and control explosives on behalf of a Type II permittee.

(F) A Type I Permit holder is currently charged with, has a pending charge of or has been convicted of any of the offenses listed in 3-3 (B) 1-3.

Section 3-10 Explosives Sales to Permittees (A) When an order for explosives is placed by a purchaser, the dealer shall request proper authorization and identification from the purchaser and shall record the purchaser’s permit number on the sales record.

(B) The purchaser shall provide to the dealer a list of Type I permittees authorized to order and receive explosives on behalf of the purchaser. A dealer shall not distribute explosive materials to a company or individual on the order of a person who does not appear on the most current list of authorized Type I permittees, and if the person does appear on the list, the dealer shall verify the identity of such person.

(C) The authorized Type I permittee who physically receives the purchased explosives shall present his permit and proper identification to the dealer. The receiver of the explosives shall sign a receipt documenting the explosives received with his legal signature and permit number.

(D) All such receipts shall be retained by the dealer for not less than 5 years from the date of purchase.

(E) The dealer shall keep a record of all explosives purchased and sold as required by federal (F) Any package containing any explosive or blasting agent that is sold or is delivered for shipment by a dealer shall be properly labeled in accordance with 9-6-105 C.R.S. to indicate its explosive classification.

ARTICLE 4 STORAGE OF EXPLOSIVE MATERIALS

Section 4-1 General Requirements (A) All explosive materials, special industrial explosive materials, and any newly developed and unclassified explosive materials shall be kept in magazines which meet the requirements as defined in these regulations, unless they are in the process of manufacture, being physically handled in the operating process, being used, or being transported to a place of storage or use.

Refer to Section 4-3 for a summary of storage requirements.

(B) High explosives shall not be stored unattended outdoors, or in any building or structure, except in a Type 1 or Type 2 magazine.

(C) Detonators that will not mass detonate (1.4s and 1.4b classification) and are in the original and closed shipping container may also be stored in a Type 4 magazine.

(D) The requirements for the storage of binary explosives shall be:

(1) Storage of the flammable liquid component of a binary explosive shall be in secure storage that complies with the uniform fire code.

(2) Storage of the powder component of a binary explosive shall be in secure storage.

(3) Liquid and powder components shall not be stored together.

(E) Detonators shall not be stored in the same magazine in which other explosives are kept or stored except under the following circumstances:

(1) In a Type 1 or Type 2 magazine, detonators may be stored with delay devices, electric squibs, safety fuse, igniters, and igniter cord.

(2) In a Type 4 magazine, detonators that will not mass detonate (1.4s and 1.4b classification) may be stored with electric squibs, safety fuse, igniters, and igniter cord.

(F) Inventory and Responsibility (1) Magazines shall be in the charge of a valid permittee at all times who shall be held responsible for the enforcement of all safety precautions.

(2) All explosives shall be accounted for at all times.

(3) Explosives not being used shall be kept in a locked magazine and the keys or combinations to the locks shall be unavailable to persons not holding a valid Type I permit.

(4) The Type II permittee shall maintain an inventory and use record of all explosive (5) Type I permittees shall record any receipt, removal, or return of explosives materials on inventory records within the magazine or at one central location on the business premises provided that transactions for each magazine are kept separate.

(6) The inventory records shall be maintained on forms approved by the Division and shall include:

(i) Type of explosive material product (ii) Manufacturer’s name or brand name (iii) Identifying or date shift code (iv) Amounts received, removed from or returned to the magazine (v) The signature of the permittee receiving, removing or returning explosive materials (vi) Total quantity remaining on hand (7) Explosive materials shall be physically counted at least monthly.

(8) Explosive materials sold and received in individual unit quantities shall be inventoried as individual units.

(9) Explosive materials sold and received as pounds shall be inventoried as pounds when in unopened cases, and as individual cartridges or units when in opened cases.

(10) The Federal Bureau of Alcohol, Tobacco, Firearms and Explosives, the Division, and local law enforcement agencies shall be notified immediately of any loss, theft, or unauthorized entry into a magazine.

(G) Surrounding Area (1) The land surrounding a magazine shall be kept clear of trash, dried grass, leaves or trees (except for live trees more than 10 feet tall) for a distance of at least 25 feet. Living foliage used to stabilize the earthen coverings of a magazine need not be removed.

(2) Any other combustible materials shall not be stored within 50 feet of magazines.

(3) Smoking, matches or an open flame shall not be permitted:

(i) In any magazine;

(ii) Within 50 feet of any outdoor magazine; or (iii) Within any room containing an indoor magazine.

(4) Firearms shall not be permitted inside of, or within 50 feet of magazines.

(5) The premises on which all outdoor magazines are located shall be posted with signs with the words “DANGER—KEEP OUT” in letters at least 3 inches high. Signs shall be posted to warn any person approaching the magazine of the hazard, but shall be located so that a bullet passing through the sign will not strike the magazines.

(6) All normal access routes to outdoor explosives storage sites shall be posted with a sign with the words “DANGER- NEVER FIGHT FIRES ON THIS SITE. CALL _______________” in letters at least 2 inches high. An emergency contact number shall be written on the sign.

(7) Indoor magazines shall be visibly marked with the words “DANGER – KEEP FIRE AWAY.”

(H) Temporary storage at a site for blasting operations shall be located away from neighboring inhabited buildings, railways, highways, and other magazines in accordance with the American Table of Distances (see Section 4-5).

(I) Storage Within Magazines (1) Packages of explosive materials shall be laid flat with top side up. Corresponding grades and brands shall be stored together in such a manner that brands and grade marks show. All stocks shall be stored so as to be easily counted and checked. Packages of explosives shall be stacked in a stable manner. When any kind of explosive is removed from a magazine for use, the oldest of that particular kind shall always be taken first.

(2) Packages of explosives requiring impact or potentially spark producing methods to open or to close shall not be opened or closed in a magazine, nor within 50 feet of a magazine or in close proximity to other explosive materials.

(3) Tools used for opening packages of explosives shall be constructed of non-sparking (4) Opened packages of explosives shall be securely closed before being returned to a magazine.

(5) Magazines shall not be used for the storage of any metal tools nor any commodity except explosives; however, this restriction shall not apply to the storage of blasting agents and non-metal blasting supplies.

(6) Magazine floors shall be regularly swept, kept clean, dry, and free of grit, paper, empty used packages, and rubbish. Brooms and other cleaning utensils shall not have any spark- producing metal parts. Sweepings from floors of magazines shall be properly disposed of. Magazine floors stained with nitroglycerin shall be cleaned according to instructions of the manufacturer.

(7) When any explosive has deteriorated to an extent that it is in an unstable or dangerous condition, or if nitroglycerin leaks from any explosives, then the person in possession of such explosives shall immediately proceed to destroy such explosives in accordance with the instructions of the manufacturer. Only Type I permittees experienced in the destruction of explosive materials shall be allowed to do the work of destroying (8) When magazines need inside repairs, all explosives shall be removed and the floors cleaned. In making outside repairs, if there is a possibility of causing sparks or fire the explosives shall be removed from the magazine. Explosives removed from a magazine in order for repair shall either be placed in another class appropriate magazine, or placed a safe distance from the magazine where they shall be properly guarded and protected until repairs have been completed, at which time they shall be returned to the magazine.

(9) Explosive materials within a magazine are not to be placed against the interior walls and must be stored so as not to interfere with ventilation when required.

(10) Any person storing explosive materials shall open and inspect the magazine at least every 7 days. This inspection need not be an inventory, but must be sufficient to determine whether there has been unauthorized entry or attempted entry into the magazine, or unauthorized removal of the contents.

(11) Flammables, such as the liquid components of binary products, shall not be stored with other explosives.

(J) Lighting Within Magazines (1) Battery-activated safety lights or battery-activated safety lanterns may be used in explosives storage magazines.

(2) Electric lighting, including wiring and fixtures, used in any explosives storage magazine must meet the standards prescribed by the National Electrical Code for the conditions present in the magazine at any time. All electrical switches are to be located outside of the magazine and also meet the standards prescribed by the National Electrical Code.

(3) Light fixtures shall be enclosed to prevent sparks or hot metal from falling on the floor or on materials stored in the magazine.

(4) Interior magazine lights shall be turned off when the magazine is unattended.

(5) Copies of invoices, work orders or similar documents which indicate that the lighting complies with the National Electrical Code must be available for inspection by the

Section 4-2 Classes of Explosive Materials and Examples For the purposes of this article, there are three classes of explosive materials. These classes, together with the description of explosive materials comprising each class, are as follows:

(A) High Explosives - Explosive materials which can be caused to detonate by means of a detonator when unconfined. Examples include:

(1) Dynamite and detonators;

(2) Detonator-sensitive slurry/water gels and emulsions; and (3) Mixed binaries.

(B) Low Explosives - Explosive materials which can be caused to deflagrate when confined.

Examples include:

(1) Black powder;

(2) Pull wire igniters; and (3) Safety fuse.

(C) Blasting Agents - Explosives materials consisting of fuel and oxidizer which cannot be detonated by means of a number 8 test detonator when unconfined. Examples include:

(1) Ammonium Nitrate/Fuel Oil mixture (ANFO); and (2) Non detonator-sensitive slurry/water gels and emulsion products.

Section 4-3 Summary of Storage Requirements Table 4-3 Summary of Storage Requirements Storage Type Classes of Explosive Materials Which May Be Stored Therein Type 1 (Permanent)

Type 2 Type 3 (“Day Box” for Temporary Storage)

Type 4 Blasting Agents, Low Explosives, Detonators (Original, Closed Cartons of 1.4b, 1.4c And 1.4s)

Type 5 Blasting Agents

Section 4-4 Storage Magazine Construction by Type Table 4-4 Storage Magazine Construction By Type Construction Features Type 1 Type 2 Type 3 Type 4 Type 5 Permanent X X X Portable or Mobile X X X X Bullet-Resistant X X Fire-Resistant X X X X X (1)

Theft- Resistant X X X X X Weather- Resistant X X X X X Ventilated X X X (1)

Over the road trucks or semi-trailers used as Type 5 magazines for temporary storage need not be fire resistant. 4-4-1 Type 1 Storage A Type 1 magazine shall be a permanent structure, e.g., a building, an igloo or Army-type structure, a tunnel, or a dugout. It shall be bullet-resistant, fire-resistant, weather-resistant, theft-resistant, and ventilated.

(A) Buildings: All building-type magazines shall be constructed of masonry, wood, metal, or a combination of these materials and shall have no openings except for entrances and ventilation.

The ground around building magazines shall slope away for drainage or other adequate drainage shall be provided.

(B) Masonry Wall Construction: Masonry wall construction shall consist of brick, concrete, tile, cement block, or cinder block and shall be not less than 8 inches in thickness. Hollow masonry units used in construction shall have all hollow spaces filled with well-tamped, coarse, dry sand or weak concrete (at least 1 part cement + 8 parts of sand with enough water to dampen the mixture while tamping in place). Interior walls shall be constructed of, or covered with, a non- sparking material.

(C) Fabricated Metal Wall Construction: Metal wall construction shall consist of sectional sheets of steel or aluminum, not less than #14 gauge, securely fastened to a metal framework. Metal wall construction shall be either lined inside with brick, solid cement blocks, hardwood not less than 4 inches thick, or shall have at least a 6-inch sand-fill between interior and exterior walls. Interior walls shall be constructed of, or covered with, a non-sparking material.

(D) Wood Frame Wall Construction: The exterior of outer wood walls shall be covered with steel or aluminum not less than #26 gauge. An inner wall of, or covered with, non-sparking material shall be constructed so as to provide a space of not less than 6 inches between the outer and inner walls. The space shall be filled with coarse, dry sand or weak concrete.

(E) Floors: Floors shall be constructed of, or covered with, a non-sparking material and shall be strong enough to bear the weight of the maximum quantity materials to be stored. Use of pallets covered with a non-sparking material is considered equivalent to a floor constructed of, or covered with, a non-sparking material.

(F) Foundations: Foundations shall be constructed of brick, concrete, cement block, stone, or wood posts. If piers or posts are used in lieu of a continuous foundation, the space under the buildings shall be enclosed with metal.

(G) Roof: Except for buildings with fabricated metal roofs, the outer roof shall be covered with no less than #26 gauge steel or aluminum fastened to 7/8-inch sheathing.

(H) Bullet-Resistant Ceilings on Roofs: Where it is possible for a bullet to be fired directly through the roof and into the magazine at such an angle that the bullet would strike the explosives within, the magazine shall be protected by one of following methods:

(1) A sand tray with a layer of building paper, plastic, or other nonporous material filled with not less than 4 inches of coarse, dry sand, shall be located at the tops of inner walls covering the entire ceiling area, except that portion necessary for ventilation.

(2) A fabricated metal roof shall be constructed of 3/16-inch thick plate steel lined with 4 inches of hardwood. For each additional 1/16-inch of plate steel, the hardwood lining may be decreased by 1 inch.

(I) Doors: All doors shall be constructed of 1/4-inch plate steel and lined with 3 inches of hardwood.

Hinges and hasps shall be attached to the doors by welding, riveting, or bolting (with nuts on the inside of the door). They shall be installed in such a manner that the hinges and hasps cannot be removed when the doors are closed and locked.

(J) Locks: Each door shall be equipped with at least one of the following types of locks:

(1) Two mortise locks (2) Two padlocks fastened in separate hasps and staples (3) A combination of a mortise lock and a padlock (4) A mortise lock that requires two keys to open (5) A three-point lock.

Padlocks shall have at least 5 tumblers and a case-hardened shackle of at least 3/8-inch in diameter. Padlocks shall be protected with 1/4-inch sheet hoods constructed so as to prevent sawing or lever action on the locks, hasps, and staples. These requirements shall not apply to magazine doors that are adequately secured on the inside by means of a bolt, lock, or bar that (K) Ventilation: Ventilation shall be provided to prevent dampness and heating of stored explosive materials. Ventilation openings shall be screened to prevent the entrance of sparks. Ventilation openings in sidewalls and foundations shall be offset or shielded for bullet-resistance purposes.

Magazines having foundation and roof ventilators with the air circulating between the side walls and the floors and between the side walls and the ceiling shall have a wooden lattice lining or equivalent to prevent the packages of explosive materials from being stacked against the side walls and blocking the air circulation.

(L) Exposed Metal: No sparking material shall be exposed to contact with the stored explosive materials. All ferrous metal nails in the floor and sidewalls which might be exposed to contact with explosive materials shall be blind-nailed, countersunk, or covered with a non-sparking latticework or other non-sparking material.

(M) Igloos, Army-Type Structures, Tunnels, & Dugouts: Igloo, army-type structure, tunnel, and dugout magazines shall be constructed of reinforced concrete, masonry, metal, or a combination of these materials. They shall have an earth mound covering of not less than 24 inches on the top, sides, and rear unless the ceiling or roof meets the bullet-resistant ceiling or roof requirements of this

section. Interior walls shall be constructed of, or covered with, a non-sparking material.

Magazines of this type shall also be constructed in conformity with the requirements of the floors, doors, locks, ventilation, and exposed metal portions outlined in this section. 4-4-2 Type 2 Storage A Type 2 magazine shall be a portable or mobile structure such as a box, skid-magazine, trailer, or semitrailer. 4-4-2-1 Outdoor Type 2 Magazines Outdoor Type 2 magazines shall be bullet-resistant, fire-resistant, weather-resistant, theft-resistant, and ventilated. They shall be supported to prevent direct contact with the ground and, if less than 1 cubic yard in size, shall be securely fastened to a fixed object. The ground around outdoor magazines shall slope away for drainage or other adequate drainage shall be provided. When unattended, vehicular magazines shall have wheels removed or shall otherwise be effectively immobilized by methods approved by the (A) Exterior Construction: The exterior and covers or doors shall be constructed of 1/4-inch steel and shall be lined with 2 inches of hardwood. Magazines with top openings shall have lids with waterresistant seals or which overlap the sides by at least 1 inch when in a closed position.

(B) Hinges & Hasps: Hinges and hasps shall be attached to the covers or doors by welding, riveting, or bolting (with nuts on the inside of the door). Hinges and hasps shall be installed so that they (C) Locks: Each door shall be equipped with at least one of the following types of locks:

(1) Two mortise locks (2) Two padlocks fastened in separate hasps and staples (3) A combination of a mortise lock and a padlock (4) A mortise lock that requires two keys to open (5) A three-point lock.

Padlocks shall have at least 5 tumblers and a case-hardened shackle of at least 3/8-inch diameter. Padlocks shall be protected with 1/4-inch steel hoods constructed so as to prevent sawing or lever action on the locks, hasps, and staples. These requirements do not apply to magazine doors that are adequately secured on the inside by means of a bolt, lock, or bar that (D) Ventilation: Ventilation shall be provided to prevent dampness and heating of stored explosive materials. Ventilation openings shall be screened to prevent the entrance of sparks. Ventilation openings in sidewalls shall be offset or shielded for bullet-resistance purposes. Packages of explosive materials shall not be stacked against the side walls and block the air circulation. 4-4-2-2 Indoor Type 2 Magazines Indoor Type 2 magazines shall be fire-resistant and theft-resistant if the buildings in which they are stored provide protection from the weather and from bullet penetration. No indoor magazine may be located in a residence or dwelling. The indoor storage of high explosives may not exceed a quantity of 50 pounds.

More than one indoor magazine may be located in the same building if the total quantity of all explosive materials stored does not exceed 50 pounds. Detonators shall be stored in separate magazines.

(A) Exterior Construction: Indoor magazines shall be constructed of wood or metal according to one of the following specifications:

(1) Indoor magazines constructed of wood shall have sides, bottoms, and lids or doors constructed of two-inch wood and shall be well-braced at the corners. The magazines shall be covered on the exterior with sheet metal of not less than #26-gauge. Nails exposed to the interior of magazines shall be countersunk.

(2) Indoor magazines constructed of metal shall have sides, bottom, and lids or doors constructed of at least #12-gauge metal and shall be lined inside with a non-sparking material. Edges of metal covers shall overlap sides at least 1 inch.

(B) Hinges & Hasps: Hinges and hasps shall be attached to the covers or doors by welding, riveting, or bolting (with nuts on the inside of the door). Hinges and hasps shall be installed so that they (C) Locks: Each door shall be equipped with at least one of the following types of locks:

(1) Two mortise locks (2) Two padlocks fastened in separate hasps and staples (3) A combination of a mortise lock and a padlock (4) A mortise lock that requires two keys to open (5) A three-point lock.

Padlocks shall have at least 5 tumblers and a case-hardened shackle of at least 3/8-inch diameter. Padlocks shall be protected with 1/4-inch steel hoods constructed so as to prevent sawing or lever action on the locks, hasps, and staples. Indoor magazines located in secure rooms, that are locked as provided in this paragraph, may have each door or opening locked with 1 steel padlock (which need not be protected by a steel hood) having at least 5 tumblers and a case-hardened shackle of at least 3/8-inch diameter, if the lock hinges and hasps are securely fastened to the magazine and to the door frame. These requirements do not apply to magazine doors that are adequately secured on the inside by means of a bolt, lock, or bar that cannot be 4-4-3 Alternate Construction Standards for Storage Facilities It has been determined that a wide range of construction criteria meet the bullet-resistant requirements of ATF Rule 76-18 as published in Bureau Of Alcohol, Tobacco, Firearms, and Explosives, Department Of The Treasury, Publication ATF p 5400.7 (2012) for the construction of storage facilities for explosive In order to promote standards of safety and security in the storage of explosive materials while allowing the industry a wide latitude in the selection of construction materials, it is held that storage facilities (magazines) that are constructed according to the following minimum specifications are bullet-resistant and meet the requirements of the regulations as set forth in 27 CFR Part 55 (all steel and wood dimensions are actual thicknesses. To meet the concrete block and brick dimensions indicated, the manufacturers’ represented thicknesses may be used).

(A) Exterior of 5/8-inch steel, lined with an interior of any type of non-sparking material.

(B) Exterior of 1/2-inch steel, lined with an interior of not less than 3/8-inch plywood.

(C) Exterior of 3/8-inch steel, lined with an interior of 2 inches of hardwood.

(D) Exterior of 3/8-inch steel, lined with an interior of 3 inches of softwood or 2¼ inches of plywood.

(E) Exterior of 1/4-inch steel, lined with an interior of 3 inches of hardwood.

(F) Exterior of 1/4-inch steel, lined with an interior of 5 inches of softwood or 5¼ inches of plywood.

(G) Exterior of 1/4-inch steel, lined with an intermediate layer of 2 inches of hardwood and an interior lining of 1½ inches of plywood.

(H) Exterior of 3/16-inch steel, lined with an interior of 4 inches of hardwood.

(I) Exterior of 3/16-inch steel, lined with an interior of 7 inches of softwood or 6¾ inches of plywood.

(J) Exterior of 3/16-inch steel, lined with an intermediate layer of 3 inches of hardwood and an interior lining of 3/4-inch of plywood.

(K) Exterior of 1/8-inch steel, lined with an interior of 5 inches of hardwood.

(L) Exterior of 1/8-inch steel, lined with an interior of 9 inches of softwood.

(M) Exterior of 1/8-inch steel, lined with an intermediate layer of 4 inches of hardwood and an interior lining of 3/4-inch plywood.

(N) Exterior of any type of fire-resistant material which is structurally sound, lined with an intermediate layer of 4 inches of solid concrete block, or 4 inches of solid brick or 4 inches of solid concrete; and, an interior lining of 1/2-inch plywood placed securely against the masonry lining.

(O) Standard 8-inch concrete block with voids filled with well-tamped sand/cement mixture.

(P) Standard 8-inch solid brick.

(Q) Exterior of any type of fire-resistant material which is structurally sound, lined with an intermediate 6-inch space filled with well-tamped dry sand or well-tamped sand/cement mixture.

(R) Exterior of 1/8-inch steel, lined with a first intermediate layer of 3/4-inch plywood, a second intermediate layer of 3⅝ inches of well-tamped dry sand or sand/cement mixture and an interior lining of 3/4-inch plywood.

(S) Second intermediate layer of 3⅝ inches well tamped dry sand or sand/cement mixture, a third intermediate layer of 3/4-inch plywood, and a fourth intermediate layer of two inches of hardwood or #14 gauge steel and an interior lining of 3/4-inch plywood.

(T) 8-inch thick solid concrete. 4-4-4 Type 3 Storage A Type 3 magazine shall be a “day-box” or other portable magazine. It shall be fire-resistant, weatherresistant, and theft-resistant. A Type 3 magazine shall be constructed of #12-gauge metal lined with either 1/2-inch plywood or 1/2-inch Masonite-type hardboard. Doors shall overlap sides by at least 1 inch.

Hinges and hasps shall be attached by welding, riveting or bolting (with nuts on the inside of the door). A single lock having at least 5 tumblers and a case-hardened shackle of at least 3/8-inch diameter shall be sufficient for locking purposes. Explosive materials may not be left unattended in Type 3 magazines, but must be removed to either a Type 1 or 2 magazine for unattended storage. 4-4-5 Type 4 Storage A Type 4 magazine shall be a building, igloo or army-type structure, tunnel, dugout, box, trailer, or a semitrailer or other mobile magazine. 4-4-5-1 Outdoor Type 4 Magazines Outdoor Type 4 magazines shall be fire-resistant, weather-resistant, theft-resistant, ventilated and shall be at least 1 cubic yard in size, or securely fasted to a fixed object. The ground around outdoor magazines shall slope away for drainage or other adequate drainage shall be provided. When unattended, vehicular magazines shall have wheels removed or shall otherwise be effectively immobilized by other methods approved by the Division.

(A) Construction: Outdoor magazines shall be constructed of masonry, metal-covered wood, fabricated metal, or a combination of these materials. Foundation shall be constructed of brick, concrete, cement block, stone, or metal or wood posts. If piers or posts are used in lieu of a continuous foundation, the space under the buildings shall be enclosed with fire-resistant material. The walls and floors shall be constructed of, or covered with, a non-sparking material or lattice work. The doors or covers shall be metal or solid wood covered with metal.

(B) Hinges and Hasps: Hinges and hasps shall be attached to the covers or doors by welding, riveting, or bolting (nuts on inside of door). Hinges and hasps shall be installed so that they (C) Locks: Each door shall be equipped with at least one of the following types of locks:

(1) 2 mortise locks (2) 2 padlocks fastened in separate hasps and staples (3) A combination of a mortise lock and a padlock (4) A mortise lock that requires two keys to open (5) A three-point lock.

Padlocks shall have at least 5 tumblers and a case-hardened shackle of at least 3/8-inch diameter. Padlocks shall be protected with 1/4-inch steel hoods constructed so as to prevent sawing or lever action on the locks, hasps, and staples. These requirements do not apply to magazine doors that are adequately secured on the inside by means of a bolt, lock, or a bar that (D) Ventilation: Ventilation shall be provided to prevent dampness and heating of stored explosive materials. Ventilation openings shall be offset or shielded and screened to prevent the entrance of sparks. The packages of explosive materials shall not be stacked against the side walls and block the air circulation. 4-4-5-2 Indoor Type 4 Magazines Indoor magazines shall be fire-resistant and theft-resistant. They need not be weather-resistant if the buildings in which they are stored provide protection from the weather. No indoor magazine may be located in a residence or dwelling. The indoor storage of low explosives may not exceed a quantity of 50 pounds. More than one indoor magazine may be located in the same building if the total quantity of all explosive materials stored does not exceed 50 pounds. Detonators that will not mass detonate shall be stored in separate magazines and the total number of detonators may not exceed 5,000.

(A) Construction: Indoor magazines shall be constructed of masonry, metal-covered wood, fabricated metal, or a combination of these materials. The walls and floors shall be constructed of, or covered with, a non-sparking material. The doors or covers shall be metal or solid wood covered with metal.

(B) Hinges & Hasps: Hinges and hasps shall be attached to the covers or doors by welding, riveting, or bolting (with nuts on the inside of the door). Hinges and hasps shall be installed so that they (C) Locks: Each door shall be equipped with at least one of the following types of locks:

(1) 2 mortise locks (2) 2 padlocks fastened in separate hasps and staples (3) A combination of a mortise lock and a padlock (4) A mortise lock that requires two keys to open (5) A three-point lock.

Padlocks shall have at least 5 tumblers and a case-hardened shackle of at least 3/8-inch diameter. Padlocks shall be protected with 1/4-inch steel hoods constructed so as to prevent sawing or lever action on the locks, hasps, and staples. Indoor magazines located in secure rooms, that are locked as provided in this paragraph, may have each door or opening locked with one steel padlock (which need not be protected by a steel hood) having at least five tumblers and a case-hardened shackle of at least 3/8-inch diameter, if the lock hinges and hasps are securely fastened to the magazine and to the door frame. These requirements do not apply to magazine doors that are adequately secured on the inside by means of a bolt, lock, or bar that cannot be 4-4-6 Type 5 Storage A Type 5 magazine shall be a building, igloo or army-type structure, tunnel, dugout, bin, box, trailer, or a semitrailer or other mobile facility. 4-4-6-1 Outdoor Type 5 Magazines Outdoor Type 5 magazines shall be weather-resistant, fire-resistant and theft-resistant. Over-the-road trucks or semi-trailers used as Type 5 magazines for temporary storage need not be fire-resistant. The ground around magazines shall slope away for drainage or other adequate drainage shall be provided.

When unattended, vehicular magazines shall have wheels removed or shall otherwise be effectively immobilized by kingpin locking devices or other methods approved by the Division.

(A) Construction: The doors or covers shall be constructed of solid wood or metal.

(B) Hinges & Hasps: Hinges and hasps shall be attached to the covers or doors by welding, riveting, or bolting (with nuts on the inside of the door). Hinges and hasps shall be installed so that they (C) Locks: Each door shall be equipped with 1 padlock having at least 5 tumblers and a casehardened shackle of at least 3/8-inch diameter. Indoor magazines located in secure rooms, that are locked as provided in this paragraph, may have each door or opening locked with 1 steel padlock (which need not be protected by a steel hood) having at least 5 tumblers and a casehardened shackle of at least 3/8-inch diameter, if the lock hinges and hasps are securely fastened to the magazine and to the door frame. These requirements do not apply to magazine doors that are adequately secured on the inside by means of a bolt, lock or bar that cannot be 4-4-6-2 Indoor Type 5 Magazines Indoor Type 5 magazines shall be theft-resistant. They need not be weather-resistant if the buildings in which they are stored provide protection from the weather. No indoor magazine may be located in a residence or dwelling. Indoor magazines containing quantities of blasting agents in excess of 50 pounds shall be subject to the American Table of Distances in Section 4-5-1 of this subpart.

(A) Construction: The doors or covers shall be constructed of wood or metal.

(B) Hinges and Hasps: Hinges and hasps shall be attached to the covers or doors by welding, riveting, or bolting (with nuts on the inside of the door). Hinges and hasps shall be installed so that they cannot be removed when the doors are closed and locked.

(C) Locks: Each door shall be equipped with 1 padlock having at least 5 tumblers and a casehardened shackle of at least 3/8-inch diameter.

Indoor magazines located in secure rooms that are locked as provided in this paragraph may have each door or opening locked with 1 steel padlock (which need not be protected by a steel hood) having at least 5 tumblers and a case-hardened shackle of at least 3/8-inch diameter if the lock hinges and hasps are securely fastened to the magazine and to the door frame. These requirements do not apply to magazine doors that are adequately secured on the inside by means of a bolt, lock or bar that cannot be actuated from the outside.

Section 4-5 Location of Magazines (A) Outdoor magazines in which high explosives are stored shall be located no closer to inhabited buildings, passenger railways, public highways or other magazines in which high explosives are stored than the minimum distances specified in the American Table of Distances for Storage of Explosive Materials in Table 4-5-1.

(B) Outdoor magazines in which low explosives are stored shall be located no closer to inhabited buildings, passenger railways, public highways or other magazines in which explosives are stored than the minimum distances specified in the American Table of Distances for Storage of Low Explosives in Table 4-5-2. The distances shown therein may not be reduced by the presence of barricades.

(C) Outdoor magazines in which blasting agents are stored shall be located no closer to inhabited buildings, passenger railways or public highways than the minimum distances specified in the American Table of Distances for Storage of Explosive Materials in Table 4-5-1.

(D) Ammonium nitrate and magazines in which blasting agents are stored shall be located no closer to magazines in which high explosives or other blasting agents are stored than the minimum distances specified in the American Table of Distances for the Separation of Ammonium Nitrate and Blasting Agents in Table 4-5-3. However, the minimum distances for magazines in which explosives and blasting agents are stored from inhabited buildings, passenger railways or public highways may not be less than the distances specified in the American Table of Distances for Storage of Explosive Materials in Table 4-5-1.

Table 4-5-1 American Table of Distances for Storage of Explosive Materials Quantity of Explosive Materials (1,2,3,4)

Distances in Feet Inhabited Buildings (9)

Public Highways with Traffic Volume of less than 3,000 Vehicles/Day (11)

Passenger Railways-Public Highways with Traffic Volume of more than 3,000 Vehicles/Day (10, 11)

Separation of Magazines (12)

Pounds Over Pounds Not Over Barricaded Unbarricaded 0 5 70 140 30 60 51 102 6 12 5 10 90 180 35 70 64 128 8 16 10 20 110 220 45 90 81 162 10 20 20 30 125 250 50 100 93 186 11 22 30 40 140 280 55 110 103 206 12 24 40 50 150 300 60 120 110 220 14 28 50 75 170 340 70 140 127 254 15 30 75 100 190 380 75 150 139 278 16 32 100 125 200 400 80 160 150 300 18 36 125 150 215 430 85 170 159 318 19 38 150 200 235 470 95 190 175 350 21 42 200 250 255 510 105 210 189 378 23 46 250 300 270 540 110 220 201 402 24 48 300 400 295 590 120 240 221 442 27 54 400 500 320 640 130 260 238 476 29 58 500 600 340 680 135 270 253 506 31 62 600 700 355 710 145 290 266 532 32 64 700 800 375 750 150 300 278 556 33 66 800 900 390 780 155 310 289 578 35 70 900 1,000 400 800 160 320 300 600 36 72 1,000 1,200 425 850 165 330 318 636 39 78 1,200 1,400 450 900 170 340 336 672 41 82 1,400 1,600 470 940 175 350 351 702 43 86 1,600 1,800 490 980 180 360 366 732 44 88 1,800 2,000 505 1,010 185 370 378 756 45 90 2,000 2,500 545 1,090 190 380 408 816 49 98 2,500 3,000 580 1,160 195 390 432 864 52 104 3,000 4,000 635 1,270 210 420 474 948 58 116 4,000 5,000 685 1,370 225 450 513 1,026 61 122 5,000 6,000 730 1,460 235 470 546 1,092 65 130 6,000 7,000 770 1,540 245 490 573 1,146 68 136 7,000 8,000 800 1,600 250 500 600 1,200 72 144 8,000 9,000 835 1,670 255 510 624 1,248 75 150 9,000 10,000 865 1,730 260 520 645 1,290 78 156 10,000 12,000 875 1,750 270 540 687 1,374 82 164 12,000 14,000 885 1,770 275 550 723 1,446 87 174 14,000 16,000 900 1,800 280 560 756 1,512 90 180 16,000 18,000 940 1,880 285 570 786 1,572 94 188 18,000 20,000 975 1,950 290 580 813 1,626 98 196 20,000 25,000 1,055 2,000 315 630 876 1,752 105 210 25,000 30,000 1,130 2,000 340 680 933 1,866 112 224 30,000 35,000 1,205 2,000 360 720 981 1,962 119 238 35,000 40,000 1,275 2,000 380 760 1,026 2,000 124 248 40,000 45,000 1,340 2,000 400 800 1,068 2,000 129 258 45,000 50,000 1,400 2,000 420 840 1,104 2,000 135 270 50,000 55,000 1,460 2,000 440 880 1,140 2,000 140 280 55,000 60,000 1,515 2,000 455 910 1,173 2,000 145 290 60,000 65,000 1,565 2,000 470 940 1,206 2,000 150 300 65,000 70,000 1,610 2,000 485 970 1,236 2,000 155 310 70,000 75,000 1,655 2,000 500 1,000 1,263 2,000 160 320 75,000 80,000 1,695 2,000 510 1,020 1,293 2,000 165 330 80,000 85,000 1,730 2,000 520 1,040 1,317 2,000 170 340 85,000 90,000 1,760 2,000 530 1,060 1,344 2,000 175 350 90,000 95,000 1,790 2,000 540 1,080 1,368 2,000 180 360 95,000 100,000 1,815 2,000 545 1,090 1,392 2,000 185 370 100,000 110,000 1,835 2,000 550 1,100 1,437 2,000 195 390 110,000 120,000 1,855 2,000 555 1,110 1,479 2,000 205 410 120,000 130,000 1,875 2,000 560 1,120 1,521 2,000 215 430 130,000 140,000 1,890 2,000 565 1,130 1,557 2,000 225 450 140,000 150,000 1,900 2,000 570 1,140 1,593 2,000 235 470 150,000 160,000 1,935 2,000 580 1,160 1,629 2,000 245 490 Table 4-5-1 American Table of Distances for Storage of Explosive Materials Quantity of Explosive Materials (1,2,3,4)

Distances in Feet Inhabited Buildings (9)

Public Highways with Traffic Volume of less than 3,000 Vehicles/Day (11)

Passenger Railways-Public Highways with Traffic Volume of more than 3,000 Vehicles/Day (10, 11)

Separation of Magazines (12)

Pounds Over Pounds Not Over Barricaded Unbarricaded 160,000 170,000 1,965 2,000 590 1,180 1,662 2,000 255 510 170,000 180,000 1,990 2,000 600 1,200 1,695 2,000 265 530 180,000 190,000 2,010 2,010 605 1,210 1,725 2,000 275 550 190,000 200,000 2,030 2,030 610 1,220 1,755 2,000 285 570 200,000 210,000 2,055 2,055 620 1,240 1,782 2,000 295 590 210,000 230,000 2,100 2,100 635 1,270 1,836 2,000 315 630 230,000 250,000 2,155 2,155 650 1,300 1,890 2,000 335 670 250,000 275,000 2,215 2,215 670 1,340 1,950 2,000 360 720 275,000 300,000 2,275 2,275 690 1,380 2,000 2,000 385 770 Table: American Table of Distances for Storage of Explosive Materials as Revised and Approved by the Institute of Makers of Explosives – June 1991 Table 4-5-2 Table of Distance for the Storage of Low Explosives Quantity of Explosives (In Pounds) Distance in Feet Over Not Over From Inhabited Buildings From Public Railways and Highways From Above Ground Magazine 0 1,000 75 75 50 1,000 5,000 115 115 75 5,000 10,000 150 150 100 10,000 20,000 190 190 125 20,000 30,000 215 215 145 30,000 40,000 235 235 155 40,000 50,000 250 250 165 50,000 60,000 260 260 175 60,000 70,000 270 270 185 70,000 80,000 280 280 190 80,000 90,000 295 295 195 90,000 100,000 300 300 200 100,000 200,000 375 375 250 200,000 300,000 450 450 300 Table: Department of Defense Ammunition and Explosives Standards, Table 5–4.1 Extract; 4145.27 M, March 1969 Table 4-5-3 Table of Separation Distances of Ammonium Nitrate and Blasting Agents from Explosives or Blasting Agents 1,6 Donor Weight Minimum Separation Distance of Acceptor when Barricaded (ft.)

Pounds Over Pounds Not Over Ammonium Nitrate Blasting Agent Minimum Thickness of Artificial Barricades (in.) 100 3 11 12 100 300 4 14 12 300 600 5 18 12 600 1,000 6 22 12 1,000 1,600 7 25 12 1,600 2,000 8 29 12 2,000 3,000 9 32 15 3,000 4,000 10 36 15 4,000 6,000 11 40 15 6,000 8,000 12 43 20 8,000 10,000 13 47 20 10,000 12,000 14 50 20 12,000 16,000 15 54 25 16,000 20,000 16 58 25 20,000 25,000 18 65 25 25,000 30,000 19 68 30 30,000 35,000 20 72 30 35,000 40,000 21 76 30 40,000 45,000 22 79 35 45,000 50,000 23 83 35 50,000 55,000 24 86 35 55,000 60,000 25 90 35 60,000 70,000 26 94 40 70,000 80,000 28 101 40 80,000 90,000 30 108 40 90,000 100,000 32 115 40 100,000 120,000 34 122 50 120,000 140,000 37 133 50 140,000 160,000 40 144 50 160,000 180,000 44 158 50 180,000 200,000 48 173 50 200,000 220,000 52 187 60 220,000 250,000 56 202 60 250,000 275,000 60 216 60 275,000 300,000 64 230 60 Table: National Fire Protection Association (NFPA) Official Standard No. 492, 1968 Explanatory Notes Essential to the Application of the American Table of Distances for Storage of Explosive Materials NOTE 1 “Explosive materials” means explosives, blasting agents and detonators.

NOTE 2 “Explosives” means any chemical compound, mixture, or device, the primary or common

purpose of which is to function by explosion. For quantity and distance purposes, detonating cord of 50 grains per foot should be calculated as equivalent to 8 lbs. of high explosives per 1,000 feet. Heavier or lighter core loads should be rated proportionately.

NOTE 3 “Blasting agents” means any material or mixture, consisting of fuel and oxidizer, intended for blasting, not otherwise defined as an explosive provided that the finished product as mixed for use or shipment, cannot be detonated by means of a No.8 test blasting cap when unconfined.

NOTE 4 “Detonator” means any device containing any initiating or primary explosive that is used for initiating detonation. A detonator may not contain more than 10 grams of total explosives by weight, excluding ignition or delay charges. The term includes, but is not limited to, electric blasting caps of instantaneous and delay types, electronic detonators, blasting caps for use with safety fuses, detonating cord delay connectors, and non-electric instantaneous and delay blasting caps which use detonating cord, shock tube, or any other replacement for electric leg wires. All types of detonators in strengths through No.8 cap should be rated at 1 1/2 lbs. of explosives per 1,000 caps. For strengths higher than No.8 cap consult the manufacturer.

NOTE 5 “Magazine” means any building, structure, or container, other than an explosives manufacturing building, approved for the storage of explosive materials.

NOTE 6 “Natural Barricade” means natural features of the ground such as hills, or timber of sufficient density that the surrounding exposures which require protection cannot be seen from the magazine when the trees are bare of leaves.

NOTE 7 “Artificial Barricade” means an artificial mound or wall of earth of a minimum thickness of three feet.

NOTE 8 “Barricaded” means the effective screening of a building containing explosive materials from the magazine or other building, railway, or highway by a natural or an artificial barrier.

A straight line from the top of any sidewall of the building containing explosive materials to the eave line of any magazine or other building or to a point twelve feet above the center of a railway or highway shall pass through such barrier.

NOTE 9 “Inhabited Building” means a building regularly occupied in whole or part as a habitation for human beings, or any church, schoolhouse, railroad station, store, or other structure where people are accustomed to assemble, except any building or structure occupied in connection with the manufacture, transportation, storage or use of explosive materials.

NOTE 10 “Railway” means any steam, electric, or other railroad or railway which carries passengers for hire.

NOTE 11 “Highway” means any public street, public alley, or public road.

NOTE 12 When two or more storage magazines are located on the same property, each magazine must comply with the minimum distances specified from inhabited buildings, railways and highways, and, in addition, they should be separated from each other by not less than the distances shown for “Separation of Magazines,” except that the quantity of explosive materials contained in detonator magazines shall govern in regard to the spacing of said detonator magazines from magazines containing other explosive materials. If any two or more magazines are separated from each other by less than the specified “Separation of Magazines” distances, then such two or more magazines, as a group, must be considered as one magazine, and the total quantity of explosive materials stored in such group must be treated as if stored in a single magazine located on the site of any magazine of the group, and must comply with the minimum of distances specified from other magazines, inhabited buildings, railways, and highways.

NOTE 13 Storage in excess of 300,000 lbs. of explosive materials, in one magazine is generally not required for commercial enterprises.

NOTE 14 This Table applies only to the manufacture and permanent storage of commercial explosive materials. It is not applicable to transportation of explosives or any handling or temporary storage necessary or incident thereto. It is not intended to apply to bombs, projectiles, or other heavily encased explosives.

NOTE 15 When a manufacturing building on an explosive materials plant site is designed to contain explosive materials, such building shall be located from inhabited buildings, public highways and passenger railways in accordance with the American Table of Distances based on the maximum quantity of explosive materials permitted to be in the building at one time.

American Table of Distances The American Table of Distances applies to the manufacture and permanent storage of commercial explosive materials. The distances specified are those measured from the explosive materials storage facility to the inhabited building, highway or passenger railway, irrespective of property lines.

The American Table of Distances covers all commercial explosive materials, including, but not limited to, high explosives, blasting agents, detonators, initiating systems and explosives materials in process. The Table is not designed to be altered or adjusted to accommodate varying explosive characteristics such as blast effect, weight strength, density, bulk strength, detonation velocity, etc.

The American Table of Distances should not be used to determine safe distances for blasting work, the firing of explosive charges for testing or quality control work, or the open detonation of waste explosive materials. The American Table of Distances may be utilized as a guide for developing distances for the unconfined, open burning of waste explosive materials where the probability of transition from burning to high order detonation is improbable.

Notes to Table of Recommended Separation Distances of Ammonium Nitrate and Blasting Agents from Explosives or Blasting Agents NOTE 1 Recommended separation distances to prevent explosion of ammonium nitrate and ammonium nitrate-based blasting agents by propagation from nearby stores of high explosives or blasting agents referred to in the Table as the “donor.” Ammonium nitrate, by itself, is not considered to be a donor when applying this Table. Ammonium nitrate, ammonium nitrate-fuel oil or combinations thereof are acceptors. If Stores of ammonium nitrate are located within the sympathetic detonation distance of explosives or blasting agents, one-half the mass of the ammonium nitrate should be included in the mass of the donor.

NOTE 2 When the ammonium nitrate and/or blasting agent is not barricaded, the distances shown in the Table shall be multiplied by six. These distances allow for the possibility of high velocity metal fragments from mixers, hoppers, truck bodies, sheet metal structures, metal containers, and the like which may enclose the “donor.” Where storage is in bullet-resistant magazines is recommended for explosives or where the storage is protected by a bullet-resistant wall, distances and barricade thicknesses in excess of those prescribed in the American Table of Distances are not required.

NOTE 3 The distances in the Table apply to ammonium nitrate and ammonium nitrate based materials that show “negative” (-) result in the UN Test Series 2 Gap Test and show “positive” (+) result in the UN Test Series 1 Gap Test. Ammonium nitrate and ammonium nitrate based materials that are DOT hazard Class 1 sensitive shall be stored at separation distances determined by the American Table of Distances.

NOTE 4 These distances apply to blasting agents which pass the insensitivity test prescribed in regulations of the U.S. Department of Transportation and the U.S. Department of the Treasury, Bureau of Alcohol, Tobacco and Firearms.

NOTE 5 Earth, or sand dikes, or enclosures filled with the prescribed minimum thickness of earth or sand are acceptable artificial barricades. Natural barricades, such as hills or timber of sufficient density that the surrounding exposures which require protection cannot be seen from the “donor” when the trees are bare of leaves, are also acceptable.

NOTE 6 For determining the distances to be maintained from inhabited buildings, passenger railways, and public highways, use the American Table of Distances for Storage of Explosives Materials on pages 58 and 59. *For construction of bullet-resistant magazines see Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury, Publication ATF P 5400.7 (9/00), ATF-Explosives Law and Regulations.

ARTICLE 5 TRANSPORTATION OF EXPLOSIVES

Section 5-1 General Requirements (A) Transportation of explosives, blasting agents, and blasting supplies on public highways, railways, and airways shall be in accordance with the provisions of Title 42 Article 20 C.R.S. and any regulations promulgated pursuant thereto and Title 49 CFR Parts 171-179 and Parts 390-397, Motor Carriers.

(B) Requirements for the transportation of explosives, blasting agents and blasting supplies by motorized vehicle or conveyance on job sites shall be:

(1) No person shall smoke, carry matches or any other flame-producing device or carry firearms or loaded cartridges while in or near a motor vehicle or conveyance transporting (2) No person shall drive, load or unload a vehicle or conveyance transporting explosives in a careless or reckless manner.

(3) Vehicles or conveyances transporting explosives, blasting agents or blasting supplies shall not be taken inside a garage or shop for repairs or servicing.

(4) Vehicles or conveyances used for transporting explosives shall be equipped to carry the load without difficulty and shall be in good mechanical condition.

(5) A motor vehicle or conveyance used for transporting explosives shall be given the following inspection prior to the transportation to determine that it is in proper condition for the safe transportation of explosives:

(i) Fire extinguishers shall be filled and in proper working order;

(ii) All electrical wiring shall be completely protected and securely fastened to prevent short-circuiting;

(iii) Chassis, motor, pan and underside of body shall be completely free of excess oil and grease;

(iv) Fuel tank and fuel line shall be secure and have no leaks;

(v) Brakes, lights, horn, windshield wipers and steering apparatus shall function properly;

(vi) Tires shall be checked for proper inflation and defects; and (vii) The vehicle shall be in proper condition in every other respect and acceptable for handling explosives.

(6) All vehicles or conveyances used for transporting explosives shall have tight floors, and any exposed spark-producing metal on the inside of the body shall be covered with wood or other non-sparking materials to prevent contact with packages of explosives.

(7) Packages of explosives or blasting agents shall not be loaded above the sides of an open- body vehicle or conveyance.

(8) Explosives shall not be transported with other materials or cargoes in the same compartment. In no case shall flammable materials be carried on the same vehicle as explosives, with the exception of desensitizing agents.

(9) Each vehicle or conveyance used for transportation of explosives shall be equipped with at least one charged fire extinguisher each with an extinguisher rating of at least 4- A:10B:C. Extinguishers shall be located where they will be accessible for immediate use.

(10) Explosives shall be transferred from a disabled vehicle or conveyance to another vehicle or conveyance only when proper and qualified supervision is provided. Local fire departments and police departments shall be notified if a transfer occurs in a congested area. In remote areas, they shall be notified if appropriate.

(11) A motorized vehicle or conveyance which contains explosives or detonators shall not be parked under any of the following circumstances:

(i) On or within 5 feet of the traveled portion of a public street or highway; or (ii) Within 300 feet of a bridge, tunnel, building, or place where people work, assemble, or congregate, except for brief periods when the necessities of operation require the vehicle or conveyance to be parked and make it impracticable to park the vehicle or conveyance in any other place.

(12) A motorized vehicle or conveyance transporting explosives, detonators, or blasting agents shall not be left unattended.

(13) A motorized vehicle or conveyance shall be deemed attended only when the driver or other attendant is physically on or in the vehicle or conveyance, or has the vehicle or conveyance within the driver or attendant’s field of vision and can reach the vehicle or conveyance quickly and without any kind of interference; attended also means the driver or attendant is awake, alert, and not engaged in any other duties or activities which may divert his/her attention from the vehicle or conveyance.

(14) Detonators may not be transported in the same vehicle or conveyance with other explosives unless:

(i) The detonators and explosives are placed in separate locked Type 2 magazines secured within the body of the vehicle or conveyance;

(ii) The detonators and explosives are placed in a suitable locked container and separated by 4 inches of hardwood and the detonators are totally enclosed or confined by the hardwood construction;

(iii) The detonators and explosives are placed in separate locked containers or container compartments constructed in accordance with the Institute of Makers of Explosives Safety Library Publication No. 22, “IME Standard for the Safe Transportation of Detonators in a Vehicle with Other Explosives”; or (iv) The detonators and explosives are placed in separate locked Type 3 magazines.

(C) Requirements for the transportation of explosives, blasting agents and blasting supplies to blasting areas by non-motorized means shall be:

(1) Explosives and blasting agents shall be carried in day boxes, original containers or shall be placed in bags or containers that are water-resistant and constructed of non-sparking and nonconductive material.

(2) Detonators shall be wrapped in suitable padding and carried in separate bags or containers from other explosives.

ARTICLE 6 USE OF EXPLOSIVE MATERIALS

Section 6-1 General Requirements (A) While explosives are being handled or used, smoking, matches or any other source of fire or flame shall not be within 50 feet of the blast site.

(B) No person shall handle explosives while under the influence of intoxicating liquors, narcotics, or other dangerous drugs. This rule does not apply to persons taking prescription drugs and/or narcotics as directed by a physician providing such use shall not endanger the worker or others.

(C) When blasting is done in populated or residential areas or in close proximity to a structure, railway, or highway or any other installation that may be damaged, the following precautions shall be taken:

(1) The blast shall be covered, before firing, with a mat or material that is capable of preventing fragments from being thrown;

(2) The blast shall be loaded in compliance with the Table of Scaled Distance (Table 6-10) or be monitored by a seismograph; and (3) All persons within the blast area shall be given reasonable notification prior to blasting operations and informed as to the type of warning signal that will be given prior to the blast.

(D) Blasters conducting blasting operations shall take every reasonable precaution, including but not limited to warning signals, flags and barricades to insure the safety of the general public and workers.

(E) Surface blasting operations shall be conducted during periods of daylight, when the blast area is clearly visible. Blasting operations conducted after periods of daylight shall be approved by the Division and local law enforcement agency prior to each blast. Approval shall only be granted if such approval serves the safety of the general public.

(F) The blaster shall perform all required notification to and obtain all required permits from local jurisdictions or authorities, including, but not limited to, the County Sheriff, local fire districts and fire departments before beginning blasting operations.

(G) Whenever blasting is being conducted in the vicinity of gas, electric, water, fire alarm, telephone, telegraph, steam utilities or transportation corridors, the blaster shall notify the appropriate transportation or utility representatives at least 24 hours in advance of blasting, specifying the location and intended time of such blasting.

(H) The blaster shall suspend all blasting operations and remove all persons from the blast site during the approach and progress of an electrical storm.

(I) No fire shall be fought where the fire is in imminent danger of contact with explosives. All employees shall be removed to a safe area and the fire area guarded against intruders.

(J) Detonators or other explosives shall never be carried in pockets of clothing.

(K) Detonators shall not be inserted in explosive materials that do not have a cap well without first making a hole in the cartridge with a non-sparking punch of proper size, or the appropriate pointed handle of a cap crimper.

(L) The detonator shall be secured within the primer so that no tension is placed on the leg wires, safety fuse, shock tube, plastic tubing or detonating cord at the point of entry into the detonator.

(M) The detonator shall be fully inserted into the primer cartridge or booster and shall not protrude from the cartridge.

(N) Cast primers and boosters shall not be used if the hole is too small for the detonator, and attempting to enlarge the hole in a cast primer or booster shall not be permissible.

(O) Primers are not to be prepared in a magazine or near large quantities of explosive materials.

(P) Explosives and blasting agents shall be kept separated from detonators until the charge is placed.

(Q) Only non-sparking metallic slitters may be used for opening fiberboard cases.

(R) Cartridges or packages of explosives showing signs of discoloration or deterioration must be carefully set aside and properly disposed of in accordance with manufacturer’s recommendations.

(S) No explosive material shall be abandoned or left in any location for any reason, nor left in such a manner that they may easily be obtained by children or other unauthorized persons. All unused explosives shall be returned to proper storage facilities.

(T) A record of each blast shall be kept. All records, including seismograph reports, shall be retained at least five years, be available for inspection by the Division, and contain at least the following minimum data, as applicable:

(1) Person for whom blasting operations are conducted (2) Name, permit number, and signature of the blaster (3) Exact location or address of the blast, date and time of detonation (4) Type of material blasted (5) Number of holes, burden and spacing (6) Diameter and depth of holes (7) Types of explosives used (8) Amount and type of explosive loaded in each borehole or used in each charge (9) Total amount of each explosive used (10) Maximum amount of explosives and holes detonated within 8 milliseconds (11) Method of firing and type of circuit (12) Direction, distance in feet, and identification of the nearest dwelling, house, public building, school, church, commercial or institutional building neither owned nor leased by the person or company conducting the blasting (13) Weather conditions (14) Type and height or length of stemming (15) A statement as to whether mats or protection against flyrock were used (16) Type of delay caps used and delay periods used (17) The person taking the seismograph reading shall accurately indicate exact location of the seismograph if used and shall show the distance of the seismograph from the blast (18) Seismograph records, where required, which shall include:

(i) Name of person and firm analyzing the seismograph record; and (ii) Seismograph reading.

(19) Sketch of blast pattern including number of holes, burden and spacing distance, delay pattern, and if decking is used, a hole profile.

Section 6-2 Drilling and Loading (A) Procedures that permit safe and efficient loading shall be established before the loading of explosive materials is started.

(B) All boreholes shall be sufficiently large to admit freely the insertion of the cartridges of explosives.

(C) Tamping shall be done only with wooden rods or with approved plastic tamping poles without exposed metal parts, but non-sparking metal connectors may be used for jointed poles. Violent tamping shall be avoided. The primer shall never be tamped.

(D) No boreholes shall be loaded except those to be fired in the next round of blasting. After loading, all remaining explosive materials shall be immediately returned to magazines or day boxes.

(E) No explosives or blasting agents shall be left unattended on a blast site.

(F) Drilling shall not be started until all remaining butts of old boreholes are examined for unexploded charges, and if any are found, they shall be refired or removed before work proceeds.

(G) No person shall be allowed to deepen boreholes that have contained explosives or blasting agents.

(H) Drilling shall not be conducted where there is a danger of intersecting a loaded borehole or misfired explosive material.

(I) Equipment, machines and all tools not used for loading explosives into boreholes shall be removed from the immediate location of boreholes being loaded with explosives. Equipment shall not be operated within 50 feet of loaded boreholes except when equipment is needed to add cover or mats.

(J) Loaded boreholes shall not be left unattended.

(K) The Type I permittee shall maintain an accurate, up-to-date record of explosives, blasting agents and all blasting supplies used in a blast and shall keep an accurate running inventory of all explosives and blasting agents stored on the operation.

(L) Pneumatic loading of blasting agents into blast holes primed with electric detonators or other static-sensitive initiation systems shall conform to the following requirements:

(1) A positive grounding device for the equipment shall be used to prevent the accumulation of static electricity.

(2) A semi-conductive hose shall be used.

(3) A qualified person shall evaluate all systems to assure that they will adequately dissipate static under potential field conditions.

(M) Primers shall be made up immediately prior to placing the primer in the borehole.

(N) Dropping or pushing a primer or any explosive with a lighted fuse attached into a borehole is prohibited.

(O) Detonators shall not be loaded into a hot hole or exposed to temperatures above 150° F unless specifically designed and approved by the manufacturer for higher temperatures.

Section 6-3 Electric Initiation of Blasts (A) Electric detonators may be used for blasting operations in congested districts, or on highways, or adjacent to highways open to traffic, except where sources of extraneous electricity make such use dangerous.

(B) Electric detonator wires shall be kept short-circuited (shunted) until they are connected into the circuit for firing.

(C) Signs shall be posted warning against the use of mobile radio transmitters on all adjacent highways and roads.

(D) Mobile radio transmitters that are less than 100 feet away from electric detonators shall be deenergized and effectively locked when the detonators are not in the original containers.

(E) Electric detonators shall be used in compliance with the recommendations of IME with regard to blasting in the vicinity of radio transmitters as stipulated in Safety Guide for the Prevention of Radio Frequency Radiation Hazards in the Use of Commercial Electric Detonators (Blasting Caps), IME Safety Library Publication No. 20, December 2011.

(F) Precautions in accordance with the recommendations of IME with regard to blasting in the vicinity of radio transmitters as stipulated in Safety Guide for the Prevention of Radio Frequency Radiation Hazards in the Use of Commercial Electric Detonators (Blasting Caps), IME Safety Library Publication No. 20, December 2011 shall be taken to prevent accidental discharge of electric detonators from current induced by radar, cellular telephones, radio transmitters, battery contact, lightning, adjacent power lines, static electricity, dust storms, blowing snow or other sources of extraneous electricity.

(G) Before adopting any system of electrical firing, the blaster shall conduct a thorough survey for extraneous currents, and all dangerous currents shall be eliminated before any holes are loaded.

(H) In any single blast using electric detonators, all detonators shall be of the same style or function and be of the same manufacture.

(I) Electric blasting shall be carried out by using blasting circuits or power circuits, in accordance with the electric detonator manufacturer’s recommendations.

(J) The firing line shall be checked with an approved testing device at the terminals before being connected to the blasting machine or other power source.

(K) The circuit, including all detonators, shall be tested with an approved testing device before being connected to the firing line.

(L) When firing a circuit of electric detonators, care shall be exercised to ensure that an adequate quantity of delivered current is available, in accordance with the manufacturer’s recommendation.

(M) Connecting wires and lead wires shall be insulated single solid wires of sufficient current- carrying capacity and shall not be less than #20 gauge (American wire gauge) solid core insulated wire.

(N) Firing line or leading wires shall be solid single wires of sufficient current carrying capacity, and shall be not less than #14 gauge (American wire gauge) solid core insulated wire. Bus wires depend on the size of the blast, but #14 gauge (American wire gauge) copper is recommended.

(O) The ends of lead wires which are to be connected to a firing device shall be shorted by twisting them together or otherwise connecting them before they are connected to the leg wires or connecting wires, and they shall be kept in the possession of the person who is doing the loading until loading is completed and the leg wires attached. Lead wires shall not be attached to the firing device until the blaster is ready to fire the shot and must be attached by the blaster.

(P) The ends of the leg wires on electric detonators shall be shorted in a similar manner and not separated until all holes are loaded and the loader is ready to connect the leg wires to the connecting wires or lead wires.

(Q) When firing electrically, the insulation on all firing lines shall be adequate and in good condition.

(R) A power circuit used for firing electric detonators shall not be grounded.

(S) When firing from a power circuit, the firing switch shall be locked in the open or “off” position at all times, except when firing. It shall be so designed that the firing lines to the cap circuit are automatically short-circuited when the switch is in the ‘off’ position. Keys to this switch shall be entrusted only to the blaster.

(T) Blasting machines shall be in good condition and the efficiency of the machine shall be tested periodically to make certain that it can deliver power at its rated capacity.

(U) When firing with blasting machines, the connections shall be made as recommended by the manufacturer of the electric detonators used.

(V) The number of electric detonators connected to a blasting machine shall not be in excess of its rated capacity. A series or circuit shall contain no more detonators than the limits recommended by the manufacturer of the electric detonators in use.

(W) The blaster shall be in charge of the blasting machines, and no other person shall connect the leading wires to the machine.

(X) Blasters, when testing circuits to charged holes, shall use only blasting testers especially designed for this purpose.

(Y) In electrical firing, only the person making leading wire connections shall fire the shot. All connections shall be made from the borehole back to the source of firing current, and the lead line wires shall remain shorted and not be connected to the blasting machine or other source of current until the charge is to be fired.

(Z) After firing an electric blast from a blasting machine, the leading wires shall be immediately disconnected from the machine and short-circuited.

(AA) When electric detonators have been used, workers shall not return to misfired holes for at least thirty minutes.

Section 6-4 Safety Fuse Initiation of Blasts (A) A safety fuse that is deteriorated or damaged in any way shall not be used.

(B) The hanging of safety fuse on nails or other projections which will cause a sharp bend to be formed in the fuse is prohibited.

(C) Before assembling fuse detonators and safety fuse, a short length shall be cut from the end of the supply reel so as to assure a fresh cut end in each fuse detonator.

(D) Only cap crimpers specifically designed for the purpose of crimping caps shall be used for attaching fuse detonators to safety fuse. Crimpers shall be kept in good repair and accessible for use.

(E) No fuse detonators and safety fuse shall be assembled, or primers made up, in any magazine or near any possible source of ignition or initiation.

(F) The assembly of fuse detonators, safety fuse and making of primers shall only be done in a place selected for this purpose and at least 100 feet away from any storage magazine.

(G) The burning rate of the safety fuse in use at any time shall be measured, posted in conspicuous locations, and brought to the attention of all workers concerned with blasting.

(H) New rolls of fuse shall be tested for burn rate prior to use and all partial rolls shall be tested at least every 30 days. A record of the burn rate shall be kept by the permittee.

(I) The length of safety fuse shall be in accordance with the manufacturer’s recommendations. In no case shall the length of fuse be less than 3 feet and shall not have a burn time of less than 120 seconds at the time of initiation.

(J) Lighting of safety fuse shall be done with hot wire lighters, pull-wire lighters, thermalite connectors, or igniter cord and thermalite connectors.

(K) Matches, cigarette lighters, cigarettes, pipes, cigars or other unsafe means shall not be used to ignite safety fuse.

(L) Igniters shall be used in accordance with the manufacturer’s recommendations and shall not be attached to a safety fuse until the charge is at the blast site and the crew is fully prepared to light the charge.

(M) At least two persons shall be present when fuse detonator and safety fuse blasting is done by hand-lighting methods.

(N) When blasting with safety fuses, consideration shall be given to the length and burning rate of the safety fuse and shall be used in accordance with the manufacturer’s recommendations. A sufficient time of not less than 120 seconds, with a margin of safety, shall always be provided for the blaster to reach a place of safety.

(O) No more than 12 safety fuses shall be lit by each blaster when hand lighting devices are used.

However, when two or more safety fuses in a group are lit as one by means of igniter cord or other similar fuse-lighting devices, they may be considered as one fuse.

(P) Fuse detonators and safety fuse shall not be used for firing mud cap charges unless charges are separated sufficiently to prevent one charge from dislodging other shots in the blast.

(Q) Only sufficient primers for one day’s use shall be made up at a time.

(R) Any loose cartridges of explosives, detonators, primers and assembled fuse detonators and safety fuse unused at the end of the shift shall be returned to their respective and separate magazines and locked up.

(S) Safety fuse shall not be used in blasting operations in populated areas, public areas, on highways or adjacent to roads open to traffic.

(T) When the fuse lighter has been ignited, the blaster shall assume initiation of the safety fuse has occurred.

(U) If the safety fuse does not show evidence of initiation, the blaster shall not attempt any further initiation and retreat to a safe location for at least one hour.

(V) When safety fuse is used, workers shall not return to a misfire for at least one hour.

(W) If explosives are suspected of burning, all persons in the endangered area shall move to a safe location and no one shall return to the area for at least one hour after signs of burning have ceased.

Section 6-5 Non-electric Initiation of Blasts (A) Blasters shall be familiar with and follow the manufacturer’s warnings and instructions, especially hook-up and safety precautions.

(B) Operations shall be discontinued during the approach and progress of electrical storms.

(C) Non-electric leads shall not be held during firing.

(D) Primary initiators shall not be attached to the round or shot until after all the connections have been made and the blasting area has been cleared.

(E) Non-electric delay connectors shall not be exposed to excessive impact, friction, flame, electrical discharge, static electricity or lightning.

(F) Delay detonators shall not be disassembled from the plastic connector block, nor shall the delay detonators be used without the block.

(G) Shock tube connections shall be at right angles to detonating cord.

(H) Connections with other initiation devices shall be secured in a manner that provides for uninterrupted propagation.

(I) Factory made units shall be used as assembled and shall not be cut except that a single splice is permitted on the lead-in trunkline during dry conditions.

(J) No tool shall be used to pry on any component containing a detonator, nor shall any tool be used to open, fasten or clean out any connector containing a detonating device.

(K) Care shall be taken to ensure that a vehicle is not driven over the tubing, connectors or any surface delay component.

(L) In multiple row blasts, the initiation system shall not be connected from row to row until all drilling and loading has been completed. In single row blasts, the components shall not be connected from hole to hole until all drilling and loading has been completed.

(M) A safety line consisting of trunkline or other non-electric tubing shall be connected to the last hole in each row and shall extend beyond the area of cover in a covered or matted blast and shall be used to check for complete detonation of each row.

(N) Before firing the shot, the blaster shall visually inspect and verify that all connections in the initiation system are made in accordance with the manufacturer’s recommendations.

Section 6-6 Use of Detonating Cord (A) Care shall be taken to select a detonating cord consistent with the type and physical condition of the borehole and stemming and the type of explosives used.

(B) Detonating cord shall be handled and used with the same respect and care given other (C) If using a detonating type cord for blasting, the double-trunkline or loop systems shall be used.

(D) In multiple-row blasts, the trunkline layout shall be designed so that the detonation can reach each blast hole from at least two directions.

(E) All detonating cord knots shall be tight and all connections shall be kept at right angles to the trunklines.

(F) The line of detonating cord extending out of a borehole or from a charge shall be cut from the supply spool before loading the remainder of the bore hole or placing additional charges.

(G) Detonating cord shall be handled and used with care to avoid damaging or severing the cord during and after loading and hooking-up.

(H) Detonating cord connections shall be made in accordance with the manufacturer’s recommended methods. Knot-type or other cord-to-cord connections shall be made only with detonating cord in which the explosive core is dry.

(I) Detonating cord shall be cut with a sharp knife, razor blade or cutters designed for use with detonating cord. Scissors or plier type cutters shall not be used.

(J) All detonating cord trunklines and branch lines shall be free of loops, sharp kinks, or angles that direct the cord back toward the oncoming line of detonation.

(K) All detonating cord connections shall be inspected before firing the blast.

(L) When detonating cord millisecond-delay connectors or short-interval-delay electric detonators are used with detonating cord, the practice shall conform strictly to the manufacturer’s recommendations.

(M) When connecting a detonator to detonating cord, the detonator shall be taped or otherwise attached securely along the side or the end of the detonating cord, with the end of the detonator containing the explosive charge pointed in the direction in which the detonation is to proceed.

(N) When initiating detonating cord with fuse detonators and safety fuse, two fuse detonators shall be required.

(O) Detonators for firing the trunkline shall not be brought to the loading area nor attached to the detonating cord until the area has been cleared for the blast.

Section 6-7 Electronic Initiation of Blasts (A) Permittees shall be trained in the manufacturer’s procedures for use of electronic detonators and shall follow the manufacturer’s warnings and instructions, especially hook-up and safety precautions.

(B) Test equipment and blasting machines designed for use with electric detonators shall not be used with electronic detonators.

(C) Manufacturer’s recommended practices shall be followed to protect electronic detonators from electromagnetic, radio frequency or other electrical interference sources.

(D) Electronic detonators shall only be fired with the equipment and procedures recommended by the (E) Electric detonators and electronic detonators shall not be used in the same blast, even when made by the same manufacturer, unless the manufacturer approves such use.

(F) Test equipment and blasting machines that are designed for electronic detonators shall not be used with electric detonators.

(G) Electronic detonator wires, connectors, coupling devices, shock tube or other components shall be protected from mechanical abuse and damage.

(H) Electronic detonators of different types and/or versions shall not be used in the same blast, even if made by the same manufacturer, unless such use is approved by the manufacturer.

(I) Equipment or electronic detonators that appear to be damaged or poorly maintained shall not be used.

(J) Only blasting machines, testers, or instruments that are specifically designed for the electronic detonator system shall be used.

(K) Never mix or use electronic detonators and equipment made by different manufacturers.

(L) The handling or use of electronic detonators shall be discontinued during the approach and progress of an electrical storm. Personnel must be withdrawn from the blast area and moved to a safe location.

(M) Electronic detonator systems shall not be exposed to or used in operational temperature and pressure ranges outside those specified by the manufacturer.

(N) Electronic detonators shall never be tested or programmed in a booster, cartridge or other explosive component (primer assembly) before it has been deployed in the borehole or otherwise loaded for final use.

(O) An electronic detonator shall not be held while it is being tested or programmed.

Section 6-8 Firing the Blast (A) It shall be the duty of the blaster to determine the time of blasting. The blaster shall conduct all blasting operations and no shot shall be fired without the blaster’s presence and approval.

(B) All blasting in congested areas or in close proximity to a structure, railway, highway or any other installation where the blasting may cause injury or damage by flying rock shall be covered with blasting mats or other protective material before firing.

(C) All persons within the blasting area shall be notified of the time of the blast and moved to a safe distance or under sufficient cover. Guards shall be posted to prevent entry into the blast area.

(D) All surplus explosive materials shall be removed to a safe location before blasting.

(E) Flaggers shall be safely posted on highways that pass through the danger zone so as to stop traffic during blasting operations.

(F) Guards shall be posted around the perimeter of the blasting area to prevent unauthorized entry into the blast area. Either visual or verbal communication must be possible between guards.

(G) Before the blast is fired, the warning signal shall be given by the blaster in charge or the individual designated by the blaster in charge.

(H) An inspection of the blast area to determine if all charges have detonated shall be done by the blaster before guards and flaggers are cleared by the blaster to leave their posts.

Section 6-9 Misfires (A) The blaster shall provide proper safeguards for excluding all unauthorized persons from the danger zone if a misfire is found.

(B) No other work shall be performed except what is necessary to remove the hazard of the misfire and only those employees necessary to perform the work shall remain in the danger zone.

(C) Explosives shall not be extracted from a hole that has misfired unless it is impossible or hazardous to detonate any unexploded explosive materials by insertion of an additional primer.

(D) If there are any misfires while using fuse detonators and safety fuse, all employees shall remain away from the charge for at least one hour. Misfires shall be handled under the direction of the person in charge of the blasting. All fuses shall be carefully traced and a search made for the unexploded charges.

(E) When electric detonators have been used, workers shall not return to the blast area for at least 30 minutes unless the manufacturer recommends additional time before returning to the blast area.

All wires shall be carefully traced and a search made for unexploded charges.

(F) When a completely non-electric initiation system, other than safety fuse, has been used, all employees shall remain away from the blast area for at least 15 minutes. All shock tubes shall be traced and a search made for unexploded charges.

(G) When electronic detonators have been used, workers shall not return to the blast area for at least 30 minutes unless the manufacturer recommends additional time before returning to the blast area.

(H) If explosives are suspected of burning in a hole, all persons in the endangered area shall move to a safe location and no one shall return to the hole for at least one hour after evidence of combustion ceases.

(I) No drilling, digging or picking shall be permitted until all missed holes have been detonated or the blaster in charge has approved that work can proceed.

(J) Explosive materials recovered from misfires shall not be reused and shall be disposed of in the manner recommended by the manufacturer.

Section 6-10 Blasting Vibration and Air Over-Pressure Standards (A) In all blasting operations, blasters shall use one of the following methods to monitor or control the intensity of motion in the ground at the nearest dwelling, house, school, church, commercial or occupied building. These limits do not apply to property owned, leased or contracted by the blaster’s company or property on which the owner provides a voluntary written waiver from these restrictions.

(1) Option 1 - Frequency Versus Particle Velocity graph. A blasting operation shall have the option to use the graph shown in Figure 6-10 to limit peak particle velocity based upon the frequency of the blast vibration. Allowable vibrations fall below the limits indicated by the central lines; non-allowable vibrationsNon-Allowable Vibrations lie above the lines.

Seismographs shall meet the following requirements:

(i) Monitoring instruments shall have a flat frequency response between 2 and 250Hz for particle velocity.

(ii) The digitizing sampling rate for peak particle measurements shall be at least 1,024 samples per second.

(iii) Seismographs shall be capable of performing a self-test of velocity transducers and printed event records shall indicate whether or not the sensor test was successful.

(iv) Monitoring instruments shall be capable of recording particle velocities with intensities ranging from 0.02 to 5.0 inches per second.

(v) Monitoring systems shall be calibrated by a service center approved by the manufacturer within at least two years of the time of use. Certificates documenting date of calibration, issued by the approved service center, shall be kept by the user.

(vi) Monitoring systems shall be capable of printing hard-copy reports showing the date and time of monitoring, the maximum peak particle velocity (PPV) measurements, and plotted PPV-time waveform plots.

(vii) For all blasts with a scaled distance less than 100 ft/lb0.5, seismographs monitoring motion shall be set to trigger at a level of 0.05 in/s.

The following equation shall be applied when calculating the scaled distance.

Where: Ds = Scaled distance (ft/lb D = Distance to the nearest structure (ft)

W = Maximum weight of explosive detonated within any 8 millisecond window (lb)

(viii) Vibration analysis results must be presented in comparison with the RI 8507, adopted by United States Bureau of Mines (USBM) and as shown in Figure 6-10.

(ix) If a valid vibration record showing compliance with the MAPV limits shown in figure 6-10 is not available for inspection, the maximum charge weight per delay (W) must conform to the scaled distance limitations as prescribed in Option 2.

FIGURE 6-10

Option 1: Particle Velocity Versus Frequency Table: U.S. Bureau of Mines RI 8507, 2009 (2) Option 2 Scaled Distance – when seismic monitoring is not performed, the maximum weight of the explosive detonating within any 8-millisecond time period shall not exceed the amount allowed by a calculation using the scaled distance factors given in Scaled Distance column of Table 6-10.

The following equation shall be applied when utilizing the scaled distance calculations to control blastinduced vibration.

Where: Ds = Scaled distance (ft/lb D = Distance to the nearest structure (ft)

W = Weight of explosive detonated within any 8 millisecond window (lb)

Example Maximum Charge Weight per Delay (W) Calculation:

Given: Ds = 55 (ft/lb D = 500 ft. therefore W = (500 / 55) = 82.6 lb Table 6-10 Blasting Vibration and Air Over-Pressure Standards Distance From Blast (Ft)

Option 2 Scaled Distance Factor Units Are Ft/Lb 0 to 300 50 301 to 5000 55 5001 and Greater 65 (B) Air over-pressure (air blast) limitation: Air over-pressure at the nearest dwelling house, school, church, or otherwise occupied buildings shall not exceed 133 dB (0.0129 psi). Measuring air overpressure is not required for all blasting operations. However, due to complaints or other circumstances, the Division may require blasters to monitor air over-pressure. All instruments used to measure air over-pressure compliance shall:

(1) Employ linear microphones with a flat frequency response between 2 and 200 Hz (2) Have a digital sampling rate of at least 1024 samples per second; and (3) Be capable of measuring air over-pressure from 120 to 140 dB-Linear (0.0029 to 0.029 psi).

ARTICLE 7 AVALANCHE MITIGATION

Section 7-1 General Requirements (A) The use of explosives and blasting agents for avalanche mitigation shall comply with this article unless explosives are used in compliance with Article 6.

(B) The requirements of this article shall only be applicable to the use of explosives for avalanche mitigation. The use of explosives for other purposes, such as demolition, site clearing or construction shall be in compliance with Article 6.

(C) Explosives and blasting agents shall not be stored, kept, assembled, combined to form armed charges, or had in any inhabited areas, structures or buildings except in compliance with this

Article or Article 4.

(D) Only blasters shall supervise the assembly, arming of explosive components, and detonation of explosive charges.

(E) Each avalanche mitigation blasting crew or team shall consist of a blaster and at least one assistant trained as applicable per Section 7-2. The crew may consist of two blasters, but only one shall act as the blaster in charge.

(F) Untrained personnel may accompany the blasting crew for training purposes but shall only participate in actual firing of charges for completion of training in accordance with Section 7- 2(B)(1)(iii)(a)(3).

(G) The blaster in charge of each crew or team shall be responsible for all decisions made regarding preparation and placement of charges.

(H) Blasting operations shall be conducted during periods of daylight with personnel guarding the area, or when the area has been closed. Nighttime blasting operations shall be approved by the Division, and approval shall only be granted if such approval serves the safety of the general public.

(I) The blaster in charge shall pre-plan the escape route and all crew members shall understand the plan before initiating the charge.

(J) No person shall accept or be given a job assignment that is beyond the individual’s ability, training, or qualifications.

(K) Cold temperatures, high winds, and heavy snowfall are conditions that should be anticipated in avalanche mitigation blasting. These conditions shall be considered in determining a person’s physical ability, training, and qualifications for conducting safe blasting operations and in the management of safe blasting operations.

(L) Operations utilizing hanging or dangling charges must have a hang cord entanglement safety procedure.

Section 7-2 Training Requirements (A) Type II Avalanche Mitigation permit applicants shall submit a training program for personnel involved in the use, storage and transportation of explosives to the Division. The Division shall approve the training program prior to issuance of the permit.

(B) The training program shall include at least the following for each personnel type:

(1) Blaster in Training:

(i) A minimum of 8 hours of classroom education and a written examination to include the following:

(a) Explosives Regulations of the Division (b) Explosives Regulations of the Division and federal requirements for the storage of explosives and magazine locations, inventory procedures, and magazine access (c) Safety procedures for explosives and blasting agents used within the company, including the properties and classification of each type of explosive, and consequences of the unsafe use of explosives (d) Explosives Regulations of the Division for preparing, handling, and using hand charges to include:

(1) Hand charge assembly procedures for both field arming and make-up room arming;

(2) Crimping procedures;

(3) Transportation to blast site by skiing or aerial tramways for both field armed charges and make-up room armed charges;

(4) Use of igniters and determining successful initiation of fuse;

(5) Misfire procedures;

(6) Procedures for clearing and guarding the blasting area; and (7) Deployment of initiated hand charges.

(e) Hazard training for cornice control operations (f) Hang cord entanglement safety procedures (g) Hazard training for avalauncher operations (h) Record keeping procedures, including:

(1) Records of transactions;

(2) Explosive inventory record keeping;

(3) Explosive use and route log record keeping; and (4) Misfire documentation.

(ii) Simulated Field Training for Hand Charges (a) During weather conditions typical to avalanche mitigation and under the supervision of a blaster, the trainee shall:

(1) Attend demonstration with simulated components;

(2) Attach igniters to fuse without a detonator and successfully ignite fuse not less than 5 times;

(3) Attach igniters to fuse without a detonator and twice simulate an unsuccessful attempt to light the fuse and follow the procedures for a misfire;

(4) Attach igniters to fuse with a detonator and successfully ignite and deploy the detonator and fuse assembly not less than 5 times; and (5) When training occurs at operations not utilizing a premanufactured detonator and safety fuse assembly, assemble detonator and fuse, attach igniters to fuse with detonator and successfully initiate and deploy the detonator and fuse assembly not less than 5 times.

(iii) Field Experience Training for Hand Charges (a) Under the supervision of a blaster, the trainee shall:

(1) Accompany a blasting crew on 5 routes or the deployment of not less than 20 charges as an observer;

(2) Accompany a blaster, as an assistant only, for the initiation and deployment of not less than 20 charges; and (3) Accompany a blaster and initiate and deploy not less than 20 charges under the direct supervision of the blaster.

(iv) Avalauncher Operator (a) Trainee shall complete 8 hours classroom and field training before becoming an avalauncher operator. This training shall include:

(1) Operating instructions for each type of avalauncher used;

(2) Procedures on performing preventive maintenance inspections;

(3) Procedures on assembly of charges;

(4) Procedures for checking the elevation, aiming, and pressure settings of the avalauncher;

(5) Procedures for test firing the avalauncher;

(6) Procedures for loading charges in the avalauncher;

(7) Procedures for clearing and guarding the target area;

(8) Emergency procedures; and (9) Requirements for securing the equipment.

(b) Qualifications for avalauncher operator shall be:

(1) One year experience as a blaster in charge;

(2) Must have assisted on the avalauncher crew not less than five times; and (3) Must load and fire the avalauncher under the supervision of a qualified operator not less than 10 times.

(2) Howitzer Operator (i) All Howitzer operations shall be conducted in accordance with the provisions of The Avalanche Artillery Users of North America Committee (AAUNAC) Standard (Revised May 16, 2012).

(3) Requirements for Annual Refresher Training (i) All blasters shall attend a minimum of 4 hours of refresher training at the beginning of each season.

(a) Classroom training shall include:

(1) Review of operation techniques such as throwing techniques, air blasting, dangling charges, hang cord entanglement safety procedures, cornice blasting, avalauncher and howitzer procedures;

(2) Review of assembly and transportation procedures; and (3) Review of snow safety program.

(b) Field training shall include:

(1) Review of initiation techniques;

(2) Review of misfire procedures; and (3) A walk through of storage and make-up facilities.

(ii) Annual refresher training may count towards the 16-hour requirement of Section 3.6(N) of these rules when the refresher training program is specifically approved by the Division.

Section 7-3 Make-up Room Requirements (A) Location of Make-up Rooms (1) Make-up rooms shall not be located in buildings or structures that are at any time open to the public.

(B) Construction of Make-up Rooms (1) The interior of the make-up room shall be finished and equipped to the following minimum standards:

(i) Walls shall be constructed of, or covered with, a non-sparking material. Nails or screws shall be countersunk, blind nailed or covered;

(ii) Floors shall be constructed of, or covered with, a non-sparking material;

(iii) The building and make-up room shall be well ventilated, and the ventilation system shall discharge to the outside from the make-up room;

(iv) The make-up table shall be constructed of non-sparking, nonconductive material; and (v) The make-up table shall be located away from the area where explosives are kept before and after assembly.

(2) The building in which the make-up room is located shall be theft-resistant and secured by at least one steel padlock having at least 5 tumblers and a case hardened shackle at least 3/8-inch in diameter. The door shall have hinges and hasps attached so that they cannot be removed from the outside when in the closed position with the lock in place.

(C) Make-up Room Restrictions (1) Heating units shall be explosion proof, dust-proof and not depend on a combustion process when properly designed and located. National Electric Code-rated explosionproof and dust-proof heating units may be located inside make-up rooms.

(2) Temperature control devices must be sufficiently designed to prevent overheating of make-up rooms where explosives are stored.

(3) Lighting fixtures shall be National Electric Code explosion-proof rated fixtures and all wiring shall be in sealed conduit.

(4) Electric control switches shall be located outside the make-up room.

(5) Electrical outlet boxes are not permissible inside the make-up room.

(6) Smoking, matches, open flames or flame or spark producing devices shall not be permitted inside the make-up room.

(7) Flammable liquids or flammable compressed gases shall not be stored or had in the make-up room.

(8) Occupancy of the make-up room shall be restricted to authorized and trained personnel when explosives are present.

(9) A make-up room shall not be used for the unattended storage of armed charges.

(10) Explosives stored inside the make-up room must be stored in at least a Type 2 storage magazine suitable for indoor storage.

(D) Make-up Room Housekeeping (1) The make-up room shall be kept clean and orderly.

(2) Metal tools shall not be used or stored in the make-up room.

(3) Brooms used in the make-up room shall be made of non-sparking materials.

(4) Sweepings and empty explosive material containers shall be disposed of as recommended by the manufacturer.

(5) The make-up room shall be cleaned and all explosives materials shall be removed before any repairs are made to the make-up room.

(6) The make-up table or bench shall be cleaned regularly and shall be kept free of any materials or tools not used in the assembly of the charges.

Section 7-4 Use of Explosives (A) General Requirements (1) While explosives are being handled or used, smoking, matches, or any other source of fire or flame shall not be within 50 feet of the blast site.

(2) No person shall handle explosives while under the influence of intoxicating liquors, narcotics or other controlled substances. This rule does not apply to persons taking prescription drugs and/or narcotics as directed by a physician, providing such use shall not influence the blaster’s ability to conduct safe blasting operations.

(3) Blasters conducting blasting operations shall take every reasonable precaution, including but not limited to warning signals, flags and barricades to insure the safety of the general public and workers.

(4) The blaster shall suspend all blasting operations and remove all persons from the blast site during the approach and progress of an electrical storm.

(5) No fire shall be fought where the fire is in imminent danger of contact with explosives. All employees shall be removed to a safe area and the fire area guarded against intruders.

(B) Explosives (1) Explosives shall have a shelf life of at least 1 operating season in the storage facilities in which they will be stored.

(2) Blasting caps must be at least a No. 6 cap and no larger than a No. 8 cap except when recommended by the explosives manufacturer for a particular explosive used within a specific application.

(3) Detonator and safety fuse assemblies manufactured with thermalite connectors shall not be used for avalanche mitigation operations.

(4) Detonating cord used for initiating primers must be at least a 25-grain cord.

(5) Explosive materials chosen must have excellent water resistance and be capable of detonation in cold temperatures.

(6) Explosive materials that are damaged, show signs of deterioration, or have misfired shall not be used.

(7) Detonators and other explosive materials, with the exception of fuse igniters, shall never be carried in pockets of clothing.

(8) Should cartridges or packages of explosive materials show signs of discoloration or deterioration, such explosive materials must be carefully set aside and properly disposed of according to the manufacturer’s recommendations.

(9) Only non-sparking metallic slitters may be used for opening fiberboard cases.

(10) No explosive material shall be abandoned or left in any location for any reason, nor left in such a manner that they may easily be obtained by children or other unauthorized persons. All unused explosives shall be returned to the proper storage facilities.

(11) A record of each blast shall be completed and signed by the Type I permittee acting as the blaster in charge. All records shall be retained at least five years, shall be available for inspection by the Division, and shall contain at least the following data:

(i) Name of company or contractor;

(ii) Date, time and location of route;

(iii) Name, permit number and signature of blaster-in-charge of the route;

(iv) Number of charges used on each route;

(v) Names of employees on each route;

(vi) Types of explosives used;

(vii) Total amount of each explosive received and used;

(viii) Method of initiation;

(ix) Type of blasting (hand charge, cornice control, avalauncher);

(x) Weather conditions; and (xi) Statement noting any misfires, the location of misfires, steps taken to recover or refire any misfires, and the date the misfire was found and disposed of.

(C) Hand Charges (1) Safety Fuse (i) Safety fuse that is deteriorated or damaged in any way shall not be used.

(ii) The hanging of safety fuse on nails or other projections which will cause a sharp bend to be formed in the fuse is prohibited.

(iii) Pre-manufactured detonator and fuse assemblies shall be used in accordance with the manufacturer’s requirements.

(iv) Before assembling fuse detonators and safety fuse, a minimum of 1 inch shall be cut from the end of the supply reel so as to assure a fresh cut end in each fuse detonator.

(v) The burning rate of the safety fuse in use at any time shall be measured, posted in conspicuous locations, and brought to the attention of all workers concerned with blasting.

(vi) New rolls of safety fuse shall be tested for burn rate prior to use and all partial rolls shall be tested at least every 30 days. A record of the burn rate shall be kept by the Type II permittee.

(vii) Only a bench or hand-held cap crimpers designed for the purpose of crimping fuse detonators shall be used for attaching fuse detonators to safety fuse.

Crimpers shall be kept in good repair and accessible for use.

(viii) No fuse detonators and fuse shall be assembled, or primers made up, in any magazine or near any possible source of initiation.

(ix) Assembly of fuse detonators and safety fuse and pre-arming of charges shall only be done in a warm, dry, well-lit make-up room.

(x) Any loose cartridges of explosives, detonators, and assembled fuse detonators and safety fuse unused at the end of the shift shall be returned to their respective and separate magazines and locked up.

(xi) Detonators, fuse detonator and fuse assemblies, armed charges or safety fuse igniters shall not be carried into nor stored in any magazine containing cartridge high explosives.

(xii) Detonators shall not be inserted in the explosives without first making a hole in the cartridge of proper size using a tool designed for that purpose.

(2) Arming of Charges With Detonators (i) Cast primers and boosters shall not be used if the hole is too small for the detonator, and attempting to enlarge the hole in a cast primer or booster shall not be permissible.

(ii) The detonator shall be secured within the primer so that no tension is placed on the safety fuse at the point of entry into the detonator.

(iii) The detonator shall be fully inserted into the primer cartridge or booster and shall not protrude from the cartridge.

(iv) After the fuse detonator and safety fuse assembly is inserted, the explosive contains a sensitive detonator and is then vulnerable to premature detonation, therefore delaying the arming of a charge until just before tossing the charge should be standard procedure when wind and/or temperatures are not severe.

(v) When arming the charge at the blast site the blaster shall:

(a) Insure that the fuse detonator is installed on the correct length of fuse prior to transporting to blast sites;

(b) Place detonators in adequate protective padding or shields before placing in approved avalanche mitigation packs;

(c) Place detonators and explosives in separate approved avalanche mitigation packs while transporting to the blast site;

(d) Safety fuse igniters shall not be placed inside the pack when it contains explosives or detonators, but shall be carried in a separate pack;

(e) Insure that the detonator is secured to the charge before attaching fuse igniter.

(vi) Depending on weather condition, the charges may be armed in a make-up room as follows:

(a) All fuse detonators shall be installed on the required length of safety fuse before the explosive cartridges or primers are brought to the make-up area;

(b) Fuse detonator and safety fuse assemblies shall be secured correctly to each type of explosive charge being used;

(c) Fuse detonator and safety fuse assemblies shall not be attached to explosive charges until just before the time of distribution to patrol personnel;

(d) Each hand charge shall be placed in an area separate from the assembly area immediately after assembly is completed; and (e) Distribution of hand charges into approved mitigation packs shall take place away from the assembly area.

(3) Initiation of Hand Charges (i) The length of safety fuse shall be in accordance with manufacturer’s recommendations, and shall be 3 feet in length or have a burn time of not less 120 seconds at the time of initiation.

(ii) The lighting of fuse shall be done with hot-wire lighters or pull-wire lighters.

(iii) Matches, cigarette lighters, cigarettes, pipes, cigars or other unsafe means shall not be used to ignite fuse.

(iv) Igniters shall be used in accordance with manufacturer’s recommendations and shall not be attached to a safety fuse until the charge is at the blast site and the crew is fully prepared to initiate the charge.

(v) At least two persons shall be present when fuse detonators and safety fuse blasting is done by hand lighting methods.

(vi) When blasting with safety fuses, consideration shall be given to the length and burning rate of the safety fuse, and safety fuse shall be used in accordance with manufacturer’s recommendations. A sufficient time of not less than 120 seconds, with a margin of safety, shall always be provided for the blaster to reach a place of safety.

(vii) When the fuse lighter has been placed on the fuse, the blaster shall assume initiation of the safety fuse has occurred.

(viii) If the safety fuse does not show evidence of initiation after the fuse lighter has been ignited, the blaster shall not attempt any further initiation of the charge but adequately mark the charge and retreat with the blasting crew to a safe distance for not less than 1 hour.

(ix) After waiting at least 1 hour, the blaster shall:

(a) Determine that initiation failed and ignite the uninitiated charge; or (b) Determine that the initiation was successful and dispose of the misfired explosive charge with a secondary charge.

(4) Use of Detonating Cord (i) Detonating cord shall be handled and used with the same respect and care given other explosives.

(ii) All detonating cord knots shall be tight and all connections shall be kept at right angles.

(iii) Detonating cord shall be handled and used with care to avoid damaging or severing the cord.

(iv) Detonating cord connections shall be made in accordance with approved and recommended methods. Knot-type or other cord-to-cord connections shall be made only with detonating cord in which the explosive core is dry.

(v) Detonating cord shall be cut with a sharp knife, razor blade, or cutters designed for use with detonating cord. Scissors or plier type cutters shall not be used.

(vi) All detonating cord connections shall be inspected before firing the blast.

(vii) When connecting a detonator to detonating cord, the detonator shall be taped or otherwise attached securely along the side of the end of the detonating cord with the end of the detonator containing the explosive charge pointed in the direction in which the detonation is to proceed.

(viii) Two fuse detonators shall be required for the initiation of detonating cord with fuse detonator and safety fuse.

(ix) Detonators shall not be attached to the detonating cord until the area has been cleared for the blast.

(5) Avalanche Mitigation Packs (i) Mitigation packs shall be constructed of material that is water-resistant, nonsparking and non-conductive.

(ii) Mitigation packs shall have sufficient individual compartments to separate hand charges or explosive components from tools or other equipment or supplies that may be carried in the pack.

(iii) Tools or other equipment shall not be placed in compartments containing (iv) Each compartment used for hand charges or explosive components shall have an independent means of closure.

(v) Mitigation packs shall be inspected daily for holes, faulty compartments or closures and explosive residue. Packs shall not be used until adequately repaired or cleaned.

(vi) Mitigation packs shall not be left unattended, or used for storing explosives. All explosive material shall be returned to the approved storage facility at the end of individual mitigation routes.

(vii) Individual mitigation team members shall not carry more than 35 pounds of explosives material in avalanche mitigation packs.

(D) Avalauncher and Launcher (1) All personnel assigned to work on an avalauncher or launcher crew shall be trained in the (i) All operating instructions;

(ii) Safety precautions;

(iii) Emergency procedures; and (iv) Securing requirements for equipment.

(2) All equipment shall be in good working condition and maintained as recommended by the (3) The components of projectile assemblies shall not be interchanged and shall be assembled and used in accordance with the manufacturer’s instructions.

(4) All projectiles shall be inspected before transporting them to the firing location. Such inspection shall include:

(i) Cast explosives for cracks, dents, fractures and smooth nose surface;

(ii) Cap wells should be clear of obstructions and debris and centered and straight for proper alignment of the cap; and (iii) Fin assembly should be inspected for properly-functioning components and safety items, including pressures plate, pressure plate arming wire, bore rider pin, safety pin, magnet and firing pin.

(5) Defective projectiles shall not be used and shall be disposed of or returned to the (6) Safety devices or components shall not be removed.

(7) If explosives are not at least 20 feet from the avalauncher/launcher during firing procedures, they shall be kept in a closed Type 3 magazine.

(8) The transport safety pin shall not be removed until just prior to inserting the projectile into the barrel.

(9) Avalaunchers/Launchers must be fired with compressed nitrogen gas only.

(10) Avalaunchers/Launchers shall be connected to the compressed nitrogen source through a satisfactory pressure regulator.

(11) The pressure regulator shall be set to limit the launch pressure to the maximum recommended by the manufacturer.

(12) The first round fired in a mitigation mission shall be a test fire to test the proper functioning of the launcher without a projectile.

(13) The blaster in charge, trained assistants, and blasters in training shall be the only personnel within 100 feet of the avalauncher/launcher during loading and firing.

(E) Misfires (1) An explosive charge or any part of an explosive charge that fails to detonate after initiation shall be considered a misfire.

(2) If a misfire occurs, the blaster shall note the location of the misfired explosive and shall not approach the misfired explosive for at least 1 hour.

(3) Explosives which are aflame or emitting smoke shall not be approached for at least 1 hour after evidence of combustion ceases.

(4) The area shall remain guarded or closed until a search of the area has been done and the misfire hazard is removed or the blaster-in-charge pronounces the area safe.

(5) Misfires shall be handled by the blaster-in-charge and only those employees necessary to remove the hazard and the area shall remain guarded.

(6) Impact to explosive materials shall be avoided when searching for nonvisible misfired charges.

(7) A misfired armed charge shall be disposed of where it is found with a secondary charge.

Section 7-5 Transportation (A) Transportation of explosives, blasting agents, and blasting supplies on public highways, railways, and airways shall be in accordance with the provisions of title 42 Article 20 C.R.S., any regulations promulgated pursuant thereto and Title 49 CFR Parts 171-179 and Parts 390-397, Motor Carriers.

(B) Requirements for the transportation of explosives, blasting agents and blasting supplies by motorized vehicles on job sites shall be:

(1) No person shall smoke, carry matches or any other flame-producing device or carry firearms or loaded cartridges while in or near a motor vehicle transporting explosives.

(2) No person shall drive, load or unload a vehicle transporting explosives in a careless or reckless manner.

(3) Vehicles transporting explosives, blasting agents or blasting supplies shall not be taken inside a garage or shop for repairs or servicing.

(4) Vehicles used for transporting explosives shall be equipped to carry the load without difficulty and shall be in good mechanical condition.

(5) A motor vehicle used for transporting explosive materials shall be inspected prior to loading to determine that it is in proper condition for the safe transportation of explosive (6) All cargo areas of vehicles used for transporting explosive materials shall have tight floors and any exposed spark-producing metal on the inside of the cargo area shall be covered with wood or other non-sparking materials to prevent contact with packages of explosive (7) Packages of explosive materials shall not be loaded above the sides of an open-body vehicle.

(8) Explosive materials shall not be transported with other materials or cargoes in the same compartment. In no case shall flammable materials be carried on the same vehicle as (9) A motorized vehicle which contains explosive materials shall not be parked under any of the following circumstances:

(i) On or within 5 feet of the traveled portion of a public street or highway;

(ii) On private property; or (iii) Within 300 feet of a bridge, tunnel, building, or place where people work, assemble, or congregate.

(10) A motorized vehicle transporting explosive materials shall not be left unattended.

(11) A motorized vehicle shall be deemed attended only when the driver or other attendant is physically on or in the vehicle or conveyance or has the vehicle within the driver’s or attendant’s field of vision and can reach the vehicle or conveyance quickly and without any kind of interference; attended also means the driver or attendant is awake, alert and not engaged in any other duties or activities which may divert his/her attention from the vehicle.

(12) Detonators may not be transported in the same vehicle with other explosives unless:

(i) The detonators and explosives are placed in separate locked Type 2 magazines secured within the body of the vehicle or conveyance;

(ii) The detonators and explosives are placed in suitable locked containers and separated by 4 inches of hardwood, and the detonators are totally enclosed or confined by the hardwood construction; or (iii) The detonators and explosives are placed in separate locked containers or container compartments constructed in accordance with the IME Safety Library Publication No. 22, “IME Standard for the Safe Transportation of Detonators in a Vehicle with Other Explosives”; or (iv) The detonators and explosives are placed in separate locked Type 3 magazines.

(C) Requirements for the transportation of explosives on passenger tramways when the public is present shall be:

(1) Explosives shall not be transported in the same enclosed passenger tramway carrier with the public.

(2) Transportation of explosives on non-enclosed passenger tramways shall require the (i) Explosives shall be attended at all times;

(ii) Warning signs indicating that explosives are currently being transported on the tramway and passengers may ride the tramway at their own discretion shall be clearly posted at the tramway entrance;

(iii) Passengers shall not be allowed to ride the passenger tramway in the opposing direction of the explosives;

(iv) A minimum distance of 200 feet shall be maintained in front of and behind the chair transporting explosives and chairs transporting the public;

(v) The amount of explosives being transported shall not exceed50 pounds per carrier; and (vi) Nothing in Section 7-5(C)(2) is intended to limit liabilities as set forth in the Colorado Ski Safety Act (C.R.S. 33-44-101 thru 114).

ARTICLE 8 GEOPHYSICAL RESEARCH

Section 8-1 General Requirements (A) Seismic Blasting shall conform to the requirements of Articles 4, 5 and 6 of these regulations for the storage and transportation of all explosive materials, for the preparation of charges, for the loading of charges and for the detonation of charges.

(B) Surface charges, above-surface charges, and armed charges loaded in seismic drill holes less than 20 feet in depth shall not be left unattended.

(C) Charges which have not been armed may be left unattended in holes less than 20 feet deep provided that:

(1) The hole has been loaded such that the charge has been anchored, cannot be removed and is capped with a hole plug;

(2) The charge does not exceed an amount that would cause damage to persons or property on the surface if accidentally detonated; and (3) The backfill material in the loaded hole is a continuous column from the charge to the collar of the drill hole. Any drill holes in which the backfill material has bridged and the hole has not been fully backfilled shall not be left unattended.

(D) Armed or unarmed charges loaded in seismic drill holes greater than 20 feet deep may be left unattended provided that:

(1) The hole has been loaded such that the charge has been anchored, cannot be removed and legwires have been made inaccessible and capped with a hole plug;

(2) The charge does not exceed an amount that would cause damage to persons or property on the surface if accidentally detonated; and (3) The backfill material in the loaded hole is a continuous column from the charge to the collar of the drill hole. Any drill holes in which the backfill material has bridged and the hole has not been fully backfilled shall not be left unattended.

(E) Armed and unarmed charges that are loaded in inhabited areas shall not be left unattended.

(F) Blasting signs shall be posted on roads and trails leading to the blast site.

ARTICLE 9 BLACK POWDER EXPLOSIVES

Section 9-1 General Requirements (A) Black powder shall be stored in shipping containers as required by regulations of the U.S.

Department of Transportation, 49 CFR, Section 173.60, as currently published.

(B) Black powder intended for personal use shall be sold and stored according to the Uniform Fire Code (sections 77.202, 77.203, and 77.203a).

ARTICLE 10 ALTERNATE METHODS AND EMERGENCY VARIANCES

Section 10-1 Alternate Methods or Procedures (A) The permittee, on specific approval by the Division as provided by this paragraph, may use an alternate method or procedure in lieu of a method or procedure specifically prescribed in these (B) The Division may approve an alternate method or procedure, subject to stated conditions, when found that:

(1) Good cause is shown for the use of the alternate method or procedure;

(2) The alternate method or procedure is within the purpose of, and consistent with the effect intended by, the specifically prescribed method or procedure and is substantially equivalent to that specifically prescribed method or procedure; and (3) The alternate method or procedure will not be contrary to any provision of law and will not result in an increase in cost to the Division or hinder the effective administration of these (C) Where the permittee desires to employ an alternate method or procedure, the permittee shall submit a written application to the Division. The application shall specifically describe the proposed alternate method or procedure and shall set forth the reasons for it.

(D) Alternate methods or procedures may not be employed until the application is approved by the (E) The permittee shall, during the period of authorization of an alternate method or procedure, comply with the terms of the approved application.

(F) Authorization of any alternate method or procedure may be withdrawn whenever, in the judgment of the Division, the effective administration of this article is hindered by the continuation of the authorization.

(G) As used in this paragraph, alternate methods or procedures include alternate construction or equipment.

Section 10-2 Emergency Variances from Requirements (A) The Division may approve construction, equipment, and methods of operation other than as specified in this part, where it is found that an emergency exists and the proposed variations from the specified requirements are necessary and the proposed variations:

(1) Will afford security and protection that are substantially equivalent to those prescribed in these regulations;

(2) Will not hinder the effective administration of these regulations; and (3) Will not be contrary to any provisions of law.

(B) Variations from requirements granted under this paragraph are conditioned on compliance with the procedures, conditions and limitations set forth in the approval of the application.

(C) Failure to comply in good faith with the procedures, conditions and limitations shall automatically terminate the authority for the variations and the permittee shall fully comply with the prescribed requirements of regulations from which the variations were authorized.

(D) Authority for any variation may be withdrawn when, in the judgment of the Division, the effective administration of these regulations is hindered by the continuation of the variation.

(E) Where the permittee desires to employ an emergency variation, the permittee shall submit a written application to the Division.

(F) The application shall describe the proposed variation and set forth the reasons for it. Variations may not be employed until the application is approved, except when the emergency requires immediate action to correct a situation that is threatening to life or property. Corrective action may then be taken concurrent with the filing of the application and notification of the Division via telephone.

Section 10-3 Retention of Approved Variations (A) The permittee shall retain, as part of his records available for examination by the Division, any application approved by the Division under this section.

ARTICLE 11 ENFORCEMENT

Section 11-1 Enforcement Program The Division provides these regulations to assist operators with maintaining safe use, manufacture, possession, sale, storage, transport, or disposal of explosives materials or blasting agents. When circumstances regarding regulated explosives materials or blasting agents are found to be not in compliance with these regulations, the Division will pursue enforcement actions against the operator.

The enforcement process will include requiring the permittee to make repairs and/or upgrades, provide records, and complete other actions necessary to come back into compliance. During and following the enforcement process, the Director will continue to assist the operator to remain in compliance. The enforcement process may include monetary penalties up to $1,000 per violation per day according to statute (C.R.S. 8-20-104) if the enforcement obligations are not implemented according to the required schedule.

Section 11-1-1 Notice of Violation (A) A notice of violation (NOV) may be issued when a regulated party is found to be out of compliance with these regulations (7 C.C.R. 1101-9) and/or statutes (C.R.S. 8-20, 9-6 and 9-7).

The notice of violation may include fines and/or an order to cease explosives-related operations until all violations are satisfactorily corrected.

(B) Within 10 working days after an NOV has been issued, the person issued the NOV may file a written request with the Division for an informal conference regarding the NOV. Upon receipt of the request, the Division shall provide the alleged violator with notice of the date, time and place of the informal conference. During the conference, the alleged violator and Division personnel may present information and arguments regarding the allegations and requirements of the NOV.

(C) Within 20 days after the informal conference, the Division shall uphold, modify, or strike the allegations within the NOV in the form of a settlement agreement or an enforcement order.

(D) If the alleged violator fails to timely request an informal conference, the terms of the NOV become a binding enforcement order not subject to further review.

Section 11-1-2 Enforcement Order (A) An enforcement order may be issued when the violations included within an NOV are not resolved within the prescribed time frame or the schedule set forth in a settlement agreement is not met.

(B) An enforcement order may include increased fines up to $1,000 per violation for each day of violation. In addition, the enforcement order may include shut-down of the explosives-related operation, suspension and/or revocation of an explosives permit.

(C) An alleged violator may appeal the enforcement order to the Division for a hearing under C.R.S. 24-4-105. The Division shall then issue a final decision which is subject to judicial review under C.R.S. 24-4-106. _________________________________________________________________________ Editor’s Notes

History Introduction, Rule 1.2, Chapters III, IV, Rule 5.1(c), Chapters VI, VII, IX eff. 01/01/2009.

Entire rule eff. 03/10/2015.

Entire rule eff. 12/01/2018.

Sections 1-3, 1-5, 3-3, 3-4, 6-1 eff. 05/01/2019.

Annotations

Rule 3-4 (B) (adopted 10/11/2018) was not extended by Senate Bill 19-168 and therefore expired 05/15/2019.

Rules 3-4 (A), 3-4 (D) (adopted 02/28/2019) were not extended by House Bill 20-1179 and therefore expired 05/15/2020.

7 CCR 1101-12 Amusement Rides and Devices Regulations {#sec-7-ccr-1101-12 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-12}

DEPARTMENT OF LABOR AND EMPLOYMENT

AMUSEMENT RIDES AND DEVICES REGULATIONS

7 CCR 1101-12 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Basis and Purpose This regulation is promulgated to establish reasonable standards for the construction, Inspection, operation, repair and maintenance of Amusement Rides and Devices located in Colorado in the interest and safety of the general public, to establish financial standards for the operation of Amusement Rides and Devices in a public setting and to provide for a Registration process for Amusement Rides and Devices.

Section 1-2 Statutory Authority The amendments to these regulations are created pursuant to 8-20-1001 through 8-20-1004 of the Colorado Revised Statutes (C.R.S.). All prior rules for Amusement Rides and Devices are hereby repealed.

Section 1-3 Effective Date This regulation shall be effective August 30, 2024. The Operators of previously unregistered Amusement Rides and Devices shall have up to three months from the effective date of these regulations to comply with Section 2-3.

Section 1-4 Scope These rules and regulations shall apply to the construction, Inspection, operation, repair and maintenance of Amusement Rides and Devices located in Colorado by any individual, corporation, company, firm, partnership, association, organization, or state or local government agency.

These rules and regulations shall not apply to:

(A) Coin operated model horse and model rocket rides, mechanical horse or bull rides, and other coin activated or self-operated arcade devices that do not require a restraint system.

(B) Playground equipment that meets the relevant ASTM standards listed in section 1.4.1 of the U.S.

Consumer Product Safety Commission’s Public Playground Handbook – Publication #325 (November 2010).

(C) Live animal rides or live animal shows.

(D) Sports and physical fitness devices and elements located in educational facilities, schools, gymnasiums, sport and public entity recreational facilities, or other facilities solely devoted to sport, education, training and instruction, as long as at least one of the following conditions is met:

(1) Staff or the facility are licensed or certified by a recognized governing association and patrons are instructed for the purpose of learning, developing a skill, fitness, or gaining competency in a sport.

(2) Individuals own or rent equipment for independent and unsupervised use in sports including and not limited to biking, boating, climbing, and skiing.

(3) The institutional trampolines are used solely for sport and fitness training. All training must be conducted by a certified gymnastics or trampoline coach. The facility and coach must carry certifications from a nationally recognized gymnastics or trampoline governing association.

(E) Inflatable Amusement Rides, as defined.

(F) Race-karts owned and operated by individuals who compete against each other, or rental Race karts available for rent at competitive sport Race-kart tracks solely used for sanctioned racing where drivers have attended and passed a practical driver safety training test to establish their competency, or hold an applicable valid competition certification from a recognized motor sport sanctioning body.

(G) Skating;laser or paintball games; bowling; miniature golf courses; exercise equipment used solely for exercise purposes; jet skis; paddle boats; air boats; hot air balloons whether tethered or untethered; batting cages; games and side shows.

(H) Any Amusement Ride and Device operated at a Private Event (as defined), or any Amusement Ride and Device owned and operated by a non-profit organization who meets all the requirements in Sections 1-5 and 2-1 of these regulations and operates their rides less than 8 days in any calendar year.

(I) Any Amusement Ride and Device Operator who notifies the Division in writing that their ride or device is certified or issued a permit by one of the following agencies shall be exempt from the requirements of these regulations, provided that the ride or device meets or exceeds the requirements of standards adopted in this regulation.

(1) Any municipality or local government within the state of Colorado (2) Another state agency within the state of Colorado (3) Any federal government agency (J) Any local government that has received a temporary or permanent waiver from the Division. To obtain a waiver the affected local government must demonstrate that the requirements in these regulations conflict with other statutes or regulations (including those of local governments) or are unduly burdensome. A cost benefit analysis or other supporting documentation should be included with the waiver request.

(K) Water slides less than 18 feet in elevation change from point of dispatch to the end of the slide.

Section 1-5 Codes and Standards (A) All Amusement Rides and Devices shall comply with the following applicable standards, unless specifically exempted in these regulations. If there is no applicable standard for an Amusement Ride and Device, Operators shall comply with the manufacturer’s recommendations. When adopted standards and manufacturer recommendations differ, the more stringent requirement shall apply. When more than one standard applies, a Qualified Person or agent thereof shall identify to which standard the ride has been designed, manufactured, inspected, operated or maintained. Amusement Rides and Devices that have not been modified since the original date of manufacture must comply with adopted design and manufacturing standards that were effective at the time of manufacture, as applicable.

(1) ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959 (a) Standard Terminology Relating to Amusement Rides and Devices: F747-15 (b) Standard Practice for Ownership, Operation, Maintenance and Inspection of Amusement Rides and Devices Designation: F770-18 (c) Standard Practice for Design and Manufacturing of Amusement Rides and Devices that are Outside the Purview of Other F24 Design Standards: F1159-16 (d) Standard Practice for Quality, Manufacture, and Construction of Amusement Rides and Devices Designation: F1193-18 (e) Standard Test Method for Composite Foam Hardness-Durometer Hardness:

F1957-17

(f) Standard Practice for Design, Manufacture, and Operation of Concession Go Karts and Facilities Designation: F2007-12 (g) Standard Practice for Measuring the Dynamic Characteristics of Amusement Rides and Devices Designation: F2137-16 (h) Standard Practice for Design of Amusement Rides and Devices Designation:

F2291-18 (i) Standard Practice for Design, Manufacture, Installation and Testing of Climbing Nets and Netting/Mesh used in Amusement Rides, Devices, Play Areas and Attractions: F2375-17 (j) Standard Practice for Classification, Design, Manufacture, Construction, and Operation of Water Slide Systems Designation: F2376-17a (k) Standard Practice for Special Requirements for Bumper Boats Designation:

F2460-11

(l) Standard Practice for Aerial Adventure Courses Designation: F2959-18 (m) Standard Practice for Permanent Amusement Railway Ride Tracks and Related Devices: F2960-16 (n) Standard Practice for Design, Manufacture, Installation, Operation, Maintenance, Inspection and Major Modification of Trampoline Courts: F2970-17 (o) Standard Practice for Auditing Amusement Rides and Devices: F2974-18 (p) Standard Practice for Operations of Amusement Railway Rides, Devices, and Facilities: F3054-18 (q) Standard Practice for Classification, Design, Manufacturing, Construction, Maintenance, and Operation of Stationary Wave Systems: F3133-16 (r) Standard Practice for Patron Transportation Conveyors Used with a Water Related Amusement Ride or Device: F3158-16 (s) Standard Practice for Characterization of Fire Properties of Materials Specified for Vehicles Associated with Amusement Rides and Devices: F3214-18 (2) National Fire Protection Association (NFPA), One Batterymarch Park, Quincy, MA 02169-7471 (a) National Electrical Code 2014 Designation: NFPA 70 (b) Life Safety Code 2024 Designation: NFPA 101 (3) Association for Challenge Course Technology (ACCT), PO Box 19797, Boulder, CO 80308 (a) Challenge Course and Canopy/Zip Line Tour Standards, ANSI/ACCT 03-2019 (B) Interested parties may inspect the referenced incorporated materials by contacting the Program Manager, Amusement Rides and Devices, 633 17th Street, Suite 500, Denver, CO 80202.

(C) This rule does not include later amendments to or editions of the incorporated material.

(D) A ride or device is not required to meet the current edition of a specific ASTM standard if it has a Service Proven design according to the ASTM F2291-18 and this design is approved by the (1) Aerial Adventure Courses that utilize the ANSI/ACCT standard shall follow the standard’s requirement to update their safety components:

(a) Pre-existing element and course modifications completed after the publication date shall comply with the requirements of ANSI/ACCT 03-2019 (b) On pre-existing elements and courses, “grandfathering” of materials and techniques is allowable only when such materials and techniques comply with the strength and performance requirements of ANSI/ACCT 03-2019. Noncompliant systems that have a history of reliability shall be given a grace period of twenty-four (24) months from the publication date of this [standard] to comply (E) The Division may grant the use of alternate methods and procedures on a case-specific basis for requirements of the adopted codes or standards listed in this section.

(1) The Division shall require justification of the alternative method or procedure.

(2) The alternate methods and procedures request shall be submitted on a form provided by the Division.

(3) A submitted alternate methods and procedures request shall not relieve an Operator from complying with the applicable standards adopted in these regulations unless the Division expressly approves the request.

(4) The Division may deny any request at its discretion.

(F) If the existing Amusement Ride and Device has had a Major Modification since the last Inspection, the post-modification Inspection of that ride or device shall be conducted in compliance with ASTM F2974-18 Section 9 or ANSI/ACCT 03-2019 Chapter 1 Section B.

(G) All Amusement Rides and Devices must conform to the current requirements of “Standard Practice for Ownership and Operation of Amusement Rides and Devices” Designation F770-18 or ANSI/ACCT 03-2019 Chapter 2 (as applicable by ride type), regardless of date of manufacture or installation.

(H) Amusement Rides and Devices of site-specific or prototype construction shall be constructed as certified, and maintained and repaired as noted in the As-built plan set from a Professional Engineer. These plan sets must be available for review by the Division.

(I) Bungee Jumping (1) A system review (structures, cords, harnesses, attachment components, etc.) that includes evaluation and inspection by a Colorado registered professional engineer, with their certification/stamp that the system design is adequate for the intended application, shall be provided to the Division.

Section 1-6 Definitions The following words when used in these rules and regulations shall mean:

AERIAL ADVENTURE COURSE: A patron participatory facility or facilities consisting of one or more elevated walkways, platforms, Zip Lines, nets, ropes, or other elements that require the use of fall hazard personal safety equipment.

Examples include ropes courses, Free Fall Devices, Zip Lines, via ferratas, and Climbing Walls designed as an Amusement Ride and Device.

AMUSEMENT RIDE AND DEVICE: Any ride or device or combination of devices which carry, convey, or direct a person(s) along, around, through, or over a fixed or restricted course or within a defined area, for the purpose of amusement, entertainment, thrills, excitement or the opportunity to experience the natural environment.

Amusement Rides and Devices include but are not limited to, an aggregation of amusement rides or devices in an amusement setting such as amusement parks, family entertainment centers, carnivals, fairs and festivals. Amusement Rides and Devices also include but are not limited to, Special Amusement Buildings, bungee jumping, Bungee Trampolines, Trampoline (Institutional, TC, TC Foam Pit), via ferrata and Climbing Walls in amusement settings, Concession Go-karts, Bumper Devices, gravity-propelled rides and devices, dry or Water Slides, Trackless Trains, Simulators, stationary wave systems, Aerial Adventure Courses, and traditional amusement rides.

AMUSEMENT RIDE, CLASS A: An amusement ride designed primarily for use by children 12 years of age or younger, typically referred to as a “kiddie ride.”

AMUSEMENT RIDE, CLASS B: Any amusement ride not defined as a Class A amusement ride.

BRAKE, EMERGENCY: A brake located on a Zip Line that is engaged upon failure of the primary brake, with no input from the Zip Line participant, in order to prevent serious injury or death resulting from primary brake failure.

BRAKE SYSTEM: An arrangement of primary and Emergency Brakes that are designed to function together.

BUMPER DEVICES: Devices that are used to bump into each other intentionally as directed by drivers as a form of entertainment.

BUNGEE TRAMPOLINES: A type of trampoline where the patron is assisted by a harness attached to bungee cords.

CERTIFICATE OF INSPECTION: The documentation of an Amusement Ride and Device Inspection conducted by an Inspector (as defined).

CIRSA: Colorado Intergovernmental Risk Sharing Agency CLIMBING WALL: An artificially constructed wall with holds for hands and feet used for climbing.

Regulated climbing walls include climbing walls located in amusement settings and fixed or portable climbing walls for use by the general public as amusement devices and not for sport or fitness training.

CONCESSION GO-KARTS: A single vehicle which is powered without connection to a common energy source, which is driver controlled with respect to acceleration, speed, braking and steering, which operates within the containment system of a defined track, which simulates competitive motor sports, and which is used by the general public. Concession go-karts typically operate at speeds of up to 25 miles per hour.

DIVISION: The Director of the Division of Oil and Public Safety of the Department of Labor and Employment, or any designees thereof which may include certain employees of the Division of Oil and Public Safety or other persons.

FREE FALL RIDE OR DEVICE: A ride or component of a ride or device, including when used within an Aerial Adventure Course, which controls a patron’s intentional descent from an elevated structure and engineered to allow the patron to experience a rapid initial descent while ensuring a controlled landing through the use of fall hazard personal safety equipment or Impact Attenuation.

IMPACT ATTENUATION: A device, material, or system designed to prevent injury to persons by absorbing impacts and/or catching falls from an Amusement Ride and Device.

INFLATABLE AMUSEMENT RIDE: An Amusement Ride and Device (as defined) designed for bounce, climb, slide, or interactive play. They are made of flexible fabric, kept inflated by continuous air flow by one or more blowers, and rely upon air pressure to maintain their shape.

INFORMATION PLATE: A manufacturer-issued information plate, printed in English, which is permanently affixed to a ride or device in a visible location, and is designed to remain legible for the expected life of a ride or device. The plate shall include, but not be restricted to, the following applicable items:

Ride Serial Number - A manufacturer-issued unique identifying number or code affixed to the ride in a permanent fashion.

Ride Name and Manufacturer - A manufacturer-issued unique identifying ride name, including the name of the manufacturer by city, state, and country.

Ride Model Number - A manufacturer-issued unique identifying number or code assigned to each manufactured type of ride having the same structural design or components.

Date of Manufacture - The date (month and year) determined by the manufacturer that the given ride or device met his required construction specifications.

Ride Speed - Maximum and minimum revolutions per minute, feet per second, or miles per hour, as applicable.

Direction of Travel - When the proper direction of travel is essential to the design operation of the ride, the manufacturer shall designate the direction of travel, including reference point for this designation.

Passenger Capacity by Weight - Maximum total passenger weight per passenger position.

Passenger Capacity by Number - Maximum total number of adult or child passengers per passenger position and per ride.

INJURY: Means an injury that results in death or requires immediate medical treatment administered by a physician or by registered professional personnel under the standing orders of a physician. Medical treatment does not include first aid treatment or one-time treatment and subsequent observation of minor scratches, cuts, burns, splinters, or other minor injuries that do not ordinarily require medical care even though treatment is provided by a physician or by registered professional personnel.

INJURY, REPORTABLE: Any Injury (as defined) caused by a malfunction or failure of an Amusement Ride and Device, or any Injury (as defined) caused by a Ride Operator or patron error.

INSPECTION: A procedure to be conducted, for new installations, Major Modifications, or annually (if an existing ride has not been modified), by an Inspector (as defined) or Division employee to determine whether an Amusement Ride and Device is being constructed, assembled, maintained, tested, operated, and inspected in accordance with the standards adopted by these regulations and the manufacturer’s recommendations, as applicable, and that determines the current operational safety of the ride or device.

All Inspections shall be documented by a written inspection report to be filed with the Operator.

INSPECTION, DAILY: A procedure to be performed and recorded by the Operator of an Amusement Ride and Device, on days the ride or device will be operated that confirms the current operational safety of the ride or device in accordance with these regulations and the manufacturer’s recommendations, as applicable.

INSPECTOR: An individual certified by the Division, to conduct Inspections of Amusement Rides and Devices in accordance with the standards adopted by these regulations and the manufacturer’s recommendations and criteria.

MAJOR MODIFICATION: Any change in either the structural or operational characteristics of the ride or device which will alter its performance from that specified in the manufacturer's design criteria.

NAARSO: National Association of Amusement Ride Safety Officials.

OPERATOR: An individual, corporation, or company or agent thereof who owns, controls or has the duty to control the operation of an Amusement Ride and Device.

PERMIT YEAR: The time during which an Operator is registered that begins on the Registration effective date and ends 12 months from the effective date. These dates appear on the signed permit that an Operator receives once the Registration application has been approved.

PRIVATE EVENT: An exclusive gathering that is not open to the general public. These events are typically invitation-only such as a private gathering limited to members and guests of a family, membership of an organization or club where access to the Amusement Ride and Device is provided without compensation. Temporary lodging, ticket sales, and/or reservation systems used to manage attendance does not amount to a private event.

QUALIFIED PERSON: An individual who, by possession of a recognized degree, certificate, or professional standing; or who, by possession of extensive knowledge, training, and/or experience in the subject field; has successfully demonstrated ability in design, analysis, evaluation, installation, inspection, specification, testing, or training in the subject work, project, or product, in accordance with the standards adopted by these regulations.

RACE-KARTS: A go-kart designed for competitive sport racing use in either sanctioned racing on tracks or other areas of competition, or in a racing school facility, and not to be used by the general public in an amusement facility. Race-kart drivers must wear approved safety equipment, consisting of a minimum of a Snell or DOT approved helmet and closed-toed shoes. Race-karts regularly reach maximum speeds in excess of 25 miles per hour.

REGISTRATION: The filing of a properly completed application with the Division and approval of the application by the Division.

RIDE OPERATOR: The person that has control of the Amusement Ride and Device at all times or is supervising a patron-directed device when it is being operated for the public’s use.

SERVICE PROVEN: As defined in ASTM F2291-18, “an amusement ride, device, or major modification to an amusement ride or device of which units(s) have been in service to the public for a minimum of five years and unit(s) that have been in service have done so without any significant design related failures or significant design related safety issues that have not been mitigated.”

SIMULATOR: Any amusement ride that is a self-contained unit that uses a motion picture simulation, along with a mechanical movement which requires the use of manufacturer-provided restraints, to simulate activities that provide amusement or excitement for the patron.

SPECIAL AMUSEMENT BUILDING: A building or portion thereof that is temporary, permanent, or mobile and contains a ride or device that conveys patrons where the patrons can be contained or restrained, or provides a walkway along, around, or over a course in any direction as a form of amusement or entertainment, and arranged so that the egress path is not readily apparent due to visual or audio distractions, contains an intentionally confounded egress path, or is not readily available due to the mode of conveyance through the building or structure.

SUBSIDIARY RELATIONSHIP: An independent company that is controlled by another company, usually referred to as the parent or holding company.

TRACKLESS TRAIN: An articulated vehicle used for the transport of passengers, comprising of a driving vehicle pulling one or more carriages connected by drawbar couplings. Also known as barrel trains.

TRAMPOLINE, INSTITUTIONAL: A trampoline intended for use in a commercial or institutional facility.

TRAMPOLINE COURT OR TC: A defined area comprising one or more institutional trampolines or a series of institutional trampolines.

TRAMPOLINE COURT FOAM PIT OR TC FOAM PIT: A combination style dismount pit designed with a rebound device, covered with loose impact absorbing blocks.

WATER SLIDES: Rides intended for use by riders in bathing attire where the action of the ride involves possible and purposeful immersion of the rider’s body either in whole or in part in water, and uses circulating water to mobilize or lubricate the rider’s transportation along a purpose built path.

ZIP LINE: A concession, commercial amusement device where participants attached to a pulley traverse by gravity from one point to another by use of a cable or rope line suspended between support structures.

ZIP LINE TOUR OR ZIP LINE COURSE: A guided aerial exploration or transit of a landscape by means of a series of Zip Lines and platforms generally supported by man-made structures.

ARTICLE 2 GENERAL REQUIREMENTS

Amusement Rides and Devices may not open to the public within the State of Colorado unless the Operator has registered with the Division, received a permit from the Division and has satisfied and is continuing to satisfy the requirements as provided herein.

Section 2-1 Financial Standards (A) Any person who operates an Amusement Ride and Device must have currently in force an insurance policy written by an insurance company authorized to do business in this state or by a surplus lines insurer, in an amount of not less than $100,000 per occurrence with a $300,000 annual aggregate for Class A Amusement Rides and Devices and an amount of not less than $1 million per occurrence for Class B Amusement Rides and Devices insuring the Operator against liability for Injury arising out of the use of the amusement ride.

(B) For governmental entities, insurance or self-insurance in accordance with 24-10-115 C.R.S. of The Governmental Immunity Act, or participation in a public entity self-insurance pool pursuant to 24-10-115.5 C.R.S. of The Governmental Immunity Act shall be deemed to meet the financial standards of this section.

Section 2-2 Access to Records and Devices 2-2-1 Access (A) Division representative may enter during normal business hours, without advance notice, the premises where Amusement Rides and Devices are located, including places of storage or use, for the purpose of device inspections and/or examining any records or documents required under these regulations. 2-2-2 Records Requirements (A) Every Amusement Ride and Device Operator shall maintain detailed records relating to the construction, repair and maintenance of its operation, including safety, inspection, maintenance records and Ride Operator training activities.

(B) Records shall be made available to the Division at reasonable times, including during an Inspection upon the Division’s request.

(C) Records of Daily Inspections must be available for inspection at the location where the ride or device is operated.

(D) All records must be maintained for a period of three years, unless otherwise specified in this

regulation.

Section 2-3 Registration No person shall open to the public and operate any Amusement Ride and Device on property owned or leased by such person until the Operator of the Amusement Ride and Device has first registered and obtained a permit for operation from the Division. 2-3-1 Application Submission and Processing (A) The Amusement Rides and Devices application shall be submitted for new installations and annually on the form prescribed by the Division and shall include the following Registration requirements.

(1) The name, address, and contact information of the Operator.

(a) Operator shall be responsible for notifying the Division of any change in ownership or contact information within 30 days of the change.

(2) The number of rides or devices being registered in a permit year.

(3) A report of any Injury occurring in any state that meets the definition of a Reportable Injury (as defined) in this regulation.

(4) A list of the dates and locations of operation of the Amusement Rides and Devices within the state for the upcoming Permit Year, including the dates at each location. This list may be updated throughout the Permit Year, provided that notification is received by the Division prior to operation.

(5) The name of all liability insurance carriers and the insurance policy numbers, and expiration dates. Proof of insurance, as required in Section 2-1 (A), shall be made to the Division upon request.

(a) When liability insurance policies expire prior to the end of the registration period, they must be renewed and the updated expiration dates shall be submitted to the (6) A Certificate of Inspection for each Amusement Ride and Device showing the name, serial number, manufacturer of the ride, year of manufacture, type of inspection, the Inspector's name, the Operator name and other information as required by these rules.

(a) For annual, new installation, or Major Modification Inspections see Section 2- 4.(7) Any other information reasonably related to the standards set forth in Article 1.

(B) Upon receipt of an application, the Division shall review the application, and upon determining that the provisions of these rules have been met, shall approve the application, register the Amusement Rides and Devices and issue a permit to operate.

(C) The submittal of a registration application does not guarantee the Registration of any Amusement Ride and Device. The Operator must obtain a permit from the Division prior to opening any ride or device to the public. 2-3-2 Application Fees Annual Registration Fees The following fee schedule applies to permits issued during the following dates:

Effective Date:

Registration Fee Per Amusement Ride and Device Operator + Registration Fee Per Amusement Ride and Device On or before December 31, 2024 $500 + $130 January 1 – December 31, 2025 $600 + $180 January 1 – December 31, 2026 $700 + $220 On or after January 1, $800 + $260 2-3-3 Incomplete Applications (A) Upon receipt of an incomplete application or an application requiring additional information, the applicant will be notified of the deficiency or additional requirements.

(B) If the deficiency is not corrected or if the Division does not receive the additional information within 180 days following the date of notification, the application shall be considered abandoned and the Division shall not retain the application. 2-3-4 Aerial Adventure Courses (A) Each Aerial Adventure Course is generally considered to be one ride or device based on the Information Plate.

(B) If an Information Plate is not provided, and the Operator registers multiple Aerial Adventure Courses as one device, the following will apply:

(1) All Aerial Adventure Courses registered as one device shall be inspected and listed on the Certificate of Inspection as one device by the Inspector.

(2) When any one Aerial Adventure Course registered in the device is shut down or inoperative, all other Aerial Adventure Courses included in the device must also be shut down.

(C) It is the responsibility of the Aerial Adventure Course Operator to correctly register each device being operated. 2-3-5 Trampoline Courts (A) Each trampoline court is generally considered to be one ride or device based on the Information Plate. 2-3-6 Zip Lines (A) Each Zip Line is generally considered to be one ride or device based on the Information Plate.

(B) If an Information Plate is not provided and the Operator registers multiple Zip Lines as one device, the following will apply:

(1) All Zip Lines registered as one device shall be inspected and listed on the Certificate of Inspection as one device by the Inspector.

(2) When any one Zip Line registered in the device is shut down or inoperative, all other Zip Lines included in the device must also be shut down.

(C) It is the responsibility of the Zip Line Operator to correctly register each device being operated.

Section 2-4 Inspections 2-4-1 Annual Inspections (A) An annual Inspection by an Inspector must be conducted on each Amusement Ride and Device.

(1) Each Amusement Ride and Device must have a current Certificate of Inspection prior to opening to the public.

(2) The Inspection shall be conducted with the Amusement Ride and Device in an operable state prior to opening to the public and include an evaluation of the ride or device for a minimum of one complete operating cycle, where applicable.

(3) The Inspection shall also include a review of the Operator's Daily Inspection records, inspection and maintenance program records and training records in accordance with the standards adopted by these regulations and the manufacturer’s recommendations, as applicable.

(B) Any Amusement Ride and Device open to the public in the state of Colorado must have a valid Certificate of Inspection on file with the Division.

(1) Each item number on the Certificate of Inspection is considered to represent one ride or device.

(2) The ride Operator shall be responsible for submitting a completed and signed Certificate of Inspection to the Division for all rides or devices being opened to the public.

(3) A grace period of 30 days immediately following the expiration date of a Certificate of Inspection shall exist and that Certificate of Inspection shall continue to be valid during that time period.

(4) An inspection report for each Amusement Ride and Device shall be made available to the Division at reasonable times, including during an Inspection, upon the Division’s request.

(C) The Certificate of Inspection shall not be submitted to the Division until all discrepancies have been resolved and all necessary repair(s) or replacement(s) required in accordance with the applicable standards of Section 1-5 have been made.

(1) Resolution of discrepancies, repairs and replacements may be documented in writing by the Operator and delivered to the Inspector.

(2) The Inspector may corroborate such letter by review thereof, subsequent re-inspection, receipt of additional documentation, or by other means which the Inspector deems appropriate.

(3) Corroborated discrepancies, repairs and replacements shall not require further Inspection.

(D) No person shall open to the public an Amusement Ride and Device that has been inspected by an Inspector or by the Division and found to be unsafe unless:

(1) All necessary repairs and modifications to the ride have been completed and certified as completed by an Inspector and (2) A valid Certificate of Inspection is on file with the Division. 2-4-2 Daily Inspections (A) In addition to the Inspection(s) required under this section, the Operator who operates an Amusement Ride and Device must perform and record Daily Inspections of each Amusement Ride and Device, including an evaluation of the ride or device for a minimum of one complete operating cycle, where applicable.

(B) Records of the Daily Inspections must be available for inspection at the location where the Amusement Ride and Device is operated, and the records must be maintained with the Amusement Ride and Device for a period of three years.

(C) The Daily Inspection records must include an inspection of equipment identified for Daily Inspection in accordance with the applicable codes and the manufacturer’s recommendations. 2-4-3 New Installation and Major Modification Inspections (A) In addition to an annual Inspection, new ride installations and following Major Modifications of existing rides and devices, a signed Certificate of Inspection shall be submitted to the Division before the ride is opened to the public.

(B) The Operator shall make available to the Division a written statement, completed by a Qualified Person or agent thereof, stating that the ride meets the applicable design requirements set forth in Section 1-5 of these regulations. The Qualified Person or agent thereof shall identify under which standards the ride was evaluated.

(C) Additionally, the Operator shall make available to the Division for any new installation or structural change, the following:

(1) An As-built document.

(2) A copy of the certificate of occupancy issued by the local building authority, if the local building authority has such a requirement. This requirement may be fulfilled within 90 days following the issuance of the Registration Permit from the Division.

(D) For sub-sections (B) and (C) these documents shall be maintained for the life of the ride or device.

Section 2-5 Ride Operations 2-5-1 General (A) Ride Operators shall be trained in accordance with these regulations, adopted codes and standards, and any applicable recommendations provided by the Amusement Ride and Device manufacturer.

(B) Amusement Ride and Device Operators are required to operate each ride or device in accordance with these regulations, adopted codes and any applicable manufacturers’ recommendations.

(C) Consideration shall be given to environmental factors, including humidity, precipitation, temperature and wind effects on patron safety, where applicable.

(D) Operators shall have a reasonable written plan in place for the management of emergencies, including, but not limited to the following, where applicable:

(1) Prevention strategies;

(2) Emergency preparedness;

(3) Administrative response to emergencies;

(4) Field response to medical emergencies;

(5) Field response to incidents/accidents and fatalities;

(6) Technical rescues;

(7) Activating the emergency medical system;

(8) Evacuations; and (9) Addressing severe weather. 2-5-2 Aerial Adventure Courses (A) Operators of Aerial Adventure Courses shall follow the general requirements listed below:

(1) Verify any connection between the patron and the device are properly made.

(2) Document these requirements in the operator’s manual.

(B) Additionally, for Zip Line operations, the Operator shall:

(1) Have a full understanding of and proficiency in the setup, operation and ongoing monitoring requirements of the Braking System in effect when operating Zip Lines.

(2) Ensure that the departure of patrons from dispatch zones is performed in a controlled manner and only when the Zip Line is clear of other persons.

(3) Ensure that the deceleration and arrest of patrons arriving at landing zones is performed in a controlled manner.

(4) Ensure that padding used as a protective element in the landing area is not used as a brake component. 2-5-3 Free Fall Ride or Device (A) For Free Fall Ride or Device operations using personal safety equipment (such as a harness), the Operator shall utilize a secondary attachment method approved by the manufacturer.

(B) For Free Fall Ride or Device operations using Impact Attenuation (such as airbags), the Operator shall ensure the departure of patrons from the dispatch zone is performed in a controlled manner and in a method approved by the manufacturer. 2-5-4 Trampolines (A) For Institutional Trampolines, known as competitive/performance trampolines in amusement settings, the Operator shall ensure:

(1) The area that contains these trampolines must be able to be secured such that unauthorized patrons in the facility are prevented from access to it.

(2) The area must be able to be closed to access when no Qualified Person is present.

(3) The device must be directly supervised by a Qualified Person when in use; staff must be able to visually monitor and immediately communicate with patrons.

(4) All patrons must participate in education, and demonstrate progressive levels of competency, to use the device and to perform progressively advanced skills/tricks. This training must be conducted by a Qualified Person.

(5) Walls around the device shall be smooth, no shelves or places to jump from height onto the trampoline are allowed.

(6) Only one jumper per trampoline.

(7) Jumpers cannot jump between trampolines.

ARTICLE 3 INSPECTOR CERTIFICATION

Section 3-1 General Requirements (A) This section describes the requirements for the Inspector certification.

(B) The Division may request documentation in addition to that described in the following sections to verify the accuracy of information provided with a certification application.

(C) For the annual Certificate of Inspection, the Inspector shall not be affiliated by employment or by a Subsidiary Relationship to the Operator of the Amusement Ride or Device.

(D) For new installations or Major Modification Certificate of Inspections, the Inspector shall not be affiliated by employment or Subsidiary Relationship to the Operator of the Amusement Ride or Device, or the manufacturer, whose modification or new installation is being inspected.

(E) For each of the Certification Types in Section 3-2, an Inspector shall have:

(1) At least 3 years of experience with that type of ride or device as a qualified designer, manufacturer, Operator, Inspector or maintenance professional, to be certified for that type.

(a) Applicable related experience will substitute for the experience requirement as evaluated and approved by the Division.

(2) A current professional liability insurance policy written by an insurance company or by a surplus lines insurer authorized to do business in this state.

(a) Proof of insurance shall be made available upon request by the Division, or the Operator for whom the work is performed.

(F) To qualify as a professional engineer, applicants must provide a professional engineering license and proof of at least 12 months of experience working in the amusement industry.

Section 3-2 Certification Types (A) The Division may certify an applicant if the applicant has satisfied certification requirements listed in Sections 3-1 through 3-3. The Inspector certification will indicate the type of rides and devices for which the certification is allowed to inspect per these regulations. The types of rides and devices Inspection endorsements are as follows.

(1) Type 1: Traditional Amusement Rides or Devices, that are typically found at carnivals and amusement parks which would include but not be limited to roller coasters, ferris wheels and Bumper Devices, and that are not of the types listed in (A)(2) through (5) of this

section.

(2) Type 2: Aerial Adventure Courses (Climbing Walls, Free Fall Rides or Devices, ropes courses, via ferratas, and Zip Lines).(3) Type 3: Trampoline Courts and Institutional Trampolines.

(4) Type 4: Water Slides.

(5) Type 5: Special devices. Any specialty devices not listed above (i.e., Trackless Trains).

(B) A person applying for an Inspector certification shall submit to the Division a completed Inspector Certification application using the form that is provided on the Division’s website.

Section 3-3 Certification Qualifications (A) Qualifications for licensing are as follows:

(1) Type 1 Inspector certification qualification shall consist of certification through one of the (a) NAARSO Level 2 Inspector or higher; or (b) AIMS Inspector Level 2 or higher; or (c) The Pennsylvania Department of Agriculture – General Qualified Inspector; or (d) Qualify as a professional engineer per Section 3-1 (F); or (e) Another nationally recognized organization approved by the Division; or (f) Experience evaluated and approved by the Division (2) Type 2 Inspector certification qualification shall consist of certification through one of the (a) NAARSO Level 2 Inspector or higher; or (b) AIMS Inspector Level 2 or higher; or (c) ACCT Level 2 Professional Inspector or higher; or (d) Qualify as a professional engineer per Section 3-1 (F); or (e) Another nationally recognized organization approved by the Division; or (f) Experience evaluated and approved by the Division (3) Type 3 Inspector certification qualification shall consist of certification through one of the (a) NAARSO Level 2 Inspector or higher; or (b) AIMS Inspector Level 2 or higher; or (c) Qualify as a professional engineer per Section 3-1 (F); or (d) Another nationally recognized organization approved by the Division; or (e) Experience evaluated and approved by the Division (4) Type 4 Inspector certification qualification shall consist of certification through one of the (a) Those listed in Section 3-3 (A)(1) (Type 1); or (b) CIRSA certification; or (c) Another nationally recognized organization approved by the Division.

(5) Type 5 Inspector certification qualification shall consist of certification that complies with

Section 3-3 (A)(1).

(B) The Division reserves the right to review an applicant or Inspector’s experience and certification status at any time to ensure that the applicant or Inspector:

(1) Demonstrates sufficient general knowledge of amusement rides to effectively inspect, evaluate, and identify issues with rides that could or will have an impact on public safety;

(2) Is fully versed in and able to apply Colorado-specific rules and regulations; and (3) Is able to communicate that information to the amusement ride Operators for whom the Inspection is being carried out.

Section 3-4 Inspector Certification and Renewal (A) Inspector certifications will expire annually on April 15.

(B) The Inspector certification issued by the Division shall be valid for up to one year. The Division may issue or renew an Inspector certification, provided the applicant submits the following:

(1) A completed Inspector certification application form.

(2) Documentation that the applicant is currently certified as listed in Section 3-2 (A) of this

section.

Section 3-5 Revocation, Suspension, or Denial of Inspector Certification (A) A certification may be denied, suspended, or revoked by the Division because of, but not limited to the following:

(1) Failure to show sufficient proof of required credentials or experience with Amusement Ride or Device Inspections;

(2) Non-compliance with an order issued by the Division within the time specified in such order;

(3) Failure to comply with these regulations;

(4) Giving false information or a misrepresentation to the Division in order to obtain or maintain a certification;

(5) Making a false affidavit or statement under oath to the Division in an application or report; or (6) Other factors which, at the discretion of the Division, indicate an unfitness to hold an Inspector certification in compliance with these regulations.

(B) The Division shall deny, suspend, or revoke an Inspector certification according to the process described in Section 6-1-3 of these regulations.

ARTICLE 4 INJURY REPORTING

Section 4-1 Reportable Injury (A) State of Colorado regulations require that Amusement Ride and Device Operators notify the Division of any Reportable Injury.

(B) A Reportable Injury is any Injury (as defined) caused by a malfunction or failure of an Amusement Ride or Device, or any Injury (as defined) caused by an Operator or patron error.

(C) A Reportable Injury (as defined) must be reported to the Division by calling 303-514-3281 or 303- 941-9438 within 24 hours of the time that the Ride Operator or Operator becomes aware of the Injury.

(D) Injury reports, as provided by the Division or equivalent, shall be maintained and made available to the Division for investigation. Copies must be submitted upon request from the Division.

Section 4-2 Reportable Injury Scene Preservation If a Reportable Injury occurs, the equipment or conditions that caused the accident shall be preserved for the purpose of an investigation by the Division unless an investigation is deemed unnecessary by the

ARTICLE 5 PATRON RESPONSIBILITY

Patrons are required to follow any written or verbal instructions that are given to them regarding the use of Amusement Rides or Devices.

ARTICLE 6 ENFORCEMENT

Section 6-1 Enforcement Program The Division provides these regulations to assist Operators and Inspectors with safe and proper operation of Amusement Rides and Devices. The Division may inspect the premises and operation of the Amusement Ride or Device to insure that the financial and safety standards in this regulation have been met. When an Amusement Ride or Device is found to be out of compliance with these regulations, the Division will pursue enforcement actions against the Operator or Inspector who is in violation of these regulations and/or statutes (8-20 C.R.S.).

The enforcement process will include requiring the Operator or Inspector to make repairs and/or upgrades, perform system tests, provide records and complete other actions to bring the Amusement Ride or Device back into compliance. During and following the enforcement process, the Division will continue to assist the Operator or Inspector to remain in compliance. The enforcement process may include monetary penalties of up to one thousand dollars ($1,000) per violation per day according to statute (8-20-104 C.R.S.) if the enforcement obligations are not implemented according to the required schedule. 6-1-1 Notice of Violation (A) A notice of violation (NOV) may be issued to an Operator when an Amusement Ride or Device is found to be out of compliance with these regulations and/or statutes. The notice of violation may include fines and/or an order to cease and desist operation of the specific Amusement Ride or Device until all violations are satisfactorily corrected.

An NOV may be issued to an Inspector when the Inspector has failed to comply with these regulations and/or statutes. The notice of violation may include fines and/or a suspension of the inspector’s certification.

(B) Within ten working days after an NOV has been issued, the person issued the NOV may file a written request with the Division for an informal conference regarding the NOV. Upon receipt of the request, the Division shall provide the alleged violator with notice of the date, time and place of the informal conference. During the conference, the alleged violator and Division personnel may present information and arguments regarding the allegations and requirements of the NOV.

(C) Within 20 days after the informal conference, the Division shall uphold, modify, or strike the allegations within the NOV in the form of a settlement agreement or an enforcement order.

(D) If the alleged violator fails to timely request an informal conference, the terms of the NOV become a binding enforcement order not subject to further review. 6-1-2 Enforcement Order (A) An enforcement order may be issued when the violations included within an NOV are not resolved within the prescribed time frame or when the schedule set forth in a settlement agreement is not met.

(B) An enforcement order may include increased fines of up to one thousand dollars ($1,000) per violation for each day of violation. In addition, the enforcement order may include shut-down of the Amusement Ride or Device and/or suspension or revocation of the permit or Inspector certification.

(C) An alleged violator may appeal the enforcement order to the Division for a hearing under 24-4- 105 C.R.S. The Division shall then issue a final decision which is subject to judicial review under 24-4-106 C.R.S. 6-1-3 Procedure on Revocation, Suspension, or Denial of Inspector Certification (A) In any case where the Division denies a certification or the applicant or certified Inspector is subject to suspension or revocation for a violation of these regulations, the Division shall notify the applicant or certified Inspector in writing by first-class mail of the grounds for denial for the violation. The notice shall state that the applicant or certified Inspector may request a hearing in accordance with 24-4-104 and 24-4-105 C.R.S.

(B) The Division may summarily suspend a certification if the Division has objective and reasonable grounds to believe that the public health, safety, or welfare requires emergency action. In such case, the Division shall notify the certified Inspector in writing by first-class mail of the grounds for summary suspension and shall state that the certified Inspector may request a hearing in accordance with 24-4-105 C.R.S.

(C) Upon notice of the revocation or suspension of any certification, the former Inspector shall immediately surrender to the Division the certification and all copies thereof.

(D) Any person whose certification has been denied or suspended under Section 3-5 may apply to the Division for a hearing in order to seek relief.

(1) The hearing shall be conducted by the Division or an Administrative Law Judge with the Division of Administrative Hearings on behalf of the Division in accordance with the procedures of 24-4-105 C.R.S.

(2) The Division may grant the relief requested in the hearing if the Division determines that the circumstances regarding the denial, suspension, or revocation, and the applicant's record and reputation are such that the granting of such relief is not contrary to public safety.

(E) Any person aggrieved by a decision or order of the Division may seek judicial review pursuant to the provisions of 24-4-106 C.R.S.

(F) The period of denial, suspension, or revocation shall be within the sound discretion of the (G) Any person who has been denied a certification may not reapply to the Division for a certification within one year of the decision, unless exception is made by the Division and the applicant establishes a substantial change in circumstances to indicate fitness to hold an Inspector certification in accordance with the requirements of these regulations.

(H) In case of revocation or suspension of an Inspector certification, the Division shall notify all certifying associations that have issued said Inspector any certifications used for the approval by the Division, after a final decision has been reached of such revocation or suspension. _________________________________________________________________________

Editor's Notes

History Entire rule eff. 12/01/2008.

Rules 1.2 to 2.0, 2.2(a), 3.0, 3.1, 5.0 to 6.0 emer. rules eff. 07/07/2010; expired eff. 11/04/2010.

Entire rule emer. rule eff. 12/30/2010; expired 04/29/2011.

Entire rule eff. 05/01/2011.

Entire rule eff. 04/14/2013.

Entire rule emer. rule eff. 11/07/2013; expired 03/07/2014.

Entire rule eff. 05/07/2014.

Entire rule eff. 07/30/2015.

Entire rule eff. 07/15/2019.

Entire rule eff. 08/30/2024.

7 CCR 1101-14 Storage Tank Regulations {#sec-7-ccr-1101-14 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-14}

DEPARTMENT OF LABOR AND EMPLOYMENT

STORAGE TANK REGULATIONS

7 CCR 1101-14 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _______________________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Statement of Basis and Purpose These regulations are promulgated to establish rules for the design, installation, registration, construction, and operation of storage tanks used to store regulated substances (including petroleum), responses to releases of regulated substances from these tanks, and to describe the financial responsibility of storage tank owner/operators. The main purpose of these regulations is to reduce damage to the environment and risk to the public caused by leaking petroleum storage tanks and to mitigate such damage effectively when it occurs.

These regulations do not apply to material classified as hazardous wastes under Subtitle C of the U.S.

Solid Waste Disposal Act.

The amendment to Article 9 of these regulations is developed pursuant to the Colorado Revised Statutes 8-20.5-103(9) that created the Petroleum Cleanup and Redevelopment Fund. The rules are designed to establish the implementation and operational guidelines of this fund.

Section 1-2 Technical Rationale The technical requirements of these regulations are supported by many studies made by petroleum industry associations, the National Fire Protection Association (NFPA), the American Society of Testing and Materials (ASTM), and by or at the behest of the U.S. Environmental Protection Agency (EPA). The requirements represent the consensus of informed persons with regard to the best methods for reducing the hazards posed by storage tanks to acceptable levels.

Section 1-3 Statutory Authority The amendments to these regulations have been created pursuant to Title 8 Article 20 Section 102 and

Article 20.5 Sections 202 and 302 of the Colorado Revised Statutes (C.R.S.). The design, construction, location, installation, and operation of liquid fuel systems and equipment and the handling of liquid fuels shall conform to the minimum standards as prescribed by the applicable sections of NFPA 30 “Flammable and Combustible Liquids Code” and NFPA 30A "Code for Motor Fuel Dispensing Facilities and Repair Garages".

Section 1-4 Effective Date These amended rules shall be effective on January 1, 2025. The prior editions of the combined UST/AST regulations were published March 17, 2019; May 1, 2018; May 1, 2017; January 1, 2017; October 15, 2014; January 1, 2014; May 1, 2013; April 14, 2011; January 1, 2009; August 1, 2008; April 30, 2006;

May 30, 2005; August 1, 2004; August 1, 2002; February 1, 1999; and January 1, 1997. Prior editions of the UST rules were published effective September 30, 1995, and December 1, 1989. Prior editions of the AST rules were published effective September 30, 1995, and October 1, 1994. A prior edition of the Emission Inspection rules was published effective January 1, 1990.

Section 1-5 Definitions Terms in these regulations shall have the same definitions as those found in Articles 20 and 20.5 of Title 8 of the Colorado Revised Statutes. In addition, unless the context otherwise requires:

“Abandoned tank” means an underground or aboveground petroleum storage tank that the current tank owner or operator or current property owner did not install, has never operated or leased to another for operation, and had no reason to know was present on the site at the time of site acquisition.

“Aboveground storage tank” (AST) means any one or a combination of containers, vessels, and enclosures, including structures and appurtenances connected to them, constructed of nonearthen materials, including but not limited to concrete, steel, or plastic, which provide structural support, used to contain or dispense fuel products and the volume of which, including the pipes connected thereto, is ninety percent or more above the surface of the ground, is not permanently closed, and except those exempted in statute and these regulations.

“Aboveground storage tank (AST) system” means all ASTs at a facility, all the connected piping and ancillary equipment, all loading facilities, and all containment systems if applicable.

“Alternative fuel” means a motor fuel that combines petroleum-based fuel products with renewable fuels.

“Ancillary equipment” means any devices including, but not limited to, such devices as piping, fittings, flanges, valves, and pumps used to distribute, meter, or control the flow of regulated substances to and from an UST.

“ASTM International (ASTM)” means an international voluntary consensus standards organization formed for the development of standards on characteristics and performance of materials, products, systems, services, and the promotion of related knowledge.

“Atmospheric tank” is a storage tank that has been designed to operate at pressures from atmospheric through 0.5 psig (760 mm Hg through 780 mm Hg) measured at the top of the tank.

“Bodily injury” shall have the meaning given to this term by applicable Colorado state law; however, this term shall not include those liabilities which, consistent with standard insurance industry practices, are excluded from coverage in liability insurance policies for bodily injury.

“Bulk plant” is that portion of a property where liquids are received by tank vessel, pipelines, tank car, or tank vehicle and are stored or blended in bulk for the purpose of distributing such liquids by tank vessel, pipeline, tank car, tank vehicle, portable tank or container. [Note: A bulk plant is normally a wholesale fuel facility where petroleum products are stored prior to resale or redistribution.]

“Calendar days” means consecutive days including weekends and nationally recognized holidays.

“Cathodic protection” is a technique to prevent corrosion of a metal surface by making that surface the cathode of an electrochemical cell. For example, an UST or AST system can be cathodically protected through the application of either galvanic anodes or impressed current.

“Cathodic protection tester” means a person who can demonstrate an understanding of the principles and measurements of all common types of cathodic protection systems as applied to buried or submerged metal piping and UST and AST systems. At a minimum, such persons must have education and experience in soil resistivity, stray current, structure-to-soil potential, and component electrical isolation measurements of buried metal piping and UST and AST systems.

“Certificate of conformance” means a document issued by the national type evaluation program constituting evidence of conformance of a weighing and measuring device with the requirements of the National Institute of Standards and Technology (NIST) Handbook 44.

“Certificate of Eligibility” is a document that entitles the bearer to participate in the Fund without further determination of compliance by the Director, if that bearer is a mortgagee who has acquired, by foreclosure or receipt of a deed in lieu of foreclosure, property on which the petroleum storage tanks covered by the certificate are located.

“CFR” Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government “Change in service” means continued use of an UST or AST to store a non-regulated substance.

“Chemicals of concern” (COCs) are chemical compounds that have been identified for evaluation due to specific risks to human health and/or the environment.

“Committee” means the Petroleum Storage Tank Committee created in C.R.S. § 8-20.5-104.

“Compatible” means the ability of two or more substances to maintain their respective physical and chemical properties upon contact with one another for the design life of the tank system under conditions likely to be encountered.

“Connected piping” means all piping including valves, elbows, joints, flanges, and flexible connectors attached to a tank system through which regulated substances flow. For the purpose of determining how much piping is connected to any individual AST or UST system, the piping that joins two systems should be allocated equally between them.

“Containment sump” means a liquid-tight container that protects the environment by containing leaks and spills of regulated substances from piping, dispensers, pumps and related components in the containment area. Containment sumps may be single walled or secondarily contained and located at the top of tank (tank top or submersible turbine pump sump), underneath the dispenser (under-dispenser containment sump), or at other points in the piping run (transition or intermediate sump).

“Contamination” means the presence of a regulated substance at or below ground that originated from a regulated storage tank system.

“Corrosion expert” means a person who, by reason of thorough knowledge of the physical sciences and the principles of engineering and mathematics acquired by professional education and related practical experience, is qualified to engage in the practice of corrosion control on buried or submerged metal piping systems and metal tanks. Such a person must be accredited or certified as being qualified by the National Association of Corrosion Engineers or be a registered professional engineer who has certification or licensing that includes education and experience in corrosion control of buried or submerged metal piping systems and metal tanks.

“Dielectric material” means a material that does not conduct direct electrical current. Dielectric coatings are used to electrically isolate systems from the surrounding soils. Dielectric bushings are used to electrically isolate portions of the system (e.g., tank from piping).

“Dispenser” means equipment that dispenses regulated substances from the storage tank system.

“Dispenser system” means the dispenser and the equipment necessary to connect the dispenser to the storage tank system.

“Director” means the Director of the Division of Oil and Public Safety of the Colorado Department of Labor and Employment or any designees thereof which may include certain employees of the Division of Oil and Public Safety of the Colorado Department of Labor and Employment or other persons.

“Downgradient” is in the direction of maximum decreasing static head.

“Electrical equipment” means underground equipment that contains dielectric fluid that is necessary for the operation of equipment such as transformers and buried electrical cable.

“Electrolyte” means the soil or liquid adjacent to and in contact with the systems, including the moisture and other chemicals contained in it; the electrically conductive material between the tank and its environment;

“Excavation zone” means the volume containing the UST system and backfill material bounded by the ground surface, walls, and floor of the pit and trenches into which the UST system is placed at the time of installation.

“Exposure pathway” is the course that a chemical of concern takes from a source area to a point of exposure. An exposure pathway describes a unique mechanism by which a person or sensitive environment is assumed to be exposed to a chemical of concern. Each exposure pathway includes a source, an exposure route, and a point of exposure. If the exposure point differs from the source, transport or exposure media (e.g., air, water, dust) are also included. All exposure pathways are assumed to be complete unless an exposure pathway elimination criteria is demonstrated. Exposure pathway elimination criteria are listed in the Owner/Operator Guidance Document.

“Farm tank” is a tank located on a tract of land devoted to the production of crops or raising animals, including fish, and associated residences and improvements. A farm tank must be located on the farm property. “Farm” includes fish hatcheries, rangeland and nurseries with growing operations.

“Financial reporting year” means the latest consecutive twelve-month period for which any report used to support a financial test is prepared. “Financial reporting year” may thus comprise a fiscal or a calendar year period.

“Fire resistant tank” is an atmospheric single or double-walled AST with thermal insulation that has been evaluated for resistance to physical damage and for limiting the heat transferred to the primary tank when exposed to a hydrocarbon pool fire, and is listed in accordance with UL 2080 or an equivalent test procedure..

“Flow-through process tank” is a tank that forms an integral part of a production process through which there is a steady, variable, recurring, or intermittent flow of materials during the operation of the process. Flow-through process tanks do not include tanks used for the storage of materials prior to their introduction into the production process or for the storage of finished products or byproducts from the production process.

“Fund” means the Petroleum Storage Tank Fund (PSTF) created in C.R.S. § 8-20.5-103.

“Gathering lines” means any pipeline, equipment, facility, or building used in the transportation of oil or gas during oil or gas production or gathering operations.

“Good Engineering Practice”, “Good Engineering Standards”, and “Nationally Recognized Standard” means in accordance with standards developed by nationally recognized laboratories or associations such as: Underwriters Laboratory (U.L.), American National Standards Institute (ANSI), American Petroleum Institute (API), American Society for Testing and Materials (ASTM), American Society of Mechanical Engineers (ASME), Steel Tank Institute (STI), Association for Materials Protection and Performance (AMPP), or the National Fire Protection Association (NFPA).

“Hazardous substance UST system” means an UST system that contains a hazardous substance defined in section 101(14) of the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (but not including any substance regulated as a hazardous waste under subtitle C) or any mixture of such substances and petroleum, and which is not a petroleum UST system.

“Heating oil” means petroleum that is No. 1, No. 2, No. 4--light, No. 4--heavy, No. 5--light, No. 5--heavy, and No. 6 technical grades of fuel oil; other residual fuel oils (including Navy Special Fuel Oil and Bunker C); and other fuels when used as substitutes for one of these fuel oils. Heating oil is typically used in the operation of heating equipment, boilers, or furnaces.

“Hydraulic conductivity” is the coefficient of proportionality describing the rate at which water can move through a permeable medium.

“Hydraulic gradient” is the slope of the water table in the direction of groundwater flow. This slope is typically expressed as a unit change in water table elevation per unit horizontal distance (e.g. ft/ft).

“Hydraulic lift tank” means a tank holding hydraulic fluid for a closed-loop mechanical system that uses compressed air or hydraulic fluid to operate lifts, elevators, and other similar devices.

“Imminent threat to human health or safety or the environment” means a condition that creates a substantial probability of harm, when the probability and potential extent of harm make it reasonably necessary to take immediate action to prevent, reduce, or mitigate the actual or potential damages to human health or safety or the environment.

“Installation of a new motor fuel dispenser system” means the installation of a new motor fuel dispenser and the equipment necessary to connect the dispenser to the system. It does not mean the installation of a motor fuel dispenser installed separately from the equipment needed to connect the dispenser to the tank system. For purposes of these rules, the equipment necessary to connect the motor fuel dispenser to the tank system may include check valves, shear valves, unburied risers or flexible connectors, or other transitional components that are beneath the dispenser and connect the dispenser to the underground piping.

“Insurer” or “qualified insurer” means an insurer or group that is authorized to transact the business of insurance or authorized to provide insurance as an excess or surplus lines insurer in Colorado.

Light non-aqueous phase liquid” (LNAPL) refers to a regulated organic liquid, such as gasoline or diesel fuel, that exists as a separate phase and is less dense than water and immiscible in water.

“Liquid” is any material that has a fluidity greater than that of 300 penetration asphalt when tested in accordance with ASTM Standard D5, Test for Penetration for Bituminous Materials. When not otherwise identified, the term “liquid” shall mean both flammable and combustible liquids. [Note 1: Class I flammable liquids include all grades of Gasoline, and most motor fuels blended using alcohol and MTBE (methyl-tertiary-butyl-ether).] [Note 2: Class II combustible liquids include #1 and #2 Diesel Fuels, #1 and #2 Heating Oil, Kerosene, and Jet-A grade Jet fuel.] [Note 3: Class III combustible liquids include most Lubricating Oils, and Heavy Fuel oils.]

“Liquid, combustible” is a liquid having a flash point at or above 100°F (37.8°C). Combustible Liquids are classified as follows:

(1) CLASS II liquids have a flash point at or above 100°F (37.8°C) and below 140°F (60°C).

(2) CLASS IIIA liquids have a flash point at or above 140°F (60°C) and below 200°F (93°C).

(3) CLASS IIIB liquids have a flash point at or above 200°F (93°C).

“Liquid, flammable” is a liquid having a flash point below 100°F (37.8°C) and having a Reid vapor pressure not exceeding 40 psia (2068 mmHg) at 100°F (37.8°C). Flammable Liquids are classified as Class I liquids. Class I liquids are further subclassified as follows:

(1) CLASS IA liquids have a flash point below 73°F (22.8°C) and a boiling point below 100°F (37.8° C).

(2) CLASS IB liquids have a flash point below 73°F (22.8°C) and a boiling point at or above 100°F (37.8°C).

(3) CLASS IC liquids have a flash point at or above 73°F (22.8°C) and below 100°F (37.8°C).

“Liquid trap” means sumps, well cellars, and other traps used in association with oil and gas production, gathering, and extraction operations (including gas production plants), for the purpose of collecting oil, water, and other liquids. These liquid traps may temporarily collect liquids for subsequent disposition or reinjection into a production or pipeline stream, or may collect and separate liquids from a gas stream.

“Marine service station” is that portion of a property where liquids used as fuels are stored and dispensed from fixed equipment on shore, piers, wharves, or floating docks into the fuel tanks of selfpropelled craft, including all facilities used in connection therewith.

“Media” are intervening substances through which something is transmitted or carried (e.g. soil, water, or air).

“Mortgagee” refers to a mortgagee or the holder of evidence of debt secured by a mortgage or deed of trust.

“Motor fuel” means petroleum or a petroleum-based substance that is motor gasoline, aviation gasoline, No. 1 or No. 2 diesel fuel, fuel products as defined in C.R.S. § 8-20.5-101(6), or any grade of gasohol, and is typically used in the operation of a motor engine.

“Motor fuel dispensing facility” means that portion of a property where motor fuels are stored and dispensed from fixed equipment into the fuel tanks of motor vehicles or marine craft or into approved containers, including all equipment used in connection therewith.

(1) “Fleet vehicle motor fuel dispensing facility” means a motor fuel dispensing facility at a commercial, industrial, governmental, or manufacturing property where motor fuels are dispensed into the fuel tanks of motor vehicles that are used in connection with the business or operation of that property by persons within the employ of such business or operation.

“Net worth” means the assets that remain after deducting liabilities; such assets do not include intangibles such as goodwill and rights to patents or royalties. For purposes of this definition, “assets” means all existing economic benefits obtained or controlled by an owner/operator.

“Noncommercial purposes” with respect to motor fuel at farms and residences means not for resale.

“On Demand Mobile Fueling” means retail dispensing of Class I and Class II liquids from a mobile fueling vehicle complying with NFPA 385, with chassis mounted tanks that do not exceed an aggregate capacity of 1200 gallons, or a vehicle with chassis-mounted tanks, each of which does not exceed 110 gallons, and that does not exceed an aggregate capacity of 1200 gallons, or a vehicle that carries a maximum of 60 gallons of motor fuel in listed metal safety cans not exceeding 5.3 gallons in capacity, into the fuel tank of a motor vehicle.

“Operational life” refers to the period beginning when installation of the tank system has commenced until the time the tank system is properly closed.

“Operator” means any person in control of, or having responsibility for the daily operation of an underground or aboveground storage tank system.

“Orphaned tank” means an underground storage tank that is owned or operated by an unidentified owner or is no longer in use and was not closed, and the property has changed ownership prior to December 22, 1988, and such property is no longer used to dispense fuels.

“Out of service” means that the tank is not being operated in accordance with its intended purpose.

“Overfill” is a release that occurs when a tank is filled beyond its capacity, resulting in a discharge of the regulated substance to the environment.

“Owner” means:

(1) In the case of an underground storage tank in use on or after November 8, 1984, or brought into use after that date, any person who owns an underground storage tank system used for the storage, use, or dispensing of regulated substances;

(2) In the case of an underground storage tank system in use before November 8, 1984, but no longer in use on or after November 8, 1984, any person who owned such tank immediately before the discontinuation of its use; or (3) Any person who owns an aboveground storage tank.

(4) Regarding reporting and responding to releases of regulated substances, Owner means the person who owned the tank system at the time of the release. The term “owner” does not include any person who, without participating in the management of an underground storage tank and otherwise not engaged in petroleum production, refining, and marketing, holds indicia of ownership primarily to protect a security interest in or lien on the tank or the property where the tank is located.

“Owner(s)/operator(s) or O/O” means that the task to which this phrase is attached may be performed by either the owner or the operator. If neither the owner nor the operator performs the task, both shall be in violation of these regulations. Duplication of the task is not required.

“Person” means an individual, trust, firm, joint stock company, federal agency, corporation, state, municipality, commission, political subdivision of a state, or any interstate body. “Person” also includes a consortium, a joint venture, a commercial entity, and the United States Government.

“Petroleum” means crude oil or any fraction thereof that is liquid at standard conditions of temperature and pressure (60 degrees Fahrenheit and 14.7 pounds per square inch absolute).

“Pipe” or “Piping” means a hollow cylinder or tubular conduit that is constructed of non-earthen materials and in accordance with NFPA or other nationally recognized piping standards for petroleum storage tanks. Piping routinely contains and conveys regulated substances from the underground tank(s) to the dispenser(s) or other end-use equipment. Such piping includes any elbows, couplings, unions, valves, or other in-line fixtures that contain and convey regulated substances from the underground tank(s) to the dispenser(s). This definition does not include vent, vapor recovery, or fill lines not connected to remote fills.

“Pipeline facilities (including gathering lines)” are new and existing pipe rights-of-way and any associated equipment, facilities, or buildings.

“Point of exposure “ (POE) is the location at which a person or sensitive environment is assumed to be exposed to a chemical of concern. POEs for benzene, toluene, ethylbenzene, total xylene, and naphthalene are: property boundaries, surficial soils, subsurface utilities, structures, groundwater wells, surface water, and sensitive environments. POEs for MTBE are: water supply wells that are used for human consumption and surface water features that are used for human consumption.

“Product deliverer” means any person who delivers or deposits product into an UST. This term may include major oil companies, jobbers, petroleum transportation companies, or other product delivery entities.

“Property damage” shall have the meaning given this term by applicable Colorado laws. This term shall not include those liabilities, which, consistent with standard insurance industry practices, are excluded from coverage in liability insurance policies for property damage. However, such exclusions for property damage shall not include corrective action associated with releases from tanks, which are covered by the policy.

“Protected tank” is an atmospheric AST with integral secondary containment and thermal insulation that has been evaluated for resistance to physical damage and for limiting the heat transferred to the primary tank when exposed to a hydrocarbon pool fire and is listed in accordance with UL 2085 Standard for Protected Aboveground Tanks for Flammable and Combustible Liquids or an equivalent test procedure.

“Provider of financial assurance” means an entity that provides financial assurance to an owner/operator of an UST through mechanisms including but not limited to being an insurer, an issuer of a letter of credit, or the trustee of a trust fund.

“Red Tag” means a tag, device, or mechanism on the tank’s fill pipes that clearly identifies an UST as ineligible for product delivery. The tag or device is easily visible to the product deliverer and clearly states and conveys that it is unlawful to deliver to, deposit into, or accept product into the ineligible UST. The tag, device, or mechanism is generally tamper-resistant.

“Refined Fuels Vehicle Tank Meter (VTM)” means a meter mounted on a refined fuels delivery tank vehicle, including those used for the measurement and delivery of liquid fuel products.

“Reimbursement” means an assignment of money from the Fund to reimburse a person for approved costs incurred in remediating petroleum contamination.

“Registered Service Agency (RSA)” means any agency, firm, company, or corporation that for hire, award, commission or any other payment of any kind installs, services, repairs, or reconditions a commercial weighing or measuring device and that voluntarily registers with the division. Under agency registration, identification of individual servicepersons shall be required.

“Regulated substance” for UST systems has the same meaning as in C.R.S. § 8-20.5-101(13) as follows:

(1) Any substance defined in Section 101 (14) of the federal “Comprehensive Environmental Response, Compensation, and Liability Act of 1980”, as amended, but not including any substance regulated as a hazardous waste under subtitle (C) of Title II of the federal “Resource Conservation and Recovery Act of 1976”, as amended.

(2) Petroleum, including crude oil or any fraction thereof, that is liquid at standard conditions of temperature and pressure (60 degrees Fahrenheit and 14.7 pounds per square inch absolute).

(3) Alternative fuel (4) Renewable fuel “Regulated substance” for AST systems means regulated fuel products as defined in C.R.S. § 8-20.5- 101(6), including alternative fuels and renewable fuels as defined in CRS 8-20.5-101(2.5) and (14.5) as follows:

(1) All gasoline, aviation gasoline, diesel, aviation turbine fuel, jet fuel, fuel oil, biodiesel, biodiesel blends, kerosene, all alcohol blended fuels, gas or gaseous compounds, and other volatile, flammable, or combustible liquids, produced, compounded, and offered for sale or used for the purpose of generating heat, light, or power in internal combustion engines or fuel cells, for cleaning or for any other similar usage.

(2) Alternative fuel (3) Renewable fuel “Release” means any spilling, leaking, emitting, discharging, escaping, leaching or disposing of a regulated substance from a regulated tank system into the environment.

“Release detection” means determining whether a release of a regulated substance has occurred from the UST or AST system into the environment or a leak has occurred into the interstitial space between the UST or AST system and its secondary barrier or secondary containment around it.

“Remediation” means actions taken to reduce concentrations of chemicals of concern (including natural attenuation), or prevent migration of chemicals of concern to POEs. Remediation shall be implemented for sites where no further action is not appropriate.

“Renewable fuel” means a motor vehicle fuel that is produced from plant or animal products or wastes, as opposed to fossil fuel sources.

“Repair” means to restore to proper operating condition a tank, pipe, spill prevention equipment, overfill prevention equipment, corrosion protection equipment, release detection equipment or other AST or UST system component.

“Replace” This term applies to underground storage tanks and piping.

For underground storage tanks – Replace means to remove an existing underground storage tank and install a new underground storage tank.

For underground piping – Replace means to remove and put back in, any amount of piping connected to a tank system. The secondary containment requirements for replaced piping are triggered when a minimum of 50% or 50 feet (whichever is less) of the total length of piping connected to a single tank is replaced. The total length of piping connected to a single tank includes the length of piping from that tank to the farthest connected dispenser, including piping runs between dispensers connected to that tank.

“Reportable quantity” means quantities of a released regulated substance that equal or exceed the reportable quantity under the federal “Comprehensive Environmental Response, Compensation, and Liability Act of 1980”, as amended, and petroleum products in quantities of twenty-five gallons or more.

“Residential tank” is a tank located on property used primarily for dwelling purposes.

“Retail motor fuel device” (RMFD) is a device designed for the measurement and delivery of liquid fuel products for internal combustion engines. The term “motor-fuel dispenser” means the same as “motor-fuel device”.

“Risk-based corrective action (RBCA)” means a consistent decision making process for the assessment and response to a petroleum release, based on the protection of human health and the environment according to ASTM 1739.

“Secondary containment” This term applies to AST and UST Systems For AST systems secondary containment is containment which prevents any release from an AST system from reaching land or waters outside of the containment area, and can include remote impounding, diking, or different types of AST construction. Where underground piping is connected to an AST, the definition of “secondary containment” for UST systems also applies to the piping.

For UST systems secondary containment is a release prevention and release detection system for an underground tank and/or piping. The release prevention part of secondary containment is an underground tank and/or piping having an inner and outer barrier. Between these two barriers is a space for monitoring. The release detection part of secondary containment is a method of monitoring the space between the inner and outer barriers for a leak or release of regulated substances from the underground tank and/or piping (called interstitial monitoring). This term includes containment sumps when used for interstitial monitoring of piping.

“Secondary containment tank” is a shop-fabricated AST that includes a steel or reinforced concrete secondary shell that will provide containment of the entire capacity of the inner tank in case of leaks or ruptures of the inner tank and having means for monitoring the interstitial space for a leak.

“Sensitive environment” is an area of particular environmental value where regulated petroleum contamination could pose a greater threat than in other less sensitive areas. Sensitive environments include: critical habitat for federally endangered or threatened species, national parks, national monuments, national recreation areas, national wildlife refuges; national forests, campgrounds; recreational areas, game management areas, wildlife management areas, designated federal wilderness areas, wetlands, wild and scenic rivers, state parks, state wildlife refuges, habitat designated for state endangered species, fishery resources, state designated natural areas, wellhead protection areas, classified groundwater areas, and county or municipal parks.

“Septic tank” is a water-tight covered receptacle designed to receive or process, through liquid separation or biological digestion, the sewage discharged from a building sewer where the effluent from such receptacle is distributed for disposal through the soil and settled solids and scum from the tank are pumped out periodically and hauled to a treatment facility.

“Service station” is a place where motor fuels are sold to the general public for cash or credit and are dispensed into the fuel tanks of motor vehicles or approved containers. This does not include unattended cardlock system facilities at bulk plants which only use proprietary cards specific to the cardlock system in question.

“Significant violation” means the failure of a person to comply with any requirement of Article 2 of 7 C.C.R. 1101-14, which includes any of the following:

(a) A violation that is causing, or threatens to cause a liquid release of a regulated substance from an UST system, including, but not limited to: the failure of any required overfill prevention system, where the failure is causing or threatens to cause a release; or the failure of a required spill containment structure, where the failure is causing or threatens to cause a release to the environment due to a spill or an overfill.

(b) A violation that impairs the ability of an UST system to detect a liquid leak or contain a liquid release of a regulated substance in the manner required by law, including, but not limited to: tampering with leak detection equipment so that the equipment is no longer capable of detecting a leak at the earliest possible opportunity.

(c) A chronic violation or a violation that is committed by a recalcitrant violator.

“Site check” means collecting soil and/or groundwater samples for laboratory analysis from locations most likely to demonstrate the presence of a release from a regulated storage tank system.

“Source concentration” is the highest concentration, in soil and/or groundwater and /or vapor, of the chemicals of concern.

“State inspector” is a person who is employed or authorized by the division to perform inspections of facilities storing regulated substances.

“Storm-water or wastewater collection system” means piping, pumps, conduits, and any other equipment necessary to collect and transport the flow of surface water run-off resulting from precipitation, or domestic, commercial, or industrial wastewater to and from retention areas or any areas where treatment is designated to occur. The collection of stormwater and wastewater does not include treatment except where incidental to conveyance.

“Subsurface soils” are all soils located at a depth of greater than one meter below the ground surface.

“Surface impoundment” is a natural topographic depression, man-made excavation, or diked area formed primarily of earthen materials (although it may be lined with man-made materials) that is not an injection well.

“Surficial soils” are all soils located from the ground surface to a depth of one meter below the ground surface.

“System test” means a test of tank system components, including any associated delivery piping, secondary containment, or spill control component, to identify releases of regulated substances.

Specifically, for underground tanks, underground piping, spill prevention equipment, and containment sumps. Owners and operators must conduct tests according to the requirements for tank tightness testing (2-3-4-2(c)), line tightness testing (2-3-4-3(a)(2)(i)), and spill prevention equipment and containment sumps (2-3-5(a)).

“Temporary closure” means a period of time that a storage tank is empty but is not permanently closed or has not changed service to store a non-regulated substance. This term does not apply when a tank system is emptied for repair.

“Training program” means any program that provides information to and evaluates the knowledge of a Class A, Class B, or Class C operator through testing, practical demonstration, or another approach acceptable to the implementing agency regarding requirements for UST systems that meet the requirements of Section 2-3-1.

“Transportation-related facilities” as used in these regulations means facilities where all ASTs with capacities from 660 to 39,999 gallons are regulated by the USDOT.

“Trustee” is a member of a Trust that is an applicant to the Fund. A trustee can be an individual or a company that acts on behalf of the Trust.

“Ullage” is the portion of a storage tank that does not contain liquid.

“Unattended cardlock system” is a vehicle fueling facility, which uses a mechanical or electronic method of tracking fuel deliveries using an identification card.

“Under-dispenser containment (UDC)” means containment underneath a dispenser that will prevent leaks from the dispenser and piping within or above the UDC from reaching soil or groundwater.

“Underground storage tank” (UST) means any one or combination of tanks, including underground pipes connected thereto, except those exempted in statute and these regulations, that is used to contain an accumulation of regulated substances and the volume of which, including the volume of underground pipes connected thereto, is ten percent or more beneath the surface of the ground and is not permanently closed.

“Underground storage tank (UST) system” refers to an underground storage tank, connected underground piping, underground ancillary equipment, and containment system, if any.

“Upgrade” means the addition or retrofit of some systems (such as cathodic protection, lining, modification of the system piping, or spill and overfill controls, etc.) to improve the ability of an UST or AST system to prevent the release of product.

“Vault” means an enclosure (other than a secondary containment tank), either above or below-grade, that completely encloses an AST.

“Wastewater treatment tank” means a tank that is designed to receive and treat influent wastewater through physical, chemical, or biological methods.

“Working days” means consecutive days, excluding weekends and nationally recognized holidays.

Section 1-6 Glossary of Acronyms and Initializations 1,2 -DCA 1,2-Dichloroethane 5 CCR 1002-41 Colorado Code of Regulations Number 41 The Basic Standards for Groundwater AMPP Association for Materials Protection and Performance ANSI American National Standards Institute API American Petroleum Institute AST Aboveground Storage Tank ASTM American Society for Testing and Materials International BTEXN Benzene, Toluene, Ethylbenzene, Xylenes, Naphthalene CAP Corrective Action Plan CC Certificate of Conformance CDPHE Colorado Department of Public Health and Environment CDWR Colorado Division of Water Resources CERCLA Comprehensive Environmental Response, Compensation, and Liability Act CFR Code of Federal Regulations COC Chemicals of Concern C.R.S. Colorado Revised Statutes EDB Ethylene Dibromide EFS Economic Feasibility Summary FRP Fiberglass reinforced plastic FR Financial responsibility ICC International Code Council LNAPL Light Non-Aqueous Phase Liquid LPG Liquid petroleum gas MRR Monitoring and Remediation Report MTBE Methyl-tertiary-butyl-ether NFA No Further Action NFAR No Further Action Request NFPA National Fire Protection Association NIOSH National Institute of Occupational Safety and Health NIST National Institute of Standards and Technology NOV Notice of Violation O/O Owner/Operator OPS Division of Oil and Public Safety PAH Polycyclic Aromatic Hydrocarbons PP Pressurized Piping POE Point of Exposure Psi Pounds per square inch Psia Pounds per square inch absolute Psig Pounds per square inch gauge PSTF Petroleum Storage Tank Fund RBCA Risk-Based Corrective Action RBSL Risk-Based Screening Level RMFD Retail Motor Fuel Dispenser/Device RD Release Detection SCR Site Characterization Report SIR Statistical Inventory Reconciliation SPA State Program Approval SPCC Spill Prevention, Control, and Countermeasure SSTL Site-Specific Target Level STP Submersible Turbine Pump TCAR Tank Closure Assessment Report TEL Tetraethyl Lead TPH Total Petroleum Hydrocarbons VP Vapor Pressure UDC Under Dispenser Containment UL Underwriters Laboratories/Underwriters Laboratories of Canada UST Underground Storage Tank USEPA United States Environmental Protection Agency

Section 1-7 Codes, Documents or Standards incorporated by reference The following codes, documents or standards are incorporated by reference and may be purchased from the websites listed below the title of each Institute or Association :

American National Standards Institute (ANSI) http://webstore.ansi.org/ Standard B31, American National Standard Code for Pressure Piping, published October 14, 2003.

American Petroleum Institute (API) http://www.techstreet.com/api Recommended Practice 1604, Closure of Underground Petroleum Storage Tanks, published February 2021.

Standard 650, Welded Tanks for Oil Storage, 13th Edition, published January 2021.

Recommended Practice 1615, Installation of Underground Hazardous Substance or Petroleum Storage Systems, published April 2011.

Recommended Practice 1621, Bulk Liquid Stock Control at Retail Outlets, published 1993.

Recommended Practice 1626, Storing and Handling Ethanol and Gasoline-Ethanol Blends at Distribution Terminals and Filling Stations, published August 2010.

Recommended Practice 1631, Interior Lining of Existing Steel Underground Storage Tanks, published June 2001.

Recommended Practice 1632, Cathodic Protection of Underground Petroleum Storage Tanks and Piping Systems, published January 1996.

Standard 2015, Requirements for Safe Entry and Cleaning of Petroleum Storage Tanks, published January 2018.

Standard 653, Tank Inspection, Repair, Alteration, and Reconstruction, published November 2023.

Standard 2000, Venting Atmospheric and Low-Pressure Storage Tanks, published March 1, 2014.

ASTM International (ASTM) https://www.astm.org/Standard/standards-and-publications.html Standard D5, Test for Penetration for Bituminous Materials, published June 1, 2005.

Standard D4814-24a, Standard Specification for Automotive Spark-Ignition Engine Fuel, published July 2024.

Standard G158, Standard Guide for Three Methods of Assessing Buried Steel Tanks, published September 10, 1998.

Annual Book of ASTM Standards, Section 5, Petroleum Products, Lubricants, and Fossil Fuels, published 2024.

Airlines for America (A4A) https://publications.airlines.org ATA Airport Fuel Facility Operations and Maintenance Guidance Manual, published April 16, 2014.

Environmental Protection Agency (EPA) https://www.epa.gov/ust EPA Form 50 FR 46602, published November 8, 1985.

Hazardous and Solid Waste Amendments of 1984, Public Law 98-616.

Association for Materials Protection and Performance (AMPP) https://www.ampp.org/home Standard Practice SP 0169, Control of External Corrosion on Underground or Submerged Metallic Piping Systems, published 2013.

Standard Practice SP 0285, External Corrosion Control of Underground Storage Tank Systems by Cathodic Protection, published 2011.

National Fire Protection Association (NFPA) http://www.nfpa.org/codes-and-standards Publication NFPA 30, Flammable and Combustible Liquids Code, published 2024.

Publication NFPA 30A, Code for Motor Fuel Dispensing Facilities and Repair Garages, published 2024.

Publication NFPA 70, National Electrical Code, published 2017.

Publication NFPA 80, Standard for Fire Doors and Fire Windows, published 2019.

Publication NFPA 90A, Standard for the Installation of Air Conditioning and Ventilating Systems, published 2018.

Publication NFPA 91, Standard for the Installation of Blower and Exhaust Systems for Dust, Stock, and Vapor Removal or Conveying, published 2015.

Publication NFPA 385, Standard for Tank Vehicles for Flammable and Combustible Liquids, published 2017.

National Institute for Occupational Safety and Health (NIOSH) https://www.cdc.gov/niosh/docs/80-106/ Criteria for a Recommended Standard, Working in Confined Spaces, DHHS (NIOSH) Publication No.80-106, published December 1979.

National Institute of Standards and Technology https://www.nist.gov/publications NIST Handbook 44, Specifications, Tolerances, and Other Technical Requirements for Commercial Weighing and Measuring Devices, 2024 Edition.

NIST Handbook 130, Uniform Laws and Regulations in the Area of Legal Metrology and Engine fuel quality, 2024 Edition.

National Leak Prevention Association (NLPA) http://www.nlpa-online.org/standards.html National Leak Prevention Association Standard 631, Spill Prevention, Minimum 10 Year Life Extension of Existing Steel Underground Tanks by Lining Without the Addition of Cathodic Protection, published 1991.

National Leak Prevention Association Standard 631, Chapter A, Entry, Cleaning, Interior Inspection, Repair, and Lining of Underground Storage Tanks, published 1991.

National Leak Prevention Association Standard 631, Chapter C, Internal Inspection of Steel Tanks for Retrofit of Cathodic Protection, published 1991.

Petroleum Equipment Institute (PEI) http://www.pei.org/recommended-practices-exams Publication RP100, Recommended Practices for Installation of Underground Liquid Storage Systems, published 2022.

Publication RP 900, Recommended Practices for the Inspection and Maintenance of UST Systems, published 2021.

Publication RP 1200, Recommended Practices for the Testing and Verification of Spill, Overfill, Leak Detection, and Secondary Containment Equipment at UST Facilities, published 2019.

Steel Tank Institute (STI) http://www.steeltank.com/Publications/STISPFAStore/tabid/487/Default.aspx STI-P3 Specification and Manual for External Corrosion Protection of Underground Steel Storage Tanks, published July 2005.

Recommended Practice R892, “Recommended Practice for Corrosion Protection of Underground Piping Networks Associated with Liquid Storage and Dispensing Systems, published January 2006.

F922 - Specification for Permatank®, published October 2014 ACT-100® Specification F894, Specification for External Corrosion Protection of FRP Composite Steel Underground Storage Tanks, published February 2017.

ACT-100-U® Specification F961, Specification for External Corrosion Protection of Composite Steel Underground Storage Tanks, published November 2015.

SP001, Standard for the Inspection of Aboveground Storage Tanks, 6th Edition.

Underwriters Laboratories/Underwriters Laboratories of Canada (UL) https://standardscatalog.ul.com/ Standard UL 142, Standard for Steel Aboveground Tanks for Flammable and Combustible Liquids, published December 28, 2006.

Standard UL 2080, Standard for Fire Resistant Tanks for Flammable and Combustible Liquids, published March 14, 2000.

Standard UL 2085, Standard for Protected Aboveground Tanks for Flammable and Combustible Liquids, published December 30, 1997.

Standard UL 971, Nonmetallic Underground Piping for Flammable Liquids, published January 2, 2004.

Standard UL 971A, Outline of Investigation for Metallic Underground Fuel Pipe, published October 18, 2006.

Standard 58, Standard for Steel Underground Tanks for Flammable and Combustible Liquids, published July 27, 1998.

Standard 567, Pipe Connectors for Flammable and Combustible and LP Gas, published October 22, 2004.

Standard 1316, Standard for Glass- Fiber-Reinforced Plastic Underground Storage Tanks for Petroleum Products, Alcohols and Alcohol-Gasoline Mixtures, published April 2, 1996.

Standard 1746, External Corrosion Protection Systems for Steel Underground Storage Tanks, published February 8, 2002.

CAN4-S603-M85, Standard for Steel Underground Tanks for Flammable and Combustible Liquids, published 2000.

CAN4-S603.1-M85, Standard for Galvanic Corrosion Protection Systems for Underground Tanks for Flammable and Combustible Liquids, published November 2003.

CAN4-S615-M83, Standard for Reinforced Plastic Underground Tanks for Flammable and Combustible Liquids, published 1998.

CAN4-S631-M84, Isolating Bushings for Steel Underground Tanks Protected with Coatings and Galvanic Systems, published 1998.

CAN4-S633-M81, Flexible Underground Hose Connectors, published August 1999.

CAN4-S660, Standard for Nonmetallic Underground Piping for Flammable and Combustible Liquids, published May 2008.

Guide ULC-107, Glass Fiber Reinforced Plastic Pipe and Fittings for Flammable Liquids, published 1993.

Department of Defense (DOD) http://www.wbdg.org/FFC/DOD/UFC/ufc_3_460_01_2010_c2.pdf Unified Facilities Criteria (UFC) 3–460–01, Petroleum Fuel Facilities, published June 17, 2015.

Department of Defense Directive 4140.25, DOD Management Policy for Energy Commodities and Related Services, published April 12, 2004.

Section 1-8 Inspection of incorporated codes Interested parties may inspect the referenced incorporated materials by contacting the Division of Oil and Public Safety at 633 17th Street, Suite 500, Denver, Colorado 80202.

Section 1-9 Later amendments not included This rule does not include later amendments to or editions of the incorporated material.

ARTICLE 1.5 MOTOR FUEL DISPENSING AND PRODUCT QUALITY

The method of sale and quality of motor fuels are regulated by the Director to ensure consumer protection and equity in the marketplace. This article lists the minimum specifications and tolerances for dispensing equipment and motor fuel quality to ensure compliance with Colorado statutes and adopted codes and standards. Further description of these requirements can be found in guidance documents, policies and procedures provided by the Director.

Section 1.5-1 Applicability (a) The requirements of Sections 1.5-2, 1.5-3, and 1.5-4 shall apply to dispensers and product quality at retail facilities, retail on-demand mobile fueling vehicles, and refined fuels vehicle tank meters (VTM).

(b) All retail and non-retail motor fuel dispensers must comply with the minimum standards as prescribed by the applicable sections of the National Fire Protection Association (NFPA) 30A.

Section 1.5-2 Retail Motor Fuel Dispensers Inspection and Testing (a) All retail motor fuel dispensers (RMFD) shall be suitable for their intended use, properly installed, and accurate, and shall be maintained in that condition by their owner/operator.

(b) All RMFDs shall have an active National Type Evaluation Program (NTEP) Certificate of Conformance (CC) prior to its installation or use for commercial purposes.

(c) The division shall be notified when any new or remanufactured RMFD is placed in service at a new or existing installation.

(1) Notification shall be submitted using a placed-in-service report provided by the division.

(d) No owner/operator of any RMFD shall use the RMFD for the measurement of liquid fuel products unless it has been proved in a manner acceptable to the Director and sealed as correct by a state inspector or registered service agency.

(e) If any RMFD fails to comply with any of the provisions of this regulation, a state inspector shall seal it in such a manner as to prohibit its use, and it shall remain sealed until it complies with all of the provisions of this regulation.

(1) When an RMFD is brought back into compliance with this regulation it must be placed back in service by a state inspector or registered service agency.

(f) All RMFDs shall comply with the minimum standards as prescribed by the applicable sections of NFPA 30A, NIST Handbook 44, and NIST Handbook 130, except as modified or rejected by this

regulation or by the Director.

(g) All RMFDs shall be labeled in accordance with the minimum standards as prescribed by the applicable sections of NFPA 30A and NIST Handbook 130, United States Environmental Protection Agency regulations, and Colorado Statutes, except as modified or rejected by this

regulation or by the director.

(h) Retail dispensing of Class I and Class II liquids from a mobile fueling vehicle into the fuel tank of a motor vehicle shall be permitted only if all of the requirements of Section 1.5-2 (a) through (g) and Chapter 14 of NFPA 30A are met.

(i) Retail dispensing of Class I and Class II liquids from metal safety cans into the fuel tank of a motor vehicle shall be permitted only if all of the requirements of Chapter 14 of NFPA 30A are met, and when such metal safety cans are pre-packaged by weight or volume and labeled in accordance with NIST Handbook 130.

(j) The dispensing of Class I and Class II liquids in the open from a tank vehicle to a motor vehicle located at commercial, industrial, governmental, or manufacturing establishments and intended for fueling vehicles used in connection with their businesses shall be permitted only if all of the requirements of NFPA 30A 9.6.1 through 9.6.9 have been met.

(k) All mobile fueling vehicles used to carry fuel products shall prominently display on the vehicle, in letters at least three inches in height, the name and address of the owner or operator.

(l) All mobile fueling vehicles shall display prominently on the rear of the tank the appropriate DOT placard for the product contained.

Section 1.5-3 Refined Fuels Vehicle Tank Meter (VTM) Inspection and Testing (a) All refined fuel vehicle tank metering systems shall be suitable for their intended use, properly installed and accurate, and shall be maintained in that condition by their owner/operator.

(b) All refined fuel vehicle tank metering systems shall have an active National Type Evaluation Program (NTEP) Certificate of Conformance (CC) prior to their installation or use for commercial purposes.

(c) The division shall be notified when any new or remanufactured refined fuels vehicle tank metering system is placed in service at a new or existing installation.

(1) Notification shall be submitted using a placed-in-service report provided by the division.

(d) No owner/operator of any refined fuels vehicle tank metering system shall use the meter for the measurement of fuel products unless it has been proved in a manner acceptable to the Director of the division and sealed as correct by a state inspector or registered service agency.

(e) If any refined fuel vehicle tank metering system fails to comply with any of the provisions of these regulations, a state inspector shall seal it in such a manner as to prohibit its use, and it shall remain sealed until it complies with all of the provisions of these regulations.

(1) When a refined fuel vehicle tank metering system is brought back into compliance with these regulations, it must be placed back in service by a state inspector or registered service agency.

(f) All refined fuels vehicle tank metering systems shall comply with the minimum standards as prescribed by the applicable sections of NFPA 385, NFPA 30A, NIST Handbook 44, and NIST Handbook 130 except as modified or rejected by these regulations or by the division.

(g) All refined fuels vehicle tank meters shall be labeled in accordance with the minimum standards as prescribed by the applicable sections of NFPA 385, NFPA 30A, NIST Handbook 44, and NIST Handbook 130 except as modified or rejected by these regulations or by the division.

(h) All refined fuel delivery trucks used to carry fuel products shall prominently display on the truck, in letters at least three inches in height, the name and address of the owner or operator.

(i) All refined fuel delivery trucks shall display prominently on the rear of the tank the appropriate DOT placard for the product contained.

Section 1.5-4 Product Quality (a) All liquid fuel products in Classes I, II, and III shall comply with the applicable specifications of ASTM, which are found in the Annual Book of ASTM Standards Section 5 “Petroleum Products, Lubricants, and Fossil Fuels”. [Note 1: Class I flammable liquids include all grades of gasoline, and most motor fuels blended using alcohol and MTBE (methyl-tertiary-butyl-ether).] [Note 2: Class II combustible liquids include #1 and #2 diesel fuels, #1 and #2 heating oil, kerosene, and Jet-A grade jet fuel.] [Note 3: Class III combustible liquids include most lubricating oils and heavy fuel oils.]

(b) If gasoline is blended with ethanol, the ASTM D 4814 specifications shall apply to the base gasoline prior to blending. Blends of gasoline and ethanol shall not exceed the ASTM D 4814 vapor pressure standard, except that, if the ethanol is blended at nine percent or higher but not exceeding ten percent, the blend may exceed the ASTM D 4814 vapor pressure standard by no more than 1.0 psi. This 1.0 psi allowance does not apply to reformulated gasoline (required by USEPA starting in 2024 in the Denver metro ozone nonattainment area) being sold at retail stations between June 1 and September 15 each year.

(c) In addition to the above, all liquid fuel products shall comply with the requirements published in the NIST Handbook 130 “Uniform Laws and Regulations in the area of legal metrology and engine fuel quality” except as modified or rejected by this regulation.

(d) The allowable reductions in vehicle antiknock requirements for altitude are 4.5 for less than 89 Antiknock Index (AKI), and 3.0 for greater than 89 AKI. Fuel may be marketed using these reductions, but the actual AKI minimum must be posted.

ARTICLE 2 UNDERGROUND STORAGE TANKS

Section 2-1 UST Program Scope and Applicability UST systems in Colorado are regulated to protect the people and environment of Colorado from the potentially harmful effects of the regulated substances contained within UST systems. The purpose of this

article is to present to owner/operators of UST systems a description of the minimum general standards for the design, construction, installation, and operation of these systems to be in compliance with these regulations and Colorado statutes. Further description of these requirements can be found in guidance documents, policies, and procedures provided by the Director. 2-1-1 Applicability (a) Regulated UST systems These UST regulations apply to all owners/operators of an UST system except as otherwise provided in paragraphs (b), (c), and (d) of this section.

(1) Previously deferred UST systems. Airport hydrant fuel distribution systems, UST systems with field-constructed tanks, and UST systems that store fuel solely for use by emergency power generators must meet the requirements of this section as follows:

(i) Airport hydrant fuel distribution systems and UST systems with field-constructed tanks must meet the requirements in Section 2.5 (UST Systems with Field Constructed Tanks and Airport Hydrant Distribution Systems).

(ii) UST systems that store fuel solely for use by emergency power generators installed on or before January 1, 2017 must meet the release detection requirements of §2.3.4 on or before January 1, 2020. [Note: UST systems storing fuel solely for use by emergency power generators that existed on or before January 1, 2017 were already required to meet all other applicable requirements of this article.]

(iii) UST systems that store fuel solely for use by emergency power generators installed after January 1, 2017 must meet all applicable requirements of this

section at installation (2) Any UST system listed in paragraph (c) of this section must meet the requirements of

Section 2-1-1-(d) (Installation Requirements for Partially Excluded UST Systems).

(b) Excluded UST Systems The following UST systems or installations are excluded from these UST regulations:

(1) Any UST system holding hazardous wastes listed or identified under Subtitle C of the Solid Waste Disposal Act, or a mixture of such hazardous waste and other regulated substances;

(2) Any wastewater treatment tank system that is part of a wastewater treatment facility regulated under Section 402 or 307(b) of the Clean Water Act;

(3) Equipment or machinery that contains regulated substances for operational purposes such as hydraulic lift tanks and electrical equipment tanks;

(4) Any UST system whose capacity is 110 gallons or less;

(5) Any UST system that contains a de minimis concentration of regulated substances;

(6) Any emergency spill or overflow containment UST system that is expeditiously emptied after use;

(7) Any farm or residential UST with a capacity of 1,100 gallons or less that is used for storing motor fuel for non-commercial purposes;

(8) Any tank used for storing heating oil for consumptive use on the premises where it is located;

(9) Any septic tank;

(10) Any pipeline facility, including its gathering lines, which is regulated under chapter 601 of Title 49 U.S.C., or which is an intrastate pipeline facility regulated under state laws as provided in chapter 601 of Title 49 U.S.C. and which is determined by the Secretary of Transportation to be connected to a pipeline, or to be operated or intended to be capable of operating at pipeline pressure or as an integral part of a pipeline;

(11) Any surface impoundment, pit, pond, lagoon, or landfill;

(12) Any storm-water or Wastewater collection system;

(13) Any flow-through process tank;

(14) Any liquid trap or associated gathering lines directly related to oil or gas production and gathering operations;

(15) Any storage tank situated in an underground area, such as a basement, cellar, mineworking, drift, shaft, or tunnel area, if the tank is situated upon or above the surface of the floor. [Note: Sections 2-1-1(b)(1) through (6) are excluded from these UST regulations per CFR 280.10 (b). Section 2-1-1(b) (7) through (15) are excluded from these UST regulations per C.R.S. § 8- 20.5-101(17)(b).]

(c) Partially Excluded UST Systems The following types of UST systems are deferred from all parts of these regulations except for release response (Article 5) and financial responsibility (Article 7).

(1) Wastewater treatment tank systems not covered under 2-1-1(b)(2).

(2) Any UST systems containing radioactive material that are regulated under the Atomic Energy Act of 1954 (42 U.S.C. § 2011 and following).

(3) Any UST system that is part of an emergency generator system at nuclear power generation facilities licensed by the Nuclear Regulatory Commission and subject to Nuclear Regulatory Commission requirements regarding design and quality criteria, including but not limited to 10 CFR Part 50.

(4) Aboveground storage tanks associated with airport hydrant fuel distribution systems.

(5) Aboveground storage tanks associated with UST systems with field-constructed tanks.

(d) Installation Requirements for Partially Excluded UST Systems (1) Owners and operators must install an UST system listed in 2-1-1(c) (1), (2), or (3) storing regulated substances (whether of single- or double- wall construction) that meets the (a) Will prevent releases due to corrosion or structural failure for the operational life of the UST system;

(b) Is cathodically protected against corrosion, constructed of non-corrodible material, steel clad with a non-corrodible material, or designed in a manner to prevent the release or threatened release of any stored substance; and (c) Is constructed or lined with material that is compatible with the stored substance.

(2) Notwithstanding paragraph (1) of this section, an UST system without corrosion protection may be installed at a site that is determined by a corrosion expert not to be corrosive enough to cause it to have a release due to corrosion during its operating life.

Owners and operators must maintain records that demonstrate compliance with the requirements of this paragraph for the remaining life of the tank. [Note: The following codes of practice may be used as guidance for complying with this section:

(A) AMPP Standard Practice SP 0285, “External Corrosion Control of Underground Storage Tank Systems by Cathodic Protection”, published 2011;

(B) AMPP Standard Practice SP 0169, “Control of External Corrosion on Underground or Submerged Metallic Piping Systems”, published 2013;

(C) American Petroleum Institute Recommended Practice 1632, “Cathodic Protection of Underground Petroleum Storage Tanks and Piping Systems”; or (D) Steel Tank Institute Recommended Practice R892, “Recommended Practice for Corrosion Protection of Underground Piping Networks Associated with Liquid Storage and Dispensing Systems”.] 2-1-2 Determination of Ownership and Use An UST that was in use before December 22, 1988, and which was not closed in accordance with national fire codes in effect at the time is considered to be in use until it is permanently closed in accordance with these regulations. An UST that is in use on or after December 22, 1988 is considered to be in use until it is permanently closed in accordance with these regulations.

Section 2-2 UST Design, Construction, Installation and Registration 2-2-1 Design and Performance standards for new and replaced UST systems In order to prevent releases due to structural failure, corrosion, or spills and overfills for as long as the UST system is used to store regulated substances, all owners/operators of new and replaced UST systems must meet the following requirements.

(a) Tanks. Secondary containment and interstitial monitoring is required for all new underground tank installations. Secondary containment must be able to contain regulated substances leaked from the primary containment until they are detected and removed and prevent the release of regulated substances to the environment at any time during the operational life of the UST system. If an existing underground tank is replaced, the secondary containment and interstitial monitoring requirements apply only to the replaced underground tank. The secondary containment requirements do not apply to repairs meant to restore an underground tank to operating condition. Each tank must be properly designed and constructed, and any portion of an underground tank that routinely contains product must be protected from corrosion in accordance with a code of practice developed by a nationally recognized association or independent testing laboratory as specified below.

(1) The tank is constructed of fiberglass-reinforced plastic; or [Note: The following codes of practice may be used to comply with paragraph (a)(1) of this (A) Underwriters Laboratories Standard 1316, “Glass- Fiber-Reinforced Plastic Underground Storage Tanks for Petroleum Products, Alcohols and Alcohol-Gasoline Mixtures”; or (B) Underwriter's Laboratories of Canada CAN4-S615-M83, “Standard for Reinforced Plastic Underground Tanks for Flammable and Combustible Liquids”.]

(2) The tank is constructed of steel and cathodically protected in the following manner:

(i) The tank is coated with a suitable dielectric material;

(ii) Field-installed cathodic protection systems are designed by a corrosion expert;

(iii) Impressed current systems are designed to allow determination of current operating status as required in 2-3-3(b); and (iv) Cathodic protection systems are operated and maintained in accordance with 2- 3-3(a); or [Note: The following codes of practice may be used to comply with paragraph (a)(2) of this section:

(A) Steel Tank Institute “sti-P3 Specification and Manual for External Corrosion Protection of Underground Steel Storage Tanks”;

(B) Underwriters Laboratories Standard1746, “External Corrosion Protection Systems for Steel Underground Storage Tanks”;

(C) Underwriters Laboratories of Canada CAN4-S603-M85 “Standard for Steel Underground Tanks for Flammable and Combustible Liquids,” and CAN4- S603.1-M85, “Standard for Galvanic Corrosion Protection Systems for Underground Tanks for Flammable and Combustible Liquids “ and CAN4-S631- M84 “Standard for Isolating Bushings for Steel Underground Tanks Protected with Coatings and Galvanic Systems “; or (D) AMPP Standard Practice SP 0285, “External Corrosion Control of Underground Storage Tank Systems by Cathodic Protection”, published 2011, and Underwriters Laboratories Standard 58, “Standard for Steel Underground Tanks for Flammable and Combustible Liquids”.]

(3) The tank is constructed of steel and clad or jacketed with a non-corrodible material; or [Note: The following codes of practice may be used to comply with paragraph (a)(3) of this (A) Underwriters Laboratories Standard 1746, “External Corrosion Protection Systems for Steel Underground Storage Tanks,”

(B) Steel Tank Institute ACT-100® Specification F894, “Specification for External Corrosion Protection of FRP Composite Steel Underground Storage Tanks.”

(C) Steel Tank Institute ACT-100-U® Specification F961, “Specification for External Corrosion Protection of Composite Steel Underground Storage Tanks”; or (D) Steel Tank Institute Specification F922, “Specification for Permatank®”.]

(4) The tank is constructed of metal without additional corrosion protection measures (i) The tank is installed at a site that is determined by a corrosion expert not to be corrosive enough to cause it to have a release due to corrosion during its operating life; and [Note: The National Association of Corrosion Engineers Standard RP-02-85, “Control of External Corrosion on Metallic Buried, Partially Buried, or Submerged Liquid Storage Systems,” may be used as guidance for complying with paragraph (4)(i) of this section.]

(ii) Owners/operators maintain records that demonstrate compliance with the requirements of paragraph (a)(4)(i) of this section for the remaining life of the tank; or (5) The tank construction and corrosion protection are determined by the Director to be designed to prevent the release or threatened release of any stored regulated substance in a manner that is no less protective of human health and the environment than paragraphs (a)(1) through (4) of this section.

(b) Piping. Secondary containment and interstitial monitoring is required for all new piping installations, including piping to remote fills. Secondary containment must be able to contain regulated substances leaked from the primary containment until they are detected and removed and prevent the release of regulated substances to the environment at any time during the operational life of the UST system. For replaced piping, secondary containment and interstitial monitoring is required for the total length of piping connected to a single UST whenever more than 50% or 50 feet (whichever is less) of the piping connected to that tank is replaced.

Installation of new or replaced piping will require the installation of containment sumps (underdispenser [UDC], submersible turbine pump [STP] or transition) on both ends of the secondarily contained pipe for interstitial monitoring. These secondary containment requirements do not apply to repairs meant to restore piping to operating condition. For the purposes of determining when secondary containment is required by these rules, a repair is any activity that does not meet the definition of “replace”. These secondary containment requirements also do not apply to vent piping, vapor recovery piping, and fill pipes not connected to remote fills.

The piping that routinely contains regulated substances and is in contact with the ground must be properly designed, constructed, and protected from corrosion in accordance with a code of practice developed by a nationally recognized association or independent testing laboratory as specified below.

(1) The piping is constructed of non-corrodible material; or [Note: The following codes and standards may be used to comply with paragraph (b)(1) of this (A) Underwriters Laboratories Standard UL 971, “Nonmetallic Underground Piping for Flammable Liquids”; or (B) Underwriters Laboratories of Canada Standard S660, “ Standard for Nonmetallic Underground Piping for Flammable and Combustible Liquids”.]

(2) The piping is constructed of steel and cathodically protected in the following manner:

(i) The piping is coated with a suitable dielectric material;

(ii) Field-installed cathodic protection systems are designed by a corrosion expert;

(iii) Impressed current systems are designed to allow determination of current operating status as required in 2-3-3(b); and (iv) Cathodic protection systems are operated and maintained in accordance with 2- 3-3(a); or [Note: The following codes and standards may be used to comply with paragraph (b)(2) of this section:

(A) American Petroleum Institute Recommended Practice 1632, “Cathodic Protection of Underground Petroleum Storage Tanks and Piping Systems”

(B) Underwriters Laboratories Standard UL 971A, “Outline of Investigation for Metallic Underground Fuel Pipe”;

(C) Steel Tank Institute Recommended Practice R892, “Recommended Practice for Corrosion Protection of Underground Piping Networks Associated with Liquid Storage and Dispensing Systems”;

(D) AMPP Standard Practice SP 0169, “Control of External Corrosion on Underground or Submerged Metallic Piping Systems”, published 2013; or (E) AMPP Standard Practice SP 0285, “External Corrosion Control of Underground Storage Tank Systems by Cathodic Protection”, published 2011.]

(3) The piping is constructed of metal without additional corrosion protection measures (i) The piping is installed at a site that is determined by a corrosion expert to not be corrosive enough to cause it to have a release due to corrosion during its operating life; and (ii) Owners/operators maintain records that demonstrate compliance with the requirements of paragraph (b)(3)(i) of this section for the remaining life of the piping; or (4) The piping construction and corrosion protection are determined by the Director to be designed to prevent the release or threatened release of any stored regulated substance in a manner that is no less protective of human health and the environment than the requirements in paragraphs (b)(1) through (3) of this section.

(c) Spill and overfill prevention equipment.

(1) Except as provided in paragraphs (c)(2) and (c)(3) of this section, to prevent spilling and overfilling associated with product transfer to the UST system, owners/operators must use the following spill and overfill prevention equipment:

(i) Spill prevention equipment that will prevent release of product to the environment when the transfer hose is detached from the fill pipe (e.g., a spill catchment basin); and (ii) Overfill prevention equipment that will:

(A) Automatically shut off flow into the tank when the tank is more than 95 percent full; or (B) Alert the transfer operator when the tank is no more than 90 percent full by restricting the flow into the tank or triggering a high-level alarm; or (C) Restrict flow 30 minutes prior to overfilling, alert the transfer operator with a high level alarm one minute before overfilling, or automatically shut off flow into the tank so that none of the fittings located on top of the tank are exposed to product due to overfilling.

(2) Owners/operators are not required to use the spill and overfill prevention equipment specified in paragraph (c)(1) of this section if:

(i) Alternative equipment is used that is determined by the Director to be no less protective of human health and the environment than the equipment specified in paragraph (c)(1)(i) or (ii) of this section; or (ii) The UST system is filled by transfers of no more than 25 gallons at one time.

(3) Flow restrictors used in vent lines may not be used to comply with paragraph (c)(1)(ii) of this section when overfill prevention is installed or replaced after January 1, 2017.

(4) Spill and overfill prevention equipment must be periodically tested or inspected in accordance with Section 2-3-5.

(d) Dispensers.

(1) Under-dispenser containment shall be required for all new motor fuel dispenser systems.

A motor fuel dispenser system is considered new when:

(i) A dispenser is installed at a location where there previously was no dispenser (new UST system or new dispenser location at an existing UST system);

(ii) An existing dispenser is removed and replaced with another dispenser and the equipment used to connect the dispenser to the UST system is replaced at any point below the fire valve. This equipment may include unburied flexible connectors or risers or other transitional components that are beneath the dispenser and connect the dispenser to the piping; or (iii) An existing dispenser is removed and replaced with another dispenser and the dispenser island has to be modified (i.e., concrete is broken) to install the dispenser.

(2) Under-dispenser containment must be liquid-tight on its sides, bottom, and at any penetrations. Under-dispenser containment must allow for visual inspection and access to the components in the containment system or be periodically monitored for leaks from the dispenser system.

(3) Under-dispenser containment shall not be required when an existing dispenser is removed and replaced with another dispenser that is not considered a new dispenser.

(e) Minimum Secondary Containment Requirements. At a minimum, secondary containment systems must be designed, constructed, and installed to:

(1) Contain regulated substances released from the tank system until they are detected and removed. To meet this requirement, all secondary containment systems, including containment sumps, shall be tested for leaks at the time of installation and within 30 calendar days of a year thereafter using a testing method listed by the National Workgroup on Leak Detection Evaluations (NWGLDE) or an alternate testing method (2) Prevent the release of regulated substances to the environment at any time during the operational life of the UST system. Periodic testing of the secondary containment system is required in accordance with Section 2-3-5. Also, if LNAPL is detected in a containment sump, the sump shall be tested at that time for leaks using a testing method listed in

Section 2-3-5.

(3) Be checked for evidence of a release at least every 30 calendar days.

(4) Include interstitial monitoring that meets the requirements of 7 C.C.R. 1101-14 §2-3-4- 2(g). If interstitial monitoring is the sole method of release detection for the UST system, sump sensors shall be installed and each sensor shall be tested for functionality by manual tripping on an annual basis.

(f) Compatibility.

(1) Owners/operators must use an UST system made of or lined with materials that are compatible with the substance stored in the UST.

(2) Owners and operators must notify the implementing agency at least 30 calendar days prior to switching to a regulated substance containing greater than 10 percent ethanol, greater than 20 percent biodiesel, or any other regulated substance identified by the implementing agency. In addition, owners and operators with UST systems storing these regulated substances must meet one of the following:

(i) Demonstrate compatibility of the UST system (including the tank, piping, containment sumps, pumping equipment, release detection equipment, spill equipment, and overfill equipment). Owners and operators may demonstrate compatibility of the UST system by using one of the following options:

(A) Certification or listing of UST system equipment or components by a nationally recognized, independent testing laboratory for use with the regulated substance stored; or (B) Equipment or component manufacturer approval. The manufacturer’s approval must be in writing, indicate an affirmative statement of compatibility, specify the range of biofuel blends the equipment or component is compatible with, and be from the equipment or component manufacturer; or (C) Use another option determined by the implementing agency to be no less protective of human health and the environment than the options listed in paragraphs (A) or (B) of this section.

(3) Owners and operators must maintain records in accordance with Section 2-3-7(b) documenting compliance with paragraph (i) of this section for as long as the UST system is used to store the regulated substance. [Note: Owners/operators storing alcohol blends may use the following codes to comply with the requirements of this section:

(A) American Petroleum Institute Recommended Practice 1626, “Storing and Handling Ethanol and Gasoline-Ethanol Blends at Distribution Terminals and Filling Stations”; and (B) American Petroleum Institute Recommended Practice 1627, “Storage and Handling of Gasoline-Methanol/Cosolvent Blends at Distribution Terminals and Service Stations.”] 2-2-2 Installation No person may install, or cause to be installed, a new or replacement UST system or facility until:

(a) An application, as described in 2-2-2-1 has been approved by the Director and an installation permit has been issued by the Director;

(b) The installation plan has been reported to the local Fire Department having jurisdiction; and (c) The application/inspection fee described in 2-2-2-1(c) has been paid. 2-2-2-1 Installation Application The Director will make available an application form to facilitate submission of required information. A complete installation application must be received by the Director no less than 20 working days prior to construction. The application must be approved before beginning construction:

(a) On any new UST system used to store regulated substances.

(b) On an UST system that is being upgraded to the standards described in these regulations or applicable statutes.

(c) For each UST installation or upgrade construction plan submitted, the owner/operator must remit a fee of one hundred fifty ($150) dollars to the Director to cover the costs of the site plan review and installation inspection.

(d) Denial, Revocation, or Modification of Permit.

(1) An UST permit application may be denied if the UST installation or operation is not in conformance with these regulations; or is not in conformance with both Code 30 and Code 30A of the National Fire Protection Association.

(2) An UST permit application may be denied if the permit application is not complete or is determined to be inaccurate.

(3) An UST installation permit may be revoked if the UST installation or operation is not in conformance with these regulations or is not in conformance with either Code 30 or Code 30A of the National Fire Protection Association. If installation activities have not begun within six months of the issuance of the UST installation permit, the UST installation permit will be automatically revoked unless the Director grants an extension in writing.

(4) Six months or later after an UST installation permit is issued, the permit may be modified by subsequent statutory or regulatory changes. 2-2-2-2 Installation Requirements (a) Installation. The UST system must be properly installed in accordance with a code of practice developed by a nationally recognized association or independent testing laboratory and in accordance with the manufacturer's instructions. [Note: Tank and piping system installation practices and procedures described in the following codes may be used to comply with the requirements of paragraph (a) of this section:

(A) American Petroleum Institute Recommended Practice 1615, “Installation of Underground Petroleum Storage Systems”;

(B) Petroleum Equipment Institute Publication RP100, “Recommended Practices for Installation of Underground Liquid Storage Systems”; or (C) National Fire Protection Association Standard 30, “Flammable and Combustible Liquids Code” and Standard 30A, “Code for Motor Fuel Dispensing Facilities and Repair Garages.”]

(b) Effective January 1, 2009, all UST system tanks and piping must be properly installed by an installer certified by the Director. To obtain certification from the Director, applicants shall submit a completed UST Installer Certification Application with copies of current certificates issued by the International Code Council (ICC) and the Petroleum Equipment Institute (PEI) indicating they have passed the ICC UST Installation/Retrofitting examination and the RP100 “Recommended Practices for Installation of Underground Liquid Storage Systems” examination, or the installer has been certified by the tank and piping manufacturers. The certified installer must be present during inspections conducted by the Director during installation, upgrade or repairs of a UST system.

(A) A current certificate issued by ICC indicating a renewed certification of the UST Installation/Retrofitting examination must be submitted to the Director upon renewal every two years.

(c) Certification of installation. All owners/operators must demonstrate compliance with paragraph (a) of this section by providing a certification of compliance on the UST registration form in accordance with 2-2-3. 2-2-2-3 Installation Inspection The Director will witness the pressurized testing of the product pipe (both primary and secondary) and hydrostatic testing of all sumps and spill containment prior to backfilling piping trenches and tank top, and inspect the UST system, before the facility opens for its intended purpose, to verify the requirements of

Section 2-2 have been met.

(a) The owner/operator shall provide notice to the Director 3 working days prior to the intended date of inspection.

(b) Any duly authorized agent or employee of the Director shall have authority to enter in or upon the premises of any facility that contains an UST system, containing a regulated substance, for the

purpose of verifying that such UST system and its required records are in compliance with these 2-2-3 UST System Registration (a) Each owner/operator of a regulated UST system must register each UST system with the Director within 30 calendar days after the first day on which the system is actually used to contain a regulated substance. This registration must be renewed annually, on or before the calendar date of the initial registration, in each succeeding year after 1989. The owner/operator is required to pay a registration fee as set by statute for each tank registered.

(b) All regulated UST systems and facilities must be registered on a form provided by the Director, regardless of use, size, or type of regulated substance stored therein; and regardless of whether the tanks and facilities are in service or in temporary closure. [Note: Owners/operators of UST systems that were in the ground on or after May 8, 1986, unless taken out of operation on or before January 1, 1974, were required to notify the Colorado Department of Health in accordance with the Hazardous and Solid Waste Amendments of 1984, Public Law 98-616, on a form published by EPA on November 8, 1985 (50 FR 46602) unless notice was given pursuant to Section 103(c) of CERCLA. Owners/operators who have not complied with the notification requirements may use the registration form described in 2-2-3(b)]

(c) Owners required to register tanks under paragraph (a) of this section must register each tank they own. Owners may register several tanks using one registration form, but owners who own tanks located at more than one place of operation must file a separate registration form for each separate place of operation.

(d) Any time there is a change in operation, including upgrading of the UST system, changes in operation including a change of owner or operator, or completed closure of an UST system, the owner/operator is required to submit an updated registration within 30 calendar days.

(e) Registration forms required to be submitted under (a) and (d) of this section must provide all of the required information for each tank.

(f) All owners/operators of new UST systems must certify in the registration form, compliance with the following requirements:

(1) Installation of tanks and piping under 2-2-2-2(a);

(2) Cathodic protection of steel tanks and piping under 2-2-1(a)(2);

(3) Financial responsibility under Article 7 of these regulations; and (4) Release detection under 2-3-4.

(g) All owners/operators of new UST systems must certify in the registration form that the method used to install the UST system complies with the requirements in Section 2-2-2-2(a).

(h) After July 1, 1989, any person who sells a tank intended to be used as an UST must notify the purchaser of such tank of the owner's registration obligations under (a) of this section.

(i) The registration form supplied by the Director will meet the requirements of Section 9002 of the federal Solid Waste Disposal Act as amended.

(j) The required fee for UST registration is $35.00 per tank per year as authorized by C.R.S. § 8- 20.5-102; and the fee for the installation plan review and the installation inspection is set at $150.00, as authorized by C.R.S. § 8-20.5-204, to cover the costs of administering this section. 2-2-4 Upgrading existing UST System Owners and operators must permanently close (in accordance with Section 2-4) any UST system that does not meet the new UST system performance standards in Section 2-2 or has not been upgraded in accordance with paragraphs (b) through (d) of this section. This does not apply to previously deferred UST systems described in Section 2-1-1-(a)(1) of this section and where an upgrade is determined to be appropriate by the implementing agency.

(a) Alternatives allowed. All existing UST systems must comply with one of the following:

(1) New UST system performance standards under Section 2-2-1; or (2) Upgrading requirements in (b) through (d) of this section; or (3) Closure requirements under Section 2-4 of these regulations, including applicable requirements for corrective action under Article 5.

(b) Tank upgrading requirements. Steel tanks must be upgraded to meet one of the following requirements in accordance with a code of practice developed by a nationally recognized association or independent testing laboratory:

(1) Internal lining. Tanks upgraded by internal lining must meet the following:

(i) The lining was installed in accordance with the requirements of Section 2-2-5, (ii) Within 10 years after lining, and every 5 years thereafter, the lined tank is internally inspected and found to be structurally sound with the lining still performing in accordance with original design specifications. If the internal lining is no longer performing in accordance with original design specifications and cannot be repaired in accordance with a code of practice developed by a nationally recognized association or independent testing laboratory, then the lined tank must be permanently closed in accordance with Section 2-4.

(2) Cathodic protection. Tanks upgraded by cathodic protection must meet the requirements of Section 2-2-1(a)(2) and the integrity of the tank must have been ensured using one of the following methods:

(i) The tank was internally inspected and assessed to ensure that the tank was structurally sound and free of corrosion holes prior to installing the cathodic protection system; or (ii) The tank has been installed for less than 10 years and is monitored monthly for releases in accordance with Section 2-3-4-2(d) through (i); or (iii) The tank had been installed for less than 10 years and was assessed for corrosion holes by conducting two (2) tightness tests that meet the requirements of Section 2-3-4-2(c). The first tightness test must have been conducted prior to installing the cathodic protection system. The second tightness test must have been conducted between three (3) and six (6) months following the first operation of the cathodic protection system; or (iv) The tank was assessed for corrosion holes by a method that is determined by the Director to prevent releases in a manner that is no less protective of human health and the environment than (b)(2)(i) through (iii) of this section.

(3) Internal lining combined with cathodic protection. Tanks upgraded by both internal lining and cathodic protection must meet the following:

(i) The lining was installed in accordance with the requirements of Section 2-2-5;

(ii) The cathodic protection system meets the requirements of Section 2-2-1(a)(2). [Note: The following historical codes of practice were listed as options for complying with this section:

(A) American Petroleum Institute Recommended Practice 1631, ““Interior Lining of Existing Steel Underground Storage Tanks”;

(B) National Leak Prevention Association Standard 631, “Spill Prevention, Minimum 10 Year Life Extension of Existing Steel Underground Tanks by Lining Without the Addition of Cathodic Protection”;

(C) National Association of Corrosion Engineers Standard RP-02-85, “Control of External Corrosion on Metallic Buried, Partially Buried, or Submerged Liquid Storage Systems”; and (D) American Petroleum Institute Recommended Practice 1632, “Cathodic Protection of Underground Petroleum Storage Tanks and Piping Systems.”]

(c) Piping upgrading requirements. Metal piping that routinely contains regulated substances and is in contact with the ground must be cathodically protected in accordance with a code of practice developed by a nationally recognized association or independent testing laboratory and must meet the requirements of Section 2-2-1(b)(2). [Note: The codes and standards listed in the note following Section 2-2-4(b)(3)(ii) may be used to comply with this requirement.]

(d) Spill and overfill prevention equipment. To prevent spilling and overfilling associated with product transfer to the UST system, all existing UST systems must comply with new UST system spill and overfill prevention equipment requirements specified in Section 2-2-1(c). 2-2-5 Repairs Owners/operators of UST systems must ensure that repairs will prevent releases due to structural failure or corrosion as long as the UST system is used to store regulated substances. The repairs must meet the (a) Repairs to UST systems must be properly conducted in accordance with a code of practice developed by a nationally recognized association or an independent testing laboratory. [Note: The following codes and standards may be used to comply with paragraph (a) of this (A) National Fire Protection Association Standard 30, “Flammable and Combustible Liquids Code”;

(B) American Petroleum Institute Recommended Practice 2200, “Repairing Crude Oil, Liquefied Petroleum Gas, and Product Pipelines”;

(C) American Petroleum Institute Recommended Practice RP 1631, “Interior Lining of Existing Steel Underground Storage Tanks”

(D) National Fire Protection Association Standard 326, “Standard for the Safeguarding of Tanks and Containers for Entry, Cleaning, or Repair”, (E) National Leak Prevention Association Standard 631, Chapter A, “Entry, Cleaning, Interior Inspection, Repair, and Lining of Underground Storage Tanks.”, (F) Steel Tank Institute Recommended Practice R972, “Recommended Practice for the Addition of Supplemental Anodes to sti-P3® Tanks”, (G) AMPP Standard Practice SP 0285, “External Corrosion Control of Underground Storage Tank Systems by Cathodic Protection”, published 2011; or (H) Fiberglass Tank and Pipe Institute Recommended Practice T-95-02, “Remanufacturing of Fiberglass Reinforced Plastic (FRP) Underground Storage Tanks”.]

(b) Repairs to fiberglass-reinforced plastic tanks may be made by the manufacturer's authorized representatives or in accordance with a code of practice developed by a nationally recognized association or an independent testing laboratory.

(c) Metal pipe sections and fittings that have released product as a result of corrosion or other damage must be replaced. Non-corrodible pipes and fittings may be repaired in accordance with the manufacturer's specifications.

(d) If a release of regulated substance is identified during repairs to UST system equipment, the owner/operator shall report the release according to Article 4.

(e) Post-repair testing (1) Repairs to secondary containment areas of tanks and piping used for interstitial monitoring and to containment sumps used for interstitial monitoring of piping must have the secondary containment tested for tightness according to the manufacturer’s instructions, a code of practice developed by a nationally recognized association or independent testing laboratory, or according to requirements established by the implementing agency within 30 calendar days following the date of completion of the repair. All other repairs to tanks and piping must be tightness tested in accordance with 2-3-4-2(c) and 2-3-4-3 within 30 calendar days following the date of the completion of the repair unless:

(i) The repaired tank is internally inspected in accordance with a code of practice developed by a nationally recognized association or an independent testing laboratory; or (ii) The repaired portion of the UST system is monitored monthly for releases in accordance with a method specified in Section 2-3-4-2(d) through (i); or (iii) Another test method is used that is determined by the Director to be no less protective of human health and the environment than those listed above. [Note: The following codes of practice may be used to comply with paragraph (e)(1) of this (A) Steel Tank Institute Recommended Practice R012, “Recommended Practice for Interstitial Tightness Testing of Existing Underground Double Wall Steel Tanks”; or (B) Fiberglass Tank and Pipe Institute Protocol, “Field Test Protocol for Testing the Annular Space of Installed Underground Fiberglass Double and Triple-Wall Tanks with Dry Annular Space”; or (C) Petroleum Equipment Institute Recommended Practice RP1200, “Recommended Practices for the Testing and Verification of Spill, Overfill, Leak Detection and Secondary Containment Equipment at UST Facilities”.]

(2) Within 6 months following the repair of any cathodically protected UST system the cathodic protection system must be tested in accordance with Section 2-3-3(a) and (b) to ensure that it is operating properly.

(3) Within 30 calendar days following any repair to spill or overfill prevention equipment, the repaired spill or overfill prevention equipment must be tested or inspected, as appropriate, in accordance with Section 2-2-5(e)(3) to ensure it is operating properly.

Section 2-3 Operation 2-3-1 Operator Training UST Operator Training is a requirement designed to ensure knowledge regarding operating and maintaining UST systems. These requirements apply to UST systems regulated under Subtitle I, except those excluded by these regulations. 2-3-1-1 Classes of Operators For purposes of implementing the operator training requirements, these regulations establish Colorado specific operator training, testing and certification requirements for three classes of operators identified as Class A, Class B, and Class C. Owners/operators are required to identify and designate, for each UST system or group of UST systems at a facility, at least one named individual for each class of operator outlined in these regulations. All individuals designated as a Class A, B, or C operator must, at a minimum, be trained and certified according to these regulations.

Separate individuals may be designated for each class of operator described above or an individual may be designated to more than one of the above operator classes. An individual who is designated to more than one operator class must be trained in each operator class for which he or she is designated.

Because an individual may be designated for more than one operator class, the Director will allow a training approach that encompasses training for more than one operator class.

To assist in identifying responsible individuals to be trained pursuant to these regulations, the following sections characterize, in general terms, each class of operator. These sections also identify general training requirements pertaining to operating and maintaining UST systems. 2-3-1-2 Class A Operator A Class A operator has primary responsibility to operate and maintain the UST system. The Class A operator’s responsibilities include managing resources and personnel, such as establishing work assignments, to achieve and maintain compliance with regulatory requirements. The general and minimum requirements for a Class A operator are as follows:

(a) General Requirements: This individual focuses on the broader aspects of the statutory and regulatory requirements and standards necessary to operate and maintain the UST system. For example, this individual typically ensures that appropriate individual(s):

(1) Properly operate and maintain the UST system.

(2) Maintain appropriate records.

(3) Are trained to operate and maintain the UST system and keep records.

(4) Properly respond to emergencies caused by releases or spills from UST systems at the (5) Make financial responsibility documents available to the Director as required.

(b) Minimum Requirements: The Class A operator must be trained in the following:

(1) A general knowledge of UST system requirements so he or she can make informed decisions regarding compliance and ensure appropriate individuals are fulfilling operation, maintenance, and recordkeeping requirements and standards of these regulations regarding:

(i) Spill prevention (ii) Overfill prevention (iii) Release detection (iv) Corrosion protection (v) Emergency response (vi) Product compatibility (2) Financial responsibility documentation requirements.

(3) Notification requirements.

(4) Release and suspected release reporting.

(5) Temporary and permanent closure requirements.

(6) Class B and C operator training requirements. 2-3-1-3 Class B Operator A Class B operator implements applicable UST regulatory requirements and standards in the field. This individual implements day-to-day aspects of operating, maintaining, and recordkeeping for USTs at one or more facilities. The general and minimum requirements for a Class B operator are as follows:

(a) General Requirements: This individual typically monitors, maintains, and ensures:

(1) Release detection method, recordkeeping, and reporting requirements are met.

(2) Release prevention equipment, recordkeeping, and reporting requirements are met.

(3) All relevant equipment complies with performance standards.

(4) Appropriate individuals are trained to properly respond to emergencies caused by releases or spills from UST systems at the facility.

(b) Minimum Requirements: Compared with training for the Class A operator, training for the Class B operator will provide a more in-depth understanding of operation and maintenance aspects, but may cover a more narrow breadth of applicable regulatory requirements. The Class B operators training must encompass the following:

(1) Components of UST systems.

(2) Materials of UST system components.

(3) Methods of release detection and release prevention applied to UST components.

(4) Operation and maintenance requirements of these regulations that apply to UST systems and include:

(i) Spill prevention (ii) Overfill prevention (iii) Release detection (iv) Corrosion protection (v) Emergency response (vi) Product compatibility (5) Reporting and recordkeeping requirements.

(6) Class C operator training requirements. 2-3-1-4 Class C Operator A Class C operator is an employee and is, generally, the first line of response to events indicating emergency conditions. This individual is responsible for responding to alarms or other indications of emergencies caused by spills or releases from UST systems. This individual notifies the Class B or Class A operator and appropriate emergency responders when necessary. It is not necessary that all employees of the facility are Class C operators, although at least one Class C Operator must be present during operating hours at attended facilities.

(a) General Requirements: This individual typically:

(1) Controls or monitors the dispensing or sale of regulated substances, or (2) Is responsible for initial response to alarms or releases.

(b) Minimum Requirements: At a minimum, the Class C operator must be trained to:

(1) Take action in response to emergencies (such as, situations posing an immediate danger or threat to the public or to the environment and that require immediate action) or alarms caused by spills or releases from an UST system. 2-3-1-5 Acceptable Training and Certification Processes Operator training must evaluate operator knowledge of the minimum training requirements described for each class of operator in Section 2-3-1(2), (3) and (4). The following is a list of acceptable approaches to meet training requirements stated in these regulations:

(a) Possession of a current certificate issued by the International Code Council (ICC) indicating he or she has passed the Colorado UST System Class A or B Operator exam.

(b) For Class C operator training, possession of a current certificate issued by the owner indicating that he or she has successfully completed training conducted by a certified Class A or Class B operator.

(c) An operator training program that has received prior approval from the Director. The program may include in-class, on-line, or hands-on training. Such a program must include an evaluation of operator knowledge through testing, practical demonstration, or other tools determined as acceptable by the state.

(d) To address operators responsible for UST systems in multiple states, the Director may accept operator training certification verification from other states that have equivalent operator training requirements. 2-3-1-6 Training and Certification Deadlines and Schedules (a) Effective January 1, 2010, designated Class A and B operators shall be trained and possess a current certificate issued by a Director-approved trainer indicating he or she has passed the Colorado UST System Class A or B operator exam.

(b) Effective January 1, 2010, designated Class C operators shall be trained and possess a current certificate issued by a Class A or B operator who developed or conducted the training.

(c) By January 1, 2010, owners of UST systems shall submit a signed statement to the Director indicating that the owner understands and is in compliance with all applicable UST requirements, and identifying the designated Class A or B operator(s) for each facility owned. The owner shall inform the Director of any change of designated Class A or B operator(s) no later than 30 calendar days after the change. Documentation identifying the designated Class C operators shall be maintained on site.

(d) After January 1, 2010 new operators shall be trained within the following timeframes:

(1) Class A and Class B operators must be trained within 30 calendar days after assuming full operation and maintenance responsibilities at the UST system.

(2) Class C operators must be trained before assuming full responsibility for responding to emergencies. 2-3-1-7 Retraining Requirements If the Director determines an UST system is out of compliance, the Class A and/or Class B operator must be retrained and recertified within 90 calendar days. At a minimum, an UST system is out of compliance if the system:

(a) Meets any of the delivery prohibition criteria outlined in Section 6-2, or (b) Is not in significant compliance with other requirements, such as temporary or permanent closure, tank registration or financial responsibility. 2-3-1-8 Documentation Owners and operators of underground storage tank systems must maintain a list of designated Class A, Class B, and Class C operators and maintain records verifying that training and retraining, as applicable, have been completed, in accordance with 2-3-7 as follows:

(a) The list must:

(1) Identify all Class A, Class B, and Class C operators currently designated for the facility;

(2) Include names, class of operator trained, date assumed duties, date each completed initial training, and any retraining.

(b) Records verifying completion of training or retraining must be a paper or electronic record for Class A, Class B, and Class C operators. The records, at a minimum, must identify name of trainee, date trained, operator training class completed, and list the name of the trainer or examiner and the training company name, address, and telephone number. Owners and operators must maintain these records for as long as Class A, Class B, and Class C operators are designated. The following requirements also apply to the following types of training:

(1) Records from classroom or field training programs (including Class C operator training provided by the Class A or Class B operator) or a comparable examination must, at a minimum, be signed by the trainer or examiner;

(2) Records from computer based training must, at a minimum, indicate the name of the training program and web address, if Internet based; and (3) Records of retraining must include those areas on which the Class A or Class B operator has been retrained. 2-3-1-9 Qualified Service Technician (a) Effective January 1, 2020 the following tasks shall only be conducted by a person certified by the Director as a Qualified Service Technician.

(1) Installation, repair, replacement, maintenance, and calibration of all UST leak detection monitoring equipment.

(2) Repair or maintenance work on in use UST systems, including replacement of components such as spill buckets, overfill prevention devices, and ancillary piping components such as flex connectors and penetration fittings located within sumps and under-dispenser containment.

(3) Annual monitoring system functionality testing and certification.

(4) Secondary containment testing, including initial testing of newly installed secondary containment systems.

(b) The Qualified Service Technician must be on-site providing direct and personal supervision at all times when any of the work listed above is being done on the UST system, and shall sign any required documentation related to such work.

(c) To obtain certification as a Qualified Service Technician, individuals shall submit a completed application on a form provided by the Director along with the following documentation from the Petroleum Equipment Institute, or an equivalent certification organization approved by the Director:

(1) A certificate indicating he or she has passed the Entry-Level Service Technician Training Course (2) A certificate indicating he or she has passed the RP900 exam. 2-3-2 Spill and Overfill Prevention (a) Owners/operators must ensure that releases due to spilling or overfilling do not occur. The owner/operator must ensure that the volume available in the tank is greater than the volume of product to be transferred to the tank before the transfer is made and that the transfer operation is monitored constantly to prevent overfilling and spilling.

(b) The owner/operator must report, investigate, and clean up any spills and overfills in accordance with Articles 4 and 5.

(c) Owners/operators must maintain spill and overfill equipment according to Section 2-2-1(c).

(d) Deliveries into all USTs shall be made through a drop tube that extends to within six inches of the tank bottom. [Note: The transfer procedures described in National Fire Protection Association Publication 385 may be used to comply with this section. Further guidance on spill and overfill prevention appears in American Petroleum Institute Recommended Practice 1621, Bulk Liquid Stock Control at Retail Outlets, and National Fire Protection Association Standard 30, “Flammable and Combustible Liquids Code.” 2-3-3 Corrosion Protection All owners/operators of steel UST systems with corrosion protection must comply with the following requirements to ensure that releases due to corrosion are prevented for as long as the UST system is used to store regulated substances or permanently closed in accordance with Section 2-4-2.

(a) All UST systems equipped with cathodic protection systems must be inspected for proper operation by a qualified cathodic protection tester in accordance with the following requirements:

(1) Frequency. All cathodic protection systems must be tested within 6 months of installation and at least every 3 years thereafter or according to another reasonable time frame established by the Director; and (2) Inspection criteria. The criteria that are used to determine that cathodic protection is adequate as required by this section must be in accordance with a code of practice developed by a nationally recognized association. [Note: National Association of Corrosion Engineers Standard RP-02-85, “Control of External Corrosion on Metallic Buried, Partially Buried, or Submerged Liquid Storage Systems,” may be used to comply with paragraph (a)(2) of this section.]

(b) UST systems with impressed current cathodic protection systems must also be inspected every 60 calendar days to ensure that the equipment is running properly.

(c) Where internal lining was installed to satisfy corrosion protection requirements, the tank must meet the requirements listed in 2-2-4(b).

(d) All corrosion protection systems must be operated and maintained to continuously provide corrosion protection to the metal components of that portion of the tank and piping that routinely contain regulated substances and are in contact with the ground. 2-3-4 Release Detection 2-3-4-1 General requirements for all UST systems (a) Owners/operators of UST systems that contain a regulated substance or hazardous substance must provide a method, or combination of methods, of release detection that:

(1) Can detect a release from any portion of the tank and the connected underground piping that routinely contains product;

(2) Is installed, calibrated, operated, and maintained in accordance with the manufacturer's instructions, including routine maintenance and service checks for operability or running condition. Beginning on January 1, 2020, electronic and mechanical components must be tested for proper operation, in accordance with one of the following: manufacturer’s instructions; a code of practice developed by a nationally recognized association or independent testing laboratory; or requirements determined by the implementing agency to be no less protective of human health and the environment than the two options listed above. A test of the proper operation must be performed at least annually and, at a minimum, as applicable to the facility, cover the following components and criteria:

(i) Automatic tank gauge and other controllers: test alarm; verify system configuration; test battery backup;

(ii) Probes and sensors: inspect for residual buildup; ensure floats move freely; ensure shaft is not damaged; ensure cables are free of kinks and breaks; test alarm operability and communication with controller;

(iii) Automatic line leak detector: test operation to meet criteria in 2-3-4-3(a)(1) by simulating a leak;

(iv) Vacuum pumps and pressure gauges: ensure proper communication with sensors and controller; and (v) Hand-held electronic sampling equipment associated with groundwater and vapor monitoring: ensure proper operation. [Note: The following code of practice may be used to comply with paragraph (a)(2) of this section:

Petroleum Equipment Institute Publication RP1200, “Recommended Practices for the Testing and Verification of Spill, Overfill, Leak Detection and Secondary Containment Equipment at UST Facilities”.] , and (3) Meets the performance requirements in 2-3-4-2, 2-3-4-3 or 2-5 as applicable, with any performance claims and their manner of determination described in writing by the equipment manufacturer or installer. In addition, the methods, must be capable of detecting the leak rate or quantity specified for that method in 2-3-4-2(b), (c), (d), (h), or (i), 2-3-4-3(a)(1) or (2), or 2-5 with a probability of detection of 0.95 and a probability of false alarm of 0.05.

(b) When a release detection method operated in accordance with the performance standards in 2-3- 4-2, 2-3-4-3 or 2-5 indicates a release may have occurred, owners/operators must notify the Director in accordance with Article 4.

(c) Any UST system that does not apply a method of release detection that complies with the requirements of this section must complete the closure procedures in 2-4 immediately. For previously deferred UST systems described in Sections 2-1 and 2-5, this requirement applies after the effective dates described in 2-1-1(a)(1)(ii) and (iii) and Section 2-5-2(a). 2-3-4-2 Requirements for regulated substance UST Systems Owners/operators of UST systems must provide release detection and the measurement of water in the bottom of the tank, to the nearest one-eighth of an inch, at least every 30 calendar days or as otherwise specified within regulations. Measurable water within any tank shall not exceed one-fourth of an inch. The methods that satisfy release detection requirements are listed below:

(a) Inventory Control.

(1) Product inventory control can be used as the sole method for release detection:

(i) Until 10 years after the tank is installed or upgraded according to 2-2-4, and (ii) If tank tightness testing as described in (c) of this section is performed at least every 5 years after the tank is installed or upgraded.

(2) Product inventory control (or another test of equivalent performance) must be conducted monthly to detect a release of at least 1.0 percent of flow-through plus 130 gallons on a monthly basis in the following manner:

(i) Inventory volume measurements for regulated substance inputs, withdrawals, and the amount still remaining in the tank are recorded each operating day;

(ii) The equipment used is capable of measuring the level of product over the full range of the tank's height to the nearest one-eighth of an inch;

(iii) The regulated substance inputs are reconciled with delivery receipts by measurement of the tank inventory volume before and after delivery; and (iv) Product dispensing is metered and recorded within an accuracy of 6 cubic inches for every 5 gallons of product withdrawn. [Note: Practices described in the American Petroleum Institute Recommended Practice 1621, “Bulk Liquid Stock Control at Retail Outlets”, may be used, where applicable, as guidance in meeting the requirements of this subsection.]

(b) Manual tank gauging.

(1) Manual tank gauging may be used as the sole method of release detection:

(i) For the life of a tank that has a nominal capacity of 1,000 gallons or less that meet the tank diameter criteria in the table in paragraph (3)(iv) of this section, or (ii) For a tank with a nominal capacity of 1,001 to 2,000 gallons:

(A) Until 10 years after the tank is installed or upgraded according to 2-2-4, (B) If tank tightness testing as described in (c) of this section is performed at least every 5 years after the tank is installed or upgraded.

(2) For tanks of greater than 2,000 gallons nominal capacity, manual tank gauging may not be used to satisfy release detection requirements of this section.

(3) Manual tank gauging must meet the following requirements:

(i) Tank liquid level measurements are taken at the beginning and ending of a period using the appropriate minimum duration of test value in the table below during which no liquid is added to or removed from the tank;

(ii) Level measurements are based on an average of two consecutive stick readings at both the beginning and end of the period;

(iii) The equipment used is capable of measuring the level of product over the full range of the tank's height to the nearest one-eighth of an inch;

(iv) A release is suspected and subject to the requirements of Article 4 if the variation between beginning and ending measurements exceeds the weekly or monthly standards in the following table:

Nominal Tank Capacity Tank Dimensions Weekly Standard 1 Test Monthly Standard Average of 4 Tests Minimum Rest Period Duration Up to 550 N/A 10 5 36 hours 551-1,000 64” diameter 9 4 44 hours 551-1,000 48” (diameter 12 6 58 hours 551-1,000 (also requires periodic tank tightness testing)

N/A 13 7 36 hours 1,000 64” (diameter) x 73” (length) 9 4 44 hours 1,000 48” (diameter) x 128” (length) 12 6 58 hours 1,001 - 2,000 (also requires periodic tank tightness testing)

N/A 26 13 36 hours (c) Tank tightness testing. Tank tightness testing (or another test of equivalent performance) must be capable of detecting a 0.1 gallon per hour leak rate, with a probability of detection of 0.95, from any portion of the tank that routinely contains product while accounting for the effects of thermal expansion or contraction of the product, vapor pockets, tank deformation, evaporation or condensation, and the location of the water table.

(d) Automatic tank gauging. Equipment for automatic tank gauging that tests for the loss of product and conducts inventory control must meet the following requirements:

(1) The automatic product level monitor test can detect a 0.2 gallon per hour leak rate from any portion of the tank that routinely contains product;

(2) The automatic tank gauging equipment must meet the inventory control (or other test of equivalent performance) requirements of (a) of this section; and (3) The test must be performed with the system operating in one of the following modes:

(i) In-tank static testing conducted at least once every 30 calendar days; or (ii) Continuous in-tank leak detection operating on an uninterrupted basis or operating within a process that allows the system to gather incremental measurements to determine the leak status of the tank at least once every 30 calendar days.

(e) Vapor monitoring. Testing or monitoring for vapors within the soil gas of the excavation zone must meet the following requirements:

(1) The materials used as backfill are sufficiently porous (e.g., gravel, sand, crushed rock) to readily allow diffusion of vapors from releases into the excavation area;

(2) The stored regulated substance, or a tracer compound placed in the UST system, is sufficiently volatile (e.g., gasoline) to result in a vapor level that is detectable by the monitoring devices located in the excavation zone in the event of a release from the tank;

(3) The measurement of vapors by the monitoring device is not rendered inoperative by the groundwater, rainfall, or soil moisture or other known interferences so that a release could go undetected for more than 30 calendar days;

(4) The level of background contamination in the excavation zone will not interfere with the method used to detect releases from the tank;

(5) The vapor monitors are designed and operated to detect any significant increase in concentration above background of the regulated substance stored in the UST system, a component or components of that substance, or a tracer compound placed in the UST system;

(6) In the UST excavation zone, the site is assessed to ensure compliance with the requirements in paragraphs (e)(1)through (4) of this section and to establish the number and positioning of monitoring wells that will detect releases within the excavation zone from any portion of the tank that routinely contains product; and (7) Monitoring wells are clearly marked and secured to avoid unauthorized access and tampering.

(f) Groundwater monitoring. Testing or monitoring for liquids on the groundwater must meet the (1) The regulated substance is immiscible in water and has a specific gravity of less than one;

(2) Groundwater is never more than 20 vertical feet from the ground surface and the hydraulic conductivity of the soil(s) between the UST system and the monitoring wells or devices is not less than 0.01 cm/sec (e.g., the soil should consist of gravels, coarse to medium sands, coarse silts or other permeable materials);

(3) The slotted portion of the monitoring well casing must be designed to prevent migration of natural soils or filter pack into the well and to allow entry of regulated substance on the water table into the well under both high and low groundwater conditions;

(4) Monitoring wells shall be sealed from the ground surface to the top of the filter pack;

(5) Monitoring wells or devices intercept the excavation zone or are as close to it as is technically feasible;

(6) The continuous monitoring devices or manual methods used can detect the presence of at least one-eighth of an inch of LNAPL on top of the groundwater in the monitoring wells;

(7) Within and immediately below the UST system excavation zone, the site is assessed to ensure compliance with the requirements in paragraphs (f)(1)-(5) of this section and to establish the number and positioning of monitoring wells or devices that will detect releases from any portion of the tank that routinely contains product;

(8) The construction and management of the wells must meet Colorado Department of Natural Resources’ Division of Water Resources requirements; and (9) Monitoring wells are clearly marked and secured to avoid unauthorized access and tampering.

(g) Interstitial monitoring. Interstitial monitoring between the UST system and a secondary barrier immediately around or beneath it may be used, but only if the system is designed, constructed and installed to detect a leak from any portion of the tank that routinely contains product and also meets one of the following requirements:

(1) For double-walled UST systems, the sampling or testing method can detect a leak through the inner wall in any portion of the tank that routinely contains product;

(2) For tanks with an internally fitted liner, an automated device can detect a leak between the inner wall of the tank and the liner, and the liner is compatible with the substance stored.

(3) For UST systems with a secondary barrier within the excavation zone, the sampling or testing method used can detect a leak between the UST system and the secondary barrier;

(i) The secondary barrier around or beneath the UST system consists of artificially constructed material that is sufficiently thick and impermeable (not more than 0.000001 cm/sec for the regulated substance stored) to direct a leak to the monitoring point and permit its detection;

(ii) The barrier is compatible with the regulated substance stored so that a leak from the UST system will not cause a deterioration of the barrier allowing a release to pass through undetected;

(iii) For cathodically protected tanks, the secondary barrier must be installed so that it does not interfere with the proper operation of the cathodic protection system;

(iv) The groundwater, soil moisture, or rainfall will not render the testing or sampling method used inoperative so that a release could go undetected for more than 30 calendar days;

(v) The site is assessed to ensure that the secondary barrier is always above the groundwater and not in a 25-year flood plain, unless the barrier and monitoring designs are for use under such conditions; and, (vi) Monitoring wells are clearly marked and secured to avoid unauthorized access and tampering.

(h) Statistical inventory reconciliation: Release detection methods based on the application of statistical principles to inventory data similar to those described in 2-3-4-2(a) must meet the (1) Report a quantitative result with a calculated leak rate;

(2) Be capable of detecting a leak rate of 0.2 gallon per hour or a release of 150 gallons within 30 calendar days; and (3) Use a threshold that does not exceed one-half the minimum detectable leak rate.

(i) Other methods. Any other type of release detection method, or combination of methods, can be used if:

(1) It can detect a 0.2 gallon per hour leak rate or a release of 150 gallons within a month with a probability of detection of 0.95 and a probability of false alarm of 0.05; or (2) The Director may approve another method if the owner/operator can demonstrate that the method can detect a release as effectively as any of the methods allowed in paragraphs (c)-(h) of this section. In comparing methods, the Director shall consider the size of release that the method can detect and the frequency and reliability with which it can be detected. If the method is approved, the owner/operator must comply with any conditions imposed by the Director on its use to ensure the protection of human health and the environment. 2-3-4-3 Requirements for Piping Underground piping that routinely contains regulated substances must be monitored for releases in a manner that meets one of the following requirements:

(a) Pressurized piping. Underground piping that conveys regulated substances under pressure must:

(1) Be equipped with automatic line leak detectors which alert the owner/operator to the presence of a leak by restricting or shutting off the flow of regulated substances through piping or triggering an audible or visual alarm may be used only if they detect leaks of 3 gallons per hour at 10 pounds per square inch line pressure within 1 hour. An annual test of the operation of the leak detector must be conducted in accordance with Section 2-3-4- 1(a)(2); and (2) Conduct periodic line release detection which will consist of:

(i) An annual test of piping that can detect a 0.1 gallon per hour leak rate at one and one-half times the operating pressure; or (ii) An applicable tank method conducted on a monthly basis. Except as described in 2-3-4-2(a), (b), and (c), any of the methods in 2-3-4-2(e)through(i) may be used if they are designed to detect a release from any portion of the underground piping that routinely contains regulated substances. Automatic tank gauges (ATG) as described in subsection 2-3-4-2(d) may be considered an applicable tank method to be used for release detection on lines if the ATG is connected to equipment that allows the capability for this type of monitoring.

(b) Suction piping. Underground piping that conveys regulated substances under suction must either have a line tightness test conducted at least once every 3 years and in accordance with 2-3-4-3 (a)(2)(i), or use a monthly monitoring method conducted in accordance with 2-3-4-3(a)(2)(ii). No release detection is required for suction piping that is designed and constructed to meet the following standards:

(1) The below-grade piping operates at less than atmospheric pressure;

(2) The below-grade piping is sloped so that the contents of the pipe will drain back into the storage tank if the suction is released;

(3) Only one check valve is included in each suction line;

(4) The check valve is located directly below and as close as practical to the suction pump;

(5) A method is provided that allows compliance with paragraphs (b)(1) – (4) of this section to be readily determined. 2-3-4-4 Requirements for hazardous substance UST systems Owners/operators of hazardous substance UST systems must provide containment that meets the following requirements and monitor these systems using 2-3-4-2(g) at least every 30 calendar days:

(a) Secondary containment systems must be designed, constructed and installed to:

(1) Contain regulated substance leaks from the primary containment until they are detected and removed;

(2) Prevent the release of regulated substances to the environment at any time during the operational life of the UST system; and (3) Be checked for evidence of a release at least every 30 calendar days. [Note: The provisions of 40 CFR 265.193, Containment and Detection of Releases, may be used to comply with these requirements for tanks installed on or before January 1, 2017.]

(b) Double-walled tanks must be designed, constructed, and installed to:

(1) Contain a leak from any portion of the inner tank within the outer wall; and (2) Detect the failure of the inner wall.

(c) External liners (including vaults) must be designed, constructed, and installed to:

(1) Contain 100 percent of the capacity of the largest tank within its boundary;

(2) Prevent the interference of precipitation or groundwater intrusion with the ability to contain or detect a release of regulated substances; and (3) Surround the tank completely (i.e., it is capable of preventing lateral as well as vertical migration of regulated substances).

(d) Underground piping must be equipped with secondary containment that satisfies the requirements of this section (e.g., trench liners, double-walled pipe). In addition, underground piping that conveys hazardous substances under pressure must be equipped with an automatic line leak detector in accordance with 2-3-4-3(a)(1).

(e) For hazardous substance UST systems installed on or before January 1, 2017 other methods of release detection may be used if owners/operators:

(1) Demonstrate to the Director that an alternate method can detect a release of the stored substance as effectively as any of the methods allowed in 2-3-4-2(b)-(j) can detect a release of petroleum;

(2) Provide information to the Director on effective corrective action technologies, health risks, and chemical and physical properties of the stored substance, and the characteristics of the UST site; and, (3) Obtain written approval from the Director to use the alternate release detection method before the installation and operation of the new UST system. [Note: Pursuant to 40 CFR § 302.6 and 355.40, a release of a hazardous substance equal to or in excess of its reportable quantity must also be reported immediately (rather than within 24 hours) to the National Response Center under Sections 102 and 103 of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 and to appropriate state and local authorities under Title III of the Superfund Amendments and Reauthorization Act of 1986.] 2-3-5 Periodic testing of spill prevention equipment and containment sumps used for interstitial monitoring of piping and periodic inspection of overfill prevention equipment.

(a) Owners and operators of UST systems with spill and overfill prevention equipment and containment sumps used for interstitial monitoring of piping must meet these requirements to ensure the equipment is operating properly and will prevent releases to the environment:

(1) Spill prevention equipment (such as a catchment basin, spill bucket, or other spill containment device) and containment sumps used for interstitial monitoring of piping must prevent releases to the environment by meeting one of the following:

(i) The equipment is double walled and the integrity of both walls is periodically monitored at a frequency not less than the frequency of the compliance inspections described in 2-3-6. Owners and operators must begin meeting paragraph (a)(1)(ii) of this section and conduct a test within 30 calendar days of discontinuing periodic monitoring of this equipment; or (ii) The spill prevention equipment and containment sumps used for interstitial monitoring of piping are tested at least once every three years, after installation or from January 1, 2017, whichever is earlier, to ensure the equipment is liquid tight by using vacuum, pressure, or liquid testing in accordance with one of the following criteria:

(A) Requirements developed by the manufacturer (Note: Owners and operators may use this option only if the manufacturer has developed requirements);

(B) Code of practice developed by a nationally recognized association or independent testing laboratory; or (C) Requirements determined by the implementing agency to be no less protective of human health and the environment than the requirements listed in paragraphs (a)(1)(ii)(A) and (B) of this section.

(2) Overfill prevention equipment must be inspected at least once every three years. At a minimum, the inspection must ensure that overfill prevention equipment is set to activate at the correct level specified in 2-2-1(c) and will activate when regulated substance reaches that level. Inspections must be conducted in accordance with one of the criteria in paragraph (a)(1)(ii)(A)-(C) of this section.

(b) Owners and operators must begin meeting these requirements as follows:

(1) For UST systems in use on or before January 1, 2017, the initial spill prevention equipment test, containment sump test and overfill prevention equipment inspection must be conducted not later than January 1, 2020; or (2) For UST systems brought into use after January 1, 2017, these requirements apply at installation.

(c) Owners and operators must maintain records as follows (in accordance with 2-3-7) for spill prevention equipment, containment sumps used for interstitial monitoring of piping, and overfill prevention equipment:

(1) All records of testing or inspection must be maintained for three years; and (2) For spill prevention equipment and containment sumps used for interstitial monitoring of piping not tested every three years, documentation showing that the prevention equipment is double walled and the integrity of both walls is periodically monitored must be maintained for as long as the equipment is periodically monitored. [Note: The following code of practice may be used to comply with paragraphs (a)(1)(ii) and (a)(2) of this

section: Petroleum Equipment Institute Publication RP1200, “Recommended Practices for the Testing and Verification of Spill, Overfill, Leak Detection and Secondary Containment Equipment at UST Facilities”.] 2-3-6 Compliance Inspections This section describes the inspections required to be conducted by the owner or operator of the UST system, as well as periodic inspections completed by the Director. 2-3-6-1 Monthly Compliance Inspections (a) The designated Class A or B operator or a delegated designee shall perform monthly visual inspections of all UST systems for which they are designated. The results of each inspection shall be recorded on a monthly inspection checklist. The monthly visual inspection shall include the following:

(1) Check to make sure the release detection equipment is operating with no alarms or other unusual operating conditions present. Ensure records of release detection testing are reviewed and current.

(2) Visually check spill containment or manholes for damage (cracks, holes, bulges etc.).

Remove liquid or debris from spill containers (fill and vapor recovery). Check for and remove obstructions in the fill pipe. Check the fill cap to make sure it is securely on the fill pipe. For double-walled spill prevention equipment with interstitial monitoring, check for a leak in the interstitial area.

(3) Inspect hanging hardware on dispensers and other visible piping for the presence of regulated substance leakage.

(4) All areas that house exposed underground product piping (including but not limited to under dispenser areas, tank top areas, and piping transition areas) must be visually inspected monthly for regulated substance leakage unless they are secondarily contained and being electronically monitored by liquid sensors capable of detecting a release.(b)

The designated operator(s) or delegated designee shall provide the owner or operator with a copy of each monthly inspection checklist, and alert the owner or operator of any condition discovered during the monthly visual inspection that may require follow-up actions.

(c) The owner or operator shall maintain a copy of the monthly inspection checklist and all attachments for the previous twelve months. Records must include a list of each area checked, whether each area checked was acceptable or needed action taken, a description of actions taken to correct an issue, and delivery records if spill prevention equipment is checked less frequently than every 30 calendar days due to infrequent deliveries. The records shall be made available for review to OPS upon request. [Note: The following code of practice may be used to comply with this section: Petroleum Equipment Institute Publication RP900, “Recommended Practices for the Inspection and Maintenance of UST Systems”.] 2-3-6-2 Annual Operational Compliance Inspections (a) The designated Class A or B operator(s) shall perform an annual operational compliance inspection of all UST systems for which they are designated. The annual operational compliance inspection shall include, but is not limited to, the following:

(1) Compile and review monthly release detection, visual inspection and corrosion protection records from the prior twelve months.

(2) Compile and review the alarm history report or log for the prior twelve months, and check that each alarm condition was documented and responded to appropriately, including the reporting of suspected or confirmed releases.

(3) Conduct functionality testing on all line leak detectors, sump sensors and overfill prevention equipment in accordance with manufacturer’s specifications to ensure proper installation and operation. Also check hand held release detection equipment such as tank gauge sticks or groundwater bailers for operability and serviceability.

(4) Conduct visual inspection of containment sumps. Check for damage, leaks to the containment area, or releases to the environment. Remove liquid (in contained sumps) or debris. For double-walled sumps with interstitial monitoring, check for a leak in the interstitial area.

(5) Check that all required testing and maintenance for the UST system has been completed, and document the dates these activities occurred.

(6) Verify that all designated Class C operators have been trained in accordance with 2-3-1-4 and 2-3-1-5 of these regulations.

(7) Complete an Annual Operational Compliance Inspection Report and Certification Form for each facility using forms provided by OPS.

(b) The designated Class A or B operator(s) shall provide the owner or operator with a copy of the annual operational compliance inspection report, and alert the owner or operator of any condition discovered during the annual compliance inspection that may require follow-up actions. The report must include a list of each area checked, whether each area checked was acceptable or needed action taken, a description of actions taken to correct an issue, and delivery records if spill prevention equipment is checked less frequently than every 30 calendar days due to infrequent deliveries.

(c) The owner or operator shall make available a copy of the annual operational compliance inspection report and all attachments for the previous twelve months to OPS upon request. 2-3-6-3 Inspections Conducted by the Director (a) Any duly authorized agent or employee of the Director shall have the authority to enter in or upon the premises of any facility that contains an UST system, containing a regulated substance, for the purpose of verifying that such UST system and its required records are in compliance with (b) Per CRS Section 8-20-223.5, the Director shall conduct an emission inspection of all USTs that are located in the geographical area designated by Regulation #7 of the Colorado Department of Public Health and Environment 5 C.C.R. 1001-9 and which contain petroleum distillate such as gasoline, to insure pollution control equipment is installed and is in operating condition. 2-3-7 Reporting and Record Keeping Owners/operators of UST systems must cooperate fully with inspections, monitoring, and testing conducted by the Director, as well as requests from OPS for document submission, testing, and monitoring pursuant to Section 9005 of Subtitle I of the Solid Waste Disposal Act, as amended.

(a) Reporting. Owners and operators must submit the following information to the implementing agency:

(1) Notification for all UST systems (Section 2-2-3), which includes certification of installation for new UST systems (Section 2-2-2-2) and notification when any person assumes ownership of an UST system (Section 2-2-3(d));

(2) Notification prior to UST systems switching to certain regulated substances (Section 2-2- 1(f));

(3) Reports of all releases including suspected releases, spills, and overfills (Section 4-1), and confirmed releases (Section 4-3);

(4) Corrective actions planned or taken including initial abatement measures (Section 5-1-1), initial site characterization (Section 5-1-2), LNAPL removal (Section 5-1-1), investigation of soil and groundwater cleanup (Section 5-2), and corrective action plan (Section 5-3);

(5) A notification before permanent closure or change-in-service (Section 2-4).

(b) Record keeping. Owners/operators must maintain the following information until the UST system is permanently closed or undergoes a change in service, unless another timeframe is noted:

(1) A corrosion expert's analysis of site corrosion potential if corrosion protection equipment is not used 2-2-1(a)(4) and (b)(3)).

(2) Documentation of operation of corrosion protection equipment as required in 2-2-1(a) and (b) and 2-2-3;

(i) The results of the last three 60-day inspections; and (ii) The results from the last two system tests.

(3) Documentation of compatibility for UST systems (Section 2-2-1(f));

(4) Documentation of UST system repairs (Section 2-2-5);

(5) Documentation of compliance for spill and overfill prevention equipment and containment sumps used for interstitial monitoring of piping (Section 2-3-5);

(6) Documentation of periodic compliance inspections (Section 2-3-6);

(7) Compliance with release detection requirements (Section 2-3-4);

(i) All written performance claims pertaining to any release detection system used, and the manner in which these claims have been justified or tested by the equipment manufacturer or installer, must be maintained for 5 years, or for another reasonable period of time determined by the Director, from the date of installation. Not later than January 1, 2020, records of site assessments required under Section 2-3-4-2(e)(6) and (f)(7) must be maintained for as long as the methods are used. Records of site assessments developed after January 1, 2017, must be signed by a professional engineer or professional geologist, or equivalent licensed professional with experience in environmental engineering, hydrogeology, or other relevant technical discipline acceptable to the implementing agency;

(ii) The results of any sampling, testing, or monitoring must be maintained for at least 1 year, or for another reasonable period of time determined by the Director, except as follows:

(a) that the results of tank tightness testing conducted in accordance with 2- 3-4-2(c) must be retained until the next test is conducted; and (iii) Written documentation of all calibration, maintenance, and repair of release detection equipment permanently located on-site must be maintained for at least one year after the servicing work is completed, or for another reasonable time period determined by the Director. Any schedules of required calibration and maintenance provided by the release detection equipment manufacturer must be retained for 5 years from the date of installation.

(8) Records in accordance with this section that are capable of demonstrating compliance with closure requirements under Section 2-4. The results of the tank closure assessment required in 2-4-2 must be maintained for at least 3 years after completion of permanent closure or change-in-service in one of the following ways:

(i) By the owners/operators who closed the UST system;

(ii) By the current owners/operators of the UST system site; or (iii) By mailing these records to the Director if they cannot be maintained at the closed facility. [Note: All applicants to the Fund may be required to maintain closure records until reimbursement is complete.]

(9) Documentation of the emptying of a tank following seasonal operation, temporary closure, or prior to a repair.

(10) Documentation of operator training (Section 2-3-1-8).

(c) Availability and Maintenance of Records. Owners/operators are required, upon request, to provide all records referenced in these regulations to the Director. Owners/operators must keep the required records either:

(1) At the UST site and immediately available for inspection by the Director; or (2) At a readily available alternative site so they can be sent to the Director upon request; or (3) In the case of permanent closure records required under this section, owners/operators are also provided with the additional alternative of mailing closure records to the Director if they cannot be kept at the site or an alternative site as indicated above.

(d) Notwithstanding the above, for Fund reimbursement purposes, persons may be required to maintain the above or other records in accordance with Fund requirements.

Section 2-4 Closure of UST Systems 2-4-1 Temporary Closure (a) Owners/operators shall notify the Director in writing at least 10 calendar days prior to placing an UST system in temporary closure, and at that same time submit records documenting the prior 12 months of release detection and corrosion protection testing (if applicable) for tanks and lines. In lieu of submitting these records, the owner/operator may conduct a precision tightness test on the tanks and lines and complete a site assessment in accordance with 4-1, and submit these results with the temporary closure notification.

(b) A temporarily closed UST system must be emptied by removing all materials using commonly employed practices so that no more than 2.5 centimeters (one inch) of residue, or 0.3 percent by weight of the total capacity of the UST system, remains in the system.

(c) When an UST system is temporarily closed, owners/operators must continue operation and maintenance of corrosion protection in accordance with 2-3-4, perform Annual Compliance Inspections in accordance with 2-3-6-2, and maintain Class A and B Operators in accordance with 2-3-1. Because the tanks must be emptied, release detection is not required.

(d) When an UST system is temporarily closed, vent lines must be left open and functioning. If the temporary closure period is 3 months or more, all pumps, manways, ancillary equipment and lines other than vent lines must be capped and secured, unless an alternate schedule is (e) When an UST system is temporarily closed for more than 12 months, owners/operators must permanently close the UST system in accordance with 2-4-2, unless the Director provides a written extension of the 12-month temporary closure period. Before requesting this extension, owners/operators must complete a site assessment in accordance with 4-1.

(f) Owner/operators shall notify the Director in writing no more than 30 calendar days prior to placing an UST back in service, and at that same time submit the following:

(1) Corrosion protection records (if applicable) for the period of temporary closure;

(2) Documentation of passing tightness tests to include ullage for the tanks conducted within the past 30 calendar days;

(3) Documentation of testing of spill prevention equipment and containment sumps used for interstitial monitoring of piping in accordance with 2-3-5(a)(1);

(4) Documentation of an inspection of overfill prevention equipment in accordance with 2-3- 5(a)(2); and (5) Documentation of release detection equipment verification in accordance with 2-3-4- 1(a)(2).

The owner/operator shall obtain passing line tests immediately following the introduction of fuel into the lines and submit documentation of testing to the Director within 10 calendar days.

(g) If an owner/operator operates a facility that has a specific period of time or season during the year when the tank system is empty, as described in (b) of this section, the requirements for maintaining corrosion protection and the following requirements below will apply:

(1) The owner/operator shall notify the Director that the facility does include seasonal operation on a form provided by the Director. If this information changes, the owner/operator shall complete and submit the form to the Director.

(2) The period may not exceed 6 consecutive months.

(3) The owner/operator shall maintain manifest documentation completed during emptying of (4) At the end of the seasonal period, the owner/operator must conduct one of the following actions:

(i) Return the tank to service.

(ii) Place the tank into proper temporary closure. The owner/operator must notify the Director in writing within 10 calendar days, submit records according to (a) as applicable and complete requirements in (d) immediately.

(iii) Permanently close the tank as required by 2-4-2. 2-4-2 Permanent Closure At least 10 calendar days before beginning either permanent closure or a change-in-service under this

section, owners/operators must notify the Director of their intent to permanently close or make the change-in-service, unless such action is in response to corrective action required by the Director. In addition to the requirements of this section, the owner/operator should contact local municipal officials, such as the fire department, to inform them of the intended closure activities.

(a) Removal To permanently close a tank by removal, owners/operators must empty the tank by removing all liquids and accumulated sludges and inert the tank prior to removal. A site assessment must be conducted according to 4-2, and a completed Closure Inspection Form must be submitted within 30 calendar days following the closure. [Note: The following cleaning and closure procedures may be used to comply with this section:

(A) American Petroleum Institute Recommended Practice 1604, “Removal and Disposal of Used Underground Petroleum Storage Tanks”;

(B) American Petroleum Institute Standard 2015, “Requirements for Safe Entry and Cleaning of Petroleum Storage Tanks”;

(C) American Petroleum Institute Recommended Practice 1631, “Interior Lining of Existing Steel Underground Storage Tanks,” may be used as guidance for compliance with this

section; and (D) The National Institute for Occupational Safety and Health “Criteria for a Recommended Standard...Working in Confined Space” may be used as guidance for conducting safe closure procedures at some hazardous substance tanks.]

(b) Closure in Place All tanks permanently closed in place must be filled with an inert solid material or closed in place in a manner approved by the Director, and a site assessment must be conducted according to 4- 1.

(c) Change in Service Continued use of an UST system to store a non-regulated substance is considered a change-inservice. Before a change-in-service, owners/operators must empty and clean the tank by removing all liquid and accumulated sludge and conduct a site assessment in accordance with 4- 1. 2-4-3 Waste Handling (a) All liquids and accumulated sludges must be removed and disposed of according to the rules adopted pursuant to the Solid Waste Disposal Regulations and the Colorado Hazardous Waste

Section 2-5 UST Systems with Field-Constructed Tanks and Airport Hydrant Fuel Distribution Systems 2-5-1 Definitions For purposes of this section, the following definitions apply:

Airport hydrant fuel distribution system (also called airport hydrant system) means an UST system which fuels aircraft and operates under high pressure with large diameter piping that typically terminates into one or more hydrants (fill stands). The airport hydrant system begins where fuel enters one or more tanks from an external source such as a pipeline, barge, rail car, or other motor fuel carrier.

Field-constructed tank means a tank constructed in the field. For example, a tank constructed of concrete that is poured in the field, or a steel or fiberglass tank primarily fabricated in the field is considered fieldconstructed. 2-5-2 General requirements (a) Implementation of requirements. Owners and operators must comply with the requirements of this

section for UST systems with field-constructed tanks and airport hydrant systems as follows:

(1) For UST systems installed on or before January 1, 2017, the requirements are effective according to the following schedule:

Requirement Effective Date Upgrading UST systems; general operating requirements; and operator training January 1, 2020 Release detection January 1, 2020 Release reporting, response, and investigation; closure; financial responsibility and notification (except as provided in paragraph (b) of this section)

January 1, 2017 (2) For UST systems installed after January 1, 2017, the requirements apply at installation.

(b) Not later than January 1, 2020, all owners of previously deferred UST systems must submit a one-time notice of tank system existence to the implementing agency, using the form described in

Section 2-2-3(b). Owners and operators of UST systems in use as of January 1, 2017, must demonstrate financial responsibility at the time of submission of the notification form.

(c) Except as provided in Section 2-5-3, owners and operators must comply with the requirements of (d) In addition to the codes of practice listed in Section 2-2-1, owners and operators may use military construction criteria, such as Unified Facilities Criteria (UFC) 3-460-01, Petroleum Fuel Facilities, when designing, constructing, and installing airport hydrant systems and UST systems with fieldconstructed tanks. 2-5-3 Additions, exceptions, and alternatives for UST systems with field-constructed tanks and airport hydrant systems (a) Exception to piping secondary containment requirements. Owners and operators may use single walled piping when installing or replacing piping associated with UST systems with fieldconstructed tanks greater than 50,000 gallons and piping associated with airport hydrant systems. Piping associated with UST systems with field-constructed tanks less than or equal to 50,000 gallons not part of an airport hydrant system must meet the secondary containment requirement when installed or replaced.

(b) Upgrade requirements. Not later than January 1, 2020, airport hydrant systems and UST systems with field-constructed tanks where installation commenced on or before January 1, 2017 must meet the following requirements or be permanently closed pursuant to 2-4 of this section.

(1) Corrosion protection. UST system components in contact with the ground that routinely contain regulated substances must meet one of the following:

(i) Except as provided in paragraph (a) of this section, the new UST system performance standards for tanks at 2-2-1(a) and for piping at 2-2-1(b); or (ii) Be constructed of metal and cathodically protected according to a code of practice developed by a nationally recognized association or independent testing laboratory and meets the following:

(A) Cathodic protection must meet the requirements of 2-2-1(a)(2)(ii), (iii) and (iv) for tanks, and 2-2-1(b)(2)(ii), (iii), and (iv) for piping.

(B) Tanks greater than 10 years old without cathodic protection must be assessed to ensure the tank is structurally sound and free of corrosion holes prior to adding cathodic protection. The assessment must be by internal inspection or another method determined by the implementing agency to adequately assess the tank for structural soundness and corrosion holes. [Note: The following codes of practice may be used to comply with this paragraph:

(A) AMPP Standard Practice SP 0285, “External Corrosion Control of Underground Storage Tank Systems by Cathodic Protection”, published 2011;

(B) AMPP Standard Practice SP 0169, “Control of External Corrosion on Underground or Submerged Metallic Piping Systems”, published 2013;

(C) National Leak Prevention Association Standard 631, Chapter C, “Internal Inspection of Steel Tanks for Retrofit of Cathodic Protection”; or (D) American Society for Testing and Materials Standard G158, “Standard Guide for Three Methods of Assessing Buried Steel Tanks”.]

(2) Spill and overfill prevention equipment. To prevent spilling and overfilling associated with product transfer to the UST system, all UST systems with field-constructed tanks and airport hydrant systems must comply with new UST system spill and overfill prevention equipment requirements specified in 2-2-1(c).

(c) Compliance inspections. In addition to the compliance inspection requirements in 2-3-6, owners and operators must inspect the following additional areas for airport hydrant systems at least once every 30 calendar days if confined space entry according to the Occupational Safety and Health Administration (see 29 CFR part 1910) is not required or at least annually if confined space entry is required and keep documentation of the inspection according to 2-3-6-1(c).

(1) Hydrant pits – visually check for any damage; remove any liquid or debris; and check for any leaks, and (2) Hydrant piping vaults – check for any hydrant piping leaks.

(d) Release detection. Owners and operators of UST systems with field-constructed tanks and airport hydrant systems must begin meeting the release detection requirements described in this section not later than January 1, 2020.

(1) Methods of release detection for field-constructed tanks. Owners and operators of fieldconstructed tanks with a capacity less than or equal to 50,000 gallons must meet the release detection requirements in Section 2-3-4. Owners and operators of fieldconstructed tanks with a capacity greater than 50,000 gallons must meet either the requirements in 2-3-4 (except 2-3-4-2(e) and (f) must be combined with inventory control as stated below) of this section or use one or a combination of the following alternative methods of release detection:

(i) Conduct an annual tank tightness test that can detect a 0.5 gallon per hour leak rate;

(ii) Use an automatic tank gauging system to perform release detection at least every 30 calendar days that can detect a leak rate less than or equal to one gallon per hour. This method must be combined with a tank tightness test that can detect a 0.2 gallon per hour leak rate performed at least every three years;

(iii) Use an automatic tank gauging system to perform release detection at least every 30 calendar days that can detect a leak rate less than or equal to two gallons per hour. This method must be combined with a tank tightness test that can detect a 0.2 gallon per hour leak rate performed at least every two years;

(iv) Perform vapor monitoring (conducted in accordance with 2-3-4-2(e) for a tracer compound placed in the tank system) capable of detecting a 0.1 gallon per hour leak rate at least every two years;

(v) Perform inventory control (conducted in accordance with Department of Defense Directive 4140.25; ATA Airport Fuel Facility Operations and Maintenance Guidance Manual; or equivalent procedures) at least every 30 calendar days that can detect a leak equal to or less than 0.5 percent of flow-through; and (A) Perform a tank tightness test that can detect a 0.5 gallon per hour leak rate at least every two years; or (B) Perform vapor monitoring or groundwater monitoring (conducted in accordance with 2-3-4-2(e) or (f), respectively, for the stored regulated substance) at least every 30 calendar days; or (vi) Another method approved by the implementing agency if the owner and operator can demonstrate that the method can detect a release as effectively as any of the methods allowed in paragraphs (i) through (v) of this section. In comparing methods, the implementing agency shall consider the size of release that the method can detect and the frequency and reliability of detection.

(2) Methods of release detection for piping. Owners and operators of underground piping associated with field-constructed tanks less than or equal to 50,000 gallons must meet the release detection requirements in Section 2-3-4. Owners and operators of underground piping associated with airport hydrant systems and field-constructed tanks greater than 50,000 gallons must follow either the requirements in 2-3-4 (except 2-3-4- 2(e) and (f) must be combined with inventory control as stated below) of this section or use one or a combination of the following alternative methods of release detection:

(i) (A) Perform a semiannual or annual line tightness test at or above the piping operating pressure in accordance with the table below.

Maximum Leak Detection Rate Per Test Section Volume Test Section Volume Semiannual Test - Leak Detection Rate Not To Exceed (Gallons Per Hour)

Annual Test - Leak Detection Rate Not To Exceed (Gallons Per Hour) < 50,000 1.0 0.5 ≥ 50,000 to < 75,000 1.5 0.75 ≥ 75,000 to < 100,000 2.0 1.0 ≥ 100,000 3.0 1.5 (B) Piping segment volumes ≥ 100,000 gallons not capable of meeting the maximum 3.0 gallon per hour leak rate for the semiannual test may be tested at a leak rate up to 6.0 gallons per hour according to the following schedule:

Phase In For Piping Segments ≥ 100,000 Gallons In Volume First test Not later than January 1, 2020 (may use up to 6.0 gph leak rate)

Second test Between January 1, 2020, and January 1, 2023 (may use up to 6.0 gph leak Third test Between January 1, 2023, and January 1, 2024 (must use 3.0 gph for leak rate)

Subsequent tests After January 1, 2024, begin using semiannual or annual line testing according to the Maximum Leak Detection Rate Per Test

Section Volume table above (ii) Perform vapor monitoring (conducted in accordance with 2-3-4-2(e) for a tracer compound placed in the tank system) capable of detecting a 0.1 gallon per hour leak rate at least every two years;

(iii) Perform inventory control (conducted in accordance with Department of Defense Directive 4140.25; ATA Airport Fuel Facility Operations and Maintenance Guidance Manual; or equivalent procedures) at least every 30 calendar days that can detect a leak equal to or less than 0.5 percent of flow-through; and (A) Perform a line tightness test (conducted in accordance with paragraph (i) of this section using the leak rates for the semiannual test) at least every two years; or (B) Perform vapor monitoring or groundwater monitoring (conducted in accordance with 2-3-4-2(e) or (f), respectively, for the stored regulated substance) at least every 30 calendar days; or (iv) Another method approved by the implementing agency if the owner and operator can demonstrate that the method can detect a release as effectively as any of the methods allowed in paragraphs (i) through (iii) of this section. In comparing methods, the implementing agency shall consider the size of release that the method can detect and the frequency and reliability of detection.

(3) Recordkeeping for release detection. Owners and operators must maintain release detection records according to the recordkeeping requirements in 2-3-6.

(e) Applicability of closure requirements to previously closed UST systems. When directed by the implementing agency, the owner and operator of an UST system with field-constructed tanks or airport hydrant system permanently closed before January 1, 2017, must assess the excavation zone and close the UST system in accordance with Section 2-4 if releases from the UST may, in the judgment of the implementing agency, pose a current or potential threat to human health and the environment.

ARTICLE 3 ABOVEGROUND STORAGE TANKS

Section 3-1 AST Program Scope and Applicability Aboveground storage tank (AST) systems in Colorado are regulated to protect the people and environment of Colorado from the potentially harmful effects of the regulated substances contained within AST systems. The purpose of this article is to present to owner/operators of AST systems a description of the minimum general standards for design, construction, location, installation and operation of these systems to be in compliance with these regulations and Colorado statutes. Further description of these requirements can be found in guidance documents, policies and procedures provided by the Director.

(a) The provisions in these regulations apply to all regulated substance AST systems unless specifically restricted to a specific system. It is the owner/operator’s responsibility to ensure compliance with all requirements.

(1) Aside from meeting these regulatory requirements:

(i) All AST systems must meet local fire district rules, zoning rules, and requirements of other authorities having jurisdiction over AST systems.

(ii) C.R.S. § 8-20-231 requires that the design, construction, location, installation, and operation of all liquid fuel product tank systems greater than 60 gallons conform to the minimum standards prescribed by the applicable sections of NFPA fire code. This includes the testing and inspection requirements contained therein.

(2) For the purposes of these regulations, a tank’s capacity is determined by the aggregate capacity of all individual primary tank compartments contained within the outer shell or structure of the tank, whether there is a shared bulkhead or not. Each compartment of an AST must meet the operational requirements contained herein individually (e.g. venting, overfill prevention, release detection, etc.)

Example: A single concrete-encased UL 2085 AST whose construction consists of two individual 500 gallon UL 142 ASTs wrapped in a polyethylene liner is considered as having a capacity of 1,000 gallons. Each compartment (tank) must be equipped to meet operational requirements (b) Per C.R.S. § 8-20.5-101(2)(b), the following ASTs or AST systems are excluded from these AST regulations:

(1) Notwithstanding requirements listed in (a)(1) of this section, any AST whose capacity is greater than 39,999 gallons or less than 660 gallons;

(2) Any AST system that contains a de minimis concentration of regulated substances;

(3) Any AST systems containing radioactive material that are regulated under the Atomic Energy Act;

(4) Any AST system that is part of an emergency generator system at nuclear power generation facilities;

(5) ASTs used to store liquefied petroleum gases that are not liquid at standard temperature and pressure;

(6) ASTs used to store liquids whose fluidity is less than that of 300 penetration asphalt when tested in accordance with ASTM Standard D5, “Test for Penetration for Bituminous Materials”.

(7) A wastewater treatment tank system that is part of a wastewater treatment facility;

(8) Equipment or machinery that contains regulated substances for operational purposes;

(9) Farm and residential ASTs or ASTs used for horticultural or floricultural operations.

(10) ASTs located at natural gas pipeline facilities that are regulated under state or federal natural gas pipeline acts;

(11) ASTs associated with natural gas liquids separation, gathering, and production;

(12) ASTs associated with crude oil production, storage, and gathering;

(13) ASTs at transportation-related facilities regulated by the federal department of transportation;

(14) ASTs used to store heating oil for consumptive use on the premises where stored;

(15) ASTs used to store flammable and combustible liquids at mining facilities and construction and earthmoving projects, including gravel pits, quarries, and borrow pits where, in the opinion of the Director, tight control by the owner or contractor and isolation from other structures make it unnecessary to meet the requirements of this article and (16) ASTs owned and operated by the federal government of The United States of America.

Section 3-2 AST System Design, Construction, Location and Installation AST systems shall be designed, constructed, located and installed in accordance with recognized engineering standards, applicable NFPA fire codes, standards and recommended practices, and the requirements of these regulations. 3-2-1 Design (a) Tank Design and Materials of Construction (1) All tanks shall be designed, built, and used in accordance with the requirements of NFPA 30. The material of tank construction shall be compatible with the liquid to be stored.

(i) Tanks designed and intended for above ground use shall not be used as underground tanks.

(ii) Tanks designed and intended for underground use shall not be used as aboveground tanks.

(b) Vent Piping (1) Vent piping design, construction, and installation shall meet the requirements of NFPA 30 and other applicable NFPA codes.

(c) Normal Venting (1) Atmospheric tanks shall be adequately vented to prevent the development of vacuum or pressure that can distort or damage the tank or that exceeds the design pressure, as a result of filling or emptying the tank or atmospheric temperature changes.

(2) For ASTs installed after September 30, 1994, normal vents shall be sized in accordance with NFPA 30.

(3) All tanks shall be equipped with venting devices or other approved means that will protect the tank against the intrusion of water, debris, or insects.

(i) Tanks containing Class I liquids shall be equipped with venting devices meeting the requirements of NFPA 30.

(ii) Tanks containing Class II and Class III liquids shall be equipped with venting devices or other approved means that will protect the tank against the intrusion of water, debris, or insects.

(d) Emergency Relief Venting (1) Every AST shall have some form of construction or device that will relieve excessive internal pressure caused by exposure to fires in accordance with NFPA 30.

(i) This requirement shall also apply to each compartment of a compartmented tank, the interstitial space of secondary containment-type tanks, and the enclosed space of closed-top dike tanks.

Exception: Secondary containment-type tanks and closed-top dike tanks constructed prior to the publication of the 1996 edition of NFPA 30 that were constructed without an opening for a device to be installed are not subject to this requirement.

(e) Piping System Design and Materials of Construction (1) The design, installation, testing, operation, and maintenance of piping systems, including but not be limited to pipe, tubing, valves, fittings, flexible connectors, etc. shall meet the requirements of NFPA 30 and other applicable NFPA codes.

(i) For the purpose of these regulations, piping connected to an AST is considered to be suction piping when the entire length of piping is at a higher elevation than the AST it is connected to, and where there is no pump installed between the tank and piping. All other piping connected to an AST is pressurized piping.

(A) ASTs with underground piping must meet all of the requirements for underground pressurized piping contained in Article 2 of these regulations, including the construction, corrosion protection, and installation requirements of 2-2-1 (b), the secondary containment requirements of 2-2-1(e) for piping installed after April 14, 2011, and release detection requirements of 2-3-4-3.

(ii) On or after October 14, 2012, where an AST is at an elevation that produces a gravity head on a motor fuel dispensing device, the tank outlet shall be equipped with a device (such as a normally closed solenoid valve) that will prevent gravity flow from the tank to the dispenser. This device shall be located adjacent to and downstream of the main tank shutoff valve required by NFPA 30. The device shall be installed and adjusted so that liquid cannot flow by gravity from the tank to the dispenser in the event of failure of the piping or hose when the dispenser is not in use.

(iii) Where a suction-type dispensing system includes a booster pump or where a suction-type dispensing system is supplied by a tank in a manner that produces a gravity head on the dispensing device, a listed, vacuum-actuated shutoff valve with a shear section or equivalent type valve shall be installed directly under the dispensing device.

(A) Suction-type dispensing systems installed before April 14, 2011, that include a solenoid valve at the tank outlet, and a listed, rigidly anchored emergency shutoff valve incorporating a fusible link or other thermally actuated device, designed to close automatically in event of severe impact or fire exposure are deemed to meet this requirement.

(f) Compatibility Requirements (1) Owners/operators must use an AST system constructed of or lined with materials that are compatible with the substance stored in the AST. [Note: Owners/operators storing alcohol blends may use the following codes to comply with the requirements of this section: (a) American Petroleum Institute Recommended Practice 1626, “Storing and Handling Ethanol and Gasoline-Ethanol Blends at Distribution Terminals and Service Stations”; and (b) American Petroleum Institute, Recommended Practice 1627, “Storage and Handling of Gasoline-Methanol/Co-solvent Blends at Distribution Terminals and Service Stations.”]

(g) Security and Housekeeping (1) After December 22, 1996, tanks that are not listed as UL 2085 Protected Aboveground Tanks and are located at motor fuel dispensing facilities shall be protected against vehicular collision by suitable barriers, which may include buildings and open space which the Director approves in writing.

(2) Tanks which are not enclosed in vaults shall be enclosed with a chain link fence at least 6 ft. high. The fence shall be separated from the tanks by at least 10 ft. and shall have a gate that is secured against unauthorized entry. This requirement applies to:

(i) Tanks at motor fuel dispensing facilities, and (ii) Tanks at all other facilities that have an individual or aggregate capacity of 12,000 gallons or more.

Exception: Tanks are not required to be enclosed with a fence if the property on which the tanks are located has a perimeter security fence.

(3) Tanks that are unsupervised for any period of time, or are located in isolated/remote areas, shall be secured and shall be marked to identify the fire hazards of the tank and the tank’s contents to the general public. Where necessary to protect the tank from tampering or trespassing, the area where the tank is located shall be secured.

(4) The area within the fence (if applicable) and within any dike shall be kept free of vegetation, debris, and any other material that is not necessary to the proper operation of the tank and piping system. 3-2-2 Location and Installation 3-2-2-1 Service Stations (Motor Fuel Dispensing Facilities and Repair Garages)

After September 30, 1994, new ASTs may only be installed at service stations if they meet all the general requirements for ASTs, and the service station requirements of this section. After December 22, 1996, tanks designed and built for underground use shall not be used as ASTs. All of the provisions in this

section also apply to marine service stations and airport service stations.

(a) For ASTs installed after September 30, 1994, tanks storing Class I and Class II liquids at an individual site shall be limited to the maximum individual and aggregate capacities indicated in NFPA 30A.

(b) For ASTs installed after September 30, 1994, and before April 14, 2011, tanks shall be located in accordance with NFPA 30A, except that for secondary containment tanks, “fire tested” tanks, “fire resistant” tanks or tanks installed in a vault, the distance requirement from tank to dispenser is waived, provided that all tanks, pipes and dispensers are satisfactorily protected from vehicular traffic.

(c) For ASTs installed on or after April 14, 2011, ASTs shall be located in accordance with NFPA 30A.

(d) Bulk Plants with Motor Fuel Dispensing.

This section does not include facilities that meet the requirements of 3-2-2-3.

(1) For facilities existing before April 14, 2011:

(i) ASTs shall meet the location and installation requirements of NFPA 30.

(ii) Where the NFPA 30A 50 ft separation distance requirement from tank to dispenser is met, the following shall apply to the ASTs used for both motor fuel dispensing and bulk operations:

ASTs storing Class I liquids shall be limited to a maximum individual capacity of 12,000 gallons, ASTs storing Class II liquids shall be limited to a maximum individual capacity of 20,000 gallons, and the aggregate capacity for all tanks shall be 80,000 gallons. [Note: There are no individual or aggregate capacity limits for ASTs used solely for bulk (iii) Where the NFPA 30A 50 ft separation distance requirement from tank to dispenser is not met, the following shall apply to the ASTs used for both motor fuel dispensing and bulk operations:

ASTs storing Class I and Class II liquids shall be limited to a maximum individual capacity of 12,000 gallons, and an aggregate capacity of 48,000 gallons. [Note: There are no individual or aggregate capacity limits for ASTs used solely for bulk (2) For new facilities installed on or after April 14, 2011:

(i) ASTs used for motor fuel dispensing shall meet the capacity and location requirements of 3-2-2-1, except that the maximum individual tank capacity of 12,000 gallons, indicated in NFPA 30A, shall be permitted to be increased to 20,000 gallons for Class II liquids, and the aggregate capacity for all tanks shall be 80,000 gallons. [Note: ASTs that are used for motor fuel dispensing shall not be used for bulk (ii) ASTs used for bulk operations shall meet the location and installation requirements of 3-2-2-4. [Note: ASTs that are used for bulk operations shall not be used for motor fuel dispensing.]

(3) ASTs used solely for bulk operations shall not be connected by piping to ASTs or USTs used for motor fuel dispensing, and shall not supply dispensing devices used for motor vehicle fueling.

Exception: Where the total capacity of all ASTs used for motor fuel dispensing and all ASTs used solely for bulk operations is within the aggregate capacities allowed by 3-2-2- 1 (d)(1) (ii) or (iii), changes to connected piping are not required.

(4) The motor fuel dispensing operations shall be separated from areas in which bulk plant operations are conducted by a fence or an approved structure (building, retaining wall, etc.), preventing direct access from one area to the other. 3-2-2-2 Governmental, Industrial and Commercial AST Facilities (Fleet Vehicle Motor Fuel Dispensing)

AST installations are permitted at commercial, industrial, governmental, and manufacturing facilities where motor fuels are dispensed into vehicles used in connection with their business by employees, but only under one of the following conditions:

(a) For ASTs installed before April 14, 2011, existing restricted-capacity fleet vehicle motor fuel dispensing operations that meet the following requirements are allowed:

(1) The facility has been inspected and approved by the Director;

(2) No more than two (2) ASTs are in service at the facility;

(3) No AST at the facility has a capacity greater than 6,000 U.S. gallons;

(4) There is not more than one (1) tank at the facility containing Class I liquids; and (5) The spacing requirements of Table 2 below are met.

TABLE 2 AST Separation at Restricted-Capacity Fleet Motor Fuel Dispensing Facilities (Before April 14, 2011)

Minimum Distance (ft)

Tank Capacity (gal)

Important Building on the Same Property Fuel Dispensing Device From Property Line That Is or Can Be Built Upon, Including the Opposite Side of a Side of Any Between Tanks 660 – 750 5 0 10 5 3 751 – 6,000 5 0 15 5 3 (b) On or after April 14, 2011, new restricted-capacity fleet vehicle motor fuel dispensing operations shall be allowed where the following requirements are met:

(1) The requirements of 3-2-2-2(a)(1) – (4) are met; and (2) The spacing requirements of Table 3 below are met.

TABLE 3

AST Separation at Restricted-Capacity Fleet Motor Fuel Dispensing Facilities (On or after April 14, 2011)

Minimum Distance (ft)

Tank Capacity (gal)

Important Building on the Same Property Fuel Dispensing Device From Property Line That Is or Can Be Built Upon, Including the Opposite Side of a Side of Any Between Tanks 660 – 2,000 25 0 50 25 3 2,001 - 6,000 25 0 75 35 3 (c) For ASTs installed before April 14, 2011, if the AST system meets the requirements of 3-2-2-1(b) it can operate under the service station capacity allowances.

(d) On or after April 14, 2011, fleet vehicle motor fuel dispensing operations shall be allowed where the location, installation, and tank capacity requirements of NFPA 30A are met. 3-2-2-3 Unattended Cardlock Systems (a) Unattended cardlock systems are those motor fuel dispensing facilities that were in existence before April 14, 2011, and are located at bulk plants, governmental, industrial, and commercial facilities where only proprietary cards (or keys) issued by the facility, and that are specific to the facility’s fuel management or point of sale system, can be used to dispense fuel. Proprietary cards do not include cards that are available for regional or national fleet fueling.

(1) Cardlock systems installed before October 1, 1994, shall meet the AST separation distances of NFPA 30.

(2) Cardlock systems installed on October 1, 1994, or thereafter shall meet the AST separation distances of NFPA 30, and the tank-to-dispenser separation distances of NFPA 30A.

(3) Persons that are issued proprietary cards (or keys) must be knowledgeable in sitespecific operating and emergency procedures for dispensing operations. 3-2-2-4 Bulk Plants (And Other Facilities Without Motor Fuel Dispensing)

This section applies to ASTs storing regulated substances, including emergency generator tanks, outdoors at bulk plants and other facilities (except those facilities covered by 3-2-2-1) where there is no motor fuel dispensing.

The location of ASTs, including separation distances, shall meet the requirements of NFPA 30 and other applicable NFPA codes. 3-2-2-5 ASTs in Vaults The provisions in this section apply only to ASTs installed after September 30, 1994. The design, construction, and installation of vaults for aboveground tanks shall meet the requirements of NFPA 30. 3-2-2-6 Tanks Inside Buildings Buildings and aboveground tanks installed inside buildings shall meet the design, construction, and installation requirements of NFPA 30 and other applicable NFPA codes. 3-2-2-7 Separation from Propane ASTs Separation distances between AST systems and LPG containers shall meet the requirements of NFPA 30, NFPA 30A, and NFPA 58. LPG systems must be installed and operated as required by the Liquified Petroleum Gas (LPG) Regulations 7 CCR 1101-15. 3-2-3 Installation, Upgrade, and Repairs (a) Application for Permit for ASTs (1) An application must be submitted to and approved by the Director before beginning construction;

(i) On any new or used/reinstalled AST system that will store a regulated substance; or (ii) Before beginning construction on any existing regulated substance AST system at a facility that is being upgraded to the standards described in these regulations or applicable statutes.

(A) This requirement applies to alterations made to tanks, piping, or equipment affecting their operation, to containment (diking or impounding), and to the security provisions of 3-2-1(i)(5) or (6). [Note: Where a tank will be moved from and returned to its original location in order to allow an alteration to its containment (e.g., changing from bare earthen diking to lined earth or concrete diking), or where a tank will be moved to a new location outside of its current footprint, a permanent closure must be performed in accordance with 3-4-2, and an application must be submitted for its reinstallation. For tanks installed before October 1, 1994 that will be moved from and returned to their original location, requests for variance from separation requirements of 3-2-2 that cannot be met must be made in writing at the time of application.]

(2) The application must include:

(i) Site Plan - A dimensioned drawing of the facility, showing the name and address of the facility, the location of existing tanks and piping that will remain at the facility, as well as new tanks and piping proposed in the application, the location of dispensers and buildings at the facility, the location of loading/unloading facilities, the location of guard posts and fences, the location of property lines, and the location and names of streets adjacent to the facility; and (ii) A written application, using the form supplied by the Director, containing information about the proposed construction. [Note: If a used AST will be installed/reinstalled, the requirements of 3-2-3(d) apply, and the results of the required inspections and testing must be submitted with the application.]

(3) Effective January 1, 2027, all AST systems must be properly installed by an installer certified by the Director. To obtain certification from the Director, applicants shall submit a completed AST Installer Certification Application with copies of current certificates issued by the International Code Council (ICC) and the Petroleum Equipment Institute (PEI) indicating they have passed the ICC AST Installation/Retrofitting examination (Exam U5) and the PEI RP200 “Recommended Practices for Installation of Aboveground Storage Systems for Motor Vehicle Fueling” examination, or the installer has been certified by the tank and piping manufacturers. The certified installer must be present during inspections conducted by the Director during installation, upgrade or repairs of the AST system.

(i) A current certificate issued by ICC indicating a renewed certification of the AST Installation/Retrofitting examination must be submitted to the Director upon renewal every two years.

(b) AST Facility Inspections Required (1) Except in emergencies, if underground piping will be replaced or added to the AST system, the Director must be notified at least 72 hours prior to beginning the air pressure/soap solution test of the piping in order that an inspection of the system may be scheduled at that time. Emergency situations will be dealt with individually by the Director, possibly by delegation of the inspection.

(2) The Director will make an inspection of the AST system, to verify that the facility was constructed according to plan. This inspection will be as detailed as practicable, but does not exempt the owner/operator from certifying that the installation was made according to all the requirements of these regulations. The owner/operator shall provide the Director with a 72 hour notice prior to the filling of the tank system.

(c) Denial or Revocation of Permit (1) An AST permit application may be denied or revoked if the AST installation or operation is not in conformance with these AST regulations.

(2) An AST permit may be denied or revoked if the AST permit application is not complete or is determined to be inaccurate.

(3) An AST permit may be revoked if the AST installation or operation is not in conformance with the facts presented in the application.

(4) An AST permit may be revoked if an inspection by the Director reveals that the construction performed is not in accordance with the installation plan submitted for approval; and may be revoked for failure to meet the operating or fire safety rules established by these regulations. (5) An AST system permit is automatically revoked six months after the date of issue unless the Director grants an extension in writing.

(6) Six months or later, after an AST permit is issued, the permit may be modified by subsequent statutory or regulatory changes.

(d) Reinstallation of ASTs (1) Used ASTs being installed to store a regulated substance must meet the following requirements:

(i) The AST itself must meet all of the fabrication, construction and performance requirements, and be equipped with all of the required equipment listed in 3-2 of (ii) The tank must be inspected per 3-3-4-2(a) and, include a formal external inspection with steel thickness readings for single-walled tanks, and any manufacturer reinstallation/relocation requirements.

(iii) The AST installation and registration requirements of 3-2-3 and 3-2-4.

(iv) Emergency relief vent devices must be tested and certified to be in good working order.

(e) Upgrading AST Systems The deadlines for the upgrading of AST systems that existed prior to AST regulations being promulgated have expired. This section remains in this revision for historical reference.

(1) On or before December 22, 1996, AST systems must meet the requirements of these regulations or permanently close the tanks in accordance with these regulations. The following requirements take effect December 22, 1996:

(i) Each AST must be sound and have an emergency relief venting device which is equivalent to those described in these regulations. The owner/operator is required to provide proof that the tank meets this requirement.

(ii) Secondary containment methods or devices must be provided and in regular use at the facility as described in 3-3-1.

(iii) The facility must meet the security requirements of 3-2-1(i).

(2) By December 22, 1998, certain AST systems must be equipped with a solenoid valve or a vacuum-actuated shutoff valve, with a shear section as described in 3-2-1(g). [Note: In applying these requirements, the following quotation will be carefully considered by the Director - “Existing plants, equipment, buildings, structures, and installations for the storage, handling or use of flammable or combustible liquids that are not in strict compliance with the terms of this code may be continued in use at the discretion of the Director provided they do not constitute a recognized hazard to life or adjoining property.

The existence of a situation that might result in an explosion or sudden escalation of a fire, such as inadequate ventilation of confined spaces, lack of adequate emergency venting of a tank, failure to fireproof the supports of elevated tanks, or lack of drainage or dikes to control spills, may constitute such a hazard.”]

(f) Repairs Allowed (1) If an AST system is damaged, it must be repaired to meet applicable requirements, or be properly closed. Owners/operators of AST systems must ensure that repairs will prevent releases due to structural failure or corrosion as long as the AST system is used to store regulated substances.

(2) The repairs must meet the following requirements:

(i) Repairs to AST systems must be properly conducted in accordance with a code of practice developed by a nationally recognized association or an independent testing laboratory. [Note: The following codes and standards may be used to comply with this section: National Fire Protection Association Standard 30, “Flammable and Combustible Liquids Code”; American Petroleum Institute Recommended Practice 2200, “Repairing Crude Oil, Liquefied Petroleum Gas, and Product Pipelines”];

(ii) Above ground metal pipe that has released product must be immediately repaired or replaced and appropriately tested. [Note: repaired piping that has previously contained flammable liquid must not be subjected to an air pressure test unless the piping has been completely cleaned and rendered vapor free]

(iii) Underground metal pipe sections and fittings connected to an AST that have released product as a result of corrosion or other damage must be replaced immediately and protected from future corrosion. Fiberglass pipes and fittings may be repaired in accordance with the equipment manufacturer's specifications.

(iv) Repaired AST underground piping must be tightness tested in accordance with 2-3-4-3(a)(2)(i) within 30 calendar days following the date of the completion of the repair. New replacement piping runs that have never contained product may be tested by an air pressure/soap bubble test at 1.5 times operating pressure if inspected and approved by the Director.

(3) If a release of regulated substance is identified during repairs to AST system equipment, the owner/operator shall report the release according to Article 4. 3-2-4 AST System Registration and Transfer of Ownership (a) Registration and Notification for ASTs.

(1) AST Registration Required. All ASTs and facility data must be registered, re-registered or updated on a form provided by the Director, regardless of whether the ASTs and facilities are currently in service or in temporary closure, according to the following provisions:

(i) The registration form must be filled out as completely as possible by the owner/operator of the AST; and must include each tank owned or operated at the (ii) Owners/operators may provide notice for several tanks at a single facility using one notification form, but owners/operators who own or operate tanks located at more than one facility must file a separate notification form for each separate (2) Registration Timing. Each owner/operator of an AST must register each AST with the Director as follows:

(i) By July 1, 1993 if the tanks were not registered previously.

(ii) Within 30 calendar days after the first day on which any AST is actually used to contain a regulated substance.

(iii) This registration information must be updated within 30 calendar days after any additional tank construction, AST system upgrading, temporary or permanent closure, or changes in operation including a change of owner or operator, has been completed.

(iv) This registration must be renewed annually during the month designated by the Director, and during the same month in each succeeding year thereafter.

(3) Registration Fee Required. The owner/operator is required to pay an annual registration fee in the amount allowed by the current state law for each regulated tank owned or operated, until the regulated AST is permanently closed as in 3-4-2 or until the owner/operator has instituted a change-in-service to a substance other than a regulated substance as in 3-4-3.

(4) Tank Vendor Responsibility. Any person who sells a tank intended to be used as an AST must notify the purchaser of such tank of the purchaser’s registration and registration fee obligations under this section.

(5) All owners/operators of new AST systems must certify in the registration form, compliance with the requirement for financial responsibility under Article 7 of these

Section 3-3 Operation 3-3-1 Spill and Overfill Protection (a) General Requirements (1) Facilities shall be provided so that any accidental discharge of any Class I, II or IIIA liquids will be prevented from endangering important facilities and adjoining property, or from reaching waterways, as provided for in subsections (b) or (c). Where constructed after September 30, 1994, these containment areas must be impervious enough to contain the product for enough time until any release therein can be cleaned up.

(2) Owners/operators of ASTs must ensure that releases due to spilling or overfilling do not occur. The owner/operator must ensure that the available capacity in the tank (ullage) is greater than the volume of product to be transferred to the tank before the transfer is made; and that the transfer operation is monitored constantly to prevent overfilling and spilling.

(3) Spill and overfill prevention equipment is required for all ASTs installed after September 30, 1994. Means shall be provided for determining the liquid level in each tank and be accessible to the delivery operator.

(i) Where electronic or mechanical gauges are used for determining tank volume (ground–level tape gauges, clock face gauges, etc.), the gauge shall be calibrated annually, per manufacturer instructions. These calibrations shall be documented and maintained.

(4) For all ASTs installed after September 30, 1994, at service stations, and for all secondary containment type tanks without diking or impounding protection, overfill prevention equipment shall be included that will automatically stop the delivery of liquid to the tank when the liquid level in the tank reaches 95 percent of capacity or sound an audible alarm when the liquid level in the tank reaches 90 percent of capacity.

(5) Delivery operations shall comply with the following requirements:

(i) The delivery vehicle shall be separated from any AST as required by the applicable NFPA code.

(ii) Tank filling shall not begin until the delivery operator has determined the available capacity in the tank (ullage) based on direct liquid level measurement converted to gallons or some equivalent method.

(A) Where spill and overfill prevention equipment that will automatically stop the delivery of liquid to the tank or sound an audible alarm that can be heard by the delivery operator described in 3-3-1-(a)(4) does not exist, tank ullage and the amount of product delivered must be documented and maintained.

(iii) Tanks shall be filled through a liquid tight connection. For ASTs installed after September 30, 1994 and are filled through fixed piping that has a point where connection and disconnection is made, the fill connection must be equipped as required by the applicable NFPA code.

(6) The owner/operator must report, investigate, and clean up any spills and overfills in accordance with Articles 4 and 5 of these Regulations.

(b) Remote Impounding Where protection of adjoining property or waterways is by means of drainage to a remote impounding area, so that impounded liquid will not be held against tanks, such systems shall meet the requirements contained in NFPA 30.

(c) Impounding Around Tanks by Diking Where protection of adjoining property or waterways is by means of impounding by diking around the tanks, such systems shall meet the requirements contained in NFPA 30.

Exceptions: For ASTs existing before October 1, 1994, size and spacing requirements for dikes enclosing existing ASTs may be reduced or waived by the Director if he determines that there are equivalent safety measures at the facility. Dikes existing before this date are also not required to meet the NFPA requirements for; a slope of not less than 1 percent away from the tank; the 10 ft. separation distance between the outside base of the dike at ground level and any property line that is, or can be, built upon; and the 5 ft separation distance between tanks and toe of interior dike walls.

(d) Secondary Containment Tanks may be installed without remote impounding or diking if they meet all of the requirements contained in NFPA 30 for secondary containment-type tanks used to provide spill control.

Exception: For ASTs existing before October 1, 1994, the NFPA 30 requirement for a 3 ft separation distance between adjacent tanks is waived.

(1) Tanks shall be filled through a liquid tight connection.

(i) If the tank is filled through a liquid tight connection mounted directly to the tank, the liquid tight connection must be installed within an approved spill container.

(ii) If the tank is filled through fixed piping that has a point where connection and disconnection is made, the fill connection must be equipped as required by the applicable NFPA code and include an approved spill container.

(e) Containment areas must be maintained free of accumulations of water, leaves, weeds, flammable material, non U.L. listed tanks or drums, and anything else that might interfere with the containment purpose of such areas. 3-3-2 Corrosion Protection (a) Internal Corrosion Protection For ASTs Installed After September 30, 1994.

When ASTs installed after September 30, 1994, are not designed in accordance with the American Petroleum Institute, American Society of Mechanical Engineers, or the Underwriters Laboratories Inc. Standards, or if corrosion is anticipated beyond that provided for in the design formulas used, additional metal thickness or suitable protective coatings or linings shall be provided to compensate for the corrosion loss expected during the design life of the tank.

(b) External Corrosion Protection for ASTs installed after September 30, 1994.

For those portions of an AST system installed after September 30, 1994, including the product pipelines that normally contain regulated substances and are in contact with the soil or with an electrolyte that may cause corrosion of the AST system, tanks and piping must be protected by either:

(1) A properly engineered, installed and maintained cathodic protection system in accordance with recognized standards of design, such as:

(i) National Association of Corrosion Engineers Standard RP-01-69, “Control of External Corrosion of Underground or Submerged Metallic Piping Systems” ;

(ii) National Association of Corrosion Engineers Standard RP-02-85 , “Control of External Corrosion on Metallic Buried, Partially Buried, or Submerged Liquid Storage Systems” ; or;

(2) Approved or listed corrosion-resistant materials or systems, which may include special alloys, fiberglass reinforced plastic, or fiberglass reinforced plastic coatings.

(c) External Coating of all Elevated Tanks.

For installations where tanks and piping are not in contact with soil or with an electrolyte, corrosion protection may consist of an appropriate external coating.

(d) Cathodic Protection Requirements.

Owners/operators must comply with the following requirements to ensure that releases due to corrosion are prevented for as long as a cathodically protected AST system is used to store regulated substances:

(1) All corrosion protection systems must be operated and maintained to continuously provide corrosion protection to the metal components of that portion of the tank and piping that routinely contain regulated substances and are in contact with the ground.

(2) Performance criteria - The criteria that are used to determine that cathodic protection is adequate as required by this section must be in accordance with a code of practice developed by a nationally recognized association.

(3) Periodic Inspections - AST systems with impressed current cathodic protection systems must be inspected every 60 calendar days to ensure that the equipment is running properly.

(e) Tanks that are not cathodically protected must be tested within 5 years after October 1, 1994, and once every two years thereafter by either:

(1) An external visual inspection, that includes the bottom of the tank, for corrosion or other visible damage; or (2) A leakage test of any type approved by the Director; or (3) An internal inspection for corrosion or other visible damage; or (4) Comply with some other alternative test for corrosion or leakage as specified by and approved by the Director in the future. 3-3-3 Release Detection (a) General Requirements for all AST Systems.

(1) ASTs that are not in contact with the ground or any electrolyte that might cause corrosion of the tank must be visually inspected at least once per month by operating personnel to detect any leakage from tank seams, connections, and fittings, including piping. Any such leakage must be repaired immediately and reported under the repair and reporting requirements of these regulations.

(2) ASTs, including metal supporting structures, that are in contact with the soil or that are in contact with an electrolyte that may promote corrosion of the tank must be inspected as in subsection (1) above and be protected from corrosion or tested periodically to prove that they are not seriously corroded, as described in 3-3-2(e).

(3) AST system piping that is not in contact with the soil or with an electrolyte that might cause corrosion of the piping must be inspected at least once each month to detect leakage from pipe seams, connections, and fittings. Any such leakage that may exceed the reportable quantity (25 gallons) must be repaired immediately and reported as in

Article 4.

(4) Underground AST piping shall meet the release detection requirements in 2-3-4-3.

(i) Pressurized piping described in 3-2-1 (g)(1)(i) shall meet the release detection requirements (automatic leak detector and line tightness testing) in 2-3-4-3(a), except that where there is no pump installed between the tank and underground piping, the requirement for an automatic line leak detector in 2-3-4-3(a)(1) does not apply.

(ii) Suction piping described in 3-2-1(g)(1)(A) shall meet the release detection requirements in 2-3-4-3(b).

(5) Inventory control shall be performed and documented for all single-wall ASTs installed on earthen materials, and all ASTs connected to underground pressurized piping that is not being monitored for releases in accordance with 2-3-4-3(a)(2)(ii). Accurate daily inventory records shall be maintained and reconciled for all applicable storage tanks.

(b) Release Detection for Secondary Containment Tanks Secondary Containment tanks that are installed without special drainage or diking according to 3- 3-1(b) or (c) must be visually inspected at least once each month to ensure that there has been no failure of the outer wall of the secondary containment tank. An interstitial liquid detector or some other positive means of leak detection must be installed to detect leaks from the inner wall of the tank; and operation of that leak detector must be verified at least monthly. A record of the inspection must be maintained [See § 3-3-5].

(c) All AST system tank and piping fittings, connections, valves, auxiliary equipment that contains product, secondary containment areas, etc. must be maintained free of obstructions that would interfere with visual detection of leaks and spills. 3-3-4 Testing and Compliance Inspections 3-3-4-1 Testing (a) Initial Testing (1) All new ASTs shall be tested before they are placed in service in accordance with the requirements of the standard or code under which they were built.

(i) An AST marked with an approved listing is considered to be in compliance with this requirement, as the testing is part of the standard to which it was constructed. Tanks not marked with an approved listing shall be tested before they are placed in service in accordance with recognized engineering standards.

(b) Tightness Testing (1) In addition to the initial testing of 3-3-4-1(a), all new and used tanks and connections shall be tested for tightness after installation/reinstallation and before being placed in service in accordance with manufacturer instructions, or NFPA 30 “Flammable and Combustible Liquids Code”where no manufacturer instructions exist. This test shall be made at operating pressure with air, inert gas, or water.

(i) Air pressure shall not be used to test tanks that contain flammable or combustible liquids or vapors.

(ii) Where the vertical length of the fill and vent pipes is such that, when filled with liquid, the static head imposed on the bottom of the AST exceeds a gauge pressure of 10 psi, the tank and its related piping shall be tested hydrostatically to a pressure equal to the static head, using recognized engineering standards.

Under no circumstances should the test pressure exceed the design pressure of the AST. 3-3-4-2 Inspections (a) All steel ASTs shall be inspected and maintained in accordance with STI SP001, “Standard for the Inspection of Aboveground Storage Tanks”, or API Standard 653, “Tank Inspection, Repair, Alteration, and Reconstruction”, whichever is applicable.

(b) Monthly Visual Inspections The owner/operator must conduct visual inspections of the tank system each month and document the results of the inspection on a form provided by the Director or on an equivalent form. These monthly visual inspections satisfy the requirements described in 3-3-3 (a)(1) through (3).

(c) Annual Visual Inspections (1) Annual inspections of all steel ASTs shall be performed, documented, and retained according to the requirements of STI SP001 “Standard for the Inspection of Aboveground Storage Tanks”.

(i) This inspection does not include ultrasonic testing (UT), and can be performed by an individual knowledgeable of storage facility operations, the type of AST and its associated components, and characteristics of the liquid stored.

(ii) Annual inspections shall be performed within 12 months after April 14, 2011, and during the same month in each year thereafter.

(d) Periodic Inspections (1) Formal external and internal inspections, and leak testing, shall be performed and documented according to the requirements of the standard being followed.

(i) These inspections shall be performed by inspectors meeting the qualifications required by the standard being followed.

(ii) The applicability and frequency of these inspections is determined by the AST type, capacity, type of installation, corrosion rate, inspection history, and standard being followed.

(iii) ASTs installed before April 14, 2011, that had no previous inspections were required to have their first inspections conducted before October 14, 2012, or before the date established by the applicable inspection standard based on the age of the tank. All other ASTs installed before April 14, 2011, were required to be reinspected before the reinspection date established by the inspection standard or October 14, 2012, whichever came first.

(iv) Re-inspection of all ASTs shall occur in the same month as the previous inspection, during the next inspection year established by the applicable inspection frequency.

(e) The Director shall have authority to enter in or upon the premises of any facility that contains an AST system containing a regulated substance, for the purpose of verifying that such AST system and its required records are in compliance with these regulations. 3-3-5 Record Keeping (a) Owners/operators must maintain the following records for an AST site as applicable:

(1) Installation permits for newly installed tanks, reinstalled used tanks or permits for upgrading existing tanks must be maintained for 5 years.

(2) Tank registration records or record of facility ID number retained until closure.

(3) Records of repairs that have been performed within the last 5 years.

(4) Monthly and annual visual inspection records of the AST system must be kept for one year. Formal inspection reports and supporting documents shall be retained for the life of (5) Most recent underground piping precision test records must be maintained.

(6) Records showing the history of each AST in terms of which Class and type of product has been stored in that tank, shall be maintained for at least one year.

(7) Electronic/mechanical tank gauge calibration documentation required by 3-3-1(a)(2)(i) must be kept for one year.

(8) Tank ullage documentation required by 3-3-1(a)(4)(ii)(A) must be kept for one year.

(9) Inventory control records required by 3-3-3(a)(5) must be kept for one year.

(10) LNAPL removal records must be maintained to document proper operation following any release of product within the last five years.

(11) Records showing the changes in status of tanks that have been temporarily closed at times then returned to service, should be maintained for at least two (2) years. Records need not be kept for tanks that have been permanently closed.

(12) Records of the operation of the cathodic protection system including results of 60-day inspection as required in 3-3-2 (d)(3).

(b) Records must be maintained at the AST site and immediately available for inspection by the Director; or at a readily available alternative site and be provided for inspection within 24 hours to the Director upon request.

(c) Notwithstanding the above, to be eligible for the Fund, persons may be required to maintain the above or other records in accordance with Fund requirements.

Section 3-4 Closure of AST Systems 3-4-1 Temporary Closure (a) Owners/operators shall notify the Director in writing at least 10 calendar days prior to placing an AST system in temporary closure, and at that same time submit records documenting the prior 12 months of monthly visual inspections, inventory control, ullage records, piping release detection records, and corrosion protection testing (if applicable) for tanks and piping. In lieu of submitting these records, the owner/operator may conduct a tightness test of the tanks and underground piping, and complete a site assessment in accordance with 4-1, and submit these results with the temporary closure notification.

(b) Temporarily closed tanks must be emptied of liquid, rendered vapor free and safeguarded against trespassing by means of locked gates, fences etc. When an AST system is temporarily closed, owners/operators must continue the operation, maintenance, inspection, and testing of corrosion protection in accordance with these regulations. Because the tanks must be emptied, release detection is not required.

(c) When an AST system is temporarily closed, vent lines must be left open and functioning. If the temporary closure period is 3 months or more, all pumps, manways, ancillary equipment and lines other than vent lines must be capped and secured, unless an alternate schedule is (d) When an AST system is temporarily closed for more than 12 months, owners/operators must permanently close the AST system in accordance with 3-4-2, unless the Director provides a written extension of the 12-month temporary closure period. Before requesting this extension, owners/operators must complete a site assessment in accordance with 4-1.

(e) Owner/operators shall notify the Director in writing no more than 30 calendar days prior to placing an AST back in service, and at that same time submit corrosion protection records (if applicable) for the period of temporary closure, and documentation of passing tightness tests for the AST conducted within the past 30 calendar days. The owner/operator shall obtain passing tightness tests for underground lines immediately upon introduction of fuel into the lines and submit documentation of testing to the Director within 10 calendar days.

(f) If an owner/operator operates a facility which has a specific period of time or season during the year when the tank system is empty, as described in (b) of this section, the requirements for maintaining corrosion protection and the following requirements below will apply:

(1) The owner/operator shall notify the Director that the facility does include seasonal operation on a form provided by the Director. If this information changes, the owner/operator shall complete and submit the form to the Director.

(2) The period may not exceed 6 consecutive months.

(3) The owner/operator shall maintain manifest documentation completed during emptying of (4) At the end of the seasonal period, the owner/operator must conduct one of the following actions:

(i) Return the tank to service.

(ii) Place the tank into proper temporary closure. The owner/operator must notify the Director in writing within 10 calendar days, submit records according to (a) as applicable and complete requirements in (c) immediately.

(iii) Permanently close the tank as required by 3-4-2. 3-4-2 Permanent Closure (a) Owners/operators shall notify the Director in writing at least 10 calendar days prior to placing an AST system in permanent closure, and at that same time submit records documenting the prior 12 months of monthly visual inspections, inventory control, ullage records, piping release detection records, and corrosion protection testing (if applicable) for tanks and piping.

Exception: Records do not need to be submitted where they have already been submitted as part of placing the tank into temporary closure as required by 3-4-1.

(b) Empty and clean the tank by removing all liquids and accumulated sludges; and (c) Clean out and plug both ends of all connected piping; and (d) Remove all dispensers; and (e) Render all connected loading facilities completely inoperative; and (f) Safeguard the AST system from trespassing as described in 3-4-1, or remove the tanks from the facility; and (g) Conduct and submit a site assessment according to 4-2; and (h) Submit a completed Closure Inspection Form within 30 calendar days following the closure. 3-4-3 Change in Service Continued use of an AST system to store a substance other than a regulated substance is considered a change-in-service. Before a change-in-service, owners/operators must complete the following:

(a) Notify the Director in writing at least 10 calendar days prior to the change of service; and (b) Empty and clean the tank, connected piping, and any other equipment that previously contained a regulated substance; and (c) Conduct a site assessment according to 4-1; and (d) Submit a completed Closure Inspection Form within 30 calendar days following the change-inservice. [Note 1: Permanently closed or non-regulated ASTs may be returned to active regulated substance service only after meeting the reinstallation rules described in 3-2-3(d).] [Note 2: These closure rules are the minimum required in Colorado; they do not preempt local fire district rules, local building codes, or local zoning rules. In fire districts where the Uniform Fire Code is in effect, the fire district may require that temporarily closed ASTs be removed or demolished.] [Note 3: The following procedures may be used to comply with 3-4:

(A) American Petroleum Institute Standard 2015, Requirements for Safe Entry and Cleaning of Petroleum Storage Tanks;

(B) National Institute for Occupational Safety and Health “Criteria for a Recommended Standard...Working in Confined Space” may be used as guidance for conducting safe closures.] 3-4-4 Waste Handling (a) All liquids and accumulated sludges must be removed and disposed of according to the rules adopted pursuant to the Solid Waste Disposal Regulations and the Colorado Hazardous Waste

Section 3-5 Oil Pollution Prevention - SPCC Plan The US EPA’s SPCC rule regulates non-transportation-related onshore and offshore facilities that could reasonably be expected to discharge oil into navigable waters of the United States or adjoining shorelines. It is the responsibility of the facility owner/operator to make the determination whether the facility is subject to the requirements of the SPCC rule. This determination is subject to review by the EPA’s Regional Administrator. All requests for information regarding SPCC should be directed to the US EPA.

Compliance with the US EPA’s SPCC rule is required. Documentation used to demonstrate compliance with the US EPA’s SPCC rule may be used to demonstrate compliance with this section.

ARTICLE 4 RELEASE IDENTIFICATION AND REPORTING

Section 4-1 Site Check A site check, as defined in Section 1-5, is required during the following occurrences or at any other time when requested by the Director:

(a) the closure-in-place of a tank system, (b) before an extension to the temporary closure of an UST, (c) before an extension to the temporary closure of a AST, (d) at a change-in-service, or (e) to confirm a suspected release.

Owners/operators must measure for the presence of a release where contamination is most likely to be present and shall collect samples of the type and at locations as specified by the Director. If contaminated soil, contaminated groundwater, petroleum vapor, or LNAPL is discovered, owners/operators must report a confirmed release in accordance with Section 4-4. All site check results must be submitted to the Director within 30 calendar days of the completion of closure, change-in-service, or discovery of the suspected release.

OPS will make relevant records available to the public online through our Public Record Center but will withhold confidential or proprietary information upon reasonable request.

The requirements of this section may be satisfied for USTs if one of the external release detection methods allowed in 2-3-4-2(e) or (f) is in use, following the requirements in 2-3-4-2 at the time of closure, and results indicate no release has occurred.

Section 4-2 Site Assessment at Permanent Closure For assessments during storage tank system removal, the owner/operator must collect soil samples from beneath each tank, beneath each dispenser, beneath areas of piping, and for ASTs, beneath any loading areas.

(a) Samples collected at all sites must be analyzed for individual chemicals of concern (COCs) as described in 5-2.

(b) If contaminated soils, contaminated groundwater, petroleum vapor, or LNAPL is discovered under this section or by any other manner, owners/operators must report the discovery in accordance with Section 4-4.

(c) A tank closure assessment report (TCAR) must be submitted within 30 calendar days of closure.

(d) If a release (e.g. a detection of COCs) is identified, refer to Article 5.

(e) When requested by the Director, the owner/operator of a closed AST system or a UST system permanently closed before December 22, 1988, must assess the facility for a release of previously stored regulated substances in accordance with Sections 2-4 and 3-4 if releases from the tank system may, in the judgment of the Director, pose a current or potential threat to human health and the environment.

Section 4-3 Suspected Releases The following conditions require reporting of a suspected release from a regulated UST or AST system to the Director within 24 hours by telephone (303-318-8547), the Release Reporting Form provided on the OPS website, or other methods provided by the Director:

(a) Inconclusive or failed SIR results that are not overturned by the third-party SIR vendor within 24 hours of the receipt of the report from the vendor.

(b) The discovery of released regulated substances at the UST site or in the surrounding area, such as the presence of LNAPL or vapors in soils, basements, sewer and utility lines, or the presence of contamination in surface, ground, well, or drinking water when the source of the contamination is not known.

(c) Unusual operating conditions observed by owners and operators (such as the erratic behavior of product dispensing equipment, the sudden loss of product from the UST system, an unexplained presence of water in the tank, or liquid in the interstitial space of secondarily contained systems), unless:

(1) The system equipment or component is found not to be releasing regulated substances to the environment;

(2) Any defective system equipment or component is immediately repaired or replaced; and (3) For secondarily contained systems, any liquid in the interstitial space not used as part of the interstitial monitoring method (for example, brine-filled) is immediately removed.

(d) Monitoring results, including investigation of an alarm, from a release detection method that indicate a release may have occurred unless:

(1) The monitoring device is found to be defective, and is immediately repaired, recalibrated or replaced, and additional monitoring does not confirm the initial result;

(2) The leak is contained in secondary containment and:

(i) Any liquid in the interstitial space not used as part of the interstitial monitoring method (for example, brine filled) is immediately removed; and (ii) Any defective system equipment or component is immediately repaired or replaced;

(3) In the case of inventory control, a second month of data does not confirm the initial result or the investigation determines no release has occurred; or (4) The alarm was investigated and determined to be a non-release event (for example, from a power surge or caused by filling the tank during release detection testing).

(e) A failed system test of a tank system component that is within secondary containment.

If outside normal working hours or on a weekend, if the release enters a storm drain or is discovered on or near surface water, or if emergency assistance is needed, also call the emergency response number (877-518-5608) at the Colorado Department of Public Health and Environment.

Section 4-3-1 Suspected Release Investigation and Confirmation Steps In response to a suspected release, the owner/operator shall:

(a) Perform a system test, as defined in Section 1-5, that determines whether a leak exists in that portion of the tank system that routinely contains product (i.e. tanks and attached delivery piping), secondary containment devices (e.g. under dispenser containment), or spill prevention equipment such as a catchment basin, spill bucket, or other spill containment device that is suspected of releasing regulated substance.

(1) The test must determine whether:

(i) A leak exists in that portion of the tank that routinely contains product, or the attached delivery piping; or (ii) A breach of either wall of the secondary containment has occurred.

(2) If the system test identifies a leak into secondary containment, owners and operators must:

(i) Report a suspected release to the Director within 24 hours, (i) Repair, replace, upgrade, or close the tank system, and (iii) Conduct a system test on the affected secondary containment system.

(3) If the system test identifies a release to the environment, owners and operators must:

(i) Report a confirmed release to the Director within 24 hours, (i) Repair, replace, upgrade, or close the tank system, and (iii) Conduct a site check as described in paragraph (b) of this section.

(4) All system test results shall be submitted to the Director within 10 calendar days of the suspected release.

(5) Further investigation including a site check as described in paragraph (b) of this section is not required if the test results for the system, tank, and delivery piping do not indicate that a release exists, unless environmental contamination is the basis for suspecting a release.

(b) Perform a site check, as defined in Section 1-5, for suspected releases per Section 4-3, where contamination is most likely to be present based on:

(1) Failed system test results when the failing component is in secondary containment, and/or (2) The presence of stained soils, soils with petroleum odors, or elevated field screening readings when the source is unknown (environmental contamination is the basis for suspecting a release).

(c) Owner/operators must collect soil and groundwater samples for laboratory analysis as described in 5-2. These samples must be collected from appropriate locations and depths in the vicinity of the suspected source(s) (i.e. tanks, lines, dispensers) to determine if a release to the environment has occurred. All site check results shall be submitted to the Director within 30 calendar days of the suspected release.

(d) All liquids and accumulated sludges must be removed and disposed of according to the rules adopted pursuant to the Solid Waste Disposal Regulations and the Colorado Hazardous Waste

Section 4-4 Confirmed Releases The following conditions require reporting a confirmed release from a regulated UST or AST system to the Director within 24 hours by telephone (303-318-8547), the Release Reporting Form provided on the OPS website, or other methods provided by the Director:

(a) A failed system test of a tank system component that is not within secondary containment, (b) A site check or other sample analyses that indicate a release (any detection of any chemical(s) of concern) to the environment has occurred from the tank system.

(c) A release of regulated substances at the site or in the surrounding area is observed, when the source of the contamination is known to be the owner’s/operator’s UST or AST system. Examples include:

(1) The presence of fuel outside of the storage tank system, (2) Identification of contamination during routine inspections, system repairs, installation, replacement or other sub-pavement work, or (3) The presence of contamination, LNAPL, or vapors in soils, basements, utility lines, or surface, ground, well or drinking water.

(d) If a fuel spill or overfill of the regulated substance of any volume is not cleaned up within 24 hours or if a fuel spill or overfill that exceeds 25 gallons of a regulated substance occurs.

If outside normal working hours or on a weekend, if the release enters a storm drain or is discovered on or near surface water, or if emergency assistance is needed, also call the emergency response number (877-518-5608) at the Colorado Department of Public Health and Environment. [Note: Pursuant to 40 CFR § 302.6 and 355.40, a release of a hazardous substance from an AST system equal to or in excess of its reportable quantity must also be reported immediately (rather than within 24 hours) to the National Response Center (800-424-8802) under Sections 102 and 103 of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980; and to appropriate state and local authorities (Colorado Department of Public Health and Environment (CDPHE): 877-518- 5608) under Title III of the Superfund Amendments and Reauthorization Act of 1986]

ARTICLE 5 RELEASE RESPONSE

Section 5-1 Response to Confirmed Releases The owner/operator of a regulated substance system shall, in response to a confirmed release, comply with the requirements of these regulations, which incorporate a risk-based corrective action (RBCA) approach. Any work performed or required under these regulations does not automatically qualify the owner/operator for reimbursement from the Petroleum Storage Tank Fund (PSTF). The obligation of the owner/operator responsible for the release remains with that owner/operator in the event that the tank system and/or property changes ownership. 5-1-1 Acute Human Health Hazards Upon discovery of a regulated substance on ground surface or surface water, or if a regulated substance has the potential to create a fire, explosion or acute health hazard, emergency response action shall be initiated immediately.

The owner/operator responsible for the release shall:

(a) Identify and mitigate fire, explosion, vapor and acute health hazards by contacting the local fire department or other first-responder and conducting other mitigation activities as capability allows;

(b) Identify and mitigate impacts to water supply wells, supply lines or surface intake;

(c) Initiate containment and removal of any free-phase hydrocarbons observed on the ground surface or surface water body; and (d) Report identification of either (a), (b) or (c) of this subsection to OPS within 24 hours of discovery. 5-1-2 Chronic and Secondary Human Health Hazards and Other Environmental Impacts After abatement of any acute human health hazards, the owner/operator responsible for the release shall:

(a) Take action to prevent any further release into the environment;

(b) Identify the source and cause of the release and repair, replace or upgrade the portion of the petroleum storage tank system that failed;

(c) Monitor and mitigate any health hazards posed by vapors or free-phase hydrocarbons that have entered into subsurface structures (such as sewers or basements); and (d) Remedy hazards posed by contaminated media that are excavated or exposed as a result of abatement activities. The owner/operator must comply with applicable state and local requirements if these remedies include treatment or disposal of contaminated media.

Section 5-2 Site Characterization The purpose of site characterization is to define source area(s) of the release, determine the distribution of contamination in the subsurface, determine if POEs are impacted or potentially impacted, evaluate all exposure pathways and determine whether active remediation is necessary. Site characterization results must be submitted to OPS within 180 calendar days of the release discovery in the appropriate and current report format provided on the OPS website.

Upon confirmation of a release and completion of emergency response, the owner/operator shall complete the following tasks:

(a) Verify the source(s) and cause(s) of the release;

(b) Collect representative environmental samples for laboratory analyses in accordance with Section 5-3-1 to determine the vertical and horizontal distribution and extent of sorbed, dissolved, vapor, and free-phase contamination. Groundwater must be assessed when the potential for groundwater contamination has occurred;

(c) Identify potential receptors;

(d) Determine if POEs are potentially impacted or are impacted. If there are imminent threats to human health or the environment, mitigate completed exposure pathways to receptors (e.g., impacted water supply wells, surface water, or structures) in consultation with OPS;

(e) Evaluate all exposure pathways;

(f) Upon discovering the potential for contamination extending beyond the facility’s property, or leased property boundary, the Responsible Party (RP) must notify OPS within 24 hours;

(g) If the extent of contamination extends beyond the facility boundary, request access to off-site properties, including rights-of-way. Send copies of requisition letter(s) to OPS and notify OPS within 30 days if access is not granted;

(h) Collect site-specific geologic and hydrogeologic data:

(1) Determine the predominant lithology in the unsaturated and saturated zones;

(2) Determine the depth to water, hydraulic gradient, and groundwater flow direction;

(3) Determine the site-specific hydraulic conductivity; and (4) Evaluate other geologic conditions that influence (LNAPL), groundwater, and soil vapor movement;

(i) Develop a Conceptual Site Model (CSM);

(j) Calculate Tier II site-specific target levels (SSTLs) for on-site contamination;

(k) Evaluate the need for active remediation to meet Tier II closure criteria and identify feasible remedial technologies; and (l) Determine whether active remediation is necessary. If pilot testing is necessary, provide the OPS technical reviewer with a detailed scope and cost for concurrence before execution. 5-2-1 Laboratory Analysis of Samples (a) Soil samples shall be analyzed for:

(1) Benzene, toluene, ethyl benzene, total xylenes, and naphthalene (BTEXN);

(2) The appropriate range(s) of total petroleum hydrocarbons (TPH) based upon the type of product released, as follows:

(i) Total volatile petroleum hydrocarbons (TVPH; gasoline range organics C6-C10);

(ii) Total extractable petroleum hydrocarbons (TEPH; diesel range organics11-C28); and/or (iii) Total recoverable petroleum hydrocarbons (TRPH; oil range organics C29-C35);

(3) Polynuclear aromatic hydrocarbons (PAHs) must be analyzed for the sample with the highest TEPH or TRPH concentration detected at the facility if the TEPH or TRPH exceeds the Tier I screening level of 500 mg/kg;

(4) The fuel additives tetraethyl lead (TEL; surface soil only), 1,2 dichloroethane (1,2 DCA), and ethylene dibromide (EDB) if any facility operated at the release location prior to January 1, 1996;

(5) Analysis of full volatile organic compounds (VOCs) when characterizing a release from a waste oil tank; and (6) If stored at the facility, other regulated compounds, including ethanol, methanol, petroleum solvents, and glycols.

(b) Water samples shall be analyzed for:

(1) Benzene, toluene, ethyl benzene, total xylenes, and naphthalene (BTEXN);

(2) The appropriate range(s) of total petroleum hydrocarbons (TPH):

(i) Total volatile petroleum hydrocarbons (TVPH; gasoline range organics C6-C10);

(ii) Total extractable petroleum hydrocarbons (TEPH; diesel range organics C11- C28); and/or (iii) Total recoverable petroleum hydrocarbons (TRPH; oil range organics C29-C35).

(3) Polynuclear aromatic hydrocarbons (PAHs), if any subsurface soil sample, contains PAHs above RBSLs. See the Petroleum Guidance for further information;

(4) The fuel additives 1,2 dichloroethane (1,2 DCA), and ethylene dibromide (EDB) if any facility operated at the release location before January 1, 1996;

(5) The fuel additive methyl tertiary butyl ether (MTBE) if any facility operated at the release location before May 1, 2002;

(6) Analysis of full volatile organic compounds (VOCs) when characterizing a release from a waste oil tank; and (7) If stored at the facility, other regulated compounds, including ethanol, methanol, petroleum solvents, and glycols.

(c) Soil vapor samples shall be analyzed for:

(1) Benzene, toluene, ethyl benzene, total xylenes, and naphthalene (BTEXN);

(2) The fuel additives 1,2 dichloroethane (1,2 DCA) and/or ethylene dibromide (EDB) if these compounds are present in soil or groundwater; and (3) Field measurements of oxygen, carbon dioxide, and methane. 5-2-2 Tier I Risk-Based Screening Levels (RBSLs)

Identify all concentrations relative to the Tier I RBSLs in Table 5-1.

Table 5-1 Tier I Risk Based Screening Levels Chemical of Concern Surficial Soil (Ingestion, Dermal, Inhalation)

Subsurface Soil (Leachate to GW, Ingestion)

Reg. 41 Colorado Groundwater Standards [μg/L]

Soil Vapor [mg/m3]

Benzene 1.6 0.52 5 213 Toluene 4,889 91 560 44,200 Ethylbenzene 8 212 700 776 Xylenes 577 364 1,400 17,200 Naphthalene 3.8 143 140 227 TVPH TEPH TRPH Polycyclic Aromatic Hydrocarbons (PAHs)

Acenaphthene 3,586 1,389 420 N/A Anthracene 17,932 22,583 2,100 N/A Benz(a) anthracene 1.3 18.6 0.16 N/A Benzo(a) pyrene 0.1 6.2 0.016 N/A Benzo(b) fluoranthene 1.3 63 0.16 N/A Benzo(k) fluoranthene 13 617 1.6 N/A Chrysene 131 1,898 16 N/A Dibenz(a,h) anthracene 0.1 20 0.016 N/A Fluoranthene 2,391 10,202 280 N/A Fluorene 2,391 1,687 280 N/A Indeno (1,2,3-cd) pyrene 1.3 205 0.16 N/A [Notes:

OPS has established a threshold value of 500 mg/kg for TPH in soil to define the extent of contamination and identify sites where PAHs may pose a risk to human health and the environment. See OPS guidance for further information.

Analysis required at release locations where a facility operated on or before January 1, 1996 (TEL; EDB; 1,2 DCA) or May 1, 2002 (MTBE).

The laboratory reporting limit must be reported in all cases.

The first number in the range is a strictly health-based value. The second number in the range is a maximum contaminant level determined to be an acceptable level of this chemical in water supplies, taking treatability and laboratory detection limits into account. OPS will default to the second number in the range unless contamination is within the boundaries of an existing or reasonably anticipated water supply.

US EPA Drinking Water Advisory based on taste/odor threshold and adopted by OPS.

Section 5-3 Corrective Action The owner/operator shall develop and implement a Corrective Action Plan (CAP) based on the need for remediation identified during Site Characterization. The purpose of the CAP is to develop an approach to reach cleanup goals of less than Tier I RBSLs at the impacted POEs and to Tier II SSTLs on-site and calculate the time frame to achieve the cleanup goals. A completed CAP report must be submitted to OPS within one year (365 calendar days) of the release discovery date in the report format provided on the OPS website. Proposed scope of work costs must be presented if the release event is eligible for reimbursement from the PSTF.

(a) If natural attenuation is being proposed in the CAP, the owner/operator shall:

(1) Calculate the time frame to achieve the remediation goals utilizing site-specific natural attenuation rates;

(2) Present milestones to evaluate natural attenuation progress; and Chemical of Concern Surficial Soil (Ingestion, Dermal, Inhalation)

Subsurface Soil (Leachate to GW, Ingestion)

Reg. 41 Colorado Groundwater Standards [μg/L]

Soil Vapor [mg/m3]

Pyrene 1,793 7,498 210 N/A Gasoline Additives Tetraethyl lead (TEL) 0.01 N/A N/A N/A Ethylene dibromide (EDB) 0.05 0.001 0.02 to 0.05 0.0674 1,2- Dichloroethan e (1,2-DCA) 0.63 0.012 0.38 to 5 0.204 Methyl tertbutyl ether (MTBE)

N/A N/A 20

N/A (3) Present a monitoring and reporting schedule for a period not to exceed two (2) years.

(b) For all other CAPs, the owner/operator shall:

(1) Continue mitigating completed exposure pathways to receptors (e.g. impacted water supply wells, surface water, or structures) to prevent exposure while remedial actions are undertaken;

(2) Define remedial objectives, identify targeted treatment areas, identify reasonable remedial options, and justify a technically and economically feasible remedial approach, including a conceptual treatment train to achieve release event closure;

(3) Identify and collect critical data needs (e.g. pilot and/or bench-scale testing) for the selected remedy(s);

(4) Prepare a full-scale remediation design that addresses all areas/zones requiring active remediation;

(5) Calculate the time needed to achieve the remediation technology objectives;

(6) Present an implementation schedule not to exceed three (3) years;

(7) Present milestones to evaluate remediation progress;

(8) Present a monitoring and reporting schedule; and (9) Continuously update the CSM, including text and illustrations, with new information (e.g. from additional assessment and/or results from remedial action). Data gaps that significantly affect the successful completion of planned remedial actions should be reported.

(c) The owner/operator must implement the CAP immediately in accordance with the implementation schedule of the approved CAP, or as directed by the Director. The owner/operator must report the results of CAP implementation in accordance with a schedule and in a format approved by the Director. Any deviation from the approved CAP, including schedule revisions, must be approved by the Director.

Section 5-4 No Further Action Request The owner/operator may request a Tier I or Tier II No Further Action (NFA) for a release at any time when the conditions below are met. For all NFA requests, the owner/operator must demonstrate that contamination is at concentrations that are protective of human health and the environment at all POE(s), and that data collected confirms no foreseeable future risk according to the RBCA process.

Tier III and Tier IV NFA criteria will only be considered after corrective action measures have been implemented correctly based on the goals set forth in the corrective action plans submitted to OPS, contamination has been removed to the maximum extent practicable (MEP), OPS concurs that a Tier II NFA is not attainable, and all other NFA conditions are met. Public notice of the presence of off-site contamination will be provided based on Section 5-5.

(a) A Tier I NFA Request must meet the following criteria:

(1) All contaminants of concern for the release are below the Tier I RBSLs (as shown in Table 5-1).

(b) A Tier II NFA will be considered if a Tier I NFA cannot be met. The following criteria must be met for a petroleum release to be considered for a Tier II NFA:

(1) Impacted media concentrations are lower than SSTLs for the applicable exposure pathways;

(2) Point of compliance monitoring wells upgradient of the nearest POE are below the Tier I RBSLs; and (3) Fate and transport modeling predicts that POEs will not become impacted in the future at concentrations above the Tier I RBSLs.

(c) Tier III NFA criteria establish conditions where COCs can remain above Tier I RBSLs at the facility property boundary (either leased property boundary or real property boundary) but not beyond an adjoining public roadway. The following criteria must be met for a petroleum release to be considered for Tier III NFA:.

(1) Contaminant removal, including LNAPL, to the MEP;

(2) The public roadway property boundary is the only impacted POE. Point of compliance locations must be established immediately upgradient of the opposite side of the public roadway;

(3) Present a summary of existing and planned construction activities along with an evaluation of how potential exposure pathways will be affected based on these activities;

(4) Post-remediation monitoring confirms the plume is stables or degrading;

(5) Fate and transport modeling predicts that POEs will not become impacted in the future at concentrations above the Tier I RBSLs; and (6) Public notice of the presence of off-site contamination to the affected properties will be provided based on Section 5-5.

(d) Tier IV NFA criteria establish conditions where COCs can remain above Tier I RBSLs at off-site properties, irrespective of land use. The following criteria must be met for a petroleum release to be considered for Tier IV NFA:

(1) The facility property on which the petroleum release originated cannot have an active petroleum storage tank system. Exceptions to this may be granted by the Director on a case-by-case basis for newer secondarily contained petroleum storage tank systems that have been operating in compliance with regulations and have no reported petroleum releases.

(2) Contaminant removal, including LNAPL, to the MEP;

(3) The facility property boundary (either leased or real property boundary) is the only impacted POE(s) where COC concentrations may be above the Tier I RBSL;

(4) Point of compliance locations must be established immediately upgradient of the nearest POE to the property boundary;

(5) Present a summary of existing and planned site uses along with an evaluation of how potential exposure pathways will be affected based on the land use;

(6) Post-remediation monitoring confirms the plume is stable or degrading:

(7) Fate and transport modeling indicates the farthest property boundary will not become impacted in the future at concentrations above the Tier I RBSLs; and (8) Public notice of the presence of off-site contamination to the affected properties will be provided based on Section 5-5.

Any release granted an NFA may be reopened if subsequent information indicates a change in exposure scenarios.

To reduce the potential risk of exposure to contamination, the owner/operator must contact OPS immediately if the property's function is modified for a different use and the new use does not include dispensing petroleum products. OPS cannot release the owner/operator from any liability that may be associated with any contamination at or from the site. See the Petroleum Guidance for additional information.

Section 5-5 Public Participation (a) For each confirmed release that requires corrective action, the Director must ensure the following:

(1) Notice is provided to the public by means designed to reach those members of the public directly affected by the release and the planned corrective action. This notice may include, but is not limited to letters to individual households; public notice in local newspapers; public service announcements; publication in a state register; personal contacts by staff; and/or information on the OPS website;

(2) Site release information and decisions concerning the CAP are made available to the public for inspection upon request;

(3) Before approving a corrective action, if necessary, hold a public meeting to consider comments on the proposed corrective action if there is sufficient public interest or for any other reason; and/or (4) Provide public notice that complies with subsection (a) of this section, if necessary, if the implementation of an approved corrective action plan does not achieve the established cleanup levels in the corrective action plan or termination of the correction action plan is under consideration by the Director.

(b) For each confirmed release that will be granted a Tier III or Tier IV risk-based NFA, the Director must ensure the following:

(1) Notice is provided to the public by means designed to reach those members of the public directly affected by the proposed and final Tier III or Tier IV risk-based NFA. This notice may include, but is not limited to letters to individual households; public notice in local newspapers; public service announcements; publication in a state register; personal contacts by staff; and/or information on the OPS website;

(2) Ensure that site release information and decisions concerning the Tier III or Tier IV riskbased NFA are made available to the public for inspection upon request (3) Before determining Tier III or IV NFA, if necessary, hold a public meeting to consider comments if there is sufficient public interest or for any other reason.

ARTICLE 6 ENFORCEMENT

Section 6-1 Enforcement Program The Director provides these regulations to assist owners/operators with safe and proper operation of regulated storage tank systems. When a facility is found to be out of compliance with these regulations (7 C.C.R. § 1101-14) and/or statutes (C.R.S. § 8-20 and 8-20.5), the Director will pursue enforcement actions against the owner/operator. The enforcement process will include requiring the owner/operator to make repairs and/or upgrades, perform system tests, keep records, and other actions to bring the facility back into compliance. During and following the enforcement process, the Director will continue to assist the owner/operator to remain in compliance. The enforcement process may include monetary penalties up to five thousand dollars ($5,000) per tank per day according to statute (C.R.S. § 8-20.5-107) if the enforcement obligations are not implemented according to the required schedule. Additionally, reductions to reimbursement amounts may be applied in accordance with Article 8. 6-1-1 Notice of Violation (a) The Director may issue a Notice of Violation (NOV) to a person who has been determined to have violated these regulations (7 C.C.R. § 1101-14) and/or statutes (C.R.S. § 8-20 and 8-20.5).

(b) The NOV will include a list of each of the violations and any actions necessary to correct the violations.

(c) Within ten (10) working days after a NOV has been issued, the owner/operator may file a written request with the Division Director for an informal conference regarding the NOV. If the owner/operator does not request an informal conference within this time frame, all provisions of the NOV shall become final and not subject to further discussion. If the NOV is not resolved within the time frame prescribed in the NOV, the Division Director may seek judicial enforcement of the NOV, or an Enforcement Order may be issued. 6-1-2 Enforcement Order (a) An Enforcement Order may be issued when the violations included within a NOV or Settlement Agreement are not resolved within the prescribed time frame. The Enforcement Order may include increased fines up to five thousand dollars ($5,000) per tank for each day of violation. In addition, the Enforcement Order may include Delivery Prohibition (Section 6-2).

(b) Within ten (10) working days after an Enforcement Order has been issued, the owner/operator may file a written request with the Executive Director (or designee) for an informal conference regarding the Enforcement Order. If the owner/operator does not request an informal conference within this time-frame, all provisions of the Enforcement Order shall become final and not subject to further discussion. If the Enforcement Order is not resolved within the prescribed time frame, the Director may then seek judicial enforcement of the Enforcement Order. 6-1-3 Informal Conference (a) Upon receipt of the request, the Director shall provide the owner/operator with notice of the date, time and place of the informal conference. The Director shall preside at the informal conference, during which the owner/operator and OPS personnel may present information and arguments regarding the allegations and requirements of the NOV or the Enforcement Order.

(b) Within twenty (20) working days after the informal conference, the Director shall issue a Settlement Agreement in which the issues from the NOV and/or Enforcement Order will be upheld, modified or stricken. The Settlement Agreement will include a schedule of required activity for resolution of the violations. If the terms and/or schedule in the Settlement Agreement are not satisfied, either an Enforcement Order will be issued, re-issued, or the Director may seek judicial enforcement.

(c) The Settlement Agreement issued by the Director may be appealed within twenty (20) working days to the Executive Director of the department. The Executive Director may either conduct the hearing personally or appoint an administrative law judge from the office of administrative courts in the department of personnel to conduct the hearing.

Section 6-2 Petroleum Storage Tank Delivery Prohibition Delivery prohibition is an enforcement action prohibiting the delivery, deposit, or acceptance of product to an AST or UST that has been determined by OPS to be ineligible for such delivery, deposit, or acceptance. For purposes of this section, the term “UST” means those tanks that satisfy the definition of UST in C.R.S. §8-20.5-101, except for those tanks identified in §8-20.5-101 17(b) and as defined in 2-1- 1(b) as excluded or deferred storage tanks. These requirements apply to regulated substance ASTs and USTs. OPS will prohibit delivery, deposit, or acceptance of product on an individual AST or UST basis, instead of to every AST or UST at a facility, except if warranted.

AST and UST owners/operators and product deliverers are responsible for not delivering, depositing, or accepting product to a tank system\ identified by OPS as ineligible to receive product. 6-2-1 Criteria for Delivery Prohibition (a) Field Inspection: OPS shall prohibit delivery, deposit, or acceptance of product during an inspection if any of the following conditions exist.

(1) Required spill prevention equipment is not installed or functional.

(2) Required overfill protection equipment is not installed, or functional.

(3) Required leak detection equipment is not installed, or functional.

(4) Required corrosion protection equipment is not installed or functional.

(5) Failure to register or maintain current registration on an AST or UST.

(6) Upon the discovery of a significant violation that poses an imminent threat to human health or safety or the environment. In addition to delivery prohibition, OPS may also require the removal of product from the tank:

(b) Enforcement Notice: OPS shall prohibit delivery, deposit, or acceptance of product if the owner/operator of that tank has been issued a written warning or citation (Settlement Agreement or Notice of Violation per C.R.S. § 8-20.5-107) under any of the following circumstances and the owner/operator has failed to take corrective action within the requested time frame.

(1) Inability to demonstrate proper operation and/or maintenance of leak detection equipment.

(2) Inability to demonstrate proper operation and/or maintenance of spill, overfill, or corrosion protection equipment.

(3) Discovery of a significant violation that poses an imminent threat to human health or safety, or to the environment. In addition to delivery prohibition, OPS may also require the removal of product from the tank. 6-2-2 Red Tag Mechanisms Used to Identify Ineligible Petroleum Storage Tank Systems Upon determination that any of the criteria for delivery prohibition have been met, including the discovery of a significant violation that poses an imminent threat to human health or safety or the environment, OPS will attach a red tag to each fill pipe of the ineligible tank system clearly identifying the tank as ineligible for delivery, deposit, or acceptance of product. Before affixing a red tag to the fill pipe of a tank system, OPS shall document the level of stored product in the tank.

(a) The red tag will be attached to the fill pipe using a tamper-resistant wire seal so that the tag is visible to any person attempting to deliver a regulated substance to the tank system.

(b) The tag shall be red in color and made of plastic or other durable and damage resistant material and shall bear the following information:

(1) The following wording, printed in white at the top of the tag in all capital letters in at least 36 point bold-faced type: “DELIVERY PROHIBITED!”

(2) The following wording, printed in white below the wording described in subsection (b)(1) in at least 16 point type: “Delivering a regulated substance, or removing, defacing, altering, or otherwise tampering with this tag may result in civil penalties of up to $5000 per day.”

(3) Printed below the wording described in subsection (b)(2), the following wording in at least 16 point type: “If you have questions call OPS (303) 318-8547”

(4) Following the wording described above, there shall be a blank area at least 1/2 inch wide by four inches long in which the OPS inspector shall, at the time of placement, write legibly in permanent ink the date, facility identification number, product type, and the inspector’s initials.

No owner or operator of a facility or delivery person may deposit or allow the deposit of a regulated substance into a tank system that has a red tag affixed to the system's fill pipe. Unless authorized by OPS, no person shall remove, deface, alter, or otherwise tamper with a red tag such that the information contained on the tag is not legible. 6-2-3 Notification Processes For Storage Tank System Owners/Operators and Product Deliverers (a) Immediately after affixing a red tag, OPS shall notify the operator, if present on site, of the significant violation(s) for which the red tag was issued, along with a written report noting the violations. OPS shall also request current owner/operator contact information for future notifications.

(b) Within 24 hours of affixing a red tag, OPS shall notify the owner in writing of the significant violation(s) for which the red tag was issued.

(c) Within 24 hours of affixing a red tag, OPS shall add the red tagged tank(s) to the OPS website list of facilities that have delivery prohibitions.

(d) If a permit is required by OPS in order to correct one or more significant violations identified, OPS shall, to the extent feasible, expedite its review and issuance of such permit(s). 6-2-4 Reclassifying Ineligible Petroleum Storage Tank Systems as Eligible to Receive Product (a) Upon notification by the owner or operator documenting to the satisfaction of OPS that there was not a significant violation or the significant violation has been corrected, or an emergency condition as described in 6-2-6 exists, OPS shall provide verbal and written authorization to the owner or operator to remove the red tag. If OPS disputes the notification provided by the owner or operator, then the procedural provisions of C.R.S. § 8-20.5-107 shall apply, except that the owner/operator may request and be entitled to an informal conference with the Director within three (3) working days. A delivery prohibition required by a red tag shall remain in effect during the time that the procedural provisions of C.R.S. § 8-20.5-107 are invoked, unless the owner or operator requests and the Director grants a stay of the effect of the red tag.

(b) By close of business (5pm) on that same day, OPS will also remove that tank from the OPS website list of facilities that have delivery prohibitions.

(c) OPS may inspect the tank system within five (5) working days of notification to determine whether the system continues to be in significant violation, regardless of whether it has authorized removal of the red tag by the owner or operator. If, upon inspection, OPS determines that the system is no longer in significant violation and it has not already authorized removal of the red tag, OPS shall immediately remove the red tag.

(d) Upon removing a red tag from a tank system, OPS shall document the level of stored product in the tank. If the owner or operator removes a red tag pursuant to written authorization by the field inspector, the owner or operator shall document the level of stored product in the tank immediately after removing the red tag.

(e) A red tag that has been removed by the owner or operator shall be returned to the OPS within five (5) working days, or sooner if requested by the field inspector. 6-2-5 Delivery Prohibition Deferral in Rural and Remote Areas OPS may decide not to identify a tank system as ineligible for delivery, deposit, or acceptance of product if such a prohibition would jeopardize the availability of, or access to, motor fuel in any rural and remote areas. However, OPS shall only defer application of delivery prohibition for 30 calendar days after determining that a tank system is ineligible for delivery, deposit, or acceptance of product. 6-2-6 Delivery Prohibition Deferral in Emergency Situations In emergency situations, the Director may decide not to identify a tank system as ineligible for delivery, deposit, or acceptance of product if such a prohibition is not in the best interest of the public, even in the cases of significant and/or sustained noncompliance. In such emergency situations, OPS shall only defer application of delivery prohibition for up to 180 calendar days after determining a tank system is ineligible for delivery, deposit, or acceptance of product. 6-2-7 Removal of Red Tag from Emergency Generator Tank Systems OPS may remove or authorize the removal of a red tag from an emergency generator tank system before a significant violation has been corrected if OPS determines that an emergency situation exists requiring operation of the system and the delivery of petroleum is necessary for the continued operation of the system during the emergency.

ARTICLE 7 FINANCIAL RESPONSIBILITY REQUIREMENTS FOR OWNERS/OPERATORS OF

PETROLEUM STORAGE TANK SYSTEMS

Section 7-1 Applicability (a) Owners and operators of petroleum storage tank systems are required to demonstrate compliance with the financial responsibility (FR) requirements in federal regulations by any of the mechanisms described in 40 CFR 280.94 through 280.103. Per C.R.S. § 8-20.5-206, FR is required for underground storage tanks. Per C.R.S. § 8-20.5-303, FR is also required for aboveground storage tanks (ASTs) in Colorado Per the June 2015 revision of EPA regulations, airport hydrant fuel distribution systems, UST systems with field constructed tanks, and UST systems that store fuel solely for use by emergency power generators must also demonstrate FR.

Approved mechanisms per these Colorado regulations are described later in this article. FR is intended to ensure that adequate monies are available in the event of an accidental release from a petroleum storage tank system to provide for cleanup of the release (corrective action) and to potentially compensate impacted third parties for bodily injury and property damage resulting from the release. According to 40 CFR 280.93, the amount of FR required ranges from $500,000 up to $2 million depending on the type of facility, monthly throughput of petroleum product and number of tanks. If an owner or operator cannot meet the required deductible amounts listed in Article 8, another FR mechanism must be identified and obtained in order for the owner or operator to remain in compliance and continue operation of the storage tank system.

(b) This FR requirement applies to the following:

(1) Owners/operators of all petroleum UST and AST systems except as otherwise provided in this section.

(2) If the owner and operator of a petroleum tank system are separate persons, only one person is required to demonstrate FR; however, both persons are jointly liable for release cleanup and third-party damages, if neither person complies with Article 7.

(c) This FR requirement does not apply to the following:

(1) State and federal government entities whose debts and liabilities are the debts and liabilities of a state or the United States.

(2) Owners/operators of any UST system exempted in 2-1-1(b) or AST system exempted in 3-1(b).

Section 7-2 Financial Responsibility Mechanisms Mechanisms to satisfy FR as described in 7-1 are listed below:

(a) 40 CFR Part 280.101 designates state funds as an approved mechanism. The Colorado Petroleum Storage Tank Fund, referred to in this section as the “Fund”, is an EPA approved Fund to provide FR to tank owners and operators in the State of Colorado. Moneys in the Fund, created pursuant to C.R.S. Section 8-20.5-103, may be used by certain owners and operators of petroleum storage tanks to demonstrate their compliance with the FR requirements in federal (b) Owners and operators not eligible for access to the Fund shall be solely responsible for securing independent financial assistance, but may use any federally approved financial assurance mechanism identified in 40 C.F.R. 280.94 through 280.103 to help fund the cost of complying with such requirements. These federally approved mechanisms are as follows.

(1) Financial Test of Self-Insurance.

(i) An owner/operator may satisfy the requirements of C.R.S. § 8-20.5-206 and § 8- 20.5-303 by passing a financial test as specified in this section. To pass the financial test of self-insurance, the owner/operator’s net worth must be based on year-end financial statements for the latest fiscal year.

(ii) The fiscal year-end financial statements of the owner/operator must be examined by an independent certified public accountant and be submitted along with the accountant's report of the examination.

(iii) The owner/operator's year-end financial statements must not include an adverse auditor's opinion, a disclaimer of opinion, or a “going concern” qualification.

(iv) To demonstrate that it meets the financial test under this subsection the chief financial officer of the owner/operator must sign, within 120 calendar days of the close of each financial reporting year, a letter stating that the owner/operator has met the financial test for self-insurance covering USTs or ASTs at the facilities listed. The letter must contain a list of the facilities covered, and the following information must be provided for each facility: the name and address of the facility, the number of tanks at the facility, the size of each tank and the regulated substance contained in each tank.

(v) If an owner/operator using the test to provide FR finds that he or she no longer meets the requirements of the financial test based on the year-end financial statements, the owner/operator must obtain alternate coverage as described in this article within 150 calendar days of the end of the year for which financial statements have been prepared or within 30 calendar days of the date of the financial statement, whichever is earlier.

(vi) The Director may require reports of financial condition from the owner/operator at any time. If the Director finds, on the basis of such reports or other information, that the owner/operator no longer meets the financial test requirements of this subsection, the owner/operator must obtain alternate coverage within 30 calendar days after notification of such a finding.

(vii) If the owner/operator fails to obtain alternate FR within 60 calendar days of finding that he or she no longer meets the requirements of the financial test based on the year-end financial statements, or within 30 calendar days of notification by the Director that he or she no longer meets the requirements of the financial test, the owner/operator must notify the Director of such failure within 10 calendar days.

(2) Insurance Coverage.

(i) An owner/operator may satisfy the requirements of C.R.S. § 8-20.5-206 and § 8- 20.5-303 by obtaining a liability insurance policy that conforms to the requirements of this section from a qualified insurer or risk retention group.

(ii) If the policy contains any type of deductible, the policy must state that the insurer will be liable for such deductible amount in the event of a default by the owner/operator.

(iii) Each insurance policy must be issued by an insurer that is authorized to transact the business of insurance or authorized to provide insurance as an excess or surplus lines insurer in Colorado. The insurer must be in compliance with all applicable regulations, policies and procedures of the Colorado Division of Insurance.

(iv) Each owner/operator must obtain a certificate of insurance from the insurer showing the name and address of each covered location, the policy number, period of coverage, name and address of the insurer and the name and address of the insured for each facility covered by insurance. In the policy, the insurer must certify the following with respect to the insurance described herein.

(A) Bankruptcy or insolvency of the insured shall not relieve the insurer of its obligations under the policy to which this certificate applies.

(B) When requested by the Director, the insurer agrees to furnish a signed duplicate original of the policy.

(C) Notice of cancellation of the insurance by the insurer must be sent to the Director and to the insured at least 60 calendar days prior to the effective date of the cancellation of the insurance. However, if the cancellation is based on one or more of the following reasons, then such notice may be sent less than 60 calendar days prior to the effective date of the cancellation of the insurance: fraud; material misrepresentation; nonpayment of premium; or any other reason approved by the Commissioner of Insurance.

(D) The insurance covers claims for any occurrence that commenced during the term of the policy that is discovered and reported to the insurer within six months of the effective date of the cancellation or other termination of the policy.

(3) Letter of Credit.

(i) An owner/operator may satisfy the requirements of C.R.S. § 8-20.5-206 and § 8- 20.5-303 by obtaining an irrevocable letter of credit that conforms to the requirements of this section. The issuing institution must be an entity that has the

authority to issue letters of credit in Colorado and whose letter of credit operations are regulated and examined by the Colorado Department of Regulatory Agencies.

(ii) The letter of credit must be irrevocable for a term specified by the issuing institution. The letter of credit must provide that credit be automatically renewed for the same term as the original term, unless, at least 90 calendar days before the current expiration date, the issuing institution notifies the Director by certified mail of its decision not to renew the letter of credit. Under the terms of the letter of credit, the 90 calendar days will begin on the date when the Director receives the notice, as evidenced by the return receipt.

(iii) The letter of credit must be payable to the Director and may be drawn on to cover corrective action and/or compensating third parties for bodily injury and property damage caused by accidental releases arising from operating the UST(s) identified in the letter of credit.

(iv) The letter of credit must list the name(s) and address(es) of the covered facility(ies) where the tanks are located, the number of tanks at each facility and the regulated substances contained by the tanks at each facility.

(4) Trust Fund.

(i) An owner/operator may satisfy the requirements of C.R.S. § 8-20.5-206 and § 8- 20.5-303 by establishing a trust fund that conforms to the requirements of this

section. The trustee must be an entity that has the authority to act as a trustee and whose trust operations are regulated and examined by the Colorado Department of Regulatory Agencies.

(ii) The trust fund, when established, must be funded for the full required amount of coverage.

(iii) The trustee must be instructed to disburse funds from the trust fund to pay the costs of corrective action and/or third-party bodily injury and property damage only as directed or approved by the Director.

(5) Certificate of Deposit or Other Secured Financial Instrument.

A certificate of deposit or another financial instrument secured by an agency of Colorado or the US Government may be used to satisfy the requirements of C.R.S. § 8-20.5-206 and § 8-20.5-303 provided that such financial instrument is made payable to the Director.

Any interest or dividends payable by such instrument may be made payable to the owner/operator using this method of assuring FR. This financial instrument will be returned to the owner/operator by the Director only after the instrument has been replaced by an alternate FR mechanism or the owner/operator is released from the FR requirement under 7-3(f) below.

Section 7-3 Maintenance of Financial Responsibility (a) Substitution of FR Mechanisms.

(1) An owner/operator may use any alternate FR mechanism specified above provided that at all times the owner/operator maintains an effective FR mechanism that satisfies the requirements of C.R.S. § 8-20.5-206.

(2) After obtaining alternate FR as specified in this Article 7, an owner/operator may cancel a prior FR mechanism by providing notice to the provider of FR.

(b) Cancellation by a Provider of FR.

If a provider of FR cancels or fails to renew for reasons other than incapacity of the provider as specified in subsection (c) below, the owner/operator must obtain alternate coverage within 60 calendar days after receipt of the notice of termination. If the owner/operator fails to obtain alternate coverage within 60 calendar days after receipt of the notice of termination, the owner/operator must notify the Director of such failure and submit:

(1) The name and address of the provider of FR;

(2) The effective date of termination; and (3) The evidence of the FR mechanism subject to termination, maintained in accordance with subsection (d).

(c) Reporting by Owner/Operator.

(1) An owner/operator must submit current evidence of FR to the Director:

(i) Within 30 calendar days after the owner/operator identifies a release from an UST or AST, which is required to be reported under Article 4.

(ii) Within 30 calendar days after the owner/operator receives notice of any of the following and fails to obtain alternate coverage as required by Article 7.

(A) Commencement of a voluntary or involuntary proceeding under Title 11 (Bankruptcy), US Code, naming a provider of FR as a debtor;

(B) Suspension or revocation of the authority of a provider of financial responsibility to issue a FR mechanism; or (C) Any other incapacity of a provider of FR. or (iii) As required by 7-2(b)(1) (vii) and 7-3 (b).

(2) An owner/operator must certify compliance with the FR requirements of Article 7 as specified in the new tank registration form when notifying the Director of the installation of a new UST under 2-2-3(f)(3) or new AST under 3-2-4.

(3) The Director may require an owner/operator to submit evidence of FR as described in subsection (d)(2) or other information relevant to compliance with Article 7 at any time.

(d) Record keeping.

(1) Owners/operators must maintain evidence of all FR mechanisms used to demonstrate financial responsibility for an UST or AST until released under subsection (f). An owner/operator must maintain such evidence at the site or at the owner's or operator's place of business. Records maintained off-site must be made available upon request by the Director.

(2) An owner/operator must maintain the following types of evidence of FR:

(i) An owner/operator using a financial test of self-insurance must maintain a copy of the chief financial officer's letter based on year-end financial statements for the most recent financial reporting year. Such evidence must be on file no later than 120 calendar days after the close of the financial reporting year or 30 calendar days from the date of the financial statement, whichever is earlier.

(ii) An owner/operator using a letter of credit must maintain a copy of the signed agreement and copies of any amendments to the agreement.

(iii) An owner/operator using an insurance policy must maintain a copy of the signed insurance policy, the certificate of insurance specified in subsection 7-2(b)(2)(iv) and any amendments to the policy.

(e) Drawing on FR Mechanisms.

(1) The Director shall require the insurer, trustee, or institution issuing a letter of credit or certificate of deposit to make available the amount of funds stipulated by the Director, up to the limit of funds provided by the financial responsibility mechanism if:

(i) The owner/operator fails to establish alternate FR within 60 calendar days after receiving notice of cancellation of insurance, letter of credit, or other FR mechanism; and (ii) The Director determines or suspects that a release from an UST or AST covered by the mechanism has occurred and so notifies the owner/operator or the owner/operator has notified the Director of a release from an UST or AST covered by the mechanism.

(2) The Director may draw on these available funds when:

(i) The Director makes a final determination that a release has occurred and immediate or long term corrective action for the release is needed, and the owner/operator, after appropriate notice and opportunity to comply, has not conducted corrective action as required; or (ii) The Director has received either:

(A) Certification from the owner/operator, and the third-party liability claimant(s) and from the attorneys representing the owner/operator and the third-party liability claimant(s) that a third-party liability claim should be paid; or (B) A valid final court order establishing a judgment against the owner/operator for bodily injury or property damage caused by an accidental release from an UST or AST covered by FR under Article 7; and the Director determines that the owner/operator has not satisfied the judgment.

(f) Release from the Requirements. An owner/operator is no longer required to maintain FR under

Article 7 for an UST or AST after any necessary corrective action has been completed and the tank has been permanently closed or undergoes a change-in-service as required by these (g) Bankruptcy or Other Incapacity of Owner/Operator or Provider of FR.

(1) Within 10 calendar days after the commencement of a voluntary or involuntary proceeding under Title 11 (Bankruptcy), US Code, naming an owner/operator as debtor, the owner/operator must notify the Director by certified mail of such commencement and submit a list of all affected UST or AST facilities.

(2) An owner/operator will be deemed to be without the required FR in the event of a bankruptcy or incapacity of its provider of FR, or a suspension or revocation of the

authority of the provider of FR to issue an insurance policy, letter of credit, or other FR mechanism. The owner/operator must obtain alternate FR as specified in Article 7 within 30 calendar days after receiving notice of such an event. If the owner/operator does not obtain alternate coverage within 30 calendar days after such notification, the owner/operator must notify the Director immediately.

(h) Reestablishment of FR.

(1) Whenever the required amount of FR has been reduced by payment of claims due to a release at any facility, and the owner/operator is responsible for another facility or other facilities then the owner/operator must immediately reestablish the ability to pay the required amounts for any release at the other facility(ies).

(2) Whenever the required amount of FR for the owner/operator of a single facility has been reduced by payment of claims due to a release at a facility and the period of corrective action for that release has been completed, the owner/operator must then immediately reestablish the required amount of FR.

ARTICLE 8 PETROLEUM STORAGE TANK FUND

Section 8-1 Eligibility (a) Only the following persons are potentially eligible for reimbursement from the Fund, provided they meet the other criteria:

(1) The current owner/operator of a regulated UST or AST system;

(2) Any past owner/operator of a regulated UST or AST system; or (3) Other persons considered not responsible for the release as set forth in C.R.S. § 8-20.5- 206 (3)(a) through (e) and CRS 8-20.5-303 (3)(a) through (e).

(b) Insurance companies or their agents are not eligible to make claims against the fund.

(c) An applicant making any claim against the Fund shall be held accountable for compliance with the following requirements.

(1) Each applicant must meet the owner/operator criteria for corrective action as established by the Director.

(2) When required by the Director, an owner/operator must demonstrate that accurate and complete records are maintained that confirm a release detected on or after July 1, 1989, except for those releases discussed in 8-1(g).

(3) Each owner/operator must have registered the tank(s) and paid the current and past annual tank registration fees. Payment penalties and percent reductions may be imposed by the Committee for non-payment or late payment of registration fees for each petroleum storage tank owned.

(4) Each owner/operator must have paid the environmental response surcharge applied to petroleum products in Colorado and must not be in default on any obligation caused by the environmental response surcharge.

(5) Each owner/operator must be in substantial compliance (as determined by the Committee) with all Colorado laws and regulations that address the handling, storage, record keeping, and dispensing of regulated substances, including but not limited to C.R.S. § 8-20-230, 8-20-231, all of 8-20.5, and NFPA Code 30 “Flammable and Combustible Liquids” and NFPA Code 30A “Code for Motor Fuel Dispensing Facilities and Repair Garages”, to be eligible for participation in the Fund.

(6) Each owner/operator must demonstrate evidence of FR of $10,000 for corrective action and $25,000 for compensation of third-party personal injury or property damage through the mechanisms or combination of the mechanisms contained in the financial responsibility established by the Director and in C.R.S. Sections 8-20.5-206 and 303.

(7) Each owner/operator must demonstrate that allowable costs have exceeded the deductible (as described in subsection (6)) for assessment and corrective action per C.R.S. § 8-20.5-208, 209, and 304.

(i) Per C.R.S. § 8-20.5-206(1)(f) and only for releases occurring after January 1, 2025, if the Committee does not impose any percent reductions for noncompliance, the owner/operator is eligible for a 10% deductible on reimbursed costs up to the first $100,000 reimbursed, with no additional deductible thereafter.

(8) Each owner/operator must comply with the criteria for reporting of a release to the Director, including but not limited to C.R.S. § 8-20.5-208.

(d) A mortgagee making any claim against the Fund shall comply with the following requirements:

(1) A mortgagee whose mortgage or deed of trust is dated before September 30, 1995 is eligible to participate in the Fund if the mortgagee has acquired, by foreclosure or receipt of a deed in lieu of foreclosure, the property on which the petroleum tank system is located and each of the following conditions has been met:

(i) The mortgagee has not actively managed the property during the period that it held a security interest;

(ii) The mortgagee has notified the Director of his/her acquisition of the property by certified mail (return receipt requested) or other documented delivery within 30 working days of the acquisition, if acquired after September 30, 1995;

(iii) The mortgagee has complied with all applicable corrective action requirements;

(iv) The mortgagee is not affiliated with or related to the mortgagor.

(2) A mortgagee whose mortgage or deed of trust is dated on or after September 30, 1995, is eligible to participate in the Fund if the mortgagee meets all provisions of subsection (1) above and has a Certificate of Eligibility issued pursuant to subsection (3) below.

There must be an operating petroleum storage tank system, which is not orphaned or abandoned, on the property at the time a Certificate of Eligibility is issued. A Certificate of Eligibility may be issued at any time before foreclosure or receipt of a deed in lieu of foreclosure; however, if the certificate is issued prior to the loan closing, the certificate will only be effective upon closing. A Certificate of Eligibility will not cover contamination detected on a property before the Certificate of Eligibility is issued.

(3) A Certificate of Eligibility may be issued to a mortgagee if the site is in compliance with all applicable laws, a Petroleum Storage Tank Status Sheet has been properly completed, and one of the following conditions has been satisfied:

(i) For a petroleum UST system:

(A) Documentation has been provided to the Director showing that all petroleum storage tanks and tank lines at the site passed a tightness test no more than 60 calendar days prior to the completion of the Petroleum Storage Tank Status Sheet; or (B) Documentation has been provided to the Director showing tanks and lines at the site are monitored by a properly installed and operating thirdparty certified monthly monitoring device; or (C) Documentation has been provided to the Director showing that an environmental site assessment performed no more than 60 calendar days prior to completion of the Petroleum Storage Tank Status Sheet indicates the site does not require site characterization or corrective action.

(ii) For an AST system, documentation has been provided to the Director showing that all underground lines at the site passed a tightness test no more than 60 calendar days prior to completion of the Petroleum Storage Tank Status Sheet and:

(A) The AST system meets the standards in 3-2-3(e) if installed before October 1, 1994;

(B) The AST system meets the standards for ASTs installed after September 30, 1994; or (C) Documentation has been provided to the Director showing that an environmental site assessment performed no more than 60 calendar days prior to completion of the Petroleum Storage Tank Status Sheet indicates the site does not require initial site characterization or corrective action.

(4) A mortgagee who is eligible to participate in the Fund pursuant to these regulations may sell the property and transfer the Certificate of Eligibility to the buyer. The buyer may participate in the Fund pursuant to C.R.S. § 8-20.5-206 (3) and 303 (3) C.R.S., provided that:

(i) The buyer is not a former tank owner/operator of the site or an affiliate or relation to such a former tank owner/operator;

(ii) The buyer, within three months of acquiring the property from the mortgagee, completes and submits to the Director sufficient documentation to show that the site is in compliance with applicable regulations; or, within three months of acquiring the property, the Director approves a plan, submitted by the buyer, showing how and when the site will be brought into compliance; and, (iii) Within six months of acquiring the property, the buyer either provides documentation to the Director showing that an environmental site assessment indicates the site does not require initial site characterization or corrective action, in which case the transferred Certificate of Eligibility is no longer a valid document; or, provides to the Director documentation that petroleum contamination is present on the property, in which case the transferred Certificate of Eligibility remains valid for the balance of the remediation, provided such remediation is conducted pursuant to Colorado statutes and regulations.

(e) Eligible Releases Only releases satisfying all of the following criteria shall be considered eligible:

(1) The release must be accidental in nature;

(2) The storage tanks and related piping are regulated under these regulations and contain petroleum product regulated by these regulations;

(3) Subject to any Committee policies on reimbursement, the Director has approved the design for corrective action at the site; and (4) Subject to any Committee policies on reimbursement, the Director has determined that the corrective action has, or when completed will have, adequately addressed the release in terms of protecting public health, welfare and the environment.

(f) Releases Not Eligible Releases with the following criteria shall be considered not eligible:

(1) Releases from USTs and ASTs used to store petroleum products intended for aviation purposes.

(2) Releases from USTs and ASTs used to store petroleum products intended for use by railroad equipment or locomotives.

(3) Releases from USTs and ASTs that are exempt or deferred in 2-1-1(b) and (c) and 3- 1(b).

(4) Releases at sites on the National Priorities List (NPL) or sites being cleaned up by the State under the federal Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA). Owners and operators of tanks containing regulated substances other than petroleum are not eligible to the Fund but must demonstrate FR using some other approved FR mechanism.

(g) Eligibility of Expenses (1) Only expenses incurred on or after July 1, 1989, are potentially eligible for reimbursement. All expenses incurred before July 1, 1989, are not eligible for reimbursement.

(2) For releases detected on or after December 22, 1988, but before July 1, 1989, expenses incurred on or after July 1, 1989, are potentially eligible for reimbursement only if the original application was submitted before January 1, 1992. This January 1, 1992, deadline does not apply to applicants determined to bear no responsibility for the release pursuant to statute.

(3) Expenses related to releases detected before December 22, 1988, are not eligible for reimbursement.

(4) Expenses related to tanks closed in place or removed before December 22, 1988, are not eligible for reimbursement. This December 22, 1988, deadline does not apply to applicants determined to bear no responsibility for the release pursuant to statute.

(h) In addition to the above, the following subsections apply to all ASTs, (1) The Director will make positive eligibility recommendations to the Committee for facilities that were in operation prior to October 1, 1994, provided that:

(i) Existing ASTs were installed and operated in substantial compliance with the applicable statutes and regulations that were in effect at the time the tank system was installed; and (ii) Existing ASTs that were required to prepare and implement a “Spill Prevention, Control and Countermeasures” (SPCC) plan as specified in the 40 CFR Part 112 were in substantial compliance with that requirement. [Note: Installation and operating rules can be found in NFPA Code 30 “Flammable and Combustible Liquids” and NFPA Code 30A Code for Motor Fuel Dispensing Facilities and Repair Garages that were in effect at the time of installation.]

(2) The Director will also make positive eligibility recommendations to the Committee for facilities that were in operation prior to October 1, 1994, that are not able to demonstrate 100% compliance with the regulations in effect at the time the ASTs were installed, (i) There are no serious safety violations, and the safety concerns listed here are satisfied.

(A) Adequate ventilation, either natural or forced must exist to guarantee that flammable liquid vapors cannot build up to 25% of the lower flammable limit anywhere because of the presence of the tank facility in question.

(B) Normal vent lines must be of sufficient capacity to ensure that no fuel drop will cause the pressure inside the tank to exceed the test pressure.

A spark arrestor cap is required at the end of the vent line and it must be located “in the clear” and at least 12 feet above ground level.

(C) A label such as U.L. 142, UL ABOVEGROUND TANK, or equivalent must be attached to the tank to verify that it meets the emergency relief venting requirement of NFPA 30 “Flammable and Combustible Liquids Code”.

(D) Adequate spill control, overfill prevention control, and secondary containment methods or devices must be provided and in regular use at the facility; and (ii) A SPCC plan, if required for the facility, has been developed, approved and followed.

(3) The Director will consider closure of a facility and/or removal of non-compliant tanks to be a mitigating factor in making the recommendation to the Committee.

(4) Nothing herein shall be construed to prevent the Committee from imposing percentage reductions upon applicants who are in substantial compliance with regulations but not in total compliance.

Section 8-2 Reimbursement (a) The owner/operator of the petroleum storage tanks from which a release has occurred, or another person eligible pursuant to statute, and for which corrective action has been performed, or his duly authorized agent; may file an application for reimbursement.

(b) An application for reimbursement shall include a completed application form provided by the Director and shall contain the following:

(1) Legible copies of invoices according to the format required by the Director.

(2) The application shall provide proof of payment of invoices as follows:

(i) The amounts shown on the invoices for which reimbursement is requested have been paid in full by the applicant according to one of the following methods;

(A) Business receipts, indicating payments received;

(B) Fronts and backs of canceled checks;

(C) The certification of a certified public accountant that the expenses for which reimbursement is requested have been paid in full;

(D) Provided the parties are unaffiliated and unrelated, a notarized affidavit signed by the person that performed the corrective action affirming that the amounts which the applicant represents as being paid were paid in full; or (ii) Provided the parties are unaffiliated and unrelated, a notarized affidavit stating that the invoices relative to the referenced application for reimbursement from the Fund will be paid in full by the applicant upon receipt of the reimbursement in accordance with a promissory agreement.

(3) Any other information which the Committee may reasonably require.

(c) Subject to Committee policies regarding reimbursement, all applicants must comply with all corrective action requirements and a corrective action plan (including a technical and economic feasibility summary) must be approved before costs, associated with the corrective action, are eligible. The applicant can be required to provide proof that all corrective action requirements have been met.

(d) The applicant may file the application at any phase of the corrective action subject to any policies adopted by the Committee.

(e) Incomplete submittals shall suspend processing of applications.

(f) Technical information may be required by the Committee or the Director as part of any application for reimbursement:

(1) A detailed account of what corrective action has been taken, why specific actions were taken, when, by whom, and with what results.

(2) An estimate of other corrective action measures that may be required to remediate the facility and the estimated time required to complete such measures.

(3) Line and tank tightness tests, release detection and release prevention records. These records may include time periods ranging from six months to three years prior to a release or detection of contamination.

(4) Documentation that a release being cleaned up is not a new release requiring payment of a separate deductible, if the Director or the Committee has any information indicating a separate release may have occurred.

(g) Applications for reimbursement shall be submitted according to the electronic format and location as required by the Director and by hard copy to:

Petroleum Storage Tank Committee Department of Labor and Employment 633 17th St, Ste 500 Denver, CO 80202-3610 (h) The date of filing of any document shall be the receipt date stamped on the document.

Section 8-3 Allowable Costs (a) Allowable costs are those costs and expenses which arise directly from the performance of necessary corrective action in accordance with the requirements of the Director and are deemed reasonable by the Committee subject to the limitations prescribed by this section.

(b) Allowable costs shall include but not be limited to the following:

(1) Abatement of impacts and immediate threats of impact to human health, safety, and the environment;

(2) Temporary provision of a water supply utilized specifically for domestic consumption;

(3) Collection and analysis of surface and subsurface soil and water, free phase hydrocarbons, and vapor samples;

(4) Emplacement of soil borings and/or monitor wells for remediation purposes;

(5) Removal, storage, treatment, recycling, transport, and disposal of free phase hydrocarbons, vapors, contaminated soils, contaminated water in accordance with applicable laws;

(6) Removal and disposal (including transport) of soils and pavement where removal is necessary to the performance of corrective action;

(7) Identification and testing of affected or potentially affected drinking water sources;

(8) Design of plans for site assessment and remediation;

(9) Permitting, acquisition, installation, startup, operation and maintenance of site assessment and remediation systems, including monitoring;

(10) Temporary relocation of utility structures when necessary to the performance of corrective action;

(11) Preparation of technical reports required pursuant to the requirements of these regulations;

(12) The fair market value of access to property outside of the facility boundaries where such access is necessary for the performance of corrective action;

(13) Performance of any corrective action measure, which is specifically required by a section of these regulations, or an order of the Director, or a written request or confirmation by the Committee;

(14) Equipment costs which are related solely to remediation. If the costs of the equipment are reimbursed by the Fund, when the equipment is no longer needed any salvage value of the equipment shall be returned to the Fund.

(15) Bodily injury or property damage suffered by third parties.

(16) Any other costs determined by the Committee to be allowable in accordance with the provisions of these regulations.

(17) Costs associated with preparing and filing an application for reimbursement not to exceed 1% of the net allowable reimbursement per application up to a maximum of $2,000 per event.

(18) Subject to Committee policy, costs for upgrades including tank removal or incentives for significant operational compliance.

Section 8-4 Unallowable Costs (a) Costs and expenses which are not applicable to the performance of necessary corrective action in accordance with the requirements of the Director or are deemed unreasonable by the Committee are unallowable for reimbursement.

(b) The following types of costs are not allowable for reimbursement.

(1) The cost of replacement, repair, maintenance, testing and upgrading of affected tanks and associated piping.

(2) The loss of income or profits, including without limitation, the loss of business income arising out of the review, processing, or payment of an application or request for assistance under these regulations.

(3) Decreased property values.

(4) Bodily injury or property damage except for injuries or damages suffered by third parties.

(5) Fees for legal services.

(6) Removal and disposal (including transport) of soils and pavement where removal is not necessary to the performance of corrective action;

(7) The costs of making improvements to the facility beyond those that are required for corrective action.

(8) Costs, including those associated with contamination assessments performed, for any

purpose other than investigating the extent and impacts of a release as required by the Director.

(9) Costs of compiling and storing records.

(10) Any activities, including those required by these regulations, which are not conducted in compliance with applicable state and federal environmental laws, including laws relating to the transport and disposal of waste.

(11) Penalties or payment for damages assessed by the Committee, Director, the Department of Public Health and Environment, and/or the Federal government.

(12) At the Committee’s sole discretion, claims for reimbursement relating to a tank owned or operated by a person who has been convicted of a violation of any law or rule that relates to the installation, operation, or management of petroleum storage tanks.

(13) Costs in excess of those considered reasonable by the Committee.

(14) At the Committee’s sole discretion, cleanup costs resulting from negligence or misconduct on the part of the owner/operator or applicant.

(15) Costs for the rental of equipment owned by the applicant if the equipment was previously reimbursed by the Fund.

(16) Interest paid on loans.

(17) Costs that are a part of normal business expenses (i.e. insurance charges).

(c) Any attempt by an applicant to claim reimbursement under circumstances when the applicant knew or should have known (this includes knowledge held by the applicant’s environmental consultant) that some or all costs would be unallowed authorizes the Committee to reduce otherwise allowable costs submitted by the applicant (whether on the same or a different application). Any reduction imposed under this section shall be equal to the amount of the unallowed costs. This subsection applies only to the unallowed costs in subsections 8-4(b)(1), (6), (7), (8), (11), and (15) above and only to applications received after March 1, 1997.

Section 8-5 Committee Review of Application (a) The Committee shall review each eligible original application received and make a determination of reimbursement, inform the applicant of its determination and, as appropriate, reimburse the applicant from the Fund.

(b) Prior to approval of reimbursement, the Committee shall affirmatively determine that:

(1) Requested reimbursement expenses are:

(i) Eligible costs;

(ii) Reasonable as determined by the Committee;

(ii) Actually, necessarily incurred for the preparation or implementation of a corrective action plan approved by the Director or for eligible third-party damages.

(2) The applicant is:

(i) Eligible for reimbursement; and (ii) In substantial compliance with all applicable rules and regulations.

(c) An application which does not contain all of the information required, may be rejected by the Committee, without prejudice. Rejection of the application by the Committee does not prevent the applicant from filing another application for the same release.

(d) The Committee is not required to commence the substantive review of an application until receipt of all information required from the applicant and the Director determines the application is properly and fully completed.

(e) If during the course of the substantive review, additional information of the type required by these regulations is needed to evaluate the application, the applicant may be required to provide such additional information. Further review of the application may be suspended until such information is received.

(f) The Committee's approval of the proposed corrective action(s) shall not be considered a finding or guarantee of safety or effectiveness of the plan(s). Nothing in these regulations shall be construed to abrogate or limit the immunity or exemption from civil liability of any agency, entity or person under any statute including the Colorado Governmental Immunity Act, Article 10 of Title 24 or C.R.S. § 13 21 108.5.

(g) The approval and disbursement of funds by the Fund and/or Committee does not constitute transfer of ownership of any contaminated soils, equipment, or related items relating to corrective action. Ownership of any and all items relating to corrective action will remain the property of the applicant.

(h) Multiple releases at a facility may be considered by the Committee either as single or separate releases to make the most efficient use of the Fund or to provide the most effective protection to human health or the environment.

Section 8-6 Fund Payment Report (a) Upon completion of the review of an application, the Committee shall prepare a Fund Payment Report (FPR) indicating which of the applicant's costs the Committee believes should be reimbursed and which costs should not be reimbursed. If the Committee finds that any cost should not be paid to the full amount requested, it shall briefly state the reasons in its report. The Committee shall submit a copy of its report to the applicant.

(b) The applicant shall review the FPR and shall, if dissatisfied with any facts therein, file a written protest with the Committee within 60 calendar days of the date of the FPR. If the applicant does not file a written protest within the 60 calendar days, the applicant will have waived his/her right to object to anything covered by the FPR. After the 60 calendar days, everything regarding the application, including the amount of reimbursement and percentage reductions (including any reductions applicable to future applications), will be deemed final. However, costs determined to be not eligible cannot be protested.

(c) The protest of the FPR must be signed by the applicant and contain any information required by the Committee or the Director, including a clear statement of each item which the applicant disputes on the FPR.

(d) The protest shall be submitted on a form provided by the Committee or the Director.

Section 8-7 Miscellaneous Regulations (a) Nothing in these regulations precludes the Committee or the Director from issuing orders, assessing administrative penalties, or taking any other action permitted by law against any person for violation of any statute, regulation or order.

(b) Nothing in these regulations changes the responsibilities of an owner/operator of a storage tank to respond to a release of regulated substances or to comply with any other state or Federal requirements, statutes, regulations or orders.

(c) No person shall knowingly submit false information to the Committee as part of any materials required to be submitted under these regulations.

(d) If an applicant owes money to the Fund or to the Director, including but not limited to penalties or past due registration fees, or owes money to any other State agency via the Vendor Offset Subsystem pursuant to CRS § 24-30-202.4, the amount owed will be deducted from any proposed reimbursement amount to the applicant.

(e) Pursuant to CRS 8-20.5-103(3.5) monies in the Petroleum Storage Tank Fund may be used to provide an incentive to underground or aboveground storage tank owners and operators for significant operational compliance or to upgrade existing systems. Notice of available incentives will be posted on the Division web page (www.colorado.gov/ops).

ARTICLE 9 PETROLEUM CLEANUP AND REDEVELOPMENT FUND (REDEVELOPMENT FUND)

Section 9-1 Redevelopment Fund Purpose The Redevelopment Fund is administered by OPS.

(a) The Redevelopment Fund will enable investigation and cleanup of petroleum contamination at petroleum storage tank sites that are not eligible for reimbursement from the Petroleum Storage Tank Fund (PSTF). Cleaning up these sites will minimize risk to Colorado’s groundwater resources and enhance the potential for these properties to be redeveloped or reused.

(b) Redevelopment Fund monies are available in the form of reimbursement to property owners upon completion of one or more of the following approved activities:

(1) Petroleum UST removal.

(2) Site assessment to determine if contamination from petroleum storage tanks is present on the property (Level I activity).

(3) Site characterization if petroleum contamination is discovered on the property (Level II activity).

(4) Cleanup of the petroleum contamination (Level III activity).

(c) This article includes sections pertaining to eligibility criteria, eligible activities, the application and funding process, establishing project costs and required cost-matching for assessment and cleanup actions. Additionally, this article defines the mechanism for distributing monies from the Redevelopment Fund.

Section 9-2 Eligibility Criteria (a) Eligibility to participate in the Redevelopment Fund is dependent on the applicant satisfying all of the following criteria:

(1) Applicant is the current property owner.

(2) Applicant can provide evidence that petroleum storage tanks are present or existed on the property.

(3) Applicant is not eligible for reimbursement from the PSTF.

(4) Applicant has a plan for redevelopment or reuse of the property.

Section 9-3 Eligible Activities (a) Petroleum UST Removal (1) For tanks with volume of 2,000 gallons or less, approved applicants shall be eligible for up to $4,000 in reimbursement of direct costs associated with each petroleum UST removed. Larger tanks will be eligible for reimbursement of $2 per gallon of removed tank volume up to a maximum of $60,000 per facility.

(2) Requests for reimbursement can be made at any time following the documented completion of the tank removal.

(b) Level I Site Assessment (1) The Level I site assessment to measure for the presence of a petroleum release from a storage tank system is considered an eligible activity. To meet the requirement to obtain a NFA determination, the petroleum storage tank area, product line and dispenser locations must be evaluated.

(2) All proposed work conducted in Level I must be clearly identified in a project work plan prior to beginning the assessment activities. The work plan shall include a budget projection and estimated project completion timeline. Work plans shall be submitted prior to conducting Level I activities.

(3) All approved applicants shall be responsible for 10% of the Level I site assessment costs, which will be deducted from the reimbursement award.

(4) The maximum amount payable from the Redevelopment Fund for a Level I site assessment is $20,000.

(c) Level II Site Characterization (1) The Level II site characterization to establish the extent of petroleum contamination that exceeds the current OPS Tier 1 RBSLs and a simple activity, such as limited excavation of petroleum-impacted soils or the development of a cleanup corrective action plan, are considered eligible activities.

(2) All proposed work conducted in Level II must be clearly identified in a project work plan prior to beginning the characterization activities. The work plan shall include a budget projection and estimated project completion timeline. Work plans shall be submitted prior to conducting Level II activities.

(3) All approved applicants shall be responsible for 10% of the Level II site characterization costs, which will be deducted from the reimbursement award.

(4) The maximum amount payable from the Redevelopment Fund for a Level II site characterization is $30,000.

(d) Level III Cleanup (1) The Level III cleanup activities associated with an economically and technically feasible approach to mitigate petroleum contamination to an acceptable level are considered eligible activities.

(2) Requests for cleanup funding must include a project work plan that contains a discussion of the project technical feasibility and cleanup goals, budget projection and estimated project completion timeline.

(3) All approved applicants shall be responsible for 50% of the Level III cleanup costs, which will be deducted from the reimbursement award.

(4) The maximum amount payable from the Redevelopment Fund for a Level III cleanup is 50% of the eligible cost or $500,000, whichever is less.

Section 9-4 Application Process (a) Applications for environmental assessment, characterization and cleanup financial assistance can be submitted at any time utilizing application forms posted on the OPS website. Applications will be periodically reviewed and evaluated based on the applicant’s ability to demonstrate the following:

(1) Project plan results in reducing risk to the environment from petroleum contamination.

(2) Applicant has the ability to meet Level I and II deductibles and has leveraged matching funds for Level III cleanup activities.

(3) Redevelopment or reuse plan generates a positive economic and/or social impact on the community.

(b) Successful applicants will be notified at least quarterly, subject to the availability of money in the Redevelopment Fund.

(c) Applicants from the same corporate family are not eligible for awards at more than one property per year.

Section 9-5 Eligible Costs and Reimbursement (a) Costs associated with eligible activities completed during the application process and subsequent project site assessment, characterization and cleanup will be reimbursed.

(b) In general, project costs shall not exceed the current Reasonable Cost Guideline unit rates.

(c) Requests for reimbursement must include the following:

(1) Documentation of the work performed per project work plan.

(2) Proof of payment for all invoices submitted for reimbursement.

(3) Affidavit of work performed, with regards to services, material, and equipment procured by the applicant.

(d) Reimbursement of Level III cleanup costs shall be contingent upon completion of project milestones in the approved cleanup work plan.

Section 9-6 Contractual Agreements Property owners that are eligible for Level I, II and III activities shall enter into a contractual agreement with OPS for the appropriate level. Upon execution of a contractual agreement, OPS will issue the property owner a notice to proceed that affirms a commitment to reimburse a specified amount of money from the Redevelopment Fund. _________________________________________________________________________ Editor’s Notes

History Articles 1, 2 eff. 08/01/2008.

Article 5 eff. 01/01/2009.

Articles 1, 3 eff. 04/14/2011.

Entire rule eff. 05/01/2013.

Entire rule eff. 01/31/2014.

Article 1 Sections 1-4 – 1-5, Article 5, Article 9 Sections 9-4 – 9-6 eff. 10/15/2014.

Articles 1, 1.5, 2, 4, 5, 7, 8 eff. 01/01/2017.

Article 1 Sections 1-4, 1-5, 1-7, 1-8, Article 2 Sections 2-2-4(b)(1), 2-3-3(d), 2-3-4-1(c), 2-3-7(b), 2-4-2(b), 2-4-3(f), Article 5 Section 5-3(d) eff. 05/01/2017.

Article 1 Sections 1-3, 1-4, 1-5, 1-7, Article 1.5 Sections 1.5-2(f), 1.5-3(a), Article 2 Sections 2-1-1(d), 2-2- 1, 2-2-2-2(a)(A), 2-2-4(b), 2-2-5(a), 2-3-2(c), 2-3-4-1(a)(2)[ Note], 2-3-6-1(c)[Note], 2-4-2(a), 2-5- 2(d), 2-5-3(b)(1), 2-5-3(d)(1)(v), 2-5-3(d)(2)(iii), Article 3 Sections 3-1(b)(6), 3-2, 3-2-1, 3-2-2-1(c) including Table 1, 3-2-2-2(d)(1)(i) including Table 4, 3-2-2-4, 3-2-2-5(f), 3-2-3(c), 3-2-3(f)(2)(i), 3- 2-4(a)(5), 3-3-1(d)(6), 3-3-4-1(b)(1), 3-3-4-2(c), 3-4-4(c), Article 4 Section 4-3(b), Article 7 Sections 7-1, 7-2(b), 7-3(c)-(g), Article 8 Sections 8-1(c)(5), 8-1(h), 8-7(e) eff. 05/01/2018.

Entire rule eff. 03/17/2019.

Entire rule eff. 01/01/2025.

Annotations The definitions of “fire resistant tank” and “protected tank” in Rule 1-5, rules 2-1-1(d)(2)(A), 2-1-1(d)(2)(B), 2-1-1(d)(2)(D), 2-2-1(a)(1)Note, 2-2-1(a)(1)(A), 2-2-1(a)(1)(B), 2-2-1(a)(2)(iv)Note, 2-2-1(a)(2)(iv)(A), 2-2- 1(a)(2)(iv)(B), 2-2-1(a)(2)(iv)(C), 2-2-1(a)(2)(iv)(D), 2-2-1(a)(3)Note, 2-2-1(a)(3)(A), 2-2-1(a)(3)(B), 2-2- 1(a)(3)(C), 2-2-1(a)(3)(D), 2-2-1(b)(1)Note, 2-2-1(b)(1)(A), 2-2-1(b)(1)(B), 2-2-1(b)(2)(iv)Note, 2-2- 1(b)(2)(iv)(A), 2-2-1(b)(2)(iv)(B), 2-2-1(b)(2)(iv)(C), 2-2-1(b)(2)(iv)(D), 2-2-1(b)(2)(iv)(E), 2-3-4-1(a)(2)Note, 2-3-6-1(c)Note, 2-5-2(d), 2-5-3(b)(1)(A), 2-5-3(b)(1)(C), 2-5-3(b)(1)(D), 2-5-3(d)(1)(v), 2-5-3(d)(2)(iii), 3-2- 1(a)(1)(iii), 3-2-1(c)(2)(i), 3-2-1(d)(2), 3-2-1(i)(4), 3-2-2-1(c) including Table 1, 3-2-2-2(d)(1)(i) including Table 4, 3-2-2-5(f), 3-2-3(c)(1), 3-2-3(c)(3), 3-2-3(c)(4), 3-3-1(d)(6) (adopted 08/16/2016) were not extended by Senate Bill 17-083 and therefore expired 05/15/2017.

7 CCR 1101-15 Liquefied Petroleum Gas (lpg) Regulations {#sec-7-ccr-1101-15 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-15}

DEPARTMENT OF LABOR AND EMPLOYMENT

LIQUEFIED PETROLEUM GAS (LPG) REGULATIONS

7 CCR 1101-15 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Basis and Purpose The basis and purpose of these regulations is to: adopt nationally-recognized codes and standards; to add or clarify terminology; to add or clarify the duties of LPG facility owners, delivery drivers and certain users; and to improve the effectiveness of the division’s LPG program.

Section 1-2 Technical Rationale The technical requirements of these regulations are generally accepted as national and international codes and standards governing the minimum levels of acceptability for the design, construction, location installation and operation of equipment for storing, handling, transporting, dispensing and utilizing LPG.

The adoption of these consistent standards is necessary for the preservation of the public health, safety, and welfare of the citizens of Colorado.

Section 1-3 Statutory Authority The amendments to these regulations are created pursuant to Sections 8-20-302, 8-20-402 and 8-20-405 of the Colorado Revised Statutes.

Section 1-4 Effective Date These amended regulations shall be effective on November 30, 2024. The previous versions of these regulations were effective September 30, 2017, May 1, 2017, February 1, 2011, and September 1, 2005.

Section 1-5 Codes Incorporated by Reference Section 1-5-1 Codes Incorporated by Reference The following codes are incorporated by reference:

(a) NFPA 58, Liquefied Petroleum Gas Code, 2024 edition.

(b) NFPA 54, National Fuel Gas Code, 2024 edition.

(c) NFPA 30A, Code for Motor Fuel Dispensing Facilities & Repair Garages, 2024 edition.

(d) NFPA 59, Utility LP-Gas Plant Code, 2024 edition.

(e) NFPA 1192, Standard on Recreational Vehicles, 2021 edition.

(f) NIST Handbook 44, Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, 2024 edition.

(g) NIST Handbook 130, Uniform Laws and regulations in the Areas of Legal Metrology and Engine Fuel Quality 2024 edition.

All NFPA codes incorporated by reference may be purchased from:

National Fire Protection Association 1 Batterymarch Park Quincy, Massachusetts USA 02169-7471 1-800-344-3555 http://www.nfpa.org All NIST codes incorporated by reference may be purchased from:

National Institute of Standards and Technology 100 Bureau Drive Gaithersburg, MD. 20899 301-975-4004 http://www.nist.gov Or for free download: https://www.nist.gov/pml/owm/publications/nist-handbooks

Section 1-5-2 Inspection of Incorporated Codes Interested parties may inspect and obtain copies of excerpts of the referenced incorporated materials for a reasonable charge by contacting the Division of Oil and Public Safety at 633 17th Street, Suite 500 Denver, CO 80202 303-318-8525 cdle_ops@state.co.us

Section 1-5-3 Later Amendments not Included These regulations do not include later amendments to or editions of the incorporated material.

Section 1-6 Definitions Terms in these regulations shall have the same meaning as those found in Title 8, Article 20 and Title 9,

Article 4 of the Colorado Revised Statutes. In addition, unless the context otherwise requires:

AHJ -- Authority Having Jurisdiction API – American Petroleum Institute.

ASME International – Formerly the American Society of Mechanical Engineers (ASME).

ASTM International – Formerly the American Society for Testing and Materials.

CETP — Certified Employee Training Program Condemned – A condemned container assembly and piping system is one determined by a state inspector to be so unsafe that further use is prohibited until it is satisfactorily repaired or replaced.

Container assembly – A container assembly includes US Department of Transportation (DOT) and ASME containers, commonly known as tanks or cylinders.

CRS – Colorado Revised Statutes.

Cylinder -- A portable container (usually DOT) with a marked water capacity of 1000 lb (454 kg) or less, designed to transport and store LP-Gas.

Division – The Division of Oil and Public Safety, the regulatory agency of the Colorado Department of Labor and Employment having jurisdiction over LPG container assemblies and piping systems as defined in these regulations.

DOT – United States Department of Transportation.

Existing installation – Any LPG container assembly and piping system that has been placed into service and received its initial inspection by a state inspector.

FSA – Fire Safety Analysis, also known as Product Release Prevention and Incident Preparedness Review or Incident Prevention Review. An FSA is a plan incorporating the various safety features used to control the product and operations at the facility, an evaluation of hazard to the immediate neighborhood and a tool to be used by an emergency response agency, such as the local fire department.

Handling – Transferring LPG into a DOT container or an ASME tank. Handling does not include transporting of LPG.

Incident – A reportable accident, as defined by 8-20-407(1), CRS.

Incident prevention review – See definition under FSA.

Installer – Person or company responsible for setting up for use any container assembly and piping system required by LPG statute or regulation to be inspected.

Interruption of service – An interruption of gas service where pressure in the fuel gas piping is below a point that the appliances can no longer operate, including an out-of-gas call, except for when conducting a test.

LPG - Liquefied Petroleum Gas (LP-Gas). Any material having a vapor pressure not exceeding that allowed for commercial propane that is composed predominantly of the following hydrocarbons, either by themselves (except propylene) or as mixtures: propane, propylene, butane (normal butane or isobutane), and butylenes.

LPG facility – Facility that has an LPG container assembly and piping system.

LPG liquid meter – A meter designed to measure LPG liquid, with an active National Type Evaluation Program (NTEP) Certificate of Conformance (CC), which includes a metering chamber or device, vapor eliminator, differential valve and register.

Marking – Container information located on container name-plate or stamped into the shell or collar of an LPG container. Marking is done in accordance with the regulations of DOT, ASME or API-ASME and is done by the original container manufacturer or a repair organization authorized by the National Board to utilize the “R” code symbol stamp.

NACE – The National Association of Corrosion Engineers.

National Board – The National Board of Boiler and Pressure Vessel Inspectors.

New installation – Any container assembly that has been placed into service but has not received its initial inspection by a state inspector.

NFPA – The National Fire Protection Association.

NIST – The National Institute of Standards and Technology. Out-of-gas call – A request for LPG delivery to an empty tank. PEP — PERC Education Program PERC – The Propane Education and Research Council.

Plant Oil Extraction – Process using LPG as a solvent for the isolation of oil from raw plant matter.

Plant Oil Extraction Equipment – Any equipment used for the purpose of plant oil extraction as defined.

Product release prevention and incident preparedness review – see definition under FSA.

Proved – The act of having verified the accuracy of meters used to measure fuel and petroleum products using a prover.

Prover – A calibrated volumetric receiver or mechanical device traceable to NIST standards.

PSI – Pounds per square inch.

Registered serviceperson – Any individual who, for hire, award, commission or any other payment of any kind, installs, services, repairs or reconditions a commercial weighing or measuring device and who voluntarily registers with the division.

Registered service agency (RSA) – Any agency, firm, company or corporation that, for hire, award, commission or any other payment of any kind, installs, services, repairs or reconditions a commercial weighing or measuring device and voluntarily registers with the division. Under agency registration, identification of individual servicepersons shall be required.

Retail – The sale of LPG from fixed dispensing equipment or by means of bobtail delivery truck, or such as at a fueling station, in small or individual quantities for direct consumption by the purchaser.

State inspector – A person who is employed or authorized by the division to perform inspections of LPG facilities.

Temporary Installation – A once only installation meeting all requirements of NFPA 58, in service no longer than 12 months.

Universal Cylinder - A cylinder (usually DOT) that can be connected for service in either the vertical or the horizontal position so that the fixed maximum liquid level gauge, pressure relief device, and filling and withdrawal appurtenances function properly in either position.

Section 1-7 Applicability The regulations contained herein shall apply to the operation of all LPG container assembly and piping systems including the following:

(a) Containers, piping and associated equipment, when delivering LPG to a building for use as a fuel gas.

(b) Pipeline terminals, natural gasoline plants, refineries, tank farms, underground storage facilities, aboveground storage facilities and chemical plants utilizing LPG in the manufacture of their products.

(c) The design, construction, installation and operation of pipeline terminals that receive LPG from pipelines under DOT jurisdiction, whose primary purpose is the receipt of LPG for delivery to transporters, distributors or users. Coverage shall begin downstream of the last pipeline valve or tank manifold inlet.

Section 1-8 Condemning an LPG Container Assembly and Piping System (a) Conditions which a state inspector may determine to be unsafe include: bypassed safety controls; inoperative relief valves; any gas leak from an LPG container assembly; any excessive gas leak from the piping system; missing nameplate; or any other condition deemed by a state inspector to be unsafe. A container assembly or piping system that meets any condition described above may be condemned by a state inspector.

(b) The owner or user must shut down the condemned LPG container assembly and piping system as directed by a state inspector. If neither the owner nor user is available, a state inspector will cause the system to be shut down.

(c) A state inspector will affix a notice to a condemned LPG container assembly and piping system stating that it has been condemned and may not be used until satisfactory repairs are made, as determined by a re-inspection by a state inspector or other person authorized by the division.

ARTICLE 2 INSTALLATION

Section 2-1 General Requirements (a) All new LPG installations shall be constructed in accordance with the incorporated editions of the NFPA and NIST codes.

(b) All existing LPG installations shall be constructed in accordance with the incorporated editions of the NFPA and NIST codes in effect at the time of construction, including any retroactive requirements adopted by the division.

Section 2-2 Installation Permits (a) Plans for all installations utilizing LPG storage containers of over 2,000 gallons water capacity shall be submitted to the division for approval before construction, including installation, replacement or relocation of such installations, begins.

(b) The division shall be notified of temporary installations of the container sizes covered in (a) before the installation is started.

(1) Notification shall be accomplished using the process and the permit application form listed in Section 2-2 Installation Permits (d)

(2) Pre-approval shall be obtained from the Division for any temporary installation that is in use for more than twelve months.

(c) Plans for any of the following shall be submitted to the division for approval before installation:

(1) Service stations supplying LPG for motor fuel.

(2) Installations for filling of DOT and ASME mobile containers and containers marked to demonstrate compliance with Federal Aviation Administration regulations.

(3) Industrial bulk storage installations and all other bulk storage installations utilizing storage containers for LPG of over 2,000 gallons aggregate water capacity.

(4) LPG liquid transfer operations using cylinders to fill other cylinders for use in plant oil extraction per 6-1 (b) of these regulations.

(d) The permit procedures are as follows:

(1) The permit application shall be submitted on an application form approved and provided by the division. The application form may be found at: https://ops.colorado.gov/Petroleum/LiquefiedCompressedGases/LiquefiedPetroleumGa s.

(2) The application shall include a plot plan containing all elements required by the division.

(3) The division may deny the application if the proposed installation does not conform to the division LPG statute or regulation or to codes adopted by the division, or if the application is incomplete or determined to be inaccurate.

(4) Construction and installation of tank and piping shall conform to code(s) in effect at the time of installation.

(5) The division may revoke a permit if construction is not performed per the approved permit, or if the construction fails to meet operating or fire safety regulations established by the division or by the applicable NFPA Code.

(6) An installation permit approved by the division is automatically revoked if construction does not begin within 6 months of approval, unless a written request for an extension is submitted to and approved by the division.

(7) For new installations with an aggregate over 4,000 gallons, an FSA must be in effect prior to the operation of the installation per NFPA 58, following guidance from Annex A, A.6.29.2 and A.6.29.3 or another nationally-accepted standard approved in advance by the division.

(8) A local authority having jurisdiction, including fire departments, may require and enforce more stringent requirements than these regulations.

Section 2-3 Access Requirements (a) The division may inspect an LPG facility at any time during its construction. Access shall be provided to the division or its agent for such purpose upon request.

(b) After an LPG container has been installed, the division may inspect the container to verify compliance with design, construction, location, installation and operation requirements.

(c) LPG installers, facility owners, tank owners and owners of locations where an LPG container is installed shall notify the division once the installation is completed and grant inspection access to the division or its agent for such purpose upon request.

Section 2-4 Corrosion Prevention Requirements (a) Corrosion protection is required for all underground steel LPG tanks and piping installed after September 1, 2005, and for all other underground steel LPG tanks by January 1, 2011.

(b) Corrosion protection shall meet the requirements of NFPA 58.

(c) Cathodic protection systems shall be installed and tested in accordance with the provisions of NFPA 58, and documentation of the results of the two most recent tests shall be retained.

(d) Installers of cathodic protection systems shall be trained in the proper installation of cathodic protection systems, using the PERC Cathodic Protection Guide, or PEP equivalent. Training shall be documented per Section 4-1 of these regulations, and refresher training shall be required at least every three years.

Section 2-5 Nameplates (a) When an ASME container assembly has a nameplate with a legible serial number but has insufficient data to be in service, and there is a Manufacturer’s Data Report (U1A) with a matching serial number and the container fits the description on the U1A, the owner/operator may then make application to the division for a tag bearing the manufacturer’s name, ASME Code symbol, maximum allowable working pressure, UG or AG (or both AG and UG) and water gallon capacity. If granted, the division shall issue an identifying tag to be permanently attached to the container by a state inspector.

(b) When an ASME container assembly has no nameplate but there is sufficient data to prove that it once had a nameplate showing the critical data thereon, the owner/operator may then make application to the division for a tag bearing the manufacturer’s name or trademark, ASME Code symbol, maximum allowable working pressure, UG or AG (or both AG and UG) and water gallon capacity. If granted, the division shall issue an identifying tag to be permanently attached to the container by a state inspector. A copy of the container’s U1A form shall be considered important data.

(c) When a container assembly and piping system has a nameplate whose stamping becomes indistinct, or the nameplate is lost or illegible but traceability to the original container assembly item is still possible, the owner or user shall have the stamped data replaced as follows:

(1) All re-stamping shall be done in accordance with the version of the code in effect at the time of container construction.

(2) A request for permission to re-stamp or replace a nameplate shall be made in advance to the division. Proof of the original stamping and the manufacturer’s data report shall be furnished with the request.

(3) Permission from the division is not required for the reattachment of nameplates that are partially attached.

(4) Re-stamping or replacement authorized by the division shall be witnessed by a state inspector.

(5) The stamping shall be identical to the original stamping. When the Code symbol is to be re-stamped, it shall be done by the original manufacturer and witnessed by a state inspector.

(6) Replacement nameplates shall be clearly marked “replacement.”

(7) After replacing a nameplate, the owner or user shall file with the division a copy of the stamping or nameplate as applied and shall include the signature of the state inspector who witnessed the replacement.

(d) If replacement of the nameplate is not possible because the container assembly cannot be traced, a hydrostatic test or other test approved by the division must be performed if the container is to remain in service.

a. Such test shall be performed by an independent contractor experienced in hydrostatic tests. The test shall be conducted according to the procedure outlined in ASTM International Designation: E 1003 – 95 (Reapproved 2000) at 1.5 times working pressure (250 psi x 1.5 = 375 psi) to evaluate the integrity of the container.

b. The owner/operator may then make application, including the results of the hydrostatic test, to the division for an exception. If granted, the division shall assign a number to the container and issue an identifying tag with that number to be permanently attached to the container by a state inspector.

c. With the division’s approval, the container may continue to operate at that location indefinitely. The container shall not be moved and reinstalled at any location, including elsewhere at the same facility.

(e) If a container was installed prior to September 1, 2005, and is missing the nameplate, one of the following shall be performed:

a. The nameplate shall be replaced per Section 2-5-1 (a) of these regulations A hydrostatic test or other test approved by the division shall be performed and approval to operate the container granted by the division per Section 2-5 (b) of these regulations.

b. The container shall be permanently removed from service.

Section 2-6 Fire Safety Analysis (FSA)

(a) For all new LPG installations in excess of 4,000 gallons in aggregate an FSA is required to be completed by the operational date of the installation.

(b) The FSA shall be prepared in accordance with the requirements of NFPA-58, including Annex A, A.6.29.2 and A.6.29.3 or any other nationally-accepted standard approved by the division in advance.

(c) It is not required that the FSA be prepared or approved by a professional engineer: however, the preparation should be completed by someone who, at a minimum, is familiar with the properties of LPG, the application of NFPA 58 and the physical layout of the installation. The preparer shall consult with the local fire protection district to complete the FSA. Some modifications to the installation may require the services of a registered professional engineer.

(d) The most current FSA document shall be maintained at the LPG installation, where it shall be available for inspection by the division upon request.

Section 2-7 Marking Underground Containers in Snow Areas (a) In areas where snow can be expected to cover the dome lids of underground containers, such containers shall be marked so that emergency and LPG service company personnel can locate the tank for emergency shut down purposes or to service the tank. Such marking shall be accomplished by placing a stake or other marking that shall be installed higher than the anticipated maximum snow level up to a height of 15 feet.

ARTICLE 3 DELIVERY AND DISPENSING

Section 3-1 LPG Delivery (a) Containers shall be filled only after determination from the point of transfer that the installation of the container and visible exterior piping system comply with the provisions of NFPA 58 and these regulations.

(b) It is permissible to fill an ASME tank whose nameplate or other marking is damaged, provided the following information can be determined:

(1) If the container is registered with the National Board and the facility can produce the Manufacturer’s Data Report (U-1A and/or U-2A) form, the manufacturer's name and container's serial number must be legible.

(2) If the container is not a National Board-registered container, the manufacturer's name, the container's serial number, the ASME stamp and the pressure rating must be legible.

(c) If the nameplate or other marking is missing, delivery to the tank is prohibited. Refer to Section 2- 5 of these regulations for instructions on re-attaching or re-placing nameplates.

(d) Delivery to a container with corrosion that appears to be greater than 1/3 of the thickness of the metal is prohibited.

(e) When noncompliance with the provisions of the incorporated codes is found, the container owner or user of record shall be notified in writing. Section 3-2 Delivery after Interruption of Service (a) When delivery is made to an LPG container assembly that has had an interruption of service as defined by these regulations, a leak check shall be performed immediately after LPG is introduced into the piping.

(b) The leak check shall be performed according to one of the methods set forth in Annex D (Suggested Method of Checking for Leakage) of NFPA 54 or another method approved by the division in advance (c) The person performing the leak check shall document that the test was performed. The documentation shall include, at minimum, the following information:

(1) Date the test was performed (2) Test start time (3) Test end time (4) Name of person performing the test (5) Name of person's employer (6) Address and phone number of person's employer (7) Type of test (8) Test start pressure and end pressure if a constant pressure is used (d) Documentation of the leak check shall be retained for a minimum of one year by the employer of the person who performed the test.

Section 3-3 Dispensing (a) The requirements of Section 3-4 of these regulations shall apply to dispensers at retail facilities.

(b) All retail and non-retail LPG dispensers must comply with the minimum standards as prescribed by the applicable sections of the incorporated codes.

(c) All LPG sales shall be offered, exposed for sale, or sold by one of the following.

(1) Weight- by the kilogram or pound.

(2) Liquid Volume- by the liter (defined as 1 liter @ 15°C) or the gallon (defined as 231 in³ at 60° F).

(3) Flat Rate- (defined as the act of filling a customer’s cylinder to the maximum allowable capacity).

Section 3-4 Retail Motor Fuel and Fuel Gas Dispenser Meter Inspection and Testing (a) All retail LPG dispensers shall be suitable for their intended use, properly installed and accurate, and they shall be maintained in that condition by their owner/operator.

(b) All retail LPG dispensers shall have an active National Type Evaluation Program (NTEP)

Certificate of Conformance (CC) prior to their installation or use for commercial purposes.

(c) The division shall be notified when any new or remanufactured retail LPG dispenser is placed in service at a new or existing installation. Notification shall be submitted using a placed in service report provided by the division.

(d) All metered sales by liquid volume shall be accompanied using a metering system as follows:

(1) Sales using metering systems with a maximum rated capacity greater than 20 gal/min shall be accomplished using a metering system that automatically compensates for the effects of temperature.

(2) Sales using metering systems with a maximum rated capacity equal to or less than 20 gal/min that were placed into service after January 1, 2026, shall be accomplished by use of a metering system that automatically compensates for the effects of temperature.

(3) Effective January 1, 2030, all metered sales (through all capacities of metering devices, regardless of installation and service date) shall be accomplished by use of a metering system that automatically compensates for temperature.

(e) No owner/operator of any retail LPG dispenser shall use the dispenser for the measurement of LPG unless it has been proved in a manner acceptable to the Director of the division and sealed as correct by a state inspector or registered service agency.

(f) If any retail LPG dispenser fails to comply with any of the provisions of this regulation, a state inspector shall seal it in such a manner as to prohibit its use, and it shall remain sealed until it complies with all of the provisions of this regulation.

(1) When a retail LPG dispenser is brought back into compliance with these regulations, it must be placed back in service by a state inspector or registered service agency.

(g) All retail LPG dispensers shall comply with the minimum standards as prescribed by the applicable sections of the incorporated codes, except as modified or rejected by these regulations or by the director.

(h) All retail LPG dispensers shall be labeled in accordance with the minimum standards as prescribed by the applicable sections of the incorporated codes except as modified or rejected by these regulations or by the division.

Section 3-5 Bobtail Delivery Truck Meter Inspection and Testing (a) All LPG bobtail delivery truck metering systems shall be suitable for their intended use, properly installed and accurate, and they shall be maintained in that condition by their owner/operator.

(b) All LPG bobtail delivery truck metering systems shall have an active National Type Evaluation Program (NTEP) Certificate of Conformance (CC) prior to their installation or use for commercial purposes.

(c) The division shall be notified when any new or remanufactured LPG bobtail delivery truck metering systems is placed in service at a new or existing installation. Notification shall be submitted using a placed in service report provided by the division.

(d) No owner/operator of any LPG bobtail delivery truck metering system shall use the meter for the measurement of LPG unless it has been proved in a manner acceptable to the Director of the division and sealed as correct by a state inspector or registered service agency.

(e) If any LPG bobtail delivery truck metering systems fails to comply with any of the provisions of these regulations, a state inspector shall seal it in such a manner as to prohibit its use, and it shall remain sealed until it complies with all of the provisions of these regulations.

(1) When an LPG bobtail delivery truck metering system is brought back into compliance with these regulations, it must be placed back in service by a state inspector or registered service agency.

(f) All LPG bobtail delivery truck metering systems shall comply with the minimum standards as prescribed by the applicable sections of the incorporated codes except as modified or rejected by these regulations or by the division.

(g) All retail LPG bobtail delivery truck meters shall be labeled in accordance with the minimum standards as prescribed by the applicable sections of the incorporated codes except as modified or rejected by these regulations or by the division.

Section 3-6 Filling Containers by Weight (a) All cylinders less than 200 pounds water capacity (i.e., 100-pound cylinders), with the exception of forklift cylinders and hot air balloon containers, shall be filled by weight.

(b) Volumetric filling of forklift cylinders from bobtail delivery trucks shall be allowed in accordance with NFPA 58, Section 6.7 and Table 6.7.2.1, and all personnel shall be trained in proper handling procedures in accordance with NFPA 58, Chapter 7.

(c) Scales used for filling LPG containers must be inspected annually and found to be in compliance with the specifications and tolerances published in NIST Handbook 44. This certification must be performed either by the Colorado Department of Agriculture or by a person authorized by the Colorado Department of Agriculture. Any necessary repairs must be completed within 30 days.

(d) If the Colorado Department of Agriculture fails to perform the annual inspection in a timely fashion, the scale may remain in operation, provided the scale owner has not prohibited or hindered such inspection by the Colorado Department of Agriculture, and further provided that any repairs required at the most recent previous inspection have been completed.

Section 3-7 Tank Delivery Truck, Semitrailer, or Truck Trailer for Bulk Storage.

(a) No tank delivery truck, semitrailer, or truck trailer shall be used as a bulk storage plant for LPG unless the same has been permitted, inspected and approved as a temporary installation by the division.

(b) Where cargo tank vehicles are filled from other cargo tank vehicles or cargo tanks, the following requirements shall apply:

(1) Transfer between cargo tanks or cargo tank vehicles where one is used as a bulk plant shall be temporary installations that comply with NFPA 58, 4.3.2, 6.18.1, 6.18.2, 6.18.4 through 6.18.6, and 7.2.3.1. through 7.2.3.2. and 7.2.3.9.

(2) Arrangement and operations of the transfer system shall be in accordance with NFPA 58 Table 6.5.3.

ARTICLE 4 TRAINING REQUIREMENTS

Section 4-1 General Training Requirements (a) Any person who transfers LPG including, but not limited to, dispenser operators, bobtail delivery drivers and transport operators, or who services or installs exterior piping of LPG vapor distribution systems, shall receive adequate training to perform all related duties safely and in accordance with the provisions of NFPA 58, Sections 4.4 and 7.2.

(b) The employer of any person referenced in (a) above, shall document that person’s training and shall make these records available to the division or its agent upon request. The records shall include the following information, at minimum:

(1) Person’s name (2) Training date(s)

(3) Name of trainer (4) Topics covered by training (5) Verification by the person’s supervisor or certification described in this Article that the person has demonstrated adequate knowledge and skill to perform assigned duties (c) For all training required under Sections 4-2 through 4-4 of these regulations, refresher training shall be required at least every three years. The training shall be documented.

(d) The employer of the person who received the training shall maintain that documentation as long as the person remains an employee.

Section 4-2 Dispenser Operator Training (a) The minimum training requirements for dispenser operators, that shall be completed prior to operating LPG dispensers, may be satisfied by certification by one of the following:

(1) Certified Employee Training Program (CETP) Basic Principles and Practices, or PEP equivalent as published by PERC.

(2) A training program which contains, at minimum, certification by the Dispensing Propane Safely , or PEP equivalent as published by PERC.

(3) Equivalent training program approved by the AHJ.

Section 4-3 Delivery Personnel Training (a) The minimum training requirements for delivery personnel shall include:

(1) Proper procedure for filling an ASME container (2) Knowledge of when a leak check is required (3) Proper procedure for conducting and documenting a leak check (4) Criteria for determining when filling a container is prohibited because of improper installation or because of excessive corrosion, dents or gouges (5) Emergency procedures as outlined in the employer’s FSA (6) Completion of the following training programs published by PERC (A) CETP Basic Principles and Practices, or PEP equivalent.

(B) CETP Bobtail Delivery Operations, or PEP equivalent.

(C) CETP Basic Plant Operations, or PEP equivalent.

(b) All required training for delivery personnel outlined in 4-3 (6) shall be completed within one year of assuming current job duties.

Section 4-4 Service and Installation Personnel Training (a) The minimum training requirements for those who service or install exterior piping of LPG vapor distribution systems may be satisfied by completing the following training programs published by PERC.

(1) CETP Basic Principles and Practices, or PEP equivalent.

(2) CETP Designing & Installing Exterior Vapor Distribution Systems, or PEP equivalent.

(3) CETP Placing Vapor Distribution Systems and Appliances into Operation, or PEP equivalent.

(b) All required training for those who service or install exterior piping of LPG vapor distribution systems shall be completed within one year of assuming current job duties.

Section 4-5 Transport Operator Training (a) The minimum training requirements for transport operators may be satisfied by completing the following training programs published by PERC.

(1) CETP Basic Principles and Practices, or PEP equivalent.

(2) PERC Transport Operator Training Program, or PEP equivalent.

(b) All required training for transport operators shall be completed within one year of assuming current job duties.

Section 4-6 Dispensing System Installer Training (a) Dispensing Systems installed after July 1, 2025, must be installed by personnel meeting minimum training requirements.

(b) The minimum training requirements for dispensing system installers may be satisfied by completing the following training programs published by PERC.

(1) CETP Basic Principles and Practices, or PEP equivalent.

(2) CETP Designing & Installing Dispenser Transfer Systems, or PEP equivalent.

ARTICLE 5 ACCIDENT REPORTS AND INVESTIGATIONS

Section 5-1 Reportable Accidents (a) Reports of accidents, fires, explosions, injuries, damage to property or loss of life at installations using liquefied petroleum gas shall be reported to the division within 24 hours after their occurrence.

(b) Subsection (a) of this Section includes accidents resulting from the improper use of equipment, appliances, and appurtenances to LPG systems. The division may investigate such occurrences and shall maintain a written record of findings, which shall be available for public examination.

Section 5-2 Reporting Requirements (a) The following persons are required to notify the division of an LPG accident that meets any of the criteria of Section 5-1 of these regulations:

(1) Owner or the owner’s representative of the LPG facility, if the accident occurred at the facility (2) Employer of the delivery personnel, if the accident occurred during delivery (3) Employer of the delivery personnel, if the accident occurred post-delivery and the employer received notification of it (b) Accidents may be reported by telephone or email using the following information:

(1) Telephone: 303-318-8547 (2) Email: cdle_oil_inspection@state.co.us (c) The accident report shall include, at minimum, the following information.

(1) The names of the operator and person making the report and their telephone numbers (2) The date, time, and location of the accident (3) The number of fatalities and personal injuries (4) All other significant facts known by the person making the report that are relevant to the cause of the accident or extent of the damages

ARTICLE 6 INSTALLATION AND USE OF CONTAINERS AND SYSTEMS FOR PLANT OIL

EXTRACTION

Section 6-1 Transfer Operations (a) LPG liquid transfer operations using cylinders shall be subject to all applicable provisions of NFPA 58 and these regulations.

(b) LPG liquid transfer operations using cylinders shall be subject to the permitting requirements located in Section 2-2 of these regulations.

(c) While cylinders are connected for transferring LPG liquid into another cylinder, and they are grouped with additional cylinders consisting of a total aggregate water capacity including the connected cylinders, of greater than 501 gallons, the entire group of cylinders shall meet the minimum separation distances outlined in NFPA 58 Table 6.4.1.1 along with 6.4.3 (2-4).

(d) LPG liquid transfer operations and points of transfer shall be located in accordance with Table 6.7.2.1 of NFPA 58.

(e) Security shall be provided to restrict unauthorized access to LPG transfer areas.

(f) The filling location must be located 15’ from combustion engine use, i.e., vehicle parking. All ignition sources shall be shut off.

(g) Where heating blankets are used, they must be listed for use in explosive environments.

(h) Smoking, portable lighting, portable electric tools, etc. shall not be in use within 25’ of the filling operation.

(i) Purging of cylinders may be performed at the cylinder filling location in accordance with NFPA 58.

(1) The cylinder must be rapidly dispersed in the atmosphere (2) Where environmental conditions do not allow rapid dispersal (i.e., wind conditions, site conditions such as neighboring buildings on lot lines not allowing adequate natural ventilation, etc.), LPG must be flared using a method in compliance with NFPA 58 (j) LPG liquid transfer operations shall be conducted outdoors unless done in a building or room that has been designed in accordance with NFPA 58 Chapter 10 requirements and provides appropriate flammable gas detection equipment.

(k) LPG liquid transfers using lighter refill-type containers using can taps or other puncture equipment is prohibited.

(l) Persons employed in the transfer of LPG liquid from one cylinder to another shall be trained in accordance with the provisions of Article 4, Sections 4-1 & 4-2 of these regulations.

(m) With the exception of a “universal cylinder”, cylinders used in transferring LPG liquid shall have a withdrawal valve incorporating a “wet leg” that allows LPG liquid to be withdrawn while the cylinder is in the upright position. Transfer of LPG liquid shall not be accomplished by means of tipping or inverting a cylinder.

(n) Fixed liquid level gauges or other “vent type” gauges, shall not be used for filling cylinders with unodorized LPG. Filling of cylinders with LPG that is unodorized shall be accomplished only by means of weight, using a scale that is in compliance with Section 3-6 (c) of this regulation, and they shall be Class I Division I listed or be of the mechanical type.

(o) Only inert gases shall be allowed to be injected into a cylinder or other container in order to transfer LPG liquid from one container to another. Injection of compressed air, oxygen, or any oxidizing gas into containers to transfer LPG liquid shall be prohibited.

(p) Electrical equipment is required to be Class I Division I within 5’ and Class I Division II within 15’ of filling operations.

(q) While cylinders are in storage awaiting use, they shall meet all of the requirements of NFPA 58

Chapter 8, Storage of Cylinders Awaiting Use, Resale, or Exchange.

(r) All containers that contain unodorized LP-Gas shall be marked in accordance with NFPA 58,

Chapter 5.2.8.5.

Section 6-2 Extraction Equipment (a) Extraction equipment using LPG are required to be listed or approved by the local AHJ.

(b) In lieu of listing, an engineering report (signed and sealed by a licensed Colorado engineer) must be retained on site and submitted to the local AHJ where required, demonstrating how the system meets national standards, i.e., NFPA 58, as a basis of design, including an analysis/description of every component of the system (c) Only closed-loop type LPG extraction equipment is permitted. Open blasting extractions or equipment that releases LPG to the atmosphere during the extraction process is strictly prohibited.

(d) An owner’s operation manual containing specific instructions regarding proper use of equipment and any safety provisions must be retained on site with the equipment and submitted to the local AHJ where required.

(e) All equipment utilizing unodorized LPG must employ flammable gas detection equipment as approved by the AHJ. _________________________________________________________________________ Editor’s Notes

History Entire rule eff. 02/01/2011.

Entire rule eff. 05/01/2017.

Sections 1-4, 1-5 eff. 09/30/2017.

Entire rule eff. 11/30/2024.

7 CCR 1101-16 Retail Natural Gas (cng/Lng) Regulations {#sec-7-ccr-1101-16 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-16}

DEPARTMENT OF LABOR AND EMPLOYMENT

RETAIL NATURAL GAS (CNG/LNG) REGULATIONS

7 CCR 1101-16 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Basis and Purpose The basis and purpose of these regulations is to set forth minimum standards for the design, construction, location, installation and operation of retail natural gas fueling facilities, including mobile refueling vehicles and equipment, which are reasonably necessary for the protection of the health, welfare and safety of the public and persons using such materials.

Section 1-2 Technical Rationale The technical requirements of these regulations are based on generally accepted national and international codes and standards governing the minimum levels of acceptability for inspections, specifications, shipment notification, record keeping, labeling of containers, use of meters or mechanical devices for measurement, submittal of installation plans and minimum standards for the design, construction, location, installation and operation of retail natural gas systems, including mobile refueling vehicles and equipment.

Section 1-3 Statutory Authority These regulations are created pursuant to 8-20-102 and 39-27-123 of the Colorado Revised Statutes.

Section 1-4 Effective Date These regulations shall be effective on September 15, 2018. The previous version of these regulations was effective January 31, 2014.

Section 1-5 Codes and Standards

Section 1-5-1 Codes incorporated by reference The following codes are incorporated by reference.

(a) NFPA 52, Vehicular Gaseous Fuel Systems Code, 2016 edition.

(b) NFPA 30-A, Code for Motor Fuel Dispensing Facilities & Repair Garages, 2018 edition.

(c) NIST Handbook 44 Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, 2018 edition.

(d) NIST Handbook 130 Uniform Laws and Regulations in the Areas of Legal Metrology and Engine Fuel Quality, 2018 edition.

All NFPA codes incorporated by reference may be purchased from:

National Fire Protection Association 1 Batterymarch Park Quincy, Massachusetts 02169-7471 1-800-344-3555 www.nfpa.org All NIST codes incorporated by reference may be purchased from:

National Institute of Standards and Technology 100 Bureau Drive Gaithersburg, Maryland 20899 303-975-4004 www.nist.gov For free download: www.nist.gov/pml/weights-and-measures/publications/nist-handbooks

Section 1-5-2 Inspection of incorporated codes Interested parties may inspect and obtain copies of excerpts of the referenced incorporated materials for a reasonable charge by contacting the Division of Oil and Public Safety at 633 17th Street, Suite 500, Denver, CO 80202 or 303-318-8525.

Section 1-5-3 Later amendments not included These regulations do not include later amendments to or editions of the incorporated material.

Section 1-6 Definitions Terms in these regulations shall have the same meaning as those found in Title 8, Article 20 and Title 9,

Article 4 of the Colorado Revised Statutes. In addition, unless the context otherwise requires:

ASME International – ASME International was formerly the American Society of Mechanical Engineers (ASME).

British Thermal Units or BTU – Means a scientific unit of measurement equal to the quantity of heat required to raise the temperature of one pound of water one degree Fahrenheit at approximately sixty degrees Fahrenheit.

Compressed Natural Gas (CNG) – Means natural gas which has been compressed and dispensed into fuel storage containers and is suitable for use as an engine fuel.

CNG DGE - 1 CNG DGE is equal to 6.384 lbs (2.895 kg) of CNG.

CNG GGE - 1 CNG GGE is equal to 5.660 lbs (2.567 kg) of CNG.

Condemned – Means a condemned container assembly and piping system which is determined by a state inspector to be so unsafe that further use is prohibited until it is satisfactorily repaired or replaced.

Container Assembly – Includes US Department of Transportation (DOT) and ASME containers, commonly known as tanks or cylinders.

CRS – Means the Colorado Revised Statutes.

Division – Means the Division of Oil and Public Safety, which is the regulatory agency of the Colorado Department of Labor and Employment having jurisdiction over retail natural gas systems per the provisions of CRS 8-20-102 (3).

Existing Installation – Includes any natural gas container assembly and piping system at a natural gas fueling facility that has been placed into service prior to the effective date of these regulations and/or has received its initial inspection by a state inspector.

Gallon Equivalent – Means either a gallon diesel equivalent or a gallon gasoline equivalent.

Gallon Diesel Equivalent – Also known as Diesel Gallon Equivalent (DGE) - Means an amount of a motor fuel that contains an average lower heating value of one hundred twenty-eight thousand (128,000) BTUs but in no case contains a lower heating value of less than one hundred twenty-four thousand (124,000) BTUs.

Gallon Gasoline Equivalent – Also known as Gasoline Gallon Equivalent (GGE) - Means an amount of a motor fuel that contains an average lower heating value of one hundred fourteen thousand (114,000) BTUs, but in no case contains a lower heating value of less than one hundred ten thousand (110,000) BTUs.

Liquefied Natural Gas (LNG) – Means natural gas that has been liquefied at –259ºF (–126.1°C) and stored in insulated cryogenic tanks for use as an engine fuel.

LNG DGE – 1 LNG DGE is equal to 6.059 lbs (2.748 kg) of LNG.

Mobile Refueling – Means the use of a United States DOT-approved vehicle or mobile equipment on- site with tank(s) and/or pump(s) that dispenses natural gas engine fuel directly to vehicles, storage vessels/cylinders or secondary refueling equipment.

Natural Gas – Means compressed natural gas (CNG) or liquefied Natural Gas (LNG) as defined by this regulation.

Natural Gas Fueling Facility – Means a facility that has a natural gas container assembly and piping system, including mobile refueling equipment, which is used for retail motor vehicle fueling.

New Installation – Means any natural gas container assembly and piping system at a natural gas fueling facility that has been placed into service after the effective date of these regulations and/or has not received its initial inspection by a state inspector.

NFPA – Means the National Fire Protection Association.

NIST– Means the National Institute of Standards and Technology.

Piping System – Means pipe, tubing, hose and flexible connectors with valves and fittings made into complete systems for conveying natural gas from one point to another within a retail natural gas fueling facility.

Proved – Means the act of having verified the accuracy of meters used to measure fuel and petroleum products using a “prover”.

Prover – Means a calibrated volumetric receiver or mechanical device traceable to NIST standards.

Registered Serviceperson – Means any individual who for hire, award, commission or any other payment of any kind installs, services, repairs or reconditions a commercial weighing or measuring device and who voluntarily registers with the division.

Registered Service Agency (RSA) – Means any agency, firm, company or corporation that for hire, award, commission or any other payment of any kind installs, services, repairs or reconditions a commercial weighing or measuring device and that voluntarily registers with the Under agency registration, identification of individual servicepersons shall be required.

Retail – Means the sale of CNG or LNG from a fixed location or by means of mobile refueling equipment or vehicles, such as at a fueling station, in small or individual quantities for direct consumption by the purchaser.

State Inspector – Means a person who is employed or authorized by the division to perform inspections of retail natural gas fueling facilities.

Section 1-7 Applicability The regulations contained herein shall apply to the installation and operation of all retail natural gas systems when used for motor vehicle fueling.

Section 1-8 Condemning a Natural Gas Container Assembly and Piping System (a) Conditions which a state inspector may determine to be unsafe include: bypassed safety controls, inoperative relief valves, any gas leak from a natural gas container assembly or piping system, missing nameplate or any other condition deemed by a state inspector to be unsafe based on codes adopted by this regulation. A container assembly or piping system that meets any condition described above may be condemned by a state inspector.

(b) The owner or user must shut down the condemned natural gas container assembly and piping system as directed by a state inspector. If neither the owner nor user is available, a state inspector will shut the system down.

(c) A state inspector will affix a notice to a condemned natural gas container assembly and piping system stating that it has been condemned and may not be used until satisfactory repairs are made, as determined by a re-inspection by a state inspector or other person authorized by the

ARTICLE 2 INSTALLATION

Section 2-1 General Requirements (a) All new retail natural gas installations shall be operated and maintained in accordance with the codes adopted by this regulation, including any retroactive requirements adopted by the division at the time of installation.

(1) Unless otherwise specified, the provisions of these regulations are not intended to require upgrading facilities, equipment, structures or installations that existed or were approved for construction or installation prior to the effective date of these regulations. Where specified, the provisions of these regulations shall be retroactive.

(2) If after inspection the division determines that an existing situation presents an unacceptable degree of risk, the division shall be permitted to apply retroactively any portion of the applicable codes listed in section 2-1 (a), as deemed appropriate.

(b) Local Authorities Having Jurisdiction, including Fire Departments and building code officials, may enforce more stringent requirements, including alternate codes and regulations. These requirements may include but are not limited to the following.

(1) Plan review and permitting for new natural gas fueling facilities.

(2) Access to natural gas fueling facilities for the purpose of conducting inspections.

(3) Delivery into containers located at natural gas fueling facilities.

Section 2-2 Installation Permits (a) Plans for all new retail natural gas installations, including mobile refueling equipment used for motor vehicle fueling, shall be submitted to and approved by the division before construction of such installations begins.

(1) Plans for the installation of new container assembly and piping systems, including mobile refueling equipment, at existing retail natural gas fueling facilities shall be submitted to the division for approval before construction of such installation begins.

(2) Modifications to fuel stations including, but not limited to, increases in working pressure or dispensing pressures shall be subject to a complete review in accordance with that required with a new installation to include a notification of any supplying utility.

(3) Plans for change of service of existing natural gas fueling facilities from non-retail service shall be submitted to the division for approval before any such change of service occurs.

(4) It is not necessary to submit plans for the repair, replacement or upgrade of compression, drying, or other ancillary equipment.

(b) The permit procedures are as follows.

(1) The permit application shall be submitted using an application form provided by the (2) The application shall include a plot plan containing all elements required by the division.

(3) The division may deny the application if the proposed installation does not conform to division statutes, to regulations or to codes adopted by the division, or if the application is incomplete or determined to be inaccurate.

(4) Construction and installation of drying, compression, storage, piping, dispensing and all other associated equipment shall conform to the code(s) in effect at time of installation.

(5) The division may revoke a permit if construction is not performed per the approved permit or if the construction fails to meet operating or fire safety regulations established by the division or by the applicable NFPA Code.

(6) An installation permit approved by the division is automatically revoked if construction does not begin within 6 months of approval, unless a written request for an extension is submitted to and approved by the division.

Section 2-3 Access Requirements (a) The division may inspect a retail natural gas system at any time during its construction. Access shall be provided to the division or its agent for such purpose upon request.

(b) After a retail natural gas system has been installed, the division may inspect the system to verify compliance with design, construction, location, installation and operation requirements. Natural gas fueling facility owners, tank owners, and owners of locations where a natural gas system is installed shall grant inspection access to the division or its agent for such purpose upon request.

ARTICLE 3 DISPENSING AND FUEL QUALITY

Section 3-1 Retail Dispensing of Natural Gas All retail dispensing of natural gas used as a motor vehicle fuel from either fixed equipment or mobile refueling equipment, including vehicles, shall be operated and maintained in accordance with the applicable requirements of the codes adopted by this regulation.

Section 3-2 Retail Motor Fuel Dispensers Inspection and Testing (a) All retail motor fuel dispensers (RMFDs) shall be suitable for their intended use, properly installed accurate and maintained in that condition by their owner/operator.

(b) All RMFDs shall have an active National Type Evaluation Program (NTEP) Certificate of Conformance (CC) prior to installation or use for commercial purposes.

(c) All RMFDs shall be capable of displaying delivered quantity in units of mass for calibration purposes. All adjustments and calibrations of RMFDs shall be made utilizing mass measurement standards.

(d) The division shall be notified when any new, repaired or remanufactured RMFD is placed in service at a new or existing installation.

(1) Notification shall be submitted using a placed in service report provided by the division.

(e) No owner/operator of any RMFD shall use the RMFD for the measurement of natural gas unless it has been proved in a manner acceptable to the division and sealed as correct by a state inspector or registered service agency.

(1) All RMFDs shall be proved and sealed as correct on an annual basis by either a state inspector or registered service agency.

(f) Containers used for proving CNG meters shall be manufactured, inspected, marked, tested, retested, equipped and used in accordance with all provisions of NFPA 52 including the following:

(1) Containers shall be fabricated of steel, aluminum, or composite materials.

(2) The container shall be designed for CNG service.

(3) The container shall be permanently marked “CNG” by the manufacturer.

(4) Containers manufactured prior to the effective date of this code shall be permitted to be used in CNG service if recommended for CNG service by the container manufacturer or if approved by the authority having jurisdiction.

(g) Cylinders shall be manufactured in accordance with both of the following:

(1) ANSI NGV 2, Compressed Natural Gas Vehicle (NGV) Fuel Containers, specifically for CNG service (2) U.S. Federal Motor Vehicle Safety Standard, 49 CFR 571.304, Compressed Natural Gas Fuel Container Integrity (h) Cylinders that have reached the labeled expiration date shall be removed from service.

(i) Composite reinforced cylinders or other cylinders marked with exemption or special permit numbers shall be removed from service.

(j) Containers used for proving LNG meters shall be designed, fabricated, tested and marked (or stamped) in accordance with all of the provisions of NFPA 52 including the following:

(1) The Regulations of DOT Specification 4L or the “Rules for the Construction of Unfired Pressure Vessels,” ASME Boiler and Pressure Vessel Code, applicable at the date of manufacture.

(2) LNG containers that are in contact with LNG or cold LNG vapor shall be physically and chemically compatible with LNG and designed for service at –260°F (–162°C).

(3) Container appurtenances shall have a rated working pressure not less than the maximum allowable working pressure of the container.

(4) For vacuum insulation, the inner tank, outer tank, and internal lines shall be tested for vacuum leaks prior to installation on the vehicle.

(5) Heat Leak. The manufacturer shall identify the maximum operating design pressure of the container.

(6) The construction of the container shall be such that the unrelieved pressure inside the container will not exceed the maximum allowable working pressure of the container within a 72 hour period after the container has been filled to its maximum filling volume with LNG stabilized at the designed operating pressure and temperature equilibrium has been established.

(7) The ambient temperature during the 72 hour period shall be 70°F (21°C).

(k) ASME Compliance for CNG and LNG Containers (1) Pressure vessels shall be manufactured, inspected, marked, and tested in accordance with ASME Boiler and Pressure Vessel Code, Section VIII or Section X.

(2) Adherence to applicable ASME Boiler and Pressure Vessel Code case interpretations and addenda shall be considered as compliant with the ASME Boiler and Pressure Vessel Code.

(3) Pressure vessels manufactured to the requirements of the ASME Boiler and Pressure Vessel Code shall be registered with the National Board of Boiler and Pressure Vessel Inspectors.

(4) The repair or alteration of an ASME pressure vessel shall comply with the requirements of NB-23, National Board Inspection Code.

(5) Other welding or brazing shall be permitted only on saddle plates, lugs, or brackets attached to the pressure vessel by the pressure vessel manufacturer.

(6) The exchange or interchange of pressure vessel appurtenances intended for the same

purpose shall not be considered a repair or alteration.

(l) Means shall be provided at the natural gas fueling facility to return all natural gas product used for proving meters back to the compression and storage equipment or other receiving vessel when proving is completed.

(m) If unable to return product to the compression and storage equipment, and if venting of product to the atmosphere is necessary, the following requirements shall apply.

(1) The venting shall be performed only by trained personnel using an approved method of atmospheric venting and following written procedures.

(2) A valve shall be used to control the discharge of gas from the proving container.

(3) Direct gas venting shall be done through a vent tube that diverts the gas flow to the atmosphere in a safe direction at least 10 feet above grade, clear of personnel, adjacent structures and ignition sources and meeting approval of the authority having jurisdiction.

(4) Venting at ground level (grade) is not permissible.

(5) The vent tube shall have a gas-tight connection to the container prior to venting.

(6) All components of the vent tube shall be grounded.

(7) The vent tube shall be constructed of Schedule 80 pipe of at least 2 in. diameter.

(8) The vent tube shall not be provided with any feature that limits or obstructs gas flow.

(9) The venting function shall be manually controlled.

(10) Personnel performing venting shall do the following.

(A) Use grounding to prevent static electric charge buildup.

(B) Limit the rate of gas release from plastic-lined containers to a value not greater than that specified by the container manufacturer.

(C) Restrain containers during venting to prevent container movement.

(n) If any RMFD fails to comply with any of the provisions of this regulation, a state inspector shall seal it in such a manner as to prohibit its use, and it shall remain sealed until it complies with all of the provisions of this regulation.

(1) When an RMFD is brought back into compliance with this regulation, it must be placed back in service by a state inspector or registered service agency.

(o) All RMFDs shall comply with the minimum standards as prescribed by the applicable sections of the codes adopted by this regulation except as modified or rejected by this regulation or by the (p) In addition to the requirements of Section 3-2 (a) through (e), all RMFDs dispensing natural gas in terms of gallon equivalents used for motor vehicle fuel shall meet the requirements of CRS 8-20- 232.5.

(q) All measuring devices installed on mobile refueling equipment including vehicles shall meet the requirements of Section 3-2 (a) through (g), Section 3-3, and Section 3-4.

Section 3-3 Retail Dispensers for Compressed Natural Gas (CNG)

(a) For the purposes of this regulation, compressed natural gas shall be identified by the term “Compressed Natural Gas” or “CNG.” This is spelled out in the definition.

(b) All CNG kept, offered or exposed for sale and sold at retail as a vehicle fuel shall be measured in terms of mass (pounds or kilograms), and indicated in the gasoline gallon equivalent (GGE), diesel gallon equivalent (DGE) units, or mass (pounds or kilograms).

(c) Each retail dispenser of CNG shall be labeled as “Compressed Natural Gas.”

(d) All retail CNG dispensers shall be labeled with the gallon equivalent conversion factor in terms of pounds or kilograms. The label shall be permanently and conspicuously displayed on the face of the dispenser and shall have either the statement “1 CNG Gasoline Gallon Equivalent (GGE) is equal to 5.660 lbs (2.567 kg) of CNG” or “1 CNG Diesel Gallon Equivalent (DGE) is equal to 6.384 lbs (2.895 kg) of CNG” consistent with the method of sale used.

(e) CNG shall be dispensed into vehicle fuel containers with working pressures of 3,600 PSI (24,821 kPa). The dispenser shall be labeled 3,000 PSI (20,684 kPa), or 3,600 PSI (24,821 kPa) corresponding to the pressure of the CNG dispensed by each fueling hose.

(f) NFPA labeling requirements also apply. Refer to NFPA 52.

(g) CNG fueling nozzles for use with vehicles less than 10,000 lbs (4,500kg) GVWR shall comply with ANSI/AGA/CGA NGV 1.

(h) Alternate nozzles than those described in Section 3-3 (g) used for fueling larger vehicles such as buses and trucks shall be designed to prevent the connection of a lower service pressure vehicle to a higher service pressure source.

Section 3-4 Retail Dispensers for Liquefied Natural Gas (LNG)

(a) For the purposes of this regulation, liquefied natural gas shall be identified by the term “Liquefied Natural Gas” or “LNG.”

(b) All LNG kept, offered, or exposed for sale and sold at retail as a vehicle fuel shall be measured in mass (pounds or kilograms) and indicated in diesel gallon equivalent (DGE) units or mass (pounds or kilograms).

(c) Each retail dispenser of LNG shall be labeled as “Liquefied Natural Gas.”

(d) All retail LNG dispensers shall be labeled with the gallon equivalent conversion factor in terms of pounds or kilograms. The label shall be permanently and conspicuously displayed on the face of the dispenser and shall have the statement “1 LNG Diesel Gallon Equivalent (DGE) is equal to 6.059 lbs (2.748 kg) of LNG.”

(e) LNG automotive fuel shall be labeled with its automotive fuel rating in accordance with 16 CFR

Part 306 (e.g. LNG 95% Methane).

(f) NFPA Labeling requirements also apply. Refer to NFPA 52.

Section 3-5 Product Quality (a) CNG shall meet the requirements of NFPA 52 Vehicular Gaseous Fuel Systems Code, for product quality and odorization.

(b) In addition to the requirements of Section 3-5 (a), CNG and LNG shall have a minimum methane content of not less than 80%.

(c) The BTU content of natural gas gallon equivalents shall meet the following requirements:

(1) A CNG GGE shall contain a lower heating value of not less than 110,000 BTUs.

(2) A CNG DGE shall contain a lower heating value of not less than 124,000 BTUs.

(3) An LNG DGE shall contain a lower heating value of not less than 124,000 BTUs.

(d) All equipment, including filters and strainers, used to prevent any foreign material, including compressor oil or water, from being dispensed into a vehicle container, shall be periodically serviced and maintained.

(e) Any shipper of natural gas products to be used for retail motor fuel, who ships such product into the state of Colorado or ships natural gas products from one point within the state to another point within the state shall make records of such shipments available to the division upon request.

ARTICLE 4 DELIVERY INTO RETAIL NATURAL GAS SYSTEMS

Section 4-1 Delivery (a) No owner/operator of a retail natural gas fueling facility shall allow natural gas to be delivered into the following:

(1) An improperly installed container assembly or piping system installed at a natural gas fueling facility.

(2) A container installed at a natural gas fueling facility that does not have a proper ASME nameplate.

ARTICLE 5 ACCIDENT REPORTS AND INVESTIGATIONS

Section 5-1 Reportable Accidents (a) Accidents, fires, explosions, injuries, damage to property or loss of life resulting from the storage or dispensing of CNG or LNG at retail natural gas fueling facilities shall be reported to the division within 24 hours after their occurrence.

(b) Subsection (a) of this Section includes accidents resulting from the improper use or installation of compression, storage and dispensing equipment or equipment failure at retail natural gas fueling facilities.

(1) The division may investigate such occurrences and shall maintain a written record of findings, which shall be available for public examination.

Section 5-2 Reporting Requirements (a) The following persons are required to notify the division of an accident that meets any of the criteria of Section 5-1.

(1) Owner/operator or other representative of the retail natural gas fueling facility.

(b) Accidents may be reported by telephone or email using the following information:

(1) Telephone: 303-318-8547 (2) Email: cdle_oil_inspection@state.co.us (c) The accident report shall include, at minimum, the following information.

(1) The names of the owner/operator and person making the report and their telephone numbers.

(2) The date, time and location of the accident.

(3) The number of fatalities and personal injuries.

(4) All other significant facts known by the person making the report that are relevant to the cause of the accident or extent of the damages. _________________________________________________________________________ Editor’s Notes

History New rule eff. 01/31/2014.

Entire rule eff. 09/15/2018.

7 CCR 1101-17 Retail Hydrogen Fueling Regulations {#sec-7-ccr-1101-17 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-17}

DEPARTMENT OF LABOR AND EMPLOYMENT

RETAIL HYDROGEN FUELING REGULATIONS

7 CCR 1101-17 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Basis and Purpose The basis and purpose of these regulations is to set forth minimum standards for the design, construction, location, installation and operation of retail hydrogen fueling facilities, which are reasonably necessary for the protection of the health, welfare and safety of the public and persons using such materials.

Section 1-2 Technical Rationale The technical requirements of these regulations are based on generally-accepted national and international codes and standards governing the minimum levels of acceptability for inspections, specifications, shipment notification, record keeping, labeling of containers, use of meters or mechanical devices for measurement, submittal of installation plans and minimum standards for the design, construction, location, installation and operation of retail hydrogen systems.

Section 1-3 Statutory Authority These regulations are created pursuant to 8-20-102 of the Colorado Revised Statutes.

Section 1-4 Effective Date These regulations shall be effective on January 1, 2017.

Section 1-5 Codes and Standards incorporated by reference The following codes are incorporated by reference.

(a) NFPA 2, Hydrogen Technologies Code, 2016 edition.

(b) NFPA 55, Compressed Gases and Cryogenic Fluids Code, 2016 edition.

(c) NFPA 30-A, Code for Motor Fuel Dispensing Facilities & Repair Garages , 2012 edition.(d) NIST Handbook 44 Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, 2016 edition.

(e) NIST Handbook 130, Uniform Laws and Regulations in the Areas of Legal Metrology and Engine Fuel Quality, 2016 edition.

(f) SAE J 2601, Fueling Protocols for Light Duty Gaseous Hydrogen Surface Vehicles, 2014 edition.

(g) SAE J 2719, Hydrogen Fuel Quality for Fuel Cell Vehicles, 2015 edition.

Section 1-5-2 Inspection of incorporated codes Interested parties may inspect the referenced incorporated materials by contacting the Division at 633 17th Street, Suite 500, Denver, CO 80202.

Section 1-5-3 Later amendments not included These regulations do not include later amendments to or editions of the incorporated material.

Section 1-6 Definitions Terms in these regulations shall have the same meaning as those found in Title 8, Article 20 of the Colorado Revised Statutes. In addition, unless the context otherwise requires:

ASME – Means the American Society of Mechanical Engineers (ASME).

ASTM International – Formerly the American Society for Testing and Materials (ASTM).

California Type Evaluation Program (CTEP) - Means the evaluation program administered by the California Department of Food and Agriculture, Division of Measurement Standards.

Condemned – Means a condemned container assembly and piping system which is determined by a state inspector to be so unsafe that further use is prohibited until it is satisfactorily repaired or replaced.

Container Assembly – Includes ASME containers, commonly known as tanks or cylinders.

CRS – Means the Colorado Revised Statutes.

Delivery – Means delivery of hydrogen to a hydrogen fueling facility by means of truck transport or connected pipeline.

Division – Means the Division of Oil and Public Safety, which is the regulatory agency of the Colorado Department of Labor and Employment having jurisdiction over retail natural gas systems per the provisions of CRS 8-20-102 (3).

Existing Installation – Includes any hydrogen container assembly and piping system at a retail hydrogen fueling facility that has been placed into service prior to the effective date of these regulations or has received its initial inspection by a state inspector.

Hydrogen Fuel – A fuel composed of molecular hydrogen intended for use in motor vehicles.

Hydrogen Fueling Facility – Means a facility that has a hydrogen fueling system which is used for motor vehicle fueling.

Hydrogen Fueling System – Means a hydrogen storage container assembly, associated piping and dispenser(s) which is used for motor vehicle fueling.

Incident – Means a reportable accident, as defined by this regulation.

National Board – Means the National Board of Boiler and Pressure Vessel Inspectors.

National Type Evaluation Program (NTEP) - Means the evaluation program administered by the National Conference on Weights and Measures.

New Installation – Means any hydrogen container assembly, associated piping or dispenser(s) at a hydrogen fueling facility that has been placed into service after the effective date of these regulations or has not received its initial inspection by a state inspector.

NFPA – Means the National Fire Protection Association.

NIST– Means the National Institute of Standards and Technology.

Piping System – Means pipes, tubing, hose and flexible connectors with valves and fittings made into complete systems for conveying hydrogen from one point to another within a retail hydrogen fueling facility.

Proved – Means the act of having verified the accuracy of meters used to measure fuel and petroleum products using a prover.

Prover – Means a calibrated volumetric receiver or mechanical device traceable to NIST standards.

Registered Serviceperson – Means any individual who for hire, award, commission or any other payment of any kind installs, services, repairs or reconditions a commercial weighing or measuring device and who voluntarily registers with the Division.

Registered Service Agency (RSA) – Means any agency, firm, company or corporation that for hire, award, commission or any other payment of any kind installs, services, repairs or reconditions a commercial weighing or measuring device and that voluntarily registers with the Division. Under agency registration, identification of individual servicepersons shall be required.

Retail – Means the sale of hydrogen at a hydrogen fueling facility, in small or individual quantities for use as a motor fuel by the purchaser.

State Inspector – Means a person who is employed or authorized by the Division to perform inspections of retail hydrogen fueling facilities.

Section 1-7 Applicability The regulations contained herein shall apply to the installation and operation of all retail hydrogen fueling facilities.

Section 1-8 Condemning a Hydrogen Container Assembly and Piping System (a) Conditions which a state inspector may determine to be unsafe include: bypassed safety controls, inoperative relief valves, any leak from a hydrogen fueling system, missing nameplate or markings, or any other condition deemed by a state inspector to be unsafe based on codes incorporated by this regulation. A hydrogen fueling system that meets any condition described above may be condemned by a state inspector.

(b) The owner or user must shut down the condemned hydrogen fueling system as directed by a state inspector. If neither the owner nor user is available, a state inspector will take necessary means to have the system safely shut down.

(c) A state inspector will affix a notice to a condemned hydrogen fueling system stating that it has been condemned and may not be used until satisfactory repairs are made, as determined by a reinspection by a state inspector or other person authorized by the Division.

ARTICLE 2 INSTALLATION AND REGISTRATION

No person may install, or cause to be installed, a new retail hydrogen fueling facility until:

(a) An application, as described in Section 2-2 has been approved by the Division and an installation permit has been issued by the Division;

(b) The installation plan has been reported to the local Fire Department having jurisdiction; and (c) The application and inspection fee described in Section 2-2(a)(3) has been paid.

Section 2-1 General Requirements (a) All new retail hydrogen fueling facilities shall be operated and maintained in accordance with the codes incorporated by this regulation, including any retroactive requirements adopted by the Division at the time of installation.

(b) All existing retail hydrogen fueling facilities shall be operated and maintained in accordance with the edition of the incorporated codes that were in effect at the time of original construction.

(1) If after inspection the Division determines that an existing situation presents an unacceptable degree of risk, the Division shall be permitted to apply retroactively any portion of the incorporated codes as deemed appropriate.

(c) Local Authorities Having Jurisdiction, including Fire Departments and building code officials, may adopt and enforce more stringent requirements than the minimum standards in these regulations.

These requirements may include, but are not limited to, the following:

(1) Plan review and permitting for new hydrogen fueling facilities.

(2) Access to hydrogen fueling facilities for the purpose of conducting inspections.

(3) Delivery into containers located at hydrogen fueling facilities.

Section 2-2 Installation Permits (a) Plans for all new retail hydrogen fueling facilities shall be submitted to and approved by the Division before construction of such facility begins.

(1) Plans for the installation of new container assembly, associated piping or dispenser(s) at existing retail hydrogen fueling facilities shall be submitted to the Division for approval before construction of such installation begins.

(2) Plans for change of service of existing hydrogen fueling facilities from non-retail to retail service shall be submitted to the Division for approval before any such change of service occurs.

(3) For each installation plan submitted, the owner/operator must remit a fee of one thousand dollars ($1,000) to the Division to cover the costs of the site plan review and installation inspection.

(4) It is not necessary to submit plans for the repair or replacement of existing equipment at a permitted facility.

(b) The permit procedures are as follows.

(1) The permit application shall be submitted using an application form provided by the Division.

(2) The application shall include a plot plan containing all elements required by the Division.

(3) The Division may deny the permit application if the proposed installation does not conform to the requirements of the Colorado Revised Statutes, this regulation or any of the codes incorporated by reference, or if the application is determined to be incomplete or inaccurate.

(4) Construction and installation of all associated equipment shall conform to the incorporated codes in effect at the time of installation.

(5) The Division may revoke a permit if construction is not performed per the approved permit or if the construction fails to meet operating or fire safety regulations established by the Division or by the applicable incorporated codes.

(6) An installation permit approved by the Division is automatically revoked if construction does not begin within 6 months of approval unless a written request for an extension is submitted to and approved by the Division.

Section 2-3 Annual Registration (a) Each owner/operator of a retail hydrogen fueling facility must register their facility with the Division within 30 calendar days after the first day on which the facility begins storing hydrogen fuel. This registration must be made on a form provided by the Division.

(b) Each owner/operator of a retail hydrogen fueling facility shall renew their registration annually, on or before the calendar date of the initial registration.

(c) Each owner/operator of a retail hydrogen fueling facility shall pay a registration fee of $1,000 per facility per year as authorized by CRS 8-20-102.

Section 2-4 Access Requirements (a) The Division may inspect a retail hydrogen fueling facility at any time during its construction.

Access shall be provided to the Division or its agent for such purpose upon request.

(b) The Division may inspect a retail hydrogen fueling facility upon completion to verify compliance with design, construction, location, installation and operation, dispensing and fuel quality requirements in these regulations. Retail hydrogen fueling facility owners, hydrogen fueling system owners and owners of locations where a retail hydrogen fueling system is installed shall grant inspection access to the Division or its agent for such purpose upon request.

ARTICLE 3 DISPENSING AND FUEL QUALITY

Section 3-1 Retail Dispensing of Hydrogen (a) All retail dispensers of hydrogen used as a motor vehicle fuel shall be operated and maintained in accordance with the applicable requirements of the codes incorporated by this regulation.

(b) All retail dispensing of hydrogen into motor vehicles shall be in conformance with SAE J2601, “Fueling Protocols for Light Duty Gaseous Hydrogen Surface Vehicles.”

Section 3-2 Retail Motor Fuel Dispensers Inspection and Testing (a) All retail motor fuel dispensers (RMFDs) shall be suitable for their intended use, properly installed, accurate and maintained in that condition by their owner/operator.

(b) All RMFDs shall have an active certificate of conformance (CC) from either the National Type Evaluation Program (NTEP) or the California Type Evaluation Program (CTEP) prior to installation or use for commercial purposes.

(c) All RMFDs shall be capable of displaying delivered quantity in units of mass and all adjustments and calibrations of RMFDs shall be made utilizing mass measurement standards.

(d) The Division shall be notified when any new or remanufactured RMFD is placed in service at a new or existing installation.

(1) Notification shall be submitted using a placed in service report provided by the Division.

(e) No owner/operator of any RMFD shall use the RMFD for the measurement of hydrogen unless it has been proved in a manner acceptable to the Division and sealed as correct by a state inspector or registered service agency (RSA).

(1) All RMFDs shall be proved and sealed as correct on an annual basis by either a state inspector or RSA.

(f) Means shall be provided at the hydrogen fueling facility to return all hydrogen product used for proving meters back to the storage equipment or the facility’s hydrogen vent system when proving is completed.

(g) If any RMFD fails to comply with any of the provisions of this regulation, a state inspector shall seal it in such a manner as to prohibit its use and it shall remain sealed until it complies with all of the provisions of this regulation.

(1) When an RMFD is brought back into compliance with this regulation, it must be placed back in service by a state inspector or RSA.

(h) All RMFDs shall comply with the minimum standards as prescribed by the applicable sections of the codes incorporated by this regulation except as modified or rejected by this regulation or by the Division.

Section 3-3 Retail Motor Fuel Dispensers for Hydrogen (a) The symbol for hydrogen vehicle fuel shall be the capital letter “H” (the word “Hydrogen” may also be used).

(b) Each RMFD of hydrogen shall be labeled with the product identity shown in a conspicuous location on the dispenser, using the symbol for hydrogen vehicle fuel (the capital letter “H” or the word “Hydrogen”).

(c) Hydrogen shall be labeled in accordance with 16 CFR 309, “FTC Labeling Alternative Fuels.”

(d) NFPA labeling requirements also apply; refer to NFPA 2.

(e) All Hydrogen kept, offered or available for sale or sold at retail as a vehicle fuel shall be in units of mass (kilograms).

(f) A computing dispenser must display the unit price in whole cents on the basis of price per kilogram (e.g., $3.49 per kg, not $3.499 per kg).

(g) The service pressure(s) of the dispenser must be conspicuously shown on the user interface bar or the SI unit of pascal (Pa) (e.g., MPa).

Section 3-4 Street Sign Prices and Advertisements (a) The unit price must be in terms of price per kilogram in whole cents (e.g., $3.49 per kg, not $3.499 per kg).

(b) The sign or advertisement must include the service pressure (expressed in megapascals) at which the dispenser(s) delivers hydrogen fuel (e.g., H35 or H70).

Section 3-5 Product Quality (a) Hydrogen Fuel shall meet the latest version of SAE J2719, “Hydrogen Fuel Quality for Fuel Cell Vehicles.”

(b) All equipment, including filters and strainers, used to prevent any foreign material, including compressor oil or water, from being dispensed into a motor vehicle shall be periodically serviced and maintained.

(c) Any shipper of hydrogen fuel products to be used for retail motor fuel who ships such product into the state of Colorado or ships hydrogen fuel products from one point within the state to another point within the state shall make records of such shipments available to the Division upon request.

ARTICLE 4 DELIVERY INTO RETAIL HYDROGEN SYSTEMS

No owner/operator of a retail hydrogen fueling facility shall allow hydrogen to be delivered into the following:

(a) An improperly-installed container assembly or piping system installed at a hydrogen fueling facility.

(b) A container installed at a hydrogen fueling facility that does not have a proper ASME nameplate.

ARTICLE 5 ACCIDENT REPORTS AND INVESTIGATIONS

Section 5-1 Reportable Accidents (a) Accidents, fires, explosions, injuries, damage to property or loss of life resulting from the storage or dispensing of hydrogen at retail hydrogen fueling facilities shall be reported to the Division within 24 hours after their occurrence.

(b) Subsection (a) of this Section includes accidents resulting from the improper use or installation of compression, storage and dispensing equipment or equipment failure at retail hydrogen fueling facilities.

(1) The Division may investigate such occurrences and shall maintain a written record of findings, which shall be available for public examination.

Section 5-2 Reporting Requirements (a) The owner/operator or other representative of the retail hydrogen fueling facility is required to notify the Division of an accident that meets any of the criteria of Section 5-1.

(b) Accidents may be reported by telephone (303-318-8547), or email (cdle_oil_inspection@state.co.us).

(c) The accident report shall include, at minimum, the following information:

(1) The names of the owner/operator and person making the report and their telephone numbers.

(2) The date, time and location of the accident.

(3) The number of fatalities and personal injuries.

(4) All other significant facts known by the person making the report that are relevant to the cause of the accident or extent of the damages. _________________________________________________________________________ Editor’s Notes

History Entire rule eff. 01/01/2017.

7 CCR 1101-18 Underground Damage Prevention Safety Commission Regulations {#sec-7-ccr-1101-18 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-18}

DEPARTMENT OF LABOR AND EMPLOYMENT

UNDERGROUND DAMAGE PREVENTION SAFETY COMMISSION REGULATIONS

7 CCR 1101-18 [Editor’s Notes follow the text of the rules at the end of this CCR Document] _________________________________________________________________________

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Statement of Basis and Purpose These regulations are promulgated to establish rules for the Underground Damage Prevention Safety Commission (Safety Commission) responsibilities within the Excavation Requirements Act §§ 9-1.5-101, et. seq., C.R.S. (the Act). The purpose of the Safety Commission is to prevent injury to persons and damage to property when excavation is occurring.

Section 1-2 Statutory Authority These regulations have been created pursuant to Section 104.2 (2)(d) and 104.2(6)(a) of the Act.

Section 1-3 Effective Date These regulations shall be effective on January 1, 2025.

Section 1-4 Definitions Terms in these regulations shall have the same definitions as those found in the Act or as defined below.

DAMAGE. Includes the penetration or destruction of any protective coating, housing, or other protective device of an underground facility, the denting or partial or complete severance of an underground facility, or the rendering of any underground facility inaccessible.

EMERGENCY SITUATIONS. Includes ruptures and leakage of pipelines, explosions, fires, and similar instances where immediate action is necessary to prevent loss of life or significant damage to property, including, without limitation, underground facilities, and advance notice of proposed excavation is impracticable under the circumstances.

EXCAVATION. Any operation in which earth is moved or removed by means of any tools, equipment, or explosives and includes augering, backfilling, boring, ditching, drilling, dredging or other underwater earth moving, grading, plowing-in, pulling-in, ripping, scraping, trenching, hydro excavating, postholing, and tunneling. “Excavation” does not include:

(1) Routine maintenance on existing planted landscapes; or (2) An excavation by a rancher or a Farmer, as defined in Section 42-20-108.5, C.R.S., occurring on a ranch or farm when the excavation involves:

(a) Any form of existing agricultural activity that is routine for that ranch or farm;

(b) Land clearing if the activity does not involve deep ripping or deep root removal of trees or shrubs; or (c) Routine maintenance of:

(i) An existing irrigation facility if the facility has been subjected to maintenance in the previous 24 months; or (ii) Existing fence lines.

FARMER. A person or such person's agent or contractor engaged in the production or raising of crops, poultry, or livestock.

FRIVOLOUS COMPLAINT. A complaint filed with the Safety Commission that is without merit and is determined by the Review Committee that it was filed to cause or that resulted in inconvenience, harassment or expense.

GRAVITY-FED SYSTEM. Any underground facility that is not pressurized and that utilizes gravity as the only means to transport its contents. These systems include sanitary sewer lines, storm sewer lines, and open-air irrigation ditches.

HOME RULE ENTITY. A home rule county, city and county, municipality, or power authority that establishes its own damage prevention safety program that is similar to the Safety Commission.

LICENSED PROFESSIONAL ENGINEER. A professional engineer as defined in Section 12-120-202 (7), C.R.S.

NOTIFICATION ASSOCIATION. The statewide notification association of owners and operators of underground facilities created in Section 9-1.5-105, C.R.S., also known as Colorado 811 and the Utility Notification Center of Colorado.

OPERATOR or OWNER. Any person, including public utilities, municipal corporations, political subdivisions, or other persons having the right to bury underground facilities in or near a public road, street, alley, right-of-way, or utility easement. Operator or owner in these regulations does not include any railroad.

PERSON. Any individual acting on his or her own behalf, sole proprietor, partnership, association, corporation, or joint venture; the state, any political subdivision of the state, or any instrumentality or agency of either; or the legal representative of any of them.

RESPONSE REQUIRED BY DATE. A date, denoted in writing, by which both parties are expected to respond as to how they plan to participate in a hearing.

REVIEW COMMITTEE. A group of 3-5 members of the Underground Damage Prevention Safety Commission appointed to review a complaint of an alleged violation of the Act.

ROUTINE MAINTENANCE. A regular activity that happens at least once per year on an existing planted landscape if earth is not disturbed at a depth of more than twelve inches by nonmechanical means or four inches by mechanical means and if the activities are not intended to permanently lessen the ground cover or lower the existing ground contours. Mechanical equipment used for routine maintenance tasks includes aerators, hand-held rototillers, soil injection needles, lawn edgers, overseeders, and hand tools.

SAFETY COMMISSION. Also known as the “Underground Damage Prevention Safety Commission.” The enforcement authority as established by statute.

SUBSURFACE UTILITY ENGINEERING NOTIFICATION. A notice to the notification association that a project is being designed by a licensed professional engineer and that the project will include the investigation and depiction of existing underground facilities that meet or exceed the ASCE 38 standard.

SUBSURFACE UTILITY ENGINEERING-REQUIRED PROJECT. A project that meets all of the following conditions:

(1) The project involves a construction contract with a public entity, as that term is defined in

Section 24-91-102, C.R.S.;

(2) The project involves primarily horizontal construction and does not involve primarily the construction of buildings;

(3) The project:

(a) Has an anticipated excavation footprint that exceeds two feet in depth, not including rotomilling, and is a contiguous one thousand square feet, not including fencing and signing projects; or (b) Involves utility boring.

(4) The project requires the design services of a licensed professional engineer.

UNDERGROUND FACILITY. Any item of personal property which is buried or placed below ground for use in connection with the storage or conveyance of water or sewage, electronic, telephonic, or telegraphic communications or cable television, electric energy, or oil, gas, or other substances.

An item of personal property, as used in this definition, includes, but is not limited to, pipes, sewers, conduits, cables, valves, lines, wires, manholes, and attachments thereto.

VIOLATION. A determination by the Safety Commission that a violation of the Act has occurred.

VIOLATION,MAJOR. A major violation includes, but is not limited to, a violation that the Review Committee finds to be in blatant disregard of the best practices and the potential for injury to the public or property is highly probable.

VIOLATION, MINOR. A minor violation includes, but is not limited to, a violation that the Review Committee finds to be valid and the potential for injury to the public or property is not a factor. The act of filing a Frivolous Complaint (as defined) is also categorized as a minor violation.

VIOLATION, MODERATE. A moderate violation includes, but is not limited to, a violation that the Review Committee finds to be outside best practices and the potential for injury to the public or property is foreseeable.

Section 1-5 Scope These regulations apply to requirements defined in Sections 104.2, 104.4, 104.7 and 104.8 of the Act, although they may refer to other Sections of the Act.

Section 1-6 Codes and Standards The following codes, documents or standards are incorporated by reference and may be purchased from the mailing addresses or websites listed with the title of each Institute or Association:

(1) American Society of Civil Engineers (ASCE), 1801 Alexander Bell Drive, Reston, VA 20191; https://ascelibrary.org/ (a) Standard Guideline for Investigating and Documenting Existing Utilities (ASCE 38-22)

Interested parties may inspect the referenced incorporated materials by contacting the Division of Oil and Public Safety at 633 17th Street, Suite 500, Denver, Colorado, 80202.

This rule does not include later amendments to or editions of the incorporated material.

Section 1-7 Safety Commission The Safety Commission will conduct itself according to its adopted Bylaws and Code of Conduct, and these regulations.

ARTICLE 2 ENFORCEMENT OF VIOLATIONS

Section 2-1 Enforcement Process The Safety Commission provides these regulations to denote its process for reviewing complaints and conducting hearings. When a person is found to be in violation of the Act and/or these regulations, the Safety Commission will pursue penalties or remedial actions against the person.

Section 2-2 Complaints (1) The Safety Commission may review complaints from any person of alleged violations of the Act.

(a) A person who brings a frivolous complaint, as determined by the Safety Commission, commits a minor violation and is subject to a fine.

(b) The person filing the complaint may voluntarily withdraw the complaint prior to a hearing.

(2) The review of a complaint shall be completed by a Review Committee. The Review Committee shall:

(a) Be comprised of three to five members of the Safety Commission.

(b) Have an equal number of members representing excavators and owners/operators.

(c) Include at least one member who does not represent either excavators or owners/operators.

(3) The complaint process shall include:

(a) A complaint form, and, if applicable, a damage form, being completed and submitted to the Safety Commission.

(i) The Safety Commission, and administrative support staff, reserve the right to not formally receive or process incomplete forms. The person filing the complaint will be advised in writing of the required missing information.

(ii) The timeline for scheduling a complaint hearing will not begin until the complaint form has been completed.

(iii) Both the person filing the complaint and the alleged violator will be sent complaint received letters, a copy of the complaint form, and, if applicable, a copy of the damage form to advise them that the Safety Commission has formally received and begun processing the complaint. Both parties shall also receive copies of supporting documentation, as available.

(b) Within 90 days of the completed complaint form, and, if applicable, a damage form, being formally received, a hearing will be scheduled.

(i) Both the person filing the complaint and the alleged violator will be sent hearing notification letters to advise them of the logistics for the hearing.

(ii) The scheduled hearing date may be modified by mutual agreement of all parties and rescheduled when the Review Committee is available. Postponement requests are possible until the Response Required By Date. Requests made after the Response Required By Date may be denied. Both parties also have the option of submitting written statements as an alternative to postponement. Only one postponement request may be made by each party per complaint.

(c) If applicable, the Safety Commission will file a Data Request Form with Colorado 811 to gain ticket information.

(i) Data may not be available if the information requested is more than three years old.

Section 2-3 Hearing (1) Hearings shall be conducted in the following manner, unless otherwise directed by the Review Committee:

(a) Presentation of positions - every party to the proceeding shall have the right to present its case by oral and documentary evidence.

(i) Remote attendance is available for involved parties as determined by the Safety Commission. If you wish to attend the hearing in person because you need a reasonable accommodation or do not have access to a phone or computer to participate remotely, this request shall be submitted to the Safety Commission by the Response Required By Date.

(ii) Written statements (denoted as such), submitted in advance of the hearing and separately from complaint forms and other supporting documentation, may be submitted in lieu of, or in addition to, attending and participating in the hearing orally.

(iii) With prior notice to the Safety Commission, parties may utilize alternative representatives to attend the hearing.

(b) Parties wanting to have supporting documentation considered shall provide either one copy or one digital copy of said supporting documentation to the Review Committee. The preferred timeline for delivery is at least one business day before the hearing.

(i) The exhibits that are presented during the hearing are the only ones included in the record.

(ii) Supporting documents submitted by the person filing the complaint shall be labeled, and referred to during the hearing, by number.

(iii) Supporting documents submitted by the person alleged to be in violation shall be labeled, and referred to during the hearing, by letter.

(c) The Review Committee shall utilize the complaint and damage forms (as applicable), presentations, the response to the Colorado 811 Data Request Form, and committee members’ experience in the field in its discussion and finding of facts.

(d) Any member of the Review Committee may ask questions of any person involved in the hearing.

(2) Hearings shall be conducted in the following order, unless otherwise directed by the Review Committee:

(a) Complaint is called.

(i) Introduction of Review Committee members and explanation of the proceedings.

(ii) Determination of whether any Review Committee members have a conflict of interest; this can be determined prior to the formation of a Review Committee, and will be reviewed at the start of the hearing.

(b) Presentation of position and submittal of documentation or other materials by the person filing the complaint.

(c) Presentation of position and submittal of documentation or other material by the person alleged to be in violation, in the complaint.

(d) Rebuttal by the person filing the complaint.

(e) Questions from the Review Committee to both parties.

(f) Discussion by the Review Committee on the findings of fact and recommendations for remedial action (if applicable).

(3) Maximum time allowed for hearings shall be the following, unless otherwise directed by the Review Committee:

(a) Each party shall have 20 minutes to present its case.

(i) The Review Committee may allow additional time for presentations.

(ii) If the Review Committee grants additional time to one person, the same amount of additional time will be offered to the other person.

(b) The person filing the complaint shall have five minutes for rebuttal.

(c) The alleged violator shall have two minutes for rebuttal to any new information that the person filing the complaint stated in their rebuttal.

(d) The Review Committee shall take as much time as is necessary to ask questions and discuss the complaint.

(4) Burden of Proof (a) The person filing the complaint has the burden to prove by a preponderance of the evidence that the alleged violator committed a violation.

(5) Dismissed Complaints (a) The Safety Commission may dismiss a complaint in the event of the person filing the complaint not responding by the Response Required By Date.

(6) Application of Technical Knowledge (a) The Review Committee may utilize its experience, technical competence, and specialized knowledge in the evaluation of the evidence presented to it.

(b) The Review Committee may take notice of general, technical, or scientific facts within its knowledge, but only if the facts so noticed are specified in the record or are brought to the attention of the persons involved in the complaint before the final determination and both the person filing the complaint and the person alleged to be in violation are afforded an opportunity to controvert the facts so noticed.

(7) Representation by Counsel (a) Any person permitted or compelled to testify or to submit data or evidence shall be entitled to the benefit of legal counsel of his or her own choosing and at his or her own expense, but a person may appear for his or her self.

(b) An attorney who is a witness may not act as counsel for the person involved in the hearing.

Section 2-4 Final Determination (1) Review Committee’s Finding of Facts:

(a) After due consideration of written and oral statements, and accompanying documentation, the Review Committee shall determine whether a violation of the law has occurred and, if appropriate, recommend remedial action, or make such determination of the matter as it shall deem appropriate consistent with the Act.

(b) Within seven business days after the completion of the hearing, the Review Committee shall provide to the Safety Commission a report of its findings and recommendations.

(2) Safety Commission’s Final Determination:

(a) The Safety Commission shall review the Review Committee’s signed findings and recommendations at its next scheduled meeting.

(i) The Safety Commission is bound by the Review Committee’s findings of fact and determination.

(ii) The Safety Commission may adjust the Review Committee’s recommendation of remedial action or penalty if an adjustment is supported by at least 12 members of the Safety Commission.

(b) Within 10 business days after the Safety Commission’s meeting to review the Review Committee’s findings and recommendations, the Safety Commission shall provide both parties involved in the complaint a summary of the Review Committee’s findings and the Safety Commission’s final determination with respect to any required remedial action or penalty.

(c) The determination of the Safety Commission is a final agency action subject to review by the District Court pursuant to Section 24-4-106, C.R.S.

Section 2-5 Remedial Actions (1) A recommendation of remedial action that includes a fine requires a unanimous vote of the Review Committee.

(2) The Review Committee shall not recommend remedial action or a fine against a homeowner, rancher or Farmer (as defined), unless the Review Committee finds by clear and convincing evidence that a violation of the law has occurred.

(3) The Safety Commission may consider training, support services or other remediation measures that will improve the behavior of the person found in violation.

(4) Guidance for the recommendation of remedial action shall be consistent with the following principles:

(a) Whether the alleged violation is classified as a Minor, Moderate or Major violation (as defined).

(b) For a person who has not had a violation in the previous 12 months, the Safety Commission may consider alternatives to fines.

(c) The number of violations, relative to the number of notifications received, are a part of the consideration.

(d) The maximum fines are set forth in Table 2-5.

Table 2-5: Potential Enforcement Penalties Type of Violation Number of Violations within the previous 12 months 1 2 3 4 Minor $250 $500 $1,000 $5,000 Moderate $1,000 $2,500 $5,000 $25,000 Major $5,000 $25,000 $50,000 $75,000

ARTICLE 3 BEST PRACTICES & STANDARDS

(1) The Safety Commission shall advise the Notification Association and other state agencies, the general assembly, and the local government on:

(a) Best practices and training to prevent damage to underground utilities.

(b) Policies to enhance public safety, including the establishment and periodic updating of industry best practices and technology advancements.

(c) Policies and best practices to improve efficiency and cost savings to the Colorado 811 program, including the review, establishment, and periodic updating of industry standards, to ensure the highest level of productivity and service for the benefit of both excavators and owners and operators.

(2) The Safety Commission shall establish standards for underground facility marking.

(a) Operators or owners of underground facilities shall mark facilities in a manner that meets the marking standards established by the Safety Commission.

(b) The marking documentation that operators or owners provide to excavators through the notification association must meet or exceed the standards established by the Safety Commission.

(c) The marking standards set forth by the Safety Commission are enforceable and may be the basis of a violation determined during a complaint hearing.

ARTICLE 4 FUNDS

(1) Damage Prevention Fund (a) All fines collected as described in Section 2-5 shall be deposited into the Damage Prevention Fund.

(b) The Safety Commission may use the money deposited in the Damage Prevention Fund to:

(i) Develop and disseminate educational programming designed to improve worker and public safety relating to excavation and underground facilities;

(ii) Provide grants to persons who have developed educational programming that the notification association and the Safety Commission deem appropriate for improving worker and public safety relating to excavation and underground facilities.

(2) Safety Commission Fund (a) The Safety Commission shall use money deposited in the Safety Commission Fund to pay for its expenses in administering the Act.

ARTICLE 5 HOME RULE ENTITIES

(1) This enforcement process shall not apply to a home rule county, city and county, municipality, or power authority established pursuant to Section 29-1-204 (1), C.R.S.; except that if the Safety Commission identifies an alleged violation by the Home Rule Entity, the Safety Commission shall:

(a) Inform the Home Rule Entity of the alleged violation.

(b) If requested by the Home Rule Entity, suggest corrective action.

(2) Every home rule entity described in Subsection (1) shall:

(a) Adopt by resolution, ordinance, or other official action either:

(i) Its own damage prevention safety program similar to that established pursuant to the Act; or (ii) A waiver that delegates its damage prevention safety program to the Safety Commission.

(b) Notify the Safety Commission of the decision in Subsection (a). _________________________________________________________________________ Editor’s Notes

History New rule emer. rule eff. 02/14/2019.

Entire rule eff. 06/14/2019.

Entire rule eff. 01/01/2025.

7 CCR 1101-19 Retail Electric Vehicle Charger Regulations {#sec-7-ccr-1101-19 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-19}

Colorado Department of Labor and Employment RETAIL ELECTRIC VEHICLE CHARGER REGULATIONS 7 CCR 1101-19 [Editor’s Notes follow the text of the rules at the end of this CCR Document.]

ARTICLE 1 GENERAL PROVISIONS

Section 1-1 Basis and Purpose The basis and purpose of these regulations is to set forth minimum standards relating to specifications and tolerances for retail electric vehicle charging equipment and methods of retail sale at publicly accessible electric vehicle charging stations to promote consistency in the marketplace.

Section 1-2 Technical Rationale The technical requirements of these regulations are based on generally accepted national and international codes and standards governing the minimum levels of acceptability for inspections, specifications, record keeping, use of meters for measurement, and minimum standards for the design and operation of retail electric vehicle charging systems.

Section 1-3 Statutory Authority These regulations are created pursuant to 8-20-102 and 8-20-107 of the Colorado Revised Statutes.

Section 1-4 Effective Date These regulations shall be effective on July 1, 2026.

Section 1-5 Definitions Terms in these regulations shall have the same meaning as those found in Title 8,

Article 20 of the Colorado Revised Statutes. In addition, unless the context otherwise requires:

Alternating Current (AC) – An electric current that reverses direction in a circuit at regular intervals.

California Type Evaluation Program (CTEP) – The evaluation program administered by the California Department of Food and Agriculture, Division of Measurement Standards.

Colorado Revised Statutes (CRS) – The official statutes of the State of Colorado, compiled by the Office of Legislative Legal Services.

Digital Network – An online-enabled application, website, or system offered or used by EVSE that allows a user to initiate a commercial transaction to dispense electrical energy from electric vehicle supply equipment to an electric vehicle.

Direct Current (DC) – An electric current that flows in one direction.

Direct Current Fast Charger (DCFC) – An EVSE capable of supplying direct current (DC) electricity to a vehicle fitted with the appropriate connection to support refueling the vehicle’s energy storage battery.

Director – The Director of the Division of Oil and Public Safety of the Colorado Department of Labor and Employment or any designees thereof which may include certain employees of the Division of Oil and Public Safety of the Colorado Department of Labor and Employment or other persons.

Division – The Division of Oil and Public Safety, which is the regulatory agency of the Colorado Department of Labor and Employment, having jurisdiction over retail electric vehicle charging per the provisions of CRS 8-20-102 (5).

Electric Vehicle Supply Equipment (EVSE) – Equipment for plug-in charging, including the ungrounded, grounded, and equipment grounding conductors, and the electric vehicle connectors, attachment plugs, personnel protection system, and all other fittings, devices, power outlets, or apparatus installed specifically for the purpose of transferring energy between the premises wiring and the electric vehicle.

Electricity as Vehicle Fuel – Electrical energy transferred to and/or stored onboard an electric vehicle primarily for the purpose of propulsion.

Kilowatt (kW) – A unit of power equal to 1,000 watts (W).

Kilowatt-hour (kWh) – A unit of energy equal to 1,000 watthours (Wh).

Level 1 EVSE – An EVSE capable of supplying 120 volt alternating current (AC), single phase electricity to a vehicle fitted with an on-board charger that can accept and convert that AC electricity into DC electricity to refuel the vehicle’s energy storage battery.

Level 2 EVSE – An EVSE capable of supplying 208 to 240 volt alternating current (AC), single phase electricity to a vehicle fitted with an on-board charger that can accept and convert that AC electricity into DC electricity to refuel the vehicle’s energy storage battery.

Manufacturer’s Certificate of Accuracy – Documentation of a metrological accuracy test of the device conducted for the device manufacturer by an RSA in accordance with the testing requirements outlined in NIST HB44 and these regulations.

National Type Evaluation Program (NTEP) – Means the evaluation program administered by the National Conference on Weights and Measures.

NFPA – The National Fire Protection Association.

NIST – The National Institute of Standards and Technology.

NCWM – The National Council on Weights & Measures.

Placed into Service – The official authorization for a weighing, measuring, or counting device to be used for commercial purposes, carried out by a representative of the Division or a Registered Service Agency.

Proved – The act of having verified the accuracy of meters used to measure electricity as a vehicle fuel using a prover.

Publicly Accessible EVSE – An EVSE and associated parking space or spaces designated by a property owner or lessee to be available to, and accessible by, the public for any period of time.

Registered Serviceperson – Any individual who is authorized by the Director to prove and seal as correct a commercial weighing or measuring device on behalf of a Registered Service Agency and who voluntarily registers with the Division.

Registered Service Agency (RSA) – Any agency, firm, company or corporation that is authorized by the Director to prove and seal a commercial weighing or measuring device as correct, and that voluntarily registers with the Division.

Under agency registration, identification of individual servicepersons shall be required.

Retail Electric Vehicle Charging – A publicly accessible electric vehicle charging station where a retail consumer’s financial charge for service is based wholly or partially on the quantity of electricity dispensed in vehicle fuel applications.

State Inspector – A person who is employed or authorized by the Division to perform inspections of retail electric vehicle charger facilities.

Watt (W) – The practical unit of electric power. In an alternating-current (AC) circuit, the power in watts is volts times amperes multiplied by the circuit power factor.

Watthour (Wh) – The practical unit of electric energy that is expended in one hour when the average power consumed during the hour is one watt.

Section 1-6 Codes, Documents, or Standards Incorporated by Reference The following codes are incorporated by reference.

(a) NIST Handbook 44 Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, 2025 edition. Copies of these documents from the NIST are available at the NIST’s website, www.nist.gov, 100 Bureau Drive, Gaithersburg, MD 20899.

(b) NIST Handbook 130, Uniform Laws and Regulations in the Areas of Legal Metrology and Engine Fuel Quality, 2025 edition. Copies of these documents from the NIST are available at the NIST’s website, www.nist.gov, 100 Bureau Drive, Gaithersburg, MD 20899.

Section 1-7 Inspection of Incorporated Codes Interested parties may inspect the referenced incorporated materials by contacting the Division of Oil and Public Safety at 707 17th Street, Suite 2400, Denver, Colorado 80202.

Section 1-8 Later Amendments not Included This rule does not include later amendments to or editions of the incorporated material.

Section 1-9 Applicability The regulations contained herein shall apply to the operation of all retail electric vehicle chargers in Colorado, except the following:

(a) Those that are owned, maintained, or used by a public utility as described in

Section 40-1-103 of the Colorado Revised Statutes, (b) Those used solely for dispensing electrical energy in connection with operations in which the amount dispensed does not affect customer charges or compensation, such as free workplace or fleet charging, free charging at multifamily units, or where free charging is offered as an amenity, (c) Those associated with the wholesale delivery of electricity, and (d) Those associated with charging vehicles at private residences, where a retail transaction does not take place.

ARTICLE 2 EVSE INSTALLATION AND REGISTRATION

Installation of retail EVSE must comply with requirements from local authorities having jurisdiction, including fire departments and building code officials. Some of these entities adopt NFPA 70E, National Electric Code, or the International Fire Code (IFC), both of which include good safety standards for EVSE installations.

Section 2-1 Registration (a) For all retail EVSE placed into service after July 1, 2026, each owner/operator of retail EVSE must register their equipment with the Division within 30 calendar days after the first day on which the EVSE is placed into service, using a form (1) For retail EVSE placed into service prior to July 1, 2026, each owner/operator must register their equipment with the Division by January 1, 2027, using a form provided by the Division.

(b) This registration must include the following information:

(1) Owner/Operator contact information including company name and primary contact details;

(2) EVSE location information including facility name, address, geographic coordinates, and facility type; and (3) EVSE information including manufacturer, model number, and serial number; installation date(s); the name of the digital network utilized for the transaction; EVSE type (Level 2 or DCFC); nominal voltage, current supported (amps), and power supported (kilowatts); and number of ports and connection types (e.g., SAE J1772, J1772 Combo, CHAdeMO).

(c) Retail EVSE owners/operators must notify the Division within 30 days of having removed or otherwise taken their retail EVSE out of service, using a form

Section 2-2 Registered Service Agency and Registered Serviceperson Requirements (a) Registered Service Agencies (RSAs) must register their company with a form (b) The metrological test equipment utilized by the RSA to conduct retail EVSE testing must be certified in accordance with the manufacturer’s recommendation or every two years by a third party, and the RSA must provide the Division with a traceable certificate of conformance (CC).

(c) To become a Registered Serviceperson, applicants must complete either the NCWM RSA: Electric Vehicle Fueling System exam or other training equivalent approved by the Division, submit a certificate of completion and register via a form provided by the Division.

ARTICLE 3 RETAIL EVSE STANDARDS

The method of sale and measurement of electricity for retail electric vehicle charging are regulated by the Director to ensure consumer protection and equity in the marketplace. This article lists the minimum specifications and tolerances for EVSE to ensure compliance with Colorado statutes and adopted codes and standards. Further description of these requirements can be found in guidance documents, policies and procedures provided by the Director.

Section 3-1 Retail EVSE Design and Operation Requirements (a) All retail EVSE shall be operated and maintained in accordance with the applicable requirements of the codes incorporated by this regulation.

(1) Retail DCFC EVSE are deferred from NIST HB 44 requirements on Accuracy Testing, Load Test Tolerances, and Indication of Delivery until January 1, 2028.

(b) Any retail EVSE installed after July 1, 2026, shall have an active certificate of conformance (CC) from the National Type Evaluation Program (NTEP) prior to installation or use for commercial purposes.

(1) By July 1, 2030, retail EVSE installed prior to July 1, 2026, shall have an active certificate of conformance (CC) from either the National Type Evaluation Program (NTEP) or the California Type Evaluation Program (CTEP), or be approved by the Director. Failure to do so shall result in the EVSE being taken out of service.

(c) All retail EVSE installed after July 1, 2026, shall be legibly and permanently labeled, in a manner that is visible to inspectors and consumers, with information about voltage, whether the voltage is alternating current (AC) or direct current (DC), amperage, the EVSE serial number, and the NTEP CC number. In addition, the name and contact information for the owner or operator of the EVSE must be displayed.

(1) Retail EVSE placed into service prior to July 1, 2026, shall meet these labeling requirements, with the exception of the NTEP CC number, by July 1, 2027, or shall be taken out of service.

(d) All retail EVSE placed into service after July 1, 2026, shall provide information at the point of sale including electrical energy, parking and/or usage fees, the unit price per kilowatt-hour, and the total price of each transaction.

(1) EVSE capable of applying multiple unit prices over the course of a single transaction shall also be capable of indicating the start and stop time, the total quantity of energy delivered, the unit price, and the total price for the quantity of energy delivered during each discrete phase corresponding to one of the multiple unit prices.

(2) EVSE capable of applying additional fees for time-based and other services shall also be capable of indicating the total time measured; the unit price(s) for the additional time-based service(s); the total computed price(s) for the time measured; and the total transaction price, including the total price for the energy and all additional fees.

(3) Retail EVSE placed into service prior to July 1, 2026, shall meet these requirements by July 1, 2030, or shall be taken out of service.

Section 3-2 Retail EVSE Inspection, Testing, and Enforcement (a) For any new or remanufactured retail EVSE installed at a new or existing location after July 1, 2026, or upon replacement of the metrological meter on any device installed prior to July 1, 2026, the owner/operator shall submit a placed in service form provided by the Division and completed by an RSA within 90 days of placing the EVSE into service.

(1) An owner/operator of a new EVSE that has a manufacturer's certificate of accuracy including the device serial number, and that is traceable and completed by an RSA, may submit that document as proof of metrological accuracy testing. The remaining tests and observations required by the Division’s placed in service form must be completed by an RSA as part of placing the device into service.

(b) For any retail EVSE installed prior to July 1, 2026, the owner/operator shall submit a placed in service form provided by the Division and completed by an RSA before July 1, 2030.

(1) An owner/operator of any retail EVSE installed prior to July 1, 2026, that has a traceable manufacturer's certificate of accuracy including the device serial number, that was issued within five (5) years prior to the date of EVSE registration with the Division, may submit that document as proof of metrological accuracy testing. The remaining tests and observations required by the Division’s placed in service form must be completed by an RSA at the installation location.

(c) The Division may inspect a retail EVSE facility upon or following being placed into service to verify compliance with the requirements in these regulations.

Retail EVSE owners shall grant inspection access to the Division or its agent for such purpose upon request.

(d) All retail EVSE shall be proved and sealed as correct at least once every five (5) years from the initial placed in service date described in 3-2(a) and (b) by an RSA.

(e) After July 1, 2027, if any retail EVSE fails to comply with any of the provisions of this regulation, a state inspector may seal it in such a manner as to prohibit its use. At that time, OPS will notify the owner/operator of the requirements to achieve compliance. It shall remain sealed until it complies with all of the provisions of this regulation.

(1) When retail EVSE is brought back into compliance with this regulation, it must be placed back in service by an RSA.

(f) All retail EVSE shall comply with the minimum standards as prescribed by the applicable sections of the codes incorporated by this regulation except as modified or rejected by this regulation or by the Division.

(g) Any retail EVSE that has had any component replacement, software change, or adjustment that could affect the accuracy of deliveries must be brought back into service by an RSA.

Section 3-3 Advertisements and Street Sign Prices (Where in Use)

(a) If street signs are used to advertise price, the unit price must be in terms of price per kilowatt-hour in whole cents (e.g., $0.35 per kWh, not $0.359 per kWh), and it must match the accurately rounded unit price indicated by the EVSE.

Editor’s Notes

History New rule eff. 07/01/2026.

1101 Division of Workers' Compensation

7 CCR 1101-3 Rule 16 Utilization Standards {#sec-7-ccr-1101-3 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3}

Department of Labor and Employment WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES 7 CCR 1101-3 [Editor’s Notes follow the text of the rules at the end of this CCR Document.]

Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page.

To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 17, Exhibit 1.

History

Rule 2-5; Rule 17-5; Rule 17-Exhibit 1; Rule 17-Exhibit 5.F.5.d; Rule 17-Exhibit 6.F.4.d;

Rule 17-Exhibit 8; Rule 17-Exhibit 9.E.5, 9.F.5, 9.F.7.g; eff. 07/01/2007.

Rules 3-1-(A), 3-6-(C), 5-4-(D) and Rule 4 eff. 09/01/2007.

Rule 5-10 eff. 10/01/2007.

Rules 8, 16 and 18 eff. 01/01/2008.

Rules 5-5, 12-3 emer. rules eff. 07/01/2008; expired 09/19/2008.

Rules 5-5, 12-3 eff. 10/01/2008.

Rule 17-Exhibit 3, Rule17-Exhibit 4 eff. 11/01/2008.

Rules 16 and 18 eff. 01/01/2009.

Rule 7-2 eff. 02/01/2009.

Rule 8-5 (B) eff. 05/01/2009.

Rule 2-5 eff. 07/01/2009.

Rule 11-11 (A) table eff. 08/01/2009.

Rules 8-8, 8-9, 8-10, 8-11, 8-12, 88-13 emer. rules eff. 08/05/2009.

Rule 17 Exhibit 6 eff. 09/01/2009.

Rule 11-11 (A) table eff. 08/01/2009.

Rules 8-8, 8-9, 8-10, 8-11, 8-12, 88-13 emer. rules eff. 08/05/2009.

Rule 17 Exhibit 6 eff. 09/01/2009.

Rules 8-8, 8-9, 8-10, 8-11, 8-12, 8-13 eff. 11/01/2009.

Rules 16, 18 eff. 01/01/2010.

Rule 2-5 eff. 07/01/2010.

Rules 7-4, 11-3(F-N) emer. rules eff. 07/01/2010

Rule 8-8 eff. 08/01/2010.

Rules 5-10, 5-14, 7-4, 11-3(F-O) eff. 09/01/2010.

Rule 17 Exhibit 2 and Exhibit 5 repealed and repromulgated as Rule 17 Exhibit 5 eff. 10/30/2010.

Rules 16, 18 eff. 01/01/2011.

Rules 16, 18, Rule 18 Exhibits 1-7 eff. 01/01/2012.

Rule 17 Exhibits 7 and 9 eff. 02/14/2012.

Rules 2-5, 7-4 eff. 07/01/2012.

Rules 16, 18, Rule 18 Exhibits 1-7 eff. 01/01/2013.

Rule 17 Exhibit 10 eff. 01/14/2013.

Rules 5-11, 10-2(E), 10-3(C), 10-4(E)(b) eff. 04/01/2013.

Rule 2-5 eff. 07/01/2013.

Rules 16, 18, Rule 18 Exhibits 1-7 eff. 01/01/2014.

Rules 5-5(F), 7-1, 7-2(B), 7-3(A)(1)-(3) eff. 03/17/2014.

Rule 17-Exhibits 1 and 8 eff. 03/30/2014.

Rules 5-10(B)(1)(c), 5-10(B)(2)(b) emer. rules eff. 07/01/2014; expired 10/07/2014.

Rule 2-5 eff. 07/30/2014.

Rules 5, 16, 18, Rule 18 Exhibits 1-8 eff. 01/01/2015.

Rule 17 Exhibits 3-4 eff. 02/01/2015.

Rule 8 eff. 04/01/2015.

Rule 2-5 eff. 07/01/2015.

Rules 16, 18, Rule 18 Exhibits 1-8 eff. 01/01/2016.

Rule 17, Exhibit 6 eff. 03/16/2016.

Rules 7, 9 eff. 04/15/2016.

Rule 2-5 eff. 07/30/2016.

Rules 1, 5-9 eff. 09/14/2016.

Rules 16, 18, Rule 18 Exhibits 1-8 eff. 01/01/2017.

Rule 17 Exhibit 5 eff. 03/02/2017.

Rule 2-5 eff. 07/01/2017.

Rule 17 Exhibits 7 and 9 eff. 11/30/2017.

Rules 13, 16, 18, Rule 18 Exhibits 1-8 eff. 01/01/2018.

Rule 2 eff. 07/01/2018.

Rules 2-3, 11, 16, 18, Rule 18 Exhibits 1-9 eff. 01/01/2019.

Rule 17 Exhibit 10 repealed and repromulgated as Rule 17 Exhibit 2 eff. 01/30/2019.

Rule 2 eff. 07/01/2019.

Rules 8, 9, 11-4(B)(5) eff. 07/15/2019.

Rule 5-5 (C)(1) emer. rule eff. 08/28/2019.

Rule 5-5(C)(1) eff. 11/30/2019.

Rules 16, 18, Rule 18 Exhibits 1-8 eff. 01/01/2020. Rule 18-7(H) emer. rule eff. 01/01/2020.

Rules of Procedure Sections 1-9 emer. rules eff. 03/24/2020.

Rules of Procedure Sections 1-6 emer. rules eff. 03/31/2020.

Rule 18-7(H) eff. 04/30/2020.

Rules of Procedure Sections 1-7 emer. rules eff. 06/15/2020; expired 10/13/2020.

Rule 2 eff. 07/01/2020.

Rules 18-3(B), 18-4(I) eff. 10/14/2020.

Rules 16, 18, Rule 18 Exhibits 1-9 repealed, new Exhibits 1-3 eff. 01/01/2021.

Rule 4 eff. 04/30/2021.

Rules 5, 6, 7 eff. 07/01/2021.

Rule 2-4 eff. 07/30/2021.

Rules 5-6 , 18-7(I) emer. rules eff. 09/07/2021.

Rules 3, 5-6, 18, Rule 18 Exhibits 1-3 eff. 01/01/2022.

Rule 17, Rule 17 Exhibits 1, 8 eff. 01/30/2022.

Rule 2-4 eff. 07/01/2022.

Rules 5-2(B)(4), 5-7(D) emer. rules eff. 08/09/2022.

Rule 3-6 eff. 08/10/2022.

Rule 5 emer. rule eff. 12/06/2022.

Rule 16, Rule 18 Fee Schedule, Rule 18 Exhibits 1-4 eff. 01/01/2023. Rule 11 emer.

rule eff. 01/01/2023.

Rule 11 eff. 03/02/2023.

Rule 5 eff. 03/30/2023.

Rules 9, 18, Rule 18 Exhibits eff. 01/01/2024.

Rule 7 eff. 07/01/2024.

Rule 16, Rule 17 Exhibit 4, Rule 18, Rule 18 Exhibits eff. 01/01/2025.

Rule 11 eff. 04/01/2025.

Rules 2-2, 2-3(G), 16-1, 16-3(E)(3), 16-8-1, 16-8-3, 16-10, 16-10-1(A), 16-10-2(A) eff. 07/01/2025.

Rule 18, Rule 18 Exhibits eff. 01/01/2026.

Rules 1, 5 eff. 07/15/2026.

7 CCR 1101-3 Rules 1-17 Rules 1 - 17: RULES OF PROCEDURE (Rule 17 exhibits published separately) {#sec-7-ccr-1101-3-rules-1-17 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 Rules 1-17}

Department of Labor and Employment WORKERS’ COMPENSATION RULES OF PROCEDURE 7 CCR 1101-3 Rules 1 - 17 (Rule 17 exhibits published separately) [Editor’s Notes follow the text of the rules at the end of this CCR Document.]

Rule 1 General Definitions and General Provisions 1.1 The following definitions shall apply unless otherwise indicated in these rules A. “Act” means articles 40 through 47 of title 8 of the Colorado Revised Statutes.

B. “ALJ” means an Administrative Law Judge with the Office of Administrative Courts or a Prehearing Administrative Law Judge with the Division of Workers’ Compensation.

C. “Claimant” means an employee or dependent(s) of a deceased employee claiming entitlement to benefits under the Act. For the purpose of notification and pleadings, the term claimant shall include the claimant’s legal representative.

D. “Director” means the Director of the Division of Workers’ Compensation.

E. “Division” means the Division of Workers’ Compensation in the Department of Labor and Employment.

F. “Electronically recorded” means a recording made using tape recording, digital recording, or some other generally accepted medium.

G. “Employee” means an individual who meets the definition of “employee” in the Act.

H. “Employer” means anyone who meets the definition of “employer” in the Act.

I. “Insurer” means every mutual company or association, every captive insurance company, and every other insurance carrier, including Pinnacol Assurance, providing workers’ compensation insurance in Colorado, and every employer authorized by the Executive Director of the Department of Labor and Employment to act as its own insurance carrier, as well as any workers’ compensation self-insurance pool authorized pursuant to statute.

J. “Notice” means actual or constructive knowledge.

K. “Service” means delivery via United States mail, hand delivery, electronic mail (“e-mail”), or through the Division’s electronic system. 1.2 Computation of time/date of filing A. Unless a specific rule or statute states to the contrary, the date a document or pleading is filed is the date the EDI transaction is successfully processed by the Division of Workers’ Compensation or the date it is mailed, e-mailed, hand delivered, or processed through an electronic system at the Division of Workers’ Compensation or the Office of Administrative Courts.

B. In computing any period of time prescribed or allowed by these rules, the day of the act, event, or default from which the designated period of time begins to run shall not be included. Thereafter, every day shall be counted, including legal Colorado state holidays, Saturdays, or Sundays. The last day of the period so computed shall be included, unless it is a Saturday, a Sunday, or a legal Colorado state holiday, in which event the period runs until the end of the next day which is not a Saturday, a Sunday, or a legal Colorado state holiday. The “next day” is determined by continuing to count forward when the period is measured after an event and backward when measured before an event.

C. As used in this rule, “business day” refers to any day other than a Saturday, Sunday, or legal Colorado state holiday. 1.3 Notarization of authorization for release of information The claimant’s signature must be notarized on all releases filed with the Division of Workers’ Compensation pursuant to §8-47-203(1)(e), C.R.S. 1.4 Service of documents A. Whenever a document is filed with the Division, a copy of the document shall be served upon each party to the claim and attorney(s) of record, if any, on the same date and manner. The certificate of service shall list the address and method by which the document was sent to each party.

B. Any document that is certified as mailed, including admissions, must be placed in the U.S. mail or delivered on the date of certification. Except where specifically permitted by the Division, documents should be filed with the Division via e-mail or uploaded through the Division’s electronic system. To the extent possible, documents that are e-mailed to the Division should also be e-mailed to all other C. Parties are required to keep the Division and all other relevant parties informed of an accurate address for service of documents. This must include a physical mailing address, but should also include an e-mail address if possible. This applies to all parties, including but not limited to claimants, injured workers, pro se litigants, employers, insurance carriers, third party administrators, and attorneys of record. There will be a presumption that anything served on the address listed in the Division file was timely received.

D. Use of the Division’s electronic system is required for all insurance carriers, selfinsured employers, and third party administrators. All other parties, including attorneys, are strongly encouraged also to utilize the Division’s system. The Director may grant an exemption to a party from electronic communications because of a small number of filings or financial hardship.

1. Any party that creates an account with the Division’s electronic system is agreeing to accept all notices, orders, and letters via electronic service through the Division’s system. 1.5 Requests for orders under §8-47-203(2), C.R.S.

A. Requests made to the Division of Workers’ Compensation pursuant to §8-47- 203(2), C.R.S., for copies or inspection of orders entered by the Director or an administrative law judge shall:

1. be made in writing and addressed to the Director, and 2. state the name of the requester and include the requester’s mailing address, e-mail address, and phone number; and 3. specifically identify the criteria for orders being requested. For example, all orders on the merits from a specific time period or all orders involving specified issues or injuries, etc.; and 4. state the purpose for requesting the orders.

B. The requester shall provide any additional information required by the Division.

After receiving such a request, the Division will provide a cost estimate for processing the request. The requester may agree to pay the costs involved or decline further processing of the request. At the discretion of the Division, payment may be required prior to the work being performed.

C. To protect the confidentiality of the claimant and the employer named in the requested orders:

1. requests shall not be accepted for orders based on claimant or employer names, or other uniquely identifying claimant or employer information; and 2. requests shall not be accepted for any criteria resulting in the inclusion of fewer than three (3) claimants or employers in the group of orders inspected, unless approved by the Director or the Director’s designee. 1.6 Employer credit for wages paid under §8-42-124(2), C.R.S.

A. An employer who wishes to pay salary or wages in lieu of temporary disability benefits may apply to the Director for authorization to proceed pursuant to §8-42- 124(2), C.R.S.

B. The application to the Director shall contain the following information:

1. a reference to the contract, agreement, policy, rule, or other plan under which the employer wishes to pay salary or wages in excess of the temporary disability benefits required by the act, and 2. a description of the employees covered by the application and a statement that these employees will not be charged with earned vacation leave, sick leave, or other similar benefits during the period the employer is seeking a credit or reimbursement.

C. An employer who has received approval from the Director to proceed under §8- 42-124(2), C.R.S., shall indicate on the employer’s first report of injury form whether the claim is subject to §8-42-124, C.R.S.

Rule 2 Workers’ Compensation Insurance Premium And Payroll Surcharges 2-1 SURCHARGE REQUIREMENTS FOR INSURANCE CARRIERS Pursuant to § 8-44-112(1), insurance carriers must file semiannual surcharge returns based upon the premium amounts for the periods July 1 through December 31 of each year and January 1 through June 30 of each year.

(A) Insurance carriers must use either Division Form WC 113 or the online surcharge application to file semiannual surcharge returns.

(B) The surcharge return must state the amount of premiums written for Colorado workers' compensation insurance, including any policy expense constants, membership fees, finance and service, or other administrative fees charged to the policyholders with the issuance or renewal of policies during the semiannual period covered by such return. These premiums are the same as the premiums reported to the Colorado Division of Insurance (DOI) in accordance with § 10-3-208, and regulations promulgated thereunder.

(C) Insurance carriers must verify the surcharge return by affidavits of at least two chief officers or agents, such as president and secretary.

(D) For the semiannual assessment period July 1 through December 31, carriers must file verifications and pay no later than the following January 31. For the semiannual assessment period January 1 through June 30, carriers must file verifications and pay no later than the following July 31.

(E) Insurance carriers may take a credit for actually refunded premiums as an offset against surcharges due within one year of the date the premium was refunded. The insurance carrier may not offset a credit of one subsidiary against the surcharge owed by another subsidiary.

2-2 SURCHARGE REQUIREMENTS FOR SELF-INSURED EMPLOYERS

Pursuant to § 8-44-112(3) every self-insured employer must report its semiannual payroll to the Division utilizing the Division’s online surcharge application.

(A) The filing must include the National Council on Compensation Insurance (NCCI) class codes, job titles and payroll for each employee, as instructed by the online surcharge application. The Division may request further information to verify the reported payroll data. The failure to report payroll timely or accurately may result in the computation of surcharge without the otherwise applicable discounts.

(B) Self-insured employer surcharges must be based on the manual premium, adjusted by Pinnacol Assurance discount applicable for the covered surcharge assessment period and modified by the experience rating factor as calculated by NCCI. No other rating factor shall be allowable. If the selfinsured employer is unable to develop the experience rating factor, the employer may apply to the director for approval to use a 1.0 experience rating factor for the following surcharge rating period.

(C) Self-insured employers must provide a completed NCCI form setting forth all of the information and methodology used in the calculation of the experience modification using the Division’s online surcharge application.

For the semiannual assessment period July 1 through December 31, selfinsured employers must report payroll and pay no later than January 31.

For the semiannual assessment period January 1 through June 30, selfinsured employers must report payroll and pay no later than July 31.

(D) All filings must be accompanied by an affidavit from a representative of the self-insured employer attesting to the accuracy of the included information.

(E) The division may audit any self-insured employer for purposes of ascertaining the correctness of the reported wage expenditure, number of persons employed, accuracy of information upon which the experience rating factor was calculated and such other information as may be necessary.

(F) If it is determined following an audit that the surcharge paid was incorrect as a result of inaccurate data or calculations submitted to the Division, the director may by order retroactively adjust the surcharge to reflect accurate data or calculations.

2-3 SURCHARGE REQUIREMENTS FOR SELF-INSURANCE POOLS

Effective for the semiannual assessment period July 1, 2021 through December 31, 2021 and continuing thereafter, every self-insurance pool must report its semiannual payroll pursuant to §§ 8-44-112(3) -204 and -205, using Division Form WC 112.

(A) The filing must include the National Council on Compensation Insurance (NCCI) class codes, job titles, and individual payroll for each employee of each pool member, as well as aggregate total payroll for each class code in a spreadsheet format. The Division may request further information to verify the reported payroll data. The failure to report payroll timely or accurately may result in the computation of surcharge without the otherwise applicable discounts.

(B) Each self-insurance pool member must provide a completed NCCI form setting forth all of the information and methodology used in the calculation of the experience modification. The pool also must set forth the methodology used in calculating its weighted experience rating factor. If any pool member is unable to develop the experience rating factor, the pool may apply to the director for approval to use a 1.0 experience rating factor for that member for the following surcharge rating period.

(C) Self-insurance pool surcharges must be based on the manual premiums of each pool member, adjusted by Pinnacol Assurance discount applicable for the covered surcharge assessment period and modified by the pool’s weighted experience rating factor. No other rating factor shall be allowable.

(D) For the semiannual assessment period July 1 through December 31, selfinsurance pools must report payroll and pay no later than January 31. For the semiannual assessment period January 1 through June 30, pools must report payroll and pay no later than July 31.

(E) All filings must be accompanied by an affidavit from a representative of the self-insurance pool attesting to the accuracy of the included information.

(F) The Division may audit any self-insurance pool for purposes of ascertaining correctness of the reported wage expenditures, number of persons employed, accuracy of information and methodology upon which the experience rating factors were calculated, and such other information as may be necessary.

(G) If it is determined following an audit that the surcharge paid was incorrect as a result of inaccurate data or calculations submitted to the Division, the director may by order retroactively adjust the surcharge to reflect accurate data or calculations.

2-4 SURCHARGE RATES

The following surcharge rates shall apply for the period beginning July 1 and continue indefinitely with periodic review by the director:

(A) The workers' compensation cash fund premium surcharge rate authorized by § 8-44-112(1)(a), shall be 1.40 percent of the amount of all premiums written as defined in section 2-1(b) or the premium equivalent amount established in section 2-2(b) of this rule.

(B) The additional assessment to fund the cost containment program authorized by § 8-44-112(1)(b)(i), shall be 0.03 percent of all premiums written, as defined in section 2-1(b). This assessment shall not be imposed on self-insured employers.

(C) The assessment to fund the subsequent injury fund authorized by §8-46- 102(2)(a)(i), and the major medical fund authorized by § 8-46-202 shall be 0.0 percent of all premiums written as defined in section 2-1(b) or the premium equivalent amount established in section 2-2(b) of this rule.

Rule 3 Insurance Coverage 3-1 REPORTING REQUIREMENTS FOR INSURANCE CARRIERS AND EMPLOYERS (A) The Division designates the National Council on Compensation Insurance, Inc. (NCCI) as its agent to receive, process, and make available to the Division, all the required notices. Insurance carriers shall transmit this data and all other data elements in the electronic format as directed by the Division through NCCI.

(B) Every insurance carrier shall advise the Division, by filing with NCCI, notice of the issuance or renewal of insurance coverage within thirty (30) calendar days of the effective date of coverage. The insurance carrier shall ensure that every policy reported to NCCI includes the correct federal employer identification number (“FEIN”) or other taxpayer identification number(s) for each covered employer, employer’s business operation, client company, and/or employing entity.

(C) Every insurance carrier shall advise the Division, by filing with NCCI, final notice of the cancellation of insurance coverage no later than thirty (30) calendar days after coverage is actually canceled. This subsection does not pertain to the preliminary notice of cancellation referenced in §8-44- 110.

(D) Every employer shall provide on request to its insurance carrier all FEINs or other taxpayer identification number(s) for all the employer’s business operations, client companies, and/or any other similar employing entities, in Colorado to which the insurance applies. All changes in FEIN or other taxpayer identification numbers shall be reported immediately to the insurance carrier. The insurance carrier shall report all changes in FEINs and taxpayer identification numbers to NCCI within thirty (30) calendar days of receipt.

(E) Every insurance carrier shall provide to the division all certificates of insurance requested by the division, unless the insurer denies coverage for the requested employer, employer’s business operation, client company, and/or employing entity. Certificates issued to the division shall contain, at a minimum, the employer’s name, employer’s address, employer’s FEIN or other taxpayer identification number, insurer’s name, insurer’s address, policy number, and effective dates of the policy. The insurer shall provide such certificate(s) or notify the division of the denial of coverage within five (5) days of the request.

(F) For purposes of the performance of the Director’s responsibilities under §8-43-409, the prehearing conference and any hearing that the Director may determine necessary may be conducted by any competent person appointed by the Director or by any other person designated by the Director.

3-2 CARRIER REPRESENTATIVE

Every insurance carrier shall notify the Division’s designated agent of the name, address and telephone number of its representative responsible for reporting coverage information. This information shall be provided within thirty (30) days upon request of either the Division or its agent, or within thirty (30) days of a change in the information.

3-3 SELF-INSURED EMPLOYERS

(A) Any pool authorized to self-insure shall advise the Division in writing of the effective date of self-insurance, the name and address of the pool administrator and the federal employer identification number of each covered member. This information shall be provided within thirty (30) days upon request of either the Division or its agent, or within thirty (30) days of a change in the information.

(B) All individual self-insurance permit holders shall advise the Division in writing of the federal employer identification number of the permit holder as well as of all covered subsidiaries. This information shall be provided within thirty (30) days upon request of either the Division or its agent, or within thirty (30) days of a change in the information. 3-4 Unreported/erroneous policies - insurance carriers (A) Every insurance carrier who fails to comply with the reporting requirements of paragraphs (a) through (e) of rule 3-1 shall be subject to penalties.

(B) For certificates of workers’ compensation insurance or other documentation that has been received by the division indicating policies that have not been reported by the insurer to NCCI or policies that contain errors in an employer’s identifying information, a list of such policies will be generated by the division and provided to each insurer containing all unreported or inaccurate policies. The insurer shall have fifteen (15) days from the date the list is issued to report/correct each listed policy to NCCI, or provide to the division a written explanation of why the policy cannot be reported/corrected to NCCI.

(C) If, within fifteen (15) days following the issuance of the division’s list of unreported or erroneous policies, the insurer fails to either report a listed policy to NCCI or provide a written explanation to the division of why the policy cannot be corrected or reported to NCCI, a deficiency notice and order to comply may be issued to the insurer for all outstanding unreported or erroneous policies. The insurer shall then have twenty (20) days from the date of issuance of the deficiency notice and order to comply to perform one of the following actions:

(1) Report a previously unreported policy to NCCI.

(2) File a corrected endorsement with NCCI in the event the policy information previously submitted to NCCI is incorrect.

(3) Provide a written explanation to the division of why the policy cannot be reported to or corrected with NCCI.

3-5 ELECTION TO REJECT COVERAGE

(A) An officer of a corporation or a member of a Limited Liability Company (“ LLC”) who elects to reject workers’ compensation coverage shall complete and submit the division prescribed rejection of coverage form to the division if all the company’s corporate officers and LLC members choose to reject coverage and the corporation or LLC has no employees other than the corporate officers or LLC members. If the corporation or LLC has workers’ compensation insurance, the corporate officer(s) or LLC member(s) shall submit the division prescribed form or the insurance carrier’s substantially equivalent form to the workers’ compensation insurance carrier.

(B) The owner(s) of a sole proprietorship or partnership performing construction work who elect(s) to reject workers’ compensation coverage shall complete and submit the division prescribed rejection of coverage form to the division if the sole proprietorship or partnership has no employees other than the owner(s). If the sole proprietorship or partnership has workers’ compensation insurance, such owner(s) shall submit the division prescribed form or the insurance carrier’s substantially equivalent form to the workers’ compensation insurance carrier.

(C) The Notice of Election to Reject Coverage shall become effective the next business day following receipt of the notice by the insurance carrier or, if none, by the Division.

3-6 NOTICES TO EMPLOYEES

Every employer shall continuously post a notice to employees in one or more conspicuous places at all of the employer’s work sites advising employees that the employer is insured for workers’ compensation as required by law, identifying the name of the employer’s insurance carrier or stating that the employer is selfinsured. Such notice shall be on the division form WC 50. For non-self-insured employers, the required notice shall be supplied by the insurer.

3-7 FINES FOR DEFAULTING EMPLOYER

(A) Following the Director’s determination that an employer has failed to obtain the required insurance or has failed to keep such insurance in force or has allowed the insurance to lapse or has failed to renew such insurance, the Director will impose fines on the defaulting employer and/or will compel the employer to cease and desist its business operations.

(B) For any period beginning three years prior to the date the employer is sent a notice to show compliance and where such employer has not previously been sent a notice to show compliance, the director shall impose a fine of five dollars ($5.00) per day for each day of the employer’s default until the date of issuance of the notice to show compliance. If the employer’s default continues after the issuance of the notice to show compliance, fines shall be issued in accordance with the following schedule until the employer complies with the requirements of the workers’ compensation act regarding insurance or until further order of the director:

1-10 DAYS $10/DAY

11-20 DAYS $30/DAY

21-30 DAYS $50/DAY

31-40 DAYS $100/DAY

41+ DAYS $250/DAY

(C) Where an employer provides the director with information related to its ability to pay the fine, the director may, if appropriate, modify the fine structure in rule 3-6(b).

(D) For the Director’s finding of an employer’s second and all subsequent defaults in its insurance obligations, daily fines from $250/day up to $500/day for each day of default will be until the employer complies with the requirements of the Workers’ Compensation Act regarding insurance or until further order of the Director.

Rule 4 Carrier Compliance 4-1 CLAIMS COMPLIANCE AUDITS (A) Every insurer shall submit to compliance audits of its claims. The purpose of compliance audits is to examine whether claims are adjusted in accordance with the Workers' Compensation Act and the Workers'

Compensation Rules of Procedure.

(1) Identifying and underlying claim information examined as part of a compliance audit is accessible only to the insurer under review and shall not otherwise be open to any person except upon order of the Director. If the Director issues an order in a specific claim the order will be sent to all parties.

(2) Division personnel shall give advance written notice of the compliance audit to the insurer and provide an initial list of claims to be audited. Unless the Division determines that circumstances warrant otherwise, the insurer will be given at least 15 calendar days notice.

(3) The insurer shall make the claims selected for the compliance audit and any requested information, including training and procedure manuals, available to the auditor at the time and place designated by the auditor. If the audit requires out-of-state travel by the auditor, the insurer may be required to pay travel costs.

(4) Failure to make claims and/or information requested by the auditor available to the auditor for audit shall be considered willful refusal to comply with Division efforts.

(5) The insurer shall indicate the dates of its receipt on all documents it files with the Division as well as on all medical bills and reports.

For those documents required to be exchanged, the insurer shall indicate on the face of the documents or by some other verifiable method, the date the documents were mailed or delivered and to whom they were mailed or delivered.

(B) A claim compliance level will be determined for each category examined during the audit. A compliance level is the ratio of deficiencies found within a category in relation to the total number of applicable audit inquiries reviewed in that category. A deficiency is a failure to comply with statute or

rule. The categories to be examined during the claim compliance audit may include but are not limited to the following:

(1) Reporting of claims.

(2) Initial positions on liability.

(3) Timeliness of compensation payments.

(4) Accuracy of compensation payments.

(5) Medical benefit payments.

(6) Termination of temporary disability benefits.

(7) Final Admissions.

(8) Average Weekly Wage.

(9) Waiting period.

(10) Document exchange.

(C) Fines will be imposed for the repeated failure to demonstrate satisfactory compliance. A compliance level of 90% or higher in each category is considered satisfactory compliance. No fine will be imposed for deficiencies in any category in which satisfactory compliance is determined in the compliance audit. For the categories listed in subparagraphs 8 through 10 in paragraph (B) of this Rule 4-1, the auditor will comment upon the insurer's adjusting practices but fines will not be imposed for deficiencies found on compliance audits in those categories.

(D) After reviewing the insurer's procedures and examining the claims selected for audit and other information requested, the auditor will provide the insurer with preliminary audit findings, including compliance levels.

Thereafter:

(1) The insurer will have thirty (30) calendar days within which to agree in writing with the preliminary audit findings. If the insurer does not agree with the preliminary audit findings it shall, within the same 30 calendar days, state with particularity and in writing to the auditor its reasons for all disagreements and provide in writing all relevant legal authority, and/or other relevant proof upon which it relies in support of its position(s) concerning its disagreements with the preliminary findings.

An extension of time not to exceed 30 additional days may be submitted in writing to the auditor prior to the expiration of the 30 calendar days afforded to the insurer to agree with the preliminary findings. Failure to timely submit a written disagreement will be considered waiver of the right to do so.

(2) A representative of the division and the insurer shall have twenty (20) calendar days after submission of the written disagreement with the preliminary audit findings within which to resolve those disagreements and to agree to the preliminary audit findings.

(3) If the representative of the division and the insurer are unable to agree on the preliminary findings within the 20-day period afforded in paragraph (D)(2) of this Rule 4-1, the preliminary audit findings along with the insurer's written disagreements will be referred to the Director for final determination regarding the audit findings.

The final determination of the relevance and/or weight given to any authority or proof submitted in connection with the insurer's disagreements regarding audit findings is reserved to the Director.

(4) When a determination regarding audit findings has been made by the Director, a Final Audit Report and/or order will be issued.

(5) When the insurer has agreed to the preliminary audit findings without disagreement, or when the insurer fails to timely provide a written disagreement or when the Director has made a determination regarding audit findings as provided in paragraph (D) of this Rule 4-1, the Final Audit Report will issue. The Final Audit Report will contain a summary of the final audit findings, comments on the insurer's adjusting practices, and a determination of the insurer's compliance levels. Fines will be ordered as determined by the Director in accordance with Rule 4- 2.

(6) Insurers may be required to correct deficiencies in all claims covered by the audit period if the compliance level for any identified category is below 90%. Insurers may also be required to undergo training if indicated by audit results or for such other reasons as may be determined by the Director. 4-2 fines for claims audits (A) An insurer's first claims audit conducted after January 1, 2006 measures and establishes the insurer's levels of compliance with applicable statutes and rules in identified categories. A compliance level below 90% in any compliance category is considered unsatisfactory. A compliance level below 90% in a compliance category listed in subparagraphs 1 through 7 in paragraph (B) of Rule 4-1, on consecutive compliance audits is considered repeated non-compliance. Repeated non-compliance in any category set out in Rule 4-1(B)(1) through (7) shall result in the insurer being ordered to pay a fine.

(B) In order for an insurer's unsatisfactory performance to result in fines for failure to meet the 90% compliance standard in any category set out in

Rule 4-1(B)(1) through (7), its compliance level in that category must be below 90% on at least two consecutive audits.

(C) Each category for which a fine may be imposed has a fine schedule. The amount of any fine will be determined in accordance with the findings in the Final Audit Report and in accordance with this Rule 4-2. Fines for repeated violations in any category set out in Rule 4-1(B)(1) through (7) are based on the compliance level for that category and as set out in this

Rule 4-2.

(D) The dollar amount of a fine is arrived at by first locating the insurer's compliance level on the appropriate schedule found in paragraph (E) of this Rule 4-2. The number of identified deficiencies in the relevant category is multiplied by the “per deficiency” dollar amount for the appropriately numbered finable occurrence indicated in the schedule to arrive at a fine amount for that category.

(E) The fine schedule for each consecutive finable compliance category is as follows:

(1) For the categories listed in Rule 4-1(B) subparagraphs 1,5,7:

(a) 80-89% $60 (b) 70-79% $90 (c) 60-69% $120 (d) <60% $150 (2) For the categories listed in Rule 4-1(B) subparagraphs 2,3,4,6:

(a) 80-89% $100 (b) 70-79% $200 (c) 60-69% $400 (d) <60% $600 4-3 POLICY COMPLIANCE AUDIT (A) Every insurer shall submit to compliance audits of its policy reporting.

Policy information to be reviewed will consist of all new, renewal and cancellation policy data information that has already been reported to the Division. The purpose of compliance audits is to examine whether insurance coverage is reported in accordance with the Workers'

Compensation Act and the Workers' Compensation Rules of Procedure.

(1) Identifying and underlying coverage information examined as part of a compliance audit is accessible only to the insurer under review and shall not otherwise be open to any person except upon order of the Director. If the Director issues an order for a specific policy the order will be sent to all parties.

(2) Division personnel shall give advance written notice of the compliance audit to the insurer setting forth the period to be audited. Unless the Division determines that circumstances warrant otherwise, the insurer will be given at least 15 calendar days notice.

(3) The insurer shall make any requested information related to the compliance audit available to the auditor at the time and place designated by the auditor.

(4) Failure to make information requested by the auditor available to the auditor for audit shall be considered willful refusal to comply with Division efforts.

(B) A compliance level will be determined for each category examined during the policy compliance audit. A compliance level is the ratio of deficiencies found within a category in relation to the total number of applicable audit inquiries reviewed in that category. A deficiency is a failure to comply with statute or rule. The categories to be examined during the compliance audit may include but are not limited to the following:

(1) Reporting of new or renewal policies (2) Reporting of policy cancellations (C) Fines will be imposed for the repeated failure to demonstrate satisfactory compliance. A compliance level of 95% or higher in each category is considered satisfactory compliance. No fine will be imposed for deficiencies in any category in which satisfactory compliance is determined in the compliance audit.

(D) After examining the relevant policy data for audit and other information requested, the auditor will provide the insurer with preliminary audit findings, including compliance levels. Thereafter:

(1) The insurer will have thirty (30) calendar days within which to agree in writing with the preliminary audit findings. If the insurer does not agree with the preliminary audit findings it shall, within the same 30 calendar days, state with particularity and in writing to the auditor its reasons for all disagreements and provide in writing all relevant legal authority, and/or other relevant proof upon which it relies in support of its position(s) concerning its disagreements with the preliminary findings.

An extension of time not to exceed 30 additional days may be submitted in writing to the auditor prior to the expiration of the 30 calendar days afforded to the insurer to agree with the preliminary findings. Failure to timely submit a written disagreement will be considered waiver of the right to do so.

(2) A representative of the Division and the insurer shall have twenty (20) calendar days after submission of the written disagreement with the preliminary audit findings within which to resolve those disagreements and to agree to the preliminary audit findings.

(3) If the representative of the Division and the insurer are unable to agree on the preliminary findings within the 20-day period afforded in paragraph (D)(2) of this Rule 4-3, the preliminary audit findings along with the insurer's written disagreements will be referred to the Director for final determination regarding the audit findings.

The final determination of the relevance and/or weight given to any authority or proof submitted in connection with the insurer's disagreements regarding audit findings is reserved to the Director.

(4) When a determination regarding audit findings has been made by the Director, a Final Audit Report and/or order will be issued.

(5) When the insurer has agreed to the preliminary audit findings without disagreement, or when the insurer fails to timely provide a written disagreement, or when the Director has made a determination regarding audit findings as provided in paragraph (D) of this Rule 4-3, the Final Audit Report will issue. The Final Audit Report will contain a summary of the final audit findings, comments on the insurer's policy reporting practices, and a determination of the insurer's compliance levels. Fines will be ordered as determined by the Director in accordance with Rule 4- 4.

(6) Insurers may be required to correct deficiencies in all policy information covered by the audit period if the compliance level for any identified category is below 95%. Insurers may also be required to undergo training if indicated by audit results or for such other reasons as may be determined by the Director.

4-4 FINES FOR POLICY AUDITS

For the categories listed in Rule 4-3(B) subparagraphs (1) and (2):

Fines per consecutive Audit Deficiency per Compliance Category Compliance Level Fine 90-94% $60 85-89% $90 80-84% $120 <80% $150

Rule 5 Claims Adjusting Requirements 5.1 Completion of Division forms A. Information required on Division forms shall be typed or legibly written in black or blue ink, completed in full and in accordance with Division requirements as to form and content. This shall include filling out any certificate of mailing or service in full, including the address to which the document was served.

B. Absent permission of the Director or order of an Administrative Law Judge, parties are required to use the most current version of a form available.

C. Insurers shall transmit data in an electronic format only as directed by the Division.

D. All first reports of injury, notices of contest, and admissions of liability filed with the Division shall be transmitted electronically via electronic data interchange (EDI). First reports of injury, notices of contest, and admissions of liability cannot be submitted to the Division via any other method without explicit permission from the Division. This rule does not negate the obligation that all documents must be served on all other parties.

E. All filings not listed in section (D) shall be sent via electronic submission to the Division.

1. Only one file per submission is permitted. All exhibits shall be combined into one file with the filing or form. Multiple attachments will not be accepted.

2. The subject line of the electronic mail (“e-mail’) and the attached file name must be named in this order: wc#, claimant first and last name, and type of document.

3. The certificate of service should reflect the date it was submitted to the Division of workers’ compensation.

4. All petitions to modify, terminate, or suspend (wc54); request for lump sum payments (wc62); and motions to close for lack of prosecution (wc192) must be sent to: cdle_dowc_claims@state.co.us a. In order to electronically submit a motion to close, all parties must have an e-mail address b. If e-mail addresses are not available, these forms will be accepted via regular mail along with self-addressed, postage-paid envelopes for all parties.

5. All other motions (other than motions to close which are addressed under

rule 7) and submissions for prehearings and settlement unit must be addressed to: cdle_dowc_prehearings@state.co.us. Motions must be accompanied by a proposed order.

6. All other communications not specifically addressed in this rule, including but not limited to objections to final admissions, entries of appearance, and workers’ claims for compensation must be addressed to: cdle_workers_compensation@state.co.us.

F. The Director may grant an exemption to an insurer from filing electronically because of a small number of filings or financial hardship. Any insurer requesting an exemption from electronic filing may do so in letter form addressed to the Director. The request should provide specific justification(s) for the requested exemption. The letter should address whether an exemption is sought for only EDI or also for internet filing.

G. In the event compliance with 5-1(F) is prevented by technological errors beyond the control of the filing party, a waiver may be requested by submitting the Division-issued paper form along with a cover letter addressed to the Director identifying the reason for the request. Upon receipt of a request the Division will either accept the paper form or notify the filing party that electronic submission will be required.

H. For any electronic submission to the Division which requires attached support documentation, the support documentation must be uploaded in concert with the underlying document.

I. In the event the carrier does not have an accurate Social Security Number for the claimant, the carrier shall utilize the following format for the employee ID assigned by jurisdiction: 999 followed by the employee’s date of birth in mmddyy format. For example, 999-05-1590 would be used for an individual with no Social Security Number who has a birthday of May 15, 1990. 5.2 Filing Employers’ First Injury Reports A. Within ten (10) days of notice or knowledge an employer shall report any workrelated injury, illness or exposure to an injurious substance as described in subsection (F), to the employer's insurer. An employer who does not provide the required notice may be subject to penalties or other sanctions.

B. A First Report of Injury shall be filed with the Division in a timely manner whenever any of the following apply. The insurer or third-party administrator may file the First Report of Injury on behalf of the employer.

1. If an injury results in a fatality, or three (3) or more employees are injured in the same accident, a first report of injury shall be filed with the Division within three (3) days of notice to the insurance carrier or self-insured employer.

2. A First Report of Injury must be filed within ten (10) days of an employer receiving notice or knowledge of any of the following events:

a. An injury or occupational disease has resulted in lost time from work for the injured employee in excess of three shifts or calendar days;

b. The occurrence of a permanently physically impairing injury;

c. After the first scheduled appointment for medical treatment intended to cure or relieve the injury is provided more than 180 days after the date of notice to the employer of the injury;

d. An employee has contracted an occupational disease listed in any of the following categories:

(1) Chronic respiratory disease;

(2) Cancer;

(3) Pneumoconiosis, including but not limited to coal worker’s lung, asbestosis, silicosis, and berylliosis;

(4) Nervous system diseases;

(5) Blood borne infectious, contagious diseases.

3. Within ten (10) days after notice or knowledge of any claim for benefits, including medical treatment only, that is denied for any reason.

C. The insurer shall state whether liability is admitted or contested within 20 days after the date the employer's First Report of Injury is filed with the Division. If an Employer's First Report of Injury should have been filed with the Division but wasn't, the insurer's statement concerning liability is considered to be due within 20 days from the date the Employer's First Report of Injury should have been filed. The date a First Report of Injury should have been filed with the Division is the last day it could have been timely filed in compliance with paragraph (B) above.

D. The insurer shall state whether liability is admitted or contested within 20 days after the date the Division sends the insurer a Worker's Claim for Compensation or Dependent's Notice and Claim for Compensation.

E. No statement regarding liability may be filed until a workers’ compensation claim number is assigned. A separate and distinct statement regarding liability is required for each claim in which a workers’ compensation claim number is assigned.

F. In the format required by the Director, each insurer shall submit a monthly summary report to the Division containing the following:

1. Injuries to employees that result in no more than three days’ or three shifts’ loss of time from work, no permanent physical impairment, no fatality, active medical treatment less than 180 days, or contraction of an occupational disease not listed in subsection (B) of this rule; and 2. Exposures by employees to injurious substances, energy levels, or atmospheric conditions when the employer requires the use of methods or equipment designed to prevent such exposures and where such methods or equipment failed, was not properly used, or was not used at all. 5.3 Initial notice to claimant At the time an insurer notifies the Division of its position on a claim, the insurer shall notify the claimant, in writing, of the insurer's claim number, the name or verifiable pseudonym, and address of the individual assigned to the adjustment of the claim, a telephone number, and e-mail address of the adjuster. Any change of adjuster lasting longer than thirty (30) days shall be reported to all parties. 5.4 Medical reports and records A. Medical reports on claims that have been reported to the Division shall be filed with the Division under the following circumstances:

2. When included as support to an admission of liability form, or a petition to suspend benefits, or 2. When otherwise required by any other rule or the Act, or 3. At the request of the Director.

3. A copy of every medical report not filed with the Division shall be exchanged with the claimant and all other parties within fifteen (15) business days of receipt. A claimant or employer may opt to not receive copies of medical reports from the insurer under this section by providing written notice to the insurer. Such notice may be revoked by the claimant or employer in writing at any time.

B. For claims which are not required to be reported to the Division, the parties shall exchange medical reports within five (5) business days of a request for such information by a party to the claim.

C. A party shall have 15 days from the date of mailing or service to complete, sign, and return a release of medical and/or other relevant information. If a written request for names and addresses of health care providers accompanies the medical release(s), a claimant shall also provide a list of names and addresses of health care providers reasonably necessary to evaluate/adjust the claim along with the completed and signed release(s). Medical information from health care providers who have treated the part(s) of the body or conditions(s) alleged by the claimant to be related to the claim, during the period five years before the date of injury and thereafter through the date of the request, will be presumed reasonable. Any request for information in excess of the presumption contained in this rule shall include a notice that the insurer is requesting information in excess of what is presumed reasonable and that providing the information is not required. If a party disputes that a request within the presumption is reasonable or that information sought is reasonably necessary, that party may file a motion with the Office of Administrative Courts or schedule a prehearing conference.

Requests for release of medical information as well as informal disclosures necessary to evaluate/adjust the claim are not considered discovery.

D. A party shall have 15 days from the date of mailing or service to respond to a reasonable request for information regarding wages paid at the time of injury and for a reasonable time prior to the date of injury and ongoing, and other relevant information necessary to determine the average weekly wage and/or entitlement to temporary indemnity benefits. Any dispute regarding such a request may be resolved by the Director or an administrative law judge. The request for an exchange of information under this Rule 5-4(D) is not considered discovery.

E. Mental health records in the possession of an insurer or self-insured employer or any agent thereof shall not be exchanged with any party other than claimant or claimant’s counsel unless necessary for medical evaluation, adjustment or adjudication of the claim or otherwise approved by the Director or an Administrative Law Judge.

An insurer may release mental health records concerning work restrictions to the employer but shall not disclose the actual mental health records to any third party unless necessary for medical evaluation, adjustment or adjudication of the claim or otherwise approved by the Director or an Administrative Law Judge. 5.5 Admissions of liability A. When the final admission is predicated upon medical reports, a narrative report and appropriate worksheets must accompany the admission. The attachment of the physician’s report of workers’ compensation injury form is required in cases where such document is supplied by the physician concurrently with the narrative report. Attached documentation must provide a statement from an authorized treating physician regarding the date of maximum medical improvement, permanent impairment, and maintenance medical benefits.

1. Final admissions predicated upon medical reports shall reflect the recommendation of the authorized treating physician completing the physician’s report of workers’ compensation injury form or narrative report with regard to the provision of medical benefits after maximum medical improvement, as may be reasonable and necessary within the meaning of the act. The admission shall state the insurer’s position on the provision of medical benefits after maximum medical improvement. If maintenance medical benefits are being admitted, the insurer or self-insured employer shall admit to those benefits without additional language limiting to any specific medical treatment. If maintenance medical benefits are being denied, the admission shall make specific reference to the medical report by listing the physician's name and the date of the report in the remarks

section of the admission.

2. The objection form prescribed by the Division as part of the final admission form shall precede any attachment.

3. For claims reported to the Division in which only medical benefits have been paid and no permanent impairment has been assigned, either the narrative report or the physician’s report of workers’ compensation injury form shall be attached as support.

4. For claims reported to the Division in which only medical benefits have been paid and no permanent impairment has been assigned, a narrative report completed after the final admission of liability has been filed must be exchanged within fifteen (15) days of receipt.

B. An admission filed for medical benefits only shall state the basis for denial of temporary and permanent disability benefits within the remarks section of the admission.

C. Upon termination or reduction in the amount of compensation, a new admission shall be filed with supporting documentation on or prior to the next scheduled date of payment, regardless of the reason for the termination or reduction. The insurer shall continue making compensation payments on each scheduled payment due date until a new admission is filed. An admission shall be filed within 30 days of any resumption or increase of benefits.

1. Following any order (except for orders which only involve disfigurement) becoming final which alters or awards benefits, an admission consistent with the order shall be timely filed.

2. The filing of an admission consistent with this section shall not be construed as a reopening of any issues closed by a prior admission or resolved by order.

D. For all injuries required to be filed with the Division with dates of injury on or after July 1, 1991:

1. Where the claimant is a state resident at the time of MMI:

a. When an authorized treating physician providing primary care is not Level II accredited and has determined the claimant has reached MMI and has sustained any permanent impairment, such physician shall, within 20 days after the determination of MMI, refer the claimant to a Level II accredited physician for a medical impairment rating. If the referral is not timely made, the insurer shall refer the claimant to a Level II accredited physician for a medical impairment rating within 40 days after the determination of MMI.

b. If the authorized treating physician determining MMI is Level II accredited, within 20 days after the determination of MMI, such physician shall determine the claimant's permanent impairment, if any.

2. Where the claimant is not a state resident at the time of MMI:

a. When an authorized treating physician providing primary care is not Level II accredited and has determined the claimant has reached MMI and has sustained any permanent impairment, within 20 days after the determination of MMI, such physician shall conduct tests to evaluate impairment and shall transmit to the insurer all test results and relevant medical information. Within 20 days of receipt of the medical information, the insurer shall appoint a Level II accredited physician to determine the claimant's medical impairment rating from the information that was transmitted.

b. When the claimant chooses not to have the treating physician providing primary care conduct tests to evaluate impairment, or if the information is not transmitted in a timely manner, the insurer shall arrange and pay for the claimant to return to Colorado for examination, testing, and rating, at the expense of the insurer. The insurer shall provide to the claimant at least 20 days advance written notice of the date and time of the impairment rating examination, and a warning that refusal to return for examination may result in the loss of benefits. Such notification shall also include information identifying travel and accommodation arrangements.

E. For those injuries required to be filed with the Division with dates of injury on or after July 1, 1991:

1. Within 30 days after the date of mailing or delivery of a determination of impairment by an authorized Level II accredited physician, or within 30 days after the date of mailing or delivery of a determination by the authorized treating physician providing primary care that there is no impairment, the insurer shall either:

a. File an admission of liability consistent with the physician’s opinion, or b. Request a Division Independent Medical Examination (DIME) in accordance with Rule 11-3 and §8-42-107.2, C.R.S., c. In cases involving only a scheduled impairment, an application for hearing or final admission may be filed without a Division Independent Medical Examination.

(1) the filing of an application for hearing by the insurer under this provision shall not prevent the claimant from seeking a Division Independent Medical Exam on the issues of MMI and/or conversion to whole person impairment. The claimant shall have thirty (30) days from the filing of the application for hearing to request an independent medical exam.

(2) at the time the insurer files an application for hearing under this provision it shall concurrently provide a notification to the claimant that the claimant may request a DIME on the issues of MMI and/or conversion to whole person impairment, as well as a copy of the Division’s notice and proposal form.

F. Within 20 days after the date of mailing or delivery of the Division’s notice of receipt of the Division Independent Medical Examiner’s report, the insurer shall either admit liability consistent with such report or file an application for hearing.

This section does not pertain to IMEs rendered under § 8-43-502, C.R.S.

G. The insurer may modify an existing admission regarding medical impairment, whenever the medical impairment rating is changed pursuant to a Division Independent Medical Exam or an order. Any such modifications shall not affect an earlier award or admission as to monies previously paid.

H. When an insurer files an admission admitting for a medical impairment, the insurer shall admit for the impairment rating in a whole number. If the impairment rating is reported with a decimal percentage, the insurer shall round up to the nearest whole number.

I. An admission of liability which includes a reduction in benefits for a safety rule violation must include a statement from a representative of the employer of the specific facts on which the reduction is asserted. The statement shall be attached as a separate document to the initial admission.

J. An admission of liability which admits to a closed period of temporary partial disability benefits must include a statement or supporting documentation as to how benefits were calculated. 5.6 Prompt payment of compensation benefits A. Benefits and penalties awarded by order are due three (3) business days after the order becomes final. Any ongoing benefits shall be paid consistent with statute and rule.

B. Initial payment of temporary disability benefits awarded by admission shall be paid no later than the date the admission awarding benefits is filed. For purposes of determining timeliness, the benefits are deemed due three (3) business days after the date of the admission. Subsequent temporary disability benefits are due at least once every two (2) weeks thereafter from the date of the admission, not the date of the last payment. When benefits are continuing, the payment shall include all benefits which are due through the due date.

1. Payment mailed via the United States Postal Service shall be presumed timely if postmarked at least three (3) business days prior to the due date, excluding legal Colorado state holidays.

2. For payments issued electronically, payment will be considered timely if the funds are received by the claimant’s financial institution on or before the scheduled payment due date, excluding legal Colorado state holidays.

Delays attributable to the insurer’s electronic processing or payment practices do not excuse a late payment.

C. Permanent impairment benefits awarded by admission are retroactive to the date of maximum medical improvement and shall be paid no later than the date the admission awarding benefits is filed. Subsequent permanent disability benefits are due at least once every two (2) weeks from the date of the admission, not the date of the last payment. When benefits are continuing, the payment shall include all benefits which are due through the due date.

1. Payment mailed via the United States Postal Service shall be presumed timely if postmarked at least three (3) business days prior to the due date, excluding legal Colorado state holidays.

2. For payments issued electronically, payment will be considered timely if the funds are received by the claimant’s financial institution on or before the scheduled payment due date, excluding legal Colorado state holidays.

Delays attributable to the insurer’s electronic processing or payment practices do not excuse a late payment.

D. An insurer shall receive credit against permanent disability benefits for any temporary disability benefits paid beyond the date of maximum medical improvement.

E. Benefits shall be calculated based on a seven (7) day calendar week.

F. “Timely” refers solely to whether the payment was mailed or issued in accordance with this rule.

G. “Due date” is defined as the last calendar day of the applicable fourteen (14) day payment schedule established by the admission awarding benefits.

H. Failure to timely pay an ordered penalty on a final order may result in the imposition of additional penalties. 5.7 Permanent partial disability benefit rate A. Permanent partial disability benefits paid as compensation for a non-scheduled injury or illness which occurred on or after July 1, 1991, shall be paid at the temporary total disability rate, but not less than one hundred fifty dollars per week and not more than fifty percent of the state average weekly wage at the time of the injury.

1. For mental permanent impairment awards, the carrier must pay the entirety of the nonscheduled permanent impairment award or thirty-six (36) weeks at the nonscheduled permanent impairment rate, whichever is lower. Any temporary total disability paid while the claimant was undergoing mental health treatment while no physical medical treatment was occurring may count against the thirty-six (36) week limitation. The thirty-six (36) week limitation does not apply to any victim of a crime of violence nor to a victim of physical injury or occupational disease that causes neurological brain damage.

B. Scheduled impairment benefits shall be paid at the calculated rate pursuant to § 8- 42- 107 (6) C.R.S.

1. For injuries resulting in a scheduled impairment, the permanent partial disability amount must be determined utilizing the scheduled rating calculation if it is higher than the nonscheduled rating calculation.

C. Where scheduled and non-scheduled injuries occurred resulting in impairment, the scheduled and non-scheduled impairment benefits shall be paid concurrently. 5.8 Admission for permanent total disability benefits A. An insurer shall file an admission of liability for permanent total disability benefits on a final admission of liability form prescribed by the Division.

B. An insurer may terminate permanent total disability benefits without a hearing by filing an admission of liability form with all of the following attachments:

1. A death certificate or written notice advising of the death of a claimant; and 2. A statement by the insurer as to its liability for payment of:

a. Death benefits; and b. If there are dependents, the unpaid portion, if any, of permanent total disability benefits the claimant would have received had s/he lived until receiving compensation at the regular rate for a period of six years. 5.9 Revising Final Admissions A. Within the time limits for objecting to the final admission of liability pursuant to § 8- 43- 203, C.R.S., the Director may allow an insurer to amend the admission for permanency, by notifying the parties that an error exists due to a miscalculation, omission, or clerical error.

B. The period for objecting to a final admission begins on the mailing or service date of the last final admission. 5.10 Lump sum payment of an award A. For lump sum requests less than or equal to $10,000.00 for permanent partial disability awards for whole person or scheduled impairment the following applies per § 8-42-107.2 C.R.S:

1. Lump sum payment of $10,000.00, or the remainder of the award, if less, shall automatically be paid, less discount, on the claimant's written request to the insurer. The insurer shall calculate the sum certain and issue payment taking applicable offsets (i.e., disability benefits, incarceration, garnishments) within ten (10) business days from the date of mailing or service of the request by the claimant.

B. For lump sum requests greater than $10,000.00 for permanent partial awards, or for any permanent total, the following applies per § 8-43-406 C.R.S.:

1. If the claimant is represented by counsel, a request for a lump sum payment of a portion or remaining benefits shall be made by submitting a Request for Lump Sum Payment form to the insurer and the Division, if the claimant has indicated that the admission will be accepted as filed, relative to permanent partial disability and maximum medical improvement. The claimant is not required to waive the right to pursue permanent total disability benefits as a condition to receiving the lump sum. Within ten (10) days of the date the Request for Lump Sum Payment form was mailed or delivered, the insurer shall issue the payment and file the required benefit payment information with the Division, the claimant and the claimant's attorney.

a. The insurer shall have ten days from the claimant's request to object to the payment of the lump sum. Prior to payment and within the same ten (10) day time-period, the insurer shall submit the lump sum calculations to claimant, claimant's attorney and the Division providing the reason for the objection. Claimant shall have ten days from the insurer’s objection to file a response. Upon receipt of the form the Director shall make a determination on the lump sum request.

b. The claimant shall have ten days from the date the payment or payment information was mailed or issued to object to the accuracy of the payment by stating the basis for the objection, in writing, to the Division and insurer. Insurer shall have ten days from the claimant’s objection to file a response. Following receipt of the objection, the Director shall make a determination on the lump sum payment.

c. The total of all lump sums issued per claim may not exceed the amount set forth in the Director’s annual maximum benefit order in effect on the date the first non-$10,000 lump sum is requested.

2. If the claimant is not represented by counsel, a request for a lump sum payment of benefits shall be made by submitting a Request for Lump Sum Payment to the insurer and the Division if the claimant has indicated that the admission will be accepted as filed, relative to permanent partial disability and maximum medical improvement. The claimant is not required to waive the right to pursue permanent total disability benefits as a condition to receiving the lump sum. Within ten (10) days of the date the Request for Lump Sum Payment form was mailed or delivered, the insurer shall file the required lump sum calculation information with the Division and the claimant.

a. The claimant shall have ten (10) days from the date of mailing or issuance of the benefit payment information provided by the insurer to object to the accuracy of this information. In the absence of an objection, a lump sum order issued by the Director will be based upon the information submitted.

b. The total of all lump sums issued per claim may not exceed the amount set forth in the Director’s annual maximum benefit order in effect on the date the first non-$10,000 lump sum is requested.

C. For lump sum requests for dependents' benefits, the following applies per § 8-43- 406 C.R.S.:

1. A request for a lump sum payment of a portion or remaining benefits shall be made by submitting a request for lump sum payment form to the insurer and the Division. Within ten (10) days of the date the request for lump sum payment form was mailed or delivered, the insurer shall file the required lump sum calculation information with the Division and the claimant.

a. The insurer shall have ten (10) days from the claimant's request to object to the payment of the lump sum. Prior to payment and within the same ten (10) day time-period, the insurer shall submit the lump sum calculations to claimant, claimant's attorney and the Division providing the reason for the objection. Claimant shall have ten (10) days from the insurer’s objection to file a response.

Upon receipt of the form, the Director shall make a determination on the lump sum request.

b. The claimant shall have ten (10) days from the date the payment or payment information was mailed or issued to object to the accuracy of the payment by stating the basis for the objection, in writing, to the Division and insurer. The insurer shall have ten (10) days from the claimant’s objection to file a response. Following receipt of the objection, the Director shall make a determination on the lump sum payment.

c. The total of all lump sums issued to all dependents may not exceed the amount set forth in the Director’s annual maximum benefit order in effect on the date the first lump sum is requested.

(1) When the weekly benefit amounts were previously determined by an Administrative Law Judge or the Director, a dependent’s individual maximum lump sum amount shall be equivalent to the percent of total benefits as ordered.

(2) When the weekly benefit amounts were not previously determined by an Administrative Law Judge or the Director, a dependent’s individual maximum lump sum amount shall be determined by the Director.

D. The insurer shall issue payment within ten (10) days of the date of mailing or service of the order by the Director. 5.11 Documentation of Apportionment A. For all claims with a date of injury on or after July 1, 2008 a carrier may not reduce a claimant's temporary total disability, temporary partial disability or medical benefits because of any prior injury, whether work-related or non workrelated.

B. If a permanent impairment rating is reduced on an admission based on a prior work- related injury, a copy of the previous award or settlement shall be attached to the admission and must establish that the award or settlement was for the same body part. If a permanent impairment rating is reduced on an admission based on non-work-related injury, documentation shall be attached to the admission establishing prior impairment to the same body part that was identified, treated and independently disabling at the time of the work-related injury. 5.12 Receipts Upon demand of the Director, an insurer shall produce to the Division a receipt, canceled check, or other proof substantiating payment of any amount due to the claimant or to a provider. 5.13 Information on claims adjusting A. Every insurer, or its designated claims adjusting administrator; shall provide the following information on claims adjusting practices to the Division’s EDI administrator:

1. The name, address, telephone number and e-mail address of the administrator(s) responsible for its claims adjusting.

2. Within thirty (30) days of any change in administrator(s) responsible for claims adjusting, the incoming insurer, third-party administrator or selfinsured employer shall complete a “notice of change of carrier or adjusting firm.”

3. Upon request of the Director, any or all records, including any insurer administrative policies or procedures, pertaining to the adjusting of Colorado Workers' Compensation claims. This authority shall not extend to personnel records of claims personnel. All documents shall remain confidential.

B. Within thirty (30) days of any change in the administrator(s) responsible for claims adjusting, notice of such change shall be provided in writing to all parties, including but not limited to the claimant, attorneys, and medical providers. Notice shall include the name, address, a telephone number, and e-mail address of the claims administrator(s). 5.14 Correspondence from the Division A. An insurer or self-insured employer may designate a third party administrator (TPA) to handle specific claims by noting the designation on the First Report of Injury or an admission of liability. No correspondence will be sent to the TPA unless such a designation is made.

1. In claims initiated by a workers’ claim for compensation, the Division will forward the claim to the insurer or self-insured employer with a request for a position statement. The insurer or self-insured employer shall be responsible for forwarding the claim to the third party administrator (if any).

2. The insurer or self-insured employer remains responsible for ensuring compliance with these rules of procedure as well as the workers’ compensation act regardless of any designation of a third party administrator 5.15 Surveys A. Within 30 days following closure of each claim that was reported to the Division, the insurer shall survey the claimant. If the claimant is deceased the survey shall be presented to the claimant’s dependents, if there are such dependents. If two or more claims have been merged or consolidated, one survey may be presented.

B. If the claimant has previously authorized the insurer to communicate through electronic transmission, the survey may be sent to the claimant electronically.

Otherwise, the survey shall be mailed to the claimant. If mailed, along with the survey, the insurer shall provide a return postage prepaid envelope for the claimant to use when returning the survey.

C. The survey shall include the name of the insurer. The survey shall also have a space for the claimant to sign if communicated by mail. The survey shall include the following language: “This survey relates to your recent workers’ compensation claim. We would like to find out how satisfied you are with the way your claim was handled.” The survey shall include instructions as to how to return the completed survey to the insurer, and the sentence “Insurers and employers are prohibited by law from taking any disciplinary action or otherwise retaliating against those who respond to this survey.” In addition, the survey shall set forth only the following questions:

1. On a scale from 1 to 5, with 1 being the least satisfied and 5 being the most satisfied, please describe your satisfaction with the level of courtesy shown to you in relation to your workers’ compensation claim.

2. On a scale from 1 to 5, with 1 being the least satisfied and 5 being the most satisfied, please describe your satisfaction with how promptly you received medical care.

3. On a scale from 1 to 5, with 1 being the least satisfied and 5 being the most satisfied, please describe your satisfaction with how promptly your claim was handled.

4. On a scale from 1 to 5, with 1 being the least satisfied and 5 being the most satisfied, please describe your satisfaction with how quickly any disputes in your claim were resolved. If you did not have any disputes, please mark NA.

5. On a scale from 1 to 5, with 1 being the least satisfied and 5 being the most satisfied, please describe your overall satisfaction with the way your claim was handled.

6. The name of the adjuster handling your claim, if known.

D. On or before the last day of January in each year, the insurer shall report the survey results to the Division. The report shall include the total number of surveys presented to claimants during the preceding calendar year but shall be based on all survey results actually received by the insurer during that time. For the questions set out in (C)(1), (C)(2), (C)(3) and (C)(5) above, the insurer shall report the number of responses to the question and the average score based on those responses. For question (C)(4), the insurer shall report the number of responses to the question, the number of responses that indicated NA, and the average of those responses that provided a numerical response. There shall be only one report per insurer per year. The insurer shall maintain the actual survey responses for a minimum of six months after providing the results to the Division and shall provide the survey results to the Division upon request.

Rule 6 Modification, Termination or Suspension of Temporary Disability Benefits 6-1 TERMINATION OF TEMPORARY DISABILITY BENEFITS IN CLAIMS ARISING FROM INJURIES ON OR AFTER JULY 1, 1991 (A) In all claims based upon an injury or disease occurring on or after July 1, 1991, an insurer may terminate temporary disability benefits without a hearing by filing an admission of liability form with:

(1) a medical report from an authorized treating physician stating the claimant has reached maximum medical improvement; provided such admission of liability states a position on permanent disability benefits. This paragraph shall not apply in cases where vocational rehabilitation has been offered and accepted, or (2) a medical report from the authorized treating physician who has provided the primary care, stating the claimant is able to return to full or regular duty, or (3) a written statement from an employer or the claimant stating the claimant has returned to work at full wages and hours or setting forth the wages paid for the work to which the claimant has returned provided such admission of liability admits for temporary partial disability benefits, if the claimant has not returned to work at full wages, or (4) A copy of a written offer delivered to the claimant with a signed certificate of service, containing both an offer of modified employment, setting forth duties, wages and hours and a statement from an authorized treating physician that the employment offered is within the claimant's physical restrictions.

(a) A written offer of modified duty may only be used to terminate benefits pursuant to this subsection if:

(i) A copy of the written inquiry to the treating physician is provided to the claimant by the insurer or EMPLOYER at the time the authorized treating physician is asked to provide a statement on the claimant's capacity to perform the offered modified duty; and (ii) The claimant is provided a period of 3 business days from the date of receipt of the offer to return to work in response to the offer of modified duty.

(5) a copy of a certified letter to the claimant or a copy of a written notice delivered to the claimant with a signed certificate of service, advising that temporary disability benefits will be suspended for failure to appear at a rescheduled medical appointment with an authorized treating physician, and a statement from the authorized treating physician documenting the claimant’s failure to appear, OR (6) a letter or death certificate advising of the death of the claimant with a statement by the insurer as to its liability for death benefits.

6-2 TERMINATION OF TEMPORARY DISABILITY BENEFITS BY AN ADMISSION

OF LIABILITY IN CLAIMS ARISING AFTER JULY 2, 1987 AT 4:16 P.M. AND

BEFORE JULY 1, 1991

(A) In all claims based upon an injury or disease which occurred after July 2, 1987, at 4:16 p.m., an insurer may terminate disability benefits without a hearing by filing an admission of liability form with:

(1) a medical report from the authorized treating physician who has provided the primary care stating the claimant has reached maximum medical improvement; provided such admission of liability states a position on permanent disability benefits. This paragraph shall not apply in cases where vocational rehabilitation has been offered and accepted, or (2) a medical report from the authorized treating physician who has provided the primary care stating the claimant is able to return to regular employment provided such admission of liability states a position on permanent partial disability benefits, or (3) a written report from the employer or the claimant stating the claimant has returned to work and setting forth the wages paid for the work to which the claimant has returned; provided such admission of liability admits for temporary partial disability benefits, if any, or (4) a letter or death certificate advising of the death of the claimant with a statement by the insurer as to its liability for death benefits.

6-3 TERMINATION OF TEMPORARY DISABILITY BENEFITS BY AN ADMISSION

OF LIABILITY IN CLAIMS ARISING PRIOR TO JULY 2, 1987, AT 4:16 P.M.

(A) In all claims based upon an injury or disease which occurred prior to July 2, 1987, at 4:16 p.m., an insurer may terminate temporary disability benefits without a hearing by filing an admission of liability form with:

(1) a report from the authorized treating physician who has provided medical improvement and is released to return to an occupation which the claimant regularly performed at the time of the injury, or (2) a report from the authorized treating physician who has provided medical improvement and a Director’s determination that the claimant is not eligible for vocational rehabilitation services, or (3) a written report from the employer or the claimant stating the claimant has returned to work and setting forth the wages paid for the work to which the claimant has returned; provided such admission admits for temporary partial disability benefits, if any, or (4) a letter or death certificate advising of the death of the claimant with a statement by the insurer as to its liability for death benefits, OR (5) a report from the authorized treating physician who has provided medical improvement and documentation the claimant has completed an approved vocational rehabilitation plan.

6-4 SUSPENSION, MODIFICATION OR TERMINATION OF TEMPORARY

DISABILITY BENEFITS BY A PETITION

(A) When an insurer seeks to suspend, modify or terminate temporary disability benefits pursuant to a provision of the Act, and Rules 6-1, 6-2, 6- 3, 6-5, 6-6, 6-7 or 6-9 are not applicable, the insurer may file a petition to suspend, modify or terminate temporary disability benefits on a form prescribed by the Division. All documentation upon which the petition is based shall be attached to the petition. The petition shall indicate the type, amount and time period of compensation for which the petition has been filed and shall set forth the facts and law upon which the petitioner relies.

(B) When an insurer seeks to retroactively decrease temporary benefits after the first indemnity admission of liability is filed. The petition must be filed within thirty (30) days of the initial indemnity admission. This section shall not be used to retroactively claim a safety rule violation.

(C) A copy of a response form prescribed by the Division shall be included with a copy of the petition to the claimant and claimant's attorney and the Division. Certification of this mailing shall be filed with the petition.

(D) If the claimant does not file a written objection with the Division within twenty (20) days of the date of mailing of the petition and response form, the Director may grant the insurer's request to suspend, modify or terminate disability benefits as of the date of the petition.

(E) When a claimant files a timely objection to a petition, the insurer shall continue temporary disability benefits at the previously admitted rate until an application for hearing is filed with the Office of Administrative Courts, and the matter is resolved by order. The Director finds that good cause exists to expedite a hearing to be held within sixty (60) days from the date of the setting, because overpayment of benefits may result if the suspension, modification or termination is granted.

(F) When a hearing is continued at the request of the claimant, the prehearing administrative law judge shall temporarily grant the relief requested in the petition, pending the continued hearing, if the reports and evidence attached to the petition and objection indicate a reasonable probability of success by the insurer. The continued hearing shall be held no later than thirty (30) days from the date of the request for continuance.

(G) When a hearing is continued at the request of the insurer, temporary disability benefits shall continue until the matter is resolved by order after the hearing.

6-5 MODIFICATION OF TEMPORARY DISABILITY BENEFITS PURSUANT TO

STATUTORY OFFSET

An insurer may modify temporary disability benefits to offset social security, disability pension or similar benefits pursuant to statute by filing an admission of liability form with the Division, with documentation which substantiates the offset and figures showing how the amount of the offset was calculated pursuant to statute.

6-6 TERMINATION OR MODIFICATION OF TEMPORARY DISABILITY BENEFITS

DUE TO CONFINEMENT

An insurer may terminate or modify temporary disability benefits pursuant to statute, by filing an admission of liability form with the Division with a document issued by a court of criminal jurisdiction, which establishes that the claimant is confined in a jail, prison, or any department of corrections facility as a result of a criminal conviction.

6-7 TERMINATION OF TEMPORARY DISABILITY BENEFITS PURSUANT TO

THIRD-PARTY SETTLEMENT

An insurer may terminate temporary disability benefits pursuant to statute, by filing an admission of liability form with the Division with a copy of a document substantiating the claimant received money damages from a third-party claim arising from the worker's compensation injury and the amount of the award that may be offset pursuant to § 8-41-203, C.R.S.

6-8 FAILURE TO COMPLY WITH REQUIREMENTS OF RULE 6

(A) Temporary disability benefits may not be suspended, modified or terminated except pursuant to the provisions of this rule; pursuant to an order from the Director or pursuant to an order of the Office of (B) If the Director concludes the insurer has not met the applicable requirements of this rule, the Director may order the insurer to continue payment of temporary disability benefits, pursuant to § §8-42-105(3) and 8- 42-106(2), C.R.S., until the requirements of this rule are followed or until a hearing is held and further order entered.

6-9 TERMINATION OF TEMPORARY DISABILITY BENEFITS DUE TO FAILURE TO

RESPOND TO AN OFFER OF MODIFIED EMPLOYMENT FROM A

TEMPORARY HELP CONTRACTING FIRM IN CLAIMS FOR INJURIES

OCCURRING ON OR AFTER JULY 1, 1996

(A) An insurer may terminate temporary disability benefits by filing an admission of liability with:

(1) a copy of the initial written offer of modified employment provided to the claimant, which clearly states that future offers of employment need not be in writing, a description of the policy of the temporary help contracting firm regarding how and when employees are expected to learn of such future offers, and a statement that benefits shall be terminated if an employee fails to timely respond to an offer of modified employment;

(2) a written statement from the employer representative giving the date, time, and method of notification which forms the basis for the termination of temporary disability benefits; and (3) a statement from the attending physician that the employment offered is within the claimant’s restrictions.

(B) The claimant is allowed a period of at least twenty-four hours, not including any part of a Saturday, Sunday, or legal holiday within which to respond to any such offer.

Rule 7 Closure of Claims and Petitions to Reopen 7-1 CLOSURE OF CLAIMS (A) A claim may be closed by order, final admission, or pursuant to subsection (C) of this section.

(B) A Final Admission of Liability may be filed based on abandonment of the claim if the claimant:

(1) Is not receiving temporary disability benefits; and (2) has not attended two or more consecutive scheduled medical appointments; and (3) has failed to respond within 30 days to a letter from the insurer or the insured asking if the claimant requires additional medical treatment or is claiming permanent impairment. The letter shall be sent after the second missed medical appointment to the claimant and the claimant's attorney if the claimant is represented. The letter must advise the claimant in bold type and capital letters that failure to respond to the letter within 30 days will result in a final admission being filed. If the claimant timely responds to the letter and objects to closure the insurer may not file a Final Admission of Liability pursuant to this rule.

(a) If a claim is abandoned and a Final Admission of Liability is filed pursuant to this rule, date of maximum medical improvement shall not be included.

(b) A copy of the letter sent to the claimant as well as documentation of the missed appointments must be attached to the final admission of liability.

(c) If the claimant timely objects to a final admission of liability filed pursuant to subsection (b) of rule 7-1 the insurer must withdraw the final admission by filing a general admission of liability..

(C) When no activity in furtherance of prosecution has occurred in a claim for a period of at least 6 months, a party may request the claim be closed.

(1) Claimant must not be receiving temporary disability benefits.

(2) The request to close the claim shall include a separate, properly captioned proposed order to show cause and prepared certificate of mailing, along with addressed, stamped envelopes for the claimant, insurer and each attorney of record who has entered an appearance in the case. Requests may be submitted via regular mail. Email submission is permitted if email addresses are provided for all parties.

(3) Following receipt of a request to close a claim, the Director may issue the order to show cause why the claim should not be closed.

If no response is mailed or delivered within 30 days of the date the order was mailed, the claim shall be closed automatically, subject to the reopening provisions of § 8-43-303, C.R.S. If a response is timely received, the Director may determine whether the claim should remain open. An application for hearing or for a division independent medical examination without further action (i.e., setting and attending a hearing or a division independent medical examination) does not automatically constitute prosecution.

(4) The Director may issue an extension of time to show cause to allow a party an opportunity to prosecute the claim. Any such extension of time to show cause shall not be reconsidered.

(D) Closure of a claim pursuant to 7-1(C) does not terminate entitlement to any of the following:

(1) maintenance medical benefits previously admitted and/or ordered.

(2) permanent medical impairment benefits previously admitted and/or ordered which have not yet been paid.

(E) A final admission of liability may be filed based on the claimant’s voluntary abandonment upon written notice that the claimant no longer wishes to pursue the claim if the claimant:

(1) is no longer receiving temporary disability benefits; and (2) acknowledges in the written notice upon a form prescribed by the division that the claimant is abandoning current and future medical care related to the claim;

(3) The claimant may object to a final admission of liability filed pursuant to 7-1(E).

7-2 PETITIONS TO REOPEN

(A) A claimant or insurer may request to reopen a claim, pursuant to §8-43- 303, C.R.S. by filing an application for hearing with the office of administrative courts and endorsing the issue of reopening.

(1) If the other party agrees to voluntarily reopen the claim the Division shall be notified by the insurer by the filing of an admission (2) If the claim is reopened pursuant to an order, the insurer shall file an admission consistent with the order within 20 days of the order becoming final.

(B) For those injuries arising after July 2, 1987 at 4:16 p.m. and prior to July 1, 1991, a Petition to Reopen shall be filed when a claimant is requesting a redetermination of the original permanent partial disability award pursuant to Section §8-42-110(3), C.R.S., (repealed 7/1/91). The petition shall be filed with a statement outlining the circumstances of termination from employment.

7-3 SINGLE LIFE EXPECTANCY TABLE 0 84.6 61 26.2 1 83.7 62 25.4 2 82.8 63 24.5 3 81.8 64 23.7 4 80.8 65 22.9 5 79.8 66 22.0 6 78.8 67 21.2 7 77.9 68 20.4 8 76.9 69 19.6 9 75.9 70 18.8 10 74.9 71 18.0 11 73.9 72 17.2 12 72.9 73 16.4 13 71.9 74 15.6 14 70.9 75 14.8 15 69.9 76 14.1 16 69.0 77 13.3 17 68.0 78 12.6 18 67.0 79 11.9 19 66.0 80 11.2 20 65.0 81 10.5 21 64.1 82 9.9 22 63.1 83 9.3 23 62.1 84 8.7 24 61.1 85 8.1 25 60.2 86 7.6 26 59.2 87 7.1 27 58.2 88 6.6 28 57.3 89 6.1 29 56.3 90 5.7 30 55.3 91 5.3 31 54.4 92 4.9 32 53.4 93 4.6 33 52.5 94 4.3 34 51.5 95 4.0 35 50.5 96 3.7 36 49.6 97 3.4 37 48.6 98 3.2 38 47.7 99 3.0 39 46.7 100 2.8 40 45.7 101 2.6 41 44.8 102 2.5 42 43.8 103 2.3 43 42.9 104 2.2 44 41.9 105 2.1 45 41.0 106 2.1 46 40.0 107 2.1 47 39.0 108 2.0 48 38.1 109 2.0 49 37.1 110 2.0 50 36.2 111 2.0 51 35.3 112 2.0 52 34.3 113 1.9 53 33.4 114 1.9 54 32.5 115 1.8 55 31.6 116 1.8 56 30.6 117 1.6 57 29.8 118 1.4 58 28.9 119 1.1 59 28.0 120+ 1.0 60 27.1

Rule 8 AUTHORIZED TREATING PHYSICIAN AND INDEPENDENT MEDICAL EXAMS 8-1 APPLICABILITY (A) This rule applies to all employers unless specified below under paragraph (B) or (C) of this section.

(B) Employers that are health care providers or governmental entities that currently have their own occupational health care provider system pursuant to §8-43-404(5)(a)(ii)(A) may designate health care providers from their own system and are otherwise exempt from the requirement to provide a list of alternate physicians or corporate medical providers (1) If emergency care is provided, an employer exempt under 8-1(B) shall designate an authorized treating physician as allowed by statute when emergency care is no longer required. If an exempt employer refers an injured worker to a physician who can attend the injured worker when the injury occurred while the worker was away from the worker's usual place of employment, such employer may designate an authorized treating physician pursuant to 8-1(B) within seven (7) business days following the date the employer has notice of the injury.

(2) If an exempt employer does not properly designate a health care provider from its own system the injured worker may select a provider of the worker's choosing.

(C) If an employer has a qualified on-site health care facility, the employer may designate that facility as the authorized treating physician.

(1) To be a qualified on-site health care facility, the on-site facility must be under the supervision and control of a physician, and a physician must be on the premises or reasonably available.

(2) If the employer designates an on-site health care facility, the employer must, within seven (7) business days following notice of an on the job injury, provide the injured worker with a designated provider list consistent with the provisions of Rule 8-2. While the on-site health care facility shall be the initial authorized treating physician, the injured worker may thereafter change to a physician or corporate medical provider on the designated provider list if the injured worker complies with all statutory and rule requirements for the one time change of physician.

8-2 DESIGNATED PROVIDER LIST

(A) When an employer has notice of an on-the-job injury, the employer or insurer shall provide the injured worker with a written list of designated providers from which the injured worker may select a physician or corporate medical provider. For purposes of this rule 8, the list will be referred to as the designated provider list.

(1) A copy of the written designated provider list must be given to the injured worker in a verifiable manner within seven (7) business days following the date the employer has notice of the injury.

(2) The designated provider list must include contact information for the insurer of record including address, phone number and claims contact information. If the employer is self-insured, the same contact information is required including the names and contact information of persons responsible for adjusting the claim.

(B) The designated provider list may include any combination of physicians and/or corporate medical providers so long as at least one physician or corporate medical provider is at a distinct location without common ownership. If there are not at least two physicians or corporate medical providers at distinct locations without common ownership within thirty miles of the employer’s place of business the list may be comprised of providers at the same location or with common ownership.

(C) The number of physicians or corporate medical providers required on the designated provider list is determined by the number of physicians or corporate medical providers willing to treat an injured employee within thirty miles of the employer’s location:

AVAILABLE PROVIDERS WITHIN 30

MILES:

REQUIRED NUMBER OF

DESIGNATED PROVIDERS TO

BE LISTED:

THREE OR LESS ONE

AT LEAST FOUR BUT LESS THAN

NINE

TWO NINE OR MORE FOUR

(D) A physician or corporate medical provider is presumed willing to treat injured workers unless the employer is specifically informed by the physician or corporate medical provider to the contrary.

(E) If the employer fails to supply the required designated provider list in accordance with this rule, the injured worker may select an authorized treating physician or chiropractor of their choosing.

8-3 EMERGENCY DESIGNATION

(A) In an emergency situation the injured worker shall be taken to any physician or medical facility that is able to provide the necessary care.

When emergency care is no longer required the provisions of section 8-2 of this rule apply.

(B) If the injured worker is away from the worker's usual place of employment at the time of the injury, the injured worker may be referred to a physician in the vicinity where the injury occurred who can attend to the injury. Within seven (7) business days following the date the employer has notice of the injury the employer shall comply with the provisions of section 8-2 of this

rule.

8-4 INFORMATION PROVIDED BY DESIGNATED PROVIDERS

(A) For the purposes of §8-43-404(5)(a)(I)(A), an interested party to a particular claim includes the injured worker, the attorneys of record, the employer, the insurer, and any third party administrator authorized to handle the specific claim.

(B) In order to provide information to assist in choosing a physician or deciding to change physicians, an interested party is entitled to receive a list of ownership interests and employment relationships involving the provision of medical care, if any, by making a written request for such information from a designated provider. A copy of the written request must be provided by the interested party to the respondents' representative(s).

A physician who provides medical services on behalf of a corporate medical provider, but does not act as a primary care physician, is not subject to this provision. A designated provider shall utilize a form established by the Division to provide this information.

(1) The designated provider's list of ownership interests and employment relationships shall be current to within thirty (30) days of the date of the request.

(2) If the form was not previously provided and an interested party requests such information from a designated provider, the form shall be provided within five (5) business days of the request.

(3) If the information referenced in this paragraph (B) is provided, no follow-up questions or request for additional information shall be permitted, except for information allowed pursuant to a hearing or discovery process.

(C) If the list of ownership interests and employment relationships was not previously provided, and an interested party requests the information in compliance with the provisions of Rule 8-4(B) and the information is not provided in a timely manner, the interested party may notify the respondents' representative(s) in writing. To be effective, such notification must be made within seven (7) business days following the date the information should have been provided.

(1) Within seven (7) business days following timely notification pursuant to this paragraph (C), the injured worker shall be provided with a substitute authorized treating physician. If a substitute authorized treating physician is not timely furnished the injured worker may select an authorized treating physician of the worker's choosing.

8-5 ONE TIME CHANGE OF AUTHORIZED TREATING PHYSICIAN WITHIN

NINETY DAYS

(A) Within ninety (90) days following the date of injury, but before reaching maximum medical improvement, an injured worker may request a onetime change of authorized treating physician pursuant to §8-43- 404(5)(a)(III). The new physician must be a physician on the designated provider list or provide medical services for a designated corporate medical provider on the list. The medical provider(s) to whom the injured worker may change is determined by the designated provider list given to the injured worker pursuant to Rule 8-2 or 8-5(C).

(B) To make a change pursuant to this Rule 8-5 the injured worker must complete and sign the form established by the division for this purpose.

The injured worker shall submit the form to the employer by mailing or hand-delivering the completed form to the person(s) designated by the employer to receive the form. The person(s) so designated is listed on the designated provider list given to the injured worker pursuant to Rule 8-2 or 8- 5(C) as the respondents' representative(s). The injured worker may, but is not required to, provide the form to the impacted physicians. In any event, the respondents' representative(s) shall notify the impacted physicians and the individual adjusting the claim of the change, unless an objection is submitted pursuant to paragraph (C) of this Rule 8-5.

(C) If the insurer or employer believes the notice provided pursuant to this rule does not meet statutory requirements and does not accept the change of physicians, it must provide written objection to the injured worker within seven (7) business days following receipt of the form referenced in paragraph (B). The written objection shall set out the reason(s) for the belief that the notice does not meet statutory requirements.

(1) If the employer or insurer does not provide timely objection as set out in this paragraph (C), the injured worker's request to change physicians must be processed and the new physician considered an authorized treating physician as of the time of the injured worker's initial visit with the new physician.

(2) If written objection is provided and the dispute continues, any party may file a motion or, if there is a factual dispute requiring a hearing, any party may request that the hearing be set on an expedited basis.

8-6 TRANSFER OF MEDICAL CARE

(A) When there is a change of authorized treating physicians, the physician who had been the authorized treating physician remains authorized and is expected to provide necessary care until the injured worker's initial visit with the new authorized physician, at which time the treating relationship with the prior authorized treating physician shall terminate.

(B) The insurer or employer may facilitate the transfer of medical records to the new authorized physician. Otherwise, the new authorized physician should request medical records from the previous physician as soon as practicable. Upon receipt of a request for medical records, the physician receiving the request shall provide the medical records to the new physician within seven (7) calendar days following the physician's receipt of the request. If any copying is necessary the insurer shall pay for the copies consistent with the medical fee schedule.

(C) The insurer, employer or injured worker may schedule an appointment for the injured worker with the new authorized physician. If the new authorized physician is unwilling or unable to schedule an appointment to treat the injured worker, the injured worker shall notify the respondents' representative(s) in writing. Upon receiving such a notification, the respondents' representative(s) shall attempt to facilitate the scheduling of an appointment, which shall be scheduled to take place within thirty (30) days following the date of receipt of the notification. If a timely appointment cannot be scheduled and the injured worker does not agree to a later appointment, the injured worker shall be provided with a substitute authorized treating physician. If, within seven (7) business days following the date the respondents' representative(s) received written notice that the appointment could not be scheduled, an appointment is not scheduled or a substitute physician provided, the injured worker may select an authorized treating physician of the worker's choosing.

8-7 CHANGE OF MEDICAL PROVIDER UNDER §8-43-404(5)(A)(VI)

(A) In addition and separately from all the other provisions of this Rule 8, an injured worker may submit a written request to change physicians to the insurer or employer’s authorized representative if self-insured. Such a request must be on the form prescribed by the division of workers’ compensation.

(B) The insurer or employer’s authorized representative if self-insured shall have twenty (20) days from the date of the certificate of service of the request form to either grant permission for the requested change of physician or object in writing on the form prescribed by the division of workers’ compensation. Failure to timely object shall be deemed a waiver of objection.

8-8 INDEPENDENT MEDICAL EXAMINATIONS

(A) The following rules apply when the employer or insurer requests an independent medical examination to be conducted pursuant to §8-43-404.

Prior to each such examination the employer or insurer shall ensure that the examining physician is provided written notice that describes the requirements relating to recording the examination as set out in statute and these rules.

(B) The examining physician shall provide both parties with a written medical report prepared as a result of the independent medical examination.

8-9 NOTICE TO CLAIMANT

(A) Prior to commencing the examination, the injured worker must review and sign a form issued by the Division that contains information regarding the independent medical examination process. A language interpreter may provide assistance if necessary. This form may be presented by the examining physician or by the employer, insurer or third-party administrator any time prior to the examination. The injured worker shall sign the form to reflect receipt of the information. The injured worker, examining physician and all parties are entitled to a copy of the signed form. The examination shall not take place unless the injured worker has signed the form. Refusing to sign the form shall constitute refusal to submit to the independent medical examination.

(B) Immediately prior to the examination, the examining physician shall verbally notify the injured worker that the examination will be audio recorded.

8- 10 AUDIO RECORDING AND FEES

(A) The examining physician shall not alter the recording.

(B) The required audio recording shall be saved in a digital format. The examining physician shall retain the original recording.

(C) The examining physician shall be compensated for conducting the examination pursuant to the medical fee schedule, Rule 18-6(G)(4)- Special Reports.

(D) If a party requests a copy of the audio recording, regardless of which party makes the initial request, the first copy of the recording is provided only to the injured worker. If the injured worker makes the initial request for a copy of the recording, he/she shall be responsible for the cost of the copy. If the employer/insurer makes the initial request for a copy of the recording, it shall be responsible for the cost of the copy provided to the injured worker.

The physician may require payment prior to releasing a copy of the recording.

8- 11 PROCESS

(A) The recording shall not be released to anyone other than a party to the claim or the Division. This rule does not prohibit an employee or vendor of the examining physician or the Division from access to the recording for purposes of copying or transcribing the recording.

(B) Any party may request a copy of the recorded examination within twenty (20) days of the date the written medical report was issued. All requests for copies shall be made to the examining physician, in writing, with a copy of the request to all other parties. The written request shall include the address to which the copy is to be provided along with payment as defined in Rule 18.

(C) If the injured worker makes the initial request for a copy of the recording, the examining physician shall, within fifteen (15) calendar days of the date of the written request, provide a copy of the recording to only the injured worker.

(D) If the employer/insurer makes the initial request for a copy of the recording, the employer/insurer’s written request shall instruct the examining physician to provide a copy of the recording only to the injured worker. The employer/insurer’s written request must also provide the address for the injured worker. The examining physician shall provide a copy to the injured worker within fifteen (15) calendar days of the date of the written request.

(E) If the injured worker alleges that the recording contains medical information not relevant to the workers’ compensation claim which should remain confidential, he/she must raise that allegation in writing within fifteen (15) calendar days of the date the copy of the recording was provided. The written allegation along with the copy of the recording and a copy of the written medical report received by the injured worker must be provided to the Division’s Customer Service Unit. A copy of the written allegation shall also be provided to the examining physician and the employer/insurer. Within ten (10) days of the allegation being provided to the employer/insurer, the employer/insurer may file a response to the injured worker’s allegation with the Division’s Customer Service Unit.

Failure to raise an allegation in a timely manner results in the injured worker having waived the right to raise any allegations of confidentiality in the recording.

(F) Only medical information that is not discussed in the written report generated by the physician as a result of the independent medical examination may be raised pursuant to paragraph (F) above. This limitation does not impact the injured worker’s ability to challenge any aspect of the written report.

(G) A written allegation from an injured worker that the recording contains medical information that should remain confidential must provide a sufficient level of detail. A sufficient level of detail exists if the written statement provides general information as to what medical information was communicated that should remain confidential, and why the information should remain confidential within the context of the workers’ compensation claim. Raising medical issues contained in the report, or failing to provide sufficient detail shall result in a summary denial of the allegation by an ALJ.

(H) If no timely allegation regarding confidential information pursuant to paragraph (F) is made, the employer/insurer may then request a copy of the recording by providing a written request to the examining physician, explaining that no allegation was made by the injured worker and a copy of the recording may be released to the employer/insurer. Payment to the examining physician shall be included with this request. The examining physician shall provide a copy of the recording within fifteen (15) calendar days of the date the written request is received.

(I) If the injured worker alleges that the recording contains confidential medical information as set out in paragraph (F) of this rule, the employer/insurer shall not request a copy of the recording until the allegation is resolved.

(J) If the Division receives an allegation pursuant to paragraph (F), the Division will submit the recording, a copy of the written medical report, the injured worker’s allegation and any response from the employer/insurer to an Administrative Law Judge either in the Prehearing Unit or the Office of (K) An Administrative Law Judge shall consider the injured workers’ allegations and any response, listen to the recording in camera if necessary, and determine if the recording contains confidential medical information not relevant to the claim.

(L) If an Administrative Law Judge determines that the recording does not contain confidential medical information, the Administrative Law Judge will issue an appropriate order and return the recording to the injured worker.

The employer/insurer may then request a copy of the recording within twenty (20) days of the date the order was issued by providing a written request, along with payment pursuant to Rule 18 to the examining physician. The examining physician shall provide a copy of the recording to the employer/insurer within fifteen (15) days calendar days of the date the written request is received.

(M) If an Administrative Law Judge determines that the recording contains confidential medical information, the Administrative Law Judge shall issue an order to the parties and the examining physician. The Administrative Law Judge shall then produce, or cause to be produced, a copy of the recording with the confidential medical information redacted. An order to redact information does not constitute a final decision as to the relevancy of that information in any future proceeding. The Administrative Law Judge will provide the original recording and the redacted recording to the Division’s Customer Service Unit. The Division will maintain the copy of the original and redacted recording until the claim is closed. Either party may obtain a copy of the redacted recording by providing a written request, along with payment of $10, to the Division.

(N) If paragraph (M) applies and for any reason the Administrative Law Judge is unable to redact the recording, the Administrative Law Judge will issue an order that copies of the recording may not be released and will provide the copy of the original recording to the Division’s Customer Service Unit.

If necessary an Administrative Law Judge may thereafter review the recording in camera to assist in resolving factual disputes that may arise.

8- 12 MAINTENANCE OF THE RECORDINGS

(A) Absent an order to the contrary, the examining physician may destroy the recording twelve (12) months after the date the examining physician’s written report was issued.

(B) Any recording in the possession of the Division may be destroyed once the claim is closed.

8- 13 DISPUTES

If a dispute arises, such as, the examination was not recorded, or if the recording is inaudible, the parties may file a motion with an Administrative Law Judge if they cannot agree on a resolution. Each dispute will be considered individually and determined based upon the specific facts in existence so that the Administrative Law Judge may fashion an appropriate remedy. Generally, the striking of the IME report will be the appropriate remedy. If the examining physician was responsible for the faulty or inaudible recording, the examining physician may be required to repeat the examination without additional payment. If another party was responsible for a faulty or inaudible recording that party may be required to pay for a repeat examination.

Rule 9 Division of Workers’ Compensation Dispute Resolution 9-1 DISCOVERY One of the goals of the workers' compensation system is to minimize litigation, but disputes do arise and a system for resolution is necessary. One of the underlying premises of an administrative adjudication system is that parties should be able to resolve disputes in, as much as possible, a quick, inexpensive and simple manner. Therefore, when discovery is authorized and appropriate, the following apply:

(A) Upon agreement of the parties or for good cause shown, an administrative law judge may allow additional discovery, may limit discovery or may modify the time limits set forth in this rule. Good cause shall include but not be limited to agreement of the parties or setting of a hearing on an expedited basis.

(B) Interrogatories and requests for production (1) When a hearing application has been filed:

(a) Written interrogatories and requests for production of documents may be served upon each adverse party. The number of interrogatories, including the requests for production of documents, to any one party shall not exceed 20. These requests are tied to the most recent hearing application, but may carry over to a subsequent application upon agreement of the parties or by order.

(b) The interrogatories and the requests for production of documents may not be submitted later than 60 days prior to hearing, except for expedited hearings, agreement of the parties, or by order.

(c) Each party is under a continuing duty to timely supplement or amend responses to discovery up to the date of the hearing.

(2) When no hearing application has been filed:

(a) Interrogatories and requests for production of documents may only be served upon agreement of the parties or with an order for good cause shown that there are relevant and/or ripe issues in dispute.

(b) The number of interrogatories, including the requests for production of documents, to any one party shall not exceed ten (10), absent agreement of the parties or an order from an administrative law judge.

(3) When permitted, responses to interrogatories and production of documents shall be provided to all opposing parties within 20 days of service of the interrogatories and requests.

(4) Each interrogatory shall be answered separately and fully, in writing, unless it is objected to. Answers to interrogatories provided pursuant to this rule shall be treated as if under oath. All objections must be signed by the attorney making them.

(C) Depositions (1) Depositions may be taken upon written motion and order, or by written consent of the parties, except that depositions of expert witnesses may be taken without an order upon agreement of the parties, provided the deposition is scheduled to occur no later than one (1) day prior to any hearing date. Expert testimony depositions may be scheduled after the hearing upon agreement of the parties or by order for good cause shown.

(2) Absent consent of the parties, permission to take a deposition of a party will be granted only when there is a specific showing:

(a) That a party who has been served with written interrogatories has failed to respond to the interrogatories; or (b) That the responses to the written set of interrogatories are insufficient.

(3) A non-party witness may object to being deposed in writing to the requesting party within five (5) days of service of the subpoena.

(a) The subpoena must be accompanied by notice to the nonparty deponent of the right to object in writing.

(b) If the non-party deponent objects, the requesting party may schedule a prehearing conference to request an order compelling the deposition.

(D) Discovery, other than depositions, shall be completed no later than 20 days prior to the hearing date, except for expedited hearings, agreement of the parties, or by order.

(E) If any party fails to comply with the provisions of this rule and any action governed by it, an administrative law judge may impose sanctions upon such party pursuant to statute and rule. However, attorney fees may be imposed only for violation of a discovery order.

(F) Once an order to compel has been issued and properly served upon the parties, failure to comply with the order to compel shall be presumed willful.

9-2 MEDIATION, SETTLEMENT CONFERENCES, PREHEARING CONFERENCES

AND ARBITRATION

(A) Mediation. Parties to a dispute may consent to submit any dispute to mediation. A request for mediation may be presented to either the Division of Workers' Compensation or the Office of Administrative Courts. If all parties agree, a conference will be scheduled.

(B) Settlement Conferences. Parties to a dispute may request a settlement conference subject to the limitations set forth in § 8-43-206. Parties are encouraged to provide a settlement statement to the administrative law judge conducting the settlement conference at least 48 hours in advance of the settlement.

(C) Prehearing Conferences. The Director, administrative law judges in the Office of Administrative Courts, or any party to a claim may request a prehearing conference before an administrative law judge. Administrative law judges may order any party to a claim to participate in a prehearing conference.

(1) The issues raised for consideration may be raised by written or oral motion at the time of setting. At the time of setting, the party setting the conference shall notify the prehearing conference unit of the issues to be heard. The prehearing conference unit will notify all parties of the issues via e-mail.

(2) Within four (4) days of the setting, any party may add issues to be heard by providing written notice to the prehearing conference unit and all other parties.

(a) Issues added more than four (4) days after the setting may be heard at the discretion of the administrative law judge.

(3) A party may request additional time to respond to an issue raised at the prehearing conference. It shall be within the discretion of the administrative law judge to determine if such additional time is necessary to protect the rights of the parties.

(4) Once a prehearing conference has been requested by a party to a claim, it shall be set. If any party objects to the prehearing conference as set, the following procedures shall apply:

(a) A party objecting to the setting of a prehearing conference or refusing to participate in the conference shall e-mail, fax or hand-deliver any objections to the prehearing unit within four (4) days following the date the prehearing conference is set.

If the administrative law judge orders that the prehearing conference proceed as set, the requesting party shall send written notice of the time and place of the prehearing conference to all other parties.

(5) Any party to a claim may request that the prehearing conference be recorded electronically either in advance or on the date of the prehearing conference. If a request for electronic recording is made, a party shall have until the date of the merit hearing, if such hearing date is pending at the time of the prehearing conference, or 100 days following the prehearing conference, whichever is shorter, within which to request that the prehearing conference unit provide a copy of the electronic recording.

(6) A party requesting a prehearing conference must make a good faith effort to confer with all opposing parties regarding both the proposed scheduling of the conference and the matters to be addressed at the conference at least one (1) day before setting the conference.

(D) Arbitration. Parties to a dispute may consent to submit any dispute to binding arbitration by written agreement. Binding arbitration shall be conducted by an eligible administrative law judge of the parties' mutual choice, or pursuant to arbitration procedures as provided by the Colorado Rules of Civil Procedure. Unless otherwise provided by the administrative law judge or upon mutual consent of the parties and/or upon the order of the arbitrator(s), proceedings in any such arbitration shall be conducted in a manner consistent with the Colorado Rules of Civil Procedure.

9-3 MOTIONS

(A) Director’s Orders: All matters for the Director's determination shall be filed with the Division of Workers' Compensation, to the attention of the Director. Matters for the Director's determination include but are not limited to:

(1) Requests for penalties for consideration by the Director;

(a) Such motion shall state with specificity the grounds upon which penalties are being sought, and include all evidence upon which the requesting party is basing the request. If no response to the motion is filed, the Director may issue an order to show cause why penalties should not be imposed. failure to respond to the order to show cause may be deemed an admission of the facts alleged in the motion and a waiver of the right to be heard in response to the request for penalties.

(2) Requests for attorney fee determinations made by the Director;

(3) Matters regarding claims handling or administration, including, but not limited to, benefit distribution, petitions to modify, terminate or suspend temporary benefits, and lump sum requests;

(4) Requests for payment of costs of a transcript due to indigence pursuant to §8-43-213 (3);

(5) Closure orders;

(6) Matters involving uninsured employers;

(7) Utilization reviews, unless the Director has referred the matter on appeal;

(8) Disputes regarding medical payments, including requests to pay in excess of the fee schedule.

(B) Motions shall be filed exclusively with either the Division of Workers’ Compensation or the Office of Administrative Courts. Duplicate copies of motions shall not be filed. Copies of these documents may be filed if required as attachments, evidence submissions, and other instances to complete the record for determination of a matter before the Director or an administrative law judge.

(C) Every motion must include a certification by the party or counsel filing the motion that he or she has conferred, or made a good faith effort to confer, with opposing counsel and unrepresented parties. If no conference has occurred, an explanation must be included in the motion.

(D) The motion shall conspicuously state in the caption if the motion is contested, uncontested or stipulated. If a motion is stipulated, or uncontested, the motion may be granted immediately.

(E) Any response or objection shall be filed within 10 days from the date the initial motion was filed. A response or objection must be simultaneously served on the opposing parties. The certificate of service must indicate that service was executed on the date of filing and indicate the method of service.

(F) The parties shall submit a proposed order with each motion and response.

The proposed order shall be in editable format and shall include a certificate of service containing the e-mail addresses for all parties. The resulting order shall be sent by e-mail to all parties. If e-mail information is not available for all parties, the order shall be sent to the moving or prevailing party who is responsible for distribution of true and correct copies of the order to all remaining parties promptly, and in any event, no later than five (5) days after the date the order is received.

(G) Motions filed for consideration by the Director or an administrative law judge may be submitted via electronic mail and should be sent to the attention of either the Director’s office or the prehearing unit, respectfully.

9-4 PRIVILEGES AND PRIVILEGE LOGS

(A) In discovery and disclosure disputes in which a privilege is being asserted (including but not limited to discovery and requests for claim files pursuant to §8-43-203) the party asserting the privilege shall prepare a privilege log with sufficient description to allow the other parties to assess the applicability of the privilege claims.

(B) The privilege log shall contain, at a minimum:

1. The date of the item for which the privilege is being asserted;

2. The author and recipient of the item;

3. A description of the subject matter sufficient to explain, without disclosing the substance of the allegedly privileged material, why the item qualifies for the asserted privilege;

4. The legal and factual basis for the claim of privilege;

5. If the privileged item contains a communication, the names and titles of the parties to that communication;

6. The page or bates number of the item for which privilege is asserted.

9-5 TRUST DEPOSITS AND SURETY BONDS

(A) The Director’s office shall be designated as trustee for purposes of §8-43- 408(2). When the provisions of §8-43-408 apply, an administrative law judge or the Director shall compute, using the best information available, the present value of the total indemnity and medical benefits estimated to be due on the claim. The employer shall provide the funds so ordered by check within ten days of the order. The trustee shall pay an amount to bring the claim current, and continue to pay the claimant benefits on a regular basis in an interval and amount ordered by an administrative law judge or the Director. The trustee shall also make payments for medical services consistent with the order of an administrative law judge or the Director. Any interest earned shall accrue to the benefit of the trust. The amount ordered to be placed in trust can be amended from time to time, and any excess amount shall be returned to the employer. The trustee shall make such disbursements as appropriate so long as funds are available, and shall not be subject to penalties or any other actions based on administration of the trust.

(B) In the alternative to the establishment of a trust, the employer shall provide a bond as set forth in §8-43-408(2). In the event that the employer fails to bring the claimant current with medical and indemnity benefits owed, or fails to continue to pay the claimant such benefits on a regular

basis in an interval and amount ordered by an administrative law judge or the Director, the surety will be obliged to do so. The surety’s liability to fulfill such obligation shall extend to the amount fixed, which can be amended by order, and exist in the form prescribed by the Director.

(C) Any disputes about the proper disbursement of funds in the trust shall be made to the Director or an administrative law judge for determination.

9-6 CONSOLIDATION AND MERGER OF CLAIMS

(A) Two or more claims or applications may be consolidated for hearing or other purposes upon the order of an administrative law judge or the Director for good cause shown.

(B) Duplicate claims may be merged into one file with one workers’ compensation number upon the order of an administrative law judge or the Director. Merger of files shall be requested via motion specifying the surviving workers’ compensation number and any other identifying information requested by the Division.

(C) No motion will be required in instances where a duplicate claim has been created as the result of a typographical error in the claimant’s social security number or the date of injury. When duplicate claims exist as a result of such an error, the claims may be merged upon written request to the Division, with copies to all parties identifying the typographical error and supplying the correct information. The parties must confirm that the request to merge is unopposed. If the parties are unable to confirm that the request is unopposed, a motion to the prehearing unit is required.

9-7 ATTORNEY REPRESENTATION

(A) To represent a party in a claim at the Division of Workers’ Compensation, an attorney shall file an entry of appearance with the Division.

(B) When a claim has closed or the claim has settled on a full and final basis, an attorney may withdraw by filing a notice of withdrawal sent to the client and all parties.

(C) When a claim is not closed, an attorney may withdraw by filing a substitution of counsel signed by both the attorney withdrawing and the attorney entering the claim and sent to all parties. Otherwise, an attorney must request an order allowing withdrawal from the claim by filing a motion to withdraw, including the required notice. The motion must be sent to the client and all parties. The notice must contain all of the following:

(1) A statement that the attorney wishes to withdraw;

(2) A statement that the client is responsible for keeping the Division of Workers’ Compensation and the other parties informed of the client’s current address and telephone number;

(3) A statement that the claim may be closed if no further action is taken;

(4) The date scheduled for any future hearings, the dates by which any pleadings or briefs are to be filed (including, if applicable, the date by which any objection to an admission must be filed); and notice that these dates will not be affected by the withdrawal of counsel;

(5) A statement that the client may object to the withdrawal by filing a written objection within 10 days of the date on the certificate of mailing of the notice, and mailing a copy of the objection to the attorney and the Division of Workers’ Compensation.

9-8 SETTLEMENT PROCEDURES

(A) When the parties enter into a full and final settlement of a claim, they shall use the form settlement agreement prescribed by the Division of Workers'

Compensation. The parties shall not alter the prescribed form, except as set out in this rule. Parties who are settling a claim for a fatality are not required to use the Division's prescribed form settlement agreement.

(B) The parties may include terms in paragraph 9(A) that are both specific to that agreement and involve an issue or matter that falls within the Workers' Compensation Act.

(C) The parties may reference exhibits attached to the agreement in paragraph 9(B) of the settlement agreement. These exhibits may include a workers' compensation Medicare set-aside arrangement (WCMSA) or other information related to the workers’ compensation claim.

(D) The parties may attach other written agreements to the prescribed form and shall list these agreements in paragraph 9(C) of the settlement agreement. These other written agreements may include an agreement involving employment, or a waiver of a claim for bad faith.

(E) Any exhibits and/or agreements attached to a settlement agreement pursuant to subsections (C) or (D) above are included for the convenience of the parties and shall not be reviewed by the Division. Approval of the settlement agreement does not constitute approval of any attachments to the settlement agreement.

(F) The monetary amount of the settlement as reflected in the written agreement shall not include any consideration for any agreements which fall outside the jurisdiction of the Division of Workers’ Compensation.

(G) The parties shall file the settlement agreement and a completed settlement routing sheet with a proposed order in the form prescribed by the Division. The settlement agreement must be signed by all parties with the claimant's signature verified by a notary public consistent with the notaries public act. The filed copy of the agreement will be retained by the Division. The parties will be responsible for retaining a copy for their records. The completed order will be distributed in accordance with the attached certificate of service. If the parties request the order be returned via the U.S. postal service, self-addressed stamped envelopes must be supplied for all parties.

(H) The settlement agreement must be accompanied by a statement from the claimant on the Division provided form indicating if an appropriate inperson advisement has occurred, if the right to an in-person advisement is waived, and/or if a telephone or online advisement by Division staff is requested.

(1) A self-represented (pro se) claimant who has waived advisement may withdraw the waiver in writing and request either an in person or telephonic advisement, provided a written notice of withdrawal is received by the Division within three (3) days of the settlement documents being signed.

(I) The Division’s prescribed form settlement agreement should be used for full and final settlements only. Parties requesting approval of a stipulation resolving one or more issues in dispute shall instead submit a motion for approval of joint stipulation to the Director or an administrative law judge.

9-9 CLAIM FILES

(A) The file at the Division of Workers’ Compensation will be retained until the claim is closed and is not subject to subpoena for administrative hearings.

The file will be retained for at least seven (7) years from the date of closure. Certified copies of any documents in the Division file can be tendered by a party to the Office of Administrative Courts and shall be considered self-authenticating. Parties may obtain certified copies of documents in the Division file by contacting the Division of Workers’ Compensation, customer service section.

(B) Absent extraordinary circumstances, no employee of the Division of Workers’ Compensation shall be expected or required to testify at a hearing.

9-10 DISFIGUREMENT AWARD (PHOTO)

(A) Requests for determination of additional compensation for disfigurement based upon submission of photographs shall be filed on the form prescribed by the Division.

(B) Requests shall be accompanied by at least one (1) photograph, clearly showing the disfigurement, taken after the injured worker has been placed at maximum medical improvement, or at least six (6) months after the disfiguring event. It is strongly encouraged that a ruler be visible in the photograph next to the disfigurement. Video submissions will not be accepted.

(C) Claimants are required to certify that the submitted photographs are a true and accurate representation of the disfigurement at the time the request is being made.

(1) The injured worker should sign and date on the back of each photograph. The date the photograph was taken shall also be listed, if different than the date of signature.

(2) The signature shall serve as the certification that the photographs are a true and accurate representation of the disfigurement at the time the request is being made.

(3) If the photograph is provided digitally, a signed certification must accompany the image(s).

(D) Any party dissatisfied with an order regarding disfigurement benefits issued pursuant to this rule may file an application for hearing before the Office of Administrative Courts.

Rule 10 Medical Utilization Review 10-1 REQUESTS FOR UTILIZATION REVIEW (A) A party shall request a utilization review by filing the Request for Utilization Form (request form) with the Division Utilization Review Coordinator. The request form must be the one prescribed by the Division, but a duplicated or reproduced request form may be used as long as it is an exact version of the original in both appearance and content.

(B) The provider under review shall remain as an authorized provider for the associated claimant during the medical utilization review process. The provider shall continue to submit bills for services rendered to the associated claimant during the review period and the insurance carrier shall continue to pay the provider’s bills as provided in these rules of procedure.

(C) As provided in section 10-2, below, an information package and medical records package shall be filed with the request form.

10-2 FILING A REQUEST FOR UTILIZATION REVIEW

(A) One copy of an information package shall be filed and shall contain the following items:

(1) completed and signed Division prescribed request form.

(2) copies of all admissions filed or orders entered in the case.

(3) a list containing the full names and medical degrees of all providers, including the provider under review, other treating providers, and individuals who are considered as referrals or who performed consultations, independent medical examinations and/or second opinions, and (4) The minimum filing fee as provided in section 10-2(E)

(B) In addition, seven (7) copies of a medical records package shall be filed in accordance with the instructions on the prescribed request form, Each copy shall be two-hole punched at the top center of each page and securely fastened. (Notebooks and plastic type covers and binders shall not be used). A blank sheet of paper shall be placed and bound to the front and back of each copy of the submitted material and if tabs are used to divide sections, they shall be positioned to the right side of the document and each copy shall contain the following items:

(1) A table of contents;

(2) A case report, which shall be prepared, signed and dated by a licensed medical professional. This report shall be dated within thirty (30) days prior to the date of filing with the Division pursuant to §8-43-501(2)(b). The case report shall be limited to the following:

(a) name, discipline of care and specialty of the provider under review, (b) claimant’s standard demographic information (age, sex, marital status, etc.), (c) claimant’s employer and occupation/job title, date(s) of claimant’s work-related injury/exposure(s), and, (d) Date of initial treatment, a brief chronological history of treatment to the present date, and any significant contributing factors which may have had a direct effect on the length of treatment; (e.g., diabetes).

(e) A brief statement from the medical professional after review of the medical records in support of utilization review.

(3) The following sections:

Section 1 – a copy of the Employer’s First Report of Injury and/or the Worker’s Claim for Compensation form.

Section 2 – all reports, notes, etc., from the provider under review as submitted to the requesting party.

Section 3 – all reports, notes, etc., of the other treating providers as

Section 4 – all reports resulting from referrals, consultations, independent medical examinations and second opinions as

Section 5 – all diagnostic test results as submitted to the requesting party.

Section 6 – all medical management reports as submitted to the requesting party.

Section 7 – all hospital/clinic records related to the injury as (C) The medical records package shall not contain billing statements, adjustor notes, vocational rehabilitation records, surveillance tapes or reports, admissions, denials or comments directed to the utilization review committee.

(D) All material contained in the medical records package shall be presented in identified sections, each section’s contents presented in chronological order.

(E) A minimum filing fee of $ 1,250.00 shall be paid at the time of filing by the requesting party. The Division will notify the requesting party of additional costs incurred, such as payment to panelists not covered by the filing fee, which require a supplemental fee. Payment of any such supplemental fee will be required for completion of the utilization review and prior to the issuance of the Director's order.

10-3 OFFICIAL NOTIFICATION OF UTILIZATION REVIEW

(A) The Division will notify in writing the provider under review of the review request, and provide a copy of the written notification to each party to the case.

(B) Along with the written notification, the provider under review, as well as each party to the case, will receive one copy of the medical records package as filed by the requesting party.

(C) Within seven (7) days of receiving the written notification, the provider under review may submit a concise written statement no longer than two (2) pages in length, limited to whether the treatment provided was reasonably necessary or reasonably appropriate. The provider shall supply seven (7) copies of the statement to the division. A timely and properly submitted written response will be added to the review packets and forwarded to all parties by the division.

(D) Any motions or requests regarding the utilization review must be submitted, in writing, to the Medical Utilization Review Coordinator. Until such time as the Director issues a final order, the medical utilization review is an internal process at the Division, under the jurisdiction of the Director.

10-4 ADDING MEDICAL RECORDS TO THE UTILIZATION REVIEW FILE

(A) The Division will not accept additional medical records filed by any individual who has not been identified as a party to the case.

(B) The Division will incorporate all properly and timely filed additional medical records into the review file. Additional medical records that are not filed timely and properly will not be included in the review file.

(C) Parties filing additional medical records should not duplicate records already submitted for review. Seven copies of any additional medical records must be provided.

(D) The provider under review and each party to the case shall have one opportunity to submit additional medical records. Medical records must be received or postmarked within thirty (30) days from the mailing of the review notification. This thirty (30) day period can be extended upon a written request which sets forth good cause.

(E) Any additional medical records shall be presented as follows:

(1) The first item in each copy shall be a dated and signed transmittal letter which contains the following information:

(a) The UR# and claimant’s name, (b) Identification of the submitting party name and relationship to the case, (c) a certification stating the seven (7) copies of additional medical records contain the same documents, and (d) an index of the additional attached medical records material.

(2) The presentation of any additional medical records shall be in an identical manner to those as provided in section 10-2(B), above.

(F) The Division will send the provider under review and each party to the case a copy of all properly filed additional medical records. 10-5 Selection of Utilization Review Committee Members (A) The Director, with input from the Medical Director, shall appoint appropriate peer professionals to serve on the utilization review committees for three years.

(B) A committee member may be suspended from participation if the member has been the subject of a utilization review which resulted in an order for change of provider, retroactive denial of payment of medical bills and/or revocation of accreditation.

(C) Committee members shall be paid a fee of $225 per hour for their time incurred in preparing and completing their reports and recommendations to the director. Services rendered by the committee members on behalf of the Division shall be concluded upon acceptance by the Division of their final reports and recommendations. Any party to a claim for benefits or any party to a utilization review proceeding who requests the presence as a witness of one or more committee members at a proceeding for any

purpose, by subpoena or otherwise, shall be responsible for payment to said committee member(s) pursuant to the fee schedule set forth in these rules of procedure.

(D) A provider may not serve on a UR Committee unless his or her professional license or certification, if applicable, is current, active and unrestricted.

(E) After the members of the utilization review committee have been established, the provider and each party to the case will receive written notice of the names of the committee members. Within ten (10) days of receiving the written notification, any allegation that a committee member has a conflict and should be removed from the committee must be submitted in writing to the medical utilization review coordinator, setting forth the basis for the alleged conflict. Any such allegations that are not raised in a timely manner are deemed to have been waived and will not be considered at any subsequent stage of the utilization review proceedings.

A conflict will be presumed to exist when the provider under review and a member of the review committee have a relationship which involves a direct or substantial financial interest. The following guidelines apply to any allegations of conflict under this Rule:

(1) Direct or substantial financial interest is a substantial interest which is a business ownership interest, a creditor interest in an insolvent business, employment or prospective employment for which negotiations have begun, ownership interest in real or personal property, debtor interest or being an officer or director in a business.

(2) The relationship will be reviewed as of the time the utilization review is being conducted. Relationships in existence before or after the review in and of themselves will have no bearing, unless a direct or substantial financial interest is raised at the time of the utilization review.

(3) Being members of the same professional association or medical group, sharing office space or having practiced together in the past are not the types of relationships which will be considered a conflict, absent a direct or substantial financial interest.

(4) Any provider who has provided services to the claimant in the case for which the utilization review has been requested, or who has any type of personal or professional relationship with the claimant, will not be allowed to serve on the utilization review committee.

(5) This rule is not intended as an opportunity to conduct discovery.

Depositions, interrogatories or any other type of discovery will not be permitted in order to make determinations as to whether a conflict exists.

(F) Members of UR Committees shall not review any material other than what is provided by the Division, and shall not engage in communication regarding the Utilization Review with any person other than Division staff, except under the following circumstances: by approval of the Director; by written agreement of the parties to the case, including the provider under review; the provider under review and the parties to the case are strictly prohibited from having any communication with the members of the UR committee while the review is pending.

10-6 COMPOSITION OF UTILIZATION REVIEW COMMITTEES

(A) The Division will strive to compose utilization committees that reflect a balance of interests. Membership of the committees may include the following:

(1) Joints/Musculoskeletal Committee – Two practitioners licensed in the same discipline of care as the provider under review and one occupational medicine practitioner (M.D. or D.O.) with a minimum of 2 years experience in occupational medicine where 30% of practice time is in occupational medicine cases or a minimum of 5 years of experience with a minimum of 15% of practice time in occupational medicine cases;

(2) Dental Committee (Teeth only) – three dentists;

(3) Psychiatry Committee – One occupational medicine practitioner (M.D. or D.O.) and two psychiatrists; and, (4) Other – Committee shall be determined by the Director to meet the specific circumstances of the utilization review case.

10-7 RESPONSIBILITIES OF UTILIZATION REVIEW COMMITTEE MEMBERS

(A) Each committee member shall perform the review based on the materials provided, and work independently while performing his/her review. The review shall be a paper review only unless a specialist opinion is requested by a majority of the committee members. The specialist’s opinion may require a physical examination of the claimant.

(B) When performing a utilization review, the members of the medical utilization review committee shall consider all applicable medical treatment guidelines under these rules of procedure. The Division shall provide copies of the appropriate guidelines to the committee upon request.

(C) The report of each member of the utilization review committee should be limited to answers to the specific questions submitted by the Division, along with a written narrative supporting or explaining the answers for each of the questions.

10-8 CHANGE OF MEDICAL PROVIDER

(A) If the Director orders that a change of provider be made, the claimant and insurer or self-insured employer shall follow the procedures set forth in §8- 43-501(4) in order to obtain a new provider. The parties shall notify the Division, on the prescribed form, as to whether the parties have agreed upon a new provider or whether the Director shall select the new provider as provided in §8-43-501(4).

(B) If the claimant chooses to remain under the care of the provider under review during the period of appeal resolution, the payor shall be responsible for payment of medical bills to the provider until an order on appeal is issued. If the insurance carrier, employer or self-insured employer prevails on appeal, the claimant may be held liable by the prevailing party for such medical costs paid during the appeal period.

(C) A provider who wishes to become a new treating provider candidate shall not be eligible unless his or her professional license or certification, if applicable, is current, active and unrestricted.

10-9 UTILIZATION REVIEW APPEALS

(A) The appealing party shall complete the appeal form prescribed by the Division. The form shall be filed with the Medical Utilization Review coordinator within the timeframes set forth in the appeal procedures.

(B) Should the Director order both retroactive denial of fees and change of provider, upon appeal the issues shall be separated and transferred to the Office of Administrative Courts for a de novo hearing on retroactive denial or a record review for change of provider.

(C) Should the appealing party be entitled to a de novo hearing, the hearing shall be scheduled according to the instructions on the appeal form. The appealing party must file an application for hearing with the Office of Administrative Courts and a copy must be provided to the Medical Utilization Review Coordinator.

Rule 11 Division Independent Medical Examination This rule applies to parties and physicians participating in the Division Independent Medical Examination (DIME) program pursuant to the Workers’ Compensation Act of Colorado, § 8-40-101, et seq. (the Act). When used in this rule, Administrative Law Judge (ALJ) refers to Administrative Law Judges in the Office of Administrative Courts or Prehearing Administrative Law Judges employed by the Division of Workers’ Compensation.

11-1 QUALIFICATIONS

A physician seeking appointment to the DIME panel pursuant to the Act, shall meet the following qualifications:

(A) Be licensed with no restrictions by the Colorado Medical Board, the Colorado Dental Board, the Colorado Board of Chiropractic Examiners, or the Colorado Podiatry Board. Physicians licensed by the Colorado Medical Board must be board-certified or board eligible by the American Board of Medical Specialties, the American Osteopathic Association, or the National Board of Physicians and Surgeons.

(B) For determination of permanent impairment and maximum medical improvement (MMI), have attained Level II accreditation and either:

(1) engaged in at least 384 hours of direct patient care (excluding medical/legal evaluation) during the past calendar year OR (2) engaged in at least 384 hours of direct patient care (including medical/legal evaluation) during the previous ten (10) years and demonstrated additional competency in the field of disability evaluation through certification by the American Board of Independent Medical Examiners, the International Academy of Independent Medical Evaluators, or equivalent continuing medical education courses.

(C) A physician who is selected to perform a DIME as a result of an agreement by the parties and who has not been appointed to the DIME panel is not required to apply for appointment; however, such physician shall comply with all other qualifications and rules governing the DIME proceedings.

11-2 DIME PHYSICIAN COMPLIANCE

A physician seeking appointment to the DIME panel shall complete the Request for Appointment to the Independent Medical Examination Panel in full, including the required certification. Upon approval of the application, the physician shall:

(A) Comply with the Act and the Workers’ Compensation Rules of Procedure;

(B) Complete a summary disclosure form;

(C) Conduct all DIMEs in an objective and impartial manner;

(D) Decline a request to conduct a DIME only with approval by the Director or an ALJ on the basis of good cause shown;

(E) Not evaluate the claimant if a conflict of interest exists. A conflict of interest may include, but is not limited to, instances where the physician or someone in the physician’s office has treated the claimant or performed an independent medical examination (IME) on the claimant. A conflict is presumed to exist when the DIME physician and a physician who previously treated or evaluated the claimant have a relationship involving a direct or substantial financial interest during the pendency of the DIME.

(1) Direct or substantial financial interest is defined as a business ownership interest, a creditor interest in an insolvent business, employment relationship, prospective employment for which negotiations have begun, ownership interest in real or personal property, debtor interest, or being an officer or director in a business.

(2) Being members of the same professional association, society, or medical group, sharing office space, or having practiced together in the past are not the types of relationships that will be considered a conflict;

(F) Not engage in communication regarding the DIME with any person other than Division staff, except under the following circumstances:

(1) The claimant during the DIME appointment;

(2) The requesting party to set the appointment, including conversations regarding preference of the physician regarding in person or virtual interpreters and/or appointments;

(3) The paying party to discuss issues regarding the invoice, including conversations regarding payment of interpretation services provided by the DIME physician, pursuant to 11-3(D);

(4) The parties negotiating selection of the DIME physician. All communications with potential DIME physicians in furtherance of these negotiations shall involve all parties to the claim;

(5) By order of the Director, an ALJ, or by written agreement of all parties;

(6) For purposes of teaching other physicians who wish to train to conduct DIMEs, and only with consent of the claimant;

(G) Not become the treating physician for the claimant, unless ordered by the Director or an ALJ, or by written agreement of all parties;

(H) Not refer the claimant to another physician for treatment or testing unless an essential test is required;

(I) Not employ invasive diagnostic procedures unless approved by the parties, the Director, or an ALJ;

(J) Not substitute any other physician as the DIME physician, unless ordered by the Director or an ALJ, or by written agreement of all parties;

(K) For each DIME assigned, make all relevant findings regarding MMI, permanent impairment, and apportionment of impairment, unless otherwise ordered by an ALJ, the Director, or by agreement of the parties;

(L) Within twenty (20) days of the examination, submit to the Division and all parties the original report with all attachments. The report shall conform to the DIME Report Template.

11-3 DIME PROCESS

(A) Application and scheduling:

(1) Either party disputing a determination of MMI or impairment made by an authorized treating physician must apply for a DIME by filing the Notice and Proposal and Application for a DIME form within thirty (30) days after the date on the certificate of service of the final admission of liability or the date of service, mailing, or physical delivery of the disputed finding or determination. Either party may amend the Notice and Proposal and Application for a DIME by order of an ALJ, the Director, or written agreement of all (2) The parties must attempt to negotiate the selection of a physician to conduct the DIME. The requesting party shall propose one or more candidates qualified under section 11-1 on the Notice and Proposal and Application for a DIME. The Notice of DIME Negotiations form shall be filed within thirty (30) days of the Notice and Proposal and Application for a DIME.

(a) If the parties have agreed on the DIME physician, either party may file the form indicating the name of the physician.

The form shall be signed by the DIME physician and all parties to the claim.

(b) If the parties are unable to agree on the DIME physician, the insurer or self-insured employer shall file the form indicating that the parties were unable to agree.

(3) When parties are unable to agree on a DIME physician, the Division will notify the parties in writing of the names and the medical specialties of three (3) physicians.

(4) Within seven (7) days of issuance of the three-physician list by the Division, a party may request summary disclosures concerning any business, financial, employment, or advisory relationship with the insurer or self-insured employer. Such a request shall be submitted by electronic mail to the Division and copied to all other parties. The parties may use the information provided on the summary disclosure forms to assist in the decision to strike a physician. The information shall not be used as a basis for the Division to remove a physician from the three-physician list.

Physicians who are agreed-upon to perform the DIME are not required to comply with this subsection.

(5) Within seven (7) days of issuance of the three-physician list by the Division, the requesting party shall strike one (1) name and inform the other party and the Division. The other party then shall have seven (7) days to strike one (1) of the remaining physicians and inform the DIME unit in writing, with confirmation to the requesting party. If the Division is not notified of the selected physician within fourteen (14) days of the issuance of the three-physician list, the Division shall randomly select one (1) name from the remaining physicians.

(6) The Division shall confirm to the parties in writing the name of the selected or agreed-upon physician by issuing a DIME Physician Confirmation.

(7) If the selected physician is unable to perform the DIME for any reason other than having been struck by a party, the Division shall provide one (1) replacement name to the original list of three physicians, and present that revised list to the parties where each shall strike one name according to the procedures set forth previously in this section.

(8) The requesting party shall schedule the DIME with the physician within fourteen (14) days of the date the DIME physician confirmation is issued. The requesting party shall immediately notify the DIME unit and the opposing party in writing of the date and time of the examination. Absent good cause as determined by the Director or an ALJ, failure to make the appointment and advise all parties within fourteen (14) days may result in termination of the DIME process.

(9) The examination shall be scheduled no earlier than 45 days or later than 75 days after the issuance of the notice of the DIME physician confirmation unless otherwise ordered by the Director or an ALJ, or by written agreement of all parties.

(10) Once a three-physician list has been issued, it will, to the extent possible, remain the same for all future DIME applications.

Physicians may be replaced at the discretion of the Division for subsequent DIME applications due to new circumstances following the issuance of the initial list. Such new circumstances necessitating physician replacement may include, but are not limited to, requested body parts or issues, or availability of the physician(s).

(B) Medical Records:

(1) The medical records packet shall include all relevant records regarding the diagnosis, treatment, and evaluation of the claimant’s work-related injury(ies) or disease(s), as well as any relevant pre-existing condition(s), injury(ies), or disease(s), if applicable and available.

(2) Surveillance recordings, depositions, vocational rehabilitation reports, non-treating case manager records, prior orders and other records may not be submitted without written agreement of all parties or by order of an ALJ or the Director.

(3) The insurer or self-insured employer shall deliver the medical records to the Division in the manner designated by the Division no later than thirty (30) days from the date of the Notice and Proposal and Application for a DIME. The claimant may supplement the medical records no later than ten (10) days after receiving notice from the Division regarding an initial draft record packet. Failure to timely and properly submit records may result in termination or rescheduling of the DIME by the Director, at the cost to the defaulting party.

(4) Following receipt of records from both parties, the Division will provide the parties a proposed medical records packet. The parties will then have ten (10) days to review for inaccuracies or missing records. Any objection to the packet must be made in writing. The parties shall provide the Division with a stipulation regarding agreed upon changes, and/or request a prehearing conference regarding disputed changes to the packet.

(5) The Division will deliver the final electronic medical records packet to the DIME physician and all parties no later than fourteen (14) days prior to the scheduled examination.

(6) Submission of supplemental records requires an order by an ALJ finding good cause. When applicable, the process for submission of supplemental records to the DIME physician will be addressed in the ALJ’s order.

(C) The parties may agree to limit the issues to be addressed in the DIME in a written document signed by all parties and served upon the DIME unit and the DIME physician no later than seven (7) days prior to the DIME examination. The written agreement may use the optional Notice of Agreement to Limit the Scope of the DIME form.

(D) The claimant shall notify the insurer or self-insured employer of the necessity for an interpreter on the Notice and Proposal and Application for a DIME no later than fourteen (14) days before the examination. The insurer or self-insured employer shall be responsible for arranging for the services of and paying for the interpreter. The interpreter may be provided on-site or via video or audio remote interpreting services, based on availability and the preference of the DIME physician. The interpreter shall be impartial and independent, and have no prior professional or personal affiliation with any party to the claim or the DIME physician. The certification, reimbursement, and cancellation provisions of Rule 18 shall apply to interpreting services provided during a DIME. If the claimant notifies the insurer or self-insured employer of the necessity for an interpreter and no interpreter is present at the scheduled DIME:

(1) The insurer or self-insured employer will be presumed the defaulting party for purposes of paying any rescheduling or noncompliance fee.

(2) The DIME physician has discretion to:

(a) Reschedule the DIME upon payment of the rescheduling fee; or (b) Retain a certified or qualified interpreter as applicable under

Rule 18, proceed with the DIME, and impose a $250 noncompliance fee on the defaulting party. No prior authorization is required when the DIME physician retains an interpreter in these circumstances.

(3) Provided the claimant timely notified the insurer or self-insured employer of the need for an interpreter, the insurer or self-insured employer shall pay a $75 non-compliance fee to the claimant when the interpreter is not present at the scheduled DIME.

(E) An order by an ALJ is required to hold a DIME in abeyance. The requesting party shall be considered the defaulting party for purposes of paying any applicable rescheduling or termination fees to the DIME physician, except as otherwise agreed upon by the parties or ordered by an ALJ.

(F) Prior to the examination, the DIME may be terminated by the requesting party or by order of an ALJ or the Director. Following the examination, the DIME may be terminated only by agreement of the parties or by order of an ALJ or the Director.

(G) The DIME process shall be considered concluded on the date the DIME unit serves the notice of completion on the parties. The twenty (20) day deadline for the insurer or self-insured employer to file an admission of liability or request a hearing does not begin to run until the DIME unit has issued the notice of completion to all parties.

11-4 PAYMENTS/FEES

(A) The fees stated in Rule 11 shall be the only fees that may be billed or charged for DIMEs. The DIME fee will be based on the total time necessary to complete the DIME, payable in 15-minute increments and at the rate prescribed in the version of Rule 18 in effect on the date of the appointment. The billable time shall begin once the Division confirms the DIME physician and will end once the physician submits the report.

(1) The DIME physician shall receive a $1,000 base fee from the requesting party prior to scheduling the examination unless the claimant has filed an indigent application pursuant to section 11- 11. If such an application is filed, the paying party shall submit the $1,000 base fee within fourteen (14) days of the order on that indigency application or within fourteen (14) days of the final DIME physician selection, whichever is later.

(2) The DIME physician shall invoice the insurer or self-insured employer the final DIME fee, minus the previously paid $1,000 base fee, after the DIME unit accepts the DIME report. In no event shall the DIME physician be paid less than $1,000.

(B) Prior to the examination, the DIME may only be rescheduled by the requesting party or by order. Rescheduling of the DIME more than once requires a finding of good cause by an ALJ. The parties and the DIME physician may use the Notice of Reschedule or Termination form to notify the DIME unit of any rescheduling, termination, or failure to attend the DIME.

(1) Termination Fees: The DIME physician shall refund the base DIME fee to the paying party, less any applicable termination fees, within fourteen (14) days of receiving a notice of cancellation. If the paying party and defaulting party are not the same, the parties shall work out reimbursement without involving the DIME physician.

(a) If the DIME is terminated more than fourteen (14) days prior to the scheduled examination, a $250 termination fee will apply, and the DIME physician shall refund $750.

(b) If the DIME is terminated fourteen (14) days or less prior to the scheduled examination, a $500 termination fee will apply, and the DIME physician shall refund $500.

(c) If the DIME is terminated five (5) days or less prior to the scheduled examination, a $1,000 termination fee will apply and the DIME physician need not refund any portion of the base fee.

(d) If the DIME physician terminates the DIME, the entire base fee must be refunded to the paying party, regardless of the timing.

(2) Rescheduling Fees: The defaulting party shall pay the rescheduling fee to the DIME physician within fourteen (14) days of receiving the invoice. The examination may not be rescheduled until after the physician receives the rescheduling fee.

(a) If the DIME is rescheduled more than fourteen (14) days prior to the examination, no rescheduling fee applies.

(b) If the DIME is rescheduled fourteen (14) days or less prior to the scheduled examination, the DIME physician shall be paid a $250 rescheduling fee.

(c) If the DIME is rescheduled five (5) days or less prior to the scheduled examination, the DIME physician shall be paid a $500 rescheduling fee.

(d) If the DIME physician reschedules the DIME, the entire base fee must be applied to the new appointment, regardless of the timing.

(i) If the DIME physician reschedules the examination more than two (2) times, the physician shall pay a $250 fee to the party who requested the DIME examination.

(C) Absent an order to the contrary, the defaulting party will be presumed to be the party that requested the DIME. The defaulting party shall pay the rescheduling or termination fee to the DIME physician within fourteen (14) days of receiving the invoice. The examination may not be rescheduled until after the physician receives the rescheduling fee. Any disputes regarding the identity of the defaulting party may be resolved by an ALJ.

(D) All tests essential for an impairment rating to be rendered under the AMA Guides, 3rd Edition (revised) or the Level II accreditation curriculum should be performed prior to the DIME. Routine tests necessary for a complete DIME should be performed as part of the DIME at no additional cost. If an essential test is non-routine or requires special facilities or equipment, and such test was not previously performed, or was previously performed but the findings are not usable at the time of the DIME, the DIME physician shall notify the DIME unit, who will notify the parties. The DIME physician will either perform the essential test or refer out the essential test for completion at the insurer or self-insured employer’s expense unless extraordinary circumstances are determined by an ALJ. A return visit for range of motion validation shall be considered a part of the initial DIME.

(E) Services rendered by a DIME physician shall conclude upon acceptance by the Division of the complete DIME report.

(F) A party who seeks the presence of a DIME physician as a witness at a proceeding for any purpose shall pay the physician at the billing increments and the rate prescribed in Rule 18 for witness testimony.

11-5 COMMUNICATION WITH A DIME PHYSICIAN

(A) During the DIME process, there shall be no communication between the parties and the DIME physician except in circumstances allowed under

section 11-2(F). The parties shall provide the DIME unit with copies of any permitted correspondence with the DIME physician. Any violation may result in termination of the DIME.

(B) After acceptance by the Division of the complete DIME report, no communication with the DIME physician shall be allowed by any party or their representative except under the following circumstances: written agreement of all parties; an order of the Director or an ALJ; or by deposition or subpoena. The parties shall provide the Division with copies of any correspondence with the DIME physician permitted under this

section.

11-6 DIME FOLLOW-UP

(A) If a DIME physician determines that a claimant has not reached MMI and recommends additional treatment, a follow-up DIME examination shall be scheduled with the same DIME physician, unless the physician is unavailable or declines to perform the examination. Either party may file the Follow-Up DIME form after the claimant completes all additional recommended treatment.

(B) The parties shall indicate on the Follow-Up DIME form if the previous DIME physician is unavailable or declines to perform the follow-up DIME.

In that case, the parties also shall indicate the name of the agreed upon new physician. If the parties are not able to agree on a new DIME physician, the following procedures shall apply:

(1) If the previous DIME physician was selected pursuant to the procedures set forth in section 11-3(A)(5), the Division shall produce a revised list of three physicians consistent with section 11-3(A)(10).

(2) If the parties have agreed on the previous DIME physician under

section 11-3(A)(2)(a) but now wish to proceed under section 11- 3(A)(5), the parties shall obtain an order from an ALJ.

(C) Either party shall notify in writing the DIME unit and all other parties of the date and time of the follow-up DIME. The rates, billing increments, and payment procedures for a follow-up DIME shall be the same as for an initial DIME, as set forth in section 11-4, except that the insurer or selfinsured employer shall pay all follow-up DIME fees, including the $1,000 base fee. The rescheduling and cancellation fees and requirements detailed in section 11-4 also shall apply. The physician must receive the follow-up base fee prior to scheduling the examination.

(D) Record packet submission for the follow-up DIME shall follow the same process as for the initial DIME.

11-7 DIMES FOLLOWING REOPENING

DIMEs performed in claims that have been reopened are considered new DIMEs subject to all procedures set forth in this rule. The party requesting the subsequent DIME shall be considered the requesting party regardless of whether that party requested the prior DIME. By filing the application form in a claim where a DIME has been completed previously, the requesting party certifies the claim has been reopened pursuant to §8-43-303.

11-8 REMOVAL OF A PHYSICIAN FROM THE SELECTION PROCESS

(A) The Director, in consultation with the Medical Director, may temporarily inactivate or permanently remove a physician from the medical review panel on any of the following grounds:

(1) A misrepresentation on the application for appointment;

(2) Refusal and/or substantial failure to comply or two or more incidents of failure to comply with the provisions of the Act, the Workers’ Compensation Rules of Procedure, and/or any other relevant statutes, rules, or instructions from the Division;

(3) Loss or suspension of Level I and/or Level II accreditation;

(4) Good cause as determined by the Director.

(B) A physician removed under this section may apply to the Director for reinstatement after six (6) months from the date of removal. The reinstatement decision is at the sole discretion of the Director.

11-9 IMMUNITY

Doctors and other individuals involved in the DIME process who have acted within the appropriate scope of their capacity shall be immune from liability in any civil action for any actions undertaken in good faith and in the reasonable belief that the actions were appropriate under the circumstances.

11-10 DISPUTES

Any disputes arising under this Rule 11 may be addressed by an ALJ or, when applicable, through the Dispute Resolution process outlined in Rule 16. The timely billing, invoicing, and payment requirements of Rules 16 and 18 shall apply to DIMEs, unless otherwise specified in this Rule.

11-11 INDIGENCE PROCESS

(A) Within 15 days of filing the Notice and Proposal and Application for a DIME, a claimant asserting indigent status shall file an Application for Indigent Determination (DIME) form with the Division’s Prehearing unit, with copies to all parties and the DIME unit.

(B) The DIME process will not be held in abeyance while the indigent application is pending unless so ordered by an ALJ.

(C) Within eight (8) days after the date of service of the Application for Indigent Determination (DIME) form, any other party to the claim may file a response. Any such response shall state with specificity the grounds for the objection.

(D) An ALJ shall issue a written order to all parties within twenty (20) days after the application is filed. A hearing will only be held if a timely submitted response raises disputed questions of material fact or if there is a lack of sufficient information in the written submissions of the parties.

Any such hearing shall be held as soon as possible and a ruling shall be issued within thirty (30) days of the date of filing of the indigent application.

In such instances where a hearing is appropriate, applications filed with the DOWC Prehearing unit will be referred to the Office of Administrative Courts.

(E) The determination regarding indigence shall be based on the claimant’s financial status on the date the application is filed, taking into account any extraordinary circumstances. Extraordinary circumstances exist where the claimant would be deprived of the ability to provide for basic necessities that cannot be deferred, such as food, shelter, clothing, utilities, and out of pocket medical costs.

(F) In cases where a claimant is determined to be indigent, the insurer or selfinsured employer shall advance the base costs of the DIME, as well as any rescheduling or termination fees found to be the responsibility of the indigent claimant, on the indigent claimant’s behalf. These costs may be taken as an offset against future indemnity benefits owed to the claimant.

Payment owed to the DIME physician in excess of the DIME base cost and/or rescheduling or termination fees found to be the responsibility of the insurer or self-insured employer may not be offset against future indemnity benefits owed.

11-12 INDIGENCE STANDARDS

(A) A person shall be found to be indigent for purposes of rule 11-12 only if:

(1) income is at or below eligibility guidelines; or (2) extraordinary circumstances” exist which merit a determination of indigence.

(B) Income eligibility guidelines:

(1) FAMILY SIZE MONTHLY INCOME GUIDELINES 1 $2,832 2 $3,814 3 $4,798 4 $5,782 5 $6,764 6 $7,748 7 $8,732 8 $9,714 *For family units with more than eight (8) members, add $984 per month for “monthly income” or $11,800, per year for "yearly income" for each additional family member.

(2) Income is gross income from all members of the household who contribute monetarily to the common support of the household.

Rule 12 Permanent Impairment Rating Guidelines 12-1 STATEMENT OF PURPOSE Pursuant to §8-42-101(3.5)(a)(II), C.R.S., all permanent impairment ratings shall be based upon the American Medical Association Guides to the Evaluation of Permanent Impairment, Third Edition (Revised), in effect as of July 1, 1991, (AMA Guides). This rule implements the Division's permanent impairment rating guidelines on how to appropriately utilize and report permanent impairment ratings.

12-2 PROVIDER RESPONSIBILITIES

(A) Where the authorized treating physician has determined that the injured worker is at maximum medical improvement (MMI) and has not returned to his/her pre-injury state, physically and/or mentally, the treating physician shall determine or cause to be determined a permanent medical impairment rating in accordance with this Rule 12.

(B) Any Level II accredited physician determining permanent impairment shall rate in accordance with their administrative, legal and medical roles as established by Level II accreditation.

12-3 APPORTIONMENT

(A) For claims with a date of injury prior to July 1, 2008, a Level II accredited physician (“the Physician”) shall apportion any preexisting medical impairment, whether work-related or non work-related, from a work-related injury or occupational disease using the AMA Guides, 3rd Edition, Revised, where medical records or other objective evidence substantiate a preexisting impairment to the same body part. Any such apportionment shall be made by subtracting from the injured worker’s impairment the preexisting impairment as it existed at the time of the subsequent injury or occupational disease. The physician shall explain in their written report the

basis of any apportionment. If there is insufficient information to measure the change accurately, the physician shall not apportion.

(B) For claims with a date of injury on or after July 1, 2008, the Physician may provide an opinion on apportionment for any preexisting work related or non work-related permanent impairment to the same body part using the AMA Guides, 3rd Edition, Revised, where medical records or other objective evidence substantiate a preexisting impairment. Any such apportionment shall be made by subtracting from the injured worker’s impairment the preexisting impairment as it existed at the time of the subsequent injury or occupational disease. The Physician shall explain in their written report the basis of any apportionment. If there is insufficient information to measure the change accurately, the Physician shall not apportion. If the Physician apportions based on a prior non work-related impairment, the Physician must provide an opinion as to whether the previous medical impairment was identified, treated and independently disabling at the time of the work-rel ated injury that is being rated. Identified and treated in this context requires facts reflecting that a medical provider previously noted and provided some level of treatment for the non workrelated impairment.

(1) The effect of the Physician’s apportionment determination is limited to the provisions in section 8-42-104. When filing an admission an insurer shall provide documentation reflecting compliance with

section 8-42-104.

(2) If the Physician provides an opinion on the apportionment of medical and temporary disability benefits, the claimant’s receipt of medical and temporary disability benefits shall not be reduced based upon any such opinion.

12-4 PERMANENT PHYSICAL IMPAIRMENT RATINGS

Any physician determining permanent physical impairment shall:

(A) Limit such rating to physical impairments not likely to remit despite medical treatment; and (B) Use the instructions and forms contained in the AMA Guides and, (C) Convert scheduled impairment rating to whole person impairments.

(D) Report final whole person and/or scheduled impairment rating percentages in whole numbers.

12-5 PERMANENT MENTAL AND BEHAVIORAL DISORDER IMPAIRMENT

RATINGS

(A) Any physician determining permanent mental or behavioral disorder impairment shall:

(1) Limit such rating to mental or behavioral disorder impairments not likely to remit despite medical treatment; and (2) Use the instructions contained in the AMA Guides giving specific attention to:

(a) Chapter 4, “Nervous System”; and (b) Chapter 14, “Mental and Behavioral Disorders”; and (3) Complete a full psychiatric assessment following the principles of the AMA Guides, including:

(a) A nationally accepted and validated psychiatric diagnosis made according to established standards of the American Psychiatric Association as contemplated by the AMA Guides;

(b) Complete history of impairment, associated stressors, treatment, attempts at rehabilitation and premorbid history so that a discussion of causality and apportionment can occur.

(B) If the permanent impairment is due to organic deficits of the brain and results in disturbances of complex integrated cerebral function, emotional disturbance or consciousness disturbance, then Chapter 4, “Nervous System,” shall be consulted and, may be used, when appropriate, with

Chapter 14, “Mental and Behavioral Disorders.” The same permanent impairment shall not be rated in both sections. The purpose is to rate the overall functioning, not each specific diagnosis. Determination of the appropriate chapter(s) is left to the professional judgment of the physician.

(C) The permanent impairment report shall include a written summary of the mental evaluation and the work sheet incorporated herein as part of this

rule (Division form WC-M3-PSYCH). The impairment rating shall be established using the “category definition guidelines” set forth in this rule, and which shall supplement the related instructions in the AMA guides.

When appropriate, the physician shall address apportionment.

(D) Where other work-related permanent impairment exists, a combined whole-body permanent impairment rating may be determined by the authorized treating physician providing primary care if Level II accredited.

Where the authorized treating physician providing primary care is not determining permanent impairment, it shall be determined by the Level II accredited rating physician designated by the authorized treating physician providing primary care.

12-6 PERMANENT IMPAIRMENT RATINGS OF THE EXTREMITIES

(A) The AMA Guides do not provide for permanent impairment ratings specifically for the partial loss of use of the following:

(1) Forearm at the elbow;

(2) Joints at the wrist or ankle;

(3) Leg at the knee; or (4) Toes at the metatarsal.

The AMA Guides define these as permanent impairments of the:

(1) Entire finger, whole hand, or whole upper extremity; or (2) Entire toe, whole foot, or whole lower extremity.

(B) When an injury causes the partial loss of use of any member specified in the scheduled injuries, as set forth in §8-42-107(2), C.R.S., the physician shall use the most distal body part. The most distal body part is the body

part farthest away from the central body.

(C) In calculating partial loss-of-use benefits, the most distal permanent impairment rating provided by the physician shall be multiplied by the number of weeks corresponding to the scheduled injury for the appropriate entire finger, whole hand, or whole upper extremity, or the appropriate entire toe, whole foot, or whole lower extremity, then multiplied by the amount pursuant to § 8-42-107(6),C.R.S.

12-7 PERMANENT IMPAIRMENT RATINGS FOR CUMULATIVE TRAUMA

(A) The Cumulative Trauma Disorder (CTD) rating system is designed for disorders that primarily involve muscular, tendinous, ligamentous and bony structures. It follows the same general principles set forth in section 3.1j of the AMA Guides and has similar relative values for traumatic soft tissue conditions. Disorders that have vascular or neurologic involvement are rated by other sections of the AMA Guides.

(B) Impairments secondary to Cumulative Trauma Disorders may be accompanied by impairments that are ratable using existing portions of the AMA Guides. The Level II accredited physician shall first calculate any applicable impairment from range of motion, neurologic and/or vascular findings, or other disorders (section 3.1j) excluding grip strength. If no impairment exists under these sections of the AMA Guides and the physician has determined that the claimant has an impairment of daily living activities with anatomic and physiologic correlation, the physician shall proceed to rate the impairment as follows:

(1) Multiple joint and upper extremity sites can be involved in CTD.

Limit the impairment determination to areas of primary pathology, with anatomic or physiologic correlation based on objective findings. Do not rate areas of reactive muscular spasm and radiating or referred pain.

(2) Determine the stage of cumulative trauma for each joint involved, Stage 1 is 0-10%, Stage 2 is 11-20%, Stage 3 is 21-30%, and Stage 4 is 31-40%. Refer to Rule 17, Exhibit 2.

(3) Identify the appropriate joint impairment found on Table 17 of

Chapter 3 of the AMA Guides.

(4) Multiply the joint impairment from Table 17 by the CTD stage impairment from step B to yield an upper extremity impairment.

(5) If there is anatomic and physiologic basis to rate other joints in the same extremity, complete the rating in the manner described and combine the extremity ratings distal to proximal.

(6) If extremity impairment is bilateral, convert each upper extremity impairment to whole person rating and then combine whole person ratings for both right and left upper extremities as referenced in the AMA Guides. Complete the upper extremity worksheets, Figure 1 of Chapter 3 of the AMA Guides, for each extremity separately.

(C) The CTD rating system is preferred to impairment determined by decrease in grip strength. If grip strength is used, the CTD rating system shall not be used as it would be duplicative. Similarly, care must be taken to avoid duplicative ratings with other associated disorders where there is significant neurovascular involvement or where there is limitation in ranges of motion. For further reference to these cautions, refer to the AMA Guides, section 3.1j.

COLORADO DEPARTMENT OF LABOR AND EMPLOYMENT

PERMANENT WORK-RELATED MENTAL IMPAIRMENT RATING

REPORT WORK SHEET

Since the AMA Guides to the Evaluation of Permanent Impairment, 3 rd Edition (Revised) does not provide a quantified method for assigning permanent impairment percentages under Chapter 14, “Mental and Behavioral Disorders,” the provider shall utilize this form.

Patien t Name Date of Service WC # _________________________ Carrier # SCORING INSTRUCTIONS:

1. This form should only be used to determine an impairment after the case has been found to meet all of the specific criteria for a Diagnostic and Statistical Manual (DSM ) diagnosis.

2. The AMA Guides to Permanent Impairment, 3rd Edition (Revised) should be consulted for guidance in determining these ratings.

3. Determination of a rating of permanent mental or behavioral impairment shall be limited to mental or behavioral disorder impairments not likely to remit with further mental health treatment.

4. Impairment ratings based on chronic pain are not applicable within the mental/behavioral domain, but are restricted to physical examination with evidence of anatomic or physiologic correlation and included within a physical impairment rating.

5. To obtain the final overall impairment rating:

a. The elements to be rated are divided into four Areas of Function: Activities of Daily Living; Social Functioning; Thinking, Concentration and Judgment; and Adaptation to Stress.

b. Assign a rating (0-6) to each subcategory of the areas of function based on patient self-report, other sources of information, and the physician’s clinical assessment. (See Category Definitions on page 6 of this form.)

Given the heavy reliance on the patient’s subjective report for information in some of the ratings, the physician should give careful consideration to any corroborating evidence that might be available.

c. Average the two highest subcategory ratings within each Area of Function to obtain the overall category rating. For example, if the two highest scores are 2 and 5, the category score is 3.5.

d. To calculate the overall impairment rating, average the two highest category ratings and then, if appropriate in the case, use clinical judgment to add or subtract up to 0.5 point from the result. If the score is modified in this fashion due to clinical judgment, justification for doing so must be documented. Factors influencing the physician’s discretion may include the following:

i. Factors influencing the patient’s believability, such as the presence of symptom magnification, or the presence or absence of corroborating information from psychological or neuropsychological testing;

ii. The extent to which medication ameliorates the effects of the condition;

e. Use the Category Conversion Table in these instructions to convert the final number to a percentage.

6. Include the DSM diagnosis at the top of the worksheet.

The final determination must include ratings for all of the elements in each area of function, the category averages reached in each area of function, the overall average, the final assigned overall permanent impairment rating, and documentation for any divergence (±0.5) from the calculated score.

CATEGORY CONVERSION

TABLE

Final Score Percentage 0 0 0.25 0 0.5 1 0.75 1 1 1 1.25 2 1.5 3 to 4 1.75 5 2 6 to 7 2.25 8 to 9 2.5 10 to 12 2.75 13 to 15 3 16 to 18 3.25 19 to 21 3.5 22 to 23 3.75 24 to 25 4 26 to 32 4.25 33 to 38 4.5 39 to 44 4.75 45 to 50 5 51 to 56 5.25 57 to 62 5.5 63 to 68 5.75 69 to 75 6 76 to 83 6.25 84 to 91 6.5 92 to 100 7. If apportionment is applicable, complete a separate form calculating the preinjury rating to be subtracted from the total current rating.

8. If there is a finding of no impairment, refer to Part V on the worksheet, if appropriate.

WORKSHEET

Patien t Name Date of Service WC # _________________________ Carrier # NOTE: Determination of a rating of permanent mental or behavioral impairment shall be limited to mental or behavioral disorder impairments not likely to remit with further mental health treatment. Further, impairment ratings based on chronic pain are not applicable within the mental/behavioral domain, but are restricted to physical examination with evidence of anatomic or physiologic correlation and included within a physical impairment rating.

I. DSM Diagnosis: Axis I:______________________ Axis II:_______________________ II. LEVELS OF PERMANENT MENTAL IMPAIRMENT Category 0. No permanent impairment 1. Minimal Category of Permanent Impairment 2. Mild Category of Permanent Impairment 3. Moderate Category of Permanent Impairment 4. Marked Category of Permanent Impairment 5. Extreme Category of Permanent Impairment 6. Maximum Category of Permanent Impairment III. AREAS OF FUNCTION 1. Activities of Daily Living. Rate only impairments due strictly to the psychiatric condition.

Self care and hygiene (dressing, bathing, eating, cooking)

Travel (driving, riding, flying) i.e. impairments in driving, riding, flying which are generally a result of symptoms of affective or anxiety disorders Overall Category 0 1 2 3 4 Sexual function (participating in usual sexual activities) 0 1 2 3 4 Sleep (restful sleep pattern)

2. Social Functioning Interpersonal relationships Overall Category Communicates effectively with others Participation in recreational activities (consider pre-injury activities of the patient)

Manage conflicts with others--negotiate, compromise ________________________ See attached Appendix for further description of all or part of the listed areas of function.

3. Thinking, Concentration & Judgment Ability to perform complex or varied tasks Judgment Problem solving Ability to abstract or understand concepts Memory, immediate and remote Overall Category Maintain attention, concentration on a specific task Perform simple, routine, repetitive tasks Comprehend/follow simple instructions 4. Adaptation to Stress Set realistic short & long term goals Overall Category Perform activities (including work) on schedule Adapt to job performance requirements I V. FINAL CALCULATIONS:

Average the two highest Area of Function ratings: + divided by 2 = Add or subtract up to 0.5 from the completed calculation above, if appropriate, based on clinical judgment.

Justify this deviation below or attach a separate sheet:

Using the Category Conversion Table on page 2 of this form, convert the final number to a percentage for the overall permanent impairment rating:

Overall Psychiatric Permanent Impairment Rating % OR IF ZERO % PSYCHIATRIC RATING RATING% V. If this patient has ZERO impairment according to the above criteria and requires continuing medication for their DSM diagnosis, an impairment of 1- 3% may be assigned _______%.

Total Whole Person Impairment (including psychiatric impairment) _________% VI .

TOTAL IMPAIRMENT RATING (if applicable)

Total Whole Person Physical Impairment = ______% Combined with psychiatric permanent impairment equals:

Physicia n:

Date (Signature)

APPENDIX

1. Activities of Daily Living Sexual Function: Scoring categories 5 and 6 are not available because the maximum impairment allowed per the AMA Guides for total loss of sexual function is 30% for a male less than 40 years of age; 20% for a male 40 or older.

Sleep: Scoring categories 5 and 6 are not available because the AMA Guides allow a maximum of 50% impairment for sleep or arousal disorders. To reach a 20% rating the activities of daily living must be affected to the extent that supervision is required in some areas. To reach a 50% rating, supervision by caretakers is required.

2. Social Functioning Social functioning refers to an individual’s capacity to interact appropriately and communicate effectively with other individuals. Social functioning includes the ability to get along with others, such as with family members, friends, neighbors, grocery clerks, landlords or bus drivers. Impaired social functioning may be demonstrated by a history of altercations, evictions, firings, fear of strangers, avoidance of interpersonal relationships, social isolation, etc. Strength in social functioning may be documented by an individual’s ability to initiate social contacts with others, communicate clearly with others, interact and participate in group activities, etc. Cooperative behaviors, consideration for others, awareness of others’ feelings, and social maturity also need to be considered. Social functioning in work situations may involve interactions with the public, responding appropriately to persons in authority, such as supervisors, or cooperative behaviors involving co-workers.

Again, it is not the number of areas in which social functioning is impaired, but the overall degree of interference with a particular functional area or combination of such areas of functioning. For example, a person who is highly antagonistic, uncooperative, or hostile, but is tolerated by local storekeepers may nevertheless have marked restrictions in social functioning because that behavior is not acceptable in other social contexts, such as work. (AMA Guides, 3 rd Edition (revised), p. 237)

3. Thinking, Concentration and Judgment Thinking, concentration, and judgment refer to the ability to sustain focused attention sufficiently long to permit the timely completion of tasks and to make reasoned or logical decisions as to alternative courses of action. Deficiencies in concentration and judgment are best observed in work and work-like settings. Major impairment in this area can often be assessed through direct psychiatric examination and/or psychological testing, although mental status examination or psychological test data alone should not be used to accurately describe concentration and sustained ability to perform work-like tasks. On mental status examinations, concentration is assessed by tasks requiring short-term memory or through tasks such as having the individual subtract serial sevens from 100.

In psychological tests of intelligence or memory, concentration can be assessed through tasks requiring short-term memory or through tasks that must be completed within established time limits. Strengths and weaknesses in areas of concentration can be discussed in terms of frequency of errors, time it takes to complete the task, and extent to which assistance is required to complete the task. (Disability Evaluation Under Social Security, p.88, Social Security Administration Pub. No. 64-039)

4. Adaptation to Stress The individual should be able to set realistic and appropriate goals. Given that the workrelated injury may have induced various limitations, the individual should demonstrate realistic adaptations to the medical/physical situation. He/she should be able to accommodate changes from pre-injury status to the current status. Adapting to performance standards requires that the individual can adequately cope with job performance and time expectations. Further, the individual should demonstrate the capacity to follow rules and policies, respond appropriately to changes in the work setting, and utilize resources available within the community, medical and family areas.

PERMANENT WORK-RELATED MENTAL IMPAIRMENT RATING

REPORT WORK SHEET

CATEGORY DEFINITION GUIDELINES

CATEGORY 0: - No Permanent Impairment.

Mental symptoms arising from the work-related psychiatric diagnosis have been absent for the past month. ADLs are not affected. Functioning is at pre-injury baseline in social and work activities in all areas; no more than everyday problems.

CATEGORY 1: Minimal Category of Permanent Impairment.

Mental symptoms, arising from the work-related psychiatric diagnosis and not likely to remit despite medical treatment, minimally impair functioning.

CATEGORY 2: Mild Category of Permanent Impairment.

Mental symptoms, arising from the work-related psychiatric diagnosis are not likely to remit despite medical treatment, and are mildly impairing. ADLs are mildly disrupted.

Functioning shows mild permanent impairment in social or work activities.

CATEGORY 3: Moderate Category of Permanent Impairment.

Mental symptoms, arising from the work-related psychiatric diagnosis and not likely to remit despite medical treatment, are moderately impairing. ADLs are moderately disrupted. Functioning shows moderate permanent impairment. Activities sometimes need direction or supervision.

CATEGORY 4: Marked Category of Permanent Impairment.

Mental symptoms, arising from the work-related psychiatric diagnosis and not likely to remit despite medical treatment, are seriously impairing. ADLs are seriously disrupted.

Functioning shows serious difficulties in social or work activities.

CATEGORY 5: Extreme Category of Permanent Impairment.

Mental symptoms, arising from the work-related psychiatric diagnosis and not likely to remit despite medical treatment, are incapacitating. At times, ADLs require structuring.

Functioning is quite poor, unsafe in work settings, at times requires hospitalization or full-time supervision. Most activities require directed care.

CATEGORY 6: Maximum Category of Permanent Impairment.

This impairment level precludes useful functioning in all areas. These individuals are generally appropriate for institutionalized settings, if available. All activities require directed care.

Rule 13 Provider Accreditation 13-1 STATEMENT OF BASIS AND PURPOSE (A) This rule implements and establishes procedures for the provider accreditation program set forth in § 8-42-101(3.5) and (3.6), C.R.S., as well educates the providers about their administrative, legal, and medical roles in the Colorado workers’ compensation system. Accreditation requirements shall apply to:

(1) Providers who seek Level I or Level II accreditation under § 8-42- 101(3.5) and (3.6), C.R.S.;

(2) Physicians providing permanent impairment evaluations of claimants; and (3) Physicians serving on the Division Independent Medical Examination Panel.

13-2 ACCREDITATION

(A) To obtain Level I Accreditation, a provider must:

(1) Qualify under § 8-42-101(3.5), C.R.S.;

(2) Complete an application form prescribed by the Division and pay the registration fee;

(3) Complete the Division Level I course;

(4) Demonstrate an understanding of the Division materials by passing a Division-administered examination. If the provider does not exhibit sufficient knowledge upon taking the examination a second time, he or she must attend the seminar again prior to any further attempts at the examination. Additional fees may apply.

(5) Agree to comply with all relevant statutes, Division rules, and all Division-issued guidance (including materials incorporated by reference);

(6) The accreditation begins on the date the provider passes the examination. The accreditation expires on July 31 st of the third year following the year the provider passed the examination.

(B) To obtain Level II Accreditation, a physician must:

(1) Receive Level I accreditation. However, a physician who received his/her initial Level II accreditation before January 1, 2018 is exempt from this requirement.

(2) Qualify under § 8-42-101(3.5), C.R.S.;

(3) Complete an application form prescribed by the Division, pay the registration fee, and indicate if full or limited accreditation is sought;

(4) Complete the Division Level II course;

(5) Demonstrate an understanding of the Division materials (including the American Medical Association Guides to the Evaluation of Permanent Impairment, as incorporated by reference into § 8-42- 101(3)(a)(I), C.R.S. (‘AMA Guides’)) by passing a Divisionadministered examination. If the provider does not exhibit sufficient knowledge upon taking the examination a second time, he or she must attend the seminar again prior to any further attempts at the examination. Additional fees may apply.

(i) Full Accreditation: A physician who passes the full Level II Accreditation examination shall be fully accredited to determine permanent impairment ratings on any workrelated injury or illness.

(ii) Limited Accreditation: A physician who seeks Level II Accreditation to rate impairment only in connection with a specialty medical practice and who satisfactorily completes specified portions of the Level II examination shall receive limited accreditation to determine permanent impairment ratings on the corresponding sections of the AMA Guides.

(6) Agree to comply with all relevant statutes, Division rules, and all Division-issued guidance (including materials incorporated by reference).

(7) Submit his/her first three (3) impairment rating reports deemed sufficient by the Division within 12 months of passing the Level II accreditation examination; and (8) Agree to the probationary one-year Level II accreditation period beginning on the date the physician passes the Level II accreditation examination. The probationary accreditation will expire if the physician fails to submit three (3) impairment rating reports deemed sufficient by the Division within one year of the examination. Non-probationary accreditation begins on the date the physician submits his/her first three (3) impairment rating reports deemed sufficient by the Division. The non-probationary accreditation expires on January 31 ST of the third calendar year following the year the physician successfully completed the Level II Accreditation examination.

13-3 RENEWAL OF ACCREDITATION

(A) The Division will attempt to notify accredited providers of impending expiration of their accreditation.

(B) A provider who does not renew his or her accreditation before the expiration date may reapply and complete the process for initial accreditation under section 13-2.

(C) To renew accreditation, a provider must:

(1) Qualify under § 8-42-101(3.5), C.R.S.;

(2) Complete an application form prescribed by the Division, pay the registration fee, and, for Level II accreditation, indicate if full or limited reaccreditation is sought;

(3) Complete the Division course requirements for the highest level of accreditation maintained;

(4) Agree to comply with all relevant statutes and Division rules; and (5) For Level II reaccreditation only, submit one impairment rating report deemed sufficient by the Division (which may be a Division Independent Medical Examination report) for audit. The purpose of providing an impairment report is to demonstrate an understanding of the requirements of a sufficient impairment rating report; to educate and provide feedback to the physician; and to assist the Division in examining its curriculum. Any correspondence or communication regarding this process is confidential and shall not be subject to discovery or examination by any person.

13-4 SANCTIONS UPON ACCREDITATION

(A) The Director, with input from the Medical Director, may initiate proceedings to sanction a Level I or Level II Accreditation on any of the following grounds:

(1) Refusal to comply, substantial failure to comply, or two or more incidents of failure to comply with the provisions of these Workers’ Compensation Rules of Procedure and all relevant statutes.

(2) Misrepresentation on the application for accreditation, or (3) A unanimous recommendation to revoke accreditation by a reviewing panel pursuant to § 8-43-501(3)(c)(III) and (4), C.R.S..

(B) The severity of any sanctions taken under these rules shall reflect the character of the failure and the attendant circumstances. Examples of sanctions include, but are not limited to, a suspension or a revocation of accreditation.

(C) A proceeding to sanction a Level I or Level II Accreditation may be initiated by the Director, with input from the Medical Director, with referral for a hearing before an administrative law judge.

(D) Following a hearing, the administrative law judge shall render proposed findings of fact and conclusions of law, and make recommendations to the Director, who shall enter an order in the case.

Rule 14 Applications For Admission And Payment Of Benefits From The Major Medical Insurance Fund, The Medical Disaster Fund And Request For Benefits From The Subsequent Injury Fund 14-1 APPLICATIONS FOR ADMISSION TO THE MAJOR MEDICAL INSURANCE FUND AND MEDICAL DISASTER FUND (A) All applications for admission shall be filed with the Division on the prescribed form along with copies of the payment history, orders, medical records and all available relevant documents that support the application for admission. Upon receipt of an application, the Director shall examine the claim file to determine whether the insurer has exhausted its $20,000 limit of liability for medical benefits as provided in §8-49-101 C.R.S, 1973.

Those applications not meeting this requirement shall be dismissed and the applicant will be so notified by the Director.

(B) Applications meeting the above requirement shall be examined by the Director in accordance with the relevant provisions of the act. The Director may approve or disapprove an application for admission to/from the fund without conducting a hearing.

14-2 APPEAL OF ORDER DENYING ADMISSION OR DENYING BENEFITS TO THE

MAJOR MEDICAL INSURANCE FUND AND MEDICAL DISASTER FUND

(A) A party who is dissatisfied with an order dismissing or denying an application for admission or dissatisfied with a written denial of benefits may apply for a hearing with the Office of Administrative Courts within 30 days from the date of the order.

(B) When a hearing is requested after a dismissal or denial of an application for admission or for a denial of benefits from the fund, the Director shall be listed as a party and served with all notices, pleadings, reports, and other documents. Where an attorney has entered an appearance for the Director in a case, such service shall be made upon that attorney.

14-3 TERMINATING BENEFITS FROM THE MAJOR MEDICAL INSURANCE FUND

(A) When a party believes that further expenditures from the Major Medical Insurance Fund will not promote recovery, alleviate pain or reduce disability, that party, may file a request with the Director to issue an order to show cause why the Director should not issue a final order to cease payments from the Major Medical Insurance Fund.

(B) Upon the discretion of the Director, an order to show cause why the claim should not be closed from the Major Medical Insurance Fund will be issued. If no response is filed to the order to show cause within 30 days the Director shall issue an order to cease payments from the Major Medical Insurance Fund. If a response to the order to show cause is received within 30 days, the Director shall determine if an order to cease payments shall be issued.

(C) If an order to cease payment is issued, and no objection is filed within 30 days of the order to cease payment, the case shall automatically be closed for payment of benefits from the Major Medical Insurance Fund.

(D) If an objection is timely filed to the order to cease payment the objecting party shall set the case for hearing within 30 days of the date of the objection by filing an application for hearing with the Office of Administrative Courts. The Major Medical Insurance Fund shall continue medical benefits until an application is filed and the matter is resolved by order.

14-4 OFFSET OF LIABILITY TO SUBSEQUENT INJURY FUND FOR ACCIDENTS

THAT OCCURRED PRIOR TO 7-1-93 AND OCCUPATIONAL DISEASES THAT

OCCURRED PRIOR TO 4-1-94

(A) Offset of liability to the Subsequent Injury Fund, shall be initiated by filing a request for offset with the Division upon the prescribed form and serving the Director with a copy of the request for offset. The party filing the request for offset with the Director shall also simultaneously file with the Director a copy of medical reports, orders and all available relevant documents that support the request for offset.

(B) A request pursuant to §8-46-101, C.R.S., shall list, to the extent available by the requesting party, all prior or pending workers’ compensation cases by name and number, a brief description of each injury and the award in each case.

(C) A request pursuant to §8-41-304(2), C.R.S., shall indicate the types of exposures alleged, the approximate dates of each exposure, and the location and the name of the employer in whose employ each exposure allegedly occurred.

(D) A request for offset shall be filed no later than the date the party requesting offset files an application for hearing or response to application for hearing, unless an administrative law judge rules that good cause has been shown for filing later. However, in no event shall a request for offset be filed after a determination, by admission or order, that a claimant is permanently and totally disabled under §8-46-101 or disabled under §8- 41-304(2).

(E) The party requesting offset shall also file a proposed order with the Office of Administrative Courts joining the Director as a party on behalf of the Subsequent Injury Fund. Sufficient copies of the order and pre-addressed envelopes for all parties shall also be filed.

(F) The administrative law judge shall consider the proposed order to join the Director and response and rule on whether to join the Director as a party.

The ruling shall be based on whether the procedural requirements of this

Rule 14 have been met and whether the request states a sufficient basis upon which offset could be granted. Until the Director is joined, notices and orders are not binding on the Subsequent Injury Fund.

(G) When the Director is joined as a party and when an attorney has entered an appearance on behalf of the Subsequent Injury Fund, copies of all reports, pleadings or other documents thereafter filed by any party shall be served upon that attorney.

14-5 STATUS OF DIRECTOR ON BEHALF OF THE SUBSEQUENT INJURY FUND,

IN FATAL CASES

(A) The Director shall be deemed to be an interested party in all fatal cases and shall be served with all pleadings, notices, reports, and documents as required for any party. Where an attorney has entered an appearance for the Director in a case, such service shall be made upon that attorney.

(B) In the event a compensable injury results in a death which has not been reported to the Division, the Director may initiate a claim for the death benefits provided by statute.

Rule 15 Vocational Rehabilitation Rules Applicable to Claims based upon an Injury or Illness Occurring prior to July 2, 1987 at 4:16 p.m.

15-1 STATEMENT OF BASIS AND PURPOSE

The rules of procedure governing the vocational rehabilitation component of worker's compensation as originally promulgated pursuant to §8-49-101(4), C.R.S 1973 (repealed 1987) provide a qualified worker an opportunity to re-enter the workforce by establishing guidelines for vocational rehabilitation.

15-2 DEFINITIONS

In addition to the definitions already adopted in the rules, the following definitions apply to vocational rehabilitation procedures:

(A) “Job Modification” is the adaptation of a job either through the use of aids or devices or the alteration of the physical environment of the job, or both, to allow an impaired individual to perform within the scope of tasks originally designed for the job flow.

(B) “Qualified Worker” means a claimant who because of the effects of a work-related injury or occupational disease, (a) is permanently precluded from engaging in his/her usual and customary occupation and is unable to perform work for which the individual has previous training or experience, and (b) can reasonably be expected to attain suitable, gainful employment upon successful completion of a vocational rehabilitation program.

(C) “Qualified Rehabilitation Consultant” means a person authorized by a rehabilitation vendor to conduct a vocational evaluation and develop a rehabilitation plan for a qualified worker.

(D) “Rehabilitation Vendor” means an individual, firm or facility which exists to provide any or all of the services necessary to determine a claimant’s eligibility as a qualified worker, and/or provide those services designed to return an individual to work.

(E) “Suitable Gainful Employment” means employment which is reasonably attainable and which offers an opportunity to restore the qualified worker as soon as possible and as nearly as possible to employment with the claimant’s qualifications, including but not limited to the claimant’s age, education, previous work history, interests and skills. Special consideration shall also be given to the economic level of the claimant at the time of injury and to the present and future labor markets, to attempt to restore him/her to the maximum level attainable.

(F) “Transferable Skills” means those skills an individual possesses which were attained through previous training or experience and are readily marketable and a need for them exists in the current labor market and would provide suitable gainful employment.

(G) “Vocational Evaluation” means the rehabilitation services and testing required by the Director to determine a claimant’s eligibility as a qualified worker.

(H) “Vocational Rehabilitation Plan” means a written document completed and signed by a qualified rehabilitation consultant which describes the manner and means by which it is proposed that a qualified worker may be returned to suitable gainful employment through the participation in a rehabilitation program.

(I) “Vocational Rehabilitation Program” means the actual providing of services as prescribed in the vocational rehabilitation plan and approved by the Director as reasonably necessary to restore a qualified worker to suitable gainful employment.

15-3 INITIATION OF VOCATIONAL EVALUATION AND DIRECTOR'S

DETERMINATION OF ELIGIBILITY

(A) A vocational evaluation shall be provided by a rehabilitation vendor designated by the insurer, or upon failure of such designation, by the Division in consultation with the claimant, immediately upon knowledge that a claimant is unlikely to be able to return to his/her usual and customary occupation on a permanent basis as determined by competent medical evidence and opinion.

(B) A vocational evaluation summary report shall be submitted to the Director on a form prescribed by the Director and shall include the minimum elements listed on the form. The Director may request additional information necessary to determine eligibility.

(C) The vocational evaluation summary report shall be signed by a qualified rehabilitation consultant responsible for the evaluation and shall contain a recommendation by the consultant whether the claimant is eligible for a vocational rehabilitation program. If the recommendation indicates the claimant is in need of vocational rehabilitation and would benefit from vocational rehabilitation, the summary shall include a description of suggested occupation(s) that would be considered for plan development.

(D) A vocational evaluation shall be completed within sixty (60) days of assignment to the rehabilitation vendor.

(E) Upon submission of the vocational evaluation summary report, the insurer shall indicate whether it is providing vocational rehabilitation voluntarily or is requesting that the Director determine eligibility. Upon a request to determine eligibility the Director shall issue a “Notice of Determination of Eligibility for Vocational Rehabilitation Benefits” within twenty days.

(F) A party may object to the determination of eligibility by filing an application for hearing with the Office of Administrative Courts within fifteen (15) days of the date of the Director's determination.

15-4 SUBMISSION AND IMPLEMENTATION OF THE VOCATIONAL

REHABILITATION PLAN

(A) If the claimant is determined a qualified worker, the Director shall order that a vocational rehabilitation plan be developed. The plan shall be developed and submitted to the Director and the parties within forty-five (45) days of the Director's determination of eligibility, unless said determination has been contested.

(B) In developing the plan, the rehabilitation vendor shall strive to return the qualified worker to suitable gainful employment within the qualified worker’s medical and physical limitations as determined in the vocational evaluation in the following priorities:

(1) Return to work for the same employer to a modified job requiring rehabilitation services.

(2) Return to work for the same or a new employer in a related occupation, for which the individual has received rehabilitation services to upgrade skills attained from previous training or experience.

(3) Return to work in an on-the-job training capacity.

(4) Return to work after the completion of a vocational program into a new occupation.

(C) Once developed, the proposed plan shall be written and submitted to the parties on the form prescribed by the Director. The written plan shall include the minimum elements listed on the form. All parties shall sign the vocational plan prior to submitting the plan to the Director for approval.

The Director may request additional information necessary to determine if the plan should be approved.

(D) The Director, upon receipt of a proposed vocational rehabilitation plan and upon review, shall order the plan either approved or disapproved or modified. Implementation of the plan may begin as soon as the qualified worker is capable of participating in the program, as indicated by competent medical evidence. The plan shall begin upon the Director's approval or the date specified in the plan as applicable, whichever is later.

The insurer shall continue to provide temporary disability benefits, if applicable, until implementation of the plan and the employee begins his vocational rehabilitation program.

(E) All matters regarding rehabilitation plans or programs shall be initially submitted to the Director except in those cases where the question of need for vocational rehabilitation first arises during the course of a hearing or hearings on other issues.

(F) If there is a dispute regarding the vocational rehabilitation plan, the disputing party shall request a hearing by filing an application for hearing at the Office of Administrative Courts.

(G) If the qualified worker does not choose to enroll in a vocational rehabilitation program, nothing in these rules and regulations shall require the qualified worker to do so.

15-5 MODIFICATION, SUSPENSION OR TERMINATION OF THE VOCATIONAL

REHABILITATION PLAN OR VOCATIONAL EVALUATION

(A) If a vocational evaluation or an approved vocational plan is modified, terminated or suspended for any reason, and the parties are in agreement, the Director shall be notified. Plan modifications shall be submitted to the Director for approval on the prescribed form for vocational plans.

(B) If there is a dispute regarding the progress of a vocational evaluation or vocational rehabilitation plan, the disputing party shall request a hearing by filing an application for hearing at the Office of Administrative Courts.

15-6 REPORTING REQUIREMENT

All vocational rehabilitation forms and reports based upon an injury occurring on or prior to July 2, 1987 at 4:16 P.M. shall be filed with the Division and all parties copied.

15-7 QUALIFIED REHABILITATION VENDOR

(A) A vendor will be considered qualified by the Director if the vendor has the services of a consultant who had previously registered with the Division when the registration program existed or can demonstrate one of the following credentials:

(1) The individual is a Certified Rehabilitation Counselor under the guidelines of the Commission on Rehabilitation Counselor Certification or can demonstrate equivalent credentials.

(2) The individual has a Master's degree in Vocational Rehabilitation, Guidance and Counseling, Psychology, or in a related field or can demonstrate equivalent work experience on a year for year basis for formal education. The individual must also have one (1) year of experience as a practitioner in the field of vocational rehabilitation.

(3) The individual has a Bachelor's degree in Vocational Rehabilitation, Guidance and Counseling, Psychology, or a related field or can demonstrate equivalent work experience on a year for year basis for formal education. The individual must also have two (2) years experience as a practitioner in the field of vocational rehabilitation.

(B) If a dispute occurs concerning a counselor’s credentials, the counselor shall submit to the Director a resume, transcripts, diploma and any other requested documentation. The Director will determine whether the counselor is qualified.

Rule 16 Utilization Standards 16-1 STATEMENT OF PURPOSE In an effort to comply with the legislative charge to assure the quick and efficient delivery of medical benefits at a reasonable cost, the Director (Director) of the Division of Workers' Compensation (Division) has promulgated these utilization standards, effective July 1, 2025. This Rule defines the standard terminology, administrative procedures, and dispute resolution procedures required to implement the Division's Medical Treatment Guidelines (Rule 17) and Medical Fee Schedule (Rule 18).

16-2 STANDARD TERMINOLOGY FOR RULES 16, 17, AND 18

A. Ambulatory Surgical Center (ASC) means licensed as such by the Colorado Department of Public Health and Environment (CDPHE).

B. Authorized Treating Provider (ATP) means any of the following:

1. The treating physician designated by the employer and selected by the injured worker;

2. A healthcare Provider to whom an ATP refers the injured worker for treatment, consultation, or impairment rating;

3. A physician selected by the injured worker when the injured worker has the right to select a Provider;

4. A physician authorized by the employer when the employer has the right or obligation to make such an authorization;

5. A healthcare Provider determined by the Director or an administrative law judge to be an ATP;

6. A Provider who is designated by the agreement of the injured worker and the Payer.

C. Billed Service(s) means any billed service, procedure, equipment, or supply provided to an injured worker by a Provider.

D. Billing Party means a service Provider or an injured worker who has incurred authorized medical expenses.

E. Children’s Hospital means federally qualified, and certified by CDPHE, and licensed as a general hospital by CDPHE.

F. Critical Access Hospital means federally qualified, and certified by CDPHE, and licensed as a general hospital by CDPHE. A list is available on the federal Health Resources and Services Administration website. For dates of service on or after July 1, 2026, Critical Access Hospital means licensed as such by CDPHE pursuant to § 25-1.5-114.5.

G. Day means a calendar day unless otherwise noted. In computing any period of time prescribed or allowed by Rules 16, 17, or 18, the parties shall refer to Rule 1-2.

H. Designated Provider List means a list of physicians as required under § 8- 43-404(5)(a)(I) and Rule 8.

I. Freestanding Facility means an entity that furnishes healthcare services and is not integrated with any other entity as a main Provider, a department of a Provider, remote location of a hospital, satellite facility, or a Provider-based entity.

J. Hospital means licensed as such by CDPHE.

K. Long-Term Acute Care Hospital means federally certified and licensed as such by CDPHE.

L. Medical Fee Schedule means Division’s Rule 18, its exhibits, and the documents incorporated by reference in that Rule.

M. Medical Treatment Guidelines (MTGs) means Division’s Rule 17, its exhibits, and the documents incorporated by reference in that Rule.

N. Non-Physician Provider means individual who is registered, certified or licensed by: (1) the Colorado Department of Regulatory Agencies (DORA) or an equivalent licensing board of a state that participates in an interstate compact applicable to the type of Provider and codified in Title 24 of the Colorado Revised Statutes; (2) the Colorado Secretary of State; or (3) a national entity recognized by the State of Colorado 1. Acupuncturist (L.Ac) licensed by the Office of Acupuncture Licensure;

2. Advanced Practice Registered Nurse (APRN) licensed by the Board of Nursing and registered on the Advanced Practice Registry;

3. Anesthesiologist Assistant (AA) licensed by the Medical Board;

4. Athletic Trainer (ATC) licensed by the Office of Athletic Trainer Licensure;

5. Audiologist (AU.D. CCC-A) licensed by the Office of Audiology and Hearing Aid Provider Licensure;

6. Certified Medical Interpreter certified by the Certification Commission for Healthcare Interpreters or the National Board of Certification for Medical Interpreters.

7. Certified Registered Nurse Anesthetist (CRNA) licensed by the Board of Nursing and registered on the Advanced Practice Registry;

8. Clinical Social Worker (LCSW) licensed by the Board of Social Work Examiners;

9. Complementary Integrative Medicine Practitioner (excluding acupuncturist) certified by the National Certification Commission for Acupuncture and Oriental Medicine;

10. Durable Medical Equipment, Prosthetic, Orthotics, and Supplies (DMEPOS) Supplier licensed by the Colorado Secretary of State;

11. Marriage and Family Therapist (LMFT) licensed by the Board of Marriage and Family Therapist Examiners;

12. Massage Therapist licensed as a massage therapist by the Office of Massage Therapy Licensure;

13. Nurse Practitioner (NP) licensed by the Board of Nursing and registered on the Advanced Practice Registry;

14. Occupational Therapist (OTR) licensed by the Office of Occupational Therapy;

15. Occupational Therapist Assistant (OTA) licensed by the Office of Occupational Therapy;

16. Pharmacist licensed by the Board of Pharmacy;

17. Physical Therapist (PT) licensed by the Physical Therapy Board;

18. Physical Therapist Assistant (PTA) licensed by the Physical Therapy Board;

19. Physician Assistant (PA) licensed by the Medical Board;

20. Practical Nurse (LPN) licensed by the Board of Nursing;

21. Professional Counselor (LPC) licensed by the Board of Professional Counselor Examiners;

22. Psychologist (PsyD, PhD, EdD) licensed by the Board of Psychologist Examiners;

23. Registered Nurse (RN) licensed by the Board of Nursing;

24. Respiratory Therapist (RTL) licensed by the Office of Respiratory Therapy Licensure;

25. Speech Language Pathologist (CCC-SLP) certified by the Office of Speech-Language Pathology Certification;

26. Surgical Assistant registered by the Office of Surgical Assistant and Surgical Technologist Registration.

O. Over-the-Counter Drugs means medications that are available for purchase by the general public without a prescription.

P. Payer means an insurer, self-insured employer, or designated agent(s) responsible for payment of medical expenses. (Use of agents, including but not limited to preferred provider organization (PPO) networks, bill review companies, third party administrators (TPAs), and case management companies shall not relieve the insurer or self-insured employer from their legal responsibilities for compliance with these Rules).

Q. Physician means individual who is licensed by the State of Colorado through one of the following boards or an equivalent licensing board of a state that participates in an interstate compact applicable to the type of Provider and codified in Title 24 of the Colorado Revised Statutes:

1. Medical Board;

2. Dental Board;

3. Podiatry Board;

4. Board of Optometry; or 5. Board of Chiropractic Examiners.

R. Prior Authorization means a guarantee of payment for treatment requested in accordance with this Rule.

S. Provider means a person or entity providing authorized health care service, whether involving treatment or not, to a worker in connection with a work-related injury or occupational disease.

T. Psychiatric Hospital means licensed as such by CDPHE.

U. Rehabilitation Hospital means licensed as such by CDPHE.

V. Rural Health Clinic means a clinic located in areas designated by the United States Census Bureau as rural, or the state as medically underserved, that is federally qualified, and certified as such by CDPHE. A list is available at www.colorado.gov/pacific/cdphe/rural-health-clinicconsumer-resources.

W. Skilled Nursing Facility (SNF) means federally certified and licensed as a nursing care facility by CDPHE.

X. State-run Psychiatric Hospital means mental health institute operated by the Colorado Department of Human Services, Office of Behavioral Health.

Y. Telemedicine means two-way, real time interactive communication between the injured worker and the Provider at a distant site. This electronic communication involves, at a minimum, audio and video telecommunications equipment. Telemedicine enables the remote evaluation and diagnosis of injured workers in addition to the ability to detect fluctuations in their medical condition(s) at a remote site in such a way as to confirm or alter the treatment plan, including medications and/or specialized therapy.

Z. Treatment means any service, procedure, or supply prescribed by an ATP as may reasonably be needed at the time of the injury or occupational disease and thereafter to cure and/or relieve the employee from the effects of the injury or occupational disease.

AA. Veterans Administration Hospital means all medical facilities overseen by the United States Department of Veterans’ Affairs.

AB. Writing, for the purposes of Rules 16 and 18, means transmitted by letter, email, fax, or other electronic means of communication.

16-3 GENERAL REQUIREMENTS

A. Any Provider not listed in 16-2 must obtain Prior Authorization when providing services related to a compensable injury.

B. Upon request, healthcare Providers must provide copies of accreditation, licensure, registration, certification, or evidence of healthcare training for billed services.

C. To the extent not otherwise precluded by the laws of this state, contracts between Providers, Payers, and any agents acting on behalf of Providers or Payers shall comply with this Rule.

D. Referrals:

1. All Providers must have a referral from a Physician managing the claim (or NP/PA working under that Physician). A Physician making the referral to another Provider shall, upon request of any party, answer any questions and clarify the scope of the referral, prescription, or the reasonableness or necessity of the care.

2. A Payer or employer shall not redirect or alter the scope of a referral to another Provider for evaluation or treatment of a compensable injury. Any party who has concerns regarding a referral or its scope shall advise the other parties and Providers involved.

E. Use of PAs and NPs:

1. All Colorado workers’ compensation (WC) claims (medical only and lost time) shall have a Physician responsible for all services rendered to an injured worker by any PA or NP.

2. For services performed by a PA or NP, the attending Physician must counter-sign patient records related to the injured worker’s inability to work resulting from the claimed work injury or disease and the injured worker’s ability to return to regular or modified employment, as required by §§ 8-42-105(2)(b) and (3)(c) and (d).

The attending Physician must sign the WC 164 Form, certifying that all requirements of this rule have been met.

3. The Physician must evaluate the injured worker when a treating PA or NP recommends it, when deemed necessary by a Physician, or when requested by the injured worker or Payer.

16-4 OUT-OF-STATE PROVIDERS

A. Relocated Injured Worker 1. Upon receipt of the “Employer’s First Report of Injury” or the “Worker’s Claim for Compensation” Form, the Payer shall notify the injured worker that the procedures for change of Provider can be obtained from the Payer should the injured worker relocate out of state.

2. A change of Provider must be made through referral by the Physician managing the claim or in accordance with § 8-43- 404(5)(a).

B. In the event an injured worker has not relocated out of state but is referred to an out-of-state Provider for treatment not available within Colorado, the referring Provider shall obtain Prior Authorization. The referring Physician’s written request for out of state treatment shall include:

1. Description of treatment requested, including medical justification, the estimated frequency and duration, and known associated medical expenses;

2. Explanation as to why the requested treatment cannot be obtained within Colorado;

3. Name, complete mailing address, and phone number of the out-ofstate Provider; and 4. Out-of-state Provider’s qualifications to provide the requested treatment.

16-5 REQUIRED USE OF THE MEDICAL TREATMENT GUIDELINES

When an injury or occupational disease falls within the purview of Rule 17, Medical Treatment Guidelines and the injury occurs on or after July 1, 1991, Providers and Payers shall use the MTG, in effect at the time of service, to prepare or review their treatment plan(s) for the injured worker. A Payer may not dictate the type or duration of medical treatment or rely on its own internal guidelines or other standards for medical determination when the treatment falls within the purview of the MTGs. Initial recommendations for a treatment or modality should not exceed the time to produce functional effect parameters in the applicable MTG. When treatment exceeds or is outside of the MTGs, Prior Authorization is required. Requesters and reviewers should consider how their decision will affect the overall treatment plan for the individual patient. In all instances of denial, appropriate processes to deny are required.

16-6 NOTIFICATION TO TREAT

A. The Notification to Treat process applies to treatment that is consistent with the MTGs and has an established value under the Medical Fee Schedule. Providers may, but are not required to, utilize Notification to ensure payment for medical treatment that falls within the purview of the MTGs. The lack of response from the Payer within the time requirement set forth below shall deem the proposed treatment authorized for B. Notification to Treat may be submitted by phone during regular business hours, or by submitting the “Authorized Treating Provider’s Notification to Treat” Form (WC 195). Notification to Treat must include:

1. Provider’s certification that the proposed treatment is medically necessary and consistent with the MTGs.

2. Citation of the specific MTG applicable to the proposed treatment.

3. Provider’s email address or fax number to which the Payer can respond.

C. Payers shall respond to a Notification to Treat submission within seven days from the receipt of the submission with an approval or a denial of the proposed treatment. Providers may accept verbal confirmation or may request written confirmation, which the Payer should provide upon request.

1. The Payer may limit its approval of initial treatment to the number or duration specified in the relevant MTG without a medical review. If subsequent medical records document functional progress, additional treatment should be approved.

2. If Payer proposes to discontinue treatment before the maximum number of treatments/treatment duration has been reached due to lack of functional progress, Payer shall support that decision with a medical review compliant with this rule.

D. Payers may deny proposed treatment for the following reasons only:

1. For claims that have been reported to the Division, no admission of liability or final order finding the injury compensable has been issued;

2. Proposed treatment is not related to the admitted injury;

3. Provider submitting Notification is not an ATP or is proposing treatment to be performed by a Provider who is not eligible to be an ATP.

4. Injured worker is not entitled to the proposed treatment pursuant to statute or settlement;

5. Medical records contain conflicting opinions among the ATPs regarding proposed treatment;

6. Proposed treatment falls outside of the MTGs.

E. If the Payer denies a Notification to Treat per sections 16-6 D 2, 5, or 6, the Payer shall notify the Provider, allow the submission of relevant supporting medical documentation as defined in section 16-7 C and review the submission as a Prior Authorization request, allowing 10 additional days for review.

F. Appeals for denied Notifications to Treat shall be made in accordance with the Prior Authorization Appeals Process outlined in this rule.

G. Any Provider or Payer who incorrectly applies the MTGs in the Notification to Treat process may be subject to penalties under the Workers’ Compensation Act.

16-7 PRIOR AUTHORIZATION

A. Prior Authorization may be requested using the “Authorized Treating Provider’s Request for Prior Authorization” (Form WC 188) or in the alternative, shall be clearly labeled as a Prior Authorization request. Prior Authorization for payment shall only be requested when:

1. A prescribed treatment exceeds the recommended limitations set forth in the MTGs.

2. The MTGs require Prior Authorization for that specific service;

3. A prescribed treatment is not priced in the Medical Fee Schedule or is identified in Rule as requiring Prior Authorization for payment.

B. Prior Authorization for prescribed treatment may be granted immediately and without a medical review. However, the Payer shall respond to all Prior Authorization requests in writing within 10 days from receipt of a completed request as defined per this Rule.

The Payer, unless it has previously notified the Provider, shall give notice to the Provider of the procedures for obtaining Prior Authorization for payment upon receipt of the initial bill from that Provider.

C. When submitting a Prior Authorization request, a Provider shall concurrently explain the reasonableness and medical necessity of the treatment requested and shall provide relevant supporting documentation (documentation used in the Provider’s decision-making process to substantiate need for the requested treatment). A complete Prior Authorization request includes the following:

1. An adequate definition or description of the nature, extent and necessity for the treatment;

2. Identification of the appropriate MTG if applicable; and 3. Final diagnosis.

16-7-1 PRIOR AUTHORIZATION DENIALS

A. If an ATP requests Prior Authorization and indicates in writing, including reasoning and supporting documentation, that the requested treatment is related to the admitted WC claim, the Payer cannot deny solely for relatedness without a medical opinion as required by this Rule. The medical review, independent medical examination (IME) report, or report from an ATP that addresses relatedness of the requested treatment to the admitted claim may precede the Prior Authorization request if:

1. The opinion was issued within 365 days prior to the date of the Prior Authorization request; and 2. An admission of liability has not been filed admitting the relatedness of the requested treatment to the admitted claim or a final order has not been entered finding the specific medical condition related to the admitted injury.

If not, the medical review, IME report, or report from the ATP must be subsequent to the prior authorization request.

B. The Payer may deny a request for Prior Authorization for medical or nonmedical reasons. Examples of non-medical reasons are listed in section 16-10-2 A.

1. If the Payer is denying a request for non-medical reasons, the Payer shall, within 10 days of receipt of the complete request, furnish the requesting ATP and the parties with a written denial that sets forth clear and persuasive reasons for the denial, including citation of appropriate statutes, rules, and/or supporting documents (e.g., a copy of claim denial or a detailed explanation why the requesting Provider is not authorized to treat).

2. If the Payer is denying a request for medical reasons, the Payer shall, within 10 days of receipt of the complete request:

a. Have all the submitted documentation reviewed by a Physician, who holds a license in the same or similar specialty as would typically manage the medical condition or treatment under review. The Physician performing this review shall be Level I or II Accredited. In addition, clinical Pharmacists (Pharm.D.) may review Prior Authorization requests for medications, and Psychologists may review requests for mental health services, without having received Level I or II Accreditation.

After reviewing all the submitted documentation and documentation referenced in the Prior Authorization request that is available to the Payer, the reviewing Physician may call the requesting Provider to expedite the communication and processing of the Prior Authorization request.

The Payer may limit approval of initial treatment to the number or duration specified in the relevant MTG without a medical review.

b. Furnish the requesting ATP and the parties with a written denial that sets forth an explanation of the specific medical reasons for the denial, including the name and professional credentials of the Provider performing the medical review and a copy of the reviewer’s opinion; the specific citation from the MTGs, when applicable; and identification of the information deemed most likely to influence a reconsideration of the denial, when applicable.

C. Failure of the Payer to timely comply in full with all Prior Authorization requirements shall be deemed authorization for payment of the requested treatment unless the Payer has scheduled an independent medical examination (IME) and notified the requesting Provider of the IME within the time prescribed for responding.

1. The IME must occur within 30 days, or upon first available appointment, of the Prior Authorization request, not to exceed 60 days absent an order extending the deadline.

2. The IME physician must serve all parties concurrently with the report within 20 days of the IME.

3. The Payer shall respond to the Prior Authorization request within 10 days of the receipt of the IME report.

4. If the injured worker does not attend or reschedules the IME, the Payer may deny the Prior Authorization request pending completion of the IME.

5. The IME shall comply with Rule 8 as applicable.

16-7-2 PRIOR AUTHORIZATION APPEALS

A. The requesting ATP shall have 10 days from the date of the written denial to submit an appeal with additional information to support the request. A written response is not considered a “special report” as defined in Rule 18.

B. The Payer shall have 10 days from the date of the appeal to issue a final decision and provide documentation of that decision to the Provider and C. If the Payer is upholding a denial for medical reasons, the Payer shall have all the submitted documentation reviewed by a Provider that meets the requirements of section 16-7-1(B)(2)(a).

D. In the event of continued disagreement, the parties should follow dispute resolution and adjudication procedures available through the Division or the Office of Administrative Courts.

E. An urgent need for Prior Authorization of health care services, as recommended in writing by an ATP, shall be deemed good cause for an expedited hearing.

16-8 REQUIRED USE OF THE FEE SCHEDULE

A. All Providers and Payers shall use the Medical Fee Schedule to determine the maximum allowable payments for any medical treatments or services within the purview of the Workers’ Compensation Act of Colorado and the Colorado Workers’ Compensation Rules of Procedure, unless one of the following exceptions applies:

1. If billed charges are less than the fee schedule, the payment shall not exceed the billed charges.

2. The Payer and an out-of-state Provider may negotiate reimbursement in excess of the fee schedule when required to obtain reasonable and necessary care for an injured worker.

3. Pursuant to § 8-67-112(3), the Uninsured Employer Board may negotiate rates of reimbursement for Providers.

B. The Medical Fee Schedule does not limit the billing charges.

C. Payment for treatment not identified or identified but without established value in the Medical Fee Schedule shall require Prior Authorization, except for when the treatment is an emergency. Similar established code values from the Medical Fee Schedule, determined in compliance with section 16-10-1 B, shall govern payment.

16-8-1 REQUIRED BILLING FORMS AND CODES

A. Effective January 1, 2026, all Payers (excluding self-insured employers) shall:

1. accept electronic bills submitted in accordance with adopted standards (X12 and Colorado Companion Guide (Exhibit #1));

2. transmit acknowledgements and remittance advices in compliance with adopted standards in response to electronically submitted medical bills; and 3. accept electronic documentation (275 transactions) and support mutually agreed upon methods to receive electronic documentation required for the adjudication of a bill.

Payers must provide receipt of a complete electronic medical bill (837) by returning an acknowledgement within two business days of submission to the submitting party, and an electronic remittance advice (835) no later than 30 days after receipt of a complete electronic medical bill or within five days of generating a payment. This requirement applies only to the date the electronic remittance advice is sent and does not modify the medical bill processing timeframes outlined in section 16-10.

B. Effective January 1, 2026, all Providers submitting 25 or more workers’ compensation medical bills per month shall:

1. implement a software system capable of exchanging medical bill data in accordance with the adopted standards or contract with a clearinghouse to exchange the data;

2. submit medical bills to any Payers that have established connectivity to the Provider’s system or clearinghouse;

3. follow the Payer’s requirements for submission of attachments, whether by electronic submission, mail, fax, email, or web upload;

4. receive and process any acceptance or rejection acknowledgments from the Payer.

C. The Accredited Standards Committee X12 (X12) standard formats for billing, remittance and acknowledgements are those adopted by the United States Department of Health and Human Services rules (45 CFR Parts 160 and 162). The formats adopted under this Rule that are aligned with the current federal HIPAA implementation and the IAIABC standard include: 005010X222A1 Health Care Claim: Professional (837); 005010X223A2 Health Care Claim: Institutional (837); 005010X224A2 Health Care Claim: Dental (837); 005010X221A1 Health Care Claim Payment/Advice (835); 005010X212 Health Care Claim Status Request and Response (276/277); 005010TA1 Interchange Acknowledgment; 005010X231 Implementation Acknowledgment for Health Care Insurance (999); 005010X214 Health Care Claim Acknowledgment (277);

NCPDP Telecommunication Standard Implementation Guide Version D.0;

NCPDP Batch Standard Implementation Guide 1.2.

The following acknowledgement formats and the attachment format have not been adopted in the current HIPAA rules but are also based on X12 standards:

1. The 005010X213 Request for Additional Information (277) is used to request additional attachments that were not originally submitted with the electronic medical bill.

2. The 005010X210 Additional Information to Support a Health Care Claim or Encounter (275) is used to transmit electronic documentation associated with an electronic medical bill. The 005010X210 can accompany the original electronic medical bill or may be sent in response to a 005010X213 Request for Additional Information.

The NCPDP Telecommunication Standard Implementation Guide Version D.0 contains the corresponding request and response messages to be used for pharmacy transactions.

D. A complete medical bill or supporting transmissions must:

1. be submitted in the correct billing formats;

2. be transmitted in compliance with the format requirements described in this Rule;

3. include, in legible text, all supporting documentation for the bill, including the medical record documentation as required by this

Rule;

4. identify the injured worker, employer, Payer, Provider, Treatment, and any other requirements as presented in the Colorado Companion Guide; and 5. accurately report the Treatment provided using valid billing codes, modifiers, instructions, and parenthetical notes as incorporated by reference in Rule 18.

Payment for any service not billed in the format or on the forms identified may be denied. Providers may be subject to penalties for inaccurate billing when the Provider knew or should have known that the treatment billed was inaccurate, as determined by the Director or an administrative law judge. Providers are responsible for acts or omissions by their agents.

E. An 837P transaction or CMS-1500 Form shall be used when billing for professional services, DMEPOS, and ambulance services, unless otherwise specified.

1. If the bill is submitted using an 837P, all segments required by X12 and the Colorado Companion Guide must be completed.

2. Providers using a CMS-1500 form shall comply with the Reference Instruction Manual adopted by the National Uniform Claim committee (NUCC) in July 2024, with additional instructions, as follows:

a. Field 10a, Condition Related to Employment – ‘ Ye s ’ b. Field 14, Date of Current Illness or Injury and Qualifier – ‘431’ c. Field 21, Diagnosis - Provider bills shall list the International Classification Diseases, Tenth Revision (ICD-10) Clinical Modification (CM) diagnosis code(s) that are current, accurate, and specific to each patient encounter, in accordance with the ICD-10-CM Chapter Guidelines provided by CMS (Centers for Medicare & Medicaid Services). Bills should include the External Causes code(s) when applicable. ICD-10 codes shall not be used as a sole factor to establish work-relatedness of an injury or treatment.

d. Field 24j, Rendering Provider ID – 10-digit NPI of rendering Provider is required unless the provider type is ineligible to obtain an NPI number.

e. All other fields when required by this Rule.

3. Non-hospital based ASCs may bill using an 837P transaction or the CMS-1500 Form, however an SG modifier must be appended to the technical component of services to indicate a facility charge and to qualify for reimbursement as a facility claim.

F. An 837I transaction or a UB-04 Form shall be used by all hospitals and facilities meeting definitions found in section 16-2, hospital-based ambulance, and hospital-based ASCs. Some outpatient hospital therapy services may also be billed on an 837I or a UB-04 Form. For these services, the bill must have Form Locator Type 13x, 074x, 075x, or 085x, and one of the following revenue codes: 042X – Physical Therapy 043X - Occupational Therapy 044X - Speech Therapy G. An 837D or American Dental Association’s Dental Claim Form, Version 2019 or 2024 shall be used by all Providers billing for dental treatment.

H. The Telecommunication Standard Implementation Guide, Version D.0, or the NCPDP (National Council for Prescription Drug Programs) Workers’ Compensation/Property and Casualty Universal Claim Form, version 1.1 shall be used by dispensing pharmacies.

I. Payers and Providers may exchange electronic data in a non-prescribed format by mutual agreement. All data elements required in the Division prescribed formats must be present in a mutually agreed upon format.

J. An invoice or other agreed upon form may be used for services incident to medical treatment, such as guardian ad litem and conservator services, language interpreting, or mileage reimbursement.

K. When resubmitting a claim, Providers must use a Claim Frequency code of ‘7’ (previously adjudicated with new or amended information). The value is populated in Loop 2300 in segment CLM05-3 of the 005010X222A1 and 005010X223A2, and 005010X224A2 electronic billing transactions, or item 22 of the CMS-1500, and item 64 of the UB-04 Form. When the Payer has provided the Payer Claim Control Number assigned to the previous bill, the Provider must use this number for the replacement bill.

L. When submitting a duplicate bill transaction prior to payment, a condition code of ‘W2’ (duplicate of the original bill) is required. The condition code is submitted based on instructions for each bill type. The value is populated in segment HI the 005010X222A1, 005010X223A2, and segment NTE of the 005010X224A2 electronic billing transactions, or item 10d of the CMS-1500, and items 18-28 of the UB-04 Form.

M. To fully void a previously adjudicated bill, a bill with CLM05-3 = ‘8’ (void/cancel) must be submitted. Do not use a Claim Frequency code of ‘8’ on totally denied bills or to make changes or corrections to an original bill.

16-8-2 TIMELY FILING

A. Providers shall submit their bills for treatment rendered within 120 days of the date of service or the bill may be denied unless extenuating circumstances exist.

1. For bills submitted through electronic data interchange (EDI), Providers may prove timely filing by showing a Payer acknowledgement (claim accepted). Rejected claims or clearinghouse acknowledgement reports are not proof of timely filing.

2. For paper bills, Providers may prove timely filing with a signed certificate of mailing listing the original date mailed and the Payer’s address; a fax acknowledgement report; or a certified mail receipt showing the date the Payer received the bill.

3. All timely filing issues will be considered final 10 months from the date of service unless extenuating circumstances exist.

B. Injured workers shall submit requests for mileage reimbursement within 120 days of the date of service or reimbursement may be denied unless good cause exists.

C. Extenuating circumstances/good cause may include, but are not limited to, delays in compensability being determined or the party has not been informed of this benefit or where to send the bill.

16-8-3 ACKNOWLEDGEMENTS

A. A Payer must acknowledge receipt of an electronic medical bill by returning an Implementation Acknowledgement (X12 999) within two business days of the receipt of the electronic submission, and a Health Care Claim Acknowledgement (X12 277CA) within two business days of the receipt.

1. If an electronic medical bill does not meet the definition of a complete electronic medical bill as defined in this Rule or does not meet the edits defined in the applicable implementation guide, the Payer must notify the Provider of the rejected bill using the appropriate acknowledgement.

2. If a Payer acknowledges acceptance of the original complete electronic medical bill, a Provider or its agent must not submit a duplicate electronic or paper medical bill earlier than 30 days from the date originally submitted. A Provider or its agent may submit a corrected medical bill electronically to the payer after receiving notification of a rejection. The corrected medical bill is submitted as a new, original bill.

B. Acceptance of a complete medical bill is not an admission of liability by the Payer. A Payer may subsequently deny an accepted electronic medical bill if the employer or other responsible party named on the medical bill is not legally liable for payment.

1. The denial is transmitted by means of an 835 transaction.

2. The subsequent denial of a previously accepted, complete electronic medical bill must occur no later than 30 days from the date of receipt.

3. The transaction to deny the previously accepted complete medical bill must clearly indicate that the payer is not legally liable for its C. Acceptance of an incomplete medical bill does not satisfy the written notice requirement from a Payer.

D. A Payer or clearinghouse that requests another Payer or clearinghouse to receive, process, or transmit a standard transaction must not charge fees in excess of the fees for normal telecommunications that the requesting entity incurs when it directly transmits, or receives a standard transaction.

16-9 REQUIRED MEDICAL RECORD DOCUMENTATION

A. The treating Provider shall maintain medical records for each injured worker when billing for the provided treatment. The rendering Provider shall sign the medical records. Electronic signatures are accepted.

B. All medical records shall legibly document the treatment billed and shall include at least the following information:

1. Patient’s name;

2. Date of treatment;

3. Name and professional designation of person providing treatment;

4. Assessment or diagnosis of current condition with appropriate objective findings;

5. Treatment provided;

6. Treatment plan, when applicable; and 7. If being completed by an authorized treating physician, all pertinent changes to work and or activity restrictions which reflect lifting, standing, stooping, kneeling, hot or cold environment, repetitive motion or other appropriate physical considerations.

C. All treatment provided to injured workers is expected to be documented in the medical record at the time it is rendered. Occasionally, certain entries related to treatment provided are not made timely. In this event, the documentation will need to be amended, corrected, or entered after rendering treatment. Amendments, corrections, and delayed entries must comply with Medicare’s widely accepted recordkeeping principles as outlined in the Medicare Program Integrity Manual Chapter 3, section 3.3.2.5, implemented August 2020. (This section does not apply to injured workers’ requests to amend records as permitted by the Health Insurance Portability and Accountability Act (HIPAA)).

D. The ATP must sign (or counter sign) and submit to the Payer, within 14 days of the initial and final visit, a completed WC 164 Form.

1. The Form shall be completed as an “initial” report when the injured worker has the initial visit with the Designated Physician, or in the case of a transfer of care, the new Designated Physician. If applicable, the emergency department (ED) or urgent care physician initially treating the injury may also complete a WC 164 initial report. In such cases, the initial report from the ED or urgent care physician, and the Designated Physician shall be reimbursed. Unless requested or prior authorized by the Payer, no other physician should complete and bill for the WC 164 initial report. See Rule 18 for required fields.

2. The Form shall be completed as a “closing” report when the ATP managing the total WC claim determines the injured worker has reached maximum medical improvement (MMI) for all covered injuries or diseases, with or without permanent impairment. See

Rule 18 for required fields.

3. The ATP shall supply the injured worker with a copy of the WC 164 at the time of completion, at no charge.

E. Providers other than hospitals shall provide the Payer with all supporting documentation and treatment records at the time of billing unless the parties have made other agreements. Hospitals shall provide documentation to the Payer upon request. Payers shall specify what portion of a hospital record is being requested (for example, only the ED chart notes, in-patient physician orders and chart notes, x-rays, pathology reports, etc.). The Payer may deny payment for billed treatment until the Provider submits the required medical documentation.

16-10 PAYMENT REQUIREMENTS FOR MEDICAL BILLS

A. All bills submitted by a Provider are due and payable in accordance with the Medical Fee Schedule within 30 days after receipt by the Payer, unless the Payer provides timely and proper reasons set forth by section 16-10-2 or 3.

B. For every medical treatment bill submitted by a Provider, the Payer shall reply with a written notice (explanation of benefits) or X12 835, respective to the method of transmission, within 30 days of receipt of the bill that includes the following:

1. Injured worker’s name;

2. Payer’s name and address;

3. Date(s) of service;

4. Each procedure code billed; and 5. Amount paid.

C. If any adjustment is made to the amount submitted on the bill, the Payer’s written notice shall also include:

1. Payer’s claim number and/or Division’s WC number;

2. Specific identifying information coordinating the notice with any payment instrument associated with the bill;

3. (If electronic) the appropriate Claim Adjustment Group Codes, Claim Adjustment Reason Codes (CARC), and associated Remittance Advice Remark Codes (RARC), denoting the reason for the payment, adjustment, or denial. NCPDP reject codes are allowed for NCPDP transactions;

4. Notice that the billing party may submit a corrected bill or an appeal within 60 days;

5. Name of insurer with admitted, ordered, or contested liability for the WC claim, when known;

6. Name and address of any third-party administrator (TPA) and/or bill reviewer associated with processing the bill;

7. Name and contact information of a person who has responsibility and authority to discuss and resolve disputes on the bill;

8. Name and address of the employer, when known;

9. For compensable treatment related to a work injury, the Payer shall notify the billing party that the injured worker shall not be balancebilled;

10. The name of any contract relied upon for a discount; and 11. If applicable, a statement that the payment is being held in abeyance because a hearing is pending on a relevant issue.

D. Any written notice that fails to include the required information is defective and does not satisfy the 30-day notice requirement.

E. If the Payer discounts a bill and the Provider requests clarification in writing, the Payer shall furnish to the requester the specifics of the discount within 30 days, including a copy of any contract relied upon for the discount. If no response is forthcoming within 30 days, the Payer must pay the maximum Medical Fee Schedule allowance or the billed charges, whichever is less.

F. The Payer must offer at least one method of payment to the Provider that does not require an associated fee and shall not restrict the method or form of payment so that the only acceptable method is a credit card payment. If the Payer initiates a payment using electronic funds transfer, including virtual credit card payments, the Payer shall:

1. Notify the Provider if any fee is associated with a particular payment method; and 2. Advise the Provider of the available payment methods and provide clear instructions as to how to select an alternative.

Once a Provider notifies the Payer of a preferred payment method, the Payer is required to send payments in the Provider’s preferred form.

G. Date of bill receipt by the Payer may be established by the Payer’s date stamp or electronic acknowledgment date required by Rule 4; otherwise, receipt is presumed to occur five days after the date the bill was mailed to the Payer’s correct address.

H. Payers shall reimburse injured workers for mileage expenses as required by statute or provide written notice of the reason(s) for denying reimbursement within 30 days of receipt.

I. An injured worker shall never be required to directly pay for admitted or ordered medical benefits covered under the Workers’ Compensation Act.

In the event the injured worker has directly paid for medical treatment that is then admitted or ordered under the Workers’ Compensation Act, the Payer shall reimburse the injured worker for the amounts actually paid for authorized treatment within 30 days of receipt of the bill. If the actual costs exceed the maximum fee allowed by the Medical Fee Schedule, the Payer may seek a refund from the Provider for the difference between the amount charged to the injured worker and the maximum fee.

16-10-1 MODIFIED, UNLISTED, AND UNPRICED CODES

A. Prior to modifying a billed code, the Payer must contact the billing Provider and determine if the code is accurate. If the Payer disagrees with the level of care billed, the Payer may deny the claim or contact the Provider to explain why the billed code does not meet the level of care criteria.

1. If the billing Provider agrees with the Payer, then the Payer shall process the service with the agreed upon code and shall document on the written notice the agreement with the Provider.

The written notice shall include the name of the party at the billing office who made the agreement.

2. If the billing Provider disagrees with the Payer, then the Payer shall proceed with a denial.

B. When no established fee is identified in the Medical Fee Schedule and the Payer agrees the service or procedure is reasonable and necessary, the Payer shall list on the written notice one of the following payment options.

1. Payment based on a similar established code value as recommended by the billing Provider.

2. A reasonable value based upon a similar established code value as determined by the Payer.

If the Payer disagrees with the billing Provider’s recommended code value, the denial shall include an explanation of why the requested fee is not reasonable, identification of the similar code as determined by Payer, and how the Payer calculated its fee recommendation. If the Provider disagrees with the Payer’s determination, it can follow the process for appealing billed treatment denials.

16-10-2 DENYING PAYMENT OF BILLED TREATMENT FOR NON-MEDICAL

REASONS

A. Non-medical reasons are administrative issues that do not require medical documentation review other than to verify the appropriate use of a billed code. Examples of non-medical reasons for denying payment include the following: no WC claim has been filed with the Payer; compensability has not been established; the Provider is not authorized to treat; the insurance coverage is at issue; typographic or date errors, or otherwise incomplete bill; failure to submit medical documentation; or unrecognized or improper use of a CPT® code.

B. If an ATP bills for medical treatment and indicates in writing, including reasoning and relevant documentation that the medical services are related to the admitted WC claim, the Payer cannot deny payment solely for relatedness without a medical opinion as required by section 16-10-3.

The medical review, IME report, or report from an ATP that addresses the relatedness of the requested treatment to the admitted claim may precede the date of service, unless the requesting physician presents new evidence as to why treatment is now related.

C. In all cases where a billed treatment is denied for non-medical reasons, the Payer’s written notice shall include all notice requirements set forth in 1. Reference to each code being denied; and 2. Clear and persuasive reasons for denying payment, including citation of appropriate statutes, rules, and/or documents supporting the Payer’s reason(s).

D. If after the treatment was provided, the Payer agrees the service was reasonable and necessary, lack of prior authorization does not warrant denial of payment. However, the Provider may still be required to provide additional supporting documentation as outlined in section 16-7 for a complete Prior Authorization request.

16-10-3 DENYING PAYMENT OF BILLED TREATMENT FOR MEDICAL

REASONS

A. The Payer shall have the bill and all supporting medical documentation reviewed by a Physician who holds a license and is in the same or similar specialty as would typically manage the medical condition or treatment under review. The Physician shall be Level I or II Accredited. In addition, a clinical Pharmacist (Pharm.D.) may review billed services for medications, and a Psychologist may review billed services for mental health, without having received Level I or II Accreditation. After reviewing the supporting medical documentation, the reviewing Provider may call the billing Provider to expedite communication and timely processing of the bill.

B. In all cases where a billed treatment is denied for medical reasons, the Payer’s written notice shall include all notice requirements set forth in 1. Reference to each code being denied;

2. Clear and persuasive medical reasons for denying payment, including the name and professional credentials of the Provider performing the medical review and a copy of the reviewer’s opinion;

3. Citation from the MTGs, when applicable; and 4. Identification of additional information deemed likely to influence reconsideration, when applicable.

16-10-4 APPEALING BILLED TREATMENT DENIALS

A. The billing party shall have 60 days from the date of the written notice to request reconsideration. The billing party’s appeal must include:

1. A copy of the original or corrected bill with condition code W3;

2. A copy of the written notice;

3. Identification of the specific code being appealed; and 4. Clear and persuasive reason(s) for the appeal, including additional supporting documentation when applicable.

B. If the billing party appeals the denial in compliance with above requirements, the Payer shall:

1. When denied for non-medical reasons, have the bill and all supporting documentation reviewed by a person who has knowledge of the bill. After reviewing the Provider’s appeal, the reviewer may call the appealing party to expedite the communication and timely processing of the appeal.

2. When denied for medical reasons, have the bill and all supporting documentation reviewed by a Physician who holds a license and is in the same or similar specialty as would typically manage the medical condition or treatment under review. The Physician shall be Level I or II Accredited. In addition, a clinical pharmacist (Pharm.D.) may review appeals for payment of medications and a Psychologist may review appeals for payment of mental health services without having received Level I or II Accreditation. After reviewing the supporting medical documentation, the reviewing Provider may call the appealing Provider to expedite communication and timely processing of the appeal.

3. If after reviewing the appeal the Payer agrees with the billing party, payment for treatment is due and payable in accordance with the Medical Fee Schedule within 30 days of receipt of the appeal.

Date of receipt may be established by the Payer’s date stamp or electronic acknowledgment date required by Rule 4; otherwise, receipt is presumed to occur five days after the date the response was mailed to the Payer’s correct address.

4. If after reviewing the appeal the Payer upholds its denial, the Payer shall send the billing party written notice within 30 days of receipt of the appeal. The written notice shall include all notice requirements set forth in sections 16-10 B and C, and shall also include:

a. Reference to each code being denied;

b. Clear and persuasive medical or non-medical reasons for upholding the denial, including the name and professional credentials of the reviewer and a copy of the reviewer’s opinion when medically based;

c. Citation of appropriate statutes, rules, and/or documents supporting the Payer’s reason(s).

5. In the event of continued disagreement, the parties should follow dispute resolution and adjudication procedures available through the Division or the Office of Administrative Courts. The parties shall do so within 12 months of the date of the original bill should have been processed in compliance with section 16-10, unless extenuating circumstances exist.

16-11 RETROACTIVE REVIEW OF MEDICAL BILLS

A. All medical bills shall be considered final at 12 months after the date of the original written notice unless the Provider is notified that:

1. a hearing is requested within the 12-month period; or 2. a request for utilization review has been filed pursuant to § 8-43- 501.

B. If the Payer conducts a retroactive review to recover overpayments from a Provider based on non- medical reasons, the Payer shall send the billing party written notice that includes all notice requirements set forth in 1. Reference to each item of the bill for which the Payer seeks to recover payment:

2. Clear and persuasive reason(s) for seeking recovery of overpayment(s), including citation of appropriate statutes, rules and/or documents supporting the Payer’s reason(s).

3. Evidence that these payments were in fact made to the Provider.

C. If the Payer conducts a retroactive review to recover overpayments from a Provider based on medical reasons, the Payer shall have the bill and all supporting documentation reviewed by a Physician who holds a license and is in the same or similar specialty as would typically manage the medical condition or treatment under review. The Physician shall be Level I or II Accredited. In addition, a clinical pharmacist (Pharm.D.) may review billed medications, and a Psychologist may review billed services for mental health, without having received Level I or II Accreditation. The Payer shall send the billing party written notice that includes all notice requirements set forth in sections 16-10 B and C, and 16-11 B.

D. In the event of disagreement, the parties may follow dispute resolution and adjudication procedures available through the Division or the Office of 16-11-1 ONSITE REVIEW OF HOSPITAL OR MEDICAL FACILITY CHARGES A. If the Payer conducts a review of billed and non-billed hospital or medical facility charges related to a specific workers’ compensation claim, the Payer shall comply with the following procedures:

1. Within 30 days of receipt of the bill, send written notification to the hospital or medical facility of its intent to conduct a review.

Notification shall include the following information:

a. Name of the injured worker;

b. Division’s WC number and/or hospital or medical facility patient identification number;

c. An outline of the items to be reviewed; and d. Name and contact information of a person designated by the Payer to conduct the review, if applicable.

B. The reviewer shall comply with the following procedures:

1. Obtain a signed release of information form from the injured worker;

2. Negotiate with the hospital or medical facility on a starting date for the review;

3. Assign staff members who are familiar with medical terminology, general hospital or medical facility charging, and medical documentation procedures or have a level of knowledge equivalent at least to that of an LPN;

4. Establish a schedule for the review which shall include, at a minimum, the dates for the delivery of preliminary findings to the hospital or medical facility, a 14 day response period for the hospital or medical facility, the delivery of an itemized list of any discrepancies, and an exit conference upon completion of the review; and 5. Provide the Payer and hospital or medical facility with a written summary of the review within 30 days of the exit conference.

C. The hospital or medical facility shall comply with the following procedures:

1. Allow the review to begin within 30 days from the Payer’s notification;

2. Upon receipt of the injured worker’s signed release of information form, allow the reviewer access to all items identified on the form;

3. Designate an individual to serve as the primary liaison between the hospital or medical facility and the reviewer, who will acquaint the reviewer with the documentation and charging practices of the hospital or medical facility;

4. Provide a written response to each preliminary review finding within 14 days of receipt of those findings; and 5. Participate in the exit conference in an effort to resolve any discrepancies.

16-12 DISPUTE RESOLUTION PROCESS

When seeking dispute resolution from the Division’s Medical Dispute Resolution Unit, the requesting party must complete the Division’s “Medical Dispute Resolution Intake Form” (WC 181) found on the Division’s web page. The items listed on the bottom of the Form must be provided at the time of submission. If necessary items are missing or if more information is required, the Division will forward a request for additional information and initiation of the process may be delayed.

When the request is properly made and the supporting documentation submitted, the Division will confirm receipt. If, after reviewing the materials, the Division believes the dispute criteria have not been met, the Division will issue an explanation of those reasons. If the Division determines there is cause for facilitating the disputed items, the other party will be sent a notice requiring response within 14 days.

The Division will facilitate the dispute by reviewing the parties’ compliance with Rules 11, 16, 17, and 18 within 30 days of receipt of the complete supporting documentation; or as soon thereafter as possible. In addition, the Payer shall pay interest at the rate of eight percent per annum in accordance with § 8-43-410(2), upon all sums not paid timely and in accordance with the Division Rules. The interest shall be paid at the same time as any delinquent amount(s).

Upon review of all submitted documentation, disputes resulting from violation of Rules 11, 16, 17, and 18, as determined by the Director, may result in a Director’s Order that cites the specific violation.

Evidence of compliance with the order shall be provided to the Director. If the party does not agree with the findings, it shall state with particularity and in writing its reasons for all disagreements by providing a response with all relevant legal authority, and/or other relevant proof in support of its position(s).

Failure to respond or cure violations may result in penalties in accordance with § 8-43- 304. Daily fines up to $1,000/day for each such offense will be assessed until the party complies with the Director’s Order.

Resolution of disputes not pertaining to Rule violations will be facilitated by the Division to the extent possible. In the event both parties cannot reach an agreement, the parties will be provided additional information on pursuing resolution and adjudicati on procedures available through the Office of Administrative Courts. Use of the dispute resolution process does not extend the 12-month application period for hearing.

Rule 17 Medical Treatment Guidelines 17-1. STATEMENT OF PURPOSE The Director adopts the Medical Treatment Guidelines pursuant to § 8-42- 101(3.5)(a)(II). The purpose of these Guidelines is to comply with § 8-40-102(1) and assure the quick and efficient delivery of disability and medical benefits to injured workers at a reasonable cost to employers, without the necessity of any litigation.

17-2. USE OF THE MEDICAL TREATMENT GUIDELINES

(A) All health care providers shall use the Medical Treatment Guidelines promulgated by the Director, as required by § 8-42-101(3)(B).

(B) Payers shall routinely and regularly review claims to ensure that care is consistent with the Division's Medical Treatment Guidelines.

17-3. PROVIDER'S RESPONSIBILITIES

(A) The health care provider shall prepare a diagnosis-based treatment plan that includes specific treatment goals with expected time frames for completion in all cases where treatment falling within the purview of the Medical Treatment Guidelines continues beyond 6 weeks.

(B) Within 14 days of request by any party, the provider shall supply a copy of the treatment plan both to the patient and to the payer. Should the patient otherwise require care that deviates from the Medical Treatment Guidelines, the provider shall supply the patient and the payer with a written explanation of the medical necessity for such care.

17-4. PROCEDURE FOR QUESTIONING CARE

(A) The Medical Treatment Guidelines set forth reasonable medical care for high cost or high frequency categories of occupational injury or disease.

However, the Division recognizes reasonable medical care may include deviations from the Guidelines in individual cases.

The provider shall request Prior Authorization if the proposed treatment falls outside the Medical Treatment Guidelines or if the Guidelines or Division Rules require Prior Authorization for a proposed treatment. The provider may submit a Notification to Treat to receive a guarantee of (B) Rule 16 governs the contest of a request for Prior Authorization or a claim for payment.

17-5. EXHIBITS TO RULE 17

(A) Exhibit 1 – Low Back Pain (B) Exhibit 2A – Mild Traumatic Brain Injury (C) Exhibit 2B – Moderate/Severe Traumatic Brain Injury (D) Exhibit 3 – Thoracic Outlet Syndrome (E) Exhibit 4 – Shoulder Injury (F) Exhibit 5 – Cumulative Trauma Conditions (G) Exhibit 6 – Lower Extremity (H) Exhibit 7 – Complex Regional Pain Syndrome / Reflex Sympathetic Dystrophy (I) Exhibit 8 – Cervical Spine Injury (J) Exhibit 9 – Chronic Pain Disorder Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 17, Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 01 Rule 17, Exhibit 1 - LOW BACK PAIN MEDICAL TREATMENT GUIDELINES {#sec-7-ccr-1101-3-r17-ex-01 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 01}

DEPARTMENT OF LABOR AND EMPLOYMENT

WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

RULE 17, EXHIBIT 1 LOW BACK PAIN MEDICAL TREATMENT GUIDELINES 7 CCR 1101-3 Rule 17 - Exhibit 1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

Section 1. Guidelines Introduction

Section 1.a. Context and Use This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of guidelines for physicians/providers treating individuals who qualify as injured workers with low back pain under the Colorado Workers’ Compensation Act.

Although the primary purposes of this document for practitioners are advisory and educational, these guidelines are enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from these guidelines, as individual cases dictate. Therefore, these guidelines are not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip or overlook any sections.

Section 1.b. Application of the Guidelines The Division provides procedures to implement medical treatment guidelines (MTGs) and to foster communication to resolve disputes among the provider, payer, and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the Office of Administrative Courts.

Section 1.c. Guidelines Recommendations and Inclusion of Medical Evidence All recommendations are based on available evidence and/or consensus judgment. A Division staff methodologist (MD, MSPH) researched and adopted literature critique criteria for certain study designs (e.g., randomized controlled trial [RCT]). Literature critiques were performed in a manner congruent with national standards and were completed independent of the multidisciplinary task force group that drafted initial recommendations. The methodology is described in detail on the Division's MTGs page at cdle.colorado.gov/medical-treatment-guidelines. Please also refer to the Division’s website for evidence tables and study critiques that provide details on the studies used to develop the evidence statements.

When possible, guidelines recommendations link to evidence tables that include the level of evidence supporting the treatment recommendation. An evidence summary is included in tables where multiple evidence statements address the same topic. It is generally recognized that early reports of a positive treatment effect are frequently weakened or overturned by subsequent research. When interpreting medical evidence statements in the guidelines, the following apply:

• “Some evidence” means the recommendation considered at least 1 adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the intervention’s effect.

• “Good evidence” means the recommendation considered the availability of multiple adequate scientific studies or at least 1 relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the intervention’s effect.

• “Strong evidence” means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the intervention’s effect.

Recommendations not linked to evidence tables are based on consensus; consensus means the judgment of experienced professionals based on general medical principles.

All recommendations in the guidelines are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guidelines as “not recommended.”

Section 1.d. Recommended Citation for This Document Colorado Division of Workers' Compensation. (2021). Low Back Pain Medical Treatment Guidelines.

Colorado Department of Labor and Employment. https://cdle.colorado.gov/medical-providers/medicaltreatment-guidelines.

Section 1.e. Glossary of Abbreviations • ADLs - Activities of daily living • ALIF - Anterior lumbar interbody fusion • BBHI 2 - Brief Battery for Health Improvement, 2nd Edition • BCIA - Biofeedback Certification International Alliance • BDI-II - Beck Depression Inventory-II • BHI-MV - Behavioral Health Index-Multimedia Version • BMI - Body mass index • BMP - Bone morphogenetic protein • CBT - Cognitive behavioral therapy • CES-D - Center for Epidemiological Studies Depression Scale • COX-2 - Cyclooxygenase-2 • CT - Computed tomography • DRAM - Distress and Risk Assessment Method • DSM - Diagnostic and Statistical Manual of Mental Disorders • ESI - Epidural steroid injection • FCE - Functional capacity evaluation • G6PD - Glucose-6-phosphate-dehydrogenase • GAD-7 - Generalized Anxiety Disorder Scale • GI - Gastrointestinal • H2-blocker - Histamine H2-receptor antagonists • MME - Morphine milligram equivalents • MMI - Maximum medical improvement • MRI - Magnetic resonance imaging • MTGs - Medical treatment guidelines • NMES - Neuromuscular electrical stimulation • NRS - Numeric rating scale • NSAIDs - Non-steroidal anti-inflammatory drugs • ODI - Oswestry Disability Index, or Oswestry Low Back Pain Disability Questionnaire • ORT - Opioid Risk Tool • PDMP - Prescription Drug Monitoring Program • PENS - Percutaneous electrical nerve stimulation • PHQ - Patient Health Questionnaire • PLIF - Posterior lumbar interbody fusion • PMMA - Polymethylmethacrylate • PRIME-MD - Primary Care Evaluation for Mental Disorders • QPOP - Quality Performance and Outcomes Payments • RCT - Randomized controlled trial • RF - Radiofrequency • rhBMP-2 - Recombinant human bone morphogenetic protein-2 • ROM - Range of motion • SF-12 - 12-item Short Form Health Survey • SF-36 - 36-item Short Form Health Survey • SI - Sacroiliac • SNRI - Serotonin norepinephrine reuptake inhibitor • SSRI - Selective serotonin reuptake inhibitors • TDR - Total disc replacement • TENS - Transcutaneous electrical nerve stimulation • TLIF - Transforaminal lumbar interbody fusion • VAS - Visual analogue scale

Section 2. General Guidelines Principles This document should be interpreted within the parameters of the following guidelines principles that may lead to more optimal medical and functional outcomes for injured workers.

Section 2.a. Education Education of the individual and family and/or support system, as well as the employer, insurer, policy makers, and the community, should be the primary emphasis in the treatment of low back pain and disability. Currently, practitioners often think of education last, after medications, manual therapy, and surgery. Practitioners must implement strategies to educate individuals with low back pain, employers, insurance systems, policy makers, and the community as a whole. An education-based paradigm should always start with inexpensive communication that provides recovery, function-focused, patient-centered, and evidence-based information to the individual with low back pain. More in-depth education is currently a component of treatment regimens that employ functional, restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention. Facilitation through language interpretation, when necessary, is a priority and part of the medical care treatment protocol.

Section 2.b. Shared Decision Making Providers should implement shared decision making as a crucial element of a successful treatment plan.

Patients, with the assistance of their health care practitioner and support system, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, psychologists, physical therapists, and other members of the health care team play an integral role in shared decision making and achievement of functional goals. Patient education and shared decision making should facilitate selfmanagement of symptoms and prevention of further injury.

Section 2.c. Return to Work Return to work is therapeutic, assuming the work is not likely to aggravate the basic problem. The practitioner must provide specific written physical limitations, and the patient should never be released to work with non-specific and vague descriptions such as “sedentary” or “light duty.” The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, carrying, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, repetitive motion tasks, sustained grip, tool usage, and vibration factors. Even if there is residual chronic pain, return to work is not usually contraindicated.

The practitioner should understand all of the physical demands of the patient’s job position before returning the patient to full duty and should request clarification of the patient’s job duties. Clarification should be obtained from the employer or, if necessary, including, but not limited to, an occupational health nurse, occupational therapist, vocational rehabilitation specialist, or an industrial hygienist.

Section 2.d. Treatment Parameter Duration Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Duration will be impacted by the individual’s adherence, as well as availability of services. Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

Section 2.e. Active Interventions Active interventions emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, are generally utilized over passive interventions, especially as treatment progresses.

Generally, passive interventions are viewed as a means to facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

Section 2.f. Active Therapeutic Exercise Program Exercise program goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

Section 2.g. Positive Patient Response Positive results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to: positional tolerances, range of motion (ROM), strength, endurance, activities of daily living (ADLs), ability to function at work, cognition and communication, psychological behavior, and efficiency/velocity measures that can be quantified. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation. Anatomic correlation must be based on objective findings. Patient completed functional questionnaires can provide useful additional confirmation, such as those recommended by the Colorado Division of Workers’ Compensation (Division) Quality Performance and Outcomes Payments program (QPOP, see Rule 18), the Patient-Specific Functional Scale, or other validated function scales.

Section 2.h. Re-evaluation of Treatment Effectiveness Re-evaluation should occur every 3 to 4 weeks or within the time to produce effect for a given treatment.

Treatment should be modified or discontinued if there is no evidence of positive results. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results. Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

Section 2.i. Surgical Interventions Surgery should be contemplated within the context of expected functional outcome and not purely for the

purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic conditions.

Section 2.j. 6-month Time Frame The prognosis drops precipitously for returning an injured worker to work once they have been temporarily totally disabled for more than 6 months. The emphasis within these guidelines is to move patients along a continuum of care and return to work within a 6-month time frame, whenever possible. It is important to note that time frames may be less pertinent for injuries that do not involve work-time loss or are not occupationally related.

Section 2.k. Delayed Recovery For patients who are failing to make expected progress 6 to 12 weeks after initiation of treatment of an injury, strongly consider a psychological evaluation, if not previously provided, as well as initiating interdisciplinary rehabilitation treatment and vocational goal setting. The Division recognizes that 3 to 10% of all industrially injured patients will not recover within the timelines outlined in this document, despite optimal care. Such individuals may require treatments beyond the timelines discussed within this document, but such treatment requires clear documentation by the authorized treating practitioner focusing on objective functional gains afforded by further treatment and impact upon prognosis.

Section 2.l. Post Maximum Medical Improvement (MMI) Care Maximum medical improvement (MMI) should be declared when a patient’s condition has plateaued to the point where the authorized treating physician no longer believes further medical intervention is likely to result in improved function. However, some patients may require treatment after MMI has been declared in order to maintain their functional state. The recommendations in these guidelines are for pre- MMI care and are not intended to limit post-MMI treatment.

Section 3. Overview of Care Introduction. Low back pain is a common condition with a lifetime prevalence of 84% and a high recurrence rate. However, only about 15% of the population has severe pain with functional/disability limitations. Most low back pain responds to therapy and self-management and does not require invasive measures. These guidelines outline a biopsychosocial approach to low back pain care and integrate biological, psychological, and social elements.

Significant trauma resulting in fractures and/or spinal cord dysfunction are not covered in these guidelines. Early imaging and surgical evaluation should be reserved for more severe issues outlined in recommendation 1. Most patients will respond to conservative care as outlined in recommendations 2 through 5 and will not require invasive treatment. Additional interventions, as indicated for less common cases, are covered by the remaining recommendations.

Recommendation 1. Early imaging and surgical evaluation is required for patients with evidence of any of the following:

• trauma with concern for acute fracture or dislocation, • epidural abscess, • myelopathy, • cauda equina syndrome, or • progressive neurologic deficits (e.g., motor weakness and abnormal reflexes) that specifically correlate with spinal cord or nerve root impingement.

Recommendation 2. Initial conservative management without imaging is strongly recommended for all low back pain patients who do not meet the criteria in recommendation 1, focusing on the following:

• education that prolonged periods of immobility are detrimental, • education on the positive impact of movement on recovery, • appropriate use of over the counter medications, and • application of ice or heat.

Recommendation 3. Bed rest is not recommended (table 1).

Recommendation 4. Close follow-up and subsequent neurologic examinations are required for patients with radicular low back pain who do not meet the criteria in recommendation 1 or recommendation 8.

Recommendation 5. Participation in self-directed exercise or an active therapy program that includes core stabilization, strengthening, and endurance is recommended as a principal low back pain treatment.

See the Active Therapies section.

Recommendation 6. Individuals with barriers to functional recovery may benefit from an interdisciplinary approach to care. See the Diagnosis section.

Recommendation 7. Referral for epidural steroid injection (ESI) evaluation within 6 weeks of pain onset is permitted when all of the following criteria are met:

• severe function-limiting pain in legs greater than the back that interferes with return to work, activities of daily living (ADLs), and/or participation in active therapy; and • positive correlation among clinical findings, the clinical course, and diagnostic tests.

See the Epidural Steroid Injections section.

Recommendation 8. Referral for discectomy evaluation within 6 weeks of pain onset is permitted when all of the following criteria are met:

• function-limiting pain in legs greater than the back that interferes with return to work, ADLs, and/or participation in active therapy;

• physical exam findings of abnormal reflexes, motor weakness, or radicular sensory deficits;

• findings on magnetic resonance imaging (MRI) indicate impingement of nerves or the spinal cord that specifically correlate with reproducible physical exam findings; and • the observed pathology is amenable to surgical intervention.

See the Discectomy section.

Recommendation 9. Referral for spinal injections is indicated when all of the following criteria are met:

• positive correlation among clinical findings, the clinical course, and diagnostic tests;

• positive functional response to diagnostic injection, if required;

• persistent functional impairment despite engagement in 6 weeks of active therapy; and • confounding psychosocial risk factors have been screened for and clinically addressed (see the Behavioral and Psychological Interventions section).

See the Injections section.

Recommendation 10. Referral for surgical evaluation at 6 weeks or greater is indicated when the expected functional outcome of surgery is better than non-operative management and all of the following criteria are met:

• symptomatic and functional improvement has plateaued with unacceptable functional disability;

• greater pain in the legs relative to back that interferes with function, return to work, and/or active • physical exam findings of abnormal reflexes, motor weakness, or radicular sensation deficits;

• findings on MRI that indicate impingement of nerves or the spinal cord that specifically correlate with reproducible physical examination findings; and • diagnostic elimination of confounding psychological or physical conditions that may respond to non-surgical techniques but may be refractory to surgical intervention (see the Behavioral and Psychological Interventions section). Also see the Surgical Interventions section.

Table 1.

Evidence Table: Return to Daily Activities and Avoidance of Bed Rest in Low Back Pain Bed rest is not helpful for treating uncomplicated low back pain. Mobilization in subacute low back pain reduces disability.

There is strong evidence against the use of bed rest in acute low back pain cases without neurologic symptoms.

Education and mobilization of subacute low back pain reduces disability. RCT Among a cohort of 33,908 healthy study volunteers, new cases of depression were potentially preventable by participation in at least 1 hour of weekly exercise.

Cohort study See related sections for additional evidence tables.

Section 4. Diagnosis Introduction. Initial and follow-up evaluation of low back pain may include a clinical history, physical examination, laboratory studies, imaging studies, and electrodiagnostic studies. Please see specific sections for diagnostic injections.

Initial Diagnostic Studies Requirements.

Recommendation 11. A detailed history of pain onset, past medical history, and a detailed neurologic examination are required at the initial low back pain evaluation (tables 2, 3).

Recommendation 12. Medical causation must establish that low back pain is a result of a specific injury, an aggravation of an underlying condition, or a previously asymptomatic condition made symptomatic by a work-related exposure (tables 4, 5).

Recommendation 13. Initial functional assessment is strongly recommended. See the Appendix Functional Screens.

Recommendation 14. A psychological screen is encouraged as a routine part of clinical care and is required as soon as any of the following barriers to functional recovery are identified (Appendix Psychological Screens):

• limited patient engagement in recovery, • activity avoidance or catastrophization due to pain, • avoidance of essential recovery activities, • inappropriate expression of a sense of injustice, • exaggeration of symptoms/situation, • low expectations of recovery, • ineffective coping skills, or • loss of vocational connection.

Individuals with barriers to functional recovery may benefit from an interdisciplinary approach to care (table 6, 7).

Recommendation 15. Imaging studies before 6 weeks are not recommended for patients with uncomplicated low back pain (table 8).

Recommendation 16. Imaging studies are recommended if the patient is 55 years or older, if there is a

history of significant trauma, if there is persistent or unexplained pain after 6 weeks, or if there is concern for any of the following:

• fracture, • instability, • occult cancer, • weakness, • pain worse at rest, • cauda equina syndrome, • epidural abscess, or • myelopathy.

Documentation shall include the specific findings under investigation and how the imaging test will influence treatment.

Recommendation 17. When clinically indicated, early laboratory studies may be ordered to evaluate for systemic illness, infection, neoplasia, underlying rheumatologic, or connective tissue disorder.

Follow-Up Diagnostic Studies Requirements.

Recommendation 18. A formal psychological or psychosocial evaluation is required for patients not making expected progress within 6 weeks of injury and whose subjective symptoms do not correlate with objective signs and tests. See the Behavioral and Psychological Interventions section.

Recommendation 19. Magnetic resonance imaging (MRI) is indicated when there is concern for myelopathy, masses, infection, metastatic disease, or cord contusion. MRI is recommended for patients who have responded poorly to initial care and there is clinical suspicion for disc herniation, nerve root compression, or annular tear. Contrast MRI can be used when there is a history of lumbar surgery or if there is possible infection, malignancy, or tumor (table 8).

Recommendation 20. Computed tomography (CT) scan is permitted to better visualize bone and to further evaluate masses and suspected fractures not clearly identified on radiographic evaluation.

Recommendation 21. Myelography is a diagnostic option when:

• CT or MRI are contraindicated or not available, and • when other tests have proven non-diagnostic in the surgical candidate.

Recommendation 22. Radioisotope bone scanning is permitted when there is clinical suspicion for metastatic or primary bone tumors, occult or stress fractures, osteomyelitis, infection, or other inflammatory lesions.

Recommendation 23. Discography is not generally recommended, but it is permitted when confirmatory information is necessary prior to proceeding with lumbar fusion or total disc replacement (TDR). See the Spinal Fusion or Total Disc Replacement sections.

Recommendation 24. Electromyography and nerve conduction studies are recommended for patients with suspected neural involvement and persistent symptoms that are unresponsive to initial conservative treatment.

Recommendation 25. Somatosensory evoked potentials may be used to evaluate myelopathy, neurogenic bladder, and sexual dysfunction, but it is not recommended to identify radiculopathy.

Recommendation 26. Surface electromyography and current perception threshold evaluation are not recommended.

Table 2.

Evidence Table: Self-reported Body Pain Diagrams in Describing Low Back Pain Pain diagrams, either manual or computerized, reliably identify pain location.

Using a computer program (electronic body surface estimation method) to measure pain distribution was found to have both high intra- and inter-examiner reliability in patients with chronic nonmalignant pain.

Using either segmental classification or Quebec Task-Force classification to measure pain location was found to have both adequate intra- and interexaminer reliability in patients with low back pain or lumbar radiculopathy.

A body diagram, in which the patients use a pencil to shade in painful areas of the body, has acceptable reliability for designating the regions in which their pain is felt.

Table 3.

Evidence Table: Physical Examination Findings and Low Back Pain A single neurologic test in isolation has limited diagnostic value.

In the setting of suspected herniated discs, a single neurologic test in isolation (such as sensory testing of specific dermatomes, weakness of specific muscles, or tendon reflexes) is of limited diagnostic value in identifying lumbar spinal disc herniation with radiculopathy. A single level disc herniation may not cause major sensory or motor deficits unless there is a large conduction block of the nerve root axons.

In the initial clinical examination findings for adults with low back pain (who presented with radicular findings), the following prognostic factors were found to be consistent for evidence; symptom response classification (i.e., centralization) and non-organic signs.

Specifically, centralization was the only factor with an association of less shortterm pain. In addition, non-organic signs were the only factors associated with poor long-term outcome of return to work.

Table 4.

Evidence Table: Non-Occupational Risk Factors for Low Back Pain Smoking is a risk factor for lumbar radicular pain. Severe obesity is associated with low back pain.

Current and ever smoking are both moderate risk factors for patients experiencing lumbar radicular pain.

Out of many modifiable lifestyle factors, severe obesity (defined as a body mass index [BMI] ≥ 35 kg/m ) was found to be most associated with lifetime chronic back pain, independent of genetic and familial factors.

Table 5.

Evidence Table: Occupational Risk Factors for Low Back Pain Standing and walking in the workplace do not cause low back pain. Occupational sitting is unlikely to cause low back pain. Lifting or trunk rotation in combination with bending the trunk are risk factors for low back pain, with or without radiculopathy. There is good evidence that the combination of trunk flexion, rotation, and lifting in the workplace cumulatively is associated with low back pain. A combination of trunk flexion while repetitively lifting 50 pounds or more is a cumulative risk factor for low back pain (e.g., lifting a 50 pound box 3 feet more than 50 times per work week). Cumulative lifting (e.g., ≥ 7 hours per week for > 9.5 years), particularly when combined with other exposures, may result in low back pain.

Standing and walking do not cause low back pain. Systematic Trunk flexion, rotation, and lifting in the workplace cumulatively is associated with low back pain.

Work-related factors, such as lifting and bending of the trunk or bending and twisting of the trunk, increase a worker’s risk of developing lumbosacral radiculopathy.

Whole body vibration has no important association with disc pathology in the lumbar spine in professional drivers.

Case control Cumulative exposure to lifting in the workplace is associated with the development of low back pain. Exposures of 7 hours per week or greater, over more than 9.5 years, is associated with low back pain in an apparent doseresponse relationship. The effects of lifting may only become apparent when considered in combination with other work exposures.

Case control Sitting does not cause low back pain. Systematic Table 6.

Evidence Table: Interdisciplinary Back Pain Care Interdisciplinary programs that include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability.

Table 6 continued.

Evidence Table: Interdisciplinary Back Pain Care Interventions addressing fear-avoidance beliefs in populations with high baseline scores on Fear-Avoidance Behavior Questionnaire or Tampa Scale of Kinesiophobia are associated with reduction in pain (or disability) and improvements in return to work in patients with low back pain of less than 6 months duration (i.e., an acute or subacute population).

Table 7.

Evidence Table: Multidisciplinary Biopsychosocial Rehabilitation Multidisciplinary interventions lead to greater improvements in function, pain, and return to work time compared to usual care or singular interventions for patients with subacute and chronic low back pain.

Patients with psychosocial risk factors are more likely to benefit from a multidisciplinary approach.

Among people with subacute (6-12 weeks) low back pain, multidisciplinary biopsychosocial rehabilitation was significantly more effective than usual care for short (≤ 3 months) and long-term (≥12 months) pain and disability improvement, but it was no more effective than other types of treatment.

For this systematic review, multidisciplinary biopsychosocial rehabilitation included a physical component (e.g., pharmacological, physical therapy, massage, manual therapy, etc.) in combination with either a psychological, social or occupational component (e.g., cognitive behavioral interventions, fearavoidance treatment, motivational interviewing).

Among people with subacute low back pain, multidisciplinary biopsychosocial rehabilitation was significantly more effective than usual care for return to work at the long term (≥ 12 months), but it was no more effective than other types of treatment in reducing sick leave periods at the long term.

For this systematic review, multidisciplinary biopsychosocial rehabilitation included a physical component (e.g., pharmacological, physical therapy, massage, manual therapy, etc.) in combination with either a psychological, social or occupational component (e.g., cognitive behavioral interventions, fearavoidance treatment, motivational interviewing).

Multidisciplinary biopsychosocial rehabilitation shows small effects in reducing pain and improving disability compared to usual care, and that multidisciplinary biopsychosocial rehabilitation was more effective than physical treatment for return to work after 12 months of treatment in patients with chronic low back Patients with a significant psychosocial impact are most likely to benefit.

Table 7 continued.

Evidence Table: Multidisciplinary Biopsychosocial Rehabilitation Patients with chronic low back pain who received multidisciplinary rehabilitation had lower short-term pain intensity and greater improvement in function than those who received usual care, no rehab, and non-multidisciplinary physical In patients with symptomatic degenerative disc disease at L4-5 or at L5-S1 lasting more than 1 year, persisting after 6 months of physical therapy or chiropractic treatment, an initial treatment regimen consisting of rehabilitation with a multidisciplinary team of specialists may effectively improve function, defined as a 15 point improvement in the Oswestry Disability Index (ODI), in up to half of patients, making it a reasonable initial treatment option.

However, a TDR is overall more effective than multidisciplinary rehabilitation for pain and function, and may improve function by the same amount in about 70% of patients.

Patients with persistent low back pain and subthreshold depression are at risk for developing a major depressive episode over the course of the next 12 months. A program of online self-help, based on cognitive-behavioral principles in which each participant completes weekly homework assignments and receives weekly guidance and feedback from a trained psychologist, may prevent the progression from subthreshold depression to a major depressive episode.

Table 8.

Evidence Table: Imaging Findings and Low Back Pain Imaging findings occur frequently in asymptomatic patients and therefore are a poor indicator for clinically significant pathology. In addition, imaging may fail to detect problems identified by clinical predictors, such as physical exam findings, pain drawing, and depression.

In the asymptomatic population, disc bulges, disc protrusions, annular tears, high intensity zone areas, and disc height loss are prevalent 40–60% of the time, depending on the condition, study, and age of the patient.

Table 8 continued.

Evidence Table: Imaging Findings and Low Back Pain Extruded discs are uncommon in asymptomatic persons and are associated with low back pain.

In patients with long-standing nerve root symptoms, MRI significantly underestimates the presence of nerve involvement otherwise detected by a combination of physical examination and simplified pain drawing.

Diagnostic Asymptomatic subjects of all ages frequently show common degenerative changes in the cervical and lumbar spine as seen on MRI. These changes are more common with increasing age. The cervical and lumbar spine are equally affected, suggesting that disc degeneration occurs in tandem in the lumbar and cervical spine.

The majority of workers over 60 show evidence of disc degeneration, and posterior disc protrusions are present in the majority of asymptomatic workers over 40 years of age.

Type 1 Modic changes are at an increased risk for no improvement in pain or function and for unsuccessful return to work at 1 year.

Depression is a more accurate predictor of the development of low back pain than many common MRI findings, such as disc bulges, disc protrusions, Modic endplate changes, disc height loss, annular tears, and facet degeneration, which are common in asymptomatic persons and are not associated with the development of low back pain.

Early radiographic imaging without clear indications is associated with prolonged care, although it does not change functional outcomes.

Section 5. Return to Activity and Work Considerations Introduction. Return to activity and/or work-related activities is a primary therapeutic component of low back pain management and rehabilitation. There are special tests performed as a part of a skilled assessment of the patient’s capacity to return to work, their strength capacities, and/or physical work demand classifications and tolerance. Terminology relevant to the activity and return to work discussion includes the following:

• computer enhanced evaluations, • immobility, • functional capacity evaluation (FCE), • jobsite evaluation or analysis, and • work tolerance screenings.

Communication among the patient, treating provider, employer, and insurer is essential for successful return to work efforts. Refer to the Active Therapies section for work conditioning and work simulation.

Absolute and Relative Contraindications to Return to Work.

• Absolute and relative contraindications include performance of job activities that pose a medical risk to the recovering worker.

Side Effects and Adverse Events Related to Return to Work.

• Side effects and adverse events include a temporary increase in discomfort or muscle soreness when correcting deconditioning after time away from typical tasks.

Recommendation 27. A job history interview should be completed at the time of the initial evaluation. A thorough job history generally includes:

• duties and demands of job held at time of injury;

• duties and demands of current job, if different;

• stressors; and • cognitive and social issues, with treatment incorporated into the plan of care.

Recommendation 28. A formal job description for the injured worker is required to identify physical demands at work and to assist in the creation of modified duty.

Recommendation 29. Ergonomic or adaptive equipment, therapeutic breaks, and workplace interventions are recommended to maintain employment (table 9).

Recommendation 30. Nurse case management is recommended in medically complex cases to facilitate communication between the primary provider, referral providers, insurer, employer, and employee. The patient may decline nurse case management services.

Workplace Tests Requirements.

Recommendation 31. A jobsite evaluation is permitted to fully understand the physical demands of a working day; this information can be used when determining medical causation, the need for ergonomic changes, and/or ability to return to work.

Recommendation 32. A work tolerance screening is recommended to determine a patient’s tolerance for performing a specific job activity or task from a cardiovascular, postural tolerance, and physical fitness perspective.

Recommendation 33. An FCE may be used to determine an individual’s capacity to work. A formal job description and jobsite evaluation, if performed, should be made available to the FCE evaluator prior to having the FCE performed.

Recommendation 34. Follow-up evaluation with the treating therapist and/or the treating physician is required between 1 to 3 days after the FCE to assess the patient’s status.

Recommendation 35. FCEs are not recommended as the sole tool for the development of temporary or permanent work restrictions (table 10).

Recommendation 36. Performance during FCEs cannot be used as the sole criteria in diagnosing malingering.

Recommendation 37. Computer-enhanced strength evaluations or performance on FCEs cannot be used alone to determine return to work restrictions.

Return to Work Requirements.

Recommendation 38. It is strongly recommended that the patient return to work in a modified capacity as soon as it is medically appropriate.

Recommendation 39. Interdisciplinary services are permitted to assist the injured worker in return to work efforts (e.g., behavioral and/or psychological support, active therapy).

Recommendation 40. A graduated return to work strategy should be incorporated into a successful medical treatment plan and rehabilitation after injury with a goal of return to full duty, if medically feasible (e.g., nature and frequency of activities, and hours worked).

Recommendation 41. Permanent work restrictions should be developed based on objective information available, including:

• history;

• findings on physical examination and diagnostic testing; and • functional response to active therapy, work conditioning, and/or modified duty.

Timing of Tests.

Timing of Tests and Maximum Allowed FCE 1 time to determine baseline status, and 1 time to determine permanent work restrictions at case closure if it is clear that the patient cannot return to the position held at the time of injury.

Jobsite evaluations 1 time for initial evaluation, 1 for mid-treatment assessment, and 1 at final evaluation.

Computer enhanced evaluations 1 time for initial evaluation, 1 for mid-treatment assessment, and 1 at final evaluation.

Work tolerance screening 1 time for the initial screen. May monitor improvements in strength every 3 to 4 weeks up to a total of 6 visits.

Table 9.

Evidence Table: Return to Work and Spine Pain For workers with musculoskeletal conditions, including low back pain, workplace interventions reduce the recurrence of further injury and reduce time away from work. Such interventions involve the worker, employer, and an occupational physician, and they include ergonomic adjustments and work modification, as needed.

For workers who have been absent from work due to musculoskeletal conditions, the cumulative time away from work in the first 12 months is likely to be reduced if there is a workplace intervention in which several stakeholders, including the workers, the employer, and an occupational physician, formulate a plan to reduce the recurrence of further injury; this generally will involve an ergonomic evaluation of the worksite and plans for work modification as needed.

Workplace interventions in which several stakeholders, including the workers, the employer, and an occupational physician formulate a plan to reduce the recurrence of further injury are also likely to shorten the time needed for a first return to work, and are likely to be beneficial in reducing the risk of a recurrence of sickness absence due to the underlying musculoskeletal condition.

An integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of Table 10.

Evidence Table: FCE FCEs are poor predictors of return to work, and there is no evidence that they predict re-injury. A short form FCE, designed for completion in 1 day, may have similar predictive value to standard FCEs.

Performance-based measures, such as those assessed in an FCE, are weakly predictive of return to work variables. Most of the variation in time for return to work is explained by factors other than the physical ability to perform specific tasks.

Time off work and gender are important predictors for return to work, and floorto-waist lifting may also help predict return to work; however, the strength of that relationship has not been determined.

In chronic low back pain patients, (1) FCE task performance is weakly related to time on disability and time for claim closure and (2) even claimants who fail on numerous physical performance FCE tasks may be able to return to work.

Table 10 continued.

Evidence Table: FCE An FCE fails to predict which injured workers with chronic low back pain will have sustained return to work.

A short form FCE reduced to a few tests produces a similar predictive quality compared to the longer 2-day version of the FCE regarding length of disability and recurrence of a claim after return to work.

There is a lack of evidence supporting the validity of FCE for prediction of reinjury following return to work.

Section 6. Essential First Line Treatment Introduction. Education about low back pain and associated disability may involve the patient, patient’s family, employer, insurer, policymakers, and community. Informed consent and shared decision making are 2 important components of patient education. Informed consent is an individual’s autonomous authorization of a medical intervention that has resulted from a conversation between a patient and provider. It is also a formal process that healthcare institutions require before permitting procedures.

Shared decision making involves an exchange of ideas between the patient and provider and collaboration in the decision itself.

Recommendation 42. Patient education is required as a primary component of low back pain treatment, beginning with the expected natural history of low back pain, with and without radicular symptoms.

Recommendation 43. In the setting of benign clinical examination, it is strongly recommended that the provider educates and reassures the patient that there is a high likelihood their condition will improve and that it is essential to self-manage their symptoms.

Recommendation 44. Patient education should include a thorough discussion of how behavioral health evaluation and treatment is an essential component to support recovery from physical injury.

Recommendation 45. Shared decision making is required when 2 or more medically reasonable treatment choices exist, regardless of whether the degree of risk is high or low. Elements of shared decision making for spine interventions must include the following:

• the patient’s experience with treatment;

• creation of individualized functional goals of treatment and anticipated barriers to success;

• documentation of expected results of diagnostic testing and possible plan of action in response to test results;

• a discussion of the continuum of treatment from the least invasive to the most invasive, with the intent of identifying a treatment along this continuum that most completely addresses the condition;

• expectation regarding the functional impact of the proposed treatment, including a discussion regarding return to work and expected timeframe for treatment;

• specific measurable and clinically meaningful criteria for determining treatment success or failure;

• confirmation of the patient’s commitment to perform active therapy to optimize treatment outcomes; and • documentation and consideration of the patient’s unique risks and benefits based on comorbid medical conditions.

Shared decision making discussions should be tailored to the patient’s health literacy.

Recommendation 46. Informed consent is required when a high risk treatment is under consideration. It includes the following elements:

• discussion of the proposed treatment’s purpose;

• benefits and risks of the proposed treatment, alternative treatments, and nontreatment; and • explicit patient agreement or refusal.

Section 7. Second Line Treatment

Section 7.a. Core Second Line Treatment

Section 7.a.i. Active Therapies Introduction. Active therapies are therapeutic exercises and/or activities that intend to restore flexibility, strength, endurance, function, and range of motion (ROM) and to alleviate discomfort. They require intrinsic motivation by the patient to complete a specific exercise or task. The following active therapies are common treatments:

• activities of daily living (ADLs) therapy, • aquatic therapy, • back schools, • functional activities therapy, • functional electrical stimulation or neuromuscular electrical stimulation (NMES), • neuromuscular re-education, • Pilates, • tai chi, • therapeutic exercise, • yoga, • work conditioning, and • work simulation.

Active therapies also include developing functional goal-setting, maintaining or returning to usual activities and exercise in a graded fashion, and providing patient education and key recovery messages. Active therapies may coincide with pain neuroscience education. Pain neuroscience education involves educating patients about the biological and physiological processes involved in their pain experience and, importantly, deemphasizing the issues associated with anatomical structures, pain generators, and tissue damage.

Individual patients may benefit from additional education approaches. Education may include, but is not limited to: a favorable prognosis for recovery, the importance of continuing daily activities, promotion of self-efficacy, problem-solving, engagement of support systems, and relaxation techniques.

Contraindications / Side Effects and Adverse Events.

Relative Contraindications to Active Therapies.

• Motor, sensory, or reflex abnormalities are relative contraindications to the use of the McKenzie Method of Mechanical Diagnosis and Therapy.

• Pulmonary or cardiac conditions limiting participation are relative contraindications to active Side Effects and Adverse Events Related to Active Therapies.

• Exercise therapy may result in temporary thoracic or lumbar muscle soreness. This side effect, within reasonable limits, should not deter continued active therapy.

Recommendation 47. Active interventions, including therapeutic exercise and/or functional treatment, are recommended in the treatment of low back pain (table 13).

Recommendation 48. Medical clearance is required prior to participation in active therapies if a patient has any of the following:

• angina/dyspnea on exertion or at rest, • paroxysmal nocturnal dyspnea and/or orthopnea, • syncope or presyncope, • arrhythmia or palpitations, or • cardiac murmur (see Contraindications to Active Therapies).

Recommendation 49. Patients in active therapy must:

• demonstrate functional progress that is documented through validated sequential functional assessment measures, • return to work with decreased restrictions, and/or • have improvement in clinical measures (e.g., strength, ROM, and ADLs).

If there is no documented evidence of functional progress after 6 treatments, the therapy will be discontinued and the patient must be referred back to their treating provider for further evaluation. Each patient is limited to a maximum of 4 discrete active therapy trials without documented functional progress (Appendix Functional Screens).

Recommendation 50. A patient is allowed up to 6 active therapy visits to advance their active home exercise program. These visits are contingent on documented demonstration of previously instructed exercises, performance of their home program at the recommended frequency, and progress in their exercise program.

Recommendation 51. Adjunct passive therapy can occur concurrently with active therapy and the frequency of passive therapies will decrease over time. See the Passive Therapies section.

• Recommendation 52. Durations of care beyond those listed as “time to produce effect” and “maximum” are warranted in certain circumstances when treatment to date has resulted in measurable and clinically meaningful functional improvement. These circumstances include:

• re-injury;

• interrupted continuity of care;

• after surgery, particularly after multiple surgeries;

• injuries (e.g., fracture); or • comorbidities.

Recommendation 53. Functional electrical stimulation or NMES home units require prior authorization, documenting medical justification for home use.

Time Frames for Active Therapies Time to produce effect Frequency Optimum duration Maximum duration 6 treatments up to 4 times per week 6 weeks 8 weeks Table 11.

Evidence Table: Therapeutic Response Considerations in Low Back Pain Stratification of patients with low back pain using the STarT Back questionnaire can identify patients at low risk of poor outcomes and prevent unnecessary referrals for physical therapy which adds little incremental benefit over minimal care. Patients at medium and high risk may also benefit from receiving appropriate referrals for physical therapy.

Table 12.

Evidence Table: Timing of Physical Therapy Initiation and Low Back Pain In patients with subacute low back pain and symptoms distal to the knee, early physical therapy produces improvements in function and pain similar to those seen with a single education session and follow-up with a primary care physician. A modified version of the ODI was used in this study.

In patients with subacute low back pain and symptoms distal to the knee, early physical therapy does not reduce the utilization of advanced imaging, spinal injection, emergency department visits, or spine surgery in the year following initial consultation. A modified version of the ODI was used in this study.

Table 13.

Evidence Summary: Active Therapies Active therapies may provide modest functional benefit and symptomatic relief in patients with subacute and chronic low back pain. No evidence demonstrates that 1 form of active therapy is superior to any other, and the selection of an active therapy may be guided by local availability and the patient’s preference and capability. While the evidence does not support the use of active therapies in acute low back pain, they are generally accepted interventions for patients at risk for immobility or deconditioning.

Patients with barriers to functional recovery may benefit from the incorporation of pain education into therapeutic exercise.

Table 14.

For patients with subacute and chronic low back pain, exercise-based interventions may reduce pain and disability.

For acute or subacute low back pain, no difference was found between exercise therapy and no exercise on pain.

Exercise alone or as part of a multi-disciplinary program results in decreased disability for workers with non-acute low back pain.

A web-based 11 minute postural and exercise program that can be used daily by sedentary workers with nonspecific low back pain who work at a computer is likely to lead to clinically important improvements in back pain disability and in the endurance of abdominal and lumbar muscles, while reducing the risk of new episodes of back pain.

Table 14 continued.

Massage therapy in combination with exercise reduces pain and improves function short-term for patients with subacute low back pain.

In patients with acute low back pain lasting less than 15 days and with a modified Oswestry Disability Index (ODI) score of 20 or higher and no symptoms distal to the knee, early intervention with physical therapy consisting of manipulation and exercise produces improvements similar to those seen with providing an instructional booklet and follow-up with a primary care physician.

In patients with acute low back pain lasting less than 15 days and with a modified ODI score of 20 or higher and no symptoms distal to the knee, early physical therapy does not appreciably reduce the utilization of advanced imaging, spinal injection, emergency department visits, and spine surgery in the year following the onset of acute low back pain.

An unsupervised, 12-week, periodized musculoskeletal rehabilitation program of weight training conducted 2, 3, or 4 days a week is effective at improving musculoskeletal strength and quality of life and at reducing pain and disability in untrained persons with chronic low back pain. The 4 days a week training volume is most effective. The volume (total number of reps) of periodized musculoskeletal rehabilitation exercise prescribed is important.

Trunk balance exercises combined with flexibility exercises are more effective than a combination of strength and flexibility exercises in reducing disability and improving physical function in patients with chronic low back pain.

There is no significant difference in the effectiveness of an 8-week supervised walking program, an evidence-based group exercise class, and usual physiotherapy for improvement in functional disability after 6 months for people with chronic low back pain; all 3 interventions resulted in small, significant improvements in physical function, reduction of pain, quality of life, and fear avoidance over time.

In those who have chronic low back pain, 12 weeks of supervised high-dose exercise, spinal manipulative therapy, or low-dose home exercise with advice are all equally effective for reducing pain in the short- and long-term (1 year).

There is a modest benefit from adding a back school to other treatments such as non-steroidal anti-inflammatory drugs (NSAIDs), massage, transcutaneous electrical nerve stimulation (TENS), and other physical therapy modalities.

Disability improved in patients with lumbar spinal stenosis who underwent 6 or 12 sessions (3 and 6 weeks respectively) of cycling as measured by the Roland Morris Questionnaire.

Table 14 continued.

Aquatic exercises can be encouraged as part of an exercise program for patients with low back pain. Aquatic exercise could increase physical function in patients with low back pain.

However, there is no evidence that aquatic exercise is superior to other forms of active physical therapy. The participation of the patient is likely to influence the outcome of the exercise program, and it is reasonable to offer aquatic exercise to patients who have a distinct preference for it over other forms of exercise.

Table 15.

Evidence Table: Motor Control Exercise and Low Back Pain Motor control exercises are more effective than no exercise in reducing pain and improving disability in patients with chronic low back pain.

In the short, intermediate, and long-term, motor control exercises that emphasize the transversus abdominis and multifidus are at least as effective as other forms of exercise and manual therapy. They are possibly more effective than other minimal interventions in reducing pain and improving disability in patients for the treatment of chronic non-specific low back pain.

For chronic low back pain, exercise and motor control exercise were associated with greater pain relief than no exercise.

Among patients with recurrent non-specific low back pain and associated motor control impairment of at least 6 weeks duration, an intervention consisting of 5 sessions of specific movement control exercise and manual therapy may be as effective as a general exercise regimen and manual therapy in reducing disability at 12 months.

Table 16.

Evidence Table: The McKenzie Method and Low Back Pain For patients with subacute back pain, the McKenzie method results in similar disability reduction as compared to chiropractic manipulation.

Table 16 continued.

Evidence Table: The McKenzie Method and Low Back Pain Centralization is a favorable prognostic factor in low back pain with and without sciatica.

A 12-week course of McKenzie therapy is at least as effective as, and may have modestly superior results to, chiropractic manipulation in reducing disability from nonspecific low back pain lasting 6 weeks or more.

Referral of patients for chiropractic care or McKenzie physical therapy in the first weeks of uncomplicated low back pain adds little to the otherwise favorable prognosis for acute low back pain and does incur additional short-term costs of The McKenzie approach provides similar outcomes in improving pain, disability, and ability to carry out work activities in comparison with cognitive behavioral therapy (CBT).

The McKenzie method is as effective as intensive dynamic strengthening training in reducing short-term back and leg pain intensity in nonspecific low Table 17.

Evidence Table: Yoga and Low Back Pain Yoga results in improved pain and disability for patients with low back pain as compared to education alone or usual care.

Yoga has small to moderate advantages over providing only a booklet in reducing low back pain and back-specific disability, but there is no evidence that yoga is superior to stretching and strengthening classes led by a licensed physical therapist.

In the setting of chronic low back pain, an 8-week mindfulness-based stress reduction meditation program with yoga or 8 weeks of CBT resulted in small, significant improvements in physical function and reduction in pain compared to usual care at 26 weeks with no significant differences in outcomes between the 2 treatments.

Table 17 continued.

Evidence Table: Yoga and Low Back Pain Compared with education, yoga was associated with lower pain intensity and better function at short-term for chronic low back pain.

Yoga is comparable to or of small additional benefit when added to usual care for chronic low back pain.

Iyengar yoga, which avoids back bending, results in improved function and decreased chronic mechanical low back pain for up to 6 months. Instruction occurred 2 times per week for 24 weeks and was coupled with home exercise.

One quarter of the participants dropped out.

Yoga emphasizing mobility, strength, and posture to relieve pain may be more effective than usual care for chronic and recurrent low back pain.

Table 18.

Evidence Table: Pilates and Tai Chi in Low Back Pain Pilates is as effective as other forms of exercise in improving disability for patients with chronic low back pain. Tai chi may reduce pain and improve function for patients with chronic low back pain.

Pilates exercise shows statistically and clinically significant reductions in pain and statistically significant improvements in function in the short-term (maximum follow-up 15 weeks) compared with usual care, no exercise, education, or physical activity for the treatment of patients with chronic low back pain.

Pilates is more effective in reducing pain and improving disability compared with a minimal intervention at intermediate term follow-up, but pilates is equally as effective as other forms of exercise in improving disability at short- or intermediate-term follow-up for the treatment of patients with chronic nonspecific low back pain.

Tai chi had a small effect on reducing pain and improving function in chronic low back pain as compared to wait-list or no tai chi.

Table 19.

Evidence Table: Active Therapies with Education for Back Pain Active therapies with education lead to greater improvements in function, pain, and return to activity, compared to active therapy alone. The professional delivering such interventions should have training to do so.

Patients with at least 6 weeks of non-specific low back pain can achieve sustained reductions in pain and disability over a 12-month period after participating in physiotherapist-led cognitive behavioral interventions.

Physiotherapist-led cognitive behavioral interventions included in this review focused on a selection of cognitive behavioral techniques designed to reduce the fear of movement and pain-related disability such as pacing, goal setting, problem-solving, relaxation, and challenging unhelpful thoughts relevant to low Furthermore, the physiotherapist in the study received 16 to 72 hours of additional training. However, the details of the training program are not wellknown, potentially limiting the reproducibility of study findings.

Among patients with non-radicular, nonspecific and uncomplicated low back pain (<8 weeks duration), disability observed at 4 weeks and 6 months post-treatment are dependent on an interaction between the type of treatment received and the baseline level of fear-avoidance beliefs. That is, the effectiveness of fearavoidance-based physical therapy depends on the level of the individual patient’s fear-avoidance beliefs regarding back pain. Patients who avoid physical activity because they fear exacerbating their pain are more likely to benefit from physical therapy if that physical therapy includes elements of the accentuated physical therapy described in this study: a graded exercise program that places special emphasis on seeing back pain as a common condition with a favorable prognosis and encourages the patient to play an active role in recovery from the current back pain episode. Patients who do not limit their activities because of these beliefs are probably better served by a standard physical therapy program.

A 2-day course focusing on the biopsychosocial model with an emphasis on the goals of returning to usual activities and fitness is as effective in reducing disability as 6 sessions of manual therapy sessions provided by physiotherapists and more limited patient education.

A cognitive intervention consisting of 2 consultations lasting 1 hour each with a physical medicine specialist and a physical therapist covering coping strategies and patient education on motion produces short-term reductions in sub-acute back disability.

Table 19 continued.

Evidence Table: Active Therapies with Education for Back Pain 12 sessions of either graded activity or physiotherapy exercises over 6 weeks were similarly effective in reducing short-term pain and disability, improving quality of life, global perceived effect, return to work, physical activity, physical capacity, and kinesiophobia in patients with chronic nonspecific low back pain.

Intensive exercise for approximately 25 hours per week for 4 weeks, combined with cognitive interventions emphasizing the benefits of maintaining usual activity, produces functional results similar to those of posterolateral fusion in patients with chronic non-radicular back pain and no stenosis or instability after 1 year.

Among patients with chronic nonspecific low back pain, a 12-week physiotherapist-led cognitive-based program emphasizing specific movement exercises, targeted functional integration activities into daily life, and physical activities suited to the patient’s preference was found to be more effective than a combination of manual therapy and exercise in improving disability and pain for up to 12 months.

Physiotherapists underwent an extensive training program prior to delivering the intervention, averaging 106 hours that consisted of workshops, patient examinations, pilot study, and clinical manuals.

An integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain.

Incorporating telephone-delivered cognitive-behavioral strategies into postoperative physical therapy for patients at-risk for poor outcomes after lumbar laminectomy with or without fusion for degenerative conditions produced significant and clinically meaningful improvements in pain, disability, general health, psychosocial risk factors, and physical performance outcomes compared with telephone-delivered education and physical therapy at 3-months post intervention.

Table 20.

Evidence Table: Pain Neuroscience Education For patients with chronic musculoskeletal pain, including low back pain, active therapy with pain neuroscience education reduces pain and increases function as compared to active therapy alone.

Pain neuroscience education combined with a physical intervention is more effective in reducing pain, improving disability, and reducing healthcare utilization compared with either usual care, exercise, other education, or another control group for the treatment of patients with chronic musculoskeletal pain.

Table 20 continued.

Evidence Table: Pain Neuroscience Education Patients with nonspecific, nonradicular, uncomplicated chronic low back pain may or may not benefit from a 6-week program of biweekly aquatic supervised exercise. They are more likely to experience pain relief and functional benefit from an aquatic program if they first receive two 90-minute sessions of pain neurophysiology education dealing with the role of the brain in pain perceptions, how pain originates in the nervous system, how pain goes from being acute to being chronic, central sensitization, cognitive and behavioral responses related to pain, psychosocial factors affecting pain, and how to manage flare-ups of The difference between the pain-education and control group for patients with chronic neck or low back pain reaches clinical relevance for both physical and mental-health domains in 36-item Short Form Health Survey (SF-36) scale and persists at 12 months.

Among motivated patients presenting with chronic non-specific low back pain, 2 group-based sessions of pain-neurophysiology education (which focused on the explanation and discussion of neurophysiology of pain) in combination with a multimodal exercise program was found to reduce pain and disability up to 3 months post treatment as compared to those participating in a multimodal exercise program alone.

Section 7.a.ii. Behavioral and Psychological Interventions Introduction. Psychological therapeutic and diagnostic interventions have selected use in acute pain problems and more widespread use in sub-acute and chronic pain populations. Psychosocial interventions include psychotherapeutic treatments for mental health conditions, as well behavioral medicine treatments. Therapeutic psychological interventions include, but are not limited to, individual counseling and group therapy. Treatment can occur within an individualized model, a multi-disciplinary model, or a structured pain management program.

These interventions may similarly benefit patients without psychiatric conditions but who may need to make major life changes in order to cope with pain or adjust to disability. Health behavior assessment and intervention services are used to identify and address the psychological, behavioral, emotional, cognitive, and interpersonal factors important to the assessment, treatment, or management of physical health problems.

The following commonly used terminology appears in the context of addressing behavioral and psychological interventions:

• biofeedback training, including: ○ electromyogram, ○ skin temperature, ○ respiration feedback, ○ respiratory sinus arrhythmia, ○ heart rate variability, ○ electrodermal response, and ○ electroencephalograph;

• cognitive behavioral therapy (CBT);

• mindfulness-based stress reduction;

• progressive relaxation;

• relaxation therapy; and • sleep hygiene training.

CBT is a psychological therapy that integrates theories of cognition and learning with treatment techniques derived from cognitive therapy and behavior therapy. It assumes that cognitive, emotional, and behavioral variables are functionally interrelated. Treatment is aimed at identifying and modifying the patient’s unproductive thought processes and behaviors through cognitive restructuring and behavioral techniques to achieve change. Variations of CBT methods can be used to treat a variety of conditions, including chronic pain, depression, anxiety, phobias, and post-traumatic stress disorder. For patients with multiple diagnoses, more than 1 type of CBT might be needed. A “manualized” approach to CBT follows a specific protocol in a manual. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for additional information on psychological evaluation.

Absolute and Relative Contraindications to Behavioral and Psychological Interventions.

• Contraindications include active suicidality, homicidality, active psychosis, or major untreated psychological comorbidity.

• Relative contraindication includes a lack of patient engagement despite interventions targeting initial resistance.

• Relative contraindications to CBT include literacy below the 6th grade level, lack of English language proficiency, and cognitive impairment.

Side Effects and Adverse Events Related to Behavioral and Psychological Interventions.

• Side effects and adverse events include emotional discomfort, cognitive dissonance, irritability, interpersonal difficulties, or temporary increase in stress.

Recommendation 54. Formal psychological or psychosocial evaluation is recommended as a component of the biopsychosocial approach to patient recovery from physical injury and should attempt to identify both primary psychological risk factors (e.g., psychosis and active suicidality) and secondary psychological risk factors (e.g., moderate depression and job dissatisfaction) (table 21). The evaluation should distinguish between pre-existing, aggravated, and/or purely causative psychological conditions.

Recommendation 55. Comprehensive psychological evaluation must be performed by a psychologist with PhD, PsyD, or EdD credentials or a physician with psychiatric MD/DO credentials.

Recommendation 56. Psychometric testing, distinct from screening psychological questionnaires, must be administered by a psychologist with a PhD, PsyD, or EdD or a health professional working under the supervision of a doctorate level psychologist. A physician with appropriate training may also administer such testing, but interpretation of the tests should be done by a properly credentialed mental health professional.

Recommendation 57. Evaluation for psychiatric medication is permitted if there is an established diagnosis consistent with the standards of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM). See the Medications section.

Recommendation 58. An initial assessment, ongoing assessment, and treatment plan with measurable and clinically meaningful behavioral goals, time frames, and specific planned interventions are required before initiating psychological/psychiatric interventions. Ongoing requirements include:

• a biweekly status report during initial, more frequent treatment and monthly thereafter, documenting progress toward functional recovery;

• a discussion of the psychosocial issues affecting the patient’s ability to participate in treatment; and • addressing pertinent issues such as pre-existing, aggravated, and/or causative issues, as well as realistic functional prognosis.

Recommendation 59. The following is recommended when obtaining a psychological evaluation:

• a full release from the patient prior to evaluation acknowledging that information that may go to the employer, and • exclusion of sensitive health information not directly related to the work-related conditions in reports sent to the insurer is essential.

CBT Requirements.

Recommendation 60. CBT is recommended for low back pain patients who catastrophize, cope ineffectively with pain, or avoid activity out of fear of re-injury (tables 22, 23).

Recommendation 61. A full psychological evaluation is required before CBT can be initiated.

Recommendation 62. A CBT provider must be a:

• psychologist with PhD, PsyD, or EdD credentials;

• psychiatric MD/DO; or • licensed mental health or licensed health care provider with training in CBT or certified as a CBT therapist with experience in treating chronic pain disorders who works in consultation with a psychologist with a PhD, PsyD, EdD, or psychiatric MD/DO.

Recommendation 63. A manualized approach to CBT is strongly recommended if it is being performed by a non-mental health professional who is supervised by a psychologist with a PhD, PsyD, EdD, or psychiatric MD/DO provider.

Recommendation 64. Candidates for CBT will have all of the following characteristics:

• adequate literacy level to complete homework that is used to teach inductive rational thinking, • adequate cognitive and education abilities to meet the requirements of a CBT protocol, and • otherwise stable social circumstances.

The selection of CBT methods should be based on the individual's literacy level, English proficiency, and cognitive capabilities, as assessed by the behavioral health provider. Individuals who are not candidates for CBT may benefit from other behavioral and psychological approaches.

Biofeedback Requirements.

Recommendation 65. Biofeedback as an adjunct to psychological therapy is recommended for patients who meet 1 of the following indications:

• musculoskeletal injury, in which muscle dysfunction or other physiological indicators of excessive prolonged stress response affects and/or delays recovery;

• a need for training to improve self-management of pain, anxiety, panic, anger or emotional distress, opioid withdrawal, insomnia, sleep disturbance, and/or other central and autonomic nervous system imbalances; and/or motivation to learn and practice biofeedback and self-regulation techniques (table 24).

Recommendation 66. If biofeedback treatment is indicated, it must be done in conjunction with the patient’s other psychosocial or medical interventions.

Recommendation 67. Psychologists or psychiatrists who provide psycho-physiological therapy, which integrates biofeedback with psychotherapy, must be either Biofeedback Certification International Alliance (BCIA) certified or practicing within the scope of their training.

• Non-licensed health care providers of biofeedback for chronic pain patients must be BCIA certified and shall have their biofeedback treatment plan approved by the authorized treating psychologist or psychiatrist.

• Biofeedback can also be provided by health care providers who follow a set treatment and educational protocol. Such treatment may utilize standardized material, relaxation recordings, or app-based interventions. App-based interventions must meet the criteria in Rule 18.

Substance Use Disorder Requirements.

Recommendation 68. Patients with substance use disorder, high-dose opioid use, or use of other drugs of abuse may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs).

Time Frames for Behavioral and Psychological Interventions Time to produce effect (sessions)

Frequency (sessions/week)

Maximum duration Group CBT up to 8 (2-hours) up to 2 16 sessions Individual CBT up to 8 (1-hour) up to 2 16 sessions Biofeedback up to 4 sessions up to 2 12 sessions ᶷ Relaxation up to 4 sessions up to 2 12 sessions ᶷ Other psychological interventions up to 8 up to 2 6 months ᶷ Treatment beyond 12 sessions must be documented with respect to need, expectation, and ability to facilitate positive symptomatic and functional gains.

For the first 2 weeks of treatment, excluding hospitalization, if required; decreasing to weekly in the 2nd month of treatment and then 2-4 times per month (with the exception of exacerbations, which may require increased frequency of visits).

Longer supervised psychological/psychiatric treatment may be required, especially if there are ongoing medical procedures or complications. If counseling beyond 6 months is indicated, the management of psychosocial risks or functional progress must be documented.

Table 21.

Evidence Table: Psychological Assessments and Outcomes Psychological testing identifies patients most likely to benefit from surgery.

Psychometric testing can predict medical treatment outcomes.

Psychological and medical risk factor assessment prior to surgery can identify patients unlikely to benefit from surgery.

Table 22.

Evidence Table: CBT CBT results in reduced pain and disability for patients with subacute and chronic low back pain.

CBT may reduce pain and disability in patients with chronic pain, but the magnitude of the benefit is uncertain.

CBT, but not behavioral therapy, shows weak to small effects in reducing pain, and small effects on improving disability, mood, and catastrophizing in the treatment of patients with chronic pain.

Psychological interventions, especially CBT, are superior to no psychological intervention for chronic low back pain. 6 group therapy sessions lasting 90 minutes each focused on CBT skills improved function and alleviated pain in uncomplicated sub-acute and chronic low back pain patients.

A stepped care program is more effective than usual care in veterans with chronic musculoskeletal pain. The stepped care program consisted of 12 weeks during which nurse case managers took a medication use history and adjusted medication dosage and scheduling through telephone contacts with patients every other week, followed by a 12-week step in which cognitive behavioral treatment was administered by 45 minute individual sessions by telephone every other week. Disability and pain interference with daily activity with stepped care were both superior to usual care in which patients were given printed handouts and were followed for all care by their primary treating physicians.

A 6-week program of cognitive-behavioral group intervention with or without physical therapy can reduce sick leave, health care utilization, and the risk for developing long-term sick leave disability (> 15 days) in workers with nonspecific low back or neck pain compared with simple verbal instruction by a physician.

CBT provided in seven 2-hour small group sessions can reduce the severity of insomnia in chronic pain patients.

Table 22 continued.

Evidence Table: CBT Among patients with low back pain who participated in a brief cognitive intervention based on a non-injury model addressing pain and fear avoidance provided over 4 sessions, the addition of either a manualized CBT program or the use of nutritional supplements did not improve on the demonstrated return to work benefit at 12 months post-intervention resulting from the brief cognitive intervention alone. 10 sessions of group-based multidisciplinary rehabilitation focusing on taskoriented exercises plus 5 sessions of CBT aimed at managing fear-avoidance beliefs over 5 weeks was significantly more effective than traditional exercises in reducing disability, kinesiophobia, pain, catastrophizing, and enhancing the quality of life in patients with chronic low back pain, and the effects lasted for at least 2 years after the end of the intervention.

The McKenzie approach provides similar outcomes in improving pain, disability, and ability to carry out work activities in comparison with CBT.

The benefits of CBT continue to be present 3 or more years after the initial intervention, although the differences between CBT and the control group are likely to become narrower with extended follow-up.

Behavioral modification, such as patient education and group or individual counseling with CBT, can be effective in reversing the effects of insomnia.

Intensive exercise coupled with CBT is as effective as posterolateral fusion for chronic un-operated low back pain.

Table 23.

Evidence Table: CBT in the Pre- and Post-Operative Setting A pre-operative program of multidisciplinary CBT focused on information about the fusion operation, pain perceptions, coping strategies, and return to activity and work may improve early mobilization and result in more rapid reduction in disability up to 3 months after surgery.

In patients scheduled for lumbar spinal fusion surgery, a 4-week preoperative program of multidisciplinary CBT, emphasizing the interactions between cognition and pain perception, coping strategies for dealing with pain, pacing principles, return to work, and details about the fusion operation, does not appear to reduce pain scores in the immediate postoperative period. However, such a CBT program as preparation for surgery does appear to be advantageous in the first 3 days after surgery by leading to earlier mobilization and independent ambulation, even though the intensity of pain scores is not significantly reduced.

Table 23 continued.

Evidence Table: CBT in the Pre- and Post-Operative Setting CBT also appears to give spinal fusion patients an advantage later in the postoperative surgical period, with a faster decrease in disability scores for at least 3 months following the operation. At 1 year, the difference in disability between CBT and no CBT is no longer significant, but the functional gains from the early postoperative period are maintained.

Table 24.

Evidence Table: Biofeedback and Relaxation Training Both biofeedback and relaxation therapy reduce pain and disability for patients with chronic low back pain as compared to CBT.

Biofeedback or relaxation therapy is equal in effect to CBT for chronic low Self-regulatory interventions, such as biofeedback and relaxation training, may be equally effective.

Progressive relaxation was the only psychological therapy associated with improvement in function as well as pain intensity compared to wait-list control in chronic low back pain.

Table 25.

Evidence Table: Mindfulness-based Stress Reduction For patients with chronic low back pain, mindfulness-based stress reduction improves function and reduces pain as compared to usual care. A mindfulness-based stress reduction meditation program with yoga results in similar functional improvement and pain reduction as CBT, when each intervention is compared to usual care.

As compared to usual care for chronic low back pain, mindfulness-based stress reduction reduced pain by 30% and improved function as well.

Table 25 continued.

Evidence Table: Mindfulness-based Stress Reduction In the setting of chronic low back pain, an 8-week mindfulness-based stress reduction meditation program with yoga or 8 weeks of CBT resulted in small, significant improvements in physical function and reduction in pain compared to usual care at 26 weeks with no significant differences in outcomes between the 2 treatments.

In the setting of chronic low back pain, 8 weeks of CBT resulted in small, significant improvements in physical function compared to usual care at 2 years post treatment with no significant differences between CBT and a mindfulness-based stress reduction meditation program with yoga. No significant differences in pain bothersomeness were shown between CBT, a mindfulness-based stress reduction meditation program with yoga, and usual care at 2 years post treatment.

Section 7.b. Adjunct Second Line Treatments, as Indicated

Section 7.b.i. Passive Therapies Introduction. Passive therapies include treatments that do not require a patient’s energy expenditure.

They are most helpful early in treatment, and they are directed at controlling symptoms and improving the rate of healing soft tissue injuries. They can be used adjunctively with active therapies to help control swelling, pain, and inflammation. The following passive therapies are common treatments:

• acupuncture, • acupuncture with electrical stimulation, • iontophoresis, • joint mobilization, • low level laser, • manipulation, • manual treatment, • manual traction, • massage, • mechanical or motorized traction, • phonophoresis, • soft tissue mobilization, • short-wave diathermy, • superficial heat and cold therapy, • trigger point dry needling, • ultrasound, and • unattended electrical stimulation (e.g., transcutaneous electrical nerve stimulation [TENS]).

Absolute and Relative Contraindications to Passive Therapies.

• High velocity / low amplitude manipulation is contraindicated in those with joint instability, fractures, severe osteoporosis, infection, metastatic cancer, active inflammatory arthritis, aortic aneurysm, and signs of progressive neurologic deficits.

• Relative contraindications to manipulation include spinal stenosis, spondylosis, and disc herniation.

• Manual traction is contraindicated in those with tumor, infection, fracture, or fracture dislocation.

• Non-oscillating inversion traction methods are contraindicated in patients with glaucoma or hypertension.

Complications of Passive Therapies.

• Rare complications of dry needling or acupuncture include pneumothorax, infection, or syncope.

Side Effects and Adverse Events Related to Passive Therapies.

• Acupuncture may result in treatment-related pain or bruising associated with needle insertion.

Recommendation 69. Patients in passive therapy must demonstrate functional progress through validated functional assessment measures. If there is no evidence of functional progress within the time to produce effect, the therapy shall be discontinued and the patient must be referred back to their treating provider for evaluation. Each patient is limited to a maximum of 4 discrete passive therapy trials.

Recommendation 70. Passive therapies must occur concurrently with self-directed exercise or formal active therapy programs (table 26).

Recommendation 71. The frequency of passive therapy must decrease over time.

Recommendation 72. Durations of care beyond those listed as “time to produce effect” and “maximum” are warranted in certain circumstances when treatment to date has resulted in measurable and clinically meaningful functional improvement. These circumstances include:

• re-injury;

• interrupted continuity of care;

• after surgery, particularly multiple surgeries;

• injuries (e.g., fracture); or • comorbidities.

Specific goals with objective measures of functional improvement must be cited to justify extended durations of care.

Recommendation 73. Manipulation under general anesthesia and manipulation under joint anesthesia are not recommended.

Recommendation 74. Mechanical or motorized traction is not recommended for low back pain patients with or without radicular symptoms (table 31).

Recommendation 75. Due to the absence of quality evidence supporting their use, ultrasound, phonophoresis, low level laser, kinesiotaping, and iontophoresis are not recommended for low back pain.

Time Frames for Passive Therapies Time to produce effect (sessions)

Frequency* (sessions/week)

Maximum duration Mobilization and Manipulation up to 6 up to 3 times/week 8 weeks Massage 1 up to 2 times/week 8 weeks Acupuncture up to 6 up to 3 times/week 15 treatments Heat/cold, short-wave diathermy, unattended electrical stimulation (e.g., TENS**) up to 4 up to 3 times/week 8 weeks Trigger point / dry needling up to 4 up to 2 times/week 8 weeks Traction (manual)*** up to 3 up to 3 times/week 4 weeks *See recommendation 71 regarding the expected decreasing frequency over time. **If TENS treatment results in documented functional benefit and is anticipated to extend beyond 4 treatments, consider purchase of a home TENS unit. ***If response is negative after 3 thirty minute treatments, discontinue.

Table 26.

Evidence Summary: Passive Therapies Passive therapies may provide functional benefit and symptomatic relief in patients with low back pain, especially when paired with an active intervention. The decision to refer a patient for 1 passive therapy over another should be based on patient preference and relative safety, not on the expectation of a greater treatment effect among passive therapy options.

Table 27.

Evidence Table: Manipulation and Mobilization Manipulation and/or mobilization, particularly when combined with exercise, may reduce pain and improve function for patients with low back pain. 2 sessions of thrust manipulation of the thoracolumbar spine followed by an exercise regimen leads to better low back function at 6 months than oscillatory non-thrust manipulation in patients with subacute low back pain. The study found patients with the following characteristics were likely to benefit from the program: segmental hypomobility, no symptoms distal to the knee, low fear avoidance scores, and preservation of at least 35 degrees of internal rotation in at least 1 hip.

For acute low back pain, spinal manipulation had greater effects on function than sham manipulation.

For acute low back pain, spinal manipulation did not result in greater pain relief than treatments considered inactive (e.g., an educational booklet, bed-rest) at short term (1-week).

For radicular low back pain, spinal manipulation in combination with home exercise resulted in greater improvement in leg and back pain at 12 weeks as compared to home exercise and advice alone.

Spinal manipulative therapy is comparable to exercise, standard medical care, and physiotherapy in reducing chronic low back pain, and spinal manipulative therapy does not provide clinically important, superior pain relief over these interventions.

Manipulation does not have a clinically greater therapeutic effect on acute, 6 weeks or less, nonspecific low back pain than other interventions including physical therapy.

Among people with acute (<6 weeks) low back pain, spinal manipulative therapy was significantly more effective than usual care, physiotherapy, and exercise for short-term pain and functional improvements. However, effects were small, with only transient minor musculoskeletal harms.

Table 27 continued.

Evidence Table: Manipulation and Mobilization A combination of spinal manipulation and exercise is more effective than exercise alone in reducing pain and improving function of low back pain for 1 year.

Referral of patients for chiropractic care or McKenzie physical therapy in the first weeks of uncomplicated low back pain adds little to the otherwise favorable prognosis for acute low back pain and does incur additional short-term costs of 6 sessions of osteopathic manual treatment, delivered over a period of 8 weeks, is likely to be an effective intervention for nonspecific, nonradicular, nontraumatic low back pain which has lasted more than 3 months.

In those who have chronic low back pain, 12 weeks of supervised high-dose exercise, spinal manipulative therapy, or low-dose home exercise with advice are all equally effective for reducing pain in the short- and long-term (1 year).

Spinal manipulation/mobilization, followed by active exercises, may be effective for the reduction of disability from nonspecific low back pain lasting more than 12 weeks. 12 sessions of spinal manipulation in 6 weeks from a chiropractor yielded the most favorable pain reduction and functional disability improvement compared to a hands-on control in the short-term (12 weeks) for chronic nonspecific low back pain. However, differences between dosage groups did not meet the predetermined minimally clinical significance standards. There was no significant difference between 12 and 18 sessions of spinal manipulation. Also, at 1 year, there was no significant difference between groups.

Table 28.

Evidence Table: Massage Massage therapy may reduce pain and improve function in patients with subacute and chronic low back pain, particularly when combined with exercise.

Massage therapy in combination with exercise reduces pain and improves function short-term for patients with subacute low back pain.

In the setting of acute uncomplicated low back pain, treatment with manual pressure at myofascial trigger points up to six 15-minute sessions over 2 weeks reduces back pain more effectively than manual pressure 30 mm away from myofascial trigger points and more effectively than conventional low back massage (effleurage).

In patients with chronic low back pain, craniosacral therapy or classic massage are equally effective in reducing disability after 10 weekly sessions of treatment and at 1 additional month of follow-up.

However, since both groups received an intervention, the trial does not address the question of the effect of these treatments in comparison to usual Among those with chronic low back pain, a 10-week course of relaxation massage is equally effective when compared to structural massage in improving functional disability and reducing pain. Both techniques are more effective than usual care and benefits persist for at least 6 months.

There were no clear differences in pain or function between foot reflexology and usual care (or sham foot massage) in chronic low back pain.

Table 29.

Evidence Table: Acupuncture True and sham acupuncture improves function in patients with chronic low back pain as compared to usual care. Acupuncture reduces pain in patients with acute low back pain, as compared to sham acupuncture. It also provides short-term relief in patients with chronic low back pain, as compared to sham acupuncture. Individuals with positive expectations of acupuncture likely experience enhanced treatment benefit.

For acute low back pain, acupuncture decreased pain intensity more than sham acupuncture with nonpenetrating needles.

Acupuncture was associated with a greater likelihood of improvement at the end of treatment as compared to NSAIDs.

For chronic low back pain, acupuncture was associated with lower pain intensity and better function after the intervention as compared to no acupuncture.

For chronic low back pain, acupuncture also decreased pain intensity more than sham acupuncture in the immediate time-frame.

There is a likely, small clinical benefit of acupuncture for acute low back pain, and it may be considered an alternative for some patients.

Acupuncture is effective in the treatment of low back pain in patients with positive expectations of acupuncture.

Table 29 continued.

Evidence Table: Acupuncture Acupuncture, true or sham, is superior to usual care for the reduction of disability and pain in patients with chronic nonspecific low back pain, but true and sham acupuncture are likely to be equally effective.

Acupuncturists must be properly trained in aseptic technique. Systematic Acupuncture is better than no acupuncture for axial chronic low back pain. RCT Among those with nonspecific low back pain, the use of integrated therapy consisting of acupuncture combined with conventional medical care appears to be more effective than conventional medical care alone.

Table 30.

Evidence Table: Laser Acupuncture In the setting of chronic nonspecific low back pain, 8 weekly sessions of high dose laser acupuncture at a dose of 0.8 Joules per acupuncture point are not more effective than a low dose laser at a dose of 0.2 Joules per acupuncture point or a sham laser treatment at a dose of 0 Joules.

Table 31.

Evidence Table: Traction Traction offers no clinical benefit for patients with radicular or non-radicular low back pain.

Mechanical traction is not useful for low back pain patients with sciatica nor those with low back pain without radicular symptoms.

Intervertebral lumbar traction does not add significantly to a graded activity program for resolution of non-radicular chronic low back pain.

Table 32.

Evidence Table: Electrical Therapies Percutaneous electrical nerve stimulation (PENS) produces improvement of pain and function compared to placebo; however, there is no evidence that the effect is prolonged after the initial 3 week treatment episode.

Among patients with chronic nonspecific low back pain, 5 days of anodal transcranial direct current stimulation compared with sham stimulation did not result in pain or disability reduction, alone or when combined with a 4-week cognitive behavioral management program.

Section 7.b.ii. Durable Medical Equipment Introduction. Durable medical equipment includes devices that can be used repeatedly to serve a medical purpose. These include braces or splints for supporting, immobilizing, or treating muscles, joint, or skeletal parts that are weak, ineffective, deformed, or injured.

Absolute and Relative Contraindications of Durable Medical Equipment.

• Deconditioning of the lumbar musculature and associated fatigue or pain.

• Skin irritation resulting from contact with the orthotic.

Foot Orthotics Requirements.

Recommendation 76. Foot orthotics and shoe inserts are appropriate for patients with spinal disorders attributed to aggravated mechanical abnormalities, such as leg length discrepancy, scoliosis, or lower extremity misalignment.

Lumbar Support Devices Requirements.

Recommendation 77. If lumbosacral support devices (e.g., lumbar corsets, braces, sacroiliac [SI] belts, and back belts) are used, the provider must educate the patient about potential for disuse and deconditioning of the lumbar musculature, skin irritation, and general discomfort. Documentation should include directions for duration and frequency of use.

Recommendation 78. Thoracolumbar orthotics are acceptable in the treatment of burst fractures (table 33).

Table 33.

Evidence Table: Orthotics in the Treatment of Burst Fractures For thoracolumbar burst fractures or compression fractures with intact posterior elements and no neurological compromise, nonoperative management may be superior to instrumented fusion. Treatment with or without a brace may lead to similar improvements. Treatment should include appropriate restrictions in the first 4-8 weeks, progressing to active therapies and returning to normal activity.

Table 33 continued.

Evidence Table: Orthotics in the Treatment of Burst Fractures In the setting of stable thoracolumbar burst fractures when there is no neurological compromise of lower extremities, bowel, or bladder, there is a lack of evidence that surgical intervention with multilevel posterior or anterior instrumented stabilization offer any advantages over conservative management with postural reduction and early bracing and mobilization in the first 2 to 4 years of follow-up. However, surgical treatment has a higher rate of subsequent surgery than conservative treatment.

In the long term of 16 to 20 years, pain and disability are distinctly superior with nonoperative management with a brace or cast than with instrumented fusion.

For neurologically intact patients who have sustained an isolated thoracolumbar burst fracture grade AO-A3, which results in retropulsion of bone into the spinal canal but spares the posterior longitudinal ligament and other posterior elements of the spine, treatment with and without a thoracolumbosacral orthosis offer equivalent benefits.

Treatment without an orthosis involves immediate mobilization as tolerated, supervised by a physical therapist, using restrictions to limit bending and rotating through the trunk, with encouragement to return to normal activities within 8 weeks. Lifting and carrying restrictions of 5 kg and restrictions of 90° hip flexion should be done for the first 8 weeks. Isometric spine stabilization exercises should begin at 4 weeks, progressing to isotonic exercises at 8 weeks, and occupation-specific rehabilitation at 9 weeks.

In the setting of acute vertebral compression fractures with intact posterior elements and the absence of neurological deficits, treatment with no brace is not inferior to treatment with a soft brace or treatment with a rigid brace; all 3 treatments lead to similar improvements in disability and pain during the 12 weeks after the onset of the fracture.

Section 8. Third Line Treatment, as Indicated

Section 8.a. Injections - Diagnostic and Therapeutic Introduction. Spinal injections are considered when function remains limited despite appropriate nonoperative treatment options. Diagnostic spinal injections are used to localize a source of pain when the results would impact the course of treatment. Therapeutic injections are used to temporarily reduce functional impairment. Most individuals with low back pain will not need a spinal injection. See the Overview of Care section.

• See the specific injection section.

Recommendation 79. Spinal injections are indicated when all of the following criteria are met:

• positive correlation among clinical findings, the clinical course, and diagnostic tests;

• positive functional response to a diagnostic injection, if required;

• persistent functional impairment despite engagement in 6 weeks of active therapy; and confounding psychosocial risk factors have been screened for and clinically addressed. See the Recommendation 80. All spinal injections should be preceded by magnetic resonance imaging (MRI) or computed tomography (CT) scan.

Recommendation 81. Informed consent is required before all invasive procedures. See the Essential First Line Treatment section.

Recommendation 82. Routine use of sedation is not recommended for diagnostic or therapeutic spinal injections. Minimal to moderate sedation and pain relief may be needed for some patients but are only permitted when there is documentation of extreme circumstances.

Recommendation 83. All injections must be accompanied by self-directed exercise or formal physical Recommendation 84. Multi-planar fluoroscopic imaging is required to create permanent images that confirm proper needle placement and contrast flow pattern. CT needle guidance may be required in rare circumstances.

Recommendation 85. Total steroid injections at all sites, including the extremities, should be limited to 4 per year to avoid side effects from steroids. Prior authorization is required for additional injections with appropriate documentation of medical reasoning and functional improvement.

Recommendation 86. Due to the absence of quality evidence supporting their use, the injection of substances other than steroids, anesthetic, or contrast solution is not recommended (e.g., orthobiologics such as platelet rich plasma, stem cells, or amniotic fluid; ozone; etc.).

Section 8.a.i. Epidural Steroid Injection (ESI) and Transforaminal Nerve Root Block Introduction. Epidural steroid injections (ESIs) are corticosteroid injections into the lumbar epidural space by a caudal, transforaminal, or interlaminar approach. A transforaminal nerve root block involves injecting steroid medication near where the nerve root exits the spinal column. The therapeutic goals of injections are to restore range of motion (ROM) and facilitate progress in active therapy programs by temporarily reducing pain and inflammation in the acute or subacute phases of injury. ESIs may result in small, short-lived reduction in leg pain and disability for individuals with lumbar radiculopathy. ESIs do not result in clinically meaningful long-term improvements in leg pain, back pain, or disability in patients with lumbar radicular pain. ESIs do not have a role in the treatment of non-radicular low back pain.

Absolute and Relative Contraindications to ESI.

• Poorly controlled diabetes mellitus, systemic or localized bacterial infection, known anatomic abnormalities, and bleeding diathesis are absolute contraindications to ESI.

• Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive ESIs.

• Patients on medications that affect coagulation require special consideration prior to ESI.

• Allergy to contrast material, somatization disorder, poorly controlled congestive heart failure, and uncontrolled hypertension are relative contraindications to ESI.

Complications of ESI.

• Long-term morbidity can occur as a result of ESI, although complications that lead to long-term morbidity are rare.

• Permanent paresis, anaphylaxis, and arachnoiditis have been rarely reported with the use of epidural steroids.

• Direct needle trauma is a reported complication (recommendation 89).

• Although major neurological complications are rare with fluoroscopically-guided lumbar ESIs, there is a much greater risk with particulate steroid injections (recommendation 90; table 35).

• Osteoporotic fractures, Cushing’s syndrome, hypopituitarism, spinal epidural lipomatosis, and growth hormone deficiency have been associated with ESI.

Side Effects and Adverse Events Related to Injectate.

• Increased blood glucose levels, decreased plasma cortisol levels, and impaired bowel or bladder function are possible side effects of ESI.

• There is a dose-dependent suppression of the hypothalamic-pituitary-adrenal axis, leading to a transient secondary adrenal insufficiency in the first few weeks after ESI (table 34).

Recommendation 87. For a patient to be a candidate for an ESI, the provider must document all of the • subjective report of severe radicular pain that correlates with objective findings;

• positive straight leg raise test, femoral stretch test, and/or reflex, motor, or sensory changes on examination that specifically correlate with imaging findings; and • imaging findings that demonstrate impingement of nerve(s) or spinal cord.

Recommendation 88. ESI is not recommended for the treatment of axial low back pain in the absence of radicular symptoms (table 39).

Recommendation 89. Multi-planar fluoroscopic imaging is required to create permanent images confirming proper needle placement and contrast flow pattern.

Recommendation 90. Particulate corticosteroid preparations are not recommended for epidural injection (table 35).

Recommendation 91. A patient who meets the ESI indications can trial an epidural injection of local anesthetic alone as an alternative to an injection containing steroid (table 36).

Recommendation 92. All patients with diabetes must be instructed to monitor their glucose levels carefully over the 7 days after steroid injection. Clinicians can pursue diabetic screening tests for those who may be at risk for Type 2 diabetes (table 37).

Recommendation 93. A diagnostic response to a selective nerve root block must be documented to show its value, including:

• improvement in at least 3 objective functional measures (e.g., spinal ROM; straight leg raise; tolerance and time limits for sitting, standing, walking, and lifting); and • at least 80% improvement in an accepted pain scale (e.g., visual analog scale [VAS] or numeric rating scale [NRS]) that is consistent with: ○ a pain diary recording an hourly response for at least 8 hours, but preferably for 1 week, post-injection. Documentation of pain response may be indicated for up to 3 weeks, depending on the nature of the injection.

A successful response to a diagnostic injection requires documentation of positive functional changes by trained personnel and may include nurses, physician assistants, medical assistants, therapists, or noninjectionist physicians. Functional progress supersedes pain improvement.

Acute Phase Requirements (Within 6 Weeks of Initial Care).

Recommendation 94. Early referral within 6 weeks for ESI is permitted when the provider documents all criteria in recommendation 87 and at least 1 of the following:

• radicular functional impairment prevents participation in active therapy and activities of daily living (ADLs), or • an opioid treatment is being considered (table 40).

Recommendation 95. A patient who meets the ESI indications in recommendation 87, but wants to avoid ESI, may trial oral gabapentin (table 38).

Subacute and Chronic Phase Requirements (After 6 Weeks of Care).

Recommendation 96. ESI or referral for surgical consultation are permitted for patients who meet the criteria in recommendation 87 and both of the following:

• functional impairment despite 6 weeks of optimal medical management and participation in active therapy, and • confounding psychosocial risk factors have been screened for and are being clinically addressed.

See the Behavioral and Psychological Interventions section (table 41).

Repeat ESI Requirements.

Recommendation 97. Repeat ESI can occur as soon as 2 weeks after the first injection when the initial injection resulted in a sustained therapeutic response for 2 weeks or more and is characterized by the • improvement in at least 3 objective functional measures (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting), and • 80% radicular pain improvement as measured using an accepted pain scale (e.g., VAS or NRS).

Functional progress supersedes pain improvement. The third injection can then be repeated after a hiatus of 6 months (Appendix Functional Screens). See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for information on subsequent injections.

Recommendation 98. Ordering a “series” of ESIs is prohibited. If the first injection fails to result in functional gain and pain relief as outlined in recommendation 97, the injection cannot be repeated at that level with the same approach.

Recommendation 99. If the decision is made to proceed with a different type of injection, the specific criteria for that injection must be satisfied.

Recommendation 100. Testing morning cortisol levels is recommended prior to the third or fourth steroid injection.

Table 34.

Evidence Table: ESI and the Hypothalamic-Pituitary-Adrenal Axis In the setting of ESI given for low back pain with radiculopathy, there is a dosedependent suppression of the hypothalamic-pituitary-adrenal axis leading to a transient secondary adrenal insufficiency in the first few weeks after the procedure, with an 80 mg dose of methylprednisolone acetate leading to secondary adrenal insufficiency in about 80% of patients the first week after the injection, and in about 50% of patients receiving a 40 mg dose.

The cortisol response to an injection of adrenocorticotropic hormone (ACTH) gradually returns to normal in the weeks after the injection, but secondary adrenal insufficiency remains detectable in some patients 4 weeks later.

Table 35.

Evidence Table: Risk of Particulate ESI ESIs with particulate steroids, such as methylprednisolone and triamcinolone, have systemic absorption effects and a much higher risk of major neurological complications than ESIs of water soluble steroids, such as betamethasone and dexamethasone.

Although major neurological complications are rare with fluoroscopicallyguided cervical and lumbar ESIs, the risk is much greater with particulate steroid injections.

Some steroid preparations have a systemic absorption effect, which is reflected in suppression of morning cortisol measurements 3 and 6 weeks after the injection. This appears to be the case with the particulate steroids, methylprednisolone and triamcinolone, but not with the water soluble steroids, betamethasone and dexamethasone.

Table 36.

Evidence table: Use of Steroid in Epidural Injections For patients with lumbar radicular pain, the addition of a corticosteroid does not provide added improvement in function or pain over epidural injections with local anesthetic alone. While the evidence does not support a benefit of adding steroids to local anesthetic spinal injections, steroids are routinely used in therapeutic spinal injections due to a presumed physiologic effect.

In the setting of low back radicular pain, there are no significant clinical differences between injections of local anesthetic alone and injections of local anesthetic plus steroid.

Among patients who achieve clinically important benefit from an epidural injection at 6 weeks, the benefits continue for 12 months after the injection.

The addition of steroids to a transforaminal bupivacaine injection has a small, clinically unimportant, and statistically insignificant effect on outcomes of pain and disability in patients with lumbar radicular pain resulting from disc herniation or spinal stenosis.

Particulate steroids offer no advantage over nonparticulate steroids in the setting of transforaminal or interlaminar ESIs for patients with lumbar or cervical radiculopathy, either with respect to pain relief or improvement of function.

Epidural injections of solutions not containing steroids (such as normal saline or local anesthetic in saline) are likely to have therapeutic effects in the setting of radicular pain, possibly arising from lavage effects and other effects not depending on the steroid component of the injected solution. The interpretation of clinical trials in which epidural steroid and non-steroid injections appear to have similar effects should be influenced by this principle.

In the setting of lumbar radiculopathy lasting 12 weeks or longer, there is no clinically important difference between a sham subcutaneous injection of 2 ml of normal saline and a 30 ml caudal injection of saline with or without triamcinolone.

Bupivacaine alone is equal to bupivacaine plus steroid, with no effect of steroid on Oswestry Disability Index (ODI), leg pain, or back pain.

Table 37.

Evidence Table: Corticosteroid-Containing ESI in Diabetic Patients In the setting of ESI for patients with adequately controlled diabetes mellitus, significant increases in fasting and postprandial blood glucose can be expected on the day of the procedure and for the first 3 days thereafter; however, the increase in blood glucose are less with a 20 mg than with a 40 mg dose of triamcinolone.

There is no difference in pain relief between the 2 steroid doses, making the 20 mg dose preferable to a 40 mg dose.

Table 38.

Evidence Table: Early Oral Gabapentin for Radicular Pain In the setting of lumbosacral radiculopathy from herniated disc or spinal stenosis, oral gabapentin without physical therapy and an ESI without physical therapy are approximately equally effective in the first 3 months, but no conclusions can be supported that either intervention is superior to placebo.

Table 39.

Evidence Table: ESI for Axial Low Back Pain ESIs are not beneficial in the treatment of axial low back pain.

ESIs have no short-term or long-term benefit for low back pain. Systematic Table 40.

Evidence Table: ESI for Radicular Pain ESIs result in a small reduction in leg pain and disability for patients with lumbar radiculopathy, but the benefits are short-lived. ESIs do not result in clinically meaningful long-term improvements in leg pain, back pain, or disability in patients with lumbar radicular pain or radiculopathy. ESI for radicular low back pain may reduce the frequency of surgery in the first year after use.

ESIs have a small average short-term benefit for leg pain and disability for those with sciatica.

ESIs do not, on average, provide clinically meaningful long-term improvements in leg pain, back pain, or disability in patients with undefined sciatica (lumbar radicular pain or radiculopathy).

After 6 weeks of conservative therapy for large herniated discs, an epidural injection may be attempted, as it does not compromise the results of a discectomy at a later date. One half of the patients in this study who were randomized to ESIs did not have surgery and this benefit persisted. Because this study did not have a control group that received neither treatment nor a group that received injections without steroids, one cannot make definite conclusions regarding the efficacy of ESI injections in this setting.

The addition of steroids to a transforaminal bupivacaine injection may reduce the frequency of surgery in the first year after treatment in patients with neurologic compression and corresponding imaging findings who also are strong candidates for surgery and have completed 6 weeks of therapy without adequate benefit. The benefits for the non-surgical group persisted for at least 5 years in most patients, regardless of the type of block given.

Table 40 continued.

Evidence Table: ESI for Radicular Pain The addition of steroids to a transforaminal bupivacaine injection may reduce the frequency of surgery in the first year after treatment.

In the setting of lumbar transforaminal ESIs, the volume of injectate plays a role in the analgesic response; an injection of 8 ml of solution with 4 mg of dexamethasone provides greater pain relief than a 3 ml injection with 4 mg of dexamethasone. However, there was no group which received an injection without a steroid component, and no inference can be made about a “pure” lavage effect of a transforaminal injection.

Table 41.

Evidence Table: Referral for Surgical Consultation In patients with disc herniation who are persistently symptomatic at 6 weeks, ESI may prevent the need for future surgery. The delay in surgery does not appear to reduce later surgical success.

Among patients with herniated discs who have remained symptomatic after 6 weeks of noninvasive care and who are likely candidates for surgery, surgical discectomy successfully leads to symptom resolution in a large majority of patients. However, patients from the same population who receive ESI after 6 weeks of unsuccessful noninvasive care frequently experience symptom resolution sufficiently well to be able to avoid surgery. The magnitude of the surgery-sparing effect of ESI has not been established, but as many as half of patients may avoid surgery for up to 3 years. Patients who have an unsuccessful ESI after 6 weeks of noninvasive care may undergo discectomy at a later time, with no evidence that the delay in surgery reduces the success of the later operation.

Table 42.

Evidence Table: ESI for Spinal Stenosis For patients with symptomatic lumbar spinal stenosis, the addition of a corticosteroid does not provide added benefit over epidural injections with local anesthetic alone. For patients with lumbar spinal stenosis and neurogenic claudication accompanied by confirmed hypertrophy of the ligamentum flavum, a minimally invasive percutaneous partial resection of the ligamentum flavum leads to greater functional improvement and reduced pain compared with ESI.

In patients with neurogenic claudication arising from lumbar central spinal stenosis, there is little difference in pain and functional benefit at 6 weeks and 12 months between an injection of a local anesthetic and an injection of a local anesthetic plus a corticosteroid.

There are no significant differences between epidural injections with corticosteroid plus local anesthetic versus local anesthetic alone in patients with symptomatic spinal stenosis.

Compared to a fluoroscopically guided interlaminar ESI, a minimally invasive percutaneous partial resection of the ligamentum flavum leads to greater functional improvement and reduced pain at 6 and 12 months in patients with lumbar spinal stenosis and neurogenic claudication accompanied by confirmed hypertrophy of the ligamentum flavum. There is good evidence that these improvements remain stable 24 months following the procedure. However, there is no evidence that the surgical procedure reduces medication use compared to the ESI.

Translaminar steroid injections do not increase walking tolerance in those with spinal stenosis compared to local anesthetic.

There is a lack of evidence of a surgery-sparing effect in symptomatic lumbar spinal stenosis.

Table 43.

Evidence Table: Repeat ESI in Central Spinal Stenosis Among patients who repeat an ESI after having received 1 injection, there is very little additional benefit to be achieved from the second or subsequent

Section 8.a.ii. Zygapophyseal (Facet) Injection Introduction. Facet joint injection consists of the intra-articular or pericapsular injection of local anesthetic and corticosteroid. It has very limited uses.

Absolute and Relative Contraindications to Facet Joint Injection.

• Systemic or localized bacterial infection and bleeding diathesis are absolute contraindications to steroid injections. Poorly controlled diabetes is a contraindication if steroids are used.

• Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive steroid injections. It is unknown if facet joint injections contribute to increased risk of vertebral fractures, but appropriate precautions should be taken for at-risk patients.

• Patients on medications that affect coagulation require special consideration prior to these • Somatization disorder, poorly controlled congestive heart failure, and uncontrolled hypertension are relative contraindications to these injections. Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.

Complications of Facet Joint Injection.

• Complications include nerve injury, bleeding, infection, contrast allergy, localized pain, or irritation.

• Extravasation of local anesthetic to the lumbar nerves may result in difficulty in ambulation.

• Extravasation to the sacral nerves may result in bowel and bladder impairment.

Side Effects and Adverse Events Related to Facet Joint Injection.

• Diabetic patients may notice a steroid-induced effect on blood glucose levels in the post-injection Recommendation 101. Facet joint injections are of very limited use. One of the following sets of requirements must be met prior to proceeding with a facet joint injection: either • at least 3 months of pain, unresponsive to 6 weeks of conservative therapies, including manual therapy; and • confounding psychosocial risk factors have been screened for and clinically addressed; and • physical examination findings are consistent with facet origin pain (e.g., pain on extension with lateral bending and referral patterns consistent with the expected pathologic level) that is affecting activity; or • the patient has refused a rhizotomy despite facet origin pain on clinical exam; or • the patient has facet findings with a thoracic component (tables 44, 45).

Recommendation 102. Repeat facet joint injections are only recommended when the first injection results in a sustained therapeutic response for 3 months or more and is characterized by the following:

• improvement in at least 3 physical examination findings consistent with facet origin pain (e.g., pain on extension with lateral bending and referral patterns consistent with the expected pathologic level), and • at least 80% improvement in an accepted pain scale (e.g., VAS or NRS).

Recommendation 103. There is no indication for combined facet injection and medial branch block.

Intraarticular facet joint steroid injections are not of diagnostic utility in determining appropriateness for radiofrequency (RF) neurotomy.

Recommendation 104. Facet injections cannot be performed at more than 2 levels, unilaterally or bilaterally.

Time Frames for Facet Joint Injections Time to produce effect Maximum duration Approximately 30 minutes for local anesthetic; 48 to 72 hours for corticosteroid. 2 injections per level per year when at least 3 months of functional benefit is documented. Prior authorization must be obtained for injections beyond 2 levels.

Table 44.

Evidence Table: Diagnosis of Facet-Mediated Pain Revel’s criteria are unsuitable as a clinical screening test to select chronic low back pain patients for initial zygapophyseal joint blocks.

Table 45.

Evidence Table: Effectiveness of Facet Joint Injection There is a lack of evidence for therapeutic benefit of intraarticular facet joint injections in treating low back In the setting of axial back pain accompanied by paraspinal tenderness, in which the facet joint is suspected to be involved in the etiology of the pain, the therapeutic effects at 1 month of an intra-articular injection of local anesthetic plus a depot steroid are similar to the effects of a medial branch block using a local anesthetic plus a depot steroid, and both interventions are similar to the injection of a saline solution at the anatomic site used for a medial branch block. In summary, there is some evidence that both interventions lack therapeutic benefit at 1 month.

Section 8.a.iii. Sacroiliac (SI) Joint Injection Introduction. Sacroiliac (SI) joint injection is an injection of local anesthetic and/or corticosteroids in an intra-articular fashion into the SI joint under fluoroscopic guidance.

Absolute and Relative Contraindications to SI Joint Injection.

• Poorly controlled diabetes mellitus, systemic or localized bacterial infection, and bleeding diathesis are absolute contraindications to steroid injections.

• Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive steroid injections. It is unknown if SI joint injections contribute to increased risk of fractures, but appropriate precautions should be taken for at-risk patients.

• Patients on medications that affect coagulation require special consideration prior to these • Somatization disorder, poorly controlled congestive heart failure, and uncontrolled hypertension are relative contraindications to these injections. Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.

Complications of SI Joint Injection.

• Complications include nerve injury, bleeding, infection, localized pain, or irritation.

• Extravasation of local anesthetic to the lumbar nerves may result in difficulty in ambulation.

• Extravasation to the sacral nerves may result in bowel and bladder impairment.

Side Effects and Adverse Events Related to SI Joint Injection.

• Diabetic patients may notice a steroid-induced effect on blood glucose levels in the post-injection Recommendation 105. The following requirements must be met prior to proceeding with a SI joint injection:

• at least 3 months of pain, unresponsive to 6 weeks of conservative therapies, including manual • confounding psychosocial risk factors have been screened for and clinically addressed; and • 3 positive physical examination findings are consistent with SI joint origin pain (i.e., compression test, thigh thrust test, sacral thrust test, Patrick’s, Gaenslen test, distraction test, Gillett test) for SI joint pain that is affecting activity.

Recommendation 106. Repeat SI joint injections are only recommended when the first injection resulted in a sustained therapeutic response for 3 months or more and is characterized by the following:

• improvement in at least 3 physical examination findings consistent with SI joint origin pain (e.g., Patrick’s sign, Gaenslen, distraction or gapping, or compression test), and • at least 80% improvement in an accepted pain scale (e.g., VAS or NRS).

Time Frames for SI Joint Injections Time to produce effect Frequency Maximum duration Approximately 30 minutes for local anesthetic; 48 to 72 hours for corticosteroid. 2 to 3 injections per year. 3 injections per year.

Table 46.

Evidence Table: Imaging Guidance for SI Joint Injection For SI joint injections, there may be minimal difference between the use of fluoroscopic guidance and the use of ultrasound guidance in the effects on function or pain.

SI joint injection with ultrasound is likely to be less accurate than fluoroscopic guidance in terms of intra-articular placement, since some of the injected solution may reach the periarticular structures. However, the significance of this difference in terms of pain relief and functional improvement is not clear.

In the setting of SI joint pain in nonobese patients with pain duration of approximately 6 months, intra-articular injection of lidocaine and dexamethasone is similarly effective when guidance of the needle is done with either ultrasound or fluoroscopy, and radiation exposure is absent with ultrasound.

In the setting of steroid and local anesthetic injection into the SI joint, the difference in pain relief at 1 month is likely to be no greater than 30% between guidance using ultrasound and guidance using fluoroscopy; however, there is a lack of evidence that either method of injection improves disability associated with SI joint pain. There is a lack of evidence that pain relief persists beyond 1 month.

Section 8.a.iv. Intradiscal Injection Introduction. Intradiscal steroid injection is a direct injection of a steroid-containing solution into an intervertebral disc.

Complications of Intradiscal Steroid Injection.

• Complications include infection, pain, bleeding, nerve injury, and allergic reaction to contrast dye.

Recommendation 107. Intradiscal injections are not recommended (table 47).

Table 47.

Evidence Table: Intradiscal Steroid Injection Intradiscal steroid injection is unlikely to relieve pain or provide functional benefit in patients with non-radicular back pain and therefore, they are not recommended.

Section 8.a.v. Medial Branch Block and Radiofrequency (RF) Denervation Introduction. Medial branch blocks are diagnostic injections used to determine whether a patient is a candidate for radiofrequency (RF) medial branch neurotomy. Medial branch neurotomy, also known as facet rhizotomy, is a procedure designed to denervate the facet joint by ablating the corresponding sensory medial branches. Continuous thermal percutaneous RF is the method frequently used. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for information on the use of repeat RF neurotomy in chronic pain maintenance management.

Absolute and Relative Contraindications to Medial Branch Block or RF Neurotomy.

• Systemic or localized bacterial infection and bleeding diathesis are absolute contraindications to medial branch blocks and RF neurotomy. Poorly controlled diabetes is a relative contraindication if steroids are used post-neurotomy.

• Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.

Complications of Medial Branch Block or RF Neurotomy.

• Complications of medial branch block or RF neurotomy include bleeding, infection, neural injury, localized neuritis, or rarely, a deafferentation centralized pain syndrome.

• Complications of repeat neurotomy include atrophy of spinal musculature.

Side Effects and Adverse Events Related to Medial Branch Block or RF Neurotomy.

• Side effects and adverse events related to medial branch block or RF neurotomy include localized pain at the injection and/or RF site and post-injection dysesthesia.

Diagnostics Medial Branch Block Requirements.

Recommendation 108. Diagnostic medial branch blocks are recommended when all of the following are present:

• physical examination findings consistent with facet origin pain (e.g., pain with extension greater than flexion, pain on extension with lateral bending, and referral patterns consistent with the expected pathologic level);

• at least 3 months of pain, unresponsive to 6 to 8 weeks of conservative therapies, including manual therapy; and • confounding psychosocial risk factors have been screened for and clinically addressed. See the Recommendation 109. Diagnostic medial branch blocks are limited to 2 anatomic facet joint levels or 3 medial branch levels. Bilateral controlled blocks are permitted, if performed in a way that preserves diagnostic accuracy.

Recommendation 110. A diagnostic response to medial branch blocks must be documented to show its value, including:

• improvement in at least 3 objective functional measures (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting); and • at least 80% improvement in an accepted pain scale (e.g., VAS or NRS) reported with postinjection provocative testing that is consistent with: ○ a post-injection pain diary with at least 8 hourly response recordings or until the block has clearly worn off.

A successful response to a diagnostic injection requires documentation of positive functional changes by trained personnel and may include nurses, physician assistants, medical assistants, therapists, or noninjectionist physicians. Functional progress supersedes pain improvement (table 48).

Recommendation 111. If the diagnostic response to the initial block is considered positive, then a separate confirmatory block using a local anesthetic of different duration on a different date must be performed to confirm the level of involvement prior to rhizotomy.

RF Neurotomy Requirements.

Recommendation 112. RF neurotomy is not recommended for patients with non-facetogenic pain generators or involvement of more than 3 levels of medial branch nerves.

Recommendation 113. RF neurotomy is only indicated for those with proven facetogenic pain who have met the criteria for a positive response to 2 controlled medial branch blocks, as defined in recommendation 110. Intra-articular facet joint steroid injections are not considered diagnostic blocks for the purposes of this criteria.

Recommendation 114. Cooled RF denervation, pulsed RF, dorsal nerve root ganglion RF ablation, and transdiscal biacuplasty are not recommended for the lumbar spine.

Repeat RF Neurotomy Requirements.

Recommendation 115. Repeat RF neurotomy may be indicated if the patient experiences sustained (6 months or more), measurable, and clinically meaningful improvement in at least 3 objective functional measures (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting) and improvement in an accepted pain scale (e.g., VAS or NRS) after initial RF neurotomy (Appendix Functional Screen). Functional progress supersedes pain improvement. The potential for atrophy of the spinal musculature should be factored into clinical decision making.

Recommendation 116. If the patient's pain presents differently than the initial rhizotomy, a confirmatory medial branch block, as outlined in recommendation 110, will be necessary.

Table 48.

Evidence Table: Medial Branch Blocks and RF Neurotomy at the Lumbar Spine Patients with substantial (80%) pain relief after controlled and blinded medial branch blocks who proceed to RF neurotomy experience decreased impairment and improved pain relief over 6 months as compared to sham procedures. Patients who experience higher levels of pain relief with medial branch blocks are more likely to benefit from RF neurotomy.

In the lumbar spine, carefully selected patients who had 80% relief with medial branch controlled blinded blocks and then had RF neurotomy had improved pain relief over 6 months and decreased impairment compared to those who had sham procedures. Pain relief was defined as 1 hour of 80% relief from the lidocaine injection and 2 hours of 80% relief with bupivacaine.

RF denervation of the lumbar facet joint with a 22 gauge probe in patients who are selected on the basis of a single medial branch block does not decrease low back pain 3 months after the procedure.

RF is more effective than placebo for suspected facet joint pain in the short term, but there is a lack of evidence for its effects on pain and function at other time points.

In the setting of axial back pain accompanied by paraspinal tenderness, in which the facet joint is suspected to be involved in the etiology of the pain, the therapeutic effects at 1 month of an intra-articular injection of local anesthetic plus a depot steroid are similar to the effects of a medial branch block using a local anesthetic plus a depot steroid, and both interventions are similar to the injection of a saline solution at the anatomic site used for a medial branch block.

There is some evidence that both interventions lack therapeutic benefit at 1 month.

Section 8.a.vi. Lateral Branch Block and Radiofrequency (RF) Denervation Introduction. Lateral branch blocks are diagnostic injections used to determine whether a patient is a candidate for radiofrequency (RF) lateral branch neurotomy. Lateral branch neurotomy is a procedure designed to denervate the SI joint by ablating the corresponding sensory lateral branches. See the Chronic Pain Disorder MTGs for information on the use of repeat RF neurotomy in chronic pain maintenance management.

Absolute and Relative Contraindications to Lateral Branch Blocks or RF Neurotomy.

• Systemic or localized bacterial infection and bleeding diathesis are absolute contraindications to lateral branch blocks and RF neurotomy. Poorly controlled diabetes is a relative contraindication if steroids are used post-neurotomy.

• Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.

Complications of Lateral Branch Blocks or RF Neurotomy.

• Complications of lateral branch block or RF neurotomy include bleeding, infection, neural injury, localized neuritis, or rarely, a deafferentation centralized pain syndrome.

• Complications of repeat neurotomy include atrophy of spinal musculature.

Side Effects and Adverse Events Related to Lateral Branch Blocks and RF Neurotomy.

• Side effects and adverse events related to lateral branch block or RF neurotomy include localized pain at the injection and/or RF site and post-injection dysesthesia.

Diagnostics Lateral Branch Blocks Requirements.

Recommendation 117. Diagnostic lateral branch blocks are recommended when all of the following are present:

• physical examination findings consistent with SI joint origin pain, including 3 positive physical exam maneuvers (e.g., compression test, thigh thrust test, sacral thrust test, Patrick’s, Gaenslen test, distraction test, and Gillett test);

• at least 3 months of pain, unresponsive to 6 to 8 weeks of conservative therapies, including manual therapy; and • confounding psychosocial risk factors are screened for and clinically addressed. See the Recommendation 118. Diagnostic lateral branch blocks should be performed in a manner consistent with the planned RF procedure without anesthetizing the nerve root or allowing intraarticular SI joint flow of medication. Bilateral controlled blocks are permitted, if performed in a way that preserves diagnostic accuracy.

Recommendation 119. A diagnostic response to lateral branch blocks must be documented to show its value, including:

• improvement in at least 3 objective functional measures (e.g., tolerance and time limits for sitting, standing, walking, and lifting); and • at least 80% improvement in an accepted pain scale (e.g., VAS or NRS) reported with postinjection provocative testing that is consistent with: ○ a post-injection pain diary with at least 8 hourly response recordings or until the block has clearly worn off.

A successful response to a diagnostic injection requires documentation of positive functional changes by trained personnel and may include nurses, physician assistants, medical assistants, therapists, or noninjectionist physicians. Functional progress supersedes pain improvement (table 49).

Recommendation 120. If the initial block is considered positive, then a separate confirmatory block using a local anesthetic of different duration on a different date must be performed to confirm the level of involvement prior to rhizotomy.

RF Neurotomy Requirements.

Recommendation 121. RF neurotomy is not recommended for patients without sacral nerve branch involvement.

Recommendation 122. RF neurotomy is only indicated for those with proven sacral nerve branch pain who have met the criteria for a positive response to 2 controlled lateral branch blocks, as defined in recommendation 119. Intra-articular SI joint steroid injections are not considered as a diagnostic block for the purposes of this criteria (table 49).

Recommendation 123. Pulsed RF, dorsal nerve root ganglion RF ablation, and transdiscal biacuplasty are not recommended for the lumbar spine.

Repeat RF Neurotomy Requirements.

Recommendation 124. Repeat RF neurotomy may be indicated if the patient experiences sustained (6 months or more), measurable, and clinically meaningful functional improvement in at least 3 objective functional measures (e.g., tolerance and time limits for sitting, standing, walking, and lifting) and improvement in an accepted pain scale (e.g., VAS or NRS) after initial RF neurotomy (Appendix Functional Screens).

Recommendation 125. If the patient's pain presents differently than the initial rhizotomy, a confirmatory lateral branch block, as outlined in recommendation 119, will be necessary.

Table 49.

Evidence Table: RF Neurotomy at the SI Joint Patients with chronic SI joint pain who experience substantial pain relief after local anesthetic lateral branch blocks and proceed to cooled RF neurotomy may have clinical benefit at 3 months post-procedure.

RF neurotomy with a cooled probe may benefit patients with chronic SI joint pain who demonstrate at least a 75% pain response to repeated nerve blocks done under fluoroscopic guidance 3 months after the procedure.

RF neurotomy with a cooled probe of the SI joint provides more pain relief than placebo RF at 3 months.

Section 8.a.vii. Prolotherapy Introduction. Prolotherapy, also known as sclerotherapy, consists of a series of injections of hypertonic dextrose, with or without glycerine and phenol, into the ligaments of the low back.

Side Effects and Adverse Events Related to SI Joint Prolotherapy.

• Side effects and adverse events include a temporary increase in low back pain and stiffness postinjection.

Recommendation 126. Prolotherapy is not recommended for nonspecific low back pain (table 50).

Recommendation 127. Prolotherapy for SI joint pain is generally not recommended. For a patient with SI joint pain to be a candidate for prolotherapy, the provider must document all of the following:

• at least 6 months of persistent functional impairment, unresponsive to intensive conservative therapies;

• localization of reported pain at the posterior superior iliac spine;

• 3 positive physical examination findings consistent with SI joint origin pain (e.g., compression test, thigh thrust test, sacral thrust test, Patrick’s, Gaenslen test, distraction test, or Gillett test);

• imaging and/or laboratory studies fail to reveal other sources that might better explain the symptoms;

• psychological evaluation and treatment, as appropriate; and • positive response to initial and confirmatory fluoroscopically-guided SI joint local anesthetic blocks, consisting of: o documented improvement in previously impaired SI joint function and provocative physical examination maneuvers within expected time frame of local anesthetic (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting; Patrick’s sign; Gaenslen; distraction; gapping and compression tests); and o 80% improvement in accepted pain scales (e.g., VAS or NRS), consistent with: ▪ the expected duration of the injected local anesthetic phase, and ▪ a post-injection pain diary with at least 8 hourly response recordings or until the block has clearly worn off.

Table 50.

Evidence Table: Prolotherapy Prolotherapy is not effective for treating non-specific low back pain, but it may provide a longer duration of pain relief than intra-articular steroid injections for SI joint pain.

Prolotherapy alone is not an effective treatment for chronic low back pain.

Prolotherapy of the SI joint is longer lasting, up to 15 months, than intraarticular steroid injections. The study was relatively small and long term blinding was unclear; however, all injections were done under fluoroscopic guidance.

Section 8.a.viii. Trigger Point Injection Introduction. Trigger point injections consist of injection of local anesthetic, with or without corticosteroid, into highly localized, extremely sensitive bands of skeletal muscle fibers that produce local and referred pain when activated.

Absolute and Relative Contraindications to Trigger Point Injection.

• Contraindications include underlying structural issues that more reasonably account for myofascial pain or infection.

Complications of Trigger Point Injection.

• Complications include infection, pneumothorax, anaphylaxis, penetration of the viscera, neurapraxia, neuropathy, syncope, and/or local myopathy (when corticosteroid injected).

Side Effects and Adverse Events Related to Trigger Point Injection.

• Side effects and adverse events include localized pain.

• If a patient experiences severe pain, there is a possibility of intraneural injection and the needle should be immediately repositioned.

Recommendation 128. Trigger point injections should be reserved for patients who meet all of the following criteria:

• consistent, well circumscribed trigger points with a local twitch response;

• characteristic radiation of pain pattern and local autonomic reaction (e.g., persistent hyperemia following palpation); and • trigger points are not responding to specific, noninvasive, myofascial interventions within a 6week time frame (table 51).

Recommendation 129. Concurrent participation in a therapeutic exercise program is required while undergoing myofascial interventions. See the Active Therapies section.

Recommendation 130. Conscious sedation is not recommended for patients receiving trigger point Time Frames for Trigger Point Injection Time to produce effect Frequency Optimum duration Maximum duration Local anesthetic - up to 30 mins No local anesthetic - up to 48 hrs Weekly 4 weeks 8 weeks No more than 4 injections per session per week to avoid significant post-injection soreness.

Occasional patients may require 2 to 4 repetitions of trigger point injections series over a 1 to 2 year period.

Table 51.

Evidence Table: Trigger Point Injection

Section 8.a.ix. Botulinum Toxin Injection Introduction. Botulinum toxin injections are used to temporarily weaken or paralyze muscles. These injections may reduce muscle pain in conditions associated with spasticity or dystonia.

Absolute Contraindications to Botulinum Toxin Injection.

• Absolute contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation.

• Infection at the proposed injection site.

• Motor neuropathy or neuromuscular junction disorders.

Complications of Botulinum Toxin Injection.

• Complications of infection at the injection site.

Side Effects and Adverse Events Related to Botulinum Toxin Injection.

• Side effects and adverse events include flu-like symptoms, dry mouth, dysphagia, weakening of the paralumbar musculature, and localized muscular tenderness at the site of injection.

• Neutralizing antibodies develop in at least 4% of patients treated with botulinum toxin type A, rendering it ineffective. Several antigenic types of botulinum toxin have been described.

Botulinum type B appears to be effective in patients who have become resistant to the type A toxin. The immune responses to botulinum toxins type A and B are not cross-reactive, allowing type B toxin to be used when type A action is blocked by antibodies.

Recommendation 131. Botulinum injections are not recommended for nonspecific low back pain.

Evidence Table. None. The above recommendation was based on consensus.

Section 8.b. Surgical Interventions Introduction. Operative treatments are considered when the natural history for surgically treated lesions is better than that of non-operatively treated lesions. Most individuals with low back pain will not need a surgical intervention. See the Overview of Care section.

• See specific surgical procedure section.

Recommendation 132. Early surgical evaluation is required for patients with evidence of any of the • acute fracture or dislocation, • epidural abscess, • myelopathy, • cauda equina syndrome, or • progressive neurologic deficits (e.g., motor weakness and reflexes) that specifically correlate with spinal cord or nerve root impingement.

Recommendation 133. Referral for surgical evaluation at 6 weeks or greater is indicated when the expected functional outcome of surgery is better than non-operative management and all of the following criteria are met:

• symptomatic and functional improvement has plateaued with unacceptable functional disability;

• greater pain in the legs relative to back that interferes with function, return to work, and/or active • physical exam findings of abnormal reflexes, motor weakness, or radicular sensation deficits;

• findings on MRI that indicate impingement of nerves or the spinal cord that specifically correlate with reproducible physical examination findings; and • diagnostic elimination of confounding psychological or physical conditions that may respond to non-surgical techniques or may be refractory to surgical intervention (see the Behavioral and Psychological Interventions section).

Recommendation 134. Continuation of exercise and/or active therapy while awaiting a surgical evaluation or surgical procedure is recommended to maintain and optimize physical conditioning.

Recommendation 135. Informed consent is required before all invasive procedures. See the Essential First Line Treatment section.

Recommendation 136. Participation in a postoperative active therapy program that includes core stabilization, strengthening, and endurance is strongly recommended. See the Active Therapies section.

Recommendation 137. Diabetes control and related routine lab work, including hemoglobin A1c, are recommended prior to surgery.

Recommendation 138. A multi-modal approach to postoperative pain management is recommended to avoid overuse and misuse of opioid medications. This approach may include any of the following:

• cognitive behavioral therapy (CBT) (see the Behavioral and Psychological Interventions section);

• pain neuroscience education (see the Active Therapies section);

• use of non-opioid medication strategies as adjunct to anesthesia and pre- or postoperative pain management (see the Medications section);

• use of peripheral regional analgesia; and/or • use of passive therapy for postoperative pain (see the Passive Therapies section).

Recommendation 139. Intraoperative neuromonitoring is permitted to evaluate spinal cord integrity and screw placement during the operative procedure.

Recommendation 140. Percutaneous RF disc decompression and intradiscal electrothermal therapy are not recommended.

Table 52.

Surgical interventions for low back pain with radiculopathy produce large and clinically important reductions in pain and disability 3 months after surgery.

However, pain and disability are not entirely eliminated in the long term, and mild to moderate pain and disability, approximately on the order of 15 to 20 points on a 100 point scale, can be expected to be present 5 years after surgery for most patients who have a successful surgical procedure for low back pain with radiculopathy.

Functional improvement and relief of back pain from most back surgery is similar between patients with a body mass index (BMI) under 25 and overweight or mildly obese patients with a BMI between 25 and 35. Mild obesity does not appear to have an adverse effect on the responsiveness to surgery for these clinical outcomes.

Section 8.b.i. Discectomy Introduction. Discectomy is a surgical treatment for ruptured or herniated discs of the lumbar spine.

There are several procedures in use to decompress extruded disc material around nerve roots, including several minimally invasive techniques. These include:

• lumbar microscopic discectomy, • percutaneous discectomy, • microdiscectomy, and • laser discectomy.

Complications of Lumbar Discectomy.

• Complications of open discectomy include nerve damage, spinal fluid leakage, disc reherniation requiring additional surgery, spinal instability, persistent disc related back pain, infection, and hemorrhage.

• Complications of percutaneous discectomy include nerve or vessel injury, infection, hematoma, incomplete nerve root dissection, disc reherniation requiring additional surgery, spinal instability, and persistent disc related back pain.

Recommendation 141. A psychological screen with a follow-up psychological evaluation, if indicated, is required prior to proceeding with discectomy. If the surgery is being performed in an emergent or urgent situation, the screen is not necessary.

Recommendation 142. For a patient to be a candidate for open or minimally invasive lumbar discectomy, the provider must document all of the following:

• subjective report of severe radicular pain;

• positive straight leg raise or femoral stretch test and/or reflex, motor, or sensory changes on examination consistent with imaging findings; and • objective findings of neural compression on imaging studies that specifically correlate with the subjective report and examination findings (table 53).

Recommendation 143. ESIs can be trialed prior to surgery if the patient has a preference to avoid surgery, is unable to participate in therapy after the first 2 weeks post-injury, and meets the criteria for ESI outlined in recommendation 94.

Recommendation 144. The decision to proceed with an open or minimally invasive technique for lumbar discectomy is left to the treating surgeon’s discretion, experience, and training in these techniques (tables 54, 55).

Acute Phase Requirements (Within 6 Weeks of Initial Care).

Recommendation 145. Early referral within 6 weeks for lumbar discectomy is permitted when the provider documents all criteria in recommendations 141 and 142 and at least 1 of the following:

• radicular pain-related functional impairment prevents participation in active therapy and ADLs;

• presence of progressive functional neurological deficits; or • an opioid treatment is being considered.

Subacute and Chronic Phase Requirements (After 6 Weeks of Care).

Recommendation 146. Referral for lumbar discectomy is permitted for patients who meet the criteria in recommendation 142 and both of the following:

• functional impairment despite 6 weeks of optimal medical management and participation in active therapy; and • confounding psychosocial risk factors have been screened for and clinically addressed (see the Behavioral and Psychological Interventions section).

Recommendation 147. Laser discectomy and percutaneous discectomy are not recommended.

Table 53.

Evidence Table: Effectiveness of Lumbar Discectomy In patients with persistently symptomatic subacute or chronic radiculopathy attributable to disc herniation, discectomy results in greater functional improvement and pain reduction compared to nonoperative management. However, it is reasonable to trial an ESI for patients who prefer to avoid surgery without concern for reducing later surgical success. An ESI may allow patients to avoid surgery.

In patients with sciatica arising from a posterolateral disc herniation at L4-5 or at L5-S1 lasting 4 to 12 months, microdiscectomy leads to greater pain reduction and functional improvement than nonoperative treatment when these outcomes are assessed 6 to 12 months after the initiation of treatment.

Table 53 continued.

Evidence Table: Effectiveness of Lumbar Discectomy Among patients with herniated discs who have remained symptomatic after 6 weeks of noninvasive care and who are likely candidates for surgery, surgical discectomy successfully leads to symptom resolution in a large majority of patients. However, patients from the same population who receive ESI after 6 weeks of unsuccessful noninvasive care frequently experience symptom resolution sufficiently well to be able to avoid surgery. The magnitude of the surgery-sparing effect of ESI has not been established, but as many as half of patients may avoid surgery for up to 3 years. Patients who have an unsuccessful ESI after 6 weeks of noninvasive care may undergo discectomy at a later time, with no evidence that the delay in surgery reduces the success of the later operation.

In the setting of lumbar microdiscectomy in which a large annular defect 4-6 mm in height and 6-10 mm in width is present, the risk of reherniation and reoperation may be significantly reduced by repair of the disc annulus with a mesh device, which is fixed to the adjacent vertebral body with a titanium anchor. The number needed to treat to prevent a reherniation may be approximately 8 and the number needed to treat to prevent a reoperation may be approximately 13.

Open discectomy is likely to benefit patients with imaging-confirmed lumbar disc herniations who are failing to improve with several weeks of conservative treatment.

The advantages of surgical over nonoperative treatment of herniated lumbar discs remain stable over an 8 year period following randomization to either surgery or nonoperative treatment, and the gains observed at 2 years do not deteriorate in the long term.

Table 54.

Evidence Table: Minimally Invasive Microdiscectomy versus Open Lumbar Discectomy Minimally invasive and open discectomy techniques appear to result in similar clinical outcomes, but there may be lower risk of surgical site infection with minimally invasive techniques.

Minimally invasive discectomy is associated with a lower risk of surgical site infection than conventional microdiscectomy and open discectomy.

Clinical outcomes such as leg pain, back pain, and functional disability are similar between minimally invasive discectomy and conventional microdiscectomy and open discectomy.

Table 54 continued.

Evidence Table: Minimally Invasive Microdiscectomy versus Open Lumbar Discectomy Minimally invasive discectomy has not been shown to improve function, extremity pain, or axial pain compared to open discectomy in the setting of cervical and lumbar primary discectomy.

Table 55.

Evidence Table: Intraoperative and Perioperative Factors in Discectomy Outcome In the setting of percutaneous lumbar discectomy, an epidural saline solution containing 40 mg of triamcinolone may reduce leg pain and disability during the first postoperative week, leading to earlier hospital discharge. However, there is insufficient information regarding the safety of epidural steroid administration with respect to wound healing and the risk of reherniation.

Preoperative administration of dexamethasone reduced acute pain during movement 2 to 24 hours postoperatively from lumbar disc surgery as measured by the VAS.

Intraoperative application of epidural corticosteroids such as DepoMedrol reduces postoperative pain for up to 1 month in patients who have undergone lumbar discectomy at either L3/L4 or L4/L5.

Following a surgical intervention for first time lumbar disc herniation, patients are likely to achieve functional and symptomatic benefits from a 12 week, 20 session program of a physical therapy based rehabilitation intervention. This program emphasizes supervised exercise activities aimed at the core stabilizers, reduces fear of movement, and also coaches patients on the best ergonomic practices for return to work.

Table 56.

Evidence Table: Postoperative Factors Influencing Discectomy Outcome Among patients with a preoperative diagnosis of lumbar disk herniation, a program of early comprehensive physiotherapy commenced within 4 weeks after discectomy (or microdiscectomy) did not increase the rate of reherniation, reoperation, and revision surgery as compared to a control treatment.

In the setting of elective open single-lumbar discectomy for herniated discs, where morphine is delivered by patient-controlled anesthesia, a low-dose separate infusion of 0.25 mcg/kg/hour of naloxone in the 24 hours after surgery may reduce morphine consumption and reduce postoperative pain, nausea, and pruritus.

In the setting of lumbar discectomy for herniated discs, a postoperative rehabilitation program consisting of in-hospital instructions for transfers (bed to chair, etc) and ADLs can lead to successful recovery if supplemented by an instructional booklet with information about core strengthening and mobilization. The addition of an immediate exercise rehabilitation program in the first 6 to 8 weeks following surgery adds very little additional benefit and is not likely to be cost-effective.

Section 8.b.ii. Decompression for Central or Lateral Spinal Stenosis Introduction. Multiple procedures described in this section offer surgical access to decompress neural elements by partial or total removal of various parts of the spinal elements. These procedures include:

• laminotomy, • laminectomy, • foraminotomy, • facetectomy, and • ligamentum flavum resection.

Absolute and Relative Contraindications to Decompressive Surgery.

• Unaddressed depression, unaddressed concomitant disorder influencing walking capacity (e.g., hip or knee arthrosis, neurologic disease, and cardiopulmonary disease), and unaddressed cardiovascular comorbidity are relative contraindications.

• Scoliosis is a relative contraindication for laminectomy.

• Laminectomy is contraindicated for patients with dynamic spinal instability.

Complications of Decompressive Surgery.

• Complications include graft dislodgement, nerve injury, post-surgical instability, cerebrospinal fluid leakage, hematoma, hemorrhage, infection, spinal cord injury causing paralysis, perineural fibrosis, ROM loss, incomplete decompression, and development of spinal instability requiring fusion surgery.

Recommendation 148. A psychological screen with a follow-up psychological evaluation, if indicated, is required prior to proceeding with decompressive surgery. If the surgery is being performed in an emergent or urgent situation, the screen is not necessary (table 57).

Recommendation 149. Surgical indications include all of the following:

• radicular symptoms or symptoms of neurogenic claudication, often with clinical evidence of radiculopathy that correlates with the patient’s pain and findings;

• evidence of nerve root or spinal compression on imaging studies; and • failure of non-surgical care, including a trial of 6 weeks of active therapy (table 58).

Table 57.

Patients undergoing spinal surgery who have perioperative depression may have poorer functional outcomes than those without depression.

Depression at the time of surgery and in the early recovery period is associated with poorer functional recovery at 2 years, even though it does not appear to be associated with worse pain at 2 years.

Table 58.

Evidence Table: Decompressive Surgery Versus Non-Operative Care for Spinal Stenosis Some patients with lumbar spinal stenosis respond favorably to non-operative management, while others eventually progress to surgery. Surgical treatment is more likely to result in functional improvement and pain relief for the first several years compared with non-operative management, but the benefits become equivalent after 5-8 years.

Surgical treatment of lumbar spinal stenosis leads to better symptomatic and functional outcomes, but patients with non-surgical treatment may also improve slightly. The non-operative improvement appears to be less likely for stenosis than for herniated discs. In a randomized spinal stenosis trial with crossover, 1/3 of those in the surgery group did not have surgery, and about 40% of those in the non-surgical group eventually had surgery.

In the setting of lumbar spinal stenosis with neurogenic claudication, an initial treatment plan for a decompressive laminectomy and an initial treatment plan for nonoperative treatment with active physical therapy, educational counseling, and home exercise are likely to be equally successful, provided that these plans are allowed to change if circumstances change, that is, if surgery is done when nonoperative treatment is not meeting with success, and if plans for surgery are changed if a patient is improving with nonoperative treatment.

Although surgery for spinal stenosis generally leads to greater benefits than nonoperative treatment for the first several years of treatment, the results of the treatment options tend to converge over a period of 5 to 8 years.

Table 58 continued.

Evidence Table: Decompressive Surgery Versus Non-Operative Care for Spinal Stenosis In patients with a confirmed diagnosis of stenosis who elect for spinal decompression surgery, a physiotherapist-led program consisting of active rehabilitation was found to improve function up to 12 months after the surgery.

The programs ranged from 30 to 90 minutes per week or on a biweekly basis, lasting up to 12 weeks.

Although decompressive laminectomy for spinal stenosis with neurogenic claudication is beneficial in terms of pain relief and improved function, the proportion of patients who consider themselves to be greatly improved from baseline tends to decline over a period of 8 years.

Table 59.

Evidence Table: Decompressive Surgery In patients with lumbar spinal stenosis, with or without spondylolisthesis, the 2year disability outcomes as measured by the ODI do not differ in a clinically important manner between decompression surgery alone and decompression with added fusion surgery.

In comparison with facet-sparing laminectomy, surgical procedures that preserve the spinous processes and other posterior elements of the spine are at least as effective as laminectomy in reducing disability and leg pain when used to treat symptomatic lumbar spinal stenosis.

Compared to a fluoroscopically guided interlaminar ESI, a minimally invasive percutaneous partial resection of the ligamentum flavum leads to greater functional improvement and reduced pain at 6 and 12 months in patients with lumbar spinal stenosis and neurogenic claudication accompanied by confirmed hypertrophy of the ligamentum flavum. There is good evidence that these improvements remain stable 24 months following the procedure.

However, there is no evidence that the surgical procedure reduces medication use compared to the ESI.

In patients with spinal stenosis associated with degenerative spondylolisthesis not exceeding 3 mm of motion on flexion-extension films, an operation involving decompressive laminectomy and instrumented posterolateral fusion leads to slightly greater improvements in general health-related quality of life than decompressive laminectomy alone, with no evidence of clinically important differences in back-specific disability as measured by the ODI.

Table 59 continued.

Evidence Table: Decompressive Surgery In comparison with facet-sparing laminectomy, surgical procedures that preserve the spinous processes and other posterior elements of the spine may reduce postoperative instability of the operated segment when treating lumbar spinal stenosis.

Section 8.b.iii. Spinal Fusion Introduction. Spinal fusion is a procedure that unites 2 or more vertebral bodies together to restrict motion and removes a degenerative disc to relieve symptoms of coexistent nerve root compression. The procedure often involves the use of bone grafts, and sometimes instrumentation, to produce a rigid connection between 2 or more adjacent vertebrae. Recombinant human bone morphogenetic protein-2 (rhBMP-2) may also be used in fusion. Discography is rarely used as an invasive diagnostic procedure for fusion candidates.

Absolute and Relative Contraindications to Lumbar Fusion and Discography.

• Morbid obesity is a relative contraindication to fusion (table 60).

• Absolute contraindications to the use of rhBMP-2 include known sensitivities to rhBMP-2, bovine type 1 collagen, or other components of the formulation.

• Contraindications to discography include infection, bleeding diathesis, significant spinal stenosis, clinical myelopathy, known allergic reaction to injectate, effacement of the cord, thecal sac, or circumferential absence of epidural fat.

Complications of Lumbar Fusion and Discography.

• Potential complications include instrumentation failure, pseudoarthrosis, superficial or deep wound infection, iliac crest bone graft donor site pain graft extrusion, acceleration of adjacent segment disease, and nerve damage.

• Potential complications associated with the use of rhBMP-2 include: o development of sensitization to rhBMP-2 or to absorbable collagen sponge, and o neurovascular encroachment due to swelling and ectopic bone formation associated with the use of rhBMP-2 outside of the anterior cage.

• Potential complications of lumbar discography include discitis, nerve damage, chemical meningitis, pain exacerbation, disc damage, and anaphylaxis (table 62).

Recommendation 150. Lumbar fusion is not recommended in the first 6 months of symptoms, except for fracture, dislocation, or for some patients with functional loss due to stenosis and instability.

Recommendation 151. Psychological evaluation is required to assess suitability for a lumbar fusion.

Documentation should include the following items with associated treatment recommendations:

• psychological factors that might influence elective surgical treatment outcomes, or • psychological factors that might complicate surgical recovery.

Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section (table 61).

Recommendation 152. The following are required prior to proceeding with spinal fusion:

• all pain generators are adequately defined and treated;

• all physical medicine and manual therapy interventions are completed;

• imaging studies demonstrate spinal stenosis with instability or disc pathology, requiring decompression;

• spine pathology is limited to 2 levels; and • psychological evaluation, as discussed in recommendation 151 (tables 64, 65, 66, 67).

Recommendation 153. Diagnostic indications for fusion include the following:

• neural arch defect with associated stenosis or instability;

• spondylolytic spondylolisthesis;

• degenerative spondylolisthesis 4 mm or greater;

• surgically induced segmental instability;

• symptomatic spinal stenosis in the presence of spondylolisthesis (>2 mm); or • primary mechanical low back pain / functional spinal unit failure with objective evidence of 2 or more of the following: o internal disc disruption (poor success rate if more than 1 disc involved), o painful motion segment, o disc resorption, o facet syndrome, and/or o ligamentous tear.

Recommendation 154. Discography is not generally recommended, but it is permitted when confirmatory information is necessary prior to proceeding with lumbar fusion (table 62).

Recommendation 155. Tobacco cessation for at least 6 weeks prior to fusion is required, unless the surgeon documents reasoning that the benefits of proceeding with surgery outweigh the risks.

Recommendation 156. The choice of bone graft donor site, grafting substance, operative technique, and surgical approach are at the discretion of the treating surgeon (tables 68, 69).

Recommendation 157. Strategic perioperative medication use is recommended for pain management to minimize opioid use and optimize surgical outcome (table 70).

Recommendation 158. Postoperative participation in an active therapy program that includes core stabilization, strengthening, and endurance is recommended. See the Active Therapies section (table 71).

Table 60.

Evidence Table: Complications Related to Lumbar Fusion Morbid obesity increases hospital length of stay, mortality, and postoperative complications after spinal fusion surgery, with concomitant increases in hospital costs.

Cross sectional Table 61.

Depression at the time of surgery predicts a worse functional outcome.

Depression at the time of surgery and in the early recovery period is associated with poorer functional recovery at 2 years, even though it does not appear to be associated with worse pain at 2 years.

Table 61 continued.

Table 62.

Evidence Table: Discography Radiographically identified spondylolisthesis more accurately identifies patients who are likely to benefit from fusion than a positive discogram. Discography may result in an increased risk of later disc herniation.

A positive discogram does not identify patients who benefit from fusion, in contrast to radiographically identified spondylolisthesis, which does identify patients likely to benefit.

Only 27% of “discogenic” pain patients had successful outcomes of fusion, even when predictors of a poor outcome were excluded from surgery; 72% of spondylolisthesis patients had success with the same surgery.

Provocative discography, facet joint blocks, and temporary external transpedicular fixation do not adequately screen patients with nonspecific low back pain for fusion success. The tests tend to be sensitive but not specific.

Discography with a small-bore needle increases the risk of later disc herniation at the level of the injected disc, and this risk should be taken into account when deciding on referral for discography.

Table 63.

Evidence Table: Factors Predicting Response to Fusion Patients undergoing rehabilitation comprised of exercise and CBT have lower levels of self-reported disability and reduced fear avoidance behavior than patients receiving usual care for up to 12 months following lumbar fusion surgery.

Table 64.

Evidence Table: Nonoperative Treatment Versus Lumbar Fusion For patients with severe symptoms due to lumbar stenosis and spondylolisthesis, decompression and fusion provide greater benefit than nonoperative treatment. For chronic non-radicular back pain without stenosis or instability, intensive exercise combined with cognitive interventions may be as effective as posterolateral fusion.

Decompression and fusion, with or without instrumentation, of lumbar stenosis with degenerative spondylolisthesis leads to better 2 year outcomes for patients whose symptoms are severe. However, patients who choose nonoperative treatment can also expect their symptoms to improve with nonsurgical treatment, and nonoperative treatment is acceptable if this is the patient preference.

Intensive exercise for approximately 25 hours per week for 4 weeks, combined with cognitive interventions emphasizing the benefits of maintaining usual activity, produces functional results similar to those of posterolateral fusion in patients with chronic non-radicular back pain and no stenosis or instability after 1 year.

Intensive exercise coupled with CBT is as effective as posterolateral fusion for chronic un-operated low back pain.

Fusion is likely to have a higher beneficial effect compared to multidisciplinary rehabilitation for patients with isthmic spondylolisthesis, as differentiated from those without the condition who suffered from chronic low back pain.

In patients scheduled for lumbar spinal fusion surgery, a 4-week preoperative program of multidisciplinary CBT, emphasizing the interactions between cognition and pain perception, coping strategies for dealing with pain, pacing principles, return to work, and details about the fusion operation, does not appear to reduce pain scores in the immediate postoperative period.

However, such a CBT program as preparation for surgery does appear to be advantageous in the first 3 days after surgery by leading to earlier mobilization and independent ambulation, even though the intensity of pain scores is not significantly reduced.

Lumbar fusion produces better symptomatic and functional results in patients with chronic nonradicular pain when several months of conservative treatment have not produced a satisfactory outcome.

Table 65.

Evidence Table: Lumbar Fusion With or Without Decompression In patients with degenerative spondylolisthesis and minimal instability, the addition of fusion to decompression surgery:

• may improve general health-related quality of life;

• provides no added benefit for function, pain, rates of complication or rates of reoperation; and • increases operative blood loss, operative time and length of stay.

In patients with lumbar spinal stenosis, the addition of fusion to decompression surgery provides no added benefit for function or pain.

In patients with degenerative spondylolisthesis and minimal instability (motion of ≤ 3 mm on flexion-extension films), decompression alone is as beneficial as decompression plus fusion for outcomes such as disability, leg and back pain, and rates of complication and reoperation.

In patients with degenerative spondylolisthesis and minimal instability (motion of ≤ 3 mm on flexion-extension films), decompression alone is associated with less operative blood loss, shorter operative time, and shorter length of stay than decompression plus fusion.

In patients with lumbar spinal stenosis, with or without spondylolisthesis, the 2year disability outcomes as measured by the ODI do not differ in a clinically important manner between decompression surgery alone and decompression with added fusion surgery.

In the setting of symptomatic lumbar spinal stenosis, the addition of a fusion procedure to a decompression procedure adds little additional benefit with respect to pain and disability, both in the short term and in the long term.

In patients with spinal stenosis associated with degenerative spondylolisthesis not exceeding 3 mm of motion on flexion-extension films, an operation involving decompressive laminectomy and instrumented posterolateral fusion leads to slightly greater improvements in general health-related quality of life than decompressive laminectomy alone, with no evidence of clinically important differences in back-specific disability as measured by the ODI.

Table 66.

Evidence Table: Lumbar Fusion Versus Other Surgical Options Fusion surgery, the use of interspinous spacers, and total disc replacement (TDR) result in similar improvements in function and pain. For patients with painful degenerative disc disease, but without facet arthritis, spondylolysis, spondylolisthesis, osteoporosis, spinal stenosis, or deformity, a TDR leads to greater functional improvement and pain relief than fusion. In lumbar fusion, the use of a single cage or 2 cages results in equal rates of radiographic fusion. However, a single cage results in less intraoperative blood loss, shorter operating time, and fewer complications.

Disc replacement is not inferior to fusion at 24 months for relief of back pain, reduction of disability, and provision of patient satisfaction.

In the setting of lumbar interbody fusion, the use of a single cage achieves equal radiographic fusion as the use of 2 cages, with less intraoperative blood loss, shorter operating time, and fewer complications.

Reoperation rates are higher with the use of interspinous spacers than with laminectomy or laminotomy in the setting of symptomatic lumbar spinal stenosis, but reoperation rates are not different between spacers and fusion operations.

In the setting of symptomatic degenerative lumbar disease from a variety of causes, motion-preserving devices, such as interspinous spacers or TDRs, can be expected to lead to pain relief and disability improvement comparable to the improvements seen with fusion surgery.

TDR is more likely than fusion to lead to long term complete pain relief in patients who have painful degenerative disc disease, no facet arthritis, spondylolysis or spondylolisthesis, osteoporosis, spinal stenosis, or deformity.

TDR also leads on average to greater improvement in the ODI than fusion over 5 years.

Both fusion and TDR lead to lasting symptomatic and functional benefits over 5 years in carefully selected patients.

An artificial disc is non-inferior to allograft fusion with a cage for single level disease.

Pain and disability outcomes at 2 years are similar for 2-level lumbar degenerative disc disease between hybrid operations involving stand-alone anterior lumbar interbody fusion (ALIF) at L4-5 plus disc replacement at L5-S1, compared to non-hybrid operations involving interbody fusion at both levels or TDR at both levels.

Table 66 continued.

Evidence Table: Lumbar Fusion Versus Other Surgical Options In the setting of stable spinal stenosis with Grade I spondylolisthesis, decompression combined with a Coflex interlaminar stabilization device achieves similar clinical benefits as decompression combined with instrumented posterolateral fusion.

In patients with symptomatic spinal stenosis at L4-5, posterior stabilization with Dynesys leads to greater motion preservation at the operated segment, and a reduced amount of excess movement at adjacent levels, than does posterior lumbar interbody fusion (PLIF) at 3 years postoperatively.

Dynesys and PLIF lead to comparable improvements in leg pain, back pain, and ODI scores at 3 years.

Dynesys requires shorter operative time, shorter hospital stays, and less blood loss than PLIF.

A 2-level lumbar disc replacement is not inferior to circumferential fusion in patients with 2 level degenerative disc disease and less than grade I spondylolisthesis 24 months after surgery.

A trial comparing TDR with circumferential fusion found superior function with lumbar disc replacement compared to fusion. However, the use of narcotics remained high even 2 years after a successful operation.

Table 67.

Evidence Table: Lumbar Fusion and Adjacent Segment Degeneration Lumbar surgery with motion-preserving devices reduces the incidence of adjacent level disease and reoperation within 2-6 years.

Over a period of 2 to 6 years, surgery with motion-preserving devices in the lumbar spine is likely to lead to a lower incidence of adjacent segment disease and to require fewer reoperations than spinal fusion.

In the setting of lumbar fusion, the risk of reoperation for adjacent segment disease is likely to be increased when there is a diagnosis of degenerative scoliosis and when the fusion extends from L4 to S1.

Review TDR of the lumbar spine reduces the 5-year risk of adjacent level degeneration compared to circumferential fusion.

Table 68.

Evidence Table: Lumbar Fusion Graft Site and Other Issues In the setting of lumbar spinal fusion, the use of bone morphogenetic protein (BMP) is associated with lower rates of reoperation over the following 2 years as compared to iliac crest bone graft. rhBMP-2 has a greater influence on promoting radiographic fusion in smokers than in nonsmokers when compared to iliac crest bone graft. rhBMP-2 promotes fusion better than iliac crest bone graft in normal weight and overweight patients, but rhBMP-2 may not influence fusion rates in obese and severely obese patients.

When instrumented single-level fusion is done for lumbar spondylolisthesis, local bone graft requires less operative time, yields equal rates of fusion and clinical improvement, and avoids persistent local symptoms at the iliac crest graft donor site.

Table 69.

Evidence Table: Lumbar Fusion - Other Technical Issues In the setting of spine fusion surgery, the use of antifibrinolytics such as tranexamic acid reduces intraoperative blood loss and total blood loss, leading to lower transfusion requirements, while not being accompanied with significant adverse effects compared to no antifibrinolytic use.

In the setting of transforaminal lumbar interbody fusion (TLIF), fusion rates are slightly lower with unilateral than with bilateral pedicle screw fixation.

In the setting of TLIF, cage migration occurs more commonly with unilateral than with bilateral pedicle screw fixation, and device-related complication rates also are likely to be higher.

In the setting of TLIF, there is less blood loss with unilateral than with bilateral pedicle screw fixation, and operative times are also shorter.

In the setting of TLIF, pain and functional outcomes are similar between unilateral and bilateral pedicle screw fixation; it is possible that the lower fusion rates and higher rates of cage migration with unilateral fixation are offset by less soft tissue dissection, shorter operative times, and less blood loss with unilateral fixation.

Table 69 continued.

Evidence Table: Lumbar Fusion - Other Technical Issues In the setting of posterior spinal fusion using posterior iliac crest bone graft, the application of a sponge soaked in 0.25% bupivacaine at the time of bone harvest may reduce donor site pain for the first several months after surgery, compared to a sponge soaked in saline.

In patients undergoing posterior lumbar surgery for stenosis or spondylolisthesis, a loading dose of 30mg/kg tranexamic acid over 15 minutes and a maintenance infusion of 2 mg/kg/hour, was found to reduce perioperative blood loss as compared to a placebo.

In the setting of instrumented posterolateral fusion of the lumbar spine for degenerative spondylolisthesis, the addition of autologous bone marrow concentrate to allograft can be expected to significantly increase the rate of radiographic fusion 2 years after the operation is done.

Table 70.

Evidence Table: Perioperative Medication Use in Fusion For patients undergoing spinal fusion surgery, preoperative analgesia may reduce postoperative pain and opioid use. Postoperative non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nonunion at higher doses.

In the setting of lumbar spinal fusion, NSAIDs at an equivalence of no more than 120 mg of ketorolac for 14 days postoperatively do not appear to increase the risk of nonunion of the operated spinal segment.

In the setting of PLIF surgery, a single saline infusion of 800 mg of ibuprofen one half hour prior to surgery may lead to less pain and morphine use in the immediate postoperative period and may thereby be an option for preoperative care of the surgical patient.

In the setting of 1-level or 2-level spinal fusion surgery, the administration of preemptive analgesia 8 hours preoperatively with acetaminophen, ketorolac, and pregabalin may confer benefits in the 48 hours following the procedure in the form of less pain, better ambulation, and less morphine use.

Table 70 continued.

Evidence Table: Perioperative Medication Use in Fusion Among patients undergoing posterior lumbar spinal fusion, the addition of preemptive analgesia using a single intravenous dose of ketorolac (30 mg) or parecoxib (40 mg) resulted in better immediate postoperative pain control as compared to a control (saline) group. However, the difference among the groups did not persist in measures from one-hour post-operatively up to 24 hours. There was no apparent opioid-sparing effect with preemptive analgesia.

The incidence of many postoperative complications such as nausea, headache, and dizziness is probably similar for gabapentin and placebo. Gabapentin may increase somnolence but may decrease the incidence of urinary retention pruritus.

In the setting of lumbar fusion without rhBMP-2, postoperative NSAIDs with an equivalent dose of more than 300 mg of diclofenac are associated with an increased risk of nonunion of the operated spinal segment. There appears to be a dose-dependent effect of postoperative NSAIDs on the risk of nonunion.

Table 71.

Evidence Table: Post-operative Rehabilitation It is appropriate to defer active rehabilitation for 12 weeks after instrumented fusion, as the group beginning 12 weeks postoperatively had greater improvements in disability compared to the 6 week group.

Section 8.b.iv. Lumbar Total Disc Replacement (TDR)

Introduction. Lumbar total disc replacement (TDR) is a surgical procedure where a degenerated disc is replaced with a prosthetic device. The endplates are positioned under intraoperative fluoroscopic guidance for optimal placement in the sagittal and frontal planes. The prosthetic device physiologically distributes the mechanical load of the vertebrae and maintains ROM.

Absolute and Relative Contraindications to Lumbar TDR.

• Absolute and relative contraindications include: o significant spinal deformity and scoliosis; o symptomatic facet joint arthrosis; o spinal instability at the pathologic or adjacent level requiring fusion; o deficient posterior elements; o infection; o any contraindication to an anterior abdominal approach, including multiple prior abdominal procedures; o previous compression or burst fracture; o spinal canal stenosis; o spondylolysis; o spondylolisthesis > 3 mm; o osteopenia, osteoporosis, or any metabolic bone disease; o chronic steroid or other medication use that interferes with bone or soft tissue healing; o allergy to device materials; o pregnancy or desire to become pregnant; o extreme obesity (e.g., BMI > 40 kg/m2 or over 100 pounds overweight); o active malignancy; and o generalized chronic pain.

Complications of Lumbar TDR.

• Complications include nerve and vascular injury, dural tears, retrograde ejaculation, malpositioning/suboptimal positioning of prosthesis, implant failure, complex regional pain syndrome, complications from abdominal surgery (e.g., hernia or adhesions), and need for reoperation.

Recommendation 159. Psychological evaluation is required to assess suitability for lumbar disc replacement. Documentation should include the following items with associated treatment recommendations:

• psychological factors that might influence elective surgical treatment outcomes, or • psychological factors that might complicate surgical recovery.

Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section.

Recommendation 160. Lumbar TDR is reserved for patients who meet all of the following criteria:

• symptomatic 1- or 2-level disc disease established by objective testing (e.g., CT scan or MRI followed by provocation discography), • symptoms unrelieved after 6 months of active nonsurgical treatment, • all pain generators are adequately defined and treated, • all physical medicine and manual therapy interventions are completed, • imaging studies demonstrate disc pathology requiring decompression, and • psychosocial evaluation as outlined in recommendation 159, with confounding issues addressed (tables 72, 73, 74, 75).

Recommendation 161. If there are signs suggestive of facet-mediated pain, the pain must be evaluated with medial branch blocks before proceeding with disc replacement.

Recommendation 162. A trial of multi-disciplinary therapy must occur prior to proceeding with surgery (table 73).

Recommendation 163. Surgeons performing total disc arthroplasty must be trained in anterior spinal techniques and lumbar disc arthroplasty, and they must have attended lumbar arthroplasty training courses or undergone lumbar arthroplasty training in fellowship. It is highly recommended that the surgeon is mentored and proctored, and it is required that they have an assistant surgeon with anterior access experience.

Table 72.

Evidence Table: Degenerative Imaging Findings and Lumbar Disc Replacement In patients with chronic non-radicular low back pain electing for lumbar disc prosthesis surgery, degenerative MRI findings may not be related to associated pain and disability.

Cross sectional Table 73.

Evidence Table: Total Disc Arthroplasty Versus Conservative Care Both TDR and multidisciplinary therapy may improve function.

Disc replacement has a slight advantage over intensive multidisciplinary treatment - 60 hours over 5 weeks.

In patients with symptomatic degenerative disc disease at L4-5 or at L5-S1 lasting more than 1 year, persisting after 6 months of physical therapy or chiropractic treatment, an initial treatment regimen consisting of rehabilitation with a multidisciplinary team of specialists may effectively improve function, defined as a 15 point improvement in the ODI, in up to half of patients, making it a reasonable initial treatment option.

However, a TDR is overall more effective than multidisciplinary rehabilitation for pain and function, and may improve function by the same amount in about 70% of patients.

Table 74.

Evidence Table: Total Disc Arthroplasty Versus Spinal Fusion TDR, fusion surgery, and the use of interspinous spacers result in similar improvements in function and pain. TDR results in a greater segmental ROM after 1-2 years compared with fusion. TDR leads to greater functional improvement and pain relief than fusion for patients with painful degenerative disc disease and without facet arthritis, spondylolysis, spondylolisthesis, osteoporosis, spinal stenosis, or deformity.

Disc replacement is not inferior to fusion at 24 months for relief of back pain, reduction of disability, and provision of patient satisfaction.

An artificial disc is non-inferior to allograft fusion with a cage for single level disease.

There is greater segmental ROM after 1-2 years with arthroplasty as compared with fusion.

Table 74 continued.

Evidence Table: Total Disc Arthroplasty Versus Spinal Fusion TDR is more likely than fusion to lead to long term complete pain relief in patients who have painful degenerative disc disease, no facet arthritis, spondylosis or spondylolisthesis, osteoporosis, spinal stenosis, or deformity.

TDR also leads on average to greater improvement in the ODI than fusion over 5 years.

Both fusion and TDR lead to lasting symptomatic and functional benefits over 5 years in carefully selected patients.

In the setting of symptomatic degenerative lumbar disease from a variety of causes, motion-preserving devices such as interspinous spacers or TDRs can be expected to lead to pain relief and disability improvement comparable to the improvements seen with fusion surgery.

A 2-level lumbar disc replacement is not inferior to circumferential fusion in patients with 2 level degenerative disc disease and less than grade I spondylolisthesis 24 months after surgery.

A trial comparing TDR with circumferential fusion found superior function with lumbar disc replacement compared to fusion. However, the use of narcotics remained high even 2 years after a successful operation.

An artificial disc is non-inferior to circumferential fusion with iliac crest autograft for single level disease.

Pain and disability outcomes at 2 years are similar for 2-level lumbar degenerative disc disease between hybrid operations involving stand-alone ALIF at L4-5 plus disc replacement at L5-S1, compared to non-hybrid operations involving interbody fusion at both levels or TDR at both levels.

Table 75.

Evidence Table: Adjacent Segment Degeneration and Lumbar TDR Lumbar surgery with motion-preserving devices reduces the incidence of adjacent level disease and reoperation within 2-6 years.

Over a period of 2 to 6 years, surgery with motion-preservation devices in the lumbar spine is likely to lead to a lower incidence of adjacent segment disease and to require fewer reoperations than spinal fusion.

Table 75 continued.

Evidence Table: Adjacent Segment Degeneration and Lumbar TDR TDR of the lumbar spine reduces the 5-year risk of adjacent level degeneration compared to circumferential fusion.

Section 8.b.v. Interspinous Spacers Introduction. Interspinous process decompression theoretically relieves narrowing of the spinal canal and neural foramen in extension, thereby reducing the symptoms of neurogenic intermittent claudication, secondary to lumbar spinal stenosis.

Absolute and Relative Contraindications to Lumbar Interspinous Spacers.

• Absolute and relative contraindications include: o anatomy that prevents implantation due to significant lumbar instability, ankylosis, acute fracture of the spinous process or pars interarticularis; o allergy to titanium or titanium alloy; o significant scoliosis; o fixed motor deficit; o cauda equina syndrome; o neural compression causing neurogenic bowel or bladder dysfunction; o previous lumbar surgery at the proposed spacer level; o significant peripheral neuropathy; o anterolisthesis greater than 1.0 (on a scale from 1-4) at the affected level; o sustained pathological fractures; o severe osteoporosis of the vertebrae or hips; o severe foraminal stenosis; o extreme obesity; o active infection or systemic disease; o Paget’s disease or metastasis to the vertebrae; o steroid use for more than 1 month within 12 months preceding surgery; and o adjacent level disease is a relative contraindication.

Complications of Lumbar Interspinous Spacers.

• Complications include symptomatic spinous process fractures, new radicular defects, recurrent back pain, device extrusion or malposition, device failure with need for further surgery, infection, hematoma, and bilateral foot drop.

Recommendation 164. Psychological evaluation is required to assess suitability for lumbar interspinous spacers. Documentation should include the following items with associated treatment recommendations:

• psychological factors that might influence elective surgical treatment outcomes, or • psychological factors that might complicate surgical recovery.

Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section (table 76).

Recommendation 165. Interspinous spacers are indicated for patients 50 years or older with intermittent neurogenic claudication caused by lumbar spinal stenosis who meet all of the following criteria:

• all pain generators are adequately defined and treated;

• all physical medicine and manual therapy interventions are completed over 6 months;

• impaired physical function is correlated with physical findings;

• CT or MRI demonstrates stenosis (e.g., evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing);

• spine pathology is limited to 1 or 2 levels;

• psychological evaluation as discussed in recommendation 164;

• ability to sit for 50 minutes without pain;

• ability to walk up to 50 feet or more; and • relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain (table 77).

Table 76.

Patients undergoing spinal surgery who have perioperative depression may have poorer functional outcomes than those without depression.

Depression at the time of surgery and in the early recovery period is associated with poorer functional recovery at 2 years, even though it does not appear to be associated with worse pain at 2 years.

Table 77.

Evidence Table: Lumbar Interspinous Spacers An interspinous spacer device is superior to continuing nonoperative treatment after 6 months of conservative care has not resolved neurogenic claudication.

Section 8.b.vi. Minimally Invasive Sacroiliac (SI) Joint Fusion Introduction. Minimally invasive sacroiliac (SI) joint fusion is performed from a lateral approach under fluoroscopic guidance. The gluteus muscle is bluntly dissected and a pin is inserted across the SI joint so that a cannulated drill and broach can create a triangular wedge-shaped cavity in the ilium and sacrum through which titanium implants (typically 2-4) are inserted. The therapeutic goal of minimally invasive SI joint fusion is to provide stabilization and minimize micromotion/rotation of the instrumented SI joint. Open SI joint fusion for acute traumatic pelvic disruption is not discussed in these guidelines.

Relative and Absolute Contraindications to Minimally Invasive SI Joint Fusion.

• A contradiction to minimally invasive SI joint fusion is acute, traumatic instability of the SI joint due to trauma.

• Generalized pain behavior (e.g., somatoform disorder and presence of Waddell’s signs) is an absolute contraindication.

• Systemic inflammatory arthropathies are a contraindication.

• Generalized pain syndromes (e.g., fibromyalgia) are relative contraindications.

Complications of Minimally Invasive SI Joint Fusion Requiring Surgical Revision.

• Complications of minimally invasive SI joint fusion that require surgical revision include symptomatic malposition, symptom recurrence, postoperative hematoma, device loosening, sacral nerve root impingement, suboptimal device positioning, iliac fracture, iliac vessel injury, and postoperative radicular pain.

• Long-term complication rates are unknown.

Complications and Adverse Events Related to Minimally Invasive SI Joint Fusion.

• Complications and adverse events include infection, wound healing issues, nerve damage, recurrent pain, urinary tract infection, bursitis, and postoperative issues.

• Long-term complication rates are unknown.

Recommendation 166. Minimally invasive SI joint fusion is not recommended in the acute or subacute Recommendation 167. Prior authorization is required before surgery. The requesting provider should document how the patient satisfies the clinical indications outlined in this section.

Recommendation 168. Psychological evaluation is required to assess suitability for minimally invasive SI joint fusion. Documentation should include the following items with associated treatment recommendations:

• psychological factors that might influence elective surgical treatment outcomes, or • psychological factors that might complicate surgical recovery.

Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section.

Recommendation 169. Minimally invasive SI joint fusion should be reserved for patients who meet all of the following indications:

• at least 6 months of persistent functional impairment and pain, unresponsive to intensive conservative therapies, including medication, manual therapy, active therapeutic exercise (e.g., optimizing lumbosacral and pelvic ROM and identification/treatment of muscular imbalance);

• patient localization of typically unilateral symptoms as indicated by Fortin finger test with reported pain at the posterior superior iliac spine;

• physical examination findings consistent with SI joint origin pain, including 3 positive physical exam maneuvers (e.g., compression test, thigh thrust test, sacral thrust test, Patrick’s, Gaenslen test, distraction test, Gillett test);

• imaging studies (e.g., CT or MRI) of the lumbar spine, and where clinically indicated, of the hip, and/or pelvis that fail to reveal other sources that might better explain the symptoms (e.g., inflammatory arthropathy, evidence of neural compression, facet disease, disc disease, degenerative labral tears, tumor, infection, fracture); and • psychological evaluation as outlined in recommendation 168 (see the Behavioral and Psychological Interventions section); and • positive response to initial and confirmatory fluoroscopically-guided SI joint local anesthetic blocks with arthrogram confirming needle placement in the SI joint, consisting of: o documented improvement in previously impaired SI joint function and provocative physical examination maneuvers within expected time frame of local anesthetic (e.g., spinal ROM; tolerance and time limits for sitting, standing, walking, and lifting; Patrick’s sign; Gaenslen; distraction; gapping and compression tests); and o 80% improvement in accepted pain scales (e.g., VAS or NRS), consistent with: ▪ the expected duration of the injected local anesthetic phase, and ▪ a post-injection pain diary with at least 8 hourly response recordings, but preferably daily for 1 week (table 78).

Recommendation 170. The surgeon must have specific training and expertise in performing this procedure.

Recommendation 171. Systemic inflammatory arthropathies, including ankylosing spondylitis and rheumatoid arthritis, are not indications for minimally invasive SI joint fusion.

Recommendation 172. Tobacco cessation for at least 6 weeks prior to fusion is required, unless the surgeon documents reasoning that the benefits of proceeding with surgery outweigh the risks.

Recommendation 173. Imaging guidance is required to perform implant placement.

Recommendation 174. An individualized postoperative rehabilitation program is appropriate for patients at the discretion of the surgeon.

Table 78.

Evidence Table: Minimally Invasive SI Joint Fusion for Chronic SI Joint Pain For patients with chronic low back pain and a high likelihood of true SI joint pathology, surgical fusion with triangular titanium implants provides greater improvement in function and pain at 6 months than continued conservative treatment. These benefits may continue for at least 4 years after the operation.

In patients with chronic low back pain originating from the SI joint, a fusion procedure using triangular titanium implants leads to greater improvements in pain and function at 6 months than continued conservative treatment with optimum medical management and individualized physical therapy.

In the setting of chronic SI joint pain, a surgical fusion procedure involving triangular titanium implants is likely to confer greater benefits in pain reduction and functional improvement than continued nonsurgical pain management with medications, steroid injection, and RF neural ablation, with benefits appearing to be maintained 2, 3, and 4 years after the operation.

Section 8.b.vii. Kyphoplasty Introduction. Kyphoplasty is a surgical procedure for the treatment of symptomatic thoracic or lumbar vertebral compression fractures and occasionally post-traumatic compression fractures and minor burst fractures that do not significantly compromise the posterior cortex of the vertebral body.

Kyphoplasty involves the percutaneous insertion of a trocar and inflatable balloon or expanding polymer into the vertebral body, which re-expands the body, elevating the endplates and reducing the compression deformity. Polymethylmethacrylate (PMMA) bone cement is injected under low pressure into the cavity created by balloon inflation.

Absolute and Relative Contraindications to Kyphoplasty.

• Absolute and relative contraindications include: o asymptomatic vertebral body compression fracture; o patient improvement with medical treatment; o presence of neurologic compromise related to fracture; o high-velocity fractures with a significant burst component; o significant posterior vertebral body wall fracture; o severe vertebral collapse (vertebra plana); o infection; and o uncorrectable coagulopathy.

Complications of Kyphoplasty.

• Complications include new vertebral compression fracture, cement leakage, infection and extravertebral extravasation of the bone cement, with rare serious complications such as cemental pulmonary embolism, radiculopathy, and paraplegia.

• Procedure-related deaths have been reported.

Recommendation 175. Kyphoplasty may occur within the first 12 weeks of care after vertebral compression fracture when all of the following criteria are met:

• compression fracture with vertebral height loss between 15% and 85%, • failure to respond to at least 4 weeks of conservative management, and • functional impairment prevents performance of ADLs (table 79).

Table 79.

Evidence Table: Kyphoplasty Versus Conservative Management for Compression Fractures Kyphoplasty results in rapid functional improvement in the first month after compression fracture as compared to non-operative treatment, but the difference between groups diminishes over time.

Kyphoplasty provides rapid improvement in function in the initial months after the fracture, as compared to non-operative treatment or analgesics alone.

In the setting of osteoporitic vertebral compression fractures, the Kiva (trademarked vertebral augmentation system) coiled implant is noninferior to conventional balloon kyphoplasty in terms of pain relief, functional improvement, and safety at 1 year after the procedure is done.

Section 8.b.viii. Vertebroplasty Introduction. Vertebroplasty is a minimally invasive surgical procedure for the treatment of painful thoracolumbar vertebral compression fractures secondary to osteoporosis or other metabolic bone disease. In this procedure, bone cement is injected with high pressure into the vertebral body under constant fluoroscopic guidance. This guidance is used throughout the procedure to minimize cement leakage. Traditionally, a low-viscosity acrylic bone cement, PMMA, is used, but other types of bone cement such as high-viscosity PMMA, glass polymers, hydroxyapatite, and calcium phosphate are also commercially available. The procedure is usually performed under intravenous sedation or light general anesthesia. The goal of the procedure is to stabilize the spine and to relieve pain.

Absolute and Relative Contraindications to Vertebroplasty.

• Absolute and relative contraindications include: o asymptomatic vertebral body compression fracture, o patient improvement with conservative measures alone, o presence of fracture-related neurologic compromise, o high-velocity fractures with a significant burst component, o posterior vertebral body wall fracture, o severe vertebral collapse (vertebra plana), o spinal canal stenosis, o allergy to bone cement or opacification agents, o infection, and o uncorrectable coagulopathy.

Complications of Vertebroplasty.

• Procedure-related deaths have been reported.

• Complications include extravertebral extravasation of the bone cement, with rare serious complications such as cemental pulmonary embolism, radiculopathy and paraplegia.

• New vertebral compression fractures may occur following vertebroplasty.

Side Effects and Adverse Events Related to Vertebroplasty.

• Side effects and adverse events include localized pain at the site of the procedure.

Core Requirements Recommendation 176. Vertebroplasty may be considered for a select subgroup of patients with vertebral compression fractures within 4 and 12 weeks of pain onset when the following criteria have been met:

• compression fracture has been radiographically confirmed to cause pain and limit activity;

• symptoms are localized clinically to the level of the vertebral fracture;

• inability to perform ADLs;

• failure to respond to at least 4 weeks of conservative management;

• patient is healthy enough to undergo surgery, if necessary, for decompression;

• vertebral height loss between 15% and 85%; and • an intact posterior wall (table 80).

Table 80.

Evidence Table: Vertebroplasty for Compression Fracture For patients with acute osteoporotic vertebral fractures and mild to moderate pain, vertebroplasty and sham vertebroplasty (infiltration of the periosteum with local anesthesia) have clinically equivalent effects on function and pain. Vertebroplasty results in greater improvement in function and pain than continued medical management and physical therapy. Sham vertebroplasty has not been compared with continued medical management.

In the setting of acute osteoporotic vertebral compression fractures with mild to moderate pain, there are no clinically important differences between true and sham vertebroplasty for pain, function, or quality of life. The addition of PMMA cement does not enhance the therapeutic effects of a local anesthetic infiltration of the periosteum of the affected vertebra. Percutaneous vertebroplasty should not be a standard treatment for these fractures.

Osteoporotic vertebral fractures improve equally with both vertebroplasty and with well-simulated sham vertebroplasty that includes infiltration of the periosteum with local anesthesia.

This study has been criticized for selection bias due to the failure of most patients to be willing to enroll in a randomized trial.

Vertebroplasty does not differ from sham vertebroplasty in patients with acute (less than 6 months duration) osteoporotic vertebral fractures demonstrated by MRI criteria of edema and or/a fracture line, but that may apply only to patients whose pain is not severe enough to lead to hospitalization.

This study has been criticized for selection bias due to the failure of most patients to be willing to enroll in a randomized trial.

In the setting of acute osteoporotic vertebral compression fractures, percutaneous vertebroplasty is associated with greater pain relief and disability improvement than continued medical management combined with physical therapy. It is uncertain whether this difference represents a placebo (expectation) effect for the procedure or whether it represents a therapeutic effect of the local anesthetic. The effect of an anesthetic infiltration of the periosteum of the affected vertebra has not been tested as a stand-alone treatment in any randomized trial published to date.

In patients with acute osteoporotic vertebral fractures accompanied by edema on MRI, a vertebroplasty procedure and a sham vertebroplasty procedure yield rapid decreases in pain and disability that persist for up to 12 months.

After a periosteal infiltration with a local anesthetic is done, the addition of a PMMA cement injection does not appear to add significant additional benefits.

Vertebroplasty improves pain scores more rapidly than individualized pharmacological therapy for patients with acute osteoporotic vertebral fractures with effects detectable in the first day and persisting up to 1 year.

In patients with severe pain (7 or more on a 0-10 scale) arising from acute osteoporotic vertebral compression fractures, treatment with vertebroplasty is more effective than sham vertebroplasty in reducing pain at 14 days postprocedure, and in patients hospitalized for osteoporotic vertebral compression fractures, vertebroplasty is likely to reduce the length of hospital stay.

Vertebroplasty is associated with earlier pain relief and functional mobility than pharmacologic treatment alone, but there may be a risk of new clinically significant vertebral fractures when more than 1 vertebra is treated.

Section 8.b.ix. Spinal Cord Stimulators Introduction. Spinal cord stimulation is the delivery of low-voltage electrical stimulation to the spinal cord or peripheral nerves to inhibit or block the sensation of pain. The system uses implanted electrical leads and a battery powered implanted pulse generator. See the Chronic Pain Disorder MTGs.

Recommendation 177. Neurostimulation is reserved for patients who meet the criteria outlined in the Chronic Pain Disorder MTGs.

Evidence Tables. See the Chronic Pain Disorder MTGs for evidence.

Section 8.b.x. Epiduroscopy with Epidural Lysis of Adhesions Introduction. Epiduroscopy and epidural lysis of adhesions involves the introduction of a fiberoptic endoscope into the epidural space via the sacral hiatus. A saline irrigation is performed with or without epiduroscopy to distend the epidural space and result in lysis of adhesions.

Complications of Epiduroscopy.

• Saline irrigation on epiduroscopy and lysis of adhesions is associated with risks of elevated pressures that may impede blood flow and venous return, possibly causing ischemia of the cauda equina and retinal hemorrhage.

• Other epiduroscopy complications associated with instrumented lysis include catheter shearing, need for catheter surgical removal, infection (including meningitis), hematoma, and possible severe hemodynamic instability during application.

Recommendation 178. Epiduroscopy and mechanical lysis of adhesions and epiduroscopy-directed steroid injections are not recommended.

Evidence Tables. None. The above recommendation was based on consensus.

Section 9. Medications Introduction. Medications are used in the treatment of low back injuries to control acute pain, chronic pain, and inflammation. Use of medications will vary widely due to the spectrum of injuries. If medications are being considered for long-term chronic pain management, refer to the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) medication section.

• See the specific medication section. The medication lists within these sections do not provide complete information on side effects, potential complications, drug interactions, or drug monitoring. For more complete information, refer to the Chronic Pain Disorder MTGs medication

section or a medication reference text.

Recommendation 179. Medication reconciliation is required at the initial visit and periodically during treatment to avoid medication errors and to discuss side effects, drug interactions, and expected functional goals. Reconciliation includes the following elements:

• current medication name, dosage, frequency, and route;

• patient understanding of indication;

• potential interaction of prescription and over the counter medications;

• drug allergies;

• comorbid medical issues;

• history of substance abuse; and • checking the Colorado Prescription Drug Monitoring Program (PDMP).

The medications documented as a part of the reconciliation will reflect those that the provider deems directly relevant to the claim-related condition.

Recommendation 180. A therapeutic trial of medications is recommended to evaluate the effect on functional status. The length of a medication trial will depend on the individual medication, and the patient should be informed on the time to expected benefit. If no functional benefit is observed at that time, the medication should be discontinued.

Recommendation 181. Medications should be initiated at the lowest dose expected to result in functional improvement and then titrated based on clinical response.

Section 9.a. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Acetaminophen Introduction. Non-steroidal anti-inflammatory drugs (NSAIDs) are medications for low back pain and inflammation. Acetaminophen is an analgesic commonly used to treat mild pain.

Absolute and Relative Contraindications to Acetaminophen and NSAIDs.

• Acetaminophen o Concomitant use of other drug products containing acetaminophen exceeding the maximum recommended daily dose of acetaminophen. o Allergy to acetaminophen or any of the inactive ingredients. o Use with caution in patients with alcoholic liver disease, patients with hepatic impairment or active liver disease, and patients with known glucose-6-phosphate-dehydrogenase (G6PD) deficiency.

• NSAIDs (table 81) o Comorbid conditions that result in an increased risk for gastrointestinal (GI), renal, or cardiovascular adverse reactions. o Patients at risk for GI bleeding, including patients who use alcohol, smoke, are older than 65 years old, take corticosteroids or anti-coagulants, and patients on longer durations of o Celecoxib is contraindicated in sulfonamide allergic patients. o Contraindicated in patients with aspirin-exacerbated respiratory disease due to crossreactivity risk and potential for a severe asthma attack.

• Topical salicylate and non-salicylate medications may result in alterations in bleeding time; they should be used with caution in patients on warfarin therapy.

Side Effects and Adverse Events Related to Specific Classes of Acetaminophen and NSAIDs.

• Acetaminophen may result in hepatotoxicity, and chronic use may result in chronic kidney disease, hypersensitivity or anaphylactic reactions, serious and potentially fatal skin reactions, hypertension, chronic daily headaches, and peptic ulcer disease.

• NSAIDs may result in abnormal or worsening renal function, including renal failure; abnormal liver function; GI bleeding, particularly in patients at higher risk for a bleed; increased risk of cardiovascular events; gastric or duodenal perforation and ulceration; anaphylactoid reaction; platelet function abnormalities; and fluid retention and edema. Postoperative NSAIDs may increase the risk of nonunion at higher doses (table 85).

• Topical agents may result in localized skin reactions.

Recommendation 182. Acetaminophen or NSAIDs are recommended for initial analgesic treatment of uncomplicated low back pain (tables 82, 83).

Recommendation 183. Co-prescription of a proton pump inhibitor, histamine H2-receptor antagonists (H2-blockers), or prostaglandin analog with NSAIDs is recommended to reduce risk of duodenal or gastric ulceration in patients with concurrent antiplatelet or corticosteroid therapy.

Recommendation 184. Cyclooxygenase-2 (COX-2) inhibitors are not recommended as a first-line agent for short-term use in low-risk patients, but they can be used for patients who do not tolerate traditional NSAIDs.

Recommendation 185. Topical NSAIDs are recommended when oral NSAID use is contraindicated due to systemic side effects. It must be started with the lowest dose expected to result in functional improvement and then titrated until functional improvement is noted (table 84).

Recommendation 186. Perioperative use of acetaminophen and/or NSAIDs, either alone or in combination with other medications, to optimize analgesia is recommended (table 85).

Recommendation 187. See the Chronic Pain Disorder MTGs medication section if acetaminophen or NSAIDs are being considered for long-term use.

Time Frames for Medications Acetaminophen up to 10 days Extended use on a case-by-case basis NSAIDs 7 days 1 year Use of this substance long-term (for 3 days per week or greater) may be associated with rebound pain upon cessation.

Table 81.

Evidence Table: Adverse Events and NSAIDs Naproxen has a more favorable cardiovascular profile than other NSAIDs when used over a long period for chronic pain.

For general low back pain, specific adverse effects of dyspepsia and GI bleeding were more frequent with NSAIDs than placebos.

Celecoxib in a dose of 200 mg per day, administered over a long period, does not have a worse cardiovascular risk profile than naproxen at a dose of up to 1000 mg per day or ibuprofen at a dose of up to 2400 mg per day.

Celecoxib has a more favorable safety profile than ibuprofen or naproxen with respect to serious GI adverse events, and has a more favorable safety profile than ibuprofen with respect to renal adverse events.

Fewer adverse events occurred in NSAIDs treatment arms as compared to placebo in patients experiencing chronic low back pain.

Table 82.

Evidence Table: Acetaminophen For acute nonspecific low back pain, acetaminophen and placebo provide similar pain relief and functional improvement. While acetaminophen as a monotherapy is not superior to placebo, its use as 1 component of a multimodal analgesic regimen is generally accepted.

In the setting of acute nonspecific low back pain, acetaminophen at a dose of up to 4 grams per day is no more effective than placebo for pain relief and for improvement of disability.

Table 83.

Evidence Table: NSAIDs for Low Back Pain NSAIDs may reduce acute low back pain and short term disability when compared to placebo, but the clinical benefit is small.

In the setting of acute low back pain lasting less than 12 weeks, NSAIDs lead to a small reduction in short term pain intensity, approximately 10 points on a 100 point scale, compared to placebo.

In the setting of acute low back pain lasting less than 12 weeks, NSAIDs lead to a small reduction in short term disability, approximately 2 points on a 24 point scale, compared to placebo.

For recent low-back pain, oral NSAIDs are equally effective as placebo or muscle-relaxants.

For persistent low back pain, oral NSAIDs are more effective than placebo or acetaminophen.

NSAIDs are not more beneficial than placebo when evaluating pain-intensity and disability outcomes; the change in these scores does not reach a minimal clinical important difference in patients experiencing chronic low back pain.

Table 84.

Evidence Table: Topical NSAIDs for Analgesia Topical NSAIDs are more effective than placebo for acute musculoskeletal injuries and have fewer systemic adverse events than oral NSAIDs.

Topical NSAIDs are more effective than placebo vehicles, such as gels or creams, in the setting of acute musculoskeletal injuries.

Topical NSAIDs are associated with fewer systemic adverse events than oral NSAIDs.

Table 85.

Evidence Table: Perioperative Medication Use for Optimal Analgesia For patients undergoing spinal fusion surgery, preoperative analgesia may reduce postoperative pain and opioid use. Postoperative NSAIDs may increase the risk of nonunion at higher doses.

In the setting of lumbar spinal fusion, NSAIDs at an equivalence of no more than 120 mg of ketorolac for 14 days postoperatively do not appear to increase the risk of nonunion of the operated spinal segment.

Table 85 continued.

Evidence Table: Perioperative Medication Use for Optimal Analgesia In the setting of posterior lumbar interbody fusion (PLIF) surgery, a single saline infusion of 800 mg of ibuprofen one half hour prior to surgery may lead to less pain and morphine use in the immediate postoperative period and may thereby be an option for preoperative care of the surgical patient.

In the setting of 1-level or 2-level spinal fusion surgery, the administration of preemptive analgesia 8 hours preoperatively with acetaminophen, ketorolac, Among patients undergoing posterior lumbar spinal fusion, the addition of preemptive analgesia using a single intravenous dose of ketorolac (30 mg) or parecoxib (40 mg) resulted in better immediate postoperative pain control as compared to a control (saline) group. However, the difference among the groups did not persist in measures from one-hour post-operatively up to 24 hours. There was no apparent opioid-sparing effect with preemptive analgesia.

In the setting of lumbar fusion without bone morphogenetic protein (BMP), postoperative NSAIDs with an equivalent dose of more than 300 mg of diclofenac are associated with an increased risk of nonunion of the operated spinal segment. There appears to be a dose-dependent effect of postoperative NSAIDs on the risk of nonunion.

Section 9.b. Muscle Relaxants Introduction. Muscle relaxants are a heterogeneous class of medications with varying mechanisms of action used to treat muscle spasm associated with low back injury.

Absolute and Relative Contraindications to Muscle Relaxants.

• Cyclobenzaprine should not be used when a patient has a history of cardiac dysrhythmia or when there is concurrent use of monoamine oxidase inhibitors.

• Metaxalone should not be used when there is a history of significantly impaired renal or hepatic disease, pregnancy, and predisposition to drug induced hemolytic anemia.

• Methocarbamol should not be used when the patient has a hypersensitivity to the medication or there is possible renal compromise.

• Tizanidine should not be used when there is concurrent use of ciprofloxacin or fluvoxamine or hepatic disease.

Side Effects and Adverse Events Related to Muscle Relaxants.

• Cyclobenzaprine may cause sedation, anticholinergic reactions, and blurred vision. Patients should also be monitored for suicidal ideation and drug abuse.

• Metaxalone may cause sedation and hematologic abnormalities.

• Methocarbamol may cause decreased cognition, lightheadedness, and GI side effects.

• Tizanidine may cause hypotension, sedation, hepatotoxicity, hallucinations, psychosis, and dry mouth.

Recommendation 188. Muscle relaxants may be used as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions (table 86).

Recommendation 189. Tizanidine (alpha-2 adrenergic agonist) is only approved by the Food and Drug Administration (FDA) for the treatment of true centrally mediated spasticity associated with musculoskeletal disorders. Use for musculoskeletal conditions, such as neck or back pain, would be “off label.”

Recommendation 190. Benzodiazepines are not recommended for use in combination with opioids due to the elevated risk of death due to respiratory depression.

Recommendation 191. See the Chronic Pain Disorder MTGs medication section if muscle relaxants are being considered for long-term use.

Time Frames for Muscle Relaxants 1 week 2 weeks or longer, if only used at night.

Table 86.

Evidence Table: Muscle Relaxants For patients with acute low back pain, muscle relaxants provide greater short-term pain relief than placebo. However, they do not provide additional benefit over NSAIDs alone, and they increase adverse events.

Non-benzodiazepine muscle relaxants are more effective than placebo for providing short-term pain relief in acute low back pain. They should be used with caution because of central nervous system side effects.

In patients with acute nontraumatic musculoskeletal low back pain who have optimized their use of NSAIDs such as naproxen, the addition of cyclobenzaprine 5mg to be taken as needed adds no significant functional benefit in the short term, but it does increase the frequency of adverse events such as dizziness, drowsiness, and GI side effects.

Table 86 continued.

Evidence Table: Muscle Relaxants In the setting of acute nonradicular, nontraumatic musculoskeletal low back pain of 2 weeks duration or less, the addition of diazepam to naproxen adds no additional pain relief or reduction of functional disability beyond that of placebo.

Section 9.c. Oral Steroids Introduction. Oral steroids are used for pain and inflammation.

Absolute and Relative Contraindications to Oral Steroids.

• Absolute and relative contraindications include poorly controlled diabetes mellitus or hypertension; heart failure with peripheral edema; cataract or glaucoma; peptic ulcer disease; presence of injection; and low bone mineral density or osteoporosis.

Complications of Oral Steroids.

• Complications include gastritis, ulcer formation, and GI bleeding.

Side Effects and Adverse Events Related to Oral Steroids.

• Side effects and adverse events fluid retention, mood disturbance, and hyperglycemia.

Recommendation 192. Oral steroids are not recommended for the treatment of acute low back pain with or without radiculopathy (table 87).

Table 87.

Evidence Table: Oral Steroids for Acute Low Back and/or Radicular Pain For patients with acute low back pain with or without radicular pain, oral steroids do not provide clinically important improvements in function or pain, nor reductions in the rate of surgery. They also increase the risk for serious adverse effects.

In patients with an acutely herniated lumbar disc with radicular symptoms, a 15-day course of tapering oral prednisone may produce a small improvement in spine function compared to placebo, but this improvement is of very uncertain clinical importance. Also, there is no evidence that oral prednisone reduces the rate of back surgery in the following year. The benefits of a small functional improvement should be weighed against the frequent occurrence of steroid-related adverse effects such as insomnia, nervousness, and increased appetite. There is no evidence that oral prednisone reduces sciatica pain compared to placebo.

Table 87 continued.

Evidence Table: Oral Steroids for Acute Low Back and/or Radicular Pain In patients who have not taken oral steroids in the past year, short-term use of an oral steroid can increase the risk of fracture, sepsis, and venous thromboembolism in the subsequent 5 to 90 days, with the greatest increased risk occurring in the first 5-30 days after the prescription is filled.

Among patients presenting to the emergency department with acute onset of musculoskeletal or radicular low back pain or acute exacerbation of chronic low back pain, a 5-day course of 50 mg oral prednisone results in similar pain reduction at 5 days post-discharge when compared to a placebo given over 5 days.

A short course of oral corticosteroids, lasting 14 days or fewer, is associated with an increased incidence of GI bleeding, sepsis, and heart failure in the period following their administration.

Table 88.

Evidence Table: Other Medications Bisphosphonates taken alone or in combination with calcium and/or vitamin D are more beneficial than placebo taken alone or with calcium and/or vitamin D for the prevention and treatment of spinal glucocorticoid induced osteoporosis, with data extending to 24 months of use.

Section 9.d. Gabapentinoids Introduction. Gabapentinoids are anticonvulsant and nerve pain medications that may be used to treat neuropathic symptoms. They include gabapentin and pregabalin.

Absolute and Relative Contraindications to Gabapentinoids.

• Renal insufficiency is a relative contraindication to gabapentin use, but dosage can be adjusted to accommodate use in the setting of renal dysfunction.

Side Effects and Adverse Events Related to Gabapentinoids.

• Gabapentinoids may cause dizziness, sedation, and respiratory depression in older patients who receive gabapentin along with other analgesics or sedatives.

• Coadministration of opioids and pregabalin or gabapentin may increase the risk of opioid related mortality.

• Gabapentinoids may be associated with an increased risk of mental health disturbance (e.g., depression, suicide), unintentional overdose, and motor vehicle accidents.

Recommendation 193. A trial of oral gabapentin, with a goal of using the lowest dose expected to result in functional improvement, can be a first line intervention before an epidural steroid injection (ESI) for a patient who meets the acute ESI indications but wishes to avoid ESI (table 89). See the Epidural Steroid Injection section.

Recommendation 194. Perioperative use of gabapentin, either alone or in combination with other medications, to optimize analgesia is recommended (table 90).

Recommendation 195. If a gabapentinoid is being considered for long-term, chronic pain management, refer to the Chronic Pain Disorder MTGs medication section.

Table 89.

Evidence Table: Gabapentinoids For patients with lumbosacral radiculopathy due to herniated disc or spinal stenosis, oral gabapentin is equally effective at reducing leg pain as ESI. This finding is limited because the interventions were not compared to placebo and were not paired with physical therapy.

Gabapentin is more effective than placebo in the relief of painful diabetic neuropathy and postherpetic neuralgia.

In the setting of lumbosacral radiculopathy from herniated disc or spinal stenosis, oral gabapentin without physical therapy and an ESI without physical therapy are approximately equally effective in the first 3 months, but no conclusions can be supported that either intervention is superior to placebo.

Table 90.

Evidence Table: Perioperative Gabapentin Use For patients undergoing spinal surgery, preoperative gabapentin may reduce postoperative pain and opioid use, without increasing complications.

The incidence of many postoperative complications such as nausea, headache, and dizziness is probably similar for gabapentin and placebo.

Gabapentin may increase somnolence but may decrease the incidence of urinary retention and pruritus.

Table 90 continued.

Evidence Table: Perioperative Gabapentin Use In patients with chronic lumbosacral radiculopathy undergoing lumbar spinal operation, combined administration of pregabalin and dexamethasone conferred a significant reduction in rescue analgesic requirement up to 2 days postoperatively compared to placebo.

In the setting of 1-level or 2-level spinal fusion surgery, the administration of pre-emptive analgesia 8 hours preoperatively with acetaminophen, ketorolac,

Section 9.e. Antidepressants Introduction. Antidepressants are used for the treatment of pain, dysesthesias, sleep disorders, and depression. If medications are being considered for chronic pain management, refer to the Chronic Pain Disorder MTGs medication section.

Absolute and Relative Contraindications to Antidepressants.

• Tricyclic antidepressants should be avoided in patients with the following: o at risk of unintentional overdose; o heart disease; o underlying cardiac conduction system disease; o dysrhythmia; o prostatic hypertrophy; o at risk for suicide; o uncontrolled hypertension or orthostatic hypotension; o those 65 years or older, particularly if a fall risk; and o seizure disorder.

• Serotonin norepinephrine reuptake inhibitors (SNRIs) should not be used in patients with seizures or eating disorders.

Complications of Antidepressants.

• Tricyclic antidepressants may cause acute hepatitis, neuroleptic malignant syndrome, and tardive dyskinesia.

• SNRIs may result in serotonin syndrome.

• Venlafaxine may cause hypertension, glaucoma, sexual dysfunction, and cardiac issues.

Side Effects and Adverse Events Related to Antidepressants.

• Tricyclic antidepressants (e.g., amitriptyline, nortriptyline) may cause anticholinergic effects (e.g., sedation, dry mouth and associated periodontal conditions, orthostatic hypotension, constipation, urinary retention); decreased seizure threshold; sexual dysfunction; diaphoresis; tremor; antihistamine effects; alpha-1-adrenergic receptor blockade; and cardiac effects, including increasing intraventricular conduction, prolonged QT interval, prolonged conduction through the atrioventricular node.

• SNRIs (e.g., duloxetine, venlafaxine) may cause nausea, dizziness, sweating, loss of appetite, dry mouth, insomnia, drowsiness, constipation, abnormal bleeding, fatigue, sexual dysfunction, and suicidal ideation and attempts in adolescents and young adults.

Recommendation 196. Tricyclic antidepressants are the recommended first-line agent for neuropathic pain, particularly in the setting of insomnia, but they are not recommended as a first-line agent for depression.

Recommendation 197. SNRIs are recommended as a second-line agent for neuropathic pain if a tricyclic offers inadequate relief. However, duloxetine may be considered a first-line agent for a patient who is a candidate for pharmacologic treatment of both chronic pain and depression.

Recommendation 198. Selective serotonin reuptake inhibitors (SSRIs) are recommended for treating depression, but they are not recommended for neuropathic pain.

Recommendation 199. Evaluation and ongoing monitoring for suicidal ideation and mood swings are required for all patients being considered for antidepressant medications.

Recommendation 200. A screening electrocardiogram may be indicated for select patients prior to initiating treatment with a tricyclic or SNRI antidepressant to assess cardiovascular risk.

Time Frames for Antidepressant Medications up to 6 months up to 12 months, with monitoring

Section 9.f. Opioids Introduction. Opioids are powerful analgesics reserved for severe, acute pain associated with major trauma, burn, sickle cell disease, and end-of-life cancer pain. If opioid medications are being considered for chronic pain management, refer to the Chronic Pain Disorder MTGs medication section.

Absolute and Relative Contraindications to Opioids.

• Opioids should not be prescribed with benzodiazepines, antihistamines, or other central nervous system depressants or when the history is consistent with regular alcohol or other substance use.

• Tramadol should be used with caution in patients who have a history of seizures, are taking medications that lower the seizure threshold, or are taking medications that impact serotonin reuptake and could increase the risk for serotonin syndrome, such as monoamine oxidase inhibitors, SSRIs, selective serotonin agonists (triptans), tricyclic antidepressants, and alcohol.

Also use caution in patients who are taking medications that result in QT prolongation. Tramadol has been associated with death in those with an emotional disturbance or concurrent use of alcohol and other opioids. Significant renal and hepatic dysfunction requires dosage adjustment.

Side Effects and Adverse Events Related to Opioids.

• Opioid medications may commonly cause nausea, vomiting, drowsiness, unsteadiness, constipation, and confusion. Occasional side effects include dry mouth, sweating, pruritus, hallucinations, and myoclonus. Adverse events include opioid-induced hyperalgesia, respiratory depression, dependence, opioid use disorder, overdose, or death. Prolonged opioid use may result in hypogonadism (tables 91, 92). Abrupt discontinuation may precipitate withdrawal.

• Certain comorbid medical conditions can increase the risk for opioid overdose (e.g., obesity, pulmonary disease, obstructive sleep apnea, congestive heart failure, history of alcohol or substance use disorder, advanced age, renal or hepatic dysfunction).

Recommendation 201. Opioid medications are not generally recommended for the treatment of low back pain. Rare exceptions include either of the following:

• acute, severe functionally limiting pain in a patient for whom other non-opioid medications are contraindicated; or • acute, severe functionally limiting pain that is refractory to non-opioid medications and nonpharmacologic treatment and an absence of risk factors for potential misuse or abuse (table 93).

Recommendation 202. Long-acting opioids are not recommended for the treatment of acute, subacute, or postoperative pain.

Recommendation 203. Opioid medications, including tramadol, are not generally recommended for use in patients with a history of opioid dependence. However, if an opioid medication is deemed clinically appropriate, a referral to a pain specialist is permitted.

Short-term Prescribing Requirements.

Recommendation 204. Prior to dispensing an opioid medication, the following steps are required:

• documented results of a rapid risk assessment for developing opioid use disorder (e.g., Opioid Risk Tool [ORT]), • risk assessment of developing opioid related adverse events, • review data on the Colorado PDMP, • education on the short- and long-term risks and side effects of opioid therapy, • realistic goals of opioid therapy and the anticipated course of recovery, • establish the lowest effective dose and shortest duration of therapy, • education on the safe storage and disposal of opioid medications, and • develop a discontinuation plan for opioids prior to prescribing.

Prescribing Requirements Beyond 7 Days.

Recommendation 205. Whenever opioids are prescribed for more than 7 days, providers must follow all recommendations for screening and follow-up of chronic pain use. See the Chronic Pain Disorder MTGs.

Time Frames for Opioids ≤ 3 days 7 days Whenever there is use of opioids for > 7 days, providers should follow all recommendations for screening and follow-ups of chronic pain use.

Table 91.

Evidence Table: Risk of Initiating Opioid Medications Short-term opioid prescriptions increase the risk of disability and the risk of developing an opioid use disorder. The use of 50 morphine milligram equivalents (MME) or greater average daily dose or the use of long-acting opioids increases the risk of opioid-related death.

In the setting of common low back injuries, when baseline pain and injury severity are taken into account, a prescription for more than 7 days of opioids in the first 6 weeks is associated with an approximate doubling of disability 1 year after the injury.

In the setting of new onset chronic noncancer pain, there is a clinically important relationship between opioid prescription and subsequent opioid use disorder. Compared to no opioid use, short-term opioid use approximately triples the risk of opioid use disorder in the next 18 months. Use of opioids for over 90 days is associated with very pronounced increased risks of the subsequent development of an opioid use disorder, which may be as much as 100-fold when doses greater than 120 MME are taken for more than 90 days.

The absolute risk of these disorders is very uncertain but is likely to be greater than 6.1% for long duration treatment with a high opioid dose.

In generally healthy patients with chronic musculoskeletal pain, treatment with long-acting opioids, compared to treatments with anticonvulsants or antidepressants, is associated with an increased risk of death of approximately 69%, most of which arises from non-overdose causes, principally cardiovascular in nature. The excess cardiovascular mortality principally occurs in the first 180 days from starting opioid treatment.

Prescription opioids in excess of 200 MME average daily doses are associated with a near tripling of the risk of opioid-related death, compared to average daily doses of 20 MME. Average daily doses of 100-200 mg and doses of 50- 99 mg per day may be associated with a doubling of mortality risk, but these risk estimates need to be replicated with larger studies.

Compared to an opioid dose under 20 MME per day, a dose of 20-50 mg nearly doubles the risk of death, a dose of 50 to 100 mg may increase the risk more than fourfold, and a dose greater than 100 mg per day may increase the risk as much as sevenfold. However, the absolute risk of fatal overdose in chronic pain patients is fairly low, and may be as low as 0.04%.

Table 92.

Evidence Table: Adverse Effects of Opioid Medications Adverse events such as constipation, dizziness, and drowsiness are more frequent with opioids than with placebo.

Opioids produce significantly more adverse effects than placebo such as constipation, drowsiness, dizziness, nausea, and vomiting.

Table 93.

Evidence Table: Opioid Medications Effectiveness The majority of patients with musculoskeletal pain, including low back pain, do not experience clinically meaningful pain relief or functional improvement with opioid treatment as compared to placebo. For patients with neuropathic pain, there is no evidence that opioid treatment improves function or quality of life. For neuropathic pain patients, opioid treatment is more likely to result in pain relief as compared to placebo, but there is no evidence that opioids are superior to gabapentin or nortriptyline for this indication.

Opioids produce significantly more adverse effects than placebo.

In the setting of chronic nonspecific low back pain, the short and intermediate term reduction in pain intensity of opioids, compared with placebo, falls short of a clinically important level of effectiveness for a majority of patients, although some patients may experience a clinically meaningful analgesic benefit.

In patients with chronic low back pain, or chronic pain from osteoarthritis of the hip and knee, opioid therapy does not lead to better pain outcomes in terms of daily functioning or in pain intensity.

In patients with acute nontraumatic musculoskeletal low back pain who have optimized their use of NSAIDs such as naproxen, the addition of oxycodone 5 mg/acetaminophen 325 mg to be taken as needed adds no significant functional benefit in the short term, but it does increase the frequency of adverse events such as dizziness, drowsiness, and GI side effects.

Opioids are more efficient than placebo in reducing neuropathic pain by clinically significant amounts during the first 8 weeks of treatment.

There is a lack of evidence that opioids improve function and quality of life more effectively than placebo.

Table 93 continued.

Evidence Table: Opioid Medications Effectiveness There is a lack of evidence that opioids are superior to gabapentin or nortriptyline for pain reduction.

Table 94.

Evidence Table: Pre- and Post-Operative Medication Use In the setting of PLIF surgery, a single saline infusion of 800 mg of ibuprofen one half hour prior to surgery may lead to less pain and morphine use in the immediate postoperative period and may thereby be an option for preoperative care of the surgical patient.

In the setting of elective open single-lumbar discectomy for herniated discs, where morphine is delivered by patient-controlled anesthesia, a low-dose separate infusion of 0.25 mcg/kg/hour of naloxone in the 24 hours after surgery may reduce morphine consumption and reduce postoperative pain, nausea, and pruritus.

In the setting of 1-level or 2-level spinal fusion surgery, the administration of pre-emptive analgesia 8 hours preoperatively with acetaminophen, ketorolac, The incidence of many postoperative complications such as nausea, headache, and dizziness is probably similar for gabapentin and placebo.

Gabapentin may increase somnolence but may decrease the incidence of urinary retention pruritus.

Section 9.g. Tobacco Cessation and Supplements Introduction. Nicotine replacement therapy is used to relieve nicotine withdrawal symptoms by providing nicotine without the use of tobacco. The mechanism of bupropion in smoking cessation is not entirely understood, but it is believed to act by enhancing central nervous system noradrenergic and dopaminergic release. Varenicline reduces the symptoms of nicotine withdrawal by binding to the receptor that mediates the reinforcing effects of nicotine dependence.

Absolute and Relative Contraindications to Tobacco Cessation Therapies.

• Use nicotine replacement therapy with caution in patients with unstable cardiovascular disease.

• Bupropion is contraindicated in those with seizure disorders.

Side Effects and Adverse Events Related to Tobacco Cessation Therapies.

• Nicotine replacement therapy can cause GI symptoms, headache, and local irritation with topical products.

• Bupropion can cause insomnia, agitation, dry mouth, and headache.

• Varenicline can cause nausea, insomnia, neuropsychiatric disorders, and abnormal dreams.

• Review package insert for supplement contraindications and side effects.

Recommendation 206. Tobacco cessation, including medication and behavioral support, are recommended when tobacco use is expected to negatively impact claim-related medical outcomes.

Medications may include nicotine patches, gum, inhaler, lozenges or nasal spray, bupropion, or varenicline (table 95).

Table 95.

Evidence Table: Smoking and Non-Operative Spine Care Patients who smoke respond less favorably to non-operative spine care than nonsmokers, and quitting smoking during treatment results in greater improvement than patients who continue smoking during treatment.

Table 96.

Evidence Table: Supplements Glucosamine does not improve pain related disability in those with chronic low back pain and degenerative changes on radiologic studies. Therefore, it is not recommended for chronic lower spinal or non-joint pain.

In patients with chronic low back pain not associated with nerve root compression or radicular symptoms, treatment with pregnenolone may have a moderate short term benefit in reducing pain of moderate intensity as compared with placebo. No information is available regarding functional benefits.

Section 10. Interdisciplinary Rehabilitation Programs Introduction. These guidelines discuss an interdisciplinary approach to low back pain treatment in the acute and subacute timeframes. Interdisciplinary rehabilitation programs are the gold standard of treatment for individuals with chronic low back pain who have not responded to less intensive modes of treatment or individuals who require concurrent treatment for chemical dependency. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for additional information, including indications, recommendations, and time frames.

Appendix Functional Tests Name of Test Body Part Description Oswestry Low Back Pain Disability Questionnaire (ODI)

Lumbar Spine Functional questions with sleeping, lifting, walking, sitting, and standing Quebec Back Pain Disability Scale Spine Functional and emotional questions Neck Disability Index Cervical Spine 10 questions addressing pain, personal care, headaches, and functional deficits 36-Item Short Form Survey (SF-36) and 12- Item Short Form Survey (SF-12)

Physical Health Assesses activities of daily living (ADLs)

Dallas Pain Questionnaire Spine Chronic pain Brief Pain Inventory General Sleep, walking, ADLs Psychological Screens Name of Test Description Brief Battery for Health Improvement, 2 nd Edition (BBHI 2)

Measures pain, functioning, somatization, depression, anxiety, and defensiveness; brief measure of risk factors for delayed recovery Distress and Risk Assessment Method (DRAM)

Measures depression and somatic symptoms of anxiety, risk factors commonly associated with chronic pain Center for Epidemiological Studies Depression Scale (CES-D)

Measures depression, 20 items Beck Depression Inventory-II (BDI-II)

Measures depression, 21 items Primary Care Evaluation for Mental Disorders (PRIME-MD) Must be filled out by a provider 2 components: paper and pencil screen for patient and follow–up interview by physician.

Assesses mood, anxiety, somatoform tendencies, and alcohol and eating disorders Zung Depression Inventory Measures depression, brief measure Patient Health Questionnaire (PHQ) and PHQ-9 Self-administered version of the PRIME-MD.

Assesses mood, anxiety, somatoform tendencies, and alcohol and eating disorders Generalized Anxiety Disorder Scale (GAD-7)

Assesses generalized anxiety, 7 questions Behavioral Health Index-Multimedia Version (BHI-MV) Screens for addiction _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011, and

rule history, are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the

History link that appears above the text in 7 CCR 1101-3. To view versions effective after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 18:

Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 02 Rule 17, Exhibit 2 - MILD AND MODERATE/SEVERE TRAUMATIC BRAIN INJURY MEDICAL TREATMENT GUIDELINES {#sec-7-ccr-1101-3-r17-ex-02 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 02}

DEPARTMENT OF LABOR AND EMPLOYMENT

WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

MILD AND MODERATE/SEVERE TRAUMATIC BRAIN INJURY MEDICAL TREATMENT GUIDELINES 7 CCR 1101-3 Rule 17, Exhibit 2 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

RULE 17, EXHIBIT 2A Mild Traumatic Brain Injury Medical Treatment Guideline A. Guideline introduction This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of guidelines for physicians/providers treating individuals who qualify as injured workers with traumatic brain injury (TBI) under the Colorado Workers’ Compensation Act.

Although the primary purposes of this document for practitioners are advisory and educational, this guideline is enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from this guideline, as individual cases dictate. Therefore, this guideline is not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip or overlook any sections.

B. General guideline principles The principles summarized in this section are key to the intended implementation of all Division of Workers’ Compensation medical treatment guidelines and critical to the reader’s application of the guidelines in this document.

B.1 Application of the guidelines The Division provides procedures to implement medical treatment guidelines and to foster communication to resolve disputes among the provider, payer, and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the office of administrative courts.

B.2 Education Education of the individual and family and/or support system, as well as the employer, insurer, policy makers, and the community, should be the primary emphasis in the treatment of TBI. Currently, practitioners often think of education last, after medications, manual therapy, and surgery. Practitioners must implement strategies to educate individuals with TBI, employers, insurance systems, policy makers, and the community as a whole. An education-based paradigm should always start with inexpensive communication that provides recovery, function-focused, patient-centered, and evidence-based information to the individual with TBI. More in-depth education is currently a component of treatment regimens that employ functional, restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention. Facilitation through language interpretation, when necessary, is a priority and part of the medical care treatment protocol.

B.3 Informed decision making Providers should implement informed decision making as a crucial element of a successful treatment plan. Patients, with the assistance of their health care practitioner and support system, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, psychologists, physical therapists, and other members of the health care team play an integral role in informed decision making and achievement of functional goals. Patient education and informed decision making should facilitate self-management of symptoms and prevention of further injury.

B.4 Treatment parameter duration Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Obviously, duration will be impacted by the individual’s adherence, as well as availability of services. Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

B.5 Active interventions Active interventions emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, are generally utilized over passive modalities, especially as treatment progresses. Generally, passive interventions are viewed as a means to facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

B.6 Active therapeutic exercise program Exercise program goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

B.7 Positive patient response Positive results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to: positional tolerances, range of motion (ROM), strength, endurance, activities of daily living, ability to function at work, cognition and communication, psychological behavior, and efficiency/velocity measures that can be quantified. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation.

Anatomic correlation must be based on objective findings. Patient completed functional questionnaires such as those recommended by the Division as part of Quality Performance and Outcomes Payments (QPOP, see Rule 18-8), the Patient Specific Functional Scale, or other validated function scales can provide useful additional confirmation.

B.8 Re-evaluation of treatment no less than every 3 to 4 weeks If a given treatment or modality is not producing positive results within 3 to 4 weeks or within the time to produce effect in the guidelines, the treatment should be either modified or discontinued. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results. Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

B.9 Surgical interventions Surgery should be contemplated within the context of expected functional outcome and not purely for the

purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic conditions.

B.10 Six-month time frame The prognosis drops precipitously for returning an injured worker to work once he/she has been temporarily totally disabled for more than six months. The emphasis within these guidelines is to move patients along a continuum of care and return to work within a six-month time frame, whenever possible.

It is important to note that time frames may be less pertinent for injuries that do not involve work-time loss or are not occupationally related.

B.11 Return to work When considering return-to-work options following TBI, the practitioner must skillfully match the individual's abilities (physical, cognitive, communicative, psychological, and behavioral) and the work requirements.

The practitioner must write detailed restrictions when returning an individual with TBI to limited duty. An individual with TBI should never be released to "sedentary or light duty" without specific physical, psychological, and cognitive limitations. The practitioner must understand essential job functions and job requirements/duties, as well as all of the physical, visual, cognitive, psychological, and behavioral demands of the individual's job position before returning him/her to full duty. Job duty clarification should be obtained from the employer or others if necessary, including but not limited to: employer supervisor or co-worker, an occupational health nurse, occupational therapist, physical therapist, speech-language pathologist, vocational rehabilitation specialist, case manager, industrial hygienist, or other appropriately trained professional.

B.12 Delayed recovery For individuals with mild TBI (mTBI), strongly consider requesting a neuropsychological evaluation, if not previously provided. Interdisciplinary rehabilitation treatment and vocational goal setting may need to be initiated for those who are failing to make expected progress 6 to 12 weeks after an injury. In individuals with mTBI, neurological recovery is generally achieved within a range of weeks/months up to one year post-injury, but functional improvements may be made beyond one year. The Division recognizes that 3– 10% of all industrially injured individuals will not recover within the timelines outlined in this document despite optimal care. Such individuals should have completed a full neuropsychological evaluation. These individuals may require treatment beyond the limits discussed within this document, but such treatment will require clear documentation by the authorized treating provider focusing on objective functional gains afforded by further treatment.

B.13 Guideline recommendations and inclusion of medical evidence All recommendations are based on available evidence and/or consensus judgment. A Division staff methodologist (MD, MSPH) researched and adopted literature critique criteria. Literature critiques were performed in a manner congruent with national standards and were completed independent of the multidisciplinary task force group which drafted initial recommendations. The methodology is described in detail on the Division’s website. Please also refer to the Division’s website for evidence tables and study critiques which provide details on the studies used to develop the evidence statements.

When possible, guideline recommendations note the level of evidence supporting the treatment recommendation. It is generally recognized that early reports of a positive treatment effect are frequently weakened or overturned by subsequent research. When interpreting medical evidence statements in the guideline, the following apply: ● Consensus means the judgment of experienced professionals based on general medical principles. Consensus recommendations are designated in the guidelines as “generally well-accepted,” “generally accepted,” “acceptable/accepted,” or “well-established.” ● “Some evidence” means the recommendation considered at least one adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the intervention’s effect. ● “Good evidence” means the recommendation considered the availability of multiple adequate scientific studies or at least one relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the intervention’s effect. ● “Strong evidence” means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the intervention’s effect.

There is limited and varied literature on TBI. Therefore, many of the studies cited focus on athletes, military personnel, or stroke survivors.

All recommendations in the guideline are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guideline as “not recommended.”

B.14 Treatment of pre-existing conditions The conditions that preexisted the work injury/disease will need to be managed under two circumstances:

(a) A pre-existing condition exacerbated by a work injury/disease should be treated until the patient has returned to their objectively verified prior level of functioning or Maximum Medical Improvement (MMI); and (b) A pre-existing condition not directly caused by a work injury/disease but which may prevent recovery from that injury should be treated until its objectively verified negative impact has been controlled. The focus of treatment should remain on the work injury/disease.

The remainder of this document should be interpreted within the parameters of these guideline principles that may lead to more optimal medical and functional outcomes for injured workers.

B.15 Post maximum medical improvement (MMI) care This document includes recommendations for post-MMI care in appropriate cases. (Refer to Section H, Maintenance management.)

C. Introduction to traumatic brain injury (TBI)

C.1 Definitions of TBI Before a diagnosis of TBI is made, the physician should assess the level of trauma exposure to the individual using available objective evidence. According to the Institute of Medicine of the National Academies, TBI is an injury to the head or brain caused by externally inflicted trauma. The Department of Defense defines TBI as a “traumatically induced structural injury and/or physiological disruption of brain functions as a result of an external force.” TBI may be caused by a blow to the head from an object or by striking an object, by acceleration or deceleration forces without impact, or by blast injury or penetration to the head that disrupts the normal function of the brain.

A diagnosis of TBI is based on acute injury parameters and should be determined by the criteria listed below. Severity of initial impairment following TBI is subdivided into two major categories, mild TBI (mTBI) and moderate/severe TBI (M/S TBI). These definitions apply to the initial severity of impairment and do not necessarily define or describe the degree of subsequent impairment or disability.

After sustaining a TBI, whether initially diagnosed as mTBI (including complicated mTBI) or M/S TBI, assessment, evaluation, and testing under the Division’s Moderate/Severe TBI Medical Treatment Guideline is appropriate when there are complex questions related to differential diagnosis (brain injury versus other diagnosis) or when the patient is not progressing in cognitive function and/or activities of daily living (ADLs). There should be a clear rationale for undertaking testing and/or treatment under the M/S TBI Guideline.

C.1.a Mild TBI (mTBI) mTBI is a traumatically induced physiological disruption of brain function, as manifested by at least one of the following, documented within 24 to 72 hours of an injury: ● any loss of consciousness ● any loss of memory for events immediately before or after the injury ● any alteration of mental status at the time of the injury (e.g., feeling dazed, disoriented, or confused) ● focal neurological deficit(s) that may or may not be transient but where the severity of the injury does not exceed the following: ○ loss of consciousness for approximately 30 minutes or less, ○ at 30 minutes, a Glasgow Coma Scale (GCS) of 13–15, and ○ post-traumatic amnesia (PTA) not greater than 24 hours.

If the GCS is not available, the closest approximation to the patient’s state at 30 minutes post-injury should be used.

If the patient presents with any of the above after 72 hours, the clinician will need to use available information to construct a diagnosis.

C.1.b Complicated mTBI Complicated mTBI is an mTBI accompanied by structural brain damage visualized on initial structural neuroimaging. More patients in this group have slow or incomplete recovery as compared to patients without this finding. However, the imaging finding alone may not fully predict the clinical course of an individual with mTBI. Based on a reanalysis of data from the Dikmen study, there is some evidence that mTBI and complicated mTBI – whether the GCS is 15 or 13-14 – are similar with respect to the frequency of persistent concussion symptoms at one month and one year. The term is not separately addressed in this guideline to determine care, but it should be understood that complicated mTBI cases will frequently require more extensive treatment than that described under mTBI and may be given access to care listed under M/S TBI as appropriate for the individual. For those cases, refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline.

C.1.c Moderate/severe TBI (M/S TBI)

M/S TBI is a traumatically induced physiological and/or anatomic disruption of brain function as manifested by at least one of the following: ● altered state of consciousness or loss of consciousness for greater than 30 minutes, ● an initial GCS of 12 or less, and/or standardized structural neuro-imaging evidence of trauma, and/or ● post-traumatic amnesia (PTA) greater than 24 hours.

If the GCS is not available, the closest approximation to the patient’s state at 30 minutes post-injury should be used.

C.1.d Other terminology Once a patient has met the criteria defined above in C.1.a for mTBI or C.1.b for complicated mTBI, the treatment patterns and diagnostic tools of this guideline apply. The following terms are noted for information only. ● Acquired brain injury (ABI): ABI refers to any type of brain injury that occurs after birth and that is not related to a congenital disorder or degenerative disease. In addition to TBI, ABI also includes damage to the brain from internal factors such as lack of oxygen, brain bleed, exposure to toxins, infection, or pressure from a tumor. Although nontraumatic ABI may have symptoms and treatments in common with TBI, this guideline was developed specifically for TBI. It is possible that some of these treatments may be useful for other types of ABI. ● Concussion: There is some disagreement in the literature regarding definitions and terminology. “Concussion” is used synonymously with mTBI in many papers. The term is only referenced in this guideline when describing studies using the terminology. ● Post-Concussive Syndrome (PCS): PCS is an accepted diagnosis that is generally determined by the number of symptoms present after an mTBI and how long they persist.

However, the symptoms used to determine the presence of PCS are frequently present in those without mTBI. In this guideline, once a person has been diagnosed with mTBI, any of the treatments for continuing symptoms may be used. Thus, the diagnostic category of PCS is not necessary and should not be used in isolation to access the treatments in this guideline.

C.2 Prevention Prevention of injuries such as TBI is an essential component of any medical treatment guideline or injury management program. TBI is a dynamic condition, and patients may deteriorate over time in the areas of physical and mental health, cognition, employment, and activities of daily living (ADLs). The following guideline-specific definitions of the various types and levels of prevention are necessary to prevent the deterioration from a healthy state to pathology and to successfully intervene at the levels of disablement described in section C.4, Disability. ● Primary prevention The goal is the prevention of disease in a susceptible, or potentially susceptible, population through specific measures, including general health promotion efforts. All health providers should remind individuals, supervisors, and employers of the primary measures for preventing recurring TBIs.

Always use appropriate protective equipment on jobs that require protection, including following all of the employment policy and procedures related to the safety of the individual, co-workers, or external customers. Examples of primary prevention include: ○ Provide safety guidelines for employer premises; ○ Wear protective helmets, complying with the American National Standards Institute (ANSI), on jobs requiring protection from falling objects or electrical hazards; ○ Wear protective helmets and headwear when involved in contact, collision, and other sports such as biking, horseback riding, skating, skiing, and snowboarding; ○ Wear safety goggles or glasses on jobs that require protection from flying objects or debris; ○ Avoid walking on wet, slippery floors on the worksite, or wear the appropriate footwear for the conditions; ○ Ensure that scaffolding has appropriate railings and/or harnesses, and that they are in good working order; ○ Use ladders in accordance with Occupational Safety and Health Administration (OSHA) recommendations (e.g., make sure that ladders over 20 feet tall have cages); ○ Provide and use airbags, safety belts, etc., in motor vehicles; ○ Avoid alcohol and other drug use, including marijuana, during recreational activities such as boating, hunting, skiing, snowboarding, etc., while driving or operating equipment, when working from elevated surfaces, and at work; ○ Avoid distracted driving (e.g., driving while texting, using cell phone, etc); ○ Practice fatigue management techniques, such as limiting duty hours and night shifts, to maintain optimal energy levels for the required work tasks; ○ Weight management and regular exercise may decrease the likelihood of an injury as well as length of recovery when an injury occurs. ● Secondary prevention Secondary prevention includes efforts to decrease duration of illness, severity of disease, and sequelae through early diagnosis and prompt intervention. mTBI is one of the most common neurologic disorders. Health care providers may play a key role in improving outcomes following mTBI. Early diagnosis of individuals with mild and moderate/severe TBI is critical in helping to avoid secondary symptoms and problems in living. Individuals with a previous history of TBI, comorbid conditions, psychiatric disorders, cognitive disorders, and substance abuse are also at greater risk for poor outcome and represent an opportunity to reduce the effects of TBI. Such individuals should receive appropriate referrals for the comorbid conditions, and treatment of these comorbid conditions should be integrated into the individual’s rehabilitation program. For mTBI, providing education about symptoms, their management, and their probable positive outcome is an essential component of treatment. Using the available diagnostic information as the basis for providing education and providing written instructions on the discharge sheet regarding high-risk activities and timing for return to regular activities may help to improve outcomes and prevent further injury. Written materials and internet references that provide appropriate education for individuals with TBI and family and/or support system about TBI care and prevention are available in English and Spanish from the Centers for Disease Control and Prevention.

Workers who have sustained a recent TBI should be especially cautious about returning to work activities that may lead to a second TBI since second injuries occurring prior to a full recovery from the initial mTBI may have more serious consequences. Providers should practice secondary prevention by setting appropriate restrictions for these workers and workers who are suffering from impairment, such as dizziness, that could lead to falls in some work environments. (Refer to Section G, Return to work.) ● Tertiary prevention Tertiary prevention encompasses the effort to decrease the degree of disability and promote rehabilitation and restoration of function in individuals with chronic and irreversible diseases and to prevent disease and disability. Life-long management and follow-up services may be required for select individuals with TBI with persistent medical, cognitive, psychological, and/or functional skill deficits.

The majority of this guideline addresses secondary and tertiary prevention of disability for workers with C.3 Interdisciplinary rehabilitation professionals An interdisciplinary treatment team is an alliance of professionals from different medical or therapeutic disciplines (as described below) that provides a coordinated treatment program. The particular treatment needs of the individual with TBI will determine the disciplines that make up the team. Those with mTBI will generally require fewer disciplines involved in their care. (Refer to Section D, Overview.) The team establishes treatment priorities and goals and provides treatment. Team members contribute their respective skills, competencies, insight, and perspectives to the rehabilitation process. This includes education, communication, and alignment of expectations to optimize treatment outcomes. It is highly recommended that the individual with TBI participate in team planning, along with his or her family and/or support system, insurance carrier, case manager, and sometimes the employer or return-to-work specialist when addressing return-to-work planning. (Refer to Section G, Return to work.)

The most common disciplines, in alphabetical order, involved in the medical and rehabilitation treatment of TBI include but are not limited to: ● Behavioral psychologist: a psychologist with special training, credentials, and licensing who specializes in the area of behavior analysis and treatment. ● Behavioral analyst: a master’s level, certified behavioral analyst who designs and supervises behavioral interventions. Behavioral assessments by an analyst do not substitute for neuropsychological assessments. ● Case manager: Case managers are initially trained under a variety of disciplines such as nursing, social work, and other health and human services fields and should be certified through the Commission for Case Manager Certification (CCMC). In order to achieve the best possible outcome for everyone involved, it is best to provide case management services in an environment in which the case manager, the client, the client’s family and/or support system, and the appropriate service personnel are able to communicate directly. It is crucial that the case manager be thoroughly educated in the complexities of treating individuals with TBI.

Case managers may perform Utilization Review (UR) as a part of case management duties, but UR alone is not case management.

The primary functions of TBI case management are: ○ to obtain information through a comprehensive assessment of the injured individual and his/her family and/or support system; ○ to work with the health care team, the injured worker, and family and/or support system in development, monitoring, and implementation of a comprehensive case management plan. Plan reassessment should be completed on a regular

basis; ○ to optimize access to appropriate health care services and maintain cost effectiveness; ○ to integrate and coordinate service delivery among all providers and to prevent fragmentation of services by facilitating communication and by involving the injured worker and family and/or support system in the decision-making process; ○ to educate and collaborate with the injured worker, family and/or support system, and the health care team when necessary about treatment options, compliance issues, and community resources; ○ to predict and avoid potential complications. ● Chiropractor: a credentialed and licensed doctor of chiropractic who assesses and treats human illness and injury, including, but not limited to: musculoskeletal injuries; movement dysfunction; impairments in strength, muscle tone, motor control, posture coordination, endurance, and functional mobility; neurological injuries; and loss of function.

Chiropractic utilizes joint manipulation and spinal and joint rehabilitation, along with various therapies and modalities. ● Clinical pharmacist: a pharmacist with expertise in medication management. He/she might be useful for patients with multiple medication regimens. ● Clinical psychologist: a psychologist with special training, credentials, and licensing who specializes in the assessment and treatment of personality and psychological disorders, education and adjustment counseling, psychotherapy, and management of behavior. ● Driver rehabilitation specialist: an individual who is trained in the health care field and certified by the Association for Driver Rehabilitation and the American Occupational Therapy Association. ● Independent life skills trainer: an individual with documented training to develop and maintain an individual’s ability to independently sustain him or herself physically, emotionally, and economically. Services may include: assessment, training, and supervision or assistance to an individual with self-care; medication supervision; task completion; communication skill building; interpersonal skill development; socialization; therapeutic recreation; sensory motor skills; mobility or community transportation training; reduction or elimination of maladaptive behaviors; problem solving skill development; benefits coordination; resource coordination; financial management; and household ● Music therapist: an individual who is board certified and trained to use music within a therapeutic relationship to improve cognitive, sensory, motor, communication, and behavioral functions that have been affected by neurologic disease. ● Neurologist: a physician with special training and credentials in the area of the nervous system who has successfully completed an approved residency in neurology. ● Neuro-ophthalmologist: an ophthalmologist or neurologist who has completed an approved residency in ophthalmology or neurology, who has completed a fellowship in neuro-ophthalmology, and who specializes in the treatment of visual disorders related to the nervous system. ● Neuro-otologist: a physician who has completed a fellowship in neurotology or otoneurology. ● Neuropsychologist: a licensed psychologist with knowledge of and special training in brain-behavior relationships, including neuropsychological assessment, causality of neurobehavioral changes, and treatment and management of neurobehavioral disorders. ● Neuroscience nurse: a registered nurse (RN) who has certification in the treatment of individual and family and/or support system responses to nervous system function and dysfunction across the healthcare continuum. ● Neurosurgeon (neurological surgeon): a physician who has special training and credentials in the surgery of nervous system disorders and who has successfully completed an approved residency in neurological surgery. ● Nurse: an RN with specialty training, credentials, and licensing who specializes in the collection and assessment of health data, health teaching, and the provision of treatment that is supportive and restorative to life and well-being. ● Occupational therapist: a registered and licensed therapist who specializes in participation in activities of daily living (ADLs). He/she assesses and treats the physical, perceptual, behavioral, and cognitive skills needed to perform self-care, home maintenance, and community skills. He/she also provides patient and family and/or support system education. ● Occupational medicine physician: a physician who has education and training in occupational medicine and preferably qualifies for board certification. ● Optometrist: a specialist with training, credentials, and licensing who examines, assesses, diagnoses, and treats select abnormal conditions of the eye and adnexa.

Optometric scope of practice varies from state to state. It is defined by statute and may include topical or systemic medical therapy. Neuro-optometrists are preferred. ● Ophthalmologist: a physician with training and credentials in the diagnosis and treatment of visual disorders, including related systemic conditions, who has successfully completed an internship and an approved residency in ophthalmology. Ophthalmologists are able to perform medical and surgical procedures on the eye, orbit, and adnexa.

Neuro-ophthalmologists are preferred. ● Otolaryngologist: a physician who specializes in ear, nose, and throat medical treatment.

He/she has completed a residency in otolaryngology. ● Physical therapist: a licensed therapist with expertise in managing movement dysfunction who specializes in the assessment and treatment of individuals with impairments, deficits and functional limitations in the areas of strength, muscle tone, motor control, posture, coordination, balance, endurance, and general functional mobility. He/she works to improve functional independence, as well as provide family and/or support system and patient education. ● Physiatrist / physical medicine and rehabilitation physician: a physician with special training, credentials, and licensing in the field of physical medicine and rehabilitation.

He/she has successfully completed an approved residency. ● Psychiatrist/neuropsychiatrist: a physician with special training, credentials, and licensing who specializes in the field of mental health and psychological disorders. He/she has successfully completed an approved residency in psychiatry. A neuropsychiatrist is a psychiatrist who has specialized training, credentials, and licensing in neurologically based behavioral, cognitive, and emotional disturbances, including specialized training in ● Rehabilitation counselor: a bachelor’s or master’s level counselor who specializes in assisting individuals in the process of independent living, productive activity, and vocational pursuits. This includes assistance with financial resources, housing, community resources, social skills, vocational evaluation and treatment, integration back into the workforce, and patient and family and/or support system counseling. ● Rehabilitation nurse: an RN who has certification in rehabilitation nursing. Rehabilitation nursing is a specialty practice area within the field of nursing. It involves recognizing, reporting, and treating human responses of individuals and groups to present or future health problems resulting from changes in functional ability and lifestyle. ● Rehabilitation psychologist: a specialty within psychology requiring additional training that focuses on interdisciplinary teamwork to achieve optimal physical, psychological, and interpersonal functioning for those with chronic or traumatic injuries. ● Social worker: a master’s level, licensed social worker who specializes in patient and family relationships, as well as housing, financial resources, and society reintegration. ● Speech-language pathologist: a certified, licensed, and master’s or doctoral level therapist who specializes in the assessment and treatment of individuals in the areas of communication (speech, language, social skills, voice), cognition, swallowing, and family and/or support system patient education. ● Therapeutic recreation specialist: a bachelor’s or master’s level therapist who specializes in the assessment and treatment of individuals in the areas of planning and management of leisure activities, time management, mental health through recreation, and community access.

C.4 Disability The World Health Organization (WHO) conceptualizes disability as the interaction of health conditions with environmental factors (such as social and legal structures) and personal factors (including age, education, and coping styles).

For the purposes of this guideline, we are adopting the International Classification of Functioning, Disability, and Health (ICF).

This model recognizes the interaction between the health condition and three major components: body functions and structures, activity, and participation. These in turn are influenced by environmental and personal issues. The following definitions are used: ● Body functions: physiological functions of body systems, including psychological functions. ● Activity limitations: difficulties an individual may have in executing activities. ● Participation restrictions: problems an individual may experience in involvement in life situations. ● Disability: activity limitations and/or participation restrictions in an individual with a health condition, disorder, or disease.

Because of the nature of TBI and the nature of learning and memory, functional skills often cannot be generalized across work environments. Therefore, the assessment of function, evaluation, and treatment should not only consider the injured worker but also include evaluations of the individual’s “real world” environment, conducted by qualified practitioners.

D. Overview The overview is intended to assist providers in caring for patients post mTBI. Related evidence statements and supporting literature can be found at the end of this section. Recommended considerations should be accomplished in a timely manner.

Payers and providers should refer to specific treatment and diagnostic sections to determine coverage for payment.

D.1 Prognosis and risk factors In general, 75–90% of people with mTBI fully recover in less than 90 days. Those who suffer an mTBI may continue to report symptoms for several months or years.

A number of factors appear to increase the risk for symptom prolongation: ● Glasgow Coma Scale score of less than 15 at 2 hours post-injury; ● work risk factors, such as very demanding or stressful vocations or being employed in the current job for a short period of time; ● age above 40 years; ● injury complicated by the presence of intracranial lesions, current or previous; ● history of prior brain injury, cognitive impairment, learning disabilities, or developmental delay; ● associated orthopedic, soft tissue, or organ injuries; ● pre-injury issues with general health or psychosocial well-being; ● psychological factors such as depression, post-traumatic stress disorder, or anxiety (see evidence statement below); ● pre-injury history of migraines or other recurrent headaches.

CT or MRI findings that do not necessitate surgery nor result in significant initial neurologic findings on physical exam may still result in a complex recovery. All patients with any CT or MRI findings should be evaluated by providers specializing in brain injury care. Upon initial presentation, in-hospital observation may be required. These patients are usually labeled complicated mTBI and will often need care under the Division’s Moderate/Severe Traumatic Brain Injury Medical Treatment Guideline.

D.2 First 2 weeks of post-injury care ● Patient education regarding the expectation for recovery is an important component of initial care. Although initially symptoms are common, these can usually be managed with conservative measures and avoidance of aggravating factors.

Because recovery is expected in the majority of cases, it is important to initially focus the patient on the likelihood of full recovery over a relatively short period of time. Common post-injury complaints are listed below. ● There should be a detailed, focused neurological exam by a physician experienced in mTBI within the first week with documentation of symptoms and risk factors. By seven days post-injury, a complete history and neurologic exam must be performed by a physician knowledgeable in mTBI protocols. The exam should define any symptoms that are continuing and also identify risks for persistence of mTBI symptoms.

Common mTBI symptoms include the following: ● headaches; ● sleep disturbances; ● dizziness; ● nausea; ● visual disturbances; ● photophobia; ● phonophobia/hyperacusis; ● tinnitus; ● attention and memory problems; ● slow processing of information; ● difficulty multi-tasking; ● increased distractibility; ● losing one’s train of thought; ● feeling foggy; ● fatigue, likely multi-factorial.

In order to decrease symptoms of distress and concern over normal reactions to mTBI injury, the second visit should allow for expanded time if there are any remaining symptoms. Patients often express cognitive problems (e.g., difficulty with attention, memory, or solving problems) or emotional issues (e.g., increased intolerance or irritability) secondary to the mTBI. The provider must realize that these symptoms may arise from other secondary problems related to the injury. For example, if there is significant cervical spasm or myofascial pain in the neck, this may cause or contribute to the severity of headaches. Also, it is not uncommon for patients to have mild vestibular problems and/or issues with visual tracking. Patients frequently report the symptoms associated with these abnormalities as dizziness or difficulty with reading and comprehension. Also, non-brain related injuries may contribute to difficulty with physical activities or to sensation of pain, which interferes with reading, attention, and sleep.

Small studies of mTBI have noted that PTSD can increase the risk for long-term symptoms. Several studies evaluating models for mTBI predictors have noted that years of education, pre-injury psychiatric disorders, and prior TBI were strong predictors of 6-month post-concussive symptoms, and these should be considered as risk factors for patients with continuing symptoms. In the same manner, patients should be screened for psychological issues in addition to PTSD.

Detailed questioning in all of these areas is important. It is equally important to report when no symptoms are present in these common areas of mTBI complaints.

The essential areas to address in the initial two weeks post-injury are: ● obtaining sufficient sleep; ● avoiding drinking alcohol or use of medication not prescribed by the provider; ● identifying and treating stress including anxiety, depression, and other psychological symptoms; ● conservative treatment of headaches and other minor pain.

D.3 Weeks 2-8 post-injury symptom management ● All patients with concerning clinical findings on exam should be referred expeditiously to a physician specialist. However, a referral to a physician specialist is usually not required for most patients with symptoms not accompanied by neurological findings on exam due to the high-expected recovery rate for uncomplicated mTBI. ● It is recommended that the first set of early treatment includes sleep hygiene recommendations; limited use of caffeine, tobacco, and alcohol; progressive return to normal work activity and exercise; prevention of subsequent head injuries; and reassurance and self-management. ● When symptoms persist beyond seven days, a number of conservative measures aimed at the causes identified in the thorough physical exam can be effective. ● Early conservative treatments for the following conditions include: ○ Pain: Over the counter medication for headaches and neck pain should be encouraged. Ergonomic positioning of the head/neck at work or home may also be important. For headaches persisting beyond four weeks or causing incapacitating symptoms, refer to the headache portion of this guideline for a number of available treatments. ○ Photophobia: Lights may disturb patients with mTBI. FL-41 tinted lenses, neutral tinted lenses, and/or other ambient lighting changes may be beneficial in managing this symptom. ○ Hyperacusis: Some patients may suffer from acute sensitivity to sounds encountered in everyday life. In these situations, the use of ear filters that do not compromise safety are likely to be beneficial. ○ Sleep disturbances: Problems with sleep should be addressed early and followed throughout the course for mTBI. Lack of sleep may be a primary instigator of cognitive complaints and is common in mTBI. Patients should be advised regarding normal sleep hygiene measures. These include: avoiding use of computers or mobile phones for several hours before bedtime, limiting use of caffeine or alcohol, and following a regular schedule for going to bed and arising.

Use of a sleep diary may assist in adjusting sleep times. Persistent sleep disturbance may also be addressed with cognitive behavioral therapy. Refer to

Section F.4, Sleep disturbances. ○ Cognitive complaints: In most cases, persistent cognitive complaints are associated with other risk factors such as additional medical problems, negative self-beliefs or expectations, or low coping skills. When symptoms persist beyond 2 weeks and are exerting any influence on daily functioning, they must be addressed by the physician.

In mTBI, it is rarely appropriate to supplement treatment with medication for cognitive issues. If medication is prescribed, the provider should follow the patient closely, especially when prescribing medication with a risk for long-term addiction.

Use of calendars or reminders on mobile phones or computers are likely to be useful during the initial stage of recovery. The patient’s support system may also provide assistance. ○ Balance and visual problems: Balance and vestibular complaints, such as dizziness and disequilibrium, and visual changes may be subtle and not detected using common neurological testing.

The provider should consider limited treatment by qualified personnel if the vestibular or visual symptoms continue beyond the first 2 weeks. Limited treatment can usually be provided by a therapist with a specialty in these areas (e.g., vestibular therapist).

Visual symptoms may be addressed with visual tracking rehabilitation in a limited number of visits. The efficacy of visual training / vision therapy without the guidance of a specialist is unproven. Therefore, it should be provided by a trained therapist such as a vestibular therapist. ○ Hearing loss or tinnitus: Any reported hearing loss requires evaluation. If tinnitus persists, no specific treatment during the acute recovery period is usually recommended; however, evaluation by a specialist is recommended for persistent symptoms. ○ Psychological concerns: It is appropriate to screen patients for anxiety, depression, stress, and post-traumatic stress disorder and to begin treatment if one of these is identified. ○ Fatigue: Fatigue associated with TBI is distinct from tiredness or sleepiness.

Treatment for fatigue should include exploration of other accompanying issues.

Patient-reported fatigue can also have a psychological basis, so it is important to account for the impact of stress and/or psychiatric diagnoses on the patient’s fatigue. Treatment may require a combination of rest, sleep, and change of task.

Blue light therapy has been shown to be useful to relieve complaints of fatigue and could be suggested for morning and afternoon use in those with fatigue. ○ Persistent symptoms without likely identifiable pathologic findings: These should be acknowledged and providers may initially treat them with the simple conservative measures described. Not all reported symptoms in mTBI require prolonged or complex treatment.

D.4 Assessment of current function This may be done by open-ended questioning supplemented with a reliable, generally accepted functional self-report assessment tool, such as the Rivermead Post Concussion Symptoms and Neurobehavioral Symptom Inventory. The Rivermead Post Concussion Symptoms and Neurobehavioral Symptom Inventory is not to be used as a diagnostic tool. Functional status evaluations not only assist the provider in choosing appropriate return-to-work modifications, they also establish the efficacy, or lack thereof, for current treatment. See Positive Patient Response under General Guideline Principles above. Payers may temporarily discontinue coverage of treatment if providers are not documenting patient functional improvement or progress. Payers are required to request that providers document improvement or lack thereof before discontinuing coverage.

D.5 Resumption of normal activities The provider should individualize recommendations for rest and timelines for resumption of modified and normal activities based on the individual circumstances of the patient and his/her work. It is suggested that the patient receive recommendations for decreased cognitive and physical activities during the first 24 hours, particularly if those activities increase any symptoms for the patient such as headache and/or photophobia. In many cases, the patient should return to limited work activities after the first 24 hours with limitations on intensive physical or cognitive activities. General guidelines have suggested that the progress of activities be based on the intensity or recurrence of physical symptoms by the patient.

However, the provider will need to weigh all this information in conjunction with the specific work load for the patient.

Literature supports an individualized approach. One study looked at young patients (11-18 years old) with mTBI and compared the treatment of rest or usual care for those patients with signs of injury based on neurocognitive and balance testing and those only reporting symptoms. The patients with signs of injury on testing benefited from the rest. In contrast, those with only symptoms were less likely to benefit from rest, and they were more likely to remain symptomatic three days after injury when prescribed rest. A recent review of the literature found no quality studies but suggested that low level of exercise could benefit athletes post mTBI. Of note, in a randomized trial of adults with mTBI who received emergency room discharge instructions of two kinds of rest (cognitive rest or gradual return to duty), there was no difference between the groups regarding time off work or school, change in the post-concussion symptom score, or follow up physician visits. 30% had some symptoms at 4 weeks. Other reviews and consensus statements confirm the lack of evidence for long-term rest or specific non-individualized return to activity.

Literature suggests that people who have had multiple TBIs may recover more slowly and thus may take more time to return to normal function.

D.6 Return to work or study Most patients can return to work within the first week when modified duty is available. The provider should carefully consider the patient’s reported symptoms and order modifications to address these.

Psychological factors also need to be considered when evaluating the appropriateness of returning the patient back to work. Restricting work during the initial stages of recovery may be indicated to promote recovery. Initially, many patients may need reduced hours at work, rest breaks, and reduced task assignments. Both physical and cognitive duties should be non-stressful initially, with a gradual increase in activity based on improvement and/or resolution of symptoms. The individual should be competent in most basic ADLs before return to work is considered. The provider may need to engage a return-to-work specialist or employer contact to obtain a job description and assess the patient’s ability to return to the workforce. Safety sensitive positions such as responsibilities that require driving or work on ladders, at heights, or across scaffolding may require reduced duties for some time until adverse symptoms which might affect job duties have abated. Repeated evaluation of both symptoms and cognitive status is recommended to help guide management considerations. Physiologic changes on a variety of diagnostic tests after sports concussion appear to persist longer than clinical changes. Clinical assessment should be used to determine relevant activity and work.

D.7 Further testing Studies support the concept that for most patients, neuropsychological testing is not advocated and is not required for mTBI during the first 30 days and that full neuropsychological battery can be delayed.

However, if the provider has clearly delineated psychological complaints such as post traumatic symptoms, anxiety, or other areas that may require testing, neuropsychological or psychological testing may be recommended earlier. If earlier testing is thought to be necessary to verify or establish specific information in a case, it should assess specific issues such as patient’s concerns, behavioral deficits, and/or cognitive deficits. It should also consider if secondary psychological issues may be interfering with cognitive functions. Serial testing may be helpful in tracking the patient’s status over time.

One study documented productivity loss in patients with mTBI and persistent post-concussion symptoms and comorbid psychiatric condition. Thus, treatment of psychological conditions is important for full functional recovery.

Screening psychological tests focused on anxiety, stress, depression, and/or post traumatic symptoms, such as those adopted by the Division of Workers’ Compensation Quality Performance and Outcome Payments (QPOP, see Rule 18-8) program may be performed by primary care providers at any time.

D.8 8-12 weeks post-injury care If a patient has persistent symptoms or complaints at 60 days and the initial portion of this guideline has been completed, it is suggested that a referral be made to a neurologist or physiatrist with extensive experience in mTBI treatment. It is important for the primary provider to remember that many frequently reported symptoms may be related to other physiologically based diagnoses, psychological issues, or pain issues. The considerations that exist for chronic pain patients also may be present for these patients.

The Division’s Chronic Pain Disorder Medical Treatment Guideline may be more appropriate for patients with multiple injuries.

When continuing symptoms persist: ● Repeat detailed neurological examination by 90 days post-injury. ● Complete neuropsychological testing, if not already performed. ● Refer to other qualified specialists, such as neuropsychologists, ophthalmologists, or neuro-otologists when continuing symptom complaints suggest additional pathology. ● Reassure patients that for most people with mTBI, persistent symptoms are unlikely to significantly interfere with most daily living activities and can be ameliorated with rehabilitation techniques. ● Reinforce the positive prognosis with the injured worker. Overall, the need for long-term treatment of a patient with mTBI is uncommon.

In approximately 10-25% of patients, chronic symptoms requiring treatment are associated with mTBI. In individuals with mTBI, neurological recovery is generally achieved at one year post-injury or sooner, but functional changes occur beyond one year. In the absence of secondary or tertiary complications like hydrocephalus, seizures, initial abnormal MRI findings, or extra-axial fluid collections (e.g., subdural or epidural fluid collections), ongoing improvement with eventual stability of symptoms is the general expectation after mTBI. Deterioration over time after mTBI is uncommon. In situations where patients have worsening complains or continuing symptoms affecting function after mTBI, other issues such as psychosocial issues, sleep disturbance, pain, or other medical issues should be considered in the differential diagnosis.

D.9 Multiple mTBIs versus chronic exposure to concussive forces Studies on chronic traumatic encephalopathy (CTE) are based on the respective number of recalled traumatic brain events and autopsy findings. Currently, a diagnosis of CTE can only be made post mortem. The applicability of these data outside of sports-related injury, in which a stereotypic application of force may have occurred multiple times and without opportunity for recovery, is not known. These limitations do not allow for a reasonable determination of the type or number of previous events that might correlate to permanent damage.

Thus, any cases alleging multiple events as causative for permanent neurological impairment will need to be determined on an individual basis. A comprehensive diagnostic evaluation should be completed to rule out dementias or other neurological factors.

Tables of evidence statements and supporting literature for the Overview Evidence statements regarding prognosis and risk factors Psychosocial factors such as pre-injury general health are important determinants of recovery from acute mild head injury and may be as predictive or more predictive of recovery than such phenomena as abnormal CT findings.

Systematic review of observational TBI is associated with an important increase in risk of all-cause mortality six months and more after injury.

This includes death from suicide, assault, and unintentional injuries. The increase in risk is approximately threefold, and it appears to be independent of sociodemographic factors such as income and marital status.

Longitudinal cohort study from a population registry database While neuropsychological testing scores resolve in complicated and uncomplicated mTBI patients during the year after injury, a significant level of physical, cognitive, and emotional symptoms persist for some patients 1 year after injury when compared to symptoms reported by patients who had been admitted to hospital emergency departments with non-head injuries.

Prospective cohort study Patients who have been seen in an emergency department for an uncomplicated mTBI do as well on a battery of standard neuropsychological tests as patients who have been treated in an emergency department for non-head injuries when these tests are administered one month after the date of injury.

Studies regarding prognosis and risk factors not resulting in evidence statements In one study, 16% of patients with mTBI had lower executive function at 1 year. This was related to post-concussion symptoms, mood, and self-report. Another study noted that those with symptoms at 1 year had significant psychological risk factors at 1 month.

Perceived injustice, a belief that one has been treated unfairly and disrespectfully, is also associated with persistent post-concussive symptoms.

An additional study identified worse performance on complex attention, cognitive flexibility, processing speed, and executive function for those with PTSD and mTBI compared to PTSD alone or controls.

A study of young military members experiencing reported post-concussion symptoms in a questionnaire found that depression, traumatic stress, loss of consciousness greater than 15 minutes, post traumatic amnesia 24 hours or more, initial normal CT scans, and poor effort or symptom magnification were all associated with positive post-concussion symptoms. The study emphasized for the need for clinical evaluations rather than sole reliance on checklists.

Other studies confirm the association of increased self-reported symptoms with injury-related stress and premorbid mental and physical health issues.

Evidence statements regarding vestibular symptoms and treatment In patients with a sport-related concussion who have persistent dizziness, neck pain, and/or headache 10 days after injury and who are suspected by a physician of having vestibular involvement or cervical spine involvement, an 8 week program of combined cervical physiotherapy and vestibular rehabilitation is likely to improve the rate of medical clearance for return to sport.

Evidence statements regarding psychological treatment From a small study: 5 individual sessions, 1.5 hours long, of Cognitive Behavioral Therapy (CBT) initiated for patients diagnosed with acute stress disorder early after TBI are significantly more effective than supportive counseling in preventing chronic PTSD in patients who develop acute stress disorder following mTBI.

Evidence statements regarding fatigue Subjective fatigue is more prevalent following mTBI than in healthy controls.

It is important to note that studies differ in how fatigue is defined, how it is tested for, and how results are interpreted. This leads to uncertainty in estimates of the frequency of fatigue. of prognostic studies of TBI Baseline fatigue, medical comorbidity, and litigation are likely to be risk factors for fatigue in patients recovering from mTBI. of prognostic studies of TBI Some post-traumatic symptoms such as fatigue are not specific to head injury but also occur with nonhead injuries such as fractures, sprains, and other injuries which are not associated with TBI.

A blue light therapy device with a wavelength of 465 nm, used in the morning upon awakening, can alleviate the severity of fatigue associated with TBI, but the benefits do not persist after the use of the light has been discontinued.

Evidence statements regarding early symptoms There is little symptomatic or functional gain for patients who have persisting symptoms, such as headaches, fatigue, blurred vision, sleep disturbance, and the like 10 days after an mTBI, and are referred for an early single follow-up office visit with a specialist.

Early and active individual rehabilitation treatment initiated within 2 to 8 weeks after an mTBI injury for patients with post-concussion symptoms does not significantly reduce post-concussion symptoms or improve life satisfaction one year after injury, compared with a non-intervention control group.

Predictors of delayed return to work include a lower level of education, nausea or vomiting on admission to an emergency room, extracranial injuries in addition to mTBI, and severe pain early after injury. Most workers with mTBI return to work within 3 to 6 months after injury, but there is a small percentage (5% to 20%) who face persisting problems 1 to 2 years after injury.

Evidence statements regarding persistent mTBI symptoms In the setting of mTBI, patients are likely to report their pre-injury status as more favorable than it was likely to have been since they tend to report fewer pre-injury problems with common phenomena such as misplacing car keys and forgetting where they parked than are reported by healthy uninjured volunteers.

Many symptoms reported after mTBI are also frequently reported after other traumatic injuries and are not pathognomonic for mTBI. Pure self-evaluation questionnaires regarding function may not accurately reflect long-term changes and can be affected by IQ. In general, return to normal function can be expected.

Evidence statements regarding chronic traumatic encephalopathy (CTE)

A history of repeated mTBI is a risk factor for the development of chronic traumatic encephalopathy, and among football players, the number of seasons of play may be correlated with the severity of disease.

Descriptive study of autopsy findings E. Diagnosis E.1 Initial diagnostic procedures E.1.a History of injury In order to establish the TBI diagnosis and treatment plans/goals, it is a generally accepted and widely used practice for a qualified practitioner to obtain a thorough history of the injury. Recommended data obtained in the history-taking generally should include: ● Identification data: Identification data should include name, address, age, gender, and marital/relationship status. ● Precipitating event: Information regarding the detailed circumstances of the TBI should include where and when the injury occurred, how the injury occurred, what the individual was doing at the time of the injury, and what happened. This may necessitate acquiring information from other sources if the patient does not have full recall. Reports from first responders should be obtained. If possible, collaborative information (e.g., witnesses, paramedic report, etc.) should be obtained to seek details of the event and the injured person’s behavioral and cognitive responses immediately following the injury. The presence of alcohol and/or drug use at or prior to the time of the injury should be noted.

All of this history should be used when establishing the presence of a TBI caused by a work-related event.

If the injury occurred as a result of a motor vehicle crash, information should be obtained as to: the speed of the vehicle; position or location of the injured worker; use of restraints or helmet; degree of damage to the vehicle; all other involved vehicles, if known; involvement of EMS system, if any; and acute or sub-acute accident-related physical complaints or injuries, including other people involved, if known. The crash outcome regarding non-TBI complaints/injuries may enhance an understanding of the forces involved in the accident and will minimize the possibility of unrecognized physical injury.

The accident report and any police records should be obtained and reviewed if available.

If the injury occurred as a result of a fall, information should be obtained regarding the type of fall, distance of the fall, type of surface, etc. The goal is to provide a review of the biomechanical forces involved in the event. ● Alteration in consciousness: History should include a review of chief complaints, presenting problems, and symptoms, with the goal of obtaining additional information regarding the alteration of consciousness associated with the index injury. Generally accepted data should include information about duration of alteration of mental status, including consciousness, degree and length of retrograde and PTA, as well as cognitive, behavioral, and physical impairments, with collateral sources of information when possible. Information should be collected regarding various time intervals for the following: ○ Current status: This is a report of the individual’s current condition, symptoms, complaints, functional problems, etc. ○ Initial status: This is a report of the individual’s neurological condition at the time of the injury, symptoms, complaints, functional problems, etc. The GCS, when performed in the field and the emergency department, may aid in grading the severity of TBI. Individuals with mTBIs may have a normal score on the GCS.

Serial GCS scores may be helpful when intoxication may be a factor. It may be helpful to ask the patient to describe in detail the first event they remember after the injury in order to assess PTA or loss of time sequence and what events they remember immediately prior to the injury. When evaluating alteration in mental state at the time of the injury, it is also important to consider the individual’s emotional reaction to the distressing event. As a practical example, the provider should contemplate whether the feeling of “being dazed” could be a manifestation of emotional numbing. It is possible to have dazing due to TBI including emotional reactions (e.g., numbing and/or detachment) or even acute pain in relation to the event. The diagnosis of acute stress disorder should be considered in evaluating individuals with possible mTBI. ○ Evolution of neurological status: This is a report of change in the individual’s recovery between the time of the injury and the present, including symptoms, complaints, and functional problems. The individual’s report of when he/she was able to return to independent activity is relevant to understanding the course of the injury. A family and/or support system member’s history of the patient’s ability to perform his/her usual duties is often helpful. Other measures of functional activity that are standardized and can be repeated during treatment may also be useful. ● Review of medical records: In addition to the individual’s self-report, practitioners should attempt to obtain and review any external sources of data, including police reports, ambulance reports, emergency department records, eyewitness reports, pre-injury medical records, etc. The practitioner should utilize this information to establish or verify the probable degree of trauma involved in the incident and the consistency between these reports and current symptoms. ● Medical/health history: Taking a history is a generally accepted practice and should include a history of past and current illnesses, injuries, previous TBIs or other disabilities, seizures/epilepsy, stroke, cerebrovascular disease, developmental/intellectual disabilities, neurodegenerative disorders, any previous intracranial pathology (such as infections, tumors, congenital malformations), pain, previous surgeries of any kind, mental health and medication history, sleep disorders, educational history, and other medical/health data. A report from family and/or support system members or other persons knowledgeable about the individual with TBI relevant to pre-injury as compared to postinjury function should be obtained. ● Activities of daily living (ADLs): A thorough history should be taken of daily activities.

Basic ADLs include: self-care and personal hygiene, communication, ambulation, attaining all normal living postures, travel, non-specialized hand activities, sexual function, sleep, and social and recreational activities. Instrumental activities of daily living (IADLs) are complex self-care activities that may be delegated to others (e.g., financial management, medications, meal preparation). This assessment should delineate the changes in the individual’s ability to perform ADLs prior to and after the injury and any assistance needed from family members or others. ● Family history: Family history should include psychiatric, including substance use and abuse, medical-legal involvement, and medical history of illness or disability within the family that is relevant to the individual’s condition. ● Social history ○ Living situation: This should include marital history, family and/or support system members, household makeup, significant others, etc. ○ Occupational history: This should include the name of the individual’s current employer, job title, primary job duties, special licenses or certifications, length of employment, prior places and dates of employment, and previous work-related injuries and their outcomes. ○ Developmental history: This should include educational history, highest level of education obtained, learning disabilities or disorders, any developmental delay, abuse, or neglect, etc. ○ Avocations: This should include common non-occupational activities, including leisure activities such as sports, hobbies, and personal interests. ○ Substance use history: This should be obtained (particularly if there is data to suggest substance abuse was involved in the injury) along with information related to the amount and duration of alcohol, drug, and marijuana use, licit and illicit, including prescription drug use and/or abuse. ○ Legal history: DUIs, violence, speeding/reckless driving violations, and other medical/legal issues. ● Review of systems: This is a generally accepted practice and should include a complete review of body systems and functions. ● Pain diagnosis: This is recommended, especially during the first visit to document all body parts involved. This should include a pain diagram completed by the patient, if able. ● Psychiatric history: Psychiatric history should be assessed at the initial visit and at followup visits. Depression and anxiety are common conditions pre-injury and following TBI, and symptoms may be subtle or unapparent unless directly assessed. Individuals may not always present with complaints of sadness or anxiety, but instead they may express feeling other symptoms that are commonly seen in clinical depression or anxiety, particularly disturbances of sleep and energy. Many individuals also tend to focus on somatic complaints that do not always correlate with objective findings. Therefore, it is crucial to question the individual, family and/or support system, and pre-injury medical records about significant changes in appetite, sleep disturbances (including nightmares), decreased interest in pleasurable activities, loss of energy, diminished ability to think or concentrate, irritability, suicidal ideation, history of suicide attempts, psychiatric hospitalizations, mental health treatment, and feelings of emptiness, worthlessness, and excessive guilt.

E.1.b Physical examination This is a well-accepted practice and should be performed by a qualified practitioner. A thorough trauma exam should be done during the initial exam and the first follow-up visit to ensure all complaints are addressed. The exam should include a complete cervical spine exam. It is hypothesized that dysfunction of the brain stem secondary to TBI may significantly contribute to the usual balance and sleep complaints accompanying mTBI.

E.1.c Neurological examination A neurological examination should be performed by a qualified practitioner and should include a mental status examination. A comprehensive neurological examination includes, but is not limited to, mental status, cranial nerves, motor status, sensory status, balance and coordination, and gait and station. The mental status examination involves both formal and informal observations. It includes observations about the individual’s presentation, social/behavioral decorum, personal hygiene, ability to provide a history, and ability to follow directions. A formal (structured) cognitive examination should be performed to the extent indicated by the situation. It includes an assessment of the individual’s alertness, orientation, attention, concentration, memory, affect, mood, thought process and content, language, ability to perform simple calculations, and higher order assessments of reasoning, judgment, and insight. Using a standard approach for all visits assists serial functional assessment.

E.1.d Neuropsychological evaluation This is the evaluation of cognitive processes and behavior using psychological and neuropsychological testing to assess central nervous system function and to diagnose specific behavioral or cognitive deficits or disorders. Neuropsychological assessments are generally accepted and widely used as a valuable component of the diagnosis and management of individuals with TBI. They include sensitive tests that are used to detect cognitive deficits, severity of impairment, and improvement over time. Neuropsychological assessment assists in the differential diagnosis of neurobehavioral disorders and the cumulative effect of multiple TBIs.

Neuropsychological assessments may be utilized to formulate how the individual's underlying TBI impacts behavior and the ability to function effectively in daily life. These assessments are also used as a basis for formulating rehabilitation strategies and may provide information related to prognosis and outcome.

Neuropsychological assessments utilize standardized testing procedures. Test reliability and validity are important considerations. Examiners should be aware that abnormal cognitive function may occur in the setting of chronic pain, psychological disorders, sleep deprivation, medication use, malingering, developmental/intellectual disabilities, acute or chronic substance abuse, and comorbid or pre-existing cognitive or neurologic disorders. In cases where comorbid diagnoses are suspected, formal psychological evaluation should accompany the neuropsychological battery to assist in characterization and differentiation of diagnoses. Multiple sources of data (self-report information, medical history, Emergency Medical Services [EMS] records, psychosocial history, family report, etc.) are integrated with test performance factors to draw inferences about brain-behavior relationships. The individual’s cultural background, race, age, primary language, and developmental and educational history should be considered. Neuropsychological testing may not be valid when English is not the patient’s primary language. When practical, educational records including history of learning disability should be obtained and reviewed.

The specific neuropsychological tests used may vary according to the symptom presentation of the individual and the purpose of the evaluation. Tests usually assess the following cognitive domains: level of orientation, attention, language, memory, praxis, executive function, speed of processing, visual-spatial ability, recognition, personality, and function. All reports should include a clinical interview that notes the patient and family medical / psychiatric / substance abuse history, developmental milestones, educational

history, psychosocial issues, and current medical conditions and treatment. Interpretation of these tests should always discuss the impact of information from the clinical interview that might affect test results, such as medications causing confusion or drowsiness, lack of sleep, anxiety, depression, and similar issues.

Based on the evidence listed in the table at the bottom of this subsection, early neuropsychological testing may not validly differentiate changes due directly to mTBI from changes due to experiencing a physically traumatic event. Therefore, neuropsychological testing is not typically recommended prior to three months post-injury.

However, there are permitted exceptions for earlier evaluation. Individuals with mTBI should be considered for testing, prior to three months when: ● the patient is not recovering well early in the course of treatment, or ● the patient has a cognitively demanding job or works in a safety sensitive position.

The referral for neuropsychological assessment prior to three months post mTBI may be advantageous for those patients meeting the indications above because it documents the attentional, memory, emotional status, other cognitive deficits and strengths, and preserved cognitive capabilities.

Neuropsychological consultation and/or assessment may be useful prior to three months for: ● documenting a post-injury baseline and the time course of improvements in attentional functioning, memory, and executive functions in order to contribute to treatment planning; ● providing relevant information regarding the individual’s current functioning in domains such as speed of information processing, memory, and executive functions. A test battery that permits serial testing focused on attention/concentration skills, memory, speed of processing, executive functions, and emotional/personality status may be indicated.

In some cases, brief neuropsychological testing may be beneficial in increasing patient awareness of the presence of impaired functioning.

Validity testing is required for all neuropsychological testing to assess performance and symptoms. The testing can provide a baseline for following the injury and permits the adequate documentation of the severity of the injury and improvements over time.

Evidence statements regarding initial neuropsychological testing for mTBI Patients who have been seen in an emergency department for an uncomplicated mTBI do as well on a battery of standard neuropsychological tests as patients who have been treated in an emergency department for non-head injuries when these tests are administered one month after the date of injury.

Prospective cohort study E.1.e Neurodiagnostic tests E.1.e.1 Imaging procedures E.1.e.1.1 Skull x-rays These are well-established diagnostic tools used to detect a fracture of the cranial vault.

Skull x-rays are generally accepted only if CT scans are not available or in cases where there is only a low suspicion of intracranial injury.

E.1.e.1.2 Computed axial tomography (CT)

For acute brain trauma, iodine contrast enhancement is not necessary. CT scans are noninvasive and will reveal the presence of blood, skull fracture, and/or structural changes in the brain. They do, however, expose the patient to higher doses of ionizing radiation than skull radiographs. CT scans provide somewhat limited information compared to MRI about intrinsic cerebral damage involving deep brain structures, although many types of intrinsic damages can be seen on CT scans.

CT is a well-established brain imaging x-ray study comprised of a mathematical reconstruction of the tissue densities of the brain, skull, and surrounding tissues. CT scans require the use of computer-based scanning equipment.

CT scans are widely accepted for acute diagnostic purposes and for planning acute treatment. They are the screening image of choice in acute brain injury and are used to assess the need for neurosurgical intervention.

If fractures are suspected, CT scanning is preferred over skull x-rays because of its much higher sensitivity and accuracy and its ability to identify clinically significant fractures as well as potentially coexistent contusions or hemorrhages.

CT scans are recommended for abnormal mental status (GCS less than 13 on admission), focal neurologic deficits, or acute seizure. CT scans are recommended for the following patients: ● High risk ○ GCS less than 15 at two hours post-injury; ○ suspected open or depressed skull fracture; ○ any sign of basilar skull fracture (e.g., hemotympanum, raccoon eyes, Battle’s Sign, CSF oto-/rhinorrhea); ○ greater than or equal to two episodes of vomiting; ○ age equal to or greater than 60. ● Other risk ○ retrograde amnesia to the event greater than or equal to 30 minutes; ○ “dangerous” mechanism (e.g., pedestrian struck by motor vehicle, occupant ejected from motor vehicle, fall from greater than three feet or more than five stairs); ○ coagulopathy, including use of use of anticoagulant medication; ○ focal neurologic deficits; ○ acute seizure; ○ severe and persistent headache; ○ physical evidence of trauma above the clavicles and/or multiple trauma and/or basilar skull fracture; ○ drug or alcohol intoxication; ○ any recent history of TBI, including mTBI.

E.1.e.1.3 Magnetic resonance imaging (MRI)

MRI is a well-established brain imaging study for patients with TBI in which the individual is positioned in a magnetic field and a radio-frequency pulse is applied. Hydrogen proton energy emission is translated into visualized structures. Altered signal intensity compared to normals may indicate trauma or other disease.

CT is superior to MRI in detecting acute intracranial bleeds and remains the preferred initial imaging study in the first 24 hours following TBI.

MRI should not be used to diagnose mTBI. Initially, MRI scans are clinically useful in the following situations to: ● determine neurological deficits in TBI not explained by CT; ● evaluate prolonged intervals of disturbed consciousness or other prolonged alteration in mental status; ● define evidence of acute changes super-imposed on previous trauma or disease.

MRI scans are also useful to assess transient or permanent changes, to determine the etiology of subsequent clinical problems, and to plan treatment.

MRI may reveal an increased amount of pathology compared to CT. Due to their high contrast resolution, MRI scans are superior to CT scans for the detection of some intracranial pathology (e.g., axonal injury, subtle cortical contusions, small extra-axial fluid collections, etc.) but not bone injuries such as fractures.

MRI is more sensitive than CT for detecting traumatic cerebral injury.

Specific MRI sequences and techniques are very sensitive for detecting acute traumatic cerebral injury.

They may include, but are not limited to: diffusion weighted imaging (DWI), susceptibility weighted imaging, gradient echo weighted imaging, and fluid attenuated inversion recovery (FLAIR). Some of these techniques are not available on an emergency basis.

E.1.e.2 Vascular imaging tests Vascular imaging tests reveal arterial or venous abnormalities in the chest, neck, head, or extremities (e.g., thrombosis, dissection, spasm, emboli, or tearing).

These tests are generally used if standard CT/MRI scans fail to demonstrate suspected vascular abnormalities. However, only rarely are they useful in mTBI. If needed, refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline.

Brain Acoustic Monitor: This device identifies turbulent blood flow in the brain. It is considered investigational for the purpose of detecting deficits requiring CT scanning in the emergency room. Based on the evidence listed in the table below, it is not recommended at the time of this guideline.

Evidence against use of a brain acoustic monitor as an initial diagnostic procedure for TBI A Brain Acoustic Monitor cannot reliably predict the development of post-concussive symptoms.

Diagnostic cohort study E.2 Further diagnostic procedures E.2.a Electrodiagnostic studies These are limited to electromyogram (EMG), nerve conduction studies, and multisensory evoked potentials including visual evoked potentials (VEP), somatosensory evoked potentials (SSEP), and brain stem auditory evoked responses (BSAER).

E.2.a.1 EMG and nerve conduction studies These are generally accepted, well-established diagnostic procedures. These studies may be useful for individuals with brain injury and EMG associated suspected peripheral nervous system involvement. They are often used to differentiate peripheral versus central spinal cord or brain deficits. These electrodiagnostic studies are possibly complementary to other imaging procedures such as CT, MRI, and/or myelography. These studies provide useful correlative neuropathophysiologic information that is unattainable from standard radiologic studies.

E.2.a.2 Electroneuronography (EnoG)

EnoG is a well-established and generally accepted test that measures facial nerve function. This test measures the action potential of different branches of a facial nerve. It is used in individuals with TBI resulting in a facial paralysis and is key in determining the need for surgical intervention. This test is most useful within the first three weeks of facial nerve dysfunction. If the action potentials on the affected side are 90–100% less than those on the normal side, it suggests significant injury to the nerve and calls for surgical exploration. Individuals with TBI whose nerve is less than 90% decreased in function have a reasonably good outcome with observation alone.

E.2.a.3 Dynamic electromyographies These are electrodiagnostic studies utilized to distinguish the voluntary capacity of a muscle from a spastic reaction. This aids the clinician in better planning specific rehabilitative treatment. This study is helpful in the differential diagnosis and diagnostic work-up of disordered muscle tone. This is a generally accepted procedure.

E.2.a.4 Evoked potential responses (EP)

EPs are generally accepted, well-established diagnostic procedures. EPs are central nervous system electrophysiologic responses to a stimulus, either externally generated via one or more sensory modalities or internally generated via the processing of information. Multisensory EP studies are limited to visually evoked potentials, brain stem auditory evoked potentials, somatosensory evoked potentials, and cognitive evoked potentials.

E.2.a.4.1 Auditory brainstem response (ABR)

ABR is a generally accepted diagnostic procedure useful in assessing damage to the brain stem, midbrain, and other neural structures that govern hearing and/or balance. A normal test does not rule out structural damage, and the test may be abnormal in middle ear and non-traumatic disease affecting the auditory pathway. Waves one, three, and particularly five are most useful in assessing injury. While amplitude and the presence of wave are important, the latency and interwave latency are equally important. This test is often sensitive but non-specific. It may be useful in some cases and requires prior E.2.a.4.2 Electroretinogram (ERG)

ERG is a generally accepted diagnostic procedure for occult retinal trauma accompanying TBI. Most traumatic retinal pathology presents as a field deficit detected by direct examination. ERG cannot detect mild changes in retinal function, and normal results should not be taken as evidence against ocular dysfunction. ERG requires prior authorization.

E.2.a.4.3 Cognitive event-related potential Event-related potential provides no diagnostic information in mTBI that cannot be obtained through other diagnostic procedures and is not recommended in mTBI. It may be justified if other neurological diagnoses are suspected. It requires prior authorization.

E.2.a.4.4 Somatosensory evoked potential (SSEP)

SSEP provides no information in mTBI that cannot be obtained through other diagnostic means. SSEP is not recommended in mTBI. It may be used when other diagnoses are suspected. It requires prior E.2.a.4.5 Visual evoked potential (VEP)

VEP is a generally accepted diagnostic procedure. Pattern reversal monocular VEP recording may detect pathology in the anterior-posterior visual pathway from the retina to the occipital cortex. It may be indicated in the event of compromised acuity or visual field defect. The VEP may occasionally be normal in cases of severe structural damage if there is enough preserved central visual field. Unfortunately, VEP is highly susceptible to artifact and has a low specificity for structural injury to the visual pathways.

Therefore, prior authorization is required.

E.2.a.4.6 Vestibular evoked myogenic potentials (VEMP)

Refer to Section E.2.i, Neuro-otology.

E.2.b Electroencephalography E.2.b.1 Electroencephalography (EEG)

EEG is a well-established diagnostic procedure that monitors brain wave activity using scalp electrodes and provocative maneuvers such as hyperventilation and photic strobe for the purpose of seizure diagnosis. Information generated includes alterations in brain wave activity such as frequency changes (non-specific) or morphologic (seizures). EEG is not generally indicated in the immediate period of emergency response or during acute evaluation and treatment. Following initial assessment and stabilization, the individual’s course should be monitored. If during this period there is failure to improve or the medical condition deteriorates, an EEG may be indicated to assess seizures, focal encephalopathy due to persistent effects of hemorrhage, diffuse encephalopathy due to the injury, or other complicating factors such as hydrocephalus or medications. A normal EEG does not definitively rule out a seizure disorder. If there is sufficient clinical concern that a seizure disorder may exist despite a normal EEG, then a 72-hour ambulatory EEG or inpatient video-EEG monitoring may be appropriate.

E.2.b.2 Quantified electroencephalography (QEEG) (Computerized EEG)

QEEG is a modification of standard EEG using computerized analysis of statistical relationships between power, frequency, timing, and distribution of scalp recorded brain electrical activity. These statistically generated values are then compared to those recorded from selected control and specific populations, generally using multiple regression analysis of multiple measurements and calculated parameters.

Recent studies suggest that in the future, QEEG may become a useful tool in the retrospective diagnosis of TBI and its severity, but this application remains investigational. QEEG is not recommended for diagnosing mTBI or M/S TBI.

E.2.c Neuroimaging Practitioners should be aware of the radiation doses associated with various procedures. Coloradans have a background exposure to radiation, and unnecessary CT scans or x-rays increase the lifetime risk of cancer death.

E.2.c.1 Structural imaging E.2.c.1.1 Computed axial tomography (CT)

CT may be used to follow identified pathology or to screen for late pathology. Subsequently, CT scans are generally accepted when there is suspected intracranial blood, extra-axial blood, hydrocephalus, altered mental state, or a change in clinical condition, including development of new neurological symptoms or post-traumatic seizure (within the first days following trauma). Once the initial acute stage has passed, MRI scans are frequently ordered as opposed to CT.

Repeat CT scans are usually not necessary for most patients with mTBI (loss of consciousness and/or retrograde amnesia and Glasgow Coma Scale greater than 12). In one study, 95 mTBI adult patients were admitted to the hospital for observation and did not have a repeat CT if their Glasgow Coma Scale was 15 at 24 hours. Patients with repeat head trauma, coagulopathy, or other medical problems were excluded. No patients needed a neurosurgical intervention, and only 8% had repeat CTs.

Another systematic review concluded that routine CT repetition rarely identified conditions needing surgical intervention. Nevertheless, risk factors for a further bleed or neurological deterioration from the following conditions would warrant repeat CTs: ● skull fracture, ● coagulopathy or anticoagulation, ● age over 60, ● epidural hematoma, ● suspected open or depressed skull fracture, ● continuing severe headache, ● moderate to severe TBI, and ● continuing TBI symptoms.

E.2.c.1.2 Magnetic resonance imaging (MRI)

MRI is the image of choice to detect the late, sub-acute, and chronic structural changes in the brain which underlie abnormal functioning. It is a well-accepted technique for follow-up imaging. Complications of TBI that may be explained by MRI include, but are not limited to: post-traumatic epilepsy, post-traumatic movement disorder, post-traumatic cranial neuropathy, post-traumatic infection, or failure to recover within the expected time frame. (Refer to Section E.2.c.3, Advanced MRI techniques, for more advanced imaging.)

Diffusion tensor imaging (DTI), susceptibility-weighted imaging, and magnetic transfer imaging: These have been used to explore the effects of mTBI. They remain research tools because, as of the time of this guideline, there are no studies validating their clinical use to differentiate patients with cognitive deficits from those without. They are not recommended to diagnose mTBI. DTI may be useful for identifying pathology and guiding treatment in patients with documented physiological deficits, such as hemianopsia, but interpretation of results is very dependent upon the experience and skill of the neuroradiologist. DTI may be used when an accompanying MRI is ordered for purposes other than diagnosing mTBI. DTI may not be used in isolation to diagnose mTBI.

E.2.c.2 Dynamic imaging In contrast to anatomical imaging procedures, the following procedures are designated to detect physiologic activity of the brain, including cerebral blood flow and cerebral metabolism. Both PET and SPECT scans can subject the patient to significant radiation levels. Prior authorization is required for these procedures.

E.2.c.2.1 Single photon emission computed tomography (SPECT)

SPECT is not generally accepted as a diagnostic test for TBI of any severity and is considered investigational for diagnostic purposes. SPECT may not be used in isolation to diagnose mTBI. It is a functional image of the brain created by a flow tracer or a receptor-binding substance tagged with a radionuclide and injected intravenously into the individual. The radiotracer is assumed to accumulate in different areas of the brain proportionately to the rate of delivery of nutrients to that volume of brain tissue.

Using a gamma camera and the techniques of CT, a 3-D image of the distribution of a radionuclide in the brain is obtained. SPECT may identify areas of decreased perfusion and provide a qualitative estimate of regional cerebral blood flow (CBF), which correlates with metabolism in many neurologic disorders. There is a variable correlation of SPECT with other measures, such as neuropsychological test findings. Its interpretation should take into account its low specificity, making the predictive value of SPECT no better than CT.

Although it should not be used to diagnose mTBI, there is some evidence that SPECT may provide useful information in some cases in which the prognosis is in question, particularly if structural neuroimaging is normal. Given its high sensitivity, SPECT may be useful when expected recovery from mTBI is not occurring within several months from the time of injury. Thus, the primary use of SPECT is as a tool for prognosis in patients with mTBI who are not progressing and have continued symptoms. A normal SPECT scan in this setting indicates a likelihood of resolution of symptoms within twelve months.

However, due to its lack of specificity, an abnormal SPECT scan does not mean that symptoms will persist. Symptoms may resolve even when areas of abnormal perfusion continue to be seen on the SPECT scan.

In all severities of TBI, prior authorization is required and it is recommended that medical necessity and clinical usefulness for this study be justified.

E.2.c.2.2 Positron emission testing (PET)

PET is a functional brain imaging procedure. A tracer molecule tagged with a positron-emitting radioisotope is injected into the body. Biodistribution of the tracer is imaged, producing information about local cerebral glucose utilization and cerebral perfusion. This procedure requires on-site access to a cyclotron.

PET can reveal areas of decreased metabolism in the brain. Little information is available about its use and results in mTBI. In all severities of TBI, it is recommended that medical necessity and clinical usefulness for this diagnostic study be justified. It is not generally accepted as a diagnostic study and should not be used solely to diagnose the presence of TBI. Any requested use requires prior Evidence statements regarding follow-up diagnostic procedures Although it should not be used to diagnose mTBI, SPECT may provide useful information in some cases in which the prognosis is in question, particularly if structural neuroimaging is normal.

Consecutive case series E.2.c.3 Advanced MRI techniques At the time of writing this guideline, all advanced MRI techniques are not recommended for diagnostic purposes. While they can identify anatomic physiologic variation, the changes cannot clearly be related to the need for specific treatment. They require prior authorization and justification of the medical necessity and clinical usefulness of the study.

E.2.c.3.1 Magnetic resonance (MR) spectroscopy This is a noninvasive test that applies a burst of radio frequency energy to tissue inside an applied magnetic field. The resulting excitation and relaxation of nuclei generates a signal that carries information about the chemical environment of those nuclei. MR spectroscopy may detect changes in levels of nacetyl-aspartate, an intermediate in neurotransmitter synthesis that is present in large amounts in normal functioning neurons but is decreased in damaged brain tissue.

Its spectral signal may correlate with neuronal integrity and function and may show loss of function in tissue, which appears normal on conventional CT or MRI studies. MR spectroscopy may increase the sensitivity of MR imaging for traumatic lesions. This sensitivity may allow for increased correlation to more specific neuro-cognitive deficits and guide treatment planning. It may be useful information in determining long-term outcome. MR spectroscopy remains predominantly a research tool at this time and should not be used solely to diagnose the presence of TBI. MR spectroscopy requires prior authorization for patients with mTBI. It may be considered with adequate documentation of its medical necessity in unusual cases, such as in patients with a minimally conscious state, when the information will assist in clarifying the pathology to direct a therapeutic approach to the individual with TBI.

E.2.c.3.2 Functional MRI (fMRI)

This uses MRI to detect physiologic responses of brain tissue to various tasks. Blood oxygenation level dependent (BOLD) contrast is the most popular fMRI technique. It derives an image from differences in the magnetic properties, and therefore differences in MR decay parameters, of oxygenated and deoxygenated hemoglobin. A typical fMRI study compares images under two or more behavioral conditions, which may involve motor, cognitive, or visual tasks. Functional MRI studies have shown functional reorganization as a general response to TBI. Alterations in patterns of cerebral activity seen on fMRIs may correlate with cognitive deficits in individuals with TBI, but the specificity of the test is not sufficient to make fMRI a diagnostic tool. At the time of this guideline, it is a research tool and not recommended for clinical use. Recent publications report problems with the mathematical formulas used, relating false positives and false negatives.

E.2.d Laboratory testing Laboratory testing is a generally accepted, well-established procedure. In mTBI, laboratory tests are rarely indicated at the time of initial evaluation unless there is suspicion of systemic illness, infection, neoplasm, drug or alcohol intoxication, endocrine dysfunction, or underlying disease. A number of blood tests have been proposed to identify brain damage in mTBI. It is currently not clear that results from these tests can more accurately diagnosis mTBI or identify mTBI which requires treatment or follow up. Thus, they are not recommended at this time. Any individual with TBI on medication will require laboratory testing to monitor therapeutic drug levels and the effects on organ function.

Endocrine testing is frequently appropriate because hypopituitarism occurs in approximately 17% of mTBI cases.

E.2.e Lumbar puncture Lumbar puncture is a well-established diagnostic procedure for examining cerebrospinal fluid (CSF) in neurological disease and injury. The procedure should be performed by qualified and trained physicians under sterile conditions.

Lumbar puncture is contraindicated in acute trauma to the spinal column, certain infections, increased intracranial pressure due to space occupying lesions, and in some coagulation disorders or defects.

Additionally, it should be avoided if there are cutaneous infections in the region of the puncture site. In individuals with suspected or known increased intracranial pressure, lumbar puncture should be preceded by fundoscopic examination and a CT scan or MRI.

E.2.f Nerve blocks – diagnostic These are generally accepted procedures involving percutaneous needle injection techniques to a specific nerve. These diagnostic blocks are typically performed with quick-acting, short duration local anesthetics such as lidocaine or bupivacaine. Temporary diagnostic nerve blocks evaluate limb ROM, dystonia, or spasticity and assist in planning subsequent, specific therapy.

E.2.g Further neuropsychological assessment and testing Neuropsychological assessment after three months is appropriate in the following situations when: ● input is needed to plan treatment to maximize long-term cognitive and overall functional outcomes; ● documentation of accommodations is needed to establish adjustments to the neurocognitive challenges; ● assessment will assist in increasing insight and be used to assist with supportive psychotherapy; ● there is a question of the individual’s ability to perform work-related duties and/or there are safety issues (i.e., possible harm to self or others) or when the person’s vocation necessitates more extensive testing prior to vocational re-entry or return to school/training; ● assistance is needed with differential diagnosis including the diagnosis of TBI; ● it is deemed necessary to evaluate and/or monitor effectiveness of treatment approaches (i.e., cognitive rehabilitation therapy, somatic therapies, or medication trials) in specific individuals; ● the patient’s presentation is such that symptom validity testing and performance validity testing may be helpful in treatment planning; ● subjective complaints are disproportionate to the clinical history or objective findings as ● the degree of disability is disproportionate to the clinical history and objective findings as ● there are questions of competency, guardianship, or conservatorship.

Neuropsychological testing should be used to document the patient’s level of effort and to provide data regarding symptom validity. Testing should not be used to diagnose malingering.

Neuropsychological testing may take into account validated testing in other areas without a direct relationship to psychological issues.

Evidence statements regarding neuropsychological assessment There is an association between poor effort on verbal memory tests and poor effort on computerized tests of postural stability in patients with TBI who are being evaluated for disability ratings.

Retrospective review of consecutive charts The following information may aid in delineating when a full neuropsychological battery is necessary versus more limited testing: ● mTBI three months post-injury: Serial testing with specialized tests that are sensitive to effort, speed of processing, memory, and executive functions will usually be appropriate for treatment planning and monitoring progress. The administration of a full neuropsychological test battery (typically including assessment of effort) may become necessary in this time period when: ○ there is no witnessed history of TBI, or there is other uncertainty regarding the diagnosis of mTBI; ○ the patient is not progressing and/or symptoms indicate mTBI may be more severe; ○ it is necessary to address issues on the initial indicators list.

E.2.h Psychological, psychiatric, or psychosocial evaluations These are generally accepted and well-established diagnostic procedures with selective use in the TBI population. They have more widespread use after three months. Diagnostic testing may be indicated for individuals with symptoms of post-traumatic disturbances of sleep, mood, anxiety, psychosis, substance use, aggression/agitation, and pain, as well as depression, delayed recovery, chronic pain, recurrent painful conditions, and disability problems. An individual with a PhD, PsyD, or psychiatric MD/DO credentials may perform these evaluations if listed as an authorized user by the test publisher.

Practitioners’ familiarity with patients with TBI is preferred.

Psychosocial evaluations can help to determine if further psychosocial or behavioral interventions are indicated for patients diagnosed with TBI. The interpretations of the evaluation can provide clinicians with a better understanding of the patient in his or her social environment, thus allowing for more effective rehabilitation. Psychosocial assessment requires consideration of variations in experience and expression resulting from affective, cognitive, motivational, and coping processes, as well as other influences such as gender, age, race, ethnicity, national origin, religion, learning disability, language, or socioeconomic status.

A comprehensive psychological evaluation should attempt to identify both primary psychiatric risk factors (e.g., psychosis, active suicidality, lack of awareness) as well as secondary risk factors (e.g., moderate depression, job dissatisfaction). Significant personality disorders should also be taken into account in treatment planning.

Psychometric testing is a valuable component of a consultation to assist the physician and other members of the treatment team in making a more effective treatment plan. Psychometric testing can assist in enhancing general medical outcomes and in predicting a patient’s likely adherence to and cooperation with medical treatment plans.

Several meta-analyses have evaluated the occurrence of depression and anxiety with non-penetrating TBI. Both anxiety and depression appear to occur at a rate about one-third higher than the general population. Both conditions are likely to increase during the initial two to five years post-injury, although anxiety may decrease after five years. Patients with mild and moderate/severe TBI are both likely to suffer from psychological stress. Increased physical activity and decreased alcohol consumption may be useful to decrease symptoms. One study found that pre-injury alcohol abuse and longer PTA predicted symptoms lasting longer than six months.

Even in cases where no diagnosable psychological condition is present, these evaluations can identify social, cultural, coping, and other variables that may be influencing the patient’s recovery process and may be amenable to various treatments, including behavioral therapy. ● Qualifications ○ A psychologist with a PhD, PsyD, or EdD credentials or a physician with psychiatric MD/DO credentials may perform the initial comprehensive evaluations. It is preferable that these professionals have experience in diagnosing and treating mTBI in injured workers. ○ Psychometric tests should be administered by psychologists with a PhD, PsyD, or EdD credentials or health professionals working under the supervision of a doctorate level psychologist. Administration and interpretation of psychological/neuropsychological measures must adhere to standards set forth by test publishers. ● Indications A psychological assessment may be necessary if symptoms do not correlate with a diagnosis of TBI. Complaints of cognitive dysfunction may also be associated with a variety of conditions that do not involve neurological disease, TBI, or mTBI. This includes conditions that may have been pre-existing or are concurrent, such as depression, anxiety, chronic pain, somatoform disorders, and factitious disorders. At times, a set of symptoms may not coincide with expected objective findings for those with a diagnosis of TBI. To identify non-neurological contributions to cognitive or other functional complaints, a psychological evaluation focusing on mental disorder diagnoses is appropriate when: ○ delayed recovery is present, ○ there is delayed access to appropriate care, ○ there is a question of whether a brain injury has occurred, ○ neuropsychological testing yields a pattern of test results that is not consistent with the clinical history, ○ neurologically improbable symptoms are present, or ○ it is necessary to assess for accompanying psychological components. ● Clinical evaluation Special note to health care providers: Most providers are required to adhere to the federal regulations under the Health Insurance Portability and Accountability Act (HIPAA).

Unlike general health insurers, workers’ compensation insurers are not required to adhere to HIPAA standards. Thus, providers should assume that sensitive information included in a report sent to the insurer could be forwarded to the employer. The Colorado statute provides a limited waiver of medical information regarding the work-related injury or disease to the extent necessary to resolve the claim. It is recommended that the health care provider either (1) obtain a full release from the patient regarding information that may go to the employer or (2) not include sensitive health information that is not directly related to the work-related conditions in reports sent to the insurer.

The clinical evaluation should address the following areas: ○ History of injury The history of the injury should be reported in the patient’s words or using similar terminology. Certified medical interpreters are preferred. Collateral information should be obtained as appropriate. This may include family, support systems, witnesses, and EMS records. ■ psychosocial circumstances of the injury ■ current symptomatic complaints ■ extent of medical corroboration ■ treatment received and results ■ compliance with treatment ■ coping strategies used, including perceived locus of control, catastrophizing, and avoidance behaviors ■ perception of medical system and employer ■ history of response to prescription medications ■ medication history related to this injury ○ Health history ■ medical history ■ psychiatric history ■ history of alcohol or substance abuse, including abuse of prescription medication ■ ADLs ■ previous injuries, including disability, impairment, and compensation ■ complete medication history, including prescription and over-the-counter medications ○ Psychosocial history ■ childhood history, including abuse/neglect and developmental/intellectual disability or delay ■ educational history ■ family history, including disability ■ relationship/marital history and other significant adulthood activities and events ■ legal history, including criminal and civil litigation ■ employment history ■ military duty: Because post-traumatic stress disorder (PTSD) might be an unacceptable condition for many military personnel to acknowledge, it may be prudent to screen initially for signs of depression or anxiety – both of which may be present in PTSD. ■ symptoms of pre-injury psychological dysfunction ■ current and past interpersonal relations, support, and living situation ■ financial history ○ Mental status exam including cognition, affect, mood, orientation, thinking, and perception. May include the Mini-Mental Status Examination or the Frontal Assessment Battery, if appropriate, and detailed neuropsychological testing. ○ Assessment of any danger posed to self or others. ○ Barriers to care should be considered as the patient may experience problems with transportation and access to appropriate care. ○ Psychological test results, if performed. ○ Current psychiatric/psychological diagnosis consistent with the standards of the American Psychiatric Association’s most recent Diagnostic and Statistical Manual of Mental Disorders. ○ Pre-existing psychiatric conditions. Treatment of these conditions is appropriate when the pre-existing condition affects recovery. ○ Causality (to address medically probable cause and effect, distinguishing preexisting psychological symptoms, traits, and vulnerabilities from current symptoms or aggravation of prior symptoms). ○ Treatment recommendations with respect to specific goals, frequency, timeframes, and expected outcomes.

Evidence statements regarding psychometric testing Psychometric testing can predict medical treatment outcome.

Prospective cohort study and observational cohort E.2.i Neuro-otology: vestibular and audiological evaluations Neurotologic evaluation is a widely used and generally accepted practice in cases of hearing loss, dizziness, balance problems, facial nerve injury, and cerebrospinal fluid leak. An individual with TBI may experience these symptoms. Any patient with complaints of vertigo or significant neurological findings on clinical exam, such as ataxia, should be referred to appropriate specialists expeditiously. Diagnostic testing for significant pathology usually requires the listed evaluations (audiometry, tympanometry, and vestibular function tests [E.2.i.3.1 – E.2.i.3.5]). It is recommended that all patients with mTBI and continual balance complaints and no clinical findings after 6 weeks be referred to clinicians with experience in balance assessment and training (see subsection E.2.i.3.6, Acquired visual dysfunction, below). Some tests may need to be repeated to clarify diagnosis.

E.2.i.1 Audiometry Audiometry is a generally accepted and well-established procedure that measures hearing. An audiologist or skilled trained technician administers the test using an audiometer. The machine presents individual frequencies to the person with TBI (typically ranging from 125–8000 Hz) at different levels of loudness (in dB HL). The individual is asked to respond to the sound at its lowest detectable intensity (threshold).

Normal thresholds are from 0-25 dB HL and are depicted on an audiogram. The audiologist or physician should determine the presence and type (non-organic, conductive, sensorineural, presbycusis, or mixed) of hearing loss based on the audiogram and other tests reasonably deemed necessary.

If available, obtain pre-injury baseline audiograms / audiometry studies to include a summary of past audiometric history, if known (e.g., prior hearing loss, prior tinnitus, prior vestibular problems, prior injury, etc.).

Baseline audiometry following TBI is indicated when the individual with TBI presents with hearing loss, dizziness, tinnitus, or facial nerve dysfunction.

Audiograms may be obtained in serial fashion to monitor inner ear function in response to time and Specific audiometric testing can be done to assess the presence of tinnitus and complaints of unilateral hearing loss (Stinger test).

E.2.i.2 Tympanometry Tympanometry is a generally accepted and well-established procedure that measures middle ear air pressures. It is used to help identify the presence of tympanic membrane perforations, ossicular abnormalities, and the presence of fluid in the middle ear.

E.2.i.3 Vestibular function tests The most common type of vertigo is benign paroxysmal positional vertigo (BPPV), which usually does not require additional testing because it is diagnosed with the clinical Dix-Hallpike maneuver and treated with a variety of canalith repositioning maneuvers (CRM), such as Epley and Semont maneuvers. (Refer to

Section F.3, Neuro-otology Treatment, Benign Paroxysmal Positional Vertigo [BPPV].) The following tests are used to verify the presence of vestibular dysfunction and specify the origin when possible.

E.2.i.3.1 Electro- or video-nystagmography (ENG/VNG)

This is a generally accepted and well-established procedure that measures inner ear/central balance function. The test measures eye movement responses to inner ear balance stimulation making use of the vestibulo-ocular reflex. There are several components to the ENG/VNG. They include oculomotor testing, positional and positioning nystagmus testing, and caloric testing. This series of tests may identify peripheral and central abnormalities, abnormalities in oculomotor function, positional nystagmus, and unilateral and bilateral vestibular dysfunction. The ENG/VNG can be helpful in identifying the affected ear.

This test is often used in individuals with TBI complaining of dizziness or dysequilibrium and may help diagnose conditions such as labyrinthine concussion, vestibular hypofunction, and central vertigo. It is often used in conjunction with other tests such as the audiogram and clinical history to help arrive at a diagnosis.

E.2.i.3.2 Rotary chair testing This is a generally accepted, although not commonly used, test that evaluates the ocular responses of the inner ear to rotation. It is used to identify the extent of bilateral vestibular loss and is more accurate than VNG caloric tests for this purpose. It is also useful in assessing the ability of vision to compensate for vestibular impairments and so provides prognostic information regarding recovery.

E.2.i.3.3 Video head impulse testing (vHIT)

This is a generally accepted, although not commonly used, test that evaluates the ocular responses of the inner ear to high acceleration head rotation. vHIT is used to evaluate the ability to maintain visual focus during head movement that can be impaired with moderate to high grade unilateral or bilateral vestibular injuries. It detects dysfunction of individual vertical semicircular canals in vestibular patients as accurately as scleral search coils but is non-invasive and easy to use. It is used to identify the extent of bilateral vestibular loss and is more accurate than VNG caloric tests for this purpose.

E.2.i.3.4 Computerized dynamic platform posturography This is a generally accepted, although not commonly used, test that assesses the contributions of vision, somatosensation, and the inner ear to balance control. It separately evaluates the role of lower extremity motor control to balance. It can be used to determine whether a vestibular lesion is present, but it does not localize the lesion. The purpose of this procedure is to identify the integral components of a functional balance deficit that may help in treatment planning. This technique also may be useful in monitoring neurologic recovery in individuals with TBI and balance deficits. These functional methods of evaluation are considered generally accepted practices in the evaluation of persistent vestibular and balance deficits that may require specific treatment and remediation strategies. Non-physiologic findings on this exam can result from either symptom exaggeration, anxiety, psychiatric disorders, atypical results, or malingering and should not be interpreted as malingering without other evidence. One study demonstrated positive VNG testing in a number of cases where dynamic posturography was non-physiologic.

E.2.i.3.5 Electrocochleography (ECoG)

This is a well-established and generally accepted procedure that indriectly tests endolymphatic fluid pressures. It identifies the affected ear in cases of post-traumatic endolymphatic hydrops and posttraumatic perilymphatic fistula.

The inner ear has two fluid chambers – the perilymphatic and the endolymphatic. After TBI, it is not uncommon for patients to develop an increase in the endolymphatic fluid pressure; this condition is called hydrops. When the endolymphatic pressures are abnormally high, the inner ear membranes distend, and the ear malfunctions. Symptoms include hearing loss, sporatic dizziness, tinnitus, aural fullness, and sensitivity to sound.

The ECoG is a test that uses evoked potentials. The patient listens to a series of clicks. Monitors, including one sitting on the tympanic membrane, measure three potentials: the cochlear microphonic, the summating potential (SP), and the action potential (AP). An increase in the ratio of the summating potential of the action potential (SP/AP) suggests the presence of hydrops or perilymphatic fistula. The test varies in sensitivity and specificity. Diagnosis of endolymphatic hydrops requires a characteristic clinical picture with progressive hearing loss, fluctuating hearing, and recurrent vertigo episodes lasting for hours. (Refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline, section F.4.l, Neuro-otology: vestibular and audiology, under treatment of progressive otologic disorders.) In the absence of these clinical features, diagnosis should not be based solely on an abnormal ECoG test result.

E.2.i.3.6 Vestibular evoked myogenic potentials (VEMP)

This is a generally accepted test that evaluates the function of the saccule, one of the gravity-sensing organs of the inner ear. It is the only objective test of these organs. It is a form of auditory evoked response and is measured using the ABR and EMG equipment. A loud sound stimulus is introduced into the ear, and a vestibulo-colic reflex response from the saccule is recorded as a brief relaxation of the ipsilateral sternocleidomastoid muscle by EMG. A characteristic wave form is recorded for each ear that is analyzed for presence or absence, threshold, amplitude, and latency. Absence of a response in persons under age 60 suggests saccular damage. Reduced thresholds are indicative of semicircular canal dehiscence. It is not useful in diagnosing benign paroxysmal positional vertigo or vestibular migraine.

E.2.i.3.7 Acquired visual dysfunction This is usually not the primary cause of imbalance. However, if ocular and/or visual abnormalities are found on testing, the patient may be further evaluated by a qualified optometrist or ophthalmologist with training and experience in TBI, balance disorders, and underlying neurology, preferably a neuroophthalmologist or neuro-optometrist. The goal is to 1) determine if there is a visual component or not, 2) determine if it is central or peripheral, 3) determine if the problem is a manifestation of an underlying vestibular disorder or a true vision problem, and 4) coordinate with the treating providers regarding most appropriate treatment.

E.2.i.3.8 Other clinical referrals The treating physician may refer individuals with TBI who have balance problems to other clinicians with appropriate training in balance dysfunction, such as neuro-otologists, neurologists, and otolaryngologists, to assist in their assessment. The referrals may include, but are not restricted to: neuro-ophthamology, optometry, physical therapy, vestibular therapists, occupational therapy, and chiropractic therapy. There should be a coordinated approach between these disciplines and the physician specialist in the individual’s treatment.

E.2.j Swallowing evaluation Swallowing impairment or dysphagia may be due to neurologic, structural, or cognitive deficits and may result from head trauma. Dysphagia may result in aspiration, airway obstruction, pneumonia, inadequate nutrition, dehydration, weight loss, failure to thrive, and death. Dysphagia is uncommon in mTBI. If treatment is needed, refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline.

E.2.k Vision evaluation There are standard examination techniques and ancillary tests to establish the diagnosis of visual disorders. It is a generally accepted practice for a qualified practitioner to provide a comprehensive vision evaluation. The qualified practitioner (optometrist, neuro-optometrist, ophthalmologist, neuroophthalmologist) should have training and experience in the neurology of TBI.

The comprehensive visual evaluation should assess afferent visual function (visual acuity, visual fields / peripheral vision), efferent function (ocular movement, fixational stability/instability, binocular alignment), and anatomic integrity of the eye and its adnexal structures. In doing so, the practitioner will obtain information about the functional status of the eyes and visual system including the presence or absence of refractive error; loss of visual acuity and/or visual field; oculomotor dysfunction with or without diplopia; ocular, orbital, and adnexal injuries; and other pathology involving intraocular structures. Vision evaluation may be necessary to evaluate acquired/traumatic central and peripheral nervous system disorders, visual acuity loss, visual field loss, nystagmus, ocular motility impairment, cranial nerve palsy, diplopia, suspected or noted ocular and visual pathology, pupillary disorders, and visual perceptual disorders.

The diagnosis/diagnoses determined following a comprehensive neuro-ophthalmic examination should be based upon objective findings that correlate with the known or suspected underlying neuro-pathology and symptoms. A simple description of symptoms may be used but should not be understood as explanatory or diagnostic, as the practitioner should seek to identify the underlying pathology.

Signs and symptoms of visual dysfunction commonly include, but are not limited to: ● Signs ○ ocular mis-alignment (strabismus), ○ nystagmus or other instability of fixation, ○ ocular discharge, ○ red or swollen eyes, ○ ptosis, ○ lagophthalmos (inability to fully close the eyelid), ○ globe dystopia (lack of orbit alignment). ● Symptoms, including complaints of ○ blurred vision or loss of vision, ○ difficulty with visual tracking or scrolling, ○ focusing problems, ○ double vision, ○ having to close or cover an eye to improve vision, ○ problems with depth perception, ○ impaired peripheral vision, ○ headache or eye strain with use of eyes, ○ head tilt to improve vision, ○ dizziness or balance problems with use of eyes, ○ photophobia, ○ reduced attention or concentration for visual tasks.

Visual evaluation is indicated when signs or symptoms consistent with a visual problem are reported by the individual or observed by others. Significant signs and symptoms not directly or solely attributable to other causes (e.g., cognitive, vestibular, medication, psychological) indicate the need for vision evaluation as soon as reasonably possible post-injury. Mild signs and symptoms do not require referral but may be monitored for several weeks to allow for resolution or improvement.

In mTBI, self-reported photosensitivity and blurred vision are relatively common, but there is usually resolution by three months post-injury. Persistent functional related visual symptoms may require specialty evaluation.

A formal vision examination may be intermediate, extended, or comprehensive, depending on the nature of the deficits. The vision examination may include, but is not limited to: case history; visual acuity at a distance and near; refraction; color vision testing; pupillary examination; visual field by confrontation;

Amsler grid testing; ocular motility examination; binocularity examination; accommodation testing; external/adnexal examination; intraocular pressure testing; and anterior and posterior segment examinations.

Ancillary diagnostic tests may include, but are not limited to: visual field testing (tangent screen campimetry, manual or automated perimetry), ultrasonography, fluorescein angiography, anterior segment and fundus photography, optical coherence tomography, electrodiagnostic studies, low vision assessment, and visual perceptual testing.

E.2.k.1 Visual field testing This is a well-established technique to evaluate central and peripheral vision. It is indicated when a deficit is suspected by the practitioner or noted by the patient and should be considered in any patient with TBI and subjective visual field loss. Visual field testing beyond the basic examination should be performed using a procedure and tool that is well-established and standardized. Examples include computerized perimetry and Goldmann perimetry.

E.2.k.2 Ultrasonography Ultrasonography is a well-established diagnostic test that is indicated for evaluation of ocular or orbital pathology. It is indicated for ocular lesions that are suspected but poorly visualized due to opaque ocular media or for further evaluation of ocular or orbital pathology.

E.2.k.3 Fluorescein angiography This is a well-established diagnostic test to evaluate the retinal and choroidal circulation. It is indicated when lesions of one or both of these circulations are suspected.

E.2.k.4 Visual perceptual testing This testing may be conducted informally by an ophthalmologist or optometrist or with a standardized battery of tests employed by a neuropsychologist. Testing consists of functional assessments to evaluate an individual’s recognition and interpretation of visual sensory information. Visual perceptual testing is indicated for determination of the level of visual perceptual impairment and/or confirmation of suspected impairment. Perceptual areas assessed include visual memory, judgment of visual spatial relationships, visual discrimination, visual motor integration, visual figure-ground discrimination, and visual attention.

Numerous tests are used for the evaluation of visual perception. Some of these tests are wellestablished. It is suggested that only tests with established norms be used in a standardized battery, and caution should be exercised in using other instruments. Visual perception testing should not be used in isolation to diagnose mTBI.

E.2.k.5 Low vision evaluation Low vision evaluation is well-established and indicated in the presence of subnormal bilateral visual acuity or visual field. The goal is to provide vision aids for distance or near vision that improve visual E.2.k.6 Electrodiagnostic studies These are well-established and possibly indicated in the presence of reduced visual acuity or visual fields, ocular pathology, or suspected optic nerve or visual pathway deficit. (Refer to Section E.2.a, Electrodiagnostic studies, for further description.)

E.2.k.7 Optical coherence tomography This is an interferometric technique, usually with near-infrared wavelengths, used to evaluate optic nerve and retinal structural integrity. This study should be used in conjunction with tests of visual function to establish the possible causes of visual deficits. Serial assessments can provide objective longitudinal data about retinal and optic nerve structure.

E.2.l Return-to-work assessment and special tests A return-to-work procedure should be part of a company’s policies and procedures, knowing that return to work can decrease anxiety, reduce the possibility of depression, and reconnect the worker with society.

Evaluations used to define these abilities, such as the functional capacity evaluation (FCE) and the worksite analysis, should be objective. The professional performing the FCE and worksite analysis should be specifically trained and familiar with the unique presentation of the individual who has sustained a TBI.

The ability to tolerate these evaluations and follow commands may be limited due to TBI and should not be construed as non-cooperative or suggestive of malingering.

Caution should be used in returning an individual to work and other activities too early. Both physical and cognitive duties should generally be non-stressful initially, with a gradual increase in activity based on improvement and/or resolution of symptoms. The individual should be competent in most basic ADLs before return to work is considered. Return to full duty depends on the rate of decrease of symptoms.

Generally, if symptoms recur during increasing job duties or exertion, duties should be decreased accordingly. Because a prolonged period of time off work will decrease the likelihood of return to work, the first weeks of treatment are crucial in preventing and/or reversing chronicity and disability mindset. In complex cases, experienced nurse case managers or occupational therapists may be required to assist in return to work. Other services, including psychological evaluation and/or treatment and vocational assistance should be employed. Two evaluations that may be used are job site evaluations and alterations and FCEs.

E.2.l.1 Job site evaluations and alterations For many patients with TBI, job alterations may be needed. These may be in the form of: (1) instructing the worker how specific duties might be performed to avoid excessive mental stress; (2) actual job worksite or duty changes; and/or (3) a formal job site evaluation and alterations at the worksite.

Job site evaluation and alteration should include input from the employee, the employer, and a health care professional with experience with TBI cases. The employee should be observed performing all job functions in order for the job site evaluation to be a valid representation of a typical workday.

A formal job site evaluation is a comprehensive analysis of the physical, mental, and sensory components of a specific job and may be important initially to determine causation. These components may include, but are not limited to: (a) postural tolerance (static and dynamic), (b) aerobic requirements, (c) ROM, (d) torque/force, (e) lifting/carrying, (f) cognitive demands, (g) social interactions, (h) interpersonal skills management, (i) visual perceptual challenges, (j) environmental requirements of a job, (k) repetitiveness, and (l) essential functions of a job.

Changes that provide a therapeutic benefit or relieve the patient’s ongoing symptoms are part of the required medical treatment for TBI, and therefore, it is assumed that the insurer will be responsible for paying for reasonably necessary job site alterations.

Job descriptions provided by the employer are helpful but should not be used as a substitute for direct observation.

A job site evaluation may include observation and instruction of how work is done, what material changes should be made, and determination of readiness to return to work. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline.

Requests for a job site evaluation should describe the expected goals for the evaluation. Goals may include, but are not limited to: ● Provide a detailed description of the physical and cognitive job requirements; ● Make recommendations for and assess the potential for job site changes; ● Assist the patient in his/her return to work by educating on how he/she may be able to do his/her job more safely; and/or ● Give detailed work/activity restrictions.

Time frames regarding job site evaluations and alterations Frequency One time with additional visits as needed for follow-up.

E.2.l.2 Functional capacity evaluation (FCE)

FCE may be indicated to identify residual physical limitations. FCE is a comprehensive assessment of the various aspects of physical and cognitive function as they relate to the individual’s ability to perform functional activities necessary for return to work. When cognitive, emotional, and/or behavioral sequelae are also present, a comprehensive FCE may provide indications of return-to-work readiness.

Components of the physical portion of the FCE may include, but are not limited to: musculoskeletal screen, cardiovascular profile/aerobic capacity, coordination, lift/carrying analysis, job specific activity tolerance, maximum voluntary effort, pain assessment, non-material and material handling activities, balance/dizziness, climbing, physical fatigue, endurance, and visual skills. The physical portion of any FCE should include all of the physical skills required for specific job placement.

Components of the cognitive portion of the FCE may include, but are not limited to: memory, executive skill function, attention and concentration, communication, speed of information processing, multi-tasking, new learning, and cognitive fatigue and endurance.

Components of the emotional portion of the FCE may include, but are not limited to: temperament, ability to manage stress, adaptation to change, mood changes, toleration of feedback, and anger control.

Components of the behavioral portion of the FCE may include, but are not limited to: appropriate social and behavioral interactions. This may present as inability to complete or cooperate with the tests, inconsistent or erratic behavior, or the inability to get along with coworkers and supervisors.

FCEs include tools that are an extension of the basic medical examination and may be useful for the determination of impairments, functional/cognitive restrictions, determination of progress, and planning and monitoring of the rehabilitation program. Whenever possible, FCEs should be supplemented with information from neuropsychology, speech therapy, occupational therapy, and physical therapy to determine physical, cognitive, and psychological abilities in order for the patient to function safely and productively in a work setting. FCEs are typically conducted in four to six hours, but for individuals who have sustained a TBI, additional time may be required or it may be necessary to conduct the evaluation in two or three separate sessions to allow for the potential variability of cognitive and physical fatigue. Total time for an FCE would rarely exceed eight to ten hours.

When an FCE is being used to determine return to a specific job site, the provider is responsible for fully understanding the job duties. A job site evaluation is frequently necessary. FCEs cannot be used in isolation to determine work restrictions. The authorized treating provider must interpret the FCE in light of the individual patient’s presentation and medical and personal perceptions. FCEs should not be used as the sole criteria to diagnose malingering.

FCEs may be beneficial in the TBI population to assist in return to work.

Time frames regarding functional capacity evaluation Frequency 2 times. When the patient is unable to return to the pre-injury position and further information is desired to determine permanent work restrictions. A repeat FCE may be needed if additional treatment is deemed necessary after the first FCE.

Prior authorization is required for more than 3 FCEs.

F. Treatment Due to the complex nature of the brain, individuals with mTBI may require coordinated interdisciplinary treatment. Usually, the impairment(s) and functional limitations are appropriately treated by more than one therapeutic discipline. Treatment should include functional, outcome-oriented, and community reintegration goals. Treatment session duration and frequency will vary depending on the individual’s tolerance and may evolve over time.

All treatment plans begin with shared decision making with the patient. Before initiation of any therapeutic procedure, an authorized treating provider, employer, and insurer must consider these important issues in the care of the injured worker: ● Patients undergoing therapeutic procedure(s) should be released or returned to modified or restricted duty during their rehabilitation at the earliest appropriate time. Refer to

Section G, Return to work, for detailed information. ● Reassessment of the patient’s functional improvement status should be documented after each treatment. If patients are not responding within the recommended time periods, alternative treatment interventions, further diagnostic studies, or consultations should be pursued. Continued response to treatment should be monitored using objective measures such as: ○ Return to work or maintaining work status; ○ Fewer restrictions at work or performing activities of daily living (ADLs); ○ Decrease in usage of medications related to the work injury; and ○ Measurable functional gains, such as: increased range of motion; documented increase in strength; increased ability to stand, sit, or lift; or patient completed functional evaluations. ● Clinicians should provide and document education to the patient. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms. ● Neuropsychological testing should be performed on all patients with mTBI requiring treatment beyond 3 months.

Interdisciplinary care among all of the disciplines providing care to the patient is required for treatment of F.1 Post-traumatic headache treatments Headaches are one of the most common symptoms seen in general medical practices. Following TBI, 50% or more of injured individuals experience headache throughout the first year post-injury. The majority of these are self-limited, but headache persisting for more than three months may occur. Evolving brain pathology is unlikely to be responsible for post-traumatic headache, which is seen more commonly after mTBI than after moderate/severe TBI. Involvement of extracranial structures, including cervical dysfunction, may be the mechanism of headache persistence following TBI. (Refer to the Division’s Cervical Spine Injury Medical Treatment Guideline when appropriate.)

Headaches are more common in those with a prior history of headaches and may be associated with other symptoms such as dizziness, memory problems, or weakness. Migraines and cervicogenic headaches are the most common type of post-injury headache.

Evidence statements regarding acupuncture for headache True acupuncture has small positive effects in reducing headache frequency in adults with episodic or chronic tension-type headache over 6 months when compared to no treatment / routine care or “sham” (placebo) acupuncture.

True acupuncture has small positive effects in reducing migraine frequency over 6 months when compared to “sham” (placebo) acupuncture, small positive effects after treatment compared to prophylactic drug treatment, and moderate positive effects in reducing migraine frequency after treatment compared to no treatment / routine care in adults with episodic migraines.

Evidence statements regarding exercise, manipulation, and patient education for headache Therapeutic patient education has small to moderate positive effects in improving quality of life and in reducing headache disability and the frequency of migraines in patients with migraines when compared to controls or usual care. 6 to 8 sessions of upper cervical and upper thoracic manipulation over 4 weeks are significantly more effective in reducing headache intensity, disability, headache frequency and duration, and medication intake than mobilization combined with exercises in patients with cervicogenic headache, and the effects are maintained at 3 months.

Spinal manipulation is effective for treatment of cervicogenic headaches.

Exercise is equally efficacious as manipulation and can be used in combination with manipulation.

The usual course of treatment was 3–6 weeks and effects were still found at 1 year. of clinical trials Summary of evidence regarding manipulation for cervicogenic headaches There is good evidence that cervicogenic headaches may benefit from manipulation based on the combined studies above with some level of evidence.

Evidence statements regarding pharmaceutical treatment for headache Aspirin is better than placebo for acute migraine headaches.

Topiramate at a dose of 100 mg/day is more effective than placebo in reducing the frequency of migraine headache.

Sumatriptan is more effective than placebo for rapid relief of acute migraine headache in adults. The subcutaneous route of administration at a dose of 4 mg or 6 mg is likely to be more effective than the oral route of either 50 or 100 mg. There is insufficient evidence to support the oral dose of 25 mg, although it may be effective as well. The intranasal route of 20 mg is supported by the evidence, but there is insufficient support for the 10 mg route. There is insufficient evidence regarding the rectal route of 25 mg due to limited data, but it is also a reasonable option under appropriate circumstances.

Meta-analyses of Propranolol is superior to placebo for migraine prophylaxis.

Amitriptyline is beneficial for chronic tension headaches. crossover trial Acetaminophen at a dose of 1000 mg/day is effective for acute migraines.

A single dose of 200-400 mg of ibuprofen is effective for acute migraines.

Valproate is more effective than placebo in reducing the frequency of migraine headache.

Adding an antiemetic to aspirin makes it more effective for headache and associated symptoms.

Indications/recommendations for post-traumatic headache treatment Every effort should be made to eliminate the “cause” and treat headaches and other symptoms as early as possible. A headache diary should be completed by the patient. This will help identify modifying factors. Migraines not present prior to injury should be termed migraine-like headaches and may not respond to traditional migraine treatment. ● Initial management Management of post-traumatic headache should be tailored to the class of headache into which it fits. Less common headache diagnosis may be present and require unique clinical options. Migraine patients should be provided with the migraine’s diet advisories and restrictions as appropriate. Relaxation techniques, stress management, biofeedback, and good sleep hygiene can all assist in decreasing headaches. Both traumatic and nontraumatic headaches may be made worse by overuse of analgesics and cause chronic daily headache, otherwise known as medication overuse headaches. Treatment should be directed toward modifying causative factors with re-establishment of activities and away from rumination on the injury.

Education, medication adjustment, and interdisciplinary team approaches may be necessary. Chronic daily headache should be considered as a diagnosis in patients whose daily headache may be in response to iatrogenic complications of other medications or substances. Patients who are prescribed analgesics or who use caffeine, alcohol, or nicotine chronically may experience chronic daily headaches as serum levels of these substances fluctuate. These patients may require treatment to carefully titrate these substances. Patients with a blow to the side of the head, with chronic neck/shoulder pain, or with bruxism may develop temporal mandibular joint pain that will result in headache. Patients with sinus involvement, sometimes evidenced on early CT imaging, may develop chronic headache pain that requires treatment of the underlying sinus pathology. A sedating antidepressant such as amitriptyline may alleviate the insomnia that often complicates headache. See the Headache Treatment Algorithm below. Referral to a specialist may be necessary if initial treatment is not effective. ● Non-pharmacologic treatments Widely accepted treatments for post-traumatic headache may include, but are not limited to: interdisciplinary treatment, pharmacology, joint manipulation, physical therapy, massage, acupuncture, biofeedback, psychotherapy (i.e., cognitive behavioral therapy), and diet.

Manipulation is appropriate for cervicogenic headaches. There is good evidence that cervicogenic headaches may benefit from manipulation based on the studies listed in the evidence table above. This may be appropriate when cervical trauma has not caused instability. However, if headache follows trauma, imaging should be done before manipulation. Refer to the Division’s Cervical Spine Injury Medical Treatment Guideline for parameters.

Acupuncture may be useful as prophylaxis for migraines. See related evidence statement in the table above. These procedures should only be continued if functional gains are documented.

Psychological evaluation is a generally accepted intervention to identify factors for delayed recovery associated with pain and the potential need for cognitive assessment.

Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for specific time frames.

Special procedures may be useful for specific or intractable head pain syndromes including nerve blocks for neuralgia, trigger point injections for myofascial pain syndromes (refer to Section F.4.j, Muscle tone and joint restriction management including spasticity, in the Division’s Moderate/Severe TBI Medical Treatment Guideline), and the use of dental splinting for temporomandibular joint syndrome.

Repeat imaging is generally not required unless there has been a change in symptoms. ● Pharmaceutical treatment The etiology of the headache should be carefully determined prior to initiation of any drug regimens. See the evidence table above for evidence statements regarding specific medications. Prescribers should take into account the significant side effects and contraindications associated with these medications.

Tension type headaches should generally be treated with limited analgesics (NSAIDS or acetaminophen) initially and/or accompanied by physical therapy modalities for neck and shoulder treatments.

The following drugs are not recommended. Petasites hybridus root (butterbur) is not recommended due to the difficulty assuring the quality. Opioid treatment should be avoided. Opioids are not recommended for headache treatment or control.

Combination therapies using caffeine and barbiturates should not be used as a first line of therapy or on a chronic basis due to a likely rebound and the drug combination.

There also is inadequate evidence to support the use of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) to prevent tension headaches.

The recommendations below in the Headache Treatment Algorithm take into account the American Academy of Neurology, the American Headache Society’s latest guideline recommendations, and the Institute of Heath Economics. ● Frequent re-occurrence and maintenance Emergency treatment or inpatient admission is sometimes required when intravenous medications (e.g., dihydroergotamine or other IV medications) and close monitoring are necessary to control migraine or analgesia rebound, especially in individuals with severe depression, suicidal ideation, or complicated medical problems. An individualized interdisciplinary outpatient treatment program may be appropriate when: greater than two disciplines are necessary; there is significant dysfunction secondary to headache; the individual has not returned to work for greater than 3 months; or treatment is geographically inaccessible.

Long-term maintenance plans are necessary in chronic headache management.

Medications may be necessary for an indefinite period; however, a distinction should be made between headache conditions that were pre-existing and those caused by the TBI.

In mTBI, most cases will not result in debilitating frequent headaches. If the patient is suffering from debilitating headaches, a full review of the diagnosis, triggering events, and psychosocial issues should take place. All headache treatment modalities should be focused on independence and return to function. Even if headaches are permanent, it is expected that the individual will be functional and able to return to work.

Headache Treatment Algorithm Initial Evaluation HEADACHES INTERFERING WITH FUNCTION INCLUDING MIGRAINES ↓

History and Physical Evaluation Establish Diagnosis Lab Studies Possible Brain and Cervical Imaging ↓ Initiate Treatment Pharmacological - Preventives Pharmacological - Abortives Non-Pharmacological To be used if 2+ headaches/week or increased headache severity or Limit use to prevent medication overuse headache Education and identification of triggers Medication if terminated rebound present Tricyclic antidepressants: amitriptyline and/or nortriptyline NSAIDs or acetaminophen Physical therapy Beta blockers Calcium channel blockers Sumatriptan and other “triptans” for migraine type headaches Biofeedback SNRIs and SSRIs may also be useful for some patients (such as venlafaxine)

An anti-emetic may accompany the medications in either of the above cells (examples include: metoclopramide, promethazine, and prochlorperazine)

Acupuncture (refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline)

Anti-epileptic drugs Topiramate Divalproex/Valproate Gabapentin Psychology including cognitive behavioral therapy Others with possible effect ACE inhibitors, angiotensin receptor blockers, a-agonists, and memantine Biofeedback relaxation training Joint manipulation therapy (refer to the Division’s Cervical Spine Injury Medical Treatment Guideline for time parameters)

Headache control Good Sub-optimal Continue treatment 3–6 months, then taper.

Preventive medications as appropriate.

Reassess diagnosis, optimize treatment, and identify other contributors.

Referral to additional specialists as needed. ● Botulinum toxin injections Botulinum toxin can be considered in a very small subset of patients with chronic migraines 12–15 days/month who have failed all other conservative treatment, including trials of at least three drug classes, and who have committed to any lifestyle changes related to headache triggers.

Evidence statements regarding botulinum toxin injections for migraine Botulinum toxin is more effective than placebo in the prophylaxis of chronic migraine with headache frequency of 15 or more days per month. trial followed by open-label study Evidence against botulinum toxin injections for cervical pain and cervicogenic headache Botulinum toxin is not different from placebo for cervical pain and is not likely to be clinically more effective than placebo for cervicogenic headache. trials and crossover Indications/recommendations for botulinum toxin injections For chronic migraines not responsive to other treatment and occurring at least 12 days per month or for cervical dystonia, a trial injection must result in documented functional Botulinum injections are no longer generally recommended for cervicogenic or other headaches based on the evidence listed above on of lack of effect. Botulinum injections are not routinely recommended, but they may be used in unusual cases.

Time frames regarding botulinum injections for migraine Maximum duration 4 per year.

F.2 Visual treatment Visual treatment is appropriate to consider for mTBI. Visual impairments may occur secondary to mTBI and in one or more of the following categories: ● visual acuity and visual field function; ● ocular motor control and ocular alignment; ● visual perception.

Note: Visual rehabilitation is also performed for dizziness. (Refer to Section F.3, Neuro-otologic treatment, under Vestibular rehabilitation for details.)

Prevalence of mTBI visual findings, including eye movement disorders and accommodation, appears to be approximately 30 – 60% in blast induced mTBI. Other studies of populations such as athletes confirm presence of visual issues in mTBI. Currently, there are no easy to perform clinical measures to clearly identify these conditions in the primary care settings. These findings generally decrease as cognition improves.

Indications/recommendations for visual treatment An ophthalmologist, neuro-ophthalmologist, neurologist, occupational therapist, certified vision therapist, or optometrist may treat visual impairment resulting from TBI. Treatment of visual impairments should be based on a comprehensive evaluation and diagnosis. When possible, therapy should be provided in an interdisciplinary integrated approach for the purposes of best outcomes and greatest convenience for the patient.

Treatment should be functionally-based and goal-directed. Individuals should be evaluated at intervals depending on his/her impairment, and progress should be clearly documented. Reliance on unvalidated outcome measures, such as performance on tests of “eye teaming” or “eye tracking,” should be avoided. ● Visual acuity and visual field function These are determined by the eye, optic nerve, optic chiasm, optic tracts, optic radiations, and visual cortex. If visual acuity deficits are caused by optic nerve trauma, the best data argues against the use of corticosteroid in almost all cases, in part because of the risk of increased morbidity and mortality from a concomitant head injury. Surgery may be indicated if the trauma results in progressive visual acuity loss in the setting of demonstrable compression of the nerve or if a hematoma is present within the optic nerve sheath. These cases are extremely rare. If visual acuity or visual field deficits are caused by intracranial visual pathway damage, acute treatment should be directed toward the specific injury.

Vision aids may be prescribed for those individuals with documented visual acuity or visual field loss after the acute injury. Lenses may be used to improve visual acuity.

Tinted FL41 lenses may be useful to treat photophobia and glare sensitivity.

The use of optical and digital compensatory devices may benefit some individuals with documented visual field loss from visual pathway disorders that affect the visual fields in both eyes.

Depending on the level of adaptation to the visual field loss, some individuals may need training and education in strategies to improve compensation. Efforts to use visuospatial interventions to improve visual field loss directly without developing compensatory visual scanning are not recommended. The use of computers as a primary and independent form of visual treatment has limited application due to: (1) limitations in the rationale and specific application of software programs to address the needs of the individual with TBI; and (2) difficulty with generalization of learned computer skills into functional environments. Integrated computer-based treatment (i.e., both individualized cognitive and interpersonal therapies) may improve functioning within the context of an interdisciplinary, neuropsychological rehabilitation program. Sole reliance on repeated exposure and practice on computer-based tasks without extensive involvement and intervention by a therapist is not recommended. Virtual reality tools may prove useful for ADL assessment and training; however, they are experimental at the time of this guideline, as there are no strong studies supporting its success. Computerized visual restoration therapy programs or other computerized visual treatment programs, such as virtual reality, are not recommended due to lack of proven clinically meaningful efficacy and cost. ● Disorders involving ocular motility and binocular vision These should be treated according to the underlying diagnosis. Ocular motility includes: ductions, versions, smooth pursuit, saccade, vergence, and vestibular eye movements.

Disorders of binocular vision include strabismus with double vision and disturbances of accommodation and vergence.

Treatment may include the use of lenses, prisms, vision rehabilitation, and/or surgery.

For individuals with disorders of ocular motor and ocular alignment that result in diplopia, the following should be considered based on severity and duration of impairments: monocular eye patching, occlusion of central or peripheral vision, prisms lenses, or strabismus surgery.

Lenses may be used to help accommodation. Because of the interaction between accommodation and vergence, lenses may also at times be used to assist in the treatment of a vergence disorder.

Prisms may be prescribed to provide an immediate improvement in diplopia and other disorders with symptoms. If diplopia is not stable, then appropriate patching (partial selective occlusion) may be more prudent. If deficits are permanent, prisms may be worn Individuals may be instructed in orthoptic techniques to address problems related to strabismus, particularly in cases with cranial nerve palsy.

Strabismus surgery may be useful in certain circumstances if the deficit is stable for several months. An immediate improvement is usually noted after the first surgery, but additional surgeries may be necessary. ● Visual perception Problems should be treated with a goal to improve visual processing skills and promote adaptation and compensation to the relevant problem.

Visual perceptual therapy may be required for some individuals as part of their overall rehabilitation treatment and is overseen by an authorized treating provider with experience in TBI. The therapy may be provided by specialists with experience in visual perceptual disorders. They may be from various disciplines, including, but not limited to, occupational therapy, speech therapy, neuropsychology, optometry and ophthalmology, neurology, and neuro-ophthalmology. ● Visual inattention This is inattention of a visual spatial region. Treatment may include the use of prisms and scanning techniques. Visuospatial rehabilitation with scanning is recommended for individuals with visuospatial perceptual deficits associated with visual neglect following TBI and especially after right parietal stroke. Scanning training is recommended as an important, even critical, intervention element for individuals with severe visual perceptual impairment that includes visual neglect after right hemispheric stroke and TBI. Efforts to use visuospatial interventions to improve visual field loss directly without developing compensatory visual scanning are not recommended.

Time frames regarding all vision therapy (orthoptic therapy)

Time to produce effect 4 hours of treatment should result in a measurable functional Frequency Outpatient: Once weekly with a daily home exercise program.

In-patient: determined by the rehabilitation team, considering the patient’s medical needs and best possible outcomes.

Frequency of treatment is dependent on in-patient versus outpatient and the medical condition of the individual.

Optimum duration 12 hours.

Maximum duration 20 hours. Throughout the treatment process, exams are performed to evaluate status. When progress is no longer occurring, then therapy should be stopped unless there are mitigating circumstances. If after 20 hours of treatment there is documented progress but the individual is not at maximum therapeutic gain, then additional therapy may be indicated. Additional therapy should take into consideration the overall rehabilitation plan for the individual.

These time frames are not meant to be applied to each section separately. The time frames are to be applied to the totality of all vision rehabilitation regardless of the type or combination of therapies being provided.

F.3 Neuro-otologic treatment: vestibular and audiologic For patients with dizziness causing nausea or affecting balance, treatment of these conditions may be necessary before other rehabilitative therapy can be accomplished.

Supporting literature and evidence statements The following recommendations were based on consensus. Supporting literature and evidence statements are also included in the subsections below when available.

Indications/treatment for neuro-otology: vestibular and audiology ● Post-traumatic tinnitus Individuals with TBI may experience debilitating tinnitus (ringing in the ears). Tinnitus may be associated with pressure or noise related trauma and ossicular or perilymphatic fistula disorder. Tinnitus can be evaluated with specific audio-metric testing techniques. Patients may benefit from anti-depressants, anti-seizure medicines, and anxiolytics. In many situations, devices are recommended. These may include hearing aids, maskers, and tinnitus trainers. Tinnitus trainers require a 30-day trial to determine the effectiveness of masking. More sophisticated devices that use music as opposed to masking are not recommended due to no proof of their superiority. ● Hyperacusis Individuals with TBI may experience significant sensitivity to sound. This is more common in association with tinnitus. These individuals may benefit from devices such as tinnitus trainers, musician’s plugs, and simple noise plugs. Continuous exposure to broadband sound may also be used. ● Benign paroxysmal positional vertigo (BPPV)

BPPV is the most common cause of post-traumatic vertigo. It is an otologic disorder in which particles normally adherent to the gravity sensors of the ear become displaced into the semicircular canals, which cause the sensation of spinning. It is characterized by recurrent, brief spells of vertigo triggered by head movements such as getting in and out of bed, rolling over in bed, tipping the head upward, or bending over. It is diagnosed by the Dix Hallpike maneuver and treated with canalith repositioning maneuvers (CRM) specific to the affected semicircular canals. Patients treated by CRM should be reevaluated within the first month to ensure resolution of symptoms. Recurrences are common after trauma. These may be treated by repeating the CRM, home exercises, or referral to physical therapy.

Some individuals may require an exercise-based approach following, or instead of, the CRM. Home exercises are safe and effective in this disorder.

Time frames regarding vestibular rehabilitation for benign paroxysmal positional vertigo Frequency 1 to 3 sessions with repeated CRM at each session and follow-up at 1 month.

Optimum duration 1 month with re-evaluation.

Maximum duration Reoccurrence can occur randomly for many years following trauma.

Home exercises are necessary for those with frequent recurrences.

Some patients are unable to perform home exercises, so repeated visits for CRM may be required. ● Semicircular canal dehiscence This is an abnormal communication between the CSF space in the skull and perilymph surrounding the inner ear. It can result from blunt head trauma with fracture of the bone separating these spaces. Symptoms include vertigo brought on by loud sounds or straining and autophony, which is the magnification of internal bodily sounds (chewing, eye movement, joint movement, heartbeat) in the affected ear. Vestibular suppressants and avoidance of provoking sounds can be used; surgery is required in severe cases. ● Vestibular migraine Individuals experiencing an exacerbation of migraine after TBI frequently have an associated dizziness. Treatment includes trigger avoidance, vestibular suppressants, and migraine prophylactic medications such as calcium channel blockers, anti-seizure medication, beta blockers, and SSRIs. (Refer to Section F.1, Post-traumatic headache treatment.) ● Vestibular rehabilitation Individuals with TBI may experience loss of inner ear balance function resulting in dizziness and imbalance. This can result from labyrinthine concussion, penetrating injuries, injury to the eighth cranial nerve, and explosive pressure changes. Patients may compensate for vestibular deficits more quickly with vestibular rehabilitation than without it.

Persistent postural perceptual dizziness: This is a condition in which patients continue to experience persistent dizziness due to mis-calibration of the sensorimotor, cerebellar, and vestibular inputs. This condition may be comorbid with anxiety. Treatment with aggressive vestibular rehabilitation and either SSRI or SNRI may be beneficial.

Symptoms of vestibular system dysfunction following TBI may be due to damage of central or peripheral structures. These symptoms may include vertigo, eye-head dyscoordination affecting the ability to stabilize gaze during head movements, and imbalance affecting stability in standing or walking. Dizziness is commonly associated with TBI. Dizziness and balance disorders may or may not co-exist in the same individual with TBI.

Vestibular rehabilitation is performed by qualified practitioners, e.g., audiologists, otologists, trained nurses, vestibular therapists, physical therapists (preferably neurology certified) or occupational therapists.

Evidence statements regarding vestibular rehabilitation Vestibular rehabilitation incorporating visual motion performed by the patient alone with brief instruction from a health care provider reduces dizziness and improves function. 2 to 6 sessions of Mulligan sustained natural apophyseal glides (SNAGs) or Maitland mobilizations over 6 weeks are significantly more effective in reducing the intensity and frequency of cervicogenic dizziness than a placebo intervention in patients with chronic cervicogenic dizziness. The effects are maintained at 12 weeks post treatment.

An 8-week program of combined cervical physiotherapy and vestibular rehabilitation is likely to improve the rate of medical clearance for return to sport for patients with a sport-related concussion who have persistent dizziness, neck pain, and/or headache 10 days after injury and who are suspected by a physician of having vestibular involvement or cervical spine involvement.

One study of patients with mTBI 4 years after the incident found 30% continuing complaints of balance problems. A patient with mTBI may complain of continuing dizziness with minor clinical findings. It is suggested that these patients be referred to a vestibular therapist or physical or occupational therapists with vestibular training and experience. ○ Balance disorders Balance disorders occur frequently following TBI. This may be due to a peripheral vestibular lesion or central vestibular lesion secondary to trauma, fracture, hemorrhage, or intracranial pressure changes.

Balance is a complex motor control task, requiring integration of sensory information, neural processing, and biomechanical factors. It is the ability to control the center of gravity (COG) over the base of support in a given sensory environment.

Assessment includes evaluation of the motor system, ROM, and sensory systems that affect the person’s ability to maintain equilibrium. Movement strategies to maintain balance require functional ROM and adequate strength.

Sensory information from the vestibular, visual, and somatosensory systems are integrated at the central level between the two sides of the body and three sensory systems. These key areas are associated with maintenance of balance or posture. Central motor planning is essential for proper strategies that are then transmitted to the peripheral motor system for execution. Deficits at the central level, peripheral motor level, or peripheral sensory level will affect balance and equilibrium.

Common clinical tests used to evaluate balance include the Balance Error Scoring System (BESS), Berg Balance Scale (BBS), Community Balance and Mobility Scale (CB&M), Clinical Test of Sensory Interaction on Balance (CTSIB), Motion Sensitivity Quotient, Sensory Organization Test (SOT), tandem gait task from the Sport Concussion Assessment Tool-3, Functional Gait Assessment (FGA), and an instrumented gait speed assessment. The disadvantage to most of these tests is that they were developed for specific age groups and may not have been studied for TBI. However, the CB&M has been studied for TBI. Selfreport instruments are also available to evaluate balance: ABC scale for dizziness, Dizziness Handicap Inventory (DHI), Vertigo Handicap Questionnaire (VHQ), and the Vestibular Disorder Activities of Daily Living Scale (VADL).

Sources of imbalance symptoms include vestibular, ocular, and cervicogenic.

Vestibular-ocular type may have visual abnormalities on testing and impaired clinical balance. It is usually treated with a vestibular rehabilitation program.

Visual or ocular motor training alone has no demonstrated benefit, and treatment should be done using an interdisciplinary approach. Cervicogenic imbalance is associated with neck pain and headaches associated with head movement. It is usually treated with head and neck proprioceptive re-training and cervical manual therapy.

The dynamic systems model recognizes that balance and dynamic equilibrium are the result of the interaction between the individual, the functional task, and the environment. Emphasis of treatments performed by a qualified physical or occupational therapist in vestibular and balance dysfunction are head exercises for habituation of vertigo, eye-head coordination exercises for improvement of gaze stabilization, and sensorimotor retraining to remediate postural dyscontrol in all functional movement positions. Exercises may be directed at habituation, desensitization by repeat exposure; substitution, alternative strategies; or adaption, improved use of remaining functioning vestibular system.

Special equipment for vestibular treatment in the clinic may include dynamic platform posturography or a foam/dome apparatus for sensory integration and balance as well as tilt or rocker boards. Other virtual reality devices used in isolation are not suggested for use with this treatment because therapist intervention and supervision are important for success. No special equipment is needed at home unless identified by the treating professional and documented as medically necessary.

Individuals with central traumatic vestibular lesions take longer to improve than those with dizziness from other causes. Studies indicate that at six months, only one-third of individuals with unilateral loss from trauma were symptom-free as compared with other causes. At 18 months, many individuals continued to show symptoms. Of those with central vestibular loss, 60-70% had persisting symptoms at five years and half were unable to return to work.

For additional related complaints, refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline treatment section for neuro-otology.

Time frames for vestibular rehabilitation for balance disorders Time to produce effect 6 to 12 weeks depending on severity.

Frequency 1-2 times per week initially for training, with 2-4 follow-up visits to reinforce treatment. Individuals are expected to perform self-directed exercises twice daily at home, but they may require supervision for guidance and safety.

Optimum duration For mTBI, 12 visits.

F.4 Sleep disturbances Sleep disturbances are a frequent occurrence in each spectrum of TBI severity, although milder injuries are associated with greater impairment than moderate or severe injuries. Pooled polysomnography data from meta-analyses have demonstrated reduced sleep efficiency (the ratio of time spent asleep compared to the amount of total time in bed), shorter total sleep duration, and increased time awake after sleep onset. These reported objective findings correlate with subjective reports of greater daytime sleepiness and reduced perceived sleep quality. Sleep-wake disturbances can have a significant impact on functional recovery in patients with TBI and exacerbate secondary symptoms such as pain, headaches, and mood disturbances.

Evidence statements regarding mTBI sleep disturbance Online cognitive behavioral treatment (CBT) programs are comparable to both face-to-face CBT programs as well as pharmacologic therapy in reducing insomnia severity and sleep efficiency.

Blue light therapy significantly reduces self-reported fatigue and daytime sleepiness symptoms and may be helpful in some patients with TBI.

Wrist actigraphy has been validated as a surrogate for sleep patterns and is utilized frequently in sleep-related clinical trials.

Obstructive sleep apnea (OSA) can develop in up to 35% of patients with TBI and should be identified and effectively treated if present. Untreated OSA can not only lead to poor neurocognitive performance and delayed recovery but also to adverse medical outcomes such as diabetes, hypertension, and ischemic heart disease due to restless sleep from repeated arousals and hypoxemia.

Indications/recommendations for sleep disturbances Although physiologic sleep is most effectively measured by polysomnography (PSG), it is often not feasible or necessary to undertake such overnight testing. Subjective self-reporting questionnaires that have been validated against objective measures are the Pittsburgh Sleep Quality Index and the Epworth Sleepiness Scale. These tests are useful tools that can evaluate sleep patterns. Sleep diaries are another subjective tool that may be used to assess self-reported sleep patterns, although there is a paucity of research validating sleep diaries with objective testing. Objective testing measures to assess sleeprelated behaviors include actigraphy and PSG. However, the treating clinician must consider the feasibility of such testing in this population.

Obstructive sleep apnea (OSA) should be identified and effectively treated if present (see studies listed in table above). Patients with OSA will complain of excessive daytime sleepiness, fatigue, and morning headaches. Bed partners may note that patients snore or appear to choke/gasp for air during the night.

OSA should be suspected in patients with symptoms and/or with elevated risk factors such as obesity, a crowded oropharyngeal airway, increased neck circumference, and hypertension. As mentioned above, PSG can be used to diagnose sleep apnea and other sleep related disorders.

Patients identified as having OSA should be treated with a positive airway pressure device such as continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), or autotitrating positive airway pressure (APAP). Patients should also be counseled regarding weight loss strategies if indicated. Frequent evaluations are important to evaluate for adherence to therapy. This may be accomplished through patient interview and review of downloaded data from their device. Objective testing is usually not indicated unless symptoms do not resolve after several weeks of therapy.

In addition to OSA, clinicians should have a low threshold to obtain PSG in patients with TBI and hypersomnia (to rule out narcolepsy) or complaints suspicious for periodic limb movement disorder (uncomfortable urge to move legs and arms during inactivity). Several small studies have suggested that sleep-related movement disorders and parasomnias occur at an increased rate in patients with TBI. If present, mild symptoms of periodic limb movement disorder may be treated with sleep hygiene measures and behavioral therapies previously discussed.

Other sleep disorders should be ruled out when appropriate symptoms are present before proceeding with the following treatments. ● Counseling on sleep hygiene Non-pharmacologic treatments for sleep-wake disturbances following TBI, including modification of sleep hygiene, should be undertaken prior to instituting pharmacologic therapy. Clinicians should be sure to take a comprehensive medical history to include sleep patterns (such as taking naps during the day) and an occupational history to identify any high-risk job duties such as commercial driving or piloting. Patients suffering from a sleep-wake disorder should first receive basic behavioral sleep hygiene and stimulus control counseling.

Counseling should include the following: ○ Set an alarm clock to wake up at a fixed time each morning, including weekends. ○ Try not to force sleep. ○ Avoid caffeinated beverages after lunch and maintain consistent eating schedules, particularly dinner. ○ Avoid alcohol. ○ Avoid smoking or other nicotine intake, particularly during the evening. ○ Adjust the bedroom environment as needed to decrease stimuli (e.g., reduce ambient light, turn off the television or radio). ○ Avoid prolonged use of light-emitting screens (laptops, tablets, smartphones, ebooks) before bedtime. ○ Resolve concerns or worries before bedtime. ○ Exercise regularly for at least 20 minutes, preferably more than 4 to 5 hours prior to bedtime. ○ Avoid daytime naps, especially if they are longer than 20 to 30 minutes or occur late in the day. ○ Go to bed only when sleepy. ○ Do not watch television, read, eat, or worry while in bed. Use bed only for sleep and sex. ○ Get out of bed if unable to fall asleep within 20 minutes and go to another room.

Return to bed only when sleepy. Repeat this step as many times as necessary throughout the night.

Additional conservative measures include the following: ○ Mental alerting activities, such as working on a computer or doing crossword puzzles, at times of rest or boredom. ○ Avoidance of aggravating factors, including consideration of withdrawal of possibly predisposing medications (antidepressants, antihistamines, dopamineblocking antiemetics, and neuroleptic agents). ○ Moderate regular exercise. ○ Reduced caffeine intake. ○ For symptomatic relief: walking, bicycling, soaking the affected limbs, and leg massage, including pneumatic compression. ● Cognitive behavioral therapy Patients with sleep disturbances refractory to these basic counseling measures may benefit from a cognitive behavioral treatment (CBT) program for insomnia. When utilizing internet delivered CBT, the clinician should institute a program of a minimum of six weeks duration and consider including some measure of personal support as opposed to fully automated programs. Additionally, these programs require technical resources which may not be feasible in all patients and a formal in-person CBT program may be more appropriate.

The general components of an effective CBT program may include the following: ○ Basic education regarding sleep and the nature and causes of chronic insomnia should be reviewed. ○ Behavioral therapy targeted problems with sleep maintenance and sleep onset using sleep restriction and stimulus control (see sleep hygiene and stimulus control recommendations). These interventions are designed to reestablish the bed as a dominant cue for sleep onset, regulate sleep-wake schedules, and consolidate sleep over a short period of time. Specifically, sleep restriction induces a state of mild sleep deprivation, which accelerates sleep onset and improves quality of sleep by establishing a “sleep window” for which patients stay in bed. To start, patients should use a sleep diary to determine the total amount of hours spent in bed as well as the amount of hours spent asleep. The amount of time the patient actually spends asleep will determine their initial window and the patient will only spend this specified amount of time in bed. For example, if a patient spends 8 hours in bed on average every night but only 6 hours is spent sleeping, then the patient’s initial window would be 6 hours. Patients can then increase or decrease the time spent in bed by 20 to 30 minutes weekly depending on their sleep efficiency (time spent asleep/total time in bed). If sleep efficiency is >90%, then the patient can increase their time in bed. If sleep efficiency is <80% the patient should decrease time spent in bed. Sleep restriction allows the patient to learn to associate the bed with sleep and sex only. ○ Relaxation training, such as the imagery method, provided as an additional coping skill for patients. Guided imagery helps to inhibit cognitive stimulation by distracting patients and helps to refocus their attention on pleasant scenes that evoke positive emotions. Patients should practice these exercises every night to help them fall asleep. ○ Cognitive components designed to assist patients in exploring how their thoughts affect their sleep behaviors and emotions. Patients should be guided through cognitive restructuring procedures focused on reducing negative self-talk and negative attitudes that can be maladaptive. ○ Sleep hygiene measures as previously mentioned should be continuously reinforced. ● Pharmacologic therapy for insomnia The use of sleep-inducing agents such as benzodiazepines and nonbenzodiazepine hypnotics should generally be avoided as randomized clinical trials directly assessing their effects on insomnia and sleep-wake disorders are scarce. However, they may be useful for the first few weeks for some patients with mTBI and for anxiety. ● Fatigue and day time sleepiness ○ Blue light therapy: Blue light therapy should be administered for 30 to 45 minutes in the morning, within two hours of awakening, with a device containing 66 lightemitting diodes (LED). Patients can self-administer light therapy at home. They should be instructed to sit in front of the light panel with the center approximately 50cm (1.5 feet) in front the eyes and look into the light source for a few seconds at least every few minutes. ○ Pharmacologic agents for fatigue: Although there is a paucity of evidence demonstrating the effectiveness of Modafinil for treatment of fatigue, it may be beneficial for the short-term treatment of excessive daytime sleepiness.

Armodafinil, the enantiomer of Modafinil with a slightly longer time to peak serum concentration, may be effective for the short-term treatment of patients with excessive daytime sleepiness despite good sleep efficiency on PSG. The use of these wakefulness-promoting agents should be restricted to short term use (4 to 6 weeks) in conjunction with nonpharmacologic therapy measures.

F.5 Cognitive treatment In mTBI, acute cognitive deficits are common. In the majority of injured individuals, spontaneous cognitive improvement is expected within the first three months, frequently within days or weeks.

For patients needing treatment, therapists or speech-language pathologists may work with the individual with mTBI in order to teach individuals adaptive skills, compensatory techniques, or new ways of solving problems that assist them in coping more effectively during recovery. The interdisciplinary treatment team approach is particularly beneficial in these cases, and it is strongly encouraged, especially during the first 12 months post-injury. The team may include specialists in neurology, rehabilitative medicine, neuropsychology, and ocular-motor, vestibular, and balance functioning.

“Cognitive rehabilitation is a systematic, functionally oriented service of therapeutic cognitive activities, based on an assessment and understanding of the person’s brain-behavior deficits. Services are directed to achieve functional changes by (1) reinforcing, strengthening, or reestablishing previously learned patterns of behavior, or (2) establishing new patterns of cognitive activity or compensatory mechanisms for impaired neurological systems.”

All cognitive rehabilitation should be focused on functional goals relative to the individual patient’s needs in performing activities of daily living and work. Progress toward achievement of specific goals should continually be monitored during treatment. Strategies should always be task or goal specific or demonstrate generalization of the learned concepts to the daily living activities of the specific patient with external cueing as necessary. Compensatory or cognitive support strategies are useful in this population.

For most patients with mTBI, cognitive therapy will focus on memory, executive function, and in some cases attention. External memory compensation tools, such as memory notebooks, smart phones, and computers can be very helpful. Self-talk strategies may be useful as patients with mTBI return to more complex executive function. When patients with mTBI are required to perform skills requiring alternating or selective attention, specific strategies can be applied to improve the success rate.

Evidence statements regarding mTBI and cognitive treatment Cognitive training has small to moderate positive effects in improving cognitive and functional outcomes in patients with mild to severe TBI who are at least 1-year post-acute TBI when compared to waiting list controls or standard rehabilitation.

Systematic review and meta-analyses of mTBI without post-traumatic amnesia does not require routine rehabilitation.

Routine scheduling for cognitive rehabilitation for uncomplicated mTBI is not likely to improve outcomes, and mTBI cases with a psychiatric history are more likely to benefit from routine assessment for cognitive rehabilitation treatment.

There is inadequate evidence to support that computerize cognitive rehabilitation adds any benefits over conventional rehabilitation for patients with mild to severe TBI or stroke.

Indications for mTBI cognitive treatment Not all patients with mTBI require cognitive treatment. Rehabilitation of cognitive impairments should be initiated if: ● the individual is not demonstrating the expected cognitive improvement; ● the individual exhibits more severe cognitive impairments on formal evaluation; ● the individual’s vocation or other life circumstances necessitate the learning of compensatory strategies; ● there are safety issues in question (e.g., possible harm to self or others).

Recommendations for mTBI cognitive treatment If therapy is required, use the time frames listed below. In individual cases, the physician may determine the need for further evaluation and treatment.

Computer-based treatment with active therapist involvement: Computer-based treatment must be accompanied by oversight from the treating provider either in person or by telehealth. Computer-based treatment is not recommended in isolation.

Assistive technology: These devices must be used in consultation with specialists and within a rehabilitation therapy program by physical therapists, occupational therapists, and speech-language pathologists to determine which tools are most suitable for individual cases.

Time frames regarding mTBI cognitive treatment Frequency Weekly 1-hour sessions initially during the first month to determine specific goals and objective outcomes as part of the primary treatment and return-to-work evaluations. Once the patient has returned to normal function without impairing symptoms, visit frequency should decrease or treatment should be terminated.

Optimum duration 1 to 3 months. Additional sessions may be required as justified. For example, in cases with complicated mTBI or a number of comorbid conditions, treatment patterns may resemble that for moderate/severe injuries.

F.6 Psychological interventions Early interventions that educate individuals, their family and/or support system, or the employer about the symptoms, natural history, prognosis, and management of mTBI symptoms are very important.

Psychological and educational interventions may include, or be performed in conjunction with, cognitive and behavioral treatment. Cognitive behavioral therapy (CBT) is a specialized goal-oriented systematic process used to problem solve that focuses on changing thought processes. It is usually provided by a trained therapist or psychologist.

The acute symptoms of mTBI (e.g., feeling dazed, disoriented, or confused) overlap with those of emotional trauma and acute stress disorder. Over the course of recovery, the symptoms of mTBI also overlap with a variety of psychological conditions, such as depression, anxiety, insomnia, and PTSD.

Consequently, the possibility that the symptoms are neuropsychiatric rather than neuropsychological in origin should be evaluated when the degree of cognitive symptoms exceeds what would be expected given objective findings, the mechanism of injury, or acute signs of mTBI or if there is an unexplained, marked worsening of cognitive symptoms over time. A psychological evaluation is especially important if the injury occurred in an emotionally traumatic context or if there are clinical indications of another mental health disorder.

Evidence statements regarding mTBI psychological/educational interventions 5 individual sessions, 1.5 hours long, of Cognitive Behavioral Therapy (CBT) initiated for patients diagnosed with acute stress disorder early after TBI are significantly more effective than supportive counseling in preventing chronic PTSD in patients who develop acute stress disorder following mTBI.

For patients with complicated mTBI and moderate TBI who have completed initial therapy, 12 weeks of telephone-based and in-person Cognitive Behavioral Therapy (CBT) interventions are no more effective than usual care for treating Major Depressive Disorder (MDD).

Due to the differences noted between groups in this study, it is not possible to determine if telephone CBT is preferable to in-person CBT after initial treatment has been completed. However, telephone CBT allowed more participation by support persons, and this may be important to patients with mTBI.

It is interesting that secondary data showed high satisfaction with CBT, 84%, and only 26% with usual care.

One study noted sustained improvement after 6 months of CBT with either face-to-face or telephone contact. This should always be performed within the construct of a more complete therapy program.

Indications for mTBI psychological/educational interventions Early intervention is appropriate in the acute stage of mTBI for patients at increased risk of prolonged symptoms to promote positive coping skills and to manage symptoms. Risk factors for prolonged symptoms include, but are not limited to: ● Glasgow Coma Scale less than 15 at 2 hours post-injury; ● work risk factors, such as very demanding or stressful vocations or being employed in the current job for a short period of time; ● age above 40 years; ● injury complicated by the presence of intracranial lesions, current or previous; ● history of prior brain injury, cognitive impairment, learning disabilities, or developmental delay; ● associated orthopedic, soft tissue, or organ injuries; ● pre-injury issues with general health or psychosocial well-being; ● psychological factors such as depression, post-traumatic stress disorder, or anxiety – see evidence statement above.

The presence of other injuries requiring medical attention should not exclude anyone from appropriate psychological treatment.

During the first 12 weeks following mTBI, the following should always be treated: ● problems that are secondary to the injury (e.g., anxiety, depression, adjustment disorder, difficulties with self-acceptance, and difficulties in adapting to one’s work demands due to diminished cognitive capacity), and ● post-traumatic stress disorder (PTSD). PTSD may be present in a minority of patients with mTBI and should be assessed early on and treated. ● It is also appropriate to consider intervention to address persistent specific problems that are directly caused by the injury (e.g., memory deficits).

Recommendations for mTBI psychological/educational interventions Early intervention in the acute stage: Psychological treatment after the first 12 weeks, by physicians with experience in brain injury care, is recommended when recovery is hindered by symptoms caused by the injury or by symptoms secondary to it as indicated above. For psychological symptoms lasting longer than six months, refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline. Primary care providers should be made aware of these recommendations as often there is delay in treatment.

Treatment may include individual psychotherapy, marital/family therapy, group therapy, instruction in relaxation and related techniques, cognitive/behavioral therapy, medication management, social skills training, repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant depression, and interventions/consultation in the community. When cognitive interventions are needed, refer to Section F.5, Cognitive treatment.

Functional gains are to be documented and achieved with therapy. They may include, but are not limited to improved mood, irritability, frustration tolerance, concentration, memory, sleep quality, and interpersonal skills (such as empathy and capacity to effectively interact with family and/or support system members and co-workers). ● During the acute stage: Psychological interventions to educate regarding coping mechanisms for common symptom amelioration may include the individual and family and/or support system or alternatively close friends and co-workers. ● During the first 12 weeks: Mental health interventions to address PTSD should be evidence based and may include individual psychotherapy, cognitive/behavioral therapy, instructions in specific techniques such as relaxation training or biofeedback, instruction in symptom management, trauma resolution techniques (e.g., EMDR), group therapy, medications, and interventions in the community.

Time frames regarding mTBI psychological/educational interventions Frequency Weekly 1-hour sessions initially during the first month as part of the primary treatment and return-to-work evaluations. Once a patient has returned to normal function without impairing symptoms, visit frequency should decrease or treatment should be terminated.

Optimum duration Optimum Duration: 1 to 3 months.

F.7 Medications Most mTBI cases do not require prescription medication as the majority of cases resolve without them.

The most common needs for medication in mTBI are anxiety, depression, nausea, and headaches.

Indications/recommendations for medications A number of patients with mTBI have a constellation of complaints including insomnia, headache, and depressive symptoms. When conservative measures are not effective and symptoms are still interfering with activity after seven to ten days, amitriptyline or an SSRI and low dose amitriptyline may be reasonable considerations.

If other medication use can be justified based on specific patient needs, refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline, Section F.4.h, Medications. Specialists should generally be involved for TBI cases requiring multiple medications.

When medication is used for mTBI, a trial of tapering by 6-12 months post-injury is recommended. ● Acetaminophen Acetaminophen is an effective analgesic with anti-pyretic but not anti-inflammatory activity.

Acetaminophen is generally well-tolerated. It causes little or no gastrointestinal (GI) irritation and is not associated with ulcer formation.

However, acetaminophen can exacerbate headache when used chronically.

Acetaminophen also has been associated with liver toxicity in overdose situations or in chronic alcohol use. Patients may not realize that many over-the-counter preparations contain acetaminophen. The total daily dose of acetaminophen is recommended not to exceed three grams per 24-hour period, from all sources, including narcoticacetaminophen combination preparations.

Time frames regarding acetaminophen Maximum duration Long-term use as indicated on a case-by-case basis. Use of this substance long-term (for 3 days per week or greater) may be associated with rebound pain upon cessation. ● Non-steroidal anti-inflammatory drugs (NSAIDs)

NSAIDs are useful for pain and inflammation. In mild cases, they may be the only drugs required for analgesia. Chronic use of NSAIDs is generally not recommended due to increased risk of cardiovascular events and GI bleeding.

There are several classes of NSAIDs. The response of the injured worker to a specific medication is unpredictable. For this reason, a range of NSAIDs may be tried in each case, with the most effective preparation being continued.

Patients should be closely monitored for adverse reactions. The FDA advises that many NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Administration of proton pump inhibitors, histamine 2 blockers, or prostaglandin analog misoprostol along with these NSAIDs may reduce the risk of duodenal and gastric ulceration in patients at higher risk for this adverse event (e.g., age > 60, concurrent antiplatelet or corticosteroid therapy).

They do not impact possible cardiovascular complications.

NSAIDs are associated with abnormal liver function and renal function, including renal failure. Patients with hepatic or renal disease may need increased dosing intervals with chronic use.

Due to the cross-reactivity between aspirin and NSAIDs, NSAIDs should not be used in aspirin-sensitive patients, and they should be used with caution in all patients with asthma.

Topical NSAIDs may be more appropriate for some patients; see evidence statements in table below.

NSAIDs may be associated with non-unions. Thus, their use with fractures is questionable.

Certain NSAIDs may have interactions with various other medications. Individuals may have adverse events not listed above. Intervals for metabolic screening are dependent on the patient's age and general health status and should be within parameters listed for each specific medication. Complete blood count (CBC) and liver and renal function should be monitored at least every six months in patients on chronic NSAIDs and initially when indicated.

There is no evidence to support or refute the use of oral NSAIDs to treat neuropathic pain ○ Non-selective non-steroidal anti-inflammatory drugs: This includes NSAIDs and acetylsalicylic acid. Serious GI toxicity, such as bleeding, perforation, and ulceration can occur at any time, with or without warning symptoms, in patients treated with traditional NSAIDs. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur.

Anaphylactoid reactions may occur in patients taking NSAIDs. NSAIDs may interfere with platelet function. Fluid retention and edema have been observed in some patients taking NSAIDs.

Time Frames regarding non-selective non-steroidal anti-inflammatory drugs Optimum duration 1 week.

Maximum duration 1 year. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation. ○ Selective cyclo-oxygenase-2 (COX-2) inhibitors: COX-2 inhibitors differ from the traditional NSAIDs in adverse side effect profiles. The major advantages of selective COX-2 inhibitors over traditional NSAIDs are that they have less GI toxicity and no platelet effects. COX-2 inhibitors can worsen renal function in patients with renal insufficiency; thus, renal function may need monitoring.

There is an absence of evidence concerning the relative safety of celecoxib at doses greater than 200 mg per day. See also evidence statements in table below.

COX-2 inhibitors should not be first-line for low risk patients who will be using an NSAID short-term. COX-2 inhibitors are indicated in select patients who do not tolerate traditional NSAIDs. Serious upper GI adverse events can occur even in asymptomatic patients. Patients at high risk for GI bleed include those who use alcohol, smoke, are older than 65 years of age, take corticosteroids or anticoagulants, or have a longer duration of therapy. Celecoxib is contraindicated in sulfonamide allergic patients.

Time frames regarding selective cyclo-oxygenase-2 (COX-2) inhibitors Maximum duration Chronic use is appropriate in individual cases. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

Evidence statements regarding nonsteroidal anti-inflammatory drugs (NSAIDs)

Celecoxib in a dose of 200 mg per day, administered over a long period, does not have a worse cardiovascular risk profile than naproxen at a dose of up to 1000 mg per day or ibuprofen at a dose of up to 2400 mg per day. noninferiority Celecoxib has a more favorable safety profile than ibuprofen or naproxen with respect to serious GI adverse events, and it has a more favorable safety profile than ibuprofen with respect to renal adverse events.

Topical NSAIDs are associated with fewer systemic adverse events than oral NSAIDs, e.g., reduced risk of gastrointestinal adverse effects by approximately one third.

F.8 Communication and swallowing Communication and swallowing issues are uncommon in mTBI. However, refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline if treatment is needed.

F.9 Therapeutic exercise Therapeutic exercises, with or without mechanical assistance or resistance, may include a number of modalities as part of the integrated occupational therapy or physical therapy program. A therapeutic exercise program should be initiated at the start of any treatment program and coordinated in an interdisciplinary approach. Such programs should emphasize education, independence, and the importance of an on-going exercise regime.

Both animal and human studies suggest therapeutic exercise has a direct relationship on recovery from a TBI.

Indications for therapeutic exercise Indications include the need for: ● cardiovascular fitness, ● improved muscle strength, ● improved connective tissue strength and integrity, ● increased bone density, ● promotion of circulation to enhance soft tissue healing, ● improvement of muscle recruitment, ● improved proprioception and coordination, and ● increased ROM.

Recommendations for therapeutic exercise Therapeutic exercise may be done as part of the overall occupational therapy or physical therapy program. It is not to be used in isolation. It should occur in an interdisciplinary treatment setting. As with all treatments, specific objective goals should be set initially and monitored during treatment.

The patient and/or caregiver should be instructed in and receive a home or community exercise program that is progressed as functional status improves.

Upon discharge from inpatient or residential rehabilitation, the patient and/or caregiver would be independent in the performance of the home exercise program and would have been educated in the importance of continuing such a program. Educational goals would be to maintain or further improve function and to minimize the risk for aggravation of symptoms in the future.

Time frames regarding therapeutic exercise Time to produce effect 2 to 6 treatments.

Frequency 1 to 3 times per week.

Optimum duration 4 to 8 weeks and concurrent with an active daily home or community exercise program.

Maximum duration 8 to 12 weeks of therapist oversight. Home exercise should continue F.10 Education Education for individuals with TBI and their family and/or support system is appropriate, generally accepted, and widely used in TBI rehabilitation. Shared decision making with the patient is preferred for patients with mTBI.

Most mTBI cases will progress to recovery with sufficient education and not require interdisciplinary Education should be provided to patient with mTBI in printed material with verbal review. It should cover symptoms and expected outcomes, normalize symptoms (i.e., explain that current symptoms are to be expected), reassure about expected positive recovery, cover gradual return to activities and life roles, and give techniques to manage stress.

Indications for education Education provided to the patient, family, and/or support systems is appropriate for all individuals with mTBI.

Recommendations for education Education for individuals and their family and/or support system should include, but is not limited to: ● communication of basic information about the brain and the effects of TBI on behavior, cognition, communication, physical function, and emotional function; ● appropriate family and/or support system interventions; ● possible short-term and long-term outcomes.

Written information and material and referral to credible internet resources may be helpful as the individual and family and/or support system may not be able to remember the vast amount of information provided to them.

For similar reasons, they may need to be provided repeated or ongoing information. Further in-depth education may be required to maximize the individual’s potential for functional living. Treatment plans should include individual and group education as a means of facilitating self-awareness, selfmanagement, and prevention of secondary disability.

In order to maximize treatment outcomes and the durability of those outcomes, treatment providers are highly encouraged to provide: hands-on, personal consultations; education (written, verbal, internet); and support services to families.

Time frames regarding mTBI education Frequency Weekly 1-hour sessions initially during the first month as part of the primary treatment and return-to-work evaluations. Once the patient has returned to normal function without impairing symptoms, visit frequency should decrease or treatment should be terminated.

Optimum duration 1 to 3 months.

F.11 Hyperbaric oxygen (HBO2)

HBO2 was initially thought to improve outcomes.

Evidence statements regarding hyperbaric oxygen HBO2 is unlikely to be beneficial in the setting of mTBI. Systematic review of randomized and nonrandomized studies of HBO2 Complications can occur, including tension pneumothrorax.

Recommendations for HBO2 Hyperbaric oxygen is not recommended acutely or chronically. Ongoing studies could affect this recommendation.

F.12 Interdisciplinary rehabilitation programs Consider referral to an interdisciplinary program based on the results of a comprehensive neuropsychological and/or psychiatric assessment, which should be conducted post-injury in individuals with mTBI and delayed recovery and as soon as appropriate for more severe cases. Informal programs with community-based services are usually most appropriate for patients with mTBI. However, formal inpatient programs may be necessary as described below. The sequencing of treatment is based on the individual’s ability to tolerate and benefit from the specific therapies.

Evidence statements regarding mTBI interdisciplinary rehabilitation programs mTBI without post-traumatic amnesia does not require routine rehabilitation.

Indications/recommendations for mTBI interdisciplinary rehabilitation programs Informal interdisciplinary programs in the workers’ compensation system should be considered for patients who are currently employed, those who cannot attend all day programs, those with language barriers, or those living in areas not offering formal programs. Before treatment has been initiated, the patient, patient’s family and/or support system, physician, and insurer should agree on the treatment approach, methods, and goals. Generally, the type of outpatient program needed will depend on the degree of impact the injury has had on the patient’s medical, physical, psychological, social, and/or vocational functioning.

However, formal inpatient rehabilitation programs may be necessary for patients with mTBI with any of the following conditions: (a) high risk for medical instability; (b) moderate-to-severe impairment of functional status; (c) moderate impairment of cognitive and/or emotional status; (d) dependence on medications from which he or she needs to be withdrawn; and (e) the need for 24-hour supervision. For formal programs, refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline.

Patients with addiction and/or substance abuse problems or high dose opioid or other drugs of potential abuse may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation. Guidelines from the American Society of Addiction Medicine are available and may be consulted relating to the intensity of services required for different classes of patients in order to achieve successful treatment.

G. Return to work & vocational rehabilitation G.1 Return to work In addition to the treatment strategies described below, practitioners should be familiar with how various state and federal statutes and regulations may impact return-to-work planning. These may include, but are not limited to, Family and Medical Leave Act (FMLA), Americans with Disabilities Act (ADA), Occupational Safety and Health Administration (OSHA), Federal Motor Carrier Safety Administration (FMCSA), and the Department of Transportation (DOT).

In the setting of TBI, there is a negative association between psychiatric comorbidity (anxiety, depression, PTSD) and return to work; however, the magnitude of this effect has not been clearly established.

One study found a relationship between perceived self-efficacy in cognitive areas and life satisfaction. The same study found a relationship with employed or volunteer work and satisfaction.

Indications/recommendations for return to work During the first five days post-injury, symptoms can be severe and significantly disrupt normal daily function. Initial considerations should include lightening task load and allowing extra time to complete normal tasks. Thus, shortening the work day or adding breaks, along with decreasing responsibility for the first several weeks, are generally suggested. Driving, heavy lifting, working with dangerous machinery, using ladders, and heights may be restricted because of possible safety risk.

Following mTBI, many individuals are able to resume normal work duties with secondary prevention precautions and education. They typically require little or no additional therapeutic intervention. A small percentage of individuals with mTBI - such as those with age greater than 40, prior TBI, loss of consciousness close to 30 minutes, or mental status changes lasting up to 24 hours - may require more assistance in return to work and accommodations. For individuals with mTBI, it may be necessary to temporarily reduce the time, amount, type, and/or intensity of their work duties or temporarily remain out of work entirely for a period of time, at the discretion of the clinician, and gradually increase hours and complex cognitive and physical duties based on symptomology.

For example, if workers with mTBI have any loss of consciousness or prolonged disorientation, providers should consider restricting higher risk job duties (such as working at heights, working with power tools, and operating heavy machinery) until they have been free from the symptoms, including dizziness and imbalance, for two consecutive weeks. Second impact syndrome (refer to Section C.2, Prevention) has been seen in younger age groups who suffer severe life threatening effects after a second TBI within a short time after the first TBI. Physicians should take this into account when writing work restrictions.

Return to full duty depends on the rate of decrease of symptoms. The individual should be competent in most basic ADLs before return to work is considered. Generally, if symptoms recur during increasing job duties or exertion, duties should be decreased slightly. Very gradual return to activity over weeks may be necessary for cases with symptoms lasting longer than 15 minutes at the time of the injury, unconsciousness lasting minutes, or prolonged amnesia.

Physicians should be aware that symptoms in workers with mTBI may include cognitive deficits in memory, attention, and executive function, even if the worker has no complaints/symptoms. Memory, attention, and executive function should be tested by asking specific questions regarding recent events and having the individual perform specified tasks. Physicians should educate the individual with TBI and his/her supervisor to be aware of possible memory and attention deficits and to accommodate accordingly. Time to return to baseline function will differ according to the individual’s pre-accident condition, age, and medication, as well as other pre-injury, injury, and post-injury factors.

Physicians should attempt to clearly and specifically document vocational restrictions and have a graded or gradual plan for re-entry to work and to communicate with the employer (e.g., supervisor, safety officer, employee health nurse). Having a significant physical disability, psychosocial impairment, cognitive impairment, or a history of alcohol and other substance abuse are factors that impede return to work.

Other factors impeding return to work include difficulties regarding transportation, coordination, and vision. An interdisciplinary team approach may be recommended, which may include a neuropsychological assessment, vocational evaluation, job site analysis, early contact with employer, assessment of vocational feasibility, supervisor education, transferable skills analysis, skillful increased titration of job duties and demands, job coaching, physical therapy, occupational therapy, speechlanguage therapy, and psychological services.

In work situations where the employer is unable to accommodate and a return to the previous occupation is not suitable or appropriate, other options include volunteer placements or supported employment opportunities. See the above return-to-work literature table for a study on volunteer work and life satisfaction. Consider vocational re-training, individualized/specialized job placement services, and job coaching as needed.

Based on the evidence listed in the evidence table above, all patients with TBI should have psychological/neuropsychological evaluations and treatment as needed.

For individuals with mTBI who have persistent deficits or who have difficulty once back at work, a returnto-work program should occur, which requires a carefully designed and managed plan involving the person with TBI, his/her employer, and the treatment team. Physicians should consider evaluation and treatment for comorbid conditions such as chronic pain, stress level, pre-existing personality disorders, depression, anxiety, and/or substance abuse. Communication among all involved parties and the avoidance of fragmentation among treatment professionals is critical to successful outcome. Case management may be indicated to facilitate communication. Following return to work, maintenance support services are appropriate to best ensure the durability of the outcome.

G.1.a Recommended vocational rehabilitation assessment According to Inter-Professional Clinical Practice Guidelines, a vocational evaluation should include some of the following: ● initial intake process, including: ○ pre-injury history; ○ educational and work histories; ○ current social status; ○ pre-injury job performance and performance evaluations; and ○ successes and failures in post-injury work trials; ● assessment of the person (individual’s perspective), including: ○ work goals, values, and meaning he/she attached to work pre- and post-injury; ○ work performance, strengths, weaknesses, current work competency; ○ compensatory strategies and support needs; ○ readiness to work and anticipated challenges/barriers to work or return to work; ○ individual’s own assessment of the costs and benefits of working; ○ individual’s view of the implications of a decision not to work (e.g., insurance and benefits); ● assessment of an individual’s functional status and level of independence; ● observations of an individual’s work-related skills and behavior during performance in real work setting, or if unavailable, simulated work tasks; ● assessment of the physical workplace environment; ● assessment of supports (i.e., formal and informal) and opportunities within the workplace and the individual’s support network including availability of accommodations and/or job modifications; ● assessment of the occupational/job requirements.

G.2 Driving If evaluation and treatment for driving is needed, refer to the Division’s Moderate/Severe TBI Medical Treatment Guideline.

G.3 Vocational rehabilitation Vocational rehabilitation is a generally accepted intervention, but the Colorado Workers’ Compensation statute limits its use.

In one study, a brain injury vocational rehabilitation program was successful at returning 41% of clients to competitive employment. The majority of the cases were 2 years or more from date of injury and had injuries classified as severe (post-traumatic amnesia duration of 1 or more days).

These cases were also without significant behavioral problems and able to function independently for ADLs. The program included cognitive training for those who had not previously received it and job trials with job coach support.

Indications/recommendations for vocational rehabilitation Initiation of vocational rehabilitation requires adequate evaluation of individuals with TBI for quantification of highest functional level, motivation, and achievement of MMI. Vocational rehabilitation should involve a comprehensive job analysis and a carefully planned return-to-work strategy with input from the treating physician and interdisciplinary team. In some instances, retraining may need to occur to access new job markets. (Refer to Section G, Return to work.)

G.4 Work conditioning These well-accepted programs are work-related, outcome-focused, and individualized treatment programs. Objectives of the program include, but are not limited to, improvement of cardiopulmonary and neuromusculoskeletal functions (strength, endurance, movement, flexibility, stability, and motor control functions), patient education, and symptom relief. The goal is for patients to gain full or optimal function and return to work.

Indications for work conditioning These programs are usually initiated once re-conditioning has been completed, but they may be offered at any time throughout the recovery phase. It should be initiated when imminent return of a patient to modified or full duty is not an option but the prognosis for returning the patient to work at completion of the program is at least fair to good.

Recommendations for work conditioning The service may include the time-limited use of modalities, both active and passive, in conjunction with therapeutic exercise, functional activities, general conditioning body mechanics, and re-training of lifting techniques. The patient should be assisted in learning to pace activities to avoid exacerbations.

Time frames regarding work conditioning Length of visit 1 to 4 hours per day.

Maximum duration 6 weeks. Participation in a program beyond 6 weeks should be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

G.5 Work simulation Work simulation is a generally accepted program where an individual completes specific work-related tasks for a particular job and return to work.

Indications/recommendations for work simulation Use of this program is appropriate when modified duty can only be partially accommodated in the work place, when modified duty in the work place is unavailable, or when the patient requires more structured supervision. The need for work-place simulation should be based on the results of a functional capacity evaluation and/or job site analysis.

Time frames regarding work simulation Length of visit 2 to 6 hours per day.

Maximum duration 6 weeks. Participation in a program beyond 6 weeks should be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

H. Maintenance management Most individuals following mTBI make a good neurological and functional recovery with minimal or no intervention, although the possibility of subtle residual impairments or functional limitations exists. Some individuals with mTBI experience impairments, functional limitations, and disabilities. Individuals with mTBI who have comorbid conditions and/or have experienced a longer period of confusion or loss of consciousness are more likely to have a poorer outcome and require longer treatment or maintenance care. For patients with mTBI with specific additional issues, further care may require treatment or followup with specialty services such as optometry, neuro-ophthalmology, neuro-otology, rehabilitation psychology, neuropsychology, and physical medicine and rehabilitation including brain injury medicine.

Medical and rehabilitation providers are encouraged to educate individuals and their family and/or support systems regarding anticipated ongoing medical and rehabilitation needs.

Patients and families and/or support systems should understand that failure to comply with the elements of the self-management program or therapeutic plan of care may affect consideration of other interventions.

Periodic reassessment of the individual’s condition will occur as appropriate. The overall maintenance plan should be reassessed at least annually by the authorized treating provider.

Programs should be individualized to specific needs and may include the following.

H.1 Exercise programs requiring gym memberships or special facilities Some individuals with mTBI may have higher compliance with an independent exercise program at a health club or a community activity-based wellness program versus participation in a home program, although individuals with mTBI may require supervision or guidance.

Indications/recommendations for exercise programs requiring gym membership or special facilities All exercise programs completed through a health club facility should be approved by the treating therapist and/or physician and focus on the same parameters of an age-adjusted and diagnosis-specific program for aerobic conditioning, flexibility, balance, stabilization, and strength. Prior to purchasing a membership, a therapist and/or exercise specialist who has treated the individual should visit the facility with the individual to ensure proper use of the equipment. Periodic program evaluation and upgrading may be necessary by the therapist. The use of a personal trainer may be necessary.

Time frames regarding exercise programs requiring special facilities: maintenance Frequency Approximately 2 times per week. Regular attendance is necessary for continuation, with an exception for a medical or sufficient intervening cause.

Continuation beyond 3 months after MMI should be based on functional benefit and compliance. At MMI, health club membership should not extend beyond 3 months if attendance drops below 2 times per week on a regular basis without a medical cause.

H.2 Home exercise programs and exercise equipment Most patients have the ability to participate in a home exercise program after completion of a supervised exercise rehabilitation program.

Indications/recommendations for home exercise maintenance programs Programs should incorporate an exercise prescription including the continuation of an age-adjusted and diagnosis-specific program for aerobic conditioning, flexibility, stabilization, balance, and strength. Home exercise programs are most effective when done three to five times a week. For chronic pain, refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline.

Follow-up evaluations in the home should occur to ensure compliance and to upgrade the home program.

H.3 Medication management Medications may be necessary for long-term management of some individuals with mTBI.

Indications/recommendations for medication maintenance management Medications may be used for medical, physical, perceptual, cognitive, neuroendocrine, and psychological reasons, and they should be prescribed by physicians experienced in mTBI medication management.

Reasons for possible medications and the types and names of medication are numerous, are individualized for each person, and are beyond the scope of these guidelines.

In situations where there are multiple providers for multiple clinical issues, coordination of the total medication regimen is essential. It is strongly recommended that changes in medication be discussed with the physician who is primarily managing the case.

As with all prescriptive regimens, physicians periodically reassess the efficacy and side effects of each medication. This is particularly true for individuals who are on long-term medication use. Physicians must follow patients who are on any chronic medication or prescription regimen for compliance, efficacy, and side effects. Individuals with mTBI are particularly susceptible to certain medication side effects, including compromised cognitive function, decreased seizure threshold, and other neurological effects. Follow-up visits should document the individual’s ability to perform routine functions. Laboratory or other testing is usually required on a regular basis to monitor medication effects on organ function. For some, medications and drug levels should be closely monitored.

Individuals with mTBI may forget to take medications and/or have difficulty with complicated medication regimens. They may need assistance with medication management, such as reminders, medication boxes, assistance with filling medication boxes, or medication administration supervision. Some medications may need to be prescribed in small amounts or locked due to safety in patients who are impulsive, forgetful, inconsistent, or otherwise unsafe in independent medication management.

Time frames regarding medication management: maintenance Frequency Medication and medical management reviews may need to be monthly or more frequently if necessary for changes in medication. Frequency depends on the medications prescribed, with laboratory and other monitoring performed as appropriate.

Maintenance duration As new medications become available and side effects of other medications are established, there may need to be changes in medical H.4 Patient education management Functional abilities and support systems for individuals with mTBI may change over time and frequently require additional support.

Indications/recommendations for patient education maintenance management Educational classes or sessions may be necessary to reinforce self-management techniques to help the individual adjust to life changes. This may be performed as formal or informal programs, either group or individual.

Time frames regarding patient education management: maintenance Frequency 2 to 6 educational sessions during one 12-month period. Changes in life circumstances or the individual’s condition may require greater frequency of educational sessions.

H.5 Cognitive/behavioral/psychological management In some cases, additional treatment may be necessary, especially when support systems or employment has changed.

Indications/recommendations for cognitive/behavioral/psychological maintenance management For select patients with mTBI, longer supervised psychological/psychiatric treatment may be required, especially if there are ongoing medical procedures or complications. The treatment plan/progress must show severity.

If counseling beyond six months is indicated, the management of psychosocial risks, functional progress, or functional stability to prevent deterioration must be documented. Treatment may be sporadic and may vary depending on the life change requirements of the patients with mTBI.

H.6 Neuromedical management Some patients with mTBI will have ongoing medical issues requiring treatment on a regular basis.

Indications/recommendations for neuromedical maintenance management Examples of related medical diagnoses include, but are not limited to: neuro-endocrine dysfunction, urinary incontinence, heterotrophic ossification, seizures, and other conditions described in the treatment sections of this guideline.

Time frames regarding neuromedical management: maintenance Frequency Medical management visit frequency will depend on the severity of the medical condition but may occur monthly or more frequently.

Visits should occur at least at 6-month intervals for extremely stable H.7 Physical, occupational, and speech-language therapy Exacerbation of symptoms or decline in functional status may require short-term intensive treatment to return the individual to maximized function.

Indications/recommendations for PT/OT/ST Therapy may be indicated on a continued basis if the therapy maintains objective physical function, decreases pain, or decreases medication use. In those situations, frequency and duration parameters as defined in this guideline apply. Changes in the individual’s living situation, role, and responsibilities at home or work, support systems, and/or life’s stressors may require monitoring to determine the impact on daily function. Short-term speech-language therapy emphasizing patient education, compensatory strategies, and functional goals measured objectively may be indicated. Participation in a PT, OT, or ST maintenance program must be documented with respect to need and the ability of the program to facilitate positive symptomatic gains or functional gains.

For time frames to address changes, refer to Section F, Treatment.

H.8 Durable medical equipment: purchase, rental, and maintenance It is recognized that some patients may require ongoing use of equipment for the purpose of maintaining MMI in the areas of strength, ROM, balance, tone control, functional mobility, ADLs, and/or analgesic effect.

Indications for purchase or rental of durable medical equipment Purchase or rental of this equipment should be done only if the assessment by the physician and/or therapist has determined the safety, effectiveness, compliance, and improved or maintained function by its application.

Recommendations for purchase, rental, and maintenance of durable medical equipment It is generally felt that large expense purchases (such as spas, whirlpools, and special mattresses) are not necessary to maintain function for patients with mTBI, but gym memberships is encouraged to keep the patient as active as possible to prevent deterioration.

Periodic maintenance and replacement of the equipment may be indicated and should be considered in the maintenance plan.

Time frames regarding durable medical equipment: maintenance Not to exceed 6 months for rental of large equipment. Purchase and maintenance should occur if effective.

RULE 17, EXHIBIT 2B Moderate/Severe Traumatic Brain Injury Medical Treatment Guideline A. Guideline introduction This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of guidelines for physicians/providers treating individuals who qualify as injured workers with traumatic brain injury (TBI) under the Colorado Workers’ Compensation Act.

Although the primary purposes of this document for practitioners are advisory and educational, this guideline is enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from this guideline, as individual cases dictate. Therefore, this guideline is not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip or overlook any sections.

B. General guideline principles The principles summarized in this section are key to the intended implementation of all Division of Workers’ Compensation medical treatment guidelines and critical to the reader’s application of the guidelines in this document.

B.1 Application of the guidelines The Division provides procedures to implement medical treatment guidelines and to foster communication to resolve disputes among the provider, payer, and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the office of administrative courts.

B.2 Education Education of the individual and family and/or support system, as well as the employer, insurer, policy makers, and the community, should be the primary emphasis in the treatment of TBI. Currently, practitioners often think of education last, after medications, manual therapy, and surgery. Practitioners must implement strategies to educate individuals with TBI, employers, insurance systems, policy makers, and the community as a whole. An education-based paradigm should always start with inexpensive communication that provides recovery, function-focused, patient-centered, and evidence-based information to the individual with TBI. More in-depth education is currently a component of treatment regimens that employ functional, restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention. Facilitation through language interpretation, when necessary, is a priority and part of the medical care treatment protocol.

B.3 Informed decision making Providers should implement informed decision making as a crucial element of a successful treatment plan. Patients, with the assistance of their health care practitioner and support system, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, psychologists, physical therapists, and other members of the health care team play an integral role in informed decision making and achievement of functional goals. Patient education and informed decision making should facilitate self-management of symptoms and prevention of further injury.

B.4 Treatment parameter duration Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Obviously, duration will be impacted by the individual’s adherence, as well as availability of services. Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

B.5 Active interventions Active interventions emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, are generally utilized over passive modalities, especially as treatment progresses. Generally, passive interventions are viewed as a means to facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

B.6 Active therapeutic exercise program Exercise program goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

B.7 Positive patient response Positive results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to: positional tolerances, range of motion (ROM), strength, endurance, activities of daily living, ability to function at work, cognition and communication, psychological behavior, and efficiency/velocity measures that can be quantified. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation.

Anatomic correlation must be based on objective findings. Patient completed functional questionnaires such as those recommended by the Division as part of Quality Performance and Outcomes Payments (QPOP, see Rule 18-8), the Patient Specific Functional Scale, or other validated function scales can provide useful additional confirmation.

B.8 Re-evaluation of treatment no less than every 3 to 4 weeks If a given treatment or modality is not producing positive results within 3 to 4 weeks or within the time to produce effect in the guidelines, the treatment should be either modified or discontinued. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results. Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

B.9 Surgical interventions Surgery should be contemplated within the context of expected functional outcome and not purely for the

purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic conditions.

B.10 Six-month time frame The prognosis drops precipitously for returning an injured worker to work once he/she has been temporarily totally disabled for more than six months. The emphasis within these guidelines is to move patients along a continuum of care and return to work within a six-month time frame, whenever possible.

It is important to note that time frames may be less pertinent for injuries that do not involve work-time loss or are not occupationally related.

B.11 Return to work When considering return-to-work options following TBI, the practitioner must skillfully match the individual's abilities (physical, cognitive, communicative, psychological, and behavioral) and the work requirements. Qualified vocational rehabilitation practitioners may be used for moderate/severe cases.

The practitioner must write detailed restrictions when returning an individual with TBI to limited duty. An individual with TBI should never be released to "sedentary or light duty" without specific physical, psychological, and cognitive limitations. The practitioner must understand essential job functions and job requirements/duties, as well as all of the physical, visual, cognitive, psychological, and behavioral demands of the individual's job position before returning him/her to full duty. Job duty clarification should be obtained from the employer or others if necessary, including but not limited to: employer supervisor or co-worker, an occupational health nurse, occupational therapist, physical therapist, speech-language pathologist, vocational rehabilitation specialist, case manager, industrial hygienist, or other appropriately trained professional.

B.12 Delayed recovery All individuals with moderate/severe TBI (M/S TBI) will require an integrated system of care.

Interdisciplinary rehabilitation treatment and vocational goal setting may need to be initiated for those who are failing to make expected progress 6 to 12 weeks after an injury. Neurological recovery following M/S TBI is greatest in the first 12 months post-injury, but may occur for up to 2 years post-injury, with further functional improvements beyond 2 years. The Division recognizes that 3–10% of all industrially injured individuals will not recover within the timelines outlined in this document despite optimal care. Such individuals should have completed a full neuropsychological evaluation. These individuals may require treatment beyond the limits discussed within this document, but such treatment will require clear documentation by the authorized treating provider focusing on objective functional gains afforded by further treatment. M/S TBI may have a prolonged recovery and frequently requires continuing treatment as addressed in the post Maximum Medical Improvement (MMI) care section.

B.13 Guideline recommendations and inclusion of medical evidence All recommendations are based on available evidence and/or consensus judgment. A Division staff methodologist (MD, MSPH) researched and adopted literature critique criteria. Literature critiques were performed in a manner congruent with national standards and were completed independent of the multidisciplinary task force group which drafted initial recommendations. The methodology is described in detail on the Division’s website. Please also refer to the Division’s website for evidence tables and study critiques which provide details on the studies used to develop the evidence statements.

When possible, guideline recommendations note the level of evidence supporting the treatment recommendation. It is generally recognized that early reports of a positive treatment effect are frequently weakened or overturned by subsequent research. When interpreting medical evidence statements in the guideline, the following apply: ● Consensus means the judgment of experienced professionals based on general medical principles. Consensus recommendations are designated in the guidelines as “generally well-accepted,” “generally accepted,” “acceptable/accepted,” or “well-established.” ● “Some evidence” means the recommendation considered at least one adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the intervention’s effect. ● “Good evidence” means the recommendation considered the availability of multiple adequate scientific studies or at least one relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the intervention’s effect. ● “Strong evidence” means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the intervention’s effect.

There is limited and varied literature on TBI. Therefore, many of the studies cited focus on athletes, military personnel, or stroke survivors.

All recommendations in the guideline are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guideline as “not recommended.”

B.14 Treatment of pre-existing conditions The conditions that preexisted the work injury/disease will need to be managed under two circumstances:

(a) A pre-existing condition exacerbated by a work injury/disease should be treated until the patient has returned to their objectively verified prior level of functioning or Maximum Medical Improvement (MMI); and (b) A pre-existing condition not directly caused by a work injury/disease but which may prevent recovery from that injury should be treated until its objectively verified negative impact has been controlled. The focus of treatment should remain on the work injury/disease.

The remainder of this document should be interpreted within the parameters of these guideline principles that may lead to more optimal medical and functional outcomes for injured workers.

B.15 Post maximum medical improvement (MMI) care This document includes recommendations for post-MMI care in appropriate cases. (Refer to Section H, Maintenance management.)

C. Introduction to traumatic brain injury (TBI)

C.1 Definitions of TBI Before a diagnosis of TBI is made, the physician should assess the level of trauma exposure to the individual using available objective evidence. According to the Institute of Medicine of the National Academies, TBI is an injury to the head or brain caused by externally inflicted trauma. The Department of Defense defines TBI as a “traumatically induced structural injury and/or physiological disruption of brain functions as a result of an external force.” TBI may be caused by a blow to the head from an object or by striking an object, by acceleration or deceleration forces without impact, or by blast injury or penetration to the head that disrupts the normal function of the brain.

A diagnosis of TBI is based on acute injury parameters and should be determined by the criteria listed below. Severity of initial impairment following TBI is subdivided into two major categories, mild TBI (mTBI) and moderate/severe TBI (M/S TBI). These definitions apply to the initial severity of impairment and do not necessarily define or describe the degree of subsequent impairment or disability.

After sustaining a TBI, whether initially diagnosed as mTBI (including complicated mTBI) or M/S TBI, assessment, evaluation, and testing under the Division’s Moderate/Severe TBI Medical Treatment Guideline is appropriate when there are complex questions related to differential diagnosis (brain injury versus other diagnosis) or when the patient is not progressing in cognitive function and/or activities of daily living (ADLs). There should be a clear rationale for undertaking testing and/or treatment under the M/S TBI Guideline.

C.1.a Mild TBI (mTBI) mTBI is a traumatically induced physiological disruption of brain function, as manifested by at least one of the following, documented within 24 to 72 hours of an injury: ● any loss of consciousness ● any loss of memory for events immediately before or after the injury ● any alteration of mental status at the time of the injury (e.g., feeling dazed, disoriented, or confused) ● focal neurological deficit(s) that may or may not be transient but where the severity of the injury does not exceed the following: ○ loss of consciousness for approximately 30 minutes or less, ○ at 30 minutes, a Glasgow Coma Scale (GCS) of 13–15, and ○ post-traumatic amnesia (PTA) not greater than 24 hours.

If the GCS is not available, the closest approximation to the patient’s state at 30 minutes post-injury should be used.

If the patient presents with any of the above after 72 hours, the clinician will need to use available information to construct a diagnosis.

Refer to the Division’s Mild Traumatic Brain Injury Medical Treatment Guideline.

C.1.b Complicated mTBI Complicated mTBI is an mTBI accompanied by structural brain damage visualized on initial structural neuroimaging. More patients in this group have slow or incomplete recovery as compared to patients without this finding. However, the imaging finding alone may not fully predict the clinical course of an individual with mTBI. Based on a reanalysis of data from the Dikmen study, there is some evidence that mTBI and complicated mTBI – whether the GCS is 15 or 13-14 – are similar with respect to the frequency of persistent concussion symptoms at one month and one year. The term is not separately addressed in this guideline to determine care, but it should be understood that complicated mTBI cases will frequently require more extensive treatment than that described under mTBI and may be given care listed under this guideline for M/S TBI as appropriate for the individual.

C.1.c Moderate/severe TBI (M/S TBI)

M/S TBI is a traumatically induced physiological and/or anatomic disruption of brain function as manifested by at least one of the following: ● altered state of consciousness or loss of consciousness for greater than 30 minutes, ● an initial GCS of 12 or less, and/or standardized structural neuro-imaging evidence of trauma, and/or ● post-traumatic amnesia (PTA) greater than 24 hours.

If the GCS is not available, the closest approximation to the patient’s state at 30 minutes post-injury should be used.

C.1.d Other terminology Once a patient has met the definitions above in C.1.c for M/S TBI or C.1.b for complicated mTBI, which requires more care, the treatment patterns and diagnostic tools of this guideline apply. The following terms are noted for information only. ● Acquired brain injury (ABI): ABI refers to any type of brain injury that occurs after birth and that is not related to a congenital disorder or degenerative disease. In addition to TBI, ABI also includes damage to the brain from internal factors such as lack of oxygen, brain bleed, exposure to toxins, infection, or pressure from a tumor. Although nontraumatic ABI may have symptoms and treatments in common with TBI, this guideline was developed specifically for TBI. It is possible that some of these treatments may be useful for other types of ABI. ● Concussion: There is some disagreement in the literature regarding definitions and terminology. “Concussion” is used synonymously with mTBI in many papers. The term is only referenced in this guideline when describing studies using the terminology. ● Post-Concussive Syndrome (PCS): PCS is an accepted diagnosis that is generally determined by the number of symptoms present after an mTBI and how long they persist.

However, the symptoms used to determine the presence of PCS are frequently present in those without mTBI. In this guideline, once a person has been diagnosed with mTBI, any of the treatments for continuing symptoms may be used. Thus, the diagnostic category of PCS is not necessary and should not be used in isolation to access the treatments in this guideline.

C.2 Prevention Prevention of injuries such as TBI is an essential component of any medical treatment guideline or injury management program. TBI is a dynamic condition, and patients may deteriorate over time in the areas of physical and mental health, cognition, employment, and activities of daily living (ADLs). The following guideline-specific definitions of the various types and levels of prevention are necessary to prevent the deterioration from a healthy state to pathology and to successfully intervene at the levels of disablement described in section C.4, Disability. ● Primary prevention The goal is the prevention of disease in a susceptible, or potentially susceptible, population through specific measures, including general health promotion efforts. All health providers should remind individuals, supervisors, and employers of the primary measures for preventing recurring TBIs.

Always use appropriate protective equipment on jobs that require protection, including following all of the employment policy and procedures related to the safety of the individual, co-workers, or external customers. Examples of primary prevention include: ○ Provide safety guidelines for employer premises; ○ Wear protective helmets, complying with the American National Standards Institute (ANSI), on jobs requiring protection from falling objects or electrical hazards; ○ Wear protective helmets and headwear when involved in contact, collision, and other sports such as biking, horseback riding, skating, skiing, and snowboarding; ○ Wear safety goggles or glasses on jobs that require protection from flying objects or debris; ○ Avoid walking on wet, slippery floors on the worksite, or wear the appropriate footwear for the conditions; ○ Ensure that scaffolding has appropriate railings/or harnesses, and that they and are in good working order; ○ Use ladders in accordance with Occupational Safety and Health Administration (OSHA) recommendations (e.g., make sure that ladders over 20 feet tall have cages); ○ Provide and use airbags, safety belts, etc., in motor vehicles; ○ Avoid alcohol and other drug use, including marijuana, during recreational activities such as boating, hunting, skiing, snowboarding, etc., while driving or operating equipment, when working from elevated surfaces, and at work; ○ Avoid distracted driving (e.g., driving while texting, using cell phone, etc.); ○ Practice fatigue management techniques, such as limiting duty hours and night shifts, to maintain optimal energy levels for the required work tasks; ○ Weight management and regular exercise may decrease the likelihood of an injury as well as length of recovery when an injury occurs. ● Secondary prevention Secondary prevention includes efforts to decrease duration of illness, severity of disease, and sequelae through early diagnosis and prompt intervention.

Early diagnosis of individuals with M/S TBI is critical in helping to avoid secondary symptoms and problems in living. Individuals with a previous history of TBI, comorbid conditions, psychiatric disorders, cognitive disorders, and substance abuse are also at greater risk for poor outcome and represent an opportunity to reduce the effects of TBI.

Such individuals should receive appropriate referrals for the comorbid conditions, and treatment of these comorbid conditions should be integrated into the individual’s rehabilitation program.

Workers who have sustained a recent TBI should be especially cautious about returning to work activities that may lead to a second TBI since second injuries occurring prior to a full recovery from the initial TBI may have more serious consequences. Providers should practice secondary prevention by setting appropriate restrictions for these workers and workers who are suffering from impairment, such as dizziness, that could lead to falls in some work environments. (Refer to Section G, Return to work.) ● Tertiary prevention Tertiary prevention encompasses the effort to decrease the degree of disability and promote rehabilitation and restoration of function in individuals with chronic and irreversible diseases and to prevent disease and disability. Life-long management and follow-up services may be required for select individuals with TBI with persistent medical, cognitive, psychological, and/or functional skill deficits.

The majority of this guideline addresses secondary and tertiary prevention of disability for workers with TBI.

C.3 Interdisciplinary rehabilitation professionals An interdisciplinary treatment team is an alliance of professionals from different medical or therapeutic disciplines (as described below) that provides a coordinated treatment program. The particular treatment needs of the individual with TBI will determine the disciplines that make up the team. The team establishes treatment priorities and goals and provides treatment. Team members contribute their respective skills, competencies, insight, and perspectives to the rehabilitation process. This includes education, communication, and alignment of expectations to optimize treatment outcomes. It is highly recommended that the individual with TBI participate in team planning, along with his or her family and/or support system, insurance carrier, case manager, and sometimes the employer or return-to-work specialist when addressing return-to-work planning. (Refer to Section G, Return to work.)

The most common disciplines, in alphabetical order, involved in the medical and rehabilitation treatment of TBI include but are not limited to: ● Behavioral psychologist: a psychologist with special training, credentials, and licensing who specializes in the area of behavior analysis and treatment. ● Behavioral analyst: a master’s level, certified behavioral analyst who designs and supervises behavioral interventions. Behavioral assessments by an analyst do not substitute for neuropsychological assessments. ● Case manager: Case managers are initially trained under a variety of disciplines such as nursing, social work, and other health and human services fields and should be certified through the Commission for Case Manager Certification (CCMC). In order to achieve the best possible outcome for everyone involved, it is best to provide case management services in an environment in which the case manager, the client, the client’s family and/or support system, and the appropriate service personnel are able to communicate directly. It is crucial that the case manager be thoroughly educated in the complexities of treating individuals with TBI.

Case managers may perform Utilization Review (UR) as a part of case management duties, but UR alone is not case management.

The primary functions of TBI case management are: ○ to obtain information through a comprehensive assessment of the injured individual and his/her family and/or support system; ○ to work with the health care team, the injured worker, and family and/or support system in development, monitoring, and implementation of a comprehensive case management plan. Plan reassessment should be completed on a regular

basis; ○ to optimize access to appropriate health care services and maintain cost effectiveness; ○ to integrate and coordinate service delivery among all providers and to prevent fragmentation of services by facilitating communication and by involving the injured worker and family and/or support system in the decision-making process; ○ to educate and collaborate with the injured worker, family and/or support system, and the health care team when necessary about treatment options, compliance issues, and community resources; ○ to predict and avoid potential complications. ● Chiropractor: a credentialed and licensed doctor of chiropractic who assesses and treats human illness and injury, including, but not limited to: musculoskeletal injuries; movement dysfunction; impairments in strength, muscle tone, motor control, posture coordination, endurance, and functional mobility; neurological injuries; and loss of function.

Chiropractic utilizes joint manipulation and spinal and joint rehabilitation, along with various therapies and modalities. ● Clinical pharmacist: a pharmacist with expertise in medication management. He/she might be useful for patients with multiple medication regimens. ● Clinical psychologist: a psychologist with special training, credentials, and licensing who specializes in the assessment and treatment of personality and psychological disorders, education and adjustment counseling, psychotherapy, and management of behavior. ● Driver rehabilitation specialist: an individual who is trained in the health care field and certified by the Association for Driver Rehabilitation and the American Occupational Therapy Association. ● Independent life skills trainer: an individual with documented training to develop and maintain an individual’s ability to independently sustain him or herself physically, emotionally, and economically. Services may include: assessment, training, and supervision or assistance to an individual with self-care; medication supervision; task completion; communication skill building; interpersonal skill development; socialization; therapeutic recreation; sensory motor skills; mobility or community transportation training; reduction or elimination of maladaptive behaviors; problem solving skill development; benefits coordination; resource coordination; financial management; and household ● Music therapist: an individual who is board certified and trained to use music within a therapeutic relationship to improve cognitive, sensory, motor, communication, and behavioral functions that have been affected by neurologic disease. ● Neurologist: a physician with special training and credentials in the area of the nervous system who has successfully completed an approved residency in neurology. ● Neuro-ophthalmologist: an ophthalmologist or neurologist who has completed an approved residency in ophthalmology or neurology, who has completed a fellowship in neuro-ophthalmology, and who specializes in the treatment of visual disorders related to the nervous system. ● Neuro-otologist: a physician who has completed a fellowship in neurotology or otoneurology. ● Neuropsychologist: a licensed psychologist with knowledge of and special training in brain-behavior relationships, including neuropsychological assessment, causality of neurobehavioral changes, and treatment and management of neurobehavioral disorders. ● Neuroscience nurse: a registered nurse (RN) who has certification in the treatment of individual and family and/or support system responses to nervous system function and dysfunction across the healthcare continuum. ● Neurosurgeon (neurological surgeon): a physician who has special training and credentials in the surgery of nervous system disorders and who has successfully completed an approved residency in neurological surgery. ● Nurse: an RN with specialty training, credentials, and licensing who specializes in the collection and assessment of health data, health teaching, and the provision of treatment that is supportive and restorative to life and well-being. ● Occupational therapist: a registered and licensed therapist who specializes in participation in activities of daily living (ADLs). He/she assesses and treats the physical, perceptual, behavioral, and cognitive skills needed to perform self-care, home maintenance, and community skills. He/she also provides patient and family and/or support system education. ● Occupational medicine physician: a physician who has education and training in occupational medicine and preferably qualifies for board certification. ● Optometrist: a specialist with training, credentials, and licensing who examines, assesses, diagnoses, and treats select abnormal conditions of the eye and adnexa.

Optometric scope of practice varies from state to state. It is defined by statute and may include topical or systemic medical therapy. Neuro-optometrists are preferred. ● Ophthalmologist: a physician with training and credentials in the diagnosis and treatment of visual disorders, including related systemic conditions, who has successfully completed an internship and an approved residency in ophthalmology. Ophthalmologists are able to perform medical and surgical procedures on the eye, orbit, and adnexa.

Neuro-ophthalmologists are preferred. ● Otolaryngologist: a physician who specializes in ear, nose, and throat medical treatment.

He/she has completed a residency in otolaryngology. ● Physical therapist: a licensed therapist with expertise in managing movement dysfunction who specializes in the assessment and treatment of individuals with impairments, deficits and functional limitations in the areas of strength, muscle tone, motor control, posture, coordination, balance, endurance, and general functional mobility. He/she works to improve functional independence, as well as provide family and/or support system and patient education. ● Physiatrist / physical medicine and rehabilitation physician: a physician with special training, credentials, and licensing in the field of physical medicine and rehabilitation.

He/she has successfully completed an approved residency. ● Psychiatrist/neuropsychiatrist: a physician with special training, credentials, and licensing who specializes in the field of mental health and psychological disorders. He/she has successfully completed an approved residency in psychiatry. A neuropsychiatrist is a psychiatrist who has specialized training, credentials, and licensing in neurologically based behavioral, cognitive, and emotional disturbances, including specialized training in ● Rehabilitation counselor: a bachelor’s or master’s level counselor who specializes in assisting individuals in the process of independent living, productive activity, and vocational pursuits. This includes assistance with financial resources, housing, community resources, social skills, vocational evaluation and treatment, integration back into the workforce, and patient and family and/or support system counseling. ● Rehabilitation nurse: an RN who has certification in rehabilitation nursing. Rehabilitation nursing is a specialty practice area within the field of nursing. It involves recognizing, reporting, and treating human responses of individuals and groups to present or future health problems resulting from changes in functional ability and lifestyle. ● Rehabilitation psychologist: a specialty within psychology requiring additional training that focuses on interdisciplinary teamwork to achieve optimal physical, psychological, and interpersonal functioning for those with chronic or traumatic injuries. ● Social worker: a master’s level, licensed social worker who specializes in patient and family relationships, as well as housing, financial resources, and society reintegration. ● Speech-language pathologist: a certified, licensed, and master’s or doctoral level therapist who specializes in the assessment and treatment of individuals in the areas of communication (speech, language, social skills, voice), cognition, swallowing, and family and/or support system patient education. ● Therapeutic recreation specialist: a bachelor’s or master’s level therapist who specializes in the assessment and treatment of individuals in the areas of planning and management of leisure activities, time management, mental health through recreation, and community access.

C.4 Disability The World Health Organization (WHO) conceptualizes disability as the interaction of health conditions with environmental factors (such as social and legal structures) and personal factors (including age, education, and coping styles).

For the purposes of this guideline, we are adopting the International Classification of Functioning, Disability, and Health (ICF).

This model recognizes the interaction between the health condition and three major components: body functions and structures, activity, and participation. These in turn are influenced by environmental and personal issues. The following definitions are used: ● Body functions: physiological functions of body systems, including psychological functions. ● Activity limitations: difficulties an individual may have in executing activities. ● Participation restrictions: problems an individual may experience in involvement in life situations. ● Disability: activity limitations and/or participation restrictions in an individual with a health condition, disorder, or disease.

Because of the nature of TBI and the nature of learning and memory, functional skills often cannot be generalized across work environments. Therefore, the assessment of function, evaluation, and treatment should not only consider the injured worker but also include evaluations of the individual’s “real world” environment, conducted by qualified practitioners.

D. Overview Care for individuals with moderate/severe brain injuries is highly individualized. A significant amount of therapy performed by multiple types of providers may be required to return the patient to reasonable function. Therefore, many of the providers described in Section C.3, Interdisciplinary rehabilitation professionals, may be required as part of the treatment team. The number and level of acute nonoperative, operative, and rehabilitative care is highly dependent on the full extent of the injury and its neurologic effects. Therefore, the M/S TBI guideline recommendations may differ based on a patient’s specific neurological injury pattern, polytrauma, psychosocial issues, and comorbidities.

Payers and providers should refer to specific treatment and diagnostic sections to determine coverage for payment.

The following areas should be considered.

D.1 Early specialty intervention Early identification and early intervention by providers with specialty training and experience is critical in the diagnosis, treatment, and management of individuals with M/S TBI. Brain injury treatment may also require immediate interdisciplinary evaluation and treatment. The treatment, and ultimate functional outcome, of individuals with TBI depends upon a complex, interacting set of pre-injury, injury, and postinjury factors. Treatment programs should be specialized, based on a comprehensive data set, inclusive of both functional goals and outcome-oriented goals, and delivered in the least restrictive setting(s) possible. Treatment settings may include acute care settings, hospitals, rehabilitation hospitals, outpatient settings, residential and behavioral settings, home, and community settings. Treatment should be well managed, time appropriate, and progress based.

Providing on-site case managers familiar with TBI rehabilitation treatment protocols is well accepted and recommended for all M/S TBI cases and for select mTBI cases, based on complexity and need.

D.2 Support system education Outcome following TBI often depends on the health, education, and resources of the individual’s family and/or support system. Therefore, educating the individual and family and/or support system, insurer, case manager, and employer should be a primary emphasis in the treatment and management of individuals with TBI. Providers should develop and implement effective strategies and forums to include family and/or support system members with the interdisciplinary treatment team. Education for individuals and their family and/or support system should include, but is not limited to: basic information about the brain and the effects of TBI on behavior, cognition, communication, physical function, and emotional function; appropriate family and/or support system interventions; and possible short-term and long-term outcomes. Written information and referral to credible internet resources may be helpful as the individual and their family and/or support system may not be able to remember the vast amount of information provided to them. For similar reasons, they may need to be provided repeated or ongoing information.

Insurance carriers, case managers, and treatment providers are highly encouraged to give hands-on personal consultations, education (written, verbal, internet-based), and support services to families in order to maximize treatment outcomes and their durability. Long-term life planning may be discussed.

Further in-depth education may be required to maximize the individual’s potential for functional living.

Treatment plans should include individual and group education as a means of facilitating self-awareness and self-management and preventing secondary disability. (Refer to Section F.4.g, Education, for further details.)

D.3 Course of recovery Following M/S TBI, neurological recovery is greatest in the first 12 months post-injury but may occur for up to two years post-injury; further functional improvements may occur beyond two years. Due to the variable and dynamic nature of disability secondary to TBI, individuals may either improve or deteriorate over time. In most cases, impairment will be life-long and will require a life-long maintenance plan of services. Complications may warrant periods of active treatment in addition to the maintenance plan.

There is good evidence that TBI is associated with an important increase in risk of all-cause mortality six months and more after injury. This includes death from suicide, assault, and unintentional injuries. The increase in risk is approximately threefold, and it appears to be independent of sociodemographic factors such as income and marital status. Thus, it is important that patients with TBI have follow-up for long-term concerns.

In at least 40% of cases, TBI is accompanied by other substantial trauma (e.g., internal, endocrine, orthopedic injuries) which may involve dysfunction in other bodily systems. Psychological issues also occur frequently; they are discussed in this guideline. Users of this TBI guideline are encouraged to employ appropriate guidelines by the Division for other disorders and dysfunction as needed.

D.4 Guardianship and conservatorship Individuals with TBI may be clinically determined to lack capacity to make competent informed decisions concerning their medical care, housing, and/or finances. Health care providers, insurance carriers, and case managers should become familiar with Colorado laws regarding incompetency, guardianship, conservatorship, medical and durable power of attorney, advanced directives, living wills, etc., in order to provide family and/or support system members with the appropriate education and/or resources concerning these issues when clinically indicated.

D.5 Systems of care Integration of systems of care has the goal of assisting individuals with TBI in progressing along a continuum of care toward achieving optimal clinical outcomes as efficiently and cost-effectively as possible. See Figure 1. Long-term outcome and “value” are recognized as superior to short-term, pricedriven management. Consumers should also be aware that CARF (Commission on Accreditation of Rehabilitation Facilities) definitions of programs and Centers for Medicare and Medicaid Services (CMS) licensing designations do not always coincide.

Figure 1: Model systems continuum of care for individuals with M/S TBI Figure 1 shows a schematic depicting an organized continuum of care for individuals with M/S TBI. The system is not a lock-step progression but a spectrum of TBI programs and services based on the individual’s unique condition and needs.

“The term rehabilitative and habilitative services includes items and services used to restore functional capacity, minimize limitations on physical and cognitive function, and maintain or prevent deterioration of functioning as a result of an illness, injury, disorder or other health condition. Such services also include training of individuals with mental and physical disabilities to enhance functional development.”

The type, amount, frequency, and duration of medical, rehabilitation, and long-term services are determined by the individual’s condition and needs, degree of functional improvement within specific time frames, as well as the individual’s potential to achieve additional, measurable functional improvements with continued provision of services. Decisions concerning treatment within the continuum of care should be made by specialists in TBI in conjunction with the individual with TBI and family and/or support system.

The following paragraphs describe care programs commonly used by individuals with M/S TBI. ● Acute care Established emergency medical services (EMS) triage guidelines and organized prehospital trauma systems should be utilized because they improve the delivery of trauma care. Trauma systems with identified regionally-designated neuro-trauma centers (preferably Level I or Level II Trauma Centers) should be utilized for the acute care of individuals with TBI. Neuro-trauma centers should have a multidisciplinary trauma team, an in-house trauma surgeon, a promptly available neurosurgeon, a continuously staffed operating room, neuroscience nurses, a neuro-intensive care unit, a laboratory, and a CAT scanner immediately available at all times. Other team members should include orthopedists, radiologists, anesthesiologists, occupational therapists, physical therapists, and speech-language pathologists. Patients with M/S TBI are usually admitted to the intensive care unit initially and then progress to acute care units where they also should receive rehabilitation services. Once M/S TBI is identified, insurance carriers should develop programs to respond quickly to individuals with TBI and their families and/or support systems. In these instances, insurance carriers are encouraged to deploy on-site certified case managers (CCM) to assist treatment providers, individuals, and family and/or support system. ● “Acute rehabilitation” - Comprehensive TBI-specialized inpatient interdisciplinary rehabilitation Following medical stability, individuals with M/S TBI should be transferred from acute hospital care to acute rehabilitation - in the form of a comprehensive TBI-specialized inpatient interdisciplinary rehabilitation program. Acute brain injury rehabilitation hospitals should have a specialty program that includes designated beds for patients with brain injuries, designated staff with interdisciplinary management protocols, designated treatment areas, specialized therapy programs tailored to specific patient and/or family needs, equipment prescription and procurement expertise, and a sufficient number of individuals with TBI to constitute peer and family education and support milieu. Acute rehabilitation hospitals should be accredited by the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) and have components consistent with the Commission on Accreditation of Rehabilitation Facilities (CARF). CARF eligibility implies that programs meet specific care standards of design and efficacy. (Refer to Section F.5.a, Comprehensive TBI-specialized inpatient interdisciplinary rehabilitation programs.)

It should be understood that Medicare CMS regards all programs after acute care as “post-acute,” including acute care inpatient rehabilitation hospitals. Some acute care inpatient rehabilitation hospitals are licensed as inpatient rehabilitation facilities (IRF) by CMS, others are licensed as long-term acute care hospitals. ● Post-acute rehabilitation Most patients with M/S TBI will require post-acute rehabilitation following a stay at a comprehensive TBI-specialized inpatient interdisciplinary rehabilitation hospital. Postacute rehabilitation should not be used in lieu of comprehensive TBI-specialized inpatient interdisciplinary rehabilitation programs as described above. These post-acute rehabilitation programs include skilled nursing facilities (SNFs), outpatient rehabilitation, residential or transitional living rehabilitation, neuro-behavioral treatment programs, home- and community-based programs, and formal occupational rehabilitation programs.

Alcohol, substance abuse, opioid, chemical, or more specific psychiatric treatment programs may also be necessary. The most appropriate post-acute rehabilitation program is dependent on the individual’s needs following inpatient hospital rehabilitation, as well as proximity and availability of services, family and/or support system dynamics, and projected long-term outcomes. Individuals with significant deficits or who require behavioral treatment or supervision for safety may require neurobehavioral residential rehabilitation. Other individuals may be able to use a combination of home- and community-based rehabilitation and outpatient or day treatment rehabilitation. Refer to

Section F.5, Interdisciplinary rehabilitation programs, for more information on these programs. ● Long-term acute care hospital (LTCH/LTACH) programs Some individuals will be unable to participate in a full inpatient program immediately following acute care because of medical instability; he/ she may need an LTCH for a period of time prior to entering a comprehensive TBI-specialized inpatient interdisciplinary rehabilitation program. LTCH is a designation by the Centers for Medicare and Medicaid Services for LTCH and rehabilitation hospitals whose average length of stay is greater than 25 days. They generally are used for medically complex patients who require longstay hospital-level care. LTCHs provide specialized care services, including skilled nursing care, to manage medical conditions so that individuals with catastrophic or acute illnesses/injuries may progress toward entry into full rehabilitation programs. LTCH programs should be accredited by the Joint Commission. LTCH rehabilitation is generally accepted but should not be used in lieu of comprehensive TBI-specialized inpatient interdisciplinary rehabilitation programs. When managing patients and families coping with severe TBI, LTCH programs should have minimal competencies for all disciplines appropriate to manage TBI related neurological, medical, and rehabilitative needs until patients are stable enough to be transferred to an acute specialized inpatient rehabilitation program as described above. Some comprehensive TBI-specialized inpatient interdisciplinary rehabilitation programs are licensed as LTCHs. Consumers are encouraged to research rehabilitation programs, regardless of their licensing designation. ● Long-term support care Across patients, the extent of long-term outcomes following TBI is diverse, ranging from virtually complete independence and function to severe and permanent disability.

Therefore, the range of necessary services is complex and individualized. In almost all cases, patients with M/S TBI should have received post-acute rehabilitation before longterm support care. Following post-acute rehabilitation, some individuals with M/S TBI will require significant care and supervision in order to perform ADLs safely. This can be done either at home by family and/or support system members with appropriate training or attendant care, in a skilled nursing care facility, or in a long-term supported living residential program. (Refer to Sections F.5.i, Supported living programs or long-term care residential services, or F.5.b, Sub-acute skilled nursing facilities.) Individuals may also benefit from periodic re-evaluations based on condition and needs. (Refer to Section H, Maintenance management.) Long-term care programs should have components consistent with certification by CARF, as CARF eligibility or certification implies that programs meet specific care standards of design and efficacy.

E. Diagnosis E.1 Initial diagnostic procedures E.1.a History of injury In order to establish the TBI diagnosis and treatment plans/goals, it is a generally accepted and widely used practice for a qualified practitioner to obtain a thorough history of the injury. Recommended data obtained in the history-taking generally should include: ● Identification data: Identification data should include name, address, age, gender, and marital/relationship status. ● Precipitating event: Information regarding the detailed circumstances of the TBI should include where and when the injury occurred, how the injury occurred, what the individual was doing at the time of the injury, and what happened. This may necessitate acquiring information from other sources if the patient does not have full recall. Reports from first responders should be obtained. If possible, collaborative information (e.g., witnesses, paramedic report, etc.) should be obtained to seek details of the event and the injured person’s behavioral and cognitive responses immediately following the injury. The presence of alcohol and/or drug use at or prior to the time of the injury should be noted.

All of this history should be used when establishing the presence of a TBI caused by a work-related event.

If the injury occurred as a result of a motor vehicle crash, information should be obtained as to: the speed of the vehicle; position or location of the injured worker; use of restraints or helmet; degree of damage to the vehicle; all other involved vehicles, if known; involvement of EMS system, if any; and acute or sub-acute accident-related physical complaints or injuries, including other people involved, if known. The crash outcome regarding non-TBI complaints/injuries may enhance an understanding of the forces involved in the accident and will minimize the possibility of unrecognized physical injury.

The accident report and any police records should be obtained and reviewed if available.

If the injury occurred as a result of a fall, information should be obtained regarding the type of fall, distance of the fall, type of surface, etc. The goal is to provide a review of the biomechanical forces involved in the event. ● Alteration in consciousness: History should include a review of chief complaints, presenting problems, and symptoms, with the goal of obtaining additional information regarding the alteration of consciousness associated with the index injury. Generally accepted data should include information about duration of alteration of mental status, including consciousness, degree and length of retrograde and PTA, as well as cognitive, behavioral, and physical impairments, with collateral sources of information when possible. Information should be collected regarding various time intervals for the following: ○ Current status: This is a report of the individual’s current condition, symptoms, complaints, functional problems, etc. ○ Initial status: This is a report of the individual’s neurological condition at the time of the injury, symptoms, complaints, functional problems, etc. The GCS, when performed in the field and the emergency department, may aid in grading the severity of TBI. Serial GCS scores may be helpful when intoxication may be a factor. It may be helpful to ask the patient to describe in detail the first event they remember after the injury in order to assess PTA or loss of time sequence and what events they remember immediately prior to the injury. When evaluating alteration in mental state at the time of the injury, it is also important to consider the individual’s emotional reaction to the distressing event. As a practical example, the provider should contemplate whether the feeling of “being dazed” could be a manifestation of emotional numbing. It is possible to have dazing due to TBI including emotional reactions (e.g., numbing and/or detachment) or even acute pain in relation to the event. ○ Evolution of neurological status: This is a report of change in the individual’s recovery between the time of the injury and the present, including symptoms, complaints, and functional problems. The individual’s report of when he/she was able to return to independent activity is relevant to understanding the course of the injury. A family and/or support system member’s history of the patient’s ability to perform his/her usual duties is often helpful. Other measures of functional activity that are standardized and can be repeated during treatment may also be useful. ● Review of medical records: In addition to the individual’s self-report, practitioners should attempt to obtain and review any external sources of data, including police reports, ambulance reports, emergency department records, eyewitness reports, pre-injury medical records, etc. The practitioner should utilize this information to establish or verify the probable degree of trauma involved in the incident and the consistency between these reports and current symptoms. ● Medical/health history: Taking a history is a generally accepted practice and should include a history of past and current illnesses, injuries, previous TBIs or other disabilities, seizures/epilepsy, stroke, cerebrovascular disease, developmental/intellectual disabilities, neurodegenerative disorders, any previous intracranial pathology (such as infections, tumors, congenital malformations), pain, previous surgeries of any kind, mental health and medication history, sleep disorders, educational history, and other medical/health data. A report from family and/or support system members or other persons knowledgeable about the individual with TBI relevant to pre-injury as compared to postinjury function should be obtained. ● Activities of daily living (ADLs): A thorough history should be taken of daily activities.

Basic ADLs include: self-care and personal hygiene, communication, ambulation, attaining all normal living postures, travel, non-specialized hand activities, sexual function, sleep, and social and recreational activities. Instrumental activities of daily living (IADLs) are complex self-care activities that may be delegated to others (e.g., financial management, medications, meal preparation). This assessment should delineate the changes in the individual’s ability to perform ADLs prior to and after the injury and any assistance needed from family members or others. ● Family history: Family history should include psychiatric, including substance use and abuse, medical-legal involvement, and medical history of illness or disability within the family that is relevant to the individual’s condition. ● Social history ○ Living situation: This should include marital history, family and/or support system members, household makeup, significant others, etc. ○ Occupational history: This should include the name of the individual’s current employer, job title, primary job duties, special licenses or certifications, length of employment, prior places and dates of employment, and previous work-related injuries and their outcomes. ○ Developmental history: This should include educational history, highest level of education obtained, learning disabilities or disorders, any developmental delay, abuse, or neglect, etc. ○ Avocations: This should include common non-occupational activities, including leisure activities such as sports, hobbies, and personal interests. ○ Substance use history: This should be obtained (particularly if there is data to suggest substance abuse was involved in the injury) along with information related to the amount and duration of alcohol, drug, and marijuana use, licit and illicit, including prescription drug use and/or abuse. ○ Legal history: DUIs, violence, speeding/reckless driving violations, and other medical/legal issues. ● Review of systems: This is a generally accepted practice and should include a complete review of body systems and functions. ● Pain diagnosis: This is recommended, especially during the first visit to document all body parts involved. This should include a pain diagram completed by the patient, if able. ● Psychiatric history: Psychiatric history should be assessed at the initial visit and at followup visits. Depression and anxiety are common conditions pre-injury and following TBI, and symptoms may be subtle or unapparent unless directly assessed. Individuals may not always present with complaints of sadness or anxiety, but instead they may express feeling other symptoms that are commonly seen in clinical depression or anxiety, particularly disturbances of sleep and energy. Many individuals also tend to focus on somatic complaints that do not always correlate with objective findings. Therefore, it is crucial to question the individual, family and/or support system, and pre-injury medical records about significant changes in appetite, sleep disturbances (including nightmares), decreased interest in pleasurable activities, loss of energy, diminished ability to think or concentrate, irritability, suicidal ideation, history of suicide attempts, psychiatric hospitalizations, mental health treatment, and feelings of emptiness, worthlessness, and excessive guilt.

E.1.b Physical examination This is a well-accepted practice and should be performed by a qualified practitioner. A thorough trauma exam should be done during the initial exam and the first follow-up visit to ensure all complaints are addressed. The exam should include a complete cervical spine exam.

E.1.c Neurological examination A neurological examination should be performed by a qualified practitioner and should include a mental status examination. A comprehensive neurological examination includes, but is not limited to, mental status, cranial nerves, motor status, sensory status, balance and coordination, and gait and station. The mental status examination involves both formal and informal observations. It includes observations about the individual’s presentation, social/behavioral decorum, personal hygiene, ability to provide a history, and ability to follow directions. A formal (structured) cognitive examination should be performed to the extent indicated by the situation. It includes an assessment of the individual’s alertness, orientation, attention, concentration, memory, affect, mood, thought process and content, language, ability to perform simple calculations, and higher order assessments of reasoning, judgment, and insight. Using a standard approach for all visits assists serial functional assessment.

E.1.d Neuropsychological evaluation This is the evaluation of cognitive processes and behavior using psychological and neuropsychological testing to assess central nervous system function and to diagnose specific behavioral or cognitive deficits or disorders. Neuropsychological assessments are generally accepted and widely used as a valuable component of the diagnosis and management of individuals with TBI. They include sensitive tests that are used to detect cognitive deficits, severity of impairment, and improvement over time. Neuropsychological assessment assists in the differential diagnosis of neurobehavioral disorders and the cumulative effect of multiple TBIs.

Neuropsychological assessments may be utilized to formulate how the individual's underlying TBI impacts behavior and the ability to function effectively in daily life. These assessments are also used as a basis for formulating rehabilitation strategies and may provide information related to prognosis and outcome.

Neuropsychological assessments utilize standardized testing procedures. Test reliability and validity are important considerations. Examiners should be aware that abnormal cognitive function may occur in the setting of chronic pain, psychological disorders, sleep deprivation, medication use, malingering, developmental/intellectual disabilities, acute or chronic substance abuse, and comorbid or pre-existing cognitive or neurologic disorders. In cases where comorbid diagnoses are suspected, formal psychological evaluation should accompany the neuropsychological battery to assist in characterization and differentiation of diagnoses. Multiple sources of data (self-report information, medical history, Emergency Medical Services [EMS] records, psychosocial history, family report, etc.) are integrated with test performance factors to draw inferences about brain-behavior relationships. The individual’s cultural background, race, age, primary language and developmental and educational history should be considered. Neuropsychological testing may not be valid when English is not the patient’s primary language. When practical, educational records including history of learning disability should be obtained and reviewed.

The specific neuropsychological tests used may vary according to the symptom presentation of the individual and the purpose of the evaluation. Tests usually assess the following cognitive domains: level of orientation, attention, language, memory, praxis, executive function, speed of processing, visual-spatial ability, recognition, personality, and function. All reports should include a clinical interview that notes the patient and family medical / psychiatric / substance abuse history, developmental milestones, educational

history, psychosocial issues, and current medical conditions and treatment. Interpretation of these tests should always discuss the impact of information from the clinical interview that might affect test results, such as medications causing confusion or drowsiness, lack of sleep, anxiety, depression, and similar issues.

In the acute setting, neuropsychological consultation and assessment in M/S TBI is indicated for: ● determining emergence from post-traumatic amnesia (PTA); ● documenting the early course of improvements in attentional functioning, memory, visualperceptual abilities, language, and executive functions. This information may be utilized in: ○ treatment planning and team consultation; ○ family and/or support system education/support and use of community services; ○ education for developing insight and use in supportive psychotherapy; ● educating and counseling patients with pre-existing psychological issues or other history predisposing to delayed recovery.

During the sub-acute phase, when cognitive/physical stamina is reduced, availability for testing may be limited due to medical priorities and other rehabilitation commitments.

Selective neuropsychological testing may be indicated to: ● identify cognitive strengths and weaknesses; ● design treatment plans such as psychotherapy; ● educate the individual and family and/or support system about TBI; ● assess or recommend behavioral management interventions.

During this time, test selection will be dependent on the individual’s neurobehavioral status and other aspects of his/her medical condition.

Neuropsychological testing is often undertaken to identify treatment goals and to monitor progress over time. During this phase, descriptive psycho-educational testing is commonly performed in rehabilitation by speech-language pathologists and occupational therapists.

Administration of a full neuropsychological test battery is not indicated in moderate/severe cases until the individual with TBI has clearly emerged from PTA. Administration of a full battery of neuropsychological tests should not be initiated until attentional functioning has improved to the point where such extensive testing will be meaningful and contribute to long-term treatment planning and rehabilitation.

Post-acute testing: Once the individual’s behavior has improved from attentional disturbance, lack of sleep, pain from other injuries, and neurobehavioral disinhibition to the point where valid test data may be obtained, testing with a full neuropsychological test battery is appropriate.

E.1.e Neurodiagnostic tests E.1.e.1 Imaging procedures E.1.e.1.1 Skull x-rays These are well-established diagnostic tools used to detect a fracture of the cranial vault.

Skull x-rays are generally accepted only if CT scans are not available or in cases where there is only a low suspicion of intracranial injury.

E.1.e.1.2 Computed axial tomography (CT)

For acute brain trauma, iodine contrast enhancement is not necessary. CT scans are noninvasive and will reveal the presence of blood, skull fracture, and/or structural changes in the brain. They do, however, expose the patient to higher doses of ionizing radiation than skull radiographs. CT scans provide somewhat limited information compared to MRI about intrinsic cerebral damage involving deep brain structures, although many types of intrinsic damages can be seen on CT scans.

CT is a well-established brain imaging x-ray study comprised of a mathematical reconstruction of the tissue densities of the brain, skull, and surrounding tissues. CT scans require the use of computer-based scanning equipment.

CT scans are widely accepted for acute diagnostic purposes and for planning acute treatment. They are the screening image of choice in acute brain injury and are used to assess the need for neurosurgical intervention.

If fractures are suspected, CT scanning is preferred over skull x-rays because of its much higher sensitivity and accuracy and its ability to identify clinically significant fractures as well as potentially coexistent contusions or hemorrhages.

CT scans are recommended for abnormal mental status (GCS less than 13 on admission), focal neurologic deficits, or acute seizure. CT scans are recommended for the following patients: ● High risk ○ GCS less than 15 at two hours post-injury; ○ suspected open or depressed skull fracture; ○ any sign of basilar skull fracture (e.g., hemotympanum, raccoon eyes, Battle’s Sign, CSF oto-/rhinorrhea); ○ greater than or equal to two episodes of vomiting; ○ age equal to or greater than 60. ● Other risk ○ retrograde amnesia to the event greater than or equal to 30 minutes; ○ “dangerous” mechanism (e.g., pedestrian struck by motor vehicle, occupant ejected from motor vehicle, fall from greater than three feet or more than five stairs); ○ coagulopathy, including use of use of anticoagulant medication; ○ focal neurologic deficits; ○ acute seizure; ○ severe and persistent headache; ○ physical evidence of trauma above the clavicles and/or multiple trauma and/or basilar skull fracture; ○ drug or alcohol intoxication; ○ any recent history of TBI, including mTBI.

E.1.e.1.3 Magnetic resonance imaging (MRI)

MRI is a well-established brain imaging study for patients with TBI in which the individual is positioned in a magnetic field and a radio-frequency pulse is applied. Hydrogen proton energy emission is translated into visualized structures. Altered signal intensity compared to normals may indicate trauma or other disease.

CT is superior to MRI in detecting acute intracranial bleeds and remains the preferred initial imaging study in the first 24 hours following TBI.

Initially, MRI scans are clinically useful in the following situations to: ● determine neurological deficits in TBI not explained by CT; ● evaluate prolonged intervals of disturbed consciousness or other prolonged alteration in mental status; ● define evidence of acute changes super-imposed on previous trauma or disease.

MRI scans are also useful to assess transient or permanent changes, to determine the etiology of subsequent clinical problems, and to plan treatment.

MRI may reveal an increased amount of pathology compared to CT. Due to their high contrast resolution, MRI scans are superior to CT scans for the detection of some intracranial pathology (e.g., axonal injury, subtle cortical contusions, small extra-axial fluid collections, etc.) but not bone injuries such as fractures.

MRI is more sensitive than CT for detecting traumatic cerebral injury.

Specific MRI sequences and techniques are very sensitive for detecting acute traumatic cerebral injury.

They may include, but are not limited to: diffusion weighted imaging (DWI), susceptibility weighted imaging, gradient echo weighted imaging, and fluid attenuated inversion recovery (FLAIR). Some of these techniques are not available on an emergency basis.

E.1.e.2 Vascular imaging tests Vascular imaging tests reveal arterial or venous abnormalities in the chest, neck, head, or extremities (e.g., thrombosis, dissection, spasm, emboli, or tearing).

These tests are generally used if standard CT/MRI scans fail to demonstrate suspected vascular abnormalities. They may be useful in M/S TBI as an adjunct to aforementioned studies. (Refer to Section E.1.e.1, Imaging procedures, under Skull x-rays, Computed axial tomography (CT), and Magnetic resonance imaging (MRI).) Often, patients with clinical signs of blunt trauma to the neck or with a significant mechanism of injury require imaging to detect injuries to the carotid or vertebral arteries that cannot be diagnosed on physical exam.

Generally accepted procedures include: ● CT angiography (CTA): At the time of this guideline, this is the most common and accepted test for screening patients for injuries to the carotid or vertebral arteries in the acute setting of trauma or focal neurologic (stroke like) symptoms. CTAs are noninvasive tests that are readily available in essentially all emergency rooms that treat patients with traumatic injuries. They can be obtained rapidly, often just subsequent to the screening CT head exam. They provide excellent 2D and 3D imaging of the vessels from the aortic arch to the skull vertex and also show the relationship of those vessels to surrounding bones and soft tissues. Some limitations include poor vessel opacification if the timing of the study is incorrect, artifact from dental hardware and the skull base, and patient motion. CTAs should generally only be performed on scanners with at least 16 detectors, with 64 being the preferable number of detectors. CT venography (CTV) is the most commonly utilized technique to evaluate the dural venous sinuses for injury in a trauma setting. ● Arteriography: Arteriography is generally accepted when the above noted traumatic vascular abnormalities are suspected but unproven with the techniques discussed thus far or when further investigation of the vascular lesion is necessary. This is particularly true with arteriovenous fistulous change. ● Venography: This is generally accepted if increased venous flow and pressure are suspected and still undemonstrated. This is done via either the jugular or orbital venous system. ● Noninvasive vascular assessment (NIVA): NIVA is the least invasive procedure and may demonstrate direction of blood flow and general patency of the carotid and vertebral arterial systems in the neck but not in the head. ● Magnetic resonance angiography (magnetic resonance arteriography [MRA] / magnetic resonance venography [MVA]): This is indicated when vessel changes are suspected but not demonstrated by other simpler tests. Internal obstruction of an artery may be demonstrated (e.g., thrombosis, spasm, dissection, neck injury, or emboli from concomitant injuries). Arterial compression due to external pressure may be demonstrated (e.g., bony fracture or mass effect from a large intra-axial hemorrhage or cerebral edema). Dissection or arteriovenous fistula formation may be seen, but as with other vascular abnormalities, conventional contrast arteriography/venography may be needed to confirm or refute the MRA or MRV findings. The source for intra- or extra-axial bleeding may be seen. Intracerebral dural venous sinus thrombosis, as well as poor venous return may be demonstrated by MRA or MRV.

Brain acoustic monitor: This device identifies turbulent blood flow in the brain. It is considered investigational for the purpose of detecting deficits requiring CT scanning in the emergency room. Based on the evidence listed in the table below, it is not recommended at the time of this guideline.

Evidence against use of a brain acoustic monitor as an initial diagnostic procedure for TBI A Brain Acoustic Monitor cannot reliably predict the development of post-concussive symptoms.

Diagnostic cohort study E.2 Further diagnostic procedures E.2.a Electrodiagnostic studies These are limited to electromyogram (EMG), nerve conduction studies, and multisensory evoked potentials including visual evoked potentials (VEP), somatosensory evoked potentials (SSEP), and brain stem auditory evoked responses (BSAER).

E.2.a.1 EMG and nerve conduction studies These are generally accepted, well-established diagnostic procedures. These studies may be useful for individuals with brain injury and EMG associated suspected peripheral nervous system involvement. They are often used to differentiate peripheral versus central spinal cord or brain deficits. These electrodiagnostic studies are possibly complementary to other imaging procedures such as CT, MRI, and/or myelography. These studies provide useful correlative neuropathophysiologic information that is unattainable from standard radiologic studies.

E.2.a.2 Electroneuronography (EnoG)

EnoG is a well-established and generally accepted test that measures facial nerve function. This test measures the action potential of different branches of a facial nerve. It is used in individuals with TBI resulting in a facial paralysis and is key in determining the need for surgical intervention. This test is most useful within the first three weeks of facial nerve dysfunction. If the action potentials on the affected side are 90–100% less than those on the normal side, it suggests significant injury to the nerve and calls for surgical exploration. Individuals with TBI whose nerve is less than 90% decreased in function have a reasonably good outcome with observation alone.

E.2.a.3 Dynamic electromyographies These are electrodiagnostic studies utilized to distinguish the voluntary capacity of a muscle from a spastic reaction. This aids the clinician in better planning specific rehabilitative treatment. This study is helpful in the differential diagnosis and diagnostic work-up of disordered muscle tone. This is a generally accepted procedure.

E.2.a.4 Evoked potential responses (EP)

EPs are generally accepted, well-established diagnostic procedures. EPs are central nervous system electrophysiologic responses to a stimulus, either externally generated via one or more sensory modalities or internally generated via the processing of information. Multisensory EP studies are limited to visually evoked potentials, brain stem auditory evoked potentials, somatosensory evoked potentials, and cognitive evoked potentials. In M/S TBI, including vegetative state (unresponsive wakefulness syndrome or UWS) and/or minimal conscious state (MCS), there is some utility in the use of these studies for differential diagnosis, prognosis, and to determine an individual’s more specific level of neurologic E.2.a.4.1 Auditory brainstem response (ABR)

ABR is a generally accepted diagnostic procedure useful in assessing damage to the brain stem, midbrain, and other neural structures that govern hearing and/or balance. A normal test does not rule out structural damage, and the test may be abnormal in middle ear and non-traumatic disease affecting the auditory pathway. Waves one, three, and particularly five are most useful in assessing injury. While amplitude and the presence of wave are important, the latency and interwave latency are equally important. This test is often sensitive but non-specific. It may be useful in some cases. It requires prior E.2.a.4.2 Electroretinogram (ERG)

ERG is a generally accepted diagnostic procedure for occult retinal trauma accompanying TBI. Most traumatic retinal pathology presents as a field deficit detected by direct examination. ERG cannot detect mild changes in retinal function, and normal results should not be taken as evidence against ocular dysfunction. ERG requires prior authorization.

E.2.a.4.3 Cognitive event-related potential This is an acceptable diagnostic procedure for M/S TBI. It may be justified if other neurological diagnoses are suspected. It requires prior authorization.

E.2.a.4.4 Somatosensory evoked potential (SSEP)

SSEP is a generally accepted diagnostic procedure for M/S TBI. It may be used when other diagnoses are suspected. It requires prior authorization.

E.2.a.4.5 Visual evoked potential (VEP)

VEP is a generally accepted diagnostic procedure. Pattern reversal monocular VEP recording may detect pathology in the anterior-posterior visual pathway from the retina to the occipital cortex. It may be indicated in the event of compromised acuity or visual field defect. The VEP may occasionally be normal in cases of severe structural damage if there is enough preserved central visual field. Unfortunately, VEP is highly susceptible to artifact and has a low specificity for structural injury to the visual pathways.

Therefore, prior authorization is required.

E.2.a.4.6 Vestibular evoked myogenic potentials (VEMP)

Refer to Section E.2.i.3.6, VEMP, in the Neuro-otology section.

E.2.b Electroencephalography E.2.b.1 Electroencephalography (EEG)

EEG is a well-established diagnostic procedure that monitors brain wave activity using scalp electrodes and provocative maneuvers such as hyperventilation and photic strobe for the purpose of seizure diagnosis. Information generated includes alterations in brain wave activity such as frequency changes (non-specific) or morphologic (seizures). EEG is not generally indicated in the immediate period of emergency response or during acute evaluation and treatment. Following initial assessment and stabilization, the individual’s course should be monitored. If during this period there is failure to improve or the medical condition deteriorates, an EEG may be indicated to assess seizures, focal encephalopathy due to persistent effects of hemorrhage, diffuse encephalopathy due to the injury, or other complicating factors such as hydrocephalus or medications. A normal EEG does not definitively rule out a seizure disorder. If there is sufficient clinical concern that a seizure disorder may exist despite a normal EEG, then a 72-hour ambulatory EEG or inpatient video-EEG monitoring may be appropriate.

E.2.b.2 Quantified electroencephalography (QEEG) (Computerized EEG)

QEEG is a modification of standard EEG using computerized analysis of statistical relationships between power, frequency, timing, and distribution of scalp recorded brain electrical activity. These statistically generated values are then compared to those recorded from selected control and specific populations, generally using multiple regression analysis of multiple measurements and calculated parameters.

Recent studies suggest that in the future, QEEG may become a useful tool in the retrospective diagnosis of TBI and its severity, but this application remains investigational. In M/S TBI, the results of QEEG are almost always redundant when traditional electroencephalographic, neurologic, and radiologic evaluations have been obtained. QEEG is not recommended for diagnosing mTBI or M/S TBI.

E.2.c Neuroimaging Practitioners should be aware of the radiation doses associated with various procedures. Coloradans have a background exposure to radiation, and unnecessary CT scans or x-rays increase the lifetime risk of cancer death.

E.2.c.1 Structural imaging E.2.c.1.1 Computed axial tomography (CT)

CT may be used to follow identified pathology or to screen for late pathology. Subsequently, CT scans are generally accepted when there is suspected intracranial blood, extra-axial blood, hydrocephalus, altered mental state, or a change in clinical condition, including development of new neurological symptoms or post-traumatic seizure (within the first days following trauma). Once the initial acute stage has passed, MRI scans are frequently ordered as opposed to CT.

A systematic review concluded that routine CT repetition rarely identified conditions needing surgical intervention. Nevertheless, risk factors for a further bleed or neurological deterioration from the following conditions would warrant repeat CTs: ● skull fracture, ● coagulopathy or anticoagulation, ● age over 60, ● epidural hematoma, ● suspected open or depressed skull fracture, ● continuing severe headache, ● moderate to severe TBI, and ● continuing TBI symptoms.

E.2.c.1.2 Magnetic resonance imaging (MRI)

MRI is the image of choice to detect the late, sub-acute, and chronic structural changes in the brain which underlie abnormal functioning. It is a well-accepted technique for follow-up imaging. Complications of TBI that may be explained by MRI include, but are not limited to: post-traumatic epilepsy, post-traumatic movement disorder, post-traumatic cranial neuropathy, post-traumatic infection, or failure to recover within the expected time frame. (Refer to Section E.2.c.3, Advanced MRI techniques, for more advanced imaging.)

Diffusion tensor imaging (DTI), susceptibility-weighted imaging, and magnetic transfer imaging: DTI may be useful for identifying pathology and guiding treatment in patients with documented physiological deficits, such as hemianopsia, but interpretation of results is very dependent upon the experience and skill of the neuroradiologist. DTI may be used when an accompanying MRI is ordered for purposes other than diagnosing mTBI.

E.2.c.2 Dynamic imaging In contrast to anatomical imaging procedures, the following procedures are designated to detect physiologic activity of the brain, including cerebral blood flow and cerebral metabolism. Both PET and SPECT scans can subject the patient to significant radiation levels. Prior authorization is required for these procedures.

E.2.c.2.1 Single photon emission computed tomography (SPECT)

SPECT is not generally accepted as a diagnostic test for TBI of any severity and is considered investigational for diagnostic purposes. It is a functional image of the brain created by a flow tracer or a receptor-binding substance tagged with a radionuclide and injected intravenously into the individual. The radiotracer is assumed to accumulate in different areas of the brain proportionately to the rate of delivery of nutrients to that volume of brain tissue. Using a gamma camera and the techniques of CT, a 3-D image of the distribution of a radionuclide in the brain is obtained. SPECT may identify areas of decreased perfusion and provide a qualitative estimate of regional cerebral blood flow (CBF), which correlates with metabolism in many neurologic disorders. There is a variable correlation of SPECT with other measures, such as neuropsychological test findings. Its interpretation should take into account its low specificity, making the predictive value of SPECT no better than CT.

For severe TBI, SPECT may be useful for individuals with prolonged low levels of responsiveness (i.e., persistent vegetative state), in cases of anoxia, or when additional data is needed.

In all severities of TBI, prior authorization is required and it is recommended that medical necessity and clinical usefulness for this study be justified.

E.2.c.2.2 Positron emission testing (PET)

PET is a functional brain imaging procedure. A tracer molecule tagged with a positron-emitting radioisotope is injected into the body. Biodistribution of the tracer is imaged, producing information about local cerebral glucose utilization and cerebral perfusion. This procedure requires on-site access to a cyclotron.

PET can reveal areas of decreased metabolism in the brain. In individuals with M/S TBI, PET findings are closely correlated with the site and the extent of cerebral dysfunction derived from neurological and neurobehavioral examinations. In all severities of TBI, it is recommended that medical necessity and clinical usefulness for this diagnostic study be justified. It is not generally accepted as a diagnostic study and should not be used solely to diagnose the presence of TBI. Any requested use requires prior E.2.c.3 Advanced MRI techniques At the time of writing this guideline, all advanced MRI techniques are not recommended for diagnostic purposes. While they can identify anatomic physiologic variation, the changes cannot clearly be related to the need for specific treatment. In complex moderate/severe cases, they could be useful for surgical and other long-term planning. They require prior authorization and justification of the medical necessity and clinical usefulness of the study.

E.2.c.3.1 Magnetic resonance (MR) spectroscopy This is a noninvasive test that applies a burst of radio frequency energy to tissue inside an applied magnetic field. The resulting excitation and relaxation of nuclei generates a signal that carries information about the chemical environment of those nuclei. MR spectroscopy may detect changes in levels of nacetyl-aspartate, an intermediate in neurotransmitter synthesis that is present in large amounts in normal functioning neurons but is decreased in damaged brain tissue. Its spectral signal may correlate with neuronal integrity and function and may show loss of function in tissue, which appears normal on conventional CT or MRI studies. MR spectroscopy may increase the sensitivity of MR imaging for traumatic lesions. This sensitivity may allow for increased correlation to more specific neuro-cognitive deficits and guide treatment planning. It may be useful information in determining long-term outcome. MR spectroscopy remains predominantly a research tool at this time and should not be used solely to diagnose the presence of TBI. MR spectroscopy requires prior authorization for patients with M/S TBI. It may be considered with adequate documentation of its medical necessity in unusual cases, such as in patients with a minimally conscious state, when the information will assist in clarifying the pathology to direct a therapeutic approach to the individual with TBI.

E.2.c.3.2 Functional MRI (fMRI)

This uses MRI to detect physiologic responses of brain tissue to various tasks. Blood oxygenation level dependent (BOLD) contrast is the most popular fMRI technique. It derives an image from differences in the magnetic properties, and therefore differences in MR decay parameters, of oxygenated and deoxygenated hemoglobin. A typical fMRI study compares images under two or more behavioral conditions, which may involve motor, cognitive, or visual tasks. Functional MRI studies have shown functional reorganization as a general response to TBI. Alterations in patterns of cerebral activity seen on fMRIs may correlate with cognitive deficits in individuals with TBI, but the specificity of the test is not sufficient to make fMRI a diagnostic tool. At the time of this guideline, it is a research tool and not recommended for clinical use. Recent publications report problems with the mathematical formulas used, relating false positives and false negatives.

E.2.d Laboratory testing Laboratory testing is a generally accepted, well-established procedure. In M/S TBI, extensive lab testing will be necessary to monitor electrolyte status, organ and endocrine functions, and other physiologic processes, depending on the medications used and the severity of the injury. Any individual with TBI on medication will require laboratory testing to monitor therapeutic drug levels and the effects on organ function.

E.2.e Lumbar puncture Lumbar puncture is a well-established diagnostic procedure for examining cerebrospinal fluid (CSF) in neurological disease and injury. The procedure should be performed by qualified and trained physicians under sterile conditions.

Lumbar puncture is contraindicated in acute trauma to the spinal column, certain infections, increased intracranial pressure due to space occupying lesions, and in some coagulation disorders or defects.

Additionally, it should be avoided if there are cutaneous infections in the region of the puncture site. In individuals with suspected or known increased intracranial pressure, lumbar puncture should be preceded by fundoscopic examination and a CT scan or MRI.

E.2.f Nerve blocks – diagnostic These are generally accepted procedures involving percutaneous needle injection techniques to a specific nerve. These diagnostic blocks are typically performed with quick-acting, short duration local anesthetics such as lidocaine or bupivacaine. Temporary diagnostic nerve blocks evaluate limb ROM, dystonia, or spasticity and assist in planning subsequent, specific therapy.

E.2.g Further neuropsychological assessment and testing Neuropsychological assessment after three months is appropriate in the following situations when: ● input is needed to plan treatment to maximize long-term cognitive and overall functional outcomes; ● documentation of accommodations is needed to establish adjustments to the neurocognitive challenges; ● assessment will assist in increasing insight and be used to assist with supportive psychotherapy; ● there is a question of the individual’s ability to perform work-related duties and/or there are safety issues (i.e., possible harm to self or others) or when the person’s vocation necessitates more extensive testing prior to vocational re-entry or return to school/training; ● assistance is needed with differential diagnosis including the diagnosis of TBI; ● it is deemed necessary to evaluate and/or monitor effectiveness of treatment approaches (i.e., cognitive rehabilitation therapy, somatic therapies, or medication trials) in specific individuals; ● the patient’s presentation is such that symptom validity testing and performance validity testing may be helpful in treatment planning; ● subjective complaints are disproportionate to the clinical history or objective findings as ● the degree of disability is disproportionate to the clinical history and objective findings as ● there are questions of competency, guardianship, or conservatorship.

Neuropsychological testing should be used to document the patient’s level of effort and to provide data regarding symptom validity. Testing should not be used to diagnose malingering.

Neuropsychological testing may take into account validated testing in other areas without a direct relationship to psychological issues.

Evidence statements regarding neuropsychological assessment There is an association between poor effort on verbal memory tests and poor effort on computerized tests of postural stability in patients with TBI who are being evaluated for disability ratings.

Retrospective review of consecutive charts The following information may aid in delineating when a full neuropsychological battery is necessary versus more limited testing: ● The administration of a full neuropsychological test battery after the acute period is appropriate in a number of situations when: ○ there are questions of competency, guardianship, or conservatorship; ○ developmental issues are interacting with a history of TBI (e.g., determining if age related memory or cognitive changes are impairing functioning in a person with a history of M/S TBI); ○ late complications develop that affect cognition and overall function (e.g., seizures, depression, anxiety disorders); ○ it is necessary to address any of the issues on the initial indications tests; ○ change in support system and ancillary support may require reevaluation of the patient’s status; ○ cognitive declines associated with aging need to be evaluated with symptom complaints and included in treatment recommendations; ○ the patient and family have questions/concerns about symptom management (with specific attention to future needs).

E.2.h Psychological, psychiatric, or psychosocial evaluations These are generally accepted and well-established diagnostic procedures with selective use in the TBI population. They have more widespread use after three months. Diagnostic testing may be indicated for individuals with symptoms of post-traumatic disturbances of sleep, mood, anxiety, psychosis, substance use, aggression/agitation, and pain, as well as depression, delayed recovery, chronic pain, recurrent painful conditions, and disability problems. An individual with a PhD, PsyD, or psychiatric MD/DO credentials may perform these evaluations if listed as an authorized user by the test publisher.

Practitioners’ familiarity with patients with TBI is preferred.

Psychosocial evaluations can help to determine if further psychosocial or behavioral interventions are indicated for patients diagnosed with TBI. The interpretations of the evaluation can provide clinicians with a better understanding of the patient in his or her social environment, thus allowing for more effective rehabilitation. Psychosocial assessment requires consideration of variations in experience and expression resulting from affective, cognitive, motivational, and coping processes, as well as other influences such as gender, age, race, ethnicity, national origin, religion, learning disability, language, or socioeconomic status.

A comprehensive psychological evaluation should attempt to identify both primary psychiatric risk factors (e.g., psychosis, active suicidality, lack of awareness) as well as secondary risk factors (e.g., moderate depression, job dissatisfaction). Significant personality disorders should also be taken into account in treatment planning.

Psychometric testing is a valuable component of a consultation to assist the physician and other members of the treatment team in making a more effective treatment plan. Psychometric testing can assist in enhancing general medical outcomes and in predicting a patient’s likely adherence to and cooperation with medical treatment plans.

Several meta-analyses have evaluated the occurrence of depression and anxiety with non-penetrating TBI. Both anxiety and depression appear to occur at a rate about one-third higher than the general population. Both conditions are likely to increase during the initial 2-5 years post-injury, although anxiety may decrease after five years. Mild and M/S TBI are both likely to suffer from psychological stress.

Increased physical activity and decreased alcohol consumption may be useful to decrease symptoms.

One study found that pre-injury alcohol abuse and longer PTA predicted symptoms lasting longer than six months.

Even in cases where no diagnosable psychological condition is present, these evaluations can identify social, cultural, coping, and other variables that may be influencing the patient’s recovery process and may be amenable to various treatments, including behavioral therapy. ● Qualifications ○ A psychologist with a PhD, PsyD, or EdD credentials or a physician with psychiatric MD/DO credentials may perform the initial comprehensive evaluations. ○ Psychometric tests should be administered by psychologists with a PhD, PsyD, or EdD credentials or health professionals working under the supervision of a doctorate level psychologist. Administration and interpretation of psychological/neuropsychological measures must adhere to standards set forth by test publishers. ● Indications A psychological assessment may be necessary if symptoms do not correlate with a diagnosis of TBI. Complaints of cognitive dysfunction may also be associated with a variety of conditions that do not involve neurological disease, TBI, or mTBI. This includes conditions that may have been pre-existing or are concurrent, such as depression, anxiety, chronic pain, somatoform disorders, and factitious disorders. At times, a set of symptoms may not coincide with expected objective findings for those with a diagnosis of TBI. To identify non-neurological contributions to cognitive or other functional complaints, a psychological evaluation focusing on mental disorder diagnoses is appropriate when: ○ delayed recovery is present, ○ there is delayed access to appropriate care, ○ there is a question of whether a brain injury has occurred, ○ neuropsychological testing yields a pattern of test results that is not consistent with the clinical history, ○ neurologically improbable symptoms are present, or ○ it is necessary to assess for accompanying psychological components. ● Clinical evaluation Special note to health care providers: Most providers are required to adhere to the federal regulations under the Health Insurance Portability and Accountability Act (HIPAA).

Unlike general health insurers, workers’ compensation insurers are not required to adhere to HIPAA standards. Thus, providers should assume that sensitive information included in a report sent to the insurer could be forwarded to the employer. The Colorado statute provides a limited waiver of medical information regarding the work-related injury or disease to the extent necessary to resolve the claim. It is recommended that the health care provider either (1) obtain a full release from the patient regarding information that may go to the employer or (2) not include sensitive health information that is not directly related to the work-related conditions in reports sent to the insurer.

The clinical evaluation should address the following areas: ○ History of injury The history of the injury should be reported in the patient’s words or using similar terminology. Certified medical interpreters are preferred. Collateral information should be obtained as appropriate. This may include family, support systems, witnesses, and EMS records. ■ psychosocial circumstances of the injury ■ current symptomatic complaints ■ extent of medical corroboration ■ treatment received and results ■ compliance with treatment ■ coping strategies used, including perceived locus of control, catastrophizing, and avoidance behaviors ■ perception of medical system and employer ■ history of response to prescription medications ■ medication history related to this injury ○ Health history ■ medical history ■ psychiatric history ■ history of alcohol or substance abuse, including abuse of prescription medication ■ ADLs ■ previous injuries, including disability, impairment, and compensation ■ complete medication history, including prescription and over-the-counter medications ○ Psychosocial history ■ childhood history, including abuse/neglect and developmental/intellectual disability or delay ■ educational history ■ family history, including disability ■ relationship/marital history and other significant adulthood activities and events ■ legal history, including criminal and civil litigation ■ employment history ■ military duty: Because post-traumatic stress disorder (PTSD) might be an unacceptable condition for many military personnel to acknowledge, it may be prudent to screen initially for signs of depression or anxiety – both of which may be present in PTSD. ■ symptoms of pre-injury psychological dysfunction ■ current and past interpersonal relations, support, and living situation ■ financial history ○ Mental status exam including cognition, affect, mood, orientation, thinking, and perception. May include the Mini-Mental Status Examination or the Frontal Assessment Battery, if appropriate, and detailed neuropsychological testing. ○ Assessment of any danger posed to self or others. ○ Barriers to care should be considered as the patient may experience problems with transportation and access to appropriate care. ○ Psychological test results, if performed. ○ Current psychiatric/psychological diagnosis consistent with the standards of the American Psychiatric Association’s most recent Diagnostic and Statistical Manual of Mental Disorders. ○ Pre-existing psychiatric conditions. Treatment of these conditions is appropriate when the pre-existing condition affects recovery. ○ Causality (to address medically probable cause and effect, distinguishing preexisting psychological symptoms, traits, and vulnerabilities from current symptoms or aggravation of prior symptoms). ○ Treatment recommendations with respect to specific goals, frequency, timeframes, and expected outcomes.

Evidence statements regarding psychometric testing Psychometric testing can predict medical treatment outcome.

Prospective cohort study and observational cohort studies E.2.i Neuro-otology: vestibular and audiological evaluation Neurotologic evaluation is a widely used and generally accepted practice in cases of hearing loss, dizziness, balance problems, facial nerve injury, and cerebrospinal fluid leak. An individual with TBI may experience these symptoms. Any patient with complaints of vertigo or significant neurological findings on clinical exam, such as ataxia, should be referred to appropriate specialists expeditiously. Diagnostic testing for significant pathology usually requires the listed evaluations for audiometry, tympanometry, and vestibular function (ENG/VNG, rotary chair testing, computerized dynamic platform posturography, ECoG, VEMP). Some tests may need to be repeated to clarify diagnosis.

E.2.i.1 Audiometry Audiometry is a generally accepted and well-established procedure that measures hearing. An audiologist or skilled trained technician administers the test using an audiometer. The machine presents individual frequencies to the person with TBI (typically ranging from 125–8000 Hz) at different levels of loudness (in dB HL). The individual is asked to respond to the sound at its lowest detectable intensity (threshold).

Normal thresholds are from 0-25 dB HL and are depicted on an audiogram. The audiologist or physician should determine the presence and type (non-organic, conductive, sensorineural, presbycusis, or mixed) of hearing loss based on the audiogram and other tests reasonably deemed necessary.

If available, obtain pre-injury baseline audiograms / audiometry studies to include a summary of past audiometric history, if known (e.g., prior hearing loss, prior tinnitus, prior vestibular problems, prior injury, etc.).

Baseline audiometry following TBI is indicated when the individual with TBI presents with hearing loss, dizziness, tinnitus, or facial nerve dysfunction.

Audiograms may be obtained in serial fashion to monitor inner ear function in response to time and Specific audiometric testing can be done to assess the presence of tinnitus and complaints of unilateral hearing loss (Stinger test).

E.2.i.2 Tympanometry Tympanometry is a generally accepted and well-established procedure that measures middle ear air pressures. It is used to help identify the presence of tympanic membrane perforations, ossicular abnormalities, and the presence of fluid in the middle ear.

E.2.i.3 Vestibular function tests The most common type of vertigo is benign paroxysmal positional vertigo (BPPV), which usually does not require additional testing because it is diagnosed with the clinical Dix-Hallpike maneuver and treated with a variety of canalith repositioning maneuvers (CRM), such as Epley and Semont maneuvers. (Refer to

Section F.4.l, Neuro-otology: vestibular and audiology, under Treatment of recurrent, non-progressive otologic disorders.) The following tests are used to verify the presence of vestibular dysfunction and specify the origin when possible.

E.2.i.3.1 Electro- or video-nystagmography (ENG/VNG)

This is a generally accepted and well-established procedure that measures inner ear/central balance function. The test measures eye movement responses to inner ear balance stimulation making use of the vestibulo-ocular reflex. There are several components to the ENG/VNG. They include oculomotor testing, positional and positioning nystagmus testing, and caloric testing. This series of tests may identify peripheral and central abnormalities, abnormalities in oculomotor function, positional nystagmus, and unilateral and bilateral vestibular dysfunction. The ENG/VNG can be helpful in identifying the affected ear.

This test is often used in individuals with TBI complaining of dizziness or dysequilibrium and may help diagnose conditions such as labyrinthine concussion, vestibular hypofunction, and central vertigo. It is often used in conjunction with other tests such as the audiogram and clinical history to help arrive at a diagnosis.

E.2.i.3.2 Rotary chair testing This is a generally accepted, although not commonly used, test that evaluates the ocular responses of the inner ear to rotation. It is used to identify the extent of bilateral vestibular loss and is more accurate than VNG caloric tests for this purpose. It is also useful in assessing the ability of vision to compensate for vestibular impairments and so provides prognostic information regarding recovery.

E.2.i.3.3 Video head impulse teating (vHIT)

This is a generally accepted, although not commonly used, test that evaluates the ocular responses of the inner ear to high acceleration head rotation. vHIT is used to evaluate the ability to maintain visual focus during head movement that can be impaired with moderate to high grade unilateral or bilateral vestibular injuries. It detects dysfunction of individual vertical semicircular canals in vestibular patients as accurately as scleral search coils but is non-invasive and easy to use. It is used to identify the extent of bilateral vestibular loss and is more accurate than VNG caloric tests for this purpose.

E.2.i.3.4 Computerized dynamic platform posturography This is a generally accepted, although not commonly used, test that assesses the contributions of vision, somatosensation, and the inner ear to balance control. It separately evaluates the role of lower extremity motor control to balance. It can be used to determine whether a vestibular lesion is present, but it does not localize the lesion. The purpose of this procedure is to identify the integral components of a functional balance deficit that may help in treatment planning. This technique also may be useful in monitoring neurologic recovery in individuals with TBI and balance deficits. These functional methods of evaluation are considered generally accepted practices in the evaluation of persistent vestibular and balance deficits that may require specific treatment and remediation strategies. Non-physiologic findings on this exam can result from either symptom exaggeration, anxiety, psychiatric disorders, atypical results, or malingering and should not be interpreted as malingering without other evidence. One study demonstrated positive VNG testing in a number of cases where dynamic posturography was non-physiologic.

E.2.i.3.5 Electrocochleography (ECoG)

This is a well-established and generally accepted procedure that indirectly tests endolymphatic fluid pressures. It identifies the affected ear in cases of post-traumatic endolymphatic hydrops and posttraumatic perilymphatic fistula.

The inner ear has two fluid chambers – the perilymphatic and the endolymphatic. After TBI, it is not uncommon for patients to develop an increase in the endolymphatic fluid pressure; this condition is called hydrops. When the endolymphatic pressures are abnormally high, the inner ear membranes distend, and the ear malfunctions. Symptoms include hearing loss, sporadic dizziness, tinnitus, aural fullness, and sensitivity to sound.

The ECoG is a test that uses evoked potentials. The patient listens to a series of clicks. Monitors, including one sitting on the tympanic membrane, measure three potentials: the cochlear microphonic, the summating potential (SP), and the action potential (AP). An increase in the ratio of the summating potential of the action potential (SP/AP) suggests the presence of hydrops or perilymphatic fistula. The test varies in sensitivity and specificity. Diagnosis of endolymphatic hydrops requires a characteristic clinical picture with progressive hearing loss, fluctuating hearing, and recurrent vertigo episodes lasting for hours. (Refer to section F.4.l, Neuro-otology: vestibular and audiology, under treatment of progressive otologic disorders.) In the absence of these clinical features, diagnosis should not be based solely on an abnormal ECoG test result.

E.2.i.3.6 Vestibular evoked myogenic potentials (VEMP)

This is a generally accepted test that evaluates the function of the saccule, one of the gravity-sensing organs of the inner ear. It is the only objective test of these organs. It is a form of auditory evoked response and is measured using the ABR and EMG equipment. A loud sound stimulus is introduced into the ear, and a vestibulo-colic reflex response from the saccule is recorded as a brief relaxation of the ipsilateral sternocleidomastoid muscle by EMG. A characteristic wave form is recorded for each ear that is analyzed for presence or absence, threshold, amplitude, and latency. Absence of a response in persons under age 60 suggests saccular damage. Reduced thresholds are indicative of semicircular canal dehiscence. It is not useful in diagnosing benign paroxysmal positional vertigo or vestibular migraine.

E.2.i.3.7 Acquired visual dysfunction This is usually not the primary cause of imbalance. However, if ocular and/or visual abnormalities are found on testing, the patient may be further evaluated by a qualified optometrist or ophthalmologist (with training and experience in TBI, balance disorders, and underlying neurology) or a neuro-ophthalmologist.

The goal is to 1) determine if there is a visual component or not, 2) determine if it is central or peripheral, 3) determine if the problem is a manifestation of an underlying vestibular disorder or a true vision problem, and 4) coordinate with the treating providers regarding most appropriate treatment.

E.2.i.3.8 Other clinical referrals The treating physician may refer individuals with TBI who have balance problems to other clinicians with appropriate training in balance dysfunction, such as neuro-otologists, neurologists, and otolaryngologists, to assist in their assessment. The referrals may include, but are not restricted to: neuro-ophthamology, optometry, physical therapy, vestibular therapists, occupational therapy, and chiropractic therapy. There should be a coordinated approach between these disciplines and the physician specialist in the individual’s treatment.

E.2.j Swallowing evaluation Swallowing impairment or dysphagia may be due to neurologic, structural, or cognitive deficits and may result from head trauma. Dysphagia may result in aspiration, airway obstruction, pneumonia, inadequate nutrition, dehydration, weight loss, failure to thrive, and death.

E.2.j.1 Clinical assessment E.2.j.1. 1 Clinical bedside swallow assessment This generally accepted clinical examination of oral-pharyngeal swallow function consists of ● pertinent medical history; ● examination of dentition and function of the jaw, lip, tongue, soft palate, pharynx, and larynx; ● examination of oral sensitivity; ● observation of dry swallow(s) and, if appropriate, swallows with various food/liquid consistencies; and ● ability to follow directions and to discipline own behaviors.

If pharyngeal dysfunction or aspiration is suspected, an instrumental assessment may be indicated.

E.2.j.1.2 Modified Evans blue-dye test (MEBDT)

This is a variation of the clinical bedside assessment used to detect the presence or absence of aspiration in an individual with tracheostomy. This procedure uses blue dye (FC&C Blue No. 1) or methylene blue placed on the tongue or into liquids, ice chips, or food items. Aspiration is assumed if tracheal suctioning reveals blue-tinged secretions. The MEBDT has not been found reliable in identifying individuals who aspirated trace amounts (less than 10% of the bolus). Recognizing the limitations and risks of MEBDT, it is a common and practical means of screening individuals to determine readiness for cuff deflation or further swallowing evaluation.

E.2.j.2 Instrumental evaluation Instrumental evaluations of swallow function are generally accepted diagnostic tests. They are conducted by a speech-language pathologist and a physician in collaboration (radiologist, ENT, or other physician familiar with the procedure as appropriate) or by a speech-language pathologist under the supervision of a physician.

E.2.j.2.1 Modified barium swallow studies (MBS) or videofluoroscopic study MBS is well-established and the most common instrumental procedure used to study swallow function.

The individual’s swallowing function involving the oral cavity, larynx, pharynx, and upper esophagus is visualized while swallowing various quantities and textures of food and/or liquid containing barium contrast material.

The MBS is useful in visualizing, identifying, and documenting the presence of risk of penetration and/or aspiration and the swallowing disorder responsible for it. Specific factors assessed during the MBS may include the anatomy and physiology of the swallow, clearance of material through the mouth and pharynx, the timing of the swallow, the percentage of penetration/aspiration, and the effectiveness of treatment techniques and strategies to improve swallow safety and efficiency. Recommendations are made concerning the safety of oral intake, medication administration, optimal delivery method for diet and hydration, diet texture/sensation modifications, therapy techniques, compensatory postures, and strategies to ensure optimum swallow safety and efficiency. Repeated studies may be needed to determine change in swallow function over time.

E.2.j.2.2 Fiberoptic endoscopic evaluation of swallowing (FEES)

FEES is used to evaluate the pharyngeal phase of the swallow with a flexible endoscope that is placed transnasally into the hypopharynx. It may be completed at bedside and may be useful in those who may not tolerate the radiographic procedure or when such procedures are not readily available. FEES permits direct visualization of anatomy as well as vocal fold motor activity and morphology. It allows for an assessment of briskness of swallow initiation, timing of bolus flow, and swallow initiation, adequacy of bolus driving/clearing forces, adequacy of velar and laryngeal valving forces, penetration or aspiration, and presence of hypopharyngeal reflux.

E.2.j.2.3 Fiberoptic endoscopic evaluation of swallowing with sensory testing (FEEST)

This is a modification of the FEES procedure that adds quantification of sensory threshold in the larynx.

The sensory evaluation involves the delivery of pulses of air at sequential pressures to elicit the laryngeal adductor reflex, thus establishing a sensory threshold. Sensory testing is a quantifiable indicator of those persons at risk for aspiration. It provides better understanding of laryngeal sensory deficits, which may be useful in dietary and behavioral management of individuals with dysphagia.

E.2.j.2.4 Manofluorographic swallowing evaluation (MSE)

MSE is a videofluoroscopic swallowing study with the addition of an oropharyngeal pressure assessment.

Solid state pressure transducer sensors are typically placed in the esophagus, upper esophageal sphincter (UES), hypopharynx, and tongue base. Manometry provides quantitative information at rest and during swallowing on pharyngeal, UES, and esophageal pressures, completeness of UES relaxation, and coordination of timing between pharyngeal contraction and UES relaxation.

E.2.k Vision evaluation There are standard examination techniques and ancillary tests to establish the diagnosis of visual disorders. It is a generally accepted practice for a qualified practitioner to provide a comprehensive vision evaluation.

The qualified practitioner (optometrist, neuro-optometrist, ophthalmologist, neuro-ophthalmologist) should have training and experience in the neurology of TBI.

The comprehensive visual evaluation should assess afferent visual function (visual acuity, visual fields / peripheral vision), efferent function (ocular movement, fixational stability/instability, binocular alignment), and anatomic integrity of the eye and its adnexal structures. In doing so, the practitioner will obtain information about the functional status of the eyes and visual system including the presence or absence of refractive error; loss of visual acuity and/or visual field; oculomotor dysfunction with or without diplopia; ocular, orbital, and adnexal injuries; and other pathology involving intraocular structures. Vision evaluation may be necessary to evaluate acquired/traumatic central and peripheral nervous system disorders, visual acuity loss, visual field loss, nystagmus, ocular motility impairment, cranial nerve palsy, diplopia, suspected or noted ocular and visual pathology, pupillary disorders, and visual perceptual disorders.

The diagnosis/diagnoses determined following a comprehensive neuro-ophthalmic examination should be based upon objective findings that correlate with the known or suspected underlying neuro-pathology and symptoms. A simple description of symptoms may be used but should not be understood as explanatory or diagnostic, as the practitioner should seek to identify the underlying pathology.

Signs and symptoms of visual dysfunction commonly include, but are not limited to: ● Signs ○ ocular mis-alignment (strabismus), ○ nystagmus or other instability of fixation, ○ ocular discharge, ○ red or swollen eyes, ○ ptosis, ○ lagophthalmos (inability to fully close the eyelid), ○ globe dystopia (lack of orbit alignment). ● Symptoms, including complaints of ○ blurred vision or loss of vision, ○ difficulty with visual tracking or scrolling, ○ focusing problems, ○ double vision, ○ having to close or cover an eye to improve vision, ○ problems with depth perception, ○ impaired peripheral vision, ○ headache or eye strain with use of eyes, ○ head tilt to improve vision, ○ dizziness or balance problems with use of eyes, ○ photophobia, ○ reduced attention or concentration for visual tasks.

Visual evaluation is indicated when signs or symptoms consistent with a visual problem are reported by the individual or observed by others. Significant signs and symptoms not directly or solely attributable to other causes (e.g., cognitive, vestibular, medication, psychological) indicate the need for vision evaluation as soon as reasonably possible post-injury. Mild signs and symptoms do not require referral but may be monitored for several weeks to allow for resolution or improvement.

Patients with M/S TBI are more likely to have eye movement and/or visual spatial deficits. Such patients should have a comprehensive evaluation if these signs are noted or symptoms are reported.

A formal vision examination may be intermediate, extended, or comprehensive, depending on the nature of the deficits. The vision examination may include, but is not limited to: case history; visual acuity at a distance and near; refraction; color vision testing; pupillary examination; visual field by confrontation;

Amsler grid testing; ocular motility examination; binocularity examination; accommodation testing; external/adnexal examination; intraocular pressure testing; and anterior and posterior segment examinations.

Ancillary diagnostic tests may include, but are not limited to: visual field testing (tangent screen campimetry, manual or automated perimetry), ultrasonography, fluorescein angiography, anterior segment and fundus photography, optical coherence tomography, electrodiagnostic studies, low vision assessment, and visual perceptual testing.

E.2.k.1 Visual field testing This is a well-established technique to evaluate central and peripheral vision. It is indicated when a deficit is suspected by the practitioner or noted by the patient and should be considered in any patient with TBI and subjective visual field loss. Visual field testing beyond the basic examination should be performed using a procedure and tool that is well-established and standardized. Examples include computerized perimetry and Goldmann perimetry.

E.2.k.2 Ultrasonography Ultrasonography is a well-established diagnostic test that is indicated for evaluation of ocular or orbital pathology. It is indicated for ocular lesions that are suspected but poorly visualized due to opaque ocular media or for further evaluation of ocular or orbital pathology.

E.2.k.3 Fluorescein angiography This is a well-established diagnostic test to evaluate the retinal and choroidal circulation. It is indicated when lesions of one or both of these circulations are suspected.

E.2.k.4 Visual perceptual testing This testing may be conducted informally by an ophthalmologist or optometrist or with a standardized battery of tests employed by a neuropsychologist. Testing consists of functional assessments to evaluate an individual’s recognition and interpretation of visual sensory information. Visual perceptual testing is indicated for determination of the level of visual perceptual impairment and/or confirmation of suspected impairment. Perceptual areas assessed include visual memory, judgment of visual spatial relationships, visual discrimination, visual motor integration, visual figure-ground discrimination, and visual attention.

Numerous tests are used for the evaluation of visual perception. Some of these tests are wellestablished. It is suggested that only tests with established norms be used in a standardized battery, and caution should be exercised in using other instruments.

E.2.k.5 Low vision evaluation Low vision evaluation is well-established and indicated in the presence of subnormal bilateral visual acuity or visual field. The goal is to provide vision aids for distance or near vision that improve visual E.2.k.6 Electrodiagnostic studies These are well-established and possibly indicated in the presence of reduced visual acuity or visual fields, ocular pathology, or suspected optic nerve or visual pathway deficit. (Refer to Section E.2.a, Electrodiagnostic studies, for further description.)

E.2.k.7 Optical coherence tomography This is an interferometric technique, usually with near-infrared wavelengths, used to evaluate optic nerve and retinal structural integrity. This study should be used in conjunction with tests of visual function to establish the possible causes of visual deficits. Serial assessments can provide objective longitudinal data about retinal and optic nerve structure.

E.2.l Return-to-work assessment and special tests A return-to-work procedure should be part of a company’s policies and procedures, knowing that return to work can decrease anxiety, reduce the possibility of depression, and reconnect the worker with society.

Evaluations used to define these abilities, such as the functional capacity evaluation (FCE) and the worksite analysis, should be objective. The professional performing the FCE and worksite analysis should be specifically trained and familiar with the unique presentation of the individual who has sustained a TBI.

The ability to tolerate these evaluations and follow commands may be limited due to TBI and should not be construed as non-cooperative or suggestive of malingering.

Caution should be used in returning an individual to work and other activities too early. Both physical and cognitive duties should generally be non-stressful initially, with a gradual increase in activity based on improvement and/or resolution of symptoms. The individual should be competent in most basic ADLs before return to work is considered. Return to full duty depends on the rate of decrease of symptoms.

Generally, if symptoms recur during increasing job duties or exertion, duties should be decreased accordingly. Because a prolonged period of time off work will decrease the likelihood of return to work, the first weeks of treatment are crucial in preventing and/or reversing chronicity and disability mindset. In complex cases, experienced nurse case managers or occupational therapists may be required to assist in return to work. Other services, including psychological evaluation and/or treatment and vocational assistance should be employed. Two evaluations that may be used are job site evaluations and alterations and FCEs.

E.2.l.1 Job site evaluations and alterations For many patients with TBI, job alterations may be needed. These may be in the form of: (1) instructing the worker how specific duties might be performed to avoid excessive mental stress; (2) actual job worksite or duty changes; and/or (3) a formal job site evaluation and alterations at the worksite.

Job site evaluation and alteration should include input from the employee, the employer, and a health care professional with experience with TBI cases. The employee should be observed performing all job functions in order for the job site evaluation to be a valid representation of a typical workday.

A formal job site evaluation is a comprehensive analysis of the physical, mental, and sensory components of a specific job and may be important initially to determine causation. These components may include, but are not limited to: (a) postural tolerance (static and dynamic), (b) aerobic requirements, (c) ROM, (d) torque/force, (e) lifting/carrying, (f) cognitive demands, (g) social interactions, (h) interpersonal skills management, (i) visual perceptual challenges, (j) environmental requirements of a job, (k) repetitiveness, and (l) essential functions of a job.

Changes that provide a therapeutic benefit or relieve the patient’s ongoing symptoms are part of the required medical treatment for TBI, and therefore, it is assumed that the insurer will be responsible for paying for reasonably necessary job site alterations.

Job descriptions provided by the employer are helpful but should not be used as a substitute for direct observation.

A job site evaluation may include observation and instruction of how work is done, what material changes should be made, and determination of readiness to return to work. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline.

Requests for a job site evaluation should describe the expected goals for the evaluation. Goals may include, but are not limited to: ● Provide a detailed description of the physical and cognitive job requirements; ● Make recommendations for and assess the potential for job site changes; ● Assist the patient in his/her return to work by educating on how he/she may be able to do his/her job more safely; and/or ● Give detailed work/activity restrictions.

Time frames regarding job site evaluations and alterations Frequency One time with additional visits as needed for follow-up.

E.2.l.2 Functional capacity evaluation (FCE)

FCE may be indicated to identify residual physical limitations. FCE is a comprehensive assessment of the various aspects of physical and cognitive function as they relate to the individual’s ability to perform functional activities necessary for return to work. When cognitive, emotional, and/or behavioral sequelae are also present, a comprehensive FCE may provide indications of return-to-work readiness.

Components of the physical portion of the FCE may include, but are not limited to: musculoskeletal screen, cardiovascular profile/aerobic capacity, coordination, lift/carrying analysis, job specific activity tolerance, maximum voluntary effort, pain assessment, non-material and material handling activities, balance/dizziness, climbing, physical fatigue, endurance, and visual skills. The physical portion of any FCE should include all of the physical skills required for specific job placement.

Components of the cognitive portion of the FCE may include, but are not limited to: memory, executive skill function, attention and concentration, communication, speed of information processing, multi-tasking, new learning, and cognitive fatigue and endurance.

Components of the emotional portion of the FCE may include, but are not limited to: temperament, ability to manage stress, adaptation to change, mood changes, toleration of feedback, and anger control.

Components of the behavioral portion of the FCE may include, but are not limited to: appropriate social and behavioral interactions. This may present as inability to complete or cooperate with the tests, inconsistent or erratic behavior, or the inability to get along with coworkers and supervisors.

FCEs include tools that are an extension of the basic medical examination and may be useful for the determination of impairments, functional/cognitive restrictions, determination of progress, and planning and monitoring of the rehabilitation program. Whenever possible, FCEs should be supplemented with information from neuropsychology, speech therapy, occupational therapy, and physical therapy to determine physical, cognitive, and psychological abilities in order for the patient to function safely and productively in a work setting. FCEs are typically conducted in four to six hours, but for individuals who have sustained a TBI, additional time may be required or it may be necessary to conduct the evaluation in two or three separate sessions to allow for the potential variability of cognitive and physical fatigue. Total time for an FCE would rarely exceed eight to ten hours.

When an FCE is being used to determine return to a specific job site, the provider is responsible for fully understanding the job duties. A job site evaluation is frequently necessary. FCEs cannot be used in isolation to determine work restrictions. The authorized treating provider must interpret the FCE in light of the individual patient’s presentation and medical and personal perceptions. FCEs should not be used as the sole criteria to diagnose malingering.

FCEs may be beneficial in the TBI population to assist in return to work.

Time frames regarding functional capacity evaluation Frequency 2 times. When the patient is unable to return to the pre-injury position and further information is desired to determine permanent work restrictions. A repeat FCE may be needed if additional treatment is deemed necessary after the first FCE.

Prior authorization is required for more than 3 FCEs.

F. Treatment Due to the complex nature of the brain, individuals with TBI require coordinated interdisciplinary treatment. Usually, the impairment(s) and functional limitations are appropriately treated by more than one therapeutic discipline. Treatment should include functional, outcome-oriented, and community reintegration goals. Treatment session duration and frequency will vary depending on the individual’s tolerance and may evolve over time.

The location of treatment sessions may be in a clinical setting initially, but eventually may be more effective in the home, workplace, or community, based on functional goals. M/S TBI may result in lifetime deficits, so a long-term disability management model is appropriate. Frequency and duration of specific, non-acute treatments should be included in every treatment plan and should be re-evaluated approximately every three to four weeks or within the time to produce effect in the guidelines. (Refer to

Section B, General guideline principles.) Experienced practitioners should not use all of the therapies and modalities listed in this guideline. Periodic modification or consultation may be necessary throughout an individual’s lifetime following TBI. Therapy for specific impairments and functional limitations may be reinitiated for goal-specific, time-limited treatment as new goals are identified and developed. Treatment should be based on medical diagnosis and associated impairment, cognitive ability, clinical evaluations, anticipated functional gains, and progress demonstrated by documented functional outcomes.

F.1 Acute-stage therapeutic procedures F.1.a Resuscitation The first priority in treating TBI is complete and rapid physiologic resuscitation.

Recommendations for M/S TBI resuscitation Special considerations for isolated communities without neurosurgical support: ● Trauma surgeons and emergency physicians may perform the initial resuscitation and neurologic treatment in the deteriorating individual. Important initial factors affecting TBI outcomes are hypotension (systolic less than 90mmHg) and hypoxemia. ● Once feasible, transport to a designated neuro-trauma center should occur expeditiously for further evaluation and management.

F.1.b Intracranial pressure (ICP) management and cerebral perfusion pressure (CPP)

Indications for M/S TBI ICP and CPP ICP monitoring is usually indicated in individuals with low GCS (less than 9) and an abnormal CT scan or when the individual cannot have continual neurologic evaluation (e.g., use of anesthesia, pain medicine for other injuries that preclude a neurologic exam), and it should also be considered when the individual’s age is over 40 or systolic blood pressure is less than 90 mmHz.

Recommendations for M/S TBI ICP management ● The patient’s head is usually elevated above the heart about 30 degrees. ● Hyperventilation may be used briefly. However, prolonged hyperventilation will eventually result in decreased cerebral blood flow and is not recommended. ● Osmotic therapy such as hypertonic saline or mannitol is frequently used; however, no one agent has been proven superior to another. ● Steroids are not recommended due to worse outcomes. ● Sedatives and/or paralytic agents may be used as needed. ● EEG monitors may be applied and anti-seizure medication may be used. ● Ventriculostomy assists in lower pressure and with hydrocephalus.

F.1.c Hyperventilation Hyperventilation may be used to temporarily decrease ICP.

Recommendations for hyperventilation In rare cases, controlled hyperventilation may be necessary for brief periods in acute neurological deterioration not attributable to systemic pathology (i.e., hypotension), but it is not recommended for prolonged periods of time. It should generally be avoided during the first 24 hours because it may decrease cerebral blood flow.

F.1.d Medications F.1.d.1 Hyperosmolar agents Hyperosmolar agents have been used to temporarily decrease ICP.

A meta-analysis did not support any particular osmotic agent for the reduction of intracranial pressure in the setting of severe TBI, and hypertonic saline solution has not been shown to be superior to or inferior to any other agent with respect to mortality in the setting of increased intracranial pressure.

Indications/recommendations for hyperosmolar agents Hyperosmolar agents may be used prior to ICP monitoring if there is neurologic deterioration not attributable to systemic pathology (i.e., hypotension) and/or signs of transtentorial herniation.

F.1.d.2 Glucocorticoids Glucocorticoids (steroids) were initially thought to decrease acute cerebral damage.

Evidence statements regarding medications: glucocorticoids Glucocorticoids do not decrease mortality. Randomized clinical trial Glucocorticoids may even increase the mortality rate in individuals with TBIs.

Randomized clinical trial Recommendations for glucocorticoids Glucocorticoids are not useful or generally accepted for improving outcome or decreasing ICP, and in some instances, they may be harmful.

F.1.d.3 Anti-epileptics Anti-epileptic agents are intended to prevent or treat seizures.

Evidence statements regarding medications: anti-epileptics In the setting of M/S TBI, treatment within 24 hours from the time of trauma with an antiepileptic drug reduces the risk of seizures in the first 7 days after trauma.

There is a lack of evidence that treatment with an antiepileptic drug reduces the risk of seizures occurring later than 7 days after trauma. There is also a lack of evidence that treatment with an antiepileptic drug reduces all-cause mortality after TBI.

Indications/recommendations for anti-epileptics Anti-epileptic treatment may be used to prevent early post-traumatic seizures in a high-risk individual.

They are also usually administered for one week in those with intracranial hemorrhage. Prevention of early seizures is reasonable to reduce seizure-associated complications during acute management.

Prophylactic anti-epileptics should be administered on a case by case basis after the first week. Clinical indicators warrant their use, such as but not limited to: brain penetration, excessive intraparenchymal bleeding, or continued seizures.

F.1.d.4 Barbiturates to induce coma Barbiturates were initially thought to improve outcomes by decreasing ICP and perhaps decreasing surgeries.

There is no evidence to suggest barbiturates used to decrease intracranial pressure improve outcomes, which may be due to the fact that they lower both intracranial pressure and cerebral perfusion pressure.

Recommendations for barbiturates Barbiturates are not recommended for use in TBI to induce coma.

F.1.d.5 Branched chain amino acids (BCAAs)

BCAAs were initially thought to improve cellular metabolism.

BCAAs have been trialed to reduce functional deficits post TBI. There is no evidence of their efficacy.

Recommendations for BCCAs BCCAs are not recommended.

F.1.d.6 Erythropoietin (EPO)

Erythropoietin has been used to increase the production of red blood cells in the setting of hypoxia.

Evidence statements regarding medications: erythropoietin In the setting of acute M/S TBI, erythropoietin reduces mortality.

There is a lack of evidence that erythropoietin improves the rate of favorable neurological outcomes, as defined by the ability to function outside the home.

Indications/recommendations for EPO EPO is not currently in common use. However, it may be used at the clinician’s discretion for M/S TBI.

Ongoing studies could affect this recommendation.

F.1.d.7 Progesterone Progesterone was initially thought to improve mortality.

In a meta-analysis, 3 of 5 trials showed increased mortality with progesterone versus placebo, and the overall evidence would not shift to show a clear benefit of progesterone over placebo even if there were a new, very large trial with a very dramatic effect on mortality.

Recommendations for progesterone Progesterone is not recommended and may have detrimental effects.

F.1.d.8 Tranexamic acid (TXA)

TXA improves blood clotting.

Evidence statements regarding medications: tranexamic acid (TXA)

When there is a risk of intracranial bleeding in the setting of TBI, TXA is more effective than placebo in reducing the risk of in-hospital mortality and unfavorable neurologic outcomes.

Indications/recommendations for TXA When reviewing the evidence statement listed above, note that many studies on TXA are small. Individual patient factors will need to be considered when choosing to prescribe TXA.

F.1.e Hypothermia Therapeutic hypothermia involves lowering of core body temperature by techniques such as surface heat exchange devices, intravascular infusion of cold crystalloid, and body cavity lavage. Theoretically, it would be performed to decrease some metabolic and physiologic processes that result in neural damage after TBI, including increased intracranial pressure (ICP).

Evidence statements regarding therapeutic hypothermia In the setting of severe TBI with intracranial pressure greater than 20 mmHg for at least 5 minutes despite stage 1 treatment such as mechanical ventilation, sedation, elevation of the head of the bed, IV fluids with or without inotropes, analgesia, surgical removal of space-occupying lesions, and ventriculostomy with or without CSF removal, the addition of therapeutic hypothermia lowering core temperature to 32 to 35° C does not improve outcomes at 6 months and may be harmful by increasing mortality and the risk of unfavorable neurological outcome.

Recommendations for therapeutic hypothermia Based on the evidence listed above, therapeutic hypothermia is not recommended.

F.1.f Surgery In many cases, surgery is appropriate. Refer to Section F.2, Operative procedures, for details.

In patients with acute extradural hematomas and bilateral fixed dilated pupils, the mortality rate was 29.7%, while in patients with acute subdural hematomas and fixed pupils, the mortality rate was 66.4%.

In patients with acute extradural hematomas, a favorable outcome was observed in 54.3%. In patients with acute subdural hematomas, a favorable outcome was seen in 6.6% of patients. All of these patients had surgery. Of these patients, younger patients are likely to have extradural hematomas while older patients are more likely to have subdural hematomas.

F.1.g Hyperbaric oxygen (HBO2)

HBO2 was initially thought to improve outcomes.

Despite evidence of limited physiological changes with hyperbaric oxygen, there is insufficient evidence to suggest that hyperbaric oxygen would functionally benefit stroke survivors or patients with Some benefit with respect to mortality or level of consciousness in the setting of acute moderate-tosevere TBI cannot be ruled out.

Complications can occur, including tension pneumothrorax.

Recommendations for HBO2 Hyperbaric oxygen is not recommended acutely or chronically. Ongoing studies could affect this recommendation.

F.2 Operative procedures It is not the intent of this medical treatment guideline to provide an exhaustive list of surgical procedures associated with TBI. Instead, an overview of the general categories is presented to illustrate the extensive range of procedures that are widely accepted for treatment of individuals with TBI. Combinations and variations of procedures should be tailored to specific cases; hence, a variety of procedures based on the clinical judgment of the treating physician is to be expected. Common procedures include, but are not F.2.a Brain ● Debride penetrating injury, gunshot wound, or foreign body. ● Decompression and evacuation ○ Hematoma: epidural, subdural, intraparenchymal. ○ Contusion. ○ Infections: abscess or empyema.

F.2.b Decompressive craniectomy Decompressive craniectomy is the removal of a large portion of the skull and dural opening to manage cerebral edema causing increased intracranial pressure (ICP). The bone flap is then stored. Often, cranioplasty is later required to correct the skull defect. When the autologous graft cannot be replaced, an alternative method allograft may be used.

Evidence statements regarding decompressive craniectomy In patients with severe TBI and raised ICP, a decompressive craniectomy procedure initiated when the ICP rises above 20 mmHg for 15 minutes out of 60 minutes despite use of first tier treatments does not improve the frequency of death or severe disability compared to continuation of nonsurgical treatment.

(DECRA trial)

Decompressive craniectomy leads to improved mortality when utilized as a last tier approach for severe and refractory intracranial hypertension in patients with severe TBI. However, while operative treatment with craniectomy appears to reduce mortality, it does appear to be associated with slightly increased rates of vegetative state as well as complications. Additionally, the study found no difference in favorable functional neurologic outcomes between surgery versus medical management, although the high cross-over rate may have affected these findings.

Parallel group (RESCUEicp trial)

The most recent randomized controlled trial, the RESCUEicp trial, assessed the effectiveness of craniectomy as a last tier intervention in patients with TBI and refractory intracranial hypertension (ICH).

The study compared medical management for severe TBI with either a bifrontotemporoparietal craniectomy for diffuse cerebral edema or unilateral frontotemporoparietal craniectomy for unilateral hemispheric edema. The study demonstrated that decompressive craniectomy decreased rates of death compared to the medical management group. There was no difference between favorable functional neurologic outcomes between the two groups. However, the operative group demonstrated higher rates of vegetative state. The operative group also demonstrated higher rates of complication, including surgical site infections, myocardial infarct, bleeding, disseminated intravascular coagulation, intraoperative respiratory failure, liver failure, and subgaleal collection.

Patients who had received an immediate hematoma evacuation procedure were included in the RESCUEicp trial if the procedure was not a craniectomy. Of note, however, there was no significant difference in percentage of patients undergoing immediate craniotomy between the medical management and surgical groups. The RESCUEicp study also had a high cross-over rate, with 37% of patients initially randomized to the medical group receiving a decompressive craniectomy due to worsening condition.

This may indicate that craniectomy may have an even more significant effect on improved mortality over standard medical management.

The RESCUEicp trial study departs from previous randomized controlled trials in its use of craniectomy as a last tier approach for more severe cases with refractory ICH. It uses a 25mmHg ICP trigger, which differs from the 20mmHg trigger used in the DECRA trial, with surgery not occurring until at least 1 hour had passed (median 2.2 hours) as opposed to 15 minutes.

The indications and outcomes from the RESCUEicp trial are used for the indications and recommendations in this guideline. ● Craniectomy: subdural hygroma or hemorrhage, contra-lateral contusions, outcome of a vegetative state, cerebral herniation. ● Syndrome of the trephined, a.k.a. sinking flap syndrome: This condition presents with progressive neurologic decline in conjunction with progressive sinking of the craniectomy skin flap. It is likely related to dysregulated brain physiology when intracranial pressure equals atmospheric pressure. ● External hydrocephalus: This is when CSF tends to accumulate in extra-axial spaces after craniectomy and puts the patient at high risk for development of post-traumatic hydrocephalus and need for permanent CSF diversion after reconstructive cranioplasty. ● Cranioplasty: infection, wound break down, bone resorption, increased rate of complication for patients with bilateral craniectomies. Reconstructive options include autologous native bone reimplantation, titanium mesh, or custom synthetic PEEK prosthesis.

Indications/recommendations for decompressive craniectomy If craniectomy is considered, it should be undertaken in patients with severe TBI and intracranial hypertension refractory to other medical management strategies such as head elevation, ventilation, sedation, inotropic therapy, ventriculostomy, and osmotic medications. Decompressive craniectomy may be performed in conjunction with evacuation of mass lesions or for intracranial hypertension with elevated intracranial pressures above 25mmHg that are refractory to tiered medical management. The possibility of death despite surgery, a vegetative state, or prolonged disability should be discussed extensively with patients and/or their families in a shared decision-making model.

F.2.c Cerebral spinal fluid (CSF)

F.2.c.1 CSF leak or fistula Lumbar spinal drain, serial lumbar puncture, or external ventricular drain placement may be used as options to promote spontaneous resolution of CSF leak or as adjuncts to surgical repair. Repair of the leak or fistula may require surgical exploration of the anterior cranial fossa, the temporal bone, and/or sinuses to identify the CSF leak and seal it.

F.2.c.2 Ventricular shunting The treatment of hydrocephalus may require ventricular shunting. Even though ventricular shunting is frequently regarded as a routine procedure, clinicians should recognize the possibilities of mechanical, biological, or technical complications. See complications listed below. Favorable outcome from CSF ventricular shunting in appropriately selected individuals will depend on the timing of intervention, the type of shunt valve used, seizure prophylaxis, and the methods of long-term follow up management. A recent advancement in this type of intervention includes the use of programmable shunt valves. This treatment may require periodic reprogramming of the shunt valve and is a generally accepted procedure. Refer to

section F.3.k, Post-traumatic hydrocephalus.

A 2017 study reported that patients meeting the criteria for ventricular shunt, based on diagnostic criteria and clinical findings, demonstrated significant increases in outcomes at discharge when the shunt was placed earlier in the first 69 days.

Complications for ventricular shunt placement have been reported up to 12%. These include but may not be limited to: ● later seizures may be related to shunt placement. Thus, longer prophylaxis may be indicated; ● hemorrhage; ● delayed wound closure; ● infections; ● shunt malfunction or failure and the need for revisions.

Indications/recommendations for ventricular shunt placement ● Progressive ventriculomegaly not due solely to cerebral atrophy and symptoms of hydrocephalus, such as nausea, headache, and unexplainable hypertension. ● A triad of gait apraxia, persistent cognitive impairment especially abulia and/or akinesis, and incontinence. ● Clinical plateau or decline. ● Persistent and/or prolonged disorder of consciousness without explainable anatomical evidence for such and with coinciding progressive ventriculomegaly on imaging. ● Following a high-volume lumbar puncture, elevated CSF pressures and/or transient improvement in the patient’s clinical status.

F.2.c.3 Ventriculostomy ● Control of ICP. ● Acute hydrocephalus ○ Obstructive. ○ communicating (usually with sub-arachnoid hemorrhage).

F.2.d Extracranial soft tissue ● Debridement and closure. ● Plastic or reconstructive.

F.2.e Maxillofacial ● Repair and stabilization of fracture. ● Facial nerve decompression. ● Repair and/or reconstruction.

F.2.f Cranial nerve decompression or repair F.2.f.1 Decompression of facial nerve If there is immediate onset of total facial paralysis or if the electroneuronography (EnoG) shows greater than 90% degeneration of the facial nerve, then exploration of the path of the facial nerve is indicated.

This usually involves a middle fossa craniotomy and mastoidectomy in order to completely decompress the facial nerve.

F.2.f.2 Other cranial nerve repair or decompression This may be required for functionally disabling conditions such as diplopia.

F.2.g Ophthalmologic ● Direct trauma to globe and/or orbital contents. ● Repair orbital fractures, decompression of orbital contents. ● Optic nerve decompression: Immediate surgery may be indicated if the trauma results in entrapment or compression of the nerve or if a hematoma is present in the optic nerve sheath. ● Strabismus: Surgery may be required to eliminate or decrease diplopia. Individuals may require several revision operations to achieve maximal results. ● Vitrectomy may be indicated in cases of vitreous hemorrhage. ● Surgery may be indicated in cases of eye-lid abnormalities, lacrimal disorders, and other traumas to the external ocular structures.

F.2.h Orthopedic ● Fracture management. ● Adjunctive tenotomies and myotomies. ○ Common upper extremity procedures may require pre-surgical evaluation inclusive of occupational therapy, physical therapy, ROM, function, diagnostic nerve blocks, and dynamic EMG. Definitive procedures include, but are not ■ shoulder muscle release; ■ functional elbow release: brachioradialis myotomy, biceps lengthening, and brachialis lengthening; ■ fractional lengthening of wrist and/or finger flexors; ■ flexor digitorum superficialis (FDS) to flexor digitorum profundus (FDP) transfer; ■ intrinsic muscle contracture release; ■ surgical release of thenar muscles for thumb-in-palm deformity; ■ individualized and customized procedures for spastic upper extremity deformities with adjunctive selective musculotendinous transfers, neurotomy, and neurectomies. ○ Common lower extremity procedures include, but are not limited to: ■ fractional muscle lengthening of knee flexors/hamstrings; ■ hip flexor releases/myotomies; ■ percutaneous vs. open release of the hip adductors; ■ percutaneous tendon Achilles lengthening; ■ Ankle/foot motor balancing surgery adjunctive to tendon-Achilles lengthening (TAL procedure) includes: (1) toe flexor release, (2) split anterior tibial tendon transfer (SPLATT procedure), (3) inter-phalangeal joint fusions, and (4) ankle fusions; ■ individualized and customized procedures for spastic lower extremity deformities with adjunctive selective musculotendinous transfers, neurotomy, and neurectomies. ○ Resection heterotopic ossification.

F.2.i Otologic F.2.i.1 Direct Trauma or barotrauma ● Ossicular discontinuity: The mechanism of head trauma causing TBI may result in dislocation of the hearing bones, creating a conductive hearing loss. This would require an exploratory tympanostomy with ossicular replacement to correct. ● Tympanic membrane perforation: This would cause a conductive hearing loss.

Tympanoplasty is indicated for correction.

F.2.i.2 Tympanostomy Tube placement alters pressure relationships in the middle and inner ear and can reduce dizziness in some patients with progressive vestibulopathy. It can be used to allow access to the middle ear for dizziness treatment devices and gentamicin perfusion. Individuals must be able to tolerate tympanostomy tubes and practice water precautions and aural hygiene to maintain tube patency.

F.2.i.3 Middle ear exploration ● Perilymphatic fistula repair: This presents as a sensorineural hearing loss and dizziness that usually worsens with exertion, straining, or altitude changes. Exploratory tympanotomy with patching or round and oval window niches is indicated in these individuals. The operation itself is as much a diagnostic tool as a therapeutic one. The success rate for treating dizziness due to fistula is 80%. ● Endolymphatic sac surgery: This is a non-destructive procedure performed in the operating room under general anesthesia. The surgeon removes the mastoid bone and uncovers the endolymphatic sac. A drain may or may not be placed in the sac at the time of surgery. This operation has a 65% success rate at controlling dizzy spells in patients with Ménière’s disease / endolymphatic hydrops. ● Labyrinthectomy: This is a destructive procedure performed in the operating room under general anesthesia. The surgeon removes the semicircular canals using the operating drill. This procedure not only obliterates balance function on the operated side, but it also renders the individual deaf in that ear. Because of its destructive nature, it is not indicated in bilateral disease. This procedure has been largely supplanted by gentamicin perfusion for first-line ablation. It can be utilized when other ablative procedures fail to control symptoms. Use should be reserved for cases with documented progressive hearing loss and/or progressive vestibular damage. ● Repair of superior canal dehiscence: This is an uncommon condition that occurs when a congenital defect becomes symptomatic. This may occur after a head injury. Symptoms include vertigo and sound distortion (from conductive hyperacusis).

F.2.i.4 Vestibular nerve section This is a destructive procedure performed in the operating room under general anesthesia. It is usually performed by a team including a neuro-otologist and a neurosurgeon. There are several approaches, but the final step is sectioning the vestibular nerve as it exits the brainstem. Being destructive in nature, it is not indicated in bilateral disease. This procedure has been largely supplanted by gentamicin perfusion for first-line ablation. It can be utilized when other ablative procedures fail to control symptoms. Use should be reserved for cases with documented progressive vestibular damage.

F.2.j Peripheral nerve injury ● May include decompression and repair and/or fracture management.

F.2.k Skull ● Debridement, elevation, and/or repair of fracture or defect including cranioplasty.

F.2.l Spasticity ● Spinal cord procedures, including percutaneous and open selective dorsal rhizotomy (SDR). ● Intrathecal baclofen (ITB) pump: The pump is surgically implanted in the abdomen.

(Refer to Section F.4.j, Muscle tone and joint restriction management, including spasticity, under recommendations for Intrathecal baclofen drug delivery.) ● Other “tone management” procedures.

F.2.m Vascular injury ● Endovascular procedures (i.e., stent, embolism). ● Direct repair. ● Occlusion, trapping, aneurysm repair.

F.3 Complications The following are listed in alphabetical order.

F.3.a Cardiopulmonary complications F.3.a.1 Cardiac system Elevated intracranial pressure and hypoxia may injure the hypothalamus and cardiac regulating centers of the brain, causing pathological changes in autonomic nervous system function. The resulting dysautonomia, paroxysmal sympathetic hyperactivity, or hyperadrenergic syndrome (autonomic storm) includes fever, hypertension, tachycardia, tachypnea, posturing, and hyperhydrosis (increased sweating and flushing). Hypertension in TBI is associated with tachycardia and increased cardiac output with normal or decreased peripheral vascular resistance. This is different from essential hypertension in which there is normal cardiac output with increased peripheral vascular resistance. The preferred treatment for this type of hypertension from hyperadrenergic activity is a beta adrenergic blocking agent or alpha-2 central agonist. However, these approaches should carefully consider the potentially negative cognitive, behavioral, and/or emotional side effects of those medications.

F.3.a.2 Pulmonary system M/S TBI and related trauma to the chest wall may adversely affect respiratory function by compromising respiratory drive, swallow function, and cough. Brain and brain stem injuries also cause abnormal neurogenic breathing patterns and a dysfunctional swallowing mechanism with the potential for aspiration and a weakened cough with poor mobilization of secretions. These individuals are at increased risk for hypoxemia leading to further central nervous system (CNS) injury, pneumonia, and adult respiratory distress syndrome. The main principle of therapeutic intervention is the avoidance of respiratory failure with appropriate oxygenation, ventilation, and airway control. Treatments may include mechanical ventilation, tracheostomy, routine swallow evaluation to evaluate for aspiration risk, and aggressive pulmonary hygiene.

F.3.b Dental, oral, and jaw complications Individuals may have oral, mandibular, and/or dental problems that are a direct result of the TBI, secondary to it, or iatrogenic. These involve issues with dental hygiene, dental decay, the temporomandibular joint (TMJ), jaw range of motion, bruxism, and xerostomia. Complications include, but are not limited to: ● impaired ability to maintain desired hygiene effectiveness; ● impaired ability to remove and insert removable prosthetics; ● altered oral sensation; oral sensation may be decreased, and normal sensations may be perceived as painful; ● impaired proprioception, motor control, or strength of teeth, soft palate, tongue, and/or lips. This could affect oral articulation for speech, control of food and liquid in the oral cavity, and chewing ability and efficiency; ● premature bone loss, periodontal disease, premature restoration failure, premature tooth loss, and peri-implantitis; ● xerostomia, which is caused by many medications and can lead to higher rates of decay and tooth loss.

Success of dental treatment is evaluated by the ability to chew, speak, and swallow. Esthetics and oral articulation are integral to speaking comfortably. When recovering from a TBI, the ability to eat healthy foods in quantities large enough to maintain or increase weight can improve morale and improve success of therapy. Thus, referral is appropriate for diagnosis and treatment.

Possible interventions include, but are not limited to: ● There may be a need for electric brush, flossing, aids, topical fluoride (varnish and trays), and/or medicated rinses. ● Fixed prosthetics may be a necessity. ● If TBI is associated with facial trauma, orthodontics and orthognathic surgery may be required to align the jaw bone prior to dental reconstruction. ● Other interventions recommended by the dentist, orthodontist, oral surgeon, and speechlanguage pathologist.

F.3.c Fluid and electrolyte complications Abnormalities in individuals with M/S TBI are usually iatrogenic or trauma induced. Specific problems may include, but are not limited to, a resulting water and salt retention with decreased urine output. There may also be problems with hyponatremia from inappropriate antidiuretic hormone, cerebral salt wasting, and increased production of aldosterone. Also, hypernatremia from dehydration or diabetes insipidus (DI) may occur. This may require careful evaluation with laboratory studies initially and serially on a follow-up basis.

F.3.d Gastrointestinal complications Individuals with M/S TBI have demonstrated delays in gastric emptying with frequent regurgitation of nasogastric administered feedings. This, accompanied with dysphagia, places the individual at risk for aspiration pneumonia. Dysphagic individuals and those at risk may require total parenteral nutrition (TPN), gastric, and/or post-pyloric feeding techniques. Either an endoscopically placed percutaneous (PEG) or surgically placed gastrostomy and/or jejunostomy may be necessary for adequate ongoing nutritional support. Individuals with gastrointestinal hypomotility may require medications. Also, erosive gastritis and acid reflux / GERD may be a frequent complication, and the use of H2 blockers, proton pump inhibitors (PPIs), and antacid treatments are usually efficacious. Individuals with TBI may also be at risk for neurogenic bowel, which includes constipation, impactions, bowel obstructions, and/or loose stools. A nursing care regimen on a routine and then consultative basis may be necessary to establish routine bowel programs.

F.3.e Genitourinary complications M/S TBI may involve cerebral structures controlling bladder storage and emptying functions. This may result in a neurogenic bladder. Treatment of a neurogenic bladder is aimed at adequate emptying, prevention and treatment of infection, preservation of upper renal tract function, and avoidance of skin soiling from incontinence. An indwelling urethral catheter is often appropriate in the early stages of recovery. Once the urethral catheter is discontinued, either a condom catheter or diaper / adult brief is used for incontinence.

Following assessment of bladder emptying utilizing ultrasonography for post-void residual checks and urodynamic studies, decisions may be made regarding longer-term management strategies. This may include intermittent catheterization or rehabilitative bladder training utilizing anticholinergic medications and time-interval voiding techniques. Urological consultation and more comprehensive diagnostic studies may also be necessary; they may include, but are not limited to: cystoscopy, urodynamics, and renal functions studies.

Sexual dysfunction may also occur, secondary to M/S TBI. Examples include disinhibition, arousal disorders, and erectile dysfunction. If present, comprehensive assessment is appropriate in guiding therapeutic management.

F.3.f Immobilization and disuse complications In an immobile individual, skin is at risk for the development of pressure decubitus ulcers that may slowly progress and increase the length of hospital stays. Tissue pressure, shear, and deformation cause the ischemia. Vigilant rehabilitation nursing protects the individual from these complications, including accurate staging, specialized beds, wheelchair cushions, padding, positioning, and weight shift F.3.g Musculoskeletal complications F.3.g.1 Long-bone fractures Early stabilization allows the prevention of prolonged immobility that has the subsequent greater risk of infection, venous thrombosis development, pulmonary complications, skin breakdown, and contractures.

Fracture healing challenges unique to TBI include the deforming effect spasticity exerts on fracture alignment and an exaggerated healing response. Fixation may be external or internal with surgery.

F.3.g.2 Heterotopic ossification (HO)

HO is defined as the development of new bone formation in soft tissue planes surrounding neurologically affected joints, especially the hips, elbows, shoulder and knees, in order of common concurrence.

Research puts the incidence at 11–75% following M/S TBI. If diagnosis and treatment are delayed, ankylosis (bony fusion) may occur with consequent functional limits in mobility. The greatest risk for development is within the first six months post-injury. Observation by nurses, physical therapists, and occupational therapists is essential and may include documentation of decreased ROM, joint inflammation, pain, and/or a low-grade fever. Appropriate work-up may include laboratory studies revealing an elevated sedimentation rate and/or alkaline phosphatase with a normal complete blood count (CBC). Plain x-rays are necessary and appropriate. However, the most sensitive radiological study includes the three-phase bone scan and/or gallium scan, MRI, and color Doppler ultrasound. These may be necessary in both the initial diagnostic and follow-up phases to guide treatment. Optimal treatment outcome involves early diagnosis, ROM exercise, and the use of disodium etidronate, which prevents mineralization. Other treatment options include non-steroidal anti-inflammatory drugs (NSAIDs), radiation, and surgery in the chronic state.

F.3.h Neuroendocrine complications Neuroendocrine abnormalities following M/S TBI are common and may occur during the acute or rehabilitation stages. Hypopituitarism occurs in approximately 28% of all TBI and although more common in M/S TBI, may also occur in mTBI with a rate approximating 17%. It is estimated that one-third of patients with TBI have persistent anterior pituitary disorders. Older age, TBI severity, and skull fractures are more commonly associated with these lesions. The degree of neuroendocrine dysfunction may vary based on differential injuries to the hypothalamus, anterior/posterior pituitary, upper or lower portions of the pituitary stalk, and connections to other brain and brainstem structures. Secondary endocrine effects may include, but are not limited to, the abnormalities of the following: salt and water metabolism including syndrome of inappropriate antidiuretic hormone (SIADH) and temporary or permanent diabetes insipidus (DI), thyroid function, sexual function, hormonal reproductive function, control of body temperature, ACTH-cortisol levels, glucose metabolism, gonadotropin, and growth hormones. These potential complications may require specialized medical evaluation and treatment if correlative symptoms exist and/or persist. Pharmaceutical treatment for other complications may also affect endocrine systems and require treatment.

F.3.i Neurological complications Often, ongoing evaluation is necessary to detect the delayed development of space occupying intraparenchymal lesions, pneumocephalus, hydrocephalus, hygromas, and extra-axial lesions such as subdural and epidural hematomas. If an individual’s neurological status worsens or plateaus, neuroimaging studies may be warranted.

F.3.j Post-traumatic seizures / post-traumatic epilepsy (PTE)

Major risk factors for the development of PTE include penetrating head wounds, hematoma, depressed skull fracture, and early seizures. The issue of seizure prophylaxis after seven days remains controversial in high-risk individuals. For acute management, refer to Section F.1.d.3, Anti-epileptics.

F.3.k Post-traumatic hydrocephalus Post-traumatic hydrocephalus (PTH) is a common complication following severe TBI with an incidence as high as 45%. It is either the result of blockage or inadequate passage of CSF within the ventricular system of the brain (non-communicating) or, most commonly, malabsorption of CSF back into the ventricular system of the brain (communicating). If not recognized, this complication may interfere with optimal recovery. PTH is treatable with CSF diversion and ventricular shunting. It may be difficult to differentiate the clinically significant symptoms of PTH from the disabling primary TBI-related symptoms that patients experience. It is also challenging for the clinician to differentiate the imaging characteristics of clinically significant PTH from ventriculomegaly (enlarged ventricles) due to atrophy - a condition referred to as hydrocephalus ex vacuo. Refer to section F.2.c.2, Ventricular shunting.

F.3.l Sleep complications Disturbances of sleep is appropriate to consider for patients with M/S TBI as well as mTBI. Refer to

Section F.4.o, Sleep disturbances, for more information including indications and time frames.

F.3.m Vascular complications Individuals with TBI are at risk for developing deep venous thrombosis (DVT) and pulmonary embolus (PE). Since diagnosis by clinical examination is difficult in this population, a high degree of suspicion is warranted. While in the hospital, daily nursing screening with lower extremity measurements is recommended. Abnormalities requiring confirmation may entail noninvasive studies such as Doppler ultrasonographic flow examination and impedance plethysmography. Also, hematologic conditions, such as but not limited to coagulopathies, may require comprehensive specialized hematologic evaluation. It is generally accepted that prophylaxis with low molecular weight heparin, intermittent compression devices (ICDs), or sequential compression stockings may reduce the incidence of both complications. If the diagnostic use of the mentioned noninvasive studies are equivocal and/or non-confirmatory, then venography and/or angiography may be necessary. If thrombotic complications occur, standard treatment includes intravenous heparin or subcutaneous low molecular weight heparin followed by oral warfarin sodium. Other newer pharmaceutical agents may also be appropriate. If neuromedical risks of anticoagulation are present and/or complications related to anticoagulation or progressive thrombosis arise, then placement of an inferior vena cava filter may be appropriate for some patients.

F.4 Specific treatments The following procedures are listed in alphabetical order.

F.4.a Activities of daily living (ADLs)

ADLs are also referred to as daily living skills, life skills, or living skills. These are tasks necessary for an individual’s day-to-day functioning, including both basic and instrumental level tasks. ● Basic ADLs: These include daily activities that tend to be repetitive, routine, and that may be gained more readily through procedural learning, such as grooming, maintaining personal hygiene, bathing/showering, toileting, dressing, feeding/eating, and using basic social skills. ● Instrumental ADLs (IADLs): IADLs include a wide range of activities that require higher level cognitive skills, including the ability to plan, execute, and monitor performance and the ability to evaluate information and make sound judgments. These abilities are essential to safe, independent functioning. They may include functional communication (e.g., writing, keyboarding, appropriate use of phone), home management, childcare, time management, financial management, food management, management of interpersonal relationships and social skills, avocation, driving, and higher level mobility skills (including navigation and public transportation).

By including ADLs in treatment, cognitive improvements may occur through the application of cognitive rehabilitation principles to the task performance. Likewise, physical deficits may be improved by applying neuromuscular rehabilitation principles to the task performance.

ADL functional limitations and disabilities in ADLs are common following TBI and are often due to changes in physical, cognitive, and emotional/behavioral abilities. Functional limitations and disability in these areas may range from mild to severe and from short-term to life-long.

Evidence statements regarding activities of daily living In the stroke population, occupational therapy provides a modest reduction in disability and risk of death.

Indications/recommendations for M/S TBI ADLs training Therapeutic intervention is generally accepted and widely used to improve performance of ADLs. The goal of treatment is to improve one’s ability to perform daily tasks in order to increase functional levels of independence. All treatment should be interdisciplinary.

Treatment in sub-acute and acute rehabilitation is provided by one or more therapeutic disciplines, including occupational therapy, physical therapy, speech therapy, social work, family counseling, psychology, nursing, and/or vocational rehabilitation as tolerated. In post-acute settings, either residential or outpatient, treatment sessions may be provided by more than one discipline. For in-home and community-based treatment, interdisciplinary treatment continues until: (1) functional goals/outcomes are achieved; (2) plateau in progress is reached; or (3) the individual is unable to participate in treatment due to medical, psychological, or social factors. When the skilled services are no longer needed for any of those reasons, the patient should be appropriately transitioned to self-care or other care.

The results of treatment intervention provided throughout the continuum of progress beginning with acute care may not be realized until the final stages of integration back into the individual’s community setting.

Treatment is often indicated at this stage to ensure that the individual is able to reintegrate as successfully as possible, given the parameters of the injury.

Impaired cognition significantly affects the rate, degree, and manner of progress toward independence with ADLs. In addition, skills learned in one setting or circumstance may facilitate the transfer of skills. All treatment to improve performance in this realm should include techniques to improve cognition.

Procedures and techniques may include, but are not limited to: (1) task analysis to develop strategies to improve task performance; (2) guided practice and repetition to develop consistent and safe performance;

(3) training in safe use of adaptive equipment; and (4) training of caregiver(s).

To alleviate the effects of the injury on the performance of ADLs, standard equipment may vary from simple to complex adaptive devices to enhance independence and safety. Certain equipment related to cognitive impairments may also be required. Equipment needs should be reassessed periodically.

As new goals are developed, therapy may be re-initiated for time limited, goal-specific treatment.

Time frames regarding M/S TBI ADLs training Time to produce effect While rate of progress will depend on the severity and complexity of the injury, effect of treatment should be noted within 1 month, with ongoing progress noted over a longer period, which may last up to 2 years or more. Treatment may be provided on an episodic basis to accommodate plateaus in the individual’s progress, with suspension of treatment for periods of time to allow for practice.

Frequency Up to daily, depending on the individual’s progress. Sessions may vary from 1 to several hours depending upon individual’s ability to respond to treatment. Periodic upgrading or consultation may be necessary throughout the individual’s lifetime following TBI.

Maximum duration 24 months or beyond, requires documentation of progress or the need for maintenance to retain ADLs.

F.4.b Behavior The neuropathological deficits occurring in TBI often result in behavioral changes and deficits in the skills needed to: (1) monitor and control one’s behavior; (2) interpret the behavior of others; and (3) respond effectively to social situations. Functional limitations and behavioral disabilities include: deficits regarding functional skills, insight judgment, self-monitoring, and behavioral and emotional regulation. These may be compounded by secondary emotional reactions such as depression or anxiety.

Behaviorally-based therapies rely on an interdisciplinary treatment team approach and are frequently implemented in conjunction with cognitive and/or other psychological treatment.

Post-traumatic neurologically-based behavioral problems may be exacerbated by comorbidities such as personal history, personality issues, family and/or support system issues, psychiatric illnesses, cognitive impairment, medication side effects, and substance abuse. TBI may be a risk factor for alcohol or other substance abuse. Successful resolution of behavioral problems will usually require treatment of these associated comorbidities. Behavioral problems are also influenced by developmental issues. Treatment requires appropriate consideration of developmental and life stage issues (i.e., adolescent, elderly).

Treatment may require specialized settings with professionals experienced in the management of these patients. Depending on the severity of the behavior problem, treatment may require focused, applied behavioral analysis available only in a specialized rehabilitation or psychiatric setting. In less severe situations, applied behavior analysis can be provided in outpatient and community settings. The setting of treatment should consider individual resources and circumstances. Inpatient and outpatient settings may require one-on-one supervision at critical phases of recovery. Treatment consistency across all environments is an important variable in the behavioral treatment outcome. Therefore, it is essential to coordinate treatment resources and professionals and to train the family and/or support system and other caregivers in the behavioral plan.

Analysis of the environment and personnel during periods of transition between treatment settings is generally essential to minimize the stress of change and to avoid the loss of critical environmental factors and learned behavior relations.

Effective behavioral management and treatment requires individualized approaches. Behavioral analysis and treatment involves: ● identification and prioritization of undesirable or negative target behaviors to be managed or extinguished; ● identification of behavioral strengths and positive/desirable target behaviors (frequently called alternative, competing, or replacement behaviors) to be encouraged and positively reinforced; ● analysis and modification of environmental variables to reduce antecedents or precursors of maladaptive behaviors (i.e., loud noise, crowds, requests to do non-preferred activities, changes in daily routines); ● analysis and modification of internal precursors of maladaptive behaviors (i.e., pain, sleep-deprivation, anxiety, helplessness, depression, thought disturbance) and environmental issues to reduce antecedents or precipitants of maladaptive behaviors; ● analysis of the function of maladaptive behavior and developing strategies that replace the need to engage in maladaptive behavior (i.e., teaching and reinforce asking for assistance instead of yelling or aggression); ● progressive refinement of the strategies of internal and environmental modifications in response to an analysis of changes in behavior; ● extensive training and monitoring of treatment plan adherence for all treating staff and family and/or support system interacting with the patient during neurobehavioral interventions; ● behavioral changes are preferably monitored using validated tools.

The following recommendations are based on consensus.

Indications/recommendations for behavior Behavioral therapy is well-accepted and widely used for TBI. It acknowledges that behavioral problems are always multi-factorial, and therefore, treatment should consider medical, neurosurgical, neurological, psychiatric, environmental, and psychosocial issues.

A behavioral therapy plan should be approved and monitored by a neuropsychologist, psychologist, behavior analyst, or physician familiar with TBI. Progress should be re-evaluated and documented every four weeks. (Refer to Section B, General guideline principles.)

As with the behavioral therapy plan described above, time frames should be approved and monitored.

In long-term maintenance programs, treatment may be appropriate on an episodic basis as follows: treatment may be ‘on hold’ for several weeks or months until certain goals are reached or until additional goals emerge. At such times, therapy may be restarted for a time-limited, goal-specific treatment as prescribed and routinely monitored by a neuropsychologist, psychologist, behavior analyst, or physician familiar with TBI. Progress should be re-evaluated and documented every 4 weeks. (Refer to Section B, General guideline principles.)

F.4.c Brain stimulation therapies F.4.c.1 Deep thalamic stimulation This technique has been used in some cases of stroke with motor and cognition problems.

There are no studies reported on patients with TBI.

Indications/recommendations for deep thalamic stimulation It is considered investigational at this time and generally not recommended. It may be used for patients with severe spasticity or motor problems who have failed other treatments.

F.4.c.2 Transcranial magnetic stimulation This noninvasive treatment and exploratory diagnostic tool is FDA approved for use in major depression that is resistant to other therapy.

There is no evidence for its use in TBI.

Some patients have experienced seizures as a side effect.

Indications/recommendations for transcranial magnetic stimulation It is not recommended for TBI or for patients who are comatose or vegetative. It is considered experimental for these conditions. Refer to section F.4.n, Psychological interventions, for use of repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant depression.

F.4.d Cognitive treatment Definition and Background In individuals with M/S TBI, rehabilitation of cognitive deficits is appropriate, clinically necessary, and based on evidence.

“Cognitive rehabilitation is a systematic, functionally oriented service of therapeutic cognitive activities, based on an assessment and understanding of the person’s brain-behavior deficits. Services are directed to achieve functional changes by (1) reinforcing, strengthening, or reestablishing previously learned patterns of behavior, or (2) establishing new patterns of cognitive activity or compensatory mechanisms for impaired neurological systems.”

Rehabilitation includes procedures designed to improve cognitive efficiency, develop specific cognitive skills, enhance awareness of impairments and skills, and develop appropriate compensation strategies for residual cognitive deficits.

Deficits in cognition are a frequent result of TBI. They may persist and may vary from mild to severe.

There may be deficits involving self-awareness, or the “process of knowing,” by which individuals: (1) effectively or efficiently attend to or engage in their environment, (2) make decisions as to the most functional ways of interacting with their environment, (3) execute those decisions, (4) monitor their responses to determine appropriateness and accuracy of their decisions, and (5) adjust their behavior if it is determined to be inappropriate and/or inaccurate.

Rehabilitation is most beneficial when an individual demonstrates adequate arousal, appropriate responsiveness to stimulation, and at least a minimum ability to focus attention. Prior to demonstration of these skills, rehabilitation efforts should focus on monitoring and attempting to elicit responses, structuring the environment (e.g., maintaining a normal sleep/wake cycle), and educating staff and family and/or support system.

A treatment plan outlining current functional goals is recommended with each evaluation. If documented improvement is not shown, the treatment goals and program should either be modified or discontinued.

Periodic upgrading or consultation may be necessary throughout a lifetime following TBI. Therapy may be re-initiated for time limited, goal-specific treatment as new goals or TBI-related problems develop.

A cognitive therapy plan should be approved and monitored by a speech-language pathologist, rehabilitation psychologist, neuropsychologist, or physician experienced with TBI. Physicians may also be involved in pharmacological treatment and management of cognitive disorders. Rehabilitation treatment for cognitive deficits may be provided by speech-language pathologists, neuropsychologists, occupational therapists, music therapists, physical therapists, or paraprofessionals closely supervised by these professionals. It frequently may be necessary for other disciplines to apply cognitive rehabilitation techniques while addressing non-cognitive goals (i.e., mobility and daily nursing activities). Family and/or support system members, caregivers, and partners should always be included in the therapy plan. Thus, therapy is routinely multi-disciplinary for patients with M/S TBI.

All cognitive rehabilitation should focus on functional goals relative to the individual patient’s needs to perform activities of daily living and work. Tasks are improved through three steps according to the Cognitive Rehabilitation Manual by the American Congress of Rehabilitation Medicine:

1. Acquisition: Identification of the goal and tools necessary to achieve the goal, 2. Application: Learning the strategy with repetition, and 3. Adaptability: Demonstrating the use of these skills in a variety of applicable daily activities, including generalization of learned strategies or procedures to new settings and transfer of training to similar tasks.

Strategies for achieving goals are generally broken down into the major areas of memory, attention, executive function, and social communication. In addition, anger management may also improve through training a patient in cognitive labeling of arousal and subsequent possible responses.

Examples of training techniques from the manual include: ● Executive function: problem solving strategies, self-monitoring of results, correcting mistakes, and dealing with frustration; ● Memory: use of external sources such as schedules and smartphones, and use of other sources such as family and caregivers; ● Attention: working with time pressure management, persistence, multiple task demands; ● Social communication: Learning to recognize a conversational partner’s linguistic or facial cues, interpreting verbal and nonverbal messages, setting time limits on talking while in a conversation, attending to other’s responses. Refer to Section F.4.e, Communication, for details.

The INCOG Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury also discuss therapy recommendations in their published series on attention and information processing speed, executive function and self-awareness, cognitive communication, and memory.

Cognitive training has small to moderate positive effects in improving cognitive and functional outcomes in patients with mild to severe TBI who are at least 1-year post-acute TBI when compared to waiting list controls or standard rehabilitation. and meta-analyses of Good evidence, Structured, goal-oriented, individualized multidisciplinary cognitive rehabilitation for patients requiring hospitalization improves mobility, personal care, and independence in ADLs for individuals with TBI.

This type of multi-disciplinary rehabilitation of patients with M/S TBI is likely to provide functional and symptomatic benefit once the patient is able to participate.

Intensive therapy - 15 hours/week for 16 weeks - in a group setting emphasizing integration of cognitive, interpersonal, and functional gains is superior to the same amount of therapy from multiple individual providers for severe TBI.

From an older study of young military patients with M/S TBI who could safely live at home without continual supervision: Psychological treatment in a supported home environment had similar results to inpatient multidisciplinary treatment.

Note: This program is not recommended for patients with work related injury as the population in this study differs from the work related injury population.

Randomized Clinical Trial Automated, audiovisual prompts and reminders delivered on home television were more effective in increasing the number of tasks completed than using self-selected or typical reminder strategies for persons with moderate to severe acquired brain injury needing to compensate for memory failures. controlled crossover A cognitive program aimed at high order reasoning instruction is likely to improve some aspects of executive function (e.g., working memory, inhibition, switching tasks) for individuals with chronic TBI.

A multi-faceted cognitive rehabilitative intervention focused on aspects of executive function can lead to lasting improvement. In this study, group treatment sessions occurred twice per week for 1 hour over a period of 3 months and were focused on self-awareness, self-initiation, goal setting, planning, flexibility, strategic behavior, self-monitoring, and self-inhibition.

Video feedback training in addition to verbal feedback significantly improved intellectual self-awareness in M/S TBI participants compared with verbal feedback alone and with no feedback after 4 training sessions. 8 weeks of occupational therapy training in the use of a personal digital assistant provided significant improvements in patients’ daily memory function and decreased functional memory failures compared with standard memory training that uses non-electronic memory aids in participants with moderate to severe acquired brain injury.

Up to 8 telephone counseling calls focused on independent problem solving over 1 year was no more effective than usual care on improving function, health/emotional status, community/work activities, and well-being at 1 and 2 years after moderate TBI.

Patients with a history of a severe TBI (characterized by 24 hours or more of post-traumatic amnesia) are better equipped to plan a complex task such as organizing a vacation when they are asked in a structured way to recall a time in their personal history when they successfully planned a complex task, such as organizing a move to a new place to live (i.e., autobiographical cueing). clinical trials and There is inadequate evidence to support that computerized cognitive rehabilitation adds any benefits over conventional rehabilitation for patients with mild to severe TBI or stroke.

Indications for M/S TBI cognitive treatment Rehabilitative treatment is indicated following a cognitive/neuropsychological and/or neurological evaluation that identifies cognitive impairments and/or impaired social pragmatics. The evaluation should include statements of TBI severity and prognosis for improvement, outline recommended goals/objectives and methodologies of treatment, and establish frequency and duration parameters.

Cognitive processes that are often impaired after TBI and targeted for treatment may include, but are not ● arousal and attention; ● processing of information (rate, amount, and complexity); ● perception of sensory (auditory, visual, olfactory, and tactile) information; ● verbal and written expression; ● auditory and reading comprehension; ● acquisition, retention, and retrieval of verbal and visual information, which impairs new learning and memory skills; ● executive functioning skills: problem solving, insight, reasoning and judgment, selfawareness and evaluation (including awareness of strengths and weaknesses), goal setting, planning, organizing, initiation, self-inhibiting (or disinhibition and self-monitoring); ● social awareness and behavior.

Recommendations for M/S TBI cognitive treatment Based on the evidence listed above, cognitive treatment is recommended for patients with cognitive impairment.

Services are directed to achieve functional changes by (1) reinforcing, strengthening, or reestablishing previously learned patterns of behavior, or (2) establishing new patterns of cognitive activity or compensatory mechanisms for impaired neurological systems.

Computer-based treatment with active therapist involvement: Computer-based treatment must be accompanied by oversight from the treating provider either in person or by telehealth. Integrated computer-based treatment (i.e., both individualized cognitive and interpersonal therapies) may improve functioning within the context of an interdisciplinary, neuropsychological rehabilitation program.

Computer-based interventions that include active therapist involvement to foster insight into cognitive strengths and weaknesses, development of compensatory strategies, and facilitation of transferring skills into real-life situations may be used as part of a multi-modal intervention for cognitive deficits. Computerbased treatment is not recommended in isolation.

Computer-based treatment without active therapist involvement: Sole reliance on repeated exposure and practice on computer-based tasks without extensive involvement and intervention by a therapist is not recommended. The use of computers as a primary and independent form of treatment in cognitive remediation has limited application because of: (1) limitations in the rationale and specific application of software programs to address the needs of the individual with TBI and (2) difficulty with generalization of learned computer skills into functional environments.

Assistive technology: A variety of devices are available to assist individuals with language and functional problems. These should be trialed within a rehabilitation therapy program by physical therapists, occupational therapists, and speech-language therapists to determine which tools are most suitable for individual cases.

Time frames regarding M/S TBI cognitive treatment Frequency Acute and post-acute – daily.

Sub-acute outpatient and home/community setting – daily to weekly.

Optimum duration Typically 8 weeks with evaluation at the 4-week mark.

Maximum duration Beyond 8 weeks requires documentation of progress with the exception of periodic consultations and new treatment goals.

F.4.e Communication Communication is basic to all daily activity and is necessary for the maintenance of positive quality of life and psychological well-being. Even the most subtle communication impairment may seriously interfere with an individual’s ability to achieve occupational, personal, and interpersonal goals.

Communication (speech-language) impairments are a common result of TBI and may be classified into the following groups: (1) motor speech disorders, which may take the form of dysarthria and/or apraxia of speech; (2) voice disorders; (3) language disorders; (4) communicative/cognitive disorders; and (5) fluency disorders. These may occur together in varying combinations in TBI. ● Motor speech disorders ○ Dysarthria Dysarthria is a reduction in speech intelligibility due to weakness and/or incoordination of the speech musculature secondary to a central or peripheral nervous system injury that involves the processes of articulation, resonance, phonation, and respiration. It accounts for approximately one-third of communication impairments following TBI. Any type or level of severity of dysarthria may occur subsequent to TBI, from very minimal slurring or hypernasality in connected speech to the absence of intelligible speech (anarthria). ○ Apraxia of speech Apraxia of speech is a motor impairment that disrupts central motor planning and interferes with voluntary positioning and sequencing of the movements of the speech musculature in the absence of paralysis or muscular weakness.

Symptoms may range from very mild articulation errors to inability to produce any functional speech volitionally. ● Voice disorders Any compromise to airway structures (nasal-pharyngeal cavities, larynx, trachea, lungs, and the muscle of respiration) or their function may cause voice disorders. These involve impairment in respiration, phonation, and/or resonance. A voice symptom may have one or several causes and may range in severity from mild vocal fatigue to the absence of voicing (aphonia). ● Language disorders Language impairment is often present in the early stages of TBI. In some cases, specific language impairment (aphasia) persists as a result of a focal lesion. Language impairments include those of receptive and expressive language in both spoken and written form, as well as gestural expression and reception. These may be impaired to varying degrees, ranging from very mild difficulty with word finding (anomia) to global impairment involving severe impairment in all language areas. ● Cognitive-communicative disorders Cognition and language are intrinsically and reciprocally related. An impairment of language may disrupt one or more cognitive processes, and an impairment of one or more cognitive processes may disrupt language. The ability to consciously, efficiently access, and manipulate the semantic system requires the complex interplay of language, cognitive, and executive processes. Impairments in linguistic and metalinguistic skills as well as impairments in non-linguistic cognitive functions (e.g., perception, attention, discrimination, organization, reasoning, memory, and self-regulation) interfere with communication of basic needs and communication in wider social contexts.

Social communication skills, also known as pragmatic language skills, encompass the meaning and use of language and other behavior in social situations. They include the interpretation of contextual clues, non-verbal communications, and other interpersonal skills. Social communication skills training is also appropriate for these cases.

Aprosodia is characterized by difficulty understanding or expressing oneself using prosody (i.e., the elements of speech that include variations in rhythm, pitch, stress, intonation, melody, pauses, and intensity). It is common following damage to the right hemisphere. It influences verbal expression or comprehension of attitudes, emotions, or communicative intent.

Evidence statements regarding speech-language disorders and treatment Patients who have had a TBI are likely to have deficits with respect to processing and expressing the social aspects of verbal communication, such as recognizing the emotional content of utterances on the basis of voice tone and other variables.

Many patients with TBI may have difficulty with respect to the recognition and expression of emotional markers of verbal communication even though they score within normal limits on standardized tests of verbal comprehension.

Group instruction, 90 minutes weekly over 12 weeks, by a skilled leader, results in improved communication skills for patients with M/S TBI.

There is insufficient evidence to support or refute the use of oral-motor exercises to affect change in speech physiology, production, and functional outcomes.

Aphasia, ranging from mild to severe, is common following TBI, and intensive language action or constraint therapy is likely to achieve benefits in both quantitative measures and qualitative patient and caregiver reported outcomes.

Indications/recommendations for cognitive-communicative treatment Speech-language therapy is well-accepted and widely used. Music therapy may be appropriate for some Certified speech-language pathologists are qualified to identify, evaluate, and determine the appropriateness of treatment for individuals with speech, language, and cognitive-communicative disorders. When treatment is indicated, speech-language pathologists develop, supervise, and/or implement a plan of treatment. Treatment of cognitive-communicative disorders has come to be included under labels such as cognitive retraining, cognitive rehabilitation, cognitive therapy, cognitive remediation, and neurotraining. Speech-language pathologists should be integral members of interdisciplinary teams who are engaged in the identification, diagnosis, and treatment of individuals with cognitivecommunicative disorders. According to the American Speech-Language and Hearing Association (ASHA), certified speech-language pathologists are qualified to identify, diagnose, and determine the appropriateness of treatment for individuals with speech, language, and cognitive-communicative disorders.

Interaction and consultation among the speech-language pathologist, medical specialists, and other members of the interdisciplinary treatment team is an essential part of the treatment of TBI-related communication disorders. There is extensive overlap in professional domains, making it important that team members from different clinical fields collaborate in their approach to assessment and intervention.

Speech-language evaluation is recommended when there is evidence to support the presence of communicative symptoms. Non English speakers should have a speech-language pathologist who speaks the native language of the patient, when possible. The evaluation includes: ● a collaborative goal-setting discussion identifying realistic functional goals and recommendations. Goal setting should include the individual and their family/support system and consider the pre-morbid level of function; ● a thorough review of relevant medical and social history; ● a comprehensive assessment of communication skills including standard and nonstandard measures; ● evidence of consultation with family members and/or support system; ● diagnosis of communication disorder; ● indication of the severity of the disorder, the individual’s candidacy for intervention, and the prognosis for improvement; ● an intervention plan that is coordinated and integrated with other services being received; ● estimated need of therapy frequency and duration with attention to the anticipated ultimate outcome; ● a plan for providing education and training to the individual’s family members and/or support system.

Constellations of communication-related deficits in TBI are extremely varied, depending on the characteristics of the individual who is injured, the nature, location, and severity of injury, and the posttrauma support systems. Coinciding with the great diversity within this group, there is a similar level of diversity in treatment approaches. These have been divided into various categories, such as “conventional” and “functional,” or those that seek to improve communicative functioning through a restorative, compensatory, or behavioral approach. Experienced therapists commonly use a combination of these approaches, depending on individual needs.

There is insufficient evidence to recommend specific types of therapy. ● As there is insufficient evidence to support or refute the use of oral-motor exercises (see studies listed above), clinicians should consider what a particular oral motor activity is likely to accomplish and if it addresses the impairment. ● Treatment for language impairment is acceptable, including approaches such as intensive language action therapy or constraint therapy. ● Melodic Intonation Therapy is a structured therapy that trains verbal reproduction with melodically intoned phrases while tapping the patient’s hand. A number of case series have supported its use in cases with non-fluent aphasia and/or auditory communication deficits when there is minimal or no damage to the right hemisphere. The therapy can take place as late as six months or longer after injury. It is often done 3–5 hours per week for six weeks.

For certain individuals, prosthetic or alternative augmentative communication (AAC) devices may be necessary to optimize communicative success. These include, but are not limited to: (1) palatal lift prostheses for velopharyngeal dysfunction resulting in severe impairment in speech intelligibility; and (2) augmentative or alternative communication devices which may be indicated when speech is inadequate for functional communication. AAC may involve the use of simple gesture systems, alphabet boards, pictures, word books, or sophisticated use of computer technology (speech generation devices). AAC strategies may enhance communicative participation by replacing, supplementing, or scaffolding residual natural speech and providing a means of repairing disrupted communication.

The process of choosing from these techniques or devices and the training in their use is integrated into the individual’s ongoing evaluation and therapy plan.

For M/S TBI, the following are recommended guidance:

Time frames regarding cognitive-communicative treatment Frequency (1) Acute setting – once to twice daily sessions;

(2) Sub-acute or outpatient and home/community setting – 1 to 5 sessions per week.

Optimum duration 12 weeks with re-evaluations at 4-week intervals. A minimum of 24 sessions for M/S TBI.

Maximum duration Intervention beyond 8 weeks requires documentation of continued functional progress towards established goals. Post-acute therapy could extend for 6 to 12 months, or more, if the individual with TBI has significant speech impairment and is making gradual documented improvement.

Ongoing reassessment and modification of therapy approaches is a part of skilled therapy. It is especially necessary with the dynamic nature of communication impairments that occur with TBI. Goal setting is an evolving and dynamic process that is pivotal to each therapy session. Because of wide variability in type, nature, and severity of communication impairments common to TBI and the lack of unanimity in the literature with respect to the nature and temporal course of post-TBI communicative dysfunction, there should be flexibility in frequency, intensity, and duration of treatment. Many cases require follow-up visits at various points to assist individuals with changes in their life, such as increasing job demands.

F.4.f Complementary and integrative treatment (CIT)

CIT is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medical care. It includes a wide range of interventions and uses methods of treatment based on a broad range of knowledge with roots in both eastern and western medicine. These integrative treatments include, but are not limited to: art therapy, craniosacral trauma release, EEG neuro feedback, dance therapy, hippotherapy, hypnosis, and horticulture therapy. Many providers may combine procedures. Some of these interventions, including the exercise-based procedures, are currently integrated into ongoing rehabilitation programs. In general, most approaches place major focus on the important relationship between physical and emotional well-being.

Indications/recommendations for CIT Integrative therapies should not be employed as the primary treatment modality, but they may be considered for individual cases when other treatments have failed to produce functional gains, when there is a valid clinical rationale for their use, when shared decision making has occurred, and when treatment goals are directed to documentable, functional improvement.

Some therapies that are listed as integrative by NCCIH are considered conventional in the Division’s guidelines. Examples include: acupuncture, biofeedback, and cervical spinal manipulations. These are widely accepted and may be used for headaches or other painful conditions. They do not require prior authorization. (Refer to Sections G.1, Acupuncture, G.2, Biofeedback, and G.19.d, Manual treatment including manipulation, in the Division’s Chronic Pain Disorder Medical Treatment Guideline). CIT therapies that are not addressed in the Division’s guidelines always require prior authorization.

Time frames regarding complementary and integrative treatment (CIT)

Time to produce effect 3 to 6 treatments.

Optimum duration 4 to 6 weeks.

Maximum duration Not well-established for CIT and should be based on specific CIT treatment, physician’s clinical judgment, and demonstration of positive symptomatic and functional gains.

F.4.g Education Formal treatment team conferences involving the individual with TBI, family and/or support system, and case managers (including insurance case manager) should be held regularly during the inpatient, residential, neurobehavioral, and outpatient phases of rehabilitation and periodically during the home and community-based phases of community reintegration.

Education may include, but may not be limited to: brain-behavior relationships, health issues related to TBI and comorbid illnesses or injury, family and/or support system interventions, emotional adjustments, and family and/or support system roles changes. Families and/or support systems and individuals with TBI require education, support, and caregiver training as part of the long-term maintenance plan.

Considerations of treatment for grief/loss may be a variable that complicates clinical progress. Education for the individual and family and/or support system can be provided by case managers, social workers, rehabilitation counselors, family counselors, licensed mental health professionals, therapists, psychologists, and/or nurses.

The following recommendations are based on consensus.

Indications for education Education for the patient and for the patient’s family and/or support system is indicated for all patients with TBI. Family and/or support systems may also benefit from education without the patient.

Recommendations for education Education for individuals with TBI and their family and/or support system is appropriate, generally accepted, and widely used in TBI rehabilitation.

Time frames regarding education Frequency and duration May require daily 1-hour sessions for the first month.

Up to twice weekly for 2 to 3 months.

Up to twice monthly for 6 months.

Monthly for an additional 6 months.

F.4.h Medications The use of medications requires careful monitoring and collaboration between the individual, physician, family and/or support system, and other members of the interdisciplinary team. Common symptom categories targeted for medication treatment may include, but are not limited to: ● pain (headache, axial, soft tissue, etc.) (Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline.); ● sensory alterations (dysesthesias); ● motor symptoms (motor control, coordination, spasticity, weakness, Parkinsonism, tremor, etc.); ● mood disorders (depression, mania, anxiety, etc.); ● affective disorders (inappropriate social responses usually due to frontal lobe damage); ● behavioral problems (poor self-monitoring, disinhibition, irritability, aggression, poor initiation, etc.); ● cognitive issues (arousal, attention, speed of processing, memory, executive function); ● psychotic symptoms (disturbances of thought content such as hallucinations and delusions, thought process, and thought disorganization, which can contribute to behavioral problems); ● neurological issues (seizures, paroxysmal sympathetic hyperactivity, etc.); ● disturbances of sleep (insomnia, hypersomnia, sleep-wake cycle reversals); ● endocrine dysfunction. (Refer to Section F.3.h, Neuroendocrine complications.)

There is no single formula for pharmacological treatment of patients with acute, sub-acute, or chronic problems due to TBI of any level of severity. Clinical pharmacists can provide useful guidance in medication selection.

A thorough medication history, including use of alternative and over-the-counter medications, should be performed initially and when medication changes are made. The medication history may consist of gathering corroborating information from caregivers and prescribing pharmacies, particularly if the individual has memory or other deficits which may impair ability to accurately report medications and adherence to the prescriber.

Appropriate application of pharmacological agents depends on the patient’s age, past history (including

history of substance abuse), drug allergies, and all medical problems. It is incumbent upon the health care provider to thoroughly understand pharmacological principles when dealing with the different drug classes and their respective side effects, drug interactions, bioavailability profiles, and the primary reason for each medication’s usage.

Non-pharmacologic interventions should be used in combination with pharmacologic treatments to minimize the amount of medication necessary in patients with all levels of severity of TBI. Patients and their caretakers should be aware that medications alone are unlikely to provide complete symptom relief.

A primary goal of drug treatment is to improve the patient’s function as measured behaviorally. Essential elements of post-traumatic deficits require continuing participation in rehabilitative programs appropriate to and consistent with the level of recovery and techniques such as cognitive rehabilitation, cognitive behavioral therapy, and other individualized physical and psychological practices, as described elsewhere in this guideline.

Control of chronic post-traumatic deficits, particularly in M/S TBI, is expected to involve the use of medication. Strategies for pharmacological control of post-traumatic symptoms cannot be precisely specified in advance. Rather, drug treatment requires close monitoring of the patient’s response to therapy, the prescriber’s flexibility, and a willingness to change treatment when circumstances change.

This includes lowering and/or discontinuing medications when symptoms improve and periodic trials of lowering medications when symptoms are stable.

Prescribed medications should be given an appropriate trial in order to test for therapeutic effect and tolerance to the medication. The length of an appropriate trial varies widely depending on the drug, as well as the individual and his or her response to the drug. Certain medications may take several weeks to months (e.g., antidepressants) to determine efficacy, while others require only a few doses (e.g., psychostimulants).

It is generally wise to begin management with lower cost medications whose safety and efficacy equals that of higher cost medications and medications with a greater safety profile. Decisions to progress to more expensive, non-generic, and/or riskier medications are made based on the drug profile, patient/caregiver feedback, and improvement in function.

Many of the drugs discussed in the medication section are FDA approved for other indications but may appropriately be used for various aspects of TBI treatment and associated conditions. When prescribing off-label FDA use of a medication, indications and functional goals should be clearly stated as part of a comprehensive, functionally-based treatment plan. Providers should recall that many medications, whether used on-label or off-label, have not been tested on individuals with TBI.

Drugs of potential abuse, such as sedative/hypnotics or benzodiazepines, should be used sparingly in properly selected patients (e.g., for refractory insomnia), although total elimination of these medications is desirable whenever clinically feasible. It is strongly recommended that such pharmacological management be monitored or managed by an experienced physician. Referral to a specialist experienced in TBI may be necessary.

The clinician should use professional resources to determine dosages, side effects, and drug interactions.

The provider should carefully balance the untoward side effects of different drugs with therapeutic benefits, as well as monitor for any drug interactions. A number of medications are not appropriate for women of childbearing age. Problems associated with mild, moderate, and severe TBI can be treated with a variety of medications. However, all have specific side effects and drug-drug interactions of which clinicians should be mindful. Persons who sustain a TBI, particularly M/S TBI, are especially sensitive to central nervous system side effects, such as sedation, dizziness, cognitive impairment, and motor impairment. Usually, starting doses need to begin low and titrating medications need to proceed slowly.

Target doses may also be lower than when using these medications in a person without a TBI. It is recommended that patients with chronic post-TBI symptoms who require maintenance medications use those that have the least serious side effects and potential for drug-drug interactions.

The following section is a general summary of the most commonly used medications. SSRIs (selective serotonin reuptake inhibitors) are recommended as first line therapy. Tricyclic antidepressants, dextromethorphan/quinidine or dopaminergic agents can be useful alternatives. Other medications, like antidepressants (venlafaxine, mirtazapine, and lamotrigine), are also used. Specialists should generally be involved for TBI cases requiring multiple medications. Clinicians should refer to informational texts or consult a pharmacist before prescribing unfamiliar medications or when there is a concern for drug interactions.

F.4.h.1 Mood and anxiety disorders medications These medications are classified into a number of categories based on their chemical structure and their effects on neurotransmitter systems. Their effects on depression are attributed to their actions on norepinephrine, serotonin, and dopamine at the level of the synapse. Although these synaptic actions are immediate, the symptomatic response in depression is delayed by several weeks.

Pharmacologic treatment for depression and anxiety will need to consider the individual patient’s needs and responses. ● Selective serotonin reuptake inhibitors (SSRIs) or Serotonin-norepinephrine reuptake inhibitors (SNRIs) may be used first line, although there is more data to support the use of SSRIs as first line intervention. Doses should be started low and slowly increased with attention to any headache, insomnia, or drowsiness, which could impede cognitive progress. ● Tricyclic antidepressants (TCAs) may also be used; however, some have sedating qualities. (Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for details, and consider the patient’s age when prescribing medications.)

F.4.h.2 Affective disorders medications Affective disorders can manifest as pathologic crying and laughing. These are not mood disorders and may be provoked by a variety of stimuli. This can be seen in M/S TBI and should be distinguished from depression and mania/hypomania to ensure that the correct medication is used. The initial choice of medications is similar to those for mood and anxiety disorders.

F.4.h.3 Behavior/aggression medications There are no FDA approved drugs for the treatment of aggression in TBI, but many agents have been shown to possibly have efficacy, including antipsychotics, antidepressants, mood stabilizers, anti-epileptic drugs, and beta blockers.

All medication use should consider the effects on cognition and interaction with other medications. If a medication is started and questionable improvement is seen, consider stopping or tapering the initial drug and trialing another drug. In some cases, adding a second drug may be preferable.

Depending on the likely source of the behavioral problem, amantadine, methylphenidate, dextroamphetamine, or bromocriptine may be used. ● If the behavior is felt to be due to regulation of ventral brain structures, the goal may be to reduce limbic catecholaminergic function and/or dopaminergic overdrive and anatomical systems, which mediate such. Agents that may be used include atypical antidepressants, beta-adrenergic receptor antagonists, SSRIs, anti-epileptic drugs, or amantadine. ● For chronic aggressive behavior, SSRIs or amantadine are first line. Usually anti-epileptic drugs (valproate, oxcarbazepine, lamotrigine or carbamazepine) are trialed. Next, other adjunctive agents include lithium, buspirone, and beta-adrenergic receptor antagonists or atypical antidepressants.

Propranolol is frequently used to treat aggression and agitation. Carbamazepine, oxcarbazepine, lamotrigine, and valproate may be effective for treating agitation and aggression.

Anti-epileptic drugs (such as oxcarbazepine, carbamazepine, valproate, and other alpha 2-receptor agonist antihypertensive medications such as clonidine) may also be beneficial.

Beta blockers are relatively contraindicated in patients with asthma, heart block, or diabetes.

Although there is some data suggesting that both conventional and atypical antipsychotics can slow recovery from TBI, they may assist in the management of highly agitated or psychotic patients and those patients with comorbid mood disorders. Use of these drugs should include careful monitoring for the development of tardive dyskinesia, weight gain, impaired cognition or coordination, hyperlipidemia, and glucose intolerance.

An attempt to periodically reduce the dose or completely eliminate the drug should be made once the patient has stabilized, and clinicians should have a low threshold for consulting a psychiatrist if prolonged use of the class of medication appears likely.

F.4.h.4 Cognitive enhancers Most cognitive enhancers fall into the general categories of stimulants, cholinesterase inhibitors, or dopamine enhancers. Several areas addressed by these agents are memory, attention, speed of information processing, executive function, and other general cognitive domains.

Medications given to improve cognition should be monitored with periodic neuropsychological assessment or cognitive screening to confirm positive response and the need to continue the medication.

Many of the medications are off-label use, and all should be carefully followed for side effects that may interfere with recovery. A number of the drugs used for cognitive enhancement have abuse potential, and risk screening for drug abuse and urine drug testing may be appropriate in some cases. These medications should also have trial decreases periodically for eventual weaning.

M/S TBI cases will require individual management due to the number of issues being addressed, cognitive changes over time, and drug interactions. Considering these issues and the limited number of adequate studies in this area (with many published articles having small case sizes or non-randomized controls), medication regimes for patients with M/S TBI have wide variation.

The cognitive enhancer table below describes classes of medications frequently used for patients with TBI. Carefully review the evidence tables before prescribing.

Evidence statements regarding cognitive enhancers Citicoline: Citicoline does not improve functional scores in patients with M/S TBI or mild complicated TBI.

Phase 3 randomized Methylphenidate: Methylphenidate has a short-term effect on improving test performance on standardized measures of attention in patients with M/S TBI. crossover trials.

Amantadine: Short-term use of amantadine at daily doses in the setting of severe TBI improves disability more than placebo during the first four weeks of treatment, but effects beyond this timeframe are not known.

Donepezil: From a small study of sub-acute patients with M/S TBI: there is improvement in working memory, retrieval of declarative information, sustained attention, and the rate of cognitive recovery with use of donepezil. The effect was evident at ten weeks and may persist after stopping the medication. crossover trial Table 1: Limited examples of medications used as cognitive enhancers (not a comprehensive list)

Class of Drug:

Examples of Drugs Cognitive Domain Somnolence Attention Deficiency Lack of Motivation/ Initiation Memory Difficulty Slowed Speed of Processi ng Motor Disturbances NMDA Receptor Antagonists:

Amantadine x x x Dopamine Modulators:

Bromocriptine Pramipexole Ropinirole Rotigotine patch x x x Carbidopa Levodopa Sympathomimetics (stimulants):

Dextroamphetamine Methylphenidate Acethycholinesterase Inhibitor:

Donepezil Rivastigmine patch Non-Amphetamine CNS Stimulant:

Modafinil Armodafinil Medications are listed alphabetically. These medications are often not effective in clinical states for which they were developed.

F.4.h.5 Hypnotics and sedatives Sedative and hypnotic drugs decrease activity, induce drowsiness, and may cause moderate agitation in some individuals. Many other medications, such as antihistamines and antidepressants, also produce these side effects. Due to the addiction potential, withdrawal symptoms, and sedating side effects, benzodiazepines and other similar drugs found in this class are not generally recommended to be initiated or continued if previously prescribed for another condition.

There is an increased likelihood of death when opioids and benzodiazepines are used together.

Therefore, it is recommended that no more than 30 morphine milligram equivalents (MMEs) should be used when hypnotics or sedatives are prescribed. If a patient has been regularly taking these medications prior to the injury, they should be assessed by a psychiatrist to determine the need for continued treatment. When used, extensive patient education should be documented. Many unintentional drug deaths are related to concomitant opioid and benzodiazepine drug use.

Retrograde amnesia can occur and is implicated in “sleep driving,” “sleep eating,” and other activities.

Some of these medications have long half-lives and sleep apnea can occur or be aggravated on these medications. Nocturnal oximetry or other sleep studies may be appropriate to identify hypoxia.

Evidence statements regarding hypnotics and sedatives Zolpidem does not appreciably enhance the effectiveness of Cognitive Behavioral Therapy. ● Zaleplon (Sonata), Eszopiclone (Lunesta, Lunestar), Zolpidem (Ambien, Edluar, Intermezzo, Zolpimist) ○ Description: a nonbenzodiazepine hypnotic. ○ Indications: As of the time of this guideline writing, formulations of zaleplon, eszopiclonem, and zolpidem have been FDA approved for insomnia. ○ Dosing and time to therapeutic effect: Time of onset is 30 to 60 minutes. ○ Major side effects: dizziness, dose-related amnesia. There are many reports of significant side effects with Zolpidem, particularly in older patients. ○ Drug interactions: increases sedative effect of other central nervous system (CNS) depressant drugs. ○ Laboratory monitoring: none required, based on individual patient history. ● Benzodiazepine-based hypnotics include temazepam (Restoril, Gelthix), triazolam (Halcion), and flurazepam (Dalmane) ● None are recommended because of habit-forming potential, withdrawal symptoms, and sedating side effects. Flurazepam has an active metabolite with a very long half-life, resulting in drug accumulation and next-day somnolence. ● These medications are not recommended for use in the working populations.

F.4.h.6 Other pain relievers F.4.h.6.1 Acetaminophen Acetaminophen is an effective analgesic with anti-pyretic, but not anti-inflammatory, activity.

Acetaminophen is generally well-tolerated. It causes little or no gastrointestinal (GI) irritation and is not associated with ulcer formation.

However, acetaminophen can exacerbate headache when used chronically. Acetaminophen also has been associated with liver toxicity in overdose situations or in chronic alcohol use. Patients may not realize that many over-the-counter preparations contain acetaminophen. The total daily dose of acetaminophen is recommended not to exceed three grams per 24-hour period, from all sources, including narcotic-acetaminophen combination preparations.

Time frames regarding acetaminophen Maximum duration Long-term use as indicated on a case-by-case basis. Use of this substance long-term (for 3 days per week or greater) may be associated with rebound pain upon cessation.

F.4.h.6.2 Non-steroidal anti-inflammatory drugs (NSAIDs)

NSAIDs are useful for pain and inflammation. In mild cases, they may be the only drugs required for analgesia. Chronic use of NSAIDs is generally not recommended due to increased risk of cardiovascular events and GI bleeding.

There are several classes of NSAIDs. The response of the injured worker to a specific medication is unpredictable. For this reason, a range of NSAIDs may be tried in each case, with the most effective preparation being continued.

Patients should be closely monitored for adverse reactions. The FDA advises that many NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Administration of proton pump inhibitors, histamine 2 blockers, or prostaglandin analog misoprostol along with these NSAIDs may reduce the risk of duodenal and gastric ulceration in patients at higher risk for this adverse event (e.g., age > 60, concurrent antiplatelet or corticosteroid therapy). They do not impact possible cardiovascular complications.

NSAIDs are associated with abnormal liver function and renal function, including renal failure. Patients with hepatic or renal disease may need increased dosing intervals with chronic use.

Due to the cross-reactivity between aspirin and NSAIDs, NSAIDs should not be used in aspirin-sensitive patients, and they should be used with caution in all patients with asthma.

Topical NSAIDs may be more appropriate for some patients; see evidence statements in table below.

NSAIDs may be associated with non-unions. Thus, their use with fractures is questionable.

Certain NSAIDs may have interactions with various other medications. Individuals may have adverse events not listed above. Intervals for metabolic screening are dependent on the patient's age and general health status and should be within parameters listed for each specific medication. Complete blood count (CBC) and liver and renal function should be monitored at least every six months in patients on chronic NSAIDs and initially when indicated.

There is no evidence to support or refute the use of oral NSAIDs to treat neuropathic pain conditions. ● Non-selective non-steroidal anti-inflammatory drugs: This includes NSAIDs and acetylsalicylic acid. Serious GI toxicity, such as bleeding, perforation, and ulceration can occur at any time, with or without warning symptoms, in patients treated with traditional NSAIDs. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur. Anaphylactoid reactions may occur in patients taking NSAIDs. NSAIDs may interfere with platelet function. Fluid retention and edema have been observed in some patients taking NSAIDs.

Time Frames regarding non-selective non-steroidal anti-inflammatory drugs Optimum duration 1 week.

Maximum duration 1 year. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation. ● Selective cyclo-oxygenase-2 (COX-2) inhibitors: COX-2 inhibitors differ from the traditional NSAIDs in adverse side effect profiles. The major advantages of selective COX-2 inhibitors over traditional NSAIDs are that they have less GI toxicity and no platelet effects. COX-2 inhibitors can worsen renal function in patients with renal insufficiency; thus, renal function may need monitoring.

There is an absence of evidence concerning the relative safety of celecoxib at doses greater than 200 mg per day. See also evidence statements in table below.

COX-2 inhibitors should not be first-line for low risk patients who will be using an NSAID short-term. COX-2 inhibitors are indicated in select patients who do not tolerate traditional NSAIDs. Serious upper GI adverse events can occur even in asymptomatic patients.

Patients at high risk for GI bleed include those who use alcohol, smoke, are older than 65 years of age, take corticosteroids or anti-coagulants, or have a longer duration of therapy.

Celecoxib is contraindicated in sulfonamide allergic patients.

Time frames regarding selective cyclo-oxygenase-2 (COX-2) inhibitors Maximum duration Chronic use is appropriate in individual cases. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

Evidence statements regarding nonsteroidal anti-inflammatory drugs (NSAIDs)

Celecoxib in a dose of 200 mg per day, administered over a long period, does not have a worse cardiovascular risk profile than naproxen at a dose of up to 1000 mg per day or ibuprofen at a dose of up to 2400 mg per day. noninferiority trial Celecoxib has a more favorable safety profile than ibuprofen or naproxen with respect to serious GI adverse events, and it has a more favorable safety profile than ibuprofen with respect to renal adverse events.

Topical NSAIDs are associated with fewer systemic adverse events than oral NSAIDs, e.g., reduced risk of gastrointestinal adverse effects by approximately one third.

F.4.h.7 Opioids Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for appropriate use.

F.4.h.8 Skeletal muscle relaxants These are most useful for acute musculoskeletal injury or exacerbation of injury. Refer to Section F.4.h.5, Hypnotics and sedatives, for benzodiazepines. Chronic use of benzodiazepines or any muscle relaxant is not recommended due to their habit-forming potential, seizure risk following abrupt withdrawal, and documented contribution to deaths of patients on chronic opioids due to respiratory depression. (For more detailed descriptions, refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline.) Due to increased mortality, opioids should not be combined with benzodiazepines or most skeletal muscle relaxants.

F.4.i Mobility Individuals who have sustained an M/S TBI may experience changes in their mobility control and may require medical, surgical, physical, and functional therapeutic management to improve their movement and function. Impairments may affect functional skills, including a propensity for falls, and may be seen in bed mobility, wheelchair mobility, seating and positioning, transfers, and ambulation.

Impaired cognition significantly affects mobility as noted by problems with attention, judgment, organization of auditory and/or visual instructions, memory, concentration, problem solving, behavior, and initiation. Therefore, cognition should also be addressed.

The following recommendations were based on consensus and evidence regarding music interventions.

Evidence statements regarding mobility treatment Rhythmic auditory stimulation music interventions significantly improve gait velocity and stride length in people with moderate to severe acquired brain injury compared with standard treatment or controls.

Music interventions for gait may be enhanced when a trained music therapist delivers the intervention.

Indications for M/S TBI mobility treatment Indications include any difficulty with mobility.

Recommendations for M/S TBI mobility treatment ● Therapy Therapeutic intervention supervised by a physical and/or occupational therapist is generally accepted and widely used to improve performance of mobility impairments.

Treatment may include, but is not limited to: the areas of bed and mat mobility skills, sensory integration, endurance, balance, coordination, strengthening, stretching, gait training, neuromuscular re-education and postural control. Training is also indicated for individuals and their family and/or support system in the areas of wheelchair mobility, seating and positioning, ROM, functional mobility (bed mobility, and transfers, ambulation), and therapeutic exercise.

The use of modalities (functional electrical stimulation, TENS, neuromuscular electrical stimulation (NMES), ultrasound, phonophoresis, biofeedback) may be indicated to improve function. Passive modalities should not be utilized in isolation without a comprehensive therapeutic intervention program.

Other indicated therapies may include pool therapy, casting/splinting programs, and facility-based exercise programs. Orthopedic and/or neuromuscular problems may develop along with mobility impairments. These may include, but are not limited to: heterotopic ossification, limb contractures, and abnormal tone, which may interfere with the advancement of independence with mobility skills.

Therapy to improve gait after M/S TBI or stroke, with foot drop or other gait impairments, is variable and includes treadmill training with body weight support, unsupported treadmill walking, electromyographic biofeedback with therapy, functional electrical stimulation assisted gait, lower extremity bracing, use of gait assistive devices, and other therapist facilitated therapy. None of these therapies is clearly superior to another. ● Adaptive devices Individuals with M/S TBI may be compromised in their mobility and accessibility to their home, work, and community environments. In order to relieve the effects of the injury, certain equipment, adaptive devices, and home modifications may be reasonable and necessary. These items may be necessary to reduce impairment and disability and to enhance functional independence and safety.

Technology is advancing rapidly in this area, and each year more adaptive equipment is available. Each case should be considered individually to determine the medical need for the equipment. Possible equipment and devices may include, but are not limited to: ○ hospital bed; ○ transfer devices and lift equipment; ○ standing frames; ○ manual wheelchair (standard or lightweight); ○ manual reclining and tilt wheelchair; ○ power wheelchairs with tilt and/or reclining mechanisms; ○ wheelchair positioning aids (laterals, headrests, seating systems, backs, lapboards); ○ wheelchair cushions; ○ lower extremity bracing; ○ ambulation aids (walkers, crutches, canes); ○ bathroom equipment, accessibility, and safety aids (shower/commode chair, bath seats and benches, tub and wall grab bars, hand held shower attachment, elevated and/or padded toilet seats, etc.); ○ orthotics/prosthetics; ○ vehicle modifications; ○ communication aids and devices including computers; ○ visual adaptive aids; ○ other adaptive equipment for independent ADLs, such as specialized eating utensils.

Environmental modifications may include, but are not limited to: ramping, modifications of the living environment to achieve reasonable levels of independence, and adaptive equipment for mobility and safety. Typically, these evaluations are done by a licensed contractor and occupational or physical therapist with experience in ADA standards. Equipment and modifications must be medically necessary.

Periodic upgrading of equipment and devices or consultation may be necessary throughout a person’s lifetime following TBI.

Therapy related to equipment and devices may be re-initiated for time limited, goal-specific treatment as new goals are developed.

Time frames regarding M/S TBI mobility treatment Time to produce effect While rate of progress will depend on the severity and complexity of the injury, effect of treatment should be noted within 1 month with ongoing progress noted over a longer period, which may last up to 2 years or more.

Treatment may be provided on an episodic basis to accommodate plateaus in the individual’s progress, with suspension of treatment for periods of time to allow for practice.

Frequency Initially, daily for most patients with M/S TBI. Depending on the individual’s progress, sessions may vary from 1 to several hours, based on the individual’s ability to respond to treatment and the setting.

Maximum duration 24 months or beyond. Requires documentation of progress or the need for maintenance to retain mobility. Periodic upgrading or consultation may be necessary throughout the individual’s lifetime following TBI.

Short-term, goal-directed mobility interventions may be periodically indicated on an ongoing basis as new changes occur in an individual’s functional mobility.

F.4.j Muscle tone and joint restriction management, including spasticity This is defined as velocity dependent hyperactivity of stretch reflexes secondary to the upper motor neuron syndrome. It is characterized by exaggerated deep tendon reflexes, increased muscle tone that results in a range of abnormal reflexes and motor patterns. The Modified Ashworth Scale is a clinical tool for measuring resistance to passive limb movement.

Individuals with M/S TBI may demonstrate changes in muscle activation based on emotional factors, positional changes, and functional demands. Treatment approaches involve the disciplines of rehabilitation nursing, physical therapy, speech-language pathology, occupational therapy, and music therapy.

Evidence statements regarding muscle tone and joint restriction management Botulinum toxin A has objective and symptomatic benefits over placebo for cervical dystonia.

Botulinum toxin A injection is effective in reducing muscle tone in the setting of symptomatic spasticity when patients have had a stroke.

The effects of botulinum toxin on functional ability are less certain, in part because motor weakness is an important component of the functional limitations imposed by upper motor neuron lesions.

The optimum dose of botulinum toxin is not certain.

Note: It is likely, although unproved, that botulinum toxin would have similar effects on patients with TBI and severe muscle spasm.

Mirror therapy improves upper or lower limb motor function after a stroke.

Note: It is likely that mirror therapy may benefit TBI Indications for M/S TBI muscle tone and joint restriction management, including spasticity If spasticity is interfering with the individual’s general functioning (which may include ROM limitations, limitations in care and/or ADLs, and limitations in mobility), then treatment is often warranted.

Recommendations for M/S TBI muscle tone and joint restriction management, including spasticity Therapeutic intervention should concentrate on active control, force production, and functional muscle use rather than just tone or spasticity reduction. Specific treatments may include, but are not limited to: ● Orthotics and casting: Serial casting may be effective to increase ROM by inhibiting tone and increasing passive muscle length. Serial casting should be reapplied every 4-7 days as appropriate with increasing stretch and may require an overall treatment period of one to two months. An orthosis may be applied across the joint involved as well as at the joints above and below to maintain tone inhibition and muscle length. These orthoses may be removed to allow therapeutic activity, hygiene, and modification based on progress in ROM and movement. Functional activity, such as reaching, grasp with the upper extremity, and gait involving the lower extremity, should be performed with the orthosis in place. Functional electrical stimulation may be used as a functional orthosis, and both devices may be required to be long-term, if not permanent. Orthotics are often prescribed to protect affected joints and to prevent contracture. Additionally, special seating positioning devices and techniques may be required above and beyond a standard positioning method. ● Postural control: Trunk control is essential for the body to remain upright and to adjust and control movements against gravity. Postural control, mobility, tone, and stability are evaluated by assessing the basic movement components of the upper and lower body, the coordinated trunk, extremity patterns, and the power production involved in equilibrium and protective reactions. Basic movement components of the trunk are then progressed to the linking of trunk and extremity movements in supine, sitting, and standing positions. The last level involves strength and stability for power production for activities such as walking, stair climbing, jumping, running, and throwing. ● Functional and therapeutic activities: These are provided with instruction for the individual and family and/or support system in the proper positions, sequences, timing, and level of assistance. Periodic functional upgrading or consultation may be necessary throughout an individual’s lifetime following M/S TBI. Therapy may be re-initiated for time limited, goal-specific treatment as new goals are developed and as new abilities in physical and cognitive function are observed or attained. (Refer to Section F.4.q, Therapeutic exercise, for further details.) ● Therapeutic nerve blocks and motor point ablations: These are useful in targeting specific muscles or muscle groups for diagnostic and therapeutic purposes. Nerve blocks can be useful for short-term reduction in pain and inflammation. The purpose of the motor point ablation is to reduce force produced by contracting spastic muscle or muscle group. This reduction in spasticity may lead to improved ROM and enhanced functioning. Therapeutic motor point ablations are primarily performed with aqueous solutions of phenol. When injected in or near a nerve bundle, phenol denatures protein in the myelin sheath or cell membrane of axons with which it makes contact. Either percutaneous or open neurolytic procedures are considered useful in a variety of spastic disorders related to TBI and are generally accepted procedures. Refer to the Division’s medical treatment guideline for the appropriate area of injury. ● Botulinum toxin injections: Botulinum toxin injections are used to temporarily weaken or paralyze muscles. They may reduce muscle pain in conditions associated with spasticity, dystonia, or other types of painful muscle spasm. The duration of treatment effect of botulinum toxin for cervical dystonia has been estimated to be approximately 12 weeks.

EMG needle guidance may permit more precise delivery of botulinum toxin to the target area. ○ Complications: Over-weakening of injected muscles, migraine, and allergic reaction to medications. Rare systemic effects include flu-like syndrome and weakening of distant muscles. There is an increased risk of systemic effects in individuals with motor neuropathy or disorders of neuromuscular junction. ○ Indications: Botulinum toxin injections are used to improve ROM and reduce painful muscle spasm, as a temporizing measure when spasticity is evolving, and during the chronic phases to support increased function. Botulinum toxin injections may be useful in musculoskeletal conditions associated with muscle spasm and in central neurologic conditions that produce spasticity or dystonia (e.g., brain injury, spinal cord injury, or stroke). There should be evidence of limited ROM prior to the injection.

Time frames regarding botulinum injections for spasticity Time to produce effect 24 to 72 hours post-injection with peak effect by 4 to 6 weeks.

Frequency Approximately 3 months between re-administration.

Optimum duration 3 to 4 months.

Maximum duration Unknown at the time of this guideline. Repeat injections should be based on functional improvement and therefore used sparingly in order to avoid development of antibodies that might render future injections ineffective. ● Pharmaceutical agents: A variety of oral and transdermal antispasticity medication may also be used. ● Intrathecal baclofen drug delivery: The intrathecal administration of baclofen is indicated for use in the management of severe spasticity. Individuals with M/S TBI should first have a positive response to a diagnostic injection of intrathecal baclofen prior to a consideration of long-term infusion via an implantable pump. An implantable pump should be reserved for those individuals unresponsive to oral baclofen therapy or for those who experience intolerable CNS side effects at effective doses. Furthermore, there should be clear-cut documentation as to the deleterious effects of their persistent spasticity if not treated effectively, as well as to the specific goals of this invasive therapy. Intrathecal baclofen is intended for use via spinal catheter or lumbar puncture and for chronic use only in implantable pumps approved by the FDA, specifically for the administration of intrathecal baclofen via the intrathecal space. ○ Diagnostic injection ■ Special requirements for diagnostic injections: Fluoroscopic and/or CT guidance may be used to document technique and needle placement. An experienced physician should perform the procedure. The subspecialty disciplines of the physicians may be varied, including, but not limited to: anesthesiology, radiology, surgery, neurology, or physiatry. ■ Complications: General complications of diagnostic injections may include, but are not limited to: transient neurapraxia, nerve injury, infection, headache, urinary retention, and vasovagal effects, as well as epidural hematoma, permanent neurological damage, dural perforation, CSF leakage, and spinal meningeal abscess. Permanent paresis, anaphylaxis, and arachnoiditis have been rarely reported. ■ Contraindications: Absolute contraindications to diagnostic injections include, but are not limited to: (a) bacterial infection, systemic or localized to the region of injection, (b) bleeding diathesis, (c) hematological conditions, and (d) possible pregnancy. Relative contraindications of diagnostic injections may include: (a) allergy to contrast, (b) aspirin/antiplatelet therapy (drug may be held three days or more prior to injection), and (c) shellfish allergy if contrast is to be used. ○ Surgical pump implantation ■ Complications: Intrathecal delivery may be associated with significant complications such as infection, catheter disconnects, CSF leak, arachnoiditis, pump failure, nerve injury, and paralysis. ■ Surgical indications: Individuals who meet the following criteria should be considered candidates for intraspinal baclofen infusions: ● The individual should have quantifiable relief from the diagnostic baclofen intrathecal injection and have demonstrated clear functional improvement. Functional gains may be evaluated by an occupational therapist and/or physical therapist prior to initiating and discontinuing a trial. ● Failure of conservative therapy, including active and/or passive therapy, medication management, or other therapeutic injections. ● The individual and family and/or support system should be motivated for the procedure and should understand the potential for complications and the requirements of treatment maintenance. ■ Contraindications: Infection or body size insufficient to support the size and weight of the implanted device. Individuals with other implanted programmable devices should not be given these pumps, since interference between devices may cause unintended changes in infusion rates. ■ Continuing use: As with other routes of drug administration, escalation of dose may be required and routine clinical monitoring is warranted.

Typically, pump refills are needed every two to three months.

F.4.k Neuromuscular re-education Neurologically-based musculoskeletal impairment may include changes in reflexes, sensory integration, ROM, muscle tone, strength, endurance, postural control, postural alignment, and soft tissue integrity.

Functional abilities that are affected may include, but are not limited to, problems in gross and fine motor coordination, motor strength and control, sensory-motor bilateral integration, and praxis.

Medical treatment may be divided into two major areas: ● Motor control: This involves stabilizing the body in space as it applies to postural and balance control and moving the body in space through motor control as it applies to movement. ● Motor learning: Motor learning is a set of processes leading to relatively permanent changes in the capability for producing skilled action. Motor performance of a skill, task, or activity requires learning. Functional motor change requires skilled intervention to ensure proper repetition, practice schedules, variable type of practice, and type and timing of feedback. Active problem solving should be part of a rehabilitation program to learn motor skills more appropriately. Continuous, accurate, and immediate feedback about muscle contraction and movement is important in the early stages. Therapist provided feedback and cues can be faded as appropriate for the patient.

Evidence statements regarding neuromuscular re-education Early onset neurorehabilitation in a trauma centre and more intensive neurorehabilitation in a rehab facility have beneficial effects on the functional recovery of patients with M/S TBI as compared to usual care.

Constraint induced motor therapy (CIMT) provides a favorable effect immediately post treatment for stroke victims with paresis of one arm and good cognition.

The motor function associated with CIMT is maintained at 24 months after treatment.

Note: It is likely that mirror therapy may benefit patients with TBI. Therefore, CIMT is a recommended therapy for similarly affected patients with TBI.

Indications/recommendations for M/S TBI neuromuscular re-education Individuals with neuromuscular impairments may require physical, therapeutic, and medical and/or surgical management to improve their movement and mobility.

Time frames regarding M/S TBI neuromuscular re-education Time to produce effect While rate of progress will depend on the severity and complexity of the injury, effect of treatment should be noted within 1 month, with ongoing progress noted over a longer period, which may last up to 2 years or more. Treatment may be provided on an episodic basis to accommodate plateaus in the individual’s progress, with suspension of treatment for periods of time to allow for practice.

Frequency Initially, daily for M/S TBI. Depending on the individual’s progress, sessions may vary from 1 to several hours, based on the individual’s ability to respond to treatment and the setting.

Maximum duration 24 months or beyond, requires documentation of progress or the need for maintenance to retain motor skills. Periodic upgrading or consultation may be necessary throughout the individual’s lifetime following TBI.

As the individual progresses, treatment frequency should be decreased. Continued treatment is based on attainment of functional goals as outlined in the treatment plan.

F.4.l Neuro-otology: vestibular and audiology For patients with dizziness causing nausea or affecting balance, treatment of these conditions may be necessary before other rehabilitative therapy can be accomplished.

Supporting literature and evidence statements The following recommendations were based on consensus. Supporting literature and evidence statements are also included in the subsections when available.

Indications/treatment for neuro-otology, vestibular and audiologic ● Treatment of fixed lesions ○ Post-traumatic tinnitus: Individuals with TBI may experience debilitating tinnitus (ringing in the ears). Tinnitus may be associated with pressure or noise related trauma and ossicular or perilymphatic fistula disorder. Tinnitus can be evaluated with specific audio-metric testing techniques. Patients may benefit from antidepressants, anti-seizure medicines, and anxiolytics. In many situations, devices are recommended. These may include hearing aids, maskers, and tinnitus trainers. Tinnitus trainers require a 30-day trial to determine the effectiveness of masking. More sophisticated devices that use music as opposed to masking are not recommended due to no proof of their superiority. ○ Hyperacusis: Individuals with TBI may experience significant sensitivity to sound.

This is more common in association with tinnitus. These individuals may benefit from devices such as tinnitus trainers, musician’s plugs, and simple noise plugs.

Continuous exposure to broadband sound may also be used. ○ Sensorineural hearing loss: Individuals with TBI may experience nerve hearing loss that may be treated with amplification (hearing aids). A full audiometric evaluation, including the Stinger Test, may determine if the individual could benefit from such devices. Difficulty in auditory processing, such as speech understanding and speech segregation has also been identified in blast exposed military. ○ Vestibular loss: Individuals with TBI may experience loss of inner ear balance function resulting in dizziness and imbalance. This can result from labyrinthine concussion, penetrating injuries, injury to the eighth cranial nerve, and explosive pressure changes. Patients may compensate for vestibular deficits more quickly with vestibular rehabilitation than without it.

Persistent postural perceptual dizziness: This is a condition in which patients continue to experience persistent dizziness due to mis-calibration of the sensorimotor, cerebellar, and vestibular inputs. This condition may be comorbid with anxiety. Treatment with aggressive vestibular rehabilitation and either SSRI or SNRI may be beneficial. ○ Repeat testing may be necessary to confirm diagnosis. ● Treatment of recurrent, non-progressive otologic disorders ○ Benign paroxysmal positional vertigo (BPPV): BPPV is the most common cause of post-traumatic vertigo. It is an otologic disorder in which particles normally adherent to the gravity sensors of the ear become displaced into the semicircular canals, which cause the sensation of spinning. It is characterized by recurrent, brief spells of vertigo triggered by head movements such as getting in and out of bed, rolling over in bed, tipping the head upward, or bending over. It is diagnosed by the Dix Hallpike maneuver and treated with canalith repositioning maneuvers (CRM) specific to the affected semicircular canals. Patients treated by CRM should be re-evaluated within the first month to ensure resolution of symptoms.

Recurrences are common after trauma. These may be treated by repeating the CRM, home exercises, or referral to physical therapy.

Some individuals may require an exercise-based approach following, or instead of, the CRM. Home exercises are safe and effective in this disorder.

Time frames regarding vestibular rehabilitation for benign paroxysmal positional vertigo Frequency 1 to 3 sessions with repeated CRM at each session and followup at 1 month.

Optimum duration 1 month with re-evaluation.

Maximum duration Reoccurrence can occur randomly for many years following trauma. Home exercises are necessary for those with frequent recurrences. Some patients are unable to perform home exercises, so repeated visits for CRM may be required. ○ Semicircular canal dehiscence: This is an abnormal communication between the CSF space in the skull and perilymph surrounding the inner ear. It can result from blunt head trauma with fracture of the bone separating these spaces. Symptoms include vertigo brought on by loud sounds or straining and autophony, which is the magnification of internal bodily sounds (chewing, eye movement, joint movement, heartbeat) in the affected ear. Vestibular suppressants and avoidance of provoking sounds can be used; surgery is required in severe cases. ○ Vestibular migraine: Individuals experiencing an exacerbation of migraine after TBI frequently have an associated dizziness. Treatment includes trigger avoidance, vestibular suppressants, and migraine prophylactic medications such as calcium channel blockers, anti-seizure medication, beta blockers, and SSRIs.

(Refer to Section F.4.m, Post-traumatic headache treatment.) ● Treatment of progressive otologic disorders ○ Progressive vestibulopathy with or without hearing loss: Injury to the ears that results in acute auditory or vestibular injuries occasionally converts to a progressively damaging disorder with recurrent vertigo spells and gradual loss of hearing and/or balance function over time. Cases with discrete vertigo spells of hours in duration associated with tinnitus and fluctuating hearing are called posttraumatic endolymphatic hydrops or Ménière’s disease. Hydrops refers to dilation of the endolymph space of the inner ear at the expense of the surrounding perilymph space and is highly associated with Ménière’s disease, although the mechanism of the ear dysfunction is not yet known. Treatments include diuretics, calcium channel blockers, steroids, gentamicin perfusion, and surgery. ○ Perilymphatic fistula: Ruptures of the round or oval windows of the inner ear or fractures through the ear can result in leakage of perilymph. This can cause progressive hearing loss and recurrent dizziness that is often triggered by straining. Treatment is bed rest with the head elevated and avoidance of straining for mild cases. Surgery is required for severe cases and those not responding to a week of bed rest. ● Treatment options including vestibular rehabilitation ○ Steroid perfusion: During this procedure, steroids are injected into the middle ear space, allowing absorption into the inner ear via the round window membrane. It can provide a temporary reduction in the frequency of vertigo spells in progressive vestibulopathy and may improve hearing after sudden losses. ○ Gentamicin perfusion: This is an in office procedure where gentamicin is injected into the middle ear space. From there it is absorbed into the inner ear via the round window membrane. This procedure may have to be repeated several times to control dizzy spells. The gentamicin is toxic to the cells of the inner ear and therefore destroys the inner ear balance function. There is also a significant risk to hearing function. This procedure has a 95% success rate, but cannot be used in bilateral disease because of its destructive nature. Use should be reserved for cases in which a unilateral progressive hearing loss and/or loss of vestibular function has been documented. ○ The Meniett device: This is a portable, alternating pressure generator that transmits low-pressure pulses to the middle ear.

Evidence statements regarding the Meniett device The Meniett device produces short-term symptomatic and functional benefit with daily use in individuals with established Ménière’s disease, reduced vestibular function, and severe vertigo, which persist despite adequate medical therapy.

The mechanism of benefit is not yet understood. Individuals must be able to tolerate tympanostomy tubes and practice water precautions and aural hygiene to maintain tube patency. Effectiveness beyond four months of treatment has not been established. **Use of the Meniett device requires a surgical procedure.

(Refer to Section F.2.i.2, Tympanostomy.)** ● Vestibular rehabilitation Symptoms of vestibular system dysfunction following TBI may be due to damage of central or peripheral structures. These symptoms may include vertigo, eye-head dyscoordination affecting the ability to stabilize gaze during head movements, and imbalance affecting stability in standing or walking. Dizziness is commonly associated with TBI. Dizziness and balance disorders may or may not co-exist in the same individual with TBI.

Vestibular rehabilitation is performed by qualified practitioners, such as audiologists, otologists, trained nurses, vestibular therapists, physical therapists (preferably neurology certified), or occupational therapists.

Evidence statements regarding vestibular rehabilitation Vestibular rehabilitation incorporating visual motion performed by the patient alone with brief instruction from a health care provider reduces dizziness and improves function. 2 to 6 sessions of Mulligan sustained natural apophyseal glides (SNAGs) or Maitland mobilizations over 6 weeks are significantly more effective in reducing the intensity and frequency of cervicogenic dizziness than a placebo intervention in patients with chronic cervicogenic dizziness. The effects are maintained at 12 weeks post treatment. ○ Balance disorders:

Balance disorders occur frequently following TBI. This may be due to a peripheral vestibular lesion or central vestibular lesion secondary to trauma, fracture, hemorrhage, or intracranial pressure changes.

Balance is a complex motor control task, requiring integration of sensory information, neural processing, and biomechanical factors. It is the ability to control the center of gravity (COG) over the base of support in a given sensory environment.

Assessment includes evaluation of the motor system, ROM, and sensory systems that affect the person’s ability to maintain equilibrium. Movement strategies to maintain balance require functional ROM and adequate strength.

Sensory information from the vestibular, visual, and somatosensory systems are integrated at the central level between the two sides of the body and three sensory systems. These key areas are associated with maintenance of balance or posture. Central motor planning is essential for proper strategies that are then transmitted to the peripheral motor system for execution. Deficits at the central level, peripheral motor level, or peripheral sensory level will affect balance and equilibrium.

Common clinical tests used to evaluate balance include the Balance Error Scoring System (BESS), Berg Balance Scale (BBS), Community Balance and Mobility Scale (CB&M), Clinical Test of Sensory Interaction on Balance (CTSIB), Motion Sensitivity Quotient, Sensory Organization Test (SOT), tandem gait task from the Sport Concussion Assessment Tool-3, Functional Gait Assessment (FGA), and an instrumented gait speed assessment. The disadvantage to most of these tests is that they were developed for specific age groups and may not have been studied for TBI. However, the CB&M has been studied for TBI. Selfreport instruments are also available to evaluate balance: ABC scale for dizziness, Dizziness Handicap Inventory (DHI), Vertigo Handicap Questionnaire (VHQ), and the Vestibular Disorder Activities of Daily Living Scale (VADL).

Sources of imbalance include vestibular, ocular, somatosensory, and cervicogenic. Vestibular-ocular type may have visual abnormalities on testing and impaired clinical balance. It is usually treated with a vestibular rehabilitation program. Visual or ocular motor training alone has no demonstrated benefit, and treatment should be done using an interdisciplinary approach. Cervicogenic imbalance is associated with neck pain and headaches associated with head movement. It is usually treated with head and neck proprioceptive re-training and cervical manual therapy.

The dynamic systems model recognizes that balance and dynamic equilibrium is the result of the interaction between the individual, the functional task, and the environment. Emphasis of treatments performed by a qualified physical or occupational therapist in vestibular and balance dysfunction are head exercises for habituation of vertigo, eye-head coordination exercises for improvement of gaze stabilization, and sensorimotor retraining to remediate postural dyscontrol in all functional movement positions. Exercises may be directed at: habituation, desensitization by repeat exposure; substitution, alternative strategies; or adaption, improved use of remaining functioning vestibular system.

Special equipment for vestibular treatment in the clinic may include dynamic platform posturography or a foam/dome apparatus for sensory integration and balance as well as tilt or rocker boards. Other virtual reality devices used in isolation are not suggested for use with this treatment because therapist intervention and supervision are important for success. No special equipment is needed at home unless identified by the treating professional and documented as medically necessary.

Individuals with central traumatic vestibular lesions take longer to improve than those with dizziness from other causes. Studies indicate that at six months, only one-third of individuals with unilateral loss from trauma were symptom-free as compared with other causes. At 18 months, many individuals continued to show symptoms. Of those with central vestibular loss, 60-70% had persisting symptoms at five years and half were unable to return to work.

Time frames regarding vestibular rehabilitation for balance disorders Time to produce effect 6 to 12 weeks depending on severity.

Frequency 1-2 times per week initially for training with 2-4 follow-up visits to reinforce treatment. Individuals are expected to perform selfdirected exercises twice daily at home, but they may require supervision for guidance and safety.

Optimum duration 2 to 6 months with re-evaluation. Limited to 24 visits within 6 months.

Maximum duration Therapy will be more intense and requires more frequent therapy for patients with moderate to severe dysfunction. If reports document treatment progress but the individual is not at maximum therapeutic gain, then additional therapy may be indicated. ○ Postural control: Treatment involves remediation of stability within the constraints following TBI in the musculoskeletal, neuromuscular, sensory/perceptual, and cognitive areas. Concurrent physical injuries and/or medication treatment may limit the individual’s ability to move in ways necessary for compensation.

Treatment in this area may include physical modalities to increase ROM, joint mobility, and flexibility. Treatment for muscular incoordination may include therapeutic exercise, electrical stimulation, biofeedback, re-education, and other therapies. A vestibular rehabilitation program needs to be individualized considering cognitive impairments and involves: ■ increased need for physical assistance because of movement problems; ■ increased need for supervision because of cognitive and behavioral problems; ■ slower progression of program.

F.4.m Post-traumatic headache treatment For patients with M/S TBI, headaches seem to present approximately 35% of the time up to 60 months post-injury. About 40% of patients with headaches at one year experience several per week.

If evaluation and treatment for headache is needed, refer to the Division’s Mild Traumatic Brain Injury Medical Treatment Guideline.

F.4.n Psychological interventions M/S TBI may result in a variety of cognitive, psychological, and/or behavioral symptoms that can negatively impact each other, recovery from TBI, and/or functional outcomes if left untreated. Therefore, psychological treatment is recommended for patients with any of these symptoms.

Evidence statements regarding M/S TBI psychological/educational interventions For patients with complicated mTBI and moderate TBI who have completed initial therapy, 12 weeks of telephone-based and in-person Cognitive Behavioral Therapy (CBT) interventions are no more effective than usual care for treating Major Depressive Disorder (MDD).

Due to the differences noted between groups in this study, it is not possible to determine if telephone CBT is preferable to in-person CBT after initial treatment has been completed.

However, telephone CBT allowed more participation by support persons, and this may be important to patients with TBI. It is interesting that secondary data showed high satisfaction with CBT, 84%, and only 26% with usual care.

Several meta-analyses have evaluated the occurrence of depression and anxiety with nonpenetrating TBI. Both anxiety and depression appear to occur at a rate about 1/3, much higher than the general population. Both conditions are likely to increase during the initial 2-5 years postinjury, although anxiety may decrease after 5 years. Mild and M/S TBI are both likely to suffer.

Increased physical activity and decreased alcohol consumption may be useful to decrease symptoms. One study found that preinjury alcohol abuse and longer PTA predicted symptoms lasting longer than 6 months.

One study identified significant anxiety, affecting activities of daily living, for most M/S TBI cases and in 21% of participants 1 year post-injury.

Window to Hope is an intervention used to decrease hopelessness in US veterans with TBI. It is a 20-hour manualized CBT intervention with problem solving modules.

Indications for M/S TBI psychological interventions Psychological treatment is indicated for all M/S TBI patients. Patients may exhibit compromised selfawareness, behavioral problems, or mood disorders. Those problems include, but are not limited to: heightened irritability; agitation; aggression; rage reactions; impulsivity; uninhibited behaviors including sexually disinhibited behaviors; emotional lability; confabulation; perseveration; impaired judgement; memory disorders; feelings of apathy, anxiety, loss, frustration, or grief; depression; suicidal risk; and sleep disturbance.

Recommendations for M/S TBI psychological interventions Psychological interventions may include, or be performed in conjunction with, cognitive and behavioral treatment. Although the effect of this treatment for the brain injured population is unknown, psychological treatment is recommended for all patients with M/S TBI. The inclusion of family support systems may serve to promote consistency, compliance, and recognition of change over time. Family and support systems may also benefit from psychological support services without the patient. ● Acutely symptomatic phase: During the period of PTA, self-awareness is often compromised, and behavioral problems such as impulsivity, agitation, uninhibited behaviors, aggression, and confabulation may emerge. At this stage, psychological interventions are typically focused on: (1) development of specific environmental strategies to manage problematic behaviors and increase the safety of the individual and staff; (2) consultation with other team members, support of the nursing staff, and ongoing contact with the individual’s family and/or support system; and (3) education of the family and/or support system about TBI and its behavioral manifestations. Cognitive status is monitored during this time period as the level of environmental stimuli is gradually and slowly increased. The psychological interventions described here typically occur throughout the period of PTA. Furthermore, psychological intervention to help manage problematic behaviors (such as perseveration, aggressive behaviors, and disorders of memory), typically continues into the acute rehabilitation phase of treatment as PTA resolves. Behavior treatment, which may include applied behavior analysis and a focused behavioral plan based on the results of a functional analysis, is frequently used in these cases. Psychological interventions may be delivered by licensed mental health clinicians. ● Early recovery phase: Once PTA has completely resolved and the patient is fully oriented in all spheres, psychological clinical services are typically provided to educate him/her about the injury, increase insight into deficits, and support the development of positive coping. Treatment also typically involves psychotherapeutic intervention to assist in dealing with feelings of anxiety, loss, frustration, and grief. Psychological treatment is often required to address depression, heightened irritability, sleep disturbance, and anxiety. Psychological interventions including psychotherapy, sleep hygiene, cognitive behavior modification, and environmental restructuring may be required to address social skills, behavioral deficits, and impulsivity excesses. In addition to psychological services provided directly to the individual, consultation by licensed mental health professionals with other team members is appropriate and encouraged in order to train team members and family and/or support system members to support the process of recovery. Family therapy and educational sessions are often indicated. ● Stabilization phase: Once the individual’s condition has stabilized, the goals of psychological treatment center on supporting the transition to and functioning within the community. Alterations in cognitive and emotional functioning (e.g., mood disorders, emotional lability, irritability, preservative and disinhibited impulsive behaviors, apathy, memory problems and disorders related to diminished or impaired judgment) may necessitate ongoing psychological treatment. Individuals with TBI typically receive psychological services before discharge from the hospital in order to address specific deficits and abilities that will play an important role in successful functioning in their home and community. Depression may be linked to a permanent decrease in functioning after treatment. These services are typically individualized and may take a variety of forms including individual psychotherapy for the patient and support system, skills training (e.g., parenting), marital/family psychotherapy, medication management, and group psychotherapy. For treatment-resistant depression, repetitive transcranial magnetic stimulation (rTMS) may be considered.

Treatment should be evidence-based and tailored to the needs of the individual and his/her cognitive deficits. For example, an individual with significant memory problems may need to have information from psychotherapy sessions video or audio recorded. For those with behavioral problems, outpatient psychotherapy may be held initially as frequently as once a day for severe problems (e.g., rage reactions, sexually disinhibited behaviors, or other behaviors that constitute safety risks). Sessions may occur several times a week to address adjustment issues in a psychotherapeutic approach. French guidelines suggest the use of pain management and therapeutic partnerships with caregivers and local facilities to decrease behavioral and effective problems. The inclusion of family support systems may serve to promote consistency and compliance. ● Consultation in regard to usage of medications: Medication management for emotional, behavioral, and cognitive and physical functioning for patients with M/S TBI is often needed. An interdisciplinary team approach is beneficial and encouraged. Thus, attending physicians will often request consultation from other physicians (including psychiatrists) and non-physician team members (such as psychologists, social workers, and family service counselors) to provide data and input regarding behavioral observations that may assist in assessing how the person is responding to various medications.

Time frames regarding M/S TBI psychological interventions Time frames will vary based on the individual’s needs. Functional status should be re-evaluated every 4 weeks for the first 2 years and quarterly thereafter to determine need for termination or continual F.4.o Sleep disturbances There is a growing awareness in society of the importance of sleep in health and well-being. Research has shown that sleep is vital for memory, cognition, creativity, behavior, cardiovascular and cerebrovascular health, and even life expectancy. Disrupted sleep and activity cycles have long been known to the clinician taking care of patients with M/S TBI, though investigation into the mechanism and treatment of these phenomena is only beginning. It is likely that sleep disturbance after an M/S TBI in the immediate post-injury period is very different from the sleep disturbance seen in the chronic period of recovery or, for that matter, the sleep disruption seen in mTBI. Although the field is only beginning to understand the problem mechanistically, it is probably worth noting that each stage of recovery following M/S TBI might hold a different problem. In terms of approach, common themes will be evident. To address the problem of disrupted sleep in these patients and to raise awareness of its existence with caregivers, families, and patients, providers must first objectively monitor sleep, either through nursing observation logs or by actigraphy. Second, providers must understand the potential impact of institutional environments and routine care in settings, like the ICU or the rehabilitation center, which may have an adverse impact on quality sleep. Finally, centrally acting medications commonly used in these patients often have a significant impact on sleep centers and may even slow neurologic recovery. (See Table 2 below.) Because of this, the recommendation for the clinician is to employ pharmacology at the lowest effective dose and short term when needed.

Supporting literature ● ICU / acute trauma center There is a limited body of literature about sleep disturbance in the acute trauma center after M/S TBI. Baumann and colleagues measured levels of orexin in the CSF of patients with M/S TBI while in the acute trauma centers. Orexin is a neuropeptide produced in the posterior lateral hypothalamus that is the primary “on” switch for the cycle of wakefulness.

Patients with the sleep disorder narcolepsy are found to have extremely low to nonexistent levels of orexin in their CSF, and this may be the primary deficit in this disorder. Baumann’s patients with M/S TBI had a marked decrease in orexin levels compared to age matched controls. Patients with the lowest levels of orexin were the least responsive patients.

There is a growing body of literature looking at disrupted sleep in the ICU setting. Helton et al. studied 62 patients in an ICU setting and found that 40% of the patients had moderate to severe sleep deprivation. They also found a positive correlation between the severity of sleep deprivation with the occurrence of delirium. The ICU environment - with ventilators, monitors, and the need for frequent vital signs and nursing assessments works against good quality sleep. Disrupted sleep in the ICU is multifactorial and chronic underlying illness such as COPD or CHF may be associated with poor sleep quality.

There have been a number of heterogeneous interventions tried in the ICU to improve sleep and reduce delirium including earplugs, bright light therapy, and medications all with varying success. ● Rehabilitation center Sleep disturbance following M/S TBI seen in the acute rehabilitation center is more widely studied, and initial prevalence of this phenomenon has been reported to be between 70% and 86%. Patients identified with disrupted sleep were noted to have longer stays in both acute trauma centers and acute rehabilitation centers, suggesting a more severe and costly injury. Confused patients who are awake during the night are at risk for falls or other injuries, and patients who are asleep during the day are less able to participate and benefit from a rehabilitation program.

The common types of sleep disturbance seen in the post-acute period include hypervigilance, insomnia, hypersomnia, and circadian phase shift. (See Table 3: Types of sleep disturbance after M/S TBI). Here it is important to distinguish between insomnia and hypervigilance. Insomnia is defined as difficulty getting to sleep, staying asleep, waking up too early, or awakening with the feeling that sleep was not restorative.

Hypervigilance, on the other hand, is the almost complete absence of consolidated sleep or highly fragmented brief sleep episodes with protracted periods of wakefulness. Not surprisingly, hypervigilance often comes with psychotic symptoms of paranoia and agitation. Others have differentiated the hypersomnolent patient from the patient with pleiosomnia. The patient with pleiosomnia has an increased sleep need that is at least two hours per 24 hours longer than pre-injury sleep history. Approaches to each of these types of sleep disturbance are very different and, therefore, highlight the need to define the type of sleep disturbance for each individual in order to provide the appropriate treatment. To this end, an objective measure of a patient’s sleep such as nursing observation logs or actigraphy data becomes essential.

In addition to monitoring the patient’s sleep patterns, the clinician in the rehabilitation center should also work to raise awareness of the problem among the patient, caregivers, and family. A comprehensive sleep history should be taken from the patient or the family if the patient is unable to provide this. It is important to note from the patient or family what type of biologic preference or “chronotype” the patient was before the injury.

Specifically, if the patient was a night owl or a morning bird. Such information can play an important role in guiding therapeutic treatment. For example, M/S TBI is an injury with a high prevalence of young adult males who typically have a phase delay to their sleep interval, meaning that they tend to go to bed late and get up late. For these chronotypes, it may be counterproductive to begin early morning ADL training at 6 a.m. After establishing pre-injury chronotype, it is important to establish sleep habits such as timing and duration of sleep exhibited by the patient prior to injury.

The prevalence of obstructive sleep apnea (OSA) in patients with TBI has been reported between 25-35%. Thus, another important part of the sleep history taken from family or bed partner should be inquiring about symptoms related to OSA such as loud snoring or apnea. A screening tool for obstructive sleep apnea such as the STOP-BANG questionnaire is useful to identify patients at a high risk for this condition. Patients with a high score on the STOP-BANG or similar tool should be referred for overnight sleep study from appropriate consultative service (pulmonary or sleep medicine).

In addition to a comprehensive sleep history, the clinician should also take a close look at institutional norms and culture to understand the impact that day-to-day operations have on sleep cycles of patients in an ICU or rehabilitation unit. The recommendations below should be implemented. This requires a full review of nursing procedures or evaluations that occur after the patient has gone to bed.

In order to ameliorate institutional challenges to sleep, many aspects of a sleep hygiene intervention can be undertaken in a rehabilitation setting. See recommendations below for aspects of a sleep hygiene intervention.

Often times, the clinician must intervene with pharmacology to try to improve sleep in patients who are not responding to environmental and behavioral interventions.

Trazadone is the most frequently used medication for sleep in patients with M/S TBI.

Quetiapine is also frequently used, particularly for confused or agitated patients with poor sleep. Melatonin has little research supporting its efficacy. Melatonin quality control can vary widely with manufacturer. Another concern is the possibility that exogenous melatonin may inhibit the patient’s own melatonin production and excretion. In general, it is thought that benzodiazepine, which suppresses slow wave sleep, and other GABA agonists should be avoided as they may delay neurologic recovery. A new orexin antagonist has been approved, although there are no clinical trials in TBI to guide its use in these patients. Given the work of Baumann and colleagues, some patients may be orexin deficient, at least in the acute phase of recovery. Finally, many clinicians use wakefulness agents like modafinil or armodafinil to improve daytime wakefulness, which then promotes consolidated sleep at night for patients with TBI. Methylphenidate or other stimulants could be used along the same lines of reasoning. Again, the recommendation for any pharmacologic approach would be to use the lowest effective dose of medication and for a limited time.

Indications/recommendations for M/S TBI sleep disturbances ICU / acute trauma center and the rehabilitation center ● Raise awareness of sleep disturbance following M/S TBI with caregivers, families, and ● Obtain a comprehensive sleep history from patient, family, and bed partners about preinjury sleep habits and chronotype or biologic preference for sleep. ● Obtain a history from bed partner or family for signs or symptoms suggestive of sleep apnea. ○ History of snoring, BMI > 33, male, HTN, neck circumference > 40cm. (See, for example, the STOP-BANG questionnaire or similar tool discussed above.) ○ Patients at high risk should be referred to a specialist for sleep study. ● Objectively track sleep patterns of patients with nursing observation logs or actigraphy, particularly on initial admission to ICU or rehabilitation center. ● Provide a healthy sleep environment for patients in ICU and rehabilitation settings with comfortable dark environments during sleep period and brightly sunlit environments or exposure during wake period. ● Examine institutional barriers to good sleep for patients: night time vitals, baths, leg measurements, and other intrusions into sleep period. ● Institute common aspects of a sleep hygiene intervention where practical and medically appropriate: ○ regular wake and bed times scheduled according to preinjury chronobiologic preference 7 days a week; ○ increase daytime physical activity and exercise; ○ limit day time napping to < 30 minutes; ○ limit caffeine intake to before noon; ○ limit screen technology 1 hour before bed time. ● For pharmacologic approach, use the lowest effective dose for a limited time.

The community/outpatient center: Sleep disturbance is a very common complaint in the outpatient clinic for patients following M/S TBI, with an incidence reported to be up to 50% at one year. Approach to the patient with complaints of sleep-wake cycle disturbance in the outpatient center will essentially follow the same approach as described for patients with mTBI. (Refer to the Division’s Mild Traumatic Brain Injury Medical Treatment Guideline). The clinician should first look for easily remedial causes such as obstructive sleep apnea. Non-pharmacologic interventions should be first line. Pharmacy should be the last measure taken and only for limited time.

Table 2: Sleep centers, neurotransmitters, and commonly used pharmacology affecting these centers Sleep center Neurotransmitter Pharmacology Ventrolateral preoptic Gaba Baclofen, BZD Locus coeruleus Norepinephrine Duloxetine, venlafaxine Lateral hypothalamus Orexin Suvorexant, modafinil Pedunculopontine Acetylcholine Donepezil, rivastigmine Raphe nucleus Serotonin Sertraline, fluoxetine Vental tegmental Dopamine Amantadine, methylphenidate, carbidopa levodopa Table 3: Types of sleep disturbance after M/S TBI Insomnia  difficulty initiating sleep, sleep fragmentation, and early morning awakening  more often reported in mTBI than M/S TBI Hypervigilance  different than insomnia  often associated with development or presence of psychosis Circadian phase shift  delayed sleep phase or irregular sleep-wake type Hypersomnolence  excessive daytime sleepiness  inability to maintain wakefulness and alertness during the day Pleiosomnia  increased need for sleep F.4.p Swallowing impairments (dysphagia)

The incidence of swallowing disorders in the M/S TBI population is high. Presenting dysphagia is usually characterized by a combination of oral and pharyngeal stage deficits. Co-existing cognitive and behavioral deficits compromise swallowing safety. Physical damage to the oral, pharyngeal, laryngeal, and esophageal structures complicates neurogenic dysphagia. Traumatic intubation in the field, prolonged ventilation, endotracheal intubation, and the presence of tracheostomy may also have a negative impact on swallow function.

Swallowing involves multiple neurologic connections including: sensation from the oropharynx, larynx, and esophagus; cortical recognition of sensation and motor response; brainstem interaction; and multiple cranial nerves. Therefore, multiple areas could be targeted for treatment.

There is insufficient evidence to support or refute the use of oral sensory-motor treatment to improve swallow function.

The following therapies have been trialed on stroke survivors: intrapharyngeal electrical stimulation, surface neuromuscular electrical stimulation, pharmacological stimuli (capsaicin, menthol, and piperine), repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (tDCS). The available studies evaluating these therapies do not meet evidence standards.

Thus, they are not routinely recommended but may be used.

Indications/recommendations for dysphagia treatment The initial goal in oral-pharyngeal dysphagia intervention involves lessening the impact of the dysphagia through prevention of medical complications, such as aspiration pneumonia or malnutrition, and the establishment of alternative nutrition if necessary for the maintenance of adequate nutrition. A stimulation program without presentation of food may be provided early in the course of therapy in preparation for later feeding. In subsequent therapy, there is gradual introduction of oral nutrition using an array of treatment techniques designed to target the physiological impairments underlying the dysphagia while the individual continues to receive alternate nutrition. There is an eventual progression towards total oral nutrition without need for supplementation and independence with any safety precautions or compensatory/therapy techniques.

Therapeutic strategies may be divided into two categories: ● Compensatory treatment: Compensatory techniques do not involve direct treatment of the swallowing disorder and may not affect the physiological function of the swallow.

They may reduce or eliminate the dysphagic symptoms and risk of aspiration by altering the movement of the bolus through the mouth and pharynx. They include strategies such as postural adjustments of the head, neck, and body to alter the dimensions of the pharynx and the flow of the bolus; altering consistency and viscosity of foods or liquids; and varying the volume and rate of presentation of the food or drink. ● Therapy techniques: This is designed to change the swallowing physiology. These include, but are not limited to: strategies such as ROM and bolus control tasks to improve neuromuscular control, swallowing maneuvers that target specific aspects of the pharyngeal phase of the swallow, and swallowing maneuvers to facilitate laryngeal closure during the pharyngeal phase of the swallow.

It is generally accepted that the speech-language pathologist or occupational therapist in consultation with the physician establishes the dysphagia treatment plan. Self-feeding and the use of adaptive equipment may be coordinated by the occupational therapist. Additional disciplines should participate in a team approach for the treatment of dysphagia. These may include, but are not limited to: professionals such as physicians (including otolaryngologist, gastroenterologists, or others), registered dietitians, nurses, and physical therapists.

Medical consultation may be necessary to assist with clinical improvement in swallowing function. Medical interventions may include, but are not limited to: medications to reduce production of saliva; elimination of medications associated with reduced saliva production; and vocal fold injection (Teflon, absorbable gelatin sponge) for unilateral vocal fold weakness provided by Ear, Nose, and Throat (ENT) doctors.

Ongoing reassessment and modification of therapy techniques and treatment goals to optimize effectiveness are integral components of therapy. Initial treatment plan and goals should be updated whenever needed but at least with each re-evaluation. During the early phases of recovery, change may occur rapidly, and formal re-evaluation (including instrumental evaluation) may be completed frequently.

Time Frames regarding dysphagia treatment Frequency (1) Acute Care – 1 to 2 times daily;

(2) Post-Acute – Once per day;

(3) Subacute outpatient/community settings – 1 to 5 sessions weekly.

Optimum duration 6 to 8 weeks with 4-week re-evaluations.

Maximum duration Beyond 8 weeks, documentation of progress is required.

Therapy is discontinued when goals are met or when it is apparent that the individual is no longer making progress. In the latter case, re-evaluation and further therapy may be appropriate if/when the individual shows new or renewed potential.

F.4.q Therapeutic exercise Therapeutic exercises, with or without mechanical assistance or resistance, may include a number of modalities as part of the integrated occupational therapy or physical therapy program. A therapeutic exercise program should be initiated at the start of any treatment program and coordinated in an interdisciplinary approach. Such programs should emphasize education, independence, and the importance of an on-going exercise regime.

Both animal and human studies suggest therapeutic exercise has a direct relationship on recovery from a TBI.

Indications for therapeutic exercise Indications include the need for: ● cardiovascular fitness, ● improved muscle strength, ● improved connective tissue strength and integrity, ● increased bone density, ● promotion of circulation to enhance soft tissue healing, ● improvement of muscle recruitment, ● improved proprioception and coordination, and ● increased ROM.

Recommendations for therapeutic exercise Therapeutic exercise may be done as part of the overall occupational therapy or physical therapy program. It is not to be used in isolation. It should occur in an interdisciplinary treatment setting. As with all treatments, specific objective goals should be set initially and monitored during treatment.

The patient and/or caregiver should be instructed in and receive a home or community exercise program that is progressed as functional status improves.

Upon discharge from inpatient or residential rehabilitation, the patient and/or caregiver would be independent in the performance of the home exercise program and would have been educated in the importance of continuing such a program. Educational goals would be to maintain or further improve function and to minimize the risk for aggravation of symptoms in the future.

Time frames regarding therapeutic exercise Time to produce effect 2 to 6 treatments.

Frequency 1 to 3 times per week.

Optimum duration 4 to 8 weeks and concurrent with an active daily home or community exercise program.

Maximum duration 8 to 12 weeks of therapist oversight. Home exercise should continue F.4.r Visual treatment Visual treatment is appropriate to consider for TBI. Visual impairments may occur secondary to TBI and in one or more of the following categories: ● visual acuity and visual field function; ● ocular motor control and ocular alignment; ● visual perception.

Note: Visual rehabilitation is also performed for dizziness. (Refer to Section F.4.l, Neuro-otology: vestibular and audiology, under Vestibular rehabilitation for details.)

Indications/recommendations for visual treatment An ophthalmologist, neuro-ophthalmologist, neurologist, occupational therapist, certified vision therapist, or optometrist may treat visual impairment resulting from TBI. Treatment of visual impairments should be based on a comprehensive evaluation and diagnosis. When possible, therapy should be provided in an interdisciplinary integrated approach for the purposes of best outcomes and greatest convenience for the patient.

Treatment should be functionally-based and goal-directed. Individuals should be evaluated at intervals depending on his/her impairment, and progress should be clearly documented. Reliance on unvalidated outcome measures, such as performance on tests of “eye teaming” or “eye tracking,” should be avoided. ● Visual acuity and visual field function These are determined by the eye, optic nerve, optic chiasm, optic tracts, optic radiations, and visual cortex. If visual acuity deficits are caused by optic nerve trauma, the best data argues against the use of corticosteroid in almost all cases, in part because of the risk of increased morbidity and mortality from a concomitant head injury. Surgery may be indicated if the trauma results in progressive visual acuity loss in the setting of demonstrable compression of the nerve or if a hematoma is present within the optic nerve sheath. These cases are extremely rare. If visual acuity or visual field deficits are caused by intracranial visual pathway damage, acute treatment should be directed toward the specific injury.

Vision aids may be prescribed for individuals with documented visual acuity or visual field loss after acute injury. Lenses may be used to improve visual acuity. Tinted FL41 lenses may be useful to treat photophobia and glare sensitivity.

The use of optical and digital compensatory devices may benefit some individuals with documented visual field loss from visual pathway disorders that affect the visual fields in both eyes.

Depending on the level of adaptation to the visual field loss, some individuals may need training and education in strategies to improve compensation. Efforts to use visuospatial interventions to improve visual field loss directly without developing compensatory visual scanning are not recommended. The use of computers as a primary and independent form of visual treatment has limited application because of (1) limitations in the rationale and specific application of software programs to address the needs of the individual with TBI and (2) difficulty with generalization of learned computer skills into functional environments. Integrated computer-based treatment (i.e., both individualized cognitive and interpersonal therapies) may improve functioning within the context of an interdisciplinary, neuropsychological rehabilitation program. Sole reliance on repeated exposure and practice on computer-based tasks without extensive involvement and intervention by a therapist is not recommended. Virtual reality tools may prove useful for ADL assessment and training; however, they are experimental at the time of this guideline, as there are no strong studies supporting its success. Computerized visual restoration therapy programs or other computerized visual treatment programs, such as virtual reality, are not recommended due to lack of proven clinically meaningful efficacy and cost. ● Disorders involving ocular motility and binocular vision These should be treated according to the underlying diagnosis. Ocular motility includes ductions, versions, smooth pursuit, saccade, vergence, and vestibular eye movements.

Disorders of binocular vision include strabismus with double vision and disturbances of accommodation and vergence.

Treatment may include the use of lenses, prisms, vision rehabilitation, and/or surgery.

For individuals with disorders of ocular motor and ocular alignment that result in diplopia, the following should be considered based on severity and duration of impairments: monocular eye patching, occlusion of central or peripheral vision, prisms lenses, or strabismus surgery.

Lenses may be used to help accommodation. Because of the interaction between accommodation and vergence, lenses may also at times be used to assist in the treatment of a vergence disorder.

Prisms may be prescribed to provide an immediate improvement in diplopia and other disorders with symptoms. If diplopia is not stable, then appropriate patching (partial selective occlusion) may be more prudent. If deficits are permanent, prisms may be worn Individuals may be instructed in orthoptic techniques to address problems related to strabismus, particularly in cases with cranial nerve palsy.

Strabismus surgery may be useful in certain circumstances if the deficit is stable for several months. An immediate improvement is usually noted after the first surgery, but additional surgeries may be necessary. ● Visual perception Problems should be treated with a goal to improve visual processing skills and promote adaptation and compensation to the relevant problem.

Visual perceptual therapy may be required for some individuals as part of the overall rehabilitation treatment and is overseen by an authorized treating provider with experience in TBI. The therapy may be provided by specialists with experience in visual perceptual disorders. They may be from various disciplines, including, but not limited to: occupational therapy, speech therapy, neuropsychology, optometry and ophthalmology, neurology, and neuro-ophthalmology. ● Visual inattention This is inattention of a visual spatial region. Treatment may include the use of prisms and scanning techniques. Visuospatial rehabilitation with scanning is recommended for individuals with visuospatial perceptual deficits associated with visual neglect following TBI and especially after right parietal stroke. Scanning training is recommended as an important, even critical, intervention element for individuals with severe visual perceptual impairment that includes visual neglect after right hemispheric stroke and TBI.

Time frames regarding all vision therapy (orthoptic therapy)

Time to produce effect 4 hours of treatment should result in a measurable functional Frequency Outpatient: once weekly with a daily home exercise program.

In-patient: determined by the rehabilitation team, considering the patient’s medical needs and best possible outcomes.

Frequency of treatment is dependent on in-patient versus outpatient and the medical condition of the individual.

Optimum duration 12 hours.

Maximum duration 20 hours. Throughout the treatment process, exams are performed to evaluate status. When progress is no longer occurring, then therapy should be stopped unless there are mitigating circumstances. If after 20 hours of treatment there is documented progress but the individual is not at maximum therapeutic gain, then additional therapy may be indicated. Additional therapy should take into consideration the overall rehabilitation plan for the individual.

These time frames are not meant to be applied to each section separately. The time frames are to be applied to the totality of all vision rehabilitation regardless of the type or combination of therapies being provided.

F.5 Interdisciplinary rehabilitation programs Interdisciplinary brain injury programs are characterized by a variety of disciplines that participate in the assessment, planning, and/or implementation of the treatment program. These programs provide outcome-focused, coordinated, goal-oriented interdisciplinary team services to measure and improve the functioning of persons. They are for patients with greater levels of disability, dysfunction, de-conditioning, and psychological involvement. Programs should have sufficient personnel to work with the individual in the following areas: neurological, medical, cognitive, behavioral, functional, pain management, psychological, social, and vocational. All programs for M/S TBI should be able to address all of the associated neuromedical conditions listed in this guideline. Programs should share information about the scope of the services and the outcomes achieved with patients, authorized providers, and insurers.

This is the recommended treatment for individuals with M/S TBI. These programs should assess the impact of the injury on the patient’s medical, physical, psychological, social, and/or vocational functioning.

The number of professions involved in the team in a TBI program may vary due to the complexity of the needs of the patient.

When referring a patient for integrated interdisciplinary rehabilitation, the Division recommends that the program meets the criteria of the Commission on Accreditation of Rehabilitation Facilities (CARF).

Programs should include the following dimensions: ● Communication: To ensure positive functional outcomes, communication between the patient, insurer, and all professionals involved must be coordinated and consistent. Any exchange of information should be provided to all professionals, including the patient.

Care decisions should be communicated to all and should include the family and/or support system. ● Documentation: Functional goals should be actively pursued and objectively measured on a regular basis to determine their achievement or need for modification. ● Risk assessments: The following should be incorporated into the overall assessment process, individual program planning, and discharge planning: aberrant medication related behavior, addiction, suicide, and other maladaptive behavior. ● Patient/caregiver education: Patients with TBI need to re-establish a healthy balance in lifestyle. All providers should educate and provide training and resources for patients/caregivers on how to overcome barriers to resuming daily activity, including management of behavioral issues, cognitive losses, decreased energy levels, financial constraints, decreased physical ability, and change in family and/or support system dynamics. ● Family / support system services as appropriate: The following should be considered in the initial assessment and program planning for the individual: ability and willingness of the family to participate in the plan, coping, expectations, educational needs, insight, interpersonal dynamics, learning style, problem solving, responsibilities, and cultural and financial factors. Support would include counseling, education, assistive technology, and ongoing communication. ● Neuropsychological evaluation and treatment: Initial full neuropsychological evaluation should occur with periodic assessments to document progress and re-evaluate treatment plans. Treatment may include cognitive, behavioral, and psychological aspects. ● Psychosocial evaluation and treatment: Psychosocial evaluation should be initiated, if not previously done. Providers of care should have a thorough understanding of the patient’s personality profile, especially if dependency issues are involved. Psychosocial treatment may enhance the patient’s ability to participate in rehabilitation, manage stress, and increase their problem-solving and self-management skills. ● Treatment modalities: Use of modalities may be necessary early in the process to facilitate compliance with and tolerance to therapeutic exercise, physical conditioning, and increasing functional activities for M/S TBI. Active treatments should be emphasized over passive treatments. Active treatments should encourage self-coping skills and compensatory behavior, which can be continued independently at home or at work.

Treatments that can foster a sense of dependency by the patient on the caregiver should be avoided. Treatment length should be decided based on observed functional improvement. For a complete list of active and passive therapies, refer to Sections F, Specific treatments, and G, Return to work and vocational rehabilitation. All treatment time frames may be extended based on the patient’s positive functional improvement. ● Therapeutic exercise programs: A therapeutic exercise program should be initiated at the start of any treatment program. Such programs should emphasize education, independence, and the importance of an on-going exercise regime. ● Medical management: The ability to serve a variety of medical issues including, but not limited to: bladder and bowel function, cardio-pulmonary function, metabolic function, musculoskeletal function, and others. ● Return to work: An authorized treating provider should continually evaluate the patient for potential to return to work. For patients who are currently employed, efforts should be aimed at keeping them employed. Formal rehabilitation programs should provide assistance in creating work profiles. For more specific information regarding return to work, refer to Section G, Return to work. ● Vocational assistance: Vocational assistance can define future employment opportunities or assist patients in obtaining future employment. (Refer to Section G, Return to work, for detailed information.)

The following areas should be addressed to promote seamless service delivery for the persons served: ● The brain injury specialty program proactively coordinates, facilitates, and advocates for appropriate transitions. ● Discharge/transition planning addresses: ○ life routines; ○ the level of understanding of the family/support system regarding the current status of the person served; ○ expectations of the person served and family/support system; ○ contingency plans; ○ the environment of the next component of the continuum of services or discharge location, including facilitation factors and barriers; ○ self-advocacy; ○ capability of the family/support system; ○ financial resources; ○ access to healthcare; ○ transportation; ○ equipment and/or adaptive devices; ○ identification of resources in the community that are or will be involved with the person served; ○ mechanisms for coordination with other resources; ○ a follow-up plan for each person served; ○ follow-up services, including services for persons who leave the program’s geographic service area; ○ designation of the individual(s) who will be responsible for coordination of the follow-up plan of the person served; ○ discharge planning from inpatient rehabilitation hospital or post-acute residential:

Follow-up visits will be necessary to ensure adherence to treatment plan.

Programs should have community and/or patient support networks available to patients on discharge.

The following programs may be necessary.

F.5.a Comprehensive TBI-specialized inpatient interdisciplinary rehabilitation programs or “acute rehabilitation”

These are generally accepted and widely used. Inpatient brain injury rehabilitation programs should have designated staff for TBI, rooms designated for patients with TBI, designated TBI treatment facilities and programs, and they should serve at least 25 to 30 individuals with TBI per year.

Evidence statements regarding acute rehabilitation Early onset neurorehabilitation in a trauma centre and more intensive neurorehabilitation in a rehab facility have beneficial effects on the functional recovery of patients with M/S TBI as compared to usual care.

One 6-week, non-randomized study with blinded outcome evaluators and a neuropsychological focus demonstrated improvement in overall productivity.

Indications/recommendations for acute rehabilitation Following medical stability, individuals with M/S TBI should be transferred from acute hospital care to acute rehabilitation - in the form of a comprehensive TBI-specialized inpatient interdisciplinary rehabilitation program - unless they are unable to participate in the program.

Inpatient rehabilitation programs may be necessary for patients with any of the following conditions: (a) high risk for medical instability; (b) moderate-to-severe impairment of functional status; (c) moderate impairment of cognitive and/or emotional status; (d) dependence on medications; and (e) the need for 24hour supervision.

The interdisciplinary team maintains consistent integration and communication to ensure that all interdisciplinary team members are aware of the plan of care for the patient, are exchanging information, and are implementing the care plan. The team members make interdisciplinary team decisions with the patient and then ensure that decisions are communicated to the entire care team.

The Medical Director of the program should be board certified in physical medicine and rehabilitation, or be board certified in his or her specialty area, and either have completed a one-year fellowship in rehabilitation or have two years of experience in an interdisciplinary brain injury rehabilitation program.

Interdisciplinary rehab disciplines include but are not limited to registered rehabilitation nursing, nutritionist, physical therapist, occupational therapist, speech-language pathologist, recreational therapist, psychologist, neuropsychologist, family service / case management, music therapist, exercise physiologist, biofeedback therapist, chiropractor, optometrist, and podiatrist. Medical specialties may include, but are not limited to: neurosurgery, neurology, internal medicine and hospitalist-based critical care, pulmonary medicine, gastroenterology, hematology, infectious disease, ophthalmology, plastic surgery, general surgery, orthopedic surgery, etc.

On-site insurance case managers are encouraged to be a part of the treatment team; attend team conferences; and assist in goal setting, facility discharge planning, and short-term and long-term management of care.

Inpatient programs should be accredited by the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) and have components consistent with the Commission on the Accreditation of Rehabilitation Facilities (CARF). CARF eligibility or certification implies that programs meet specific care standards of design and efficacy.

The length of initial rehabilitation depends on the severity of deficits, complications, and the individual’s medical progress. Continued lengths of stay should be based on documented functional progress. The individual should be re-evaluated every 30 days.

Time frames regarding acute rehabilitation Time to produce effect 2 to 12 weeks Frequency Full time programs – No less than 3 hours per day, 5 days per week.

Part-time programs – 1-3 hours per day, 2–3 days per week.

Optimum duration 2 to 16 weeks with 24/7 programming.

Maximum duration 4 months for cases without severe medical complications. Periodic review and monitoring thereafter for 1 year. Additional follow-up based on the documented maintenance of functional gains.

F.5.b Sub-acute skilled nursing facilities (SNFs)

SNFs provide care in specialty licensed units of nursing homes.

Indications for SNFs SNF care is generally accepted and widely used for those who have completed extensive inpatient rehabilitation therapy and who are not able to be managed by a home care agency, in a private home, supported living program, group home, or community setting. Individuals appropriate for this type of care do not generally require skilled nursing care but require ongoing care that is supervised by RNs (if medications are involved, it is skilled care).

Recommendations for SNFs Rehabilitation therapies may be necessary to supplement nursing care. Rehabilitation programs are established by appropriately licensed or certified therapists but may be delivered by paraprofessionals.

The goal of care is to maintain and improve function, if possible. This usually occurs at a slower rate over an extended period of time.

Accreditation by the Joint Commission is recommended.

F.5.c Post-acute rehabilitation: outpatient rehabilitation services Outpatient rehabilitation services are generally accepted and widely used. These therapeutic interventions may be delivered in a hospital, free-standing outpatient facility, or community-based postacute facility with focused goals for home and community functioning.

Typically, outpatient treatments are interdisciplinary and include one or more of the following disciplines: physical therapy, occupational therapy, speech therapy, music therapy, mental health counseling, neuropsychology, therapeutic recreation, family counseling, vocational rehabilitation, and chiropractic Evidence statements regarding outpatient rehabilitation services Multidisciplinary rehabilitation by expert neurological rehabilitation services for patients with M/S TBI who required hospital admission are likely to benefit functionally and symptomatically.

Indications/recommendations for outpatient rehabilitation services Immediately following inpatient rehabilitation, outpatient rehabilitation is usually intensive and followed by a systematic and gradual reduction in therapy as appropriate.

Outpatient rehabilitation should be functionally oriented, goal specific, time limited, and case managed.

Formal outpatient rehabilitation programs should be accredited by the Joint Commission and have components consistent with certification by CARF. CARF eligibility or certification implies that programs meet specific care standards of design and efficacy.

Time Frames regarding outpatient rehabilitation services Frequency 2 to 8 hours per day, 1 to 5 days per week. More intensive treatment initially; M/S TBI usually require extended sessions.

Optimum duration Up to 24 months or beyond with monthly re-evaluations.

F.5.d Post-acute rehabilitation: residential or transitional living rehabilitation Residential rehabilitation, also called residential or transitional living, is clinically appropriate and generally accepted for individuals who have completed initial inpatient rehabilitation.

Indications for residential or transitional living rehabilitation This treatment is indicated for individuals who continue to have significant deficits, who are deemed unsafe to be discharged home, who require continued behavioral treatment, or who are deemed to be more effectively treated in a residential setting.

Recommendations for residential or transitional living rehabilitation Residential rehabilitation typically includes treatment and management by an interdisciplinary treatment team with an emphasis on safety, independent living skills, and functional community re-integration.

Residential rehabilitation is also appropriate for (1) those whose condition has changed, such as in caregiver death, disability, or unavailability, (2) those who may not have had access to appropriate or adequate inpatient or sub-acute rehabilitation treatment, or (3) those in whom cognitive, communicative, physical, or behavioral status has deteriorated.

Residential programs should be accredited by the Joint Commission and have components consistent with CARF certification. CARF eligibility or certification implies that programs meet specific care standards of design and efficacy.

The length of residential rehabilitation treatment depends on the severity of deficits, complications, progress, and available discharge options.

Time frames regarding residential or transitional living rehabilitation Optimum duration Residential rehabilitation is a generally adopted and widely used practice, ranging typically from 90 to 180 days, depending on the individual’s condition and discharge needs, with re-evaluations every 30 days.

F.5.e Post-acute rehabilitation: neuro-behavioral programs These are generally accepted TBI inpatient or residential rehabilitation programs designed for individuals with TBI who have persistent and significant maladaptive behaviors.

Behavioral programs may be physically located in secured hospital units or in community-based residential programs, which may also be secured.

Indications for neuro-behavioral programs While all TBI rehabilitation programs treat behavior, behavioral programs are usually required for individuals who are unsafe; who have suicidal, homicidal, or violent behavior; or who cannot be treated in less restrictive environments.

Behavioral programs are also appropriate for severe behavioral problems due to other concomitant diagnoses (such as alcohol or substance abuse) and psychiatric disorders (including any personality disorders). Categorical adolescent inpatient hospital and residential programs may be appropriate for adolescent behavioral disorders due to TBI.

Recommendations for neuro-behavioral programs Behavioral programs generally use an interdisciplinary approach that may include behavior analysis and modification, medications, socialization skills training, substance abuse treatment, family therapy, and physical management programs, as well as traditional interdisciplinary treatment.

Use of psychiatric hospitals that are not experienced in TBI rehabilitation is not recommended. Sole reliance on psychoactive medications for behavioral management is not recommended.

Upon discharge from behavioral programs, disposition is either back to inpatient acute rehabilitation, inpatient programs, supported living programs, or home and community-based programs.

Time frames regarding neuro-behavioral programs Optimum duration Length of stay may greatly vary depending on etiology and severity of the behavioral disorders and may typically range from 1 to 6 months or longer.

F.5.f Post-acute rehabilitation: home and community-based rehabilitation This encompasses services provided in an individual’s home and/or community settings and may be delivered as a separate service or in conjunction with outpatient therapy in a treatment facility.

Home and community-based services are designed to maximize the transition and generalization of skills and behaviors in those with moderate/severe injuries from facility settings to application and assimilation in the community.

Indications for home and community-based rehabilitation These post-acute services are generally accepted and widely used for individuals with TBI who have completed inpatient or residential rehabilitation or for those who have not required inpatient or residential services.

Recommendations for home and community-based rehabilitation One or more therapeutic disciplines are appropriate to deliver home and community-based services, including qualified/credentialed clinicians from physical therapy, occupational therapy, speech therapy, music therapy, medicine, neuropsychology, clinical psychology, behavioral treatment, counseling, therapeutic recreation, nursing, vocational rehabilitation, and chiropractic treatment. Case management should continue during home and community-based treatment.

Programs should preferably be accredited by the Joint Commission and have components consistent with CARF certification. CARF eligibility or certification implies that programs meet specific care standards of design and efficacy.

Time frames regarding home and community-based rehabilitation Frequency 1 to 7 hours per day, 1 to 5 times per week.

Optimum duration Up to 24 months or beyond with monthly re-evaluations.

F.5.g Post-acute rehabilitation: formal occupational rehabilitation This is a formal interdisciplinary program addressing a patient’s employability and return to work. It includes a progressive increase in the number of hours per day in which a patient completes work simulation tasks until the patient can tolerate a full work day. A full work day is case specific and is defined by the previous employment of the patient. Safe workplace practices and education of the employer and family and/or social support system regarding the person’s status should be included. This is accomplished by addressing the medical, psychological, behavioral, physical, functional, and vocational components of employability and return to work.

Indications/recommendations for formal occupational rehabilitation The following are best practice recommendations for an occupational rehabilitation program: ● work assessments, including a work-site evaluation when possible. (Refer to Section G, Return to work.); ● practice of component tasks with modifications as needed; ● development of strength and endurance for work tasks; ● education on safe work practices; ● education of the employer regarding functional impairments of the worker when possible; ● involvement of family members and/or support system for the worker; ● promotion of responsibility and self-management; ● assessment of the worker in relationship to productivity, safety, and worker behaviors; ● identification of transferable skills of the worker; ● development of behaviors to improve the ability of the worker to return to work or benefit from other rehabilitation; ● discharge includes functional/work status, functional abilities as related to available jobs in the community, and a progressive plan for return to work if needed.

The occupational medicine rehabilitation interdisciplinary team should, at a minimum, be comprised of a qualified medical director who is board certified with documented training in occupational rehabilitation, team physicians with experience in occupational rehabilitation, an occupational therapist, and a physical therapist. As appropriate, the team may also include any of the following: a chiropractor, an RN, a case manager, a psychologist, a vocational specialist, or a certified biofeedback therapist.

Programs should preferably be accredited by the Joint Commission and have components consistent with CARF certification. CARF eligibility or certification implies that programs meet specific care standards of design and efficacy.

Time frames regarding formal occupational rehabilitation Time to produce effect 2 weeks.

Frequency 2 to 5 visits per week, up to 8 hours per day.

Maximum duration 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

F.5.h Post-acute rehabilitation: opioid/chemical treatment programs Patients with addiction and/or substance abuse problems or high dose opioid or other drugs of potential abuse may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation. Guidelines from the American Society of Addiction Medicine are available and may be consulted relating to the intensity of services required for different classes of patients in order to achieve successful treatment.

Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline. Recent programs which incorporate both interdisciplinary therapy and weaning from opioids appear to demonstrate positive longterm results.

F.5.i Supported living programs or long-term care residential services These include licensed personal care boarding homes (group homes), supported apartment living programs, or supported inpatient programs designed for long-term living at the completion of the rehabilitation continuum.

Indications for supported living programs or long-term care residential services SLPs are designed for those who, due to their TBI, are not able to care for themselves safely and independently in the community and for whom home placement is unavailable or inappropriate. Such programs are appropriate for individuals who are at risk for medical, cognitive, physical, and psychological complications but who do not require a secured setting.

Recommendations for supported living programs or long-term care residential services These programs are becoming more available and are generally accepted services for individuals with chronic brain injury who are moderately to severely disabled and who require care, supervision, and support services. Housing, food, supervision, activity programs, sheltered employment, transportation, and case management are typical components of supported living programs.

Specialty supported living programs are available for behaviorally challenged individuals.

G. Return to work and vocational rehabilitation G.1 Return to work In addition to the treatment strategies described below, practitioners should be familiar with how various state and federal statutes and regulations may impact return-to-work planning. These may include, but are not limited to: Family and Medical Leave Act (FMLA), Americans with Disabilities Act (ADA), Occupational Safety and Health Administration (OSHA), Federal Motor Carrier Safety Administration (FMCSA), and the Department of Transportation (DOT).

In the setting of TBI, there is a negative association between psychiatric comorbidity (anxiety, depression, PTSD) and return to work; however, the magnitude of this effect has not been clearly established.

One study found a relationship between perceived self-efficacy in cognitive areas and life satisfaction.

The same study found a relationship with employed or volunteer work and satisfaction.

A 10 year follow-up study of patients with severe brain injuries suggested that for some patients there is a decline in employment between 5 and 10 years.

Indications/recommendations for return to work Following M/S TBI, some individuals are unable to return to work. Successful return to work among individuals with moderate/severe injury may require an interdisciplinary approach including neuropsychological assessment, speech-language assessment, functional capacity evaluation, assessment of vocational feasibility, transferable skill analysis, mental health counseling, family counseling, and follow-up services. The employer should be contacted to assist in establishing the essential job duties and demands, job site analysis, as well as supervisor education and the potential need for a skillful increased titration of job duties and demands.

In work situations where the employer is unable to accommodate and a return to the previous occupation is not suitable or appropriate, other options include volunteer placements or supported employment opportunities. See the above return-to-work literature table for a study on volunteer work and life satisfaction. Consider vocational re-training, individualized/specialized job placement services, and job coaching as needed.

Based on the evidence listed in the evidence table above, all patients with TBI should have psychological/neuropsychological evaluations and treatment as needed.

Additional return-to-work assistance may be necessary after the initial return to work (see literature table above for related study).

The following should be considered when attempting to return an injured worker with M/S TBI to work: ● Job history interview The authorized treating provider should perform a job history interview at the time of the initial evaluation and before any plan of treatment is established. Documentation should include the worker’s job demands, stressors, duties of current job, and duties of job at the time of the initial injury. In addition, cognitive and social issues should be identified, and treatment of these issues should be incorporated into the plan of care. ● Coordination of care and communication Management of the case is a significant part of return to work and may be the responsibility of the authorized treating provider, occupational health nurse, risk manager, or others. Case management is a method of communication between the primary provider, referral providers, insurer, employer, and employee. Because case management may be coordinated by a variety of professionals, the case manager should be identified in the medical record. Communication is essential between the patient, patient’s support system/team, authorized treating provider, employer, and insurer.

Employers should be contacted to verify employment status, job duties and demands, and policies regarding injured workers. In addition, availability and duration of temporary and permanent restrictions, as well as other placement options, should be discussed and documented. All communications in the absence of the patient are required to be documented and made available to the patient. ● Establishment of return-to-work status Return to work for persons with TBI should be thought of as therapeutic, assuming that work is not likely to aggravate the basic problem or increase discomfort. The goal of return to work would be to implement a plan of care to return the worker to any level of employment with their current employer or to return them to any type of new employment even though the worker may not be currently working or employed due to their recovery time. ● Establishment of activity level restrictions A formal job description is necessary to identify physical and cognitive demands at work and assist in the creation of modified duty. A job site evaluation may be utilized to identify tasks such as pushing, pulling, lifting, reaching above shoulder level, grasping, pinching, sitting, standing, posture, balance, ambulatory distance and terrain, and if applicable, environment for temperature, air flow, noise, tolerance for scanning, scrolling and other computer use, cognitive activities, and the number of hours that may be worked per day.

Due to the lack of predictability regarding exacerbation of symptoms affecting function, an extended and occupationally focused functional capacity evaluation may be necessary to determine the patient’s tolerance for job type tasks over a continuing period of time. Job requirements should be reviewed for the entire eight hours, or more, of the working day.

When prescribing the functional capacity evaluation (FCE), the physician must assess the probability of return to work against the potential for exacerbation of the work related condition. Work restrictions assigned by an authorized treating provider may be temporary or permanent. The case manager should continue to seek out modified work until restrictions become less cumbersome or as the worker’s condition improves or deteriorates. Ergonomic changes recommended by the worksite evaluation should be put in place.

Between one and three days after the evaluation, there should be a follow-up evaluation by the treating therapist and/or an authorized treating provider to assess the patient’s status. Patients should be encouraged to report their status post-FCE. ● Rehabilitation and return to work As part of rehabilitation, every attempt should be made to simulate work activities so that the authorized treating provider may promote adequate job performance. The use of ergonomic or adaptive equipment, therapeutic breaks, assistive devices, and interventional modalities at work may be necessary to maintain employment. ● Vocational assistance Formal vocational rehabilitation is a generally accepted intervention and can assist disabled persons in returning to viable employment, when they are unable to return to their previous work duties. Assisting patients to identify vocational goals will facilitate medical recovery and aid in the maintenance of Maximum Medical Improvement (MMI) by (1) increasing motivation towards treatment and (2) alleviating the patient’s emotional distress. Patients with TBI will benefit most if vocational assistance is provided during the interdisciplinary rehabilitation phase of treatment. To assess the patient’s vocational capacity, a vocational assessment utilizing the information from occupational and physical therapy assessments may be used to identify rehabilitation program goals and to optimize both patient motivation and utilization of rehabilitation resources. It may be useful to initially work in volunteer settings or for community groups. This may be extremely helpful in decreasing the patient’s fear regarding an inability to earn a living which can add to their anxiety and depression.

G.1.a Recommended vocational rehabilitation assessment According to Inter-Professional Clinical Practice Guidelines, a vocational evaluation should include some of the following: ● initial intake process, including: ○ pre-injury history; ○ educational and work histories; ○ current social status; ○ pre-injury job performance and performance evaluations; and ○ successes and failures in post-injury work trials; ● assessment of the person (individual’s perspective), including: ○ work goals, values, and meaning he/she attached to work pre- and post-injury; ○ work performance, strengths, weaknesses, current work competency; ○ compensatory strategies and support needs; ○ readiness to work and anticipated challenges/barriers to work or return to work; ○ individual’s own assessment of the costs and benefits of working; ○ individual’s view of the implications of a decision not to work (e.g., insurance and benefits); ● assessment of an individual’s functional status and level of independence; ● observations of an individual’s work-related skills and behavior during performance in real work setting, or if unavailable, simulated work tasks; ● assessment of the physical workplace environment; ● assessment of supports (i.e., formal and informal) and opportunities within the workplace and the individual’s support network including: availability of accommodations and/or job modifications; ● assessment of the occupational/job requirements.

G.2 Driving Independent driving is considered a complex activity of daily living. An individual’s potential for safe driving is influenced by an intricate interaction of physical, cognitive, visual, and behavioral impairments.

Supporting literature and evidence table Evidence statements regarding driving evaluation and treatment The Useful Field of View (UFOV) tool is a large screen computer that uses specialized software to evaluate and retrain 3 aspects of visual attention (visual processing speed, divided attention, and selective attention). It can improve driving performance in patients with a right hemisphere stroke and may be useful in patients with of clinical trials and observational Indications/recommendations for driving evaluation and treatment Self-report of feeling confident with driving ability may not be reliable; some studies of patients have demonstrated this. An individual’s ability to drive is typically evaluated and treated under physician orders by a certified driver rehabilitation specialist.

Physicians, neuropsychologists, or rehabilitation therapists can perform an initial screening to determine driving ability by assessing visual acuity, visual fields, memory, visual perception, visual processing, visual spatial skills, selective and divided attention, executive skills, motor and sensory function coordination, pain, and cognitive and physical fatigue.

In addition, the treatment and evaluation process may require the services of a: ● certified driving rehabilitation specialist; ● ophthalmologist or optometrist for visual evaluation; ● commercial vendor and rehab engineer for adaptive equipment; ● neuropsychologist for cognitive evaluation; ● speech-language pathologist for communication evaluation and compensatory strategies; ● occupational or physical therapist with expertise in acquired brain injury.

Unfortunately, at the time of this guideline, there is no evidence for the use of one system of assessment over another to predict driving skills. ● The Useful Field of View (UFOV) tool has been shown to be effective in stroke survivors to evaluate visual attention. It may be useful in the TBI population. See related evidence statement above. ● The AMA suggests confrontational field testing, Snellen E acuity testing, Trail Making Test part B, clock drawing test, and rapid pace test (walk 10 feet back and forth in 9 seconds) as an initial screening, along with ROM and motor strength testing. ● In addition, a thorough history should be taken which includes: (1) a review of all medication that might affect cognition or coordination; (2) screening for sleep apnea (BMI > 35, neck size > 15.5 inches for females or 17 inches for males, daytime sleepiness, Eppworth Sleepiness Scale score of 10 or greater, 2 or more hypertension medications);

(3) history of accidents and/or tickets; and (4) consultation with family and/or support system members or others regarding driving ability. Reluctance of others to ride with the patient may be an indication of problems. Patients may also fill out surveys that have some predictive abilities.

Public and personal safety and compliance with State Department of Motor Vehicles procedures ultimately determine individual driving privileges. Evaluation and treatment typically occur during the postacute phase of rehabilitation. Usually, successful driving results are obtained within the first two years post-injury, but this is not always the case.

If the individual fails the evaluation, he or she may be required to participate in additional driving practice and repeat the behind-the-wheel test. The evaluation may be repeated at 3- to 12-month intervals as determined by the evaluator and physician. Several repeat assessments may be necessary to determine safe driving readiness.

Recommendations and physician prescriptions for necessary adaptive equipment and vehicle modification for safe driving or for dependent passenger transport in vehicles may be necessary. Van lifts and other adaptive equipment and vehicle modifications may be required for dependent individuals in order to provide access to community services and activities. Therapeutic assistance is necessary to help the individual and physician comply with State Department of Motor Vehicles standards for practices and procedures for driver’s licensure.

Significant and multiple cognitive impairments, as well as motor and visual impairment, may decrease, delay, or prevent an individual from achieving functional driving independence. Individuals with M/S TBI may or may not be able to successfully compensate for these impairments.

Time frames regarding driving evaluation and treatment Frequency and time to produce effect Evaluation time of a minimum of 1 to 2 sessions to evaluate physical, perceptual, cognitive, and behavioral skills and for collaboration with other interdisciplinary team members.

Optimum duration Between 2 to 6 sessions of behind-the-wheel driving evaluation and training on the road.

G.3 Vocational rehabilitation Vocational rehabilitation is a generally accepted intervention, but the Colorado Workers’ Compensation statute limits its use.

In one study, a brain injury vocational rehabilitation program was successful at returning 41% of clients to competitive employment. The majority of the cases were 2 years or more from date of injury and had injuries classified as severe (PTA duration of 1 or more days). These cases were also without significant behavioral problems and able to function independently for ADLs. The program included cognitive training for those who had not previously received it and job trials with job coach support.

Indications/recommendations for vocational rehabilitation Initiation of vocational rehabilitation requires adequate evaluation of individuals with TBI for quantification of highest functional level, motivation, and achievement of MMI. Vocational rehabilitation should involve a comprehensive job analysis and a carefully planned return-to-work strategy with input from the treating physician and interdisciplinary team. In some instances, retraining may need to occur to access new job markets. (Refer to Section G, Return to work.)

G.4 Work conditioning These well-accepted programs are work-related, outcome-focused, and individualized treatment programs. Objectives of the program include, but are not limited to, improvement of cardiopulmonary and neuromusculoskeletal functions (strength, endurance, movement, flexibility, stability, and motor control functions), patient education, and symptom relief. The goal is for patients to gain full or optimal function and return to work.

Indications for work conditioning These programs are usually initiated once re-conditioning has been completed, but they may be offered at any time throughout the recovery phase. It should be initiated when imminent return of a patient to modified or full duty is not an option but the prognosis for returning the patient to work at completion of the program is at least fair to good.

Recommendations for work conditioning The service may include the time-limited use of modalities, both active and passive, in conjunction with therapeutic exercise, functional activities, general conditioning body mechanics, and re-training of lifting techniques. The patient should be assisted in learning to pace activities to avoid exacerbations.

Time frames regarding work conditioning Length of visit 1 to 4 hours per day.

Maximum duration 6 weeks. Participation in a program beyond 6 weeks should be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

G.5 Work simulation Work simulation is a generally accepted program where an individual completes specific work-related tasks for a particular job and return to work.

Indications/recommendations for work simulation Use of this program is appropriate when modified duty can only be partially accommodated in the work place, when modified duty in the work place is unavailable, or when the patient requires more structured supervision. The need for work place simulation should be based on the results of a functional capacity evaluation and/or job site analysis.

Time frames regarding work simulation Length of visit 2 to 6 hours per day.

Maximum duration 6 weeks. Participation in a program beyond 6 weeks should be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

H. Maintenance management Management of M/S TBI continues after the individual has met the definition of Maximum Medical Improvement (MMI). MMI is reached when an individual’s condition has plateaued and the authorized treating provider believes no further medical intervention is likely to result in improved function. For patients with M/S TBI, this is not likely to occur for at least two years post-injury. Injured workers are entitled to lifetime medical benefits that are reasonable, necessary, and related to maintaining them at MMI. When the individual has reached MMI, a physician must describe in detail the plan for maintenance treatment, including the level and type of care and support services. (Refer to Section D.3, Course of recovery.) Failure to address long-term management as part of the overall treatment program may lead to higher costs and greater dependence on the health care system.

Individuals with M/S TBI may experience lifetime impairment, functional limitations, and disabilities. They are at risk the remainder of their lives for long-term medical, psychiatric, physical, and cognitive complications. Subsequent brain injuries, the onset of seizures, endocrine or other medical conditions, maladaptive social skills, aggressive behaviors, substance abuse, and psychiatric disorders are common examples of some negative long-term consequences of TBI. Patients with M/S TBI are also at a higher risk of isolation and depression. Individuals with M/S TBI generally require long-term support to prevent secondary disability and to maintain an optimal level of medical and psychological health and functional independence achieved through rehabilitation. These long-term supports should include avocational activities, socialization, and activities designed to foster connectedness through community and family activities.

Maintenance care of individuals with M/S TBI requires a close working relationship among the insurance carrier, the clinical providers, the family and/or support system, and the individual with TBI. Clinical providers have an obligation to design a cost-effective, medically appropriate program that is predictable and allows the carrier to set aside appropriate reserves. Insurers and adjusters have an obligation to ensure that medically appropriate, cost effective programs are authorized in a timely manner. A designated primary physician for maintenance team management is recommended.

Health professionals with experience in life care plans are frequently involved in making assessments for long-term care. Providers and carriers should adopt a long-term case management model for these individuals. Common lifetime supports that are reasonable and necessary include, but are not limited to: physician oversight, nursing services, various periodic rehabilitation therapies, life skills training, supported living programs, attendant care, supported employment, productive activity recreation, transportation, medication, psychological services, and individual/family/support system education.

Supported employment may assist in return to work outside a sheltered work setting.

The specific type and amount of support necessary will vary in each individual case and may change over time. Practitioners are encouraged to analyze risk factors and to establish viable long-term maintenance plans. Long-term maintenance programs should be managed by an experienced certified case manager who may intervene quickly when necessary. Case management should not be discontinued when a person completes acute rehabilitation; it should continue at a frequency necessary for successful longterm management.

Medical and rehabilitation providers are encouraged to educate individuals and their family and/or support systems regarding anticipated ongoing medical and rehabilitation needs. Because the long-term medical needs of individuals with M/S TBI are uncertain, each individual, his/her family and/or support system, and providers should plan for unforeseen medical, psychiatric, social, physical, and cognitive complications as individuals with TBI age. As time since injury progresses, patients and their family/support systems require assistance with overall quality of life, as well as basic medical When developing a maintenance plan of care, the individual, his/her physician, and the insurer should attempt to meet the following goals: ● Maximum independence will be achieved through the use of home and community-based programs and services. ● Individuals with TBI shall maximally participate in decision-making, self-management, and self-applied treatment.

Treatment involving more than one provider shall be coordinated through an authorized treating provider with the assistance of a case manager.

The authorized treating provider should reassess treatment at least every six months.

Treatment by all practitioners should focus on establishing the highest possible level of self-sufficiency.

Most passive modalities are oriented toward pain management. They should be limited and emphasize self-management and self-applied treatment with a demonstrated goal of increasing activity, function, and quality of life.

Patients and families and/or support systems should understand that failure to comply with the elements of the self-management program or therapeutic plan of care may affect consideration of other interventions.

Periodic reassessment of the individual’s condition will occur as appropriate. The overall maintenance plan should be reassessed at least annually by the authorized treating provider.

Programs should be individualized to specific needs and may include the following.

H.1 Neuromedical management Patients with M/S TBI will have ongoing medical issues requiring treatment on a regular basis.

Indications/recommendations for neuromedical maintenance management Examples of related medical diagnoses include, but are not limited to: neuro-endocrine dysfunction, urinary incontinence, heterotrophic ossification, seizures, and other conditions described in the treatment sections of this guideline.

Time frames regarding neuromedical management: maintenance Frequency Medical management visit frequency will depend on the severity of the medical condition but may occur monthly or more frequently.

Visits should occur at least at 6-month intervals for extremely stable H.2 Medication management Medications may be necessary for management of chronic conditions for individuals with M/S TBI.

Indications/recommendations for medication maintenance management Medications may be used for medical, physical, perceptual, cognitive, neuroendocrine, and psychological reasons, and they should be prescribed by physicians experienced in TBI medication management.

Reasons for possible medications and the types and names of medication are numerous, individualized for each person, and beyond the scope of these guidelines.

In situations where there are multiple providers for multiple clinical issues, coordination of the total medication regimen is essential. It is strongly recommended that changes in medication be discussed with the physician who is primarily managing the case.

As with all prescriptive regimens, physicians periodically reassess the efficacy and side effects of each medication. This is particularly true for individuals who are on long-term medication use. Physicians must follow patients who are on any chronic medication or prescription regimen for compliance, efficacy, and side effects. Individuals with TBI are particularly susceptible to certain medication side effects, including compromised cognitive function, decreased seizure threshold, and other neurological effects. Follow-up visits should document the individual’s ability to perform routine functions. Laboratory or other testing is usually required on a regular basis to monitor medication effects on organ function. For some, medications and drug levels should be closely monitored.

Individuals with TBI may forget to take medications and/or have difficulty with complicated medication regimens. They may need assistance with medication management, such as reminders, medication boxes, assistance with filling medication boxes, or medication administration supervision. Some medications may need to be prescribed in small amounts or locked due to safety in patients who are impulsive, forgetful, inconsistent, or otherwise unsafe in independent medication management.

Time frames regarding medication management: maintenance Frequency Medication and medical management reviews may need to be monthly or more frequently if necessary for changes in medication. Frequency depends on the medications prescribed, with laboratory and other monitoring performed as appropriate.

Maintenance duration As new medications become available and side effects of other medications are established, there may need to be changes in medical H.3 Physical, occupational, and speech therapy Exacerbation of symptoms or decline in functional status may require short-term intensive treatment to return the individual to maximized function.

Evidence statements regarding outpatient rehabilitation: maintenance Physical, occupational, or multi-disciplinary outpatient therapy reduces deterioration of ADLs and independence for stroke survivors living in the community.

Note: It is likely that this also applies to patients with M/S TBI.

Indications/recommendations for PT/OT/ST Therapy with the individual actively involved and/or passive therapy may be indicated on a continued

basis if the therapy maintains objective physical function, decreases pain, or decreases medication use.

Additionally, issues of aging that result in decreased function in mobility, balance, and overall physical function may require active or passive intervention. In those situations, frequency and duration parameters as defined in this guideline apply.

Over time, speech, language, and/or cognitive functioning may deteriorate due to changes in life’s stressors, support systems, and/or the individual’s living situation, role, and responsibilities at home or work. Short-term speech therapy emphasizing patient education, compensatory strategies, and objectively measured functional goals may be indicated. Aging issues of the individual or the caregiver may also result in a decline of speech, language, and/or cognitive functioning requiring speech therapy.

Participation in a PT, OT, or ST maintenance program must be documented with respect to need and the ability of the program to facilitate positive symptomatic gains or functional gains and/or to prevent further deterioration.

For time frames to address changes due to aging or acute aggravations, refer to Section F.4, Specific treatments, and Section G, Return to work and vocational rehabilitation.

H.4 Cognitive/behavioral/psychological management Due to the fact that deficits from M/S TBI can persist throughout life, intermittent mental health interventions may be required during the course of the individual’s lifetime in order to address the behavioral problems and emotional distress that may arise secondary to developmental issues, the onset of medical/neurologic/psychiatric comorbidities, or changes in environmental structure.

Researchers are learning more about long-term mood disorders, such as depression and anxiety, as well as executive dyscontrol, emotional dysregulation, and all other disorders for which medication may be beneficial. Regaining insight or self-awareness into the changes caused by TBI is often accompanied by an increase in symptoms of depression. Depression is common following TBI. Increased suicidal ideation has also been reported to occur for many years following TBI. Psychosis is an uncommon but serious sequela of TBI that also requires psychotropic medication and close monitoring. Refer to Section F.1.d, Medications.

One study followed patients with M/S TBI for 20 years and found depression rates of up to 28%.

Indications for cognitive/behavioral/psychological maintenance management Developmental issues, changes in the individual’s support system, and development or exacerbation of a mood or other psychiatric disorder may require psychological treatment to return the individual to the highest level of functioning possible.

Individuals with or without TBI frontal involvement may need periodic reassessments and psychiatric and/or psychological interventions.

Some individuals with persistent behavioral problems (i.e., impulsivity or other behavioral dyscontrol) may require regular psychological maintenance therapy to help the individual to function maximally in the community.

Recommendations for cognitive/behavioral/psychological maintenance management The maintenance program for individuals with M/S TBI should be oriented toward maintaining the highest level of independent function that he/she has been able to achieve. When possible, the person with moderate/severe injury should be involved in social skills training, support groups, and/or other community-based activities to promote socialization. Some individuals with severe injuries will require periodic consultation to correct problems that have developed to allow them to continue to function in the community.

Health care providers who provide services to maintain the functioning of individuals with TBI in the community are obligated to identify the specific diagnosis and symptoms on which treatment is focused and to document the ongoing results of such treatment.

Periodic assessment by the treating physician and/or an occupational therapist, physical therapist, or speech-language pathologist may be necessary to maintain and/or upgrade the patient’s program and provide additional strategies if needed.

Supportive education and counseling may also be needed for the family/support system and, when necessary, should be available to primary care givers individually and with the patient.

Substance abuse, particularly alcohol abuse, can occur or recur after TBI and can worsen psychiatric and psychological comorbidities. It should be screened for and treated if present.

Periodic psychological treatment, upgrading, or consultation may be necessary throughout a person’s lifetime following TBI. Therapy may be reinitiated for time limited, goal-specific treatment as new goals or TBI related problems develop. Aging or significant life change is likely to have an effect on cognitive, psychological, and behavioral function and may require further treatment.

Time frames regarding cognitive/behavioral/psychological management: maintenance Maintenance duration The number of sessions will depend on the individual and the situation.

H.5 Durable medical equipment: purchase, rental, and maintenance It is recognized that some patients with TBI may require ongoing use of equipment for the purpose of maintaining MMI in the areas of strength, ROM, balance, tone control, functional mobility, ADLs, and/or analgesic effect.

Indications for purchase or rental of durable medical equipment Purchase or rental of this equipment should be done only if the assessment by the physician and/or therapist has determined the safety, effectiveness, compliance, and improved or maintained function by its application.

Recommendations for purchase, rental, and maintenance of durable medical equipment Equipment may include, but is not limited to: ● exercise equipment; ● bathroom ADL equipment; ● assistive devices, such as shower/bath seats, assistive mobility devices, splints and/or braces, and assistive technology for memory and medication support; ● functional electrical muscle stimulators; ● TENS units; and ● Continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP).

Periodic maintenance and replacement of the equipment may be indicated and should be considered in the maintenance plan.

Time frames regarding durable medical equipment: maintenance Not to exceed 6 months for rental of large equipment. If effective, purchase and maintenance should occur.

H.6 Patient education maintenance management Functional abilities and support systems for individuals with M/S TBI may change over time and frequently require additional support.

Indications/recommendations for patient education maintenance management Educational classes, sessions, or programs may be necessary to reinforce self-management techniques and social skills training and to help the individual and their support system adjust to life changes. This may be performed as formal or informal programs, either group or individual.

Time frames regarding patient education management: maintenance Frequency 2 to 6 educational sessions during one 12-month period. Changes in life circumstances or the individual’s condition may require greater frequency of educational sessions.

H.7 Home exercise programs and exercise equipment Most patients have the ability to participate in a home exercise program after completion of a supervised exercise rehabilitation program. Some patients with M/S TBI may benefit from the purchase or rental of equipment to maintain a home exercise program.

Indications/recommendations for home exercise maintenance programs Programs should incorporate an exercise prescription including the continuation of an age-adjusted and diagnosis-specific program for aerobic conditioning, flexibility, stabilization, balance, and strength. Home exercise programs are most effective when done three to five times a week.

Determination for the need of home equipment should be based on medical necessity to maintain MMI, compliance with an independent exercise program, and reasonable cost. Prior to purchasing or renting the equipment, a therapist and/or exercise specialist who has treated the patient should visit a facility with the patient to ensure proper use of the equipment. The patient should be able to demonstrate the proper use and effectiveness of the equipment. Effectiveness of equipment should be evaluated on its ability to improve or maintain functional areas related to ADLs or work activity.

For chronic pain, refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline.

Follow-up evaluations in the home should occur to ensure compliance and to upgrade the home program.

Occasionally, compliance evaluations may be made through a 4-week membership at a facility offering similar equipment to that purchased/rented for the patient.

H.8 Exercise programs requiring gym memberships or special facilities Some individuals with TBI may have higher compliance with an independent exercise program at a health club or a community activity-based wellness program versus participation in a home program, although individuals with TBI may require supervision or guidance.

Indications/recommendations for exercise programs requiring special facilities All exercise programs completed through a health club facility should be approved by the treating therapist and/or physician and focus on the same parameters of an age-adjusted and diagnosis-specific program for aerobic conditioning, flexibility, balance, stabilization, and strength. Prior to purchasing a membership, a therapist and/or exercise specialist who has treated the individual should visit the facility with the individual to ensure proper use of the equipment. Periodic program evaluation and upgrading may be necessary by the therapist. The use of a personal trainer may be necessary.

Time frames regarding exercise programs requiring special facilities: maintenance Frequency Approximately 2 times per week. Regular attendance is necessary for continuation, with an exception for a medical or sufficient intervening cause.

Continuation beyond 3 months after MMI should be based on functional benefit and compliance. At MMI, health club membership should not extend beyond 3 months if attendance drops below 2 times per week on a regular basis without a medical cause.

H.9 Sustained return to work The functional status of patients with M/S TBI is likely to change over time. Therefore, additional assistance may be needed to support work.

A 10-year follow-up study of patients with severe brain injuries suggested that for some patients there is a decline in employment between 5 and 10 years.

Indications/recommendations for sustained return to work.

Based on the study described above, additional return-to-work assistance may be necessary after the initial return to work.

H.10 Maintenance home care Individuals with M/S TBI may require ongoing home care to assist with a variety of services necessary to maintain their MMI.

Indications/recommendations for maintenance home care The type of the services required will be dependent on the nature and severity of residual deficits.

Services may include skilled nursing, certified nursing assistants, life skills trainer, homemaker, companion care, or a combination of these services. Transportation services may also be required.

It is essential for providers to be very specific about the level and type of care necessary for each individual to maintain optimum health and safety. Long-term home health care is one of the most costly services of a maintenance program, and availability of professional resources may be limited. Physicians should prescribe only care that is reasonably necessary to maintain the individual’s functional status or to cure and relieve the effects of the injury.

Over time, the individual’s status or family and/or support system’s status may change, resulting in the need to either increase or decrease the frequency, type, or level of care. Therefore, with each evaluation, or at least annually, providers shall assess any possible need for a change in home care.

Time frames regarding home care - maintenance Frequency The frequency of the services required will be dependent on the nature and severity of residual deficits.

Maintenance duration Care may be necessary for limited periods of time or, in some cases, may be required for the course of the individual’s lifetime.

H.11 Long-term residential care A number of individuals with M/S TBI will require residential care as it is unsafe for them to live without supervision.

Indications/recommendations for long-term residential care Some individuals with M/S TBI may require long-term residential care due to the aging process, loss of a caregiver, becoming unsafe in their environment, or other similar changes. Such facilities or programs may provide the individual with TBI the necessary supervisory support so that he/she may safely maintain his/her maximum level of function in as least restrictive an environment as possible. In most cases, these individuals may be referred to skilled nursing facilities. (Refer to Section F.5.b, Sub-acute skilled nursing facilities, or Section F.5.i, Supported living programs or long-term care residential services.) _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 18, Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 03 Rule 17, Exhibit 3 - THORACIC OUTLET SYNDROME MEDICAL TREATMENT GUIDELINES {#sec-7-ccr-1101-3-r17-ex-03 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 03}

DEPARTMENT OF LABOR AND EMPLOYMENT

WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

RULE 17, EXHIBIT 3 THORACIC OUTLET SYNDROME MEDICAL TREATMENT GUIDELINES 7 CCR 1101-3 Rule 17 - Exhibit 3 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ A. INTRODUCTION This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of guidelines for physicians/providers treating injured workers with upper extremity involvement pursuant to the Colorado’s Workers’ Compensation Act.

Although the primary purpose of this document is advisory and educational, these guidelines are enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from these guidelines, as individual cases dictate. Therefore, these guidelines are not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip or overlook any sections.

B. GENERAL GUIDELINES PRINCIPLES

The principles summarized in this section are key to the intended implementation of all Division of Workers’ Compensation guidelines and critical to the reader’s application of the guidelines in this document.

1. APPLICATION OF GUIDELINES: The Division provides procedures to implement medical treatment guidelines and to foster communication to resolve disputes among the provider, payer, and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the Office of Administrative Courts.

2. EDUCATION: Education of the patient and family, as well as the employer, insurer, policy makers and the community should be the primary emphasis in the treatment of chronic pain and disability. Currently, practitioners often think of education last, after medications, manual therapy, and surgery. Practitioners must implement strategies, to educate patients, employers, insurance systems, policy makers, and the community as a whole. An education-based paradigm should always start with inexpensive communication providing reassuring and evidence-based information to the patient. More in-depth patient education is currently a component of treatment regimens which employ functional restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention.

3. INFORMED DECISION MAKING: Providers should implement informed decision making as a crucial element of a successful treatment plan. Patients, with the assistance of their health care practitioner, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, physical therapists, and other members of the health care team play an integral role in informed decision making and achievement of functional goals. Patient education and informed decision making should facilitate self-management of symptoms and prevention of further injury.

4. TREATMENT PARAMETER DURATION: Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Obviously, duration will be impacted by patient compliance, as well as availability of services. Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

5. ACTIVE INTERVENTIONS: emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, are generally emphasized over passive modalities, especially as treatment progresses. Generally, passive and palliative interventions are viewed as a means to facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

6. ACTIVE THERAPEUTIC EXERCISE PROGRAM: goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

7. POSITIVE PATIENT RESPONSE: results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to, positional tolerances, range of motion (ROM), strength, endurance, activities of daily living, cognition, psychological behavior, and efficiency/velocity measures that can be quantified. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation. Anatomic correlation must be based on objective findings.

8. RE-EVALUATE TREATMENT EVERY 3 TO 4 WEEKS: If a given treatment or modality is not producing positive results within three to four weeks, the treatment should be either modified or discontinued. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results. Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

9. SURGICAL INTERVENTIONS: should be contemplated within the context of expected functional outcome and not purely for the purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic conditions.

10. SIX-MONTH TIME FRAME: The prognosis drops precipitously for returning an injured worker to work once he/she has been temporarily totally disabled for more than six months. The emphasis within these guidelines is to move patients along a continuum of care and return to work within a six-month time frame, whenever possible. It is important to note that time frames may not be pertinent to injuries that do not involve work time loss or are not occupationally related.

11. RETURN-TO-WORK: is therapeutic, assuming the work is not likely to aggravate the basic problem or increase long-term pain. The practitioner must provide specific physical limitations and the patient should never be released to “sedentary” or “light duty.” The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, data entry and other repetitive motion tasks, sustained grip, tool usage and vibration factors. Even if there is residual chronic pain, return-to-work is not necessarily contraindicated.

The practitioner should understand all of the physical demands of the patient’s job position before returning the patient to full duty and should request clarification of the patient’s job duties.

Clarification should be obtained from the employer or, if necessary, including, but not limited to, an occupational health nurse, occupational therapist, vocational rehabilitation specialist, or an industrial hygienist.

12. DELAYED RECOVERY: Strongly consider a psychological evaluation, if not previously provided, as well as initiating inter-disciplinary rehabilitation treatment and vocational goal setting, for those patients who are failing to make expected progress 6 to 12 weeks after an injury. The Division recognizes that 3 to 10% of all industrially injured patients will not recover within the timelines outlined in this document despite optimal care. Such individuals may require treatments beyond those discussed within this document, but such treatment will require clear documentation by the authorized treating practitioner focusing on objective functional gains afforded by further treatment and impact upon prognosis.

13. GUIDELINE RECOMMENDATIONS AND INCLUSION OF MEDICAL EVIDENCE: All recommendations are based on available evidence and/or consensus judgment. When possible, guideline recommendations will note the level of evidence supporting the treatment recommendation. It is generally recognized that early reports of a positive treatment effect are frequently weakened or overturned by subsequent research. When interpreting medical evidence statements in the guideline, the following apply:

• Consensus means the judgment of experienced professionals based on general medical principles. Consensus recommendations are designated in the guideline as “generally well-accepted,” “generally accepted,” “acceptable/accepted,” or “well-established.”

• “Some” means the recommendation considered at least one adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the intervention’s effect.

• “Good” means the recommendation considered the availability of multiple adequate scientific studies or at least one relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the intervention’s effect.

• “Strong” means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the intervention’s effect.

All recommendations in the guideline are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guideline as “not recommended.”

14. CARE BEYOND MAXIMUM MEDICAL IMPROVEMENT (MMI): should be declared when a patient’s condition has plateaued to the point where the authorized treating physician no longer believes further medical intervention is likely to result in improved function. However, some patients may require treatment after MMI has been declared in order to maintain their functional state. The recommendations in this guideline are for pre-MMI care and are not intended to limit post-MMI treatment.

The remainder of this document should be interpreted within the parameters of these guideline principles that may lead to more optimal medical and functional outcomes for injured workers.

C. DEFINITION OF THORACIC OUTLET SYNDROME

Thoracic Outlet Syndrome (TOS) may be described as a neurovascular disorder affecting the upper extremity which, on rare occasions, is caused by workplace factors, such as jobs that require repetitive activities of the upper extremities with forward head and shoulder postures. It should be emphasized that occupational TOS is a relatively uncommon disorder and other disorders with similar symptomatology need to be ruled out. (These syndromes can be associated with motor vehicle accident trauma, especially while wearing a shoulder strap).

There are three types of thoracic outlet syndrome. The two vascular types, comprised of subclavian vein or artery pathology, are diagnosed with imaging. Neurogenic TOS (described by some literature as true or classic TOS) consists of a chronic lower trunk brachial plexopathy diagnosed by positive electrodiagnostic testing. It is usually unilateral, predominantly affects women, and results in classic electrophysiologic and physical exam findings such as hand atrophy.

Venous TOS (VTOS) is obstruction of the subclavian vein causing arm swelling. It can be with or without thrombosis. In the workplace, VTOS is usually caused by repetitive activities with the arms above shoulder level. Most workers with this condition also present thrombosis of the subclavian vein. Venous TOS is seldom caused by work-related conditions.

Arterial TOS is usually associated with a cervical rib or anomalous first rib. This is regarded primarily as a predisposing factor. Most people with these ribs never develop symptoms. Precipitating factors in patients with cervical or anomalous ribs are trauma such as motor vehicle accidents or other events causing hyperextension neck injuries. Arterial TOS is rarely a work-related condition.

The majority of patients who present with some physical exam findings of TOS do not have vascular or neurogenic TOS. Their symptoms are caused by myofascial dysfunction. The usual physiologic cause includes abnormal posture, scapular dyskinesis, and pectoralis minor shortening. Myofascial dysfunction with TOS symptoms does not qualify as an operative condition (some literature classifies these cases under the older term of non-specific or disputed TOS). A more general, commonly used diagnostic term for myofascial dysfunction with TOS symptoms is thoracic sprain. Treatment should follow recommendations in the active therapy section. Refer to Section F.11. Therapy-Active.

D. INITIAL DIAGNOSTIC PROCEDURES

The Division recommends the following diagnostic procedures be considered, at least initially, the responsibility of the workers’ compensation carrier to ensure that an accurate diagnosis and treatment plan can be established. Standard procedures that should be utilized when initially diagnosing a workrelated TOS complaint are listed below.

1. HISTORY TAKING AND PHYSICAL EXAMINATION (HX & PE): are generally accepted, wellestablished and widely used procedures which establish the basis for diagnosis, and dictate all other diagnostic and therapeutic procedures. When findings of clinical evaluations and those of other diagnostic procedures are not complementing each other, the objective clinical findings should have preference. Neurogenic TOS will be described separately from vascular TOS, although some general symptoms may occasionally overlap. Vascular TOS usually requires urgent or emergent treatment as described in the surgical section. Over 90% of all TOS cases are neurogenic, 1% arterial and 3-5% venous. Although the cervical rib has been implicated in TOS, less than 1% of the population has a supernumerary rib from the 7 th cervical vertebra, and only 10% of this population has symptoms. Treatment for patients with TOS symptoms begins with jobsite alteration and therapy as described in Section F does not require surgical intervention.

Neurogenic TOS may require early surgical intervention if there is significant weakness with corresponding Electromyography/Nerve Conduction Velocities (EMG/NCV) changes. The medical records should reasonably document the following:

a. History Taking:

A careful history documenting exacerbating activities and positions which relieve symptoms is essential. Timing of the onset of symptoms is important. TOS has been associated with trauma and motor vehicle accidents. Clavicular fractures can be related.

Baseball pitchers may present with TOS symptoms. Avocational pursuits should also be specifically documented. A cervical rib is congenital, and considerations regarding work relatedness should take this into account.

i. Symptoms common to Neurogenic TOS:

Neurological symptoms are usually consistent. Other neurologic diagnoses should be considered such as other brachial plexus injuries. Neck pain is often the first symptom with complaints within the first few days of injury. Occipital headaches may also occur early. Some patients experience coldness or color changes in the hands. Neurogenic symptoms include the following:

A) Forearm (frequently medial), or proximal upper extremity pain including: neck, trapezius, chest, axillar, shoulder and/or arm. Examiner should ask specifically about each area.

B) Numbness and paresthesia in arm, hand and fingers:

1. The most common patterns are 4th and 5th digits or all 5 fingers.

2. Symptoms may occur in the1st, 2nd and 3rd digits, but one must

rule out carpal tunnel syndrome.

C) The most common complaints are upper extremity weakness in the arm and/or hand. Frequently dropping things is a common complaint.

D) Arm elevation is an exacerbating factor. Common complaints are disturbed sleep, trouble combing hair, putting on clothing, driving a car, or carrying objects with shoulder straps such as back packs.

ii. Symptoms in Venous TOS:

A) Arm swelling.

B) Color change – dark red, purple.

C) Pain is mild. Arm feels tight.

• Sudden onset of swelling suggests a venous blood clot. This is urgent, but not emergent. Requires treatment within 24 hours. Arm viability is NOT threatened.

iii. Symptoms of Arterial TOS – are due to arterial embolus to arm or hand A) Never swollen.

B) Color change – white, looks ischemic.

C) Claudication – pain in forearm when using it for any activity.

D) Pain at rest – suggests ischemia, pregangrene.

E) Numbness – suggests ischemia, pregangrene.

• This condition is urgent to emergent. Needs attention within 6-12 hours.

iv. Functional assessment: Functional ability should be assessed and documented at the beginning of treatment. Periodic assessment should be recorded throughout the course of care to follow the trajectory of recovery. In addition to being more relevant to recovery from TOS, functional measures are likely to be more reliable over time than pain measures Patient-reported outcomes, whether of pain or function, are susceptible to a phenomenon called response shift. This refers to changes in self-evaluation which may accompany changes in health status. Patient self-reports may not coincide with objective measures of outcome, due to reconceptualization of the impact of pain on daily function and internal recalibration of pain scales.

Response shift has potential to obscure treatment effects in clinical trials and clinical practice, and may lead to apparent discrepancies in patient-reported outcomes following treatment interventions. While methods of measuring and accounting for response shift are not yet fully developed, understanding that the phenomenon exists can help clinicians understand what is happening when some measures of patient progress appear inconsistent with other measures of progress.

Questionnaires may also be helpful to describe and follow symptoms and to identify coexisting conditions. Examples include Disability of the Arm, Shoulder and Hand (DASH), the Cervical Brachial Symptom Questionnaire, and depression screening such as the Beck depression scale.

b. Occupational Relationship for Neurogenic and Vascular TOS:

In many cases, trauma is the cause of venous and arterial or neurogenic TOS. Clavicular fractures, cervical strain (including whiplash), and other causes of cervical trauma injuries have been associated with TOS. Continual overhead lifting or motion may contribute as can static postures in which the shoulders droop and the head is inclined forward.

Activities which cause overdeveloped scalene muscles such as weight-lifting, baseball, rowing and swimming may contribute. The causes of TOS can be placed into 3 general categories: trauma, posture, and repetitive activities.

The Paget-Schroetter syndrome, or effort thrombosis of the subclavian vein, may occur in athletes or workers with repetitive overhead forceful motion and neck extension. It may be caused by microtraumas and by venous stasis induced by mechanical stress on the vein.

Arterial thrombosis or symptoms from subclavian aneurysms or stenosis are usually not related to work or trauma, but are associated with a cervical rib or an anomalous first rib.

Both classic neurogenic TOS (usually due to a cervical or anomalous first rib) and TOS due to arterial compromise from stenosis or aneurysm are rarely work-related conditions.

None of the following anatomical findings are pathognomonic for TOS as they occur frequently in the asymptomatic population also:

• congenital bands and ligaments around the scalene muscles • a complete or incomplete cervical rib • interdigitating muscle fibers between the anterior and middle scalene muscles.

c. Physical Findings:

Physical examination signs used to diagnose classic or non-specific neurogenic TOS.

Both extremities should be examined to compare symptomatic and asymptomatic sides.

i. Provocative maneuvers (listed below) must reproduce the symptoms of TOS to be considered positive.

A) Tenderness over scalene muscles in supraclavicular area.

B) Pressure in supraclavicular area elicits symptoms in arm/hand, or Tinel’s sign over the brachial plexus is positive. The supraclavicular pressure test is positive for paresthesia in approximately 15% of asymptomatic individuals.

C) Elevated arm stress test (EAST) is performed with the arms abducted and shoulders externally rotated to 90 degrees with elbows bent to 90 degrees for 1 minute. The patient may also be asked to repetitively open and close fists (Roos Test), however, this is not required. A positive test reproduces upper extremity symptoms or dropping of arms to alleviate symptoms within 60 seconds, often within 30 seconds.

Some literature has suggested another provocative elevated arm stress test, Wright’s test. The patient holds his arms over head for one minute with elbows extended, wrists in a neutral position, and forearm midway between supination and pronation. If symptoms are reproduced, the test is positive.

D) Upper Limb Tension Test (ULTT). This test is comparable to straight leg raising in the lower extremity. It is a modification of Elvey’s test first described in about 1990. There are 3 steps, or positions:

1. Arm is extended 90º with elbow straight out.

2. Wrist is dorsi-flexed.

3. Head is tilted to opposite side, putting ear to shoulder (contralateral side).

A positive response is onset of paresthesia in the hand or pain down the arm. This test is not specific for neurogenic TOS and may be positive in other upper extremity neurogenic conditions.

ii. Posture related brachial tests (listed below) must reproduce the symptoms of TOS to be considered positive.

A) Head tilting: lateral flexion of the neck (ear to shoulder) causes radiating pain and paresthesia in the contralateral arm consistent with TOS.

B) Neck Rotation or Adson’s: Turn the chin all the way to the side and move opposite arm into extension, abduction and then external rotation. A positive response is the onset of pain and/or paresthesia on the opposite (contralateral) side.

iii. Neurological examination:

A) Sensory exam: may show decreased sensation to light touch, pain, vibration, and/or temperature in lower brachial plexus distribution. The entire ring finger is frequently involved. The entire little finger and lateral side of the ring finger may show sensory changes and occasionally the long finger showed sensory changes. This contrasts with ulnar neuropathy, which usually involves only the ulnar side of the ring finger.

B) Motor exam: weakness and/or muscle atrophy in either upper or lower trunk distributions including, but not limited to, valid dynamometer readings indicative of relative weakness in the affected limb compared to the unaffected limb. In lower plexus injuries, the abductor pollicus brevis often demonstrates more involvement and atrophy than the intrinsic interosseous muscles.

Atrophy of the thenar eminence as compared to the asymptomatic hand can occasionally be observed.

iv. Physical exam findings for venous and arterial TOS cases:

Suspicion of vascular compromise should lead to confirmation using appropriate imaging procedures.

A) Arterial cases usually demonstrate an absent radial pulse at rest, a pale hand, and often ischemic fingers.

B) Venous obstruction presents with visible or distended superficial veins on the affected side involving the anterior axillary fold and chest wall. The arm is usually swollen and cyanotic.

Measurement of the circumference of wrist and upper arm/biceps may objectively demonstrate asymmetry.

v. Physical Exam - other tests which are recommended and may indicate additional diagnostic considerations.

A) Neck rotation may be restricted and can indicate the presence of additional pathology.

B) Rotator cuff/acromioclavicular (AC) joint tenderness suggests rotator cuff, biceps tendonitis, or AC joint disease.

C) Trapezius muscle, shoulder girdle muscles or paraspinal muscle tenderness suggests a myofascial component or protective spasm. Trapezius tenderness is common in both neurogenic TOS and pectoralis minor syndrome.

D) Drooping shoulders secondary to nerve injuries can be present with TOS symptoms. If a spinal accessory, long thoracic or other nerve injury is identified, treatment should focus on therapy for the nerve injury in addition to conservative measures for TOS.

Refer to the Shoulder Injury Medical Treatment Guidelines,

Section E.4. Brachial Plexus and Shoulder Nerve Injuries.

E) The following tests suggest carpal tunnel syndrome: carpal tunnel compression test, flicking the wrist secondary to paresthesia, Tinel’s sign and/or Phalen’s sign.

F) Positive Tinel’s sign at elbow (over ulnar groove) suggests ulnar nerve entrapment.

G) Positive Tinel’s sign over the pronator teres muscle suggests median nerve involvement. Positive Tinel’s sign over the radial tunnel suggests radial nerve compression.

d. Cervical Spine X-ray: is a generally accepted, well-established procedure indicated to

rule out cervical spine disease, fracture, cervical rib, or rudimentary first rib when clinical findings suggest these diagnoses. Cervical spine x-rays should also be considered when there is an asymmetric diminished pulse in an arm that is symptomatic. X-rays are most useful when arterial TOS is suspected. The presence of a cervical rib does not confirm the diagnosis unless other clinical signs and symptoms are present, as many cervical ribs are asymptomatic. Therefore, routine roentgenographic evaluation of the cervical spine is frequently unnecessary early in the course of treatment for patients with thoracic outlet symptoms due to myofascial dysfunction.

e. Vascular Studies: Vascular laboratory studies, including duplex scanning, Doppler studies, standard and MR arteriography and venography are required for patients presenting with arterial or venous occlusion, as these patients may require immediate thrombolytic intervention. These studies are not indicated for neurogenic TOS.

E. FOLLOW-UP DIAGNOSTIC IMAGING AND TESTING PROCEDURES

One diagnostic imaging procedure may provide the same or distinctive information as another procedure.

Therefore, the prudent choice of a single diagnostic procedure, a complement of procedures or a sequence of procedures will optimize diagnostic accuracy, maximize cost effectiveness (by avoiding redundancy), and minimize potential adverse effects to patients.

All diagnostic imaging procedures have a significant percentage of specificity and sensitivity for various diagnoses. None is specifically characteristic of a certain diagnosis. Clinical information obtained by

history taking and physical examination should form the basis for selecting an imaging procedure and interpreting its results.

Practitioners should be aware of the radiation doses associated with various procedures and provide appropriate warnings to patients. Coloradans have a background exposure to radiation, and unnecessary CT scans or X-rays increase the lifetime risk of cancer death.

When a diagnostic procedure, in conjunction with clinical information, can provide sufficient information to establish an accurate diagnosis, the second diagnostic procedure will become a redundant procedure. At the same time, a subsequent diagnostic procedure can be a complementary diagnostic procedure if the first or preceding procedures, in conjunction with clinical information, cannot provide an accurate diagnosis. Usually, preference of a procedure over others depends upon availability, a patient’s tolerance, and/or the treating practitioner’s familiarity with the procedure.

1. CERVICAL COMPUTED AXIAL TOMOGRAPHY OR MAGNETIC RESONANCE IMAGING

(CT/MRI): are generally accepted, well-established procedures indicated to rule out cervical disc or other cervical spine disorders when clinical findings suggest these diagnoses. It should not be routinely performed for TOS. MRI is the preferred test over a CT unless a fracture is suspected, and then CT may be superior to MRI. CT/MRI is not indicated early unless there is a neurological deficit and/or the need to rule out a space-occupying lesion, such as a tumor. A number of anatomic variants which may be identified are not necessarily pathognomonic for TOS. Refer to Section D.1.b. Occupational Relationship for Neurogenic and Venous and Arterial TOS. Repeat cervical MRI is not indicated for TOS. If cervical spine injury is confirmed, refer to Division’s Cervical Spine Injury Medical Treatment Guidelines. If a cervical spine disorder is not suspected, conservative therapy as indicated in Section F. Nonoperative Procedures should be done for at least 8 to 12 weeks, prior to ordering an MRI for persistent symptoms.

2. ELECTRODIAGNOSTIC STUDIES

a. Electromyography/Nerve Conduction Velocities (EMG/NCV): are generally accepted, well-established procedure. EMG/NCV is primarily indicated to rule out other nerve entrapment syndromes such as cervical nerve roots, ulnar neuropathy, carpal tunnel or cubital tunnel syndrome when indicated by clinical examination, or to establish neurogenic TOS. Most cases of myofascial dysfunction with thoracic outlet symptoms have normal electrodiagnostic studies, but EMG/NCV should be considered when symptoms have been present for approximately 3 months or if the patient has failed 8 weeks of conservative therapy. EMG/NCV may also be performed to rule out other disorders. F wave measurements have no utility in the work up for TOS. Nerve conduction studies across the thoracic outlet are considered controversial for diagnostic purposes by some authors.

The diagnosis should be made by comparison to the normal extremity. For bilateral disease, each EMG lab must establish its own absolute limits of latency and amplitude from volunteer controls, so that measurements exceeding these limits can be noted. The EMG and NCV study is an extension of the physical exam. Thus, an electrical diagnosis cannot be made without clinical correlation.

Criteria for True Neurogenic TOS:

i. Reduction of the ulnar sensory nerve action potential to digits (usually less than 60% of unaffected side); or ii. Medial antebrachial cutaneous nerve sensory action potential which is low or absent compared to the unaffected side; or iii. Reduction of the median M-wave amplitude (usually less than 50% of unaffected side); or iv. Needle EMG examination reveals neurogenic changes in intrinsic hand muscles and the abductor pollicus brevis muscle.

v. Abnormal nerve conduction of one of the following: medial antebrachial cutaneous (MAC) nerve amplitude retro between sides of 2 or more, amplitude under 10 mV, latency difference of between sides of 0.3 or more, or latency more than 2.4 msec; or.

vi. A C8 stimulation study may be done when there are equivocal findings from the above tests, i through v. A positive test would demonstrate slowed velocity.

Related Studies:

There is some evidence that a latency in the MAC nerve greater than or equal to 2.4 ms and an amplitude less than 10 microvolts may confirm a clinical diagnosis of neurogenic TOS, but need not be a required part of the diagnostic evaluation.

There is inadequate evidence that it is a robust diagnostic test for neurogenic TOS, since in this study the clinical examination was used to select patients for surgery even if electrodiagnostic testing is optional.

One study concluded that comparison of the amplitude of sensory nerve action potential of MAC on the injured or non-injured side was comparatively helpful for the diagnosis of TOS; however, the latency difference between the medial antebrachial cutaneous nerve and the ulnar nerve did not differ significantly between the TOS side and the asymptomatic side.

b. Portable Automated Electrodiagnostic Device: (also known as SurfaceEMG) is not a substitute for conventional EMG/NCV testing in clinical decision making, and therefore, is not recommended.

c. Quantitative Sensory Testing (QST): Research is not currently available on the use of QST in the evaluation of TOS. QST tests the entire spectrum of the neurological system including the brain. It is not able to reliably distinguish between organic and psychogenic pathology and therefore, is not recommended.

3. VASCULAR STUDIES: Noninvasive vascular testing, such as pulse-volume recording in different positions, is not indicated in cases of neurogenic TOS. Since the presence or absence of a pulse cutoff on physical examination is not helpful in establishing a diagnosis of TOS, the recording of finer degrees of positional pulse alteration will not add to the diagnosis. Vascular laboratory studies, including duplex scanning, Doppler studies, standard and MR arteriography and venography, are not cost-effective in cases of neurogenic TOS. These studies are only indicated in patients who have arterial or venous occlusive signs. Dynamic venography with the arm in 180 degrees of abduction may be used in cases with continued swelling and/or periodic cyanosis who have not improved with conservative therapy. Approximately 20% of asymptomatic individuals will have an abnormal dynamic venogram. Some individuals may have a pectoralis minor syndrome which occludes the axillary vein rather than the subclavian vein. In these cases, less invasive surgery than the TOS operative procedures may be indicated.

4. THERMOGRAPHY: is not generally accepted or widely used for TOS. It may be used if the differential diagnosis includes CRPS; in such cases, refer to the Division’s Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy Medical Treatment Guidelines.

5. ANTERIOR SCALENE OR PECTORALIS MUSCLE BLOCKS: may be performed to provide additional information prior to expected surgical intervention. It is recommended that EMG or sonography guidance be used to assure localization. Patients who have work-related cumulative trauma are likely to have less pain relief than those with specific injuries. A recent review of multiple TOS surgical articles found that comorbidities were better predictors of long-term improvement in quality of life than pre-operative positive scalene blocks.

6. BOTULINUM INJECTIONS: There is some evidence that botulinum toxin type A in a dose of 75U injected into the scalene muscles does not differ appreciably from an injection of placebo in patients with TOS of several years’ duration. Complications include dysphagia and dysphonia.

Thus, it is not recommended for diagnosis.

7. PERSONALITY/PSYCHOLOGICAL/PSYCHOSOCIAL EVALUATIONS: are generally accepted and well-established diagnostic procedures with selective use in the acute TOS population and more widespread use in the sub-acute and chronic TOS population.

Diagnostic testing procedures may be useful for patients with symptoms of depression, delayed recovery, chronic pain, recurrent painful conditions, disability problems, and for pre-operative evaluation as well as a possible predictive value for post-operative response. Psychological testing should provide differentiation between pre-existing depression versus injury caused depression, as well as post-traumatic stress disorder.

Formal psychological or psychosocial evaluation should be performed on patients not making expected progress within 6 to 12 weeks following injury and whose subjective symptoms do not correlate with objective signs and tests. In addition to the customary initial exam, the evaluation of the injured worker should specifically address the following areas:

a. Employment history;

b. Interpersonal relationships — both social and work;

c. Leisure activities;

d. Current perception of the medical system;

e. Results of current treatment;

f. Perceived locus of control; and g. Childhood history, including abuse and family history of disability.

This information should provide clinicians with a better understanding of the patient, and enable a more effective rehabilitation.

The evaluation will determine the need for further psychosocial interventions, and in those cases, a Diagnostic Statistical Manual (DSM) of mental disorders diagnosis should be determined and documented. An individual with a PhD, PsyD, or Psychiatric MD/DO credentials should perform initial evaluations, which are generally completed within one to two hours. A professional fluent in the primary language of the patient is strongly preferred. When such a provider is not available, services of a professional language interpreter must be provided. When issues of chronic pain are identified, the evaluation should be more extensive and follow testing procedures as outlined in the Division’s Chronic Pain Disorder Medical Treatment Guidelines.

• Frequency: One time visit for evaluation. If psychometric testing is indicated as a portion of the initial evaluation, time for such testing should not exceed an additional two hours of professional time.

8. SPECIAL TESTS: are generally well-accepted tests and are performed as part of a skilled assessment of the patients’ capacity to return to work, his/her strength capacities, and physical work demand classifications and tolerance. The procedures in this subsection are listed in alphabetical order, not by importance.

a. Computer-Enhanced Evaluations: These may include isotonic, isometric, isokinetic and/or isoinertial measurement of movement; ROM; endurance; or strength. Values obtained can include degrees of motion, torque forces, pressures, or resistance.

Indications include determining validity of effort, effectiveness of treatment, and demonstrated motivation. These evaluations should not be used alone to determine return-to-work restrictions.

• Frequency: One time for evaluation, one for mid-treatment assessment, and one at final evaluation.

b. Functional Capacity Evaluation (FCE): This is a comprehensive or modified evaluation of the various aspects of function as they relate to the worker’s ability to return to work.

Areas such as endurance, lifting (dynamic and static), postural tolerance, specific ROM, coordination and strength, worker habits, employability, as well as psychosocial aspects of competitive employment may be evaluated. Reliability of patient reports and overall effort during testing is also reported. Components of this evaluation may include: (a) musculoskeletal screen; (b) cardiovascular profile/aerobic capacity; (c) coordination; (d) lift/carrying analysis; (e) job-specific activity tolerance; (f) maximum voluntary effort; (g) pain assessment/psychological screening; and (h) non-material and material handling activities. Standardized national guidelines (such as National Institute for Occupational Safety and Health (NIOSH)) should be used as the basis for FCE recommendations.

There is some evidence that an FCE fails to predict which injured workers with chronic low back pain will have sustained return to work. Another cohort study concluded that there was a significant relation between FCE information and return to work, but the predictive efficiency was poor. There is some evidence that time off work and gender are important predictors for return to work. Floor-to-waist lifting may also help predict return to work, however, the strength of that relationship has not been determined.

A full review of the literature reveals that there is no evidence to support the use of FCEs to prevent future injuries. There is some evidence in chronic low back pain patients that (1) FCE task performance is weakly related to time on disability and time for claim closure and (2) even claimants who fail on numerous physical performance FCE tasks may be able to return to work.

Full FCEs are rarely necessary. In many cases, a work tolerance screening or return to work performance will identify the ability to perform the necessary job tasks. There is some evidence that a short form FCE reduced to a few tests produces a similar predictive quality compared to the longer 2-day version of the FCE regarding length of disability and recurrence of a claim after return to work.

When an FCE is being used to determine return to a specific jobsite, the provider is responsible for fully understanding the physical demands and the duties of the job the worker is attempting to perform. A jobsite evaluation is usually necessary. A job description should be reviewed by the provider and FCE evaluator prior to having this evaluation performed. FCEs cannot be used in isolation to determine work restrictions. It is expected that the FCE may differ from both self-report of abilities and pure clinical exam findings in chronic pain patients. The length of a return to work evaluation should be based on the judgment of the referring physician and the provider performing the evaluation. Since return to work is a complicated multidimensional issue, multiple factors beyond functional ability and work demands should be considered and measured when attempting determination of readiness or fitness to return to work. FCEs should not be used as the sole criteria to diagnose malingering.

• Frequency: Can be used: (1) initially to determine baseline status; and (2) for case closure when patient is unable to return to the pre-injury position and further information is desired to determine permanent work restrictions. Prior authorization is required for FCEs performed during treatment.

c. Jobsite Evaluation: is a comprehensive analysis of the physical, mental and sensory components of a specific job. These components may include, but are not limited to: (a) postural tolerance (static and dynamic); (b) aerobic requirements; (c) range of motion; (d) torque/force; (e) lifting/carrying; (f) cognitive demands; (g) social interactions; (h) visual perceptual; (i) sensation; (j) coordination; (k) environmental requirements; (l) repetitiveness; and (m) essential job functions. Job descriptions provided by the employer are helpful but should not be used as a substitute for direct observation.

A jobsite evaluation may include observation and instruction of how work is done, what material changes (desk, chair) should be made, and determination of readiness to return to work. Postural risk factors should be identified and awkward postures of overhead reach, hyperextension or rotation of the neck, shoulder drooped or forward-flexed and head-chin forward postures should be eliminated. Unless combined with one of the above postures, repetitiveness is not by itself a risk factor. Refer to Cumulative Trauma Disorder and Shoulder Guidelines for further suggestions.

Requests for a jobsite evaluation should describe the expected goals for the evaluation.

Goals may include, but are not limited to the following:

i. To determine if there are potential contributing factors to the person’s condition and/or for the physician to assess causality;

ii. To make recommendations for, and to assess the potential for ergonomic changes;

iii. To provide a detailed description of the physical and cognitive job requirements;

iv. To assist the patient in their return to work by educating them on how they may be able to do their job more safely in a bio-mechanically appropriate manner;

v. To give detailed work/activity restrictions.

• Frequency: One time with additional visits as needed for follow-up per jobsite.

d. Vocational Assessment: If the injury is such that the practitioner can easily determine that the worker will be unable to return to his/her previous occupation, then vocational rehabilitation assistance at that time may aid in the overall medical management and rehabilitation of the patient. The physician may decide that the patient is unable to return to the previous occupation prior to declaration of MMI.

The vocational assessment should provide valuable guidance in the determination of future rehabilitation program goals. It should clarify rehabilitation goals, which optimize both patient motivation and utilization of rehabilitation resources. The physician should have identified the expected permanent limitation(s) prior to the assessment. Declaration of MMI should not be delayed solely due to lack of attainment of a vocational assessment.

• Frequency: One time with additional visits as needed for follow-up.

e. Work Tolerance Screening: is a determination of an individual's tolerance for performing a specific job based on a job activity or task and may be used when a full Functional Capacity Evaluation is not indicated. The screening is monitored by a therapist and may include a test or procedure to specifically identify and quantify work relevant cardiovascular, physical fitness and postural tolerance. It may also address ergonomic issues affecting the patient’s return-to-work potential.

• Frequency: One time for initial screen. May monitor improvements in strength every 3 to 4 weeks up to a total of 6 visits.

F. THERAPEUTIC PROCEDURES - NON-OPERATIVE

Before initiation of any therapeutic procedure, the authorized treating provider, employer, and insurer must consider these four important issues in the care of the injured worker.

First, patients undergoing therapeutic procedure(s) should be released or returned to modified or restricted duty during their rehabilitation at the earliest appropriate time. Refer to Section F.10. Return to Work for detailed information.

Second, cessation and/or review of treatment modalities should be undertaken when no further significant subjective or objective improvement in the patient’s condition is noted. If patients are not responding within the recommended duration periods, alternative treatment interventions, further diagnostic studies, or consultations should be pursued.

Third, providers should provide and document patient education. Before diagnostic tests or referrals for invasive treatment take place, the patient should be able to clearly articulate the goals of the intervention, the general side effects and associated risks, and the patient’s agreement with the expected treatment plan. Sleep positions should be addressed to avoid abduction, overhead posture or pressure.

Last, formal psychological or psychosocial evaluation should be performed on patients not making expected progress within 6 to 12 weeks following injury and whose subjective symptoms do not correlate with objective signs and tests.

Home therapy is an important component of therapy and may include active and passive therapeutic procedures, as well as other modalities to assist in alleviating pain, swelling, and abnormal muscle tone.

The following procedures are listed in alphabetical order.

1. ACUPUNCTURE: When acupuncture has been studied in randomized clinical trials, it is often compared with sham acupuncture and/or no acupuncture (usual care). The differences between true acupuncture and usual care have been moderate, but clinically important. These differences can be partitioned into two components: non-specific effects and specific effects. Non-specific effects include patient beliefs and expectations, attention from the acupuncturist, administration of acupuncture in a relaxing setting, and other components of what is often called the placebo effect. Specific effects refer to any additional effects which occur in the same setting of expectations and attention, but they are attributable to the penetration of the skin in the specific, classic acupuncture points on the surface of the body by the needles themselves.

A sham procedure is a non-therapeutic procedure that appears similar to the patient as the purported therapeutic procedure being tested. In most controlled studies, sham and classic acupuncture have produced similar effects. However, the sham controlled studies have shown consistent advantages of both true and sham acupuncture over no acupuncture when the studies have included a third comparison group that was randomized to usual medical care. Having this third comparison group has been advantageous in the interpretation of the non-specific effects of acupuncture, since the third comparison group controls for some influences on study outcome.

These influences include more frequent contact with providers, the natural history of the condition, regression to the mean, the effect of being observed in a clinical trial, and, if the followup observations are done consistently in all three treatment groups, for biased reporting of outcomes. Controlling for these factors enables researchers to more closely estimate the contextual and personal interactive effects of acupuncture as it is generally practiced.

Because the sham acupuncture interventions in the clinical trials are generally done by trained acupuncturists, and not by totally untrained personnel, the sham acupuncture interventions may include some of the effects of true acupuncture, much as a partial agonist of a drug may produce some of the effects of the actual drug. For example, a sham procedure involving toothpicks rather than acupuncture needles may stimulate cutaneous afferents in spite of not penetrating the skin, much as a neurological sensory examination may test nociceptor function without skin penetration. To the extent that afferent stimulation is part of the mechanism of action of acupuncture, interpreting the sham results as purely a control group would lead to an underestimation of the analgesic effects of acupuncture. Thus, we consider in our analysis that “sham” or non-classic acupuncture may have a positive clinical effect when compared to usual care.

Clinical trials of acupuncture typically enroll participants who are interested in acupuncture, and who may respond to some of the non-specific aspects of the intervention more than would be expected of patients who have no interest in or desire for acupuncture. The non-specific effects of acupuncture may not be produced in patients who have no wish to be referred for it.

Another study provides good evidence that true acupuncture at traditional medians is marginally better than sham acupuncture with blunt needles in reducing pain, but effects on disability are unclear. In these studies 5–15 treatments were provided. Comparisons of acupuncture and sham acupuncture have been inconsistent, and the advantage of true over sham acupuncture has been small in relation to the advantage of sham over no acupuncture.

Acupuncture is recommended for subacute or chronic pain patients who are trying to increase function and/or decrease medication usage and have an expressed interest in this modality. It is also recommended for subacute or acute pain for patients who cannot tolerate nonsteroidal antiinflammatory drugs (NSAIDs) or other medications. Acupuncture is not the same procedure as dry needling for coding purposes; however, some acupuncturists may use acupuncture treatment for myofascial trigger points. Dry needling is performed specifically on myofascial trigger points.

Refer to Section F.3.c. Trigger Point Injections and Dry Needling Treatment.

Credentialed practitioners with experience in evaluation and treatment of chronic pain patients must perform acupuncture evaluations prior to acupuncture treatments. The exact mode of action is only partially understood. Western medicine studies suggest that acupuncture stimulates the nervous system at the level of the brain, promotes deep relaxation, and affects the release of neurotransmitters. Acupuncture is commonly used as an alternative or in addition to traditional Western pharmaceuticals. It may be used when pain medication is reduced or not tolerated; as an adjunct to physical rehabilitation and surgical intervention; and/or as part of multidisciplinary treatment to hasten the return of functional activity. Acupuncture must be performed by practitioners with the appropriate credentials in accordance with state and other applicable regulations. Therefore, if not otherwise within their professional scope of practice and licensure, those performing acupuncture must have the appropriate credentials, such as L.A.c., R.A.c, or Dipl. Ac.

a. Acupuncture: is the insertion and removal of filiform needles to stimulate acupoints (acupuncture points). Needles may be inserted, manipulated and retained for a period of time. Acupuncture can be used to reduce pain, reduce inflammation, increase blood flow, increase range of motion, decrease the side effect of medication induced nausea, promote relaxation in an anxious patient, and reduce muscle spasm.

Indications include joint pain, joint stiffness, soft tissue pain and inflammation, paresthesia, post-surgical pain relief, muscle spasm, and scar tissue pain.

b. Acupuncture with Electrical Stimulation: is the use of electrical current (microamperage or milli-amperage) on the needles at the acupuncture site. It is used to increase effectiveness of the needles by continuous stimulation of the acupoint.

Physiological effects (depending on location and settings) can include endorphin release for pain relief, reduction of inflammation, increased blood circulation, analgesia through interruption of pain stimulus, and muscle relaxation.

It is indicated to treat chronic pain conditions, radiating pain along a nerve pathway, muscle spasm, inflammation, scar tissue pain, and pain located in multiple sites.

c. Total Time Frames for Acupuncture and Acupuncture with Electrical Stimulation:

Time frames are not meant to be applied to each of the above sections separately. The time frames are to be applied to all acupuncture treatments regardless of the type or combination of therapies being provided.

• Time to Produce Effect: 3 to 6 treatments.

• Frequency: 1 to 3 times per week.

• Optimum Duration: 1 to 2 months.

• Maximum Duration: 15 treatments.

Any of the above acupuncture treatments may extend longer if objective functional gains can be documented and when symptomatic benefits facilitate progression in the patient’s treatment program. Treatment beyond 14 treatments must be documented with respect to need and ability to facilitate positive symptomatic and functional gains. Such care should be re-evaluated and documented with each series of treatments.

d. Other Acupuncture Modalities: Acupuncture treatment is based on individual patient needs and therefore treatment may include a combination of procedures to enhance treatment effect. Other procedures may include the use of heat, soft tissue manipulation/massage, and exercise. Refer to Sections F.11. Therapy-Active (Therapeutic Exercise) and F.12. Therapy- Passive (Massage and Superficial Heat and Cold Therapy) for a description of these adjunctive acupuncture modalities and time frames.

2. BIOFEEDBACK: Biofeedback is a form of behavioral medicine that helps patients learn selfawareness and self-regulation skills for the purpose of gaining greater control of their physiology, such as muscle activity, brain waves, and measures of autonomic nervous system activity.

Stress-related psycho-physiological reactions may arise as a reaction to organic pain and, in some cases, may cause pain. Electronic instrumentation is used to monitor the targeted physiology and then displayed or fed back to the patient visually, auditorily, or tactilely, with coaching by a biofeedback specialist. There is good evidence that biofeedback or relaxation therapy is equal in effect to cognitive behavioral therapy for chronic low back pain.

Indications for biofeedback include cases of musculoskeletal injury, in which muscle dysfunction or other physiological indicators of excessive or prolonged stress response affects and/or delays recovery. Other applications include training to improve self-management of pain, anxiety, panic, anger or emotional distress, opioid withdrawal, insomnia/sleep disturbance, and other central and autonomic nervous system imbalances. Biofeedback is often utilized for relaxation training.

Mental health professionals may also utilize it as a component of psychotherapy, where biofeedback and other behavioral techniques are integrated with psychotherapeutic interventions.

Biofeedback is often used in conjunction with physical therapy or medical treatment.

Recognized types of biofeedback include the following:

a. Electromyogram (EMG): Used for self-management of pain and stress reactions involving muscle tension.

b. Skin Temperature: Used for self-management of pain and stress reactions, especially vascular headaches.

c. Respiration Feedback (RFB): Used for self-management of pain and stress reactions via breathing control.

d. Respiratory Sinus Arrhythmia (RSA): Used for self-management of pain and stress reactions via synchronous control of heart rate and respiration. Respiratory sinus arrhythmia is a benign phenomenon that consists of a small rise in heart rate during inhalation, and a corresponding decrease during exhalation. This phenomenon has been observed in meditators and athletes, and is thought to be a psycho-physiological indicator of health.

e. Heart Rate Variability (HRV): Used for self-management of stress via managing cardiac reactivity.

f. Electrodermal Response (EDR): Used for self-management of stress involving palmar sweating or galvanic skin response.

g. Electroencephalograph (EEG, QEEG): Used for self-management of various psychological states by controlling brainwaves.

The goal in biofeedback treatment is normalizing the physiology to the pre-injury status to the extent possible and involves transfer of learned skills to the workplace and daily life. Candidates for biofeedback therapy or training should be motivated to learn and practice biofeedback and self-regulation techniques. In the course of biofeedback treatment, patient stressors are discussed and self-management strategies are devised. If the patient has not been previously evaluated, a psychological evaluation should be performed prior to beginning biofeedback treatment for chronic pain. The psychological evaluation may reveal cognitive difficulties, belief system conflicts, somatic delusions, secondary gain issues, hypochondriasis, and possible biases in patient self-reports, which can affect biofeedback. Home practice of skills is often helpful for mastery and may be facilitated by the use of home training tapes.

Psychologists or psychiatrists who provide psycho-physiological therapy, which integrates biofeedback with psychotherapy, should be either Biofeedback Certification International Alliance (BCIA) certified or practicing within the scope of their training. All non-licensed health care providers of biofeedback for chronic pain patients must be BCIA certified and shall have their biofeedback treatment plan approved by the authorized treating psychologist or psychiatrist.

Biofeedback treatment must be done in conjunction with the patient’s psychosocial intervention.

Biofeedback may also be provided by health care providers who follow a set treatment and educational protocol. Such treatment may utilize standardized material or relaxation tapes.

• Time to Produce Effect: 3 to 4 sessions.

• Frequency: 1 to 2 times per week.

• Optimum Duration: 6 to 8 sessions.

• Maximum Duration: 10 to 12 sessions. Treatment beyond 12 sessions must be documented with respect to need, expectation, and ability to facilitate positive symptomatic and functional gains.

3. INJECTIONS - THERAPEUTIC:

a. Scalene Blocks: have no therapeutic role in the treatment of TOS.

b. Botulinum Toxin: Used to temporarily weaken or paralyze muscles. May reduce muscle pain in conditions associated with spasticity, dystonia, or other types of painful muscle spasm. Neutralizing antibodies develop in at least 4% of patients treated with botulinum toxin type A, rendering it ineffective. Several antigenic types of botulinum toxin have been described. Botulinum toxin type B, first approved by the Food and Drug Administration (FDA) in 2001, is similar pharmacologically to botulinum toxin type A. It appears to be effective in patients who have become resistant to the type A toxin. The immune responses to botulinum toxins type A and B are not cross-reactive, allowing type B toxin to be used when type A action is blocked by antibody. Experimental work with healthy human volunteers suggests that muscle paralysis from type B toxin is not as complete or as long-lasting as that resulting from type A. The duration of treatment effect of botulinum toxin type B for cervical dystonia has been estimated to be 12 to 16 weeks. EMG needle guidance may permit more precise delivery of botulinum toxin to the target area.

There is some evidence that botulinum toxin type A in a dose of 75U injected into the scalene muscles does not differ appreciably from an injection of placebo in patients with TOS of several years’ duration. Therefore, it is not recommended. In addition, because muscle paralysis from the injection can lead to muscle atrophy and other unexpected pathology over time, botulinum toxin is not recommended.

c. Trigger Point Injections and Dry Needling Treatment:

i. Description  Trigger point injections are a generally accepted treatment.

Trigger point treatment can consist of dry needling or injection of local anesthetic, with or without corticosteroid, into highly localized, extremely sensitive bands of skeletal muscle fibers that produce local and referred pain when activated.

Medication is injected in a four-quadrant manner in the area of maximum tenderness. Injection efficacy can be enhanced if injections are immediately followed by myofascial therapeutic interventions, such as vapo-coolant spray and stretch, ischemic pressure massage (myotherapy), specific soft tissue mobilization and physical modalities. There is conflicting evidence regarding the benefit of trigger point injections. A truly blinded study comparing dry needle treatment of trigger points is not feasible. There is no evidence that injection of medications improves the results of trigger-point injections. Needling alone may account for some of the therapeutic response. Needling must be performed by practitioners with the appropriate credentials in accordance with state and other applicable regulations.

There is no indication for conscious sedation for patients receiving trigger point injections. The patient must be alert to help identify the site of the injection.

ii. Indications  Trigger point injections may be used to relieve myofascial pain and facilitate active therapy and stretching of the affected areas. They are to be used as an adjunctive treatment in combination with other treatment modalities such as active therapy programs. Trigger point injections should be utilized primarily for the purpose of facilitating functional progress. Patients should continue in an aggressive aerobic and stretching therapeutic exercise program as tolerated throughout the time period they are undergoing intensive myofascial interventions. Myofascial pain is often associated with other underlying structural problems and any abnormalities need to be ruled out prior to injection.

Trigger point injections are indicated in those patients where well circumscribed trigger points have been consistently observed, demonstrating a local twitch response, characteristic radiation of pain pattern and local autonomic reaction, such as persistent hyperemia following palpation. Generally, these injections are not necessary unless consistently observed trigger points are not responding to specific, noninvasive, myofascial interventions within approximately a 6-week time frame. However, trigger point injections may be occasionally effective when utilized in the patient with immediate, acute onset of pain.

i. Complications  Potential but rare complications of trigger point injections include infection, pneumothorax, anaphylaxis, penetration of viscera, neurapraxia, and neuropathy. If corticosteroids are injected in addition to local anesthetic, there is a risk of local myopathy. Severe pain on injection suggests the possibility of an intraneural injection, and the needle should be immediately repositioned.

• Time to produce effect: Local anesthetic 30 minutes; 24 to 48 hours for no anesthesia.

• Frequency: Weekly. Suggest no more than 4 injection sites per session per week to avoid significant post-injection soreness.

• Optimum duration: 4 Weeks total for all injection sites.

• Maximum duration: 8 weeks total for all injection sites. Occasionally, patients may require 2 to 4 repetitions of trigger point injection series over a 1 to 2 year period.

4. INTERDISIPLINARY REHABILITATION PROGRAMS: This is the gold standard of treatment for individuals who have not responded to less intensive modes of treatment. There is good evidence that interdisciplinary programs which include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability. These programs should assess the impact of pain and suffering on the patient’s medical, physical, psychological, social, and/or vocational functioning. In general, interdisciplinary programs evaluate and treat multiple and sometimes irreversible conditions, including, but not limited to: painful musculoskeletal, neurological, and other chronic pain conditions and psychological issues; drug dependence, abuse, or addiction; high levels of stress and anxiety; failed surgery; and pre-existing or latent psychopathology. The number of professions involved on the team in a chronic pain program may vary due to the complexity of the needs of the person served. The Division recommends consideration of referral to an interdisciplinary program within six months post-injury in patients with delayed recovery, unless successful surgical interventions or medical and/or psychological treatment complications occur.

Chronic pain patients need to be treated as outpatients within a continuum of treatment intensity.

Outpatient chronic pain programs are available with services provided by a coordinated interdisciplinary team within the same facility (formal) or as coordinated among practices by the authorized treating physician (informal). Formal programs are able to provide a coordinated, highintensity level of services and are recommended for most chronic pain patients who have received multiple therapies during acute management.

Patients with addiction problems, high-dose opioid use, or use of other drugs of abuse may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation. Guidelines from the American Society of Addiction Medicine are available and may be consulted relating to the intensity of services required for different classes of patients in order to achieve successful treatment.

Informal interdisciplinary pain programs may be considered for patients who are currently employed, those who cannot attend all-day programs, those with language barriers, or those living in areas where formal programs are not available. Before treatment has been initiated, the patient, physician, and insurer should agree on treatment approach, methods, and goals.

Generally, the type of outpatient program needed will depend on the degree of impact the pain has had on the patient’s medical, physical, psychological, social, and/or vocational functioning.

When referring a patient for formal outpatient interdisciplinary pain rehabilitation, an occupational rehabilitation program, or an opioid treatment program, the Division recommends the program meets the criteria of the Commission on Accreditation of Rehabilitation Facilities (CARF).

Inpatient pain rehabilitation programs are rarely needed but may be necessary for patients with any of the following conditions: (a) high risk for medical instability; (b) moderate-to-severe impairment of physical/functional status; (c) moderate-to-severe pain behaviors; (d) moderate impairment of cognitive and/or emotional status; (e) dependence on medications from which he/she needs to be withdrawn; and (f) the need for 24-hour supervised nursing.

Whether formal or informal programs, they should be comprised of the following dimensions:

• Communication: To ensure positive functional outcomes, communication between the patient, insurer, and all professionals involved must be coordinated and consistent. Any exchange of information must be provided to all professionals, including the patient. Care decisions should be communicated to all and should include the family and/or support system.

• Documentation: Through documentation by all professionals involved and/or discussions with the patient, it should be clear that functional goals are being actively pursued and measured on a regular basis to determine their achievement or need for modification.

• Treatment Modalities: Use of modalities may be necessary early in the process to facilitate compliance with and tolerance to therapeutic exercise, physical conditioning, and increasing functional activities. Active treatments should be emphasized over passive treatments. Active and self-monitored passive treatments should encourage selfcoping skills and management of pain, which can be continued independently at home or at work. Treatments that can foster a sense of dependency by the patient on the caregiver should be avoided. Treatment length should be decided based upon observed functional improvement. For a complete list of active and passive therapies, refer to

Section F.11. Therapy – Active and F.12. Therapy – Passive. All treatment timeframes may be extended based on the patient’s positive functional improvement.

• Therapeutic Exercise Programs: A therapeutic exercise program should be initiated at the start of any treatment rehabilitation. Such programs should emphasize education, independence, and the importance of an on-going exercise regimen. There is good evidence that exercise alone or part of a multi-disciplinary program results in decreased disability for workers with non-acute low back pain. There is not sufficient evidence to support the recommendation of any particular exercise regimen.

• Return to Work: The authorized treating physician should continually evaluate the patient for their potential to return to work. For patients currently employed, efforts should be aimed at keeping them employed. Formal rehabilitation programs should provide assistance in creating work profiles. For more specific information regarding return to work, refer to Section F.10. Return to Work.

• Patient Education: Patients with pain need to re-establish a healthy balance in lifestyle.

All providers should educate patients on how to overcome barriers to resuming daily activity, including pain management, decreased energy levels, financial constraints, decreased physical ability, and change in family dynamics.

• Psychosocial Evaluation and Treatment: Psychosocial evaluation should be initiated, if not previously done. Providers of care should have a thorough understanding of the patient’s personality profile, especially if dependency issues are involved. Psychosocial treatment may enhance the patient’s ability to participate in pain treatment rehabilitation, manage stress, and increase their problem-solving and self-management skills.

• Vocational Assistance: Vocational assistance can define future employment opportunities or assist patients in obtaining future employment. Refer to Section F.10. Return to Work for detailed information.

Interdisciplinary programs are characterized by a variety of disciplines that participate in the assessment, planning, and/or implementation of the treatment program. These programs are for patients with greater levels of perceived disability, dysfunction, de-conditioning, and psychological involvement. Programs should have sufficient personnel to work with the individual in the following areas: behavioral, functional, medical, cognitive, pain management, psychological, social, and vocational.

a. Formal Interdisciplinary Rehabilitation Programs:

i. Interdisciplinary Pain Rehabilitation: An Interdisciplinary Pain Rehabilitation Program provides outcome-focused, coordinated, goal-oriented interdisciplinary team services to measure and improve the functioning of persons with pain and encourage their appropriate use of health care system and services. The program can benefit persons who have limitations that interfere with their physical, psychological, social, and/or vocational functioning. The program shares information about the scope of the services and the outcomes achieved with patients, authorized providers, and insurers.

The interdisciplinary team maintains consistent integration and communication to ensure that all interdisciplinary team members are aware of the plan of care for the patient, are exchanging information, and implement the plan of care. The team members make interdisciplinary team decisions with the patient and then ensure that decisions are communicated to the entire care team.

The Medical Director of the pain program should ideally be board certified in pain management; or he/she should be board certified in his/her specialty area and have completed a one-year fellowship in interdisciplinary pain medicine or palliative care recognized by a national board or have two years of experience in an interdisciplinary pain rehabilitation program. Teams that assist in the accomplishment of functional, physical, psychological, social, and vocational goals must include: a medical director, pain team physician(s), and a pain team psychologist. Professionals from other disciplines on the team may include, but are not limited to: a biofeedback therapist, an occupational therapist, a physical therapist, a registered nurse (RN), a case manager, an exercise physiologist, a psychologist, a psychiatrist, and/or a nutritionist.

• Time to Produce Effect: 3 to 4 weeks.

• Frequency: Full time programs – No less than 5 hours per day, 5 days per week; part-time programs – 4 hours per day, 2–3 days per week.

• Optimum Duration: 3 to 12 weeks at least 2–3 times a week. Follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

• Maximum Duration: 4 months for full-time programs and up to 6 months for part-time programs. Periodic review and monitoring thereafter for 1 year, AND additional follow-up based on the documented maintenance of functional gains.

ii. Occupational Rehabilitation: This is a formal interdisciplinary program addressing a patient’s employability and return to work. It includes a progressive increase in the number of hours per day that a patient completes work simulation tasks until the patient can tolerate a full work day. A full work day is case specific and is defined by the previous employment of the patient. Safe workplace practices and education of the employer and family and/or social support system regarding the person’s status should be included. This is accomplished by addressing the medical, psychological, behavioral, physical, functional, and vocational components of employability and return to work.

There is some evidence that an integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain.

The occupational medicine rehabilitation interdisciplinary team should, at a minimum, be comprised of a qualified medical director who is board certified with documented training in occupational rehabilitation; team physicians having experience in occupational rehabilitation; an occupational therapist; and a physical therapist.

As appropriate, the team may also include any of the following: chiropractor, an RN, a case manager, a psychologist, a vocational specialist, or a certified biofeedback therapist.

• Time to Produce Effect: 2 weeks.

• Frequency: 2 to 5 visits per week, up to 8 hours per day.

• Optimum Duration: 2 to 4 weeks.

• Maximum Duration: 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

iii. Opioid/Chemical Treatment Programs: Refer to the Division’s Chronic Pain Disorder Medical Treatment Guidelines.

b. Informal Interdisciplinary Rehabilitation Program: A coordinated interdisciplinary pain rehabilitation program is one in which the authorized treating physician coordinates all aspects of care. This type of program is similar to the formal programs in that it is goaloriented and provides interdisciplinary rehabilitation services to manage the needs of the patient in the following areas: (a) functional, (b) medical, (c) physical, (d) psychological, (e) social, and (f) vocational.

This program is different from a formal program in that it involves lower frequency and intensity of services/treatment. Informal rehabilitation is geared toward those patients who do not need the intensity of service offered in a formal program or who cannot attend an all-day program due to employment, daycare, language, or other barriers.

Patients should be referred to professionals experienced in outpatient treatment of chronic pain. The Division recommends the authorized treating physician consult with physicians experienced in the treatment of chronic pain to develop the plan of care.

Communication among care providers regarding clear objective goals and progress toward the goals is essential. Employers should be involved in return to work and work restrictions, and the family and/or social support system should be included in the treatment plan. Professionals from other disciplines likely to be involved include: a biofeedback therapist, an occupational therapist, a physical therapist, an RN, a psychologist, a case manager, an exercise physiologist, a psychiatrist, and/or a nutritionist.

• Time to Produce Effect: 3 to 4 weeks.

• Frequency: Full-time programs – No less than 5 hours per day, 5 days per week;

Part-time programs – 4 hours per day for 2–3 days per week.

• Optimum Duration: 3 to 12 weeks at least 2–3 times a week. Follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

• Maximum Duration: 4 months for full-time programs and up to 6 months for parttime programs. Periodic review and monitoring thereafter for 1 year, and additional follow-up based upon the documented maintenance of functional gains.

5. MEDICATIONS

Thrombolytic agents will be required for some vascular TOS conditions.

Medication use is appropriate for pain control in TOS. A thorough medication history, including use of alternative and over the counter medications, should be performed at the time of the initial visit and updated periodically.

Acetaminophen is an effective and safe initial analgesic. Nonsteroidal anti-inflammatory drugs (NSAIDs) are useful in the treatment of inflammation, and for pain control. Pain is subjective in nature and should be evaluated using a scale to rate effectiveness of the analgesic in terms of functional gain. Other medications, including antidepressants and anti-convulsants, may be useful in selected patients with neuropathic and/or chronic pain (Refer to the Division’s Chronic Pain Medical Treatment Guidelines). Opioids are rarely indicated for treatment of TOS, and they should be primarily reserved for the treatment of acute severe pain for a limited time on a caseby-case basis. Topical agents may be beneficial in the management of localized upper extremity pain.

The use of a patient completed pain drawing, visual analog scale (VAS), is highly recommended to help providers track progress. Functional objective goals should be monitored regularly to determine the effectiveness of treatment. The patient should be advised regarding the interaction with prescription and over-the-counter herbal products.

The following medications are listed in alphabetical order:

a. Acetaminophen: An effective analgesic with anti-pyretic but not anti-inflammatory activity. Acetaminophen is generally well-tolerated, causes little or no gastrointestinal (GI) irritation, and is not associated with ulcer formation. Acetaminophen has been associated with liver toxicity in overdose situations or in chronic alcohol use. Patients may not realize that many over-the-counter preparations contain acetaminophen. The total daily dose of acetaminophen is recommended not to exceed three grams per 24-hour period, from all sources, including narcotic-acetaminophen combination preparations.

• Optimum Duration: 7 to 10 days.

• Maximum Duration: Chronic use as indicated on a case-by-case basis. Use of this substance long-term (for 3 days per week or greater) may be associated with rebound pain upon cessation.

b. Anticonvulsants: Although the mechanism of action of anticonvulsant drugs in neuropathic pain states remains to be fully defined, some appear to act as nonselective sodium channel blocking agents. A large variety of sodium channels are present in nervous tissue. Some of these channels are important mediators of nociception, as they are found primarily in unmyelinated fibers and their density increases following a nerve injury. While the pharmacodynamic effects of the various anticonvulsant drugs are similar, the pharmacokinetic effects differ significantly. Gabapentin and pre-gabapentin, by contrast, is a relatively non-significant enzyme inducer, creating fewer drug interactions. Because anticonvulsant drugs may have more problematic side-effect profiles, their use should usually be deferred until tricyclic-related medications have failed to relieve pain. All patients on these medications should be monitored for suicidal ideation.

Carbamazepine has important effects as an inducer of hepatic enzymes and may influence the metabolism of other drugs enough to present problems in patients taking interacting drugs. There is some evidence that oxcarbazepine (Trileptal) may be effective for neuropathic pain, but dose escalation must be done carefully, since there is good evidence that rapid dose titration produces side-effects greater than the analgesic benefits. Carbamazepine is generally not recommended.

There is an association between older anticonvulsants including gabapentin and nontraumatic fractures for patients older than 50, which should be taken into account when prescribing these medications.

i. Gabapentin A) Description – Structurally related to gamma-aminobutyric acid (GABA) but does not interact with GABA receptors.

B) Indications – As of the time of this guideline writing, formulations of gabapentin have been FDA approved for post-herpetic neuralgia and partial seizures.

There is some evidence that gabapentin may benefit some patients with post-traumatic neuropathic pain. There is good evidence that gabapentin is not superior to amitriptyline. There is some evidence that nortriptyline and gabapentin are equally effective for pain relief of post herpetic neuralgia. There is some evidence that gabapentin given with morphine may result in lower side effects from morphine and produces greater analgesia at lower doses than those usually required for either medication alone. There is strong evidence that gabapentin is more effective than placebo for neuropathic pain, even though it provides complete pain relief to a minority of patients. There is some evidence that a combination of gabapentin and nortriptyline provides more effective pain relief than monotherapy with either drug. Given the cost of gabapentin, it is recommended that patients who are medically appropriate receive a trial of tricyclics before use of gabapentin.

C) Relative Contraindications – Renal insufficiency. Dosage may be adjusted to accommodate renal dysfunction.

D) Dosing and Time to Therapeutic Effect – Dosage should be initiated at a low dose in order to avoid somnolence and may require 4 to 8 weeks for titration. Dosage should be adjusted individually.

E) Major Side Effects – Sedation, confusion, dizziness, peripheral edema.

Patients should also be monitored for suicidal ideation and drug abuse.

F) Drug Interactions – antacids.

G) Laboratory Monitoring – Renal function.

ii. Pregabalin A) Description – Structurally related to gamma-aminobutyric acid (GABA) but does not interact with GABA receptors.

B) Indications –As of the time of this guideline writing, formulations of pregabalin have been FDA approved for neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, and fibromyalgia. It may also be an adjunctive therapy for partial-onset seizures.

There is strong evidence that pregabalin has a substantive benefit for a minority, about 25%, of neuropathic pain patients, most of whom report between 30 and 50% relief of symptoms. Given the cost of pregabalin and its response for a minority of patients, it is recommended that patients who are medically appropriate receive a trial of amitriptyline or another first-line agent before use of pregabalin.

C) Contraindications – allergy to medication, prior history of angioedema.

Renal insufficiency is a relative contraindication, requiring a modified dose.

D) Dosing and Time to Therapeutic Effect – Dosage may be increased over several days and doses above 150 mg are usually required. The full benefit may not be achieved for 6 to 8 weeks.

E) Major Side Effects – Dizziness, confusion, sedation, dry mouth, weight gain, and visual changes have been reported. Patients should also be monitored for suicidal ideation and drug abuse. Congestive heart failure may be exacerbated in some patients. Decreased platelets have been reported.

F) Drug Interactions – Opioids, benzodiazepines, and alcohol.

G) Laboratory Monitoring – Renal function, and platelets, and creatinine kinase as appropriate for individual cases.

iii. Topiramate A) Description – Sulfamate substitute monosacchride.

B) Indications – FDA approved for partial seizures or prophylaxis for migraines. There is good evidence that topiramate demonstrates minimal effect on chronic lumbar radiculopathy or other neuropathic pain.

Therefore it is generally not recommended for chronic pain with the exception of chronic, functionally impairing headache. If it is utilized, this would be done as a third or fourth line medication in appropriate patients.

iv. Lamotrigine – This anti-convulsant drug is not FDA approved for use with neuropathic pain. Due to reported deaths from toxic epidermal necrolysis and Stevens-Johnson syndrome, increased suicide risk, and incidents of aseptic meningitis, it is used with caution for patients with seizure or mood disorders.

There is good evidence that lamotrigine is not effective for neuropathic pain and that the potential harms are likely to outweigh the benefits, therefore it is not recommended for most patients.

c. Antidepressants: are classified into a number of categories based on their chemical structure and their effects on neurotransmitter systems. Their effects on depression are attributed to their actions on disposition of norepinephrine and serotonin at the level of the synapse. Although these synaptic actions are immediate, the symptomatic response in depression is delayed by several weeks. When used for chronic pain, the effects may in part arise from treatment of underlying depression, but may also involve additional neuromodulatory effects on endogenous opioid systems, raising pain thresholds at the level of the spinal cord.

Pain responses may occur at lower drug doses with shorter times to symptomatic response than are observed when the same compounds are used in the treatment of mood disorders. Neuropathic pain, diabetic neuropathy, post-herpetic neuralgia, and cancer-related pain may respond to antidepressant doses low enough to avoid adverse effects that often complicate the treatment of depression. First line drugs for neuropathic pain are the tricyclics with the newer formulations having better side effect profiles.

Serotonin Norepinephrine Reuptake Inhibitors (SNRIS) are considered second line drugs due to their costs and the number needed to treat for a response. Selective serotonin reuptake inhibitors (SSRIS) are used generally for depression rather than neuropathic pain and should not be combined with moderate to high-dose tricyclics.

All patients being considered for anti-depressant therapy should be evaluated and continually monitored for suicidal ideation and mood swings.

i. Tricyclics and older agents.

(e.g., amitriptyline, nortriptyline, doxepin.

A) Description – Serotonergics, typically tricyclic antidepressants (TCAs), are utilized for their serotonergic properties as increasing Central Nervous System (CNS) serotonergic tone can help decrease pain perception in non-antidepressant dosages. Amitriptyline is known for its ability to repair Stage 4 sleep architecture, a frequent problem found in chronic pain patients and to treat depression, frequently associated with chronic pain. However, higher doses may produce more cholinergic side effects than newer tricyclics such as nortriptyline and desipramine.

Doxepin and trimipramine also have sedative effects.

B) Indications – Some formulations are FDA approved for depression and anxiety. For the purposes of this guideline, they are recommended for neuropathic pain and insomnia. They are not recommended as a drug treatment for depression. There is good evidence that gabapentin is not superior to amitriptyline. Given the cost of gabapentin, it is recommended that patients who are medically appropriate to undergo a trial of lower cost tricyclic before use of gabapentin.

C) Major Contraindications – Cardiac disease or dysrhythmia, glaucoma, prostatic hypertrophy, seizures, high suicide risk, uncontrolled hypertension and orthostatic hypotension. A screening cardiogram may be done for those 40 or older, especially if higher doses are used.

D) Dosing and Time to Therapeutic Effect – Varies by specific tricyclic. Low dosages, less than 100 mg are commonly used for chronic pain and/or insomnia. Lower doses decrease side effects and cardiovascular risks.

E) Major Side Effects – Side effects vary according to the medication used; however, the side effect profile for all of these medications is generally higher in all areas except GI distress, which is more common among the SSRIs and SNRIs. Anticholinergic side effects include, but not limited to, dry mouth, sedation, orthostatic hypotension, cardiac arrhythmia, urinary retention, and weight gain. Patients should also be monitored for suicidal ideation and drug abuse.

F) Drug Interactions – Tramadol (may cause seizures, both also increase serotonin/norepinephrine, so serotonin syndrome is a concern), clonidine, cimetidine, sympathomimetics, valproic acid, warfarin, carbamazepine, bupropion, anticholinergics, quinolones.

G) Recommended Laboratory Monitoring – Renal and hepatic function.

Electrocardiogram (EKG) for those on high dosages, or with cardiac risk.

ii. Selective serotonin reuptake inhibitors (SSRIs) (e.g., citalopram, fluoxetine, paroxetine, sertraline) are not recommended for neuropathic pain. They may be used for depression.

iii. Selective Serotonin Nor-epinephrine Reuptake Inhibitor (SSNRI)/Serotonin Norepinephrine Reuptake Inhibitors (SNRI).

A) Description – Venlafaxine, duloxetine, and milnacipran.

B) Indications – At the time of this guideline writing, duloxetine has been FDA approved for treatment of diabetic neuropathic pain and chronic musculoskeletal pain. There is good evidence that it is superior to placebo for neuropathic pain at doses of 60mg or 120mg. There is some evidence that it is comparable to pregabalin and gabapentin.

As of the time of this guideline writing, formulations of venlafaxine hydrochloride have been FDA approved for generalized anxiety disorder.

There is some evidence it is modestly effective in diabetic neuropathic pain at doses of 150 to 225 mg. There is no evidence of superiority over tricyclics.

As of the time of this guideline writing, formulations of milnacipran have been FDA approved for treatment of fibromyalgia and has a success rate similar to imipramine. It is not recommended in patients as a first or second line treatment and is reserved for patients who fail other regimes due to side effects.

C) Relative Contraindications – Seizures, eating disorders.

D) Major Side Effects - Depends on the drug, but commonly includes dry mouth, nausea, fatigue, constipation, and abnormal bleeding. Serotonin syndrome is also a risk. GI distress, drowsiness, and sexual dysfunction are less frequent than other classes. Hypertension and glaucoma.

Cardiac issues with venlafaxine and withdrawal symptoms unless tapered. Studies show increased suicidal ideation and attempts in adolescents and young adults. Patients should also be monitored for suicidal ideation and drug abuse.

E) Drug Interactions – Drug specific.

F) Laboratory Monitoring – Drug specific. Hepatic and renal monitoring, venlafaxine may cause cholesterol or triglyceride increases.

iv. Atypical Antidepressants/Other Agents. May be used for depression; however, are not appropriate for neuropathic pain.

d. Muscle Relaxants: Appropriate for objective findings of muscle spasm with pain. When prescribing these agents, physicians must seriously consider all CNS side effects including drowsiness or dizziness and the fact that benzodiazepines may be habitforming. Carisoprodol should not be used as its active metabolite, meprobamate is commonly abused. Chronic use of benzodiazepines or any muscle relaxant is not recommended due to their habit-forming potential, seizure risk following abrupt withdrawal, and documented contribution to deaths of patients on opioids due to respiratory depression. A number of muscle relaxants interact with other medications.

• Optimum Duration: 1 week.

• Maximum Duration: 2 weeks (or longer if used only at night).

e. Nonsterodial Anti Inflammatory Drugs (NSAIDs): Useful for pain and inflammation. In mild cases, they may be the only drugs required for analgesia. There are several classes of NSAIDs, and the response of the individual injured worker to a specific medication is unpredictable. For this reason, a range of NSAIDs may be tried in each case, with the most effective preparation being continued. Patients should be closely monitored for adverse reactions. The FDA advises that many NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. There is good evidence that naproxen has the least risk for cardiovascular events when compared to other NSAIDs. Administration of proton pump inhibitors, Histamine 2 Blockers or prostaglandin analog misoprostol along with these NSAIDs may reduce the risk of duodenal and gastric ulceration, in those at higher risk for this adverse event (e.g. age > 60, concurrent antiplatelet or corticosteroid therapy). They do not impact possible cardiovascular complications. Due to the cross-reactivity between aspirin and NSAIDs, NSAIDs should not be used in aspirin-sensitive patients, and it should be used with caution in all asthma patients. NSAIDs are associated with abnormal renal function, including renal failure and abnormal liver function. Patients with renal or hepatic disease may need increased dosing intervals with chronic acetaminophen use. Chronic use of NSAIDs is generally not recommended due to increased risk of cardiovascular events and GI bleeding.

Certain NSAIDs may have interactions with various other medications. Individuals may have adverse events not listed above. Intervals for metabolic screening are dependent on the patient's age and general health status and should be within parameters listed for each specific medication. Complete Blood Count (CBC) and liver and renal function should be monitored at least every six months in patients on chronic NSAIDs and initially when indicated.

ii. Non-Selective Non-Steroidal Anti-Inflammatory Drugs:

Includes NSAIDs and acetylsalicylic acid (aspirin). Serious GI toxicity, such as bleeding, perforation, and ulceration can occur at any time, with or without warning symptoms, in patients treated with traditional NSAIDs. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur. Anaphylactoid reactions may occur in patients taking NSAIDs. NSAIDs may interfere with platelet function. Fluid retention and edema have been observed in some patients taking NSAIDs.

• Optimum Duration: 1 week.

• Maximum duration: 1 year. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

iii. Selective Cyclo-oxygenase-2 (COX-2) Inhibitors:

COX-2 inhibitors differ from the traditional NSAIDs in adverse side effect profiles.

The major advantages of selective COX-2 inhibitors over traditional NSAIDs are that they have less GI toxicity and no platelet effects. COX-2 inhibitors can worsen renal function in patients with renal insufficiency; thus, renal function may need monitoring.

COX-2 inhibitors should not be first-line for low risk patients who will be using an NSAID short-term, but are indicated in select patients for whom traditional NSAIDs are not tolerated. Serious upper GI adverse events can occur even in asymptomatic patients. Patients at high risk for GI bleed include those who use alcohol, smoke, are older than 65, take corticosteroids or anti-coagulants, or have a longer duration of therapy. Celecoxib is contraindicated in sulfonamide allergic patients.

• Optimal Duration: 7 to 10 days.

• Maximum Duration: Chronic use is appropriate in individual cases. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

f. Opioids: Should be primarily reserved for the treatment of severe upper extremity pain.

There are circumstances where prolonged use of opioids is justified based upon specific diagnosis and in pre- and post–operative patients. In these and other cases, it should be documented and justified. In mild-to-moderate cases of upper extremity pain, opioid medication should be used cautiously on a case-by-case basis. Adverse effects include respiratory depression, the development of physical and psychological dependence, and impaired alertness.

Opioids medications should be prescribed with strict time, quantity, and duration guidelines, and with definitive cessation parameters. Pain is subjective in nature and should be evaluated using a pain scale and assessment of function to rate effectiveness of the opioid prescribed. Any use beyond the maximum should be documented and justified based on the diagnosis and/or invasive procedures. Adverse effects include respiratory depression, impaired alertness, and the development of physical and psychological dependence.

• Optimum Duration: Up to 7 days.

• Maximum Duration: 2 weeks. Use beyond 2 weeks is acceptable in appropriate cases when functional improvement is documented. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guidelines, which give a detailed discussion regarding medication use in chronic pain management. Use beyond 30 days after non-traumatic injuries, or 6 weeks post-surgery after the original injury or post-operatively is not recommended. If necessary, the physician should access the Colorado Prescription Drug Monitoring Program (PDMP) and follow recommendations in the Chronic Pain Guideline. This system allows the prescribing physician to see most of the controlled substances prescribed by other physicians for an individual patient.

6. EDUCATION/INFORMED DECISION MAKING: of the patient and family, as well as the employer, insurer, policy makers and the community should be the primary emphasis in the treatment of TOS pain and disability. Unfortunately, practitioners often think of education and informed decision making last, after medications, manual therapy, and surgery.

Informed decision making is the hallmark of a successful treatment plan. In most cases, the continuum of treatment from the least invasive to the most invasive (e.g. surgery) should be discussed. The intention is to find the treatment along this continuum that most completely addresses the condition. Patients should identify their personal functional goals of treatment at the first visit. It is recommended that specific individual goals are articulated at the beginning of treatment as this is likely to lead to increased patient satisfaction above that achieved from improvement in pain or other physical function. Progress toward the individual functional goals identified should be addressed at follow up visits and throughout treatment by other members of the health care team as well as the authorized physicians.

Documentation of this process should occur whenever diagnostic tests or referrals from the authorized treating physician are contemplated. The informed decision making process asks the patient to set their personal functional goals of treatment, describe their current health status and any concerns regarding adhering to the diagnostic or treatment plan proposed. The provider should clearly describe the following:

• The expected functional outcomes from the proposed treatment, or expected results and plan of action if diagnostic tests are involved.

• Any side effects and risks to the patient.

• Required post treatment rehabilitation time and impact on work, if any.

• Alternative therapies or diagnostic testing.

Before diagnostic tests or referrals for invasive treatment take place the patient should be able to clearly articulate the goals of the intervention, the general side effects and risks associated with it and their decision regarding compliance with the suggested plan. There is some evidence that information provided only by video is not sufficient education:

Practitioners must develop and implement an effective strategy and skills to educate patients, employers, insurance systems, policy makers, and the community as a whole. An educationbased paradigm should always start with providing reassuring information to the patient and informed decision making. More in-depth education currently exists within a treatment regimen employing functional restoration, prevention, and cognitive behavioral techniques. Patient education and informed decision making should facilitate self-management of symptoms and prevention.

• Time to produce effect: Varies with individual patient • Frequency: Should occur at every visit.

7. PERSONALITY/PSYCHOSOCIAL/PSYCHOLOGICAL INTERVENTION: Psychosocial treatment is a well-established therapeutic and diagnostic intervention with selected use in acute pain problems and more widespread use in sub-acute and chronic pain populations. Psychosocial treatment is recommended as an important component in the total management of a patient with chronic pain and should be implemented as soon as the problem is identified.

If a diagnosis consistent with the standards of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM) has been determined, the patient should be evaluated for the potential need for psychiatric medications. Use of any medication to treat a diagnosed condition may be ordered by the authorized treating physician or by the consulting psychiatrist. Visits for management of psychiatric medications are medical in nature and are not a component of psychosocial treatment. Therefore, separate visits for medication management may be necessary, depending on the patient and medications selected.

Psychosocial interventions include psychotherapeutic treatments for mental health conditions, as well as behavioral medicine treatments. These interventions may similarly be beneficial for patients without psychiatric conditions, but who may need to make major life changes in order to cope with pain or adjust to disability. Examples of these treatments include cognitive behavioral therapy (CBT), relaxation training, mindfulness training, and sleep hygiene training.

The screening or diagnostic workup should clarify and distinguish between pre-existing, aggravated, and/or purely causative psychological conditions. Therapeutic and diagnostic modalities include, but are not limited to, individual counseling and group therapy. Treatment can occur within an individualized model, a multi-disciplinary model, or a structured pain management program.

A psychologist with a PhD, PsyD, EdD credentials, or a psychiatric MD/DO may perform psychosocial treatments. Other licensed mental health providers or licensed health care providers with training in CBT, or certified as CBT therapists who have experience in treating chronic pain disorders in injured workers, may also perform treatment in consultation with a PhD, PsyD, EdD, or psychiatric MD/DO.

CBT refers to a group of psychological therapies that are sometimes referred to by more specific names, such as Rational Emotive Behavior Therapy, Rational Behavior Therapy, Rational Living Therapy, Cognitive Therapy, and Dialectic Behavior Therapy. Variations of CBT methods can be used to treat a variety of conditions, including chronic pain, depression, anxiety, phobias, and post-traumatic stress disorder (PTSD). For patients with multiple diagnoses, more than one type of CBT might be needed. The CBT used in research studies is often “manualized CBT,” meaning that the treatment follows a specific protocol in a manual. In clinical settings, CBT may involve the use of standardized materials, but it is also commonly adapted by a psychologist or psychiatrist to the patient’s unique circumstances. If the CBT is being performed by a non-mental health professional, a manual approach would be strongly recommended. CBT must be distinguished from neuropsychological therapies used to teach compensatory strategies to brain injured patients, which are also called “cognitive therapy.”

It should be noted that most clinical trials on CBT exclude subjects who have significant psychiatric diagnoses. Consequently, the selection of patients for CBT should include the following considerations. CBT is instructive and structured, using an educational model with homework to teach inductive rational thinking. Because of this educational model, a certain level of literacy is assumed for most CBT protocols. Patients who lack the cognitive and educational abilities required by a CBT protocol are unlikely to be successful. Further, given the highly structured nature of CBT, it is more effective when a patient’s circumstances are relatively stable.

For example, if a patient is about to be evicted, is actively suicidal, or is coming to sessions intoxicated, these matters will generally preempt CBT treatment for pain, and require other types of psychotherapeutic response. Conversely, literate patients whose circumstances are relatively stable, but who catastrophize or cope poorly with pain or disability are often good candidates for CBT for pain. Similarly, literate patients whose circumstances are relatively stable, but who exhibit unfounded medical phobias, are often good candidates for CBT for anxiety.

There is good evidence that cognitive intervention reduces low back disability in the short term and in the long term. In one of the studies, the therapy consisted of 6, 2-hour sessions given weekly to workers who had been sick-listed for 8-12 weeks. Comparison groups included those who received routine care. There is good evidence that psychological interventions, especially CBT, are superior to no psychological intervention for chronic low back pain, and that selfregulatory interventions, such as biofeedback and relaxation training, may be equally effective.

There is good evidence that six group therapy sessions lasting one and a half hours each focused on CBT skills improved function and alleviated pain in uncomplicated sub-acute and chronic low back pain patients. There is some evidence that CBT provided in seven two-hour small group sessions can reduce the severity of insomnia in chronic pain patients. A Cochrane meta-analysis grouped very heterogenous behavioral interventions and concluded that there was good evidence that CBT may reduce pain and disability but the effect size was uncertain. In total, the evidence clearly supports CBT, and it should be offered to all chronic pain patents who do not have other serious issues, as discussed above.

CBT is often combined with active therapy in an interdisciplinary program, whether formal or informal. It must be coordinated with a psychologist or psychiatrist. CBT can be done in a small group or individually, and the usual number of treatments varies between 8 and16 sessions.

Before CBT is done, the patient must have a full psychological evaluation. The CBT program must be done under the supervision of a PhD, PsyD, EdD, or psychiatric MD/DO.

Psychological Diagnostic and Statistical Manual of Mental Disorders (DSM) Axis I disorders are common in chronic pain. One study demonstrated that the majority of patients who had failed other therapy and participated in an active therapy program also suffered from major depression.

However, in a program that included CBT and other psychological counseling, the success rate for return to work was similar for those with and without a DSM IV diagnosis. This study further strengthens the argument for having some psychological intervention included in all chronic pain treatment plans.

For all psychological/psychiatric interventions, an assessment and treatment plan with measurable behavioral goals, time frames, and specific interventions planned, must be provided to the treating physician prior to initiating treatment. A status report must be provided to the authorized treating physician every two weeks during initial more frequent treatment and monthly thereafter. The report should provide documentation of progress toward functional recovery and a discussion of the psychosocial issues affecting the patient’s ability to participate in treatment. The report should also address pertinent issues such as pre-existing, aggravated, and/or causative issues, as well as realistic functional prognosis.

a. Cognitive Behavioral Therapy (CBT) or Similar Treatment:

• Time to Produce Effect: 6 to 8 1–2 hour session, group or individual (1-hour individual or 2-hour group).

• Maximum Duration: 16 sessions.

NOTE: Before CBT is done, the patient must have a full psychological evaluation. The CBT program must be done under the supervision of a PhD, PsyD, EdD, or Psychiatric MD/DO.

b. Other Psychological/Psychiatric Interventions:

• Time to Produce Effect: 6 to 8 weeks.

• Frequency: 1 to 2 times weekly for the first 2 weeks (excluding hospitalization, if required), decreasing to 1 time per week for the second month. Thereafter, 2 to 4 times monthly with the exception of exacerbations, which may require increased frequency of visits. Not to include visits for medication management • Optimum Duration: 2 to 6 months.

• Maximum Duration: 6 months. Not to include visits for medication management.

For select patients, longer supervised psychological/psychiatric treatment may be required, especially if there are ongoing medical procedures or complications. If counseling beyond 6 months is indicated, the management of psychosocial risks or functional progress must be documented. Treatment plan/progress must show severity.

8. RESTRICTION OF ACTIVITIES: Continuation of normal daily activities is the recommendation for most patients since immobility will negatively affect rehabilitation. Prolonged immobility results in a wide range of deleterious effects, such as a reduction in aerobic capacity and conditioning, loss of muscle strength and flexibility, increased segmental stiffness, promotion of bone demineralization, impaired disc nutrition, and the facilitation of the illness role. Mobility is generally therapeutic and should be encouraged. Activity should be increased based on the improvement of core strengthening.

Patients should be educated regarding the detrimental effects of immobility versus the efficacious use of limited rest periods. Adequate rest allows the patient to comply with active treatment and benefit from the rehabilitation program. In addition, complete work cessation should be avoided, if possible, since it often further aggravates the pain presentation and promotes disability. Modified return to work is almost always more efficacious and rarely contraindicated in the vast majority of injured workers.

9. RETURN-TO-WORK: Return to work and/or work-related activities whenever possible is one of the major components in treatment and rehabilitation. Return to work is a subject that should be addressed by each workers’ compensation provider at the first meeting with the injured employee and updated at each additional visit. A return-to-work format should be part of a company’s health plan, knowing that return to work can decrease anxiety, reduce the possibility of depression, and reconnect the worker with society.

Because a prolonged period of time off work will decrease the likelihood of return to work, the first weeks of treatment are crucial in preventing and/or reversing chronicity and disability mindset. In complex cases, experienced nurse case managers may be required to assist in return to work.

Other services, including psychological evaluation and/or treatment, jobsite analysis, and vocational assistance, may be employed.

Two counseling sessions with an occupational physician, and work site visit if necessary, may be helpful for workers who are concerned about returning to work.

At least one study suggest that health status is worse for those who do not return to work than those who do. Self-employment and injury severity predict return to work. Difficulty with pain control, activities of daily living (ADLs), and anxiety and depression were common.

The following should be considered when attempting to return an injured worker with chronic pain to work.

a. Job History Interview: The authorized treating physician should perform a job history interview at the time of the initial evaluation and before any plan of treatment is established. Documentation should include the workers’ job demands, stressors, duties of current job, and duties of job at the time of the initial injury. In addition, cognitive and social issues should be identified, and treatment of these issues should be incorporated into the plan of care.

b. Coordination of Care: Management of the case is a significant part of return to work and may be the responsibility of the authorized treating physician, occupational health nurse, risk manager, or others. Case management is a method of communication between the primary provider, referral providers, insurer, employer, and employee. Because case management may be coordinated by a variety of professionals, the case manager should be identified in the medical record.

c. Communication: This is essential between the patient, authorized treating physician, employer, and insurer. Employers should be contacted to verify employment status, job duties and demands, and policies regarding injured workers. In addition, the availability and duration of temporary and permanent restrictions, as well as other placement options, should be discussed and documented. All communications in the absence of the patient are required to be documented and made available to the patient.

d. Establishment of Return-to-Work Status: Return to work for persons with chronic pain should be considered therapeutic, assuming that work is not likely to aggravate the basic problem or increase the discomfort. In most cases of chronic pain, the worker may not be currently working or even employed. The goal of return to work would be to implement a plan of care to return the worker to any level of employment with the current employer or to return him/her to any type of new employment. Temporary restrictions may be needed while recommended ergonomic or adaptive equipment is obtained; employers should obtain recommended equipment in a timely manner.

e. Establishment of Activity Level Restrictions: A formal job description for the injured worker is necessary to identify physical demands at work and assist in the creation of modified duty. A jobsite evaluation may be utilized to identify applicable tasks such as pushing, pulling, lifting, reaching, grasping, pinching, sitting, standing, posture, ambulatory distance and terrain, and if applicable, environment for temperature, air flow, noise, and the number of hours that may be worked per day. Due to the lack of predictability regarding exacerbation of symptoms affecting function, an extended, occupationally focused functional capacity evaluation may be necessary to determine the patient’s tolerance for job type tasks over a continued period of time. Job requirements should be reviewed for the entire 8 hours or more of the working day. Between one and three days after the evaluation, there should be a follow-up evaluation by the treating therapist and/or the authorized treating physician to assess the patient’s status. When prescribing the FCE, the physician must assess the probability of return to work against the potential for exacerbation of the work-related condition. Work restrictions assigned by the authorized treating physician may be temporary or permanent. The case manager should continue to seek out modified work until restrictions become less cumbersome or as the worker’s condition improves or deteriorates.

f. Rehabilitation and Return to Work: As part of rehabilitation, every attempt should be made to simulate work activities so that the authorized treating physician may promote adequate job performance. The use of ergonomic or adaptive equipment, therapeutic breaks, and interventional modalities at work may be necessary to maintain employment.

g. Vocational Assistance: Formal vocational rehabilitation is a generally accepted intervention and can assist disabled persons to return to viable employment. Assisting patients to identify vocational goals will facilitate medical recovery and aid in the achievement of MMI by (1) increasing motivation towards treatment and (2) alleviating the patient’s emotional distress. Physically limited patients will benefit most if vocational assistance is provided during the interdisciplinary rehabilitation phase of treatment. To assess the patient’s vocational capacity, a vocational assessment utilizing the information from occupational and physical therapy assessments may identify rehabilitation program goals. This assessment also may optimize both patient motivation and utilization of rehabilitation resources. This may be extremely helpful in decreasing the patient’s fear regarding an inability to earn a living, which can add to his/her anxiety and depression.

Recommendations to Employers and Employees of Small Businesses: employees of small businesses who are diagnosed with chronic pain may not be able to perform any jobs for which openings exist. Temporary employees may fill those slots while the employee functionally improves. Some small businesses hire other workers, and if the injured employee returns to the job, the supervisor/owner may have an extra employee.

To avoid this, it is suggested that case managers be accessed through their payer or third-party administrator. Case managers may assist with resolution of these problems, as well as assist in finding modified job tasks, or find jobs with reduced hours, etc., depending on company philosophy and employee needs.

Recommendations to Employers and Employees of Mid-sized and Large Businesses:

Employers are encouraged by the Division to identify modified work within the company that may be available to injured workers with chronic pain who are returning to work with temporary or permanent restrictions. To assist with temporary or permanent placement of the injured worker, it is suggested that a program be implemented that allows the case manager to access descriptions of all jobs within the organization.

10. THERAPY-ACTIVE The following active therapies are widely used and accepted methods of care for a variety of work-related injuries. They are based on the philosophy that therapeutic exercise and/or activity are beneficial for restoring flexibility, strength, endurance, function, range of motion, and can alleviate discomfort. Active therapy requires physical effort by the individual to complete a specific exercise or task. This form of therapy requires supervision from a therapist or medical provider such as verbal, visual, and/or tactile instruction(s). At times, the provider may help stabilize the patient or guide the movement pattern but the energy required to complete the task is predominately executed by the patient.

Abnormal posture, head tilting forward and scapular dyskinesia are frequently contributors to thoracic outlet symptoms. These tip the scapula anteriorly, altering motor control of the scapulothoracic and glenohumeral articulations. The most noticeable feature is prominence of the inferior angle of the scapula. Dysfunction of the pectoralis minor and other scapular muscles places the acromion closer to the rotator cuff and humeral head, compromising the subacromial space. The altered relations of length and tension of the deltoid and cuff muscles results in poor motor control of the humerus on the glenoid fossa.

The use and integration of active and passive therapies should be directed at addressing impairments found in the clinical examination which may include abnormal posture, head tilting forward, scapula dyskinesia and joint/tissue hypomobility/hypermobility. These clinical findings are frequently contributors to the thoracic outlet symptoms and many times result in scapula anterior tipping and altered motor control of the scapula/thoracic and glenohumeral joints. In this classification of scapula dysfunction, the primary external visual feature is the anterior tilting of the scapula in the sagittal plane which produces the prominent inferior angle of the scapula. Many times the anterior tilting is associated with shortening of the pectoralis minor and poor function of the scapula muscles controlling the inferior angle. This myofascial and scapula dysfunction places the acromion in a position closer to the rotator cuff and humeral head and can thereby compromise the subacromial space. Additionally, this resultant scapula dyskinesia disrupts the length tension relationships of the shoulder complex’s static and dynamic constraints and subsequently facilitates poor humeral head positioning on the glenoid. (The static constraints are the glenohumeral ligaments and the dynamic constraints are the deltoid and cuff musculature.)

Therefore the treatment of this scapula dyskinesia and myofascial dysfunction is important for restoration of the normal upper quarter function.

The healthy function of the upper body is inextricably dependent on the proper function and balanced relationships with its neighboring structures: cervical, thoracic, costal, when one acknowledges the role of fascia, particularly the thoracodorsal fascia. Therefore, effective and expedient rehabilitation requires providers to have an excellent understanding of the functional anatomy of these structures and their dynamic inter-relatedness. Shoulder injuries are complex.

Successful treatment of these injuries requires the providers to have expert skills. Collaboration is essential in achieving optimal outcomes.

Patients should be instructed to continue active therapies at home as an extension of the treatment process in order to maintain improvement levels. Follow-up visits to reinforce and monitor progress and proper technique are recommended. Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices.

The use of a patient completed pain drawing, VAS, and functional outcome tools is highly recommended to help providers track progress. Functional objective goals including minimum clinically important difference (MCID) of the functional tools should be monitored and documented regularly to determine the effectiveness of treatment.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as “maximum.” Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care and comorbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. It is recommended that, if no functional gain is observed after the number of treatments under “time to produce effect” have been completed, then alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

The following active therapies are listed in alphabetical order:

a. Activities of Daily Living (ADL): are well-established interventions which involve instruction, active-assisted training, and/or adaptation of activities or equipment to improve a person's capacity in normal daily activities such as self-care, work reintegration training, homemaking, and driving.

• Time to Produce Effect: 4 to 5 treatments.

• Frequency: 3 to 5 times per week.

• Optimum Duration: 4 to 6 weeks.

• Maximum Duration: 6 weeks.

b. Aquatic Therapy: is a well-accepted treatment which consists of using aquatic immersion for therapeutic exercise to promote range-of-motion, core stabilization, endurance, flexibility, strengthening, body mechanics, and pain management. Aquatic therapy includes the implementation of active therapeutic procedures in a swimming or therapeutic pool. The water provides a buoyancy force that lessens the amount of force gravity applies to the body. The decreased gravity effect allows the patient to have a mechanical advantage and more likely have a successful trial of therapeutic exercise.

Literature has shown that the muscle recruitment for aquatic therapy versus similar nonaquatic motions is significantly less. Because there is always a risk of recurrent or additional damage to the muscle tendon unit after a surgical repair, aquatic therapy may be preferred by surgeons to gain early return of range of motion. In some cases, the patient will be able to do the exercises unsupervised after the initial supervised session.

Parks and recreation contacts may be used to develop less expensive facilities for patients. Indications include:

• Postoperative therapy as ordered by the surgeon; or • Intolerance for active land-based or full-weight bearing therapeutic procedures; or • Symptoms that are exacerbated in a dry environment; and • Willingness to follow through with the therapy on a regular basis.

The pool should be large enough to allow full extremity range of motion and fully erect posture. Aquatic vests, belts, snorkels, and other devices may be used to provide stability, balance, buoyancy, and resistance.

• Time to Produce Effect: 4 to 5 treatments.

• Frequency: 3 to 5 times per week.

• Optimum Duration: 4 to 6 weeks.

• Maximum Duration: 8 weeks.

A self-directed program is recommended after the supervised aquatics program has been established, or, alternatively a transition to a self-directed dry environment exercise program.

c. Functional Activities: are well-established interventions which involve the use of therapeutic activity to enhance mobility, body mechanics, employability, coordination, balance, and sensory motor integration.

• Time to Produce Effect: 4 to 5 treatments.

• Frequency: 3 to 5 times per week.

• Optimum Duration: 4 to 6 weeks.

• Maximum Duration: 6 weeks.

d. Nerve Gliding: is an accepted therapy for TOS. Nerve gliding exercises consist of a series of gentle movements of the neck, shoulder and arm that produce longitudinal movement along the length of the nerves of the upper extremity. These exercises are based on the principle that the tissues of the peripheral nervous system are designed for movement, and glide (excursion) of nerves may have an effect on neurophysiology through alterations in vascular and axoplasmic flow. Biomechanical principles have been more thoroughly studied than clinical outcomes. The exercises should be done by the patient after proper instruction and monitoring by the therapist.

• Time to Produce Effect: 2 to 4 weeks.

• Frequency: Up to 5 times per day by patient (patient-initiated).

• Optimum Duration: 4 to 6 sessions.

• Maximum Duration: 6 to 8 sessions.

e. Neuromuscular Re-education: is a generally accepted treatment. Neuromuscular reeducation is the skilled application of exercise with manual, mechanical, or electrical facilitation to enhance strength, movement patterns, neuromuscular response, proprioception, kinesthetic sense, coordination, education of movement, balance, and posture. Changes in posture and scapula movements are important to restore normal upper quarter movements and minimize thoracic outlet symptoms. Indications include the need to promote neuromuscular responses through carefully timed proprioceptive stimuli to elicit and improve motor activity in patterns similar to normal neurologically developed sequences and improve neuromotor response with independent control. Muscles that should be targeted for correct timing and recruitment include the serratus anterior, upper trapezius, lower trapezius, and middle trapezius. Accessory stabilizers including the rhomboids, latissimus dorsi and levator scapula should also be addressed to assist with scapula setting. Normal scapula positioning and movements should be the goal of the neuromuscular re-education. Furthermore, the limitations in flexibility and motor control of the pectoralis minor are a common incriminator with this type of dysfunction.

• Time to Produce Effect: 2 to 6 treatments.

• Frequency: 3 times per week.

• Optimum Duration: 4 to 8 weeks.

• Maximum Duration: 8 weeks. Additional visits may be necessary in cases of reinjury, interrupted continuity of care, exacerbation of symptoms, and in those patients with comorbidities. Functional gains including increased range of motion f. Therapeutic Exercise: is a generally well-accepted treatment. Therapeutic exercise with or without mechanical assistance or resistance, may include manual facilitation, isoinertial, isotonic, isometric and isokinetic types of exercises. The exact type of program and length of therapy should be determined by the treating physician with the physical or occupational therapist. In most cases the therapist instructs the patient in a supervised clinic and home program to increase motion with tissue elasticity and subsequently increase strength and endurance. Usually, manual therapy is performed initially to assure correct muscle activation followed by isometrics and progressing to isotonic exercises as tolerated.

• Time to Produce Effect: 2 to 6 treatments.

• Frequency: 2 to 3 times per week.

• Optimum Duration: 16 to 24 sessions.

• Maximum Duration: 36 sessions. Additional visits may be necessary in cases of re-injury, interrupted continuity of care, exacerbation of symptoms, and in those patients with comorbidities. Functional gains including increased range of motion 11. THERAPY – PASSIVE:

The following passive therapies and modalities are generally accepted methods of care for a variety of work-related injuries. Passive therapy includes those treatment modalities that do not require energy expenditure on the part of the patient. They are principally effective during the early phases of treatment and are directed at controlling symptoms such as pain, inflammation and swelling and to improve the rate of healing soft tissue injuries. They should be used adjunctively with active therapies such as postural stabilization and exercise programs to help control swelling, pain and inflammation during the rehabilitation process. Please refer to Section B.4, General Guidelines Principles, Active Interventions. Passive therapies may be used intermittently as a therapist deems appropriate or regularly if there are specific goals with objectively measured functional improvements during treatment.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as “maximum.” Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care and comorbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. It is recommended that, if no functional gain is observed after the number of treatments under “time to produce effect” has been completed, alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

The following passive therapies and modalities are listed in alphabetical order.

a. Electrical Stimulation (Unattended): is an accepted treatment. Once applied, electrical stimulation (unattended) requires minimal on-site supervision by the physical therapists, occupational therapist or other provider. Indications include pain, inflammation, muscle spasm, atrophy, decreased circulation, and the need for osteogenic stimulation. A home unit should be purchased if treatment is effective and frequent use is recommended.

• Time to Produce Effect: 2 to 4 treatments.

• Frequency: Varies, depending upon indication, between 2 to 3 times/day to 1 time/week.

• Optimum Duration: 1 month.

• Maximum Duration: Use beyond 6 weeks requires a home unit.

b. Iontophoresis: is an accepted treatment which consists of the transfer of medication, including, but not limited to, steroidal anti-inflammatories and anesthetics, through the use of electrical stimulation. Indications include pain (Lidocaine), inflammation (hydrocortisone, salicylate, dexamethasone), edema (mecholyl, hyaluronidase, and salicylate), ischemia (magnesium, mecholyl, and iodine), muscle spasm (magnesium, calcium), calcifying deposits (acetate), scars, and keloids (sodium chloride, iodine, acetate). An experimental study with healthy human volunteers showed that an iontophoretic preparation of dexamethasone phosphate penetrated up to a depth of 12 mm, but even after 400 minutes following iontophoresis, half of the dexamathasone had penetrated no deeper than 2 mm. Iontophoresis appears to be effective only in superficial tissues. Per the Colorado Physical Therapy Practice Act, referring physician must write a prescription for medication, and the individual must bring the medication (not the prescription for medication) to the treating therapist for use in iontophoresis.

• Time to Produce Effect: 1 to 4 treatments.

• Frequency: 3 times per week with at least 48 hours between treatments.

• Optimum Duration: 8 to 10 treatments.

• Maximum Duration: 10 treatments.

c. Manipulation: is a generally accepted treatment. Manipulative treatment (not therapy) is defined as the therapeutic application of manually guided forces by an operator to improve physiologic function and/or support homeostasis that has been altered by the injury or occupational disease, and has associated clinical significance.

High velocity, low amplitude (HVLA) technique, chiropractic manipulation, osteopathic manipulation, muscle energy techniques, counter strain, and non-force techniques are all types of manipulative treatment. This may be applied by osteopathic physicians (D.O.), chiropractors (D.C.), properly trained physical therapists (P.T.), properly trained occupational therapists (O.T.), or properly trained medical physicians. Under these different types of manipulation exist many subsets of different techniques that can be described as a) direct- a forceful engagement of a restrictive/pathologic barrier, b) indirect- a gentle/non-forceful disengagement of a restrictive/pathologic barrier, c) the patient actively assisting in the treatment and d) the patient relaxing, allowing the practitioner to move the body tissues. When the proper diagnosis is made and coupled with the appropriate technique, manipulation has no contraindications and can be applied to all tissues of the body. Pre-treatment assessment should be performed as part of each manipulative treatment visit to ensure that the correct diagnosis and correct treatment is employed. Mobilization may be directed at the first rib and the scapula.

• Time to produce effect for all types of manipulative treatment: 1 to 6 treatments.

• Frequency: Up to 3 times per week for the first 3 weeks as indicated by the severity of involvement and the desired effect.

• Optimum Duration: 10 treatments.

• Maximum Duration: 12 treatments. Additional visits may be necessary in cases of re-injury, interrupted continuity of care, exacerbation of symptoms, and in those patients with comorbidities. Functional gains including increased range of motion d. Massage-Manual or Mechanical: is a generally well-accepted treatment Massage is manipulation of soft tissue with broad ranging relaxation and circulatory benefits. This may include stimulation of acupuncture points and acupuncture channels (acupressure), application of suction cups and techniques that include pressing, lifting, rubbing, pinching of soft tissues by, or with the practitioner’s hands. Indications include edema (peripheral or hard and non-pliable edema), muscle spasm, adhesions, the need to improve peripheral circulation and range of motion, or to increase muscle relaxation and flexibility prior to exercise. In cases with edema, deep vein thrombosis should be ruled out prior to treatment.

• Time to Produce Effect: Immediate.

• Frequency: 1 to 2 times per week.

• Optimum Duration: 6 weeks.

• Maximum Duration: 2 months.

e. Mobilization (Joint): is a generally well-accepted treatment. Mobilization is passive movement, which may include passive range of motion performed in such a manner (particularly in relation to the speed of the movement) that it is, at all times, within the ability of the patient to prevent the movement if they so choose. It may include skilled manual joint tissue stretching. Indications include the need to improve joint play, improve intracapsular arthrokinematics, or reduce pain associated with tissue impingement.

Mobilization may be directed at the first rib and the scapula.

• Time to Produce Effect: 6 to 9 treatments.

• Frequency: 3 times per week.

• Optimum Duration: 6 weeks.

• Maximum Duration: 2 months.

f. Mobilization (Soft Tissue): is a generally well-accepted treatment. Mobilization of soft tissue is the skilled application of muscle energy, strain/counter strain, myofascial release, manual trigger point release and manual therapy techniques designed to improve or normalize movement patterns through the reduction of soft tissue pain and restrictions. These can be interactive with the patient participating or can be with the patient relaxing and letting the practitioner move the body tissues. Indications include muscle spasm around a joint, trigger points, adhesions, and neural compression.

Mobilization should be accompanied by active therapy.

• Time to Produce Effect: 2 to 3 weeks.

• Frequency: 2 to 3 times per week.

• Optimum Duration: 4 to 6 weeks.

• Maximum Duration: 6 weeks.

g. Superficial Heat and Cold Therapy: is a generally accepted treatment. Superficial heat and cold therapies are thermal agents applied in various manners that lower or raise the body tissue temperature for the reduction of pain, inflammation, and/or effusion resulting from injury or induced by exercise. It may be used acutely with compression and elevation. Indications include acute pain, edema and hemorrhage, need to increase pain threshold, reduce muscle spasm and promote stretching/flexibility. Includes portable cryotherapy units and application of heat just above the surface of the skin at acupuncture points.

• Time to Produce Effect: Immediate.

• Frequency: 2 to 5 times per week.

• Optimum Duration: 3 weeks as primary, or up to 2 months if used intermittently as an adjunct to other therapeutic procedures.

• Maximum Duration: 2 months.

h. Transcutaneous Electrical Nerve Stimulation (TENS): is a generally accepted treatment and should include at least one instructional session for proper application and use. Indications include muscle spasm, atrophy, and decreased circulation and pain control. Minimal TENS unit parameters should include pulse rate, pulse width and amplitude modulation. Consistent, measurable functional improvement must be documented prior to the purchase of a home unit.

• Time to Produce Effect: Immediate.

• Frequency: Variable.

• Optimum Duration: 3 sessions.

• Maximum Duration: 3 sessions. If beneficial, provide with home unit or purchase if effective.

i. Ultrasound (including Phonophoresis): is an accepted treatment and includes ultrasound with electrical stimulation and phonophoresis. Ultrasound uses sonic generators to deliver acoustic energy for therapeutic thermal and/or non-thermal soft tissue effects. Indications include scar tissue, adhesions, and muscle spasm, and the need to extend muscle tissue or accelerate the soft tissue healing.

Ultrasound with electrical stimulation is concurrent delivery of electrical energy that involves a dispersive electrode placement. Indications include muscle spasm, scar tissue, pain modulation, and muscle facilitation.

Phonophoresis is the transfer of medication to the target tissue to control inflammation and pain through the use of sonic generators. These topical medications include, but are not limited to, steroidal anti-inflammatory and anesthetics.

• Time to Produce Effect: 6 to 15 treatments.

• Frequency: 3 times per week.

• Optimum Duration: 4 to 8 weeks.

• Maximum Duration: 2 months.

12. VOCATIONAL REHABILITATION: is a generally accepted intervention, but Colorado limits its use as a result of Senate Bill 87-79. Initiation of vocational rehabilitation requires adequate evaluation of patients for quantification highest functional level, motivation and achievement of maximum medical improvement. Vocational rehabilitation may be as simple as returning to the original job or as complicated as being retrained for a new occupation.

It may also be beneficial for full vocational rehabilitation to be started before MMI if it is evident that the injured worker will be unable to return to his/her previous occupation. A positive goal and direction may aid the patient in decreasing stress and depression, and promote optimum rehabilitation.

G. THERAPEUTIC PROCEDURES - OPERATIVE

All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic condition(s). It is imperative to rule out non-physiologic modifiers of pain presentation or non-operative conditions mimicking operative conditions (e.g., peripheral neuropathy, myofascial pain, scleratogenous or sympathetically mediated pain syndromes, psychological), prior to consideration of elective surgical intervention. Operative procedures are only appropriate for Neurogenic or Vascular TOS as defined below. Patients with thoracic outlet symptoms due to myofascial issues are not surgical candidates.

In addition, operative treatment is indicated when the natural history of surgically treated lesions is better than the natural history for non-operatively treated lesions. All patients being considered for surgical intervention should first undergo a comprehensive neuro-musculoskeletal examination to identify mechanical pain generators that may respond to non-surgical techniques or may be refractory to surgical intervention.

Structured rehabilitation interventions should be strongly considered post-operative in any patient not making expected functional progress within three weeks post-operative.

Post-operative therapy will frequently require a repeat of the therapy provided pre-operatively. Refer to

Section F. Therapeutic Procedures, Non-operative, and consider the first post-operative visit as visit number one, for the time frame parameters provided.

Return-to-work restrictions should be specific according to the recommendation in Section F.10, Therapeutic Procedures – Non-operative.

The patient and treating physician must identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work activities. The patient should agree to comply with the pre- and post-operative treatment plan, including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative treatment required and the length of partial- and full-disability expected post-operatively. The patient should have committed to the recommended post-operative treatment plan and fully completed the recommended active, manual and pre-operative treatment plans.

Informed decision making should be documented for all invasive procedures. This must include a thorough discussion of the pros and cons of the procedure and the possible complications as well as the natural history of the identified diagnosis. Since most patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make wellinformed decisions regarding their treatment.

1. NON-VASCULAR DIAGNOSTIC CRITERIA FOR SURGICAL PROCEDURES:

a. Neurogenic TOS:

i. Clinical: at least two consistent clinical signs plus symptoms consistent with TOS (Refer to Section D. Initial Diagnostic Procedures).

ii. Neurophysiologic: meets criteria for neurogenic TOS (Refer to Section E.2.a Electromyography/Nerve Conduction Velocities (EMG/NCV)).

iii. The following diagnoses may present similarly to TOS and should be investigated and eliminated to establish the diagnosis: Cervical herniated disc or spondylosis, complex regional pain syndrome, other peripheral nerve disorders or brachial plexus neuritis, tumors or space occupying lesions, cervical dystonia, opioid hyperalgesia, and shoulder conditions.

b. Pectoralis Minor Syndrome without TOS:

Compression of the neurovascular bundle by the pectoralis muscle. This syndrome, described by a few authors, is usually caused by neck or shoulder trauma and generally resolves with physical therapy.

i. Clinical: Patients do not meet criteria for neurogenic TOS. They generally have pain over the anterior chest wall near the pectoralis minor and into the axilla, arm, and forearm. They may complain of paresthesia or weakness, and have fewer complaints of headache, neck or shoulder pain. On physical exam there is tenderness with palpation over the pectoralis minor and in the axilla which reproduces the patient’s symptoms in the arm. Disabling symptoms have been present for more than 3 months despite active participation in an appropriate therapy program and alternative diagnoses have been explored and tests are negative.

ii. Neurophysiologic and other diagnostic tests: EMG/NCV studies may show medial antebrachial cutaneous nerve changes compared to the normal side. The axillary vein may show some occlusion. Pectoralis minor block should be positive.

2. SURGICAL INDICATIONS:

a. Early surgical intervention should be performed if there is:

i. Documented EMG/NCV evidence of nerve compression with sensory loss, and weakness (with or without muscle atrophy) or ii. Acute subclavian vein thrombosis or arterial thrombosis; or iii. Subclavian artery aneurysm or stenosis secondary to a cervical or anomalous rib (Note: this condition is almost never work related.)

b. If early surgery is not indicated, surgery may be performed after failed conservative therapy. The following criteria must be fulfilled. Note: Workers compensation status has been found to predict a poor outcome in several studies, thus all criteria should be met for operative procedures.

i. Neurogenic: see criteria in the preceding subsection; and ii. Failed 3 months of active participation in non-operative therapy including worksite changes; and iii. Disabling symptoms interfering with work, recreation, normal daily activities, sleep; and iv. Pre-surgical psychiatric or psychological evaluation and clearance has been obtained, demonstrating motivation and long-term commitment without major issues of secondary gain or other psychological contraindications for surgery, and with an expectation that surgical relief of pain probably would improve the patient’s functioning.

A long-term follow-up study of patients having surgery for neurogenic TOS reported that disability at 4 years postoperatively was strongly related to the presence of major depression, as evaluated by the Beck Depression Inventory taken preoperatively. The adjusted odds ratio for depression and disability was 15.7. Even though the response rate for the four-year survey was only 58% of the eligible population, the association between preoperative depression and long-term disability was robust and not likely to be vulnerable to nonresponse bias. Refer to Section E.7 Personality/Psychological/Psychosocial Evaluations.

c. Even if return to their prior job is unlikely, an individual may need surgical intervention to both increase activities-of-daily living and/or return-to-work in a different job.

d. It is critically important that all other pathology be treated prior to surgical intervention for TOS. Other pathologies were commonly diagnosed in this population. Comorbid conditions of the shoulder, cervical spine, and carpal tunnel should be treated or ruled out before surgery is considered.

e. Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and provided with appropriate counseling.

f. Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work activities. The patient should agree to comply with the pre- and postoperative treatment plan including home exercise requirements. The patient should understand the amount of post-operative therapy required and the length of partial and full disability expected post operatively. Certain comorbidities predict less favorable outcomes: chronic pain syndrome, use of opioids, smoking, and age over forty.

3. SURGICAL PROCEDURES:

Since the success rates for the various surgical procedures are similar, the Division suggests that the surgeon performing the procedure use the technique with which the surgeon has the most experience and is most appropriate for the patient.

Vascular TOS procedures include resection of the abnormal rib and repair of the involved vessel.

Anticoagulation is required for thrombotic cases.

a. First rib resection.

b. Anterior and middle scalenectomy.

c. Anterior scalenectomy.

d. Combined first rib resection and scalenectomy.

e. Pectoralis minor tenotomy. This procedure is done under local anesthesia, normally in an out-patient setting for patients meeting the criteria for pectoralis minor syndrome. Return to activity and work occurs early, with full range of motion at 3 days and 85% return to continuing work. Complication rate is lower than for other procedures.

4. COMPLICATIONS: Complications and/or unsatisfactory outcomes are reportedly in the range of 10 to 20%. Acknowledged complications depend on the procedure and include complex regional pain syndrome; Horner’s syndrome; lymphocele; permanent brachial plexus damage; phrenic, intercostal brachial cutaneous or long thoracic nerve damage; and pneumothorax.

5. POST-OPERATIVE TREATMENT:

Individualized rehabilitation programs based upon communication between the surgeon and the therapist.

a. Overhead activities and lifting are usually avoided for 2 to 4 weeks. Therapy programs should address any identified neuromuscular or posture abnormalities. Generally, progressive resistive exercises no earlier than 2 months post-operatively with gradual return to full activity at 4 months.

b. Return-to-work and restrictions after surgery may be made by an experienced primary occupational medicine physician in consultation with the surgeon or by the surgeon.

Depending upon the patient's functional response and their job requirements, return-towork with job modifications may be considered as early as one week post operatively.

The employer must be able to fully accommodate restrictions of overhead activities or heavy lifting. Work restrictions should be evaluated every 4 to 6 weeks during postoperative recovery and rehabilitation, with appropriate written communications to both the patient and the employer.

c. Should progress plateau, the provider should re-evaluate the patient's condition and make appropriate adjustments to the treatment plan.

d. Post-operative therapy will frequently require a repeat of the therapy provided preoperatively. Refer to Section F. Therapeutic Procedures, Non-operative, and consider the first post-operative visit as visit number one for the time frame parameters provided.

e. Refer to the following areas in the non-operative therapeutic section for post-operative time parameters.

• Activities of Daily Living.

• Functional Activities.

• Nerve gliding.

• Neuromuscular re-education.

• Therapeutic exercise.

• Proper work techniques: Refer to Section E.8.c. Jobsite Evaluation, and Section F.10. Return-to-Work of these guidelines.

• Limited passive therapies may be appropriate in some cases. _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 18: Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 04 Rule 17, Exhibit 4 - SHOULDER INJURY MEDICAL TREATMENT GUIDELINES {#sec-7-ccr-1101-3-r17-ex-04 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 04}

DEPARTMENT OF LABOR AND EMPLOYMENT

WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

RULE 17, EXHIBIT 4 SHOULDER INJURY MEDICAL TREATMENT GUIDELINES 7 CCR 1101-3 Rule 17 - Exhibit 4 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

Section 1. Guidelines Introduction

Section 1.a. Context and Use This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of guidelines for physicians/providers treating individuals who qualify as injured workers with shoulder injuries under the Colorado Workers’ Compensation Act.

Although the primary purposes of this document for practitioners are advisory and educational, these guidelines are enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from these guidelines, as individual cases dictate. Therefore, these guidelines are not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip or overlook any sections.

Section 1.b. Application of the Guidelines The Division provides procedures to implement Medical Treatment Guidelines (MTGs) and to foster communication to resolve disputes among the provider, payer, and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the Office of Administrative Courts.

Section 1.c. Guidelines Recommendations and Inclusion of Medical Evidence All recommendations are based on available evidence and/or consensus judgment. Division staff researched and adopted evidence critique criteria. Evidence evaluation was performed in a manner congruent with national standards and completed independent of the multidisciplinary task force group that drafted recommendations. The methodology is described in detail on the Division's website, including documents on the literature search and evidence base.

References are provided in the evidence document when high-quality evidence that met the Division’s methodological standards was available to support recommendations. Recommendations without qualifying evidence are based on consensus; consensus means the judgment of experienced professionals based on general medical principles.

All recommendations in the Medical Treatment Guidelines (MTGs) are considered to represent reasonable care in appropriately selected cases, irrespective of the amount of evidence or consensus attached to them. The inclusion of a treatment as acceptable does not imply that every patient meeting the MTGs criteria must or should have that treatment. It means that for individuals meeting the criteria, the treatment should be approved when the provider and patient decide to proceed with it. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the MTGs as “not recommended.” Treatments or indications for treatments not addressed by the MTGs require prior authorization for a case-by-case assessment of appropriateness. See Workers' Compensation Rules of Procedure Rule 16 Utilization Standards for more information on prior authorization.

Section 1.d. Recommended Citation for This Document Colorado Division of Workers' Compensation. (2024). Shoulder Injury Medical Treatment Guidelines.

Colorado Department of Labor and Employment. https://cdle.colorado.gov/medical-providers/medicaltreatment-guidelines.

Section 2. General Guidelines Principles The general guidelines principles provide a framework for care for all injured workers. This document should be interpreted within the parameters of the following guidelines principles that may lead to more optimal medical and functional outcomes for injured workers.

Section 2.a. Education Education of the individual and family and/or support system, as well as the employer, insurer, policymakers, and the community, should be the primary emphasis in the treatment of injured workers.

Currently, practitioners often think of education last, after medications, manual therapy, and surgery.

Practitioners must implement strategies to educate injured workers, employers, insurance systems, policymakers, and the community as a whole. An education-based paradigm should always start with inexpensive communication that provides recovery, function-focused, patient-centered, and evidencebased information. More in-depth education is currently a component of treatment regimens that employ functional, restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention. Facilitation through language interpretation, when necessary, is a priority and part of the medical care treatment protocol.

Section 2.b. Shared Decision Making Providers should implement shared decision making as a crucial element of a successful treatment plan.

Patients, with the assistance of their health care practitioner and support system, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, psychologists, physical therapists, and other members of the health care team play an integral role in shared decision making and achievement of functional goals. Patient education and shared decision making should facilitate selfmanagement of symptoms and prevention of further injury.

Section 2.c. Return to Work Return to work is therapeutic, assuming the work is not likely to aggravate the basic problem. The practitioner must provide specific written physical limitations, and the patient should never be released to work with non-specific and vague descriptions such as “sedentary” or “light duty.” The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, carrying, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, repetitive motion tasks, sustained grip, tool usage, and vibration factors. Even if there is residual chronic pain, return to work is not usually contraindicated.

The practitioner should understand all of the physical demands of the patient’s job position before returning the patient to full duty and should request clarification of the patient’s job duties. Clarification should be obtained from the employer or, if necessary, including, but not limited to, an occupational health nurse, occupational therapist, vocational rehabilitation specialist, or an industrial hygienist.

Section 2.d. Treatment Parameter Duration Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Duration will be impacted by the individual’s adherence, as well as availability of services. Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

Section 2.e. Active Interventions Active interventions emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, are generally utilized over passive interventions, especially as treatment progresses.

Generally, passive interventions are viewed as a means to facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

Section 2.f. Active Therapeutic Exercise Program Exercise program goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

Section 2.g. Positive Patient Response Positive results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to: positional tolerances, range of motion (ROM), strength, endurance, activities of daily living (ADLs), ability to function at work, cognition and communication, psychological behavior, and efficiency/velocity measures that can be quantified. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation. Anatomic correlation must be based on objective findings. Patient-completed functional questionnaires can provide useful additional confirmation, such as those recommended by the Colorado Division of Workers’ Compensation (Division) Quality Performance and Outcomes Payments program (QPOP, see Rule 18), the Patient-Specific Functional Scale, or other validated function scales.

Section 2.h. Re-evaluation of Treatment Effectiveness Re-evaluation should occur every 3 to 4 weeks or within the time to produce effect for a given treatment.

Treatment should be modified or discontinued if there is no evidence of positive results. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results. Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

Section 2.i. Surgical Interventions Surgery should be contemplated within the context of expected functional outcome and not purely for the

purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic conditions.

Section 2.j. 6-month Time Frame The prognosis drops precipitously for returning an injured worker to work once they have been temporarily totally disabled for more than 6 months. The emphasis within these guidelines is to move patients along a continuum of care and return to work within a 6-month time frame, whenever possible. It is important to note that time frames may be less pertinent for injuries that do not involve work-time loss or are not occupationally related.

Section 2.k. Delayed Recovery For patients who are failing to make expected progress 6 to 12 weeks after initiation of treatment of an injury, strongly consider a psychological evaluation, if not previously provided, as well as initiating interdisciplinary rehabilitation treatment and vocational goal setting. The Division recognizes that 3% to 10% of all industrially injured patients will not recover within the timelines outlined in this document, despite optimal care. Such individuals may require treatments beyond the timelines discussed within this document, but such treatment requires clear documentation by the authorized treating practitioner focusing on objective functional gains afforded by further treatment and impact upon prognosis.

Section 2.l. Post Maximum Medical Improvement (MMI) Care Maximum medical improvement (MMI) should be declared when a patient’s condition has plateaued to the point where the authorized treating physician no longer believes further medical intervention is likely to result in improved function. However, some patients may require treatment after MMI has been declared in order to maintain their functional state. The recommendations in these guidelines are for pre- MMI care and are not intended to limit post-MMI treatment.

Section 3. Diagnoses Covered by this Medical Treatment Guideline (MTG)

The following diagnoses are addressed in this Medical Treatment Guideline (MTG): ● Acromioclavicular (AC) joint sprain and/or dislocation ● Arthritis that is either aggravated or exacerbated by a work injury or that is secondary to a claim-related trauma or surgery ● Biceps tendon disorder, including tendinopathy, subluxation, and/or disruption ● Brachial plexus and peripheral nerve conditions ● Bursitis ● Fracture ● Glenohumeral instability, also called shoulder instability, such as from dislocation, Bankart injuries, Hill-Sachs lesions ● Labral tears, including superior labrum anterior and posterior (SLAP) lesions ● Post-traumatic stiff shoulder, including frozen shoulder and adhesive capsulitis, that is secondary to a claim-related trauma or surgery ● Rotator cuff tear ● Rotator cuff tendinopathy, including calcific and non-calcific tendonitis ● Subacromial impingement syndrome.

Section 4. Diagnosis

Section 4.a. History Taking and Physical Examination Recommendation 1. A detailed history of symptom onset, past medical history, physical examination, and a detailed neurologic examination are required at the initial evaluation.

Recommendation 2. Initial functional assessment is strongly recommended. See examples of functional outcome measures in the Appendix.

Section 4.b. Diagnostic Procedures

Section 4.b.i. Compartment Pressure Testing.

Recommendation 3. Compartment pressure testing is acceptable for patients who present with symptoms consistent with compartment syndrome.

Section 4.b.ii. Electrodiagnostic Testing.

Recommendation 4. Electromyography and nerve conduction studies are recommended for patients with suspected neural involvement and persistent symptoms that are unresponsive to at least 6 weeks of conservative care emphasizing Active Therapies as outlined in Section 7.a.i. It is acceptable to test the non-affected side for comparison.

Recommendation 5. Surface electromyography and current perception threshold evaluation are not recommended.

Section 4.b.iii. Imaging.

Arthrography.

Recommendation 6. It is acceptable to add arthrography to magnetic resonance imaging (MRI) or computed tomography (CT) advanced imaging studies for patients with previous shoulder surgery, complex fractures, and those with a history and physical findings suggestive of shoulder instability, rotator cuff tear, osteochondral defects, intra-articular loose bodies, and/or labral tear.

Recommendation 7. Conventional (X-ray) arthrography is acceptable for evaluation of patients with metal implants and previous shoulder surgery.

Bone Scan (All Radioisotopes).

Recommendation 8. Radioisotope bone scanning is rarely used. It is acceptable when there is clinical suspicion for metastatic or primary bone tumors, occult or stress fractures, osteomyelitis, infection, or other inflammatory lesions.

Computed Tomography (CT).

Recommendation 9. A computed tomography (CT) scan is acceptable for better visualization of bone and further evaluation of masses and suspected fractures not clearly identified on X-ray radiographic evaluation.

Diagnostic Sonography.

Recommendation 10. Diagnostic ultrasound before 4 weeks post-injury is acceptable for cases with the presence of significant weakness on elevation or rotation, a palpable defect at the greater tuberosity, or an acute traumatic injury.

Recommendation 11. Diagnostic ultrasound is acceptable for visualization of soft tissue structures when shoulder pain and functional deficits persist after at least 4 weeks of conservative care emphasizing Active Therapies as outlined in Section 7.a.i.

Magnetic Resonance Imaging (MRI).

Recommendation 12. Magnetic resonance imaging (MRI) before 4 weeks post-injury is acceptable for cases with the presence of significant weakness on elevation or rotation, a palpable defect at the greater tuberosity, or an acute traumatic injury.

Recommendation 13. Magnetic resonance imaging (MRI) is acceptable for visualization of soft tissue structures when shoulder pain and functional deficits persist after at least 4 weeks of conservative care emphasizing Active Therapies as outlined in Section 7.a.i.

Vascular Imaging (Doppler Ultrasonography, Plethysmography, Arteriogram, or Venogram).

Recommendation 14. Doppler ultrasonography or plethysmography are acceptable for diagnosing vascular and circulatory disorders.

Recommendation 15. Arteriogram and venogram are acceptable to better visualize suspected vascular injury or disease not clearly identified following doppler ultrasonography or plethysmography.

X-ray (Radiograph).

Recommendation 16. X-ray studies of the shoulder are acceptable.

Section 4.b.iv. Joint Aspiration.

Recommendation 17. Joint aspiration and fluid analysis is acceptable in cases of suspected infection, inflammation, or crystal-induced arthropathies.

Section 4.b.v. Laboratory Testing.

Recommendation 18. When clinically indicated, early laboratory studies are acceptable to evaluate for systemic illness, infection, neoplasia, or underlying rheumatologic or connective tissue disorder.

Section 4.b.vi. Psychological or Psychosocial Screening and Evaluation.

Recommendation 19. A psychological screen is encouraged as a routine part of clinical care and is required as soon as any of the following barriers to functional recovery are identified (see examples of psychological screens in the Appendix): ● limited patient engagement in recovery, or ● activity avoidance, or ● catastrophization due to pain, or ● avoidance of essential recovery activities, or ● low expectations of recovery, or ● ineffective coping skills, or ● loss of vocational connection.

Individuals with barriers to functional recovery may benefit from an interdisciplinary approach to care.

Recommendation 20. A formal psychological or psychosocial evaluation is acceptable for those with elevated scores on psychosocial screening tests and/or for surgical candidates. It is required for patients not making expected progress within 6 weeks of injury and whose subjective symptoms do not correlate with objective signs and tests. See the Behavioral and Psychological Interventions section.

Section 4.b.vii. Screening.

Diabetic Screening.

Recommendation 21. Diabetic screening and monitoring is acceptable when poorly controlled diabetes is expected to negatively impact claim-related medical outcomes (e.g., prior to surgery; before and after steroid injection).

Implant Component Allergy Screening and Testing.

Recommendation 22. Screening and testing for allergy to implant components is acceptable.

Osteoporosis Screening and Treatment.

Recommendation 23. Osteoporosis screening tests, including bone density tests and vitamin D levels, are acceptable for patients who experience a fracture and are at risk for osteoporosis.

Recommendation 24. Claim-related treatment is acceptable when untreated osteoporosis is expected to negatively impact medical outcomes, but long-term care for osteoporosis is not covered under workers’ compensation.

Section 4.c. Determining Work-Relatedness

Section 4.c.i. All Conditions.

Recommendation 25. Medical causation must establish that the condition or injury results from a specific injury, an aggravation of an underlying condition, or a previously asymptomatic condition made symptomatic by a work-related exposure.

Recommendation 26. Occupational risk factors are listed in Sections 4.c.ii-4.c.x below. The risk factors are based on available evidence related to medical causation. Due to limited evidence, the occupational exposures listed are not fully comprehensive, and work-relatedness must be determined on a case-by-case basis.

Section 4.c.ii. Acromioclavicular (AC) Joint Sprain and/or Dislocation Risk Factors. ● a fall with a landing on the point of the shoulder, driving the acromion downward; or ● a backward and outward force on the shoulder, such as a fall on an outstretched hand or elbow with an adducted arm.

Section 4.c.iii. Bursitis Risk Factors.

Bursitis may occur with an occupational strain or tendinopathy. It may be caused by work-related trauma, chronic overuse (particularly repetitive reaching away from the body or overhead), abnormal scapular mechanics, scapular dyskinesia, arthritis, and/or acute or chronic infection.

Section 4.c.iv. Calcific Tendonitis Risk Factors.

Symptomatic calcific tendonitis may be related to degeneration of the rotator cuff tendons. This can be aggravated by work exposures related to the affected tendon.

Section 4.c.v. Fracture Risk Factors. ● a crushing, twisting, and/or high-energy fall; or ● trauma to the shoulder, arm, hand, and/or chest wall.

Section 4.c.vi. Nerve Injury Risk Factors.

Nerve Injury, General. ● trauma from an injury or surgery; ● nerve stretch such as from traction of the shoulder, arm, and/or chest wall; or ● direct internal compression, such as secondary to a hematoma or post-traumatic cyst.

Nerve Injury, Specified.

In addition to the general risk factors for nerve injury described above, there are also occupational risk factors associated with individual nerve injuries:

Axillary Nerve Injury. ● upward pressure on the axilla; ● humeral neck fracture; or ● dislocation of the shoulder.

Brachial Plexus Injury. ● weight-lifting; ● carrying heavy backpacks; ● shoulder subluxation; ● clavicular fracture; ● forceful deviation of the head away from the arm; or ● direct forceful impact to the brachial plexus region.

Long Thoracic Nerve Injury. ● chronic, repeated, or forceful shoulder depression; ● severe traction with the shoulder compressed and the head tilted; or ● repeated forward, overhead motion of the arms with the head tilted or rotated to the unaffected side.

Musculocutaneous Nerve Injury. ● backpack use; ● heavy weight-lifting; ● malposition during sleep or surgery; or ● a sudden, forceful extension of the elbow.

Spinal Accessory Nerve Injury. ● traumatic, forceful, downward compression of the shoulder; or ● deviation of the head away from the traumatized shoulder.

Suprascapular Nerve Injury. ● a fall on an outstretched arm; or ● supraclavicular trauma, stretch, friction, or compression through the suprascapular notch or the spinoglenoid notch.

Section 4.c.vii. Post-Traumatic Stiff Shoulder Risk Factors.

Post-traumatic stiff shoulder should include a history of work-related injury or surgery resulting in significantly decreased range of motion.

Section 4.c.viii. Shoulder Instability and/or Glenohumeral Instability Risk Factors. ● a direct traumatic blow to the shoulder; ● a fall on an outstretched arm; ● a significant traction injury to the arm; ● direct fall on the shoulder resulting in posteriorly directed forces; or ● electrocution and/or seizure.

Section 4.c.ix. Shoulder Tendon Related Pathology Risk Factors.

Biceps Tendon Disorder. ● acute trauma to the long head of the biceps tendon of the shoulder girdle; ● acute distractive force or transection of the tendon; or ● an extension force applied to a flexed elbow.

Rotator Cuff Tear.

Occupational risk factors may include sudden shoulder trauma, such as breaking a fall with an overhead railing or an outstretched arm.

Rotator Cuff Tendinopathy.

Rotator cuff tendinopathies are often seen with frequent overhead motion. Symptoms may include pain and/or achiness that occur after blunt trauma or repetitive use of the shoulder.

Chronic Shoulder Tendon Disorders.

Risk factors include any of the following; however, this is not a comprehensive list, and workrelatedness must be determined on a case-by-case basis. ● Overhead work consisting of additive time per day of at least 30 minutes/day for a minimum of 5 years. ● Work that requires shoulder movement at the rate of 15-36 repetitions per minute and no 2-second pauses for 80% of the work cycle. ● Work that requires shoulder movement with force and has no 2-second pauses for 80% of the work cycle. ● It is also likely that jobs requiring daily heavy lifting at least 10 times per day over the years may contribute to shoulder disorders. ● Vibration can also be considered an additional risk factor.

Section 4.c.x. Superior Labrum Anterior Posterior (SLAP) Lesions Risk Factors. ● compression injury, such as: ○ a fall on an outstretched arm with the shoulder in forward flexion and abduction, or ○ a direct blow to the glenohumeral joint; ● traction injury, such as: ○ repetitive overhead throwing, ○ experiencing a sudden pull when losing hold of a heavy object, or ○ attempting to break a fall from a height; ● a fall on an adducted arm with upward force directed on the elbow; or ● driving an automobile that is rear-ended.

Section 5. Return to Activity and Work Considerations

Section 5.a. Job History and Communication Recommendation 27. A job history interview should be completed at the time of the initial evaluation. A thorough job history generally includes: ● duties and demands of job held at time of injury; and ● duties and demands of current job, if different; and ● stressors; and ● cognitive and social issues, with treatment incorporated into the plan of care.

Recommendation 28. A formal job description for the injured worker is recommended to identify physical demands at work and to assist in the creation of medically appropriate work restrictions. Job descriptions are helpful but should not be used as a substitute for thorough patient interview and/or direct observation.

Recommendation 29. Nurse case management is recommended in medically complex cases to facilitate communication between the primary provider, referral providers, insurer, employer, and employee. The patient may decline nurse case management services.

Section 5.b. Return to Work Recommendation 30. It is strongly recommended that the patient return to work as soon as it is medically appropriate, even if it is in a modified capacity.

Recommendation 31. Ergonomic or adaptive equipment, therapeutic breaks, and workplace interventions are acceptable to maintain employment.

Recommendation 32. Interdisciplinary services are acceptable to assist the injured worker in return to work efforts (e.g., behavioral and/or psychological support, active therapy).

Recommendation 33. For patients with work restrictions, a graduated return to work is recommended as

part of a successful medical treatment plan with a goal of return to full duty, if medically feasible (e.g., nature and frequency of activities; hours worked).

Recommendation 34. Permanent work restrictions, when needed, should be developed based on objective information available, including: ● history; ● findings on physical examination and diagnostic testing; and ● functional response to active therapy, work conditioning, and/or modified duty.

Section 5.c. Workplace Tests Recommendation 35. A jobsite evaluation is acceptable to fully understand the physical demands of an individual’s work. This information can be used when determining medical causation, the need for ergonomic changes, and/or ability to return to work. The timing and maximum allowed for jobsite evaluation are as follows: ● 1 time for initial evaluation, 1 for mid-treatment assessment, and 1 at final evaluation.

Recommendation 36. A work tolerance screening is acceptable to determine a patient’s tolerance for performing a specific job activity or task from a cardiovascular, postural tolerance, ergonomic, and physical fitness perspective. The timing and maximum allowed for work tolerance screening are as follows: ● 1 time for the initial screen. May monitor improvements in physical work capacity every 3 weeks up to a total of 6 visits.

Recommendation 37. A functional capacity evaluation (FCE) is acceptable to determine an individual’s capacity to work. A formal job description and jobsite evaluation, if performed, should be made available to the FCE evaluator prior to having the FCE performed. The timing and maximum allowed for FCE are as follows: ● 1 time to determine baseline status, and 1 time to determine permanent work restrictions at case closure if the provider needs additional information regarding the patient’s physical work capacity.

Recommendation 38. Follow-up evaluation with the treating therapist and/or the treating physician is required within 3 days after the functional capacity evaluation (FCE) to assess the patient’s status.

Recommendation 39. Functional capacity evaluations (FCEs) and computer-enhanced evaluations are not recommended as the sole tool for the development of temporary or permanent work restrictions.

Recommendation 40. Performance during functional capacity evaluations (FCEs) cannot be used as the sole criteria in diagnosing malingering.

Recommendation 41. Computer-enhanced evaluations (including computerized dynamometry) are acceptable. The timing and maximum are as follows: ● 1 time for initial evaluation, 1 for mid-treatment assessment, and 1 at final evaluation.

Section 6. Essential First-Line Treatment

Section 6.a. Education, Shared Decision Making, and Informed Consent Recommendation 42. Patient education is required as a primary component of treatment, beginning with the expected natural history of the injury or condition. Education about the injury or condition and associated disability may involve the patient, patient’s family, employer, insurer, policymakers, and community.

Recommendation 43. In the setting of benign clinical examination, it is strongly recommended that the provider educates and reassures the patient that there is a high likelihood their condition will improve and that it is essential to self-manage their symptoms.

Recommendation 44. Patients should be educated regarding restriction of activities, including the following: ● The detrimental effects of immobility versus the efficacious use of limited rest periods.

Adequate rest allows the patient to participate in active treatment and benefit from the rehabilitation program. ● Avoidance of complete work cessation, if possible, since it often further aggravates the pain presentation and promotes disability. ● Modified return to work is almost always more efficacious than work cessation and rarely contraindicated in the vast majority of injured workers.

Recommendation 45. Patient education should include a thorough discussion of how behavioral health evaluation and treatment is an essential component to support recovery from physical injury.

Recommendation 46. Shared decision making by the provider and patient, including the exchange of ideas and collaboration in the decision, is required, regardless of whether the degree of risk is high or low.

Discussions should be tailored to the patient’s health literacy. Elements of shared decision making must include the following: ● the patient’s experience with treatment; and ● creation of individualized functional goals of treatment and anticipated barriers to success; and ● documentation of expected results of diagnostic testing and possible plan of action in response to test results; and ● a discussion of the continuum of treatment from the least invasive to the most invasive, with the intent of identifying a treatment along this continuum that most completely addresses the condition; and ● expectation regarding the functional impact of the proposed treatment, including a discussion regarding return to work and expected time frame for treatment; and ● specific measurable and clinically meaningful criteria for determining treatment success or failure; and ● confirmation of the patient’s commitment to perform active therapy to optimize treatment outcomes; and ● documentation and consideration of the patient’s unique risks and benefits based on comorbid medical conditions.

Recommendation 47. Informed consent is required when a high-risk treatment is under consideration. It includes the following elements: ● discussion of the proposed treatment’s purpose; and ● benefits, limitations, and risks of the proposed treatment, alternative treatments, and nontreatment; and ● explicit patient agreement or refusal.

Section 7. Second-Line Treatment

Section 7.a. Core Second-Line Treatment

Section 7.a.i. Active Therapies.

Recommendation 48. Active therapies are acceptable. They require intrinsic motivation by the patient to complete a specific exercise or task, in contrast with passive therapies. Interventions may include, but are not limited to, the following: ● activities of daily living (ADLs) therapy, ● aquatic therapy, ● functional activities therapy, ● in-office use of functional electrical stimulation or neuromuscular electrical stimulation (NMES) in which the patient is active, ● a home exercise program, ● neuromuscular re-education, ● therapeutic exercise, ● work conditioning, ● working modified duty with gradual advancement of activities, and ● work simulation.

Recommendation 49. Providing education alongside active therapies is acceptable. Education may include, but is not limited to, the following: ● a favorable prognosis for recovery, ● the importance of continuing daily activities, ● promotion of self-efficacy, ● problem-solving, ● engagement of support systems, ● pain neuroscience education, and ● relaxation techniques.

Recommendation 50. Specialist medical clearance is required prior to participation in active therapies if a patient has any of the following unexplained symptoms: ● angina/dyspnea on exertion or at rest, or ● paroxysmal nocturnal dyspnea and/or orthopnea, or ● syncope or presyncope, or ● arrhythmia or palpitations, or ● cardiac murmur.

Recommendation 51. Patients in active therapy must: ● demonstrate functional progress that is documented through validated sequential functional assessment measures; ● return to work with decreased restrictions; and/or ● have improvement in clinical measures (e.g., strength, range of motion [ROM], and activities of daily living [ADLs]).

If there is no documented evidence of functional progress after 6 treatments, the therapy will be discontinued and the patient must be referred back to their treating provider for further evaluation.

Each patient is limited to a maximum of 4 discrete active therapy trials without documented functional progress. (See examples of functional outcome measures in the Appendix.)

Recommendation 52. It is acceptable for adjunct passive therapy to occur concurrently with active therapy, and the frequency of passive therapies will decrease over time. See the Passive Therapies section.

Recommendation 53. Functional electrical stimulation or neuromuscular electrical stimulation (NMES) home units require prior authorization, documenting medical justification for home use.

For transcutaneous electrical nerve stimulation (TENS) home units see Recommendation 69.

Recommendation 54. A patient is allowed up to 6 active therapy visits to advance their active home exercise program. These visits are contingent on documented demonstration of previously instructed exercises, performance of their home program at the recommended frequency, and progress in their exercise program.

Recommendation 55. Time frames for active therapies are as follows: ● Time to produce effect: 6 treatments. ● Frequency: up to 4 times per week.

Recommendation 56. Durations of care beyond those listed as “time to produce effect” and “maximum” are acceptable in the following circumstances: ● once scheduled for a surgery, preoperative active treatment while waiting for the surgery without expectation of typical functional gains; or ● after surgery, particularly after multiple surgeries; or ● re-injury, interrupted continuity of care, specific diagnoses (such as fracture, post-traumatic stiff shoulder, non-surgical management of rotator cuff or labral tears, aggravated arthritis), returning to a highly physically demanding job, and/or comorbidities when treatment to date has resulted in measurable and clinically meaningful functional improvement.

Section 7.a.ii. Behavioral and Psychological Interventions.

Recommendation 57. Early initiation of behavioral and psychological interventions is acceptable if psychosocial or behavioral factors appear to be interfering with functional recovery (see Recommendation 19 and Recommendation 20). See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for recommendations and treatment time frames.

Section 7.b. Adjunct Second-Line Treatments, as Indicated

Section 7.b.i. Passive Therapies.

All Passive Therapies.

Recommendation 58. Passive therapies include treatments that do not require a patient’s energy expenditure. Patients in passive therapy must demonstrate functional progress through validated functional assessment measures. If there is no evidence of functional progress within the time to produce effect, the therapy shall be discontinued and the patient must be referred back to their treating provider for evaluation. Each patient is limited to a maximum of 4 discrete passive therapy trials.

Recommendation 59. Passive therapies must occur concurrently with self-directed exercise or formal active therapy programs.

Recommendation 60. The frequency of passive therapy must decrease over time.

Recommendation 61. Durations of care beyond those listed as “time to produce effect” and “maximum” are acceptable in the following circumstances: ● after surgery, particularly after multiple surgeries; or ● re-injury, interrupted continuity of care, specific diagnoses (such as fracture, post-traumatic stiff shoulder, non-surgical management of rotator cuff or labral tears, aggravated arthritis), and/or comorbidities when treatment to date has resulted in measurable and clinically meaningful functional improvement.

Acupuncture.

Recommendation 62. Acupuncture is acceptable within the following parameters: ● Time to produce effect: up to 6 sessions. ● Maximum duration: 15 treatments.

Bone Growth Stimulation.

Recommendation 63. Electrical bone growth stimulation requires prior authorization.

Recommendation 64. Low-intensity pulsed ultrasound (LIPUS) is not recommended for clavicular fracture.

Continuous Passive Motion.

Recommendation 65. Continuous passive motion is not generally recommended. It is acceptable if there is a diagnosis of post-traumatic stiff shoulder and access to therapy is limited.

Diathermy.

Recommendation 66. Radio wave diathermy is not recommended.

Dry Needling.

Recommendation 67. Dry needling is acceptable within the following parameters: ● Frequency: up to 2 sessions per week. See Recommendation 60 regarding the Elastic Taping (e.g., Kinesiotaping).

Recommendation 68. Elastic taping is acceptable as part of active therapy sessions (see Recommendation 55 for time frames). Discontinue use if there is no documented functional benefit.

Electrical Stimulation (In-Clinic Use).

Recommendation 69. In-office electrical stimulation in which the patient is passive is acceptable within the following parameters: ● Maximum duration: 4 weeks. ● If transcutaneous electrical nerve stimulation (TENS) treatment results in documented functional benefit and is anticipated to extend beyond 4 treatments, consider purchase of a home TENS unit.

Hyperbaric Oxygen Therapy.

Recommendation 70. Hyperbaric oxygen therapy is not recommended.

Iontophoresis.

Recommendation 71. Iontophoresis is acceptable within the following parameters: ● Frequency: 3 sessions per week with at least 48 hours between sessions. See Recommendation 60 regarding the expected decreasing frequency over time. ● Maximum duration: 10 treatments.

Laser Therapy.

Recommendation 72. Low-level laser therapy is not recommended.

Manual Treatment.

Recommendation 73. Manual treatment is acceptable, including manipulation, joint mobilization, soft tissue mobilization, and myofascial release, within the following parameters: ● Time to produce effect: up to 6 sessions.

Massage.

Recommendation 74. Massage is acceptable within the following parameters: ● Time to produce effect: 6 sessions. ● Frequency: up to 2 sessions per week. See Recommendation 60 regarding the Shockwave Therapy.

Recommendation 75. Shockwave therapy is not a first-line therapy. It is not recommended in the absence of a documented calcium deposit but is acceptable for patients with calcific tendonitis who have not achieved functional goals after at least 2 months of conservative care emphasizing Active Therapies as outlined in Section 7.a.i. within the following parameters: ● Time to produce effect: 3 days after a treatment. ● Frequency: every 4 days. See Recommendation 60 regarding the expected decreasing frequency over time. ● Maximum duration: 4 sessions.

Recommendation 76. Anesthesia and conscious sedation are not recommended during shockwave therapy.

Superficial Heat and Cold Therapy.

Recommendation 77. Superficial heat and cold therapy is acceptable within the following parameters:

Ultrasound, including Phonophoresis (In-Clinic Use).

Recommendation 78. Therapeutic ultrasound, including phonophoresis, is acceptable for calcific tendinopathy within the following parameters: ● Time to produce effect: up to 15 sessions. ● Frequency: 3 sessions per week. See Recommendation 60 regarding the ● Maximum duration: 2 months.

Section 7.b.ii. Durable Medical Equipment.

Recommendation 79. Fabrication and modification of orthotics is acceptable to facilitate better motion response, stabilize a joint with insufficient muscle or proprioceptive/reflex competencies, protect subacute conditions as needed during movement, and/or correct biomechanical problems.

The time frames are as follows: ● Maximum Duration: 4 sessions of evaluation, casting, fitting, and re-evaluation.

Recommendation 80. Training on the proper use of orthotic devices and/or prosthetic limbs is acceptable. Instruction and training includes, but is not limited to, stump preparation, donning and doffing limbs, wearing schedule, orthotic/prosthetic maintenance, and techniques for activities of daily living and self-care. The time frames are as follows: ● Frequency: 4 times per week. ● Maximum Duration: 4 months.

Recommendation 81. Splints, slings, braces, immobilizers, and adaptive equipment are acceptable if used to improve safety, reduce stress on the injury, and reduce risk of re-injury.

Sessions for their design, fabrication, modification, and/or training on their use are acceptable.

The time frames are as follows: ● Maximum Duration: 3 sessions.

Recommendation 82. Adaptive equipment is acceptable if used to improve safety, reduce stress on the injury, and reduce risk of re-injury. Equipment includes high and low-technology assistive options such as workplace modifications, computer interface or seating, and self-care aids.

Sessions for training on their use are acceptable. The time frames are as follows: ● Maximum Duration: 3 sessions.

Section 8. Third-Line Treatment

Section 8.a. Injections

Section 8.a.i. Anesthesia-Only Injections (Selective Nerve Blocks).

Recommendation 83. Injections containing only anesthesia, also called selective nerve blocks, are acceptable for diagnostic purposes to identify pain generators or pathology.

Recommendation 84. Imaging guidance for anesthesia-only injections using sonography or fluoroscopy is acceptable.

Section 8.a.ii. Distension Arthrography.

Recommendation 85. Distension arthrography or brisement is acceptable for post-traumatic stiff shoulder when all of the following parameters are met: ● the condition is refractory to at least 3 months of conservative care emphasizing Active Therapies as outlined in Section 7.a.i.; and ● range of motion remains significantly restricted; and ● early therapy to maintain range of motion and to restore strength and function follows distension arthrography.

Section 8.a.iii. Glucocorticosteroid Injections.

Recommendation 86. An initial steroid injection is acceptable. They may target the subacromial space, glenohumeral joint, acromioclavicular (AC) joint, biceps tendon sheath, subdeltoid bursa, subcoracoid space, or around the suprascapular nerve.

Recommendation 87. Steroid injections beyond the first one are acceptable given the following parameters: ● There is documentation of functional improvement from the previous injection. ● Injections are at least 4 weeks apart. ● The maximum is 4 injections per year for all sites combined.

Recommendation 88. Imaging guidance for glucocorticosteroid injections using sonography or fluoroscopy is acceptable.

Section 8.a.iv. Hyaluronic Acid Viscosupplementation.

Recommendation 89. Viscosupplementation is acceptable for glenohumeral arthritis in the absence of other symptomatic shoulder pathology within all of the following parameters: ● the condition limits function and is unresponsive to at least 6 weeks of conservative care emphasizing Active Therapies as outlined in Section 7.a.i.; and ● each course of treatment is at least 6 months apart. The number of injections in each course depends on the product used.

Recommendation 90. Viscosupplementation is not recommended for any of the following: ● rotator cuff tendinopathy, or ● adhesive capsulitis, or ● subacromial impingement syndrome.

Section 8.a.v. Lavage and Aspiration.

Recommendation 91. Prior authorization is required for ultrasound-guided needle lavage and aspiration for patients with calcific tendonitis who have not responded to conservative care emphasizing Active Therapies as outlined in Section 7.a.i.

Section 8.a.vi. Platelet-Rich Plasma Injections.

Recommendation 92. Platelet-rich plasma injections are generally not recommended. They are acceptable when all of the following parameters are met: ● there is tendon damage; and ● the condition is not responding to at least 6 weeks of conservative care emphasizing Active Therapies as outlined in Section 7.a.i; and ● the next level of guideline-consistent therapy would involve an invasive procedure with risk of significant complications.

Recommendation 93. Platelet-rich plasma injections beyond the first one are acceptable when all of the following parameters are met: ● there is documentation of significant functional benefit from the previous injection; and ● the patient has not returned to full function or full duty at work; and ● the injections are at least 4 weeks apart. ● The maximum is 1 repeat injection.

Section 8.a.vii. Prolotherapy.

Recommendation 94. Prolotherapy and sclerotherapy are not recommended.

Section 8.a.viii. Stem Cell Injections.

Recommendation 95. Stem cell injections are not recommended. These include but are not limited to mesenchymal, adipose-derived, amniotic, and bone marrow-derived stem cells.

Section 8.a.ix. Trigger Point Injections.

Recommendation 96. Trigger point injections are acceptable when all of the following parameters are met: ● there are consistent, well-circumscribed trigger points with a local twitch response; and ● there is a characteristic radiation of pain pattern and local autonomic reaction (e.g., persistent hyperemia following palpation); and ● trigger points are not responding to specific, noninvasive, myofascial interventions within a 6-week time frame; and ● concurrent participation in Active Therapies as outlined in Section 7.a.i. is required; and ● the maximum frequency is 1 session per week, with a maximum of 4 injections per session; and ● the maximum duration is 8 weeks. Beyond 8 weeks, refer to the Chronic Pain Disorder Medical Treatment Guidelines (MTGs).

Recommendation 97. Sedation is not recommended for patients receiving trigger point injections.

Section 8.b. Surgical Interventions

Section 8.b.i. All Surgeries.

Recommendation 98. The inclusion of a surgical intervention as acceptable does not imply that every patient meeting the Medical Treatment Guideline (MTG) criteria must or should have that surgery. It means that for individuals meeting the criteria, the surgery should be approved when the treating surgeon and patient decide to proceed with it.

Recommendation 99. With the exception of conditions requiring urgent surgery, referral for surgical evaluation is indicated when the criteria listed for specific surgeries are met, along with all of the following criteria: ● symptomatic and functional improvement has plateaued with continued functional impairment that interferes with return to work and/or participation in active therapy; and ● findings on advanced imaging correlate with clinical findings to confirm a specific diagnosis; and ● confounding psychological or physical conditions that may respond to nonsurgical techniques but may be refractory to surgical intervention have been diagnostically eliminated; and ● the expected functional outcome following surgery is better than that of nonoperative management and outweighs the risk of harm.

Section 8.b.ii. Acromioclavicular (AC) Joint Stabilization and Ligament Reconstruction.

Recommendation 100. Urgent surgical stabilization and ligament reconstruction is acceptable for acromioclavicular (AC) joint separations of Rockwood classification Type IV or above.

Recommendation 101. Stabilization and ligament reconstruction is acceptable for Rockwood Type III acromioclavicular (AC) joint separations following failure of 3 months of conservative care emphasizing Active Therapies as outlined in Section 7.a.i. For patients with particularly high physical demands on their shoulder, orthopedic consultation with surgical intervention as early as two weeks from the date of injury may be considered.

Recommendation 102. Stabilization and ligament reconstruction is not recommended for acromioclavicular (AC) joint sprains (Rockwood Type I or Type II).

Section 8.b.iii. Arthrodesis (Fusion).

Recommendation 103. Arthrodesis is acceptable as a salvage procedure when other procedures have failed to restore shoulder function.

Section 8.b.iv. Arthroplasty (Joint Replacement).

Recommendation 104. Arthroplasty is acceptable when all of the following parameters are met, and the form of arthroplasty is at the surgeon’s discretion: ● the presence of any of the following conditions: ○ severe arthritis, or ○ massive rotator cuff tears, or ○ humeral head fracture or osteonecrosis, or ○ humeral malunion; and ● functional impairment remains despite conservative management; and ● the condition is not amenable to less invasive treatment; and ● there is integrity of the deltoid.

Recommendation 105. Revision arthroplasty is acceptable, provided that a second shoulder orthopedist agrees, in cases of hardware failure, chronic pain and stiffness, painful glenoid erosion, or difficulty with activities of daily living. Prior authorization is required.

Section 8.b.v. Biceps Tendon Surgery.

Recommendation 106. Urgent surgical repair is acceptable for distal biceps tendon rupture.

Recommendation 107. Repair without delay is acceptable for proximal biceps tendon rupture or complete dislocation following shared decision making as not all patients require surgical repair (see Recommendation 99).

Recommendation 108. Tenotomy or tenodesis is acceptable for bicipital tendonitis, subluxing bicipital tendon, or biceps pulley disorder when functional deficits interfere with activities of daily living (ADLs) and/or job duties after 12 weeks of conservative care emphasizing Active Therapies as outlined in Section 7.a.i.

Section 8.b.vi. Brachial Plexus and Peripheral Nerve Exploration and Repair.

Recommendation 109. Nerve exploration and surgical intervention is acceptable in any of the following cases, and surgical approach is at the surgeon’s discretion: ● suspicion of nerve laceration or substantial injury from trauma or surgery; or ● progressive weakness or loss of function post-injury or postoperatively; or ● when functional deficits interfere with activities of daily living (ADLs) and/or job duties after 3 months of conservative care emphasizing Active Therapies as outlined in Section 7.a.i.

Section 8.b.vii. Distal clavicle resection.

Recommendation 110. Distal clavicle resection is acceptable for patients with arthritis of the acromioclavicular (AC) joint after 6 weeks of conservative care emphasizing Active Therapies as outlined in Section 7.a.i. when there is a symptomatic AC joint with reproducible pain. See Recommendation 112 for clavicular fracture and Recommendation 118 for use in rotator cuff repair.

Section 8.b.viii. Fracture Repair.

Recommendation 111. Reduction and internal fixation is acceptable for fracture not amenable to less invasive treatment.

Recommendation 112. Distal clavicle resection is acceptable as part of the repair of a clavicular fracture.

Section 8.b.ix. Hardware Removal.

Recommendation 113. Hardware removal for a claim-related condition is acceptable at the surgeon’s discretion.

Section 8.b.x. Manipulation Under Anesthesia and Capsular Release.

Recommendation 114. Manipulation under anesthesia and/or capsular release is acceptable for post-traumatic stiff shoulder only after 3 months of conservative care emphasizing Active Therapies as outlined in Section 7.a.i. if range of motion (ROM) is below the norm and functional deficits continue to interfere with activities of daily living (ADLs) and/or job duties.

Section 8.b.xi. Rotator Cuff Tear Repair and Associated Procedures.

Recommendation 115. Surgery is only acceptable for symptomatic rotator cuff tears that result in weakness, decreased range of motion (ROM), decreased function, and/or pain. Surgical approach is at the surgeon’s discretion. Timing for surgery depends on the type of tear: ● Immediate repair of acute full-thickness tears that are symptomatic is acceptable. ● Repair of acute partial-thickness tears or chronic tears is acceptable only if they continue to be symptomatic after 6 weeks of conservative care emphasizing Active Therapies as outlined in Section 7.a.i.

Recommendation 116. Use of a graft augmentation or patch as part of a rotator cuff tear repair requires prior authorization.

Recommendation 117. Superior capsular reconstruction requires prior authorization.

Recommendation 118. Distal clavicle resection is not recommended as a routine addition to rotator cuff repair. It is only acceptable when there is a symptomatic acromioclavicular (AC) joint with reproducible pain.

Recommendation 119. Biceps tenotomy or tenodesis is not recommended as a routine addition to rotator cuff repair. It is only acceptable when there is evidence of a biceps tendon disorder or to augment a large rotator cuff repair or revision surgery.

Section 8.b.xii. Shoulder/Glenohumeral Stabilization.

Recommendation 120. Shoulder/glenohumeral stabilization surgery is acceptable in any of the following cases, and patient eligibility and surgical approach is at the surgeon’s discretion: ● dislocation with significant rotator cuff tear, significant labral injury (e.g., Bankart lesion), clinically significant bony deformity or loss (e.g., Hill-Sachs lesion), or fracture not amenable to immobilization; or ● recurrent dislocations when not accompanied by generalized ligamentous laxity.

Recommendation 121. Surgery is acceptable for patients with shoulder instability who do not meet the indications in Recommendation 120 only after 12 weeks of conservative care emphasizing Active Therapies as outlined in Section 7.a.i. if functional deficits continue to interfere with activities of daily living (ADLs) and/or job duties. Early surgery is acceptable if there is a recurrent dislocation during the conservative care phase.

Recommendation 122. Thermal capsulorrhaphy is not recommended.

Section 8.b.xiii. Subacromial Decompression (including Bursectomy, Acromioplasty, or Spur Removal).

Recommendation 123. Subacromial decompression (including bursectomy, acromioplasty, or spur removal) is not generally recommended for subacromial impingement syndrome, rotator cuff tendinopathy, or as an adjunct to rotator cuff repair.

Section 8.b.xiv. Superior Labrum Anterior and Posterior (SLAP) Repair.

Recommendation 124. In the absence of other surgical shoulder pathology, surgery for symptomatic superior labrum anterior and posterior (SLAP) tears is acceptable only after at least 3 months of conservative care emphasizing Active Therapies as outlined in Section 7.a.i. when functional limitations remain and/or instability significantly affects activities of daily living (ADLs) or work duties. Surgical approach is at the surgeon’s discretion.

Recommendation 125. Arthroscopic exam and superior labrum anterior and posterior (SLAP) repair is acceptable when performed in conjunction with other surgical procedures. The time frames and indications for the primary procedure, as described in this Medical Treatment Guideline (MTG), must be followed. Surgical approach is at the surgeon’s discretion.

Section 8.b.xv. Surgical Intervention for Calcific Tendonitis.

Recommendation 126. Surgery for calcific tendonitis is acceptable only after 3 months of conservative care emphasizing Active Therapies as outlined in Section 7.a.i. if functional deficits continue to interfere with activities of daily living (ADLs) and/or job duties. Surgical approach is at the surgeon’s discretion.

Section 9. Medications

Section 9.i. All Medications Recommendation 127. Medication reconciliation is required at the initial visit and periodically during treatment to avoid medication errors and to discuss side effects, drug interactions, and expected functional goals. Reconciliation includes the following elements: ● current medication name, dosage, frequency, and route; ● patient understanding of indication; ● potential interaction of prescription and over-the-counter medications; ● drug allergies; ● comorbid medical issues; ● history of substance abuse; and ● checking the Colorado Prescription Drug Monitoring Program (PDMP) when prescribing controlled substances.

Recommendation 128. A therapeutic trial of medications is recommended to evaluate the effect on functional status. The length of a medication trial will depend on the individual medication, and the patient should be informed on the time to expected benefit. If no functional benefit is observed at that time, the medication should be discontinued.

Recommendation 129. Medications should be initiated at the lowest dose expected to result in functional improvement and then titrated based on clinical response.

Recommendation 130. If anticonvulsants are being considered for neuropathic pain or any medications are being considered for long-term chronic pain management, refer to the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) medications section.

Section 9.ii. Antidepressants Recommendation 131. Tricyclic antidepressants are acceptable as the first-line agent for neuropathic pain, particularly in the setting of insomnia. They are not recommended as a first-line agent for depression.

Recommendation 132. Serotonin and norepinephrine reuptake inhibitors (SNRIs) are acceptable as a second-line agent for neuropathic pain if a tricyclic antidepressant offers inadequate relief. However, duloxetine is acceptable as a first-line agent for a patient who is a candidate for pharmacologic treatment of both chronic pain and depression.

Recommendation 133. Selective serotonin reuptake inhibitors (SSRIs) are acceptable for treating depression. They are not recommended for neuropathic pain.

Recommendation 134. The time frames for antidepressant medications are as follows: ● Time to produce effect: up to 6 months, depending on the medication. ● Maximum duration: up to 12 months, with monitoring.

Recommendation 135. Evaluation and ongoing monitoring for suicidal ideation and mood swings are required for all patients being considered for antidepressant medications.

Recommendation 136. A screening electrocardiogram is acceptable prior to initiating treatment with a tricyclic antidepressant or selective serotonin reuptake inhibitor (SNRI) to assess cardiovascular risk.

Section 9.iii. Muscle Relaxants Recommendation 137. Non-benzodiazepine muscle relaxants, except for carisoprodol, are acceptable as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions. The maximum duration is 2 weeks, or longer if used only at night.

Recommendation 138. While use of tizanidine (alpha-2 adrenergic agonist) is “off-label” for musculoskeletal conditions other than centrally mediated spasticity, its use is acceptable for patients who might functionally benefit from the medication’s shorter half-life based on the provider’s discretion.

Recommendation 139. Benzodiazepines and carisoprodol are not generally recommended. They are not recommended for use in combination with opioids.

Section 9.iv. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Acetaminophen Recommendation 140. Acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) are acceptable for initial analgesic treatment. Long-term use of acetaminophen or NSAIDs should be evaluated on a case-by-case basis; see the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for more information.

Recommendation 141. Co-prescription of a proton pump inhibitor, histamine H2-receptor antagonists (H2blockers), or prostaglandin analog with non-steroidal anti-inflammatory drugs (NSAIDs) is acceptable to reduce risk of duodenal or gastric ulceration in patients with concurrent antiplatelet or corticosteroid therapy.

Recommendation 142. Cyclooxygenase-2 (COX-2) inhibitors are acceptable for patients who do not tolerate traditional non-steroidal anti-inflammatory drugs (NSAIDs) or for patients who the treating provider feels may be at risk for complications. They are not recommended as a first-line agent for shortterm use in patients at low risk for complications with NSAIDs.

Recommendation 143. Perioperative use of acetaminophen and/or non-steroidal anti-inflammatory drugs (NSAIDs), either alone or in combination with other medications, to optimize analgesia is recommended.

Section 9.v. Opioids Recommendation 144. Opioid medications are not generally recommended. Rare exceptions include either of the following: ● acute, severe functionally limiting pain in a patient for whom other non-opioid medications are contraindicated; or ● acute, severe functionally limiting pain that is refractory to non-opioid medications and nonpharmacologic treatment and an absence of risk factors for potential misuse or abuse. This includes postoperative use.

Recommendation 145. Prior to prescribing an opioid medication, all of the following steps are required: ● documented results of a rapid risk assessment for developing opioid use disorder (e.g., Opioid Risk Tool [ORT]); and ● risk assessment of developing opioid-related adverse events; and ● review data on the Colorado Prescription Drug Monitoring Program (PDMP); and ● education on the short- and long-term risks and side effects of opioid therapy; and ● realistic goals of opioid therapy and the anticipated course of recovery; and ● establish the lowest effective dose and shortest duration of therapy; and ● education on the safe storage and disposal of opioid medications; and ● develop a discontinuation plan for opioids prior to prescribing.

Recommendation 146. When opioids are prescribed, the time frames are as follows: ● The optimum duration is 3 days or less. ● The maximum duration is 7 days. ● Whenever opioids are prescribed for more than 7 days, providers must follow all recommendations for screening and follow-up of chronic pain use. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs).

Recommendation 147. Long-acting opioids are not recommended for the treatment of acute, subacute, or postoperative pain.

Recommendation 148. Due to the elevated risk of death due to respiratory depression, opioids should not be prescribed with benzodiazepines, antihistamines, or other central nervous system depressants or when there is a significant risk resulting from concurrent alcohol or substance use.

Recommendation 149. Opioid medications, including tramadol, are not generally recommended for use in patients with a history of opioid dependence. However, if an opioid medication is deemed clinically appropriate, a referral to a pain management specialist is acceptable.

Section 9.vi. Tobacco Cessation and Supplements Recommendation 150. Tobacco cessation (including medication, behavioral, and laboratory support) is acceptable when tobacco use is expected to negatively impact claim-related medical outcomes.

Medications may include nicotine patches, gum, inhaler, lozenges or nasal spray, bupropion, or varenicline.

Section 9.vii. Topical Medications Recommendation 151. Topical medications as single agents are acceptable for pain management for acute and subacute upper extremity injuries. This includes topical capsaicin, lidocaine, and non-steroidal anti-inflammatory drugs (NSAIDs) when oral NSAID use is contraindicated due to systemic side effects.

Recommendation 152. Topical medications must be started with the lowest dose expected to result in functional improvement and then titrated until functional improvement is noted.

Recommendation 153. For information about compounded topical agents and chronic pain considerations, see the Chronic Pain Disorder Medical Treatment Guidelines (MTGs). The recommendations in that MTG are also applicable to acute and subacute shoulder injury.

Section 10. Interdisciplinary Rehabilitation Recommendation 154. Interdisciplinary rehabilitation is acceptable for individuals who have not responded to less intensive modes of treatment or individuals who require concurrent treatment for chemical dependency. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for additional information, including indications, recommendations, and time frames.

Appendix Functional Outcome Measures Name of Test Body Part Description 36-Item Short Form Survey (SF-36) and 12-Item Short Form Survey (SF-12)

Physical Health Assesses activities of daily living (ADLs)

Brief Pain Inventory General Sleep, walking, ADLs Focus on Therapeutic Outcomes (FOTO) Various Body Parts Functional ADLs specific to body part Oxford Shoulder Instability Score Shoulder Functional ADLs Quick DASH (Disabilities of the Arm, Shoulder and Hand)

Upper Shoulder, elbow and hand assessment Simple Shoulder Test Shoulder Shoulder function only Upper Extremity Functional Scale Upper Functional ADLs related to Upper Psychological Screens Name of Test Description Brief Battery for Health Improvement, nd Edition (BBHI 2)

Measures pain, functioning, somatization, depression, anxiety, and defensiveness; brief measure of risk factors for delayed recovery Distress and Risk Assessment Method (DRAM) Measures depression and somatic symptoms of anxiety, risk factors commonly associated with chronic pain Center for Epidemiological Studies Depression Scale (CES-D)

Measures depression, 20 items Beck Depression Inventory-II (BDI-II) Measures depression, 21 items Primary Care Evaluation for Mental Disorders (PRIME-MD) Must be filled out by a provider 2 components: paper and pencil screen for patient and follow–up interview by physician. Assesses mood, anxiety, somatoform tendencies, and alcohol and eating disorders Zung Depression Inventory Measures depression, brief measure Patient Health Questionnaire (PHQ) and PHQ-9 Self-administered version of the PRIME-MD. Assesses mood, anxiety, somatoform tendencies, and alcohol and eating disorders Name of Test Description Generalized Anxiety Disorder Scale (GAD-7) Assesses generalized anxiety, 7 questions Behavioral Health Index-Multimedia Version (BHI- MV)

Screens for addiction _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 18: Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 05 Rule 17, Exhibit 5 - CUMULATIVE TRAUMA CONDITIONS MEDICAL TREATMENT GUIDELINES {#sec-7-ccr-1101-3-r17-ex-05 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 05}

DEPARTMENT OF LABOR AND EMPLOYMENT

WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

RULE 17, EXHIBIT 5 CUMULATIVE TRAUMA CONDITIONS MEDICAL TREATMENT GUIDELINES 7 CCR 1101-3 Rule 17 - Exhibit 5 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ A. INTRODUCTION This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of guidelines for physicians/providers treating individuals qualifying under Colorado’s Workers’ Compensation Act as injured workers with cumulative trauma conditions.

Although the primary purpose of this document is advisory and educational, these guidelines are enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from these guidelines, as individual cases dictate. Therefore, these guidelines are not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip nor overlook any sections.

B. GENERAL GUIDELINES PRINCIPLES

The principles summarized in this section are key to the intended implementation of all Division of Workers’ Compensation guidelines and critical to the reader’s application of the guidelines in this document.

1. APPLICATION OF THE GUIDELINES: The Division provides procedures to implement medical treatment guidelines and to foster communication to resolve disputes among the provider, payer, and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the Office of Administrative Courts.

2. EDUCATION: Education of the patient and family, as well as the employer, insurer, policy makers, and the community should be the primary emphasis in the treatment of chronic pain and disability. Currently, practitioners often think of education last, after medications, manual therapy, and surgery. Practitioners must implement strategies to educate patients, employers, insurance systems, policy makers, and the community as a whole.

An education-based paradigm should always start with inexpensive communication providing reassuring and evidence-based information to the patient. More in-depth patient education is currently a component of treatment regimens which employ functional, restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention.

3. INFORMED DECISION MAKING: Providers should implement informed decision making as a crucial element of a successful treatment plan. Patients, with the assistance of their health care practitioners, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, physical therapists, and other members of the health care team play an integral role in informed decision making and achievement of functional goals. Patient education and informed decision making should facilitate self-management of symptoms and prevention of further injury.

4. TREATMENT PARAMETER DURATION: Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Obviously, duration will be impacted by patient compliance, as well as availability of services.

Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

5. ACTIVE INTERVENTIONS: Emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, is generally emphasized over passive modalities, especially as treatment progresses. Generally, passive interventions facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

6. ACTIVE THERAPEUTIC EXERCISE PROGRAM: Goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

7. POSITIVE PATIENT RESPONSE: Results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to, positional tolerances, range-of-motion, strength, endurance, activities of daily living (ADL), cognition, psychological behavior, and quantifiable efficiency/velocity measures.

Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation. Anatomic correlation must be based on objective findings.

8. RE-EVALUATE TREATMENT EVERY 3 TO 4 WEEKS: If a given treatment or modality is not producing positive results within three to four weeks, the treatment should be either modified or discontinued. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results. Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

9. SURGICAL INTERVENTIONS: Surgical interventions should be contemplated within the context of expected functional outcome and not purely for the purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic condition(s).

10. SIX-MONTH TIME FRAME: The prognosis drops precipitously for returning an injured worker to work once he/she has been temporarily totally disabled for more than six months. The emphasis within these guidelines is to move patients along a continuum of care and return to work within a six-month time frame, whenever possible. It is important to note that time frames may not be pertinent to injuries that do not involve work-time loss or are not occupationally related.

11. RETURN-TO-WORK: A return-to-work is therapeutic, assuming the work is not likely to aggravate the basic problem or increase long-term pain. The practitioner must provide specific physical limitations, and the patient should never be released to non-specific and vague descriptions such as “sedentary” or “light duty.” The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, data entry and other repetitive motion tasks, sustained grip, tool usage, and vibration factors. Even if there is residual chronic pain, return-to-work is not necessarily contraindicated.

The practitioner should understand all of the physical demands of the patient’s job position before returning the patient to full duty and should request clarification of the patient’s job duties. Clarification should be obtained from the employer or, if necessary, from including, but not limited to, an occupational health nurse, occupational therapist, vocational rehabilitation specialist, an industrial hygienist, or another professional.

12. DELAYED RECOVERY: Strongly consider a psychological evaluation, if not previously provided, as well as initiating interdisciplinary rehabilitation treatment and vocational goal setting, for those patients who are failing to make expected progress 6 to 12 weeks after an injury. The Division recognizes that 3 to 10% of all industrially injured patients will not recover within the timelines outlined in this document, despite optimal care. Such individuals may require treatments beyond the timelines discussed within this document, but such treatment requires clear documentation by the authorized treating practitioner focusing on objective functional gains afforded by further treatment and impact upon prognosis.

13. GUIDELINES RECOMMENDATIONS AND INCLUSION OF MEDICAL EVIDENCE: All recommendations are based on available evidence and/or consensus judgment. When possible, guideline recommendations will note the level of evidence supporting the treatment recommendation. It is generally recognized that early reports of a positive treatment effect are frequently weakened or overturned by subsequent research. When interpreting medical evidence statements in the guideline, the following apply: ● Consensus means the judgment of experienced professionals based on general medical principles. Consensus recommendations are designated in the guidelines as “generally well-accepted,” “generally accepted,”

“acceptable/accepted,” or “well-established.” ● “Some evidence” means the recommendation considered at least one adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the intervention’s effect. ● “Good evidence” means the recommendation considered the availability of multiple adequate scientific studies or at least one relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the intervention’s effect. ● “Strong evidence” means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the intervention’s effect.

All recommendations in the guideline are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guideline as “not recommended.”

14. CARE BEYOND MAXIMUM MEDICAL IMPROVEMENT (MMI): MMI should be declared when a patient’s condition has plateaued to the point where the authorized treating physician no longer believes further medical intervention is likely to result in improved function. However, some patients may require treatment after MMI has been declared in order to maintain their functional state. The recommendations in this guideline are for pre-MMI care and are not intended to limit post-MMI treatment. The remainder of this document should be interpreted within the parameters of these guidelines principles that may lead to more optimal medical and functional outcomes for injured workers.

C. DEFINITIONS AND MECHANISMS OF INJURY

Cumulative trauma related conditions (CTC) of the upper extremity comprise a heterogeneous group of diagnoses which include numerous specific clinical entities including disorders of the muscles, tendons and tendon sheaths, nerves, joints and neurovascular structures.

The terms “cumulative trauma disorder”, “repetitive motion syndrome”, “repetitive strain injury”, “myofascial pain” and other similar nomenclatures are umbrella terms that are not acceptable, specific diagnoses. The health care provider must provide specific diagnoses in order to appropriately educate, evaluate, and treat the patient. Examples include: de Quervain’s disease, cubital tunnel syndrome, and lateral/medial epicondylitis (epicondylalgia). Many patients present with more than one diagnosis, which requires a thorough upper extremity and cervical evaluation by the health care provider. Furthermore, there must be a causal relationship between work activities and the diagnosis (See Section D.3 Initial Diagnostic Procedures, Medical Causation Assessment). The mere presence of a diagnosis that may be associated with cumulative trauma does not presume work-relatedness unless the appropriate work exposure is present.

Mechanisms of injury for the development of cumulative trauma related conditions have been controversial. However, repetitive awkward posture, force, vibration, cold exposure, and combinations thereof are generally accepted as occupational risk factors for the development of cumulative trauma related conditions.

Evaluation of cumulative trauma related conditions require an integrated approach that may include ergonomics assessment, clinical assessment, past medical history and psychosocial evaluation on a case-by-case basis.

The normal working age population may have non-specific pain complaints that require minimum treatment and may be considered part of the normal aging process. When pain continues or a complete history indicates a potential for other diagnoses, a medical workup may be necessary to screen for other diseases. However, in cases where there is no specific diagnosis and corresponding work related etiology, the work-up should generally be performed outside of the workers’ compensation system.

D. INITIAL DIAGNOSTIC PROCEDURES

The Division recommends the following diagnostic procedures be considered, at least initially, the responsibility of the workers’ compensation carrier to ensure that an accurate diagnosis and treatment plan can be established. Standard procedures that should be utilized when initially diagnosing a work-related upper extremity complaint are listed below.

1. HISTORY-TAKING AND PHYSICAL EXAMINATION (HX & PE)

History-taking and physical examination are generally accepted, well-established and widely used procedures that establish the foundation for subsequent stages of diagnostic and therapeutic procedures. When findings of clinical evaluations and those of other diagnostic procedures are not complementing each other, the objective clinical findings should have preference. The medical records should reasonably document the following:

a. History of Present Injury i. Age, hand dominance, and gender should be documented.

ii. Onset: date of onset, triggering event (if present) versus gradual onset.

Activity at or before onset of symptoms.

iii. Nature of symptoms: pain, numbness, tingling, weakness, swelling, stiffness, temperature change, moisture change, and color change.

iv. Functional Assessment: Functional ability should be assessed and documented at the beginning of treatment. Periodic assessment should be recorded throughout the course of care to follow the trajectory of recovery. Functional measures are likely to be more reliable over time than pain measures.

Patient-reported outcomes, whether of pain or function, are susceptible to a phenomenon called response shift. Response shift refers to changes in self-evaluation, which may accompany changes in health status.

Patient self-reports may not coincide with objective measures of outcome, due to reconceptualization of the impact of pain on daily function and internal recalibration of pain scales. Response shift may obscure treatment effects in clinical trials and clinical practice, and it may lead to apparent discrepancies in patient-reported outcomes following treatment interventions. While methods of measuring and accounting for response shift are not yet fully developed, understanding that the phenomenon exists can help clinicians understand what is happening when some measures of patient progress appear inconsistent with other measures of progress.

v. Pain: any history of pain, intermittent or constant, and intensity. A pain scale (0 = no pain, and 10 = worst imaginable pain) may be used. The use of a patient completed pain drawing, Visual Analog Scale (VAS) is highly recommended, especially during the first 2 weeks following injury to assure that all work related symptoms are addressed. Use comprehensive pain diagrams as it is important to solicit the reporting of more proximal symptoms. Evaluate the patient's overall pain behavior.

The behavior should be consistent with the current pain levels reported by the patient. Pain assessments should include a description of functional activity performed by the patient at various pain levels.

vi. Provocative and alleviating factors (occupational and non-occupational):

Identify the specific physical factors that are aggravating or alleviating the problem. Include the patient's perception of cause of symptoms.

vii. Sleep disturbances secondary to the condition including sleeping viii. Other associated signs and symptoms noted by the injured worker.

ix. Ability to perform activities of daily living (ADLs): ADLs include such activities as self-care and personal hygiene, communication, ambulation, attaining all normal living postures, travel, non-specialized hand activities, sexual function, sleep, and social and recreational activities.

Specific movements in this category include: pinching or grasping keys/pens/other small objects (brushing teeth, doing laundry), grasping cups or other similar-sized objects, and opening jars. The quality of these activities is judged by the independence, appropriateness, and effectiveness with which they are completed. Assess not simply the number of restricted activities but the overall degree of restriction or combination of restrictions.

x. Prior occupational and non-occupational injuries to the same area including specific prior treatment and any prior supportive devices.

xi. Discussion of any symptoms present in the uninjured extremity or similar symptoms in the lower extremities.

xii. Patient’s expectation of recovery and return to work.

b. Relationship to Work and Other Activity Assess the individual’s ability to perform job duties. This frequently includes a job site evaluation including an ergonomic assessment as well as the patient’s description of the job duties. Job title alone is not sufficient information. The clinician is responsible for documenting specific information regarding repetition, force, other risk factors, and duration of employment. Refer to risk factors as listed in Section D.3.d Risk Factors Definitions Table and Section D.3.e Diagnosis-Based Risk Factors Table. A formal job site evaluation may be necessary. A formal job site evaluation may not be necessary when the physician is intimately familiar with the job position and associated work activities and there are no new job alterations.

Information should be obtained regarding other employment, sports, recreational, and avocational activities that might contribute to or be impacted by the cumulative trauma condition. Activities such as video gaming, smartphone use, crocheting/needlepoint, baseball/softball, playing musical instruments, home computer operation, golf, tennis, and gardening are included in this category.

Duration of these activities should be documented. In most cases, the duration of these activities will be less than three hours per day, the minimum necessary to meet the causation standard. Therefore, these activities will not be considered major contributions to the medical condition.

Behavioral adaptations to symptoms should be documented.

c. Past History i. Demographics.

ii. Past injury/symptoms involving the upper extremities, trunk and cervical spine.

iii. Past work-related injury or occupational disease.

iv. Past personal injury or disease that resulted in temporary or permanent job limitation.

v. Medical conditions associated with cumulative trauma: The following are examples of medical conditions which have been commonly seen in association with cumulative trauma conditions. These require treatment and may impact the recovery of the work comp injury.

A) Amyloidosis;

B) Arthropathies, including connective tissue disorders, rheumatoid arthritis, systemic lupus erythematosus, gout, osteoarthritis and spondyloarthropathy;

C) Cancer;

D) Diabetes mellitus, including family history or gestational diabetes;

E) Hypothyroidism, especially in older females;

F) Obesity;

G) Pregnancy;

H) Depression.

vi. History of smoking and alcohol use; history of substance abuse;

vii. Medication history including, birth control pills, corticosteroid use, and other prescription and non-prescription medications; and viii. Psychosocial history (including history of hobbies and recreational activities).

d. Physical Examination The evaluation of any upper extremity complaint should begin at the neck and upper back and then proceed down to the fingers and include the contralateral region. It should include evaluation of vascular and neurologic status, and describe any dystrophic changes or variation in skin color or turgor. A description of the patient’s general posture (e.g., neck rotation, shoulder depression, spine kyphosis), and body mass index [BMI] should be documented. Additional physical exam components may be necessary based on past medical history.

A neurological examination typically includes bilateral assessments of pinprick, 2 point sensation as applicable, motor strength and reflexes. These assessments of the upper extremities including a vascular assessment will provide information regarding polyneuropathic processes such as diabetic neuropathy. Vibratory sense and Achilles reflexes are frequently lost in diabetic neuropathy. Decreased response to cold temperature or pain response to cold temperature has been related to radicular findings in the spine as discriminated from axial pain. To confirm a reported hypoalgesic area, some examiners may choose to complete multiple tests that may be done with the patient’s eyes closed: 1) having the patient say yes or no whenever the patient thinks a stimulus has been applied; 2) repeatedly redefining the affected area.

Refer to the following Physical Examination Findings Reference Tables for details.

e. Physical Examination Findings Reference Table: Specific Musculoskeletal Diagnoses Aggravated Osteoarthritis of the Wrist Pain usually in the carpometacarpal joints; or in metacarpophalangeal joints. ● Positive grind test resulting in pain; crepitus; ● Subluxation of the metacarpal may be induced in advanced cases; ● Swelling; ● Reduced motion; ● Angular deformities; ● Tenderness with palpation of thumb metacarpophalangeal or carpometacarpal joint. de Quervain’s Disease Tenderness over the first dorsal extensor compartment (anatomical snuff box). ● Pain worsened by resisted thumb abduction and/or extension with or without resistance; ● Positive Finkelstein’s test.

Epicondylitis- Lateral (Epicondylalgia)

Elbow pain over the lateral epicondyle increased with gripping.

Tenderness to palpation at/near lateral epicondyle and pain over the lateral epicondyle and/or extensor mass of the forearm with one of the following maneuvers: ● Active or resisted wrist extension; ● Active or resisted middle finger extension; ● Active or resisted supination.

Epicondylitis- Medial (Epicondylalgia)

Elbow pain over the medial epicondyle. Tenderness to palpation at/near medial epicondyle and pain over the medial epicondyle and/or flexor mass of the forearm with one of the following maneuvers: ● Active or resisted wrist flexion; ● Active or resisted pronation.

Extensor Tendon Disorders of the Wrist Pain localized to the affected tendon(s) worsened by wrist or finger extension.

Pain and/or tenderness with active or resisted wrist/digit extension, specific to the extensor mechanism involved.

Flexor Tendon Disorders of the Wrist Pain/tenderness localized to affected tendons.

Reproduction of pain with active or resisted wrist/digit flexion or ulnar deviation specific to the flexor mechanism involved.

Triangular Fibrocartilage Complex Tear (TFCC)

Symptoms mainly on ulnar side of the wrist.

Tenderness over the TFCC complex and localized pain, clicking, or findings of abnormal motion with one of the following movements: ● Forced supination and pronation with axial pressure on an ulnar deviated wrist; ● The patient pushes up from a seating position using the hand, and/or ● Ballottement of the distal ulna with the wrist supinated causes abnormal motion as compared to the asymptomatic side.

Trigger Finger Difficulty flexing the finger with a catching or triggering sensation.

One of the following: ● Tenderness at the A-1 pulley with finger flexion; ● Triggering of the digit; ● Difficulty flexing and extending the finger with a palpable nodule.

f. Physical Examination Findings Reference Table: Specific Peripheral Nerve Diagnoses Specific paresthesias in 2 of the following digits: thumb, index, and middle finger.

Shaking of the hand (to relieve symptoms) and nocturnal symptoms are common. ● Positive Phalen’s sign; ● Positive Tinel’s sign over the carpal tunnel; ● Positive closed fist test; ● Positive compression test; ● Thenar atrophy may be present later in course; ● Weakness of abductor pollicis brevis; ● Sensory loss to pinprick, light touch, two-point discrimination or Semmes-Weinstein monofilament tests in a median nerve distribution. No loss of sensation in the central palm.

Cubital Tunnel Paresthesias or dull, aching sensations in the 4th and 5th digits (ring and small fingers) and discomfort near the medial aspect of the elbow.

Paresthesias or dull, aching in the 4th and 5th digits and at least one of the following exam findings: ● Diminished sensation of the fifth and ulnar half of the ring fingers, which may sometimes include sensory loss to pinprick, light touch, two-point discrimination or Semmes-Weinstein monofilament tests in an ulnar nerve distribution; ● Positive elbow flexion/ulnar compression test; ● Later stages manifested by: intrinsic atrophy and ulnar innervated intrinsic weakness;

Wartenberg’s sign; Froment’s sign.

Guyon Canal (Tunnel)

Paresthesias in the 4th and 5th digits (ring and small fingers) without proximal ulnar complaints.

At least one of the following exam findings: ● Positive Tinel’s at hook of hamate; ● Numbness or paresthesias of the palm surface of the ring and small fingers; ● Decreased strength of the adductor pollicis, abductor digiti minimi, and/or lumbricals.

Posterior Interosseous Nerve Entrapment (PIN)

Weakness of finger and thumb extension Weakness or inability to extend fingers, thumb or wrist in neutral or ulnar deviation;

Pronator Syndrome Pain/paresthesias in the median nerve distribution distal to the elbow.

Paresthesias in the median nerve distribution and at least one of the following reproduces median nerve symptoms:

Pronator Syndrome, continued ● Resisted pronation with elbow flexed at 90 degrees or elbow extended; ● Positive Tinel’s at the proximal edge of the pronator teres muscle over the median nerve.

Radial Tunnel Pain over the lateral posterior forearm. May occur in conjunction with and must be distinguished from lateral epicondylitis.

May include paresthesias over the dorsal radial hand and wrist.

The following two elements are required: ● Tenderness over the radial nerve near the proximal edge of the supinator muscle; ● Resisted supination or resisted middle finger extension with the forearm pronated and extended reproduces symptoms.

2. LABORATORY TESTING

Laboratory tests are generally accepted, well-established and widely used procedures. Patients should be carefully screened at the initial exam for signs or symptoms of diabetes, hypothyroidism, arthritis, and related inflammatory diseases. The presence of concurrent disease does not refute work-relatedness of any specific case. This frequently requires laboratory testing.

In one study of patients with cumulative trauma conditions (other than carpal tunnel syndrome) who have been seen by specialists, 3% were diagnosed with diabetes, 6% with hypothyroidism, and 9% with a chronic inflammatory disease including spondyloarthropathy, arthritis, and systemic lupus erythematosus. Up to two thirds of the patients were not aware of their concurrent disease. When a patient's history and physical examination suggest infection, metabolic or endocrinologic disorders, tumorous conditions, systemic musculoskeletal disorders (e.g., rheumatoid arthritis or ankylosing spondylitis), or problems potentially related to medication (e.g., renal disease and non-steroidal anti-inflammatory medications), then laboratory tests, including, but not limited to the following can provide useful diagnostic information:

a. Thyroid stimulating hormone (TSH) for hypothyroidism;

b. Diabetic screening: recommended for men and women with a BMI over 30, patients with a family history of diabetes, those from high risk ethnic groups, and patients with a previous history of impaired glucose tolerance. There is some evidence that patients with upper extremity disorders are less likely to control their diabetes. Therefore, it is appropriate to order a hemoglobin A1c to screen any diabetic patients with a cumulative trauma condition or for initial screening;

c. Serum protein electrophoresis;

d. Sedimentation rate and C-reactive protein (CRP) are nonspecific but elevated in infection, neoplastic conditions and rheumatoid arthritis. Other screening tests to

rule out inflammatory or autoimmune disease may be added when appropriate;

e. Serum calcium, phosphorus, uric acid, alkaline and acid phosphatase for metabolic, endocrine and neo-plastic conditions;

f. Complete blood count (CBC), liver and kidney function profiles for metabolic or endocrine disorders, or for adverse effects of various medications;

g. Bacteriological (microorganism) work-up for wound, blood, and tissue;

h. Serum B6: Routine screening is not recommended due to the fact that Vitamin B6 supplementation has not been proven to affect the course of carpal tunnel syndrome. However, it may be appropriate for patients on medications that interfere with the effects of Vitamin B6 or for those with significant nutritional problems.

The Division recommends that the workers’ compensation carrier cover initial lab diagnostic procedures to ensure that an accurate diagnosis and treatment plan is established. When the authorized treating provider has justification for the test, insurers should cover the costs. Laboratory testing may be required periodically to monitor patients on chronic medications.

3. MEDICAL CAUSATION ASSESSMENT FOR CUMULATIVE TRAUMA CONDITIONS

General Principles of Medical Causation Assessment The clinician must determine if it is medically probable (greater than 50% likely or more likely than not) that the need for treatment in a case is due to a work-related exposure or injury. Treatment for a work-related condition is covered when: 1) the work exposure causes a new condition; or 2) the work exposure activates or exacerbates a previously asymptomatic latent medical condition; or 3) the work exposure combines with, accelerates, or aggravates a pre-existing symptomatic condition; or 4) the work exposure combines with a pre-existing co-morbid condition, such as diabetes, to render the occurrence of a cumulative trauma condition more probable in combination with the work related exposure. The provider should consider: “Is it medically probable that the patient would need the recommended treatment if the work exposure had not taken place?" If the answer is “yes,” then the condition is probably not work-related. In some cases, the clinician may need to order diagnostic testing or job site evaluations to make a judgment on medical probability.

The medical causation assessment for cumulative trauma conditions is not a substitute for a legal determination of causation/compensability by an Administrative Law Judge.

Legal causation is based on the totality of medical and non-medical evidence, which may include age, gender, pregnancy, BMI, diabetes, wrist depth/ratio, and other factors based on epidemiologic literature.

The steps in a medical causation assessment for cumulative trauma conditions are:

Step 1: Make a specific and supportable diagnosis. Remember that cumulative trauma, repetitive strain and repetitive motion are not diagnoses. Examples of appropriate diagnoses include: specific tendinopathies, strains, sprains, and mononeuropathies. Refer to Section F Specific Musculoskeletal Disorders and Section G Specific Peripheral Nerve Disorders for the specific findings of common cumulative trauma conditions. Less common cumulative trauma conditions not listed specifically in these Guidelines are still subject to medical causation assessment.

Step 2: Determine whether the disorder is known to be or is plausibly associated with work. The identification of work-related risk factors is largely based on comparison of the patient's work tasks with risk factors (as described in Section D.3.a Foundations for Evidence of Occupational Relationships and Section D.3.b Using Risk Factors to Determine Causation).

Step 3: Interview the patient to find out whether risk factors are present in sufficient degree and duration to cause or aggravate the condition. Consider any recent change in the frequency or intensity of occupational or non-occupational tasks. In some cases, a formal job site evaluation may be necessary to quantify the actual ergonomic risks. Refer to Section E.6.c Job Site Evaluations.

Step 4: Complete the required match between the risk factors identified in Section D.3.d Risk Factors Definitions Table and the established diagnosis using the system described in Section D.3.b. Remember that preexisting conditions may be aggravated by, or contribute to, exposures lower than those listed on the table.

Those preexisting conditions must be determined by the authorized treating physician based on physiologic plausibility.

Step 5: Determine whether a temporal association exists between the workplace risk factors and the onset or aggravation of symptoms.

Step 6: Identify non-occupational diagnoses, such as rheumatoid arthritis, obesity, diabetes, as well as avocational activities, such as golf and tennis. This information can affect the medical causation assessment. It may be applicable when exposure levels are low and the case does not meet evidence-based criteria.

a. Foundations for Evidence of Occupational Relationships All results described in this section are a result of a thorough review of the epidemiologic literature available at the time of these Guidelines. One limitation of an epidemiological literature review is that studies rely most heavily upon healthy worker populations and may not reflect the worker population with other concurrent disease or comorbidities. No single epidemiological study fulfills all the criteria for medical causation. Consequently, individual variability lies outside the scope of epidemiological studies and must be addressed by a physician who takes into account not only force, posture, and repetition but also other premorbid risk factors.

The clinician is responsible for documenting specific information regarding the force, posture, repetition, and other risk factors as listed in Section D.3.d Risk Factors Definitions Table. Job title alone is not sufficient to determine the risk factors. A job site evaluation is usually necessary.

Many studies have been completed in industrial settings and focus on cumulative trauma conditions or upper extremity complaints in relationship to work exposures. The studies vary in several ways that directly affect the interpretation of their results. Studies that provide the strongest evidence have 1) an accepted clinical exam confirming the diagnosis and 2) work exposures validated by direct observation or questionnaires that were correlated with direct observation. Welldone, prospective, longitudinal studies (cohort studies) are preferred. However, for uncommon disorders, these studies may not be able to identify all factors contributing to causation. These Guidelines consider other large prevalence and incidence studies which meet minimum quality criteria and use reliable questionnaires for self-reported exposure.

Many studies report symptoms rather than diseases. These studies are useful for ergonomic research or as pilot studies but do not directly affect the evidence level for causation. They are mentioned, when useful, as indirect evidence. If multiple well-done symptom studies show no increase in symptomatology with specific activities, it follows that there is very little chance that the studied exposure causes disease.

In addition, there are a few studies which address less common musculoskeletal diagnoses or peripheral nerve conditions other than carpal tunnel syndrome, such as posterior interosseous nerve entrapment and pronator syndrome. In these cases, these Guidelines rely upon studies which report the risks for related conditions.

Many of the original studies identifying diagnosable cumulative trauma conditions were performed in manufacturing industries and meat, fish and poultry processing companies. In these industries, most workers are exposed to highly repetitive mono-task jobs which frequently involve a forceful grip, awkward postures, vibration, and cold environments. The evidence for increased disorders when these multiple risk factors are present is compelling. Research attempting to define clear, threshold exposure limits for increased risk from isolated tasks and/or intermittent exposures has less consistent results.

The quality of keyboarding studies is highly variable. Most of the studies rely on self-report. Self-report appears to approximately double the actual time spent using the keyboard. Some studies show distortion highest in the medium range of use. There appears to be less inflation for self-reported mouse use.

Fortunately, a few studies have provided more objective keyboard use data.

The group of studies now available provides good evidence that keyboarding in a reasonable ergonomic posture (wrist with 30 degrees or less of extension and 15 degrees or less of radial deviation) up to 7 hours per day under usual conditions is very unlikely to cause carpal tunnel syndrome or other upper extremity disorders. This conclusion is based on studies of carpal tunnel pressure under a variety of typing and wrist positions as well as a number of studies of workers who keyboard on a regular basis. Clinicians may determine in a particular case that there is a relationship based on the ergonomic conditions or on excessive typing, such as more than 7 hours per day of essentially uninterrupted keyboard use or full-day court reporting.

There is some evidence that mouse use appears to be associated with carpal tunnel syndrome and related symptoms with 4 hours or greater of continuous use per day. Studies of pressure within the carpal tunnel indicated that pressures may rise to levels which could affect the median nerve when the mouse is being dragged or clicked. Again, the actual ergonomics of the work place should be considered for each individual patient before making a final causation decision.

There is a large variety in assessment strategies for lower quality studies.

Examples include: 1) symptom only reports; 2) dichotomous choices for exposures, e.g., 1 hour or less per week of repetitive activities versus more than 1 hour per week; 3) self-reported data that does not follow basic pathophysiology, e.g., mouse use between 2.5 and 5 hours per week causing wrist pain; and 4) bias introduced due to prior knowledge of the participants regarding expected work and symptom correlations. In order to reasonably integrate the volume of disparate data, interpretation of lower quality studies took into account reasonable pathophysiology and exposure limits. Dose response relationships were also examined to look for trends in exposure which resulted in increased disease or symptoms.

Most studies were unable to truly assess repetition alone. Indirect evidence from a number of studies supports the conclusion that task repetition up to 6 hours per day unaccompanied by other risk factors is not causally associated with cumulative trauma conditions. Risk factors likely to be associated with specific CTC diagnostic categories include: extreme wrist or elbow postures; force including regular work with hand tools greater than 1 kg or tasks requiring greater than 50% of an individual’s voluntary maximal strength; work with vibratory tools at least 2 hours per day; or cold environments.

The variability in study design presented a challenge for creating physiologically reasonable hour limits for the specific primary and secondary risk factors. These Guidelines define risk factor cutoff measures by selecting the strongest studies for specific risks and extrapolating measures. For example, ¾ of a day exposure was translated to a 6 hour exposure. Exposure measures and groups extrapolated in this manner constitute the primary risk factor definitions used in these Guidelines.

Regarding secondary risk factors, the previous version of these Guidelines used a 4 hour exposure cutoff for determining physiologically acceptable limits based on: 1) one study which provides some direct evidence of 4 hours for the most common risks and 2) indirect evidence from other studies, such as one assessing upper extremity functional impairment and another determining the presence of upper extremity symptoms. Two new studies now suggest that 3 hours is a preferable cutoff for determining physiologically acceptable secondary risks.

No studies examined the relationship between the development of ganglion cysts and work activities. However, work activities, such as bending or twisting of the wrist repetitively, may cause an aggravation of existing ganglion cysts that interferes with function.

Aggravation of a pre-existing medically established diagnosis must be determined on an individual case basis. A comparison of the worker’s specific job duties with usual activities of daily living and the occupational risk factors should contribute to the discussion.

Non-occupational exposures Most studies demonstrate an association of cumulative trauma conditions with older age; high BMI; the presence of other upper extremity musculoskeletal diagnoses; related diseases such as auto-immune conditions, diabetes, hypothyroidism and rheumatologic diseases; and psychosocial issues including relationships with supervisors. The influence of these non-occupational risk factors varies according to the specific diagnoses involved. These additional factors may contribute to the disorder and may impact legal causation, but they do not negate the actual evidence from the defined risk factors supporting a specific work related condition.

Use Section D.3.d Risk Factors Definitions Table and Section D.3.e Diagnosis- Based Risk Factors Table with the following directions to formulate the causation of diagnoses established as cumulative trauma conditions.

b. Using Risk Factors for Medical Causation Assessment of Cumulative Trauma Conditions The physician should perform the following:

Step 1. Determine the diagnosis.

Using the history, physical examination and supporting studies, a medical diagnosis must be established. Refer to Section F Specific Musculoskeletal Diagnosis and Section G Specific Peripheral Nerve Diagnosis. Less common cumulative trauma conditions not listed specifically in these Guidelines are still subject to medical causation assessment.

Step 2. Clearly define the job duties of the worker.

Do not rely solely on the employer’s description of job duties. The worker’s description of how they actually perform the duties is extremely important. Job site evaluations are always appropriate, but they are sometimes unnecessary when the physician can identify the job duty that appears to be causing the symptoms and provide a method for ergonomically correcting the activity. Job site evaluations performed to identify risk factors should always include appropriate ergonomic alterations. It may not be possible to recommend ergonomic alterations in industrial settings where the employer is incapable of making changes or ergonomic changes are not feasible.

Step 3. Compare the worker’s duties with the Primary Risk Factor Definition Table.

Hours are calculated by adding the total number of hours per day during which the worker is exposed to the defined risk. Breaks, time performing other activities, and inactive time are not included in the total time. When the employee meets the definition for a sole Primary Risk Factor and the risk factor is physiologically related to the diagnosis, it is likely that the worker will meet causation for the cumulative trauma condition. When the Primary Risk Factor identified is not physiologically related to the diagnosis, causation will not be established at this point. The provider then needs to consider Step 4.

Step 4. Compare the worker’s risk factors identified in Step 2 with the Secondary Risk Factor definitions on the Risk Factor Definition Table. If secondary risk factors are identified, proceed to the Diagnosis Based Risk Factor Table.

When no Primary Risk Factors are present but one or more Secondary Risk Factors are found on the Risk Factor Definitions Table, proceed to the Diagnosis Based Risk Factor Table. Elements in this table are listed under the strength of evidence headings. This includes a category for strength of evidence for risks that have been demonstrated not to be related to the diagnosis. Consult the diagnostic category pertaining to the worker. For a number of less common diagnoses, little direct research has been done that meets the quality standards. Therefore, the risk factors for these diagnoses use the risk factors from physiologically related, better researched diagnostic titles. Initially, check the evidence statements for or against causation based on the secondary risks identified previously. If the Diagnosis Based Risk Factor table establishes a match between the Secondary Risk Factor(s) and other job duties using the evidence based columns for the established diagnosis, the case is likely work-related. If none of the evidence categories match the worker, causation based solely on epidemiological evidence from research has not been established.

Step 5. If an evidence-based medical causation relationship, based on Steps 1- 4, has not been established and the worker has one Secondary Risk Factor from Section D.3.d Risk Factors Definitions Table, the physician may consult the last column of Section D.3.e Diagnosis-Based Risk Factors Table entitled “Additional Risk Factors.” This category describes medically accepted physiological risk factors for the diagnosis and risk factors which demonstrated an association with the diagnosis in lower quality studies that did not meet the standards of evidence. Some of the additional risk factors have less clear definitions due to lack of definition in the lower quality studies. These risk factors were added only when the medical professionals on the multi-disciplinary task force agreed they were physiologically plausible. When a Secondary Risk Factor has been identified that does not meet the evidence based definitions Section D.3.e Diagnosis-Based Risk Factors Table, physicians may use the other “Additional Risk Factors,” as appropriate, to establish the presence of combined risk factors. The worker must have met at least one of the Secondary Risk Factor definitions from the Risk Factors Definition Table and that risk factor must be physiologically related to the diagnosis, in order to use the “Additional Risk Factors” in the Diagnosis Based Risk Factor Table. Additional Risk factors that duplicate the conditions in the Secondary Risk Factor identified for the case may not be used. Any conclusions using this methodology are not strictly evidence-based and therefore the physician should include a discussion of why the Additional Risk Factors are pertinent in the particular case.

c. Algorithmic Steps for Medical Causation Assessment Step 2 – Job duties clearly described. Job evaluation may be necessary.

Job duties meet the following on risk factor definitions from the table Neither Primary nor Secondary risks from the Risk Factor Definition Table are present One or more Primary risk factors from the Risk Factor Definition Table are present One or more Secondary risk factors from the Risk Factor Definition Table are present, without primary risk factors Primary risk factor is Go to Step 4 algorithm Case probably not job related Physiologically related to diagnosis Not physiologically related to diagnosis medically work related No secondary physiologically related factor is present A physiologically related Secondary Risk Factor is present go to Step 4 Algorithm Case is probably not medically work related* Step 3 Step 1 – Diagnosis established using Section D.1.f Tables Algorithmic Steps for Medical Causation Assessment continued *In the case of an aggravation or exacerbation of a pre-existing condition, the provider will need to make an individualized causation decision based on the presence of other accompanying conditions.

Step 4 – Consult Diagnosis-Based Risk Factor tables Secondary Risk Factors matches Diagnostic-Based Risk Factors tables medically work related Secondary risk is physiologically related to the diagnosis but does not meet Diagnosis-Based Risk Factors No Additional present not medically work related An Additional Risk Factor present from the Diagnosis-Based Risk Factor table that does not overlap the Secondary Case may be work related d. Risk Factors Definitions Table Category As a Primary Risk Factor Secondary Risk Factor Force and Repetition/Duration 6 hrs. of: use of 2 pounds pinch force or 10 pounds hand force 3 times or more per minute. 3 hrs. of: use of 2 pounds pinch force or 10 pounds hand force 3 times or more per minute. 6 hrs. of: lifting 10 lbs > 60x per hour. 3 hrs. of: lifting 10 lbs > 60x per hour. 6 hrs. of: use of hand held tools weighing 2 lbs or greater. 3 hrs. of: use of hand held tools weighing 2 lbs or greater.

Awkward Posture and Repetition/Duration 4 hrs. of: Wrist flexion > 45 degrees, extension > 30 degrees, or ulnar deviation > 20 degrees. 6 hrs. of: Elbow - flexion > 90 degrees. 3 hrs. of: Elbow - flexion > 90 degrees. 4 hrs. of: Supination/pronation with task cycles 30 seconds or less or posture is used for at least 50% of a task cycle. 3 hrs. of: Supination/pronation of 45° with power grip or lifting.

Category As a Primary Risk Factor Secondary Risk Factor Computer Work Note: Up to 7 hours per day at an ergonomically correct workstation is not a risk factor.

Refer to Section H. 6.e Ergonomic Considerations Table for definition of ergonomic risk factors. > 4 hrs. of: Mouse use.

Use of handheld vibratory power tools and Duration 6 hrs. for more common types of vibration exposure. 2 hrs. when accompanied by other risks.

Cold Working Environment Ambient temperature of 45F or less for 4 hrs. or more, such as handling frozen foods that are 10 degrees. This risk factor does not stand alone. It is used in combination with other secondary risk factors. Refer to the following Diagnostic- Based Risk Factors Table.

e. Diagnosis-Based Risk Factors Table DIAGNOSIS-BASED RISK FACTORS Hours are calculated by totaling the cumulative exposure time to the risk over an 8 hour day. Breaks or periods of inactivity or performing other types of work tasks are not included. Unless the hours are specifically stated below, “combination” of factors described below uses the Secondary Risk Factor Definitions from the Risk Factor Definition Table.

Aggravated Osteoarthritis of the Thumb, Carpometacarpal (CMC) and Wrist No Quality Evidence Available Work studies support repetitive thumb movement 20 times per minute in women contributing to CMC arthritis.

Awkward Posture (depending on the joint involved).

Repetition of activities affecting the joint involved for 4 hrs.

Prior Injury.

Combination of force, repetition, and vibration. 2,4 Wrist bending or awkward posture for 4 hrs.

High repetition defined as task cycle times of less than 30 seconds or performing the same task for more than 50% of the total cycle time.

Syndrome, continued Combination of repetition and force for 6 hours.

Combination repetition and forceful tool use with awkward posture for 6 repetition, and awkward Combination of 2 pound pinch or 10 pound hand force 3 times or more per minute for 3 hours.

Mouse use more than 4 hours.

Combination cold and forceful repetition for 6 hours - Frozen food handling.

Good evidence - Keyboarding less than or equal to 7 hrs. in good ergonomic position IS NOT RELATED.

Good evidence- Repetition alone less than or equal to 6 hrs. IS NOT RELATED.

Tasks using a hand grip.

Extreme wrist radial/ulnar positions or elbows in awkward postures.

Cubital Tunnel Combination forceful tool use, repetition and probably posture for 6 hrs- Holding a tool in position with repetition.

Wrist bending and/or full elbow flexion/extension, repetition for 4 hours, vibration.

Repetitive pronation of forearm.³ Sustained pressure at the cubital tunnel.

DeQuervain’s Disease 2,4 Wrist in ulnar deviation.³ Repetitive thumb abduction and extension.

Precise hand motions e.g., dental hygienists.

Epicondylitis Lateral Combination – awkward posture (forearm supination past 45 degrees) and forceful lifting.

Combination force and possible awkward posture – study used repetition and turning and screwing.

Combination forearm pronation 45° or greater with power grip or lifting for 3 hours per day.

Combination of wrist bending for 4 hours and rotation the forearm for 2 hours.

Combination repetition and awkward posture including static Some evidence keyboard use IS NOT RELATED.

Wrist posture in extension and repetitive supination of the forearm and/or elbow extension.³ One adequate study Epicondylitis Medial Combination – force & repetition, force and wrist and hand repetition.

Combination of wrist bending for 4 hours and rotation the forearm for 2 Some evidence keyboard use IS NOT RELATED.

Wrist posture in flex and repetitive pronation and/or elbow extension.³ Extensor tendon disorders of the Wrist Combination - force & repetition, force and wrist and hand repetition.

Combination - forceful exertion and repetition 6 2, 4 Sustained tool use.

Awkward posture.³ No relationship to keyboard use is expected in a good ergonomic workstation.

Flexor tendon disorders of the Wrist 2, 4 Sustained tool use.

Awkward posture.

No relationship to keyboard use is expected in a good ergonomic workstation.

Guyon Canal No Quality Evidence Available. Ulnar wrist posture and flexion. Direct Posterior Interroseous Nerve Entrapment Refer to lateral epicondylitis section above for indirect evidence.

No specific evidence available.

Ulnar wrist posture and flexion. Direct Pronator Refer to medial epicondylitis section above for indirect evidence.

No specific evidence available.

Ulnar wrist posture and flexion. Direct Trigger Finger Hand tool use – 6 Repeated digital flexion.

Radial Tunnel Repetition and force - force of 1 kg with cycle time < 1 minute or awkward posture (static posture) elbow > 90 Repetitive Supination.

Extension of the elbow from 0 to 45 AGAINST Specific One adequate study Triangular Fibrocartilage Compression No Quality Evidence Available. Usually from traumatic hyperextension which may become symptomatic over time.

Wrist posture in extension and repetitive supination of the forearm and/or elbow extension.

For occupational, usually unilateral with ulnar wrist pain while supinating and extending the wrist as part of the regular work duty.

1. Physiological risk factors are those generally agreed upon by the medical community to cause the specific condition described. Other risk factors described are those identified in lower quality studies that are possibly related. These are consensus risk factors.

2. Combined factors refer to the Secondary Risk Factor definitions found in the Risk Factor Definition Table.

3. Caution: These additional risk categories may not be used when awkward posture, using a similar definition, has been cited as a Secondary Risk Factor.

4. Evidence rated as strong by National Institute for Occupational Safety and Health (NIOSH) 1997 criteria are placed in the “good” category because the NIOSH strong evidence definition matches the Colorado “good” level of evidence requiring multiple adequate studies.

5. Due to small case size and a definition of low force/high repetition jobs that likely included many jobs qualifying for a force risk from the “Risk Definitions” table, this study does not support repetition as a sole risk factor.

6. STAGING MATRIX TO CALCULATE CUMULATIVE TRAUMA CONDITION

IMPAIRMENT

Cumulative trauma staging is used to rate permanent impairment of specific disorders when no other rating is available in the American Medical Association (AMA) Guides to the Evaluation of Permanent Impairment, 3rd Edition Revised. Specific diagnoses must be provided prior to the assignment of an impairment rating. Remember that the terms “cumulative trauma disorder,” “repetitive motion syndrome,” “repetitive strain injury,” and similar nomenclatures are umbrella terms that are not acceptable diagnoses. Cumulative Trauma Conditions can be staged only after taking a thorough history and performing an appropriate physical examination (see Section D.1 History-Taking and Physical Examination). The factors included in the Cumulative Trauma Condition Staging Matrix are:

A = History and Physical Examination.

B = Response to Modification of Specific Aggravating Factors.

C = Activities of Daily Living.

It is expected that objective signs on physical examination will correlate with subjective symptoms. The signs and symptoms are staged in the Cumulative Trauma Staging Matrix as:

Stage 1 = Minimal.

Stage 2 = Mild.

Stage 3 = Moderate.

Stage 4 = Severe.

Stages 3 and 4 frequently may be associated with other secondary symptoms of chronic pain such as sleep alteration or depression.

When using the Staging Matrix for impairment rating at maximum medical improvement (MMI), assignment of the patient to a stage should be based primarily on limitations in ADLs and history and physical examination findings. The response to modification of specific aggravating activities may be used to aid the rater in choosing a number within the available rating range.

The staging number chosen from the “Impairment Grades at MMI” row is to be used as a multiplier in conjunction with the AMA Guides to the Evaluation of Permanent Impairment, 3rd Edition Revised, Chapter 3 and Table 17 to determine the impairment rating for each specific diagnosis. The primary presenting joint that corresponds to each specific established diagnosis should be rated. Descriptions of painful conditions without clear physiologic findings may not be rated using this chart. Examples include pain in the elbow or other upper extremity joint and myofascial pain disorder.

The staging matrix is only used to rate a cumulative trauma condition diagnosis when there is no impairment rating under range of motion, specific diagnosis, and/or peripheral nerve injuries in the AMA Guides, 3rd Edition Revised. All impairment ratings from this table are provided in upper extremity terms and must be multiplied by the upper extremity total impairment rating for the appropriate joint found in Table 17 on page 48 of the AMA Guides, 3rd Edition Revised. The upper extremity rating is then converted to whole person. The table is not intended to distinguish between permanent partial disability paid under §§ 8-42-107(2) and -107(8), C.R.S. This information is also available in the Impairment Rating Tips Desk Aid #11.

Cumulative Trauma Staging Matrix Stage 1 (Minimal)

Stage 2 (Mild)

Stage 3 (Moderate)

Stage 4 (Severe)

History and Physical Examination 1 to 2 symptoms with signs identified on

history and supported by physical 2 or more by physical 3 or more by the physical 3 or more by physical AND AND AND AND Response to Modification of Specific Aggravating and/or signs improve or resolve with and/or signs may improve but will not resolve completely with and/or signs do not improve with the specific activity but may improve with elimination of the and/or signs do not improve with modification or elimination of the AND AND AND AND Activities of Daily Living (ADLs)

Minimal problems with Noticeable aggravation by more difficult Significant interference with most ADLs Severe limitations of Impairment Grades at MMI (See Note below to obtain Multiplier) 0-10% 11-20% 21-30% 31-40% E. FOLLOW-UP DIAGNOSTIC IMAGING AND TESTING PROCEDURES One diagnostic imaging procedure may provide the same or distinct information as another procedure. Therefore, the prudent choice of a single diagnostic procedure, a complement of procedures, or a sequence of procedures will optimize diagnostic accuracy, maximize cost effectiveness (by avoiding redundancy), and minimize potential adverse effects to patients.

All diagnostic imaging procedures have a significant percentage of specificity and sensitivity for various diagnoses. None is specifically characteristic of a certain diagnosis. Clinical information obtained by history-taking and physical examination should be the basis for selection and interpretation of imaging procedure results.

Practitioners should be aware of the radiation doses associated with various procedures and provide appropriate warnings to patients. Coloradans have a background exposure to radiation, and unnecessary CT scans or X-rays increase the lifetime risk of cancer death.

When a diagnostic procedure, in conjunction with clinical information, provides sufficient information to establish an accurate diagnosis, the second diagnostic procedure will become a redundant procedure. At the same time, a subsequent diagnostic procedure can be a complementary diagnostic procedure if the first or preceding procedures, in conjunction with clinical information, cannot provide an accurate diagnosis. Usually, preference of a procedure over others depends upon availability, a patient’s tolerance, and/or the treating practitioner’s familiarity with the procedure.

1. ELECTRODIAGNOSTIC (EDX) STUDIES

This section does not include automated electrodiagnostic testing such as neurometers and portable automated electrodiagnostic devices. These testing devices are not adequate to determine peripheral neuropathies, radiculopathies, or unusual nerve compression syndromes and should not be used. Neurometers and portable electrodiagnostic testing devices may not be used to make a diagnosis and are not recommended in treatment settings. Refer also to Section E.5.a.i Electroneurometer and

Section E.5.a.ii Portable Automated Electrodiagnostic Devices.

a. Electrodiagnostic (EDX) studies are well-established and widely accepted for evaluation of patients suspected of having peripheral nerve pathology. They should only be performed by physicians trained in electromyography. Studies may confirm the diagnosis or direct the examiner to alternative disorders. Studies require clinical correlation due to the occurrence of false positive and false negative results. Symptoms of peripheral nerve pathology may occur with normal EDX studies, especially early in the clinical course.

Because EDX studies may be negative early in the clinical course, they should be delayed until the patient has been symptomatic for 3 to 6 weeks. Refer to Sections F and G on specific diagnoses for details.

When polyneuropathy is suspected, it is prudent to perform electrodiagnostic testing in the lower extremities.

b. To assure accurate testing, temperature should be maintained at 32 to 34 degrees C, preferably recorded from the hand/digits.

c. All studies must include normative values for their laboratories.

d. Patients should follow the electrodiagnostic physician’s recommendations prior to their exam. These usually include: 1) Notifying the physician if you are taking blood thinners, if you are taking a medication affecting the nervous system, or if you have a pacemaker, 2) not smoking or using caffeine before the exam, and 3) wearing loose fitting clothing for the exam.

2. IMAGING STUDIES

a. Radiographic Imaging Radiographic imaging of the upper extremities is a generally accepted, wellestablished and widely used diagnostic procedure when specific indications based on history and/or physical examination are present. It should not be routinely performed for cumulative trauma injuries. It may be useful when clinical findings suggest a fracture, arthritis, avascular necrosis or ligament or cartilage injuries involving the carpals or pain persists after initial treatment. The mechanism of injury and specific indications for the radiograph should be listed on the request form to aid the radiologist and x-ray technician. For additional specific clinical indications, see Section F Specific Musculoskeletal Diagnosis, Testing and Treatment and Section G Specific Peripheral Nerve Diagnosis, Testing and Treatment.

b. Magnetic Resonance Imaging (MRI)

MRI may show increased T2-weighted signal intensity of the common extensor tendon in lateral epicondylitis, but this is common in the asymptomatic contralateral elbow and not sufficiently specific to warrant the use of MRI as a diagnostic test for epicondylitis. MRI may be helpful to diagnose triangular fibrocartilage complex tears and other suspected ligament or bone pathology when clinical findings suggest these diagnoses. Its routine use for cumulative trauma conditions is not recommended.

c. Computed Axial Tomography (CT)

CT is generally accepted and provides excellent visualization of bone. It is rarely needed for cumulative trauma conditions. When clinical findings suggest possible bone pathology it may be used to further evaluate bony masses and suspected fractures not clearly identified on radiographic window evaluation. Instrument scatter reduction software provides better resolution when metallic artifact is of concern.

d. Diagnostic Sonography Diagnostic Sonography is an accepted diagnostic procedure to rule out mass lesions. It is rarely appropriate for cumulative trauma condition diagnoses.

However, it may be used to rule out ganglions, other space occupying lesions, and tendon injuries. It should not be used to diagnosis carpal tunnel syndrome.

The performance of sonography is operator dependent, and is best when done by a specialist in musculoskeletal radiology.

3. JOINT ASPIRATION

Joint aspiration is a generally accepted, well-established and widely used procedure when specifically indicated and performed by individuals properly trained in these techniques. It is rarely indicated for cumulative trauma conditions but may be needed when history and/or physical examination are of concern for a septic joint, gout, or bursitis as well as for some acute injuries. Persistent or unexplained effusions may be examined for evidence of infection, rheumatologic, or inflammatory processes. The presence of fat globules in the effusion strongly suggests occult fracture.

4. PERSONALITY/PSYCHOLOGICAL/PSYCHOSOCIAL EVALUATIONS

These are generally accepted and well-established diagnostic procedures with selective use in the cumulative trauma conditions population but with more widespread use in subacute and chronic pain populations. Diagnostic testing procedures may be useful for patients with symptoms of depression, delayed recovery, chronic pain, recurrent painful conditions, disability problems, and for pre-operative evaluation. These procedures also have a possible predictive value for post-operative response. Psychological testing should provide differentiation between pre-existing depression versus injury caused depression, as well as post-traumatic stress disorder. Formal psychological or psychosocial evaluation should be performed on patients not making expected progress within 6 to 12 weeks following injury and whose subjective symptoms do not correlate with objective signs and tests. In addition to the customary initial exam, the evaluation of the injured worker should specifically address the following areas: ● Employment history; ● Interpersonal relationships — both social and work; ● Leisure activities; ● Current perception of the medical system; ● Results of current treatment; ● Perceived locus of control; and ● Childhood history, including abuse and family history of disability.

This information should provide clinicians with a better understanding of the patient, thus allowing for a more effective rehabilitation. The evaluation will determine the need for further psychosocial interventions. In those cases, a Diagnostic Statistical Manual for Mental Disorders (DSM) diagnosis should be determined and documented. An individual with a PhD, PsyD, or Psychiatric MD/DO credentials should perform initial evaluations, which are generally completed within 1 to 2 hours. When issues of chronic pain are identified, the evaluation should be more extensive and follow testing procedures as outlined in the Division’s Chronic Pain Disorder Medical Treatment Guidelines.  Frequency: 1 time visit for evaluation. If psychometric testing is indicated as a portion of the initial evaluation, time for such testing should not exceed an additional 2 hours of professional time.

5. ADJUNCTIVE TESTING

These tests are not used to establish a diagnosis. They may be used to follow the progress of the patient, depending on their diagnosis or to conduct research.

a. Automated Electrodiagnostic Testing i. Electroneurometer: not recommended as a diagnostic tool because it requires patient participation, cannot distinguish between proximal and distal lesions, and does not have well validated reference values.

ii. Portable Automated Electrodiagnostic Devices: measures distal median nerve motor latency and F-wave latency at the wrist and has been tested in research settings. It performed well in this setting following extensive calibration of the device. Motor nerve latency compared favorably with conventional electrodiagnostic testing, but F-wave latency added little to diagnostic accuracy. It remains an investigational instrument whose performance in a primary care setting is as yet not established, and is not recommended as a substitute for conventional electrodiagnostic testing in clinical decision making.

b. Pinch and Grip Strength Measurements Pinch and grip strength measurements are not generally accepted as a diagnostic tool for cumulative trauma conditions. Strength is defined as the muscle force exerted by a muscle or group of muscles to overcome a resistance under a specific set of circumstances. Pain, the perception of pain secondary to abnormal sensory feedback, and/or the presence of abnormal sensory feedback affecting the sensation of the power used in grip/pinch may cause a decrease in the force exerted and thereby not be a true indicator of strength. When a bellshaped curve is present, these measures provide a method for quantifying strength that can be used to follow a patient's progress and to assess response to therapy. In the absence of a bell-shaped curve, clinical reassessment is indicated. These measurements may also be useful to determine an individual's fitness for duty or as a reassessment after therapy and/or surgery.

c. Quantitative Sensory Testing (QST)

QST may be used as an assessment tool to monitor the patient’s progress throughout treatment. Results of tests and measurements of sensory integrity are integrated with the history and review of systems findings and the results of other tests and measures. QST tests the entire sensory pathway, limiting its ability to localize a deficit precisely. It depends on the patient’s report of perception and may not be objective. Cutaneous conditions may alter sensory thresholds.

QST may be useful for peripheral polyneuropathy but not for isolated nerve injury or compression syndromes. Although it is not useful diagnostically, it may be used post-operatively for surgically treated mononeuropathies.

i. Threshold tests measure topognosis, the ability to exactly localize a cutaneous sensation, and pallesthesia, the ability to detect mechanical sensation using vibration discrimination testing (quickly adapting fibers); and/or Semmes-Weinstein monofilament testing (slowly adapting fibers);

ii. Density tests also measure topognosis and pallesthesia using static twopoint discrimination (slowly adapting fibers); and/or moving two-point discrimination (quickly adapting fibers).

6. SPECIAL TESTS

These are generally well-accepted and are performed as part of a skilled assessment of the patient’s capacity to return to work, his/her strength capacities, physical work demand classifications, and tolerance. The procedures in this subsection are listed in alphabetical order.

a. Computer-enhanced Evaluations These may include isotonic, isometric, isokinetic and/or isoinertial measurements of movement; range of motion; endurance; or strength. Values obtained can include degrees of motion, torque forces, pressures, or resistance. Indications include determining validity of effort, effectiveness of treatment, and demonstrated motivation. These evaluations should not be used alone to determine return-to-work restrictions.  Frequency: One time for evaluation, one for mid-treatment assessment, and one at final evaluation.

b. Functional Capacity Evaluation (FCE)

This is a comprehensive or modified evaluation of the various aspects of function as they relate to the worker’s ability to return to work. Areas such as endurance, lifting (dynamic and static), postural tolerance, specific range of motion, coordination and strength, worker habits, employability, as well as psychosocial aspects of competitive employment may be evaluated. Reliability of patient reports and overall effort during testing is also reported. Components of this evaluation may include: (a) musculoskeletal screen; (b) cardiovascular profile/aerobic capacity; (c) coordination; (d) lift/carrying analysis; (e) job-specific activity tolerance; (f) maximum voluntary effort; (g) pain assessment/psychological screening; and (h) non-material and material handling activities. Standardized national guidelines (such as National Institute for Occupational Safety and Health (NIOSH)) should be used as the basis for FCE recommendations.

Most studies examining FCEs were performed utilizing cases involving chronic low back pain. There is some evidence that an FCE fails to predict which injured workers with chronic low back pain will have sustained return to work. Another cohort study concluded that there was a significant relation between FCE information and return to work, but the predictive efficiency was poor. There is some evidence that time off work and gender are important predictors for return to work, and floor-to-waist lifting may also help predict return to work. However, the strength of that relationship has not been determined.

A full review of the literature reveals no evidence to support the use of FCEs to prevent future injuries. There is some evidence in chronic low back pain patients that (1) FCE task performance is weakly related to time on disability and time for claim closure, and (2) even claimants who fail on numerous physical performance FCE tasks may be able to return to work. These same issues may exist for lower extremity injuries.

Full FCEs are rarely necessary. In many cases, a work tolerance screening or return to work performance will identify the ability to perform the necessary job tasks. There is some evidence that a short form FCE reduced to a few tests produces a similar predictive quality compared to the longer 2-day version of the FCE regarding length of disability and recurrence of a claim after return to work.

When an FCE is being used to determine return to a specific job site, the provider is responsible for fully understanding the physical demands and the duties of the job the worker is attempting to perform. A job site evaluation is usually necessary. A job description should be reviewed by the provider and FCE evaluator prior to this evaluation. FCEs cannot be used in isolation to determine work restrictions. It is expected that the FCE may differ from both self-report of abilities and pure clinical exam findings in chronic pain patients. The length of a return to work evaluation should be based on the judgment of the referring physician and the provider performing the evaluation. Since return to work is a complicated multidimensional issue, multiple factors beyond functional ability and work demands should be considered and measured when attempting determination of readiness or fitness to return to work. FCEs should not be used as the sole criteria to diagnose malingering.  Frequency: Once, when patient is unable to return to the pre-injury position and further information is desired to determine permanent work restrictions.

Prior authorization is required for repeat Functional Capacity Evaluations.

c. Job Site Evaluations and Alterations Ergonomic alterations should be done early to assure that appropriate changes are accomplished early in the treatment program. Whenever a case is identified as a work-related cumulative trauma condition, job alterations are an expected treatment. These may be in the form of: 1) instructing the worker how specific duties might be performed to meet ergonomic standards; 2) actual job worksite or duty changes; and/or 3) a formal job site evaluation at the worksite. Job site evaluation and alteration should include input from a healthcare professional with experience in ergonomics or a certified ergonomist, the employee, and the employer. The employee must be observed performing all pertinent job functions in order for the job site evaluation to be a valid representation of a typical workday. If the employee is unable to perform the job function for observation, a co-worker in an identical job position may be observed instead. The job site evaluation should include a job demand analysis with an ergonomic evaluation, which directly addresses the causation risk factors described in Section D.3 Medical Causation Assessment for Cumulative Trauma Conditions and the five goals listed below.

A formal job site evaluation is a comprehensive analysis of the physical, mental and sensory components of a specific job. It may be important initially to determine causation. These components may include, but are not limited to: (a) postural tolerance (static and dynamic); (b) aerobic requirements; (c) range-ofmotion; (d) torque/force; (e) lifting/carrying; (f) cognitive demands; (g) social interactions; (h) visual perceptual; (i) environmental requirements of a job; (j) repetitiveness; and (k) essential functions of a job. Ergonomic changes that provide a therapeutic benefit or relieve the patient’s ongoing symptoms are part of the required medical treatment for cumulative trauma conditions. Therefore, it is assumed that the insurer will be responsible for paying for such job site alterations. Job descriptions provided by the employer are helpful but should not be used as a substitute for direct observation. A job site evaluation may include observation and instruction of how work is done, what material changes (desk, chair) should be made, and determination of readiness to return to work. Refer to

Section H.6 Job site Alterations for specific ergonomic recommendations.

Requests for a job site evaluation should describe the expected goals for the evaluation. Goals may include, but are not limited to the following:

i. To determine if there are potential contributing factors to the person’s condition and/or for the physician to assess causality;

ii. To make recommendations for, and to assess the potential for ergonomic changes;

iii. To provide a detailed description of the physical and cognitive job requirements;

iv. To assist the patient in their return to work by educating him/her on how to do the job more safely in a bio-mechanically appropriate manner; and/or v. To give detailed work/activity restrictions.  Frequency: 1 time with additional visits as needed for follow-up per job site.

d. Vocational Assessment Once an authorized practitioner has determined that a patient will not be able to return to his/her former employment and can prognosticate final restrictions, a timely vocational assessment can be implemented. The vocational assessment should provide valuable guidance in the determination of future rehabilitation program goals. It should clarify rehabilitation goals, which optimize both patient motivation and utilization of rehabilitation resources. The effectiveness of vocational rehabilitation may be enhanced when performed in combination with work hardening or work conditioning. If prognosis for return to former occupation is poor, except in the most extenuating circumstances, vocational assessment should be implemented within 3 to 12 months post-injury. Declaration of maximum medical improvement should not be delayed solely due to lack of attainment of a vocational assessment.  Frequency: 1 time with additional visits as needed for follow-up.

e. Work Tolerance Screening (Fitness for Duty)

Work Tolerance Screening (Fitness for Duty) is a determination of an individual's tolerance for performing a specific job as based on a job activity or task. It may include a test or procedure to specifically identify and quantify work-relevant cardiovascular demands, physical fitness, and postural tolerance. It may also address ergonomic issues affecting the patient’s return-to-work potential. May be used when a full Functional Capacity Evaluation is not indicated.

F. SPECIFIC MUSCULOSKELETAL DIAGNOSIS, TESTING & TREATMENT PROCEDURES

Cumulative trauma related conditions comprise a number of specific diagnoses with diagnostic findings and treatment. Cumulative trauma disorder itself is not a diagnosis and cannot be treated or evaluated until the specific diagnosis is identified. Refer to Section C Definitions and Mechanisms of Injury for details.

Cumulative trauma conditions often involve several diagnoses and conservative treatment of all applicable diagnoses should be treated simultaneously. See Section G for peripheral neuropathies.

1. AGGRAVATED OSTEOARTHRITIS OF THE DIGITS, HAND OR WRIST

a. Description/Definition: Internal wrist joint pathology accompanied by cartilage loss. Pain usually in the carpometacarpal joints or in the metacarpophalangeal joints.

b. Occupational Relationship: Refer to Section D.3 Medical Causation c. Specific Physical Exam Findings: The most common joint affected is the first carpometacarpal joint. The thumb metacarpophalangeal joint may also be involved.

i. Required findings are at least one of the following:

A) Positive grind test: The “grind test” consists of applying an axial load to the first metacarpal and rotating it medially and laterally.

A positive test results in pain and/or crepitus;

B) Subluxation of the metacarpal may be induced in advanced cases;

C) Tenderness with palpation of thumb carpometacarpal or metacarpophalangeal joint.

ii. Additional findings may include:

A) Swelling;

B) Reduced motion; and C) Angular deformities.

When a patient presents with pain at the base of the thumb, tests for de Quervain’s, flexor carpi radialis tendonitis, and scaphoid pathology should all be considered.

d. Diagnostic Testing Procedures: X-ray, diagnostic injection and/or aspiration, and MRI can be done if space occupying lesions are suspected. X-ray findings do not necessarily correlate with symptomatic arthritis.

e. Non-operative Treatment Procedures:

i. Initial Treatment: Splinting may be used nocturnally and for protection during specific activities. Wrist splinting should maintain neutral mechanics to avoid nerve stretch or ligamentous changes. There is good evidence that custom splints used nocturnally for 1 year decrease pain and increase function. Historically, both hand-based and forearm-based splints have been used effectively and the type of splint should probably be based on patient preference as this will also influence long-term compliance.

There is some evidence that home-based hand exercises with phone call follow-up and monitoring plus hand osteoarthritis (HOA) information is more effective than only giving HOA information in improving hand functionality in women with HOA. Self-application of heat or ice and ergonomic changes of the job site are recommended.

ii. Medications such as analgesics (including NSAIDs) and over the counter medications for symptomatic relief may be helpful. Topical salicylates and nonsalicylates have been shown to be effective in relieving pain in acute and chronic musculoskeletal conditions. There is good evidence that diclofenac gel reduces pain and improves function in mild-tomoderate hand osteoarthritis. Diclofenac gel has been FDA approved for acute pain due to minor strains, pains, and contusions and for relief of pain due to osteoarthritis of the joints amenable to topical treatment, such as those of the knees and hands (Food and Drug Administration).

There is some evidence that topical ketoprofen patches are more effective than placebo in reducing pain of upper extremity tendonitis; however, the need for continuous skin application may limit overall use.

Use of ketoprofen topical patch for the disorders described in these Guidelines has not been FDA approved at the time these Guidelines were written. Liver enzymes should be monitored when using topical or oral NSAIDs.

Refer to medication discussions in Section H.7 Medications and Medical Management for further details.

iii. Patient education: should include instruction in self-management techniques, ergonomics, and home therapy program. One study demonstrated a 70% reduction in the number of patients desiring surgery when they were provided with 3 sessions of hand therapy explaining the use of splints; accessories such as fitted scissors, book support, pen handles; and modification of their work environment. It is strongly suggested that all patients receive hand therapy support before considering surgery, especially if the job requirements place a high demand on fine hand activities. Episodes of recurrence are common, so patient education regarding provocative activities is essential for long term recovery.

iv. Job site evaluations and alterations: Ergonomic alterations should be done early to assure that appropriate changes are accomplished early in Alterations and Section H.6 Job Site Alteration.

v. Steroid injections: may decrease inflammation and allow the therapist to pressure should be avoided, as the needle may be penetrating the tendon and injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture. Steroid injections may be useful in early stage osteoarthritis when used with a splint. ❖ Optimum Maximum Frequency: 3 injections in 1 year spaced at least 4 to 8 weeks apart. ❖ Steroid injections should be used cautiously in diabetic patients.

Diabetic patients should be reminded to check their blood glucose levels at least daily for 2 weeks after injections. Refer to

Section H.4 Injections for further information on steroid vi. Viscosupplementation/Intracapsular acid salts involve the injection of hyaluronic acid and its derivatives into the joint space. Hyaluronic acid is secreted into the joint space by the healthy synovium and has functions of lubrication and cartilage protection.

vii. There is no evidence that hyaluronate injections are superior to steroid injections for carpometacarpal thumb arthritis. There is some evidence that intra-articular hyaluronan is not superior to placebo for improving pain in the setting of carpometacarpal osteoarthritis. There is also some evidence that intra-articular hyaluronan does not improve function in a clinically important way in the first six months after injection. Therefore, they are not recommended.

viii. Return to work with appropriate restrictions should be considered early in ix. Other therapies in Section H Therapeutic Procedures – Non-operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often i. The patient may be a good surgical candidate when functional deficits interfere with activities of daily living and/or job duties after at least 3 months of active patient participation in non-operative therapy including job site changes, medication, injections, and splints.

One study demonstrated a 70% reduction in the number of patients desiring surgery after 7 months when they were provided with 3 sessions of hand therapy explaining the use of splints; accessories such as fitted scissor, book support, pen handles; and modification of their work environment. It is strongly suggested that all patients receive hand therapy support and job site alterations before considering surgery.

ii. Thumb carpometacarpal joint arthritis Early stage arthritis with functional deficits may be amenable to debridement and thermal capsular shrinkage. For later stages, synthetic material and interposition materials may have more complications than biologicals.

A) Due to the complexity of the wrist joint and the lack of clear superiority of any one procedure, the choice of the type of procedure for an individual patient must be made on a case-bycase basis by the surgeon and patient.

There is currently a lack of convincing evidence that any operative intervention for osteoarthritis of the base of the thumb is more or less effective than any other operative intervention.

The most common current procedures for thumb carpometacarpal arthritis are trapeziectomy with or without suspension procedures, including ligament reconstruction and/or tendon interposition. There is good evidence that these procedures have similar outcomes at 1 year. There is uncertainty regarding the risk of adverse events between simple trapeziectomy and trapeziectomy combined with other procedures. However, a lower risk of complications with simple trapeziectomy cannot be ruled out. Osteotomies may be additional procedures in some cases and fusions are occasionally performed, usually in younger active patients.

Ligament and tendon procedures are thought to protect the other carpal joints from earlier deterioration and allow greater stability for the thumb. Most patients have not been followed long enough to compare rates of subsequent arthritis and resulting functional deficits between those having a simple trapeziectomy and those with suspension procedures. In one follow up study, there was an increase in x-ray joint changes without a clinical impact.

B) The use of implants or spacers remains highly controversial.

Most long-term studies of these have shown unacceptable levels of subsidence, subluxation or breakage. Due to the lack of evidence, implant procedures should only be considered after a second opinion by a hand surgeon specializing in the techniques and thorough understanding of the patient regarding expectation from the procedure, recovery time, and possible complications.

iii. Arthritis at other joints: Scaphotrapezio-trapezoid joint arthritis resistant to conservative treatment is usually treated with fusion, although trapezoidectomy has also been used. Fusion may be recommended for thumb metacarpophalangeal arthritis when surgery is necessary.

iv. Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work, as well as possible complications. The patient should agree to comply with the preand post-operative treatment plan, including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the v. Informed decision making should be documented for all invasive natural history of the identified diagnosis. Since many patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

vi. Smoking may affect soft tissue healing through tissue hypoxia. Patients g. Operative Procedures: Arthroscopic trapeziectomy with or without suspension procedures including ligament reconstruction and/or tendon transposition; trapezoidectomy; fusion; osteotomy.

Complications from wrist arthroscopy are approximately 4.7%, including ulnar or posterior interosseous nerve damage. Total wrist arthroplasty is not currently recommended due to long-term problems with dislocation or compartment loosening. If it is being considered, then prior authorization and a second opinion by a hand surgeon are required.

h. Post-operative Treatment i. An individualized rehabilitation program based upon communication communication between the physician and the therapist is important to the timing of exercise progressions.

ii. Hand therapy should be started early to prevent loss of motion in adjacent joints. Treatment may include the following: splinting, restricted activities and other active therapy with or without passive therapy. Exact treatment regimens are based on the surgeon’s recommendation and may include other therapies from Section H Therapeutic Procedures – Non-operative.

iii. There is some evidence that in the post-operative management at one year following trapeziometacarpal (TMC) arthroplasty, there is no significant difference in pain, function, range of motion, or grip strength between patients who wore standard rigid orthoses and patients who wore semi-rigid orthoses from 2 to 6 weeks following TMC arthroplasty.

iv. Continuous passive motion after metacarpophalangeal joint arthroplasty is not supported by scientific evidence and therefore is not v. Return to work and restrictions after surgery may be made by an 2. DE QUERVAIN’S DISEASE a. Description/Definition: Pain and swelling in or over the first dorsal extensor compartment (anatomical snuffbox) and/or over the radial styloid; pain radiating into the hand and forearm; pain worsened by thumb abduction and/or extension may be caused by thickening of the extensor tendons and extensor retinaculum rather than inflammation.

b. Occupational Relationship: Refer to Section D.3 Medical Causation assessment, the reader must comply with all sections of this guideline.

c. Specific Physical Exam Findings: De Quervain’s disease affects the first dorsal extensor compartment.

i. Required elements for diagnosis of de Quervain's disease are at least one of the following:

A) Pain worsened by resisted thumb abduction and/or extension with or without resistance;

B) Positive Finkelstein’s: The Finkelstein test is positive when localized pain results from ulnar wrist deviation with the thumb adducted;

C) Positive Stress Finkelstein's: Finkelstein's maneuver with pressure over the abductor pollicus longus.

ii. Other possible exam findings include:

A) Positive Eichoff-thumb clinched in fist followed by wrist ulnar movement;

B) Positive Tinel's may be present over the superficial radial sensory nerve;

C) Crepitus may be present, and tenderness over the first dorsal compartment is common.

D) Less common and examiner-dependent findings include thickening of the first dorsal tendon sheath, swelling in the same area.

d. Diagnostic Testing Procedures: X-ray and other imaging may be performed to

rule out other differential diagnoses or when there is an indication that additional pathology, such as a space-occupying lesion, may be present. Electro diagnostic testing can be considered to rule out neurological sources of pain.

e. Non-operative Treatment Procedures:

i. Initial Treatment: over-the-counter medications for symptomatic relief, thumb spica, splint or cast, ice, contrast baths and restriction of activities.

ii. Patient education: should include instruction in self-management iii. Job site evaluations and alterations: Ergonomic alterations should be same job position. Generally, patients should avoid repetitive thumb or wrist movements, grasping, and wrist ulnar deviation. Refer to Section E.6.c Job Site Evaluations and Section H.6 Job Site Alteration.

iv. Steroid injections: The proceduralist must exercise caution as the needle may disrupt the tendon and injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture.

Observational studies suggest that steroid injections may be beneficial even when splints are not used. However, there is insufficient evidence to favor steroid injections over thumb spica splinting. There is some evidence that in the setting of de Quervain’s disease, functional benefits of a corticosteroid injection are enhanced by a thumb spica cast which reduces stress on the abductor pollicis longus and extensor pollicis brevis tendons. There is inadequate evidence to show that a thumb spica cast, compared to other splinting methods, is necessary to achieve this added benefit. There is not clear evidence that steroid injections are more effective than splinting alone.

These injections are best performed by a specialist. Ultrasound guided injections may assist when a separation is present between the extensor pollicis brevis and the abductor pollicis longus although there is insufficient evidence to routinely recommend this treatment.

Post injection, the hand is usually placed at rest for several days and a splint may be used. weeks apart injection. ❖ Maximum Frequency: 4 per year if injections result in functional benefit without local reactions or complications.

Steroid injections should be used cautiously in diabetic patients.

Diabetic patients should be reminded to check their blood glucose levels at least daily for 2 weeks after injections. Refer to

Section H.4.c Steroid Injections for further details.

v. Return to work with appropriate restrictions should be considered early in vi. Other therapies in Section H Therapeutic Procedures – Non-operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often First extensor compartment release is rarely necessary. Most cases resolve spontaneously over a number of months. Surgery may be performed to achieve functional gains for those with the required diagnostic exam findings who continue to have significant ongoing impaired activities of daily living after 8 weeks of treatment which include job modifications, injections, and other therapy.

There is some evidence that endoscopic and open release result in equally satisfactory 24 week outcomes and approximately equal return to work times for de Quervain’s tenosynovitis. However, with endoscopic release there is a lower risk of transient injury to the superficial radial nerve, better scar satisfaction, and a slightly more rapid resolution of pain and functional limitations.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The significantly over time without invasive interventions, patients must be able to g. Operative Procedures: First extensor compartment release, open or endoscopic. Complications may include: radial sensory nerve injury, volar subluxation of tendon, and infection.

h. Post-operative Treatment:

i. An individualized rehabilitation program based upon communication timing of exercise progression. Treatment may include the following: elevating the hand and moving fingers to prevent scar adhesions, splinting to rest hand and decrease thumb activity, and other active therapy with or without passive therapy.

ii. Return to work and restrictions after surgery may be made by an 3. EPICONDYLITIS (EPICONDYLALGIA) – LATERAL AND MEDIAL a. Description/Definition- Lateral Epicondylitis: Lateral epicondylitis is also known as tennis elbow, lateral elbow pain, rowing elbow, tendinopathy of the common extensor origin, and peri-tendinopathy of the elbow. It is characterized by elbow pain and tenderness over the lateral epicondyle of the humerus.

Patients describe tenderness to palpation slightly anterior and distal to the lateral epicondyle and/or over the bony prominence of the lateral epicondyle. Patients frequently complain of pain with grasping when the elbow is extended and pronated.

b. Description/Definition - Medial Epicondylitis: Pain emanating from the medial elbow; mild grip weakness; medial elbow pain exacerbated by repetitive wrist extensions or forward flexion.

c. Occupational Relationship: Refer to Section D.3 Medical Causation d. Specific Physical Exam Findings - Lateral Epicondylitis:

i. Required elements for the diagnosis of lateral epicondylitis are as follows:

A) The patient must report tenderness to palpation at/near lateral epicondyle; and B) In addition, at least one of the following examiner maneuvers must result in pain over the lateral epicondyle and/or extensor mass of the forearm: ● Active or resisted wrist extension; ● Active or resisted middle finger extension; ● Active or resisted supination.

ii. Pain may also increase with gripping. Swelling, erythema, and warmth are generally not seen in this condition.

e. Specific Physical Exam Findings - Medial Epicondylitis:

i. Required elements for the diagnosis of medial epicondylitis are as follows:

A) The patient must report tenderness to palpation at/near medial epicondyle; and B) In addition, at least one of the following examiner maneuvers must result in pain over the medial epicondyle and/or flexor mass of the forearm: ● Active or resisted wrist flexion; ● Active or resisted long finger flexion; ● Active or resisted pronation.

ii. The exam may include elements for diagnosing cubital tunnel syndrome if appropriate.

f. Diagnostic Testing Procedures: The clinical diagnosis of epicondylitis is made by the combination of patient complaints and required objective physical findings.

Additional studies such as plain radiographs, MRI, and sonogram examinations are not routinely ordered to establish the diagnosis of epicondylitis. However, these studies may be used to rule out other conditions that may produce similar symptoms, including radial tunnel syndrome, cervical radiculopathy, osteochondral radiocarpal lesion, posterolateral elbow plica, and posterolateral elbow instability. X-rays may be normal or demonstrate spur formation over the involved epicondyle.

Electro diagnostic studies can be considered to rule out neurological sources of pain, such as radial tunnel syndrome or posterior interosseous nerve entrapment.

g. Non-operative Treatment Procedures:

i. Initial Treatment: over-the-counter medications for symptomatic relief, ice, bracing, and restriction of activities. Topical NSAIDs are commonly used, although there is no evidence that topical or oral NSAIDs are effective.

Literature indicates that over 80% of patients with greater than 4 weeks of pain recovered by 1 year. The natural history of epicondylitis supports an expectation of improvement within 3 months of using patient education and modified activities.

ii. Patient education: should include instruction in self-management techniques, ergonomics, and home therapy program. Episodes of iii. Bracing: The rationale for braces is to rest the wrist extensor or flexor muscles while reducing tension at the extensor or flexor origin, allowing healing of the muscle and tendon.

Brace types include proximal forearm band/sleeve, cock-up wrist splint, forearm/hand splint, and dynamic extensor brace.

Braces may be used in patients who are able to tolerate wearing the brace during activity and do not experience worsening pain and/or additional symptoms due to brace, but should be discontinued in the event of adverse effects.

There is no evidence that one brace type is superior to other types.

However, some brace types may be impractical for use in most workers.

For example, surgical technicians and food handlers would be unable to use most braces involving the wrist due to incompatibility with occupational function. The forearm band brace type appears to be the least cumbersome brace option and may be the best tolerated. However, this brace has the disadvantage of sometimes putting pressure on the radial nerve or occasional incorrect use by the patient.

Selecting the appropriate brace type is a decision that should be made by both patient and treating physician or therapist and should include appropriate patient education and follow-up. Braces which restrict range of motion should not be used continuously as this may result in permanent loss of motion. Compression straps should not be positioned in a manner which would irritate branches of the radial nerve. Braces should achieve maximum function and patient comfort.

iv. Job site evaluations and alterations: Ergonomic alterations should be v. Steroid injections: may decrease inflammation, pain, and allow the therapist to progress with rehabilitation therapy.

Steroid injections under significant pressure should be avoided as the needle may be penetrating the tendon and injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture.

There is strong evidence that in the setting of lateral epicondylitis, the effects of corticosteroid injections on pain and function are more favorable than placebo in the first four weeks, but these benefits are reversed by six months and are detrimental compared to placebo injections in the intermediate and long term. Thus, injections for epicondylitis must include a discussion with the patient regarding lack of long-term benefits compared to no injection, as well as the need to combine other therapy, including a slow increase of activities that aggravate the condition. Steroid injections do provide short term benefit and may be considered an adjunctive therapy for some patients. ❖ Maximum Frequency: 3 to 4 per year if injections result in vi. Return to work with appropriate restrictions should be considered early in vii. Botulinum toxin injection: The rationale for botulinum toxin treatment is that it reversibly paralyzes the extensor muscles and thereby prevents repetitive micro-trauma of the tendonous fibers at their origin from the osseous lateral epicondyle. The unit dosage varies significantly depending on the brand used. Usage for lateral and medial epicondylitis is not FDA approved at the time of these Guidelines writing. There is good evidence that botulinum toxin can alleviate the pain of lateral epicondylitis in the short term, with significant but reversible extensor weakness. However, the long-term consequences and functional benefits are unknown. There is also good evidence that botulinum toxin A injections cause weakness in finger extension and/or digit paresis.

Additional complications may include: allergic reaction to medications, increased risk of systemic effects in patients with motor neuropathy or disorders of the neuromuscular junction.

Botulinum toxin injection is known to cause short-term third (middle) finger strength deficits and possible digit paresis, which may persist for up to 3 to 4 months. Botulinum toxin injection should only be used in patients whose occupational performance will be unaffected by this side effect, and should not be used in patients with physically demanding job descriptions.

It should not be considered a first line of treatment. Other conservative measures should be tried first. A single botulinum toxin type A injection may provide pain reduction for up to 3 to 4 months in patients with chronic lateral epicondylitis which has persisted after 3 months of Botulinum toxins are manufactured at different potencies, and units of the different manufacturers are not equivalent. Careful botulinum toxin dosing should be used to avoid complete paresis and allow maintained functionality and return to work.

The decision to use botulinum toxin for pain relief from chronic lateral epicondylitis symptoms should be made carefully by both patient and treating physician, with knowledge of the known side effects and consideration of the individual occupational demands of the patient.

Botulinum injection should only be performed by a physician or surgeon who has expertise in the anatomy of the upper extremity and who is experienced in the use of this agent. Ultrasound guidance may be helpful. Prior authorization is required. ❖ Maximum: One injection episode.

viii. Other injections:

A) Prolotherapy and polidocanol (sclerosing agent) have all been used in studies too small and/or inadequate to make any recommendations. Due to lack of evidence of their effectiveness and the cost involved, prolotherapy and polidocanol are not B) Autologous Whole Blood Injections/Platelet-Rich Plasma Injections:

1. Autologous Whole Blood Injections: are relatively inexpensive treatments and may be used in patients who have not made sufficient functional progress with initial therapy for lateral or medial epicondylitis after 10 to 12 weeks.

There is some evidence that, for patients with symptoms lasting 6 months or more, autologous blood injections result in better pain and functional outcomes after 1 year than steroid injections. ❖ Optimum Frequency: 2 injections may be required.

2. Platelet-Rich Plasma Injections: There is good evidence that, for patients with symptoms lasting 6 months or more, platelet-rich plasma injections result in better pain and functional outcomes after 1 year than steroid There is good evidence that in the setting of lateral epicondylitis, platelet-rich plasma injections may lead to a small to moderate functional benefit in comparison to autologous whole blood or saline at two to three months, but effects on pain are uncertain.

There is good evidence that platelet-rich plasma injections produces more favorable symptomatic and functional improvement than triamcinolone injection in patients with chronic lateral epicondylitis, with this advantage persisting for 24 months after treatment.

In summary, there is strong evidence for the use of platelet-rich plasma injections in patients who have not improved with conservative therapy. ❖ Optimum Frequency: 2 injections may be required.

ix. There is no clinical evidence or sound physiologic rationale for magnets or diathermy, therefore, they are not recommended.

x. Low Level Laser: There is good evidence that low level laser is not more effective than placebo for lateral epicondylitis, and its use is not xi. Extracorporeal shock wave therapy (ESWT): The natural history of epicondylitis supports an expectation of improvement within 3 months using patient education and modified activities. There is some evidence that highly motivated tennis players may show up to a 35% additional improvement over no other treatment when administered low energy shock wave treatment without local anesthesia. Two other studies are not of sufficient quality to qualify as evidence. There is some evidence that three weekly sessions of radial ESWT and sham ESWT lead to statistically similar symptomatic and functional outcomes at three months. However, a benefit of radial ESWT cannot be ruled out due to uncertainties in the data. The preponderance of evidence does not support the efficacy of ESWT in the working population; therefore, it is not recommended.

xii. Acupuncture: There is some evidence that acupuncture has a very short term 2 week effect on pain compared to sham acupuncture for lateral epicondylitis. The patients may request this treatment. Refer to Section H.1 Acupuncture for more information.

xiii. Other therapies in Section H Therapeutic Procedures – Non-operative A) Topical Glyceryl Trinitrate: There is some evidence from a small study that wearing a topical patch containing glyceryl trinitrate over an area of tendinopathy is more effective than a placebo patch in reducing pain and improving overall clinical recovery in subjects with lateral epicondylitis over a period of 6 months.

However, improvement in function was not clearly demonstrated.

There is also some evidence that topical glyceryl trinitrate is not effective for lateral epicondylitis from a study demonstrating no benefit compared to placebo with varied doses. Side effects include headaches. The patch must be applied every day.

Therefore it is not generally recommended and may only be used if there is failure of other conservative care at 8-12 weeks.

B) Ultrasound with corticosteroids (phonophoresis) and iontophoresis may be used occasionally to facilitate other therapy, but there is no evidence that they alter long-term function. Thus these passive treatments may be used on a limited basis.

A systematic review of low quality studies found a lack of evidence for the effectiveness of ultrasound, laser, pulsed electromagnetic field therapy, TENS, and extracorporeal shock wave for the treatment of lateral epicondylitis. Therefore, they are not recommended. However, high volt or interferential may be useful in some patients.

ix. Physical Therapy, Mobilization, and Manipulation:

This subsection reviews the evidence base for using physical therapy, including mobilization and manipulation, in the treatment of epicondylitis.

There is good evidence that there are early benefits from an 8 week program of weekly, individualized physical therapy for patients who do not receive a corticosteroid injection. However, the natural history of the condition tends to obscure these early benefits at one year from the time therapy begins.

There is some evidence that for subjects with long-term lateral epicondylalgia, a daily 6-week eccentric home exercise regimen is effective in increasing pain-free hand-grip, increasing wrist-extensor strength, and reducing the number of cases that meet the diagnostic criteria for lateral epicondylalgia.

There is some evidence that the addition of Mulligan mobilization to a regimen comprising of ultrasound therapy and progressive exercises is more effective in decreasing pain and increasing pain-free grip strength than ultrasound therapy and progressive exercises alone in the treatment of lateral epicondylitis.

Although one Cochrane found inadequate evidence to support deep transverse friction massage alone, another study is supportive of deep tissue massage combined with manipulation. There is some evidence that both Cyriax physiotherapy (deep transverse friction massage combined with Mills manipulation) and phonophoresis with supervised exercise and static stretching are effective over a period of 4 weeks of treatment for lateral epicondylalgia in decreasing pain, increasing painfree grip strength, and improving functional status. However, Cyriax physiotherapy provides a superior benefit compared to phonophoresis with supervised exercise and static stretching.

The muscle energy technique is a manual therapy technique in which the patient performs voluntary contraction against a counter force from the provider to stretch muscles and improve range of motion. There is some evidence that the muscle energy technique is superior to corticosteroid injection in improving grip strength in lateral epicondylitis. However, it is not clear that the technique is better than no treatment.

There is good evidence that manual and manipulative therapy combined with exercise and/or multimodal therapy shows small, clinically important reductions in pain and improved physical function in the short-term care (≤ 3-6 months) of patients with lateral epicondylitis and carpal tunnel syndrome.

There is good evidence that physical therapy using manipulation, home exercise and supervised exercise reduced pain at 6 weeks but not at 52 weeks. This may be appropriate therapy to hasten return to work.

In summary, physical therapy including manual and manipulative therapy is encouraged based on good evidence.  Time to Produce Effect: 4 treatments.  Optimum Frequency: 12 treatments over 6 weeks.

h. Surgical Indications/Considerations: Since cumulative trauma conditions often Lateral epicondyle release/debridement is generally accepted; however, over 80% of cases improve with conservative therapy only. Intermittent discomfort may recur over 6 months to 1 year after initial conservative treatment.

The patient may be a good surgical candidate when the diagnosis is confirmed on physical exam (Refer to Section D.1.d Physical Examination) and functional deficits interfere with activities of daily living and/or job duties after at least 3 months of active patient participation in non-operative therapy including worksite changes, medication, splints, and injections or other therapy noted above.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals, the likelihood of achieving improved ability to perform activities of daily living or work, and possible complications. The patient should significantly over time, without invasive interventions, patients must be able to i. Operative Procedures: Lateral or medial epicondyle release/debridement.

There is good evidence that no specific surgical intervention is effective for lateral elbow pain.

j. Post-operative Treatment:

i. An individualized rehabilitation program based upon communication ii. Return to work and restrictions after surgery may be made by an with the surgeon or by the surgeon. Full return to normal activities usually occurs by approximately 3 months.

4. EXTENSOR TENDON DISORDERS OF THE DIGIT OR WRIST

a. Description/Definition: pain localized to the affected tendon(s) and muscles that is worsened by active and/or resisted wrist or finger extension. A number of specific disorders may occur including intersection syndrome and extensor carpi ulnaris tenosynovitis.

b. Occupational Relationship: Refer to Section D.3 Medical Causation c. Specific Physical Exam Findings:

i. Required elements for the diagnosis of extensor tendon disorders of the wrist are the following: pain and/or tenderness with active or resisted wrist/digit extension, specific to the extensor mechanism involved.

ii. Intersection Syndrome is due to the action of the extensor pollicis brevis and the abductor pollicis longus on the wrist extensors in the second dorsal compartment. It is frequently accompanied by a sandpaper appearance to the dermis. It is reproduced by wrist extension.

iii. Extensor carpi ulnaris tenosynovitis is identified when resisted ulnar wrist deviation with forearm pronation or wrist extension with forearm supination reproduces the pain.

iv. Other common findings include creaking/crepitus with wrist extension and swelling along the dorsal aspects of the hand/wrist/forearm.

d. Diagnostic Testing Procedures: X-ray and other imaging may be also performed to rule out other differential diagnoses or when there is an indication additional pathology may be present.

e. Non-operative Treatment Procedures:

i. Initial Treatment: over-the-counter medications for symptomatic relief, wrist splints for wrist flexors and splinting.

ii. Patient education: should include instruction in self-management recurrence are common so patient education regarding provocative iii. Job site evaluations and alterations: Ergonomic alterations should be iv. Steroid Injections: may decrease inflammation, pain, and allow the  Maximum Frequency: 3 to 4 per year if injections result in v. Return to work with appropriate restrictions should be considered early in vi. Other therapies in Section H Therapeutic Procedures – Non-operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often problems in the upper extremity. Surgery is indicated when a tendon is ruptured, chronically enlarged or entrapped, or on rare occasions when conservative measures have failed and tendonitis is clearly present.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals, the likelihood of achieving improved ability to perform activities of daily living or work, and possible complications. The patient should significantly over time, without invasive interventions, patients must be able to g. Operative Procedures: Tenosynovectomy, synovectomy, repair, and/or reconstruction of the extensor tendon.

h. Post-operative Treatment:

i. An individualized rehabilitation program based upon communication ii. Return to work and restrictions after surgery may be made by an 5. FLEXOR TENDON DISORDERS OF THE DIGIT OR WRIST a. Description/Definition: pain and/or tenderness localized to the affected tendons; pain in the affected tendons associated with wrist/digit flexion and ulnar deviation, especially against resistance.

b. Occupational Relationship: Refer to Section D.3 Medical Causation c. Specific Physical Exam Findings:

i. Required elements for the diagnosis of general wrist or digit flexion tendon disorders include one of the following:

A) Reproduction of pain with active or resisted wrist/digit flexion;

B) Ulnar deviation specific to flexor mechanism involved; or C) Flexor carpi radialis may present with accompanying radial volar wrist pain with resisted wrist flexion and radial deviation.

ii. Crepitus with active motion of the flexor tendons may also be present.

d. Diagnostic Testing Procedures: X-ray and other imaging may be also performed to rule out other differential diagnoses or when there is an indication additional pathology may be present.

e. Non-operative Treatment Procedures:

i. Initial Treatment: over-the-counter medications for symptomatic relief, wrist splints for wrist flexors and splinting.

ii. Patient education: should include instruction in self-management techniques, ergonomics, home therapy program and intermittent splinting for contractures. Recurrence is common, so patient education regarding provocative activities is essential for long term recovery.

iii. Job site evaluations and alterations: Ergonomic alterations should be iv. Steroid Injections: may decrease inflammation and pain and allow the  Maximum Frequency: 3 to 4 per year if injections result in functional benefit without local reactions or complications.

v. Return to work with appropriate restrictions should be considered early in the course of treatment. Refer to Section H.11 Return- to-Work.

vi. Other therapies in Section H Therapeutic Procedures – Non-operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often Surgery is rarely necessary but may be indicated when a tendon is ruptured, chronically enlarged or entrapped, or on rare occasions when conservative measures have failed and tendonitis is clearly present.

Any decision for surgical intervention should be based on a hand surgeon's evaluation of need and the existence of a clear functional deficit that can be corrected by surgical intervention.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals, the likelihood of achieving improved ability to perform activities of daily living or work, and possible complications. The patient should significantly over time, without invasive interventions, patients must be able to g. Operative Procedures: The surgical procedures will depend on the specific condition and may include tenosynovectomy, synovectomy, or repair/reconstruction of the flexor tendon.

h. Post-operative Treatment:

i. An individualized rehabilitation program based upon communication ii. Return to work and restrictions after surgery may be made by an 6. TRIANGULAR FIBROCARTILAGE COMPLEX TEAR (TFCC)

a. Description/Definition: pain and/or tenderness localized to the affected tendons; pain in the affected tendons associated with wrist/digit flexion and ulnar deviation, especially against resistance.

b. Occupational Relationship: This condition may be asymptomatic and then aggravated due to occupational exposures and require treatment. Refer to

Section D.3 Medical Causation Assessment for Cumulative Trauma Conditions.

To perform a proper causation assessment, the reader must comply with all sections.

c. Specific Physical Exam Findings:

i. Required elements for the diagnosis of TFCC are:

A) Tenderness over the TFCC complex; and B) One positive provocative test with localizing pain, clicking or findings of abnormal motion. Provocative tests include:

• Forced supination and pronation with axial pressure on an ulnar deviated wrist;

• The patient pushes up from a seating position using the hand; and/or • Ballottement of the distal ulna with the wrist supinated causes abnormal motion as compared to the asymptomatic side.

ii. Crepitus: clicking/popping are frequently present.

iii. Extensor or flexor carpi ulnaris tendinitis may also be confused with TFC C.

d. Diagnostic Testing Procedures: x-ray and MRI or MRI arthrography (MRA).

There is good evidence that MRA is a more sensitive and more specific diagnostic test for TFCC than MRI. There is also good evidence that many patients who do not have TFCC can be more accurately identified with MRA rather than MRI. As with knee degenerative changes, many patients with TFCC tears are asymptomatic. In one study of patients with a history of TFCC and related falls, ligament disruptions were commonly found in the opposite asymptomatic hand over 50% of the time. Therefore, it may be reasonable to also image the opposite wrist if it is asymptomatic. Those with a corresponding abnormality in the opposite wrist should have an especially rigorous diagnostic review before proceeding to a surgical intervention.

e. Non-operative Treatment Procedures:

i. Initial Treatment: rest, splinting, ice and later heat.

ii. Medications such as analgesics and over-the-counter medications for symptomatic relief may be helpful. Refer to medication discussions in

Section H.7 Medications and Medical Management.

iii. Patient education: should include instruction in self-management iv. Job site evaluations and alterations: Ergonomic alterations should be same job position. Refer to Section E.6.c Job Site Evaluations and H.6 Job Site Alteration.

v. Steroid Injections: may decrease inflammation and pain and allow the ❖ Maximum Frequency: 3 to 4 per year if injections result in daily for 2 weeks after injections.

vi. Return to work with appropriate restrictions should be considered early in vii. Other therapies in Section H Therapeutic Procedures – Non-operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often A patient may be a surgical candidate if there are concomitant fractures, instability, or if symptoms continue to interfere with ADLs or job duties after nonsurgical interventions for 2 to 3 months.

i. Non-surgical interventions should include: rest from inciting factors, ergonomic job changes, and steroid injections. Pathology is usually identified on MRI and there should not be another diagnosis which better explains the patient’s complaints.

Those with a corresponding abnormality in the opposite wrist should have an especially rigorous diagnostic review before proceeding to a surgical intervention.

ii. Prior to surgical intervention, the patient and treating physician should identify functional operative goals, the likelihood of achieving improved ability to perform activities of daily living or work, and possible complications. The patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

Informed decision making should be documented for all invasive natural history of the identified diagnosis. Since many patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

Smoking may affect soft tissue healing through tissue hypoxia. Patients For both non-union and soft-tissue: Smokers have a higher risk of nonunion and post-operative costs. Therefore, if a treating physician recommends a specific smoking cessation program peri-operatively, it based on the operative procedure. Refer to Section H.7 Medications for further details.

g. Operative Procedures: numerous procedures including arthroscopy debridement and/or repair, ulnar shortening and wafer procedure when there is a carpal detachment or detachment of the radius. The surgical procedures will depend on the specific deficit.

h. Post-operative Treatment:

i. An individualized rehabilitation program based upon communication ii. Wrist splints are usually required for 6 weeks, and power grip and axial loading are discouraged. Range of motion is usually begun at 2 weeks.

iii. Return to work and restrictions after surgery may be made by an with the surgeon or by the surgeon. Usually light activity only is recommended for 3 months.

7. TRIGGER DIGIT

a. Description/Definition: difficulty extending and flexing the digit which may be accompanied by a history of “catching" or “triggering.” Other conditions may be related to this complaint. Thus, history alone does not confirm the diagnosis.

b. Occupational Relationship: Refer to Section D.3 Medical Causation c. Specific Physical Exam Findings: Required elements for the diagnosis of trigger digits include one of the following:

i. Tenderness at the A1 pulley with digit motion;

ii. Triggering of the digit;

iii. A history of difficulty flexing and extending the digit with a palpable nodule.

Active range of motion may be affected, usually only in severe cases.

d. Diagnostic Testing Procedures: X-ray and other imaging may be performed to

rule out other differential diagnoses or when there is an indication that additional pathology may be present.

e. Non-operative Treatment Procedures:

i. Initial Treatment: over-the-counter medications for symptomatic relief.

ii. Orthosis: a metacarpal or proximal interphalangeal joint blocking splint for 3 – 6 weeks.

iii. Patient education: should include instruction in self-management techniques, ergonomics, and home therapy program. Recurrence is iv. Job site evaluations and alterations: Ergonomic alterations should be v. Steroid injections for trigger digit provide decreased symptoms and are frequently a first line treatment.

There is some evidence that in the intermediate term (up to three months), injections with triamcinolone and with diclofenac are equally effective in patients with trigger digit.

The patient should rest the digit partially or completely for 0 – 7 days after the injection.

Steroid Injections: may decrease inflammation and pain and allow the  Maximum Frequency: If additional injections are being considered, referral to a specialist should be considered.

vi. Return to work with appropriate restrictions should be considered early in vii. Other therapies in Section H Therapeutic Procedures – Non-operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often Surgery is often not necessary. Any decision for surgical intervention should be based on a hand surgeon's evaluation of need and the existence of a clear functional deficit that can be corrected by surgical intervention. Trigger digit release, open or percutaneous, may be indicated when: 1) diagnosis has been verified; and 2) symptoms persist after conservative management including steroid injections over at least 4 weeks. Surgery should be performed to achieve functional gains on those with significant ongoing impaired activities of daily living or work-related functions. There is good evidence that open and percutaneous trigger digit release have similar success rates and similar complication rates.

There is good evidence that percutaneous release has a lower rate of recurrence than does a steroid injection.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals, the likelihood of achieving improved ability to perform activities of daily living or work, and possible complications. The patient should significantly over time without invasive interventions, patients must be able to g. Operative Procedures: trigger digit release.

h. Post-operative Treatment:

i. An individualized rehabilitation program based upon communication splinting, elevating the hand post-operatively, and active therapy with or without passive therapy. Digital motion per surgeon’s instructions will avoid scar formation.

ii. Return to work and restrictions after surgery may be made by an with the surgeon or by the surgeon. Usually no heavy lifting or forceful activity for 2 – 4 weeks post-operatively.

G. SPECIFIC PERIPHERAL NERVE DIAGNOSIS, TESTING &TREATMENT PROCEDURES

1. CARPAL TUNNEL SYNDROME

a. Description/Definition: The median nerve is vulnerable to compression and injury in the region of the wrist and palm. In this area, the nerve is bound by the wrist bones and the transverse carpal ligament. The most common site of compression is at the proximal edge of the flexor retinaculum (an area near the crease of the wrist). Stenosing tenosynovitis may occur proximal and distal to the carpal tunnel area. There is often a myofascial component in the patient's presentation. This should be considered when proceeding with the diagnostic testing and therapeutic intervention.

The following elements are commonly associated with carpal tunnel syndrome:

i. Exacerbating and alleviating factors of the reported symptoms. The physician should explore and report on non-work related, as well as work-related activities.

ii. Prior occupational and non-occupational injuries to the same area including specific prior treatment and any prior bracing devices.

iii. Discussion of any symptoms present in the unexposed extremity.

b. Occupational Relationship: Refer to Section D.3 Medical Causation Assessment for Cumulative Trauma Conditions. To properly assess causation, the reader must comply with all sections.

c. Non-Occupational relationship: Hypothyroidism, diabetes types 1 and 2, and being overweight all are modest risk factors for carpal tunnel syndrome. Obesity and a square shaped wrist also increase the probability of carpal tunnel in the wrist, with an odds ratio of around 2. However, causation should be determined by the assessment in these Guidelines. These additional factors may only be considered for cases not meeting the evidence based criteria. Pregnancy is a known risk factor with up to 20% experiencing symptoms which are more frequent in later pregnancy.

d. Specific Physical Exam Findings: No one test is predictive of carpal tunnel syndrome. Multiple tests should be recorded with the patient’s exact response.

Final diagnosis is dependent on a correlation of symptoms, physical exam findings, and nerve conduction velocity (NCV) testing as any of these alone may have a false positive or false negative result. Phalen’s and Tinel’s appear to have similar predictive values as the flick test, between 73 and 87% for the positive predictive value and negative predictive values between 35 and 40%. Comparing physical exam findings to electrodiagnostic findings, Phalen’s and Durkan’s have an accuracy of 64-68% and weakness tests have a higher sensitivity.

i. The clinical diagnosis is confirmed by 1) patient’s history of paresthesia in two of the following digits: thumb, index and middle finger; and 2) at least one of the physical exam signs listed below. Provocative tests must recreate symptoms in the median nerve distribution.

A) Positive Phalen’s sign.

B) Modified Phalen’s test: There is some evidence that in patients with suspected carpal tunnel syndrome, a modified Phalen’s test can, in comparison with the traditional Phalen’s test, increase the sensitivity of the physical examination without sacrificing specificity. The test involves placing the hands of the patient in the usual flexed position for the traditional Phalen’s test and applying a 2.83 unit Semmes-Weinstein monofilament perpendicular to the palmar aspect and to the lateral side of the distal phalanx of the digits innervated by the median nerve.

Report as positive any test result in which the patient is unable to detect the application of the filament. The distal phalanx of the fifth digit should be used as a control.

C) Positive Tinel’s sign over the carpal tunnel.

D) Positive closed fist test (holding fist closed for 60 seconds reproducing median nerve paresthesia).

E) Positive compression test (applying compression over the median nerve for 30 to 60 seconds reproducing symptoms).

F) Compression with wrist flexed at 60º, elbow flexed and forearm supinated.

G) Thenar atrophy may be present, usually late in the course.

H) Weakness of the abductor pollicis brevis. Apply resistance at the first metacarpophalangeal joint.

I) Sensory loss to pinprick, light touch, two-point discrimination, or Semmes Weinstein monofilament tests in a median nerve distribution. No loss of sensation in the central palm. The middle finger is likely to demonstrate 2 point discrimination or Semmes Weinstein changes that correlate to positive electrodiagnostic tests.

J) The scratch test is interesting but appears to be less accurate than other tests.

ii. Physicians should be aware that both NCV-diagnosed carpal tunnel syndrome and physician-diagnosed carpal tunnel syndrome fluctuate over time in both directions for individual cases.

iii. Evaluation of the contralateral wrist is recommended due to the frequency of bilateral involvement.

iv. Evaluation of the proximal upper extremity and cervical spine for other conditions is recommended: cervical radiculopathy, thoracic outlet syndrome, other peripheral neuropathies, and other musculoskeletal conditions.

v. Assessment for signs of underlying medical disorders associated with carpal tunnel syndrome is recommended (e.g., diabetes mellitus, arthropathy, and hypothyroidism).

vi. Myofascial findings requiring treatment may present in additional soft tissue areas. These should be identified and treated in accordance with medical treatment guidelines.

e. Diagnostic Testing Procedures:

i. Diagnostic Steroid Injections: Classic findings of carpal tunnel syndrome include subjective numbness or dysesthesias confined to the median nerve distribution, worsening of symptoms at night, and positive exam findings. When the diagnosis is in question, steroid injection into the carpal tunnel is a strongly supportive test if it is followed by significant relief of symptoms. A negative diagnostic steroid injection does not eliminate the diagnosis of carpal tunnel syndrome.

ii. Electrodiagnostic (EDX) Testing: Nerve conduction needle electromyography (EMG) and nerve conduction velocity (NCV) are wellestablished and widely accepted for evaluation of patients suspected of having carpal tunnel syndrome. The results are sensitive and specific for the diagnosis when clinical symptoms are present. Studies may confirm the diagnosis or direct the examiner to alternative conditions. When polyneuropathy is suspected, it may be worthwhile to perform electrodiagnostic testing in the lower extremities. Studies require clinical correlation due to the occurrence of false positive and false negative results. Symptoms of carpal tunnel syndrome may occur with normal EDX studies, especially early in the clinical course.

EDX studies are imperfect indicators of the outcome of treatment of carpal tunnel syndrome, since they may be only weakly correlated with functional scores. However, they may provide useful information when symptomatic and functional recovery after treatment has not occurred.

EDX findings in carpal tunnel syndrome reflect slowing of median motor and sensory conduction across the carpal tunnel region due to demyelination. Axonal loss, when present, is demonstrated by needle electromyography in median nerve supplied thenar muscles.

A) Needle electromyography of a sample of muscles innervated by the C5 to T1 spinal roots, including a forearm muscle and/or thenar muscle innervated by the median nerve of the symptomatic limb, is frequently required.

B) The following EDX studies are not recommended to confirm a clinical diagnosis of carpal tunnel syndrome:

1. Due to low sensitivity and specificity compared to other EDX studies, multiple median F wave parameters and sympathetic skin response are not recommended.

2. Investigational studies: Evaluation of the effect on median nerve conduction with limb ischemia, dynamic hand exercises, and brief or sustained wrist positioning are not recommended.

3. Electroneurometer: This is not recommended as a diagnostic tool because it requires patient participation, cannot distinguish between proximal and distal lesions, and does not have well-validated reference values.

4. Portable Automated Electrodiagnostic Device: measures distal median nerve motor latency and F-wave latency. It remains an investigational instrument whose performance in a primary care setting is not yet established and is not recommended as a substitute for conventional electrodiagnostic testing in clinical decision making. Refer to Section E Follow-up Diagnostic Imaging and Testing Procedures for details.

C) To assure accurate testing, temperature should be maintained at 32 to 34C, preferably recorded from the hand/digits. For temperature below 32C, the hand should be warmed.

D) Positive Findings: Any of these nerve conduction study findings must be accompanied by median nerve symptoms to establish the diagnosis:

1. Slowing of median distal sensory and/or motor conduction through the carpal tunnel region.

2. Electromyographic changes in the median thenar muscles in the absence of proximal abnormalities.

3. Suggested guidelines for the upper limits of normal latencies:

a) Median distal motor latency (DML): 4.5 ms / 8 cm.

b) Median distal sensory peak latency (DSL): 3.6 ms / 14 cm.

c) Median intrapalmar peak latency (palm/wrist): 2.2 ms / 8 cm.

d) Median-ulnar palmar sensory latency difference: 0.4 ms at 8 cm.

e) Median Comparison with radial nerve sensory/mixed latency: 0.4 ms at 10 cm.

f) Some examiners suggest comparing the sensory latencies for index and ring finger both the half distance and full distance to confirm the diagnosis.

g) Other comparisons may also be used.

4. Because laboratories establish their own norms, a degree of variability from the suggested guideline values (as described in 3 above) is acceptable.

E) Normative values may be provided with the neuro-diagnostic evaluation.

F) Suggested grading scheme by electrodiagnostic criteria for writing a consultation or report may be:

1. Mild carpal tunnel syndrome: prolonged (relative or absolute) median sensory or mixed action potential distal latency (orthodromic, antidromic, or palmar).

2. Moderate carpal tunnel syndrome: abnormal median sensory latencies as above and prolongation (relative or absolute) of median motor distal latency.

3. Severe carpal tunnel syndrome: prolonged median motor and sensory distal latencies, with either absent sensory or palmar potential, or low amplitude or absent thenar motor action potential. Needle examination reveals evidence of acute or chronic denervation with axonal loss.

G) Frequency of Studies/Maximum Number of Studies:

1. Indications for Initial Testing:

a) Patients with clinically significant carpal tunnel syndrome who do not improve symptomatically or functionally with conservative measures for carpal tunnel syndrome over a 3 to 4 week period.

b) Patients for whom the diagnosis is in question.

c) Patients for whom surgery is contemplated.

d) To rule out other nerve entrapments or alternative radiculopathy.

2. Repeated studies may be performed, preferably by the previous electrodiagnostician:

a) At 8 to 12 weeks for inadequate improvement with non-surgical treatment.

b) At 12 weeks or longer when the initial studies were normal and carpal tunnel syndrome is still suspected.

c) Post-operative 3 to 6 months for persistent or recurrent symptoms following carpal tunnel release, unless an earlier evaluation is required by the surgeon.

iii. Laboratory Tests: In one study of carpal tunnel patients seen by specialists, 9% of patients were diagnosed with diabetes, 7% with hypothyroidism, and 15% with chronic inflammatory disease including spondyloarthropathy, arthritis, and systemic lupus erythematosus. Up to two thirds of the patients were not aware of their concurrent disease.

Estimates of the prevalence of hypothyroidism in the general population vary widely, but data collected from the Colorado Thyroid Disease Prevalence Study revealed subclinical hypothyroidism in 8.5% of participants not taking thyroid medication. The prevalence of chronic joint symptoms in the Behavioral Risk Factor Surveillance System (BRFSS) from the Centers for Disease Control (CDC) was 12.3%. If initial history suggests concomitant disease or after 2 to 3 weeks the patient is not improving, the physician should strongly consider the following laboratory studies: thyroid function studies, rheumatoid screens, chemical panels, and others if clinically indicated. In one study, 14% of carpal tunnel syndrome patients were diagnosed with new onset diabetes. There is some evidence that diabetic patients with upper extremity disorders are more likely to be under poor diabetic control. Therefore, it is appropriate to order a hemoglobin A1c for any diabetic patients with a carpal tunnel syndrome or other laboratory tests to detect diabetes.

Laboratory testing for cumulative trauma conditions may be required periodically to monitor patients on chronic medications.

iv. Other Tests:

A) Imaging, MRI, and sonography are not recommended unless a space occupying lesion is suspected.

B) Electroneurometer and other portable automated electrodiagnostic devices are not recommended. Refer to Section E Follow-up Diagnostic Imaging and Testing Procedures.

C) Ultrasound has been shown to be useful. However, it has not surpassed the need for EMG to determine the need for surgery.

f. Non-operative Treatment Procedures:

i. Initial Treatment: medications such as analgesics and over the counter medications for symptomatic relief, wrist splint at night, and restriction of activities based on a job site ergonomic evaluation when indicated.

There is strong evidence that, in patients with carpal tunnel syndrome which has not become chronic, carpal tunnel release leads to a moderate treatment advantage with respect to functional improvement 6 months after surgery. While there is considerable benefit from conservative treatment such as splinting and individualized hand therapy, there is insufficient evidence to identify which patients are likely not to benefit from conservative treatment sufficiently to avoid surgery.

ii. Patient education: should include instruction in self-management techniques, including sleeping postures which avoid excessive wrist flexion; ergonomics; and a home therapy program. Episodes of iii. Job site evaluations and alterations: Ergonomic alterations should be done early to assure that appropriate changes are accomplished early in the treatment program. In a 2007 published study, it was noted that 73% of mild cases referred for carpal tunnel surgery received splints, 23% steroid injections and only 15% modification in activities recommendations. This emphasizes the need for basic initial care including job site modification for all patients, especially in milder cases that may not require surgery.

There is insufficient evidence to support ergonomic positioning or keyboards as clearly beneficial for carpal tunnel syndrome.

One study of a variety of vertical and gel mouse pads did not support the use of any particular pad to decrease carpal tunnel pressure.

Whenever a case is identified as a work related cumulative trauma and/or 3) a formal job site evaluation at the worksite.

Ergonomic job site evaluation and change are a required treatment for all cumulative trauma conditions as this may eliminate the need for invasive Suggested ergonomic changes usually also apply to uninjured workers in the same job position. Refer to Section E.6.c Job Site Evaluations and iv. Medications and Medical Treatment: Use of medications in the treatment of carpal tunnel syndrome is appropriate for controlling acute and chronic pain and inflammation. All drugs should be used according to patient needs. A thorough medication history, including use of alternative and over the counter medications, should be performed at the time of the initial visit and updated periodically.

There is good evidence that NSAIDS and diuretics add no benefits for symptom improvement compared to placebo at 4 weeks, and some evidence that Vitamin B6 adds no benefit on symptom improvement compared to placebo at 10-12 weeks. The American Academy of Orthopaedic Surgeons (AAOS) says there is moderate evidence against non-steroid oral medications. Although NSAIDs are not curative, they and other analgesics may provide symptomatic relief.

Oral Steroids: There is good evidence that oral steroids are more effective than placebo in improving symptoms in the short term, and there is some evidence that they are not effective in the long term (12 months). There is some evidence that 6 weeks of oral steroids are more effective than splinting in improving function but not symptoms in the short term. Given the lack of long term effects and the problematic side effects, steroids are not recommended.

v. Orthotics/Immobilization with Splinting: Splints should be loose and soft enough to maintain comfort while supporting the wrist in a relatively neutral position. This can be accomplished using a soft or rigid splint with a metal or plastic support. Some splints include immobilization of the metacarpophalangeal joints. Splint comfort is critical and may affect compliance. Although off-the-shelf splints are usually sufficient, custom thermoplastic splints may provide a better fit for certain patients.

There is no evidence in favor of full-time use of a wrist splint compared with night-only use. There is no evidence in favor of a wrist splint in the neutral position compared to an extended wrist position of 20° in the short term (2 weeks). There is insufficient evidence to support a specific type of splint for splinting over other treatment.

There is some evidence in the short term (4 weeks) and absence of evidence in the midterm (4-6 months) that a nocturnal hand brace is more effective for reducing pain and improving function compared to no treatment. There is some evidence in the short term that a 3-month night treatment with either the soft hand brace or the wrist splint is effective in reducing symptoms and improving function, but there is no significant difference between the 2 interventions.

Splints may be effective when worn at night or during portions of the day, depending on activities. Depending on job activities, intermittent daytime splinting can also be helpful. Splint use is rarely mandatory. Providers should be aware that over-usage is counterproductive and should counsel patients to minimize daytime splint use in order avoid detrimental effects such as stiffness and dependency over time.  Time to Produce Effect: 2 to 4 weeks. If after 4 weeks, the patient has partial improvement, continue to follow since neuropathy may worsen, even in the face of diminished symptoms.

vi. Steroid injections: may be considered for management of mild to moderate carpal tunnel symptoms after conservative therapies have failed. There is good evidence that steroid injections have better results at 3 months than oral steroids. There is good evidence that a steroid injection produces a significant decrease in carpal tunnel symptoms for up to 10 weeks, with outcomes comparable to surgery. Another study showed some evidence of significant improvement in symptom scores at 6 weeks in both injection and surgery. However, by 20 weeks, there was a diminishing of the response to injection while the surgery group had a persistent improvement in symptoms. It should be noted that while the symptoms worsened over time in the injection group, there was still an increase in grip strength at 4 months of 2.4kg whereas the surgery group had a decrease of 1.7kg. There is also good evidence showing that improvement in symptoms after steroid injection begins to decrease over time and by 1 year, 73-81% of those patients receiving steroids require surgical intervention due to relapsing symptoms. An additional study demonstrated some evidence that only 51% percent of patients with mild to moderate carpal tunnel symptoms responded to steroid injections with a significant response, and of those that responded, 49% required additional injections and/or surgery by 1 year.

There is good evidence that in patients with carpal tunnel syndrome who have not improved after 2 months of splinting, an injection of 80 mg of methylprednisolone and of 40 mg of methylprednisolone are equally likely to lead to short-term 5-week improvements in carpal tunnel symptoms compared to placebo. However, the success of methylprednisolone in avoiding surgery in carpal tunnel syndrome patients is modest. Although approximately 92% of placebo-injected patients are likely to require carpal tunnel release within one year, about three quarters of patients who have a methylprednisolone injection are also likely to have surgery. However, this modest difference in rates of surgery may prevent a large number of carpal tunnel release operations if steroid injections are offered to a large population of carpal tunnel syndrome patients who continue to have symptoms after a 2 month trial of splinting.

There is some evidence that 60mg methylprednisone injection is more effective than 20 or 40mg methylprednisone at 6 months but not at one year. There is some evidence that there is no significant difference between a single corticosteroid injection of 15mg methylprednisolone compared with 2 local corticosteroid injections regarding symptom improvement at 8, 24, and 40 weeks after injection.

When approaching the decision to consider steroid injection in a patient with mild to moderate carpal tunnel syndrome, it is important to consider the trend of a good initial therapeutic response followed by a diminishing response after 3 months and high rates of relapse by 1 year. Underlying medical conditions and potential ergonomic risk factors for carpal tunnel syndrome should be considered and addressed, if possible. In the case of an identified modifiable condition, a steroid injection may provide a less invasive short-term response to manage symptoms. Shared decision making with the patient should be had regarding the high risk of relapse and the potential lack of response after steroid injection. If a steroid injection is performed and symptoms recur following the first injection symptomatic relief, the decision to perform a second injection must be weighed against alternative treatments such as surgery.  Maximum Frequency: 3 injections.

vii. Nerve Gliding: Exercises consist of range of motion of the upper extremity and neck that produce tension and longitudinal movement along the length of the median and other nerves of the upper extremity.

These exercises are based on the principle that the tissues of the peripheral nervous system are designed for movement and that tension and glide (excursion) of nerves may have an effect on neurophysiology through alterations in vascular and axoplasmic flow. The exercises are simple to perform and can be done by the patient after brief instruction.

Biomechanical principles have been more thoroughly studied than clinical outcomes.

There is no evidence in favor of the addition of tendon and nerve gliding exercises to 4 weeks of night splinting compared to splinting alone.

There is good evidence that neuro-dynamic technique plus splinting add no benefit to reduce pain or improve function compared to splinting alone after 3 weeks.

Due to lack of quality evidence, use of mobilization and exercise should be based on patient preference and provider expertise.  Time to Produce Effect: 2 to 4 weeks.  Frequency: Up to 5 times per day by patient (patient-initiated).  Optimum Duration: 2 provider-directed sessions.  Maximum Duration: 3 provider-directed sessions.

viii. Manual Therapy Techniques: There is good evidence that manual and manipulative therapy combined with exercise and/or multimodal therapy shows small, clinically important reductions in pain and improved physical function in the short-term care (≤3-6 months) of patients with lateral epicondylitis and carpal tunnel syndrome.

There is some evidence from a high quality randomized controlled trial that an initial treatment approach for carpal tunnel syndrome involving physical manual therapy directed at the entire course of the median nerve from the scalene muscles to the wrist, in combination with nerve and tendon gliding exercises, is as successful as carpal tunnel release at 6 months and at 1 year. The physical manual therapy combined with nerve and tendon gliding exercises may show advantages over surgery at 1 and 3 months. However, there was incomplete analysis of patient data.

There is good evidence that soft tissue mobilization plus home exercises is effective in reducing pain and improving function at 6 months.

Use of mobilization and exercise should be based on patient preference and provider expertise.  Time to Produce Effect: 4 to 6 weeks.

ix. Ultrasound: There is some evidence that ultrasound is no more effective than placebo at 2 weeks of follow-up regarding pain, symptoms, and function. However, there is some evidence that ultrasound is more effective in improving symptoms only, not function, compared to placebo at 7 weeks of follow-up and in the midterm (4-6 months). There is some evidence that there is no significant difference between an ultrasound intensity of 1.5W/cm compared with 0.8W/cm regarding pain and symptom improvement after 2 weeks. There is some evidence that ultrasound is more effective on pain and function than low level laser therapy at 4 weeks; however, low level laser is ineffective. There is some evidence that there is no beneficial effectiveness of pulsed or continuous ultrasound combined with splint therapy compared to sham ultrasound and splint therapy in reducing pain and symptoms and improving functionality for treating patients with mild or moderate idiopathic carpal tunnel syndrome. This study is inconclusive in its ability to find an effect due to only 70% power and a small sample size.

Another systematic review found insufficient evidence to support ultrasound therapy.

There is some evidence that ultrasound therapy plus splinting is no more effective than placebo ultrasound plus splinting in reducing pain and symptoms and improving functionality in the conservative treatment of patients with carpal tunnel syndrome.

Therefore, ultrasound without phonophoresis is not recommended.

x. Low Level Laser Therapy (LLLT): There is some evidence that LLLT adds no short term benefit for reducing symptoms and improving function compared to full-time splinting for 3 months. There is good evidence that laser therapy is ineffective regarding pain and function compared with placebo as an intervention to treat carpal tunnel syndrome in the short term. This is some evidence that LLLT is no more effective than placebo LLLT in reducing pain and symptoms and improving functionality in the conservative treatment of patients affected by carpal tunnel syndrome.

There is some evidence that LLLT plus splinting is no more effective than splinting alone in reducing carpal tunnel symptoms and improving functionality in the conservative treatment of patients affected by carpal tunnel syndrome. There is good evidence from a number of adequate studies that LLLT does not add benefit and it is not recommended.

xi. Yoga: There is some evidence that yoga is equally as effective in reducing pain and improving grip strength as wrist splinting in the short term. There is some evidence that Hatha yoga instruction may reduce pain and improve grip strength as effectively as splinting. However, the evidence was inadequate to show superiority over splinting. This, as is the case with other complementary/alternative exercise, should be done with oversight of a physician or other appropriate healthcare professional for motivated patients preferring this treatment.  Frequency: 2 times per week.  Optimum and Maximum Duration: 4 to 8 weeks.

xii. Iontophoresis: may be an appropriate option for patients refusing or wishing to delay surgery and injections. There is no evidence in favor of dexamethasone iontophoresis on symptom improvement compared to a placebo control group at 3 and 6 months. Under current FDA regulations, the physician will issue a prescription to the patient for the dexamethasone for this treatment and the patient will usually need to transport the medication to the treatment location.  Optimum and Maximum Frequency: 6 to 9 sessions over 5 weeks.

xiii. Acupuncture and Magnets: There is no evidence for the use of magnets, laser acupuncture, or chiropractic treatment. Therefore, these interventions are not recommended.

There is some evidence that laser acupuncture adds no benefits to night pain improvement compared to placebo at 3 weeks. There is some evidence that there are no differences between needle acupuncture combined with a wrist brace and placebo needle acupuncture combined with a wrist brace. Neither treatment is clinically effective in improving function in patients with mild or moderate carpal tunnel syndrome.

Therefore, it is not recommended.

xiv. There is no evidence in favor of massage therapy, heat wrap therapy, and cupping therapy for the treatment of carpal tunnel syndrome in the short term.

xv. Return to work with appropriate restrictions should be considered early in xvi. Other therapies in Section H Therapeutic Procedures – Non-Operative may be used for myofascial symptoms accompanying carpal tunnel syndrome.

g. Surgical Indications/Considerations: Since cumulative trauma conditions often There is strong evidence that in patients with carpal tunnel syndrome which has not become chronic, carpal tunnel release leads to a moderate treatment advantage with respect to functional improvement 6 months after surgery.

However, there is considerable benefit to conservative treatment such as worksite ergonomic changes, splinting, and individualized hand therapy, which are appropriate for first-line treatment. There is insufficient evidence to identify which patients are likely not to benefit from conservative treatment sufficiently to avoid surgery.

For patients with clinically typical carpal tunnel symptoms of median nerve distribution numbness, with or without pain, which awakens the patient at night and is alleviated by shaking the hand: there is some evidence that the symptom and function outcomes of mini-open carpal tunnel release are similar at 6 months for patients who do and do not undergo preoperative nerve conduction studies.

However, the study excluded patients with atypical symptoms or unusual courses of disease, recurrent syndrome, diabetic neuropathy, and cervical radiculopathy.

Overall, it is probably reasonable to expect that 40 to 50% of patients with mild exam findings may improve or remain stable overtime.

There is strong evidence that surgery is more effective than splinting or injections in producing long-term symptom relief and normalization of median nerve conduction velocity for those patients with clinically significant carpal tunnel syndrome with positive nerve conduction velocity findings. There is also a positive cost utility for surgery over conservative care for patients with positive nerve conduction studies. There is good evidence that surgery improves symptoms more effectively than steroid injection for up to five months.

In one prospective study, duration of symptoms prior to surgery, up to 5 years, did not affect the ability to achieve symptom or functional outcome success with surgery. Patients with more severe symptoms and longer duration of symptoms showed significant improvement with surgery. Patients with thenar atrophy, weakness of the abductor pollicis brevis, and fixed sensory deficits may still improve with surgery. Patients with mild symptoms and functional deficits demonstrated the smallest changes from pre- to post-operative scores. However, their post-operative scores were higher than the post-operative scores of those with more severe symptoms.

i. Surgery should be considered as an initial therapy in situations where clinical evidence of carpal tunnel syndrome is present based on the criteria below.

A) Median nerve trauma has occurred; “acute carpal tunnel syndrome;” or B) Thenar atrophy is present and due to median nerve compression; or C) Electrodiagnostic evidence of moderate to severe entrapment or compression neuropathy is present. EMG findings showing evidence of acute or chronic motor denervation suggest the possibility that irreversible damage may be occurring. There is good evidence that surgery is more beneficial than non-surgical treatment for patients with a motor latency of more than 4.5 ms.

ii. For cases with positive EDX findings, non-surgical treatment may be beneficial in some cases. Therefore, conservative management, including job alterations, should be tried over 4 to 6 weeks before surgery is considered. One prospective cohort study notes that negative electrodiagnostic testing decreases the likelihood of surgery by 11%. At least one study suggests that patients with more severe symptoms who fail one course of conservative therapy should progress to surgery.

iii. Surgery may be considered in cases where electro diagnostic testing is normal and initial non-operative therapy has failed. A second opinion from a hand surgeon is strongly recommended. The following criteria should be considered in deciding whether to proceed with surgery:

A) The patient's signs and symptoms are specific for carpal tunnel syndrome;

AND B) The patient experiences significant temporary relief of at least 80% improvement on a Visual Analog Scale following steroid injection into the carpal tunnel.

iv. Prior to surgical intervention, the patient and the treating physician should identify functional operative goals, the likelihood of achieving improved ability to perform activities of daily living or work, and possible complications. The patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

v. Informed decision making should be documented for all invasive natural history of the identified diagnosis. Since patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

vi. Smoking may affect soft tissue healing through tissue hypoxia. Patients h. Operative Procedures:

i. Open and endoscopic carpal tunnel release techniques: There is some evidence that, in patients with carpal tunnel syndrome requiring surgery, endoscopic carpal tunnel release (ECTR) leads to earlier recovery of grip strength and earlier return to work than open carpal tunnel release (OCTR). There is good evidence that ECTR and OCTR are nearly equivalent with respect to short-term and long-term pain, numbness, and patient-reported general hand function. Choice of technique should be left to the discretion of the surgeon.

ii. Complications: Endoscopic and open carpal tunnel releases have low rates of serious complications, reportedly up to 0.5%. However, some studies have reported higher rates of complex regional pain syndrome after surgery unrelated to the anesthetic technique. The most commonly seen serious complications are incomplete transection of the transverse carpal ligament and inadvertent nerve or vessel injuries. Serious complications are rare and include permanent nerve damage and infection. Pillar pain may persist for 20 months; a burning sensation and scar tenderness are also common in up to 18% of cases. Reoccurrence is possible, although reoperation usually occurs in less than 5% of the population.

iii. There is some evidence that, in patients undergoing endoscopic carpal tunnel release, local anesthesia controls intraoperative pain as effectively as intravenous regional anesthesia, and local anesthesia may be simpler and less invasive to perform, with shorter tourniquet inflation and operating room times than intravenous regional anesthesia.

iv. Neurolysis: has not been proven advantageous for carpal tunnel syndrome. Internal neurolysis should never be done.

v. Tenosynovectomy: For routine cases of carpal tunnel syndrome, tenosynovectomy has not proven to be beneficial. Although achy pain in the wrist and forearm commonly may accompany carpal tunnel syndrome, paresthesias tends to be the predominant complaint. In occasional cases, pain may be the predominant complaint. If a patient with documented carpal tunnel syndrome experiences pain along the volar wrist, hand, and/or distal forearm as the predominant symptom, clearly overshadowing the paresthesias, there may be a significant component of tenosynovitis. Tenosynovectomy should be considered in these unusual cases at the time of carpal tunnel release.

i. Post-operative Treatment:

i. Patients should receive a home therapy protocol involving stretching, range of motion, scar management, and resistive exercises. Patients should be encouraged to use the hand as much as possible for daily activities, allowing pain to guide their activities.

ii. There is some evidence that immediate mobilization of the wrist following surgery is associated with less scar pain and faster return to work. There is some evidence that removal of a bulky dressing after mini-open Carpal Tunnel Release and replacement with an adhesive strip at 48 to 72 hours causes no wound complications and results in equal short-term (2week) clinical and subjective outcome measures compared with using a bulky dressing for 2 weeks. Final decisions regarding the need for splinting post-operatively should be left to the discretion of the treating physician based upon the surgical technique used and the specific conditions of the patient.

iii. An individualized rehabilitation program may be helpful in patients who do not show functional improvements post-operatively or in patients with heavy or repetitive job activities. There is good evidence that routine use of hand therapy after surgery does not improve pain, function, or return to work in carpal tunnel syndrome uncomplicated by endocrine disease, arthritis, or advanced median nerve disease. However, workers’ compensation patients may have slower return to work and therefore at least 2 visits with the therapist are recommended to insure appropriate scar management and return to function.

There is insufficient evidence to formulate a post-operative care plan.

The rehabilitation program should be based upon communication between the surgeon and the therapist and using therapies as outlined in

Section H Therapeutic Procedures – Non-Operative. In all cases, timing of exercise progressions.

iv. Return to work and restrictions after surgery may be made by an Suggested parameters for return-to-work are:

Time Frame Activity Level 2 days Return to work with restrictions on utilizing the affected extremity 2 to 3 weeks Sedentary and non-repetitive work 4 to 6 weeks Case-by-case basis 6 to 12 weeks Heavy labor, forceful and repetitive Note: All return-to-work decisions are based upon clinical outcome.

v. Considerations for repeat surgery: The single most important factor in predicting symptomatic improvement following carpal tunnel release is the severity of preoperative neuropathy. Patients with moderate electro diagnostic abnormalities have better results than those with either very severe and/or mild findings. Incomplete cutting of the transverse carpal ligament or iatrogenic injury to the median nerve are rare.

Relief from steroid injections may provide additional confirmation. If median nerve symptoms do not improve following initial surgery or the symptoms improve initially and then recur but are unresponsive to nonoperative therapy (Section H Therapeutic Procedures – Non-Operative), consider the following:

A) Recurrent synovitis;

B) Repetitive work activities may be causing “dynamic” carpal tunnel syndrome;

C) Scarring;

D) Work-up for systemic diseases.

A second opinion by a hand surgeon and repeat nerve conduction studies are required if repeat surgery is contemplated. The decision to undertake repeat surgery must factor in all of the above possibilities.

Results of surgery for recurrent carpal tunnel syndrome vary widely depending on the etiology of recurrent symptoms.

2. CUBITAL TUNNEL SYNDROME

a. Description/Definition: The following are typical symptoms of cubital tunnel syndrome:

i. Activity related pain/paresthesias involving the 4th and 5th fingers coupled with discomfort near the medial aspect of the elbow;

ii. Pain/paresthesias worse at night;

iii. Decreased sensation of the 5th finger and ulnar half of the ring finger (including dorsum 5th finger);

iv. Progressive inability to separate fingers;

v. Loss of power grip and dexterity.

b. Occupational Relationship: Refer to Section D.3 Medical Causation c. Specific Physical Exam Findings: Required elements for the diagnosis include paresthesias or dull ache in the 4th and 5th digits and at least one of the following exam findings:

i. Diminished sensation of the fifth and ulnar half of the ring fingers, which may sometimes include sensory loss to pinprick, light touch, two-point discrimination or Semmes Weinstein monofilament tests in an ulnar nerve distribution;

ii. Positive elbow flexion/ulnar compression test. The combination flexion pressure test can be performed by fully flexing the elbow in supination and applying pressure to the ulnar nerve proximal to the cubital tunnel for 60 seconds. Reproduction of symptoms is a positive test;

iii. Testing elbow maximum flexion at 1 and 3 minutes also appears to have reasonable sensitivity and specificity;

iv. Later stages manifested by intrinsic atrophy or weakness and ulnar innervated intrinsic weakness. Specific physical signs include clawing of the ulnar 2 digits, ulnar drift of the 5th finger (Wartenberg’s sign), or flexion at the thumb interphalangeal (IP) joint during pinch (Froment’s sign).

d. Diagnostic Testing Procedures:

MRI: Imaging is generally not indicated but may be useful when space occupying lesions are suspected.

EDX: Electrodiagnostic (EDX) studies are well-established and widely accepted for evaluation of patients suspected of having peripheral nerve pathology.

Studies may confirm the diagnosis or direct the examiner to alternative disorders. electrodiagnostic testing in the lower extremities. Studies require clinical correlation due to the occurrence of false positive and false negative results.

Symptoms of peripheral nerve pathology may occur with normal EDX studies, especially early in the clinical course.

To assure accurate testing, temperature should be maintained at 32 to 34 degrees C, preferably recorded from the hand/digits. For temperature below 32 degrees C, the hand should be warmed.

All studies must include normative values for their laboratories. Studies of both upper extremities may be done for comparison.

During the study, the elbow should be maintained in moderate flexion, usually 70-90 degrees. Two positive findings in this position constitute a positive test.

The following criteria are used:

i. Absolute motor nerve conduction velocity from above elbow to below elbow less than 50 ms.

ii. Above to below elbow segment more than 10 ms slower than the below elbow to wrist segment.

iii. Decrease in compound muscle action potential (CMAP) negative peak amplitude from below the elbow to above the elbow of 20%.

iv. Significant change in CMAP configuration at the above elbow site compared to below elbow.

v. Desynchronization of the motor action potential after stimulation proximal, but not distal, to the ulnar groove.

vi. Focal slowing on inching studies across the elbow; latency exceeding 0.7 milliseconds across 2 inches.

vii. Indications for testing:

A) Initial testing:

1. Patients with clinically significant cubital tunnel findings who do not improve symptomatically or functionally with conservative measures, including job site alteration over a 3 to 4 week period.

2. Patients for whom the diagnosis is in question.

3. Patients for whom surgery is contemplated.

4. To rule out other nerve entrapments, or alternative radiculopathy, including C8 or brachial plexopathy.

B) Other studies may be performed:

1. At 3 months or longer when the initial studies were normal and cubital tunnel syndrome is still suspected.

2. At 8 to 12 weeks for inadequate improvement with nonsurgical treatment.

3. Post-operative 3 to 6 months for persistent or recurrent symptoms following ulnar nerve surgery, unless an earlier evaluation is required by the surgeon.

e. Non-operative Treatment Procedures:

i. Initial Treatment: Medications such as analgesics and over the counter medications for symptomatic relief; elbow pad anteriorly at 30 to 60 degrees or towel around elbow at night, optional posterior pad for daywear, and restriction of activities.

ii. Patient education: should include instruction in self-management techniques including avoidance of excessive or repetitive elbow flexion, ergonomics, and a home therapy program. There is some evidence that a trial of conservative treatment for cubital tunnel syndrome is as effective as a treatment program involving nocturnal bracing and a program involving gliding exercises. However, this conservative treatment should educate the patient on nerve anatomy, causes of symptoms, and appropriate elbow movements. Recurrence is common, so patient education regarding provocative activities is essential for long term recovery.

iii. Job site evaluations and alterations: Ergonomic alterations should be the treatment program. It is important to avoid activities that apply mechanical pressure to the elbow or cause repetitive flexion.

iv. Whenever a case is identified as a work-related cumulative trauma and/or 3) a formal job site evaluation at the worksite. Workers should avoid repetitive full flexion or extension or posterior pressure on the elbow. Employers should consider applying the ergonomic changes to uninjured workers in the same job position. Refer to Section E.6.c Job Site Evaluations and Section H.6 Job Site Alteration.

v. Steroid injections are not recommended due to the lack of evidence and difficulty entering the correct area without causing damage.

vi. Return to work with appropriate restrictions should be considered early in vii. Other therapies in Section H Therapeutic Procedures – Non-Operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often Surgery may be considered when 1) findings on history and objective evidence deficits persist after 6 to 8 weeks.

Subjective complaints should be localized and appropriate to the diagnosis, neurologic complaints should be consistent with the nerve distribution in question, and physical exam findings should correlate with the history. Objective evidence should be present and include: positive physical exam findings as described in Section G.2.c or a motor deficit commensurate with the suspected neurologic lesion. In general, patients with minimal symptoms or without objective findings of weakness tend to respond better to conservative treatment.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals, the likelihood of achieving improved ability to perform activities of daily living or work, and possible complications. The patient should significantly over time, without invasive interventions, patients must be able to A second opinion by a hand surgeon and repeat nerve conduction studies are required if repeat surgery is contemplated.

g. Operative Procedures: simple decompression or transposition with or without, medial epicondylectomy, anterior subcutaneous transfer, and submuscular or intramuscular transfer. There is good evidence that simple decompression and anterior transposition lead to equally good functional outcomes. There is good evidence that the complication rate in terms of post-operative infection is considerably higher with anterior transposition than with simple decompression, for which the infection rate is approximately two thirds lower. Transposition is a more complicated procedure requiring greater operative experience. Simple decompression appears to be cost effective and may be a preferable procedure.

Simple decompression appears to be effective even in patients with more severe disease, and it has fewer complications. There may be a subset of patients not yet identified by the current literature who would benefit more from a transposition. The complications and complexity of these procedures varies.

Patients should understand the risks of each procedure, expected recovery, and need for follow-up therapy before consenting to the procedure.

h. Post-operative Treatment: an individualized rehabilitation program based upon exercise progressions. Treatment may include the following: splinting, scar management, nerve gliding, and active therapy with or without passive therapy.

Early active motion is appropriate for most patients. Work restrictions vary based on the procedure from approximately 2 – 6 weeks.

3. GUYON CANAL (TUNNEL) SYNDROME

a. Description/Definition: Typical symptoms/findings are (1) paresthesias in the ulnar nerve distribution (ring and small fingers) distal to the wrist, and/or (2) weakness in digital adductors, abductors or lumbricals, without proximal ulnar complaints.

b. Occupational Relationship: Refer to Section D.3 Medical Causation assessment, the reader must comply with all sections. Occupational and nonoccupational causes frequently result from mechanical pressure on the wrist or palm, e.g., cycling, vibratory tools.

c. Specific Physical Exam Findings: Required elements for the diagnosis must include at least one of the following exam findings:

i. Positive Tinel’s at hook of hamate.

ii. Numbness or paresthesias of the palmar surface of the ring and small fingers without proximal ulnar complaints.

iii. Later stages or types may affect ulnar innervated intrinsic muscle strength.

There are five types of the Guyon Canal Syndrome based on the anatomic area of compression and neurological signs. Testing should include strength of the adductor pollicis, abductor digiti minimi, and lumbricals. Testing the ability of the long finger to cross the index finger is useful.

d. Diagnostic Testing Procedures: Nerve conduction velocity studies of both sides for comparison to normal side. EMGs may be needed to rule out radiculopathy or more proximal ulnar nerve compression. When polyneuropathy is suspected, it may be worthwhile to perform electrodiagnostic testing in the lower extremities. Several sites of ulnar nerve entrapment at the wrist may be documented with electrodiagnostic testing.

MRI or ultrasound may be used to rule out space occupying lesions.

Diagnostic injections may be done to confirm the diagnosis.

e. Non-operative Treatment Procedures:

i. Initial Treatment: medications such as analgesics and over the counter medications for symptomatic relief, wrist bracing, splints, restriction of activities and ergonomic changes. For those with mild symptoms lasting less than 3 months, a neutral wrist splint not immobilizing fingers may be tried.

ii. Patient education: should include instruction in self-management techniques, ergonomics, and a home therapy program. The provider should thoroughly discuss activities that may cause mechanical compression with the patient. Recurrence is common, so patient education regarding provocative activities is essential for long term recovery.

iii. Job site evaluations and alterations: Ergonomic alterations should be iv. Steroid injections: may decrease inflammation and allow the therapist to progress with rehabilitation therapy, although the Guyon’s canal is narrow. Steroid injections under significant pressure should be avoided as the needle may be penetrating the tendon and injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture. daily for 2 weeks after injections. Refer to Section H.4 Injections for further details.

v. Return to work with appropriate restrictions should be considered early in the course of treatment. Refer to Section H.11 Return-to-Work for further details.

vi. Other therapies in Section H Therapeutic Procedures – Non-Operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often Surgery may be considered when: 1) findings on history and objective evidence deficits persist after 6 to 8 weeks. Subjective complaints should be localized and appropriate to the diagnosis, neurologic complaints should be consistent with the nerve distribution in question, and physical exam findings should correlate with the history. Objective evidence should be present and includes: positive physical exam findings as described in Section G.3.c; positive electrodiagnostic (EDX) studies, diagnostic peripheral nerve block which eradicates the majority of the patient’s symptoms, or a motor deficit commensurate with the suspected neurologic lesion.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals, the likelihood of achieving improved ability to perform activities of daily living or work, and possible complications. The patient should significantly over time, without invasive interventions, patients must be able to g. Operative Procedures: ulnar nerve decompression at the wrist (ulnar tunnel release or Guyon’s Canal release). Complications may occur and include infection, injury to the nerve, and deformity at the operative site.

h. Post-operative Treatment: an individualized rehabilitation program based upon exercise progressions. Treatment may include the following: bracing, scar management, edema control, ergonomic advice to prevent mechanical loading of the nerve, and active therapy with or without passive therapy. Splinting is usually not necessary unless protection from mechanical stress is needed or for severe pain.

4. POSTERIOR INTEROSSEOUS NERVE ENTRAPMENT (PIN)

a. Description/Definition: weakness of finger and thumb extension. Complaints of pain can be present. Symptoms are similar to radial tunnel syndrome.

b. Occupational Relationship: Refer to Section D.3 Medical Causation c. Specific Physical Exam Findings: Required exam findings include weakness or inability to extend fingers or thumb with wrist in neutral or ulnar deviation.

Usually can extend wrist in radial deviation. Weakness of thumb abduction usually occurs. If paresthesias in the radial nerve distribution or significant weakness of the wrist, suspect other diagnoses. Testing the ability of the long finger to cross the index finger is useful.

d. Diagnostic Testing Procedures: nerve conduction velocity studies of both sides for comparison to normal side. EMGs may be needed to rule out radiculopathy. electrodiagnostic testing in the lower extremities. Diagnostic injections may be useful.

MRI can be done if space occupying lesions are suspected.

e. Non-operative Treatment Procedures:

i. Initial Treatment: medications such as analgesics and over the counter medications for symptomatic relief, splints, restriction of activities, ergonomic changes, stretching and exercise.

ii. Patient education: should include instruction in self-management iii. Job site evaluations and alterations: Ergonomic alterations should be iv. Whenever a case is identified as a work-related cumulative trauma v. Steroid injections: may decrease inflammation and allow the therapist to pressure should be avoided as the needle may be penetrating the tendon and injection into the tendon can cause possible tendon weeks apart vi. Return to work with appropriate restrictions should be considered early in vii. Other therapies in Section H Therapeutic Procedures – Non-Operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often Surgery may be considered when 1) findings on history and objective evidence deficits persist after 8 to 10 weeks. Subjective complaints should be localized and appropriate to the diagnosis, neurologic complaints should be consistent with the nerve distribution in question, and physical exam findings of weakness should correlate with the history. Objective evidence should be present and may include: positive physical exam findings as described in section 6.c; positive electrodiagnostic (EDX) studies; or a motor deficit commensurate with the suspected neurologic lesion.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The significantly over time, without invasive interventions, patients must be able to g. Operative Procedures: nerve decompression.

h. Post-operative Treatment: An individualized rehabilitation program based upon exercise progressions. Treatment may include the following: bracing, scar management and active therapy with or without passive therapy.

5. PRONATOR SYNDROME

a. Description/Definition: pain/paresthesias in median nerve distribution distal to elbow.

b. Occupational Relationship: Refer to Section D.3 Medical Causation c. Specific Physical Exam Findings: Required elements for the diagnosis include paresthesias in the median nerve distribution and at least one of the following related exam findings:

i. Tingling in median nerve distribution on resisted pronation with elbow flexed at 90 degrees or elbow extended. When symptoms are reproduced with resisted elbow flexion in supination, the lacertus fibrosis may be responsible. The flexor digitorum superficialis may be responsible if symptoms are reproduced with resisted flexion of the proximal interphalangeal joint of the long finger.

ii. Positive Tinel’s at the proximal edge of the pronator teres muscle over the median nerve.

There may be sensation loss over the palm and over the thenar eminence which is not present with carpal tunnel syndrome.

d. Diagnostic Testing Procedures: X-rays of the elbow may be useful to rule out other conditions. Nerve conduction velocity tests of both extremities for comparison to normal; however, findings are frequently negative. EMG should always be included to test median nerve innervated muscles below and above the wrist to rule out carpal tunnel syndrome. When polyneuropathy is suspected, it may be worthwhile to perform electrodiagnostic testing in the lower extremities.

e. Non-operative Treatment Procedures:

i. Initial Treatment: medications such as analgesics and over the counter medications for symptomatic relief; posterior elbow splint, wrist splint, and restriction of activities such as forceful gripping, and repetitive elbow flexion or forearm pronation.

ii. Patient education: should include instruction in self-management common so patient education regarding provocative activities is essential for long term recovery.

iii. Job site evaluations and alterations: Ergonomic alterations should be iv. Whenever a case is identified as a work-related cumulative trauma v. Steroid injections: may decrease inflammation and allow the therapist to progress with rehabilitation therapy. Ultrasound guidance may be useful.

Steroid injections under significant pressure should be avoided because the needle may penetrate the tendon and injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture.

vi. Return to work with appropriate restrictions should be considered early in vii. Other therapies in Section H Therapeutic Procedures – Non-Operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often Most patients with this condition recover with conservative therapy. Surgery may be considered when: 1) findings on history and objective evidence correlate specifically with the diagnosis; and 2) job site alteration and other conservative measures have not alleviated the symptoms; and 3) functional deficits persist after 8 to 10 weeks. Subjective complaints should be localized and appropriate to the diagnosis, neurologic complaints should be consistent with the nerve distribution in question, and physical exam findings should correlate with the

history. Objective evidence should be present and includes: positive physical exam findings as described in Section G.4.c; positive electrodiagnostic (EDX) studies; or a diagnostic peripheral nerve block which eradicates the majority of the patient’s symptoms. Surgery may be considered as an initial therapy in situations where there is clinical and electrodiagnostic evidence of severe or progressive neuropathy.

When no objective evidence is present and the patient continues to have signs and symptoms consistent with the diagnosis after 6 months of conservative treatment including a psychological evaluation, a second opinion should be obtained before operative treatment is considered.

Electrodiagnostic (EDX) studies may show delayed median nerve conduction in the forearm. If nerve conduction velocity is normal with suggestive clinical findings, the study may be repeated after a 3 to 6 month period of continued conservative treatment. If the study is still normal, the decision on treatment is made based on the consistency of clinical findings and the factors noted above.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The significantly over time, without invasive interventions, patients must be able to g. Operative Procedures: median nerve decompression in the forearm (pronator teres or flexor digitorum superficialis release).

h. Post-operative Treatment: An individualized rehabilitation program based upon outlined in Section H Therapeutic Procedures – Non-Operative. Some motion is usually allowed 1 week after surgery. In all cases, communication between the physician and therapist is important to the timing of exercise progressions.

Treatment may include the following: bracing, scar management, and active therapy with or without passive therapy.

6. RADIAL TUNNEL SYNDROME

a. Description/Definition: pain over the lateral posterior forearm. May occur in conjunction with and must be distinguished from lateral epicondylitis. Often includes paresthesias over the dorsal radial hand and wrist. Symptoms are similar to posterior interosseous nerve entrapment.

b. Occupational Relationship: Refer to Section D.3 Medical Causation c. Specific Physical Exam Findings: The following two elements are required for the clinical diagnosis:

i. Tenderness over the radial nerve near the proximal edge of the supinator muscle. This may be tested by applying pressure along the radial nerve at points corresponding to the diameter of a half dollar beginning just distal to the elbow. At the third pressure point, no symptoms should be reproducible. There may be subtle weakness of finger extension but weakness of wrist extension suggests nerve compression proximal to the radial tunnel as do sensation changes.

ii. Resisted supination or resisted middle finger extension with the forearm pronated and extended reproduces symptoms.

d. Diagnostic Testing Procedures: nerve conduction velocity studies of both sides for comparison to normal side. EMGs may be needed to rule out radiculopathy. electrodiagnostic testing in the lower extremities. Electrodiagnostic (EDX) studies are helpful when positive. However, negative studies do not exclude the diagnosis.

MRI or ultrasound may be done if space occupying lesions are suspected.

X-rays may be normal or demonstrate spur formation over the involved epicondyle.

Diagnostic lidocaine injections may be used to confirm the diagnosis if surgery is being considered, as EMGs are frequently normal in this condition.

e. Non-operative Treatment Procedures:

i. Initial Treatment: medications such as analgesics and over the counter medications for symptomatic relief; restriction of activities and ergonomic changes. Most cases should respond to conservative treatment.

ii. Patient education: should include instruction in self-management iii. Job site evaluations and alterations: Ergonomic alterations should be iv. Steroid injections: may decrease inflammation and allow the therapist to pressure should be avoided as the needle may be penetrating the tendon and injection into the tendon can cause tendon breakdown, tendon degeneration, or rupture.

v. Return to work with appropriate restrictions should be considered early in vi. Other therapies in Section H Therapeutic Procedures – Non-Operative f. Surgical Indications/Considerations: Since cumulative trauma conditions often Surgery may be considered when: 1) findings on history and objective evidence deficits persist after 8 to 10 weeks. Subjective complaints should be localized and appropriate to the diagnosis, neurologic complaints should be consistent with the nerve distribution in question, and physical exam findings should correlate with the history. Objective evidence should be present and includes: positive physical exam findings as described in Section G.5.c.; positive electrodiagnostic (EDX) studies, or diagnostic peripheral nerve block which eradicates the majority of the patient’s symptoms.

When no objective evidence is present and the patient continues to have signs and symptoms consistent with the diagnosis after 6 months of conservative treatment and a psychological evaluation, a second opinion should be obtained before operative treatment is considered.

Most cases improve with conservative treatment. Surgery should only be performed to achieve functional gains on those with significant ongoing impaired activities of daily living.

Complications: Radial nerve decompression is reported to have good success.

However, complications can occur and include infection, damage to the posterior interosseous nerve, or damage to the extensor carpi radialis brevis or extensor digitorum communis.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals, the likelihood of achieving improved ability to perform activities of daily living or work, and possible complications. The patient should partial-and full-disability expected post-operatively. significantly over time, without invasive interventions, patients must be able to g. Operative Procedures: radial nerve decompression.

h. Post-operative Treatment:

i. An individualized rehabilitation program based upon communication

Section H Therapeutic Procedures – Non-Operative. In all cases, timing of exercise progressions.

ii. Treatment may include the following: bracing, scar management and active therapy with or without passive therapy. Stretching is usually started early and strengthening may begin 3 to 6 weeks after surgery.

Recovery is expected to last no longer than 4 months.

iii. Return to work and restrictions after surgery may be made by an H. THERAPEUTIC PROCEDURES – NON-OPERATIVE Treating providers, employers, and insurers are highly encouraged to reference Section B General Guidelines Principles before initiating any therapeutic procedure. All treatment plans should specify frequency, duration, and expected treatment milestones. Before initiation of any therapeutic procedure, the authorized treating provider, employer, and insurer must consider these important issues in the care of the injured worker.

First, patients undergoing therapeutic procedure(s) should be released or returned to modified- or restricted-duty during their rehabilitation at the earliest appropriate time. Refer to Section H.11 Return-to-Work for detailed information.

Second, cessation and/or review of treatment modalities should be undertaken when no further significant subjective or objective improvement in the patient’s condition is noted. If patients are not responding within the recommended duration periods, alternative treatment interventions, further diagnostic studies, or consultations should be pursued.

Third, providers should provide and document patient education. Functional progression is expected through prescribed activity such as neuromuscular and postural re-education/repatterning exercises. Before diagnostic tests or referrals for invasive treatment take place, the patient should be able to clearly articulate the goals of the intervention, the general side effects, and associated risks, as well as agree with the expected treatment plan.

Lastly, formal psychological or psychosocial evaluation should be performed on patients not making expected progress within 6 to 12 weeks following injury and whose subjective symptoms do not correlate with objective signs and tests.

Home therapy is an important component of therapy and may include active and passive therapeutic procedures as well as other modalities to assist in alleviating pain, swelling, and abnormal muscle tone.

1. ACUPUNCTURE

ACUPUNCTURE: When acupuncture has been studied in randomized clinical trials, it is often compared with sham acupuncture and/or no acupuncture (usual care). The differences between true acupuncture and usual care have been moderate but clinically important. These differences can be partitioned into two components: non-specific effects and specific effects. Non-specific effects include patient beliefs and expectations, attention from the acupuncturist, administration of acupuncture in a relaxing setting, and other components of what is often called the placebo effect. Specific effects refer to any additional effects which occur in the same setting of expectations and attention, but they are attributable to the penetration of the skin in the specific, classic acupuncture points on the surface of the body by the needles themselves.

A sham procedure is a non-therapeutic procedure that appears similar to the patient as the purported therapeutic procedure being tested. In most controlled studies, sham and classic acupuncture have produced similar effects. However, the sham controlled studies have shown consistent advantages of both true and sham acupuncture over no acupuncture when the studies have included a third comparison group that was randomized to usual medical care. Having this third comparison group has helped to interpret the non-specific effects of acupuncture, since the third comparison group controls for some influences on study outcome. These influences include more frequent contact with providers, the natural history of the condition, regression to the mean, the effect of being observed in a clinical trial, and--if the follow-up observations are done consistently in all three treatment groups--biased reporting of outcomes. Controlling for these factors enables researchers to more closely estimate the contextual and personal interactive effects of acupuncture as it is generally practiced.

Clinical trials of acupuncture typically enroll participants who are interested in acupuncture, and who may respond to some of the non-specific aspects of the intervention more than patients who have no interest in or desire for acupuncture. The non-specific effects of acupuncture may not be produced in patients who have no wish to be referred for it.

Another study provides good evidence that true acupuncture at traditional meridians is marginally better than sham acupuncture with blunt needles in reducing pain, but effects on disability are unclear. In these studies, 5–15 treatments were provided. Comparisons of acupuncture and sham acupuncture have been inconsistent, and the advantage of true over sham acupuncture has been small in relation to the advantage of sham over no acupuncture.

Acupuncture is recommended for subacute or chronic pain patients who are trying to increase function and/or decrease medication usage and have an expressed interest in this modality. It is also recommended for subacute or acute pain for patients who cannot tolerate NSAIDs or other medications.

Acupuncture is not the same procedure as dry needling for coding purposes. However, some acupuncturists may use acupuncture treatment for myofascial trigger points. Dry needling is performed specifically on myofascial trigger points. Refer to Section H.4.d Trigger Point Injections.

Acupuncture should generally be used in conjunction with manipulative and physical therapy/rehabilitation.

Credentialed practitioners with experience in evaluation and treatment of chronic pain patients must evaluate prior to acupuncture treatments. The exact mode of action is only partially understood. Western medicine studies suggest that acupuncture stimulates the nervous system at the level of the brain, promotes deep relaxation, and affects the release of neurotransmitters. Acupuncture is commonly used as an alternative or in addition to traditional Western pharmaceuticals. It may be used when pain medication is reduced or not tolerated; as an adjunct to physical rehabilitation and surgical intervention; and/or as part of multidisciplinary treatment to hasten the return of functional activity.

Acupuncture must be performed by practitioners with the appropriate credentials in accordance with state and other applicable regulations. Therefore, if not otherwise within their professional scope of practice and licensure, those performing acupuncture must have the appropriate credentials, such as L.A.c. R.A.c, or Dipl. Ac.

There is some evidence that acupuncture has a very short term 2 week effect on pain compared to sham acupuncture for lateral epicondylitis.

Indications: All patients being considered for acupuncture treatment should have subacute or chronic pain (lasting approximately 3-4 weeks depending on the condition) and meet the following criteria:

• they should have participated in an initial active therapy program; and • they should show a clear preference for this type of care or previously have benefited from acupuncture; and • they must continue to be actively engaged in physical rehabilitation therapy and return to work.

a. Acupuncture: is the insertion and removal of filiform needles to stimulate acupoints (acupuncture points). Needles may be inserted, manipulated and retained for a period of time. Acupuncture can be used to reduce pain, reduce inflammation, increase blood flow, increase range-of-motion, decrease the side effect of medication-induced nausea, relax an anxious patient, and reduce muscle spasm.

Indications include joint pain, joint stiffness, soft tissue pain and inflammation, paresthesia, post-surgical pain relief, muscle spasm, and scar tissue pain.

b. Acupuncture with Electrical Stimulation: is the use of electrical current (microamperage or milli-amperage) on the needles at the acupuncture site. It is used to increase effectiveness of the needles by continuous stimulation of the acupoint.

Physiological effects (depending on location and settings) can include endorphin release for pain relief, reduction of inflammation, increased blood circulation, analgesia through interruption of pain stimulus, and muscle relaxation.

It is indicated to treat chronic pain conditions, radiating pain along a nerve pathway, muscle spasm, inflammation, scar tissue pain, and pain located in multiple sites.

c. Total Time Frames for Acupuncture & Acupuncture with Electrical Stimulation: Time frames are not meant to be applied to each of the above sections separately. The time frames are to be applied to all acupuncture treatments regardless of the type or combination of therapies being provided.  Time to Produce Effect: 3 to 6 treatments.  Optimum Duration: 1 to 2 months.  Maximum Duration: 14 treatments.

Any of the above acupuncture treatments may extend longer if objective functional gains can be documented and symptomatic benefits facilitate progression in the patient’s treatment program. Treatment beyond 14 treatments must be documented with respect to need and ability to facilitate positive symptomatic or functional gains. Such care should be re-evaluated and documented with each series of treatments.

d. Other Acupuncture Modalities: Acupuncture treatment is based on individual patient needs and therefore may include a combination of procedures to enhance treatment effect. Other procedures may include the use of heat, soft tissue manipulation/massage, and exercise. Refer to Section H.13 Therapy-Active (Therapeutic Exercise) and Section H.14 Therapy-Passive (Massage and Superficial Heat and Cold Therapy) for a description of these adjunctive acupuncture modalities and time frames.

2. BIOFEEDBACK

BIOFEEDBACK: Biofeedback is a form of behavioral medicine that helps patients learn self-awareness and self-regulation skills to increase control of their physiology, such as muscle activity, brain waves, and measures of autonomic nervous system activity.

Stress-related psycho-physiological reactions may arise as a reaction to organic pain and in some cases may cause pain. Electronic instrumentation is used to monitor the targeted physiology and then displayed or fed back to the patient visually, auditorily, or tactilely, with coaching by a biofeedback specialist. There is good evidence that biofeedback or relaxation therapy is equal in effect to cognitive behavioral therapy for chronic low back pain.

Indications for biofeedback include cases of musculoskeletal injury, in which muscle dysfunction or other physiological indicators of excessive or prolonged stress response affects and/or delays recovery. Other applications include training to improve selfmanagement of pain, anxiety, panic, anger or emotional distress, opioid withdrawal, insomnia/sleep disturbance, and other central and autonomic nervous system imbalances. Biofeedback is often utilized for relaxation training. Mental health professionals may also utilize it as a component of psychotherapy, where biofeedback and other behavioral techniques are integrated with psychotherapeutic interventions.

Biofeedback is often used in conjunction with physical therapy or medical treatment.  Time to Produce Effect: 3 to 4 sessions.  Frequency: 1 to 2 times per week.  Optimum Duration: 5 to 6 sessions.  Maximum Duration: 10 to 12 sessions. Treatment beyond 12 sessions must be documented with respect to need, expectation, and ability to facilitate functional gains.

3. EDUCATION/INFORMED DECISION MAKING

EDUCATION/INFORMED DECISION MAKING: of patients, families, employers, insurers, policy makers, and the community should be the primary emphasis in the treatment of shoulder pain and disability. Unfortunately, practitioners often think of education and informed decision making last, after medications, manual therapy, and surgery.

Informed decision making is the hallmark of a successful treatment plan. In most cases, the continuum of treatment from the least invasive to the most invasive (e.g., surgery) should be discussed. The intention is to find the treatment along this continuum which most completely addresses the condition. Patients should identify their personal functional goals of treatment at the first visit. It is recommended that specific individual goals are articulated at the beginning of treatment as this is likely to lead to increased patient satisfaction above that achieved from improvement in pain or other physical function. Progress toward the individual functional goals identified should be addressed at follow up visits and throughout treatment by other members of the health care team as well as the authorized physicians.

Documentation of this process should occur whenever diagnostic tests or referrals from the authorized treating physician are contemplated. The informed decision making process asks the patients to set their personal functional goals of treatment, describe their current health status and any concerns they have regarding adhering to the diagnostic or treatment plan proposed. The provider should clearly describe the following:

a. The expected functional outcomes from the proposed treatment, or expected results and plan of action if diagnostic tests are involved.

b. Any side effects and risks to the patient.

c. Required post treatment rehabilitation time and impact on work, if any.

d. Alternative therapies or diagnostic testing.

Before diagnostic tests or referrals for invasive treatment take place, the patient should be able to clearly articulate the goals of the intervention, the general side effects and risks associated with it, and their decision regarding compliance with the suggested plan.

There is some evidence that information provided only by video is not sufficient education.

Practitioners must develop and implement an effective strategy and skills to educate patients, employers, insurance systems, policy makers, and the community as a whole.

An education-based paradigm should always start with reassuring information to the patient and informed decision making. More in-depth education currently exists within a treatment regimen employing functional restoration, prevention, and cognitive behavioral techniques. Patient education and informed decision making should facilitate selfmanagement of symptoms and prevention.  Time to produce effect: Varies with individual patient  Frequency: Should occur at every visit.

4. INJECTIONS – THERAPEUTIC

INJECTIONS – THERAPEUTIC: are generally accepted, well-established procedures that may play a significant role in the treatment of patients with upper extremity pain or pathology. Therapeutic injections involve the delivery of anesthetic and/or antiinflammatory medications to the painful structure. Therapeutic injections have many potential benefits. Ideally, a therapeutic injection will: (a) reduce inflammation in a specific target area; (b) relieve secondary muscle spasm; and (c) diminish pain and support therapy directed to functional recovery. Diagnostic and therapeutic injections should be used early and selectively to establish a diagnosis and support rehabilitation. If injections are overused or used outside the context of a monitored rehabilitation program, they may be of significantly less value.

Special Considerations: The use of injections has become progressively sophisticated.

Each procedure considered has an inherent risk. Risk versus benefit should be evaluated when considering injection therapy. In addition, all injections must include sterile technique.

Contraindications: General contraindications include local or systemic infection, bleeding disorders, allergy to medications used, and patient refusal. Specific contraindications may apply to individual injections.

a. Autologous Whole Blood Injections/Platelet-Rich Plasma Injections:

i. Autologous Whole Blood Injections: Autologous whole blood injections are inexpensive and may be used in patients who have not made sufficient functional progress with initial therapy for lateral or medial epicondylitis after 10 to 12 weeks. Refer to Section F.3.g Non-operative Treatment Procedures (Epicondylitis) and Section F.4.e Non-operative Treatment Procedures (Extensor Tendon Disorders).

There is some evidence in literature on lateral epicondylitis that, for patients with symptoms lasting 6 months or more, autologous blood injections result in better pain and functional outcomes after 1 year than steroid injections.

ii. Platelet-Rich Plasma (PRP) Injections: There is good evidence in literature on lateral epicondylitis that, for patients with symptoms lasting 6 months or more, platelet-rich plasma injections result in better pain and functional outcomes after 1 year than steroid injections.

There is good evidence that, in the setting of lateral epicondylitis, PRP may lead to a small to moderate functional benefit in comparison to autologous whole blood or saline at two to three months, but effects on pain are uncertain.

There is good evidence that PRP produces more favorable symptomatic and functional improvement than triamcinolone injection in patients with chronic lateral epicondylitis, with this advantage persisting for 24 months after treatment.

In summary, there is strong evidence for the use of PRP in patients who have not improved with conservative therapy. Ultrasound guided may be useful.  Optimum frequency: 2 injections may be required b. Botulinum Toxin Injections: Botulinum toxin treats lateral and medial epicondylitis by reversibly paralyzing the extensor muscles and thereby preventing repetitive micro-trauma of the tendonous fibers at their origin from the osseous lateral/medial epicondyle. The unit dosage varies significantly depending on the brand used. Usage for lateral and medial epicondylitis is not FDA approved at the time of this guideline writing. There is good evidence that botulinum toxin A injection may provide short-term pain relief from pain due to chronic (3 months or longer) lateral epicondylitis. However, the long-term functional benefits are unknown. There is also good evidence that botulinum toxin A injections cause weakness in finger extension and/or digit paresis.

Additional complications may include: allergic reaction to medications, increased risk of systemic effects in patients with motor neuropathy or disorders of the neuromuscular junction.

Botulinum toxin injections should not be considered a first line of treatment. Other conservative measures should be tried first. Careful botulinum toxin dosing should be used to avoid complete paresis and maintain function and return to work.

Botulinum toxin injections are listed in this guideline as a treatment option for lateral and medial epicondylitis. Prior authorization is required. For more specific details, the reader must refer to Section F.3.g Non-operative Treatment Procedures (Epicondylitis) and Section F.4.e Non-operative Treatment Procedures (Extensor Tendon Disorders).  Maximum: 1 injection per episode of symptomatic treatment (for some conditions there may be re-occurrences).

c. Steroid Injections: including joint, bursa and peri-tendonous insertions are wellestablished procedures with varying degrees of evidence depending on the diagnosis. Peri-tendonous injections under significant pressure should be avoided as the needle may inadvertently penetrate the tendon. Injection into the tendon can cause tendon degeneration, tendon breakdown, or rupture. When performing peri-tendonous injections, the risk of tendon rupture should be discussed with the patient and the need for temporary restricted-duty emphasized.

There is strong evidence that, in the setting of lateral epicondylitis, the effects of corticosteroid injections on pain and function are more favorable than placebo in the first four weeks, but these benefits are reversed by six months. In addition, corticosteroid injections are detrimental compared to placebo injections in the intermediate and long term.

There is some evidence for steroid injections as a short term treatment in carpal tunnel syndrome. Refer to Section G.1 Carpal Tunnel Syndrome for more details.

General complications of injections may include transient neurapraxia, nerve injury, infection, hematoma, glucose elevation, and endocrine changes.

The majority of diabetic patients will experience an increase in glucose following steroid injections. Average increases in one study were 125mg/dL and returned to normal in 48 hours. In other studies, the increased glucose levels remained elevated up to 7 days, especially after multiple injections. All diabetic patients should be told to follow their glucose levels carefully over the 7 days after a steroid injection. For patients who have not been diagnosed with diabetes, one can expect some increase in glucose due to insulin resistance for a few days after a steroid injection. Clinicians should consider diabetic screening tests for those who appear to be at risk for type 2 diabetes and checking hemoglobin A1c and/or glucose for diabetics. Caution should be used when considering steroid injections for patients with an A1c level of 8% or greater.

Intra-articular or epidural injections cause rapid drops in plasma cortisol levels which usually resolve in one to 4 weeks. There is some evidence that an intraarticular injection of 80 mg of methylprednisolone acetate into the knee has about a 25% probability of suppressing the adrenal gland response to exogenous adrenocortocotrophic hormone ACTH for four or more weeks after injection, but complete recovery of the adrenal response is seen by week 8 after injection. This adrenal suppression could require treatment if surgery or other physiologically stressful events occur.

Case reports of Cushing’s syndrome, hypopituitarism and growth hormone deficiency have been reported uncommonly and have been tied to systemic absorption of intra-articular and epidural steroid injections. Cushing’s syndrome has also been reported from serial occipital nerve injections and paraspinal Morning cortisol measurements may be ordered prior to repeating steroid injections or prior to the initial steroid injection when the patient has received multiple previous steroid injections.

Given this information regarding increase in blood glucose levels, effects on the endocrine system, and possible osteoporotic influence, it is suggested that intraarticular and epidural injections be limited to a total of 3 to 4 per year (all joints combined). For further specific recommendations, refer to diagnostic sections of this guideline.  Time to Produce Effect: Immediate with local anesthesia, or within 3 days if no anesthesia.  Optimum Duration: Usually 1 to 2 injections is adequate.  Maximum Frequency: Not more than 3 to 4 times annually.

d. Trigger Point Injections: Although generally accepted, have only rare indications in the treatment of cumulative trauma disorders. Therefore, the Division does not recommend their routine use in the treatment cumulative trauma disorders.

Description: Trigger point injections and dry needling are both generally accepted treatments. Trigger point treatments can consist of dry needling or the injection of local anesthetic, with or without corticosteroid, into highly localized, extremely sensitive bands of skeletal muscle fibers. These muscle fibers produce local and referred pain when activated. Medication is injected in a four-quadrant manner in the area of maximum tenderness. Injection and dry needling efficacy can be enhanced if treatments are immediately followed by myofascial therapeutic interventions, such as vapo-coolant spray and stretch, ischemic pressure massage (myotherapy), specific soft tissue mobilization and physical modalities.

There is conflicting evidence regarding the benefit of trigger point injections. A truly blinded study comparing dry needle treatment of trigger points is not feasible. There is no evidence that injection of medications improves the results of trigger-point injections. Needling alone may account for some of the therapeutic response of injections. Needling must be performed by practitioners with the appropriate credentials in accordance with state and other applicable regulations.

There is no indication for conscious sedation for patients receiving trigger point injections or dry needling. The patient must be alert to help identify the site of the injection.

Indications: Trigger point injections and dry needling may be used to relieve myofascial pain and facilitate active therapy and stretching of the affected areas.

They are to be used as an adjunctive treatment in combination with other treatment modalities such as active therapy programs. Trigger point injections should be utilized primarily to facilitate functional progress. Patients should continue in an aggressive aerobic and stretching therapeutic exercise program, as tolerated, while undergoing intensive myofascial interventions. Myofascial pain is often associated with other underlying structural problems. Any abnormalities need to be ruled out prior to injection.

Trigger point injections and dry needling are indicated in patients with consistently observed, well-circumscribed trigger points. Trigger point injections and dry needling may demonstrate a local twitch response, characteristic radiation of pain pattern, and local autonomic reaction such as persistent hyperemia following palpation. Generally, neither trigger point injections nor dry needling are necessary unless consistently observed trigger points are not responding to specific, noninvasive, myofascial interventions within approximately a 6-week time frame. However, both trigger point injections and dry needling may be occasionally effective when utilized in the patient with immediate, acute onset of pain or in a post-operative patient with persistent muscle spasm or myofascial pain.

Complications: Potential but rare complications of trigger point injections and dry needling include infection, pneumothorax, anaphylaxis, penetration of viscera, neurapraxia, and neuropathy. If corticosteroids are injected in addition to local anesthetic, there is a risk of local myopathy. Severe pain on injection suggests the possibility of an intraneural injection, and the needle should be immediately repositioned. The following treatment parameters apply to both interventions combined.  Time to produce effect: Local anesthetic 30 minutes; 24 to 48 hours for no anesthesia.  Frequency: Weekly. Suggest no more than 4 injection sites per session per week to avoid significant post-injection or post-needling soreness.  Optimum duration: 4 weeks total for all sites.  Maximum duration: 8 weeks total for all sites. Occasional patients may require 2 to 4 repetitions of trigger point injection or dry needling series over a 1 to 2 year period.

e. Prolotherapy: (also known as sclerotherapy) consists of peri-articular injections of hypertonic dextrose with or without phenol. The goal of prolotherapy is to induce an inflammatory response that will recruit cytokine growth factors involved in the proliferation of connective tissue. Advocates of prolotherapy propose that these injections will alleviate complaints related to joint laxity by promoting the growth of connective tissue and stabilizing the involved joint.

Laboratory studies may lend some biological plausibility to claims of connective tissue growth, but high quality published clinical studies are lacking. The dependence of the therapeutic effect on the inflammatory response is poorly defined, raising concerns about the use of conventional anti-inflammatory drugs when proliferate injections are given. There is no evidence that prolotherapy compared to a steroid injection for aggravated carpometacarpal arthritis provides a clinically meaningful advantage. Therefore, it is not recommended.

f. Viscosupplementation/Intracapsular Acid Salts: involves the injection of hyaluronic acid and its derivatives into the joint space. Hyaluronic acid is normally secreted by the healthy synovium into the joint space and functions to lubricate the joint and protect the cartilage. These injections may only be used for osteoarthritis.

There is no evidence that hyaluronate injections are superior to steroid injections for carpometacarpal thumb arthritis. There is some evidence that intra-articular hyaluronan is not superior to placebo for improving pain in the setting of carpometacarpal osteoarthritis and that it does not improve function in a clinically important way in the first six months after injection. Therefore, they are not 5. INTERDISCIPLINARY REHABILITATION PROGRAMS INTERDISCIPLINARY REHABILITATION PROGRAMS: This is the gold standard of treatment for individuals who have not responded to less intensive modes of treatment.

There is good evidence that interdisciplinary programs that include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability. These programs should assess the impact of pain and suffering on the patient’s medical, physical, psychological, social, and/or vocational functioning. In general, interdisciplinary programs evaluate and treat multiple and sometimes irreversible conditions. These conditions include, but are not limited to, painful musculoskeletal, neurological, and other chronic pain conditions and psychological issues; drug dependence, abuse, or addiction; high levels of stress and anxiety; failed surgery; and pre-existing or latent psychopathology. The number of professionals on the team in a chronic pain program may vary due to the complexity of the needs of the person served.

The Division recommends consideration of referral to an interdisciplinary program within six months post-injury in patients with delayed recovery, unless successful surgical interventions or other medical and/or psychological treatment complications are at issue.

Chronic pain patients need to be treated as outpatients within a continuum of treatment intensity. Outpatient chronic pain programs are available with services provided by a coordinated interdisciplinary team within the same facility (formal) or as coordinated among practices by the authorized treating physician (informal). Formal programs are able to provide a coordinated, high-intensity level of services and are recommended for most chronic pain patients who have received multiple therapies during acute management.

Patients with addiction problems, high-dose opioid use, or abuse of other drugs may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation. Guidelines from the American Society of Addiction Medicine are available and may be consulted relating to the intensity of services required for different classes of patients in order to achieve successful Informal interdisciplinary pain programs may be considered for patients who are currently employed, those who cannot attend all-day programs, those with language barriers, or those living in areas not offering formal programs. Before treatment has been initiated, the patient, physician, and insurer should agree on treatment approach, methods, and goals. Generally, the type of outpatient program needed will depend on the degree of impact the pain has had on the patient’s medical, physical, psychological, social, and/or vocational functioning.

When referring a patient for formal outpatient interdisciplinary pain rehabilitation, an occupational rehabilitation program, or an opioid treatment program, the Division recommends the program meets the criteria of the Commission on Accreditation of Rehabilitation Facilities (CARF).

Inpatient pain rehabilitation programs are rarely needed but may be necessary for patients with any of the following conditions: (a) high risk for medical instability; (b) moderate-to-severe impairment of physical/functional status; (c) moderate-to-severe pain behaviors; (d) moderate impairment of cognitive and/or emotional status; (e) dependence on medications from which he/she needs to be withdrawn; and (f) the need for 24-hour supervised nursing. Whether formal or informal programs, programs should have the following dimensions:

• Communication: To ensure positive functional outcomes, communication between the patient, insurer, and all professionals involved must be coordinated and consistent. Any exchange of information must be provided to all parties, including the patient. Care decisions should be communicated to all parties and should include the family and/or support system.

• Documentation: Through documentation by all professionals involved and/or discussions with the patient, it should be clear that functional goals are being actively pursued and measured on a regular basis to determine their achievement or need for modification. It is advisable to have the patient undergo objective functional measures.

• Treatment Modalities: Use of modalities may be necessary early in the process to facilitate compliance with and tolerance to therapeutic exercise, physical conditioning, and increasing functional activities. Active treatments should be emphasized over passive treatments. Active and self-monitored passive treatments should encourage self-coping skills and management of pain, which can be continued independently at home or at work. Treatments that can foster a sense of dependency by the patient on the caregiver should be avoided.

Treatment length should be decided based upon observed functional improvement. For a complete list of active and passive therapies, refer to Section H.13 Therapy – Active and H.14 Therapy – Passive. All treatment timeframes may be extended based on the patient’s positive functional improvement.

• Therapeutic Exercise Programs: A therapeutic exercise program should be initiated at the start of any treatment rehabilitation. Such programs should emphasize education, independence, and the importance of an on-going exercise regimen. There is good evidence that exercise, alone or as part of a multi-disciplinary program, results in decreased disability for workers with nonacute low back pain. There is not sufficient evidence to support the recommendation of any particular exercise regimen over any other exercise regimen.

• Return-to-Work: The authorized treating physician should continually evaluate the patients for their potential to return to work. For patients who are currently employed, efforts should be aimed at keeping them employed. Formal rehabilitation programs should provide assistance in creating work profiles. For more specific information regarding return to work, refer to H.11 Return-to-Work.

• Patient Education: Patients with pain need to re-establish a healthy balance in lifestyle. All providers should educate patients on how to overcome barriers to resuming daily activity, including pain management, decreased energy levels, financial constraints, decreased physical ability, and change in family dynamics.

• Psychosocial Evaluation and Treatment: Psychosocial evaluation should be initiated, if not previously done. Providers should have a thorough understanding of the patient’s personality profile, especially if dependency issues are involved.

Psychosocial treatment may enhance the patient’s ability to participate in pain treatment rehabilitation, manage stress, and increase their problem-solving and self-management skills.

• Vocational Assistance: Vocational assistance can define future employment opportunities or assist patients in obtaining future employment. Refer to H.11 Return-to-Work for detailed information.

• Interdisciplinary programs are characterized by a variety of disciplines that participate in the assessment, planning, and/or implementation of the treatment program. These programs are for patients with greater levels of perceived disability, dysfunction, de-conditioning, and psychological involvement. Programs should have sufficient personnel to work with the individual in the following areas: behavioral, functional, medical, cognitive, pain management, psychological, social, and vocational.

a. Formal Interdisciplinary Rehabilitation Programs:

i. Interdisciplinary Pain Rehabilitation: An Interdisciplinary Pain Rehabilitation Program provides outcome-focused, coordinated, goaloriented interdisciplinary team services to measure and improve the functioning of persons with pain and encourage their appropriate use of health care system and services. The program can benefit persons who have limitations that interfere with their physical, psychological, social, and/or vocational functioning. The program shares information about the scope of the services and the outcomes achieved with patients, authorized providers, and insurers.

The interdisciplinary team maintains consistent integration and communication to ensure that all team members are aware of the plan of care for the patient, are exchanging information, and implement the plan of care. The team members make interdisciplinary team decisions with the patient and then ensure that decisions are communicated to the entire care team.

The Medical Director of the pain program should ideally be board certified in pain management. Alternatively, he/she should be board certified in his/her specialty area and have completed a one-year fellowship in interdisciplinary pain medicine or palliative care recognized by a national board. As a final alternative, he or she should have two years of experience in an interdisciplinary pain rehabilitation program.

Teams that assist in the accomplishment of functional, physical, psychological, social, and vocational goals must include: a medical director, pain team physician(s), who should preferably be board certified in an appropriate specialty, and a pain team psychologist. Professionals from other disciplines on the team may include, but are not limited to: a biofeedback therapist, an occupational therapist, a physical therapist, a registered nurse (RN), a case manager, an exercise physiologist, a psychologist, a psychiatrist, and/or a nutritionist.  Time to Produce Effect: 3 to 4 weeks.  Frequency: Full time programs – No less than 5 hours per day, 5 days per week; part-time programs – 4 hours per day, 2–3 days per week.  Optimum Duration: 3 to 12 weeks at least 2–3 times a week. Followup visits weekly or every other week during the first 1 to 2 months after the initial program is completed.  Maximum Duration: 4 months for full-time programs and up to 6 months for part-time programs. Periodic review and monitoring thereafter for 1 year, and additional follow-up based on the documented maintenance of functional gains.

ii. Occupational Rehabilitation: This is a formal interdisciplinary program addressing a patient’s employability and return to work. It includes a progressive increase in the number of hours per day in which a patient completes work simulation tasks until the patient can tolerate a full work day. A full work day is case specific and is defined by the previous employment of the patient. Safe workplace practices and education of the employer and family and/or social support system regarding the person’s status should be included. This is accomplished by addressing the medical, psychological, behavioral, physical, functional, and vocational components of employability and return to work.

There is some evidence that an integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain. The occupational medicine rehabilitation interdisciplinary team should, at a minimum, be comprised of a qualified medical director who is board certified with documented training in occupational rehabilitation; team physicians having experience in occupational rehabilitation; an occupational therapist; and a physical therapist.

As appropriate, the team may also include any of the following: chiropractor, an RN, a case manager, a psychologist, a vocational specialist, or a certified biofeedback therapist.  Time to Produce Effect: 2 weeks.  Frequency: 2 to 5 visits per week, up to 8 hours per day.  Maximum Duration: 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

iii. Opioid/Chemical Treatment Programs: Refer to the Division’s Chronic Pain Disorder Medical Treatment Guidelines.

b. Informal Interdisciplinary Rehabilitation Program: A coordinated interdisciplinary pain rehabilitation program is one in which the authorized treating physician coordinates all aspects of care. This type of program is similar to the formal programs in that it is goal-oriented and provides interdisciplinary rehabilitation services to manage the needs of the patient in the following areas:

(a) functional, (b) medical, (c) physical, (d) psychological, (e) social, and (f) vocational.

This program is different from a formal program in that it involves lower frequency and intensity of services/treatment. Informal rehabilitation is geared toward those patients who do not need the intensity of service offered in a formal program or who cannot attend an all-day program due to employment, daycare, language, or other barriers.

Patients should be referred to professionals experienced in outpatient treatment of chronic pain. The Division recommends the authorized treating physician consult with physicians experienced in the treatment of chronic pain to develop the plan of care. Communication among care providers regarding clear objective goals and progress toward the goals is essential. Employers should be involved in return to work and work restrictions. The family and/or social support system should be included in the treatment plan. Professionals from other disciplines likely to be involved include: a biofeedback therapist, an occupational therapist, a physical therapist, an RN, a psychologist, a case manager, an exercise physiologist, a psychiatrist, and/or a nutritionist.  Time to Produce Effect: 3 to 4 weeks.  Frequency: Full-time programs – No less than 5 hours per day, 5 days per week; Part-time programs – 4 hours per day for 2–3 days per week.  Optimum Duration: 3 to 12 weeks at least 2–3 times a week. Follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.  Maximum Duration: 4 months for full-time programs and up to 6 months for

part-time programs. Periodic review and monitoring thereafter for 1 year, and additional follow-up based upon the documented maintenance of functional gains.

6. JOB SITE ALTERATION

General Principles of Job Site Alteration There is no single factor or combination of factors that is proven to prevent or ameliorate cumulative trauma conditions, but a combination of ergonomic and psychosocial factors are generally considered to be important. Ergonomic factors that may be considered include use of force, repetition, awkward positions, upper extremity vibration, cold environment, and contact pressure on the nerve. Psychosocial factors to be considered include pacing, degree of control over job duties, perception of job stress, and supervisory support.

All job site evaluations should include suggested ergonomic changes as applicable. It is inappropriate to limit a job site evaluation to a strict isolated evaluation of causation risk factors only.

Job evaluation and modification should include input from a licensed health care professional with training in ergonomics or a certified ergonomist; the employee; and the employer. The employee must be observed performing relevant job functions in order for the job site evaluation to be a valid representation of a typical workday. If the employee is unable to perform the job function for observation, a co-worker in an identical job position may be observed instead. Periodic follow-up is recommended to assess the effectiveness of the intervention and need for additional ergonomic changes.

Because ergonomic changes are a required medical treatment for cumulative trauma conditions and the person performing the evaluations is a health care professional, it is assumed the insurer will pay for the job site evaluation.

a. Interventions: There are no conclusive studies with convincing evidence of standard ergonomic changes that will accommodate all workers. Individual characteristics, such as height or strength, affect the ideal organization of the workstation. The worksite should be adjusted to support neutral, yet natural, positions. In addition, workers should be counseled to vary tasks throughout the day whenever possible. OSHA suggests that workers who perform repetitive tasks, including keyboarding, change activities over a 5-minute interval every hour. Mini-breaks may include stretching exercises. The following should be considered: engineering controls, e.g., mechanizing the task, and changing the tool used, or adjusting the job site; or administrative controls, e.g., adjusting the time an individual performs the task.

b. Seating Description: The following description may aid in evaluating seated work positions: The head should be in a neutral position, and if a monitor is used, there should be at least 18 inches of viewing distance with no glare. Arms should rest naturally, with the elbow at the side and flexed to 90 degrees or slightly extended. Some individuals may prefer a wrist pad to reduce wrist extension.

Wrists should be straight or minimally extended. It is generally preferable to avoid dependence on arm rests. The back must be properly supported by a chair with the back upright or leaning backwards slightly, allowing change in position with backrest adjustment. There should be good knee and legroom, with the feet resting comfortably on the floor or footrest. Tools should be within easy reach, and twisting or bending should be avoided.

c. Job Hazard Checklist: The following table entitled, “Ergonomic Considerations,” is adopted with modification from Washington State’s job hazard checklist. This table is a generally accepted guide for identifying job duties which may pose ergonomic hazards. The fact that an ergonomic hazard exists at a specific job, or is suggested in the table, does not establish a causal relationship between a job and a musculoskeletal injury. However, when an individual has a work-related injury and ergonomic hazards exist that affect the injury, appropriate job modifications should be made. Proper correction of hazards may prevent future injuries to others, as well as aid in the recovery of the injured worker.

d. Tools: The tools should be assessed for the individual and not used universally.

It is important to select the right tool for the task. In general, the person should work in the most neutral position possible and use the least force possible. For force tools, the grip should not span more than 3.5 inches, and the handle diameter should not be greater than 2 inches. Precision tools may require a smaller diameter. If possible, highly repetitive forearm tasks requiring manual supination/pronation should be avoided by using power tools.

SEE NEXT PAGE FOR ERGONOMIC CONSIDERATIONS TABLE

e. Ergonomic Considerations Table: * Type of Job Duty Hours per Day Pinching an unsupported object(s) weighing 2 lbs or more per hand, or pinching with a force of 4 lbs or more per hand (comparable to pinching a half-ream of paper):

More than 3 1. Highly repetitive motion.

2. Wrist palmar flexion greater than 45 degrees, wrist extension greater than 30 degrees, ulnar deviation greater than 20 degrees, or radial deviation greater than 20 degrees.

3. Most of the work cycle performed with the elbow flexed equal to or greater than 90 4. No other risk factors. More than 4 Gripping (an) unsupported object(s) weighing 10 lbs or more/hand, or gripping with a force of 10 lbs or more/hand (comparable to clamping light duty automotive jumper cables onto a batter): *Handles should be rounded and soft, with at least 1.25’’-2.0” in diameter grips at least 5” long. Preferably, a power grip should be used.

More than 3 1. Highly repetitive motion.

2. Wrist palmar flexion greater than 45 degrees, wrist extension greater than 30 degrees, ulnar deviation greater than 20 degrees, or radial deviation greater than 20 degrees.

3. Most of the work cycle performed with the elbow flexed equal to or greater than 90 No other risk factors. More than 4 Repetitive Motion (using the same motion with little or no variation) with a cycle time 30 seconds or less or greater than 50% of cycle time performing the same task:

More than 2 1. High, forceful exertions with the hands, with wrist palmar flexion greater than 45 degrees, wrist extension greater than 30 degrees, ulnar deviation greater than 20 degrees, or radial deviation greater than 20 degrees.

2. Most of the work cycle performed with the elbow flexed equal to or greater than 90 3. No other risk factors. More than 6 Intensive Keying:

More than 4 1. Wrist palmar flexion greater than 45 degrees, wrist extension greater than 30 degrees, ulnar deviation greater than 20 degrees, or radial deviation greater than 20 degrees.

2. Most of the work cycle performed with the elbow flexed equal to or greater than 90 3. No other risk factors. More than 7 Repeated Impact:

More than 2 1. Using the hand (heel/base of palm) as a hammer more than once per minute.

Vibration: Two determinants of the tolerability of segmental vibration of the hand are the frequency and the acceleration of the motion of the vibrating tool, with lower frequencies being more poorly tolerated at a given level of imposed acceleration, expressed below in multiples of the acceleration due to gravity.

More than 30 minutes at a time 1. Frequency range 8-15 Hz and acceleration 6 g 2. Frequency range 80 Hz and acceleration 40 g 3. Frequency range 250 Hz and acceleration 250 g Vibration, continued:

More than 4 hours at a time 4. Frequency range 8-15 Hz and acceleration 1.5 g 5. Frequency range 80 Hz and acceleration 6 g 6. Frequency range 250 Hz and acceleration 20 g * This table may not be used to establish causation. Refer to Section D.3 Medical Causation for Cumulative Trauma Conditions. Recommendations for ergonomic changes to make the workplace more comfortable and efficient for the worker are not identical to risk factors which may cause an identified cumulative trauma condition.

7. MEDICATIONS AND MEDICAL MANAGEMENT Use of medications in the treatment of cumulative trauma related conditions is generally accepted for controlling acute pain and inflammation. Use of medications will vary widely due to the spectrum of injuries from simple strains to post-surgical analgesia. A thorough medication history, including use of alternative and over-the-counter medications, should be performed at the time of the initial visit and updated periodically. Treatment for pain control is initially accomplished with acetaminophen and/or NSAIDs. The patient should be educated regarding the interaction with prescription and over the counter medications as well as the contents of over the counter herbal products.

Oral non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen are useful in treating conditions associated with degenerative joint disease and/or inflammation.

Topical medications may also be useful in controlling pain.

a. Acetaminophen: an effective analgesic with anti-pyretic but not antiinflammatory activity. Acetaminophen is generally well-tolerated, causes little or no gastrointestinal (GI) irritation, and is not associated with ulcer formation.

Acetaminophen has been associated with liver toxicity in overdose situations or in chronic alcohol use. Patients may not realize that many over-the-counter preparations contain acetaminophen. The total daily dose of acetaminophen is recommended not to exceed three grams per 24-hour period, from all sources, including narcotic-acetaminophen combination preparations.

There is good evidence that acetaminophen is not more effective than placebo for the treatment of knee osteoarthritis. Thus, it may not be useful for upper extremity osteoarthritis. It may be used on patients with contraindications to other medications.  Optimum Duration: 7 to 10 days.  Maximum Duration: Long-term use as indicated on a case-by-case basis.

Use of this substance long-term (for 3 days per week or greater) may be associated with rebound pain upon cessation.

b. Minor Tranquilizer/Muscle Relaxants: They are generally not recommended for use in patients with cumulative trauma conditions and, if used, should not exceed 2 weeks total.

c. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): useful for pain and inflammation. In mild cases, they may be the only drugs required for analgesia.

There are several classes of NSAIDs. The response of the individual injured worker to a specific medication is unpredictable. For this reason, a range of NSAIDs may be tried in each case, with the most effective preparation being continued. Patients should be closely monitored for adverse reactions. The FDA advises that many NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. There is good evidence that naproxen has the least risk for cardiovascular events when compared to other NSAIDs. Administration of proton pump inhibitors, Histamine 2 Blockers or prostaglandin analog misoprostol along with these NSAIDs may reduce the risk of duodenal and gastric ulceration, in patients at higher risk for this adverse event (e.g., age > 60, concurrent antiplatelet or corticosteroid therapy). They do not impact possible cardiovascular complications. Due to the cross-reactivity between aspirin and NSAIDs, NSAIDs should not be used in aspirin-sensitive patients, and it should be used with caution in all asthma patients. NSAIDs are associated with abnormal renal function, including renal failure, as well as abnormal liver function. Patients with renal or hepatic disease may need increased dosing intervals with chronic use.

Chronic use of NSAIDs is generally not recommended due to increased risk of cardiovascular events and GI bleeding.

Topical NSAIDs may be more appropriate for some patients as there is some evidence they are associated with fewer systemic adverse events than oral NSAIDs.

NSAIDs may be associated with non-unions; thus, their use with fractures is questionable.

Certain NSAIDs may have interactions with various other medications.

Individuals may have adverse events not listed above. Intervals for metabolic screening are dependent on the patient's age and general health status and should be within parameters listed for each specific medication. Complete Blood Count (CBC) and liver and renal function should be monitored at least every six months in patients on chronic NSAIDs and initially when indicated.

i. Non-Selective Non-Steroidal Anti-Inflammatory Drugs: includes NSAIDs and acetylsalicylic acid. Serious GI toxicity, such as bleeding, perforation, and ulceration can occur at any time, with or without warning symptoms, in patients treated with traditional NSAIDs. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur. Anaphylactoid reactions may occur in patients taking NSAIDs. NSAIDs may interfere with platelet function.

Fluid retention and edema have been observed in some patients taking NSAIDs.  Maximum duration: 1 year. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation. ii Selective Cyclo-oxygenase-2 (COX-2) Inhibitors: COX-2 inhibitors differ from the traditional NSAIDs in adverse side effect profiles. The major advantages of selective COX-2 inhibitors over traditional NSAIDs are that they have less GI toxicity and no platelet effects. COX-2 inhibitors can worsen renal function in patients with renal insufficiency; thus, renal function may need monitoring.

COX-2 inhibitors should not be first-line for low risk patients who will be using an NSAID short-term. COX-2 inhibitors are indicated in select patients who do not tolerate traditional NSAIDs. Serious upper GI adverse events can occur even in asymptomatic patients. Patients at high risk for GI bleeding include those who use alcohol, smoke, are older than 65, take corticosteroids or anti-coagulants, or have a longer duration of therapy. Celecoxib is contraindicated in sulfonamide allergic patients.  Optimal Duration: 7 to 10 days.  Maximum Duration: Chronic use is appropriate in individual cases.

Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

d. Opioids: should be primarily reserved for the treatment of severe upper extremity pain. There are circumstances where prolonged use of opioids is justified based upon specific diagnosis and in pre- and post-operative patients. In these and other cases, it should be documented and justified. In mild-tomoderate cases of upper extremity pain, opioid medication should be used cautiously on a case-by-case basis. Adverse effects include respiratory depression, the development of physical and psychological dependence, and impaired alertness.

Opioids medications should be prescribed with strict time, quantity, and duration guidelines, and with definitive cessation parameters. Pain is subjective in nature and should be evaluated using a pain scale and assessment of function to rate effectiveness of the opioid prescribed. It is recommended that the provider access the Colorado Prescription Drug Monitoring Program (PDMP) before prescribing opioids. The PDMP allows the prescribing physician to see most of the controlled substances prescribed by other physicians for an individual patient.

Any use beyond the maximum should be documented and justified based on the diagnosis and/or invasive procedures.  Optimum Duration: Usually 3-5 days post-operatively  Maximum Duration: 2 weeks. Use beyond 2 weeks is acceptable in appropriate cases when functional improvement is documented. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guidelines, which give a detailed discussion regarding medication use in chronic pain management.

Use beyond 30 days after non-traumatic injuries, or 6 weeks post-operatively is not recommended. If longer treatment is justified, the physician should access the Colorado Prescription Drug Monitoring Program (PDMP) and follow recommendations in the Chronic Pain Guideline.

e. Psychotropic/Anti-anxiety/Hypnotic Agents: may be useful for treatment of mild and chronic pain, dysesthesias, sleep disorders, and depression. Postoperative patients may receive medication to assure normal sleep cycles.

Antidepressant medications, such as tricyclics and Selective Serotonin Reuptake Inhibitors (SSRIs), are useful for affective disorder and chronic pain management. Tricyclic anti-depressant agents, in low dose, are useful for chronic pain but have more frequent side effects.

Anti-anxiety medications are best used for short-term treatment (i.e., less than 6 months). Accompanying sleep disorders are best treated with sedating antidepressants prior to bedtime. Frequently, combinations of the above agents are useful. As a general rule, physicians should assess the patient’s prior history of substance abuse or depression prior to prescribing any of these agents.

Due to the habit-forming potential of the benzodiazepines and other drugs found in this class, they are not generally recommended. Refer to the Chronic Pain Guidelines which give a detailed discussion regarding medication use in chronic pain management.  Optimal Duration: 1 to 6 months.  Maximum Duration: 6 to 12 months, with monitoring.

f. Smoking Cessation Medications and Treatment: Tobacco dependence is chronic and may require repeated attempts to quit. All smoking cessation programs should be accompanied by behavioral support which may include practical counseling sessions, social support, and telephone follow up. A variety of medications have been used, including Bupropion SR, nicotine patches, gum, inhaler, lozenges or nasal spray, and varenicline. When nicotine supplements are used, cotinine testing will be positive. Urine anabasine or exhaled carbon monoxide 5 ppm or less may be used to check tobacco abstinence.

There is some evidence that among adults motivated to quit smoking, 12 weeks of open-label treatment including counseling and one of the following: nicotine patch, varenicline, or combination nicotine replacement therapy (nicotine patch and nicotine lozenge) are equally effective in assisting motivated smokers to quit smoking over a period of one year.

There is some evidence that among adults motivated to quit smoking, abrupt smoking cessation is more effective than gradual cessation for abstinence lasting over a period of 4 weeks to 6 months, even for smokers who initially prefer to quit by gradual reduction.

g. Topical Drug Delivery: Creams and patches may be an alternative treatment of localized musculoskeletal disorders.

It is necessary that all topical agents be used with strict instructions for application as well as the maximum number of applications per day to obtain the desired benefit and avoid potential toxicity. As with all medications, patient selection must be rigorous to select those patients with the highest probability of compliance. Refer to Section H.14.c Iontophoresis in Therapy-Passive for information regarding topical iontophoretic agents.

i. Topical Salicylates and Nonsalicylates: have been shown to be effective in relieving pain in acute and chronic musculoskeletal conditions. Topical salicylate and nonsalicylates achieve tissue levels that are potentially therapeutic, at least with regard to COX inhibition.

ii. There is good evidence that diclofenac gel reduces pain and improves function in mild-to-moderate hand osteoarthritis. There is some evidence that topical ketoprofen patches are more effective than placebo in reducing pain of upper extremity tendonitis. However, the need for continuous skin application may limit overall use. Use of ketoprofen topical patch for the disorders described in these guidelines has not been FDA approved at the time of this guideline writing.

iii. Other than local skin reactions, the side effects of therapy exist but are minimal. The usual contraindications to use of these compounds need to be considered. Local skin reactions are rare and systemic effects are even less common. Their use in patients receiving warfarin therapy may result in alterations in bleeding time. Overall, the low level of systemic absorption can be advantageous, allowing topical use of these medications when systemic administration is relatively contraindicated.

Examples include patients with hypertension, cardiac failure, or renal insufficiency. Hepatic changes have been documented with topical NSAID use and therefore monitoring of liver enzymes is recommended.  Maximal Duration: 2 weeks per episode.

iv. Capsaicin: is another medication option for topical drug use in upper extremity injury. Capsaicin offers a safe and effective alternative to systemic NSAID therapy. Although it is quite safe, effective use of capsaicin is limited by the local stinging or burning sensation that typically dissipates with regular use, usually after the first 7 to 10 days of treatment. Patients should be advised to apply the cream on the affected area with a plastic glove or cotton applicator and to avoid inadvertent contact with eyes and mucous membranes.  Maximal Duration: 2 weeks per episode.

v. Iontophoretic Agents: Refer to Section H.14.c Iontophoresis in Therapy- Passive.

vi. Topical Glyceryl Trinitrate: There is some evidence from a small study that wearing a topical patch containing glyceryl trinitrate over an area of tendinopathy is more effective than a placebo patch in reducing pain and improving overall clinical recovery in subjects with lateral epicondylitis over a period of 6 months. Improvement in function was not clearly demonstrated. There is some evidence that topical glyceryl trinitrate is not effective for epicondylitis from a study demonstrating no benefit compared to placebo with varied doses. Side effects include headaches.

The patch must be applied every day. Therefore it is not generally recommended and may only be used if there is failure of other conservative care at 8-12 weeks.  Time to effect: 3 weeks vii. Topical Lidocaine: There is no evidence that lidocaine patches have a functional benefit over other well-accepted treatment for carpal tunnel. At the time of this writing, post-herpetic neuralgia is the only medical condition for which topical lidocaine patch is FDA approved (Food and Drug Administration). The patches are not generally recommended, although may be used when the primary complaint of the patient is pain and the patient refuses a steroid injection.

h. Glucosamine and chondroitin: are sold in the United States as dietary supplements. Their dosage, manufacture, and purity are not regulated by the Food and Drug Administration. Pharmaceutical grade versions are not available in the United States and thus, these medications are not recommended.

i. Vitamin B6: Randomized trials on non-surgical treatment for carpal tunnel syndrome have demonstrated conflicting results. Higher doses may result in development of a toxic peripheral neuropathy. In the absence of definitive literature showing a beneficial effect, use of Vitamin B6 cannot be recommended.

8. NON-INTERDISCIPLINARY OCCUPATIONAL REHABILITATION PROGRAMS

These generally-accepted programs are work-related, outcome focused, individualized treatment programs. Objectives of the programs include, but are not limited to, improvement of cardiopulmonary and neuromusculoskeletal functions (strength, endurance, movement, flexibility, stability, and motor control functions), patient education, and symptom relief. The goal is for patients to gain full- or optimal-function and return to work. The service may include the time limited use of passive modalities with progression to achieve treatment and/or simulated/real work.

a. Work conditioning: is usually initiated once re-conditioning has been completed but may be offered at any time throughout the recovery phase. It should be initiated when imminent return of a patient to modified or full-duty is not an option, but the prognosis for returning the patient to work at completion of the program is at least fair to good.  Length of Visit: 1 to 2 hours per day.  Frequency: 2 to 5 visits per week.  Maximum Duration: 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic or functional gains.

b. Work simulation: is a program where an individual completes specific workrelated tasks for a particular job and return-to-work. Use of this program is appropriate when modified duty can only be partially accommodated in the workplace, when modified duty in the workplace is unavailable, or when the patient requires more structured supervision. The need for workplace simulation should be based upon the results of a Functional Capacity Evaluation (FCE) and/or job site Evaluation.  Length of Visit: 2 to 6 hours per day.  Frequency: 2 to 5 visits per week.  Maximum Duration: 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic or functional gains.

9. PERSONALITY/PSYCHOSOCIAL/PSYCHOLOGICAL INTERVENTION

Psychosocial treatment is a well-established therapeutic and diagnostic intervention with selected use in acute pain patients and more widespread use in sub-acute and chronic pain populations. Psychosocial treatment is recommended as an important component in the total management of a patient with chronic pain and should be implemented as soon as the problem is identified.

Several studies have noted lack of a direct connection between impairment and disability.

It appears that the lack of connection is due to differences among individuals in level of depression, coping strategies, or other psychological distress.

If a diagnosis consistent with the standards of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM) has been determined, the patient should be evaluated for the potential need for psychiatric medications. The authorized treating physician or the consulting psychiatrist may order the use of any medication to treat a diagnosed condition. Visits for management of psychiatric medications are medical in nature and are not a component of psychosocial treatment.

Therefore, separate visits for medication management may be necessary, depending on the patient and medications selected.

Psychosocial interventions include psychotherapeutic treatments for mental health conditions as well as behavioral medicine treatments. These interventions may similarly be beneficial for patients without psychiatric conditions but who may need to make major life changes to cope with pain or adjust to disability. Examples of these treatments include cognitive behavioral therapy (CBT), relaxation training, mindfulness training, and sleep hygiene training.

The screening or diagnostic workup should clarify and distinguish between pre-existing, aggravated, and/or purely causative psychological conditions. Therapeutic and diagnostic modalities include, but are not limited to, individual counseling and group therapy.

Treatment can occur within an individualized model, a multi-disciplinary model, or a structured pain management program.

A psychologist with a PhD, PsyD, or EdD credentials or a psychiatric MD/DO may perform psychosocial treatments. The following professionals may also treat in consultation with a psychologist with a PhD, PsyD, or EdD or a psychiatric MD/DO: other licensed mental health providers; licensed health care providers with training in CBT; or licensed and certified CBT therapists who have experience in treating chronic pain disorders in injured workers.

CBT is a group of psychological therapies that are sometimes referred to by more specific names such as Rational Emotive Behavior Therapy, Rational Behavior Therapy, Rational Living Therapy, Cognitive Therapy, and Dialectic Behavior Therapy. Variations of CBT methods can be used to treat a variety of conditions, including chronic pain, depression, anxiety, phobias, and post-traumatic stress disorder (PTSD). For patients with multiple diagnoses, more than one type of CBT might be needed. The CBT used in research studies is often “manualized CBT,” meaning that the treatment follows a specific protocol in a manual. In clinical settings, CBT may involve the use of standardized materials, but it is also commonly adapted by a psychologist or psychiatrist to the patient’s unique circumstances. If the CBT is being performed by a non-mental health professional, a manual approach would be strongly recommended. CBT must be distinguished from neuropsychological therapies used to teach compensatory strategies to brain injured patients, which are also called “cognitive therapy.”

It should be noted that most clinical trials on CBT exclude subjects who have significant psychiatric diagnoses. Consequently, the selection of patients for CBT should include the following considerations. CBT is instructive and structured, using an educational model with homework to teach inductive rational thinking. Because of this educational model, a certain level of literacy is assumed for most CBT protocols. Patients who lack the cognitive and educational abilities required by a CBT protocol are unlikely to be successful. Further, given the highly structured nature of CBT, it is more effective when a patient’s circumstances are relatively stable. For example, if a patient is about to be evicted, is actively suicidal, or is coming to sessions intoxicated, these matters will generally preempt CBT treatment for pain, and require other types of psychotherapeutic response. Conversely, literate patients whose circumstances are relatively stable, but who catastrophize or cope poorly with pain or disability are often good candidates for CBT for pain. Similarly, literate patients whose circumstances are relatively stable, but who exhibit unfounded medical phobias, are often good candidates for CBT for anxiety.

There is good evidence that cognitive intervention reduces low back disability in the short-term and in the long-term. In one of the studies, the therapy consisted of 6, 2-hour sessions given weekly to workers who had been sick-listed for 8-12 weeks. Comparison groups include those who received routine care. There is good evidence that psychological interventions, especially CBT, are superior to no psychological intervention for chronic low back pain. There is also good evidence that self-regulatory interventions, such as biofeedback and relaxation training, may be equally effective. There is good evidence that six group therapy sessions lasting one and a half hours each focused on CBT skills improved function and alleviated pain in uncomplicated sub-acute and chronic low back pain patients. There is some evidence that CBT provided in 7, 2-hour small group sessions can reduce the severity of insomnia in chronic pain patients. A Cochrane meta-analysis grouped very heterogeneous behavioral interventions and concluded that there was good evidence that CBT may reduce pain and disability, but the effect size was uncertain. In total, the evidence clearly supports CBT, and it should be offered to all chronic pain patients who do not have other serious issues, as discussed above.

CBT is often combined with active therapy in an interdisciplinary program, whether formal or informal. It must be coordinated with a psychologist or psychiatrist. CBT can be done in a small group or individually, and the usual number of treatments varies between 8 and 16 sessions.

Before CBT is done, the patient must have a full psychological evaluation. The CBT program must be done under the supervision of a psychologist with a PhD, PsyD, EdD, or psychiatric MD/DO.

Psychological Diagnostic and Statistical Manual of Mental Disorders (DSM) disorders are common in chronic pain. One study demonstrated that the majority of patients who had failed other therapy and participated in an active therapy program also suffered from major depression. However, in a program that included CBT and other psychological counseling, the success rate for return to work was similar for those with and without a DSM diagnosis. This study further strengthens the argument for having some psychological intervention included in all chronic pain treatment plans.

For all psychological/psychiatric interventions, an assessment and treatment plan with measurable behavioral goals, time frames, and specific interventions must be provided to the treating physician prior to initiating treatment. A status report must be provided to the authorized treating physician every two weeks during initial more frequent treatment and monthly thereafter. The report should provide documentation of progress toward functional recovery and a discussion of the psychosocial issues affecting the patient’s ability to participate in treatment. The report should also address pertinent issues such as pre-existing, aggravated, and/or causative issues, as well as realistic functional prognosis.

a. Cognitive Behavioral Therapy (CBT) or Similar Treatment:  Time to Produce Effect: 6 to 8 1–2 hour sessions, group or individual (1-hour individual or 2-hour group).  Maximum Duration: 16 sessions.

NOTE: Before CBT is done, the patient must have a full psychological evaluation.

The CBT program must be done under the supervision of a psychologist with a PhD, PsyD, or EdD or a Psychiatric MD/DO.

b. Other Psychological/Psychiatric Interventions:  Time to Produce Effect: 6 to 8 weeks.  Frequency: 1 to 2 times weekly for the first 2 weeks (excluding hospitalization, if required), decreasing to 1 time per week for the second month. Thereafter, 2 to 4 times monthly with the exception of exacerbations, which may require increased frequency of visits. Not to include visits for medication management  Optimum Duration: 2 to 6 months.  Maximum Duration: 6 months. Not to include visits for medication management. For select patients, longer supervised psychological/psychiatric treatment may be required, especially if there are ongoing medical procedures or complications. If counseling beyond 6 months is indicated, the management of psychosocial risks or functional progress must be documented. Treatment plan/progress must show severity.

10. RESTRICTION OF ACTIVITIES

Continuation of normal daily activities is the recommendation for most patients, since immobility will negatively affect rehabilitation. Prolonged immobility results in a wide range of deleterious effects, such as a reduction in aerobic capacity and conditioning, loss of muscle strength and flexibility, increased segmental stiffness, promotion of bone demineralization, impaired disc nutrition, and the facilitation of the illness role.

Some level of immobility may occasionally be appropriate, including splinting/casting.

While these interventions may be occasionally ordered in the acute phase, the provider should be aware of their impact on the patient’s ability to adequately comply with and successfully complete rehabilitation. Activity should be increased based on the improvement of core strengthening.

Patients should be educated regarding the detrimental effects of immobility versus the efficacious use of limited rest periods. Adequate rest allows the patient to comply with active treatment and benefit from the rehabilitation program. In addition, complete work cessation should be avoided, if possible, since it often further aggravates the pain presentation and promotes disability. Modified return to work is almost always more efficacious and rarely contraindicated in the vast majority of injured workers.

11. RETURN-TO-WORK

Return to work and/or work-related activities, whenever possible, is one of the major components in treatment and rehabilitation. Return to work should be addressed by each workers’ compensation provider at the first meeting with the injured employee and updated at each additional visit. A return-to-work format should be part of a company’s health plan, knowing that return to work can decrease anxiety, reduce the possibility of depression, and reconnect the worker with society.

Because a prolonged period of time off work will decrease the likelihood of return to work, the first weeks of treatment are crucial in preventing and/or reversing chronicity and disability mindset. In complex cases, experienced nurse case managers may be required to assist in return to work. Other services, including psychological evaluation and/or treatment, job site analysis, and vocational assistance, may be employed.

Two counseling sessions with an occupational physician, and work site visit if necessary, may be helpful for workers who are concerned about returning to work.

At least one study suggests that health status is worse for those patients who do not return to work than those who do. Self-employment and injury severity predict return to work. Difficulty with pain control, ADLs, and anxiety and depression were common.

The following should be considered when attempting to return an injured worker with chronic pain to work.

a. Job History Interview: The authorized treating physician should perform a job

history interview at the time of the initial evaluation and before any plan of treatment is established. Documentation should include the worker’s job demands, stressors, duties of current job, and duties of job at the time of the initial injury. In addition, cognitive and social issues should be identified, and treatment of these issues should be incorporated into the plan of care.

b. Coordination of Care: Management of the case is a significant part of return to work and may be the responsibility of the authorized treating physician, occupational health nurse, risk manager, or others. Case management is a method of communication between the primary provider, referral providers, insurer, employer, and employee. Because case management may be coordinated by a variety of professionals, the case manager should be identified in the medical record.

c. Communication: This is essential between the patient, authorized treating physician, employer, and insurer. Employers should be contacted to verify employment status, job duties and demands, and policies regarding injured workers. In addition, the availability and duration of temporary and permanent restrictions, as well as other placement options, should be discussed and documented. All communications in the absence of the patient are required to be documented and made available to the patient.

d. Establishment of Return-to-Work Status: Return to work for persons with chronic pain should be considered therapeutic, assuming that work is not likely to aggravate the basic problem or increase the discomfort. In some cases of chronic pain, the worker may not be currently working or even employed. The goal of return to work would be to return the worker to any level of employment with the current employer or to return him/her to any type of new employment.

Temporary restrictions may be needed while recommended ergonomic or adaptive equipment is obtained; employers should obtain recommended equipment in a timely manner.

e. Establishment of Activity Level Restrictions: A formal job description for the injured worker is necessary to identify physical demands at work and assist in the creation of modified duty. A job site evaluation may be utilized to identify applicable tasks such as pushing, pulling, lifting, reaching, grasping, pinching, sitting, standing, posture, and ambulatory distance and terrain. If applicable, a job site evaluation may also be utilized to assess temperature, air flow, noise, and the number of hours worked per day in a specific environment. Also refer to

Section H.6 Job Site Alterations. Because exacerbation of symptoms affecting function is unpredictable, an extended, occupationally focused functional capacity evaluation may be necessary to determine the patient’s tolerance for job type tasks over a continued period of time. Job requirements should be reviewed for the entire 8 hours or more of the working day. Between one and three days after the evaluation, there should be a follow-up evaluation by the treating therapist and/or the authorized treating physician to assess the patient’s status.

When prescribing the functional capacity evaluation, the physician must assess the probability of return to work against the potential for exacerbation of the work related condition. Work restrictions assigned by the authorized treating physician may be temporary or permanent. The case manager should continue to seek out modified work until restrictions become less cumbersome or as the worker’s condition improves or deteriorates.

f. Rehabilitation and Return to Work: As part of rehabilitation, every attempt should be made to simulate work activities so that the authorized treating physician may promote adequate job performance. The use of ergonomic or adaptive equipment, therapeutic breaks, and interventional modalities at work may be necessary to maintain employment.

g. Vocational Assistance: Formal vocational rehabilitation is a generally accepted intervention and can assist disabled persons to return to viable employment.

Identification of vocational goals will facilitate medical recovery and aid in the achievement of maximum medical improvement by (1) increasing motivation towards treatment and (2) alleviating the patient’s emotional distress. Physically limited patients will benefit most if vocational assistance is provided during the interdisciplinary rehabilitation phase of treatment. To assess the patient’s vocational capacity, a vocational assessment may utilize the information from occupational and physical therapy assessments. This vocational assessment may identify rehabilitation program goals and optimize both patient motivation and utilization of rehabilitation resources. This may be extremely helpful in decreasing the patient’s fear regarding an inability to earn a living, which can add to his/her anxiety and depression.

Recommendations to Employers and Employees of Small Businesses: employees of small businesses who are diagnosed with chronic pain may not be able to perform any jobs for which openings exist. Temporary employees may fill those slots while the employee functionally improves. Some small businesses hire other workers, and if the injured employee returns to the job, the supervisor/owner may have an extra employee. Case managers may assist with resolution of these problems and with finding modified job tasks or jobs with reduced hours, etc., depending on company philosophy and employee needs.

Recommendations to Employers and Employees of Mid-sized and Large Businesses: Employers are encouraged by the Division to identify modified work within the company that may be available to injured workers with chronic pain who are returning to work with temporary or permanent restrictions. To assist with temporary or permanent placement of the injured worker, it is suggested that a program be implemented that allows the case manager to access descriptions of all jobs within the organization.

12. SLEEP DISTURBANCES

Sleep disturbances are a common secondary symptom of cumulative trauma conditions.

Although primary insomnia may accompany pain as an independent co-morbid condition, it more commonly occurs secondary to the pain condition itself. Exacerbations of pain often are accompanied by exacerbations of insomnia; the reverse can also occur. Sleep laboratory studies have shown disturbances of sleep architecture in pain patients. Loss of deep slow-wave sleep and increase in light sleep occur and sleep efficiency, the proportion of time in bed spent asleep, is decreased. These changes are associated with patient reports of non-restorative sleep. Many affected patients develop behavioral habits that exacerbate and maintain sleep disturbances. Excessive time in bed, irregular sleep routine, napping, low activity, and worrying in bed are all maladaptive responses that can arise in the absence of any psychopathology. Behavioral modifications are accepted interventions, easily implemented, and can include:

a. Maintaining a regular sleep schedule, retiring and rising at approximately the same time on weekdays and weekends.

b. Avoiding daytime napping.

c. Avoiding caffeinated beverages after lunchtime.

d. Making the bedroom quiet and comfortable, eliminating disruptive lights, sounds, television sets, and keeping a bedroom temperature of about 65 degrees Fahrenheit.

e. Avoiding alcohol or nicotine within 2 hours of bedtime.

f. Avoiding large meals within 2 hours of bedtime.

g. Exercising vigorously during the day, but not within 2 hours of bedtime, since this may raise core temperature and activate the nervous system.

h. Associating the bed with sleep and sexual activity only, using other parts of the home for television, reading, and talking on the telephone.

i. Leaving the bedroom when unable to sleep for more than 20 minutes, returning to the bedroom when ready to sleep again.

These modifications should be undertaken before sleeping medication is prescribed for long-term use.

13. THERAPY–ACTIVE

The following active therapies are widely used and accepted methods of care for a variety of work-related injuries. They are based on the philosophy that therapeutic exercise and/or activity are beneficial for restoring flexibility, strength, endurance, function, range of motion, and alleviating discomfort. Active therapy requires an internal effort by the individual to complete a specific exercise or task, and thus assists in developing skills promoting independence and self-care after discharge. This form of therapy requires supervision from a therapist or medical provider such as verbal, visual, and/or tactile instructions. At times a provider may help stabilize the patient or guide the movement pattern, but the energy required to complete the task is predominantly executed by the patient.

Patients should be instructed to continue active therapies at home as an extension of the treatment process in order to maintain improvement levels. Follow-up visits to reinforce and monitor progress and proper technique are recommended. Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices. Frequency times and duration of treatment apply only to diagnoses not previously covered in Sections F and G.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as "maximum.” Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care, need for post-operative therapy, and comorbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. If no functional gain is observed after the number of treatments under “time to produce effect” has been completed, then the treatment should be discontinued and alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

a. Activities of Daily Living (ADLs): are well-established interventions which involve instruction, active-assisted training, and/or adaptation of activities or equipment to improve a person's capacity in normal daily activities such as selfcare, work re-integration training, homemaking, and driving.  Time to Produce Effect: 4 to 5 treatments.

b. Functional Activities: are generally well-accepted interventions which involve the use of therapeutic activity to enhance mobility, body mechanics, employability, coordination, and sensory motor integration.  Time to Produce Effect: 4 to 5 treatments.

c. Nerve Gliding: exercises are generally accepted. These exercises consist of a series of flexion and extension movements of the hand, wrist, elbow, shoulder, and neck, producing tension and longitudinal movement along the length of the median and other nerves of the upper extremity. These exercises are based on the principle that the tissues of the peripheral nervous system are designed for movement. The second principle is that tension and glide (excursion) of nerves may have an effect on neurophysiology through alterations in vascular and axoplasmic flow. Biomechanical principles have been more thoroughly studied than clinical outcomes. There is some evidence that a trial of conservative treatment for cubital tunnel syndrome, with emphasis on education, is as effective as a treatment program involving nocturnal bracing and a program involving gliding exercises. This education covers nerve anatomy, causes of symptoms, and appropriate elbow movements. Due to lack of quality evidence, use of mobilization and exercise should be based on patient preference and provider expertise.  Time to Produce Effect: 2 to 4 weeks.  Frequency: Up to 5 times per day by patient (patient-initiated).  Optimum Duration: 2 provider-directed sessions.  Maximum Duration: 3 provider-directed sessions.

d. Neuromuscular Re-education: is an accepted treatment that involves the skilled application of exercise with manual, mechanical, or electrical facilitation.

The goal is to enhance strength, movement patterns, neuromuscular response, proprioception, kinesthetic sense, coordination education of movement, balance, and posture. Indications include the need to promote neuromuscular responses through carefully timed proprioceptive stimuli, to elicit and improve motor activity in patterns similar to normal neurologically developed sequences, and improve neuromotor response with independent control.  Frequency: 3 times per week.

e. Proper Work Techniques: Please refer to Section E.6.c Job Site Evaluations and Alterations and Section H.6 Job Site Alterations.

f. Therapeutic Exercise: is generally well-accepted and widely used. It is done with or without mechanical assistance or resistance may include isoinertial, isotonic, isometric and isokinetic types of exercises. Indications include the need for cardiovascular fitness, reduced edema, improved muscle strength, improved connective tissue strength and integrity, increased bone density, promotion of circulation to enhance soft tissue healing, improvement of muscle recruitment, increased range of motion, and more normal movement patterns. The treatment can also include complementary/alternative exercise such as movement therapy (with oversight of a physician or other appropriate healthcare professional).

14. THERAPY–PASSIVE

Most of the following passive therapies and modalities are generally well-accepted methods of care for a variety of work-related injuries. This includes those treatment modalities that do not require energy expenditure on the part of the patient. They are principally effective during the early phases of treatment and are directed at controlling symptoms such as pain, inflammation, swelling, and at improving the rate of healing soft tissue injuries. They should be used in adjunct with active therapies to help control swelling, pain and inflammation during the rehabilitation process. They may be used intermittently as a therapist deems appropriate or regularly if there are specific goals with objectively measured functional improvements during treatment.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as "maximum.” Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care, need for post-operative therapy, and comorbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. If no functional gain is observed after the number of treatments under “time to produce effect” has been completed, then the treatment should be discontinued and alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

The following passive therapies and modalities are listed in alphabetical order.

a. Electrical Stimulation (Unattended): is an accepted treatment. Once applied, it requires minimal on-site supervision by the physician or non-physician provider.

Indications include pain, inflammation, muscle spasm, atrophy, and decreased circulation.

Electrical stimulation is rarely used in cumulative trauma conditions. However, high voltage, galvanic, and/or interferential stimulators may assist in edema control to decrease pain and improve therapy compliance. It may be appropriate in rare situations when nerve damage or other work related issues have resulted in muscle atrophy and the patient is unable to engage in sufficient active therapy to increase muscle mass. TENS therapy or PENS are not indicated for diagnoses in these Guidelines. Refer to Exhibit 9 Chronic Pain Medical Treatment Guidelines for usage.  Time to Produce Effect: 2 to 4 treatments.  Frequency: Varies, depending upon indication, between 2 to 3 times/day to 1 time/week. Provide home unit if frequent use.  Maximum Duration: Home unit as needed.

b. Extracorporeal Shock Wave Therapy (ESWT): The natural history of epicondylitis supports an expectation of improvement within 3 months using patient education and modified activities.

There is some evidence that highly motivated tennis players may show up to a 35% additional improvement over no other treatment when administered low energy shock wave treatment without local anesthesia. Two other studies are not of sufficient quality to qualify for evidence. There is some evidence that three weekly sessions of radial ESWT and sham ESWT lead to statistically similar symptomatic and functional outcomes at three months, but a benefit of radial ESWT cannot be ruled out due to uncertainties in the data.

The preponderance of evidence does not support the efficacy of ESWT in the working population; therefore, it is not recommended.

c. Iontophoresis: is an accepted treatment. It is the transfer of medication, including, but not limited to, steroidal anti-inflammatories and anesthetics, through the use of electrical stimulation. Indications include pain (lidocaine), inflammation (hydrocortisone, salicylate), edema (mecholyl, hyaluronidase, and salicylate), ischemia (magnesium, mecholyl, and iodine), muscle spasm (magnesium, calcium), calcific deposits (acetate), and scars and keloids (chlorine, iodine, acetate). Refer to the specific diagnosis for use with cumulative trauma. Under current FDA regulations, the physician issues a prescription to the patient for the dexamethasone for this treatment and the patient transports the medication to the treatment location.  Time to Produce Effect: 1 to 4 treatments.  Frequency: 2 to 3 times per week with at least 48 hours between treatments.  Optimum Duration: 6 to 9 treatments.  Maximum Duration: 9 treatments.

d. Low Level Laser Therapy (LLLT): There is some evidence that low-level laser therapy adds no short term benefit for reducing symptoms and improving function compared to full-time splinting for 3 months. There is good evidence that laser therapy is ineffective regarding pain and function compared with placebo as an intervention to treat carpal tunnel syndrome in the short term. This is some evidence that LLLT is no more effective than placebo LLLT in reducing pain and symptoms and improving functionality in the conservative treatment of patients affected by carpal tunnel syndrome. There is some evidence that LLLT plus splinting is no more effective than splinting alone in reducing carpal tunnel symptoms and improving functionality in the conservative treatment of patients affected by carpal tunnel syndrome. There is good evidence that LLLT is not more effective than placebo for lateral epicondylitis. There is good evidence from a number of adequate studies comparing low level laser to sham therapy and splinting that low level laser does not add benefit, and it is not recommended.

e. Manipulation: Is a generally accepted, well-established and widely used therapeutic intervention for upper extremity injuries. Manipulative treatment (not therapy) is defined as the therapeutic application of manually guided forces by an operator to improve physiologic function and/or support homeostasis that has been altered by the injury or occupational disease, and has associated clinical significance.

High velocity, low amplitude (HVLA) technique, chiropractic manipulation, osteopathic manipulation, muscle energy techniques, counter strain, and nonforce techniques are all types of manipulative treatment. This may be applied by osteopathic physicians (D.O.), chiropractors (D.C.), properly trained physical therapists (P.T.), properly trained occupational therapists (O.T.), or properly trained physicians. Under these different types of manipulation exist many subsets of different techniques that can be described as a) “direct,” or a forceful engagement of a restrictive/pathologic barrier; b) “indirect,” or a gentle/nonforceful disengagement of a restrictive/pathologic barrier; c) the patient actively assisting in the treatment; and d) the patient relaxing, allowing the practitioner to move the body tissues. When the proper diagnosis is made and coupled with the appropriate technique, manipulation has no contraindications and can be applied to all tissues of the body. Pre-treatment assessment should be performed as part of each manipulative treatment visit to ensure that the correct diagnosis and correct treatment is employed. Refer to the specific diagnosis for use with cumulative trauma conditions.

There is good evidence that manual and manipulative therapy combined with exercise and/or multimodal therapy shows small, clinically important reductions in pain and improved physical function in the short-term care (≤3-6 months) of patients with lateral epicondylitis and carpal tunnel syndrome.

There is some evidence that both Cyriax physiotherapy (deep transverse friction massage combined with mills manipulation) and phonophoresis with supervised exercise and static stretching are effective over 4 weeks. Both treatments decrease pain, increase pain-free grip strength, and improve functional status in people with lateral epicondylalgia. However, Cyriax physiotherapy provides a superior benefit compared to phonophoresis with supervised exercise and static stretching.  Time to Produce Effect (for all types of manipulative treatment): 1 to 6 treatments.  Frequency: Up to 3 times per week for the first 3 weeks as indicated by the severity of involvement and the desired effect.  Optimum Duration: 10 treatments.  Maximum Duration: 12 treatments. Additional visits may be necessary in cases of re-injury, interrupted continuity of care, exacerbation of symptoms, and in those patients with co-morbidities. Functional gains including increased range of motion must be demonstrated to justify continuing f. Manual Therapy Techniques: are passive interventions in which the provider uses his/her hands to administer skilled movements. The movements are designed to modulate pain; increase joint range of motion; reduce/eliminate soft tissue swelling, inflammation or restriction; induce relaxation; and improve contractile and non-contractile tissue extensibility. These generally accepted techniques are applied only after a thorough examination is performed to identify those for whom manual therapy would be contraindicated or for whom manual therapy must be applied with caution.

There is some evidence that the muscle energy technique is superior to corticosteroid injection in improving grip strength in lateral epicondylitis. The muscle energy technique is a manual therapy technique in which the patient performs voluntary contraction against a counter force from the provider to stretch muscles and improve range of motion. However, it is not clear that the technique is better than no treatment.

There is good evidence that manual and manipulative therapy combined with exercise and/or multimodal therapy shows small, clinically important reductions in pain and improved physical function in the short-term care (≤3-6 months) of patients with lateral epicondylitis and carpal tunnel syndrome.

There is some evidence that both Cyriax physiotherapy (deep transverse friction massage combined with mills manipulation) and phonophoresis with supervised exercise and static stretching are effective over 4 weeks. Both treatments decrease pain, increase pain-free grip strength, and improve functional status in people with lateral epicondylalgia. However, Cyriax physiotherapy provides a superior benefit compared to phonophoresis with supervised exercise and static stretching.

i. Mobilization (Joint)/Manipulation: Mobilization is passive movement involving oscillatory motions to the involved joints. The passive mobility is performed in a graded manner (I, II, III, IV, or V), which depicts the speed of the maneuver. It may include skilled manual joint tissue stretching.

Indications include the need to improve joint play, improve intracapsular arthrokinematics, or reduce pain associated with tissue impingement.

Contraindications include joint instability, fractures, severe osteoporosis, infection, metastatic cancer, active inflammatory arthritis, and signs of progressive neurologic deficits.  Time to Produce Effect: 4 to 6 treatments.

ii. Mobilization (Soft Tissue): Mobilization of soft tissue is the skilled application of manual techniques designed to normalize movement patterns through the reduction of soft tissue pain and restrictions.

Indications include muscle spasm around a joint, trigger points, adhesions, and neural compression.  Time to Produce Effect: 4 to 6 treatments.

g. Massage, Manual or Mechanical: Massage is manipulation of soft tissue with broad ranging relaxation and circulatory benefits. It is an accepted treatment.

This may include stimulation of acupuncture points and acupuncture channels (acupressure), application of suction cups, and techniques that include pressing, lifting, rubbing, pinching of soft tissues by or with the practitioners’ hands.

Indications include edema, muscle spasm, adhesions, the need to improve peripheral circulation and range of motion, or to increase muscle relaxation and flexibility prior to exercise.  Time to Produce Effect: Immediate.  Frequency: 1 to 2 times per week.  Optimum Duration: 6 weeks.  Maximum Duration: 2 months.

h. Orthotics/Immobilization with Splinting and Bracing: is a generally accepted, well-established and widely used therapeutic procedure. Depending on the specifics of the condition, the treatment plan, and the daily activities, splints may be effective when worn at night or during portions of the day. Splints should be loose and soft enough to maintain comfort while supporting the involved joint in a relatively neutral position.

Splint comfort is critical and may affect compliance. Although off-the-shelf splints are usually sufficient, custom thermoplastic splints may provide better fit for certain patients. Splint use is rarely mandatory. Providers should be aware that over usage is counterproductive, and counsel patients to minimize daytime splint use in order avoid detrimental effects, such as, stiffness and dependency over time.  Time to Produce Effect: 1 to 4 weeks.  Frequency: Daytime intermittent or night use, depending on symptoms and activities.  Maximum Duration: 2 to 4 months. If symptoms persist, consideration should be given to further diagnostic studies or to other treatment options.

i. Paraffin Bath: is a superficial heating modality that uses melted paraffin (candle wax and mineral oil) to treat irregular surfaces such as the hand. Accepted indications include the need to enhance collagen extensibility before stretching, reduce muscle guarding, or reduce inflammatory response.  Time to Produce Effect: 1 to 4 treatments.  Optimum Duration: 4 weeks.  Maximum Duration: 1 month. If beneficial, provide with home unit or purchase if effective.

j. Superficial Heat and Cold Therapy: is an accepted intervention. Thermal agents are applied in various manners that lower or raise the body tissue temperature for the reduction of pain, inflammation, and/or effusion resulting from injury or induced by exercise. It includes application of heat just above the surface of the skin at acupuncture points. Indications include acute pain, edema, and hemorrhage and the need to increase pain threshold, reduce muscle spasm, and promote stretching/flexibility. Cold and heat packs can be used at home as an extension of therapy in the clinic setting.  Time to Produce Effect: Immediate.  Frequency: 2 to 5 times per week (clinic). Home treatment as needed.  Optimum Duration: 3 weeks as primary or intermittently as an adjunct to other therapeutic procedures up to 2 months.  Maximum Duration: 2 months. If symptoms persist, provider should consider further diagnostic studies or other treatment options.

k. Ultrasound (Including Phonophoresis): is an accepted treatment. It uses sonic generators to deliver acoustic energy for therapeutic thermal and/or non-thermal soft tissue effects. Refer to Sections F and G on specific diagnoses for use.

Indications include scar tissue, adhesions, collagen fiber, muscle spasm, and to improve muscle tissue extensibility and soft tissue healing. Ultrasound with electrical stimulation is concurrent delivery of electrical energy that involves dispersive electrode placement. Indications include: muscle spasm, scar tissue, pain modulation, and muscle facilitation. Phonophoresis is the transfer of medication to the target tissue to control inflammation and pain through the use of sonic generators. These topical medications include, but are not limited to, steroidal anti-inflammatory and anesthetics. Under current FDA regulations, the physician issues a prescription to the patient for the dexamethasone for this treatment and the patient usually transports the medication to the treatment location.  Time to Produce Effect: 4 to 8 treatments.  Maximum Duration: 2 months.

15. VOCATIONAL REHABILITATION

VOCATIONAL REHABILITATION: is a generally accepted intervention. However, Senate Bill 87-79 limits the use of vocational rehabilitation in Colorado. This treatment requires adequate evaluation of patients for quantification of highest functional level, motivation, and achievement of maximum medical improvement (MMI). Vocational rehabilitation may be as simple as returning to the original job or as complicated as being retrained for a new occupation. The effectiveness of vocational rehabilitation may be enhanced when performed in combination with work hardening and work conditioning.

It may also be beneficial for full vocational rehabilitation to be started before MMI if it is evident that the injured worker will be unable to return to his/her previous occupation. A positive goal and direction may aid the patient in decreasing stress and depression, and promote optimum rehabilitation. _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011, and

rule history, are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the

History link that appears above the text in 7 CCR 1101-3. To view versions effective after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 18:

Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 06 Rule 17, Exhibit 6 - LOWER EXTREMITY INJURY MEDICAL TREATMENT GUIDELINES {#sec-7-ccr-1101-3-r17-ex-06 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 06}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Workers’ Compensation WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

RULE 17, EXHIBIT 6 LOWER EXTREMITY INJURY MEDICAL TREATMENT GUIDELINES 7 CCR 1101-3 Rule 17 - Exhibit 6 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ A. INTRODUCTION This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of providers treating individuals qualifying under Colorado Workers’ Compensation Act as injured workers with lower extremity injuries.

Although the primary purpose of this document is advisory and educational, these guidelines are enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from these guidelines, as individual cases dictate. Therefore, these guidelines are not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip nor overlook any sections.

B. GENERAL GUIDELINES PRINCIPLES

The principles summarized in this section are key to the intended implementation of all Division of Workers’ Compensation guidelines and critical to the reader’s application of the guidelines in this document.

1. APPLICATION OF THE GUIDELINES: The Division provides procedures to implement medical treatment guidelines and to foster communication to resolve disputes among the provider, payer, and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the Office of Administrative Courts.

2. EDUCATION: Education of the patient and family, as well as the employer, insurer, policy makers, and the community should be the primary emphasis in the treatment of chronic pain and disability. Currently, practitioners often think of education last, after medications, manual therapy, and surgery. Practitioners must implement strategies to educate patients, employers, insurance systems, policy makers, and the community as a whole. An education-based paradigm should always start with inexpensive communication providing reassuring and evidence-based information to the patient. More in-depth patient education is currently a component of treatment regimens which employ functional, restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention.

3. INFORMED DECISION MAKING: Providers should implement informed decision making as a crucial element of a successful treatment plan. Patients, with the assistance of their health care practitioner, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, physical therapists, and other members of the health care team play an integral role in informed decision making and achievement of functional goals. Patient education and informed decision making should facilitate self-management of symptoms and prevention of further injury.

4. TREATMENT PARAMETER DURATION: Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Obviously, duration will be impacted by patient compliance, as well as availability of services.

Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

5. ACTIVE INTERVENTIONS: Emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, is generally emphasized over passive modalities, especially as treatment progresses. Generally, passive interventions facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

6. ACTIVE THERAPEUTIC EXERCISE PROGRAM: Goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

7. POSITIVE PATIENT RESPONSE: Results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to, positional tolerances, range-of-motion (ROM), strength, endurance, activities of daily living (ADL), cognition, psychological behavior, and quantifiable efficiency/velocity measures. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation. Anatomic correlation must be based on objective findings.

8. RE-EVALUATE TREATMENT EVERY 3 TO 4 WEEKS: If a given treatment or modality is not producing positive results within three to four weeks, the treatment should be either modified or discontinued. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results. Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

9. SURGICAL INTERVENTIONS: Surgical interventions should be contemplated within the context of expected functional outcome and not purely for the purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic condition(s).

10. SIX-MONTH TIME FRAME: The prognosis drops precipitously for returning an injured worker to work once he/she has been temporarily totally disabled for more than six months. The emphasis within these guidelines is to move patients along a continuum of care and return to work within a six-month time frame, whenever possible. It is important to note that time frames may not be pertinent to injuries that do not involve work-time loss or are not occupationally related.

11. RETURN-TO-WORK: A return-to-work is therapeutic, assuming the work is not likely to aggravate the basic problem or increase long-term pain. The practitioner must provide specific physical limitations and the patient should never be released to non-specific and vague descriptions such as “sedentary” or “light duty.” The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, data entry and other repetitive motion tasks, sustained grip, tool usage and vibration factors. Even if there is residual chronic pain, return-to-work is not necessarily contraindicated.

The practitioner should understand all of the physical demands of the patient’s job position before returning the patient to full duty and should request clarification of the patient’s job duties. Clarification should be obtained from the employer or, if necessary, from including, but not limited to, an occupational health nurse, occupational therapist, vocational rehabilitation specialist, an industrial hygienist, or another professional.

12. DELAYED RECOVERY: Strongly consider a psychological evaluation, if not previously provided, as well as initiating interdisciplinary rehabilitation treatment and vocational goal setting, for those patients who are failing to make expected progress 6 to 12 weeks after an injury. The Division recognizes that 3 to 10% of all industrially injured patients will not recover within the timelines outlined in this document, despite optimal care. Such individuals may require treatments beyond the timelines discussed within this document, but such treatment requires clear documentation by the authorized treating practitioner focusing on objective functional gains afforded by further treatment and impact upon prognosis.

13. GUIDELINES RECOMMENDATIONS AND INCLUSION OF MEDICAL EVIDENCE: All recommendations are based on available evidence and/or consensus judgment.

When possible, guideline recommendations will note the level of evidence supporting the treatment recommendation. It is generally recognized that early reports of a positive treatment effect are frequently weakened or overturned by subsequent research. When interpreting medical evidence statements in the guideline, the following apply:

• Consensus means the judgment of experienced professionals based on general medical principles. Consensus recommendations are designated in the guidelines as “generally well-accepted,” “generally accepted,”

“acceptable/accepted,” or “well-established.”

• “Some evidence” means the recommendation considered at least one adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the strength of the medical evidence.

• “Good evidence” means the recommendation considered the availability of multiple adequate scientific studies or at least one relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the strength of the medical evidence.

• “Strong evidence” means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the strength of the medical evidence All recommendations in the guideline are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guideline as “not recommended.”

14. CARE BEYOND MAXIMUM MEDICAL IMPROVEMENT (MMI): MMI should be declared when a patient’s condition has plateaued to the point where the authorized treating physician no longer believes further medical intervention is likely to result in improved function. However, some patients may require treatment after MMI has been declared in order to maintain their functional state. The recommendations in this guideline are for pre-MMI care and are not intended to limit post-MMI treatment.

The remainder of this document should be interpreted within the parameters of these guidelines principles that may lead to more optimal medical and functional outcomes for injured workers.

C. INITIAL DIAGNOSTIC PROCEDURES

The Division recommends the following diagnostic procedures be considered, at least initially, the responsibility of the workers’ compensation carrier to ensure that an accurate diagnosis and treatment plan can be established. Standard procedures that should be utilized when initially diagnosing a work-related lower extremity complaint are listed below.

1. HISTORY-TAKING AND PHYSICAL EXAMINATION (HX & PE) are generally accepted, well-established and widely used procedures that establish the foundation/basis for and dictate subsequent stages of diagnostic and therapeutic procedures. When findings of clinical evaluations and other diagnostic procedures are not complementing each other, the objective clinical findings should have preference. The medical records should reasonably document the following:

a. History of Present Injury:

i. Mechanism of injury. This includes details of symptom onset and progression. It should include such details as: the activity at the time of the injury, patient description of the incident, and immediate and delayed symptoms. The history should elicit as much detail about these mechanisms as possible.

For acute injuries:

• Did the patient hear a pop at the time of the injury?

• Was he or she able to bear weight immediately following the injury?

• Could he or she straighten the knee and did it swell immediately?

ii. Functional Assessment: Functional ability should be assessed and documented at the beginning of treatment. Periodic assessment should be recorded throughout the course of care to follow the trajectory of recovery. In addition to being more relevant to recovery from lower extremity pain, functional measures are likely to be more reliable over time than pain measures.

Patient-reported outcomes, whether of pain or function, are susceptible to a phenomenon called response shift. This refers to changes in selfevaluation, which may accompany changes in health status. Patient selfreports may not coincide with objective measures of outcome, due to reconceptualization of the impact of pain on daily function and internal recalibration of pain scales. Response shift may obscure treatment effects in clinical trials and clinical practice, and may lead to apparent discrepancies in patient-reported outcomes following treatment interventions. While methods of measuring and accounting for response shift are not yet fully developed, understanding that the phenomenon exists can help clinicians understand what is happening when some measures of patient progress appear inconsistent with other measures of progress.

iii. Relationship to work. This includes a statement of the probability that the illness or injury is work-related.

iv. History of locking, clicking, popping, giving way, acute or chronic swelling, crepitation, pain while ascending or descending stairs (e.g. handrail used, ‘foot by foot’ instead of ‘foot over foot’) inability to weight bear due to pain, intolerance for standing or difficulty walking distances on varied surfaces, difficulty crouching or stooping, and wear patterns on footwear. Patients may also report instability or mechanical symptoms. A

history of grinding, locking of the knee, or instability are also useful diagnostic elements.

v. Any history of back and joint pain distal and proximal to the site of injury.

The use of a patient completed pain drawing, Visual Analog Scale (VAS), is highly recommended, especially during the first two weeks following injury to assure that all work related symptoms are addressed. Location of hip pain may be useful for identifying the diagnosis. Anterior hip and groin are more likely to reflect intra-articular pathology whereas posterior or lateral hip pain may be present without hip pathology.

vi. Ability to perform job duties and activities of daily living; and vii. Exacerbating and alleviating factors of the reported symptoms. The physician should explore and report on non-work related and work related activities.

viii. Prior occupational and non-occupational injuries to the same area, including specific prior diagnostic tests, treatment, and any prior bracing ix. Discussion of any symptoms present in the uninjured extremity.

x. Lower extremity injuries are frequently not isolated, but are accompanied by other injuries. In the setting of a traumatic brain injury (TBI), long bone fracture management must consider the effect of TBI on bone metabolism and may require more aggressive treatment. Refer to the Traumatic Brain Injury Medical Treatment Guidelines, Section H.5.

Musculoskeletal Complications.

xi. Manifestations of a possible joint infection may include complaints of joint warmth, swelling, fever, or chills.

b. Past History:

i. Past medical history includes neoplasm, gout, arthritis, previous musculoskeletal injuries, and diabetes;

ii. Review of systems includes symptoms of rheumatologic, neurological, endocrine, neoplastic, and other systemic diseases;

iii. History of smoking, alcohol use, and substance abuse;

iv. History of corticosteroid use; and v. Vocational and recreational pursuits.

c. Physical Examination: Examination of a joint should begin with examination of the uninjured limb and include assessment of the joint above and below the affected area of the injured limb. Physical examinations should include accepted tests as described in textbooks or other references and exam techniques applicable to the joint or region of the body being examined, including:

i. Visual inspection;

Swelling: may indicate joint effusion from trauma, infection or arthritis.

Swelling or bruising over ligaments or bones can indicate possible fractures or ligament damage The “sweep test” is useful for assessing the presence and degree of joint effusion in the knee. The examiner supports the medial tibiofemoral joint line, and strokes toward the suprapatellar bursa and then strokes downward toward lateral joint line. A positive test produces a bulge medially;

ii. Palpation: for joint line tenderness, effusion, and bone or ligament pain.

Palpation may be used to assess tissue tone and contour; myofascial trigger points; and may be graded for intensity of pain. Palpation may be further divided into static and motion palpation. Static palpation consists of feeling bony landmarks and soft tissue structures and consistency.

Motion palpation is commonly used to assess joint movement patterns and identify joint dysfunction;

iii. Assessment of activities of daily living including gait abnormalities, especially after ambulating a distance and difficulties ascending/descending stairs;

Assessment of activities such as the inability to crouch or stoop may give important indications of the patient’s pathology and restrictions;

iv. Range-of-motion/quality-of-motion; should be assessed actively and passively;

v. Strength;

vi. Limb length (bilaterally to assess for limb length discrepancy);

vii. Height, weight, body mass index (BMI);

viii. Joint stability;

The following describe specific anatomic area exams.

ix. Hip exam: In general, multiple tests are needed to reliably establish a clinical diagnosis. Spinal pathology and groin problems should always be considered and ruled out as a cause of pain for patients with hip symptomatology. Providers should be aware that patients with osteoarthritis may have positive pain complaints with various maneuvers based on their osteoarthritis rather than ligamentous or labral damage The following is a list of commonly performed tests;

A) Flexion-Abduction-External Rotation (FABER-aka Patrick’s) test is frequently used as a test for sacral pathology such as SI joint pain, but also may be positive with hip inflammation or pain;

B) Log roll test - may be used to assess iliofemoral joint laxity or intra-articular hip pain;

C) Ober’s is used to test the iliotibial band;

D) Greater trochanter bursitis or femoral-acetabular impingement, with or without labral tear may be aggravated by external rotation and adduction and resisted hip abduction or external rotation.

Greater trochanter bursitis also presents with pain with direct palpation over the greater trochanter.

E) Iliopectineal bursitis may be aggravated by stretching the tendon in hip extension;

F) Internal and external rotation is usually painful in osteoarthritis or femoroacetabular impingement, with or without a labral tear;

G) The maneuvers of flexion, adduction and internal rotation (FADIR- also known as anterior impingement sign) will generally reproduce pain in cases of labral tears, femoral acetabular impingement, and with piriformis strain/irritation.

H) Anterior acetabular labrum testing: With the patient in a supine position, the hip is flexed, externally rotated, and abducted. The hip is then extended, internally rotated, and adducted. Groin pain reproduction with or without an audible click suggests a possible anterior labral tear.

x. Knee exam: In general multiple tests are needed to reliably establish a clinical diagnosis. The expertise of the physician performing the exam influences the predictability of the exam findings. Providers should be aware that patients with osteoarthritis may have positive pain complaints with various maneuvers based on their osteoarthritis rather than ligamentous or meniscal damage. The following is a partial list of commonly performed tests:

A) Bilateral thigh circumference measurement: assesses for quadriceps wasting which may occur soon after a knee injury.

The circumferences of both thighs should be documented approximately 15 cm above a reference point, either the joint line or patella. It may be useful to assess multiple areas of atrophy and swelling: mid-calf; mid joint; suprapatella, 7 cm suprapatella and mid-thigh 15 cm.

B) Anterior Cruciate Ligament tests:

• Lachman’s test;

• Anterior drawer test;

• Lateral pivot shift test.

C) Meniscus tests: Joint line tenderness and effusions are common with acute meniscal tears. Degenerative meniscal tears are fairly common in older patients with degenerative changes and may be asymptomatic.

• McMurray test;

• Apley compression test;

• Medial lateral grind test;

• Weight-bearing tests - include Thessaly and Ege’s test.

D) Posterior Cruciate Ligament tests:

• Posterior drawer test;

• Extension lag may also be measured passively by documenting the heel height difference with the patient prone.

• Gravity or Posterior Sag Test (Godfrey): While supine, the patient’s involved lower extremity is positioned with the thigh vertical to the floor and the lower leg perpendicular to the thigh. With the heel supported and the patient relaxed,.any posterior subluxation of the tibia on the femur is observed (movement caused by gravity).

E) Collateral Ligament tests:

• Medial stress test – Usually performed at 0 and 30 degrees flexion. A positive test in full extension may include both medial collateral ligament and cruciate ligament pathology;

• Lateral stress test-Usually performed at 0 and 30 degrees flexion. A positive test in full extension may include both lateral collateral ligament and cruciate ligament pathology F) Patellar Instability tests:

• Apprehension test;

• J sign;

• Q angle.

G) Dial Test: May indicate a posterolateral corner injury. External rotation is compared at 30 and 90 degrees. The test is positive if it is greater on the injured side.

H) The “sweep test” is useful for assessing the presence and degree of joint effusion in the knee. The examiner supports the medial tibiofemoral joint line, and strokes toward the suprapatellar bursa and then strokes downward toward lateral joint line. A positive test produces a bulge medially.

xi. Foot and ankle exam: Providers should be aware that patients with osteoarthritis may have positive pain complaints with various maneuvers based on their osteoarthritis rather than ligamentous or cartilage damage.

In general, multiple tests are needed to reliably establish a clinical diagnosis. The expertise of the physician performing the exam influences the predictability of the exam findings. Lateral ankle assessments may include anterior drawer exam, talar tilt test. Syndesmotic exam may include external rotation stress test, cross leg stress test and the tibiafibula squeeze test. Achilles tendon may be assessed with the Thompson's test. Foot examinations may include assessment of or for: subtalar, midtarsal, and metatarsal-phalangeal joints; and tarsal tunnel.

Tendon assessments may include single to raise test for posterior tibial tendon pathology, as well as dorsiflexion eversion stress exam to assess for peroneal pathology and subluxation. Mulders test and side-to-side compression exam may be used to assess Morton's neuroma. The piano key push up test and Abduction Stress test may be utilized to assess Lisfranc injury.

xii. If applicable, full neurological exam including muscle atrophy and gait abnormality.

xiii. If applicable to injury, integrity of distal circulation, sensory, and motor 2. RADIOGRAPHIC IMAGING of the lower extremities is a generally accepted, wellestablished and widely used diagnostic procedure when specific indications based on

history and/or physical examination are present. It should not be routinely performed. The mechanism of injury and specific indications for the radiograph should be listed on the request form to aid the radiologist and x-ray technician. For additional specific clinical indications, see Section E. Specific Lower Extremity Injury Diagnosis, Testing and Treatment. Indications for initial imaging may include any of the following:

a. The inability to flex knee to 90 degrees or to transfer weight for four steps at the time of the immediate injury and at the initial visit, regardless of limping;

b. Bony tenderness on any of the following areas: over the head of the fibula; isolated to the patella; of the lateral or medial malleolus from the tip to the distal 6 cm; at the base of the 5th metatarsal; or at the navicular;

c. History of significant trauma, especially blunt trauma or fall from a height;

d. Age over 55 years;

e. History or exam suggestive of intravenous drug abuse or osteomyelitis;

f. Pain with swelling and/or range of motion (ROM) limitation localizing to an area of prior fracture, internal fixation, or joint prosthesis; or g. Unexplained or persistent lower extremity pain over two weeks.

Occult fractures, especially stress fractures, may not be visible on initial x-ray. A follow-up radiograph, MRI and/or bone scan may be required to make the diagnosis.

Weight-bearing radiographs are used to assess osteoarthritis and alignment prior to some surgical procedures.

3. LABORATORY TESTING Laboratory tests are generally accepted, well-established and widely used procedures. They are, however, rarely indicated at the time of initial evaluation unless there is suspicion of systemic illness, infection, neoplasia, connective tissue disorder, or underlying arthritis or rheumatologic disorder based on history and/or physical examination. Laboratory tests can provide useful diagnostic information. The Division recommends that lab diagnostic procedures be initially considered the responsibility of the workers' compensation carrier to ensure that an accurate diagnosis and treatment plan can be established.

Tests include, but are not limited to:

a. Complete blood count (CBC) with differential can detect infection, blood dyscrasias, and medication side effects;

b. Erythrocyte sedimentation rate, rheumatoid factor, antinuclear antigen (ANA), human leukocyte antigen (HLA), and C-reactive protein (CRP) can be used to detect evidence of a rheumatologic infection or connective tissue disorder;

c. Serum calcium, phosphorous, uric acid, alkaline phosphatase, and acid phosphatase can detect metabolic bone disease;

d. Liver and kidney function may be evaluated for prolonged anti-inflammatory use or other medications requiring monitoring; and e. Analysis of joint aspiration for bacteria, white cell count, red cell count, fat globules, crystalline birefringence and chemistry to evaluate joint effusion.

4. OTHER PROCEDURES

a. Joint Aspiration: is a generally accepted, well-established and widely used procedure when specifically indicated and performed by individuals properly trained in these techniques. This is true at the initial evaluation when history and/or physical examination are of concern for a septic joint or bursitis and for some acute injuries. Not all knee effusions require aspirations. Particularly at the knee, aspiration of a large effusion can help to decrease pain and speed functional recovery. Persistent or unexplained effusions may be examined for evidence of infection, rheumatologic, or inflammatory processes. The presence of fat globules in the effusion strongly suggests occult fracture.

Risk factors for septic arthritis include joint surgery, knee arthritis, joint replacement, skin infection, diabetes, age greater than 80, immunocompromised states, and rheumatoid arthritis. More than 50% of patients with septic joints have a fever greater than 37.5 degrees centigrade and joint swelling. Synovial white counts of greater than 25,000 and polymorphonuclear cells of at least 90% increase the likelihood of a septic joint.

D. FOLLOW-UP DIAGNOSTIC IMAGING AND TESTING PROCEDURES

One diagnostic imaging procedure may provide the same or distinctive information as other procedures. Therefore, a prudent choice of a single diagnostic procedure, a complementary procedure in combination with other procedures(s), or a proper sequential order of multiple procedures will maximize diagnostic accuracy, minimize adverse effect to patients, and ensure cost effectiveness.

All diagnostic imaging procedures have a significant percentage of specificity and sensitivity for various diagnoses. None is specifically characteristic of a certain diagnosis. Clinical information obtained by history taking and physical examination should be the basis for selection and interpretation of imaging procedure results.

Practitioners should be aware of the radiation doses associated with various procedures and provide appropriate warnings to patients. Coloradans have a background exposure to radiation, and unnecessary CT scans or X-rays increase the lifetime risk of cancer death.

When a diagnostic procedure, in conjunction with clinical information, provides sufficient information to establish an accurate diagnosis, the second diagnostic procedure will become redundant. At the same time, a subsequent diagnostic procedure can be complementary if the first or preceding procedures, in conjunction with clinical information, cannot provide an accurate diagnosis. Usually, preference of any procedure over others depends upon availability, a patient’s tolerance, and/or the treating practitioner’s familiarity with the procedure.

1. IMAGING STUDIES When indicated, the following additional imaging studies can be utilized for further evaluation of the lower extremity, based upon the mechanism of injury, symptoms, and patient history. For specific clinical indications, see Section E. Specific Lower Extremity Injury Diagnosis, Testing, and Treatment. The studies below are listed in frequency of use, not importance.

a. Magnetic Resonance Imaging (MRI): is a generally accepted, well-established, and widely used diagnostic procedure. It provides a more definitive visualization of soft tissue structures, including ligaments, tendons, joint capsule, menisci and joint cartilage structures, than x-ray or Computed Axial Tomography. It is also more helpful in the evaluation of traumatic or degenerative injuries. The addition of intravenous or intra-articular contrast can enhance the definition of selected pathologies.

The high field, closed MRI provides a better resolution. A lower field scan may be indicated when a patient cannot fit into a high field scanner or is too claustrophobic despite sedation. Inadequate resolution on the first scan may require a second MRI using a different technique or with a reading by a musculoskeletal radiologist. All questions in this regard should be discussed with the MRI center and/or radiologist.

MRIs have high sensitivity and specificity for meniscal tears and ligamentous injuries. However, when physical exam findings and functional deficits indicate the need for surgery, an MRI may not be necessary. MRI is less accurate for articular cartilage defects (sensitivity 76%) than for meniscal and ligamentous injury (sensitivity greater than 90%).

MRIs have not been shown to be reliable for diagnosing symptomatic hip bursitis.

b. MR Arthrography (MRA): This accepted investigation uses the paramagnetic properties of gadolinium to shorten T1 relaxation times and provide a more intense MRI signal. It should be used to diagnose hip labral tears. Pelvic MRIs are not sufficient for this purpose. Arthrograms are also useful to evaluate mechanical pathology in knees with prior injuries and/or surgery.

c. Computed Axial Tomography (CT): is generally accepted and provides excellent visualization of bone. It is used to further evaluate bony masses and suspected fractures not clearly identified on a radiographic window evaluation.

CT is also used for surgical management. For example, CT is also used for preoperative planning in cases of hip fractures; femoroacetabular impingement (FAI). Instrument scatter-reduction software provides better resolution when metallic artifact is of concern.

d. Diagnostic Sonography: is an accepted diagnostic procedure. The performance of sonography is operator-dependent, and is best done by a specialist in musculoskeletal radiology. It may also be useful for postoperative pain after total knee arthroplasty (TKA), and for dynamic testing especially of the foot or ankle.

e. Lineal Tomography: is infrequently used, yet may be helpful in the evaluation of joint surfaces and bone healing.

f. Bone Scan (Radioisotope Bone Scanning): is generally accepted, wellestablished and widely used. 99MTechnecium diphosphonate uptake reflects osteoblastic activity and may be useful in metastatic/primary bone tumors, stress fractures, osteomyelitis, and inflammatory lesions, but cannot distinguish between these entities.

Bone scanning is more sensitive but less specific than MRI. It is useful for the investigation of trauma, infection, stress fracture, occult fracture, Charcot joint, Complex Regional Pain Syndrome and suspected neoplastic conditions of the lower extremity.

g. Other Radionuclide Scanning: Indium and gallium scans are generally accepted, well-established, and widely used procedures usually to help diagnose lesions seen on other diagnostic imaging studies. 67Gallium citrate scans are used to localize tumor, infection, and abscesses. 111Indium-labeled leukocyte scanning is utilized for localization of infection or inflammation.

h. Arthrogram: is an accepted diagnostic procedure. It may be useful in the evaluation of internal derangement of a joint, including when MRI or other tests are contraindicated or not available. Potential complications of this more invasive technique include pain, infection, and allergic reaction. Arthrography gains additional sensitivity when combined with CT in the evaluation of internal derangement, loose bodies, and articular cartilage surface lesions. Diagnostic arthroscopy should be considered before arthrogram when there are strong clinical indications.

2. OTHER DIAGNOSTIC TESTS The following diagnostic procedures listed in this subsection are listed in alphabetical order.

a. Compartment Pressure Testing and Measurement Devices: such as pressure manometer, are useful in the evaluation of patients who present symptoms consistent with a compartment syndrome.

b. Doppler Ultrasonography/Plethysmography: is useful in establishing the diagnosis of arterial and venous disease in the lower extremity and should usually be considered prior to the more invasive venogram or arteriogram study.

Doppler is less sensitive in detecting deep vein thrombosis in the calf muscle area. If the test is initially negative; a D-dimer, fibrin degradation product, test is positive; and symptoms continue, an ultrasound should usually be repeated 7 days later to rule out popliteal thrombosis. It is also useful for the diagnosis of popliteal mass when MRI is not available or is contraindicated.

c. Electrodiagnostic Testing: Electrodiagnostic tests include, but are not limited to Electromyography (EMG), Nerve Conduction Studies (NCS) and Somatosensory Evoked Potentials (SSEP). These are generally accepted, well-established and widely used diagnostic procedures. The SSEP study, although generally accepted, has limited use. Electrodiagnostic studies may be useful in the evaluation of patients with suspected involvement of the neuromuscular system, including disorder of the anterior horn cell, radiculopathies, peripheral nerve entrapments, peripheral neuropathies, neuromuscular junction and primary muscle disease.

In general, these diagnostic procedures are complementary to imaging procedures such as CT, MRI, and/or myelography or diagnostic injection procedures. Electrodiagnostic studies may provide useful, correlative neuropathophysiological information that would be otherwise unobtainable from standard radiologic studies.

d. Personality/Psychological/Psychosocial Evaluations: are generally accepted and well-established diagnostic procedures with selective use in the acute lower extremity population. These evaluations have more widespread use in sub-acute and chronic lower extremity populations.

Diagnostic testing procedures may be useful for patients with symptoms of depression, delayed recovery, chronic pain, recurrent painful conditions, disability problems. These evaluations may also be used pre-operatively and have a possible predictive value for postoperative response. Psychological testing should provide differentiation between pre-existing depression versus injurycaused depression, as well as post-traumatic stress disorder.

Formal psychological or psychosocial evaluation should be performed on patients not making expected progress within 6 to 12 weeks following injury and whose subjective symptoms do not correlate with objective signs and tests. In addition to the customary initial exam, the evaluation of the injured worker should specifically address the following areas:

i. Employment history;

ii. Interpersonal relationships — both social and work;

iii. Leisure activities;

iv. Current perception of the medical system;

v. Results of current treatment;

vi. Perceived locus of control;

vii. History of smoking, alcohol use, and substance abuse; and viii. Childhood history, including abuse and family history of disability.

This information should provide clinicians with a better understanding of the patient, thus allowing for more effective rehabilitation.

The evaluation will determine the need for further psychosocial interventions, and in those cases, a Diagnostic Statistical Manual (DSM) of Mental Disorders diagnosis should be determined and documented. An individual with a PhD, PsyD, or Psychiatric MD/DO credentials who is familiar with work injury care should perform initial evaluations, which are generally completed within one to two hours. When issues of chronic pain are identified, the evaluation should be more extensive and follow testing procedures as outlined in the Division’s Chronic Pain Disorder Medical Treatment Guidelines. The evaluator should be aware that workers compensation insurers are not covered under HIPAA therefore, some information may need to be redacted when reports are forwarded.

• Frequency: One time visit for evaluation. If psychometric testing is indicated as a portion of the initial evaluation, time for such testing should not exceed an additional two hours of professional time.

e. Venogram/Arteriogram: is useful for investigation of vascular injuries or disease, including deep venous thrombosis. Potential complications may include pain, allergic reaction, and deep vein thrombosis.

3. SPECIAL TESTS are generally well-accepted and are performed as part of a skilled assessment of the patient's capacity to return-to-work, his/her strength capacities, and physical work demand classifications and tolerances. The procedures in this subsection are listed in alphabetical order.

a. Computer-Enhanced Evaluations: These may include isotonic, isometric, isokinetic and/or isoinertial measurements of movement; ROM; endurance; or strength. Values obtained can include degrees of motion, torque forces, pressures, or resistance. Indications include determining validity of effort, effectiveness of treatment, and demonstrated motivation. These evaluations should not be used alone to determine return-to-work restrictions.

• Frequency: One time for evaluation, one for mid-treatment assessment, and one at final evaluation.

b. Functional Capacity Evaluation (FCE): This is a comprehensive or modified evaluation of the various aspects of function as they relate to the worker’s ability to return to work. Areas such as endurance, lifting (dynamic and static), postural tolerance, specific ROM, coordination and strength, worker habits, employability, as well as psychosocial aspects of competitive employment may be evaluated.

Reliability of patient reports and overall effort during testing is also reported.

Components of this evaluation may include: (a) musculoskeletal screen; (b) cardiovascular profile/aerobic capacity; (c) coordination; (d) lift/carrying analysis;

(e) job-specific activity tolerance; (f) maximum voluntary effort; (g) pain assessment/psychological screening; and (h) non-material and material handling activities. Standardized national guidelines (such as National Institute for Occupational Safety and Health (NIOSH) should be used as the basis for FCE There is some evidence that an FCE fails to predict which injured workers with chronic low back pain will have sustained return to work. Another cohort study concluded that there was a significant relation between FCE information and return to work, but the predictive efficiency was poor. There is some evidence that time off work and gender are important predictors for return to work, and floor-to-waist lifting may also help predict return to work, however, the strength of that relationship has not been determined.

A full review of the literature reveals no evidence to support the use of FCEs to prevent future injuries. There is some evidence in chronic low back pain patients that (1) FCE task performance is weakly related to time on disability and time for claim closure and (2) even claimants who fail on numerous physical performance FCE tasks may be able to return to work. These same issues may exist for lower extremity issues.

Full FCEs are rarely necessary. In many cases, a work tolerance screening or return to work performance will identify the ability to perform the necessary job tasks. There is some evidence that a short form FCE reduced to a few tests produces a similar predictive quality compared to the longer 2-day version of the FCE regarding length of disability and recurrence of a claim after return to work.

When an FCE is being used to determine return to a specific jobsite, the provider is responsible for fully understanding the physical demands and the duties of the job the worker is attempting to perform. A jobsite evaluation is usually necessary.

A job description should be reviewed by the provider and FCE evaluator prior to this evaluation. FCEs cannot be used in isolation to determine work restrictions.

It is expected that the FCE may differ from both self-report of abilities and pure clinical exam findings in chronic pain patients. The length of a return to work evaluation should be based on the judgment of the referring physician and the provider performing the evaluation. Since return to work is a complicated multidimensional issue, multiple factors beyond functional ability and work demands should be considered and measured when attempting determination of readiness or fitness to return to work. FCEs should not be used as the sole criteria to diagnose malingering.

• Frequency: Can be used: (1) initially to determine baseline status; and (2) for case closure when patient is unable to return to the pre-injury position and further information is desired to determine permanent work restrictions. Prior authorization is required for FCEs performed during treatment.

c. Jobsite Evaluation: is a comprehensive analysis of the physical, mental and sensory components of a specific job. These components may include, but are not limited to: (a) postural tolerance (static and dynamic); (b) aerobic requirements; (c) range of motion; (d) torque/force; (e) lifting/carrying; (f) cognitive demands; (g) social interactions; (h) visual/perceptual; (i) sensation; (j) coordination; (k) environmental requirements of a job; (l) repetitiveness; and (m) essential job functions, including job licensing requirements. Job descriptions provided by the employer are helpful but should not be used as a substitute for direct observation.

A jobsite evaluation may include observation and instruction of how work is done, what material changes (desk, chair) should be made, and determination of readiness to return to work.

Requests for a jobsite evaluation should describe the expected goals for the evaluation. Goals may include, but are not limited to the following:

i. To determine if there are potential contributing factors to the person’s condition and/or for the physician to assess causality;

ii. To make recommendations for, and to assess the potential for ergonomic changes;

iii. To provide a detailed description of the physical and cognitive job requirements;

iv. To assist the patients in their return to work by educating them on how they may be able to do their job more safely in a bio-mechanically appropriate manner; and/or v. To give detailed work/activity restrictions. ● Frequency: One time with additional visits as needed for followup visits per jobsite.

d. Vocational Assessment: Once an authorized practitioner has reasonably determined and objectively documented that a patient will not be able to return to her/her former employment and can reasonably prognosticate final restrictions, implementation of a timely vocational assessment can be performed. The vocational assessment should provide valuable guidance in the determination of future rehabilitation program goals. It should clarify rehabilitation goals, which optimize both patient motivation and utilization of rehabilitation resources. The effectiveness of vocational rehabilitation may be enhanced when performed in combination with work hardening or work conditioning. If prognosis for return to former occupation is determined to be poor, except in the most extenuating circumstances, vocational assessment should be implemented within 3 to 12 months post-injury. Declaration of Maximum Medical Improvement should not be delayed solely due to lack of attainment of a vocational assessment.

• Frequency: One time with additional visits as needed for follow-up.

e. Work Tolerance Screening (Fitness for Duty): is a determination of an individual's tolerance for performing a specific job based on a job activity or task.

It may include a test or procedure to specifically identify and quantify workrelevant cardiovascular, physical fitness and postural tolerance. It may also address ergonomic issues affecting the patient’s return-to-work potential. May be used when a full FCE is not indicated.

• Frequency: One time for initial screen. May monitor improvements in strength every 3 to 4 weeks up to a total of 6 visits.

E. SPECIFIC LOWER EXTREMITY INJURY DIAGNOSIS, TESTING, AND TREATMENT

1. FOOT AND ANKLE

a. Achilles Tendinopathy/or Injury and Rupture:

i. Description/Definition: Rupture (aka complete tear) or incomplete tear of Achilles tendon. This section also includes insertional or non-insertional tendinopathy.

ii. Occupational Relationship: Incomplete tears or ruptures are related to a fall, twisting, jumping, or sudden load on ankle with dorsiflexion.

Tendinopathy may be exacerbated by continually walking on hard surfaces or repetitive motions such as jumping in and out of a vehicle or climbing up and down ladders.

iii. Specific Physical Exam Findings: Swelling and pain at tendon, sometimes accompanied by crepitus and pain with passive motion.

Achilles tendinopathy can be palpated with a bulbous indurated tendon which is painful on side to side compression.

Rupture or partial tear may present with palpable deficit in tendon. If there is a full tear, Thompson test will usually be positive. A positive Thompson's test is lack of plantar flexion with compression of the calf when the patient is prone with the knee flexed.

iv. Diagnostic Testing Procedures: MRI or ultrasound may be performed if surgery is being considered for tears. However, imaging may delay timely surgical care and some information indicates that a clinical examination by a specialist may be sufficient for appropriate diagnosis in the absence of imaging. Ultrasound may be more cost-effective than MRI in some instances, but the choice of the appropriate exam must be made by the treating provider taking into account the patient’s clinical presentation. In the case of complete Achilles tendon ruptures, there may not be a need for imaging, at the discretion of the specialist.

For tendinopathy, radiography may be performed to identify Haglund’s deformity; however, many Haglund’s deformities are asymptomatic.

v. Non-operative Treatment Procedures:

A) Initial Treatment for incomplete tears of the Achilles tendon: casting in non-weight-bearing is the treatment of choice.

B) Initial Treatment for complete tears (rupture) of Achilles tendon: this may be treated by surgical or non-surgical means.

1. Specialist Evaluation: It is important that individuals with complete Achilles tendon ruptures be evaluated by a specialist within 48 hours if conservative management is being considered. In those individuals, placement of a splint in plantar flexion should be considered until evaluation by a specialist to prevent solidification of the hematoma that may prevent opposition of the ruptured tendon.

2. There is some evidence that, for non-operatively treated complete Achilles tendon ruptures, immediate weight bearing with a flexible orthosis presents no disadvantages for return to function in comparison to delayed weight-bearing in a plaster cast. Additionally, there is some evidence that in the setting of acute Achilles tendon rupture which is treated non-operatively with an orthotic, weight-bearing on the first day leads to outcomes equally favorable to those of delaying weightbearing for six weeks after injury. However, this study indicates that the orthotic should provide equinus position of the foot and crutches should be available to the patient during the early phase of healing.

3. In the setting of non-operative treatment of a complete Achilles tendon rupture, the efficacy of different immediate weight-bearing rehabilitation protocols remains unclear. However, weight-bearing in the first week is safe and appropriate.

4. Individuals undergoing conservative management for an Achilles tendon rupture will likely require much more imaging, typically dynamic ultrasounds, in order to ensure appropriate healing. The frequency of the ultrasounds is at the discretion of the specialist based upon the individual patient’s clinical presentation.

C) Non-Operative Treatment for Achilles tendinopathy 1) Benefits for Achilles tendinopathy may be achieved through therapeutic rehabilitation and rehabilitation interventions. Eccentric training alone or with specific bracing may be used for tendinopathy. Manual therapy may also be used. Therapy will usually include range-ofmotion (ROM), active therapies, and a home exercise program. Active therapies include proprioception training, restoring normal joint mechanics, and clearing dysfunctions from adjacent structures. Passive as well as active therapies may be used to control pain and swelling.

2. There is no evidence to support the use of injection therapies, including steroids, for treating Achilles tendinopathy. Steroid injections should generally be avoided in these patients since they present a risk for later rupture. Therefore, steroid injections are not recommended for any pathology of the Achilles tendon.

3. There is insufficient evidence for or against the use of Platelet Rich Plasma (PRP) in the setting of Achilles tendinopathy. Another systematic review provided insufficient evidence to recommend for or against PRP injections for non-insertional Achilles tendinopathy.

Therefore, PRP is not generally recommended, but may be considered in unusual circumstances for cases which have not responded to appropriate conservative measures in order to forestall an invasive procedure with risk of significant complications. If PRP is found to be indicated in these select patients, the first injection may be repeated once after 4 weeks when significant functional benefit, such as increased walking tolerance, is reported but the patient has not returned to full For more information, please refer to Section F.6.d.

Platelet Rich Plasma.

4. Additionally, there is insufficient evidence to recommend for or against autologous blood injections, sclerosing agent injections, protease inhibitor injections, deproteinized hemodialysate injections, or prolotherapy for non-insertional Achilles tendinopathy. Therefore, these injections are not recommended for Achilles tendinopathy.

5. Animal studies have indicated that low level laser may reduce inflammatory factors, moderate growth factors and myogenic regulatory factors, and increase angiogenesis. Results of studies on humans have varied due to the strength of the study and also the type and strength of the laser. There is no evidence that low level laser treatment is effective in the treatment of Achilles tendinopathy. Studies show that low level laser is largely absorbed within the first 1 mm of skin, thus meaningful therapy is extremely unlikely physiologically. Therefore, it is not recommended.

6. An adequate systematic review failed to provide evidence that extracorporeal shockwave therapy (ESWT) is superior to sham ESWT for Achilles tendinopathy. This review examined the only two studies in the past 10 years that had adequate blinding of participants. However, a clinically important effect has not been ruled out and future research may change the unbiased estimate of the effect of ESWT. Additionally, there is some evidence that, in generally healthy patients with non-calcific insertional Achilles tendinopathy who have failed 6 months of prior treatment, three sessions of a moderate dose (flux density of 0.12 mJ/mm2) are likely to be more successful than a 12 week program of eccentric loading exercise. As such, providers may consider adding ESWT to their treatment options for insertional Achilles tendinopathy that has failed 6 months of conservative management or those for whom the next level of guideline-consistent therapy would involve an invasive procedure with risk of significant complications.

D) General non-operative treatment for Achilles tendon pathology 1) Patient education should include instruction in selfmanagement techniques, ergonomics, body mechanics, home exercise, joint protection, and weight 2) Medications such as analgesics and anti-inflammatories may be helpful. Refer to medication discussions in

Section F.7. Medications and Medical Management.

3. Therapy should progress to strengthening and an independent home exercise program targeted to further improve ROM, strength, and normal joint mechanics influenced by distal and proximal structures. Refer to

Section F. Therapeutic Procedures, Non-operative 4) Passive modalities are most effective as adjunctive treatments to improve the results of active treatment.

They may be used as found in Section F. Therapeutic 5) Return to work with appropriate restrictions should be considered early in the course of treatment. A job site evaluation may be appropriate to identify aggravating factors and to provide suggestions for work task modifications. Refer to Section F.13. Return to Work.

6. Other therapies in Section F. Therapeutic Procedures, Non-operative may be employed in individual cases.

vi. Surgical Indications/Considerations: Rupture (aka complete tear) or incomplete tear of Achilles tendon.

There have been recent studies suggesting that the effectiveness of nonoperative treatment of complete Achilles tendon ruptures may be comparable to operative treatment. This has led some surgeons to offer non-operative treatment to patients who meet certain clinical criteria.

This is consistent with the recent clinical practice guideline released by the AAOS indicating that non-operative treatment is an option for all patients with acute Achilles tendon rupture. However, there is good evidence from an adequate meta-analysis that operative repair of a complete Achilles tendon rupture does lower the re-rupture rate when compared to non-operative immobilization, but increases the rate of other complications including deep tissue infection. While the difference in re-rupture rates between surgically and conservatively treated Achilles tendon ruptures was recently contradicted in a meta-analysis, this is inadequate for evidence due to the use of an inappropriate statistical model. When the same data is examined appropriately, there is clearly a significant protective effect against re-rupture with surgical management.

However, the need for surgery will depend on the individual case based upon individual functional goals. Consideration of conservative management is especially important for individuals who may be at risk of complications from surgery, such as smokers or diabetics.

vii. Operative Procedures: Repair of tendons open or percutaneously with or without anchors may be required. Tendon grafts are used for chronic cases or primary surgery failures when tendon tissue is poor.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include the following: restricted weight-bearing, bracing, active therapy with or without passive therapy. There is some evidence that in patients undergoing surgical repair of a ruptured Achilles tendon, a rehabilitation program involving immediate weight bearing with a flexible orthosis is more effective in returning patients to normal function than a program involving immobilization in a plaster cast.

C) Range of motion may begin at 3 weeks depending on wound healing. Therapy and some restrictions will usually continue for 6 to 8 weeks.

D) Return to work and restrictions after surgery may be made by an b. Aggravated Osteoarthritis:

i. Description/Definition: Internal joint pathology of ankle.

ii. Occupational Relationship: The provider must establish the occupational relationship by establishing a change in the patient’s baseline condition and a relationship to work activities, for example frequent jumping, climbing, or squatting.

Other causative factors to consider: Prior significant injury to the ankle may predispose the joint to osteoarthritis. In order to entertain previous trauma as a cause, the patient should have a medically documented injury with radiographs or MRI showing the level of anatomic change.

The prior injury should have been at least 2 years from the presentation for the new complaints and there should be a significant increase of pathology on the affected side in comparison to the original imaging or operative reports and/or the opposite un-injured extremity.

iii. Specific Physical Exam Findings: Pain within joint, swelling. Crepitus, locking of the joint, reduced range of motion, pain with stress tests, angular deformities.

iv. Diagnostic Testing Procedures: X-ray – mechanical axis views, CT, MRI, diagnostic injection.

v. Non-operative Treatment Procedures:

A) Initial Treatment: May include orthoses, custom shoes with rocker bottom shoe inserts, and braces. Cane may also be useful. AFO (ankle foot orthosis) braces may also provide some benefit in end stage ankle osteoarthritis.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and E) Steroid injections may decrease inflammation and allow the motion. Steroid injections under significant pressure should be avoided as the needle may be penetrating the tendon and injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture. Injections should be minimized for patients under 30 years of age. Caution should be used when considering steroid injections for patients with an A1c level of 8% or greater.

• Time to Produce Effect: One injection.

• Maximum Duration: 3 injections in one year spaced at least F) A recent meta-analysis has garnered a large amount of support for use of hyaluronic acid injections in the ankle. However, a major statistical error in the findings has been overlooked by many reviewers. The study, when examined appropriately, does not reveal a statistically significant difference between hyaluronic acid and saline. Thus, there is inadequate evidence that HA is more effective than saline for treatment of ankle osteoarthritis.

Another study revealed insufficient evidence as to the efficacy of hyaluronic acid for ankle osteoarthritis. Hyaluronic acid injections are, therefore, not recommended for ankle osteoarthritis due to the small effect size documented in knee conditions and the lack of evidence supporting its use in the ankle.

G) Return to work with appropriate restrictions should be considered H) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations:

A) The patient is a good surgical candidate and pain continues to interfere with ADLs after non-surgical interventions including weight control, therapy with active patient participation, and medication.

B) Refer to Section G. for specific indications for osteotomy, ankle fusion or arthroplasty.

C) Implants are less successful than similar procedures in the knee or hip. While the volume of total ankle arthroplasty procedures is increasing, there are no high quality clinical trials comparing arthrodesis to ankle replacement. Patients with ankle fusions generally have good return to function and fewer complications than those with joint replacements. Salvage procedures for ankle replacement include revision with stemmed implant or allograft fusion. There is some retrospective information indicating that the intermediate-term clinical outcomes of total ankle replacement and ankle arthrodesis may be comparable.

However, the rates of reoperation and major complications were more than two times higher after ankle replacement. Given these factors, an ankle arthroplasty requires prior authorization and a second opinion by a surgeon specializing in lower extremity D) There is some concern that ankle arthrodesis may affect the development of adjacent-joint arthritis. However, a recent systematic review found no consensus in the literature as to the effects of ankle arthrodesis on biomechanics or whether ankle arthrodesis leads to adjacent-joint arthritis.

E) Diabetes clearly effects outcomes and the incidence of F) Prior to surgical intervention, the patient and treating physician G) In cases where surgery is contraindicated due to obesity, it may patient is unsuccessful losing weight on their own. Coverage for weight loss would continue only for motivated patients who have demonstrated continual progress with weight loss.

H) Because smokers have a higher risk of nonunion and postoperative costs, it is recommended that carriers cover a smoking cessation program peri-operatively. Typically the patient should show some progress toward cessation at about six weeks. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels for long-term cessation.

Patients with demonstrated success may continue the program up to 3 months or longer if needed based on the operative vii. Operative Procedures: Arthroscopy, ankle arthroplasty or fusion with appropriate ancillary procedures as necessary.

Ankle distraction arthroplasty requires an external fixator for 3 months and therefore a significant patient commitment. Arthroscopic debridement is usually performed at the same time as the procedure.

There is some information that ankle distraction arthroplasty may be useful as an alternative to arthrodesis and joint replacement for the treatment of post traumatic ankle osteoarthritis in younger populations.

This is because the procedure preserves the joint for more invasive later procedures. However, due to the limited amount of prospective literature addressing efficacy and long-term clinical results, there is insufficient information to recommend for or against the procedure. There is some information that ankle distraction arthroplasty may result in a decline in ankle function over time. There is some evidence that, when an external distractor is used to treat ankle osteoarthritis in patients under 60, a hinged device which allows for ankle flexion and extension is preferred over a fixed distractor which allows for no ankle motion. Given these factors, ankle distraction arthroplasty requires prior authorization and a second opinion by a surgeon specializing in lower extremity surgery.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) In all cases, communication between the physician and therapist is important to the timing of weight-bearing and exercise progressions.

C) Treatment may include the following: restricted weight-bearing, bracing, gait training and other active therapy with or without passive therapy.

D) Refer to Section G. for Ankle Fusion, Osteotomy, or Arthroplasty for further specific information.

E) Return to work and restrictions after surgery may be made by an c. Ankle or Subtalar Joint Dislocation:

i. Description/Definition: Dislocation of ankle or subtalar joint.

ii. Occupational Relationship: Usually occurs with falling or twisting.

iii. Specific Physical Exam Findings: Disruption of articular arrangements of ankle, subtalar joint may be tested using ligamentous laxity tests.

iv. Diagnostic Testing Procedures: Radiographs, CT scans. MRI may be used to assess for avascular necrosis of the talus which may occur secondary to a dislocation.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Closed reduction under anesthesia with preand post-reduction neurovascular assessment followed by casting and weight-bearing limitations.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and rehabilitation interventions. They should include range of motion E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Inability to reduce closed fracture, association with unstable fractures.

vii. Operative Procedures: Open or closed reduction of dislocation.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment usually includes initial immobilization with restricted weight-bearing, followed by bracing and active therapy with or without passive therapy.

C) Return to work and restrictions after surgery may be made by an d. Ankle Sprain/Fracture:

i. Description/Definition: An injury to the ankle joint due to abnormal motion of the talus that causes a stress on the malleolus and the ligaments.

Injured ligaments in order of disruption include the anterior talofibular ligament (ATFL), calcaneofibular ligament (CFL), posterior talofibular ligament (PTFL), deltoid ligaments, and syndesmotic ligaments.

Instability can result from a fracture of a malleolus (malleolli), rupture of ligaments, or a combination thereof. Circumstances surrounding the injury, including consideration of location and additional injuries are important. Additionally, the position of the foot at the time of injury is helpful in determining the extent and type of injury. Grading of soft tissue injuries includes:

A) Grade 1 Injury: those with overstretching or microscopic tears of the ligament, minimal swelling, normal stress testing, and the ability to bear weight.

B) Grade 2 Injury: have partial disruption of the ligament, significant swelling, indeterminate results on stress testing, and difficulty bearing weight.

C) Grade 3 Injury: have a ruptured ligament, swelling and ecchymosis, abnormal results on stress testing, and the inability to bear weight. May also include a chip avulsion fracture on xray.

ii. Occupational Relationship: sudden twisting, direct blunt trauma and falls.

Inversion of the ankle with a plantar-flexed foot is the most common mechanism of injury.

iii. Specific Physical Exam Findings: varies with individual. With lower grade sprains the ankle may appear normal, with minimal tenderness on examination. The ability/inability to bear weight, pain, swelling, or ecchymosis should be noted. If the patient is able to transfer weight from one foot onto the affected foot and has normal physical findings, then likelihood of fracture is reduced. Stress testing using the anterior drawer stress test, the talar tilt test and the external rotation stress test may be normal or abnormal depending on the involved ligament.

Syndesmotic injury can occur with external rotation injuries and requires additional treatment. Specific physical exam tests include the squeeze test and external rotation at neutral.

iv. Diagnostic Testing Procedures: Radiographs. Refer to Initial Diagnostic

Section which generally follows the Ottawa Ankle Rules. The Ottawa Ankle Rules are a decision aid for radiography. Commonly missed conditions include ankle syndesmosis injuries, osteochondral injuries, or fractures. The instrument has a sensitivity of almost 100% and a modest specificity, and its use should reduce the number of unnecessary radiographs by 30 to 40%.

For an acute, unstable ankle or a repeat or chronic ankle injury, a MRI and/or diagnostic injection may be ordered. Arthroscopy can be used in unusual cases with persistent functional instability and giving way of the ankle, after conservative treatment, to directly visualize the ruptured ligament(s).

v. Non-operative Treatment Procedures:

Initial treatment for patients able to bear weight: NSAIDs, RICE (rest, ice, compression and elevation), and early functional bracing is used. Oral and topical NSAIDs are likely to be beneficial in the short-term treatment of acute ankle sprains, but there is no evidence on long-term effects, and oral NSAIDs may be associated with possible adverse events. In addition, crutches may be beneficial for comfort. Early functional treatment, including range of motion and strengthening exercises along with limited weight-bearing, are preferable to strict immobilization with rigid casting for improving outcome and reducing time to return to work.

Additionally, in the setting of a Grade 1 or Grade 2 acute ankle sprain, patients can be encouraged to begin mobilization and flexion/extension functional movement pattern exercises during the first week after the injury with instruction from a physical therapist or physician. Standard treatment generally includes protection, rest, ice, compression, and elevation. The injured joint need not be kept immobile in the first week after the sprain has occurred.

Initial treatment for patients unable to bear weight: bracing plus NSAIDs and RICE are used. When patient becomes able to bear weight, a walker boot is frequently employed. There is good evidence that use of either device combined with functional therapy results in similar long-term recovery. Small avulsion fractures of the fibula with minimal or no displacement can be treated as an ankle sprain.

There is good evidence that for ankle fractures immobilized with a removable boot, a below-the-knee ankle injury stocking is more effective than a tubular bandage in controlling swelling and in yielding functional gains six months after the initial injury. Therefore, tubular bandage is not For patients with a clearly unstable joint, immobilize with a short leg cast or splint for 2 to 6 weeks along with early weight-bearing.

Balance/coordination training is a well-established treatment which improves proprioception and may decrease incidence of recurrent sprains.

There is good evidence that, for chronic ankle instability, 4 weeks of neuromuscular training aimed at improving balance and proprioception are more effective than no training at producing functional recovery.

Patient education should include instruction in self-management There is some evidence that, for ankle sprains, a 4 week program of twice weekly manual physical therapy plus home exercise provides benefits in addition to home exercise alone at the end of treatment.

However, these differences decrease over a 6 month period as the natural history of ankle sprains begins to resolve. Manual therapy may also improve motion in the setting of a degenerative joint and should be coupled with instruction on both self-mobilization and range of motion exercises.

Medications/Vitamins: All patients with conditions that require bone healing, especially those over 50, should be encouraged to ingest at least 1000 mg of calcium and 1000 IU of vitamin D per day. Refer to

Section F.9.i. Osteoporosis Management.

For all fractures, an initial vitamin D level should be obtained if there is any clinical suspicion of deficiency. Monitoring and treatment for any deficiency should continue as clinically indicated.

Medications such as analgesics and anti-inflammatories may be helpful.

There is some evidence that, in the setting of long bone fractures of the femur, tibia and humerus, administration of non-steroid anti-inflammatory drugs (NSAIDs) in the first 48 hours after injury is associated with poor healing of the fracture. Therefore, NSAID use is not generally recommended during the healing time for fractures of the lower extremity fractures or immediately after the injury. Refer to medication discussions in Section F.9. Medications and Medical Management.

Heel wedges or other orthotics may be used for rear foot varus or valgus deformities.

There is also good evidence from an adequate systematic review that, in Grade 2 or Grade 3 ankle ligament injuries, external support with a semirigid brace or a short-term cast promotes injury healing more effectively than support with taping or with a tubular bandage. This is because a tubular bandage may not furnish adequate protection against inversion of the ankle joint. There is good evidence that in the setting of ankle instability, ankle taping and bracing has no influence on proprioception, and that their effect in reducing recurrent ankle injury probably arises from other mechanisms.

A) When fractures are involved refer to comments related to osteoporosis in Section F.7.h. Therapeutic Procedures, Nonoperative, Osteoporosis Management.

B) There is good evidence that smoking significantly increases the C) Return-to-work with appropriate restrictions should be considered early in the course of treatment. Refer to Section F.13. Return to Work.

D) Other therapies in Section F. Therapeutic Procedures, Non- E) Hyperbaric oxygen therapy is not recommended.

vi. Surgical Indications/Considerations:

A) Acute surgical indications include sprains with displaced fractures, syndesmotic disruption or ligament sprain associated with a fracture causing instability. However, younger or more active patients warrant consideration of operative treatment.

Weber type B fractures of the ankle demonstrate a widening of the radiographic interval between the medial edge of the talar dome and the lateral edge of the medial malleolus upon external rotation of the foot. These types of fractures generally have a positive manual external rotation stress test upon examination.

There is some evidence that, in the setting of ankle fractures that meet these two criteria, functional outcomes and recovery times are similar with operative and with non-operative treatment.

B) There is no conclusive evidence that surgery as opposed to functional treatment for an uncomplicated Grade 1, 2, or 3 ankle sprain improves patient outcome. There is no indication to consider surgery for an acute ankle sprain.

C) Chronic indications are functional problems, such as recurrent instability remaining after at least 2 months of active participation in a non-operative therapy program including balance training.

D) Diabetes clearly effects outcomes and the incidence of E) Prior to surgical intervention, the patient and treating physician agree to comply with the pre- and postoperative treatment plan, There is some information from a single trial that does not rise to the level of evidence that providing educational pamphlets may not lead to improved functional outcomes but may improve patient satisfaction with the treating staff in the first three months following surgical stabilization of ankle fractures.

F) If injury is a sprain: Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and be provided with appropriate counseling by the physician.

G) If injury is a fracture: Because smokers have a higher risk of nonunion and postoperative costs, it is recommended that carriers cover a smoking cessation program peri-operatively.

Typically the patient should show some progress toward cessation at about six weeks. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels for longterm cessation. Patients with demonstrated success may continue the program up to 3 months or longer if needed based on the operative procedure.

vii. Operative Treatment: Repair of fractures or other acute pathology as necessary. Primary ligament ankle reconstruction with possible tendon transplant.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon Treatment may include short-term post-surgical casting. In all cases, communication between the physician and therapist is important to the timing of weight-bearing and exercise progressions.

For surgically treated ankle sprains: There is also good evidence that in patients who have undergone surgical repair of the ankle ligaments, early mobilization with a prefabricated walking boot leads to earlier return to work and activity than plaster immobilization for six weeks.

For surgically treated ankle fractures: There is some evidence that early mobilization done with a removable brace, after primary wound healing has taken place, improves range of motion more rapidly and results in an earlier return to work.

However, there is some evidence that immediate mobilization with a brace on the day of fracture surgery leads to a higher risk of wound infection than with an immobilizing cast. Additionally, one high quality study provides good evidence that patients who undergo internal fixation of acute non-pathological ankle fractures do not need to remain at bed rest for the first postoperative day. There is also good evidence that mobilization can safely be started with gait aids on the first morning after surgery, leading to shorter length of hospital stay, no increase in the need for opioid analgesia, and equally satisfactory wound healing two weeks after surgery. However, early mobilization should not be confused with weight bearing. Weight bearing immediately following surgical fixation of an ankle fracture is not For acute syndesmotic injuries treated with a syndesmotic screw, there is a lack of evidence to recommend between mobilization within two weeks after surgery and a strategy which delays mobilization for six weeks. The decision regarding optimal timing of mobilization should be tailored to each individual patient.

B) The surgical procedures and the patient’s individual results dictate the amount of time a patient has non weight-bearing restrictions. Fractures usually require 6 to 8 weeks while tendon transfers may be 6 weeks. Other soft tissue repairs, such as the Brostrom lateral ankle stabilization, may be as short as 3 weeks.

C) Return to work and restrictions after surgery may be made by an e. Calcaneal Fracture:

i. Description/Definition: Osseous fragmentation/separation confirmed by diagnostic studies.

ii. Occupational Relationship: Usually occurs by fall or crush injury.

iii. Specific Physical Exam Findings: Pain with range of motion and palpation of calcaneus. Inability to bear weight, mal-positioning of heel, possible impingement of sural nerve.

iv. Diagnostic Testing Procedures: Radiographs and CT scan to assess for intra-articular involvement. Lumbar films and urinalysis are usually performed to rule out lumbar crush fractures when the mechanism of injury is a fall from a height.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Non weight-bearing 6 to 8 weeks, followed by weight-bearing cast at physician’s discretion and active therapy with or without passive therapy.

B) Patient education should include instruction in self-management C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments related to osteoporosis in Section F.7.h.

E) There is good evidence that smoking significantly increases the F) Return to work with appropriate restrictions should be considered G) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Displacement of fragments, joint depression, intra-articular involvement, mal-position of heel. Historically, consensus opinion has recommended that calcaneal fractures of Sanders grade II or above be repaired surgically. However, two comparable studies in combination yield good evidence that the pain and functional difference between surgical and non-operative treatment of most calcaneal fractures at one to two years is small, and likely not to be clinically significant. A clinically significant difference in favor of surgery at 8 or more years in preventing subtalar arthritis requiring arthrodesis cannot be ruled out. Additionally, a recent Cochrane review found insufficient high quality studies relating to current practice to establish whether surgical or conservative treatment is better for adults with displaced intra-articular calcaneal fracture. However, based on a single adequate study in a meta-analysis there is some evidence that, in the setting of displaced intra-articular calcaneal fractures, return to work is more likely with surgical than with nonsurgical treatment. There is also some evidence that a heavy workload makes return to work less likely than with a light or moderate workload. Surgical repair is generally favored to reestablish the general anatomy of the calcaneus, such as restoring height, width, length, and articular surface of the calcaneus, which would allow easier arthrodesis if needed in the future.

One systematic review does provide some pertinent information that the outcomes of calcaneal fractures depend greatly on the occurrence of complications, which do not commonly determine the outcome of most other fractures. This study suggests that this may be the reason for the ongoing controversy about the management of these fractures.

Therefore, the need for surgery will depend on the individual case.

Relative contraindications: smoking, diabetes, or immunosuppressive disease.

vii. Operative Procedures: Open reduction internal fixation. Subtalar fusion may be necessary in some cases when the calcaneus is extremely comminuted. External fixation has been used when the skin condition is poor. There is some information that a minimally invasive approach may have similar clinical results to open reduction and internal fixation and may be an option in less complex fractures. However, the need for open or minimally invasive surgery is dependent upon the individual patient presentation and the surgeon’s clinical judgment.

One study provides some evidence that in the open reduction of intraarticular calcaneal fractures, allograft yields anatomic and functional outcomes equal to those achieved with iliac crest autograft, and that donor site morbidity can be avoided if this is done, but there is inadequate evidence that the addition of PRP enhances the outcomes in a clinically relevant manner. As such, PRP in the setting of open reduction internal fixation (ORIF) of calcaneal fractures is not generally recommended. However, calcaneal fractures requiring allografts frequently also utilize advanced orthobiologics. Prior authorization should be obtained except in urgent open fracture repairs.

Complications may include wound infections requiring skin graft.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) The patient is usually non weight-bearing for 6 to 8 weeks followed by weight-bearing for approximately 6 to 8 weeks at physician’s discretion.

C) Treatment may include the following: restricted weight-bearing, D) Return to work and restrictions after surgery may be made by an f. Chondral and Osteochondral Defects:

i. Description/Definition: Cartilage or cartilage and bone defect of the talar surface. May be associated with ankle sprain or other injuries.

ii. Occupational Relationship: Usually caused by a traumatic ankle injury.

iii. Specific Physical Exam Findings: Ankle effusion, pain in joint and with walking.

iv. Diagnostic Testing Procedures: MRI may show bone bruising, osteochondral lesion, or possibly articular cartilage injury. Radiographs, contrast radiography, CT may also be used.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Acute injuries may require immobilization followed by active therapy with or without passive therapy.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations:

A) Functional deficits not responsive to conservative therapy, or with evidence of anatomical derangement. Identification of an osteochondral lesion by diagnostic testing procedures should be done to determine the size of the lesion and stability of the joint.

B) Microfracture is the initial treatment unless there are other anatomic variants such as a cyst under the bone.

C) Osteochondral Autograft/Allograft Transfer System (OATS) may be effective in patients younger than 55, without other areas of osteoarthritis, a BMI of less than 35, and a failed microfracture.

Additionally, newer techniques allow OATS replacement of failed microfractures without malleolar osteotomies. This procedure may be indicated when functional deficits interfere with activities of daily living and/or job duties at least 3 to 6 months after a failed microfracture with active patient participation in nonoperative therapy and appropriate clinical indications. This procedure is only appropriate in a small subset of patients and requires prior authorization.

D) Autologous cartilage implants are not currently FDA approved for the ankle. Additionally, a Cochrane review examining the topic in 2010 indicated that there is currently insufficient evidence from randomized trials to determine which interventions are best for osteochondral defects of the talus in adults. These procedures do show some early promise for full-thickness defects that have not responded to debridement and microfracture. However, due to the small numbers of ankles treated with autologous cartilage implants represented in the current literature and the largely retrospective nature of the information, these are considered to be pilot studies, and these experimental procedures are therefore not recommended in the ankle.

E) Diabetes clearly effects outcomes and the incidence of F) Prior to surgical intervention, the patient and treating physician G) Smoking may affect tissue healing through tissue hypoxia.

vii. Operative Procedures: Arthroscopy with debridement or shaving of cartilage, microfracture, mosiacplasty, fixation of loose osteochondral fragments. Arthroscopic debridement followed by bone marrow stimulation is considered the primary means of treating osteochondral lesions of the talar dome.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon communication between the surgeon and the therapist and using therapies as outlined in Section F. Therapeutic Procedures, Non-operative. In all cases, communication between the physician and therapist is important to the timing of weight-bearing and exercise progressions.

B) Treatment may include the following: restricted weight-bearing, C) Return to work and restrictions after surgery may be made by an g. Metatarsal-Phalangeal, Tarsal-Metatarsal and Interphalangeal Joint Arthropathy:

i. Description/Definition: Internal derangement of joint.

ii. Occupational Relationship: Jamming, contusion, crush injury, repetitive impact, or post-traumatic arthrosis.

iii. Specific Physical Exam Findings: Pain with palpation and ROM of joint, effusion. The piano key test may be used, where the examiner stabilizes the heel with one hand and presses down on the distal head of the metatarsals, assessing for pain proximally.

iv. Diagnostic Testing Procedures: Radiographs, diagnostic joint injection, CT, MRI.

v. Non-operative Treatment Procedures:

A) Patient education should include instruction in self-management B) Medications such as analgesics and anti-inflammatories may be C) Benefits may be achieved through therapeutic rehabilitation and and swelling. Orthotics and iontophoresis are usually included. A carbon fiber Morton extension may be useful. Therapy should progress to strengthening and an independent home exercise program targeted to further improve ROM, strength, and normal joint mechanics influenced by distal and proximal structures.

Refer to Section F. Therapeutic Procedures, Non-operative.

D) Steroid injections may decrease inflammation and allow the motion. Steroid injections under significant pressure should be avoided as the needle may be penetrating the tendon and injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture. Steroid injections should also be used cautiously in hallux rigidus due to the potential for subluxation. Injections should be minimized for patients under 30 • Time to Produce Effect: One injection.

• Maximum Duration: 3 injections in one year spaced at least E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations:

A) Pain, unresponsive to conservative care and interfering with activities of daily living. Surgery is rarely indicated for a painless metatarsal-phalangeal joint.

B) First metatarsal arthritis or avascular necrosis can interfere with function and gait.

C) Diabetes clearly effects outcomes and the incidence of D) Prior to surgical intervention, the patient and treating physician E) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: if debridement of the arthritic joint and other conservative treatment is unsuccessful in correcting gait and walking tolerance, other procedures may be considered. Other procedures include: fusion of first metatarsal-phalangeal joint, cheilectomy, osteotomies, Keller arthroplasty and soft tissue procedures.

There is some evidence that the first metatarsal-phalangeal joint arthritis is better treated with arthrodesis than arthroplasty for pain and functional improvement. Therefore, total joint arthroplasties are not recommended for any metatarsal-phalangeal joints due to less successful outcomes than fusions. There may be an exception for first and second metatarsalphalangeal joint arthroplasties when a patient is older than 60, has low activity levels, and cannot tolerate non weight-bearing for prolonged periods or is at high risk for nonunion.

Metallic hemi-arthroplasties are still considered experimental as longterm outcomes remain unknown in comparison to arthrodesis, and there is a significant incidence of subsidence. Therefore, these are not recommended at this time.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) For fusions and osteotomies, reduced weight-bearing and the use of special shoes will be necessary for at least 6 weeks postoperative. For other procedures early range-of-motion, bracing, and/or orthotics. Treatment usually also includes other active therapy with or without passive therapy.

C) Return to work and restrictions after surgery may be made by an h. Midfoot (Lisfranc) Fracture/Dislocation:

i. Description/Definition: Fracture/ligamentous disruption of the tarsalmetatarsal joints, i.e., metatarsal-cuneiform and metatarsal-cuboid bones.

ii. Occupational Relationship: Usually occurs from a fall, crush, axial load with a plantar flexed foot, or abductory force on the forefoot.

iii. Specific Physical Exam Findings: Pain and swelling at the Lisfranc joint, first and/or second metatarsal cuneiform articulation, palpable dorsal dislocation, pain on forced abduction.

Dislocation may not always be apparent. Pronation and supination of the forefoot with the calcaneus fixed in the examiner’s opposite hand may elicit pain in a Lisfranc injury. This may help distinguish a Lisfranc injury from an ankle sprain, in which this maneuver is expected to be painless.

The piano key test may be used, where the examiner stabilizes the heel with one hand and presses down on the distal head of the metatarsal, assessing for pain proximally. The dorsalis pedis artery crosses the second metatarsal and may be disrupted. Therefore, the dorsalis pedis pulse and capillary filling should be assessed.

iv. Diagnostic Testing Procedures: X-rays, CT scans, MRI, mid-foot stress x-rays.

v. Non-operative Treatment Procedures:

A) Initial Treatment: If minimal or no displacement then casting, non-weight-bearing 6 to 8 weeks. Orthoses may be used later.

There is some information that non-operative treatment for Lisfranc fractures should be reserved for those with stable Stage I injuries, and that good results may be achieved with a nonweight-bearing cast for 6 weeks or with immediate weightbearing in an orthotic. In those treated non-operatively, an initial non-weight-bearing period of 2 weeks should be observed before reexamination. If, upon reevaluation, there is no tenderness or displacement on weight-bearing radiographs, protected weight bearing with a long walker-boot or orthotic support may be considered. Persistence of tenderness requires further immobilization.

B) Patient education should include instruction in self-management C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments related to osteoporosis in Section F.7.h.

E) There is good evidence that smoking significantly increases the F) Return to work with appropriate restrictions should be considered G) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Displacement of fragments or intraarticular fracture. Most Lisfranc fracture/dislocations are treated surgically.

In regards to timing of surgery, there is some information that significantly poorer results are seen if operative treatment is delayed for more than 6 months. However, a 1-2 week delay to allow reduction of soft-tissue swelling has not been shown to negatively affect outcomes of open reduction and internal fixation.

Due to higher rates of both infectious and non-infectious complications in the postoperative period following surgical correction of Lisfranc fractures, diabetes is also considered a relative contraindication.

vii. Operative Procedures: Open reduction internal fixation with possible removal of hardware at approximately 3 to 6 months, pending healing status. Alternatively, arthrodesis of the medial 2 or 3 metatarsals. There continues to be considerable debate regarding whether ORIF or arthrodesis is the most appropriate operative treatment of Lisfranc fractures. The most appropriate operative treatment must be decided upon by the surgeon after consideration of the patient’s presentation and functional goals.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon treatments as outlined in Section F. Therapeutic Procedures, Non-operative. In all cases, communication between the physician and therapist is important to the timing of weightbearing and exercise progressions.

B) The patient is usually in cast or fracture walker for 6 to 8 weeks non weight-bearing. Orthoses may be indicated after healing.

C) Treatment may include the following: restricted weight-bearing, D) Return to work and restrictions after surgery may be made by an i. Morton’s Neuroma:

i. Description: This condition is a perineural fibrosis of the intermetatarsal nerve creating pain and/or paresthesias in the forefoot region. Symptoms appear with weight-bearing activities. Usually occurs between the third and fourth metatarsals or between the second and third metatarsals.

ii. Occupational Relationship: Acute injuries may include excessive loading of the forefoot region caused from jumping or pushing down on the ball of the foot. Non-traumatic occurrences must be confirmed by a physician after review of environmental and biomechanical risk factors.

iii. Specific Physical Exam Findings: Paresthesias and/or pain with palpation of the inter-metatarsal nerve, Mulder’s sign, a palpable click from compression of the nerve, or Tinel’s sign.

iv. Diagnostic Testing Procedures: Radiographs to rule out osseous involvement. Diagnostic and therapeutic injections. Diagnosis is usually based on clinical judgment; however, MRI and ultrasound imaging have also been employed in difficult cases.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Nonsteroidal anti-inflammatories and foot orthoses are primary treatments.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories are usually helpful. Refer to medication discussions in Section F.7.

D) Steroid injections may decrease inflammation and allow the motion. There is some evidence that an ultrasound-guided injection of methylprednisolone improves global perception of foot health more effectively than an injection of local anesthetic at one month and at three months. However, there is no information regarding the effectiveness of an injection for preventing the need for surgery at a later date. Steroid injections under significant pressure should be avoided as the needle may be penetrating the tendon and injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture. Injections should be minimized for patients under 30 • Time to Produce Effect: One injection.

• Maximum Duration: 3 injections in one year spaced at least E) Alcohol injections are thought to produce a chemical neurolysis.

Alcohol injection with ultrasound guidance may be used to decrease symptoms.

• Optimum Duration: 4 treatments.

• Maximum Duration: 7 treatments.

F) Return to work with appropriate restrictions should be considered G) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations:

A) Functional deficits persisting after 2 to 3 months of active participation in therapy.

B) Diabetes clearly effects outcomes and the incidence of C) Prior to surgical intervention, the patient and treating physician D) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Excision of the neuroma; nerve transection or transposition.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may involve a period of non-weight-bearing for up to two weeks, followed by gradual protected weight-bearing 4 to 6 C) Return to work and restrictions after surgery may be made by an j. Pilon Fracture:

i. Description/Definition: Crush/comminution fracture of distal metaphyseal tibia that has intra-articular extensions into the weight-bearing surface of the tibio-talar joint.

ii. Occupational Relationship: Usually from a fall.

iii. Specific Physical Exam Findings: Swelling, pain with weight-bearing, ecchymosis, and palpable tenderness.

iv. Diagnostic Testing Procedures: Radiographs, CT scans.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Prolonged non weight-bearing at physician’s discretion.

B) Patient education should include instruction in self-management C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments related to osteoporosis in Section F.7.h.

E) There is good evidence that smoking significantly increases the F) Return to work with appropriate restrictions should be considered G) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Displacement of fracture, severe comminution necessitating primary fusion.

vii. Operative Procedures: Open reduction internal fixation, fusion, external fixation. In some cases staged procedures may be necessary beginning with external fixation. In some cases, intramedullary nailing may also be a treatment of choice.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon treatment as outlined in Section F. Therapeutic Procedures, Non-operative. In all cases, communication between the physician and therapist is important to the timing of weightbearing and exercise progressions.

B) Treatment may include the following: restricted weight-bearing, C) Return to work and restrictions after surgery may be made by an k. Plantar Fasciitis/Plantar Fasciopathy/Plantar Fasciosis (aka Heel Spur Syndrome, or Chronic Plantar Heel Pain)

i. Description: Pain along the inferior aspect of the heel at the calcaneal attachment of the plantar fascia and/or along the plantar fascia. The most commonly reported symptom is “first-step pain,” that is, pain that is worst with the first steps of the day after arising from bed. Heel pain typically improves with walking but worsens again with prolonged weight bearing or after periods of inactivity.

ii. Occupational Relationship: Condition may be exacerbated by prolonged standing or walking on hard surfaces. Acute injury may be caused by trauma. This may include jumping from a height or hyperextension of the forefoot upon the rear foot.

iii. Specific Physical Exam Findings: Pain with palpation of the origin of the plantar fascia at the medial calcaneal tubercle is a typical exam finding.

Gastrocnemius tightness may be tested with the Silfverskiöld test. The foot is passively dorsiflexed with the knee extended and then with knee flexed while stabilizing the subtalar joint in neutral position. The test is positive for gastrocnemius tightness if dorsiflexion is greater with the knee flexed than with the knee extended.

iv. Diagnostic Testing Procedures: Standard radiographs to rule out fracture. Bone scans and/or MRI may be used to rule out stress fractures in chronic cases.

v. Non-operative Treatment Procedures:

A) Initial Treatment: This condition usually responds to conservative management consisting of eccentric exercise and stretching of the gastrocnemius, plantar fascial stretching, taping, soft-tissue mobilization, and orthoses. Regardless of specific treatment, more than 80% of patients have resolution of symptoms within 12 months.

• Behavior Modification: Patients with plantar fasciitis often exhibit fear of movement (fear avoidance) behaviors associated with their plantar fasciitis pain. Behavioral modifications may produce some benefit in resolving these behaviors, such as positive encouragement and graded exposure to fearful activities. Providers and therapists should be aware of this and take it into consideration in developing the treatment plan.

• Stretching (Plantar Fascia Specific & Calf Stretching):

Active stretching and strengthening of the entire lower extremity is appropriate in the initial treatment of plantar fasciitis.

There is good evidence that, in the setting of plantar fasciitis of recent onset, a program of home stretching exercises directed at the plantar fascia is more effective in reducing pain than radial shock wave therapy.

There is some evidence that, in workers who spend the majority of working hours on their feet and who have developed plantar fasciopathy, a physical therapy program consisting of exercises combining gastrocnemius stretching, plantar fascia stretching, balance exercises, and ankle inversion/eversion exercises produce functional and symptomatic benefits equal to those of a single injection of 4 mg of dexamethasone at 6 and at 12 weeks.

• Manual Therapy (Articular & Soft Tissue): There is some evidence that, in patients with plantar fasciitis, six sessions of individually tailored manual therapy with exercise more effectively improves pain six months later than six sessions of standardized program of exercise with ultrasound, dexamethasone iontophoresis, and ice.

• Taping: There is some evidence for small to moderate short-term (1 week) pain reduction from calcaneal taping, low dye taping (anti-pronation taping below the ankle). Some literature has studied elastic taping of both the plantar fascia and gastrocnemius. Evidence for duration of benefit after removal of tape is lacking.

Evidence for effect on function is insufficient. Practical issues regarding taping are the considerable time and labor involved, the moderate complexity of the techniques which may be difficult to teach to patients, potential difficulty or inability of many patients to do selftaping because of physical limitations, and the need to change the tape at least weekly.

• Orthoses: There is good evidence that orthoses have a small, short-term (3 months) functional benefit compared to sham orthosis. There is also some literature indicating overall subjective improvement from various types of orthoses plus stretching compared to stretching alone.

Evidence does not support pain reduction from orthoses.

There is strong evidence that the effectiveness of prefabricated orthoses is equivalent to, and possibly better than, custom-made orthoses. Generally, custom made orthoses are not necessary, except in specific cases, such significant anatomic or alignment abnormalities of the foot.

• Patient education should include instruction in selfmanagement techniques, ergonomics, body mechanics, home exercise, joint protection, and weight B) Medications such as analgesics and anti-inflammatories may be helpful. Refer to medication discussions in Section F. 7, C) Night Splinting: There is inadequate evidence regarding effectiveness of night splinting. A single randomized controlled trial of night splinting was identified but did not meet criteria for adequate evidence due to large risk of bias. However, night splinting is commonly used for plantar fasciitis and may be incorporated as a part of the stretching protocol.

D) Corticosteroid Injections: There is good evidence for a small to moderate reduction in pain from corticosteroid injection, whether guided by ultrasound or palpation. Tibial nerve block does not add benefit to the procedure. It is unclear whether factors such as the specific corticosteroid, the injection approach (e.g. medial vs. posterior), the injection target (e.g. parallel to the plantar fascia vs. into the plantar fascia), or mixing of local anesthetic with the steroid influence outcomes.

Safety concerns regarding steroid injection of the heel exist, including plantar fascia rupture and heel pad atrophy. Steroid injection under significant pressure should be avoided as the needle may be penetrating the tendon, and injection into the tendon could cause tendon breakdown, degeneration, or rupture.

Injections should be minimized for patients under 30 years of age.

• Time to produce effect: 1 injection.

• Maximum Duration: 3 injections in 1 year spaced at least 4 to 8 weeks apart. No more than 4 steroid injections to all body parts should be performed in one year.

Steroid injections should be used cautiously in diabetic patients.

Diabetic patients should be reminded to check their blood glucose levels at least daily for 2 weeks after injections. Caution should be used when considering steroid injections for patients with an A1c level of 8% or greater. For more information, please refer to Section F.6.a. Steroid Injections.

E) Platelet-Rich Plasma injections: There is inadequate evidence to recommend for the use of PRP in the setting of plantar fasciitis to improve pain, function, or alignment. Therefore, PRP is not generally recommended. However, PRP may be considered in unusual circumstances for patients who have not responded to appropriate conservative measures for 4 to 6 months in order to forestall an invasive procedure with risk of significant complications. If PRP is found to be indicated in these select patients, the first injection may be repeated once after 4 weeks when significant functional benefit, such as increased walking tolerance, is reported but the patient has not returned to full Refer to Section F.6.d Platelet Rich Plasma.

F) Botulinum Toxin Injections: There is some evidence that, in patients with plantar fasciitis lasting 3 months or more, botulinum toxin injected into the gastrocnemius-soleus complex combined with stretching produces greater pain reduction and greater functional improvement than corticosteroid injection into the heel combined with stretching. The effect sizes were clinically significant and lasted through 6 months. A therapeutic response to a botulinum toxin type A injection into the gastrocnemiussoleus complex may also be helpful in determining which patients would respond favorably to a gastrocnemius recession surgery. This is not a FDA approved indication. Thus, the evidence supports injections into the gastrocnemius-soleus complex and this is an accepted procedure.

There is insufficient evidence and no plausible physiological theory to support a botulinum toxin injection into the plantar fascia. Therefore, it is not recommended.

Refer to Section F.6.h. Botulinum Toxin Injections for more information.

G) Extracorporeal Shock Wave Therapy (ESWT): There is good evidence from one high quality trial that high intensity ESWT is more effective than sham ESWT for improving pain and function in chronic plantar fasciitis which has not responded to conservative treatment after 6 months of symptoms. There is also some evidence from one adequate trial that high dose shock wave produces successful outcomes similar to those for endoscopic plantar fascia release in patients with persistent plantar fasciopathy which has not responded to more conservative treatment. However, two flawed meta-analyses failed to provide evidence that ESWT, regardless of energy level, produces a clinically meaningful reduction in pain or increase in function when compared to placebo for patients with plantar fasciitis lasting 6 months or more. While both meta-analyses did find a benefit for ESWT, the effect did not reach the level of clinical significance, and provided conflicting evidence for which energy level is more effective. However, there is good evidence that plantar fascia specific stretching as initial treatment is more effective than radial ESWT in reducing pain and increasing function. Therefore, only ESWT at high intensity (0.25 mJ/mm2) may be considered in patients who have failed 4 to 6 months of conservative treatment, including stretching, physical therapy, orthoses, ice, and NSAIDs, and have significant functional deficits. This may be attempted for a maximum of 3 sessions spaced at least a week apart.

Refer to Section F. 5. EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) for more details.

H) Radiation Therapy: There is inadequate evidence regarding effectiveness of radiation therapy for plantar fasciitis. Two randomized controlled trials were identified but neither included a placebo or “standard therapy” control group. They merely compared different doses of radiation therapy. Furthermore, one study was stopped early for benefit, introducing a large risk of selective reporting bias. Therefore, it is not recommended.

I) Dry Needling: There is some evidence that, in the setting of plantar fasciitis, six weekly sessions of dry needling have a small benefit for pain in the first steps in the morning, but no measurable effects on foot function. Frequent local pain during the treatment sessions and mild bruising at the insertion site are common complications of dry needling for plantar fasciitis.

J) Other therapies in Section F. Therapeutic Procedures, Non- K) Return to work with appropriate restrictions should be considered suggestions for work task modifications. Refer to Section F. 13, vi. Surgical Indications/Considerations:

A) Surgery is employed only after failure of at least 6 months of active patient participation of non-operative treatment.

B) Indications for gastrocnemius recession include a positive Silfverskiöld test, but a negative Silfverskiöld test does exclude gastrocnemius contracture as a causal factor. Gastrocnemius recession does not weaken the arch as may occur with a plantar fascial procedure. While some observational studies have reported positive results of gastrocnemius recession in plantar fasciitis patients no randomized controlled trials have been published. Furthermore, consensus on the best specific procedure for gastrocnemius recession is lacking.

C) Diabetes clearly effects outcomes and the incidence of D) Prior to surgical intervention, the patient and treating physician agree to comply with the pre- and postoperative treatment plan, E) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Treatment Procedures: Plantar fascial release with or without calcaneal spur removal, endoscopic or open gastrocnemius recession.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon therapies as outline in Section F, Therapeutic Procedures, Non- Treatment may include the following: restricted weight-bearing, bracing, active therapy with or without passive therapy. Usually non-weight-bearing for 7 to 10 days followed by weight-bearing cast or shoe for 4 weeks; however, depending on the procedure, some patients may be restricted from weight-bearing for 4 to 6 l. Posterior Tibial Tendon Dysfunction:

i. Description/Definition: Pain in the posteromedial ankle with plantar flexion.

ii. Occupational Relationship: Repetitive or forced plantar flexion after an ankle sprain or athletic activity.

iii. Specific Physical Exam Findings: Painful posterior tibial tendon with active and passive non weight-bearing motion, reproduction of pain with forced plantar flexion and inversion of the ankle, difficulty performing single heel raise, pain with palpation from the posterior medial foot along the medial malleous to the navicular greater tuberosity. The patient should also be evaluated for a possible weak gluteus medius as a contributing factor.

iv. Diagnostic Testing Procedures: X-ray, MRI may be used to rule out other diagnoses.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Short ankle articulated orthosis and therapy including low-load strengthening or eccentric training exercises with progression to home program. Other active and passive therapy including iontophoresis, orthotics and possible strengthening for the gluteus medius.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Return to work with appropriate restrictions should be considered E) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations:

A) Failure of non-operative treatment. Surgery is rarely necessary as success rate for non-operative treatment is around 90%.

Generally speaking, for Stage I and Stage II, non-operative treatment should continue for 6 to 12 months prior to the need for MRI or consideration of surgical intervention. An exception to waiting for 6 to 12 months might be if a specialist finds that a delay greater than 6 months is contraindicated after consideration of particular patient needs based on examination and functional conditions. Stage III and Stage IV, which result in an inflexible flat foot deformity that cannot be reduced, may require arthrodesis or other surgical correction significantly sooner.

B) Diabetes clearly effects outcomes and the incidence of C) Prior to surgical intervention, the patient and treating physician D) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Resection of anomolous muscle segments or tenolysis. In severe cases, tendon transfer, osteotomies and/or arthrodesis may be necessary.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include the following: restricted weight-bearing, C) Return to work and restrictions after surgery may be made by an m. Puncture Wounds of the Foot:

i. Description/Definition: Penetration of skin by foreign object.

ii. Occupational Relationship: Usually by stepping on foreign object, open wound.

iii. Specific Physical Exam Findings: Site penetration by foreign object consistent with history. In early onset, may show classic signs of iv. Diagnostic Testing Procedures: X-ray, MRI, ultrasound.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Appropriate antibiotic therapy, tetanus toxoid booster, non-weight-bearing at physician’s discretion.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Return to work with appropriate restrictions should be considered E) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Cellulitis, retained foreign body suspected, abscess, compartmental syndrome, and bone involvement.

vii. Operative Procedures: Incision and drainage with cultures.

viii. Postoperative Treatment:

A) Patient is usually non-weight-bearing with antibiotic therapy based upon cultures. Follow-up x-rays and/or MRI may be needed to evaluate for osseous involvement.

B) An individualized rehabilitation program based upon treatment as outlined in Section F. Therapeutic Procedures, C) Return to work and restrictions after surgery may be made by an n. Severe Soft Tissue Crush Injuries:

i. Description/Definition: Soft tissue damage to the foot.

ii. Occupational Relationship: Crush injury or heavy impact to the foot or ankle.

iii. Specific Physical Exam Findings: Pain and swelling over the foot.

iv. Diagnostic Testing Procedures: X-ray and other tests as necessary to

rule out other possible diagnoses such as compartment syndrome which requires emergent compartment pressure assessment.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Usually needs initial rest from work with foot elevation and compression wraps.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: If compartmental pressures are elevated, emergent fasciotomy is warranted.

vii. Operative Procedures: Emergency fasciotomy. In some cases a delayed primary closure is necessary.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include the following: elevation, restricted weightbearing, active therapy with or without passive therapy.

C) Return to work and restrictions after surgery may be made by an o. Stress Fracture:

i. Description/Definition: Fracture without displacement usually to metatarsals, talus, navicular or calcaneus.

ii. Occupational Relationship: May be related to repetitive, high impact walking; running; or jumping.

iii. Specific Physical Exam Findings: Pain over the affected bone with palpation or weight-bearing.

iv. Diagnostic Testing Procedures: X-ray, CT, MRI, bone scan v. Non-operative Treatment Procedures:

A) Initial Treatment: Immobilization for 4 to 8 weeks with limited weight-bearing may be appropriate.

B) Patient education should include instruction in self-management C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments related to osteoporosis in Section F.7.h.

E) There is good evidence that smoking significantly increases the F) There is some literature indicating that shock absorbing boot inserts may decrease the incidence of stress fractures in military training. Shock absorbing boot inserts of other orthotics may be used in some cases after a stress fracture has occurred or to prevent stress fractures in appropriate work settings.

G) Return to work with appropriate restrictions should be considered H) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Fractures that have not responded to conservative therapy.

vii. Operative Procedures: Most commonly percutaneous screws or plate fixation.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include the following: restricted weight-bearing, C) Return to work and restrictions after surgery may be made by an p. Talar Fracture:

i. Description/Definition: Osseous fragmentation of talus confirmed by radiographic, CT or MRI evaluation.

ii. Occupational Relationship: Usually occurs from a fall or crush injury.

iii. Specific Physical Exam Findings: Clinical findings consistent with fracture of talus: pain with range of motion, palpation, swelling, ecchymosis. Pain with weight-bearing attempt.

iv. Diagnostic Testing Procedures: Radiographs, CT scans, MRI. CT scans preferred for spatial alignment.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Non weight-bearing for 6 to 8 weeks for nondisplaced fractures. Monitoring for avascular necrosis (AVN) should be considered, including serial x-rays.

B) Patient education should include instruction in self-management C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments related to osteoporosis in Section F.7.h.

E) There is good evidence that smoking significantly increases the F) Return to work with appropriate restrictions should be considered G) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Osseous displacement, joint involvement and instability.

vii. Operative Procedures: Open reduction internal fixation.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include the following: Non weight-bearing 6 to 8 weeks followed by weight-bearing cast. MRI follow-up if avascular necrosis is suspected. Active therapy with or without passive therapy.

C) Return to work and restrictions after surgery may be made by an q. Tarsal Tunnel Syndrome:

i. Description: Pain and paresthesias along the medial aspect of the ankle and foot due to nerve irritation and entrapment of the tibial nerve or its branches. These symptoms can also be caused by radiculopathy.

ii. Occupational Relationship: Acute injuries may occur after blunt trauma along the medial aspect of the foot. Non-traumatic occurrences are confirmed by a physician after review of environmental and biomechanical risk factors. Non work related causes include space occupying lesions.

iii. Specific Physical Exam Findings: Positive Tinel's sign. Pain with percussion of the tibial nerve radiating distally or proximally. Pain and paresthesias with weight-bearing activities.

iv. Diagnostic Testing Procedures: Nerve conduction velocity studies of both sides for comparison to normal side. EMGs may be needed to rule out radiculopathy. MRI to rule out space occupying lesions. Diagnostic injections to confirm the diagnosis.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Cast or bracing, immobilization and foot orthoses are appropriate initial management.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Return to work with appropriate restrictions should be considered suggestions for work task modifications.

Orthotics or accommodative footwear is usually necessary before workers can be returned to walking on hard surfaces.

E) Other therapies in Section F. Therapeutic Procedures, Non- Nerve mobilization exercise may be used by some therapists though it lacks evidence to support it.

vi. Surgical Indications/Considerations:

A) Continued functional deficits after active participation in therapy for 3 to 6 months.

B) Diabetes clearly effects outcomes and the incidence of C) Prior to surgical intervention, the patient and treating physician D) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Tarsal tunnel release with or without a plantar fascial release.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include the following: restricted weight-bearing, orthotics, bracing, active therapy with or without passive therapy.

C) Return to work and restrictions after surgery may be made by an r. Tendinopathy:

For Achilles Tendinopathy, Refer to Section E.1.a. for other types of tendinopathy of the foot and ankle. General recommendations can be found in Section E.2.k.

Tendinopathy of the Knee.

2. KNEE

a. Aggravated Osteoarthritis (OA):

i. Description/Definition: Swelling and/or pain in a joint due to an aggravating activity in a patient with pre-existing degenerative change in a joint. Age greater than 50 and morning stiffness lasting less than 30 minutes are frequently associated with this condition. The lifetime risk for symptomatic knee arthritis is probably around 45% and is higher among obese persons. Radiographic findings do not correlate well with clinical symptoms. Loss of range of motion, muscle strength reduction, laxity of the knee joint, proprioceptive problems, and other health co-morbidities are risk factors for functional decline. Although functional loss is common over time, approximately 30% of patients do improve.

ii. Occupational Relationship: The provider must establish the occupational relationship by establishing a change in the patient’s baseline condition and a relationship to work activities including but not limited to physical activities such as repetitive kneeling or crawling, squatting and climbing, or heavy lifting.

There is also good evidence that intensive physical work more than doubles the risk of symptomatic knee OA with knee replacement, and that there is a dose-response relationship between work load and the development of knee OA with knee replacement. Intensive physical labor is defined as job categories such as forestry employee, dockworker, farm worker, or ditch digger.

iii. Non-occupational Risk Factors: Body mass index (BMI) of 25 or greater is a significant risk factor for eventual knee replacement. There is good evidence that obesity increases the risk of symptomatic knee OA resulting in knee replacement six fold in men and eleven fold in women.

There is strong evidence of increased BMI as a significant risk factor for the occurrence of onset of knee OA. Numerous studies document an increased odds ratio for developing knee osteoarthritis for BMIs greater than 30. Progression of symptomatic knee osteoarthritis is variable. In one study over a two year span, 70% of patients showed no significant joint space narrowing, 20% showed slow progression and only 9% had more significant changes.

There is strong evidence for hand OA as a significant marker of risk for knee OA.

Other causative factors to consider - Previous meniscus or ACL damage may predispose a joint to degenerative changes. There is strong evidence that an ACL injury increased the ten-year risk of developing Kellgren-Lawrence defined osteoarthritic changes compared to the uninjured knee. This risk is approximately fourfold both for minimal OA and for moderate to severe OA. There is good evidence that meniscal damage, even in the absence of knee surgery, is associated with a significantly increased risk of development of radiographic tibiofemoral OA within 30 months of its detection on MRI. There is strong evidence for previous knee injury as a significant risk factor for OA. A number of studies indicate that patients with ACL injuries and meniscus pathology are likely to develop degenerative osteoarthritis. Percentages range from approximately 25% to 50%. It is unclear whether the repair of ACLs significantly decreases the degenerative pathology. One study found more severe arthritis present in those with an ACL repair. In order to entertain previous trauma as a cause, the patient should have medical documentation of the following: menisectomy; hemarthrosis at the time of the original injury; or evidence of MRI or arthroscopic meniscus or ACL damage. The prior injury should have been at least 2 years from the presentation for the new complaints. In addition, there should be a significant increase of pathology on the affected side in comparison to the original imaging or operative reports and/or the opposite un-injured side or extremity.

iv. Specific Physical Exam Findings: Increased pain and/or swelling in a joint with joint line tenderness; joint crepitus; and/or joint deformity.

v. Diagnostic Testing Procedures: Radiographs, The Kellgren-Lawrence Scale is the standard radiographic scale for knee osteoarthritis. It is based on the development of osteophytes, on bone sclerosis, and on joint space narrowing. The degree of joint space narrowing may not predict disability.

Grade 1: doubtful narrowing of joint space, and possible osteophytic lipping.

Grade 2: definite osteophytes, definite narrowing of joint space.

Grade 3: moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour.

Grade 4: large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour.

MRI to rule out degenerative menisci tears. MRI may identify bone marrow lesions which are correlated with knee pain or trauma and instability. These lesions may reflect increased water, blood, or other fluid inside bone and may contribute to the causal pathway of pain.

These are incidental findings and should not be used to determine a final diagnosis or make decisions regarding surgery. Knee pain from osteoarthritis is most clearly associated with bone marrow lesions and effusion synovitis identified on MRI.

vi. Synovial fluid testing is rarely appropriate.

vii. Non-operative Treatment Procedures:

A) Patient education should include instruction in self-management protection, and weight management developed through shared decision making. There is good support in the literature for selfmanagement using weight loss, exercise, pacing of activities, unloading the joint with braces, taping, and medications as needed. Programs should be individually tailored with short and long-term goals. Patients should be encouraged to perform aerobic activity such as walking or biking. However, activities such as ladders, stairs and kneeling may be restricted. Weight loss of at least 5% of body weight is encouraged when BMI is greater than 25.

B) Medications such as analgesics and anti-inflammatories may be helpful.

• There is good evidence that duloxetine more effectively decreases knee OA pain in older adults than placebo.

However, the side effect profile of constipation and other symptoms should be considered if the drug is given to older adults.

• Glucosamine and chondroitin are sold in the United States as dietary supplements. Their dosage, manufacture, and purity are not regulated by the Food and Drug Administration.

There is good evidence that glucosamine sulfate and glucosamine hydrochloride are ineffective for relieving pain in patients with knee or hip OA. There is some evidence that glucosamine sulfate treatment for more than 6 months shows a small improvement in joint function compared to placebo controls in people with osteoarthritis of the knee or hip. One study purported to show chondroitin sulfate and glucosamine equivalence to celecoxib, however, celecoxib was actually superior at 4 months.

Pharmaceutical grade versions are not available in the United States and thus, these medications are not • For occasional patients Tramadol may be used. Refer to Chronic Pain Guidelines • Outpatient fentanyl use is not recommended for work related osteoarthritis.

• There is good evidence that oral doxycycline has no therapeutic effect on knee OA.

• There is good evidence that acetaminophen is not more effective than placebo for the treatment of knee osteoarthritis. A trial of acetaminophen may be done when the patient has a contraindication to or an intolerance of oral and topical NSAIDs.

• For occasional patients topical capsaicin may be used.

Refer to Chronic Pain Guidelines.

Refer to medication discussions in Section F.7, Medications and Medical Management.

C) Benefits may be achieved through therapeutic rehabilitation and mechanics, and clearing dysfunctions from distal to proximal structures.

There is good evidence that exercise shows moderate, clinically important reductions in pain and disability in people with osteoarthritis of the knee. An optimal exercise program for knee OA should focus on improving aerobic capacity, quadriceps muscle strength, or lower extremity performance. This exercise program should be supervised, carried out 3 times weekly, and consist of at least 12 sessions. It is suggested that aerobic exercise and strength training should be performed in different sessions in order to achieve the greatest effect.

There is good evidence that land-based exercise shows a moderate clinically important benefit for the relief of pain and improvement in function at the completion of a supervised exercise program. The evidence shows that somewhat smaller benefits are sustained for at least another two to six months among people with symptomatic osteoarthritis of the knee.

There is good evidence that 4 weeks of resistance training is effective for improving maximal strength, functional ability, and reducing pain when used as a therapeutic rehabilitation program for various musculoskeletal conditions including chronic tendinopathy, knee osteoarthritis, and after hip replacement There is good evidence that exercise programs based on tai chi, aerobic, and mixed exercise, and not hydrotherapy programs, are effective in improving functional aerobic capacity in patients with hip and knee osteoarthritis.

Results for the cost-effectiveness of exercise and lifestyle treatment for hip and knee osteoarthritis are mixed. One study showed an improvement in function with a supervised exercise and diet program.

Low impact aerobic exercise should be encouraged.

There is some evidence that 12 weeks of behavioral graded activity does not result in better long-term effectiveness in reducing pain or improving function at 5 years than usual exercise therapy in patients with osteoarthritis (OA) of the hip or knee. Behavioral graded activity (BGA) uses operant behavior principles within an individually tailored exercise program in which patients’ most problematic physical activities are gradually increased in a time-contingent manner to improve impairments limiting the performance of these activities.

There is good evidence that aquatic exercise and land-based exercise show comparable outcomes for function and mobility among people with symptomatic osteoarthritis of the knee or hip.

Aquatic therapy may be used as a type of active intervention when land-based therapy is not well-tolerated. Proprioceptive exercises may also have some short-term benefit. structures distal and proximal to the knee.

D) Manipulation / Manual Therapy: There is good evidence that supervised exercise therapy with added manual mobilization shows moderate, clinically important reductions in pain compared to non-exercise controls in people with osteoarthritis of the knee.

E) Acupuncture: This is a high quality study that provides good evidence that neither laser nor needle acupuncture reduces pain or improves function in patients older than 50 years with moderate to severe chronic knee pain.

There is good evidence that, in people with osteoarthritis of the knee or hip, the effects of true needle acupuncture treatment relative to sham acupuncture may be too small to be perceived by participants as beneficial. Therefore, true needle acupuncture may not actually result in significant, clinically relevant functional improvement or significant pain reduction. Thus, there is strong evidence that acupuncture is not effective for osteoarthritis pain relief. Acupuncture is performed with a variety of techniques and to date none have been shown to have superior clinical results. It is not generally recommended but may be used in some patients if functional gains are demonstrated and it would be beneficial to delay arthroplasty. Refer to Section F.1.

Acupuncture for more information.

F) A Cochrane meta-analysis supports good evidence that pulsed electromagnetic field or electrical stimulation treatment has a small clinical pain relief benefit in people with osteoarthritis of the knee. However, the effect on function is very uncertain. If used, it must be accompanied by an exercise program and should be limited to 6-8 total sessions.

G) Bracing and Insoles:

There is good evidence that valgus knee bracing provides moderate improvement in pain and function compared to those that do not use another type of orthosis. There is also good evidence that this type of bracing provides a small improvement in pain associated with medial knee osteoarthritis as compared to another type of orthosis. Thus, valgus knee bracing is a reasonable treatment for medial knee osteoarthritis.

There is some evidence that conservative management using either the valgus knee brace or the lateral wedged insole reduces pain and improves function in adults with medial tibiofemoral osteoarthritis of the knee. There were no significant differences between the two orthoses in any of the clinical outcomes. Participants wore the insoles more consistently than the braces, and this may reflect convenience and greater acceptance of use. There is some evidence that laterally elevated wedged insoles are more effective in reducing pain, improving function, and reducing NSAID usage than neutrally wedged insoles in adults with medial compartment knee osteoarthritis. Participants wore the neutral insoles more consistently than the elevated insoles, and this may reflect comfort and greater acceptance of use. Thus, there is good evidence for the use of laterally elevated wedged soles for those with medial osteoarthritis. Insoles are not required prior to use of a brace.

Patellar taping may also provide short-term relief.

H) Functional tests should always be used to track progress of therapy. The Osteoarthritis Research Society International (OARSI) recommends the following tests for those with knee or hip osteoarthritis: 30 second chair stand, 40 meter fast paced walk, a stair climb, timed up-and-go, and 6 minute walk test.

I) Therapeutic Injections – • Steroid injections may decrease inflammation and allow the therapist to progress with functional exercise and ROM.

Caution should be used when considering steroid There is good evidence that steroid injection in the setting of knee osteoarthritis produces rapid but shortlasting pain relief compared to placebo, likely to last at least one week but not likely to last 4 weeks or longer.

• Time to Produce Effect: One injection.

• Maximum Duration: 3 injections in one year at least 4 to 8 weeks apart. Not to exceed 4 injections of any body part in one year.

Steroid injections should be avoided if arthroplasty is planned within 3 months.

• Viscosupplementation - There is strong evidence that, in the setting of knee osteoarthritis, the effectiveness of viscosupplementation is clinically unimportant, and may impose a risk of adverse events on the patient.

Therefore, it is generally not recommended. It may occasionally be appropriate for patients with significant functional deficits who are not yet eligible for or wish to delay an arthroplasty. Refer to Section F.6.e.

Viscosupplementation for more information.

• PRP Injection - There is some evidence that, in the setting of knee OA, intra-articular injection with PRP is more effective than hyaluronic acid or placebo in improving knee function and pain. There is some evidence that in patients with knee OA, a single PRP injection is more beneficial than a saline injection, and that more than one PRP injection is likely to be more beneficial than a single PRP injection when the Kellgren- Lawrence grade is less than Grade IV, and that a single PRP injection is as beneficial as three hyaluronic acid injections for knee OA. Therefore, it may be used for patients with significant functional deficits who are not yet eligible for or wish to delay an arthroplasty when authorized by a knee specialist with familiarity with PRP preparation .Refer to Section F.6.d. Platelet Rich Plasma (PRP) for more information.

J) Neurotomy - There is currently inadequate evidence to support radiofrequency neurotomy for knee osteoarthritis failing conservative therapy. The one randomized controlled study identified was inadequate to support this invasive procedure.

K) Return to work with appropriate restrictions should be considered L) Other therapies in Section F. Therapeutic Procedures, Nonviii. Surgical Indications/Considerations:

A) Arthroscopic Debridement and/or Lavage. There is good evidence from a randomized controlled trial that arthroscopic debridement alone provides no benefit over recommended therapy for patients with uncomplicated Grade 2 or higher arthritis. The comparison recommended treatment in the study followed the American College of Rheumatology guidelines, including: patient education, supervised therapy with a home program, instruction on ADLs, and stepwise use of analgesics and hyaluronic acid injections if desired. Complicated arthritic patients excluded from the study included patients who required other forms of intervention due to the following conditions: large meniscal bucket handle tears, inflammatory or infectious arthritis, more than 5 degrees of varus or valgus deformity, previous major knee trauma, or Grade 4 arthritis in 2 or more compartments.

Therefore, arthroscopic debridement and/or lavage are not recommended for patients with arthritic findings, continual pain and functional deficits unless there is meniscal or cruciate pathology or a large loose body causing locking. Refer to the specific conditions in this Section E, for specific diagnostic B) There is inadequate evidence of the effectiveness of PRP in the setting of microfracture in patients with knee OA over the age of 40. Therefore, it is not recommended.

C) Osteotomy and joint replacement are indicated when conservative treatment, including active participation in nonoperative treatment has failed to result in sufficient functional improvement (Refer to Sections G. 4., Knee Arthroplasty, and G. 8., Osteotomy). Tibial osteotomy is a choice for younger patients with unicompartmental disease who have failed conservative D) In cases where surgery is contraindicated due to obesity, it may patient is unsuccessful losing weight on their own. Coverage for weight loss would continue only for motivated patients who have demonstrated continual progress with weight loss.

E) Diabetes clearly effects outcomes and the incidence of F) Prior to surgical intervention, the patient and treating physician G) Because smokers have a higher risk of nonunion and postoperative costs, it is recommended that carriers cover a smoking cessation program peri-operatively. Typically the patient should show some progress toward cessation at about six weeks. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels for long-term cessation.

Patients with demonstrated success may continue the program up to 3 months or longer if needed based on the operative ix. Operative Procedures: Total or unicompartmental joint replacement, and osteotomy.

Free-floating interpositional unicompartmental replacement is not recommended for any patients due to high revision rate at 2 years and less than optimal pain relief. Refer also to Section G.4., Knee Arthroplasty, or G. 8, Osteotomy as appropriate.

x. Postoperative Treatment:

A) An individualized rehabilitation program based upon communication between the surgeon and therapist and using the B) Return to work and restrictions after surgery may be made by an b. Anterior Cruciate Ligament (ACL) Injury:

i. Description/Definition: Rupture or partial rupture of the anterior cruciate ligament; may be associated with other internal derangement of the knee.

ii. Occupational Relationship: May be caused by virtually any traumatic force to the knee but most often caused by a twisting or a hyperextension force, with a valgus stress. The foot is usually planted and the patient frequently experiences a “popping” feeling and “giving way” sensation.

iii. Specific Physical Exam Findings: Findings on physical exam include effusion or hemarthrosis, instability, positive Lachman’s test, positive pivot shift test, and/or positive anterior drawer test. The Lachman’s test has the highest sensitivity at 0.81 with equal specificity.

iv. Diagnostic Testing Procedures: MRI is the imaging modality of choice for detecting ACL rupture. Radiographs may show avulsed portion of the lateral tibial plateau (Segond sign), but this is a rare finding. MRI is also a good test for detecting associated meniscal lesions. The overall sensitivity and specificity for detecting meniscus tears in chronic ACLdeficient knees on MRI were 90% and 89%, respectively, when verified with results of arthroscopy.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Patient education should include instruction in self-management techniques, ergonomics, body mechanics, home exercise, joint protection, and weight management.

B) Benefits may be achieved through therapeutic rehabilitation and structures bracing may be beneficial. Passive as well as active normal joint mechanics influenced by structures distal and proximal to the knee (Refer to Section F. Therapeutic Procedures, Non-operative). Passive modalities are most effective as adjunctive treatments to improve the results of active treatment. They may be used as found in Section F. Therapeutic Elastic knee braces may be useful for increasing postural stability.

C) There is some evidence that, in the setting of acute ACL tears, a treatment plan which refers the patient to physical therapy with an option for delayed surgery can be expected to be as successful at 5 years as a treatment plan which refers the patient for early surgery. This delayed surgery treatment plan may make some ACL operations unnecessary. However, over 1/3 of patients eventually had an ACL reconstruction and it is possible that delaying reconstruction may increase osteoarthritis and meniscus tears in the long-term.

A recent systematic review found good function for non-operated partial ACL tears for patients with limited sports activities with an average of 5.2 years of follow-up.

Outside of the setting where the patient has a locked knee, an ACL rupture does not require emergent treatment. The decision to provide immediate surgical reconstruction should depend on patient preference and work and recreational activities. Young active patients 18-35 years are likely to prefer surgical reconstruction.

A six-week course of progressive rehabilitation with a focus on strengthening the quadriceps muscles may lead to improved knee function and self-reported outcomes postoperatively. The quadriceps and hamstring muscles provide dynamic stabilization of the knee while the ACL typically provides passive stabilization.

Adequate pre-operative rehabilitation will poise the affected knee for postoperative rehabilitation success.

Eccentric exercise may provide better results than concentric exercise.

D) Delaying surgery until full, symmetric range of motion is restored, the effusion is resolved, the patient demonstrates good quadriceps muscle control, and has a normal gait pattern may be a reasonable pre-operative approach.

E) Medications such as analgesics and anti-inflammatories may be helpful. Refer to Section F.7, Medications and Medical F) Regardless of the chosen intervention, patients should be encouraged to remain physically active and maintain a healthy body weight.

G) Other therapies in Section F. Therapeutic Procedures, Non- H) Platelet Rich Plasma:

There is no evidence showing improved clinical outcome with use of PRP for augmentation of ACL reconstruction. Therefore, it is not recommended.

I) Return to work with appropriate restrictions should be considered J) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: an individual with complaints of recurrent instability interfering with function, physical findings, and imaging consistent with an ACL partial or complete tear, and who has failed initial treatment. Surgery may also be performed without delay if other pathology requiring surgery is present or if the patient is engaged in work or job related activity which requires knee stability.

A detailed occupational history, documenting the circumstances under which ACL rupture occurred, will provide a sense for the physical demands of the patient’s job, which may affect injury management.

Occupations that rely heavily on ACL stability might involve squatting, pivoting, twisting, climbing and stepping laterally or on uneven ground.

Construction is an example of an occupation that might fit this criterion.

Persons in occupations that are sedentary in nature or involve predominantly straight-line activities (i.e. standing, walking on even surfaces, running, cycling, etc.) may benefit from rehabilitation with no need for surgical intervention. It is equally important to consider the patient’s typical recreational activities. If the patient is involved in sports or other hobbies requiring cutting and pivoting actions of the knee (i.e. soccer, basketball, etc.), then early surgery before 5 months may be the preferable approach to ACL rupture.

Patients who undergo early ligament reconstruction for ACL rupture are more likely to have tibiofemoral stability on clinical testing, and a lower incidence of subsequent meniscal surgery. However, however knee function does not appear to be greater and there is no clear evidence that early reconstruction either increases return to pre-injury levels of activity or prevents later development of osteoarthritis.

A) There is some evidence that, in the setting of an acute ACL injury not complicated by high grade chondral defects, surgical repair performed an any time in the first six weeks is as effective as immediate surgery. However, this is true only if the preoperative period is accompanied by an exercise rehabilitation and by a locking knee brace to support any weight-bearing.

B) There was some evidence based on two studies reviewed, that undergoing non-operative initial treatment is as likely to be successful as an initial plan for prompt surgery. However, about half of individuals who initially delay surgery will have persistent symptomatic instability that interferes with function, necessitating referral to orthopedics and possible surgery.

C) Adverse events at two years were not significantly different between the group randomly assigned to receive rehabilitation with early reconstruction (three with graft rupture and one with arthrofibrosis) as compared to those assigned to receive rehabilitation with an option for delayed repair (one graft rupture).

However, the patients who did not have surgery were more likely to have instability and meniscus issues. Current long-term studies indicate that a difference in rates of radiographic osteoarthritis between operative versus non-operative treatments has not been demonstrated after ten years.

D) There is no clear evidence that surgery decreases the likelihood of developing osteoarthritis secondary to the original injury.

E) Smoking may affect soft tissue healing through tissue hypoxia.

F) Diabetes clearly effects outcomes and the incidence of G) Prior to surgical intervention, the patient and treating physician H) Patient education should include a discussion regarding realistic expectations for return to pre-injury level of function with early surgery (within 10 weeks of injury) versus with rehabilitation and an option for delayed reconstruction. The studies reviewed examined physically active, athletically inclined populations. In this population return to pre-injury sports level was the exception rather than the rule. At five-years follow up, the percentage of subjects capable of return to pre-injury activity levels were similar for the early ACL reconstruction and the delayed reconstruction groups (23% and 20%, respectively), and down from two-year follow up of 44% and 36%, respectively. Although this highly active group was unable to return to their previous level of physical activity, the patients were by no means disabled from their full range of daily activities, such as walking, climbing stairs, cycling, or jogging.

At two- and five-year follow up, patient-reported functional outcomes as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) were similar in the early ACL reconstruction group and the rehabilitation with option for delayed repair groups. Knee laxity, as measured by physical exam and arthrometry, however, were significantly less in the early ACL surgical group.

vii. Operative Procedures:

Diagnostic/surgical arthroscopy followed by ACL reconstruction using autograft or allograft. If a meniscus repair is performed, the ACL repair is preferably performed concurrently.

There is good evidence that medial meniscal tears are more commonly present when ACL reconstruction is done more than 12 months after injury than when it is done within 12 months of injury. Thus, surgery should be performed before one year and preferably by 5 months if the patient chooses an operative procedure after conservative treatment failure.

Patients tend to have more pain associated with patellar grafts while patients with hamstring replacement seem to have an easier rehabilitation. Choice of graft is made by the surgeon and patient on an individual basis.

One study found no evidence for improvement when bone marrow stem cells were added to an ACL reconstruction. Therefore, stem cells are not There is good evidence that computer assisted surgery does not improve outcomes over conventional surgery for knee ligament reconstruction, but may add to operating time. Therefore, it is not recommended.

viii. Complications: graft rupture, arthrofibrosis, continued instability. The overall failure rate is about 12%.

ix. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include the following: active therapy with or without passive therapy and bracing. Early active extension does not cause increased laxity at 2 years.

Initiation of a graduated physical therapy program, as early as the first postoperative day, is as safe and effective as delayed rehabilitation.

There is some evidence that rehabilitation can begin safely as early as the immediate postoperative period with weight-bearing, flexion up to 90 degrees, and quadriceps strengthening.

One study found a 12 week program beginning 3 weeks postoperatively focusing on eccentric exercise improved function and muscle volume more than standard rehabilitation when assessed one year postoperatively.

There is good evidence that, in the setting of postoperative ACL rehabilitation, knee bracing is not always necessary; continuous passive motion has no benefits; and home exercises may be as effective as outpatient rehabilitation in motivated patients.

Therefore, continuous passive motion is not recommended.

C) A structured postoperative rehabilitation program incorporating whole body conditioning, range of motion exercises, and neuromuscular training is appropriate. Proprioception undoubtedly enhances the physiologic function of dynamic stabilizers of the knee. While recognizing that proprioception is integral to proper knee function, the current body of literature limits the ability to make an evidence-based recommendation for a specific method of neuromuscular training.

D) Return to work and restrictions after surgery may be made by an attending physician experienced in occupational medicine, in consultation with the surgeon or by the surgeon. In general, the patient may reasonably return to sedentary work within two weeks of surgery.

c. Bursitis of the Lower Extremity:

i. Description/Definition: Inflammation of bursa tissue. Bursitis can be precipitated by tendonitis, bone spurs, foreign bodies, gout, arthritis, muscle tears, or infection.

ii. Occupational Relationship: Soft tissue trauma, contusion, or physical activities of the job such as sustained direct compression force, or other repetitive forceful activities affecting the knee.

iii. Specific Physical Exam Findings: Palpable, tender and enlarged bursa, decreased ROM, warmth. The patient may have increased pain with ROM.

iv. Diagnostic Testing Procedures: Lab work may be done to rule out inflammatory disease. Bursal fluid aspiration with testing for connective tissue, rheumatic disease, and infection may be necessary.

Radiographs, CT, MRI are rarely indicated.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Diagnostic/therapeutic aspiration, ice, therapeutic injection, treatment of an underlying infection, if present. Aspirations may be repeated as clinically indicated.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and (ROM), active therapies, including a home exercise program.

Active therapies include, proprioception training, restoring normal joint mechanics, and clearing dysfunctions from distal and proximal joints. Passive as well as active therapies may be used to control pain and swelling. Therapy should progress to knee. Refer to Section F. Therapeutic Procedures, Non- E) Steroid Injections- Steroid injections may decrease inflammation and allow the therapist to progress with functional exercise and ROM. Steroid injections may be useful for aseptic bursitis.

Caution should be used when considering steroid injections for patients with an A1c level of 8% or greater.

• Time to Produce Effect: One injection.

• Maximum Duration: 3 injections in one year. Not to exceed 4 injections of any body part in one year.

F) Return to work with appropriate restrictions should be considered G) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical indications/Considerations:

A) Failure of conservative therapy.

B) Diabetes clearly effects outcomes and the incidence of C) Prior to surgical intervention, the patient and treating physician D) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Surgical excision of the bursa.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon the therapies as outlined in Section F. Therapeutic Procedures, B) Return to work and restrictions after surgery may be made by an d. Chondral and Osteochondral Defects:

i. Description/Definition: Cartilage or cartilage and bone defect at the articular surface of a joint. Deficits may be identified in up to 60% of arthroscopies; however, only around 30% of these lesions are isolated deficits and even fewer are Grade III or IV deficits which might qualify for cartilage grafts.

Defects in cartilage and bone are common at the femoral condyles and patella. The Outerbridge classification grades these defects according to their size and depth.

Grade 0: normal cartilage.

Grade I: softening and swelling of cartilage.

Grade II: partial-thickness defects with surface fissures that do not exceed 1.5 cm in diameter and do not reach subchondral bone.

Grade III: fissuring that reaches subchondral bone in an area with a diameter greater than 1.5 cm.

Grade IV: exposed subchondral bone.

Chondral deficits can be asymptomatic. In a study of professional athletes, full thickness chondral deficits were present in 36% of the population, however half of these were not symptomatic.

ii. Occupational Relationship: Typically caused by a traumatic knee injury.

Chondral deficits can also be present secondary to osteoarthritis.

iii. Specific Physical Exam Findings: Knee effusion, joint line tenderness.

iv. Diagnostic Testing Procedures: MRI may show bone bruising, osteochondral lesion, or possibly articular cartilage injury. The mere presence of a full thickness deficit does not confirm the diagnosis as some deficits are asymptomatic. Radiographs, contrast radiography, or CT may also be used. Diagnostic arthroscopy may be performed when surgical indications listed in Section VI are met.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Non-operative treatment may be indicated for chondral lesions associated with 1) degenerative changes, refer to aggravated osteoarthritis (Section E.2., a); 2) other knee lesions not requiring surgery (refer to Specific Diagnosis); and/or 3) non-displaced stable lesions. Acute injuries may require immobilization followed by active therapy with or without passive B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and therapies include, proprioception training, restoring normal joint structures. Passive as well as active therapies may be used to knee. Refer to Section F. Therapeutic Procedures, Non- E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations:

Surgery for isolated chondral defects may be indicated when functional deficits interfere with activities of daily living and/or job duties after 6 to 12 weeks of active patient participation in non-operative therapy.

Identification of the lesion should have been accomplished by diagnostic testing procedures which describe the size of the lesion and stability of the joint.

If a lesion is detached or has fluid underlying the bone on MRI, in some cases surgery may be necessary before a trial of conservative therapy is completed. Early surgery may consist of fixation, grafts, microfracture and removal of the fragment.

A systematic review of autologous chondrocyte implantation (ACI) found that ACI, as well as microfracture and osteochondral autograft provides short-term success. Another systematic review found microfracture to be successful for smaller lesions and matrix-associated autologous chondrocyte implantation more effective for lesions greater than 4 square cm than microfracture.

A) Microfractures: Normally the first line of surgical treatment.

Indications: An isolated small full-thickness articular chondral defect with normal joint space, when the patient has not recovered functionally after active participation in therapy.

Microfracture is likely ineffective for large lesions. Patients 45 or younger are likely to have better results.

B) Osteochondral Autograft/Allograft Transfer System (OATS) or Allograft One non-controlled study followed patients less than 50 years of age with OAT mosiacplasty or microfracture for 5 years.

Outcomes were similar except for athletes. There is some evidence that, in highly athletic patients with osteochondritis dissecans or with posttraumatic full-thickness chondral lesions of the knee who are fully compliant with an active postoperative rehabilitation program, an OAT procedure is more likely than a microfracture procedure to lead to return to sports, higher functional knee scores, and fewer reoperations during the ten years following treatment of the injury.

Indications: The knee must be stable with intact ligaments and menisci, normal joint space and a large full-thickness defect less than 3 square cubic cm and 1 cm depth. The patient should be 55 years old or younger, with a BMI less than 35, and engaged in athletics and/or an equally physically demanding occupation.

Lesions should be unipolar. Surgery may be indicated when functional deficits interfere with activities of daily living and/or job duties after 6 to 12 weeks of active patient participation in nonoperative therapy. Occasionally, surgery may also be indicated as an initial procedure for chondral defects of traumatic origin in patients with very active physical job duties. This procedure may be appropriate in a small subset of patients and requires prior authorization.

C) Autologous chondrocyte implantation (ACI) with or without matrices: These procedures are technically difficult and require specific physician expertise. Cartilage transplantation requires the harvesting and growth of patients’ cartilage cells in a highly specialized lab. This procedure also carries significant laboratory charges.

In one observation study of patients receiving autologous chrondrocyte implantation after failing microfractures, 76% were deemed successful although 49% had subsequent surgical procedures. Follow up studies of first generation and matrix induced ACI demonstrated significant functional improvement over baseline for up to 10 years. Per one systematic review, lesions with 4 cubic cm or greater had better outcomes with ACI.

One study showed better results with matrices versus microfracture. However, the review showed no evidence for one matrix over another. A meta-analysis suggests that second and third generation ACI are superior to microfracture for five years after the procedure and for larger lesions. A cohort study suggests that early ACI before microfracture may provide better overall results, although there was no difference in the activities participated in. In one follow up study, 50% of patients did not complete the procedure due to relief from the initial harvesting procedure. However, one Cochrane study found insufficient evidence to support autologous chrondrocyte implantation.

This procedure is controversial but may be appropriate in a small subset of patients with physically rigorous employment or recreational activities. It requires prior authorization.

Indications: The area of the lesion should be between 2 square cm and 4 square cm. The patient should have failed 4 or more months of active participation in therapy and a microfracture, abrasion, arthroplasty or drilling with healing time from 4 months to over one year. Those with lesions greater than 4 square cm may have ACI as a primary procedure. The knee must be stable with intact ligaments and meniscus, and normal joint space.

Patients should be 55 years old or younger, with a BMI less than 35, and engaged in athletics and/or an equally physically demanding occupation.

Contraindications: General contraindications for grafts and transplants are individuals with obesity, inflammatory or osteoarthritis with multiple chondral defects, associated ligamentous or meniscus pathology, or who are older than 55 D) Prior to either graft or implantation intervention the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work. The patient should agree to comply with the pre- and post-operative treatment plan including home exercise.

The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

E) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Arthroscopy with debridement or shaving of cartilage, microfracture, drilling, abrasion arthroplasty, mosiacplasty or osteochondral autograft/allograft (OATS), fixation of loose osteochondral fragments and autologous chondrocyte implantation (ACI).

There is inadequate evidence of the effectiveness of PRP in the setting of microfracture in patients with knee OA over the age of 40. Therefore, it is not recommended.

Biologics such as stem cell or PRP have been used, however, their efficacy is currently unproven. Prior authorization is required for their use. They may be most appropriate for patients with complex cases or otherwise at high risk.

Complications: Graft hypertrophy especially with periosteal ACI, arthrofibrosis, graft failure, infection, need for repeat procedures.

viii. Post-operative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include the following: restricted weight-bearing, bracing, active therapy with or without passive therapy. Full weight-bearing usually occurs by or before 8 weeks. Full recovery may take up to 12 months.

C) Continuous passive motion is used postoperatively for microfractures and ACI. Refer to section F.16.a Continuous Passive Motion, for more details.

D) Return to work and restrictions after surgery may be made by an consultation with the surgeon or by the surgeon. Return to fullduty usually occurs by between four and six months.

e. Collateral Ligament Pathology:

i. Description/Definition: Strain or tear of medial or lateral collateral ligaments which provide some stabilization for the knee.

ii. Occupational Relationship: Typically a result of forced abduction and external rotation to an extended or slightly flexed knee. A direct blow to the lateral aspect of the knee may cause a medial collateral ligament strain.

iii. Specific Physical Exam Findings: Swelling or ecchymosis over the collateral ligaments and increased laxity or pain with applied stress.

Laxity with the knee in full extension suggests severe injury to the ligament and likely associated injuries.

iv. Diagnostic Testing Procedures: X-rays to rule out fracture. Imaging is more commonly ordered when internal derangement is suspected.

Bilateral stress x-rays may be useful.

v. Non-operative Treatment Procedures:

A) Initial Treatment: braces, ice, and protected weight-bearing.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be helpful. Refer to medication discussions area in Section F.7, D) Benefits may be achieved through therapeutic rehabilitation and rehabilitation interventions. Early functional rehabilitation is encouraged. Treatment should include early range-of-motion structures. Bracing may be beneficial for Grades II-III. A light weight hinged knee brace may be used to protect valgus stress.

For more severe isolated injuries a mid-weight polycentric hinged brace should be used to maximize ligament healing. Passive as well as active therapies may be used to control pain and swelling. Cryotherapy and leg elevation is useful for the first 48 hours. Therapy should progress to strengthening and an structures distal and proximal to the knee. Refer to Section F.

Therapeutic Procedures, Non-operative.

E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Surgery is rarely necessary except when functional instability persists after active participation in nonoperative treatment or indications for surgery exist due to other accompanying injuries. Such accompanying injuries may include a large bony avulsion, tibial plateau fracture or cruciate ligament tear. MCL repair is usually not required, but may be done in conjunction with an ACL reconstruction at the surgeon’s discretion. When Lateral collateral ligament (LCL) injuries are associated with other knee pathology, repair is indicated.

A) Diabetes clearly effects outcomes and the incidence of B) Prior to surgical intervention, the patient and treating physician agree to comply with the pre- and post-operative treatment plan, C) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Surgical repair with graft reconstruction.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon procedures as outlined in Section F. Therapeutic Procedures, B) Return to work and restrictions after surgery may be made by an f. Meniscus Injury:

i. Description/Definition: A tear, disruption, or avulsion of medial or lateral meniscus tissue. Locking of the knee or clicking is frequently reported.

Patients may describe a popping, tearing, or catching sensation followed by stiffness.

ii. Occupational Relationship: Trauma to the menisci from rotational shearing, torsion, and/or impact injuries while in a flexed position.

There is good evidence from a meta-analysis of observational studies that there is an increased risk of degenerative meniscal tears with age over 60; BMI over 25; male gender; work-related kneeling and squatting; and regularly climbing greater than 30 flights of stairs per day for 12 months.

There is also good evidence that acute meniscal tears occur more frequently in soccer and rugby.

iii. Specific Physical Exam Findings: Joint line tenderness, Positive McMurray’s test; Thessaly test, locked joint, or, occasionally, effusion.

The joint line tenderness in one study had a diagnostic accuracy of 81% for medial meniscus and 90% for lateral meniscus. The Thessaly test at 20º of flexion has also been found highly diagnostic for lateral or medial meniscus tears. The Apley’s compression test is also used.

iv. Diagnostic Testing Procedures: Radiographs including standing Posterior/Anterior (PA), lateral, tunnel, and skyline views. MRI is the definitive imaging test. MRI is sensitive and specific for meniscal tear.

However, meniscal MRI is frequently abnormal in asymptomatic patients.

In one study of volunteers without a history of knee pain, swelling, locking, giving way, or any knee injury, 16% of the volunteers had MRIevident meniscal tears; and 36% of volunteers older than 45 had MRIevident meniscal tears. Therefore, clinical correlation with history and physical exam findings specific for meniscus injury is critically important.

Providers planning treatment should therefore consider the patient's complaints and presence of arthritis on MRI carefully, because not all meniscus tears in the middle aged and older populations are related to the patients’ complaints of pain.

MRI arthrograms may be used to diagnose recurrent meniscal tears, particularly after previous surgery.

v. Non-operative Treatment:

A) Initial Treatment: ice, bracing, and protected weight-bearing.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and structures. Passive as well as active therapies may be used to knee. Refer to Section F. Therapeutic Procedures, Non- There is some evidence that, for many patients with nontraumatic degenerative tears of the medial meniscus, an exercise program alone will be an adequate treatment for up to 5 years post initiation of symptoms. However, one third of patients initially treated conservatively may go on to require surgery and will have an outcome similar to patients treated with early There is some evidence that, in patients with degenerative tears of the medial meniscus, a conservative treatment plan may yield substantial functional and symptomatic benefits similar to arthroscopic meniscectomy when measured 2 years after the beginning of treatment. This conservative treatment plan must include both supervised physical therapy and a home exercise program.

There is good evidence that, in the initial management of knee OA with a torn meniscus, it is reasonable to start with nonoperative physical therapy. There is also good evidence that about 30% of patients may not respond to PT alone. The appropriate treatment changes for the patients who do not do well with PT are not evident from the study, since little is known about what accounts for their lack of benefit from the PT program.

E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Non- G) Surgical Indications/Considerations:

1. Locked or blocked knee precluding active therapy;

2. Isolated acute meniscus tear with appropriate physical exam findings;

3. Isolated degenerative meniscal tear is not an indication without locking or other major functional symptoms Multiple studies note increased osteoarthritis in knees with menisectomy, with a greater incidence in patients who have had a total menisectomy, allograft, lateral menisectomy, or degenerative tear.

There is some evidence that, in patients with degenerative tears of the medial meniscus, a conservative treatment plan may yield substantial functional and symptomatic benefits similar to arthroscopic meniscectomy when measured 2 years after the beginning of treatment. The conservative treatment plan must include both supervised physical therapy and a home exercise program There is some evidence that, in the setting of nontraumatic meniscal tears, a treatment plan focusing on supervised exercise followed by home exercise has an equal probability of success as a treatment plan involving early arthroscopic partial meniscectomy. This assumes that a surgical option is offered to patients who have persistent knee limitations after several months of exercise therapy.

There is good evidence that, in the initial management of knee OA with a torn meniscus, it is reasonable to start with non-operative physical therapy. There is also good evidence that about 30% of patients may not respond to PT alone. The appropriate treatment changes for the patients who do not do well with PT are not evident from the study, since little is known about what accounts for their lack of benefit from the PT program.

There is good evidence that, in patients with nontraumatic degenerative meniscal tears who have full knee range of motion and mild or no osteoarthritis, whose symptoms have not resolved with three months of conventional conservative treatment, both arthroscopic partial meniscectomy and a sham diagnostic arthroscopic intervention are followed by clinically important improvements in pain and function, and that arthroscopic meniscotomy is not superior to the sham diagnostic procedure which leaves the meniscus intact.

In summary, there is strong evidence that partial menisectomy provides no clear benefit over initial exercise therapy for patients with an isolated degenerative meniscal tear. Therefore, it is not recommended. It may be appropriate for the patients who continue to have significant functional deficits of activities of daily living or work duties after 6 weeks of therapy. It requires prior authorization.

Meniscal repair is appropriate for tears in the red-red zone or red-white zone as these areas have better vascular supply for healing.

One case series of the patients receiving meniscus allograft demonstrated increased graft failure in the patients with grade 3b or higher articular damage.

H) Meniscal allograft should only be performed on patients with a stable knee, previous meniscectomy with 2/3 removed, lack of function despite active therapy, BMI less than 30, and sufficient joint surface to support repair.

I) Diabetes clearly effects outcomes and the incidence of J) Prior to surgical intervention, the patient and treating physician K) Smoking may affect soft tissue healing through tissue hypoxia.

vi. Operative Treatment: Repair of meniscus, partial or complete excision of meniscus, or meniscus allograft. Debridement of the meniscus is not recommended in patients with severe arthritis as it is unlikely to alleviate symptoms. Complete excision of meniscus should only be performed when clearly indicated due to the long-term risk of arthritis in these patients.

vii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include the following: Passive therapy progressively moving toward active therapy, bracing, cryotherapy and other treatments found in Section F.

C) Return to work and restrictions after surgery may be made by an consultation with the surgeon or by the surgeon. Return initially with restrictions 2-6 weeks.

g. Patellar Fracture:

i. Description/Definition: Fracture of the patella.

ii. Occupational Relationship: Usually from a traumatic injury such as a fall or direct blow. An indirect force may cause minimally displaced transverse fracture.

iii. Specific Physical Exam Findings: Significant hemarthrosis/effusion usually present. Extension may be limited and may indicate disruption of the extensor mechanism. It is essential to rule out open fractures; therefore a thorough search for lacerations is important.

iv. Diagnostic Testing Procedures: Aspiration of the joint and injection of local anesthetic may aid the diagnosis. A saline load injected in the joint can also help rule out an open joint injury. Radiographs are performed, including tangential (sunrise) or axial views and x-ray of the opposite knee in many cases. CT or MRI is rarely needed.

v. Non-operative Treatment Procedures:

A) Initial Treatment: For non-displaced closed fractures, protected weight-bearing and functional bracing or a hinged knee brace locked in extension for 4 to 6 weeks. When radiographs demonstrate consolidation, active motion and strengthening exercise may begin.

B) Patient education should include instruction in self-management C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments related to osteoporosis in Section F.7.h.

E) There is good evidence that smoking significantly increases the F) Benefits may be achieved through therapeutic rehabilitation and therapies including proprioception training, restoring normal joint mechanics, clearing dysfunctions from adjacent structures, and a home exercise program. Passive as well as active therapies may be used to control pain and swelling. Therapy should progress to targeted to further improve ROM, strength, restoring normal joint mechanics, influenced by proximal and distal structures. Therapy should include training on the use of adaptive equipment and home and work site evaluations when appropriate. Bracing may be appropriate. Refer to Section F. Therapeutic Procedures, G) Return to work with appropriate restrictions should be considered H) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Open fractures require immediate intervention and may need repeat debridement. Internal fixation is usually required for comminuted or displaced fractures. Nonunion may also require surgery.

There is no adequate level of evidence to guide the choice of treatment for patellar fractures. full-disability expected postoperatively. Many patients continue to have symptomatic and functional complaints post-surgery.

vii. Operative Procedures: internal fixation; partial patellectomy, or total patellectomy. Total patellectomy results in instability with running or stairs and significant loss of extensor strength. Therefore, this is usually a salvage procedure. not recommended for delayed union or nonunion of fractures.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include protected weight-bearing and active therapy with or without passive therapy for early range of motion if joint involvement. A hinged brace may be used with some weight bearing for 6 weeks.

C) Return to work and restrictions after surgery may be made by an D) Hardware removal may be necessary after 3 to 6 months.

h. Patellar Subluxation:

i. Description/Definition: Incomplete subluxation or dislocation of the patella. Recurrent episodes can lead to subluxation syndrome that can cause frank dislocation of the patella. Patient may report a buckling sensation, pain with extension, or a locking of the knee with exertion.

ii. Occupational Relationship: Primarily associated with a direct contact lateral force or the leg rotating around a planted foot. Secondary causes associated with shearing forces on the patella.

iii. Specific Physical Exam Findings: Lateral retinacular tightness with associated medial retinacular weakness, swelling, effusion, and marked pain with patellofemoral tracking/compression and glides. In addition, other findings may include atrophy of muscles, positive patellar apprehension test, and patella alta.

iv. Diagnostic Testing Procedures: CT or Radiographs including Merchant views, and MRI for loose bodies or chondral pathology. A recent systematic review found insufficient evidence to support the reliability of isolated radiologic findings.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Reduction if necessary, ice, taping, and bracing followed by active therapy. For those with more instability, a knee immobilizer, patella stabilizing brace, or hinged brace may be used.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and structures. Taping the patella or bracing may be beneficial.

Passive as well as active therapies can be used to control pain structures distal and proximal to the knee. Specific strengthening should be done to optimize patellofemoral mechanics and address distal foot mechanics that influence the patellofemoral joint. Refer to Section F. Therapeutic Procedures, Non-operative.

E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations:

A) Fracture, loose bodies, and recurrent dislocation. Surgical repair of first-time dislocation in young adults generally is not recommended. A Cochrane review does not indicate a clear advantage for repair in first time dislocations. Retinacular release, quadriceps reefing, and patellar tendon transfer should only be considered for subluxation after 4 to 6 months of active patient participation in non-operative treatment.

B) Diabetes clearly effects outcomes and the incidence of C) Prior to surgical intervention, the patient and treating physician D) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: arthroscopy with possible arthrotomy; debridement of soft tissue and articular cartilage disruption; open reduction internal fixation of an osteochondral fracture; quadriceps reefing; medial retinaculum reefing and/or repair; lateral release with or without medial soft-tissue realignment; and medial patellofemoral ligament (mPFL) reconstruction with grafts with or without tibial tubercle osteotomy. The patients with a mPFL repair [1] have a higher rate of failure (27%) vs mPFL reconstruction (6.6%).

Complications: Infection, secondary complications at graft site.

Recurrence may be up to 33% with some procedures.

viii. Postoperative Treatment:

A) Individualized rehabilitation program based upon communication between the surgeon and the therapist using the treatments B) Treatment may include active therapy with or without passive therapy, bracing. Therapy usually lasts 12 weeks.

C) Return to work and restrictions after surgery may be made by an addressed for temporary or permanent physical restrictions.( i. Patellofemoral Pain Syndrome (aka Retropatellar Pain Syndrome) and Patellar Tendinopathy:

i. Description/Definition: Patellofemoral pathologies are associated with resultant weakening, instability, and pain of the patellofemoral mechanism. Diagnoses can include patellofemoral chondromalacia, malalignment, persistent quadriceps tendonitis, distal patellar tendonitis, patellofemoral arthrosis, and symptomatic plica syndrome. Patient complains of pain, instability and tenderness that interfere with daily living and work functions such as sitting with bent knees, climbing stairs, squatting, running or cycling. About 60% of patients will recover by 12 months. Those with worse knee pain and symptoms and longer duration at base-line are likely to have poor recovery.

ii. Occupational Relationship: Usually associated with contusion; repetitive patellar compressive forces; shearing articular injuries associated with subluxation or dislocation of patella; fractures; and/or infection. Most commonly occurs in young patients who participate in athletic activities involving jumping.

iii. Specific Physical Exam Findings: Findings on physical exam may include retinacular tenderness, pain with patellar compressive ranging, positive patellar glide test, atrophy of quadriceps muscles, and positive patellar apprehensive test. Associated anatomical findings may include increased Q angle, ligament laxity, and effusion. Some studies suggest that the patellar tilt test (assessing the patella for medial tilt) and looking for active instability with the patient supine and knee flexed to 15 degrees and an isometric quad contraction, may be most useful for distinguishing normal from abnormal findings. A recent systematic review suggested a relationship between loss of strength in hip abduction and external rotations as well as knee extension torque. In addition, a larger Q-angle, sulcus angle, and patellar tilt were thought to be associated. A recent systematic review found no evidence to support any specific tests and noted the need to rule out other diagnoses such as osteoarthritis, plica syndrome, and subluxation before the diagnosis of patellofemoral pain syndrome is strongly considered.

iv. Diagnostic Testing Procedures: Radiographs including tunnel view, axial view of patella at 30 degrees, lateral view and. Merchant views. MRI rarely identifies pathology. Occasional CT or bone scans.

v. Non-operative Treatment Procedures:

A) Patient education should include instruction in self-management B) Medications such as analgesics and anti-inflammatories may be C) Benefits may be achieved through therapeutic rehabilitation and rehabilitation interventions. The program should include bracing and/or patellar taping, prone quad stretches, hip external rotation, balanced strengthening, range-of-motion (ROM), active include proprioception training, restoring normal joint mechanics, and clearing dysfunctions from distal and proximal structures. and swelling.

D) Therapy should progress to strengthening and an independent home exercise program targeted to further improve ROM, strength, and normal joint mechanics influenced by structures distal and proximal to the knee.

• There is good evidence that the addition of hip muscle strengthening exercises to knee-focused strengthening and stretching exercises results in greater improvements in pain and function. The addition of hip muscle strengthening exercises is also more effective than knee-strengthening exercises alone in individuals with patellofemoral pain syndrome (PFPS).

• There is some evidence that, in the setting of patellar tendinopathy, a home program beginning with eccentric exercise is as effective as one beginning with referral to surgery, although referral to surgery in the first six months may be necessary for some patients. Although heavy slow resistance training may be an acceptable alternative to eccentric exercise, it requires special equipment, and has no advantage over eccentric exercise which can be done at home with a simple 25° decline squat board.

• Proprioceptive neuromuscular education may be useful.

• It may be that women and those with longer duration of pain will benefit the most from exercise therapy. Refer to operative. Orthotics may be useful in some cases.

E) Knee pain, when associated with abnormal foot mechanics, may be favorably treated with appropriate orthotics. There is some evidence that off the shelf foot orthoses were found to be better than flat foot inserts in the short-term. In this study both physiotherapy and foot orthoses had similar outcomes at 52 weeks. Physiotherapy once each week for 6 weeks included joint mobilization, taping and quadriceps muscle strengthening.

Although foot orthoses added to PT did not appear to change long-term outcome, it is possible they may hasten return to work.

In another study, patients who benefited most from orthoses had 3 of the following: older than 25; height less than 165cm; worst pain less than 5.3/10, and mid foot width difference from nonweight bearing to weight bearing greater than 10.96mm.

F) Botulinum toxin injections for the relief of patellofemoral pain are considered experimental and are not generally recommended.

G) Autologous blood and platelet-rich plasma are considered experimental and not recommended.

H) Steroid Injections:

Steroid injections may decrease inflammation and allow the therapist to progress with functional exercise and ROM. Steroid injections under significant pressure should be avoided as the needle may be penetrating the tendon. Injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture. Injections near the patellar tendon should generally be avoided. Injections should be minimized for patients less than 30 injections for patients with an A1c level of 8% or greater. There is no evidence that steroid injections are more effective than eccentric exercise.

• Time to Produce Effect: One injection.

• Maximum Duration: 3 injections in one year spaced at least I) Sclerosing Injections:

Sclerosing injections have not been compared with exercise and there is no evidence to support their use.

J) Extracorporeal Shock Wave Therapy (ESWT): There is no evidence that ESWT is effective for patellar tendinopathy.

K) Return to work with appropriate restrictions should be considered Other therapies in Section F. Therapeutic Procedures, Non-operative may be employed in individual cases.

vi. Surgical Indications/Considerations: patellar tendon disruption, quadriceps tendon rupture/avulsion, fracture. The majority of patients with anterior knee pain will improve over time without surgery.

A) Retinacular release, quadriceps reefing, and tibial transfer procedures should only be considered after 4 to 6 months of active participation in non-operative treatment by young active patients. There is no evidence that arthroscopy for patellofemoral syndrome is more efficacious than exercise.

B) Lateral release and reconstruction is not recommended for patellofemoral arthritis or middle aged adults.

C) In cases of severe Grade III-IV isolated patellofemoral arthritis where walking, steps, and other functional activities are significantly impacted after adequate conservative treatment, prosthesis may be considered in those less than 55 years. A patellofemoral arthroplasty is generally contraindicated if there is patellofemoral instability or malalignment, tibiofemoral mechanical malalignment, fixed loss of knee motion (greater than 10 degrees extension or less than 110 degrees flexion), inflammatory arthritis, and other systemic related issues. For patellar resurfacing, refer to Section G. 4. Knee Arthroplasty.

D) Diabetes clearly effects outcomes and the incidence of E) Prior to surgical intervention, the patient and treating physician F) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Arthroscopic debridement of articular surface, plica, synovial tissue, loose bodies; arthrotomy; open reduction internal fixation with fracture; patellar prosthesis with isolated Grade III-IV OA, and possible patellectomy for young active patients with isolated arthritis.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include active therapy with or without passive therapy; and bracing.

C) Return to work and restrictions after surgery may be made by an j. Posterior Cruciate Ligament (PCL) Injury:

i. Description/Definition: Rupture of PCL. May be associated with concurrent ACL rupture or collateral ligament injury.

ii. Occupational Relationship: Most often caused by a posterior force directed to flexed knee, such as a dashboard injury, or by a fall on the knee with the foot plantar flexed.

iii. Specific Physical Exam Findings: Findings on physical exam include acute effusion, instability, reverse Lachman’s test, reverse pivot shift, posterior drawer test.

iv. Diagnostic Testing Procedures: MRI, radiographs including kneeling view, may reveal avulsed bone. MRI is very sensitive to identifying a tear but less likely to differentiate partial from complete tears.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Ice, bracing, and protected weight-bearing followed by active therapy.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and rehabilitation interventions. They should include bracing then range-of-motion (ROM), active therapies, and a home exercise program. Eighty percent of isolated Grade I or II PCL injuries will improve without surgery. Open kinetic chain flexion exercises should generally be avoided, due to increased PCL stress.

Resisted motion including weight bearing should be limited to a flexion range of 0-60 degrees. Closed chain exercises are recommended. Active therapies include proprioception training, restoring normal joint mechanics, and clearing dysfunctions from distal and proximal structures.

ROM, strength, and normal joint structures distal and proximal to the knee. Refer to Section F. Therapeutic Procedures, Non- E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations:

A) Carefully consider the patients’ normal daily activity level before initiation of surgical intervention. Isolated Grade 1 instability does not require surgical intervention. Grades 2 or 3 may have surgical intervention if there remains demonstrable instability which interferes with athletic or work pursuits of the patient. In a second degree strain there is significant posterior motion of the tibia on the femur in active testing. A third degree strain demonstrates rotary instability due to medial or lateral structural damage. Surgery is most commonly done when the PCL rupture is accompanied by multi-ligament injury or accompanying an avulsion of bone. Not recommended as an isolated procedure in patients over 50 with Grade 3 or 4 osteoarthritis.

B) Diabetes clearly effects outcomes and the incidence of C) Prior to surgical intervention, the patient and treating physician D) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Autograft or allograft reconstruction or augmentation. There is good evidence that computer assisted surgery does not improve outcomes over conventional surgery for knee ligament reconstruction, but may add to operating time. Therefore, it is not viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include active therapy with or without passive therapy, bracing.

C) Return to work and restrictions after surgery may be made by an k. Tendinopathy:

i. Description/Definition: Inflammation of the lining of the tendon sheath or of the enclosed tendon. Usually occurs at the point of insertion into bone or a point of muscular origin. Can be associated with bursitis, calcium deposits, or systemic connective diseases. Patellar and quadriceps tendinopathy are most common in the knee. The patellar tendon may be also referred to as the patellar ligament.

ii. Occupational Relationship: Extreme or repetitive trauma, strain, or excessive unaccustomed exercise or work. Patellar tendinitis, also called jumper’s knee, is associated with volleyball and basketball.

iii. Specific Physical Exam Findings: Involved tendons may be visibly swollen with possible fluid accumulation and inflammation; popping or crepitus; and decreased ROM.

iv. Diagnostic Testing Procedures: Lab work may be done to rule out inflammatory disease. Other tests are rarely indicated.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Ice, protected weight-bearing and/or restricted activity, possible taping and/or bracing.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and (ROM), active therapies, including a home exercise program.

Active therapies include, proprioception training, restoring normal joint mechanics, and clearing dysfunctions from distal and proximal structures. Quadriceps stretching is particularly important for this condition. The use of outcome measures, supervised rehabilitation, therapeutic exercise, neuromuscular electrical stimulation, neuromuscular reeducation, and eccentric strengthening is recommended. Passive as well as active normal joint mechanics influenced by structures distal and proximal to the knee. Refer to Section F. Therapeutic There is good evidence that 4 weeks of resistance training is effective for improving maximal strength, functional ability, and reducing pain. This training should be used as a therapeutic rehabilitation program for various musculoskeletal conditions, including chronic tendinopathy and knee osteoarthritis, as well as after hip replacement surgery.

E) For isolated patellar tendinopathy, patellar tendon strapping or taping may be appropriate.

F) Return to work with appropriate restrictions should be considered G) Other therapies in Section F. Therapeutic Procedures, Non- H) Therapeutic Injections:

Steroid injections may decrease inflammation and allow the therapist to progress with functional exercise and ROM. Steroid injections under significant pressure should be avoided as the needle may be penetrating the tendon. Injection into the tendon can cause possible tendon breakdown, tendon degeneration, or rupture. Injections should be minimized for patients less than 30 • Time to Produce Effect: One injection.

• Maximum Duration: 3 injections in one year spaced at least vi. Surgical Indications/Considerations:

A) Complete ruptures are uncommon but require early repair.

Quadriceps/Patellar tendon rupture presents with inability to completely extend the knee B) Suspected avulsion fracture, or severe functional impairment unresponsive to a minimum of 4 months of active patient participation in non-operative treatment. There is no evidence that surgery is better than eccentric training for patellar tendinopathy of the inferior pole (jumper’s knee).

C) Diabetes clearly effects outcomes and the incidence of D) Prior to surgical intervention, the patient and treating physician E) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Tendon repair. Rarely indicated and only after extensive conservative therapy.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Return to work and restrictions after surgery may be made by an 3. HIP AND LEG a. Acetabular Fracture:

i. Description/Definition: Subgroup of pelvic fractures with involvement of the hip articulation.

ii. Occupational Relationship: Usually from a traumatic injury such as a fall iii. Specific Physical Exam Findings: Displaced fractures may have short and/or abnormally rotated lower extremity.

iv. Diagnostic Testing Procedures: Radiographs, CT scanning.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Although surgery is frequently required, protected weight-bearing may be considered for un-displaced fractures or minimally displaced fractures that do not involve the weight-bearing surface of the acetabular dome.

B) Patient education should include instruction in self-management C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments on osteoporosis in Section E.1.d, Ankle Sprain/Fracture.

E) There is good evidence that smoking significantly increases the F) Benefits may be achieved through therapeutic rehabilitation and include ambulation with appropriate assistive device, proprioception training, restoring normal joint mechanics, and clearing dysfunctions from adjacent structures. Passive as well as active therapies may be used to control pain and swelling.

Therapy should progress to strengthening and an independent home exercise program targeted to further improve ROM, strength, and normal joint mechanics influenced by proximal and distal structures. Therapy should include training on the use of appropriate. Bracing may be appropriate. Refer to Section F.

Therapeutic Procedures, Non-operative.

G) Return to work with appropriate restrictions should be considered H) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Displaced or unstable fracture.

vii. Operative Procedures: Usually open reduction and internal fixation or total hip replacement. Percutaneous fixation is possible in some cases. fractures. They are not recommended for acetabular fractures.

Complications: infection, nonunion, nerve damage.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon communication between the surgeon and the therapist, and using therapies as outlined in Section F. Therapeutic Procedures, Non-operative. In all cases, communication between the physician and therapist is important to the timing of weight-bearing, and exercise progressions.

B) Treatment usually includes active therapy with or without passive therapy for early range of motion and weight-bearing then progression to, strengthening, flexibility, neuromuscular training, and gait training with appropriate assistive devices.

C) Return to work and restrictions after surgery may be made by an b. Aggravated Osteoarthritis:

i. Description/Definition: hip pain with radiographic evidence of joint space narrowing or femoral acetabular osteophytes, and sedimentation rate less than 20mm/hr with symptoms. Patients usually have gradual onset of pain increasing with use and relieved with rest, progressing to morning stiffness and then to night pain. About 5% of the population 60 or older will have symptomatic hip osteoarthritis but few will need surgery.

Reduced muscle strength, proprioceptive inaccuracy, standing balance, range of hip motion, and co-morbid diagnosis all contribute to functional decline.

ii. Occupational Relationship: The provider must establish the occupational relationship by showing a change in the patient’s baseline condition and a relationship to work activities or specific injury to the hip. The work activities include, but are not limited to repetitive heavy lifting (25 kg) or heavy physical workload such as farming. Obesity is a risk factor for hip osteoarthritis but it is of lower importance for hip osteoarthritis than knee osteoarthritis.

Other causative factors to consider: Prior significant injury to the hip may predispose the joint to osteoarthritis. In order to entertain previous trauma as a cause, the patient should have a medically documented injury with radiographs or MRI showing the level of anatomic change.

The prior injury should have been at least 2 years from the presentation for the new complaints and there should be a significant increase of pathology on the affected side in comparison to the original imaging or operative reports and/or the opposite un-injured side or extremity.

iii. Specific Physical Exam Findings: Bilateral exam including knees and low back is necessary to rule out other diagnoses. Pain with the hip in external and/or internal hip rotation with the knee in extension is the strongest indicator. One study suggests that, if the following 5 findings are present on exam, osteoarthritis is the likely diagnosis: Patrick’s, squatting pain, range of motion active flexion causing lateral hip pain, internal rotation less than 25º, active hip extension causing pain, and scour test with adduction causing lateral hip or groin aggravation pain.

iv. Diagnostic Testing Procedures: standing pelvic radiographs demonstrating joint space narrowing to 2 mm or less, osteophytes or sclerosis at the joint. MRI may be ordered to rule out other more serious disease. One meta-analysis found no support for using a hip injection as a diagnostic procedure.

v. Non-operative Treatment Procedures:

A) Patient education should include instruction in self-management protection, and weight management developed through shared decision making. Programs should be individually tailored with short and long-term goals. Patients should be encouraged to perform aerobic activity such as walking or biking. However, activities such as ladders, stairs and kneeling may be restricted.

Weight loss of at least 5% of body weight is encouraged when BMI is greater than 25.

B) Medications such as analgesics and anti-inflammatories may be helpful. There is good evidence that glucosamine sulfate and glucosamine hydrochloride are ineffective for relieving pain in patients with knee or hip OA. There is some evidence that glucosamine sulfate treatment for more than 6 months shows a small improvement in joint function compared to placebo controls in people with osteoarthritis of the knee or hip. However, due to investigations finding that 79% of herbal supplements did not contain the substance listed on the label, these supplements are Outpatient fentanyl use is not recommended for work related osteoarthritis. Refer to medication discussions in Section F.7, C) Benefits may be achieved through therapeutic rehabilitation and (ROM), active therapies, including flexibility and strength exercise, and a home exercise program. Active therapies include gait training with appropriate assistive devices, proprioception training restoring normal joint mechanics, and clearing normal joint mechanics influenced by proximal and distal structures. Therapy should include training on the use of appropriate, Refer to Section F. Therapeutic Procedures, Non- There is strong evidence that land-based supervised exercise program shows small, but clinically important benefits for the relief of pain and improvement in function. These benefits are sustained for at least another three to six months among people with symptomatic osteoarthritis of the hip.

There is some evidence that 12 weeks of supervised exercise therapy in addition to patient education results in better long-term cumulative survival of the native hip and reduces the need for surgery compared with patient education alone in patients with osteoarthritis (OA) of the hip.

There is some evidence that a 12-week multimodal physical therapy program, consisting of a combination of manual therapy, exercise, and education, provides no additional reductions in pain or improvements in physical function than sham physical therapy among people with hip osteoarthritis. However, the sham therapy group appeared to have a more active lifestyle at baseline.

D) There is good evidence that aquatic exercise and land-based exercise show comparable outcomes for function and mobility among people with symptomatic osteoarthritis of the knee or hip.

Aquatic therapy may be used as a type of active intervention to improve muscle strength and range of motion when land-based therapy is not well-tolerated.

There is good evidence that exercise programs based on tai chi, aerobic, and mixed exercise, and not hydrotherapy programs, are effective in improving functional aerobic capacity in patients with hip and knee osteoarthritis.

There is some evidence that 12 weeks of behavioral graded activity does not result in better long-term effectiveness in reducing pain or improving function at 5 years than usual exercise therapy in patients with osteoarthritis (OA) of the hip or knee. Behavioral graded activity is defined as an exercise/behavioral treatment integrating operant behavioral principles, and additional booster sessions.Overall there is strong evidence supporting exercise programs for most patients with hip osteoarthritis.

E) The use of insoles, adaptive equipment, cane, may be beneficial.

F) Acupuncture –Refer to Section F. Therapeutic Procedures, Non- G) Manual Therapy – There is some evidence that a 6-week patient education and manual therapy (PE and MT) intervention is more effective in reducing pain in patients with hip osteoarthritis than a control group receiving a minimal intervention of home stretching.

There is some evidence that in the setting of symptomatic hip OA of Kellgren-Lawrence grades 0 to 3, nine 30 minute sessions of manual and manipulative therapy (MMT) targeted at the hip are as beneficial as nine 30 minute sessions of MMT with additional manipulations of joints in the kinetic chain. The kinetic chain may include the lumbar, knee, ankle, and foot joints. Both programs are accompanied by gradually increasing exercise instructions. Generally, manipulation may be limited to 4 areas.

There is some evidence that, in the setting of hip OA with Kellgren-Lawrence grades 0 through 3, a short 5 week course of 9 sessions of manual therapy yields better overall improvement and hip function in daily activities than a supervised exercise program of similar duration and number of supervised sessions.

In addition to the above evidence manual therapy is recommended by other guidelines and therefore is appropriately used for hip osteoarthritis. Refer to Sections F.16.i Manipulation and F.16.l Mobilization (Joint) for more information.

H) Functional tests should always be used to track progress of therapy. The following tests are recommended for those with knee or hip osteoarthritis: 30 second chair stand, 40 meter fast paced walk, a stair climb, timed up-and-go, and 6 minute walk test.

I) Steroid Injections - Steroid injections may decrease inflammation and allow the therapist to progress with functional exercise and ROM. Caution should be used when considering steroid There is some evidence that a fluoroscopically guided injection of triamcinolone into an osteoarthritic hip relieves pain and improves function for up to three months.

• Time to Produce Effect: One injection.

• Maximum Duration: 3 injections in one year spaced at least J) Return to work with appropriate restrictions should be considered K) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Refer to Section G.5. Hip Arthroplasty.

c. Femoral Osteonecrosis (Avascular Necrosis (AVN) of the Femoral Head):

i. Description/Definition: Death of the bone tissue of the femoral head following loss of blood supply to the area. Destruction of the articular surfaces of the hip joint may lead to arthritis.

ii. Occupational Relationship: Trauma resulting in displaced subcapital fracture of the hip or hip dislocation may cause AVN. Previous surgical procedures and systemic steroids may also lead to AVN. In the general population, risk factors include, but are not limited to alcohol abuse, smoking, Caisson disease (also known as the bends), sickle cell anemia, autoimmune disease, and hypercoagulable states. Often, the cause cannot be identified. Involvement of the opposite hip may occur in more than half of cases not caused by trauma.

iii. Specific Physical Exam Findings: Hip or groin pain made worse by motion or weight-bearing and alleviated by rest is the classical presentation. Symptoms may begin gradually, often months after the vascular compromise of blood flow. A limp may result from limited tolerance for weight-bearing.

iv. Diagnostic Testing Procedures: X-ray abnormalities include sclerotic changes, cystic lesions, joint space narrowing, and degeneration of the acetabulum. The x-ray may be normal in the first several months of the disease process. AVN should be suspected when hip pain occurs and risk factors are present. X-rays should be done first, but may be followed by an MRI. When AVN is not due to trauma, both hips should be imaged.

MRI is extremely sensitive. Lesions usually progress over time. Bone marrow edema on imaging and location and extent of the lesion are prognostic signs for femoral head collapse. Frequently pre collapse signs of osteonecrosis are asymptomatic. Osteonecrosis should be differentiated from the self-limited condition of transient osteoporosis.

v. Non-operative Treatment Procedures:

A) Initial Treatment: protected weight-bearing and bracing followed by active therapy with or without passive therapy. Conservative approaches may suffice when the lesion is small, but larger lesions are expected to require surgical intervention when symptoms are disabling.

B) Patient education should include instruction in self-management protection, and weight management. Weight-bearing restrictions may be appropriate.

C) Medications such as analgesics and anti-inflammatories may be D) Smoking may affect bone healing. Patients should be strongly E) Return to work with appropriate restrictions should be considered appropriate to identify job tasks that stress the hip joint and to provide recommendations for modifications. Refer to Section F.13. Return to Work.

F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Core decompression may be appropriate for some patients with early disease (Stages 1 and 2A) who have functionally disabling symptoms. Femoral head osteotomies or resurfacing hemiarthroplasties may also be appropriate for younger patients when disease is limited to the femoral head. Those 50 or older and patients with total joint collapse or severely limiting disease will usually require an implant arthroplasty.

Some authors suggest preoperative digital subtraction angiography prior to a core decompression as arterial supply insufficiency leads to poor results.

vii. Operative Procedures: Osteotomy, core decompression with or without bone graft, arthroplasty. Refer to Section G., Therapeutic Proceduresoperative for details.

Core decompression appears to yield the best results for the patients with necrotic lesions less than 50% of the total lesion. On average, almost 26% of patients who had a core decompression required eventual arthroplasty.

There is some evidence from one study that, in the setting of core decompression, the use of bone marrow derived mesenchymal stem cells, taken from subtrochanteric marrow, cultured in vitro for two weeks, and implanted back into the necrotic lesion, greatly reduces the rate of progression of the disease process over the following five years. The procedure similarly reduces the need for total hip replacement. Core decompression has been tried with mesenchymal stem cells and bone marrow derived cells. However, currently stem cells cannot be cultured in the United States. Due to differing techniques and study methodology these continue to be considered experimental and are not generally viii. Postoperative Treatment:

A) Anticoagulant therapy to prevent deep venous thrombosis for most procedures. Refer Section F. Therapeutic Procedures, B) Treatment usually includes active therapy with or without passive therapy. Refer to section G and specific procedures for further details.

C) An individualized rehabilitation program based upon D) Treatment should include gait training with appropriate assistive E) Therapy should include training on the use of adaptive F) Return to work and restrictions after surgery may be made by an d. Femur Fracture:

i. Description/Definition: Fracture of the femur distal to the lesser trochanter.

ii. Occupational Relationship: Usually from a traumatic injury such as a fall iii. Specific Physical Exam Findings: May have a short, abnormally rotated extremity. Effusion if the knee joint is involved.

iv. Diagnostic Testing Procedures: Radiographs. Occasionally CT scan or MRI particularly if the knee joint is involved.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Although surgery is usually required, nonoperative procedures may be considered in stable, nondisplaced fractures and will require protected weight-bearing.

B) Patient education should include instruction in self-management protection, weight management. Weight-bearing restrictions may be appropriate.

C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Back pain may occur after femur fracture and should be addressed and treated as necessary.

E) Refer to comments related to osteoporosis in Section F.7.h.

F) There is good evidence that smoking significantly increases the G) Orthotics such as heel lifts and custom shoe build-ups may be required when leg-length discrepancy persists.

H) Return to work with appropriate restrictions should be considered I) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Supracondylar femur fracture with joint incongruity or displaced subtrochanteric fractures.

vii. Operative Procedures: Rod placement or open reduction/internal fixation.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon communication between the surgeon and the therapist, using and the therapist is important to the timing of weight-bearing and exercise progression.

B) Treatment usually includes active therapy with or without passive therapy for protected weight-bearing, early range of motion if joint involvement.

C) Refer to bone-growth stimulators in Section F. Therapeutic D) Return to work and restrictions after surgery may be made by an e. Hamstring Tendon Rupture:

i. Description/Definition: Most commonly, a disruption of the muscular portion of the hamstring. Extent of the tear is variable. Occasionally a proximal tear or avulsion. Rarely a distal injury.

ii. Occupational Relationship: Excessive tension on the hamstring either from an injury, excessive stretching or from a rapid, forceful contraction of the muscle.

iii. Specific Physical Exam Findings: Local tenderness, swelling, ecchymosis, weakness.

iv. Diagnostic Testing Procedures: Occasionally radiographs, MRI or ultrasound for proximal tears/possible avulsion fracture.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Protected weight-bearing and ice.

B) Patient education should include instruction in self-management techniques, ergonomics, body mechanics, home exercise, and weight management.

C) Medications such as analgesics and anti-inflammatories may be D) Most hamstring injuries do not involve avulsions and can be resolved with non-operative therapy. Benefits may be achieved through therapeutic rehabilitation and rehabilitation interventions.

They may include range-of-motion (ROM), active therapies, and a home exercise program. Active therapies include proprioception training, restoring normal joint mechanics, and clearing dysfunctions from adjacent structures. One study suggested that stretching four times per day could reduce time to full activity. Passive as well as active therapies may be used to mechanics influenced by proximal and distal structures. Bracing may be appropriate. Refer to Section F. Therapeutic Procedures, E) Return to work with appropriate restrictions should be considered F) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations:

A) Surgery is indicated for proximal or distal injuries only when significant functional impairment is expected without repair. If surgery is indicated, it is preferably performed within three months.

B) Diabetes clearly effects outcomes and the incidence of C) Prior to surgical intervention, the patient and treating physician D) Smoking may affect soft tissue healing through tissue hypoxia.

vii. Operative Procedures: Re-attachment of proximal avulsions and repair of distal tendon disruption. Achilles allograph may be required for chronic repairs with functional deficits.

Complications: Uncommon however, may include re-rupture, thrombosis, or infection. Some patients report residual pain.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include protected weight-bearing for 6 – 8 weeks.

Splinting in a functional brace may reduce time off work. Active therapy is usually progressed at 5 – 8 weeks. A number of strength and balance maneuvers may be done at 8 – 12 weeks depending on the patient’s functional goals.

C) Return to work and restrictions after surgery may be made by an f. Hip Dislocation:

i. Description/Definition: Disengagement of the femoral head from the acetabulum.

ii. Occupational Relationship: Usually from a traumatic injury such as a fall iii. Specific Physical Exam Findings: Most commonly a short, internally rotated, adducted lower extremity with a posterior dislocation and a short externally rotated extremity with an anterior dislocation.

iv. Diagnostic Testing Procedures: Radiographs, CT scanning.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Urgent closed reduction with sedation or general anesthesia.

B) Patient education should include instruction in self-management C) Medications such as analgesics and anti-inflammatories may be D) Benefits may be achieved through therapeutic rehabilitation and rehabilitation interventions. They should include bracing then range-of-motion (ROM), active therapies, and a home exercise program. Active therapies include proprioception training, gait training with appropriate assistive devices, restoring normal joint proximal and distal structures. Therapy should include training on the use of adaptive equipment and home and work site evaluations when appropriate. Bracing may be appropriate Refer to Section F. Therapeutic Procedures, Non-operative.

E) There is good evidence that smoking significantly increases the counseling by the physician when a fracture is involvled.

F) Return to work with appropriate restrictions should be considered G) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Failure of closed reduction.

Associated fracture of the acetabulum or femoral head, loose fragments in joint or open fracture. costs, when a fracture is involved it is recommended that insurers cover a smoking cessation program peri-operatively. Typically the patient should show some progress toward cessation at about six weeks.

Physicians may monitor smoking cessation with laboratory tests such as cotinine levels for long-term cessation. Patients with demonstrated success may continue the program up to 3 months or longer if needed based on the operative procedure.

vii. Operative Procedures: Open reduction of the femoral head or acetabulum and possible internal fixation.

viii. Postoperative Treatment Procedures:

A) An individualized rehabilitation program based upon B) Treatment should include gait training with appropriate assistive C) Treatment may include protected weight-bearing and active therapy with or without passive therapy for early range of motion.

D) Return to work and restrictions after surgery may be made by an g. Hip Fracture:

i. Description/Definition: Fractures of the neck and peri-trochanteric regions of the proximal femur.

ii. Occupational Relationship: Usually from a traumatic injury such as a fall or crush. Patients with intracapsular femoral fractures have a risk of developing avascular necrosis of the femoral head requiring treatment months to years after the initial injury.

Non Occupational Relationship: There is strong evidence that in adults at risk of hip fracture, obesity, defined as a BMI of 30 or greater, is associated with a substantial reduction in the risk of hip fracture compared to non-obese persons. Osteoporosis predisposes to hip iii. Specific Physical Exam Findings: Often a short and externally rotated lower extremity.

iv. Diagnostic Testing Procedures: Radiographs. Occasional use of CT scan or MRI.

v. Non-operative Treatment Procedures:

A) Initial Treatment: protected weight-bearing and bracing followed by active therapy with or without passive therapy. Although surgery is usually required, non-operative procedures may be considered in stable, non-displaced fractures. In cases of intracapsular femoral neck fractures of the hip, monitoring for avascular necrosis (AVN) should be considered, including serial X-rays.

B) Patient education should include instruction in self-management protection, and weight management. Weight-bearing restrictions may be appropriate.

C) Medications/Vitamins All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Back pain may occur after hip fracture and should be addressed and treated as necessary.

E) Refer to comments on osteoporosis in Section E.1, d. Ankle Sprain/Fracture.

F) There is good evidence that smoking significantly increases the G) Return to work with appropriate restrictions should be considered H) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Surgery is indicated for unstable peritrochanteric fractures and femoral neck fractures.

vii. Operative Procedures: Prosthetic replacement for displaced femoral neck fractures. Reduction and internal fixation for peritrochanteric fractures, and un-displaced, or minimally-displaced neck fractures. May include hemiarthroplasty or total hip arthroplasty for older workers.

There is inadequate evidence to support the effect of pre-operative traction for the relief of pain in people with a fractured hip. Therefore, it is viii. Postoperative Treatment:

A) Anti-coagulant therapy to prevent deep vein thrombosis. Refer to

Section F. 9. c. Deep Venous Thrombosis Prophylaxis.

B) Treatment usually includes active therapy with or without passive C) An individualized rehabilitation program based upon D) Treatment should include gait training with appropriate assistive E) Therapy should include training on the use of adaptive F) Return to work and restrictions after surgery may be made by an h. Impingement/Labral Tears:

i. Description/Definition: Two types of impingement are described. Pincertype impingement results from over- coverage of the acetabulum. Camtype impingement, results from the head of the femur being misshapen at the junction of the head and neck of the femur. Labral tears can also be isolated; however, they are frequently accompanied by bony abnormalities. Patients usually complain of catching or painful clicking which should be distinguished from a snapping iliopsoas tibial tendon. A pinch while sitting may be reported and hip or groin pain. Patients frequently complain of difficulty squatting or using stairs.

ii. Occupational Relationship: Impingement abnormalities are usually congenital; however, they may be aggravated by repetitive rotational force or trauma. Labral tears may accompany impingement or result from high energy trauma.

iii. Specific Physical Exam Findings: Positive labral tests. May have some range of motion deficits with impingement. No physical exam tests can reliably identify impingement or labral pathology in isolation.

iv. Diagnostic Testing Procedures: Cross table laterals, standing AP pelvis and frog leg lateral x-rays. In young healthy adults, some cam impingement findings occur in up to 50% of males and slightly fewer females. Physical exam findings of impingement along with x-ray findings are much lower, 7.3% in males. Cam deformity alpha angles can vary.

However, among a large sample, greater than 60 º was unusual, and 78º was considered pathological in a middle aged population.

MRI may reveal abnormality; however, false positives and false negatives are also possible. MRI arthrogram with gadolinium should be performed to diagnose labral tears, not a pelvic MRI. Intra-articular injection should help rule out extra-articular pain generators.

To confirm the diagnosis of labral tear, the patient should demonstrate changes on a pain scale accompanied by recorded functional improvement post-injection. This is important, as labral tears do not always cause pain and over-diagnosis is possible using imaging alone).

v. Non-operative Treatment Procedures:

A) Patient education should include instruction in self-management techniques, ergonomics, body mechanics, reducing hip adduction and internal rotation home exercise, joint protection, and weight management.

B) Medications such as analgesics and anti-inflammatories may be C) Benefits may be achieved through therapeutic rehabilitation and (ROM), active therapies and a home exercise program. Active therapies include proprioception training, neuromuscular reeducation, restoring normal joint mechanics, and clearing therapies may be used to control pain and swelling. Manual therapy may be appropriate for some patients. Therapy should progress to strengthening and an independent home exercise program targeted to further improve ROM, strength, and normal joint mechanics influenced by proximal and distal structures.

Refer to Section F. Therapeutic Procedures, Non-operative.

vi. Steroid Injections - Steroid injections may decrease inflammation and allow the therapist to progress with functional exercise and ROM. To confirm the diagnosis of labral tear, the patient should demonstrate changes on a pain scale accompanied by recorded functional improvement post-injection. This is important, as labral tears do not always cause pain and over-diagnosis is possible using imaging alone).

Caution should be used when considering steroid injections for patients with an A1c level of 8% or greater.

• Time to Produce Effect: One injection.

• Maximum Duration: 3 injections in one year spaced at least 4 to 8 weeks apart. Not to exceed 4 injections of any body part in one year.

For more information, please refer to Section F.6.a. Steroid Injections.

vii. Return to work with appropriate restrictions should be considered early in the course of treatment. A job site evaluation may be appropriate to provide suggestions for work task modifications. Refer to Section F.13.

viii. Other therapies in Section F. Therapeutic Procedures, Non-operative may be employed in individual cases.

ix. Surgical Indications/Considerations:

A) Surgery is indicated when 1) functional limitations persist after 8 weeks of active patient participation in treatment, 2) there are clinical signs and symptoms suggestive of the diagnosis and 3) other diagnoses, such as trochanteric bursitis or iliotibial band snapping have been ruled out. Iliotibial band pathology usually responds to physiotherapy. Bursitis is treated with lifestyle changes and steroid injections. Surgery is rarely required for these diagnoses.

B) Diabetes clearly effects outcomes and the incidence of C) Prior to surgical intervention, the patient and treating physician D) In cases where surgery is contraindicated due to obesity, it may patient is unsuccessful losing weight on his or her own.

Coverage for weight loss would continue only for motivated patients who have demonstrated continual progress with weight loss.

E) Smoking may affect soft tissue healing through tissue hypoxia.

x. Operative Procedures: Debridement or repair of labrum and removal of excessive bone. There is some evidence that, in women with pincer or combined cam-pincer femoroacetabular impingement, surgery which repairs the labrum is more likely to lead to normal hip function at one year than surgery which debrides part of the labrum. One study noted slightly better outcomes with a complete versus partial capsular repair.

No research studies have been completed that are of sufficient quality to accurately determine the benefit and safety of surgery for femoroacetabular impingement. There is no evidence that surgical treatment provides a clear benefit. However, it may improve range of motion and hip function.

Complications- low rate of minor and major complications, revision surgery may be necessary.

xi. Postoperative Treatment:

A) When bone is removed and/or the labrum is repaired, weightbearing restrictions usually apply for debridement for 2 weeks with at least 4 weeks of restricted hip rotation. For labral repair up to 6 weeks of weight bearing restrictions may apply.

B) An individualized rehabilitation program based upon communication between the surgeon and the therapist that includes gait training with appropriate assistive devices. Refer to

Section F., Therapeutic Procedures Non-operative.

C) Return to work and restrictions after surgery may be made by an i. Pelvic Fracture:

i. Description/Definition: Fracture of one or more components of the pelvic ring (sacrum and iliac wings).

ii. Occupational Relationship: Usually from a traumatic injury such as a fall iii. Specific Physical Exam Findings: Displaced fractures may cause pelvic deformity and shortening, or rotation of the lower extremities.

iv. Diagnostic Testing Procedures: Radiographs, CT scanning. Occasionally MRI, angiogram, urethrogram, emergent sonogram.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Protected weight-bearing. Although surgery is usually required, non-operative procedures may be considered in a stable, non-displaced fracture.

B) Patient education should include instruction in self-management C) Medications/Vitamins All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments related to osteoporosis in Section F.7.h.

E) There is good evidence that smoking significantly increases the F) Benefits may be achieved through therapeutic rehabilitation and include, proprioception training, gait training with appropriate assistive devices, restoring normal joint mechanics, and clearing normal joint mechanics influenced by proximal and distal structures. Therapy should include training on the use of appropriate. Refer to Section F. Therapeutic Procedures, Non- G) Return to work with appropriate restrictions should be considered H) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Unstable fracture pattern, or open improved ability to perform activities of daily living or work , as well as vii. Operative Procedures: External or internal fixation dictated by fracture pattern. not recommended for delayed union or nonunion of long bone fractures or pelvic fractures.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment usually includes active therapy with or without passive therapy for gait, pelvic stability, strengthening, and restoration of joint and extremity function. Treatment should include gait training with appropriate assistive devices.

C) Graduated weight-bearing according to fracture healing.

D) Return to work and restrictions after surgery may be made by an j. Tendinopathy: Refer to Section E.2.k., Tendinopathy for general k. Tibial Fracture:

i. Description/Definition: Fracture of the tibia proximal to the malleoli.

Open tibial fractures are graded in severity according to the Gustilo- Anderson Classification:

• Type I: Less than 1 cm (puncture wounds).

• Type II: 1 to 10 cm.

• Type III-A: Greater than 10 cm, sufficient soft tissue preserved to cover the wound (includes gunshot wounds and any injury in a contaminated environment).

• TYPE III-B: Greater than 10 cm, requiring a soft tissue coverage • TYPE III-C: With vascular injury requiring repair.

ii. Occupational Relationship: Usually from a traumatic injury such as a fall iii. Specific Physical Exam Findings: May have a short, abnormally rotated extremity. Effusion if the knee joint involved.

iv. Diagnostic Testing Procedures: Radiographs. CT scanning or MRI.

v. Non-operative Treatment Procedures:

A) Initial Treatment: Protected weight-bearing; functional bracing.

There is some support in the medical literature for use of pneumatic braces with stress fractures.

B) Patient education should include instruction in self-management C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments related to osteoporosis in Section F.7.h.

E) There is good evidence that smoking significantly increases the F) Benefits may be achieved through therapeutic rehabilitation and therapies including proprioception training, restoring normal joint mechanics, clearing dysfunctions from adjacent structures, and a home exercise program. Passive as well as active therapies may be used to control pain and swelling. Therapy should progress to targeted to further improve ROM, strength, restoring normal joint mechanics, influenced by proximal and distal structures. Therapy should include training on the use of adaptive equipment and home and work site evaluations when appropriate. Bracing may be appropriate. Refer to Section F. Therapeutic Procedures, G) Orthotics such as heel lifts and custom shoe build-ups may be required when leg-length discrepancy persists.

There is some evidence that, in the setting of tibial fractures which have delayed union at 16 weeks, low-intensity pulsed ultrasound (LIPUS) may accelerate gains in bone mineral density and fracture gap area when used daily for 16 weeks. However, there is strong evidence that LIPUS has no clinical efficacy in returning fracture patients to normal activities. There is also strong evidence that the estimates of effectiveness in accelerating radiographic fracture healing are likely to be biased and inaccurate. Numerous other reviews have identified only low quality studies. Thus, evidence does not support the clinical effectiveness of ultrasound for delayed union and therefore it is There is good evidence that, in the setting of acute tibial shaft fractures, pulsed electromagnetic field devices provide no benefits in terms of reducing the rate of secondary surgical procedures in the first twelve months following the acute fracture.

H) Return to work with appropriate restrictions should be considered I) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Unstable fracture pattern, displaced fracture (especially if the knee joint is involved), open fracture, and nonunion.

vii. Operative Procedures: Often closed rodding for shaft fractures. Open reduction and internal fixation is more common for fractures involving the knee joint or pilon fractures of the distal tibia. Procedures may include plate fixation, intramedullary nailing, and external fixation.

Local antibiotics, sometimes in the form of bead chains, may be used particularly with intramedullary nailing.

Human bone morphogenetic protein (RhBMP): this material is used for surgical repair of open tibial fractures. Refer to Section G, 11 Therapeutic Procedures, Operative for further specific information. There is some evidence that, in the setting of open tibial fractures treated with reamed intramedullary nailing, the use of rh-BMP at the time of fracture fixation does not measurably improve fracture healing, and may increase risks of infection. There is good evidence that there are no measureable benefits of BMP over standard of care without BMP for tibial fractures.

There is good evidence that, for open tibial shaft fractures, BMP does not enhance fracture healing at 20 weeks when used to augment with intramedullary nailing. Therefore, it is not recommended.

Complications: infections, nonunion, residual knee and ankle pain which is unlikely to interfere with employment.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Treatment may include protected weight-bearing and active therapy with or without passive therapy for early range of motion if joint involvement.

C) Negative pressure wound therapy may decrease the infection rate of open grade III-b fractures.

D) Return to work and restrictions after surgery may be made by an l. Trochanteric Fracture:

i. Description/Definition: Fracture of the greater trochanter of the proximal femur.

ii. Occupational Relationship: Usually from a traumatic injury such as a fall iii. Specific Physical Exam Findings: Local tenderness over the greater trochanter. Sometimes associated swelling, ecchymosis.

iv. Diagnostic Testing Procedures: Radiographs, CT scans or MRI.

v. Non-operative Treatment Procedures:

A) Initial Treatment: protected weight-bearing.

B) Patient education should include instruction in self-management C) Medications/Vitamins: All patients with conditions that require day. Refer to Section F.9.i. Osteoporosis Management.

D) Refer to comments related to osteoporosis in Section F.7.h.

E) There is good evidence that smoking significantly increases the F) Benefits may be achieved through therapeutic rehabilitation and include proprioception training, restoring normal joint mechanics, clearing dysfunctions from adjacent structures, and a home exercise program. Passive as well as active therapies may be used to control pain and swelling. Therapy should progress to mechanics influenced by proximal and distal structures. Bracing may be appropriate. Refer to Section F. Therapeutic Procedures, G) Return to work with appropriate restrictions should be considered H) Other therapies in Section F. Therapeutic Procedures, Nonvi. Surgical Indications/Considerations: Large, displaced fragment, open vii. Operative Procedures: Open reduction, internal fixation.

viii. Postoperative Treatment:

A) An individualized rehabilitation program based upon B) Protected weight-bearing is usually needed. Full weight-bearing with radiographic and clinical signs of healing.

C) Return to work and restrictions after surgery may be made by an F. THERAPEUTIC PROCEDURES — NON-OPERATIVE Before initiation of any therapeutic procedure, the authorized treating provider, employer, and insurer must consider these four important issues in the care of the injured worker.

First, patients undergoing therapeutic procedure(s) should be released or returned to modified or restricted duty during their rehabilitation at the earliest appropriate time. Refer to F.12. Return to Work for detailed information.

Second, cessation and/or review of treatment modalities should be undertaken when no further significant subjective or objective improvement in the patient’s condition is noted. If patients are not responding within the recommended duration periods, alternative treatment interventions, further diagnostic studies, or consultations should be pursued.

Third, providers should provide and document patient education. Functional progression is expected through prescribed activity such as neuromuscular and postural re-education/repatterning exercises. Before diagnostic tests or referrals for invasive treatment take place, the patient should be able to clearly articulate the goals of the intervention, the general side effects and associated risks, and his or her agreement with the expected treatment plan.

Last, formal psychological or psychosocial evaluation should be performed on patients not making expected progress within 6 to 12 weeks following injury and whose subjective symptoms do not correlate with objective signs and tests.

Home therapy is an important component of therapy and may include active and passive therapeutic procedures as well as other modalities to assist in alleviating pain, swelling, and abnormal muscle tone.

The following procedures are listed in alphabetical order.

1. ACUPUNCTURE: When acupuncture has been studied in randomized clinical trials, it is often compared with sham acupuncture and/or no acupuncture (usual care). The differences between true acupuncture and usual care have been moderate, but clinically important. These differences can be partitioned into two components: non-specific effects and specific effects. Non-specific effects include patient beliefs and expectations, attention from the acupuncturist, administration of acupuncture in a relaxing setting, and other components of what is often called the placebo effect. Specific effects refer to any additional effects which occur in the same setting of expectations and attention, but they are attributable to the penetration of the skin in the specific, classic acupuncture points on the surface of the body by the needles themselves.

A sham procedure is a non-therapeutic procedure that appears similar to the patient as the purported therapeutic procedure being tested. In most controlled studies, sham and classic acupuncture have produced similar effects. However, the sham controlled studies have shown consistent advantages of both true and sham acupuncture over no acupuncture when the studies have included a third comparison group that was randomized to usual medical care. Having this third comparison group has been advantageous in the interpretation of the non-specific effects of acupuncture, since the third comparison group controls for some influences on study outcome. These influences include more frequent contact with providers, the natural history of the condition, regression to the mean, the effect of being observed in a clinical trial, and, if the follow-up observations are done consistently in all three treatment groups, for biased reporting of outcomes. Controlling for these factors enables researchers to more closely estimate the contextual and personal interactive effects of acupuncture as it is generally practiced.

Clinical trials of acupuncture typically enroll participants who are interested in acupuncture, and who may respond to some of the non-specific aspects of the intervention more than patients who have no interest in or desire for acupuncture. The non-specific effects of acupuncture may not be produced in patients who have no wish to be referred for it.

Another study on chronic low back pain provides good evidence that true acupuncture at traditional meridians is marginally better than sham acupuncture with blunt needles in reducing pain, but effects on disability are unclear. In these studies, 5–15 treatments were provided. Comparisons of acupuncture and sham acupuncture have been inconsistent, and the advantage of true over sham acupuncture has been small in relation to the advantage of sham over no acupuncture.

A recent study of acupuncture use for knee osteoarthritis casts doubt on the actual biological effects of acupuncture versus the effect of positive provider patient visits. It is generally agreed from multiple low quality studies that acupuncture can provide shortterm pain relief and functional improvement with a small effect size. The physiologic response has been attributed to changes in brain activity on functional MRI’s with acupuncture, sham acupuncture, and in response to painful stimulus.

Acupuncture is recommended for subacute or chronic pain patients who are trying to increase function and/or decrease medication usage and have an expressed interest in this modality. It is also recommended for subacute or acute pain for patients who cannot tolerate NSAIDs or other medications.

Acupuncture is not the same procedure as dry needling for coding purposes; however, some acupuncturists may use acupuncture treatment for myofascial trigger points. Dry needling is performed specifically on myofascial trigger points. Refer to F.5.c. Trigger Point Injections and Dry Needling Treatment.

Acupuncture should generally be used in conjunction with manipulative and physical therapy/rehabilitation.

Credentialed practitioners with experience in evaluation and treatment of chronic pain patients must perform evaluations prior to acupuncture treatments. The exact mode of action is only partially understood. Western medicine studies suggest that acupuncture stimulates the nervous system at the level of the brain, promotes deep relaxation, and affects the release of neurotransmitters. Acupuncture is commonly used as an alternative or in addition to traditional Western pharmaceuticals. It may be used when pain medication is reduced or not tolerated; as an adjunct to physical rehabilitation and surgical intervention; and/or as part of multidisciplinary treatment to hasten the return of functional activity. Acupuncture must be performed by practitioners with the appropriate credentials in accordance with state and other applicable regulations. Therefore, if not otherwise within their professional scope of practice and licensure, those performing acupuncture must have the appropriate credentials, such as L.A.c. R.A.c, or Dipl. Ac.

There is good evidence that the small therapeutic effects of needle acupuncture, active laser acupuncture, and sham acupuncture for reducing pain or improving function among patients older than 50 years with moderate to severe chronic knee pain from symptoms of osteoarthritis are due to non-specific effects similar to placebo. Therefore, acupuncture should only be offered as an option to patients who independently express interest in receiving it, and who expect to benefit from it.

There is good evidence that, in people with osteoarthritis of the knee or hip, the effects of true needle acupuncture treatment relative to sham acupuncture may be too small to be perceived by participants as beneficial. Therefore, true needle acupuncture may not actually result in significant, clinically relevant functional improvement or significant pain reduction. Thus, there is strong evidence that acupuncture is not effective for osteoarthritis pain relief and it is not generally recommended. It may be appropriate in cases where arthroplasty is being delayed and patients request acupuncture for temporary relief.

Indications: All patients being considered for acupuncture treatment should have subacute or chronic pain (lasting approximately 3-4 weeks depending on the condition) and meet the following criteria:

• they should have participated in an initial active therapy program; and • they should show a clear preference for this type of care or previously have benefited from acupuncture; and • they must continue to be actively engaged in physical rehabilitation therapy and return to work.

a. Acupuncture: is the insertion and removal of filiform needles to stimulate acupoints (acupuncture points). Needles may be inserted, manipulated and retained for a period of time. Acupuncture can be used to reduce pain, reduce inflammation, increase blood flow, increase range-of-motion, decrease the side effect of medication-induced nausea, promote relaxation in an anxious patient, and reduce muscle spasm.

Indications include joint pain, joint stiffness, soft tissue pain and inflammation, paresthesia, post-surgical pain relief, muscle spasm, and scar tissue pain.

b. Acupuncture with Electrical Stimulation: is the use of electrical current (microamperage or milli-amperage) on the needles at the acupuncture site. It is used to increase effectiveness of the needles by continuous stimulation of the acupoint.

Physiological effects (depending on location and settings) can include endorphin release for pain relief, reduction of inflammation, increased blood circulation, analgesia through interruption of pain stimulus, and muscle relaxation.

It is indicated to treat chronic pain conditions, radiating pain along a nerve pathway, muscle spasm, inflammation, scar tissue pain, and pain located in multiple sites.

c. Total Time Frames for Acupuncture and Acupuncture with Electrical Stimulation: Time frames are not meant to be applied to each of the above sections separately. The time frames are to be applied to all acupuncture treatments regardless of the type or combination of therapies being provided.

• Time to Produce Effect: 3 to 6 treatments.

• Frequency: 1 to 3 times per week.

• Optimum Duration: 1 to 2 months.

• Maximum Duration: 14 treatments.

Any of the above acupuncture treatments may extend longer if objective functional gains can be documented and when symptomatic benefits facilitate progression in the patient’s treatment program. Treatment beyond 14 treatments must be documented with respect to need and ability to facilitate positive symptomatic or functional gains. Such care should be re-evaluated and documented with each series of treatments.

d. Other Acupuncture Modalities: Acupuncture treatment is based on individual patient needs and therefore treatment may include a combination of procedures to enhance treatment effect. Other procedures may include the use of heat, soft tissue manipulation/massage, and exercise. Refer to Active Therapy (Therapeutic Exercise) and Passive Therapy sections (Massage and Superficial Heat and Cold Therapy) for a description of these adjunctive acupuncture modalities and time frames.

2. BIOFEEDBACK: Biofeedback is a form of behavioral medicine that helps patients learn self-awareness and self-regulation skills for the purpose of gaining greater control of their physiology, such as muscle activity, brain waves, and measures of autonomic nervous system activity. Stress-related psycho-physiological reactions may arise as a reaction to organic pain and in some cases may cause pain. Electronic instrumentation is used to monitor the targeted physiology and then displayed or fed back to the patient visually, auditorily, or tactilely, with coaching by a biofeedback specialist. There is good evidence that biofeedback or relaxation therapy is equal in effect to cognitive behavioral therapy for chronic low back pain. There is no evidence of the effect of EMG-biofeedback on knee OA. Therefore, it is not recommended.

Indications for biofeedback include cases of musculoskeletal injury, in which muscle dysfunction or other physiological indicators of excessive or prolonged stress response affects and/or delays recovery. Other applications include training to improve selfmanagement of pain, anxiety, panic, anger or emotional distress, opioid withdrawal, insomnia/sleep disturbance, and other central and autonomic nervous system imbalances. Biofeedback is often utilized for relaxation training. Mental health professionals may also utilize it as a component of psychotherapy, where biofeedback and other behavioral techniques are integrated with psychotherapeutic interventions.

Biofeedback is often used in conjunction with physical therapy or medical treatment.

• Time to Produce Effect: 3 to 4 sessions.

• Frequency: 1 to 2 times per week.

• Optimum Duration: 5 to 6 sessions.

• Maximum Duration: 10 to 12 sessions. Treatment beyond 12 sessions must be documented with respect to need, expectation, and ability to facilitate functional gains.

3. BONE-GROWTH STIMULATORS

a. Electrical: Pre-clinical and experimental literature has shown a stimulatory effect of externally applied electrical fields on the proliferation and calcification of osteoblasts and periosteal cells.

There is good evidence that, in the setting of acute tibial shaft fractures, pulsed electromagnetic field devices do not reduce the rate of secondary surgical procedures in the first twelve months following the acute fracture. Therefore, the use of these devices is not recommended.

b. Low-intensity Pulsed Ultrasound (LIPUS): There is strong evidence that LIPUS does not have clinical efficacy in returning fracture patients to normal activities, and that the estimates of effectiveness in accelerating radiographic fracture healing are likely to be biased and inaccurate.

There is no evidence of the effect of low-intensity ultrasound (LIPUS), highintensity focused ultrasound (HIFUS) and extracorporeal shockwave therapies (ESWT) as part of the treatment for acute fractures in adults. Therefore, the use of external bone growth stimulation in the setting of acute fractures in high risk patients requires prior authorization.

4. EDUCATION/INFORMED DECISION MAKING of the patient and family, as well as the employer, insurer, policy makers and the community should be the primary emphasis in the treatment of shoulder pain and disability. Unfortunately, practitioners often think of education and informed decision making last, after medications, manual therapy, and Informed decision making is the hallmark of a successful treatment plan. In most cases, the continuum of treatment from the least invasive to the most invasive (e.g. surgery) should be discussed. The intention is to find the treatment along this continuum which most completely addresses the condition. Patients should identify their personal functional goals of treatment at the first visit. It is recommended that specific individual goals are articulated at the beginning of treatment as this is likely to lead to increased patient satisfaction above that achieved from improvement in pain or other physical function. Progress toward the individual functional goals identified should be addressed at follow up visits and throughout treatment by other members of the health care team as well as the authorized physicians.

Documentation of this process should occur whenever diagnostic tests or referrals from the authorized treating physician are contemplated. The informed decision making process asks the patients to set their personal functional goals of treatment, describe their current health status and any concerns they have regarding adhering to the diagnostic or treatment plan proposed. The provider should clearly describe the following:

• The expected functional outcomes from the proposed treatment, or expected results and plan of action if diagnostic tests are involved.

• Any side effects and risks to the patient.

• Required post treatment rehabilitation time and impact on work, if any.

• Alternative therapies or diagnostic testing.

Before diagnostic tests or referrals for invasive treatment take place, the patient should be able to clearly articulate the goals of the intervention, the general side effects and risks associated with it and their decision regarding compliance with the suggested plan.

There is some evidence that information provided only by video is not sufficient education.

Practitioners must develop and implement an effective strategy and skills to educate patients, employers, insurance systems, policy makers, and the community as a whole.

An education-based paradigm should always start with providing reassuring information to the patient and informed decision making. More in-depth education currently exists within a treatment regimen employing functional restoration, prevention, and cognitive behavioral techniques. Patient education and informed decision making should facilitate self-management of symptoms and prevention.

• Time to produce effect: Varies with individual patient • Frequency: Should occur at every visit.

5. EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)

Extracorporeal shock wave therapy (ESWT) delivers an externally applied acoustic pulse to the plantar fascia. Focused ESWT concentrates the acoustic pulse on a single point in the heel, while radial ESWT distributes the pulse along the entire plantar fascia. It has been hypothesized that ESWT causes microtrauma to the fascia, inducing a repair process involving the formation of new blood vessels and delivery of nutrients to the affected area. High energy ESWT is delivered in one session and may be painful, requiring some form of anesthesia. Conscious sedation is not recommended. The procedure may be performed with local blocks.

There is good evidence from one high quality trial that high intensity ESWT (0.25 mJ/mm2) is more effective than sham ESWT for improving pain and function in chronic plantar fasciitis which has not responded to conservative treatment after 6 months of symptoms. There is also some evidence from one adequate trial that high dose shock wave produces successful outcomes similar to those for endoscopic plantar fascia release in patients with persistent plantar fasciopathy which has not responded to more conservative treatment. However, two flawed meta-analyses failed to provide evidence that ESWT, regardless of energy level, produces a clinically meaningful reduction in pain or increase in function when compared to placebo for patients with plantar fasciitis lasting 6 months or more. While both meta-analyses did find a benefit for ESWT, the effect did not reach the level of clinical significance and provided conflicting evidence for which energy level is more effective. However, there is good evidence that plantar fascia specific stretching as initial treatment is more effective than radial ESWT in reducing pain and increasing function. Therefore, only ESWT at high intensity (0.25 mJ/mm2) may be considered in patients who have failed 6 months of conservative treatment, including stretching, physical therapy, orthoses, ice, and NSAIDs, and have significant functional deficits. This may be attempted for a maximum of 3 sessions spaced at least a week apart. ESWT may be a cost-effective alternative to plantar fascial release or a final noninvasive treatment option before surgery.

There is no evidence for extracorporeal shockwave therapies (ESWT) as part of the treatment for acute fractures in adults.

An adequate systematic review failed to provide evidence that extracorporeal shockwave therapy (ESWT) is superior to sham ESWT for Achilles tendinopathy. This review examined the only two studies in the past 10 years that had adequate blinding of participants. However, a clinically important effect has not been ruled out, and future research may change the unbiased estimate of the effect of ESWT. Additionally, a single randomized controlled trial does provide some evidence that in patients with insertional Achilles tendinopathy who have no calcification of the tendon at the calcaneus, three sessions of a moderate dose (flux density of 0.12 mJ/mm2) is likely to be more successful than a 12 week program of eccentric loading exercise. As such, providers should be free to add ESWT to their treatment options for Achilles tendinopathy.

• Indications: Patients who have failed 6 months of standard therapy for plantar fasciitis and have significant functional deficits should be considered for ESWT. These patients should meet the indications for surgery found in Section E, heel spurs, plantar fascia pain. Tarsal tunnel syndrome should be ruled out. Peripheral vascular disease, lower extremity neuropathy, and diabetes are all relative contraindications.

Diagnostic testing may be needed to rule out these conditions.

ESWT may also be considered for those patients who have failed conservative treatment for Achilles tendinopathy.

• Time to Effect: 2 sessions.

• Optimum/Maximum Duration: 3 sessions one week or more apart.

6. INJECTIONS-THERAPEUTIC

Description ⎯ Therapeutic injection procedures are generally accepted, well-established procedures that may play a significant role in the treatment of patients with upper extremity pain or pathology. Therapeutic injections involve the delivery of anesthetic and/or anti-inflammatory medications to the painful structure. Therapeutic injections have many potential benefits. Ideally, a therapeutic injection will: (a) reduce inflammation in a specific target area; (b) relieve secondary muscle spasm; (c) allow a break from pain; and (d) support therapy directed to functional recovery. Diagnostic and therapeutic injections should be used early and selectively to establish a diagnosis and support rehabilitation. If injections are overused or used outside the context of a monitored rehabilitation program, they may be of significantly less value.

Caution should be used when ordering four or more steroid injections total for all anatomic sites in one year. Please refer to Section F.4.d. Shoulder Joint Steroid Diagnostic injections are procedures which may be used to identify pain generators or pathology. For additional specific clinical indications, see Specific Diagnosis, Testing and Treatment Procedures.

Contraindications ⎯ General contraindications include local or systemic infection, bleeding disorders, allergy to medications used and patient refusal. Specific contraindications may apply to individual injections.

a. Steroid Injections: are generally accepted, well-established procedures that can be performed as analgesic or anti-inflammatory procedures. There is good evidence that steroid injection in the setting of knee osteoarthritis produces rapid but short-lasting pain relief compared to placebo, likely to last at least one week but not likely to last 4 weeks or longer.

There is good evidence for a small to moderate reduction in pain from corticosteroid injection, whether performed under ultrasound guidance or by palpation alone. Tibial nerve blocks (heel blocks) do not add benefit to the procedure. It is unclear whether factors such as the specific corticosteroid, the injection approach (e.g. medial vs. posterior), the injection target (e.g. parallel to the plantar fascia vs. into the plantar fascia), or mixing of local anesthetic with the steroid influence outcomes.

Steroid injections to the Achilles tendon should generally be avoided in these patients since this is a risk for later rupture. Therefore, steroid injections are not recommended for any pathology of the Achilles tendon.

Combination steroid and local anesthetics increase chrondrocyte death in cell cultures. This calls into questions its long-term effects on osteoarthritis.

Complications: Safety concerns regarding steroid injection of the heel exist, including plantar fascia rupture and heel pad atrophy. Steroid injection under significant pressure should be avoided as the needle may be penetrating the tendon, and injection into the tendon could cause tendon breakdown, degeneration, or rupture. Injections should be minimized for patients under 30 General complications of injections may include transient neurapraxia, nerve injury, infection, hematoma, glucose elevation, and endocrine changes.

The majority of diabetic patients will experience an increase in glucose following steroid injections. Average increases in one study were 125mg/dL and returned to normal in 48 hours. In other studies, the increased glucose levels remained elevated up to 7 days, especially after multiple injections. All diabetic patients should be told to follow their glucose levels carefully over the 7 days after a steroid injection. For patients who have not been diagnosed with diabetes, one can expect some increase in glucose due to insulin resistance for a few days after a steroid injection. Clinicians should consider diabetic screening tests for those who appear to be at risk for type 2 diabetes and checking hemoglobin A1c and/or glucose for diabetics. Caution should be used when considering steroid Intra-articular or epidural injections cause rapid drops in plasma cortisol levels which usually resolve in one to 4 weeks. There is some evidence that an intraarticular injection of 80 mg of methylprednisolone acetate into the knee has about a 25% probability of suppressing the adrenal gland response to exogenous adrenocortocotrophic hormone ACTH for four or more weeks after injection, but complete recovery of the adrenal response is seen by week 8 after injection. This adrenal suppression could require treatment if surgery or other physiologically stressful events occur.

Case reports of Cushing’s syndrome, hypopituitarism and growth hormone deficiency have been reported uncommonly and have been tied to systemic absorption of intra-articular and epidural steroid injections. Cushing’s syndrome has also been reported from serial occipital nerve injections and paraspinal injections.

Morning cortisol measurements may be ordered prior to repeating steroid injections or prior to the initial steroid injection when the patient has received multiple previous steroid injections.

The effect of steroid injections on bone mineral density (BMD) and any contribution to osteoporotic fractures is less clear. Patients on long-term steroids are clearly more likely to suffer from fractures than those who do not take steroids. However, the contribution from steroid injections to this phenomena does not appear to be large. A well-controlled, large retrospective cohort study found that individuals with the same risk factors for osteoporotic fractures were 20% more likely to suffer a lumbar fracture if they had an epidural steroid injection. The risk increased with multiple injections. Other studies have shown inconsistent findings regarding BMD changes.

Given this information regarding increase in blood glucose levels, effects on the endocrine system, and possible osteoporotic influence, it is suggested that intraarticular and epidural injections be limited to a total of 3 to 4 per year [all joints combined].

• Time to Produce Effect: Immediate with local anesthesia, or within 3 days if no anesthesia.

• Optimum Duration: Usually one to two injections is adequate.

• Maximum Duration: No more than 4 steroid injections to all body parts should be performed in one year.

b. Soft Tissue Injections: include bursa and tendon insertions. Injections under significant pressure should be avoided as the needle may be penetrating the tendon. Injection into the tendon can cause tendon degeneration, tendon breakdown, or rupture. Injections should be minimized for patients under 30 When performing tendon insertion injections, the risk of tendon rupture should be discussed with the patient and the need for restricted duty emphasized.

• Time to Produce Effect: Immediate with local anesthesia, or within 3 days if no anesthesia.

• Optimum Duration: Usually one to two injections is adequate.

• Maximum Duration: Not more than three to four times annually.

For more information, please refer to Section F.6.a. Steroid Injections.

c. Stem Cell Injections: The purpose of stem cell therapy is to supply mesenchymal stem cells to a site of injury. The cells may then differentiate into cells that may aid recovery. In the U.S., stem cells are usually obtained from fat cells obtained from the patient through liposuction or bone marrow cells obtained through bone marrow aspiration. They are then injected into the injury site. There are also other stem cell products, including cells obtained through amniotic fluid.

To date the FDA has only approved one stem cell product, a cord blood-derived product for use in specific disorders involving the blood forming system only. A number of scams have been reported in the area of stem cells. Patients and providers must perform diligence regarding the use of amniotic fluids and other sources of stem cells.

Numerous trials are currently in process or have not been published regarding the use of stem cells from bone marrow aspirate or demineralized bone matrix.

The only clear effects are on small bone deficits. They are considered to be experimental and thus are not recommended for delayed union or nonunion of long bone fractures.

There is some evidence from one study that, in the setting of core decompression, the use of bone marrow derived mesenchymal stem cells, taken from subtrochanteric marrow, cultured in vitro for two weeks, and implanted back into the necrotic lesion, greatly reduces the rate of progression of the disease process over the following five years. There is also some evidence that the procedure similarly reduces the need for total hip replacement. It is not known how this study related to non-cultured stem cells. Core decompression has been tried with mesenchymal stem cells and bone marrow derived cells. However, currently stem cells cannot be cultured in the United States. Due to differing techniques and study methodologies, these procedures continue to be considered experimental and are not generally recommended.

d. Platelet Rich Plasma (PRP): Platelet Rich Plasma injections are intended to augment soft tissue healing. Blood is obtained from the patient, centrifuged to increase the platelet content and re-injected into the injury site.

There is insufficient evidence for or against the use of PRP in the setting of Achilles tendinopathy or application to the ACL patellar tendon donor site. There is also no evidence supporting the use of PRP for augmentation of ACL reconstruction. There is also insufficient evidence from another recent systematic review to recommend for or against PRP injections for non-insertional Achilles tendinopathy. Additionally, there is insufficient evidence from randomized controlled trials to draw conclusions on the use, or to support the routine use, of injection therapies, including PRP, for the treatment of Achilles tendinopathy.

There is insufficient evidence to support use of PRP with an open reduction of a calcaneus fracture.

There is inadequate evidence of the effectiveness of PRP in the setting of microfracture in patients with knee OA over the age of 40. Therefore, it is not There is some evidence that, in the setting of total knee arthroplasty, intraoperative use of PRP can reduce blood loss, improve levels of postoperative hemoglobin, and reduce the need for blood transfusions by the third postoperative day. There is also some evidence that PRP theoretically may improve pain control and promote earlier return to function. Therefore it may be used in total knee arthroplasty.

There is inadequate evidence to recommend for the use of PRP in the setting of plantar fasciitis to improve pain, function, or alignment. Therefore, PRP is not generally recommended to treat plantar fasciitis, but may be considered in unusual circumstances for cases which have not responded to appropriate conservative measures for 4 to 6 months.

There is some evidence that, in the setting of knee OA, intra-articular injection with PRP is more effective than HA or placebo in improving knee function and pain. There is some evidence that in patients with knee OA, a single PRP injection is more beneficial than a saline injection, and that more than one PRP injection is likely to be more beneficial than a single PRP injection when the Kellgren-Lawrence grade is less than Grade IV, and that a single PRP injection is as beneficial as three hyaluronic acid injections for knee OA. Therefore, it may be used for patients with significant functional deficits who are not yet eligible for or to forestall an arthroplasty.

Therefore, PRP is not generally recommended. It may be considered in unusual circumstances for cases which meet the following three criteria:

• tendon damage or osteoarthritis; and • non-responsiveness to appropriate conservative measures; and • the next level of guideline -consistent therapy would involve an invasive procedure with risk of significant complications and.

• Approval from the designated authorized treating physician.

If PRP is found to be indicated in these select patients, the first injection may be repeated twice when significant functional benefit is reported but the patient has not returned to full function.

Steroid injections prior to use of PRP are believed to lower the chance of healing.

Generally, PRP injections should not be used for at least 2 months following a steroid injection.

e. Viscosupplementation/Intracapsular Acid Salts:

There is strong evidence that, in the setting of knee osteoarthritis, the effectiveness of viscosupplementation is clinically unimportant, and may impose a risk of adverse events on the patient.

A recent meta-analysis has garnered a large amount of support for use of hyaluronic acid injections in the ankle. This seemingly confirmed findings from some previous randomized controlled trials while contradicting others. However, a major statistical error in the findings of this meta-analysis has been overlooked by many reviewers. The study, when examined appropriately, does not reveal a statistically significant difference between hyaluronic acid and saline. Thus, there is inadequate evidence that HA is more effective than saline for treatment of ankle osteoarthritis. Hyaluronic acid injections are, therefore, not recommended for ankle osteoarthritis due to the small effect size documented in knee conditions and the lack of evidence supporting its use in the ankle. Therefore, the patient and treating physician should identify functional goals and the likelihood of achieving improved ability to perform activities of daily living or work activities with injections versus other treatments. The patient should agree to comply with the treatment plan including home exercise. These injections may be considered an alternative in patients who have failed non-operative treatment and for whom surgery is not an option, particularly if non-steroidal anti-inflammatory drug treatment is contraindicated or has been unsuccessful. Viscosupplementation’s efficacy beyond 6 months is not well-established. There is no evidence that one product significantly outperforms another. Prior authorization is required to approve product choice and for repeat series of injections.

Due to lack of efficacy, viscosupplementation for knee or ankle is not recommended and requires prior authorization. It may be used for patients with significant functional deficits who are not eligible for or wish to delay arthroplasty.

Viscosupplementation is not recommended for hip arthritis given the probable superiority of corticosteroid injections. In rare cases a patient with significant hip osteoarthritis who does not qualify for surgical intervention may try viscosupplementation. It should be done with ultrasound or fluoroscopic guidance and will not necessarily require a series of three injections. The patient may choose to have repeat injections when the first injection was successful.

• Time to Produce Effect:1-3 injections; one injection may provide sufficient relief, a series of three is not required.

• Frequency: One injection or 1 series (3 to 5 injections generally spaced 1 week apart).

• Optimum/Maximum Duration: 2 series. Efficacy beyond 6 months is not wellestablished.

f. Prolotherapy: (also known as sclerotherapy) consists of peri-articular injections of hypertonic dextrose with or without phenol with the goal of inducing an inflammatory response that will recruit cytokine growth factors involved in the proliferation of connective tissue. Advocates of prolotherapy propose that these injections will alleviate complaints related to joint laxity by promoting the growth of connective tissue and stabilizing the involved joint.

Laboratory studies may lend some biological plausibility to claims of connective tissue growth, but high quality published clinical studies are lacking. The dependence of the therapeutic effect on the inflammatory response is poorly defined, raising concerns about the use of conventional anti-inflammatory drugs when proliferant injections are given. There is no evidence to support the use of injection therapies, including steroids, for treating Achilles tendinopathy. The evidence in support of prolotherapy is insufficient and therefore, its use is not recommended in lower extremity injuries.

g. Trigger Point Injections & Dry Needling: although generally accepted, have only rare indications in the treatment of lower extremity disorders. Therefore, the Division does not recommend their routine use in the treatment of lower extremity injuries.

Description - Trigger point injections and dry needling are both generally accepted treatments. Trigger point treatments can consist of dry needling or the injection of local anesthetic, with or without corticosteroid, into highly localized, extremely sensitive bands of skeletal muscle fibers. These muscle fibers produce local and referred pain when activated. Medication is injected in a four-quadrant manner in the area of maximum tenderness. Injection and dry needling efficacy can be enhanced if treatments are immediately followed by myofascial therapeutic interventions, such as vapo-coolant spray and stretch, ischemic pressure massage (myotherapy), specific soft tissue mobilization and physical modalities. There is conflicting evidence regarding the benefit of trigger point injections. A truly blinded study comparing dry needle treatment of trigger points is not feasible. There is no evidence that injection of medications improves the results of trigger-point injections. Needling alone may account for some of the therapeutic response of injections. Needling must be performed by practitioners with the appropriate credentials in accordance with state and other applicable regulations.

There is no indication for conscious sedation for patients receiving trigger point injections or dry needling. The patient must be alert to help identify the site of the injection.

Indications - Trigger point injections and dry needling may be used to relieve myofascial pain and facilitate active therapy and stretching of the affected areas.

They are to be used as an adjunctive treatment in combination with other treatment modalities such as active therapy programs. Trigger point injections should be utilized primarily for the purpose of facilitating functional progress.

Patients should continue in an aggressive aerobic and stretching therapeutic exercise program, as tolerated, while undergoing intensive myofascial interventions. Myofascial pain is often associated with other underlying structural problems. Any abnormalities need to be ruled out prior to injection.

Trigger point injections and dry needling are indicated in patients with consistently observed, well-circumscribed trigger points. This demonstrates a characteristic radiation of pain pattern, and local autonomic reaction such as persistent hyperemia following palpation. Generally, neither trigger point injections nor dry needling are necessary unless consistently observed trigger points are not responding to specific, noninvasive, myofascial interventions within approximately a 6-week time frame. However, both trigger point injections and dry needling may be occasionally effective when utilized in the patient with immediate, acute onset of pain or in a post-operative patient with persistent muscle spasm or myofascial pain.

Complications - Potential but rare complications of trigger point injections and dry needling include infection, pneumothorax, anaphylaxis, penetration of viscera, neurapraxia, and neuropathy. If corticosteroids are injected in addition to local anesthetic, there is a risk of local myopathy. Severe pain on injection suggests the possibility of an intraneural injection, and the needle should be immediately repositioned. The following treatment parameters apply to both interventions combined.

• Time to produce effect: Local anesthetic 30 minutes; 24 to 48 hours for no anesthesia.

• Frequency: Weekly. Suggest no more than 4 injection sites per session per week to avoid significant post-injection or post-needling soreness.

• Optimum duration: 4 Weeks total for all sites.

• Maximum duration: 8 weeks total for all sites. Occasional patients may require 2 to 4 repetitions of trigger point injection or dry needling series over a 1 to 2 year period.

h. Botulinum Toxin Injections: Description – Used to temporarily weaken or paralyze muscles. May reduce muscle pain in conditions associated with spasticity, dystonia, or other types of painful muscle spasm. EMG needle guidance may permit more precise delivery of botulinum toxin to the target area.

There is some evidence that, in patients with plantar fasciitis lasting 3 months or more, botulinum toxin type A injected into the gastrocnemius-soleus complex combined with stretching produces greater pain reduction and greater functional improvement than corticosteroid injection into the heel combined with stretching.

The effect sizes were clinically significant and lasted through 6 months. A therapeutic response to a botulinum toxin type A injection into the gastrocnemius-soleus complex may also be helpful in determining which patients would respond favorably to a gastrocnemius recession surgery. This is not a FDA approved indication. Thus, the evidence supports injections into the gastrocnemius-soleus complex.

There is insufficient evidence and no plausible physiologic theory to support a botulinum toxin injection into the plantar fascia. Therefore, it is not Complications – Rare systemic effects include flu-like syndrome, and weakening of distant muscles.

• Time to Produce Effect: 24 to 72 hours post injection with peak effect by 4 to 6 weeks.

• Frequency: No less than 3 months between re-administration. Patients should be reassessed after each injection session for an 80% improvement in pain (as measured by accepted pain scales) and evidence of functional improvement for 3 months. A positive result would include a return to base line function, return to increased work duties, and measurable improvement in physical activity goals, including return to baseline after an exacerbation.

• Optimum Duration: 3 to 4 months.

• Maximum Duration: 1 time. Prior authorization is required for additional injections. Repeat injections should be based upon functional improvement.

In most cases, not more than four injections are appropriate due to accompanying muscle atrophy.

7. INTERDISCIPLINARY REHABILITATION PROGRAMS: This is the gold standard of treatment for individuals who have not responded to less intensive modes of treatment.

There is good evidence that interdisciplinary programs that include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability. These programs should assess the impact of pain and suffering on the patient’s medical, physical, psychological, social, and/or vocational functioning. In general, interdisciplinary programs evaluate and treat multiple and sometimes irreversible conditions, including, but not limited to: painful musculoskeletal, neurological, and other chronic pain conditions and psychological issues; drug dependence, abuse, or addiction; high levels of stress and anxiety; failed surgery; and pre-existing or latent psychopathology. The number of professions involved on the team in a chronic pain program may vary due to the complexity of the needs of the person served. The Division recommends consideration of referral to an interdisciplinary program within six months post-injury in patients with delayed recovery, unless successful surgical interventions or other medical and/or psychological treatment complications intervene.

Chronic pain patients need to be treated as outpatients within a continuum of treatment intensity. Outpatient chronic pain programs are available with services provided by a coordinated interdisciplinary team within the same facility (formal) or as coordinated among practices by the authorized treating physician (informal). Formal programs are able to provide a coordinated, high-intensity level of services and are recommended for most chronic pain patients who have received multiple therapies during acute Patients with addiction problems, high-dose opioid use, or abuse of other drugs may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation. Guidelines from the American Society of Addiction Medicine are available and may be consulted relating to the intensity of services required for different classes of patients in order to achieve successful treatment.

Informal interdisciplinary pain programs may be considered for patients who are currently employed, those who cannot attend all-day programs, those with language barriers, or those living in areas not offering formal programs. Before treatment has been initiated, the patient, physician, and insurer should agree on treatment approach, methods, and goals. Generally, the type of outpatient program needed will depend on the degree of impact the pain has had on the patient’s medical, physical, psychological, social, and/or vocational functioning.

When referring a patient for formal outpatient interdisciplinary pain rehabilitation, an occupational rehabilitation program, or an opioid treatment program, the Division recommends the program meets the criteria of the Commission on Accreditation of Rehabilitation Facilities (CARF).

Inpatient pain rehabilitation programs are rarely needed but may be necessary for patients with any of the following conditions: (a) high risk for medical instability; (b) moderate-to-severe impairment of physical/functional status; (c) moderate-to-severe pain behaviors; (d) moderate impairment of cognitive and/or emotional status; (e) dependence on medications from which he/she needs to be withdrawn; and (f) the need for 24-hour supervised nursing.

Whether formal or informal programs, they should be comprised of the following dimensions (CARF 2010-11):

• Communication: To ensure positive functional outcomes, communication between the patient, insurer, and all professionals involved must be coordinated and consistent. Any exchange of information must be provided to all parties, including the patient. Care decisions should be communicated to all parties and should include the family and/or support system.

• Documentation: Through documentation by all professionals involved and/or discussions with the patient, it should be clear that functional goals are being actively pursued and measured on a regular basis to determine their achievement or need for modification. It is advisable to have the patient undergo objective functional measures.

• Treatment Modalities: Use of modalities may be necessary early in the process to facilitate compliance with and tolerance to therapeutic exercise, physical conditioning, and increasing functional activities. Active treatments should be emphasized over passive treatments. Active and self-monitored passive treatments should encourage self-coping skills and management of pain, which can be continued independently at home or at work. Treatments that can foster a sense of dependency by the patient on the caregiver should be avoided.

Treatment length should be decided based upon observed functional improvement. For a complete list of active and passive therapies, refer to F.12.

Therapy – Active and F.13. Therapy – Passive. All treatment timeframes may be extended based on the patient’s positive functional improvement.

• Therapeutic Exercise Programs: A therapeutic exercise program should be initiated at the start of any treatment rehabilitation. Such programs should emphasize education, independence, and the importance of an on-going exercise regimen. There is good evidence that exercise alone or part of a multidisciplinary program results in decreased disability for workers with non-acute low back pain. There is not sufficient evidence to support the recommendation of any particular exercise regimen over any other exercise regimen.

• Return to Work: The authorized treating physician should continually evaluate the patients for their potential to return to work. For patients who are currently employed, efforts should be aimed at keeping them employed. Formal rehabilitation programs should provide assistance in creating work profiles. For more specific information regarding return to work, refer to F.11. Return to Work.

• Patient Education: Patients with pain need to re-establish a healthy balance in lifestyle. All providers should educate patients on how to overcome barriers to resuming daily activity, including pain management, decreased energy levels, financial constraints, decreased physical ability, and change in family dynamics.

• Psychosocial Evaluation and Treatment: Psychosocial evaluation should be initiated, if not previously done. Providers should have a thorough understanding of the patient’s personality profile, especially if dependency issues are involved.

Psychosocial treatment may enhance the patient’s ability to participate in pain treatment rehabilitation, manage stress, and increase their problem-solving and self-management skills.

• Vocational Assistance: Vocational assistance can define future employment opportunities or assist patients in obtaining future employment. Refer to F.13.

Return to Work for detailed information.

Interdisciplinary programs are characterized by a variety of disciplines that participate in the assessment, planning, and/or implementation of the treatment program. These programs are for patients with greater levels of perceived disability, dysfunction, deconditioning, and psychological involvement. Programs should have sufficient personnel to work with the individual in the following areas: behavioral, functional, medical, cognitive, pain management, psychological, social, and vocational.

a. Formal Interdisciplinary Rehabilitation Programs:

i. Interdisciplinary Pain Rehabilitation: An Interdisciplinary Pain Rehabilitation Program provides outcome-focused, coordinated, goaloriented interdisciplinary team services to measure and improve the functioning of persons with pain and encourage their appropriate use of health care system and services. The program can benefit persons who have limitations that interfere with their physical, psychological, social, and/or vocational functioning. The program shares information about the scope of the services and the outcomes achieved with patients, authorized providers, and insurers.

The interdisciplinary team maintains consistent integration and communication to ensure that all interdisciplinary team members are aware of the plan of care for the patient, are exchanging information, and implement the plan of care. The team members make interdisciplinary team decisions with the patient and then ensure that decisions are communicated to the entire care team.

The Medical Director of the pain program should ideally be board certified in pain management. Alternatively, he/she should be board certified in his/her specialty area and have completed a one-year fellowship in interdisciplinary pain medicine or palliative care recognized by a national board. As a final alternative, he or she should have two years of experience in an interdisciplinary pain rehabilitation program.

Teams that assist in the accomplishment of functional, physical, psychological, social, and vocational goals must include: a medical director, pain team physician(s), who should preferably be board certified in an appropriate specialty, and a pain team psychologist. Professionals from other disciplines on the team may include, but are not limited to: a biofeedback therapist, an occupational therapist, a physical therapist, a registered nurse (RN), a case manager, an exercise physiologist, a psychologist, a psychiatrist, and/or a nutritionist.

• Time to Produce Effect: 3 to 4 weeks.

• Frequency: Full time programs – No less than 5 hours per day, 5 days per week; part-time programs – 4 hours per day, 2–3 days per week.

• Optimum Duration: 3 to 12 weeks at least 2–3 times a week. Followup visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

• Maximum Duration: 4 months for full-time programs and up to 6 months for part-time programs. Periodic review and monitoring thereafter for 1 year, AND additional follow-up based on the documented maintenance of functional gains.

ii. Occupational Rehabilitation: This is a formal interdisciplinary program addressing a patient’s employability and return to work. It includes a progressive increase in the number of hours per day in which a patient completes work simulation tasks until the patient can tolerate a full work day. A full work day is case specific and is defined by the previous employment of the patient. Safe workplace practices and education of the employer and family and/or social support system regarding the person’s status should be included. This is accomplished by addressing the medical, psychological, behavioral, physical, functional, and vocational components of employability and return to work.

There is some evidence that an integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain.

The occupational medicine rehabilitation interdisciplinary team should, at a minimum, be comprised of a qualified medical director who is board certified with documented training in occupational rehabilitation; team physicians having experience in occupational rehabilitation; an occupational therapist; and a physical therapist.

As appropriate, the team may also include any of the following: chiropractor, an RN, a case manager, a psychologist, a vocational specialist, or a certified biofeedback therapist.

• Time to Produce Effect: 2 weeks.

• Frequency: 2 to 5 visits per week, up to 8 hours per day.

• Optimum Duration: 2 to 4 weeks.

• Maximum Duration: 6 weeks. Participation in a program beyond 6 facilitate positive symptomatic and functional gains.

iii. Opioid/Chemical Treatment Programs: Refer to the Division’s Chronic Pain Disorder Medical Treatment Guidelines.

b. Informal Interdisciplinary Rehabilitation Program: A coordinated interdisciplinary pain rehabilitation program is one in which the authorized treating physician coordinates all aspects of care. This type of program is similar to the formal programs in that it is goal-oriented and provides interdisciplinary rehabilitation services to manage the needs of the patient in the following areas:

(a) functional, (b) medical, (c) physical, (d) psychological, (e) social, and (f) vocational.

This program is different from a formal program in that it involves lower frequency and intensity of services/treatment. Informal rehabilitation is geared toward those patients who do not need the intensity of service offered in a formal program or who cannot attend an all-day program due to employment, daycare, language, or other barriers.

Patients should be referred to professionals experienced in outpatient treatment of chronic pain. The Division recommends the authorized treating physician consult with physicians experienced in the treatment of chronic pain to develop the plan of care. Communication among care providers regarding clear objective goals and progress toward the goals is essential. Employers should be involved in return to work and work restrictions, and the family and/or social support system should be included in the treatment plan. Professionals from other disciplines likely to be involved include: a biofeedback therapist, an occupational therapist, a physical therapist, an RN, a psychologist, a case manager, an exercise physiologist, a psychiatrist, and/or a nutritionist.

• Time to Produce Effect: 3 to 4 weeks.

• Frequency: Full-time programs – No less than 5 hours per day, 5 days per week; Part-time programs – 4 hours per day for 2–3 days per week.

• Optimum Duration: 3 to 12 weeks at least 2–3 times a week. Follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

Maximum Duration: 4 months for full-time programs and up to 6 months for parttime programs. Periodic review and monitoring thereafter for 1 year, and additional follow-up based upon the documented maintenance of functional gains.

8. JOBSITE ALTERATION Early evaluation and training of body mechanics are essential for every injured worker. Risk factors to be addressed include: repetitive work, lifting, and forces that have an impact on the lower extremity. In some cases, this requires a jobsite evaluation. There is no single factor or combination of factors that is proven to prevent or ameliorate lower extremity pain, but a combination of ergonomic and psychosocial factors are generally considered to be important. Physical factors that may be considered include use of force, repetitive work, squatting, climbing, kneeling, crouching, crawling, prolonged standing, walking a distance or on uneven surfaces, jumping, running, awkward positions requiring use of force, and lower extremity vibration. Psychosocial factors to be considered include pacing, degree of control over job duties, perception of job stress, and supervisory support.

The job analysis and modification should include input from the employee, employer, and a medical professional familiar with work place evaluation. An ergonomist may also provide useful information. The injured worker must be present and an employee must be observed performing all applicable job functions in order for the jobsite analysis to be valid. Periodic follow-up is recommended to evaluate effectiveness of the intervention and need for additional ergonomic changes.

a. Ergonomic Changes: may be made to modify the hazards identified. In addition, workers should be counseled to vary tasks throughout the day. When possible, employees performing repetitive tasks should take 15 to 30 second breaks every 10 to 20 minutes, or 5-minute breaks every hour. Mini-breaks should include stretching exercises.

b. Interventions: should consider engineering controls (e.g., mechanizing the task, changing the tool used, or adjusting the jobsite), or administrative controls (e.g., adjusting the time an individual performs the task).

9. MEDICATIONS AND MEDICAL MANAGEMENT Use of medications will vary widely due to the spectrum of injuries from simple strains to complicated fractures. A thorough medication history, including use of alternative and over-the-counter medications, should be performed at the time of the initial visit and updated periodically. Treatment for pain control is initially accomplished with acetaminophen and/or NSAIDs. The patient should be educated regarding the interaction with prescription and over-the-counter medications as well as the contents of over-the-counter herbal products.

Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen are useful in the treatment of injuries associated with degenerative joint disease and/or inflammation.

These same medications can be used for pain control.

Topical agents can be beneficial for pain management in lower extremity injuries. This includes topical capsaicin, nonsteroidals, as well as topical iontphoretics/phonophoretics, such as steroid creams and lidocaine.

Glucosamine and chondroitin are sold in the United States as dietary supplements. Their dosage, manufacture, and purity are not regulated by the Food and Drug Administration.

There is good evidence that glucosamine sulfate and glucosamine hydrochloride are ineffective for relieving pain in patients with knee or hip OA. There is some evidence that glucosamine sulfate treatment for more than 6 months shows a small improvement in joint function compared to placebo controls in people with osteoarthritis of the knee or hip. There is some evidence that chondroitin plus glucosamine has no clinically important effect on knee pain and function when taken for two years. An effect of slowing of the progression of joint space narrowing cannot be ruled out. However, due to investigations finding that 79% of herbal supplements did not actually contain the substance on the label, these supplements are not recommended.

S-adenosyl methionine (SAM-e), like glucosamine and chondroitin, is sold as a dietary supplement in the United States, with a similar lack of standard preparations of dose and manufacture. There is some evidence that a pharmaceutical-grade SAM-e is as effective as celecoxib in improving pain and function in knee osteoarthritis, but its onset of action is slower. Studies using liquid chromatography have shown that it may lose its potency after several weeks of storage. In addition, SAM-e has multiple additional systemic effects. It is not currently recommended due to lack of availability of pharmaceutical quality, systemic effects, and loss of potency with storage.

There is insufficient evidence to evaluate if topical herbal therapies (arnica, capsicum, and comfrey extract gels) are effective for treating patients with knee or hip OA. There is insufficient evidence to evaluate if avocado-soybean unsaponifiables (ASU) or the proprietary ASU product Piasclidine® are effective for treating patients with knee or hip OA. There is good evidence that Boswellia serrata is marginally effective for decreasing pain and improving function in treating patients with knee or hip OA. However, due to investigations finding that 79% of herbal supplements did not actually contain the substance on the label, these supplements are not recommended.

The following are listed in alphabetical order.

a. Acetaminophen: An effective analgesic with anti-pyretic but not antiinflammatory activity. Acetaminophen is generally well-tolerated, causes little or no gastrointestinal (GI) irritation, and is not associated with ulcer formation.

Acetaminophen has been associated with liver toxicity in overdose situations or in chronic alcohol use. Patients may not realize that many over-the-counter preparations contain acetaminophen. The total daily dose of acetaminophen is recommended not to exceed three grams per 24-hour period, from all sources, including narcotic-acetaminophen combination preparations.

There is good evidence that acetaminophen is not more effective than placebo for the treatment of knee osteoarthritis. It is likely the acetaminophen is also not effective for hip arthritis either. It may be used on patients with contraindications to other medications.

• Optimum Duration: 7 to 10 days.

• Maximum Duration: Long-term use as indicated on a case-by-case basis.

Use of this substance long-term (for 3 days per week or greater) may be associated with rebound pain upon cessation.

b. Bisphosphonates: may be used for patients who qualify under osteoporosis guidelines. Long-term use for the purpose of increasing prosthetic fixation is not recommended as long-term improvement in fixation is not expected.

There is some evidence that a post-surgery single infusion of zoledronic acid is not effective in reducing the time to clinical osteotomy healing compared to a control infusion. Other medications such as alendronate have been tried for femoral osteonecrosis; however, results are inconsistent. Therefore, they are not recommended for those without osteopenia or osteoporosis. See Section 7.h.

Osteoporosis Management Section below.

c. Deep Venous Thrombosis (DVT) Prophylaxis: is a complex issue involving many variables such as individual patient characteristics, the type of surgery, anesthesia used, and agent(s) used for prophylaxis. Final decisions regarding prophylaxis will depend on the surgeon’s clinical judgment. The following are provided as generally accepted concepts regarding prophylaxis at the time of writing of these guidelines.

All patients undergoing lower extremity surgery or prolonged lower extremity immobilization should be evaluated for elevated risk for DVT and should receive education on prevention. Possible symptoms should be discussed. Patients at higher risk than the normal population include, but are not limited to, those with known hypercoagulable states and those with previous pulmonary embolism or DVT. Those with a higher risk for bleeding, may alter thromboprophylaxis protocols. This includes patients with a history of a bleeding disorder, severe renal failure, use of an antiplatelet agent, active liver disease, revision surgery, extensive dissection or difficult to control bleeding.

There is no evidence to support mandatory prophylaxis for all patients who have isolated lower extremity injuries with immobilization. No prophylaxis is recommended for knee arthroscopy in patients without a history of prior venous thrombosis.

Hip and knee arthroplasties and hip fracture repair are standard risk factors requiring thromboprophylaxis.

There is good evidence that, in the setting of total hip or knee replacement, a venous foot pump or a strategy using chemoprophylaxis with low-molecular weight heparin, heparin, or heparin combined with aspirin, confer approximately equal benefits for preventing thrombotic events and pulmonary emboli. However, pulmonary emboli are a rare complication.

Chemoprophylaxis begins 12 hours pre or postoperatively. Low molecular weight heparin may be preferred. Dual prophylaxis, chemical and intermittent pneumatic compression devices may be more appropriate for at risk patients and during the hospital stay. However, single prophylaxis is also acceptable. Prophylaxis may be extended to 35 days. Chemical prophylaxis may use low-molecular-weight heparin, fondaparinux, apixaban, dabigatran, rivaroxaban, low-dose unfractionated heparin, adjusted-dose vitamin K antagonist and aspirin. One Cochrane review found similar prophylaxis for direct thrombin inhibitors as for warfarin, low molecular weight heparin or coumarin. However, new agents caused more bleeding. Aspirin is generally used with compressive devices and is one recommended option.

Combined compression and chemoprophylaxis may be important for patients with previous venous thrombosis and compression should be used for all patients during hospitalization. Patients with a history of bleeding disorders should receive mechanical compression only.

All patients should be mobilized as soon as possible after surgery. Mechanical prophylaxis such as pneumatic devices that are thigh/calf, calf only, or foot pumps should be considered immediately postoperatively and/or until the patient is discharged. Thigh length or knee high graduated compression stockings are used for most patients. With prolonged prophylaxis, lab tests must be drawn regularly. These may be accomplished with home health care or outpatient laboratories when appropriate.

Asymptomatic patients should not have Doppler or duplex ultrasound screening before discharge.

d. Doxycycline: There is good evidence that oral doxycycline has no therapeutic effect on knee OA.

e. Minor Tranquilizer/Muscle Relaxants: Appropriate for objective findings of muscle spasm with pain. When prescribing these agents, physicians must seriously consider all central nervous system (CNS) side effects including drowsiness or dizziness and the fact that benzodiazepines may be habit-forming.

Carisoprodol, which metabolizes into meprobamate, is a known addictive drug.

Chronic use of benzodiazepines or any muscle relaxant is not recommended due to their habit-forming potential, seizure risk following abrupt withdrawal, and documented contribution to deaths of patients on opioids due to respiratory depression. A number of muscle relaxants interact with other medications.

• Optimum Duration: 1 week.

• Maximum Duration: 2 weeks (or longer if used only at night).

f. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Useful for pain and inflammation. In mild cases, they may be the only drugs required for analgesia.

There are several classes of NSAIDs. The response of the individual injured worker to a specific medication is unpredictable. For this reason, a range of NSAIDs may be tried in each case, with the most effective preparation being continued. Patients should be closely monitored for adverse reactions. The FDA advises that many NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. There is good evidence that naproxen has the least risk for cardiovascular events when compared to other NSAIDs. Administration of proton pump inhibitors, Histamine 2 Blockers or prostaglandin analog misoprostol along with these NSAIDs may reduce the risk of duodenal and gastric ulceration, in patients at higher risk for this adverse event (e.g. age > 60, concurrent antiplatelet or corticosteroid therapy). They do not impact possible cardiovascular complications. Due to the cross-reactivity between aspirin and NSAIDs, NSAIDs should not be used in aspirin-sensitive patients, and it should be used with caution in all asthma patients. NSAIDs are associated with abnormal renal function, including renal failure, as well as abnormal liver function. Patients with renal or hepatic disease may need increased dosing intervals with chronic use.

Chronic use of NSAIDs is generally not recommended due to increased risk of cardiovascular events and GI bleeding.

Topical NSAIDs may be more appropriate for some patients as there is some evidence that topical NSAIDs are associated with fewer systemic adverse events than oral NSAIDs.

Oral and topical NSAIDs are likely to be beneficial in the short-term treatment of acute ankle sprains, but there is no evidence on long-term effects, and oral NSAIDs may be associated with possible adverse events.

There is some evidence that a six week postoperative course of 75 mg of daily indomethacin does not reduce the risk of heterotopic ossification compared to placebo, and that the risk of nonunion may be increased with 6 weeks of indomethacin.

There is some evidence that, in the setting of long bone fractures of the femur, tibia, and humerus, NSAID administration in the first 48 hours after injury is associated with poor healing of the fracture.

Certain NSAIDs may have interactions with various other medications.

Individuals may have adverse events not listed above. Intervals for metabolic screening are dependent on the patient's age and general health status and should be within parameters listed for each specific medication. Complete Blood Count (CBC) and liver and renal function should be monitored at least every six months in patients on chronic NSAIDs and initially when indicated.

i. Non-Selective Non-Steroidal Anti-Inflammatory Drugs:

Includes NSAIDs and acetylsalicylic acid. Serious GI toxicity, such as bleeding, perforation, and ulceration can occur at any time, with or without warning symptoms, in patients treated with traditional NSAIDs.

Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur. Anaphylactoid reactions may occur in patients taking NSAIDs. NSAIDs may interfere with platelet function. Fluid retention and edema have been observed in some patients taking NSAIDs.

• Optimal Duration: 1 week.

• Maximum duration: 1 year. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

ii. Selective Cyclo-oxygenase-2 (COX-2) Inhibitors:

COX-2 inhibitors differ from the traditional NSAIDs in adverse side effect profiles. The major advantages of selective COX-2 inhibitors over traditional NSAIDs are that they have less GI toxicity and no platelet effects. COX-2 inhibitors can worsen renal function in patients with renal insufficiency; thus, renal function may need monitoring.

COX-2 inhibitors should not be first-line for low risk patients who will be using an NSAID short-term. COX-2 inhibitors are indicated in select patients who do not tolerate traditional NSAIDs. Serious upper GI adverse events can occur even in asymptomatic patients. Patients at high risk for GI bleed include those who use alcohol, smoke, are older than 65, take corticosteroids or anti-coagulants, or have a longer duration of therapy. Celecoxib is contraindicated in sulfonamide allergic patients.

• Optimal Duration: 7 to 10 days.

• Maximum Duration: Chronic use is appropriate in individual cases.

Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

g. Opioids: should be primarily reserved for the treatment of severe lower extremity pain. There are circumstances where prolonged use of opioids is justified based upon specific diagnosis and in pre- and post–operative patients. In these and other cases, it should be documented and justified. In mild-to-moderate cases of lower extremity pain, opioid medication should be used cautiously on a case-bycase basis. Adverse effects include respiratory depression, the development of physical and psychological dependence, and impaired alertness.

Opioids medications should be prescribed with strict time, quantity, and duration guidelines, and with definitive cessation parameters. Pain is subjective in nature and should be evaluated using a pain scale and assessment of function to rate effectiveness of the opioid prescribed. Any use beyond the maximum should be documented and justified based on the diagnosis and/or invasive procedures.

• Optimum Duration: Up to 10 days.

• Maximum Duration: 2 weeks. Use beyond 2 weeks is acceptable in appropriate cases when functional improvement is documented. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guidelines, which give a detailed discussion regarding medication use in chronic pain management.

Use beyond 30 days after non-traumatic injuries, or 6 weeks post-surgery after the original injury or postoperatively is not recommended. If necessary the physician should access the Colorado Prescription Drug Monitoring Program (PDMP) and follow recommendations in Chronic Pain Guideline.

This system allows the prescribing physician to see most of the controlled substances prescribed by other physicians for an individual patient.

h. Oral Steroids: have limited use but are accepted in cases requiring potent antiinflammatory drug effect in carefully selected patients. A one-week regime of steroids may be considered in the treatment of patients who have arthritic flareups with significant inflammation of the joint. The physician must be fully aware of potential contraindications for the use of all steroids such as hypertension, diabetes, glaucoma, peptic ulcer disease, etc., which should be discussed with the patient.

• Optimal Duration: 3 to 7 days.

• Maximum Duration: 7 days.

i. Osteoporosis Management:

One in 5 men and one in 2 Caucasian women will experience an osteoporosis related fracture in their lifetime.

Medications/Vitamins: All patients with conditions which require bone healing, calcium and 1000 IU of vitamin D per day which is similar to recommendations for older patients or those with osteoporosis and age greater than 50. Natural sources for vitamins, diet and sunlight, may be preferred but supplements are frequently necessary. A Cochrane review noted that supplements of vitamin D and calcium may prevent hip or any type of fracture. A systematic review was unable to find evidence for the role of vitamin D alone. Monitoring of vitamin D levels can be considered and may be appropriate for delayed healing of fracture, lack of radiographic signs of healing, or suspected vitamin D deficiency. For all fractures, an initial vitamin D level should be obtained if there is any clinical suspicion of deficiency. Monitoring and treatment for any deficiency should continue as clinically indicated.

There is some evidence that, for women in the older age group (58 to 88) with low hip bone density, greater callus forms for those who adhere to these recommendations than those who do not. Although the clinical implications of this are not known, there is greater nonunion in this age group and thus, coverage for these medications during the fracture healing time period is recommended. At this time there is no evidence that bisphosphonates increase acute fracture healing.

Patients with a low energy fracture, female patients 65 and older, and men 70 and older should have a bone mineral density test. A bone mineral density test may also be considered for men and women aged 50-69. Patients who have been on prednisone at a dose of 5 mg for more than 3 months should be evaluated for glucocorticoid induced osteoporosis. Risk factors for osteoporosis include alcohol use of 3 or more drinks per day, tobacco use, low BMI, parental

history of hip fracture, 2º osteoporosis, age, and rheumatoid arthritis. Those with risk factors for secondary osteoporosis may require further workup. In one adequate study, all patients aged 50 to 75 referred to an orthopaedic department for treatment of wrist, vertebral, proximal humerus, or hip fractures received bone mass density testing. 97% of patients had either osteoporosis (45%) or osteopenia (42%). Referral is important to prevent future factures in these groups. Long-term care for osteoporosis is not covered under workers compensation even though it may be discovered due to an injury-related acute fracture. It is unclear if bisphosphonate use beyond 5 years is necessary.

Patients should be counseled regarding prevention, including decreased alcohol consumption, smoking cessation, regular exercise, and vitamin D and calcium consumption, preferably from dietary sources.

j. Psychotropic/Anti-anxiety/Hypnotic Agents: May be useful for treatment of mild and chronic pain, dysesthesias, sleep disorders, and depression.

Antidepressant medications, such as tricyclics and Selective Serotonin Reuptake Inhibitors (SSRIs), are useful for affective disorder and chronic pain management. Tricyclic antidepressant agents, in low doses, are useful for chronic neurogenic pain with difficulty sleeping but have more frequent side effects.

There is good evidence that duloxetine more effectively decreases knee OA pain in older adults than placebo. However, the side effect profile of constipation and other symptoms should be considered if the drug is given to older adults.

Anti-anxiety medications are best used for short-term treatment (i.e. less than 6 months). Accompanying sleep disorders are best treated with sedating antidepressants prior to bedtime. Frequently, combinations of the above agents are useful. The physician should be aware of potential drug interactions with these combinations. As a general rule, physicians should assess the patient’s prior

history of substance abuse or depression prior to prescribing any of these agents.

Due to the habit-forming potential of the benzodiazepines and other drugs found in this class, they are not generally recommended. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guidelines, which give a detailed discussion regarding medication use in chronic pain management.

• Optimum Duration: 1 to 6 months.

• Maximum Duration: 6 to 12 months, with monitoring.

k. Topical Drug Delivery: Creams and patches may be an alternative treatment of localized musculoskeletal disorders. It is necessary that all topical agents be used with strict instructions for application as well as maximum number of applications per day to obtain the desired benefit and avoid potential toxicity. As with all medications, patient selection must be rigorous to select those patients with the highest probability of compliance.

i. Topical Salicylates and Nonsalicylates: have been shown to be effective in relieving pain in acute and chronic musculoskeletal conditions. Topical salicylate and nonsalicylates achieve tissue levels that are potentially therapeutic, at least with regard to COX inhibition. Other than local skin reactions, the side effects of therapy are minimal, although not nonexistent. The usual contraindications to use of these compounds needs to be considered. Local skin reactions are rare and systemic effects were even less common. Their use in patients receiving warfarin therapy may result in alterations in bleeding time. Overall, the low level of systemic absorption can be advantageous by allowing the topical use of these medications when systemic administration is relatively contraindicated. This may be the case in patients with hypertension, cardiac failure, or renal insufficiency.

There is strong evidence from a meta-analysis that topical NSAIDs are more effective than placebo vehicles such as gels or creams in the setting of acute musculoskeletal injuries, and some evidence that topical NSAIDs are associated with fewer systemic adverse events than oral NSAIDs.

There is no evidence that topical agents are more effective than oral medications. Therefore, they should not generally be used unless the patient has an intolerance to oral anti-inflammatories.

• Optimum Duration: One week.

• Maximum Duration: 2 weeks per episode.

ii. Capsaicin: is another medication option for topical drug use in lower extremity injury. Capsaicin offers a safe alternative to systemic NSAID therapy. Although it is quite safe, effective use of capsaicin is limited by the local stinging or burning sensation that typically dissipates with regular use, usually after the first 7 to 10 days of treatment. Patients should be advised to apply the cream on the affected area with a plastic glove or cotton applicator and to avoid inadvertent contact with eyes and mucous membranes.

• Optimum Duration: One week.

• Maximum Duration: 2 weeks per episode.

iii. Other Agents: Other topical agents, including prescription drugs (i.e. lidocaine), prescription compound agents, and prescribed over-thecounter medications (i.e. blue ice), may be useful for pain and inflammation. These drugs should be used when there are demonstrated functional gains or decreased use of oral medication with side-effects. .

• Optimum Duration: Varies with drug or compound.

• Maximum Duration: Varies with drug or compound.

iv. Iontophoretic Agents: Refer to Section F.15.e. Iontophoresis.

l. Tramadol: Tramadol was recently classified as a controlled substance in the U.S. Tramadol is useful in the relief of pain and has been shown to provide pain relief equivalent to that of commonly prescribed NSAIDs. Tramadol is an atypical opioid with norepinephrine and serotonin reuptake inhibition. Although Tramadol may cause impaired alertness, it is generally well-tolerated, does not cause GI ulceration, and does not exacerbate hypertension or congestive heart failure.

Tramadol should be used cautiously in patients who have a history of seizures or who are taking medication that may lower the seizure threshold, such as monoamine oxidase (MAO) inhibitors, SSRIs, some muscle relaxants, and tricyclic antidepressants. Because it inhibits the reuptake of norepinephrine and serotonin, use with other agents that increase norepinephrine and/or serotonin (e.g. SNRIs, mirtazapine, TCAs, SSRIs) can result in serotonin syndrome. This medication has physically addictive properties, and withdrawal may follow abrupt discontinuation; thus, it is not recommended for those with prior opioid addiction.

There is good evidence that, in the setting of hip OA, the analgesic and functional effects of tramadol compared to placebo are likely to be small enough to be clinically unimportant. Careful dose titration is recommended as some patients experience intolerance. There may be fewer life-threatening adverse events with tramadol than with commonly used NSAIDs. However, it is commonly used for chronic pain and may be useful for some patients.

• Optimum Duration: 3 to 7 days.

• Maximum Duration: 2 weeks. Use beyond 2 weeks is acceptable in appropriate cases.

m. Tranexamic Acid: Tranexamic acid is an effective anti fibrinolytic agent which decreases the need for blood transfusions. Blood transfusions increase the likelihood of infection for hip and knee arthroplasties. It is usually given in two doses intravenously or topically on the surgical site. There is strong evidence that tranexamic acid in the setting of total knee arthroplasty reduces blood loss, reduces the risk of transfusion, and reduces the number of units transfused, without increasing the risk of pulmonary embolus or deep vein thrombosis. It is also used for hip arthroplasty. Contraindications include patients with hypercoagulable states, cardiac stints, previous strokes. Dosage adjustment for those with renal compromises.

10. OCCUPATIONAL REHABILITATION PROGRAMS

a. Non-Interdisciplinary: These generally accepted programs are work-related, outcome-focused, individualized treatment programs. Objectives of the program include, but are not limited to, improvement of cardiopulmonary and neuromusculoskeletal functions (strength, endurance, movement, flexibility, stability, and motor control functions), patient education, and symptom relief. The goal is for patients to gain full or optimal function and return to work. The service may include the time-limited use of passive modalities with progression to treatment and/or simulated/real work.

i. Work Conditioning: These programs are usually initiated once reconditioning has been completed but may be offered at any time throughout the recovery phase. It should be initiated when imminent return of a patient to modified- or full-duty is not an option, but the prognosis for returning the patient to work at completion of the program is at least fair to good.

• Length of visit: 1 to 2 hours per day.

• Frequency: 2 to 5 visits per week.

• Optimum Duration: 2 to 4 weeks.

• Maximum Duration: 6 weeks. Participation in a program beyond six facilitate positive symptomatic or functional gains.

ii. Work Simulation: is a program where an individual completes specific work-related tasks for a particular job and return-to-work. Use of this program is appropriate when modified duty can only be partially accommodated in the work place, when modified duty in the work place is unavailable, or when the patient requires more structured supervision.

The need for work place simulation should be based upon the results of a Functional Capacity Evaluation and/or Jobsite Analysis.

• Length of visit: 2 to 6 hours per day.

• Frequency: 2 to 5 visits per week.

• Optimum Duration: 2 to 4 weeks.

• Maximum Duration: 6 weeks. Participation in a program beyond six facilitate positive symptomatic or functional gains.

11. ORTHOTICS AND PROSTHETICS

a. Fabrication/Modification of Orthotics: would be used when there is a need to normalize weight-bearing, facilitate better motion response, stabilize a joint with insufficient muscle or proprioceptive/reflex competencies, to protect subacute conditions as needed during movement, and correct biomechanical problems.

Footwear modifications may be necessary for work shoes and everyday shoes.

Replacement is needed every six months to one year. For specific types of orthotics/prosthetics see Section E, “Specific Lower Extremity Injury Diagnosis, Testing and Treatment.”

There is good evidence that valgus knee bracing provides moderate improvement in pain and function compared to patients who do not use another type of orthosis. There is also good evidence that the use of valgus knee bracing also provides a small improvement in pain among patients with medial knee osteoarthritis, compared to patients who use another type of orthosis. Thus, valgus knee bracing is a reasonable treatment for medial knee osteoarthritis.

There is some evidence that conservative management using either the valgus knee brace or the lateral wedged insole reduces pain and improves function in adults with medial tibiofemoral osteoarthritis of the knee. There were no significant differences between the two orthoses in any of the clinical outcomes.

Participants wore the insoles more consistently than the braces, and this may reflect convenience and greater acceptance of use. There is some evidence that laterally elevated wedged insoles are more effective in reducing pain, improving function, and reducing NSAID usage than neutrally wedged insoles in adults with medial compartment knee osteoarthritis. Participants wore the neutral insoles more consistently than the elevated insoles, and this may reflect on their comfort and greater acceptance of use. Thus, there is good evidence for the use of laterally elevated wedged soles for those with medial osteoarthritis.

There is good evidence that orthoses have a small, short-term (3 months) functional benefit compared to sham orthosis in the treatment of plantar fasciitis.

There is also some literature indicating overall subjective improvement from various types of orthoses plus stretching compared to stretching alone. Evidence does not support pain reduction from orthoses. There is strong evidence that the effectiveness of prefabricated orthoses is equivalent to, and possibly better than, custom-made orthoses. There is insufficient information to support the superiority of custom-made orthoses over those that are prefabricated. Generally custom made orthoses are not necessary except in specific cases such as those with anatomic or alignment abnormalities of the foot.

There is some evidence that off the shelf foot orthoses were found to be better than flat foot inserts in the short-term for patellofemoral pain syndrome. In this study both physiotherapy and foot orthoses had similar outcomes at 52 weeks.

Physiotherapy once each week for 6 weeks included joint mobilization, taping and quadriceps muscle strengthening. Although foot orthoses added to PT did not appear to change long-term outcome, it is possible they may hasten return to work. In another study, patients with patellofemoral pain syndrome who benefited most from orthoses met 3 of the following criteria: older than 25; height less than 165cm; worst pain less than 5.3/10; and mid foot width difference from nonweight bearing to weight bearing greater than 10.96mm.

• Time to Produce Effect: 1 to 3 sessions (includes wearing schedule and evaluation).

• Frequency: 1 to 2 times per week.

• Optimum/Maximum Duration: Over a period of approximately 4 to 6 weeks for casting, fitting, and re-evaluation.

b. Orthotic/Prosthetic Training: is the skilled instruction (by qualified providers) in the proper use of orthotic devices and/or prosthetic limbs including stump preparation, donning and doffing limbs, instruction in wearing schedule and orthotic/prosthetic maintenance training. Training can include gait, mobility, transfer and self-care techniques.

• Time to Produce Effect: 2 to 6 sessions.

• Frequency: 3 times per week.

• Optimum/Maximum Duration: 2 to 4 months.

c. Splints or Adaptive Equipment: indications for splints and adaptive equipment include the need to 1) control stress during functional activities following neurological and orthopedic injuries and 2) modify tasks through instruction in the use of a device or physical modification of a device. This includes design, fabrication, and/or modification. Equipment and any associated training should improve safety and reduce risk of re-injury. This includes high and low technology assistive options such as workplace modifications, crutch or walker training, and self-care aids.

There is inadequate evidence to recommend for or against night splinting for plantar fasciitis. A single randomized controlled trial of night splinting was identified but did not meet criteria for evidence due to large risk of bias. Night splinting is commonly used for plantar fasciitis and may be incorporated as a part of the stretching protocol.

• Time to Produce Effect: Immediate.

• Frequency: 1 to 3 sessions or as indicated to establish independent use.

• Optimum/Maximum Duration: 1 to 3 sessions.

12. PERSONALITY/PSYCHOSOCIAL/PSYCHOLOGICAL INTERVENTION Psychosocial treatment is a well-established therapeutic and diagnostic intervention with selected use in acute pain problems and more widespread use in sub-acute and chronic pain populations. Psychosocial treatment is recommended as an important component in the total management of a patient with chronic pain and should be implemented as soon as the problem is identified.

If a diagnosis consistent with the standards of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM) has been determined, the patient should be evaluated for the potential need for psychiatric medications. Use of any medication to treat a diagnosed condition may be ordered by the authorized treating physician or by the consulting psychiatrist. Visits for management of psychiatric medications are medical in nature and are not a component of psychosocial treatment.

Therefore, separate visits for medication management may be necessary, depending on the patient and medications selected.

Psychosocial interventions include psychotherapeutic treatments for mental health conditions, as well as behavioral medicine treatments. These interventions may similarly be beneficial for patients without psychiatric conditions, but who may need to make major life changes in order to cope with pain or adjust to disability. Examples of these treatments include cognitive behavioral therapy (CBT), relaxation training, mindfulness training, and sleep hygiene training.

The screening or diagnostic workup should clarify and distinguish between pre-existing, aggravated, and/or purely causative psychological conditions. Therapeutic and diagnostic modalities include, but are not limited to, individual counseling and group therapy.

Treatment can occur within an individualized model, a multi-disciplinary model, or a structured pain management program.

A psychologist with a PhD, PsyD, EdD credentials, or a psychiatric MD/DO may perform psychosocial treatments. Other licensed mental health providers or licensed health care providers with training in CBT, or certified as CBT therapists who have experience in treating chronic pain disorders in injured workers, may also perform treatment in consultation with a PhD, PsyD, EdD, or psychiatric MD/DO.

CBT refers to a group of psychological therapies that are sometimes referred to by more specific names such as Rational Emotive Behavior Therapy, Rational Behavior Therapy, Rational Living Therapy, Cognitive Therapy, and Dialectic Behavior Therapy. Variations of CBT methods can be used to treat a variety of conditions, including chronic pain, depression, anxiety, phobias, and post-traumatic stress disorder (PTSD). For patients with multiple diagnoses, more than one type of CBT might be needed. The CBT used in research studies is often “manualized CBT,” meaning that the treatment follows a specific protocol in a manual. In clinical settings, CBT may involve the use of standardized materials, but it is also commonly adapted by a psychologist or psychiatrist to the patient’s unique circumstances. If the CBT is being performed by a non-mental health professional, a manual approach would be strongly recommended. CBT must be distinguished from neuropsychological therapies used to teach compensatory strategies to brain injured patients, which are also called “cognitive therapy.”

It should be noted that most clinical trials on CBT exclude subjects who have significant psychiatric diagnoses. Consequently, the selection of patients for CBT should include the following considerations. CBT is instructive and structured, using an educational model with homework to teach inductive rational thinking. Because of this educational model, a certain level of literacy is assumed for most CBT protocols. Patients who lack the cognitive and educational abilities required by a CBT protocol are unlikely to be successful. Further, given the highly structured nature of CBT, it is more effective when a patient’s circumstances are relatively stable. For example, if a patient is about to be evicted, is actively suicidal, or is coming to sessions intoxicated, these matters will generally preempt CBT treatment for pain, and require other types of psychotherapeutic response. Conversely, literate patients whose circumstances are relatively stable, but who catastrophize or cope poorly with pain or disability are often good candidates for CBT for pain. Similarly, literate patients whose circumstances are relatively stable, but who exhibit unfounded medical phobias, are often good candidates for CBT for anxiety.

There is good evidence that cognitive intervention reduces low back disability in the short-term and in the long-term. In one of the studies, the therapy consisted of 6, 2-hour sessions given weekly to workers who had been sick-listed for 8-12 weeks. Comparison groups included those who received routine care. There is good evidence that psychological interventions, especially CBT, are superior to no psychological intervention for chronic low back pain. There is also good evidence that self-regulatory interventions, such as biofeedback and relaxation training, may be equally effective. There is good evidence that six group therapy sessions lasting one and a half hours each focused on CBT skills improved function and alleviated pain in uncomplicated sub-acute and chronic low back pain patients. There is some evidence that CBT provided in seven two-hour small group sessions can reduce the severity of insomnia in chronic pain patients. A Cochrane meta-analysis grouped very heterogenous behavioral interventions and concluded that there was good evidence that CBT may reduce pain and disability, but the effect size was uncertain. In total, the evidence clearly supports CBT, and it should be offered to all chronic pain patents who do not have other serious issues, as discussed above.

CBT is often combined with active therapy in an interdisciplinary program, whether formal or informal. It must be coordinated with a psychologist or psychiatrist. CBT can be done in a small group or individually, and the usual number of treatments varies between 8 and16 sessions.

Before CBT is done, the patient must have a full psychological evaluation. The CBT program must be done under the supervision of a PhD, PsyD, EdD, or psychiatric MD/DO.

Psychological Diagnostic and Statistical Manual of Mental Disorders (DSM) Axis I disorders are common in chronic pain. One study demonstrated that the majority of patients who had failed other therapy and participated in an active therapy program also suffered from major depression. However, in a program that included CBT and other psychological counseling, the success rate for return to work was similar for those with and without a DSM IV diagnosis. This study further strengthens the argument for having some psychological intervention included in all chronic pain treatment plans.

For all psychological/psychiatric interventions, an assessment and treatment plan with measurable behavioral goals, time frames, and specific interventions planned, must be provided to the treating physician prior to initiating treatment. A status report must be provided to the authorized treating physician every two weeks during initial more frequent treatment and monthly thereafter. The report should provide documentation of progress toward functional recovery and a discussion of the psychosocial issues affecting the patient’s ability to participate in treatment. The report should also address pertinent issues such as pre-existing, aggravated, and/or causative issues, as well as realistic functional prognosis.

a. Cognitive Behavioral Therapy (CBT) or Similar Treatment:

• Time to Produce Effect: 6 to 8 1–2 hour session, group or individual (1-hour individual or 2-hour group).

• Maximum Duration: 16 sessions.

NOTE: Before CBT is done, the patient must have a full psychological evaluation. The CBT program must be done under the supervision of a PhD, PsyD, EdD, or Psychiatric MD/DO.

b. Other Psychological/Psychiatric Interventions:

• Time to Produce Effect: 6 to 8 weeks.

• Frequency: 1 to 2 times weekly for the first 2 weeks (excluding hospitalization, if required), decreasing to 1 time per week for the second month. Thereafter, 2 to 4 times monthly with the exception of exacerbations, which may require increased frequency of visits. Not to include visits for medication management • Optimum Duration: 2 to 6 months.

• Maximum Duration: 6 months. Not to include visits for medication management. For select patients, longer supervised psychological/psychiatric treatment may be required, especially if there are ongoing medical procedures or complications. If counseling beyond 6 months is indicated, the management of psychosocial risks or functional progress must be documented. Treatment plan/progress must show severity.

13. RESTRICTION OF ACTIVITIES Continuation of normal daily activities is the recommendation for most patients since immobility will negatively affect rehabilitation.

Prolonged immobility results in a wide range of deleterious effects, such as a reduction in aerobic capacity and conditioning, loss of muscle strength and flexibility, increased segmental stiffness, promotion of bone demineralization, impaired disc nutrition, and the facilitation of the illness role.

Some level of immobility may occasionally be appropriate which could include bracing.

While these interventions may occasionally have been ordered in the acute phase, the provider should be aware of their impact on the patient’s ability to adequately comply with and successfully complete rehabilitation. Activity should be increased based on the improvement of core strengthening.

Patients should be educated regarding the detrimental effects of immobility versus the efficacious use of limited rest periods. Adequate rest allows the patient to comply with active treatment and benefit from the rehabilitation program. In addition, complete work cessation should be avoided, if possible, since it often further aggravates the pain presentation and promotes disability. Modified return to work is almost always more efficacious and rarely contraindicated in the vast majority of injured workers.

14. RETURN-TO-WORK Return to work and/or work-related activities whenever possible is one of the major components in treatment and rehabilitation. Return to work is a subject that should be addressed by each workers’ compensation provider at the first meeting with the injured employee and updated at each additional visit. A return-to-work format should be part of a company’s health plan, knowing that return to work can decrease anxiety, reduce the possibility of depression, and reconnect the worker with society.

Because a prolonged period of time off work will decrease the likelihood of return to work, the first weeks of treatment are crucial in preventing and/or reversing chronicity and disability mindset. In complex cases, experienced nurse case managers may be required to assist in return to work. Other services, including psychological evaluation and/or treatment, jobsite analysis, and vocational assistance, may be employed.

Two counseling sessions with an occupational physician, and work site visit if necessary, may be helpful for workers who are concerned about returning to work.

At least one study suggests that health status is worse for those patients who do not return to work than those who do. Self-employment and injury severity predict return to work. Difficulty with pain control, ADLs, and anxiety and depression were common.

The following should be considered when attempting to return an injured worker with chronic pain to work.

a. Job History Interview: The authorized treating physician should perform a job

history interview at the time of the initial evaluation and before any plan of treatment is established. Documentation should include the worker’s job demands, stressors, duties of current job, and duties of job at the time of the initial injury. In addition, cognitive and social issues should be identified, and treatment of these issues should be incorporated into the plan of care.

b. Coordination of Care: Management of the case is a significant part of return to work and may be the responsibility of the authorized treating physician, occupational health nurse, risk manager, or others. Case management is a method of communication between the primary provider, referral providers, insurer, employer, and employee. Because case management may be coordinated by a variety of professionals, the case manager should be identified in the medical record.

c. Communication: This is essential between the patient, authorized treating physician, employer, and insurer. Employers should be contacted to verify employment status, job duties and demands, and policies regarding injured workers. In addition, the availability and duration of temporary and permanent restrictions, as well as other placement options, should be discussed and documented. All communications in the absence of the patient are required to be documented and made available to the patient.

d. Establishment of Return-to-Work Status: Return to work for persons with chronic pain should be considered therapeutic, assuming that work is not likely to aggravate the basic problem or increase the discomfort. In some cases of chronic pain, the worker may not be currently working or even employed. The goal of return to work would be to return the worker to any level of employment with the current employer or to return him/her to any type of new employment.

Temporary restrictions may be needed while recommended ergonomic or adaptive equipment is obtained; employers should obtain recommended equipment in a timely manner.

e. Establishment of Activity Level Restrictions: A formal job description for the injured worker is necessary to identify physical demands at work and assist in the creation of modified duty. A jobsite evaluation may be utilized to identify applicable tasks such as pushing, pulling, lifting, reaching, grasping, pinching, sitting, standing, posture, and ambulatory distance and terrain. If applicable, a job site evaluation may also be utilized to assess temperature, air flow, noise, and the number of hours worked per day in a specific environment. Also refer to

Section F.6. Jobsite Alterations. Due to the lack of predictability regarding exacerbation of symptoms affecting function, an extended, occupationally focused functional capacity evaluation may be necessary to determine the patient’s tolerance for job type tasks over a continued period of time. Job requirements should be reviewed for the entire 8 hours or more of the working day. Between one and three days after the evaluation, there should be a followup evaluation by the treating therapist and/or the authorized treating physician to assess the patient’s status. When prescribing the FCE, the physician must assess the probability of return to work against the potential for exacerbation of the work related condition. Work restrictions assigned by the authorized treating physician may be temporary or permanent. The case manager should continue to seek out modified work until restrictions become less cumbersome or as the worker’s condition improves or deteriorates.

f. Rehabilitation and Return to Work: As part of rehabilitation, every attempt should be made to simulate work activities so that the authorized treating physician may promote adequate job performance. The use of ergonomic or adaptive equipment, therapeutic breaks, and interventional modalities at work may be necessary to maintain employment.

g. Vocational Assistance: Formal vocational rehabilitation is a generally accepted intervention and can assist disabled persons to return to viable employment.

Assisting patients in identifying vocational goals will facilitate medical recovery and aid in the achievement of MMI by (1) increasing motivation towards treatment and (2) alleviating the patient’s emotional distress. Physically limited patients will benefit most if vocational assistance is provided during the interdisciplinary rehabilitation phase of treatment. To assess the patient’s vocational capacity, a vocational assessment utilizing the information from occupational and physical therapy assessments may be performed. This vocational assessment may identify rehabilitation program goals and optimize both patient motivation and utilization of rehabilitation resources. This may be extremely helpful in decreasing the patient’s fear regarding an inability to earn a living, which can add to his/her anxiety and depression.

Recommendations to Employers and Employees of Small Businesses: employees of small businesses who are diagnosed with chronic pain may not be able to perform any jobs for which openings exist. Temporary employees may fill those slots while the employee functionally improves. Some small businesses hire other workers, and if the injured employee returns to the job, the supervisor/owner may have an extra employee. Case managers may assist with resolution of these problems and with finding modified job tasks or jobs with reduced hours, etc., depending on company philosophy and employee needs.

Recommendations to Employers and Employees of Mid-sized and Large Businesses: Employers are encouraged by the Division to identify modified work within the company that may be available to injured workers with chronic pain who are returning to work with temporary or permanent restrictions. To assist with temporary or permanent placement of the injured worker, it is suggested that a program be implemented that allows the case manager to access descriptions of all jobs within the organization.

15. THERAPY-ACTIVE The following active therapies are widely used and accepted methods of care for a variety of work-related injuries. They are based on the philosophy that therapeutic exercise and/or activity are beneficial for restoring flexibility, strength, endurance, function, range-of-motion, and can alleviate discomfort. Active therapy requires individual effort to complete a specific exercise or task. This form of therapy requires supervision from a therapist or medical provider such as verbal, visual and/or tactile instruction(s). At times, the provider may help stabilize the patient or guide the movement pattern, but the energy required to complete the task predominately comes from the patient.

Patients should be instructed to continue active therapies at home as an extension of the treatment process in order to maintain improvement levels. Follow-up visits to reinforce and monitor progress and proper technique are recommended. Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as “maximum.” Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care, and co-morbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. It is recommended that, if no functional gain is observed after the number of treatments under “time to produce effect” have been completed, then alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

The following active therapies are listed in alphabetical order:

a. Activities of Daily Living (ADL): are well-established interventions which involve instruction, active-assisted training, and/or adaptation of activities or equipment to improve a person's capacity in normal daily activities such as selfcare, work re-integration training, homemaking, and driving.

• Time to Produce Effect: 4 to 5 treatments.

• Frequency: 3 to 5 times per week.

• Optimum Duration: 4 to 6 weeks.

• Maximum Duration: 6 weeks.

b. Aquatic Therapy: is a well-accepted treatment which consists of the therapeutic use of aquatic immersion for therapeutic exercise to promote ROM, flexibility, core stabilization, endurance, strengthening, body mechanics, and pain management. Aquatic therapy includes the implementation of active therapeutic procedures in a swimming or therapeutic pool. The water provides a buoyancy force that lessens the amount of force gravity applies to the body. The decreased gravity effect allows the patient to have a mechanical advantage and more likely to have a successful trial of therapeutic exercise. Studies have shown that the muscle recruitment for aquatic therapy versus similar non–aquatic motions is significantly less. Because there is always a risk of recurrent or additional damage to the muscle tendon unit after a surgical repair, aquatic therapy may be preferred by surgeons to gain early return of ROM. In some cases, the patient will be able to do the exercises unsupervised after the initial supervised session.

Parks and recreation contacts may be used to locate less expensive facilities for patients. There is some evidence that, for osteoarthritis of the hip or knee, aquatic exercise may slightly reduce pain and slightly improve function over 3 months. There is also some information that aquatic exercise may reduce pain and improve function in the setting of chronic ankle instability. Indications include:

• Postoperative therapy as ordered by the surgeon; or • Intolerance for active land-based or full-weight-bearing therapeutic procedures; or • Symptoms that are exacerbated in a dry environment; and • Willingness to follow through with the therapy on a regular basis.

The pool should be large enough to allow full extremity ROM and fully erect posture. Aquatic vests, belts, snorkels, and other devices may be used to provide stability, balance, buoyancy, and resistance.

• Time to Produce Effect: 4 to 5 treatments.

• Frequency: 3 to 5 times per week.

• Optimum Duration: 4 to 6 weeks.

• Maximum Duration: 8 weeks.

A self-directed program is recommended after the supervised aquatics program has been established, or alternatively a transition to a self-directed dry environment exercise program.

c. Functional Activities: are the use of therapeutic activity to enhance mobility, body mechanics, employability, coordination, balance, and sensory motor integration.

• Time to Produce Effect: 4 to 5 treatments • Frequency: 3 to 5 times per week.

• Optimum Duration: 4 to 6 weeks.

• Maximum Duration: 6 weeks d. Functional Electrical Stimulation: is the application of electrical current to elicit involuntary or assisted contractions of atrophied and/or impaired muscles.

Indications include muscle atrophy, weakness, sluggish muscle contraction, neuromuscular dysfunction, or peripheral nerve lesion. Indications also may include an individual who is precluded from active therapy.

• Time to Produce Effect: 2 to 6 treatments.

• Frequency: 3 times per week.

• Optimum Duration: 8 weeks.

• Maximum Duration: 8 weeks. If beneficial, provide with home unit. Home use is not recommended for neuromuscularly intact patients.

e. Gait Training: is crutch walking, cane, or walker instruction to a person with lower extremity injury or surgery. Indications include the need to promote normal gait pattern with assistive devices; instruct in the safety and proper use of assistive devices; instruct in progressive use of more independent devices (i.e., platform-walker, to walker, to crutches, to cane); instruct in gait on uneven surfaces and steps (with and without railings) to reduce risk of fall, or loss of balance; and/or instruct in equipment to limit weight-bearing for the protection of a healing injury or surgery. The physician should assess whether the patient has sufficient upper body strength and request strength and core stabilization for those patients that require moe than simple gait training in order to use crutches following non-weight bearing orders.

• Time to Produce Effect: 2 to 6 treatments.

• Frequency: 2 to 3 times per week.

• Optimum Duration: 2 weeks.

• Maximum Duration: 2 weeks.

f. Neuromuscular Re-education: is the skilled application of exercise with manual, mechanical, or electrical facilitation to enhance strength, movement patterns, neuromuscular response, proprioception, kinesthetic sense, coordination, education of movement, balance, and posture. Indications include the need to promote neuromuscular responses through carefully timed proprioceptive stimuli to elicit and improve motor activity in patterns similar to normal neurologically developed sequences, and improve neuromotor response with independent control.

There is good evidence that, for chronic ankle instability, 4 weeks of neuromuscular training aimed at improving balance and proprioception are more effective than no training at producing functional recovery.

• Time to Produce Effect: 2 to 6 treatments.

• Frequency: 3 times per week.

• Optimum Duration: 4 to 8 weeks.

• Maximum Duration: 8 weeks.

g. Therapeutic Exercise: is a generally accepted treatment with or without mechanical assistance or resistance, may include isoinertial, isotonic, isometric and isokinetic types of exercises.

There is some evidence that a treatment approach consisting of a combination of hip- and knee-strengthening exercises was more effective in improving function and reducing pain over a 1-year period than knee-strengthening exercises alone in sedentary women with patellofemoral pain syndrome (PFPS).

There is good evidence that 4 weeks of resistance training is effective for improving maximal strength, functional ability, and reducing pain when used as a therapeutic rehabilitation program for various musculoskeletal conditions, including chronic tendinopathy, knee osteoarthritis, and after hip replacement There is some evidence that, in the setting of hip OA with Kellgren-Lawrence grades 0 through 3, a short 5 week course of 9 sessions of manual therapy yields better overall improvement and hip function in daily activities than a supervised exercise program of similar duration and number of supervised sessions.

There is some evidence that 3-weeks of a home preoperative quadriceps exercise program prior to knee arthroplasty is more effective in reducing pain, and improving function and quadriceps strength in the short-term up to 3 months postoperatively compared with usual care in patients with knee osteoarthritis.

However, these effects are not sustained at 6 months after total knee arthroplasty. Thus, there is good evidence supporting pre-operative exercise.

Indications include the need for cardiovascular fitness, reduced edema, improved muscle strength, improved connective tissue strength and integrity, increased bone density, promotion of circulation to enhance soft tissue healing, improvement of muscle recruitment, increased range of motion and are used to promote normal movement patterns. May also include complementary/alternative exercise movement therapy.

• Time to Produce Effect: 2 to 6 treatments.

• Frequency: 3 to 5 times per week.

• Optimum Duration: 4 to 8 weeks.

• Maximum Duration: 8 weeks.

h. Wheelchair Management and Propulsion: is the instruction and training of selfpropulsion and proper use of a wheelchair. This includes transferring and safety instruction. This is indicated in individuals who are not able to ambulate due to bilateral lower extremity injuries, inability to use ambulatory assistive devices, and in cases of multiple traumas.

• Time to Produce Effect: 2 to 6 treatments.

• Frequency: 2 to 3 times per week.

• Optimum Duration: 2 weeks.

• Maximum Duration: 2 weeks.

16. THERAPY-PASSIVE Most of the following passive therapies and modalities are generally well-accepted methods of care for a variety of work-related injuries. Passive therapy includes those treatment modalities that do not require energy expenditure on the

part of the patient. They are principally effective during the early phases of treatment and are directed at controlling symptoms such as pain, inflammation, and swelling, as well as improving the rate of healing soft tissue injuries. They should be used adjunctively with active therapies to help control swelling, pain, and inflammation during the rehabilitation process. They may be used intermittently as a therapist deems appropriate or regularly if there are specific goals with objectively measured functional improvements during treatment.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as “maximum.” Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care, and comorbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. It is recommended that, if no functional gain is observed after the number of treatments under “time to produce effect” has been completed, alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

The following passive therapies and modalities are listed in alphabetical order.

a. Continuous Passive Motion (CPM): is a form of passive motion using specialized machinery that acts to move a joint. Home use of CPM is expected after some chondral defect surgery or manipulation of a joint under anesthesia.

Use of this equipment may require home visits.

There is good evidence that, in people with osteoarthritis of the knee, continuous passive motion following total knee arthroplasty does not have clinically important short-term effects on active knee flexion ROM or medium-term effects on function or quality of life.

There is some evidence that there are no beneficial effects of early aggressive continuous passive motion (CPM) and fixed flexion CPM preceding progressive CPM on the short-term outcomes of range of motion (ROM), pain, and hospital length of stay compared to standardized physical therapy alone in patients following total knee arthroplasty. Therefore, it is not recommended..

There is good evidence that, in the setting of postoperative ACL rehabilitation, knee bracing is not always necessary. Continuous passive motion has no benefits. Home exercises may be as effective as outpatient rehabilitation in motivated patients. Therefore, it is not recommended for ACL repair.

Indications: Postoperative for knee microfracture, autologous cartilage implantation, or joint manipulation under anesthesia. Postoperative for hip microfracture.

• Time to Produce Effect: Immediate.

• Frequency: 6-8 hours per day.

• Optimum Duration: Up to 4 weeks post-surgical.

• Maximum Duration: 6 weeks if progress in range of motion is demonstrated.

b. Contrast Baths: can be used for alternating immersion of extremities in hot and cold water. Indications include edema in the sub-acute stage of healing, the need to improve peripheral circulation and decrease joint pain and stiffness.

• Time to Produce Effect: 3 treatments.

• Frequency: 3 times per week.

• Optimum Duration: 4 weeks.

• Maximum Duration: 1 month.

c. Dynamic Splinting: splinting which gradually increases range of motion through increasing the angle of the splint approximately every 2 weeks.

Indications: for patients whose postoperative knee or ankle has limited range of motion and impedes function. Increasing range of motion is used to judge the effect of splinting. Physical therapy should continue with the use of dynamic splints.

• Time to Produce Effect: 2 weeks.

• Frequency: Usually 6-8 hours per day.

• Optimum Duration: 8 weeks.

• Maximum Duration: 16 weeks- may be continued if function ROM has not been reached but continual ROM increase is demonstrated with use.

d. Electrical Stimulation (Unattended): once applied, requires minimal on-site supervision by the physician or non-physician provider. Indications include pain, inflammation, muscle spasm, atrophy, decreased circulation, and the need for osteogenic stimulation. Refer to 3a for Bone Growth Stimulators.

• Time to Produce Effect: 2 to 4 treatments.

• Frequency: Varies, depending upon indication, between 2 to 3 times per day to 1 time a week. Provide home unit if treatment is effective and frequent use is recommended.

• Optimum Duration: 1 to 3 months.

• Maximum Duration: 3 months.

e. Fluidotherapy: employs a stream of dry, heated air that passes over the injured body part. The injured body part can be exercised during the application of dry heat. Indications include the need to enhance collagen extensibility before stretching, reduce muscle guarding, or reduce inflammatory response.

• Time to Produce Effect: 1 to 4 treatments.

• Frequency: 1 to 3 times per week.

• Optimum Duration: 4 weeks.

• Maximum Duration: 1 month.

f. Hyperbaric Oxygen Therapy: There is no evidence to support long-term benefit of hyperbaric oxygen therapy for nonunion lower extremity fractures. It is not g. Infrared Therapy: is a radiant form of heat application. There is no evidence of the effect of monochromatic infrared energy (MIRE) on knee OA. Indications include the need to elevate the pain threshold before exercise and to alleviate muscle spasm to promote increased movement.

• Time to Produce Effect: 2 to 4 treatments.

• Frequency: 3 to 5 times per week.

• Optimum Duration: 3 weeks as primary, or up to 2 months if used intermittently as an adjunct to other therapeutic procedures.

• Maximum Duration: 2 months.

h. Iontophoresis: is the transfer of medication, including, but not limited to, steroidal anti-inflammatory and anesthetics, through the use of electrical stimulation. Indications include pain (Lidocaine), inflammation (hydrocortisone, salicylate), edema (mecholyl, hyaluronidase, and salicylate), ischemia (magnesium, mecholyl, and iodine), muscle spasm (magnesium, calcium); calcific deposits (acetate), scars, and keloids (chlorine, iodine, acetate).

• Time to Produce Effect: 1 to 4 treatments.

• Frequency: 3 times per week with at least 48 hours between treatments.

• Optimum Duration: 8 to 10 treatments.

• Maximum Duration: 10 treatments.

i. Manipulation: is a generally accepted, well-established and widely used therapeutic intervention for lower extremity injuries. Manipulative treatment (not therapy) is defined as the therapeutic application of manually guided forces by an operator to improve physiologic function and/or support homeostasis that has been altered by the injury or occupational disease, and has associated clinical significance.

High velocity, low amplitude (HVLA) technique, chiropractic manipulation, osteopathic manipulation, muscle energy techniques, counter strain, and nonforce techniques are all types of manipulative treatment. This may be applied by osteopathic physicians (D.O.), chiropractors (D.C.), properly trained physical therapists (P.T.), properly trained occupational therapists (O.T.), or properly trained medical physicians. Under these different types of manipulation exist many subsets of different techniques that can be described as a) direct – a forceful engagement of a restrictive/pathologic barrier, b) indirect – a gentle/nonforceful disengagement of a restrictive/pathologic barrier, c) the patient actively assists in the treatment and d) the patient relaxing, in allowing the practitioner to move the body tissues. When the proper diagnosis is made and coupled with the appropriate technique, manipulation has no contraindications and can be applied to all tissues of the body. Pre-treatment assessment should be performed as part of each manipulative treatment visit to ensure that the correct diagnosis and correct treatment is employed.

There is some evidence that, in patients with plantar fasciitis, six sessions of individually tailored manual therapy with exercise is more effective in improving foot function six months later than six sessions of a standardized program of exercise with ultrasound, dexamethasone iontophoresis, and ice.

There is some evidence that, for ankle sprains, a 4 week program of twice weekly manual physical therapy plus home exercise provides benefits in addition to home exercise alone at the end of treatment. However, these differences decrease over a 6 month period as the natural history of ankle sprains begins to resolve.

• Time to Produce Effect (for all types of manipulative treatment): 1 to 6 treatments.

• Frequency: Up to 3 times per week for the first 3 weeks as indicated by the severity of involvement and the desired effect.

• Optimum Duration: 10 treatments.

• Maximum Duration: 12 treatments. Additional visits may be necessary in cases of re-injury, interrupted continuity of care, exacerbation of symptoms, and co-morbidities. Functional gains including increased ROM must be demonstrated to justify continuing treatment.

j. Manual Electrical Stimulation: is used for peripheral nerve injuries or pain reduction that requires continuous application, supervision, or involves extensive teaching. Indications include muscle spasm, atrophy, decreased circulation, osteogenic stimulation, inflammation, peripheral neuropathies and the need to facilitate muscle hypertrophy, muscle strengthening, and muscle responsiveness.

• Time to Produce Effect: Variable, depending upon use.

• Frequency: 3 to 7 times per week.

• Optimum Duration: 8 weeks.

• Maximum Duration: 2 months.

k. Massage—Manual or Mechanical: Massage is manipulation of soft tissue with broad ranging relaxation and circulatory benefits. This may include stimulation of acupuncture points and acupuncture channels (acupressure), application of suction cups and techniques that include pressing, lifting, rubbing, pinching of soft tissues by, or with, the practitioners’ hands. Indications include edema (peripheral or hard and non-pliable edema), muscle spasm, adhesions, the need to improve peripheral circulation and range of motion, or to increase muscle relaxation, and flexibility prior to exercise. In cases with edema, deep vein thrombosis should be ruled out prior to treatment.

• Time to Produce Effect: Immediate.

• Frequency: 1 to 2 times per week.

• Optimum Duration: 6 weeks.

• Maximum Duration: 2 months.

l. Mobilization (Joint): Joint mobilization is the skilled application of manual therapy techniques such as gliding, rolling, oscillation and traction to a joint to improve joint play, improve intracapsular arthrokinematics, or reduce symptoms associated with impingement.

There is good evidence that supervised exercise therapy with added manual mobilization shows moderate, clinically important reductions in pain compared to non-exercise controls in people with osteoarthritis of the knee. It may include skilled manual joint tissue stretching. Indications include the need to improve joint play, improve intracapsular arthrokinematics, or reduce pain associated with tissue impingement.

• Time to Produce Effect: 6 to 9 treatments.

• Frequency: 3 times per week.

• Optimum Duration: 6 weeks.

• Maximum Duration: 2 months.

m. Mobilization (Soft Tissue): is a generally well-accepted treatment. Mobilization of soft tissue is the skilled application of muscle energy, strain/counter strain, myofascial release, manual trigger point release, manual therapy techniques, and tool assisted connective tissue mobilization. Mobilization is designed to improve or normalize movement patterns through the reduction of soft tissue pain and restrictions. The techniques can be interactive with the patient participating or can be with the patient relaxing and letting the practitioner move the body tissues. Indications include muscle spasm around a joint, trigger points, adhesions, and neural compression. Mobilization should be accompanied by active therapy.

There is some evidence that, for ankle sprains, a 4 week program of twice weekly manual physical therapy plus home exercise provides benefits in addition to home exercise alone at the end of treatment. However, these differences decrease over a 6 month period as the natural history of ankle sprains begins to resolve.

• Time to Produce Effect: 2 to 3 weeks.

• Frequency: 2 to 3 times per week.

• Optimum Duration: 4 to 6 weeks.

• Maximum Duration: 6 weeks.

n. Paraffin Bath: is a superficial heating modality that uses melted paraffin (candle wax) to treat irregular surfaces such as the foot or ankle. Indications include the need to enhance collagen extensibility before stretching, reduce muscle guarding, or reduce inflammatory response.

• Time to Produce Effect: 1 to 4 treatments.

• Frequency: 1 to 3 times per week.

• Optimum Duration: 4 weeks.

• Maximum Duration: 1 month. If beneficial, provide with home unit or purchase if effective.

o. Superficial Heat and Cold Therapy: Superficial heat and cold therapies are thermal agents applied in various manners that lower or raise the body tissue temperature for the reduction of pain, inflammation, and/or effusion resulting from injury or induced by exercise. It may be used acutely with compression and elevation. Indications include acute pain, edema and hemorrhage, need to increase pain threshold, reduce muscle spasm, and promote stretching/flexibility.

It includes portable cryotherapy units and application of heat just above the surface of the skin at acupuncture points.

• Time to Produce Effect: Immediate.

• Frequency: 2 to 5 times per week.

• Optimum Duration: 3 weeks as primary, or up to 2 months if used intermittently as an adjunct to other therapeutic procedures.

• Maximum Duration: 2 months.

p. Short-wave Diathermy: involves the use of equipment that exposes soft tissue to a magnetic or electrical field. Indications include enhanced collagen extensibility before stretching, reduced muscle guarding, reduced inflammatory response, and enhanced re-absorption of hemorrhage, hematoma, or edema.

• Time to Produce Effect: 2 to 4 treatments.

• Frequency: 2 to 3 times per week up to 3 weeks.

• Optimum Duration: 3 to 5 weeks.

• Maximum Duration: 5 weeks.

q. Traction: Manual traction is an integral part of manual manipulation or joint mobilization. Indications include decreased joint space, muscle spasm around joints, and the need for increased synovial nutrition and response.

• Time to Produce Effect: 1 to 3 sessions.

• Frequency: 2 to 3 times per week.

• Optimum Duration: 30 days.

• Maximum Duration: 1 month.

r. Transcutaneous Electrical Nerve Stimulation (TENS): is a generally accepted treatment. TENS should include at least one instructional session for proper application and use. Indications include muscle spasm, atrophy, and decreased circulation and pain control. Minimal TENS unit parameters should include pulse rate, pulse width and amplitude modulation. Consistent, measurable functional improvement must be documented prior to the purchase of a home unit.

• Time to Produce Effect: Immediate.

• Frequency: Variable.

• Optimum Duration: 3 sessions.

• Maximum Duration: 3 sessions. If beneficial, provide with home unit or purchase if effective. Due to variations in costs and in models, prior authorization for home units is required.

s. Ultrasound: is an accepted treatment which includes ultrasound with electrical stimulation and Phonophoresis. Ultrasound uses sonic generators to deliver acoustic energy for therapeutic thermal and/or non-thermal soft tissue effects.

Indications include scar tissue, adhesions, collagen fiber and muscle spasm, and the need to extend muscle tissue or accelerate the soft tissue healing.

Ultrasound with electrical stimulation is concurrent delivery of electrical energy that involves a dispersive electrode placement. Indications include muscle spasm, scar tissue, pain modulation, and muscle facilitation.

There is no evidence of the effect of ultrasound on knee osteoarthritis. However, there is some evidence that in primary hip osteoarthritis, the addition of ultrasound (US) treatment with conventional physical therapy is more effective in reducing pain and improving function one and 3 months after treatment compared with conventional physical therapy alone. Therefore, ultrasound may be used for treatment of osteoarthritis when combined with active therapy.

Phonophoresis is the transfer of medication to the target tissue to control inflammation and pain through the use of sonic generators. These topical medications include, but are not limited to, steroidal anti-inflammatory and anesthetics.

• Time to Produce Effect: 6 to 15 treatments.

• Frequency: 3 times per week.

• Optimum Duration: 4 to 8 weeks.

• Maximum Duration: 2 months.

t. Vasopneumatic Devices: are mechanical compressive devices used in both inpatient and outpatient settings to reduce various types of edema. Indications include pitting edema, lymphedema and venostasis. Maximum compression should not exceed minimal diastolic blood pressure. Use of a unit at home should be considered if expected treatment is greater than two weeks.

• Time to Produce Effect: 1 to 3 treatments.

• Frequency: 3 to 5 times per week.

• Optimum Duration: 1 month.

• Maximum Duration: 1 month. If beneficial, provide with home unit.

17. VOCATIONAL REHABILITATION is a generally accepted intervention, but Colorado law limits its use. Initiation of vocational rehabilitation requires adequate evaluation of patients for quantification of highest functional level, motivation, and achievement of maximum medical improvement (MMI). Vocational rehabilitation may be as simple as returning to the original job or as complicated as being retrained for a new occupation.

The effectiveness of vocational rehabilitation may be enhanced when performed in combination with work hardening or work conditioning.

It may also be beneficial for full vocational rehabilitation to start before MMI if it is evident that the injured worker will be unable to return to his/her previous occupation. A positive goal and direction may aid the patient in decreasing stress and depression, and promote optimum rehabilitation.

G. THERAPEUTIC PROCEDURES — OPERATIVE

All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic condition(s). It is imperative to rule out non-physiologic modifiers of pain presentation or non-operative conditions mimicking operative conditions (e.g. peripheral neuropathy, myofascial pain, scleratogenous or sympathetically mediated pain syndromes, psychological), prior to consideration of elective surgical intervention.

In addition, operative treatment is indicated when the natural history of surgically treated lesions is better than the natural history for non-operatively treated lesions. All patients being considered for surgical intervention should first undergo a comprehensive neuro-musculoskeletal examination to identify mechanical pain generators that may respond to non-surgical techniques or may be refractory to surgical intervention.

Structured rehabilitation interventions should strongly be considered postoperatively in any patient not making expected functional progress within three weeks after surgery.

Postoperative therapy will frequently require a repeat of the therapy provided pre-operatively.

Refer to Section F. Therapeutic Procedures - Non-operative, and consider the first postoperative visit as visit number one, for the time frame parameters provided.

Return-to-work restrictions should be specific according to the recommendation in Section F.13.

Return-To-Work.

The patient and treating physician should have identified functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work. The patient should agree to comply with the pre- and postoperative treatment plan, including home exercise.

The provider should be especially careful to make sure the patient understands the amount of postoperative treatment required and the length of partial- and full-disability expected postoperatively. The patient should have committed to the recommended postoperative treatment plan and fully completed the recommended active, manual and pre-operative treatment plans.

Informed decision making should be documented for all invasive procedures. This must include a thorough discussion of the pros and cons of the procedure and the possible complications as well as the natural history of the identified diagnosis. Since most patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

1. ANKLE AND SUBTALAR FUSION

a. Description/Definition: Surgical fusion of the ankle or subtalar joint.

b. Occupational Relationship: Usually post-traumatic arthritis or residual deformity.

c. Specific Physical Exam Findings: Painful, limited range of motion of the joint(s).

Possible fixed deformity.

d. Diagnostic Testing Procedures: Radiographs. Diagnostic injections, MRI, CT scan, and/or bone scan.

e. Surgical Indications/Considerations: All reasonable conservative measures have been exhausted and other reasonable surgical options have been seriously considered or implemented. Patient has disabling pain or deformity. Fusion is the procedure of choice for individuals with osteoarthritis who plan to return to physically demanding activities.

There is some concern that ankle arthrodesis may affect the development of adjacent-joint arthritis. However, a recent systematic review found no consensus in the literature as to the effects of ankle arthrodesis on biomechanics or on whether ankle arthrodesis leads to adjacent-joint arthritis.

Medications/Vitamins: All patients with conditions that require bone healing, calcium and 1000 IU of vitamin D per day. Refer to Section F.9.i. Osteoporosis Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The significantly over time, without invasive interventions, patients must be able to f. Operative Procedures: Open reduction internal fixation (ORIF) with possible bone grafting. External fixation may be used in some cases.

Some information from a retrospective case series indicates that both open and arthroscopic arthrodesis significantly reduces pain and improves function.

However, the arthroscopic approach may result in a shorter hospital stay and better outcomes at one and two years.

Autologous bone graft is currently considered the gold standard for all indications for bone grafting procedures. However, due to the limited availability and donor site complications, new products are being developed to eliminate the need for autograft. Thus, allograft in combination with advanced orthobiologics may be considered in lieu of autograft, but advanced orthobiologics require prior authorization.

g. Postoperative Treatment:

i. An individualized rehabilitation program based upon communication ii. When bony union is achieved, treatment usually includes active therapy with or without passive therapy, including gait training and ADLs.

Osseous union may need to be verified by CT scan in order to ensure appropriate healing prior to advancing rehabilitation.

iii. Rocker bottom soles or shoe lifts may be required. A cast is usually in place for 6 to 8 weeks followed by graduated weight-bearing. Modified duty may last up to 4 to 6 months.

iv. Return to work and restrictions after surgery may be made by an 2. KNEE FUSION a. Description/Definition: Surgical fusion of femur to the tibia at the knee joint.

b. Occupational Relationship: Usually from post-traumatic arthritis or deformity.

c. Specific Physical Exam Findings: Stiff, painful, sometime deformed limb at the knee joint.

d. Diagnostic Testing Procedures: Radiographs. MRI, CT, diagnostic injections or bone scan.

e. Surgical Indications/Considerations: All reasonable conservative measures have been exhausted and other reasonable surgical options have been seriously considered or implemented, e.g. failure of arthroplasty. Fusion is a consideration particularly in the young patient who desires a lifestyle that would subject the knee to high mechanical stresses. The patient should understand that the leg will be shortened and there may be difficulty with sitting in confined spaces and climbing stairs. Although there is generally a painless knee, up to 50% of cases may have complications.

Medications/Vitamins: All patients with conditions that require bone healing, calcium and 1000 IU of vitamin D per day. Refer to Section F.9.i. Osteoporosis Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The and the possible complications, as well as the natural history of the identified significantly over time, without invasive interventions, patients must be able to f. Operative Procedures: Open reduction internal fixation (ORIF) with possible bone grafting. External fixation or intramedullary rodding may also be used.

g. Postoperative Treatment:

i. An individualized rehabilitation program based upon communication ii. When bony union is achieved, treatment usually includes active therapy with or without passive therapy, including gait training and ADLs. Non weight-bearing or limited weight-bearing and modified duty may last up to 4 and 6 months.

iii. Return to work and restrictions after surgery may be made by an 3. ANKLE ARTHROPLASTY a. Description/Definition: Prosthetic replacement of the articulating surfaces of the ankle joint.

b. Occupational Relationship: Usually from post-traumatic arthritis.

c. Specific Physical Exam Findings: Stiff, painful ankle. Limited range-of-motion of the ankle joint.

d. Diagnostic Testing Procedures: Radiographs, MRI, diagnostic injections, CT scan, bone scan.

e. Surgical Indications/Considerations: When pain interferes with ADLs, and all reasonable conservative measures have been exhausted and other reasonable surgical options have been considered or implemented. A very limited population of patients are appropriate for ankle arthroplasty.

Requirements include:

• Good bone quality;

• BMI less than 35;

• Nonsmoker currently;

• Patient is 55 or older;

• No lower extremity neuropathy;

• Patient does not pursue physically demanding work or recreational activities.

• Diabetics under confirmed control with Hgb A1c no greater than 8%.

The following issues should be addressed when determining appropriateness for surgery: ankle laxity, bone alignment, surrounding soft tissue quality, vascular status, presence of avascular necrosis, history of open fracture or infection, motor dysfunction, and treatment of significant knee or hip pathology.

Ankle implants are less successful than similar procedures in the knee or hip.

While the volume of total ankle arthroplasty procedures is increasing, there are no quality studies comparing arthrodesis to ankle replacement. Patients with ankle fusions generally have good return to function and fewer complications than those with joint replacements. Re-operation rates may be higher in ankle arthroplasty than in ankle arthrodesis. Long-term performance beyond ten years for current devices is still unclear. Salvage procedures for ankle replacement include revision with stemmed implant or allograft fusion. Given these factors, an ankle arthroplasty requires prior authorization and a second opinion by a surgeon specializing in lower extremity surgery.

For ankle distraction arthroplasty please refer to section E.1.b Aggravated Osteoarthritis.

Complications: Infection, need for revision, prolonged hospital stay. Revision rates may be somewhat higher for arthroplasty than for arthrodesis.

Contraindications - severe osteoporosis, significant general disability due to other medical conditions, psychiatric issues.

In cases where surgery is contraindicated due to obesity, it may be appropriate to their own. Coverage for weight loss would continue only for motivated patients who have demonstrated continual progress with weight loss. low back pain issues that may affect rehabilitation.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The significantly over time, without invasive interventions, patients must be able to f. Operative Procedures: Prosthetic replacement of the articular surfaces of the ankle; DVT prophylaxis is not always required but should be considered for patients who have any risk factors for thrombosis.

Complications – include pulmonary embolism, infection, bony lysis, polyethylene wear, tibial loosening, instability, malalignment, stiffness, nerve-vessel injury, and peri-prosthetic fracture.

g. Postoperative Treatment:

i. An individualized rehabilitation program based upon communication between the surgeon and the therapist while using therapies as outlined in Section F. Therapeutic Procedures, Non-operative. In all cases, ii. NSAIDs may be used for pain management after joint replacement. They have also been used to reduce heterotopic ossification after ankle heterotopic ossification in this setting, but there is some evidence (in literature on hip arthroplasty) that they do not improve functional outcomes and they may increase the risk of bleeding events in the postoperative period. Their routine use for prevention of heterotopic bone formation is not recommended.

iii. Treatment may include the following: bracing, active therapy with or without passive therapy, gait training, and ADLs. Rehabilitation postoperatively may need to be specifically focused on the following problems: contracture, gastrocnemius muscle weakness, and foot and ankle malalignment. Thus, therapies may include braces, shoe lifts, orthoses, and electrical stimulation accompanied by focused therapy.

iv. In some cases, aquatic therapy may be used. Refer to Section F.

Therapeutic Procedures, Non-operative 14, b, Aquatic Therapy. Pool exercises may be done initially under therapist's or surgeon's direction then progressed to an independent pool program.

v. Prior to revision surgery, there should be an evaluation to rule out vi. Return to work and restrictions after surgery may be made by a treating physician experienced in occupational medicine in consultation with the surgeon or by the surgeon. Patient should be able to return to sedentary work within 4 to 6 weeks. Some patients may have permanent restrictions based on their job duties.

vii. Patients are usually seen annually after initial recovery to check plain xrays for signs of loosening.

4. KNEE ARTHROPLASTY

a. Description/Definition: Prosthetic replacement of the articulating surfaces of the knee joint.

b. Occupational Relationship: Usually from post-traumatic osteoarthritis.

c. Specific Physical Exam Findings: Stiff, painful knee, and possible effusion.

d. Diagnostic Testing Procedures: Radiographs.

e. Surgical Indications/Considerations: Severe osteoarthritis and all reasonable conservative measures have been exhausted and other reasonable surgical options have been considered or implemented. Significant changes such as advanced joint line narrowing are expected. Refer to subsection E.2. a, Aggravated Osteoarthritis.

There is good evidence that in patients with knee OA and with moderate level pain, total knee replacement followed by nonsurgical rehabilitation leads to improvements in knee symptoms, function, and quality of life which are superior to nonsurgical rehabilitation alone. However, adverse events such as deep vein thrombosis and knee stiffness requiring manipulation under anesthesia occur in approximately 16% of knee replacements, and as many as 75% of patients can improve symptomatically over the course of 12 months with nonsurgical rehabilitation alone, and a shared decision-making process is appropriate for knee OA patients who are eligible for knee replacement.

Patients younger than 50 may be considered for unicompartmental replacement if there is little or no arthritis in the lateral compartment, there is no inflammatory disease and/or deformity, and BMI is less than 35. They may be considered for lateral unicompartmental disease when the patient is not a candidate for osteotomy. Outcome is better for patients with social support.

In cases where surgery is contraindicated due to obesity, it may be appropriate to his or her own. Coverage for weight loss would continue only for motivated patients who have demonstrated continual progress with weight loss. A nutritional consultation is recommended for anyone with a BMI over 40. A number of studies suggest that obesity correlates with an increased risk of complications following TKA. Furthermore several studies suggest that morbid obesity (BMI > or = to 40) is associated with lower implant survivorship, lower functional outcome, and a higher rate of complications in TKA patients. Patients with BMI greater than 40 require a second expert surgical opinion.

Contraindications - severe osteoporosis, significant general disability due to other medical conditions, psychiatric issues. low back pain issues that may affect rehabilitation.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The of partial and full disability expected postoperatively. One decision quality tool, the Hip/Knee Osteoarthritis Decision Quality Instrument, may be valuable in assessing patients’ understanding of the procedure. diagnosis. There is good evidence that in patients with knee OA and with moderate level pain, total knee replacement followed by nonsurgical rehabilitation leads to improvements in knee symptoms, function, and quality of life which are superior to nonsurgical rehabilitation alone. However, adverse events such as deep vein thrombosis and knee stiffness requiring manipulation under anesthesia occur in approximately 16% of knee replacements, and as many as 75% of patients can improve symptomatically over the course of 12 months with nonsurgical rehabilitation alone, and a shared decision-making process is appropriate for knee OA patients who are eligible for knee replacement.

There is some evidence that a supervised, 8-week preoperative program of neuromuscular exercise prior to hip or knee arthroplasty is more effective in improving function and reducing pain 6 weeks after surgery than no pre-operative exercise. However, the effect is no longer present at 3 month post-surgery. There is some evidence that 3-weeks of a home preoperative quadriceps exercise program prior to knee arthroplasty is more effective in reducing pain and improving function and quadriceps strength in the short-term up to 3 months postoperatively compared with usual care in patients with knee osteoarthritis.

However, these effects are not sustained at 6 months after TKA. This adequate study provides some evidence that 6-weeks of a home preoperative exercise program prior to knee arthroplasty is more effective in improving range of motion, and knee function before TKA, and in reducing the time to reach functional postoperative recovery (90° of knee flexion) after TKA compared with usual care in patients with knee osteoarthritis, but these effects are not sustained one year after TKA. Thus, there is good evidence supporting pre-operative exercise. Preoperative neuromuscular exercise is recommended prior to arthroplasty. This is frequently accomplished prior to the decision to perform arthroplasty as treatment for aggravated osteoarthritis is recommended. There is good evidence that preoperative exercise with education programs improve function 3 months after total hip replacement among people with symptomatic osteoarthritis of the hip.

Allergy to implant components can play a role in arthroplasty failure. Preoperative screening of patients with the following questions is suggested:

1. Do you have an allergy to metal, such as nickel?

2. Have you ever had a rash or itching under jewelry, jean snaps, or watchbands?

3. If you have ever worn artificial nails, did you ever have a skin reaction?

4. Have you ever developed a rash from topical antibiotics, such as Neosporin?

If there are positive or equivocal responses to any of the questions, patch and or lymphocyte proliferation testing is recommended in advance of surgery.

f. Operative Procedures: Prosthetic replacement of the articular surfaces of the knee; total or uni-compartmental with DVT prophylaxis. May include patellar resurfacing and computer assistance.

There is currently conflicting evidence on the effectiveness of patellar resurfacing. Isolated patellofemoral resurfacing is performed on patients under 60 only after diagnostic arthroscopy does not reveal any arthritic changes in other compartments. The diagnostic arthroscopy is generally performed at the same time as the resurfacing. Resurfacing may accompany a total knee replacement at the discretion of the surgeon. There is good evidence that patellar resurfacing reduces the risk of later reoperation for a small number of arthroplasties. If 25 arthroplasties are done with resurfacing, one later reoperation may be avoided.

Alignment is only one of many factors that may affect the implant longevity. One study provides some evidence that, in patients having bilateral total knee replacements, there are no radiographic alignment differences postoperatively and no functional differences at five years between the knee which was operated on with computer navigation and the knee which was operated on without computer navigation. Another study provides some evidence that navigated total knee arthroplasty (TKA) improves coronal alignment compared to conventional TKA, increasing the likelihood that the implant will have alignment within 3° of neutral. However, there is no evidence that this alignment leads to improved knee function or implant durability compared to conventional TKA in patients who do not have considerations of extra-articular deformity, retained implants, or other factors precluding conventional alignment guides. Thus, there is good evidence that computer navigation does not improve the functional outcome in total knee arthroplasty and therefore it is not recommended. There is strong evidence that in the setting of total knee replacement, the use of patient-specific cutting instrumentation does not offer benefits over conventional instrumentation in terms of postoperative radiographic joint alignment.

There is good evidence that, in patients undergoing primary TKA who do not have patellar resurfacing, circumferential denervation of the patella during the operation can reduce pain postoperatively and improve patient satisfaction two years later.

Tranexamic acid is an effective anti-fibrinolytic agent which decreases the need for blood transfusions. Blood transfusions increase the likelihood of infection for hip and knee arthroplasties. It is usually given in two doses intravenously or topically on the surgical site. There is strong evidence that tranexamic acid in the setting of total knee arthroplasty reduces blood loss, reduces the risk of transfusion, and reduces the number of units transfused, without increasing the risk of pulmonary embolus or deep vein thrombosis. It is also used for hip arthroplasty. Contraindications include patients with hypercoagulable states, cardiac stints, previous strokes. Dosage adjustment for those with renal compromises.

There is some evidence that, in the setting of TKA, intraoperative use of PRP can reduce blood loss, improve levels of postoperative hemoglobin, and reduce the need for blood transfusions by the third postoperative day. Intraoperative use of PRP theoretically may improve pain control and promote earlier return to function. It is rarely used as tranexamic acid is usually prescribed.

There is strong evidence that femoral nerve block (FNB) reduces postoperative pain from total knee replacement more effectively than patient-controlled opioid intravenous analgesia. There is also strong evidence that total opioid use in the immediate postoperative period is lower with FNB than with PCA opioids.

There is some evidence that periarticular injections provide comparable pain relief to femoral sciatic nerve blocks as part of postoperative pain management in patients after total knee arthroplasty, but peripheral nerve blocks have a higher rate of peripheral nerve dysesthesia 6 weeks after surgery and require greater expertise, thus periarticular injections may be preferable.

Complications – Complications may include pulmonary embolism, infection, bony lysis, polyethylene wear, tibial loosening, instability, malalignment, stiffness, patellar tracking abnormality, nerve-vessel injury, and peri-prosthetic fracture.

There is good evidence that adverse events such as deep vein thrombosis and knee stiffness requiring manipulation under anesthesia occur in approximately 16% of knee replacements. More complications including infections occur with BMI greater than 30. Patients with pre-existing psychiatric conditions may have more complications.

g. Postoperative Treatment:

i. Anti-coagulant therapy to prevent deep vein thrombosis. Refer to Section F. 9. c. Deep Venous Thrombosis Prophylaxis.

ii. NSAIDs may be used for pain management after joint replacement. They have also been used to reduce heterotopic ossification after knee heterotopic ossification in this setting, but there is some evidence (in literature on total hip arthroplasty) that they do not improve functional outcomes and they may increase the risk of bleeding events in the postoperative period. Their routine use for prevention of heterotopic bone formation is not recommended.

iii. There is some evidence that local infiltration analgesia with ropivacaine and ketorolac during and for the first two days after TKA has relevant advantages over intrathecal morphine on the day of the procedure.

These advantages include lower postoperative consumption of morphine, less postoperative pain, and earlier return to activity. Local Infiltration Analgesia (LIA) with intraoperative administration of local anesthetic in various combinations with Epinephrine, Non-Steroidal Antiinflammatories, Opioids and Steroids has been gaining clinical interest as a simple surgeon-administered technique for the treatment of postoperative pain after hip and knee arthroplasty. This technique has gained widespread use, although optimal design, including interoperative injection technique and drug mixture, has not been completely evaluated.

A FNB may hinder early postoperative mobilization because of motor blockade of the Quadriceps muscle, and patients may have a risk of falling in first days after surgery. For these reasons, LIA may be preferable to FNB, although FNB remains identified in the literature as the gold standard after TKA.

iv. There is good evidence that a conventional cold pack is as effective as an advanced computer-controlled cryotherapy device in relieving pain after knee arthroplasty for osteoarthritis. Therefore, computer controlled cryotherapy is not recommended.

v. There is some evidence that there are no beneficial effects of early aggressive continuous passive motion (CPM) and fixed flexion CPM preceding progressive CPM on the short-term outcomes of range of motion (ROM), pain, and hospital length of stay compared to standardized physical therapy alone in patients following total knee arthroplasty. In addition, there is good evidence that, in people with osteoarthritis of the knee, continuous passive motion (CPM) following total knee arthroplasty does not have clinically important short-term effects on active knee flexion ROM, medium-term effects on function or quality of life, or on preventing thromboembolism. CPM also appears to provide no cost advantage. For these reasons, CPM is not recommended for knee arthroplasty.

vi. An individualized rehabilitation program must be based upon communication between the surgeon and the therapist and use therapies outlined in Section F. Therapeutic Procedures, Non-operative. In all cases, communication between the physician and therapist is important to the timing of weight-bearing, and exercise progressions.

There is some evidence that initiating rehabilitation treatment within 24 hours versus 48–72 hours after total knee arthroplasty for osteoarthritis is more effective in reducing the hospital stay and reducing pain leading to an earlier onset of postoperative recovery.

vii. Treatment may include the following: bracing and active therapy with or without passive therapy. Rehabilitation postoperatively may need to be specifically focused on the following problems: knee flexion contracture, quadriceps muscle weakness, knee flexion deficit, and foot and ankle malalignment. It is not clear that early progressive strength training changes outcomes when added to regular rehabilitation. It is also not clear that early monitored home exercise has worse outcomes than usual rehabilitation. A balanced rehabilitation program may increase function for some patients. Active stretching, passive stretching, and proprioceptive neuromuscular facilitation all have similar positive effects on increasing knee flexibility. In summary, therapists will need to develop individual rehabilitation programs based on the patient needs and their professional expertise.

There is some evidence that a long-term, 12-month home exercise program intervention is not more effective in reducing pain or improving function in patients after primary total knee arthroplasty than a control group receiving normal care. However, there is some evidence that this program is more effective in improving walking speed and knee flexion strength. Home exercise should be encouraged for all post knee arthroplasty patients in order to maintain function. This may require occasional physiotherapy visits – approximately 3-4 after traditional rehabilitation.

Specialized taping postoperatively may be useful. Other therapy may include knee braces, shoe lifts, orthoses, and electrical stimulation, accompanied by focused active therapy.

viii. Return to work and restrictions after surgery may be made by an with the surgeon or by the surgeon. Patient should be able to return to sedentary work within 4 to 6 weeks. Some patients may have permanent restrictions based on their job duties.

ix. In some cases, aquatic therapy may be used. Refer to Section F.15.b.

Aquatic Therapy. Pool exercises may be done initially under therapist's or surgeon's direction then progressed to an independent pool program.

x. Consider need for manipulation under anesthesia or arthroscopic lysis of adhesions if range of motion remains compromised after knee arthroplasty.

xi. Prior to revision surgery there should be an evaluation to rule out xii. Patients are usually seen annually after initial recovery to check plain xrays for signs of loosening.

5. HIP ARTHROPLASTY

a. Description/Definition: Prosthetic replacement of the articulating surfaces of the hip joint. In some cases, hip resurfacing may be performed.

b. Occupational Relationship: Usually from post-traumatic arthritis, hip dislocations and femur or acetabular fractures. Patients with intracapsular femoral fractures have a risk of developing avascular necrosis of the femoral head, requiring treatment months to years after the initial injury.

c. Specific Physical Exam Findings: Stiff, painful hip.

d. Diagnostic Testing Procedures: Standing pelvic radiographs demonstrating joint space narrowing to 2 mm or less, osteophytes, or sclerosis at the joint. MRI may be ordered to rule out other more serious disease.

e. Surgical Indications/Considerations: Severe osteoarthritis, all reasonable conservative measures have been exhausted, and other reasonable surgical options have been considered or implemented. Refer to subsection E. 3. b.

Aggravated Osteoarthritis.

Possible contraindications - inadequate bone density, prior hip surgery, and obesity.

There is good evidence that preoperative exercise with education programs improve function 3 months after total hip replacement among people with symptomatic osteoarthritis of the hip.

Another study provided some evidence that a supervised, 8-week preoperative program of neuromuscular exercise prior to hip or knee arthroplasty is more effective in improving function and reducing pain 6 weeks after surgery.

However, the effect is no longer present at 3 month post-surgery. Pre-operative neuromuscular exercise is recommended prior to arthroplasty. This is frequently accomplished prior to the decision to perform arthroplasty as treatment for aggravated osteoarthritis.

In cases where surgery is contraindicated due to obesity, it may be appropriate to his or her own. Coverage for weight loss would continue only for motivated patients who have demonstrated continual progress with weight loss. low back pain issues affecting rehabilitation.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The of partial and full disability expected postoperatively. One decision quality tool, the Hip/Knee Osteoarthritis Decision Quality Instrument, may be valuable in assessing patients’ understanding of the procedure. significantly over time, without invasive interventions, patients must be able to The success rate of hip arthroplasty is high regarding improved function and patient satisfaction.

Allergy to implant components can play a role in arthroplasty failure. Preoperative screening of patients with the following questions is suggested:

1. Do you have an allergy to metal, such as nickel?

2. Have you ever had a rash or itching under jewelry, jean snaps, or watchbands?

3. If you have ever worn artificial nails, did you ever have a skin reaction?

4. Have you ever developed a rash from topical antibiotics, such as Neosporin?

If there are positive or equivocal responses to any of the questions, patch and or lymphocyte proliferation testing is recommended in advance of surgery.

f. Operative Procedures: Prosthetic replacement of the articular surfaces of the hip, ceramic or metal prosthesis, with DVT prophylaxis. Ceramic prosthesis is more expensive; however, it is expected to have greater longevity and may be appropriate in some younger patients. Hip resurfacing, metal on metal, is an option for younger or active patients likely to out-live traditional total hip replacements. Metal-on-metal prosthesis are not generally recommended.

There is good evidence that the risk of recurrent fracture is lower with a hemiarthroplasty than with a total hip replacement. There is also good evidence that cemented hemiarthroplasty has a lower risk of intraoperative and postoperative fractures than an uncemented hemiarthroplasty. There is good evidence that unipolar and bipolar hemiarthroplasty yield similar results for mortality, acetabular erosion, reoperations, or mobility. The evidence regarding functional and pain outcomes of hemiarthroplasty versus total hip replacement remains unclear at this time. The surgeon will determine the arthroplasty type for Complications include leg length inequality, deep venous thrombosis with possible pulmonary embolus, hip dislocation, possible renal effects, need for transfusions, future infection, need for revisions, fracture at implant site. Patients who have received a metal on metal total hip are likely to have elevated cobalt levels compared to ceramic on ceramic models. These patients should have their chromium and cobalt levels monitored regularly. With metal on metal implants, there is concern regarding adverse local tissue reactions as a result of metal particles around the implant.

Tranexamic acid is an effective anti- fibrinolytic agent which decreases the need for blood transfusions. Blood transfusions increase the likelihood of infection for hip and knee arthroplasties. It is usually given in two doses intravenously or topically on the surgical site. There is strong evidence that tranexamic acid in the setting of total knee arthroplasty reduces blood loss, reduces the risk of transfusion, and reduces the number of units transfused, without increasing the risk of pulmonary embolus or deep vein thrombosis. It is also used for hip arthroplasty. Contraindications include patients with hypercoagulable states, cardiac stints, previous strokes. Dosage adjustment for those with renal compromises.

The long-term benefit for computer assisted hip replacements is unknown. It improves acetabular cup placement. However, the long-term functional advantages are not clear. Prior authorization is required.

Robotic assisted surgery is considered experimental and not recommended due to technical difficulties.

Patients with pre-existing psychiatric conditions may have more complications than those without.

g. Postoperative Treatment:

i. Anti-coagulant therapy to prevent deep vein thrombosis. Refer to Section F. 9. c. Deep Venous Thrombosis Prophylaxis.

ii. NSAIDs may be used for pain management after joint replacement. They have also been used to reduce heterotopic ossification after hip heterotopic ossification in this setting, but there is some evidence that they do not improve functional outcomes and they may increase the risk of bleeding events in the postoperative period. Their routine use for prevention of heterotopic bone formation is not recommended.

iii. An individualized rehabilitation program based upon communication between the surgeon and the therapist and using the therapies as outlined in Section F. Therapeutic Procedures Non-operative. In all cases, communication between the physician and therapist is important to the timing of weight-bearing and exercise progressions.

iv. Treatment usually includes active therapy with or without passive therapy with emphasis on gait training with appropriate assistive devices.

Patients with accelerated return to therapy appear to do better. Training should include knee flexors and extensors for strength, balance training, correction of faulty gait, and increased range of motion. Limitations exist for 6-12 weeks. Therapy should include training on the use of adaptive There is some evidence that adding a 4-week maximal strength training intervention to a conventional hip rehabilitation program in the early postoperative phase after undergoing total hip arthroplasty (THA) is effective in improving lower extremity muscle and hip abductor strength in the short-term (5 weeks postoperative), and in improving work efficiency 6 and 12 months after THA.

There is good evidence that 4 weeks of resistance training is effective for improving maximal strength, functional ability, and reducing pain when used as a therapeutic rehabilitation program for various musculoskeletal conditions and after hip replacement surgery. The musculoskeletal conditions include chronic tendinopathy and knee osteoarthritis.

There is some evidence that, for patients older than 60, early multidisciplinary therapy may shorten hospital stay and improve activity level for those receiving hip replacement. Therefore, this may be used for selected patients.

There is good evidence for the use of aquatic therapy. Refer to Section F., 14. b. Therapeutic Procedures, Non-operative. Pool exercises may be done initially under a therapist's or surgeon's direction then progressed to an independent pool program.

v. Return to activities at 4 to 6 weeks with appropriate restrictions by the surgeon. Initially, range of motion is usually restricted. Return to activity after full recovery depends on the surgical approach. Patients can usually lift, but jogging and other high impact activities are avoided.

Return to work and restrictions after surgery may be made by an vi. Helical CT or MRI with artifact minimization may be used to investigate prosthetic complications. The need for implant revision is determined by age, size of osteolytic lesion, type of lesion and functional status.

Revision surgery may be performed by an orthopedic surgeon in cases with chronic pain and stiffness or difficulty with activities of daily living.

Prior authorization is required and a second opinion by a surgeon with special expertise in hip/knee replacement surgery should usually be performed.

vii. Patients are usually seen annually after the initial recovery to check plain x-rays for signs of loosening.

viii. Aseptic loosening of the joint requiring revision surgery occurs in some patients. Prior to revision, the joint should be checked to rule out possible infection. This may require a bone scan as well as laboratory procedures, including a radiologically directed joint aspiration.

ix. Cobalt and chromium should be check serially on patients who received metal on metal implants. Increasing levels may indicate malfunctioning of the implant.

6. AMPUTATION

a. Description/Definition: Surgical removal of a portion of the lower extremity.

b. Occupational Relationship: Usually secondary to post-traumatic bone, soft tissue, vascular or neurologic compromise of part of the extremity.

c. Specific Physical Exam Findings: Non-useful or non-viable portion of the lower extremity.

d. Diagnostic Testing Procedures: Radiographs, vascular studies, MRI, bone scan.

e. Surgical Indications/Considerations: Non-useful or non-viable portion of the extremity.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The significantly over time, without invasive interventions, patients must be able to f. Operative Procedures: Amputation.

g. Postoperative Treatment:

i. An individualized rehabilitation program based upon communication ii. Rigid removable dressings are used initially.

iii. Therapies usually include active therapy with or without passive therapy for prosthetic fitting, construction and training, protected weight-bearing, training on the use of adaptive equipment, and home and jobsite evaluation. Temporary prosthetics are used initially with a final prosthesis fitted by the second year. Multiple fittings and trials may be necessary to assure the best functional result.

iv. For prosthesis with special adaptive devices, e.g. computerized prosthesis; prior authorization and a second opinion from a physician knowledgeable in prosthetic rehabilitation and who has a clear description of the patients expected job duties and daily living activities are required.

v. Return to work and restrictions after surgery may be made by an 7. MANIPULATION UNDER ANESTHESIA a. Description/Definition: Passive range of motion of a joint under anesthesia.

b. Occupational Relationship: Joint stiffness that usually results from a traumatic injury, compensation related surgery, or other treatment.

c. Specific Physical Exam Findings: Joint stiffness in both active and passive modes.

d. Diagnostic Testing Procedures: Radiographs. CT, MRI, diagnostic injections.

e. Surgical Indications/Considerations: Consider if routine therapeutic modalities, including therapy and/or dynamic bracing, do not restore the degree of motion that should be expected after a reasonable period of time, usually at least six Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The significantly over time, without invasive interventions, patients must be able to f. Operative Treatment: Not applicable.

g. Postoperative Treatment:

i. An individualized rehabilitation program based upon communication

Section F. Therapeutic Procedures, Non-operative. Therapy includes a temporary increase in frequency of both active and passive therapy to maintain the range of motion gains from surgery.

ii. Continuous passive motion is frequently used postoperatively.

iii. Return to work and restrictions after surgery may be made by an 8. OSTEOTOMY a. Description/Definition: A reconstructive procedure involving the surgical cutting of bone for realignment. It is useful for patients that would benefit from realignment in lieu of total joint replacement.

b. Occupational Relationship: Post-traumatic arthritis or deformity.

c. Specific Physical Exam Findings: Painful decreased range of motion and/or deformity.

d. Diagnostic Testing Procedures: Radiographs, MRI scan, CT scan.

e. Surgical Indications/Considerations: Failure of non-surgical treatment when avoidance of total joint arthroplasty is desirable. For the knee, joint femoral osteotomy may be desirable for young or middle age patients with varus alignment and medial arthritis or valgus alignment and lateral compartment arthritis. High tibial osteotomy is also used for medial compartment arthritis.

Multi-compartmental degeneration is a contraindication. Patients should have a range of motion of at least 90 degrees of knee flexion. Those with BMI less than 30, lower disability scores on the WOMAC (Western Ontario McMaster University Osteoarthritis) index, and aged less than 55 are likely to have better outcome for high tibial osteotomy. For the ankle, supra malleolar osteotomy may be appropriate. High body mass is a relative contraindication.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The of partial and full disability expected postoperatively. Patients should know that total knee arthroplasty may be necessary later and is somewhat more complex after an osteotomy. significantly over time, without invasive interventions, patients must be able to f. Operative Procedures: Peri-articular opening or closing wedge of bone, usually with grafting and internal or external fixation.

Complications - new fractures, lateral peroneal nerve palsy, infection, delayed unions, compartment syndrome, or pulmonary embolism.

g. Postoperative Treatment:

i. An individualized rehabilitation program based upon communication ii. Weight-bearing and range-of-motion exercises depend on the type of procedure performed. Partial or full weight-bearing restrictions can range from 6 weeks partial weight-bearing, to 3 months full weight-bearing. It is usually 6 months before return to sports or other rigorous physical activity.

iii. If femoral intertrochanteric osteotomy has been performed, there is some evidence that electrical bone growth stimulation may improve bone density. Refer to Section F., 3. Therapeutic Procedures, Non-operative, Bone Growth Stimulators for description.

iv. Return to work and restrictions after surgery may be made by an 9. HARDWARE REMOVAL Hardware removal frequently occurs after initial MMI.

Physicians should document the possible need for hardware removal and include this as treatment in their final report on the WC 164 form.

a. Description/Definition: Surgical removal of internal or external fixation device, commonly related to fracture repairs.

b. Occupational Relationship: Usually following healing of a post-traumatic injury that required fixation or reconstruction using instrumentation.

c. Specific Physical Exam Findings: Local pain to palpation, swelling, erythema.

d. Diagnostic Testing Procedures: Radiographs, tomography, CT scan, MRI.

e. Surgical Indications/Considerations: Persistent local pain, irritation around hardware.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The significantly over time, without invasive interventions, patients must be able to f. Operative Procedures: Removal of hardware may be accompanied by scar release/resection, and/or manipulation. Some instrumentation may be removed in the course of standard treatment without symptoms of local irritation.

g. Postoperative Treatment:

i. An individualized rehabilitation program based upon communication ii. Treatment may include therapy with or without passive therapy for progressive weight-bearing, range of motion.

iii. Return to work and restrictions after surgery may be made by an 10. RELEASE OF CONTRACTURE a. Description/Definition: Surgical incision or lengthening of contracted tendon or peri-articular soft tissue.

b. Occupational Relationship: Usually following a post-traumatic complication.

c. Specific Physical Exam Findings: Shortened tendon or stiff joint.

d. Diagnostic Testing Procedures: Radiographs, CT scan, MRI scan.

e. Surgical Indications/Considerations: Persistent shortening or stiffness associated with pain and/or altered function.

Prior to surgical intervention, the patient and treating physician should identify perform activities of daily living or work, as well as possible complications. The significantly over time, without invasive interventions, patients must be able to f. Operative Procedures: Surgical incision or lengthening of involved soft tissue.

g. Postoperative Treatment:

i. An individualized rehabilitation program based upon communication ii. Treatments may include active therapy with or without passive therapy for stretching, range of motion exercises.

iii. Return to work and restrictions after surgery may be made by an 11. HUMAN BONE MORPHOGENETIC PROTEIN (RHBMP)

Bone morphogenetic proteins (BMPs) are proteins secreted by cells which serve as signaling agents that influence cell division, matrix synthesis, and tissue differentiation.

Most BMP studies examine utility in tibial fractures. For acute tibial fractures, BMP has been used at the site of fracture in conjunction with reamed or undreamed intramedullary nail fixation in an effort to promote bone formation and fracture healing. It has also been used in tibial nonunion.

A recent systematic review and meta-analysis examined the use of BMP for fracture healing in skeletally mature adults with acute or nonunion fractures with the primary outcomes of time to union and union rate. The eleven studies were of overall poor quality due to bias, measurement error, and potential for selective outcome reporting. These biases generally tend to favor the intervention. Yet, the included studies failed to identify differences in fracture healing rates between the BMP and control groups or evidence for benefit of BMP in achieving union for nonunion fractures. This further supports the conclusion that the addition of BMP does not result in significant gains in attaining union without a second procedure over the standard of care.

One study included in that meta-analysis found a higher rate of secondary procedures in the group not treated with BMP. However, this study was susceptible to assessment bias as the decision to proceed with more invasive secondary procedures may have been influenced by knowledge of allocation. Additionally, the study protocol did not specify a minimum waiting period prior to assessing the need for a secondary procedure. This omission may have influenced outcomes, as the authors did not allow sufficient time for fracture healing.

There is currently a lack of evidence to recommend the use of BMP in the treatment of tibial fractures. There is good evidence that there are no measureable benefits of BMP over standard of care without BMP for tibial fractures. There is good evidence that, for open tibial shaft fractures, BMP does not enhance fracture healing at 20 weeks compared to fracture fixation with intramedullary nailing.

Addition of BMP does not accelerate healing in the treatment of acute open tibial fractures, result in significant gains in attaining union without a secondary procedure over the standard of care, or affects the risk of hardware failure. If unusual circumstances arise, a provider may feel that a patient will benefit from addition of BMP. BMP should only be used for long bone fractures with a nonunion or high risk arthrodesis procedures and requires prior authorization. _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 18: Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 07 Rule 17, Exhibit 7 - COMPLEX REGIONAL PAIN SYNDROME/REFLEX SYMPATHETIC DYSTROPHY MEDICAL TREATMENT GUIDELINES {#sec-7-ccr-1101-3-r17-ex-07 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 07}

DEPARTMENT OF LABOR AND EMPLOYMENT

WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

RULE 17, EXHIBIT 7 COMPLEX REGIONAL PAIN SYNDROME/REFLEX SYMPATHETIC

DYSTROPHY MEDICAL TREATMENT GUIDELINES 7 CCR 1101-3 Rule 17, Exhibit 7 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ A. INTRODUCTION This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of guidelines for physicians/providers treating individuals qualifying under Colorado’s Workers’ Compensation Act as injured workers with Complex Regional Pain Syndrome (CRPS), formerly known as Reflex Sympathetic Dystrophy (RSD).

Although the primary purpose of this document is advisory and educational, these guidelines are enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from these guidelines, as individual cases dictate. Therefore, these guidelines are not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip nor overlook any sections.

B. GENERAL GUIDELINE PRINCIPLES

The principles summarized in this section are key to the intended implementation of all Division of Workers’ Compensation medical treatment guidelines and critical to the reader’s application of the guidelines in this document.

1. APPLICATION OF GUIDELINES The Division provides procedures to implement medical treatment guidelines and to foster communication to resolve disputes among the provider, payer and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the office of administrative courts.

2. EDUCATION Education of the patient and family, as well as the employer, insurer, policy makers, and the community, should be the primary emphasis in the treatment of chronic pain and disability. Currently, practitioners often think of education last, after medications, manual therapy, and surgery. Practitioners must implement strategies to educate patients, employers, insurance systems, policy makers, and the community as a whole.

An education-based paradigm should always start with inexpensive communication providing reassuring and evidence-based information to the patient. More in-depth patient education is currently a component of treatment regimens which employ functional, restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention. Facilitation through language interpretation, when necessary, is a priority and part of the medical care treatment protocol.

3. INFORMED DECISION MAKING Providers should implement informed decision making as a crucial element of a successful treatment plan. Patients, with the assistance of their health care practitioner, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, physical therapists, and other members of the health care team play an integral role in informed decision making and achievement of functional goals. Patient education and informed decision making should facilitate self-management of symptoms and prevention of further injury.

4. TREATMENT PARAMETER DURATION Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Obviously, duration will be impacted by patient adherence, as well as availability of services. Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

5. ACTIVE INTERVENTIONS emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, are generally emphasized over passive modalities, especially as treatment progresses. Generally, passive interventions are viewed as a means to facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

6. ACTIVE THERAPEUTIC EXERCISE PROGRAM goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

7. POSITIVE PATIENT RESPONSE Positive results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to: positional tolerances, range-of-motion, strength, endurance, activities of daily living, ability to function at work, cognition, psychological behavior, and efficiency/velocity measures that can be quantified. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation. Anatomic correlation must be based on objective findings. Patient completed functional questionnaires such as those recommended by the Division as part of Quality Performance and Outcomes Payments (QPOP, see Rule 18-8) and/or the Patient Specific Functional Scale can provide useful additional confirmation.

8. RE-EVALUATION OF TREATMENT NO LESS THAN EVERY 3 TO 4 WEEKS If a given treatment or modality is not producing positive results within 3 to 4 weeks or within the time to produce effect in the guidelines, the treatment should be either modified or discontinued. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results.

Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

9. SURGICAL INTERVENTIONS Surgery should be contemplated within the context of expected functional outcome and not purely for the purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic conditions.

10. SIX-MONTH TIME FRAME The prognosis drops precipitously for returning an injured worker to work once he/she has been temporarily totally disabled for more than six months. The emphasis within these guidelines is to move patients along a continuum of care and return-to-work within a six-month time frame, whenever possible. It is important to note that time frames may be less pertinent for injuries that do not involve work-time loss or are not occupationally related.

11. RETURN-TO-WORK A return-to-work is therapeutic, assuming the work is not likely to aggravate the basic problem or increase long-term pain. The practitioner must provide specific physical limitations and the patient should never be released to non-specific and vague descriptions such as “sedentary” or “light duty.” The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, data entry and other repetitive motion tasks, sustained grip, tool usage and vibration factors. Even if there is residual chronic pain, return-to-work is not necessarily contraindicated. The practitioner should understand all of the physical demands of the patient’s job position before returning the patient to full duty and should request clarification of the patient’s job duties. Clarification should be obtained from the employer or, if necessary, from including, but not limited to, an occupational health nurse, occupational therapist, vocational rehabilitation specialist, an industrial hygienist, or another professional.

12. DELAYED RECOVERY Strongly consider a psychological evaluation, if not previously provided, as well as initiating interdisciplinary rehabilitation treatment and vocational goal setting, for those patients who are failing to make expected progress 6 to 12 weeks after initiation of treatment of an injury. Therefore, all chronic pain patients should have a documented psychological evaluation and psychological treatment as appropriate to address issue of chronic pain. It is also appropriate to clinically reassess the patient, function goals, and differential diagnosis. The Division recognizes that 3 to 10% of all industrially injured patients will not recover within the timelines outlined in this document, despite optimal care. Such individuals may require treatments beyond the timelines discussed within this document, but such treatment requires clear documentation by the authorized treating practitioner focusing on objective functional gains afforded by further treatment and impact upon prognosis.

13. GUIDELINE RECOMMENDATIONS AND INCLUSION OF MEDICAL EVIDENCE All recommendations are based on available evidence and/or consensus judgment. When possible, guideline recommendations will note the level of evidence supporting the treatment recommendation. It is generally recognized that early reports of a positive treatment effect are frequently weakened or overturned by subsequent research. When interpreting medical evidence statements in the guideline, the following apply:

• Consensus means the judgment of experienced professionals based on general medical principles. Consensus recommendations are designated in the guidelines as “generally well-accepted,” “generally accepted,”

“acceptable/accepted,” or “well-established.”

• “Some evidence” means the recommendation considered at least one adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the intervention’s effect.

• “Good evidence” means the recommendation considered the availability of multiple adequate scientific studies or at least one relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the intervention’s effect.

• “Strong evidence” means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the intervention’s effect.

All recommendations in the guideline are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guideline as “not recommended.”

Please refer to the Colorado Department of Labor and Employment’s website for evidence tables and study critiques which provide details on the studies used to develop the evidence statements.

14. TREATMENT OF PRE-EXISTING CONDITIONS that preexisted the work injury/disease will need to be managed under two circumstances: (a) A preexisting condition exacerbated by a work injury/disease should be treated until the patient has returned to their objectively verified prior level of functioning or Maximum Medical Improvement (MMI); and (b) A preexisting condition not directly caused by a work injury/disease but which may prevent recovery from that injury should be treated until its objectively verified negative impact has been controlled. The focus of treatment should remain on the work injury/disease.

The remainder of this document should be interpreted within the parameters of these guideline principles that may lead to more optimal medical and functional outcomes for injured workers.

C. INTRODUCTION TO COMPLEX REGIONAL PAIN SYNDROME

Complex Regional Pain Syndrome (CRPS Types I and II) describes painful syndromes, which were formerly referred to as Reflex Sympathetic Dystrophy (RSD) and causalgia. CRPS conditions usually follow injury that appears regionally and have a distal predominance of abnormal findings, exceeding the expected clinical course of the inciting event in both magnitude and duration and often resulting in significant impairment of limb function.

CRPS I (RSD) is a syndrome that usually develops after an initiating noxious event, is not limited to the distribution of a single peripheral nerve, and appears to be disproportionate to the inciting event. It is associated at some point with evidence of edema, changes in skin, blood flow, abnormal sudomotor activity in the region of the pain, allodynia, or hyperalgesia. The site is usually in the distal aspect of an affected extremity or with a distal to proximal gradient. The peripheral nervous system and possibly the central nervous system are involved.

CRPS II (Causalgia) is the presence of burning pain, allodynia, and hyperpathia usually in the hand or foot after partial injury to a nerve or one of its major branches. Pain is within the distribution of the damaged nerve but not generally confined to a single nerve.

Historically, three stages Stage 1- Acute (Hyperemic), Stage 2- Dystrophic (Ischemic), and Stage 3 (Atrophic) were thought to occur. However, the Stages in CRPS I are not absolute and in fact, may not all be observed in any single patient. Signs and symptoms fluctuate over time and are reflective of ongoing dynamic changes in both the peripheral and central nervous systems.

Although there has been some debate regarding both the existence and pathophysiologic basis of CRPS, as with all chronic pain, psychological issues should always be addressed, but there are a number of studies identifying pathological findings.

Historically, the following studies provide further basis for the CRPS pathological model.

In animals, a mice model with tibial fracture and cast immobilization is used to create CRPS. For mice with clinical signs of CRPS, transcriptional changes in gene expression were found. Another study found that patients with CRPS versus those healthy controls perceive their affected hand to be larger than the unaffected hand. The finding corresponded to disease duration, decrease tactile thresholds, and a neglect score. A functional MRI study confirmed an enlarged somatosensory cortex representation of the healthy hand. Other studies have supported a difference in the primary somatosensory cortex or neuroimaging, although the quality of studies is low.

Another small study noted an increase in blood oxygenation level in the cortical representation of the affected hand after a successful sympathetic block indicating clear central involvement for the CRPS pain.

D. DEFINITIONS

1. AFTER SENSATION: refers to the abnormal persistence of a sensory perception, provoked by a stimulus even though the stimulus has ceased.

2. ALLODYNIA: pain due to a non-noxious stimulus that does not normally provoke pain.

Mechanical Allodynia: refers to the abnormal perception of pain from usually non-painful mechanical stimulation.

Static Mechanical Allodynia: refers to pain obtained by applying a single stimulus such as light pressure to a defined area.

Dynamic Mechanical Allodynia: obtained by moving the stimulus such as a brush or cotton tip across the abnormal hypersensitive area.

Thermal Allodynia: refers to the abnormal sensation of pain from usually non-painful thermal stimulation such as cold or warmth.

3. CENTRAL PAIN: pain initiated or caused by a primary lesion or dysfunction in the central nervous system (CNS).

4. CENTRAL SENSITIZATION: the experience of pain evoked by the excitation of nonnociceptive neurons or of nerve fibers that normally relay non-painful sensations to the spinal cord. This results when non-nociceptive afferent neurons act on a sensitized central nervous system (CNS). Experimental data suggest that pathways normally carrying pain signals themselves become overstimulated and/or fail to respond to inhibitory influences causing increased pain. An example is ‘wind-up’ which occurs when cells in the dorsal horn of the spinal cord increase their rate of action potential discharge in response to repeated stimulation by nociceptors.

5. DYSTONIA: state of abnormal (hypo or hyper) tonicity in any of the tissues.

6. HYPERALGESIA: refers to an exaggerated pain response from a usually painful stimulation.

7. HYPEREMIA: presence of increased blood in a part or organ.

8. HYPERESTHESIA: (Positive Sensory Phenomenon): includes allodynia, hyperalgesia, and hyperpathia. Elicited by light touch, pin-prick, cold, warm vibration, joint position sensation, or two-point discrimination, which is perceived as increased or more.

9. HYPERPATHIA: a condition of altered perception such that stimuli which would normally be innocuous, if repeated or prolonged, result in severe explosive persistent pain.

10. HYPOESTHESIA: (also hypesthesia): diminished sensitivity to stimulation.

11. PAIN BEHAVIOR: the nonverbal actions (such as grimacing, groaning, limping, using visible pain relieving or support devices, and requisition of pain medications, among others) that are outward manifestations of pain and through which a person may communicate that pain is being experienced.

12. SUDOMOTOR CHANGES: alteration in function of sweat glands. Sweat output may increase or decrease due to changes in autonomic input to the gland.

13. SYMPATHETICALLY MAINTAINED PAIN (SMP): a pain that is maintained by sympathetic efferent innervations or by circulating catecholalmines and which may be a separate condition from CRPS.

14. TROPHIC CHANGES: tissue alterations due to interruption of nerve or blood supply; may include changes in hair growth and texture of skin.

15. VASOMOTOR CHANGES: alteration in regulation of dilation or constriction of blood vessels.

E. INITIAL EVALUATION

The Division recommends the following diagnostic procedures be considered, at least initially, the responsibility of the workers’ compensation carrier to ensure that an accurate diagnosis and treatment plan can be established. Standard procedures that should be utilized when initially diagnosing a work-related chronic pain complaint are listed below. Because CRPS I is commonly associated with other injuries, it is essential that all related diagnoses are defined and treated.

These disturbances are typically restricted to one extremity, usually distally, but are variable in their expression.

1. HISTORY TAKING AND PHYSICAL EXAMINATION (HX & PE): are generally accepted, well-established, and widely used procedures that establish the foundation/basis for and dictates subsequent stages of diagnostic and therapeutic procedures. When findings of clinical evaluations and those of other diagnostic procedures are not complementing each other, the objective clinical findings should have preference. Before the diagnosis of CRPS I or CRPS II is established, an experienced practitioner must perform a detailed neurological and musculoskeletal exam to exclude other potentially treatable pain generators or neurological lesions. The medical records should reasonably document the following:

a. Medical History: As in other fields of medicine, a thorough patient history is an important part of the evaluation of pain. In taking such a history, factors influencing a patient’s current status can be made clear and taken into account when planning diagnostic evaluation and treatment. It may be necessary to acquire previous medical records. One efficient manner in which to obtain historical information is by using a questionnaire. The questionnaire may be sent to the patient prior to the initial visit or administered at the time of the office visit.

History should ascertain the following elements:

i. General Information: General items requested are name, sex, age, birth date, etc.

ii. Level of Education: The level of patient’s education may influence response to treatment.

iii. Work History/Occupation: to include both impact of injury on job duties and impact on ability to perform job duties, work history, job description, mechanical requirements of the job, duration of employment, and job satisfaction.

iv. Current employment status.

v. Marital status.

vi. Family Environment: Is the patient living in a nuclear family or with friends? Is there, or were there, any family members with chronic illness or pain problems? Responses to such questions reveal the nature of the support system or the possibility of conditioning toward chronicity.

vii. Ethnic Origin: Ethnicity of the patient, including any existing language barriers, may influence the patient’s perception of and response to pain.

Literature indicates that providers may under-treat patients of certain ethnic backgrounds due to underestimation of their pain.

viii. Belief System: Patients should be asked about their value systems, including spiritual and cultural beliefs, in order to determine how these may influence the patient’s and family’s response to illness and treatment recommendations.

ix. Functional Assessment: Functional ability should be assessed and documented at the beginning of treatment. Periodic assessment should be recorded throughout the course of care to follow the trajectory of recovery. Functional measures are likely to be more reliable over time than pain measures.

Patient-reported outcomes, whether of pain or function, are susceptible to a phenomenon called response shift. This refers to changes in selfevaluation, which may accompany changes in health status. Patient selfreports may not coincide with objective measures of outcome, due to reconceptualization of the impact of pain on daily function and internal recalibration of pain scales. Response shift may obscure treatment effects in clinical trials and clinical practice, and it may lead to apparent discrepancies in patient-reported outcomes following treatment interventions. While methods of measuring and accounting for response shift are not yet fully developed, understanding that the phenomenon exists can help clinicians understand what is happening when some measures of patient progress appear inconsistent with other measures of progress.

x. Activities of Daily Living: Pain has a multidimensional effect on the patient that is reflected in changes in usual daily vocational, social, recreational, and sexual activities.

xi. Past and present psychological problems.

xii. History of abuse: physical, emotional, sexual.

xiii. History of disability in the family.

xiv. Sleep disturbances: Poor sleep has been shown to increase patient’s self-perceived pain scores. Pre-injury and post-injury sleep should be recorded.

xv. Causality: How did this injury occur? Was the problem initiated by a work-related injury or exposure? Patient’s perception of causality (e.g., was it their fault or the fault of another).

xvi. Presenting symptoms related to CRPS:

A) Severe, generally unremitting burning and/or aching pain and/or allodynia.

B) Swelling of the involved area.

C) Changes in skin color.

D) Asymmetry in nail and/or hair growth.

E) Abnormal sweat patterns of the involved extremity.

F) Motor dysfunction: limited active range-of-motion, atrophy, tremors, dystonia, weakness.

G) Subjective temperature changes of the affected area.

b. Pain History: Characterization of the patient’s pain and of the patient’s response to pain is one of the key elements for CRPS diagnosis.

i. Site of Pain: Localization and distribution of the pain help determine the type of pain the patient has (i.e., central versus peripheral).

ii. Pain Diagram drawing to document the distribution of pain.

iii. Visual Analog Scale (VAS): including a discussion of the range of pain during the day and how activities, use of modalities, and other actions affect the intensity of pain.

iv. Duration: including intermittent pain, activity related pain.

v. Circumstances during which the pain began (e.g., an accident, an illness, a stressful incident, or spontaneous onset).

vi. Pain characteristics: such as burning, shooting, stabbing, aching. Time of pain occurrence as well as intensity, quality, and radiation give clues to the diagnosis and potential treatment. The quality of pain can be helpful in identifying neuropathic pain which is normally present most of the day, at night, and is described as burning.

vii. Response of pain to activity: list of activities which aggravate or exacerbate, ameliorate, or have no effect on the level of pain.

viii. Associated Symptoms: Does the patient have numbness or paresthesia, dysesthesia, weakness, bowel or bladder dysfunction, decreased temperature, increased sweating, cyanosis or edema? Is there local tenderness, allodynia, hyperesthesia or hyperalgesia?

c. Medical Management History:

i. History of diagnostic tests and results including but not limited to any response to sympathetic nerve blocks, results of general laboratory studies, EMG and nerve conduction studies, radiological examinations, for demineralization, triple phase bone scan, or thermography with autonomic stress testing, and tests of sudomotor functioning such as Quantitative Sudomotor Axon Reflex Test (QSART).

ii. Prior Treatment: chronological review of medical records including previous medical evaluations and response to treatment interventions. In other words, what has been tried and what has been helpful?

iii. Prior Surgery: If the patient has had prior surgery specifically for the pain, he/she may be less likely to have a positive outcome.

iv. History of and current use of medications, including over-the-counter and herbal/dietary supplements to determine drug usage (or abuse) interactions and efficacy of treatment. Drug allergies and other side effects experienced with previous or current medication therapy and adherence to currently prescribed medications should be documented.

Ideally, this includes dosing schedules as reported by the patient or patient representative. Information should be checked against the Colorado Prescription Drug Monitoring Program, offered by the Colorado Pharmacy Board.

v. Review of Systems Check List: Determine if there is any interaction between the pain complaint and other medical conditions.

vi. Psychosocial Functioning: Determine if any of the following are present: current symptoms of depression or anxiety; evidence of stressors in the workplace or at home; and past history of psychological problems or other confounding psychosocial issues may be present, such as the presence of psychiatric disease. Due to the high incidence of co-morbid problems in populations that develop chronic pain, it is recommended that patients diagnosed with CRPS be referred for a full psychosocial evaluation. All patients with CRPS have chronic pain and are likely to suffer psychosocial consequences.

vii. Pre-existing Conditions: Treatment of these conditions is appropriate when the preexisting condition affects recovery from chronic pain.

viii. Family history pertaining to similar disorders.

d. Substance Use/Abuse:

i. Alcohol use.

ii. Smoking history and use of nicotine replacements.

iii. History of current and prior prescription and/or illicit drug use and abuse.

iv. The use of caffeine or caffeine-containing beverages.

v. Substance abuse information may be only fully obtainable from multiple sources over time. Patient self-reports may be unreliable. Patient selfreports should always be checked against medical records.

e. Other Factors Affecting Treatment Outcome:

i. Compensation/Disability/Litigation.

ii. Treatment Expectations: What does the patient expect from treatment: complete relief of pain or reduction to a more tolerable level?

f. Physical Examination: should include examination techniques applicable to those portions of the body where the patient is experiencing subjective symptomatology. The following should be documented:

i. Inspection: changes in appearance of the involved area, to include trophic changes, changes in hair and nail growth, muscular atrophy, changes in skin turgor, swelling and color changes.

ii. Temperature Evaluation: Palpable temperature changes may not be detectable in early disease stages, and the examiner will generally only be able to appreciate significant temperature variations. Objective testing is preferred to demonstrate temperature asymmetries. Temperature differences of 1 ̊C may be significant; however, these differences also occur commonly with other pain conditions.

iii. Edema: is an important finding in CRPS. Its presence should be described in detail by the physician and when possible verified with objective testing such as volumetric testing or bilateral circumference measurements, usually performed by therapists.

iv. Motor Evaluation: involuntary movements, dystonia, muscle weakness, atrophy, or limited range of active motion in the involved limb(s).

v. Sensory Evaluation: A detailed sensory examination is crucial in evaluating a patient with chronic pain complaints, including the presence of allodynia and the anatomic pattern of any associated sensory abnormalities to light touch, deep touch, pain, and thermal stimulation.

Quantitative sensory testing may be useful.

vi. Musculoskeletal Evaluation: presence of associated myofascial problems, such as contractures, Range-of-Motion (ROM), or trigger points.

vii. Evaluation of Non-physiologic Findings: Determine the presence of the following: variabilities on formal exam including variable sensory exam; inconsistent tenderness, and/or swelling secondary to extrinsic sources.

Inconsistencies between formal exam and observed abilities of range-ofmotion, motor strength, gait, and cognitive/emotional state; and/or observation of inconsistencies between pain behaviors, affect and verbal pain rating, and physical re-examination can provide useful information.

F. OVERVIEW OF CARE FOR CRPS OR SYMPATHETICALLY MEDIATED PAIN [Note: Based primarily on Washington State Guidelines.] Once a patient has met the clinical criteria for CRPS or has disproportionate pain from the initial workers’ compensation injury with additional physical findings suggestive of sympathetic involvement, directed care should begin.

Active initial treatment is the keystone to preventing disability. The date of onset of the CRPS symptoms should be documented with the physical exam findings in all of the pertinent areas: sensory, vasomotor, sudomotor and edema, and weakness or trophic changes of hair, nails, or skin.

Measurable goals should then be agreed upon with the patient. Initial treatment begins as quickly as possible with cognitive behavior therapy desensitization, neuromuscular re-education (graded motor imagery and/or mirror box therapy), progressive active therapy, and additional activities aimed at the identified functional goals.

Sympathetic blocks are performed in order to decrease pain and encourage active therapy. Thus, progressive active therapy should take place within 24 hours of an injection.

Medication used for pain relief is primarily based on medications effective for neuropathic pain, although, bisphosphonates may be useful in some cases. Opioids are rarely useful for neuropathic pain and should be used sparingly.

As with all chronic pain patients, psychological consultation and treatment and multidisciplinary treatment is strongly recommended.

G. DIAGNOSTIC CRITERIA AND PROCEDURES

1. DIAGNOSIS OF CRPS: Diagnosis of CRPS continues to be controversial. The clinical criteria used by the International Association for the Study of Pain is thought to be overly sensitive and unable to differentiate well between those patients with other pain complaints and those with actual CRPS. One study in which different diagnostic sets were reviewed using patient report and physician confirmed signs, the highest specificities were found for the signs of hyperesthesia, allodynia, temperature asymmetry, skin color asymmetry, and edema. This pattern is predominant in the other studies reporting on similar assessed physical findings. Sudomotor/sweating limb differences and atrophic changes, including nail, hair and skin changes, occur in less than half of the clinical CRPS patients; in contrast, verified temperature asymmetry, edema, and decreased motor function are frequently cited as predictive.

Clinical criteria alone are not dependable nor necessarily reliable and require objective testing. One study of interrater reliability for diagnosing CRPS I showed poor reliability for assessment of temperature difference and color difference between the affected limbs.

Two other studies compared physician’s assessment with actual measured signs of CRPS I. The first study advocated bedside use of infrared thermometer and volume measurements. The study found a volume difference between the hands of 30.4 cc and a dorsal hand temperature difference of at least 0.78°C could be used to help establish the diagnosis. The study also noted frequent decreased mobility in the little finger. This study only included patients known to have CRPS; thus, agreement between the objective measurements and the physicians’ observations was good. The second study compared physicians’ clinical assessments with measured objective results and found that the clinical establishment of temperature and volume asymmetry was inadequate. It also noted poor to moderate correspondence between patient reported severity of symptoms and the physicians’ clinical judgment and actual measurements.

A separate study used skin surface temperature to differentiate between CRPS in patients after a fracture and control patients with other complaints following a fracture.

This study also incorporated a control group of healthy patients without complaints.

Notably there was significantly more asymmetry between the temperature findings in the CRPS group than in both the control groups, with and without complaints. However, the control group with complaints had greater temperature differences than the otherwise healthy group. The study concluded that the ability of skin surface temperatures under resting conditions to discriminate between CRPS patients and other patients is limited.

Historically some authors have used 2°C as a limit for temperature differences and others have used lower cutoffs. This study also applied various temperature asymmetry cut offs and could identify no specific combination resulting in sufficient predictive power.

However, the negative predictive power was 84% for resting temperature asymmetry less than 0.7°C. This would seem to suggest that it is unlikely a patient has CRPS if they do not have resting temperature asymmetry; however, resting temperature asymmetry differences may be due to a variety of reasons other than CRPS.

Several studies have assessed skin temperature changes in variable settings. In one study skin temperature measurements were recorded over 5-8 hours and the instruments were able to compare the difference between the limbs with every day activities. Twentytwo patients with CRPS, 18 with limb pain of other origin, and 22 of healthy controls were compared. Examining the asymmetry throughout the time period, a difference of 2°C could differentiate CRPS from patients with other painful disease with specificity of 67% and 79% versus healthy controls. It was noted many patients in all groups had a 2°C difference between the limbs at one time or another. However, the persistence of the difference and the asymmetry was important in the diagnosis. The difference between the limbs could occur in either direction, warmer or cooler, than the unaffected side.

Thermographic imaging has been done in two studies using whole body warming and cooling. The initial study established the fact that in CRPS patients the temperature difference between hands increases significantly when the sympathetic system is provoked with whole body temperature changes. A separate more detailed study induced whole body warming and cooling and compared temperature and blood flow in three sets of patients, one with CRPS, one with patients of extremity pain of other origins, and a third group of healthy volunteers. None of the participants were on medications affecting vascular functions. Three patterns of temperature change were noted for CRPS patients.

In some patients with “warm” CRPS, the temperature continually exceeded the temperature of the unaffected limb during the cooling and warming period. In others, where the affected limb was cooler than the unaffected limb, the affected limb may have remained cooler throughout the cooling and warming period. Finally, in a few patients, there was an unusual crossover where initially the patient had a warm or cooler limb compared to the unaffected side and later the affected limb showed temperature differences in the opposite direction. All of these patterns demonstrate an autonomic asymmetry that was not found in healthy volunteers whose limbs temperatures adjust in a symmetrical manner. Previous tests comparing Laser Doppler flow of extremities in healthy controls and patients with distal radius fracture to CRPS I patients showed significant sympathetic changes after contralateral cold exposure. Another study of patients with radius fractures found that non-stress thermography had a sensitivity of 58% and specificity of 66%. Thus, the asymmetry of limb temperature under stress appears to be the most important factor. In this study, the temperature differences needed to exceed 2.2°C to distinguish between the groups.

Another study reviewed skin temperature from thermography, thermoregulatory sweat tests (TST), and quantitative sudomotor axon reflex test (QSART), early and late in patients with clinically diagnosed CRPS. In this study, the differences identified with TST persisted during later testing while QSART differences did not. Skin temperature was asymmetrical between the limbs early and late, although generally in opposite directions.

This study describes the dynamic nature of CRPS.

These studies appear to confirm the fact that causing an objectively measured, sympathetically evoked response is likely to be more predictive of CRPS than merely resting temperature differences or resting sudomotor/sweating differences. Temperature testing at any one point in time is probably not sensitive and able to distinguish between patients with pain complaints and those with CRPS. Other review articles have made similar observations regarding the need for dynamic testing.

There is good evidence that CRPS is characterized by inhibition of sympathetic cutaneous responses on the affected side and by blunted sympathetic response to physiologic stimuli. Based on the relatively common finding of temperature discrepancy in non-CRPS patients with chronic pain, a stress test thermogram should be used.

Unfortunately, only two studies have been published in this area and neither used a blinded control for comparison. The most commonly reported stress tests consist of contralateral extremity cooling or whole body suit. However, the physiology behind the stress thermography testing is convincing given the prior studies.

In a similar manner, the QSART provides an autonomic stress that is measurable.

Perhaps the main issue with the sudomotor test in isolation is that it appears some CRPS patients do not have an abnormal sweat test. To verify the diagnosis, all of these test results need to be compared to other test results, physical exam findings, and symptoms.

Thermal quantitative sensory testing has been used to study neuropathic conditions and CRPS. Components of the test include identification of light touch, warmth, cold, and pain with pressure, cold or heat. The testing relies on patient response to various recordable levels of testing in these areas. Generally, CRPS patients appear to demonstrate hypoalgesia in both the affected and unaffected limbs when compared to normals; hyperalgesia to thermal pain generators and hyperalgesia to blunt pressure. Findings on the specific TST test components differ according to the CRPS classification of warm or cold. There is also some overlap of findings with other neuropathic conditions. In addition, patient response testing can be problematic in a medical legal setting. Thus, more objective tests are used for confirmation of CRPS. Routine clinical exam techniques should be used to evaluate the patient for hyper- and hypoalgesia and allodynia.

Significant harm can be done to individuals by over-diagnosing CRPS and subjecting patients to the side effects and potential morbidity of multiple sympathetic blocks, invasive procedures, or chronic medications, as well as psychological effects from the diagnosis. In order to safe guard against such harmful outcomes, patients should have objective testing to verify their diagnosis before such procedures are considered and/or are continued after the initial diagnosis. Several reviews on the subject have identified the need for more objective measurements. Therefore, individuals must have a confirmed diagnosis of CRPS to receive these procedures.

Evidence Statements Regarding Diagnosis of CRPS CRPS is characterized by inhibition of sympathetic cutaneous responses on the affected side and by blunted sympathetic response to physiologic stimuli.

Physiology experiment, Basic science (physiologic) study 2. DIAGNOSTIC COMPONENTS OF CLINICAL CRPS: Patients who meet the following criteria for clinical CRPS, consistent with the Budapest criteria, may begin initial treatment with oral steroids and/or tricyclics, physical therapy, a diagnostic sympathetic block, and other treatments found in the Division’s Chronic Pain Disorder Medical Treatment Guideline. All treatment should be periodically evaluated with validated functional measures. Patient completed functional questionnaires such as those recommended by the Division as part of Quality Performance and Outcomes Payments (QPOP, see Rule 18-8) and/or the Patient Specific Functional Scale can provide useful additional confirmation. Further invasive or complex treatment will require a confirmed diagnosis.

Patient must meet the criteria below.

a. Continuing pain, which is disproportionate to any inciting event; and b. At least one symptom in 3 of the 4 following categories:

• Sensory: reports of hyperesthesia and/or allodynia;

• Vasomotor: reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry;

• Sudomotor/edema: reports of edema and/or sweating changes and/or sweating asymmetry; or - Motor/trophic: reports of decreased range-of-motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).

c. At least one sign at time of evaluation in 2 or more of the following categories:

• Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement);

• Vasomotor: evidence of temperature asymmetry and/or skin color changes and/or asymmetry. Temperature asymmetry should ideally be established by infrared thermometer measurements showing at least a 1°C difference between the affected and unaffected extremities;

• Sudomotor/edema: evidence of edema and/or sweating changes and/or sweating asymmetry. Upper extremity volumetrics may be performed by therapists that have been trained in the technique to assess edema; or - Motor/trophic: evidence of decreased range-of-motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).

d. No other diagnosis that better explains the signs and symptoms. It is essential that other diagnoses which may require more urgent treatment, such as infection, allergy to implants, or other neurologic conditions, are diagnosed expediently before defaulting to CRPS.

e. Psychological evaluation should always be performed as this is necessary for all chronic pain conditions.

3. DIAGNOSTIC COMPONENTS OF CONFIRMED CRPS: Patients should have a confirmed diagnosis of CRPS to proceed to other treatment measures in this guideline.

Both CRPS I and II confirmed diagnoses require the same elements. CRPS II is distinguished from CRPS I by the history of a specific peripheral nerve injury as the inciting event.

Patient must meet the below criteria:

a. A clinical diagnosis meeting the above criteria in 2, and b. At least 2 positive tests from the following categories of diagnostic tests:

i. Trophic tests - Comparative x-rays of both extremities including the distal phalanges.

• Triple phase bone scan.

ii. Vasomotor/Temperature test: Infrared stress thermography.

iii. Sudomotor test: Autonomic test battery with an emphasis on QSART.

iv. Sensory/ Sympathetic nerve test: Sympathetic blocks.

4. SYMPATHETICALLY MAINTAINED PAIN (SMP): Patients who do not qualify as confirmed CRPS may have SMP. Patients with SMP may use sympathetic blocks and active and passive therapy from this guideline. For all other treatment, refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline. Characteristics of SMP are a patient who:

a. Complains of pain;

b. Usually does not have clinically detectable vasomotor or sudomotor signs; and c. Has significant pain relief with sympathetic blocks.

5. NOT CRPS OR SMP: Criteria listed below. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for treatment.

a. Patient complains of pain;

b. May or may not have vasomotor or sudomotor signs;

c. No relief with sympathetic blocks; and d. No more than one other diagnostic test procedure is positive.

6. DIAGNOSTIC IMAGING: is a generally accepted diagnostic procedure for CRPS.

Results must be interpreted within the context of a full medical evaluation.

a. Plain Film Radiography:

Description: A radiological finding in CRPS may be unilateral osteoporosis; however, osteoporosis may be absent in many cases. In CRPS I, the osteoporosis may be rapid in progression. The disorder typically affects the distal

part of an extremity such as a phalanges, hand or foot; however, intermediate joints such as the knee or elbow may be involved. Contralateral x-rays should be taken for comparison and should include the distal phalanges.

Results: The radiological appearance of osteoporosis has been characterized as spotty or patchy. CRPS I may exist in the absence of osteoporosis; the diagnosis of CRPS I cannot be made solely on the basis of radiographic appearance or the osteoporosis alone.

b. Triple Phase Bone Scan:

Description: Radionuclide imaging scintigraphy employing radio-pharmaceutical technetium coupled to a phosphate complex has been used to help facilitate the diagnosis of CRPS I. Unfortunately, there are many different types of conditions that also produce osteoporosis, and a triple-phase bone scan does not distinguish between the causes of bone demineralization.

Results: Clinical information may be derived from each of the three phases of the bone scan following injection. In the early course of CRPS I, there is usually an increased uptake seen during Phase 1. However, in the late course of the disease process, there can actually be decreased uptake. In Phase 2, which reflects the soft tissue vascularity, an increased diffuse uptake may be appreciated during the early course of CRPS I. During Phase 3, one may see a diffuse uptake of multiple bone involvement of the involved limb, reflecting the bone turnover secondary to osteoporosis. Negative bone scans may be found in up to 40% of patients clinically diagnosed with CRPS I; however, it may help to confirm the diagnosis of CRPS I when positive.

The physician should consider the risks of medical radiation and whether the diagnostic benefit of a bone scan will outweigh the risk.

7. INJECTIONS – DIAGNOSTIC SYMPATHETIC:

Description: Diagnostic sympathetic injections are generally accepted procedures to aid in the diagnosis of CRPS I & II and SMP. Sympathetic blocks lack specificity for CRPS I & II. Each diagnostic injection has inherent risk and risk versus benefit should always be evaluated when considering injection therapy. Since these procedures are invasive, less invasive or non-invasive procedures should be considered first. Selection of patients, choice of procedure, and localization of the level for injection should be determined by clinical information.

Special Considerations: Injections with local anesthetics of differing duration are required to confirm a diagnosis. In some cases, injections at multiple levels may be required to accurately diagnose pain. Refer to Section H.6, Injections – Therapeutic, for information on specific injections.

Since fluoroscopic and/or CT guidance during procedures is recommended to document technique and needle placement, an experienced physician should perform the procedure. In addition, physicians should obtain fluoroscopy training and must also have the appropriate training in radiation safety, usually overseen by a radiation safety officer.

Complications: Complications may include transient neurapraxia, nerve injury, inadvertent spinal injection, infection, venous or arterial vertebral puncture, laryngeal paralysis, respiratory arrest, vasovagal effects, as well as permanent neurological damage.

Contraindications: Absolute contraindications of diagnostic injections include: (a) bacterial infection – systemic or localized to region of injection, (b) bleeding diatheses, (c) hematological conditions, and (d) possible pregnancy.

Relative Contraindications: Relative contraindications of these injections may include: (a) allergy to contrast or shellfish, (b) poorly controlled diabetes mellitus and/or hypertension.

Drugs affecting coagulation, such as aspirin, NSAIDs and other anti-platelets or anticoagulants require restriction from use. Decisions regarding the number of restricted days should be made in consultation with the prescribing physician and other knowledgeable experts.

Test Results: To confirm the accuracy of the block, there should be a documented temperature difference between the affected and unaffected extremities of at least 1°C.

The interpretation of the test result is primarily based upon pain relief of 50% or greater and evidence of functional improvement, for at least the duration of the local anesthetic used. A pain diary must be recorded as part of the medical record that documents response hourly for a minimum requirement of the first 8 hours post injection or until the block has clearly worn off and preferably for the week following an injection. The patient must have minimal sedation from opioids or other medication in order to be conscious and responsive during the procedure. The diagnostic significance of the test result should be evaluated in conjunction with clinical information and further information should be obtained from functional and physical reassessment performed by physical and/or occupational therapy the same day of the block.

Local anesthetics of different durations of action should be considered and could take the place of doing a "placebo" block (i.e., procaine, lidocaine, bupivacaine). Pain relief should be at least 50% or greater for the duration of the local anesthetic accompanied by functional improvement. It should be noted that with CRPS I, it is not unusual for the relief to last longer than the duration of the local anesthetic. If a placebo block is done, the needle should not be placed down to the sympathetic chain nor should an injection of saline be done around the sympathetic chain. A "sham block" would be preferable to see if the patient is a placebo responder. Contact with the sympathetic nerves by a needle or pressure on the chain by saline can cause a temporary sympathetic block and give a false positive placebo test. Additionally, patients with definite CRPS I can also be placebo responders. The fact that the patient responds positively to a placebo does not mean that he/she does not have CRPS I. It merely means that the patient is a placebo responder.

This increases the value of doing another confirmatory test.

a. Stellate Ganglion Block: for diagnosis and treatment of sympathetic pain involving the face, head, neck, and upper extremities secondary to CRPS I and II. This block is commonly used for differential diagnosis and is one of the treatments for CRPS I pain involving the upper extremity. For diagnostic testing, use two blocks over a 3-14 day period. For a positive response, pain relief should be 50% or greater for the duration of the local anesthetic and pain relief should be associated with demonstrated functional improvement.

b. Lumbar Sympathetic Block: useful for diagnosis and treatment of pain of the pelvis and lower extremity secondary to CRPS I and II. This block is commonly used for differential diagnosis and is the preferred treatment of sympathetic pain involving the lower extremity. For diagnostic testing, use two blocks over a 3-14 day period. For a positive response, pain relief should be 50% or greater for the duration of the local anesthetic and pain relief should be associated with demonstrated functional improvement.

c. Phentolamine Infusion Test: are not recommended for diagnosis or treatment due to lack of effect on sudomotor testing, pain, regional blood flow, or hyperalgesia.

8. THERMOGRAPHY (INFRARED STRESS THERMOGRAPHY):

Description: There is good evidence that CRPS is characterized by inhibition of sympathetic cutaneous responses on the affected side and by blunted sympathetic response to physiologic stimuli. Based on the relatively common finding of temperature discrepancy in non-CRPS patients with chronic pain, a stress test thermogram should be used. Infrared thermography may be useful for patients with suspected CRPS I and II and SMP. Thermography can distinguish abnormal thermal asymmetry of 1.0°C which is not distinguishable upon physical examination. It may also be useful in cases, to differentiate, of suspected small caliber fiber neuropathy and to evaluate patient response to sympatholytic interventions.

Special Considerations: The practitioner who supervises and interprets the thermographic evaluation shall follow recognized protocols and be board certified by one of the examining boards of the American Academy of Medical Infrared Imaging, American Academy of Thermology, or American Chiropractic College of Thermology, or have equivalent documented training.

Medications with anticholinergic activity (tricyclics, cyclobenzaprine, antiemetics, antipsychotics) may interfere with autonomic testing. The pre-testing protocol which includes cessation of specific medication therapy must be followed for accurate test results. Results of autonomic testing may be affected by peripheral polyneuropathy, radiculopathy or peripheral nerve injury, peripheral vascular disease, generalized autonomic failure, or by Shy-Drager syndrome.

Thermographic Tests: Functional autonomic stress testing may include the following methods:

a. Cold Water Stress Test (Cold Pressor Test): Paroxysmal response in the affected upper extremity is strongly suggestive of vasomotor instability.

b. Warm Water Stress Test: Paroxysmal response in the affected upper extremity is strongly suggestive of vasomotor instability.

c. Whole Body Thermal Stress: Analysis of persistent non-dermal temperature anomalies in response to whole body thermal stress from a cooling and/or warming suit.

9. AUTONOMIC TEST BATTERY:

Description: Resting skin temperature (RST), resting sweat output (RSO), and quantitative sudomotor axon reflex test (QSART) are a generally accepted test battery.

There is good evidence that CRPS is characterized by inhibition of sympathetic cutaneous responses on the affected side and by blunted sympathetic response to physiologic stimuli. The tests can provide additional information regarding malfunction of the sympathetic system and the diagnosis of CRPS. Prior authorization is required. As with all diagnostic testing, the results must be interpreted in relationship to the patient’s signs and symptoms.

Special Considerations: Medications with anticholinergic activity (tricyclics, cyclobenzaprine, antiemetics, anti-psychotics) may interfere with autonomic testing.

Results of autonomic testing may be affected by peripheral polyneuropathy, radiculopathy or peripheral nerve injury, peripheral vascular disease, generalized autonomic failure, or by Shy-Drager syndrome.

Test Battery: These tests measure asymmetries in physiologic manifestations of autonomic activity between an affected limb and an unaffected contralateral limb. Skin temperature reflects vasomotor activity and sweat output measures sudomotor activity.

The results of the three test components must be combined and scored. The battery of tests must include a measurement of each component (RST, RSO, and QSART).

a. Infrared Resting Skin Temperature (RST): provides thermographic measurements between the affected and unaffected limb. Generally, a 1 Celsius difference is significant. Given the previous discussion regarding differences in resting temperature between the affected and unaffected limbs in non-CRPS patients, the temperature findings may need to be interpreted cautiously as they do not reflect a stress on the sympathetic system.

b. Resting Sweat Output (RSO): measures an increase or reduction of 50% between the affected and unaffected limb.

c. Quantitative Sudomotor Axon Reflex Test (QSART): measures the sweat output elicited by iontophoretic application of acetylcholine. An increase or reduction of 50% between the affected and unaffected limb is significant.

The results of these tests should be recorded separately as abnormal or within the normal range.

A further assessment can then be done by the clinician when this information is collaborated with clinical findings. However clinical analysis is separate from the strict interpretation of each of the above three tests.

10. OTHER DIAGNOSTIC TESTS NOT SPECIFIC FOR CRPS: The following tests and procedures are not used to establish the diagnosis of CRPS but may provide additional information. The following are listed in alphabetical order.

a. Electrodiagnostic Procedures: Electromyography (EMG) and Nerve Conduction Studies (NCS) are generally accepted, well-established, and widely used for localizing the source of the neurological symptoms and establishing the diagnosis of focal nerve entrapments, such as carpal tunnel syndrome or radiculopathy, which may contribute to or coexist with CRPS II (causalgia).

Traditional electrodiagnosis includes nerve conduction studies, late responses (F-Wave, H-reflex), and electromyographic assessment of muscles with needle electrode examination. As CRPS II occurs after partial injury to a nerve, the diagnosis of the initial nerve injury can be made by electrodiagnostic studies.

However, the later development of sympathetically mediated symptomatology has no pathognomonic pattern of abnormality on EMG/NCS. When issues of diagnosis are in doubt, a referral or consultation with a physiatrist or neurologist trained in electrodiagnosis is appropriate.

b. Laboratory Tests: Laboratory tests are generally accepted, well-established, and widely used procedures. Patients should be carefully screened at the initial exam for signs or symptoms of diabetes, hypothyroidism, arthritis, and related inflammatory diseases. The presence of concurrent disease does not refute work-relatedness of any specific case. This frequently requires laboratory testing.

When a patient's history and physical examination suggest infection, metabolic or endocrinologic disorders, tumorous conditions, systemic musculoskeletal disorders (e.g., rheumatoid arthritis or ankylosing spondylitis), or problems potentially related to medication (e.g., renal disease and NSAIDs), then laboratory tests, including, but not limited to the following can provide useful diagnostic information:

i. Thyroid stimulating hormone (TSH) for hypothyroidism;

ii. Diabetic screening: recommended for men and women with a BMI over 30, patients with a family history of diabetes, those from high risk ethnic groups, and patients with a previous history of impaired glucose tolerance. There is some evidence that diabetic patients with upper extremity disorders have sub-optimal control of their diabetes;

iii. Serum protein electrophoresis;

iv. Sedimentation rate and C-reactive protein (CRP) are nonspecific but elevated in infection, neoplastic conditions, and rheumatoid arthritis.

Other screening tests to rule out inflammatory or autoimmune disease may be added when appropriate;

v. Serum calcium, phosphorus, uric acid, alkaline, and acid phosphatase for metabolic, endocrine and neo-plastic conditions;

vi. Complete blood count (CBC), liver, and kidney function profiles for metabolic or endocrine disorders or for adverse effects of various medications; and/or vii. Bacteriological (microorganism) work-up for wound, blood, and tissue.

The Division recommends that the workers’ compensation carrier cover initial lab diagnostic procedures to ensure that an accurate diagnosis and treatment plan is established. When an authorized treating provider has justification for the test, insurers should cover the costs. Laboratory testing may be required periodically to monitor patients on chronic medications.

c. Peripheral Blood Flow (Laser Doppler or Xenon Clearance Techniques):

This is currently being evaluated as a diagnostic procedure in CRPS I and is not recommended at this time.

11. PERSONALITY/ PSYCHOLOGICAL/PSYCHOSOCIAL EVALUATIONS FOR PAIN

MANAGEMENT: are generally accepted, well-established, and widely used diagnostic procedures not only with selected use in acute pain problems but also with more widespread use in subacute and chronic pain populations. Diagnostic evaluations should distinguish between conditions that are pre-existing, aggravated by the current injury, or work related.

Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for more information on clinical evaluation, a list and description of psychological functioning tests, and evidence.

12. SPECIAL TESTS: are generally well-accepted tests and are performed as part of a skilled assessment of the patient’s capacity to return to work, his/her strength capacities, and/or physical work demand classifications and tolerance.

Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for indications, evidence, and time frames for the following procedures: computer-enhanced evaluations, functional capacity evaluations, jobsite evaluations and alterations, vocational assessment, and work tolerance screening (fitness for duty).

H. THERAPEUTIC PROCEDURES – NON-OPERATIVE

Non-operative therapeutic rehabilitation is applied to patients with Complex Regional Pain Syndrome (CRPS) or Sympathetically Mediated Pain (SMP) who experience chronic and complex problems of de-conditioning and functional disability. Treatment modalities may be utilized sequentially or concomitantly depending on chronicity and complexity of the problem, and treatment plans should always be based on a diagnosis utilizing appropriate diagnostic procedures.

Before initiation of any therapeutic procedure, the authorized treating physician, employer, and insurer must consider these important issues in the care of the injured worker:

• Patients undergoing therapeutic procedure(s) should be released or returned to modified or restricted duty during their rehabilitation at the earliest appropriate time. Refer to

Section H.14, Return-to-Work, for detailed information.

• Reassessment of the patient’s status in terms of functional improvement should be documented after each treatment. If patients are not responding within the recommended time periods, alternative treatment interventions, further diagnostic studies, or consultations should be pursued. Continued treatment should be monitored using objective measures such as:

• Return to work or maintaining work status;

• Fewer restrictions at work or performing activities of daily living (ADLs);

• Decrease in usage of medications related to the work injury; and • Measurable functional gains, such as increased range-of-motion or documented • Clinicians should provide and document education to the patient. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms.

• Psychological or psychosocial screening should be performed on all chronic pain patients.

The following procedures are listed in alphabetical order:

1. ACUPUNCTURE

Acupuncture for the treatment of CRPS is thought to work by promoting relaxation and allowing chemicals and blood within the body to flow properly. Acupuncture may not be well tolerated by CRPS patients, but some have reported relief of pain that is immediate, but temporary, lasting only 1 or 2 hours. Acupuncture is recommended for subacute or chronic pain patients who are trying to increase function and/or decrease medication usage and have an expressed interest in this modality. It is also recommended for subacute or acute pain for patients who cannot tolerate NSAIDs or other medications, and it should generally be used in conjunction with manipulative and physical therapy/rehabilitation. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for indications, evidence, and time frames.

2. BIOFEEDBACK

Biofeedback is a form of behavioral medicine that helps patients learn self-awareness and self-regulation skills for the purpose of gaining greater control of their physiology, such as muscle activity, brain waves, and measures of autonomic nervous system activity. Stress-related psycho-physiological reactions may arise as a reaction to organic pain and in some cases may cause pain. Electronic instrumentation is used to monitor the targeted physiology and then displayed or fed back to the patient visually, auditorily, or tactilely, with coaching by a biofeedback specialist.

Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for indications, 3. COMPLEMENTARY MEDICINE Complementary Medicine, termed Complementary Alternative Medicine (CAM) in some systems, is a term used to describe a broad range of treatment modalities, a number of which are generally accepted and supported by some scientific literature and others which still remain outside the generally accepted practice of conventional Western Medicine. In many of these approaches, there is attention given to the relationship between physical, emotional, and spiritual well-being. While CAM may be performed by a myriad of both licensed and non-licensed health practitioners with training in one or more forms of therapy, credentialed practitioners should be used when available or applicable.

All CAM treatments require prior authorization and must include agreed upon number of visits for time to produce functional effects.

Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for indications, 4. DISTURBANCES OF SLEEP Disturbances of sleep are common in chronic pain. An essential element of chronic pain treatment is restoration of normal sleep cycles. Although primary insomnia may accompany pain as an independent co-morbid condition, it more commonly occurs secondary to the pain condition itself. Exacerbations of pain often are accompanied by exacerbations of insomnia; the reverse can also occur. Sleep laboratory studies have shown disturbances of sleep architecture in pain patients. Loss of deep slow-wave sleep and an increase in light sleep occur. Sleep efficiency, the proportion of time in bed spent asleep, is also decreased. These changes are associated with patient reports of nonrestorative sleep. Sleep apnea may also occur as a primary diagnosis or be caused or exacerbated by opioid and hypnotic use.

Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for more information on behavioral modifications to address sleep disturbances.

5. EDUCATION/INFORMED/SHARED DECISION MAKING of the patient and family, as well as the employer, insurer, policy makers, and the community should be the primary emphasis to prevent disability. Unfortunately, practitioners often think of education and informed decision making last, after medications, manual therapy, and surgery.

Informed decision making is the hallmark of a successful treatment plan. In most cases, the continuum of treatment from the least invasive to the most invasive (e.g., surgery) should be discussed. The intention is to find the treatment along this continuum which most completely addresses the condition. Patients should identify their personal values and functional goals of treatment at the first visit. It is recommended that specific individual goals are articulated at the beginning of treatment as this is likely to lead to increased patient satisfaction above that achieved from improvement in pain or other physical function. Progress toward the individual functional goals identified should be addressed at follow-up visits and throughout treatment by other members of the health care team as well as an authorized physician.

Documentation of the informed decision process should occur whenever diagnostic tests or referrals from an authorized treating physician are contemplated. The informed decision making process asks the patients to set their personal functional goals of treatment and describe their current health status and any concerns they have regarding adhering to the diagnostic or treatment plan proposed. The provider should clearly describe the following:

a. The expected functional outcomes from the proposed treatment or the expected results and plan of action if diagnostic tests are involved.

b. Expected course of illness/injury without the proposed intervention.

c. Any side effects and risks to the patient.

d. Required post-treatment rehabilitation time and impact on work, if any.

e. Alternative therapies or diagnostic testing.

Before diagnostic tests or referrals for invasive treatment take place, the patient should be able to clearly articulate the goals of the intervention, the general side effects and risks associated with it, and his/her decision regarding compliance with the suggested plan. There is some evidence that information provided only by video is not sufficient education.

Practitioners must develop and implement an effective strategy and skills to educate patients, employers, insurance systems, policy makers, and the community as a whole.

An education-based paradigm should always start with providing reassuring information to the patient and informed decision making. More in-depth education currently exists within a treatment regimen employing functional restoration, prevention, and cognitive behavioral techniques. Patient education and informed decision making should facilitate self-management of symptoms and prevention.

Evidence Statements Regarding Education / Informed Decision Making Information provided only by video is not sufficient education.

Prospective randomized controlled trial Time Frames for Education / Informed Decision Making Time to Produce Effect Varies with individual patient Frequency Should occur at every visit.

6. INJECTIONS – THERAPEUTIC When considering the use of injections in CRPS management, the treating physician must carefully consider the inherent risks and benefits. First, it is understood that these injections are seldom meant to be “curative” and when used for therapeutic purposes they are employed in conjunction with other treatment modalities for maximum benefit.

Second, education of the patient should include the proposed goals of the injections, expected gains, risks or complications, and alternative treatment.

Lastly, reassessment of the patient’s status in terms of functional improvement should be documented after each injection and/or series of injections. Any continued use of injections should be monitored using objective measures such as:

• Return to work or maintaining work status.

• Fewer restrictions at work or when performing activities of daily living (ADLs).

• Decrease in usage of medications related to the work injury.

• Measurable functional gains, such as increased range-of-motion or documented Visual analog scales (VAS) provide important subjective data but cannot be used to measure function.

The physician must be aware of the possible placebo effect as well as the long-term effects of injections related to the patient’s physical and mental status. Strict adherence to contraindications, both absolute and relative, may prevent potential complications.

Subjecting the patient to potential risks (i.e., needle trauma, infection, nerve injury, or systemic effects of local anesthetics and corticosteroids) must be considered before the patient consents to such procedures.

For post-MMI care, refer to Section J.4, Maintenance Management, Injection Therapy, in this guideline.

a. Sympathetic Injections:

Description: Sympathetic injections are generally accepted, well-established procedures. They include stellate ganglion blocks and lumbar sympathetic blocks. Unfortunately, there are no high quality randomized controlled trials in this area. It is recommended that all patients receiving therapeutic blocks participate in an appropriate exercise program that may include a functionally directed rehabilitation program. However, a recent Cochrane review did not find intravenous regional blockade with guanethidine effective in CRPS, and the procedure appears to be associated with the risk of significant adverse events.

Indications: greater than 50% pain relief and demonstrated functional improvement from previous diagnostic or therapeutic blocks. Range-of-motion or increased strength are examples of objective gains that can be documented for most CRPS patients.

Special Considerations: Except for Bier blocks, fluoroscopic and/or CT guidance during procedures is recommended to document technique and needle placement; an experienced physician should perform the procedure. The physician should participate in ongoing injection training workshops provided by organizations such as the Spine Intervention Society (SIS), formerly known as the International Spine Intervention Society. Physicians should obtain fluoroscopy training and must also have the appropriate training in radiation safety, usually overseen by a radiation safety officer.

Complications: Complications may include transient neurapraxia, nerve injury, inadvertent spinal injection, infection, venous or arterial vertebral puncture, laryngeal paralysis, respiratory arrest, vasovagal effects, as well as permanent neurologic damage.

Contraindications: Absolute contraindications of therapeutic injections include: (a) bacterial infection – systemic or localized to region of injection, (b) bleeding diatheses, (c) hematological conditions, and (d) possible pregnancy.

Relative Contraindications: Relative contraindications of these injections may include: (a) allergy to contrast or shellfish, (b) poorly controlled diabetes mellitus and/or hypertension.

Drugs affecting coagulation, such as aspirin, NSAIDs, and other anti-platelets or anti-coagulants require restriction from use. Decisions regarding the number of restricted days should be made in consultation with the prescribing physician and other knowledgeable experts.

Treatment Parameters: To be effective as a treatment modality, the patient should be making measurable progress in their rehabilitation program and should be achieving an increasing or sustained duration of relief between blocks. If appropriate outcomes are not achieved, changes in treatment should be undertaken.

Time Frames for Sympathetic Injections Time to Produce Effect 1 to 2 blocks. Demonstrated greater than 50% pain relief and objective/functional gains as noted under treatment parameters.

Frequency Variable, depending upon duration of pain relief and functional gains.

During the first 2 weeks of treatment, blocks may be provided every 3 to 5 days, based on patient response meeting above criteria. The blocks must be combined with active therapy. After the first 2 weeks, blocks may be given weekly with tapering for a maximum of 7 -10.

Optimum Duration 10 over a period of 6 months with documentation of progressive functional gain verified by therapist or increased work capability after each injection.

Maximum Duration If sympathetic and functional benefits are documented with the blocks, refer to Section J, Maintenance Management, for information on further blocks.

b. Peripheral Nerve Blocks: These are diagnostic injections that may be used for specific nerve injury or entrapment syndromes. Not all peripheral nerve blocks require fluoroscopy. On occasion they are used for treatment in chronic pain or CRPS. Repeat injection for treatment should be based on functional changes.

These injections are usually limited to 3 injections per site per year.

c. Other Intravenous Medications and Regional Blocks: Only low quality evidence is available regarding the use of local anesthetic blockade for treating complex regional pain syndrome. There is some evidence that there is little advantage of IV regional block with guanethidine over saline blocks with respect to the resolution of tenderness in the affected hand, but the resolution of vasomotor instability may be delayed by guanethidine. It is possible that it assists with rehabilitative therapy.

In addition, regional blocks given by the Bier block method have the potential of aggravating CRPS due to the constriction of the extremity required for the procedure. Another inadequately powered study found no advantage from Bier blocks of lidocaine and methylprednisolone.

It is unlikely that either type of block provides a significant clinical advantage to the patient; therefore, they are not recommended. Intravenous blocks with guanethidine, ketanserin, bertyllium phentolamin, reserpine, droperidol and atropine are also not recommended due to lack of effect in small studies.

In rare cases where repeat sympathetic blocks are contraindicated or ineffective, Bier blocks (usually alpha sympathetic blocking agent with lidocaine) may be useful when the patient has peripheral findings (CRPS II) and demonstrates functional gains. The number of blocks should not exceed those done for sympathetic blocks and active therapy must be done at the same time.

Evidence Statements Regarding Other Intravenous Medications and Regional Blocks There is little advantage of IV regional block with guanethidine over saline blocks with respect to the resolution of tenderness in the affected hand, but the resolution of vasomotor instability may be delayed by guanethidine.

d. Continuous Brachial Plexus Infusions: are not recommended due to possible complications of bleeding, infection, pneumothoracic, phrenic nerve paralysis, lack of literature documenting effectiveness and cost.

e. Epidural Infusions: These are not recommended. Literature on epidural clonidine treatment is not adequate to support their long term benefit. There is some evidence of a high rate of infection (33%), which can include meningitis.

Evidence Statements Regarding Epidural Infusions There is high rate of infection (33%), which can include meningitis.

Crossover randomized f. Ketamine: is referenced in this guideline in Section G, Therapeutic Procedures, Non-Operative, CRPS-Specific Medications.

7. INTERDISCIPLINARY REHABILITATION PROGRAMS

a. Overview: Interdisciplinary Rehabilitation Programs are the gold standard of treatment for individuals who have not responded to less intensive modes of treatment. There is good evidence that interdisciplinary programs that include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability. There is good evidence that multidisciplinary rehabilitation (physical therapy and either psychological, social, or occupational therapy) shows small effects in reducing pain and improving disability compared to usual care and that multidisciplinary biopsychosocial rehabilitation is more effective than physical treatment for disability improvement after 12 months of treatment in patients with chronic low back pain. Patients with a significant psychosocial impact are most likely to benefit. The Agency for Healthcare Research and Quality (AHRQ) supports multidisciplinary rehabilitation as effective for chronic low back pain. These programs should assess the impact of pain and suffering on the patient’s medical, physical, psychological, social, and/or vocational functioning.

The International Classification of Functioning, Disability and Health (ICF) model should be considered in patient program planning. The following factors should be addressed: body function and structures, activity expectations, participation barriers, and environmental and personal factors. In general, interdisciplinary programs evaluate and treat multiple and sometimes irreversible conditions, including but not limited to: painful musculoskeletal, neurological, and other chronic pain conditions and psychological issues; drug dependence, abuse, or addiction; high levels of stress and anxiety; failed surgery; and pre-existing or latent psychopathology. The number of professions involved on the team in a chronic pain program may vary due to the complexity of the needs of the person served. The Division recommends consideration of referral to an interdisciplinary program within 6 months post-injury in patients with delayed recovery, unless successful surgical interventions or other medical and/or psychological treatment complications intervene.

Chronic pain patients need to be treated as outpatients within a continuum of treatment intensity. Outpatient chronic pain programs are available with services provided by a coordinated interdisciplinary team within the same facility (formal) or as coordinated among practices by an authorized treating physician (informal).

Formal programs are able to provide a coordinated, high-intensity level of services and are recommended for most chronic pain patients who have received multiple therapies during acute management.

Patients with addiction problems, high-dose opioid use, or abuse of other drugs may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation.

Guidelines from the American Society of Addiction Medicine are available and may be consulted relating to the intensity of services required for different classes of patients in order to achieve successful treatment.

There is some evidence that a telephone-delivered collaborative care management intervention for primary care veteran patients produced clinically meaningful improvements in pain at 12-month follow-up compared with usual care by increasing non-opioid analgesic medications and without changing opioid usage for the management of chronic musculoskeletal pain. The management was directed by nurse case managers. Because the control group was usual care rather than an attention control, the non-specific effects of attention received in the intervention group could have contributed to the effectiveness of the intervention. If an attention control had been used as the control group, the effect size observed for improvement in pain in the intervention group may have been smaller. It is unknown how successful this would be with injured workers.

Informal interdisciplinary pain programs may be considered for patients who are currently employed, those who cannot attend all-day programs, those with language barriers, or those living in areas not offering formal programs. Before treatment has been initiated, the patient, physician, and insurer should agree on treatment approach, methods, and goals. Generally, the type of outpatient program needed will depend on the degree of impact the pain has had on the patient’s medical, physical, psychological, social, and/or vocational functioning.

When referring a patient for formal outpatient interdisciplinary pain rehabilitation, an occupational rehabilitation program, or an opioid treatment program, the Division recommends the program meets the criteria of the Commission on Accreditation of Rehabilitation Facilities (CARF).

Inpatient pain rehabilitation programs are rarely needed but may be necessary for patients with any of the following conditions: (a) high risk for medical instability, (b) moderate-to-severe impairment of physical/functional status, (c) moderate-to-severe pain behaviors, (d) moderate impairment of cognitive and/or emotional status, (e) dependence on medications from which he/she needs to be withdrawn, and (f) the need for 24-hour supervised nursing. Whether formal or informal programs, they should be comprised of the following dimensions:

i. Communication: To ensure positive functional outcomes, communication between the patient, insurer, and all professionals involved must be coordinated and consistent. Any exchange of information must be provided to all parties, including the patient. Care decisions should be communicated to all parties and should include the family and/or support system.

ii. Documentation: Thorough documentation by all professionals involved and/or discussions with the patient. It should be clear that functional goals are being actively pursued and measured on a regular basis to determine their achievement or need for modification. It is advisable to have the patient undergo objective functional measures.

iii. Risk assessments: The following should be incorporated into the overall assessment process, individual program planning, and discharge planning: aberrant medication related behavior, addiction, suicide, and other maladaptive behavior.

iv. Treatment Modalities: Use of modalities may be necessary early in the process to facilitate compliance with and tolerance to therapeutic exercise, physical conditioning, and increasing functional activities.

Active treatments should be emphasized over passive treatments. Active and self-monitored passive treatments should encourage self-coping skills and management of pain, which can be continued independently at home or at work. Treatments that can foster a sense of dependency by the patient on the caregiver should be avoided. Treatment length should be decided based upon observed functional improvement. For a complete list of active and passive therapies, refer to Section H.15, Therapy – Active, and Section H.16, Therapy – Passive. All treatment time frames may be extended based on the patient’s positive functional improvement.

v. Therapeutic Exercise Programs: A therapeutic exercise program should be initiated at the start of any treatment rehabilitation. Such programs should emphasize education, independence, and the importance of an on-going exercise regimen. There is good evidence that exercise alone or as part of a multi-disciplinary program results in decreased disability for workers with non-acute low back pain. There is not sufficient evidence to support the recommendation of any particular exercise regimen over another exercise regimen.

vi. Return-to-Work: An authorized treating physician should continually evaluate the patients for their potential to return to work. For patients who are currently employed, efforts should be aimed at keeping them employed. Formal rehabilitation programs should provide assistance in creating work profiles. For more specific information regarding return to work, refer to Section H.14, Return-to-Work.

vii. Patient Education: Patients with pain need to re-establish a healthy balance in lifestyle. All providers should educate patients on how to overcome barriers to resuming daily activity, including pain management, decreased energy levels, financial constraints, decreased physical ability, and change in family dynamics.

viii. Psychosocial Evaluation and Treatment: Psychosocial evaluation should be initiated, if not previously done. Providers should have a thorough understanding of the patient’s personality profile, especially if dependency issues are involved. Psychosocial treatment may enhance the patient’s ability to participate in pain treatment rehabilitation, manage stress, and increase their problem-solving and self-management skills.

ix. Family/Support System Services as appropriate: The following should be considered in the initial assessment and program planning for the individual: ability and willingness to participate in the plan, coping, expectations, educational needs, insight, interpersonal dynamics, learning style, problem solving, responsibilities, and cultural and financial factors. Support would include counseling, education, assistive technology, and ongoing communication.

x. Vocational Assistance: Vocational assistance can define future employment opportunities or assist patients in obtaining future employment. Refer to Section H.14, Return-to-Work, for detailed information.

xi. Discharge Planning: Follow-up visits will be necessary to assure adherence to treatment plan. Programs should have community and/or patient support networks available to patients on discharge.

xii. Interdisciplinary Teams: Interdisciplinary programs are characterized by a variety of disciplines that participate in the assessment, planning, and/or implementation of the treatment program. These programs are for patients with greater levels of perceived disability, dysfunction, deconditioning, and psychological involvement. Programs should have sufficient personnel to work with the individual in the following areas: behavioral, functional, medical, cognitive, communication, pain management, physical, psychological, social, spiritual, recreation and leisure, and vocational. Services should address impairments, activity limitations, participation restrictions, environmental needs, and personal preferences of the worker.

b. Formal Interdisciplinary Rehabilitation Programs:

i. Interdisciplinary Pain Rehabilitation: An Interdisciplinary Pain Rehabilitation Program provides outcome-focused, coordinated, goaloriented interdisciplinary team services to measure and improve the functioning of persons with pain and encourage their appropriate use of health care system and services. The program can benefit persons who have limitations that interfere with their physical, psychological, social, and/or vocational functioning. The program shares information about the scope of the services and the outcomes achieved with patients, authorized providers, and insurers.

The interdisciplinary team maintains consistent integration and communication to ensure that all interdisciplinary team members are aware of the plan of care for the patient, are exchanging information, and are implementing the plan of care. The team members make interdisciplinary team decisions with the patient and then ensure that decisions are communicated to the entire care team.

Teams that assist in the accomplishment of functional, physical, psychological, social, and vocational goals must include: a medical director, pain team physician(s) who should preferably be board certified in an appropriate specialty, and a pain team psychologist. The Medical Director of the pain program and each pain team physician should be board certified in pain management or be board certified in his/her specialty area and have one of the following: 1) completed a one-year fellowship in interdisciplinary pain medicine or palliative care recognized by a national board, 2) two years of experience in an interdisciplinary pain rehabilitation program, or 3) if less than 2 years of experience, participate in a mentorship program with an experienced pain team physician. The pain team psychologist should have 1) one year’s fulltime experience in an interdisciplinary pain program, or 2) if less than 2 years of experience, participate in a mentorship program with an experienced pain team psychologist. Professionals from other disciplines on the team may include but are not limited to: a biofeedback therapist, an occupational therapist, a physical therapist, a registered nurse (RN), a case manager, an exercise physiologist, a psychologist, a psychiatrist, and/or a nutritionist. A recent French interdisciplinary functional spine restoration program demonstrated increased return to work at 12 months.

Time Frames for Interdisciplinary Pain Rehabilitation Time to Produce Effect 3 to 4 weeks.

Frequency Full time programs – No less than 5 hours per day, 5 days per week; part-time programs – 4 hours per day, 2–3 days per week.

Optimum Duration 3 to 12 weeks at least 2–3 times a week. Follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

Maximum Duration 4 months for full-time programs and up to 6 months for

part-time programs. Periodic review and monitoring thereafter for 1 year, and additional follow-up based on the documented maintenance of functional gains.

ii. Occupational Rehabilitation: This is a formal interdisciplinary program addressing a patient’s employability and return to work. It includes a progressive increase in the number of hours per day in which a patient completes work simulation tasks until the patient can tolerate a full work day. A full work day is case specific and is defined by the previous employment of the patient. Safe workplace practices and education of the employer and family and/or social support system regarding the person’s status should be included. This is accomplished by addressing the medical, psychological, behavioral, physical, functional, and vocational components of employability and return to work.

The following are best practice recommendations for an occupational rehabilitation program:

A) Work assessments including a work-site evaluation when possible (Refer to Section H.14, Return-To-Work).

B) Practice of component tasks with modifications as needed.

C) Development of strength and endurance for work tasks.

D) Education on safe work practices.

E) Education of the employer regarding functional implications of the worker when possible.

F) Involvement of family members and/or support system for the worker.

G) Promotion of responsibility and self-management.

H) Assessment of the worker in relationship to productivity, safety, and worker behaviors.

I) Identification of transferable skills of the worker.

J) Development of behaviors to improve the ability of the worker to return to work or benefit from other rehabilitation.

K) Discharge includes functional/work status, functional abilities as related to available jobs in the community, and a progressive plan for return to work if needed.

There is some evidence that an integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain. The occupational medicine rehabilitation interdisciplinary team should, at a minimum, be comprised of a qualified medical director who is board certified with documented training in occupational rehabilitation, team physicians having experience in occupational rehabilitation, an occupational therapist, and a physical therapist. As appropriate, the team may also include any of the following: a chiropractor, an RN, a case manager, a psychologist, a vocational specialist, or a certified biofeedback therapist.

Time Frames for Occupational Rehabilitation Time to Produce Effect 2 weeks.

Frequency 2 to 5 visits per week, up to 8 hours per day.

Maximum Duration 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

i. Opioid/Chemical Treatment Programs: Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline. Recent programs which incorporate both weaning from opioids and interdisciplinary therapy appear to demonstrate positive long-term results.

c. Informal Interdisciplinary Rehabilitation Program:

A coordinated interdisciplinary pain rehabilitation program is one in which an authorized treating physician coordinates all aspects of care. This type of program is similar to the formal programs in that it is goal-oriented and provides interdisciplinary rehabilitation services to manage the needs of the patient in the following areas: (a) functional, (b) medical, (c) physical, (d) psychological, (e) social, and (f) vocational.

This program is different from a formal program in that it involves lower frequency and intensity of services/treatment. Informal rehabilitation is geared toward those patients who do not need the intensity of service offered in a formal program or who cannot attend an all-day program due to employment, daycare, language, or other barriers.

Patients should be referred to professionals experienced in outpatient treatment of chronic pain. The Division recommends an authorized treating physician consult with physicians experienced in the treatment of chronic pain to develop the plan of care. Communication among care providers regarding clear objective goals and progress toward the goals is essential. Employers should be involved in return to work and work restrictions, and the family and/or social support system should be included in the treatment plan. Professionals from other disciplines likely to be involved include: a biofeedback therapist, an occupational therapist, a physical therapist, an RN, a psychologist, a case manager, an exercise physiologist, a psychiatrist, and/or a nutritionist.

Time Frames for Informal Interdisciplinary Rehabilitation Program Time to Produce Effect 3 to 4 weeks.

Frequency Full-time programs – No less than 5 hours per day, 5 days per week; Part-time programs – 4 hours per day for 2–3 days per week.

Optimum Duration 3 to 12 weeks at least 2–3 times a week. Follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

Maximum Duration 4 months for full-time programs and up to 6 months for parttime programs. Periodic review and monitoring thereafter for 1 year, and additional follow-up based upon the documented maintenance of functional gains.

Evidence Statements Regarding Interdisciplinary Rehabilitation Programs Interdisciplinary programs that include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability.

Cluster randomized trial, Randomized clinical trial Multidisciplinary rehabilitation (physical therapy and either psychological, social, or occupational therapy) shows small effects in reducing pain and improving disability compared to usual care, and multidisciplinary biopsychosocial rehabilitation is more effective than physical treatment for disability improvement after 12 months of treatment in patients with chronic low back pain. Patients with a significant psychosocial impact are most likely to benefit.

Exercise alone or as part of a multi-disciplinary program results in decreased disability for workers with non-acute low back pain.

Telephone-delivered collaborative care management intervention for primary care veteran patients produced clinically meaningful improvements in pain at 12-month follow-up compared with usual care by increasing non-opioid analgesic medications and without changing opioid usage for the management of chronic musculoskeletal pain. The management was directed by nurse case managers.

Because the control group was usual care rather than an attention control, the non-specific effects of attention received in the intervention group could have contributed to the effectiveness of the intervention. If an attention control had been used as the control group, the effect size observed for improvement in pain in the intervention group may have been smaller. It is unknown how successful this would be with injured workers.

Single-blind randomized An integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain.

Randomized clinical trial 8. MEDICATIONS AND MEDICAL MANAGEMENT a. General Chronic Pain Medication Management:

There is no single formula for pharmacological treatment of patients with chronic nonmalignant pain. A thorough medication history, including use of alternative and over-the-counter medications, should be performed at the time of the initial visit and updated periodically. The medication history may consist of evaluating patient refill records through pharmacies and the Physician Drug Monitoring Program (PDMP) to determine if the patient is receiving their prescribed regimen.

Appropriate application of pharmacological agents depends on the patient’s age, past history (including history of substance abuse), drug allergies, and the nature of all medical problems. It is incumbent upon the healthcare provider to thoroughly understand pharmacological principles when dealing with the different drug families, their respective side effects, drug interactions, and primary reason for each medication’s usage. Patients should be aware that medications alone are unlikely to provide complete pain relief. In addition to pain relief, a primary goal of drug treatment is to improve the patient’s function as measured behaviorally. Besides taking medications, continuing participation in exercise programs and using self-management techniques such as biofeedback, cognitive behavioral therapy, and other individualized physical and psychological practices are required elements for successful chronic pain management. Management must begin with establishing goals and expectations, including shared decision making about risks and benefits of medications.

Medication reconciliation is the process of comparing the medications that the patient is currently taking with those for which the patient has orders. This needs to include drug name, dosage, frequency, and route. The reconciliation can assist in avoiding medications errors such as omissions, duplications, dosing errors, or drug interactions. The results can also be used to assist discussion with the patient regarding prescribing or changing medications and the likelihood of side effects, drug interactions, and achieving expected goals. At a minimum, medication reconciliation should be performed for all patients upon the initial visit and whenever refilling or prescribing new medications.

Control of chronic non-malignant pain is expected to frequently involve the use of medication. Strategies for pharmacological control of pain cannot be precisely specified in advance. Rather, drug treatment requires close monitoring of the patient’s response to therapy, flexibility on the part of the prescriber, and a willingness to change treatment when circumstances change. Many of the drugs discussed in the medication section were originally licensed for indications other than analgesia but are effective in the control of some types of chronic pain.

It is generally wise to begin management with lower cost non-opioid medications whose efficacy equals higher cost medications and medications with a greater safety profile. Decisions to progress to more expensive, non-generic, and/or riskier products are made based on the drug profile, patient feedback, and improvement in function. The provider must carefully balance the untoward side effects of the different drugs with therapeutic benefits, as well as monitor for any drug interactions.

All medications should be given an appropriate trial in order to test for therapeutic effect. The length of an appropriate trial varies widely depending on the individual drug. Certain medications may take several months to determine the efficacy, while others require only a few doses. It is recommended that patients with chronic nonmalignant pain be maintained on drugs that have the least serious side effects. For example, patients need to be tried or continued on acetaminophen and/or low dose generic antidepressant medications whenever feasible, as part of their overall treatment for chronic pain. Patients with renal or hepatic disease may need increased dosing intervals with chronic acetaminophen use. Chronic use of NSAIDs is generally not recommended due to increased risk of cardiovascular events and GI bleeding.

Opioid analgesics and other drugs of potential abuse such as sedative hypnotics or benzodiazepines may be used in properly selected cases for CRPS patients, with total elimination desirable whenever clinically feasible. It is strongly recommended that such pharmacological management be monitored or managed by an experienced pain medicine physician. Multimodal therapy is the preferred mode of treatment for chronic pain patients whether or not these drugs were used acutely or sub-acutely.

Pharmaceutical neuropathic pain studies are limited. Diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN) are the two most frequently studied noncancer neuropathic pain conditions in randomized clinical trials of drug treatment. Some studies enroll only DPN or PHN patients, while other studies may enroll both kinds of patients. There appear to be consistent differences between DPN and PHN with respect to placebo responses, with DPN showing greater placebo response than PHC. Thus, there is an increased likelihood of a “positive” trial result for clinical trials of drug treatment for PHN than for DPN.

Although many studies focus on mean change in pain, this may not be the most reliable result. It does not necessarily allow for subgroups that may have improved significantly. Furthermore, the DPN and PHN studies do not represent the type of neurologic pain usually seen in workers’ compensation.

For these reasons, few pharmaceutical agents listed in this Guideline are supported by high levels of evidence, but the paucity of evidence statements should not be construed as meaning that medication is not to be encouraged in managing chronic pain patients.

General Order for Trial of Neuropathic Pain Medications Treating physician are encouraged to follow this sequence taking into consideration the patient’s individual tolerance for types of medications, their side effects, and their other medical conditions will guide pharmaceutical choices.

1. Tricyclic anti-depressants.

2. Gabapentin or pregabalin and/or serotonin norepinephrine reuptake inhibitors.

3. Other anticonvulsants as listed.

4. Opioids low dose including, tramadol, tapentadol.

It is advisable to begin with the lowest effective dose proven to be useful for neuropathic pain in the literature. If the patient is tolerating the medication and clinical benefit is appreciated, maximize the dose for that medication or add another second line medication with another mechanism of action. If a medication is not effective, taper off the medication and start another agent.

Maintain goal dosing for up to 8 weeks before determining its effectiveness.

Many patients will utilize several medications from different classes to achieve maximum benefit.

It is also useful to remember that there is some evidence that in the setting of uncomplicated low back pain lasting longer than 3 months, patients who were willing to participate in a trial of capsules clearly labelled as placebo experienced short-term reductions in pain and disability after the principles of the placebo effect had been explained to them.

The preceding principles do not apply to chronic headache or trigeminal neuralgia patients. These patients should be referred to a physician specializing in the diagnosis and treatment of headache and facial pain (refer to the Division’s Traumatic Brain Injury Medical Treatment Guideline).

For the clinician to interpret the following material, it should be noted that: (1) drug profiles listed are not complete; (2) dosing of drugs will depend upon the specific drug, especially for off-label use; and (3) not all drugs within each class are listed, and other drugs within the class may be appropriate for individual cases. Clinicians should refer to informational texts or consult a pharmacist before prescribing unfamiliar medications or when there is a concern for drug interactions.

Evidence Statements Regarding Medication Management In the setting of uncomplicated low back pain lasting longer than 3 months, patients who were willing to participate in a trial of capsules clearly labelled as placebo experienced short-term reductions in pain and disability after the principles of the placebo effect had been explained to them.

b. CRPS Specific Medication Management:

For CRPS management, a burst of oral steroids is usually prescribed initially followed by tricyclics. Bisphosphonates are used when osteotrophic changes are present. Neuropathic pain can be treated with a variety of medications; however, all have specific side effects and other interactions that clinicians must be mindful of. It is suggested that patients with significant peripheral neuropathic pain be trialed with a tricyclic medication initially, as low dose medication in this category frequently is tolerated and performs sufficiently to decrease pain 30 to 50%.

When these fail, side effects are not tolerated, or a patient has medical issues precluding the use of this class of drugs, other appropriate medications can be tried. Second-line drugs include the anti-convulsants gabapentin (Fanatrex, Gabarone, Gralise, Horizant, Neurontin) and pregabalin (Lyrica). Comparison studies of amitriptyline (Elavil, Endep, Vanatrip) and gabapentin or carbamazepine (Carbatrol, Epitol, Equetro, Tegretol) have shown no appreciable difference between the drugs; thus, there is good evidence that there is little clinical outcome difference between the medications, although gabapentin may be better tolerated. Third line drugs are the SNRIs, which have demonstrated some effectiveness for treating neuropathic pain, and topical lidocaine. The SNRI duloxetine (Cymbalta) has not been shown to be superior to the tricyclic amitriptyline, and there is no reason to prefer duloxetine in patients who have not been treated with a tricyclic. However, it may be preferable when the patient requires concomitant treatment of CRPS and depression as tricyclics are not well tolerated at doses therapeutic for depression. Fourth line drugs are opioids and tramadol (Rybix, Ryzolt, Ultram). Other medications have few clinical trials to support them but may be helpful in some patients.

For the clinician to interpret the following material, it should be noted that: (1) drug profiles listed are not complete; (2) dosing of drugs will depend upon the specific drug, especially for off-label use; and (3) not all drugs within each class are listed, and other drugs within the class may be appropriate for individual cases. Clinicians should refer to informational texts or consult a pharmacist before prescribing unfamiliar medications or when there is a concern for drug interactions.

Evidence Statements Regarding CRPS Specific Medication Management There is little clinical outcome difference between amitriptyline (Elavil, Endep, Vanatrip) and gabapentin or carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), although gabapentin may be better tolerated.

Randomized crossover trial, Randomized clinical trial, Meta-analysis of randomized trials The following drug classes are outlined for CRPS specific neuropathic pain:

c. CRPS-Specific Medications:

i. Oral Steroids:

Inflammation is thought to be one of the first physiological changes in CRPS; therefore, strong anti-inflammatories should provide some relief especially if provided early. There is good evidence to support oral steroid use early in the course of CRPS. The strongest study was performed on patients with CRPS of the shoulder and hand following a stroke. Forty milligrams of prednisone (Deltasone, Liquid Pred, Medicorten, Orasone, Prednicen-M, Prednicot, Sterapred, Sterapred DS) were given for 14 days and then tapered by 10 mg per week while physical therapy was provided.

This early treatment may be trialed on patients who meet the clinical diagnostic criteria for CRPS and do not have contraindications to steroid use. Side effects in some patients include mood changes, fluid retention, hyperglycemia, gastric irritation and ulcers, aseptic necrosis, and others.

ii. Bisphosphonates: are potent inhibitors of bone resorption. There is good evidence that their use effectively decreases pain and some evidence it increases joint motion in patients with CRPS. One study used alendronate (Fosamax) 40 mg orally for 8 weeks and another used IV clodronate 300 mg daily for 10 days. Several other studies that did not meet evidence criteria used different medications and dosages. It should not be used in those with severe renal dysfunction. Osteonecrosis of the jaw has been reported and there may be an association with atypical subtrochanter femoral fractures especially with long term use. The FDA recently approved Neridronate for use in the CRPS population. It may be used for qualified patients.

iii. Vitamin C: There is some evidence that Vitamin C 500mg to 2 grams taken for 50 days after a wrist fracture may help to prevent CRPS. It may be useful to prescribe Vitamin C to patients who historically have had or currently have CRPS if they suffer a fracture in order to prevent exacerbation of CRPS.

iv. Ketamine Hydrochloride:

Description: An N-methyl-D-aspartate (NMDA) receptor antagonist.

Proponents of using NMDA receptor antagonists in CRPS suspect that prolonged and high intensity pain induces the NMDA receptors which trigger inflammation and central sensitization of pain leading to abnormal pain manifestations such as allodynia and hyperalgesia.

Indications: As of the time of this guideline writing, formulations of ketamine hydrochloride have been FDA approved for injection as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. There is some evidence that in CRPS I patients, low dose daily infusions of ketamine can provide pain relief compared to placebo. The relief, however, faded within a few weeks.

Studies have not shown any functional improvements in patients with CRPS treated with ketamine infusions. Because their potential harm, as described below, outweighs evidence of limited short-term benefit in patients with CRPS, NMDA receptor antagonists are not recommended.

Less harmful therapies with longer term effects are available.

Contraindications: can cause significant elevations in blood pressure.

Side Effects: known to cause emergence reactions in anesthetic doses in 12% of patients. These reactions range from pleasant dream-like states to delirium accompanied by irrational behavior. Ketamine is reported to cause cognitive impairment and cystitis. Repeated prolonged injections have resulted in drug-induced liver damage that resolved when treatment was stopped. Respiratory depression, apnea, and laryngospasm have occurred in anesthetic doses. Patients treated for CRPS with ketamine infusions up to 18% have had hallucinations. Ketamine is also an abused drug.

Drug interactions: When given with barbiturates or opioids, patients may have a prolonged recovery time.

Due to the potential harm and limited short-term benefit in patients with CRPS, ketamine NMDA receptor antagonists are not recommended since less harmful therapies are available.

If ketamine is being considered for a CRPS patient who has been refractory to other treatments, there must be a complete discussion with the patient regarding lack of evidence for treatment, the possible side effects and the unknown long term side effects of repeat treatment.

v. Calcitonin: has been described in two low quality studies and was not shown to benefit CRPS patients. It was thought to provide analgesic properties through release of b-endorphin and the inhibition of bone resorption. It is not approved by the FDA for use with CRPS. Some patients have GI side effects and hyperglycemia has been reported.

Rare cases of neurological side effects have been reported. It is not recommended.

Evidence Statements Regarding CRPS-Specific Medications: Oral Steroids There is good evidence to support oral steroid use early in the course of CRPS.

Evidence Statements Regarding CRPS-Specific Medications: Bisphosphonates Use of bisphosphonates effectively decreases pain. Randomized clinical Use of bisphosphonates increases joint motion in patients with CRPS.

Evidence Statements Regarding CRPS-Specific Medications: Vitamin C Vitamin C 500mg to 2 grams taken for 50 days after a wrist fracture may help to prevent CRPS.

Evidence Statements Regarding CRPS-Specific Medications: Ketamine Hydrochloride In CRPS I patients, low dose daily infusions of ketamine can provide pain relief compared to placebo. The relief, however, faded within a few weeks.

Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for a list of drug classes to address neuropathic pain, including evidence and time frames for alphaacting agents, anticonvulsants, antidepressants, cannabinoid products, hypnotics and sedatives, NSAIDs, post-operative pain management, skeletal muscle relaxants, smoking cessation medications and treatment, topical drug delivery, and other agents.

d. Opioids: Opioids are the most powerful analgesics. Their use in acute pain and moderate-to-severe cancer pain is well accepted. Their use in chronic nonmalignant pain, however, is fraught with controversy and lack of scientific research. Deaths in the United States from opioids have escalated in the last 15 years. The CDC states the following in their 2016 guideline for prescribing opioids: Opioid pain medication use presents serious risk, including overdose and opioid use disorder. From 1999 to 2014, more than 165,000 persons died from overdose related to opioid pain medication in the United States. In the past decade, while the death rates for the top leading causes of death such as heart disease and cancer have decreased substantially, the death rate associated with opioid pain medication has increased markedly. Sales of opioid pain medication have increased in parallel with opioid-related overdose deaths. The Drug Abuse Warning Network estimated that >420,000 emergency department visits were related to the misuse or abuse of narcotic pain relievers in 2011, the most recent year for which data are available. Opioid poisoning has also been identified in work-related populations.

Effectiveness and Side Effects: Opioids include some of the oldest and most effective drugs used in the control of severe pain. The discovery of opioid receptors and their endogenous peptide ligands has led to an understanding of effects at the binding sites of these naturally occurring substances. Most of their analgesic effects have been attributed to their modification of activity in pain pathways within the central nervous system; however, it has become evident that they also are active in the peripheral nervous system. Activation of receptors on the peripheral terminals of primary afferent nerves can mediate anti-nociceptive effects, including inhibition of neuronal excitability and release of inflammatory peptides. Some of their undesirable effects on inhibiting GI motility are peripherally mediated by receptors in the bowel wall.

Most studies show that only around 50% of patients tolerate opioid side effects and receive an acceptable level of pain relief. Depending on the diagnosis and other agents available for treatment, the incremental benefit can be small.

There is strong evidence that in the setting of chronic nonspecific low back pain, the short and intermediate term reduction in pain intensity of opioids, compared with placebo, falls short of a clinically important level of effectiveness. There is an absence of evidence that opioids have any beneficial effects on function or reduction of disability in the setting of chronic nonspecific low back pain. AHRQ found that opioids are effective for treating chronic low back pain. However, the report noted no evidence regarding the long-term effectiveness or safety for chronic opioids.

There is good evidence that opioids are more efficient than placebo in reducing neuropathic pain by clinically significant amounts. There is a lack of evidence that opioids improve function and quality of life more effectively than placebo. There is good evidence that opioids produce significantly more adverse effects than placebo such as constipation, drowsiness, dizziness, nausea, and vomiting.

There is a lack of evidence that they are superior to gabapentin or nortriptyline for neuropathic pain reduction.

Patients should have a thorough understanding of the need to pursue many other pain management techniques in addition to medication use in order to function with chronic pain. They should also be thoroughly aware of the side effects and how to manage them. There is strong evidence that adverse events such as constipation, dizziness, and drowsiness are more frequent with opioids than with placebo. Common side effects are drowsiness, constipation, nausea, and possible testosterone decrease with longer term use.

There is some evidence that in the setting of chronic low back pain with disc pathology, a high degree of anxiety or depressive symptomatology is associated with relatively less pain relief in spite of higher opioid dosage than when these symptoms are absent. A study comparing Arkansas Medicaid and a national commercial insurance population found that the top 5% of opioid users accounted for 48-70% of total opioid use. Utilization was increased among those with mental health and substance use disorders and those with multiple pain conditions. Psychological issues should always be screened for and treated in chronic pain patients. Therefore, for the majority of chronic pain patients, chronic opioids are unlikely to provide meaningful increase in function in daily activities.

However, a subpopulation of patients may benefit from chronic opioids when properly prescribed and all requirements from medical management are followed.

Hyperalgesia: Administration of opioid analgesics leads not only to analgesia, but may also lead to a paradoxical sensitization to noxious stimuli. Opioid induced hyperalgesia has been demonstrated in animals and humans using electrical or mechanical pain stimuli. This increased sensitivity to mildly painful stimuli does not occur in all patients and appears to be less likely in those with cancer, clear inflammatory pathology, or clear neuropathic pain. When hyperalgesia is suspected, opioid tapering is appropriate.

Opioid Induced Constipation (OIC): Some level of constipation is likely ubiquitous among chronic opioid users. An observational study of chronic opioid users who also used some type of laxative at least 4 times per week noted that approximately 50% of the patients were dissatisfied and they continue to report stool symptoms. 71% used a combination of natural and dietary treatment, 64.3% used over-the-counter laxatives, and 30% used prescription laxatives.

Other studies report similar percentages. There are insufficient quality studies to recommend one specific type of laxative over others.

The easiest method for identifying constipation, which is also recommended by a consensus, multidisciplinary group, is the Bowel Function Index. It assesses the patient’s impression over the last 7 days for ease of defecation, feeling of incomplete bowel evacuation, and personal judgment re-constipation.

Stepwise treatment for OIC is recommended, and all patients on chronic opioids should receive information on treatment for constipation. Dietary changes increasing soluble fibers are less likely to decrease OIC and may cause further problems if GI motility is decreased. Stool softeners may be tried, but stimulant and osmotic laxatives are likely to be more successful. Osmotic laxatives include lactulose and polyethylene glycol. Stimulants include bisacodyl, sennosides, and sodium picosulfate, although there may be some concern regarding use of stimulants on a regular basis.

Opioid rotation or change in opioids may be helpful for some patients. It is possible that sustained release opioid products cause more constipation than short acting agents due to their prolonged effect on the bowel opioid receptors.

Tapentadol is a u-opioid agonist and norepinephrine reuptake inhibitor. It is expected to cause less bowel impairment then oxycodone or other traditional opioids. Tapentadol may be the preferred opioid choice for patients with OIC.

Other prescription medications may be used if constipation cannot adequately be controlled with the previous measures. Naloxegol is a pegylaped naloxone molecule that does not pass the blood brain barrier and thus can be given with opioid therapy. There is good evidence that it can alleviate OIC and that 12.5 mg starting dose has an acceptable side effect profile.

Methylnaltrexone does not cross the blood brain barrier and can be given subcutaneously or orally. It is specifically recommended for opioid induced constipation for patients with chronic non-cancer pain.

Misoprostol is a synthetic prostaglandin E1 agonist and has the side effect of diarrhea in some patients. It also has been tried for opioid induced constipation, although it is not FDA approved for this use.

Lubiprostone is a prostaglandin E1 approved for use in opioid constipation.

Most patients will require some therapeutic control for their constipation. The stepwise treatment discussed should be followed initially. If that has failed and the patient continues to have recurrent problems with experiencing severe straining, hard or lumpy stool with incomplete evacuation, or infrequent stools for 25% of the time despite the more conservative measures, it may be appropriate to use a pharmaceutical agent.

Evidence Statements Regarding Effectiveness and Side Effects of Opioids In the setting of chronic nonspecific low back pain, the short and intermediate term reduction in pain intensity of opioids, compared with placebo, falls short of a clinically important level of effectiveness.

Systematic review and meta-analysis Adverse events such as constipation, dizziness, and drowsiness are more frequent with opioids than with placebo.

Opioids are more efficient than placebo in reducing neuropathic pain by clinically significant amounts.

Systematic review and meta-analysis of Opioids produce significantly more adverse effects than placebo such as constipation, drowsiness, dizziness, nausea, and vomiting.

Naloxegol can alleviate opioid induced constipation and 12.5 mg starting dose has an acceptable side effect profile.

Two identical and simultaneous multicenter randomized doubleblind studies In the setting of chronic low back pain with disc pathology, a high degree of anxiety or depressive symptomatology is associated with relatively less pain relief in spite of higher opioid dosage than when these symptoms are absent.

Prospective cohort study Physiologic Responses to Opioids: Physiologic responses to opioids are influenced by variations in genes which code for opiate receptors, cytochrome P450 enzymes, and catecholamine metabolism. Interactions between these gene products significantly affect opiate absorption, distribution, and excretion.

Hydromorphone, oxymorphone, and morphine are metabolized through the glucuronide system. Other opioids generally use the cytochrome P450 system.

Allelic variants in the mu opiate receptor may cause increased analgesic responsiveness to lower drug doses in some patients. The genetic type can predict either lower or higher needs for opioids. For example, at least 10% of Caucasians lack the CYP450 2D6 enzyme that converts codeine to morphine. In some cases genetic testing for cytochrome P450 type may be helpful. When switching patients from codeine to other medications, assume the patient has little or no tolerance to opioids. Many gene-drug associations are poorly understood and of uncertain clinical significance. The treating physician needs to be aware of the fact that the patient’s genetic makeup may influence both the therapeutic response to drugs and the occurrence of adverse effects.

Adverse Events: Physicians should be aware that deaths from unintentional drug overdoses exceed the number of deaths from motor vehicle accidents in the US.

Most of these deaths are due to the use of opioids, usually in combination with other respiratory depressants such as alcohol or benzodiazepines. The risk for out of hospital deaths not involving suicide was also high. The prevalence of drug abuse in the population of patients undergoing pain management varies according to region and other issues. One study indicated that ¼ of patients being monitored for chronic opioid use have abused drugs occasionally, and ½ of those have frequent episodes of drug abuse. 80% of patients admitted to a large addiction program reported that their first use of opioids was from prescribed medication.

There is good evidence that in generally healthy patients with chronic musculoskeletal pain, treatment with long-acting opioids, compared to treatments with anticonvulsants or antidepressants, is associated with an increased risk of death of approximately 69%, most of which arises from non-overdose causes, principally cardiovascular in nature. The excess cardiovascular mortality principally occurs in the first 180 days from starting opioid treatment.

There is some evidence that compared to an opioid dose under 20 MME per day, a dose of 20-50 mg nearly doubles the risk of death, a dose of 50 to 100 mg may increase the risk more than fourfold, and a dose greater than 100 mg per day may increase the risk as much as sevenfold. However, the absolute risk of fatal overdose in chronic pain patients is fairly low and may be as low as 0.04%.

There is good evidence that prescription opioids in excess of 200 MME average daily doses are associated with a near tripling of the risk of opioid-related death, compared to average daily doses of 20 MME. Average daily doses of 100-200 mg and doses of 50-99 mg per day may be associated with a doubling of mortality risk, but these risk estimates need to be replicated with larger studies.

Doses of opioids in excess of 120 MME have been observed to be associated with increased duration of disability, even when adjusted for injury severity in injured workers with acute low back pain. Higher doses are more likely to be associated with hypo-gonadism, and the patient should be informed of this risk.

Higher doses of opioids also appear to contribute to the euphoric effect. The CDC recommends limiting to 90 MME per day to avoid increasing risk of overdose.

In summary, there is strong evidence that any dose above 50 MME per day is associated with a higher risk of death and 100 mg or greater appears to significantly increase the risk.

Workers who eventually are diagnosed with opioid abuse after an injury are also more likely to have higher claims cost. A retrospective observational cohort study of workers’ compensation and short-term disability cases found that those with at least one diagnosis of opioid abuse cost significantly more in days lost from work for both groups and in overall healthcare costs for the short-term disability groups. About 0.5% of eligible workers were diagnosed with opioid abuse.

Evidence Statements Regarding Opioids and Adverse Events In generally healthy patients with chronic musculoskeletal pain, treatment with long-acting opioids, compared to treatments with anticonvulsants or antidepressants, is associated with an increased risk of death of approximately 69%, most of which arises from non-overdose causes, principally cardiovascular in nature. The excess cardiovascular mortality principally occurs in the first 180 days from starting opioid treatment.

Retrospective matched cohort study Prescription opioids in excess of 200 MME average daily doses are associated with a near tripling of the risk of opioid-related death, compared to average daily doses of 20 MME. Average daily doses of 100-200 mg and doses of 50- 99 mg per day may be associated with a doubling of mortality risk, but these risk estimates need to be replicated with larger studies.

Nested case-control study with incidence density sampling Compared to an opioid dose under 20 MME per day, a dose of 20-50 mg nearly doubles the risk of death, a dose of 50 to 100 mg may increase the risk more than fourfold, and a dose greater than 100 mg per day may increase the risk as much as sevenfold. However, the absolute risk of fatal overdose of in chronic pain patients is fairly low, and may be as low as 0.04%.

Case-cohort study Dependence versus Addiction: The central nervous system actions of these drugs account for much of their analgesic effect and for many of their other actions, such as respiratory depression, drowsiness, mental clouding, reward effects, and habit formation. With respect to the latter, it is crucial to distinguish between two distinct phenomena: dependence and addiction.

• Dependence is a physiological tolerance and refers to a set of disturbances in body homeostasis that leads to withdrawal symptoms, which can be produced with abrupt discontinuation, rapid reduction, decreasing blood levels, and/or by administration of an antagonist.

• Addiction is a primary, chronic, neurobiological disease, with genetic, psychological, and environmental factors influencing its development and manifestations. It is a behavioral pattern of drug craving and seeking which leads to a preoccupation with drug procurement and an aberrant pattern of use. The drug use is frequently associated with negative consequences.

Dependence is a physiological phenomenon, which is expected with the continued administration of opioids, and need not deter physicians from their appropriate use. Before increasing the opioid dose, the physician should review other possible causes for the decline in analgesic effect. Increasing the dose may not result in improved function or decreased pain. Remember that it is recommended for total morphine milligram equivalents (MME) per day to remain at 50 or below. Consideration should be given to possible new psychological stressors or an increase in the activity of the nociceptive pathways. Other possibilities include new pathology, low testosterone level that impedes delivery of opioids to the central nervous system, drug diversion, hyperalgesia, or abusive use of the medication.

Choice of Opioids: No long-term studies establish the efficacy of opioids over one year of use or superior performance by one type. There is no evidence that one long-acting opioid is more effective than another, or more effective than other types of medications, in improving function or pain. There is some evidence that long-acting oxycodone (Dazidox, Endocodone, ETH-oxydose, Oxycontin, Oxyfast, OxyIR, Percolone, Roxicodone) and oxymorphone have equal analgesic effects and side effects, although the milligram dose of oxymorphone (Opana) is ½ that of oxycodone. There is no evidence that long-acting opioids are superior to short-acting opioids for improving function or pain or causing less addiction. A number of studies have been done assessing relief of pain in cancer patients. A recent systematic review concludes that oxycodone does not result in better pain relief than other strong opioids including morphine and oxymorphone. It also found no difference between controlled release and immediate release oxycodone. There is some evidence that extended release hydrocodone has a small and clinically unimportant advantage over placebo for relief of chronic low back pain among patients who are able to tolerate the drug and that 40% of patients who begin taking the drug do not attain a dose which provides pain relief without unacceptable adverse effects. Hydrocodone ER does not appear to improve function in comparison with placebo. A Cochrane review of oxycodone in cancer pain also found no evidence in favor of the longer acting opioid. There does not appear to be any significant difference in efficacy between once daily hydromorphone and sustained release oxycodone. Nausea and constipation are common for both medications between 26-32%.

There is some evidence that in the setting of neuropathic pain, a combination of morphine plus nortriptyline produces better pain relief than either monotherapy alone, but morphine monotherapy is not superior to nortriptyline monotherapy, and it is possible that it is actually less effective than nortriptyline.

Long-acting opioids should not be used for the treatment of acute, sub-acute, or post-operative pain, as this is likely to lead to drug dependence and difficulty tapering the medication. Additionally, there is a potential for respiratory depression to occur. The FDA requires that manufacturers develop Risk Evaluation and Mitigation Strategies (REMS) for most opioids. Physicians should carefully review the plans or educational materials provided under this program.

Clinical considerations should determine the need for long-acting opioids given their lack of evidence noted above.

Addiction and abuse potentials of commonly prescribed opioid drugs may be estimated in a variety of ways, and their relative ranking may depend on the measure which is used. One systematic study of prescribed opioids estimated rates of drug misuse were estimated at 21-29% and addiction at 8-12%. There is good evidence that in the setting of new onset chronic non-cancer pain, there is a clinically important relationship between opioid prescription and subsequent opioid use disorder. Compared to no opioid use, short-term opioid use approximately triples the risk of opioid use disorder in the next 18 months. Use of opioids for over 90 days is associated with very pronounced increased risks of the subsequent development of an opioid use disorder, which may be as much as one hundredfold when doses greater than 120 MME are taken for more than 90 days. The absolute risk of these disorders is very uncertain but is likely to be greater than 6.1% for long duration treatment with a high opioid dose.

Hydrocodone is the most commonly prescribed opioid in the general population and is one of the most commonly abused opioids in the population. However, the abuse rate per 1000 prescriptions is lower than the corresponding rates for extended release oxycodone, hydromorphone (Dilaudid, Palladone), and methadone. Extended release oxycodone appears to be the most commonly abused opioid, both in the general population and in the abuse rate per 1000 prescriptions. Tramadol, by contrast, appears to have a lower abuse rate than for other opioids. Newer drug formulations such as oxymorphone, have been assumed to be relatively abuse-resistant, but their abuse potential is unknown and safety cannot be assumed in the absence of sound data.

Types of opioids are listed below:

i. Buprenorphine: (various formulations) is prescribed as an intravenous injection, transdermal patch, buccal film, or sublingual tablet due to lack of bioavailability of oral agents. Depending upon the formulation, buprenorphine may be indicated for the treatment of pain or for the treatment of opioid dependence (addiction).

Buprenorphine for Opioid Dependence (addiction): FDA has approved a number of buccal films including those with naloxone and a sublingual tablet to treat opioid dependence (addiction).

Buprenorphine for Pain: The FDA has approved specific forms of an intravenous and subcutaneous injectable, transdermal patch, and a buprenorphine buccal film to treat pain. However, by law, the transdermal patch and the injectable forms cannot be used to treat opioid dependence (addiction), even by DATA-2000 waivered physicians authorized to prescribe buprenorphine for addiction. Transdermal forms may cause significant skin reaction. Buprenorphine is not recommended for most chronic pain patients due to methods of administration, reports of euphoria in some patients, and lack of proof for improved efficacy in comparison with other opioids.

There is insufficient evidence to support or refute the suggestion that buprenorphine has any efficacy in any neuropathic pain condition. There is good evidence transdermal buprenorphine is noninferior to oral tramadol in the treatment of moderate to severe musculoskeletal pain arising from conditions like osteoarthritis and low back pain. The population of patients for whom it is more appropriate than tramadol is not established but would need to be determined on an individual patient

basis if there are clear reasons not to use oral tramadol.

In a well done study, 63% of those on buccal buprenorphine achieved a 30% or more decrease in pain at 12 weeks compared to a 47% placebo response. Approximately 40% of the initial groups eligible for the study dropped out during the initial phase when all patients received the drug to test for incompatibility.

There is strong evidence that in patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine. There is strong evidence that buprenorphine is superior to placebo with respect to retention in treatment, and good evidence that buprenorphine is superior to placebo with respect to positive urine testing for opiates.

There is an adequate meta-analysis supporting good evidence that transdermal fentanyl and transdermal buprenorphine are similar with respect to analgesia and sleep quality, and they are similar with respect to some common adverse effects such as constipation and discontinuation due to lack of effect. However, buprenorphine probably causes significantly less nausea than fentanyl, and it probably carries a lower risk of treatment discontinuation due to adverse events. It is also likely that both transdermal medications cause less constipation than oral Overall, due to cost and lack of superiority, buprenorphine is not a front line opioid choice. However, it may be used in those with a history of addiction or at high risk for addiction who otherwise qualify for chronic opioid use. It is also appropriate to consider buprenorphine products for tapering strategies and those on high dose morphine 90 MME ii. Codeine with Acetaminophen: Some patients cannot genetically metabolize codeine and therefore have no response. Codeine is not generally used on a daily basis for chronic pain. Acetaminophen dose per day should be limited to 2 grams.

iii. Fentanyl (Actiq, Duragesic, Fentora, Sublimaze): is not recommended for use with musculoskeletal chronic pain patients. It has been associated with a number of deaths and has high addiction potential.

Fentanyl should never be used transbuccally in this population. If it is being considered for a very specific patient population, it requires support from a pain specialist.

iv. Meperidine (Demerol): is not recommended for chronic pain. It and its active metabolite, normeperidine, present a serious risk of seizure and hallucinations. It is not a preferred medication for acute pain as its analgesic effect is similar to codeine.

v. Methadone: requires special precautions given its unpredictably long half-life and non-linear conversion from other opioids such as morphine.

It may also cause cardiac arrhythmias due to QT prolongation and has been linked with a greater number of deaths due to its prolonged half-life.

No conclusions can be made regarding differences in efficacy or safety between methadone and placebo, other opioids, or other treatments.

There is strong evidence that in patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine. Methadone should only be prescribed by those with experience in managing this medication. Conversion from another opioid to methadone (or the other way around) can be very challenging, and dosing titration must be done very slowly (no more than every 7 days).

Unlike many other opioids, it should not be used on an “as needed”

basis, as decreased respiratory drive may occur before the full analgesic effect of methadone is appreciated. If methadone is being considered, genetic screening is appropriate. CYP2B6 polymorphism appears to metabolize methadone more slowly than the usual population and may cause more frequent deaths.

vi. Morphine: may be used in the non-cancer pain population. A study in chronic low back pain suggested that individuals with a greater amount of endogenous opioids will have a lower pain relief response to vii. Oxycodone and Hydromorphone: There is no evidence that oxycodone (as oxycodone CR) is of value in treating people with painful diabetic neuropathy, postherpetic neuralgia, or other neuropathic conditions.

There was insufficient evidence to support or refute the suggestion that hydromorphone has any efficacy in any neuropathic pain condition.

Oxycodone was not associated with greater pain relief in cancer patients when compared to morphine or oxymorphone.

viii. Propoxyphene (Darvon, Davon-N, PP-Cap): has been withdrawn from the market due to cardiac effects including arrhythmias.

ix. Tapentadol (Nucynta): is a mu opioid agonist which also inhibits serotonin and norepinephrine reuptake activity. It is currently available in an intermediate release formulation and may be available as extended release if FDA approved. Due to its dual activity, it can cause seizures or serotonin syndrome, particularly when taken with other SSRIs, SNRIs, tricyclics, or MAO inhibitors. It has not been tested in patients with severe renal or hepatic damage. It has similar opioid abuse issues as other opioid medication; however, it is promoted as having fewer GI side effects, such as constipation. There is good evidence that extended release tapentadol is more effective than placebo and comparable to oxycodone. In that study, the percent of patients who achieved 50% or greater pain relief was: placebo, 18.9%, tapentadol, 27.0%, and oxycodone, 23.3%. There is some evidence that tapentadol can reduce pain to a moderate degree in diabetic neuropathy, average difference 1.4/10 pain scale, with tolerable adverse effects. However, a high quality systematic review found inadequate evidence to support tapentadol to treat chronic pain. Tapentadol is not recommended as a first line opioid for chronic, subacute, or acute pain due to the cost and lack of superiority over other analgesics. There is some evidence that tapentadol causes less constipation than oxycodone. Therefore, it may be appropriate for patients who cannot tolerate other opioids due to GI side effects.

x. Tramadol (Rybix, Ryzolt, Ultram):

A) Description: an opioid partial agonist that does not cause GI ulceration or exacerbate hypertension or congestive heart failure.

It also inhibits the reuptake of norepinephrine and serotonin which may contribute to its pain relief mechanism. There are side effects similar to opioid side effects and may limit its use. They include nausea, sedation, and dry mouth.

B) Indications: mild to moderate pain relief. As of the time of this guideline writing, formulations of tramadol has been FDA approved for management of moderate to moderately severe pain in adults. This drug has been shown to provide pain relief equivalent to that of commonly prescribed NSAIDs. Unlike other pure opioids agonists, there is a ceiling dose to tramadol due to its serotonin activity (usually 300-400 mg per day). There is some evidence that it alleviates neuropathic pain following spinal cord injury. There is inadequate evidence that extended-release tramadol/acetaminophen in a fixed-dose combination of 75mg/650 mg is more effective than placebo in relieving chronic low back pain; it is not more effective in improving function compared to placebo. There is some evidence that tramadol yields a short-term analgesic response of little clinical importance relative to placebo in post-herpetic neuralgia which has been symptomatic for approximately 6 months. However, given the effectiveness of other drug classes for neuropathic pain, tramadol should not be considered a first line medication. It may be useful for patients who cannot tolerate tricyclic antidepressants or other medications.

C) Contraindications: use cautiously in patients who have a history of seizures, who are taking medication that may lower the seizure threshold, or taking medications that impact serotonin reuptake and could increase the risk for serotonin syndrome, such as monoamine oxidase inhibitors (MAO) inhibitors, SSRIs, TCAs, and alcohol. Use with caution in patients taking other potential QT prolonging agents. Not recommended in those with prior opioid addiction. Has been associated with deaths in those with an emotional disturbance or concurrent use of alcohol or other opioids. Significant renal and hepatic dysfunction requires dosage adjustment.

D) Side Effects: may cause impaired alertness or nausea. This medication has physically addictive properties, and withdrawal may follow abrupt discontinuation.

E) Drug Interactions: opioids, sedating medications, any drug that affects serotonin and/or norepinephrine (e.g., SNRIs, SSRIs, MAOs, and TCAs).

F) Laboratory Monitoring: renal and hepatic function.

Health care professionals and their patients must be particularly conscientious regarding the potential dangers of combining over-the-counter acetaminophen with prescription medications that also contain acetaminophen. Opioid and acetaminophen combination medication are limited due to the acetaminophen component. Total acetaminophen dose per day should not exceed 4 grams per any 24-hour period and is preferably limited to 2 grams per day to avoid possible liver damage.

Indications: The use of opioids is well accepted in treating cancer pain, where nociceptive mechanisms are generally present due to ongoing tissue destruction, expected survival may be short, and symptomatic relief is emphasized more than functional outcomes. In chronic non-malignant pain, by contrast, tissue destruction has generally ceased, meaning that central and neuropathic mechanisms frequently overshadow nociceptive processes. Expected survival in chronic pain is relatively long, and return to a high-level of function is a major goal of treatment. Therefore, approaches to pain developed in the context of malignant pain may not be transferable to chronic non-malignant pain. Opioids are generally not the best choice of medication for controlling neuropathic pain.

Tricyclics, SNRIs, and anticonvulsants should be tried before considering opioids for neuropathic pain.

In most cases, analgesic treatment should begin with acetaminophen, aspirin, and NSAIDs. While maximum efficacy is modest, they may reduce pain sufficiently to permit adequate function. When these drugs do not satisfactorily reduce pain, medications specific to the diagnosis should be used (e.g., neuropathic pain medications as outlined in Section G.10, Medications).

There is good evidence from a prospective cohort study that in the setting of common low back injuries, when baseline pain and injury severity are taken into account, a prescription for more than 7 days of opioids in the first 6 weeks is associated with an approximate doubling of disability one year after the injury.

Therefore, prescribing after 2 weeks in a non-surgical case requires a risk assessment. If prescribing beyond 4 weeks, a full opioid trial is suggested including toxicology screen. Best practice suggests that whenever there is use of opioids for more than 7 days, providers should follow all recommendations for screening and follow-ups of chronic pain use.

Consultation or referral to a pain specialist behavioral therapist should be considered when the pain persists but the underlying tissue pathology is minimal or absent and correlation between the original injury and the severity of impairment is not clear. Consider consultation if suffering and pain behaviors are present and the patient manifests risk behaviors described below, or when standard treatment measures have not been successful or are not indicated.

A psychological consultation including psychological testing (with validity measures) is indicated for all chronic pain patients as these patients are at high risk for unnecessary procedures and treatment and prolonged recovery.

Many behaviors have been found related to prescription-drug abuse patients.

None of these are predictive alone, and some can be seen in patients whose pain is not under reasonable control; however, the behaviors should be considered warning signs for higher risk of abuse or addiction by physicians prescribing chronic opioids. Refer to subsection v, on High Risk Behavior, below.

Recommendations for Opioid Use: When considering opioid use for moderate to moderately severe chronic pain, a trial of opioids must be accomplished as described below and the patient must have failed other chronic pain management regimes. Physicians should complete the education recommended by the FDA, risk evaluation and mitigation strategies (REMS) provided by drug manufacturing companies.

i. General Indications: There must be a clear understanding that opioids are to be used for a limited term as a trial (see trial indications below).

The patient should have a thorough understanding of all of the expectations for opioid use. The level of pain relief is expected to be relatively small, 2 to 3 points on a VAS pain scale, although in some individual patients it may be higher. For patients with a high response to opioid use, care should be taken to assure that there is no abuse or diversion occurring. The physician and patient must agree upon defined functional goals as well as pain goals. If functional goals are not being met, the opioid trial should be reassessed. The full spectrum of side effects should be reviewed. The shared decision making agreement signed by the patient must clarify under what term the opioids will be tapered. Refer to subsection iii.E, on the shared decision making agreement, below.

ii. Therapeutic Trial Indications: A therapeutic trial of opioids should not be employed unless the patient has begun multi-disciplinary pain management. The trial shall last one month. If there is no functional effect, the drug should be tapered.

Chronic use of opioids should not be prescribed until the following have been met:

A) The failure of pain management alternatives by a motivated patient including active therapies, cognitive behavioral therapy, pain self-management techniques, and other appropriate medical techniques.

B) Physical and psychological and/or psychiatric assessment including a full evaluation for alcohol or drug addiction, dependence or abuse, performed by two specialists including the authorized treating physician and a physician or psychologist specialist with expertise in chronic pain. The patient should be stratified as to low, medium, or high risk for abuse based on behaviors and prior history of abuse. High risk patients are those with active substance abuse of any type or a history of opioid abuse. These patients should generally not be placed on chronic opioids. If it is deemed appropriate to do so, physician addiction specialists should be monitoring the care. Moderate risk factors include a history of non-opioid substance abuse disorder, prior trauma particularly sexual abuse, tobacco use, widespread pain, poor pain coping, depression, and dysfunctional cognitions about pain and analgesic medications (see below). Pre-existing respiratory or memory problems should also be considered.

Patients with a past history of substance abuse or other psychosocial risk factors should be co-managed with a physician addiction specialist.

C) Risk Factors to Consider:

History of severe post-operative pain Opioid analgesic tolerance (daily use for months)

Current mixed opioid agonist/antagonist treatment (e.g., buprenorphine, naltrexone)

Chronic pain (either related or unrelated to the surgical site)

Psychological comorbidities (e.g., depression, anxiety, catastrophizing)

History of substance use disorder

History of “all over body pain”

History of significant opioid sensitivities (e.g., nausea, sedation)

History of intrathecal pump use or nerve stimulator implanted for pain control D) Employment requirements are outlined. The patient’s employment requirements should also be discussed as well as the need to drive. It is generally not recommended to allow workers in safety sensitive positions to take opioids. Opioid naïve patients or those changing doses are likely to have decreased driving ability. Some patients on chronic opioids may have nominal interference with driving ability; however, effects are specific to individuals. Providers may choose to order certified driver rehabilitation assessment.

E) Urine drug screening for substances of abuse and substances currently prescribed. Clinicians should keep in mind that there are an increasing number of deaths due to the toxic misuse of opioids with other medications and alcohol. Drug screening is a mandatory component of chronic opioid management. It is appropriate to screen for alcohol and marijuana use and have a contractual policy regarding both alcohol and marijuana use during chronic opioid management. Alcohol use in combination with opioids is likely to contribute to death.

F) Review of the Physician Prescription Drug Monitoring Program.

Informed, written, witnessed consent by the patient including the aspects noted above. Patients should also be counseled on safe storage and disposal of opioids.

G) The trial, with a short-acting agent, should document sustained improvement of pain control, at least a 30% reduction, and of functional status, including return-to-work and/or increase in activities of daily living. It is necessary to establish goals which are specific, measurable, achievable, and relevant prior to opioid trial or adjustment to measure changes in activity/function.

Measurement of functional goals may include patient completed validated functional tools such as those recommended by the Division as part of Quality Performance and Outcomes Payments (QPOP, see Rule 18-8) and/or the Patient Specific Functional Scale can provide useful additional confirmation.

Frequent follow-up at least every 2 to 4 weeks may be necessary to titrate dosage and assess clinical efficacy.

iii. On-Going, Long-Term Management after a successful trial should include:

A) Prescriptions from a single practitioner;

B) Ongoing review and documentation of pain relief, functional status, appropriate medication use, and side effects; full review at least every 3 months;

C) Ongoing effort to gain improvement of social and physical function as a result of pain relief;

D) Review of the Physician Drug Monitoring Program (PDMP);

E) Shared decision making agreement detailing the following:

• Side effects anticipated from the medication;

• Requirement to continue active therapy;

• Need to achieve functional goals including return to work for most cases;  Reasons for termination of opioid management, referral to addiction treatment, or for tapering opioids (tapering is usually for use longer than 30 days). Examples to be included in the contract include, but are not limited to:  Diversion of medication  Lack of functional effect at higher doses  Non-compliance with other drug use  Drug screening showing use of drugs outside of the prescribed treatment or evidence of non-compliant use of prescribed medication  Requests for prescriptions outside of the defined time frames  Lack of adherence identified by pill count, excessive sedation, or lack of functional gains  Excessive dose escalation with no decrease in use of short-term medications  Apparent hyperalgesia  Shows signs of substance use disorder (including but not limited to work or family problems related to opioid use, difficulty controlling use, craving)  Experiences overdose or other serious adverse event  Shows warning signs for overdose risk such as confusion, sedation, or slurred speech Patient Agreements should be written at a 6th grade reading level to accommodate the majority of patients.

F) Use of drug screening initially, randomly at least once a year and as deemed appropriate by the prescribing physician. Drug screening is suggested for any patients who have been receiving opioids for 8 to 90 days. A discussion regarding how screens positive for marijuana or alcohol will be handled should be included in the opioid contract. The concept of opioid misuse encompasses a variety of problems distinct from the development of addiction, such as nonmedical use, diversion, consultation with multiple prescribers, and unintentional overdose. In office only drug screening is insufficient as it does not identify metabolites of drugs prescribed.

Urine testing, when included as one part of a structured program for pain management, has been observed to reduce abuse behaviors in patients with a history of drug misuse. Clinicians should keep in mind that there are an increasing number of deaths due to the toxic misuse of opioids with other medications and alcohol. Drug screening is a mandatory component of chronic opioid management. Clinicians should determine before drug screening how they will use knowledge of marijuana use. It is appropriate to screen for alcohol and marijuana use and have a contractual policy regarding both alcohol and marijuana use during chronic opioid management. Alcohol use in combination with opioids is likely to contribute to death. From a safety standpoint, it is more important to screen for alcohol use than marijuana use as alcohol is more likely to contribute to unintended overdose.

Physicians should recognize that occasionally patients may use non-prescribed substances because they have not obtained sufficient relief on the prescribed regime.

Although drug screens done for chronic pain management should not be routinely available to employers, as screens are

part of the treatment record to which employers have limited access, patients should be aware that employers might obtain the records through attorneys or the insurer.

G) Chronic use limited to 2 oral opioids.

H) Transdermal medication use, other than buprenorphine, is generally not recommended.

I) Use of acetaminophen-containing medications in patients with liver disease should be limited, including over-the-counter medications. Acetaminophen dose should not exceed 4 grams per day for short-term use or 2-3 grams/day for long-term use in healthy patients. A safer chronic dose may be 1800mg/day.

J) Continuing review of overall therapy plan with regard to nonopioid means of pain control and functional status.

K) Tapering of opioids may be necessary for many reasons including the development of hyperalgesia, decreased effects from an opioid, lack of compliance with the opioid contract, or intolerance of side effects. Some patients appear to experience allodynia or hyperalgesia on chronic opioids. This premise is supported by a study of normal volunteers who received opioid infusions and demonstrated an increase in secondary hyperalgesia. Options for treating hyperalgesia include withdrawing the patient from opioids and reassessing their condition. In some cases, the patient will improve when off of the opioid. In other cases, another opioid may be substituted.

Tapering may also be appropriate by patient choice, to accommodate “fit-for-duty” demands, prior to major surgery to assist with post-operative pain control, to alleviate the effects of chronic use including hypogonadism, medication side effects, or in the instance of a breach of drug agreement, overdose, other drug use aberrancies, or lack of functional benefit. It is also appropriate for any of the tapering criteria listed in section E above.

Generally tapering can be accomplished by decreasing the dose 10% per week. This will generally take 6 to 12 weeks and may need to be done one drug class at a time. Behavioral support is required during this service. Tapering may occur prior to MMI or in some cases during maintenance treatment.

L) Medication assisted treatment with buprenorphine or methadone may be considered for opioid abuse disorder, in addition to behavioral therapy. Refer to Section H.9. Opioid Addiction Treatment.

M) Inpatient treatment may be required for addiction or opioid tapering in complex cases. Refer to Section H.7, Interdisciplinary Rehabilitation Programs, for detailed information on inpatient criteria.

iv. Relative Contraindications: Extreme caution should be used in prescribing controlled substances for workers with one or more “relative contraindications.” Consultation with a pain or addiction specialist may be useful in these cases.

A) History of alcohol or other substance abuse, or a history of chronic, benzodiazepine use.

B) Sleep apnea: If patient has symptoms of sleep apnea, diagnostic tests should be pursued prior to chronic opioid use.

C) Off work for more than 6 months with minimal improvement in function from other active therapy.

D) Severe personality disorder or other known severe psychiatric disease per psychiatrist or psychologist.

E) Monitoring of behavior for signs of possible substance abuse indicating an increased risk for addiction and possible need for consultation with an addiction specialist.

v. High Risk Behavior: The following are high risk warning signs for possible drug abuse or addiction. Patients with these findings may need a consultation by a physician experienced in pain management and/or addiction. Behaviors in the left hand column are warning signs, not automatic grounds for dismissal, and should be followed up by a reevaluation with the provider. Repeated behaviors in the left hand column may be more indicative of addiction. Behaviors in the right hand column should be followed by a substance abuse evaluation.

Less suggestive for addiction but are increased in depressed patients More suggestive of addiction and are more prevalent in patients with substance use disorder  Frequent requests for early refills; claiming lost or stolen prescriptions  Opioid(s) used more frequently, or at higher doses than prescribed  Using opioids to treat non-pain symptoms  Borrowing or hoarding opioids  Using alcohol or tobacco to relieve pain  Requesting more or specific opioids  Recurring emergency room visits for pain  Concerns expressed by family member(s)  Unexpected drug test results  Inconsistencies in the patient’s

history  Buying opioids on the street; stealing or selling drugs  Multiple prescribers (“doctor shopping”)  Trading sex for opioids  Using illicit drugs, + urine drug tests for illicit drugs  Forging prescriptions  Aggressive demands for opioids  Injecting oral/topical opioids  Signs of intoxication (ETOH odor, sedation, slurred speech, motor instability, etc.)

Both daily and monthly users of nicotine were at least 3 times more likely to report non-medical use of opioid in the prior year. At least one study has demonstrated a prevalence of smokers and former smokers among those using opioids and at higher doses compared to the general population. It also appeared that smokers and former smokers used opioids more frequently and in higher doses than never smokers. Thus, tobacco use history may be a helpful prognosticator.

In one study, four specific behaviors appeared to identify patients at risk for current substance abuse: increasing doses on their own, feeling intoxicated, early refills, and oversedating oneself. A positive test for cocaine also appeared to be related.

One study found that half of patients receiving 90 days of continuous opioids remained on opioids several years later and that factors associated with continual use included daily opioid greater than 120 MME prior opioid exposure, and likely opioid misuse.

One study suggested that those scoring at higher risk on the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) also had greater reductions in sensory low back pain and a greater desire to take morphine. It is unclear how this should be viewed in practice.

vi. Dosing and Time to Therapeutic Effect: Oral route is the preferred route of analgesic administration because it is the most convenient and costeffective method of administration. Transbuccal administration should be avoided other than for buprenorphine. A daily dosage above 50 MME may be appropriate for certain patients. However, when the patient’s dosage exceeds 50 MME per day and/or the patient is sedentary with minimal function, consideration should be given to lowering the dosage.

Some patients may require dosages above 90 MME per day. However, if the patient reaches a dosage above 90 MME per day, it is appropriate to taper or refer to a pain or addiction specialist. The provider should also adhere to all requirements in this guideline and closely monitor the patient as this is considered a high risk dosage. In some cases buprenorphine may be a preferred medication for pain control in those patients. Consultation may be necessary.

vii. Major Side Effects: There is great individual variation in susceptibility to opioid-induced side effects and clinicians should monitor for these potential side effects. Common initial side-effects include nausea, vomiting, drowsiness, unsteadiness, and confusion. Occasional sideeffects include dry mouth, sweating, pruritus, hallucinations, and myoclonus. Rare side effects include respiratory depression and psychological dependence. Constipation and nausea/vomiting are common problems associated with long-term opioid administration and should be anticipated, treated prophylactically, and monitored constantly.

Stool softeners, laxatives, and increased dietary fluid may be prescribed.

Refer to Section H.8.d, Opioid Induced Constipation. Chronic sustained release opioid use is associated with decreased testosterone in males and females and estradiol in pre-menopausal females. Patients should be asked about changes in libido, sexual function, and fatigue.

viii. Naloxone: may be prescribed when any risk factors are present. The correct use of Naloxone should be discussed with the patient and family.

ix. Benzodiazepines: should not be prescribed when opioids are used.

Refer to Section G.10.e, Hypnotics and Sedatives, in the Division’s Chronic Pain Disorder Medical Treatment Guideline for more information.

x. Sedation: driving and other tasks – Although some studies have shown that patients on chronic opioids do not function worse than patients not on medication, caution should be exerted, and patients should be counseled never to mix opioids with the use of alcohol or other sedating medication. When medication is increased or trials are begun, patients should not drive for at least 5 days. Chronic untreated pain and disordered sleep can also impair driving abilities.

xi. Drug Interactions: Patients receiving opioid agonists should not be given a mixed agonist-antagonist such as pentazocine (Talacen, Talwin) or butorphanol (Stadol) because doing so may precipitate a withdrawal syndrome and increase pain.

All sedating medication, especially benzodiazepines, should be avoided or limited to very low doses. Over-the-counter medications such as antihistamines, diphenhydramine, and prescription medications such as hydroxyzine (Anx, Atarax, Atazine, Hypam, Rezine, Vistaril) should be avoided except when being used to manage withdrawal during tapering of opioids. Alcohol should not be used.

xii. Recommended Laboratory Monitoring: Primary laboratory monitoring is recommended for acetaminophen/aspirin/NSAIDs combinations (renal and liver function, blood dyscrasia), although combination opioids are not recommended for long-term use. Morphine and other medication may require renal testing and other screening.

xiii. Sleep Apnea Testing: Both obstructive and central sleep apnea are likely to be exaggerated by opioid use or may occur secondary to higher dose chronic opioid use and combination medication use, especially benzodiazepines and sedative hypnotics. Patients should be questioned about sleep disturbance and family members or sleeping partners questioned about loud snoring or gasping during sleep. If present, qualified sleep studies and sleep medicine consultation should be obtained. Portable sleep monitoring units are generally not acceptable for diagnosing primary central sleep apnea. Type 3 portable units with 2 airflow samples and an 02 saturation device may be useful for monitoring respiratory depression secondary to opioids, although there are no studies on this topic.

xiv. Regular consultation of the Prescription Drug Monitoring Program (PDMP): Physicians should review their patients on the system whenever drug screens are done. This information should be used in combination with the drug screening results, functional status of the patient, and other laboratory findings to review the need for treatment and level of treatment appropriate for the patient. There is a separate billing code created by the DOWC to cover this service. Refer to Rule 18, Medical Fee Schedule.

xv. Addiction: If addiction occurs, patients will require treatment. Refer to

Section H.9, Opioid Addiction Treatment. After detoxification, they may need long-term treatment with naltrexone (Depade, ReVia), an antagonist which can be administered in a long-acting form or buprenorphine which requires specific education per the Drug Enforcement Agency (DEA).

xvi. Potentiating Agents: There is some evidence that dextromethorphan does not potentiate the effect of morphine opioids and therefore is not recommended to be used with opioids.

Evidence Statements Regarding Choice of Opioids, Indications, and Recommendations for Use In patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine.

Buprenorphine is superior to placebo with respect to retention in treatment.

Buprenorphine is superior to placebo with respect to positive urine testing for opiates.

In the setting of new onset chronic noncancer pain, there is a clinically important relationship between opioid prescription and subsequent opioid use disorder. Compared to no opioid use, short-term opioid use approximately triples the risk of opioid use disorder in the next 18 months. Use of opioids for over 90 days is associated with very pronounced increased risks of the subsequent development of an opioid use disorder, which may be as much as one hundredfold when doses greater than 120 MME are taken for more than 90 days. The absolute risk of these disorders is very uncertain but is likely to be greater than 6.1% for long duration treatment with a high opioid dose.

Retrospective cohort study using claims data from a large health care database Extended release tapentadol is more effective than placebo and comparable to oxycodone. The percent of patients who achieved 50% or greater pain relief was: placebo, 18.9%, tapentadol, 27.0%, and oxycodone, 23.3%.

Transdermal buprenorphine is noninferior to oral tramadol in the treatment of moderate to severe musculoskeletal pain arising from conditions like osteoarthritis and low back pain.

The population of patients for whom it is more appropriate than tramadol is not established but would need to be determined on an individual patient basis if there are clear reasons not to use oral tramadol.

Phase III noninferiority Good Evidence, Transdermal fentanyl and transdermal buprenorphine are similar with respect to analgesia and sleep quality, and they are similar with respect to some common adverse effects such as constipation and discontinuation due to lack of effect. However, buprenorphine probably causes significantly less nausea than fentanyl, and it probably carries a lower risk of treatment discontinuation due to adverse events. It is also likely that both transdermal medications cause less constipation than oral Network meta-analysis of randomized clinical Evidence Statements Regarding Choice of Opioids, Indications, and Recommendations for Use In the setting of common low back injuries, when baseline pain and injury severity are taken into account, a prescription for more than seven days of opioids in the first 6 weeks is associated with an approximate doubling of disability one year after the injury.

Prospective cohort study Long-acting oxycodone (Dazidox, Endocodone, ETH-oxydose, Oxycontin, Oxyfast, OxyIR, Percolone, Roxicodone) and oxymorphone have equal analgesic effects and side effects, although the milligram dose of oxymorphone (Opana) is ½ that of oxycodone.

Extended release hydrocodone has a small and clinically unimportant advantage over placebo for relief of chronic low back pain among patients who are able to tolerate the drug and that 40% of patients who begin taking the drug do not attain a dose which provides pain relief without unacceptable adverse effects. Hydrocodone ER does not appear to improve function in comparison with placebo.

Randomized trial with a screening period of 7- 14 days followed by an open-label titration period of up to 6 weeks followed by a double blind treatment period of up to 12 weeks In the setting of neuropathic pain, a combination of morphine plus nortriptyline produces better pain relief than either monotherapy alone, but morphine monotherapy is not superior to nortriptyline monotherapy, and it is possible that it is actually less effective than nortriptyline.

Crossover randomized Tapentadol can reduce pain to a moderate degree in diabetic neuropathy, average difference 1.4/10 pain scale, with tolerable adverse effects.

Tapentadol causes less constipation than oxycodone. Meta-analysis of Dextromethorphan does not potentiate the effect of morphine opioids and therefore is not recommended to be used with opioids.

Three randomized clinical trials Tramadol alleviates neuropathic pain following spinal cord injury.

Tramadol yields a short-term analgesic response of little clinical importance relative to placebo in postherpetic neuralgia which has been symptomatic for approximately 6 months.

9. OPIOID ADDICTION TREATMENT:

The DSM-V renames opioid addiction as substance use disorder (SUD) and classifies opioid use disorder according to categories defined as mild (2 – 3 features of stated criteria), moderate (4 – 5 features of stated criteria), or severe (6 – 7 features of stated criteria).

Definitions:

• Opioid physical dependence: opioid withdrawal symptoms (withdrawals) which occur as a result of abrupt discontinuation of an opioid in an individual who became habituated to the medication or through administration of an antagonist.

Opioid physical dependency is not in and of itself consistent with the diagnosis of addiction/substance use disorder.

• Tolerance: a physiologic state caused by the regular use of an opioid in which increasing doses are needed to maintain the same affect. In patients with "analgesic tolerance," increased doses of the opioid may be needed to maintain pain relief.

• Opioid misuse: the utilization of opioid medications outside of the prescribing instructions for which it was originally prescribed. Misuse may be as innocuous as taking slightly more or less medications than prescribed to crushing or snorting an opioid.

• Opioid abuse: the use of any substance for a non-therapeutic purpose or the use of a medication for purposes other than those for which the agent is prescribed.

Abuse includes intentional use for altering a state of consciousness. Abuse frequently affects the individual’s ability to fulfill normal societal roles, resulting in difficulty with employment, or legal, or interpersonal problems.

• Pseudo-addiction: addiction-like behaviors consistent with overutilization of medications outside of the prescribing provider's instructions and recommendations for the express purpose of improved pain management. This occurs when a patient believes there is insufficient pain relief. Once pain is adequately managed with a higher dose of medications than initially prescribed or with improved therapy, the behaviors consistent with addiction are discontinued.

• Addiction: a primary chronic neurobiological disease influenced by genetic, psychosocial, and/or environmental factors. It is characterized by impaired control over drug use, compulsive drug use, and continued drug use despite harm and because of craving.

Substance use disorder/addiction in the workers’ compensation system can be encountered in three ways. First, the individual has an active substance use disorder at the time of injury. The party responsible for treatment of the substance use disorder may be outside of the workers’ compensation system. However, if there is no other paying party and the treatment is necessary in order to recover from the current workers’ compensation injury, treatment may be covered by the workers’ compensation payor.

The second possibility is that a patient with a substance use disorder, who is currently in recovery at the time of the workers’ compensation injury, relapses as a result of the medications which are prescribed by the treating provider. This patient may become readdicted and will manifest substance use disorder characteristics and symptoms consistent with the diagnosis. The third possibility is an individual with no history of substance use disorder who is injured as a result of an occupational accident. This particular individual becomes "addicted" to the medications as a result of the medications being prescribed. This is most likely to occur with the use of opioids but could possibly occur with use of other medications such as benzodiazepines or specific muscle relaxants such as carisoprodol.

If the treating provider is suspicious of a patient exhibiting opioid misuse, abuse, or addiction, the patient should preferably be evaluated by a specialist in the field of addiction medicine. It would be the responsibility of the specialist to identify medication misuse, abuse, addiction, or pseudo-addiction and to determine what additional treatment, if any, needs to be implemented.

During the initial injury evaluation, an authorized treating provider should obtain an addiction history as part of a complete history and physical. If it is determined at the time of the initial evaluation by the treating provider that there is the pre-existing condition of active SUD or history of opioid addiction/SUD, then it is prudent to consider an evaluation with an addiction medicine physician prior to issuing opioid treatments if possible. The addiction medication specialist will be able to counsel the patient accordingly, determine medication needs, and determine the appropriate follow-up to hopefully avoid aggravation or relapse of substance abuse disorders which will complicate the recovery process. Many patients exhibit opioid misuse, opioid abuse, and pseudo-addictive behaviors. These issues can be managed once the problem is identified and a discussion is carried out with the patient regarding these abnormal behaviors.

Once the diagnosis of SUD is confirmed, an addiction medicine specialist familiar with addiction treatment should assist in co-managing the patient's care and the problematic drug prescriptions. This co-management technique is critical for the injured worker with a SUD diagnosis during the initial injury phase, recovery, and stabilization phase until he/she has reached MMI. If it is determined during the active treatment and recovery phase that there is no longer a need for opioids, then the addiction medicine specialist will be in charge of the transition from use of opioids to safe taper/discontinuation of the opioids while monitoring for relapse of addiction.

Co-management is equally important for managing the chronic pain patient that has a concomitant opioid addiction/SUD with a legitimate need for analgesic medications. The addiction medicine specialist in all likelihood will monitor the patient more closely including judicious prescribing, PDMP reviews, urine drug testing, drug counts, and clarifying functional improvement as a result of the medications prescribed and frequent follow-ups which may initially seem excessive.

All abstinence addiction treatment begins with a discontinuation of the addicting substance; this is referred to as the detox phase of the treatment and can be performed in a number of ways. However, detoxification alone is not considered adequate addiction treatment. Detoxification is simply a method of discontinuing the medications in an effort to stabilize the patient prior to more extensive treatment.

Phase 1:

The methods of detoxification can include 1) abrupt discontinuation – not recommended due to high rate of relapse due to craving and withdrawal symptoms, 2) slow but progressive taper – 10% of total dosage per week as an outpatient treatment, 3) conversion to a different medication opioid (buprenorphine/naloxone) to enable a more stable and comfortable taper occasionally done as an outpatient but commonly done as

part of a more comprehensive treatment program, and 4) rapid detox under anesthesia – not recommended due to relatively high incidence of complications and high expense.

The methodology chosen for phase 1 detoxification is left up to the specialist and is simply the initial phase of stabilization prior to considering the need for a phase 2 of addiction treatment program.

Phase 2:

Once a patient is safely through the detoxification phase and the condition is stabilized regardless of the method chosen, then successful addiction treatment begins generally utilizing a number of techniques to prevent the return to active substance use and addiction. This phase of treatment generally involves teaching the patient to develop control over the compulsions, psychosocial factors, and associated mental health issues which are critical to maintain abstinence. This phase of treatment is generally managed in a 30 – 90 day non-hospital residential treatment program. The treatment prescribed in a residential treatment program generally includes individual and group therapy with certified addiction counselors and psychologists. Phase 2 of treatment may or may not be combined with opioid substitution therapy with medications such as buprenorphine/naloxone (partial agonist of the opioid receptor), methadone, or naltrexone. Injectable depot naltrexone may be used.

Buprenorphine/naloxone therapy utilizes a sublingual partial opioid receptor agonist which binds to the opioid receptor, reducing craving and resulting in analgesia when necessary. Due to its high affinity to the opioid receptor, it blocks the effect of nonapproved additional opioid use. The buprenorphine is administered either sublingually or, when FDA approved, as a subcutaneous implant. Naloxone was added to the sublingual drug formulation to discourage using this medication intravenously. With intravenous administration of buprenorphine/naloxone, the naloxone becomes absorbed neutralizing the effects of opioids. Buprenorphine/naloxone can be an excellent option in patients requiring analgesic medications with a prior history of opioid addiction because buprenorphine results in less sedation and euphoria then the other standard schedule II opioid medications. Prescribing Suboxone film (buprenorphine/naloxone) for addiction purposes can only be done by a physician and requires special training and certification.

Once special training is completed, an application is filed with the DEA to obtain a special DEA license referred to as an X-DEA number. This X–DEA number needs to accompany all prescription for Suboxone when delivered to the pharmacy and identifies the prescription is being issued specifically for the treatment of addiction/SUD.

Methadone may be an option if the patient is admitted to a federally licensed methadone treatment facility where a daily dose of medication is administered and the patient continues to utilize therapeutic treatments/cognitive behavioral therapies as noted above.

There is strong evidence that in patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine. The methodology and rationale for methadone treatment is to saturate the opioid receptors with methadone (a slow onset and prolonged duration opioid), reducing the opioid craving. The majority of the opioid receptors are bound by the methadone leaving very few unbound opioid receptors available in the event additional opioids are utilized in an attempt to achieve the euphoric effect. When the patient is stabilized on a methadone dose determined by the federally licensed methadone clinic and their associated physicians, the patient's drug-seeking, craving, legal issues, and attempts to utilize non-approved medications is reduced. Patients will frequently return to more productive lives free of the compulsions, cravings, and legal issues and are usually able to maintain jobs and improve family dynamics.

Other medications which may be useful and can be utilized during the phase 2 and 3 treatment include opioid receptor antagonists such as naltrexone (ReVia, Vivitrol) which produces no euphoria. The purpose of naltrexone therapy is to add an additional layer of protection and treatment for the patients by allowing them to receive a daily oral dose of naltrexone (ReVia) or a monthly injection of naltrexone (Vivitrol). Administration of naltrexone will bind with very high affinity to the opioid receptor resulting in the opioid receptors being non-responsive to other opioid utilization thereby preventing any euphoric response or reinforcement with unsanctioned opioid use. This treatment method can be problematic in an individual receiving intramuscular naltrexone therapy especially if that individual requires surgery and post-operative pain management because the analgesics needed for post-operative pain management will be significantly less effective because of the prolonged opioid antagonist properties of the naltrexone.

In Summary:

Medication assisted treatment for patients addicted to opioids is the treatment recommended by most experts. A Canadian evidence-based guideline recommends long-term treatment with buprenorphine/naloxone, or methadone for some patients, based on the high relapse rate without medication assistance. The likelihood of relapse in the workers’ compensation population for individuals who have become addicted through prescription drug use is unknown. Buprenorphine implants are likely equally effective as sublingual buprenorphine for preventing illicit opioid use. Implants are significantly more costly. Naltrexone treatment, an opioid agonist, has also been used to maintain abstinence. It can be provided in monthly injections or orally 3 times per week. Choice of these medications should be made by the addiction specialist.

Phase 3:

Aftercare begins after discharge from the non-hospital residential treatment program and is designed for long-term management of addiction. This phase is potentially the time when relapse is most likely to occur if the patient has not developed significant skills necessary to deal with the compulsions, cravings, and associated psychosocial factors contributing to SUD. Long-term strategies include 1) intense outpatient programs (IOP), 2) group therapy/meetings such as Narcotics Anonymous, and 3) residential communities (RC) which are groups of patients living together in a community for up to 6 months for the express purpose of maintaining abstinence from their drug of choice but at the same time transitioning and learning how to live in the general community. Residential communities are extremely useful to give patients an opportunity to be reintroduced to employment and psychosocial interactions with family and friends while maintaining contact with the community supporting their addiction recovery. In addition, phase 3 medication treatment may include utilization of opioid substitution therapy (buprenorphine/naloxone) or opioid receptor antagonist therapy as noted above.

It must be noted that relapse is common despite the utilization of intense cognitive behavioral therapy, addiction treatment strategies, and long-term phase 3 treatment and medication. Risk monitoring should be continued, including checking for behavioral aberrancies, checking the PDMP, and drug testing,. Additional treatment or readmission for repeat treatment is not uncommon.

Evidence Statements Regarding Opioid Addiction Treatment In patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine.

10. OPIOID/CHEMICAL TREATMENT PROGRAMS:

Chemical dependency for workers’ compensation issues will usually be related to opioids, anxiolytics, or hypnotics as prescribed for the original workers’ compensation injury.

Chemical dependency should be treated with specific programs providing medical and psychological assessment, treatment planning, and individual as well as group counseling and education. Established functional goals which are measurable, achievable, and time specific are required.

Inpatient or outpatient programs may be used, depending upon the level of intensity of services required. Formal inpatient treatment programs are appropriate for patients who have more intense (e.g., use extraordinarily excessive doses of prescription drugs to which they have developed tolerance) or multiple drug abuse issues (e.g., benzodiazepines and/or alcohol) and those with complex medical conditions or psychiatric issues related to drug misuse. A medical physician with appropriate training and preferably board certified in addiction medicine should provide the initial evaluation and oversee the program. Full primary assessment should include behavioral health assessment; medical history; physical examination; mental status; current level of functioning; employment history; legal history; history of abuse, violence, and risk taking behavior; education level; use of alcohol, tobacco and other drugs; and social support system. The initial medical exam should include appropriate laboratory testing such as liver function, screening for sexual diseases, etc.

Addiction specialists, alcohol and drug counselors, psychologists, psychiatrists, and other trained health care providers as needed, are involved in the program. Peer and group support is an integral part of the program and families are encouraged to attend. Peer support specialists should receive competency based training. A designated individual is assigned to each worker to assist in coordinating care. There should be good communication between the program and other external services, external health care providers, Al-Anon, Alcoholics Anonymous (AA), and pain medicine providers. Drug screening should be performed as appropriate for the individual, at least weekly during the initial detoxification and intensive treatment phases. At least 8 random drug screens per year should be completed for those on medication assisted treatment and drug diversion control methods should be in place.

Clear withdrawal procedures are delineated for voluntary, against medical advice, and involuntary withdrawal. Withdrawal programs must have a clear treatment plan and include description of symptoms of medical and emotional distress, significant signs of opioid withdrawal, and actions taken. All programs should have clear direction on how to deal with violence in order to assure safety for all participants. Transition and discharge should be carefully planned with full communication to outside resources. Duration of inpatient programs are usually 4 weeks while outpatient programs may take 12 weeks.

Drug detoxification may be performed on an outpatient or inpatient basis. Detoxification is unlikely to succeed in isolation when not followed by prolonged chemical dependency treatment. Isolated detoxification is usually doomed to failure with very high recidivism rates.

Both ultra-rapid and rapid-detoxification are not recommended due to possible respiratory depression and death and the lack of evidence for long range treatment success. Refer to Section H.9, Opioid Addiction Treatment, for more specific details on treatment plans.

Tapering opioids on an outpatient basis requires a highly motivated patient and diligent treatment team and may be accomplished by decreasing the current dose 10% per day or per week. Tapering programs under the supervision of physicians with pain expertise may proceed more aggressively. Tapering should be accompanied by addiction counseling. Failing a trial of tapering, a patient should be sent to a formal addiction program. When the dose has reached 1/3 of the original dose, the taper should proceed at half or less of the initial rate. Doses should be held or possibly increased if severe withdrawal symptoms, pain, or reduced treatment failure otherwise occurs. This method is tedious, time consuming, and more likely to fail than more rapid and formalized treatment programs.

Time Frames for Opioid / Chemical Treatment Programs Time to Produce Effect 3 to 4 weeks Frequency Full time programs - no less than 5 hours/day, 5 days/week; part time programs - 4 hours/day for 2-3 days per week.

Optimum Duration 2 to 12 weeks at least 2-3 times a week. With follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

Maximum Duration 4 months for full time programs and up to 6 months for part-time programs. Periodic review and monitoring thereafter for 1 year, additional follow-up based upon the documented maintenance of functional gains.

11. ORTHOTICS/PROSTHETICS/EQUIPMENT: Devices and adaptive equipment are rarely necessary for CRPS patients as motion is to be encouraged. Specific devices may be useful in rare cases to aid in return to work duties.

12. PERSONALITY/PSYCHOLOGICAL/PSYCHOSOCIAL/PSYCHIATRIC INTERVENTION:

Psychosocial treatment is a well-established therapeutic and diagnostic intervention with selected use in acute pain problems and more widespread use in sub-acute and chronic pain populations. Psychosocial treatment is recommended as an important component in the total management of a patient with chronic pain and should be implemented as soon as the problem is identified.

Refer the Division’s Chronic Pain Disorder Medical Treatment Guideline for indications, 13. RESTRICTION OF ACTIVITIES: Continuation of normal daily activities is the recommendation for most patients since immobility will negatively affect rehabilitation.

Prolonged immobility results in a wide range of deleterious effects, such as a reduction in aerobic capacity and conditioning, loss of muscle strength and flexibility, increased segmental stiffness, promotion of bone demineralization, impaired disc nutrition, and the facilitation of the illness role.

Some level of immobility may occasionally be appropriate which could include splinting/casting or as part of a structured schedule that includes energy conservation or intentional rest breaks between activities. While these interventions may occasionally have been ordered in the acute phase, the provider should be aware of their impact on the patient’s ability to adequately comply with and successfully complete rehabilitation.

Activity should be increased based on the improvement of core strengthening.

Patients should be educated regarding the detrimental effects of immobility versus the efficacious use of limited rest periods. Adequate rest allows the patient to comply with active treatment and benefit from the rehabilitation program. In addition, complete work cessation should be avoided, if possible, since it often further aggravates the pain presentation and promotes disability. Modified return to work is almost always more efficacious and rarely contraindicated in the vast majority of injured workers.

14. RETURN-TO-WORK: Return-to-work and/or work-related activities whenever possible is one of the major components in treatment and rehabilitation. Return-to-work is a subject that should be addressed by each workers’ compensation provider at the first meeting with the injured employee and updated at each additional visit. A return-to-work format should be part of a company’s health plan, knowing that return to work can decrease anxiety, reduce the possibility of depression, and reconnect the worker with society.

A prolonged time off work is likely to lead to chronic disability. In complex cases, experienced nurse case managers may be required to assist in return to work. Other services, including psychological evaluation and/or treatment, jobsite analysis, and vocational assistance, may be employed.

Refer the Division’s Chronic Pain Disorder Medical Treatment Guideline for considerations and recommendations.

15. THERAPY- ACTIVE: The following active therapies are widely used and accepted methods of care for a variety of work-related injuries. Active therapy is based on the philosophy that therapeutic exercise and/or activity can alleviate discomfort and are beneficial for restoring flexibility, strength, endurance, function, and range-of-motion. All active therapy plans should be made directly with patients in the interest of achieving long-term individualized goals.

Active therapy requires an internal effort by the individual to complete a specific exercise or task. This form of therapy requires supervision from a therapist or medical provider such as verbal, visual, and/or tactile instruction(s). Active therapy is intended to promote independence and self-reliance in managing the physical pain as well as to improve functional status in regard to the specific diagnosis, general conditioning, and well-being.

At times, a provider may help stabilize the patient or guide the movement pattern but the energy required to complete the task is predominately executed by the patient. Therapy in this section should not be merely a repeat of previous therapy but should focus specifically on the individual goals and abilities of the patient with CRPS.

The goal of active therapy is to teach the patient exercises that they can perform regularly on their own. Patients should be instructed to continue active therapies at home as an extension of the treatment process in order to maintain improvement levels. Followup visits to reinforce and monitor progress and proper technique are recommended.

Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as "maximum.” Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care, need for post-operative therapy, and comorbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. It is recommended that, if no functional gain is observed after the number of treatments under “time to produce effect” has been completed, then alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

Pain Neuroscience Education (PNE): PNE is an educational strategy used by physical therapists and other practitioners that focuses on teaching people in pain more about the neurobiological and neurophysiological processes involved in their pain experience, versus a focus on anatomical and pathoanatomical education. PNE helps patients develop an understanding of various pain processes including central sensitization, peripheral sensitization, inhibition, facilitation, the brain’s processing of threat appraisal, and various biological systems involved in a pain experience. This reconceptualization of pain via PNE is then combined with various behavioral strategies including aerobic exercise, pacing, graded exposure, graded activity, and goal setting. PNE is likely to positively influence pain ratings, disability, fear-avoidance behaviors, pain catastrophization, limitations in movement, pain knowledge, and healthcare utilization.

PNE is recommended with active therapy for chronic pain patients.

Evidence Statements Regarding Patient Education Pain neuroscience education combined with a physical intervention is more effective in reducing pain, improving disability, and reducing healthcare utilization compared with either usual care, exercise, other education or another control group for the treatment of patients with chronic musculoskeletal pain.

Narrative systematic review of randomized clinical trials A cognitive intervention consisting of 2 consultations lasting 1 hour each with a physical medicine specialist and a physical therapist covering coping strategies and patient education on motion produces short-term reductions in subacute back disability.

In the setting of non-specific chronic low back pain, patientcentered cognitive functional therapy from physical therapists produced superior outcomes for pain reduction and functional improvement compared with traditional manual therapy and exercise at post-intervention and at 12month follow-up.

Since CRPS and SMP patients frequently have additional myofascial pain generators, other active therapies not listed may be used in treatment. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for therapies and timeframe parameters not listed.

The following active therapies are listed in alphabetical order:

a. Activities of Daily Living (ADL): instruction, active-assisted training, and/or adaptation of activities or equipment to improve a person's capacity in normal daily activities such as self-care, work re-integration training, homemaking, and driving.

Time Frames for Activities of Daily Living Frequency 1 to 5 times per week.

Maximum Duration 6 weeks.

b. Aquatic Therapy: is a well-accepted treatment which consists of the therapeutic use of aquatic immersion for therapeutic exercise to promote strengthening, core stabilization, endurance, range-of-motion, flexibility, body mechanics, and pain management. Aquatic therapy is the implementation of active therapeutic procedures (individual or group) in a swimming or therapeutic pool heated to 88 to 92°F. The pool should be large enough to allow full extremity range-of-motion and fully erect posture. Aquatic vests, belts, and other devices can be used to provide stability, balance, buoyancy, and resistance. The water provides a buoyancy force that lessens the amount of force of gravity applied to the body.

The decreased gravity effect allows the patient to have a mechanical advantage and more likely have a successful trial of therapeutic exercise. In addition, the compression of the water against the affected extremity and ability to move easier with decreased gravity allow for resulting muscular compression against vessels improving lymphatic drainage resulting in decreased edema. Aquatic therapy may also provide an additional stimulus to assist with desensitization.

There is good evidence that aquatic exercise and land-based exercise show comparable outcomes for function and mobility among people with symptomatic osteoarthritis of the knee or hip.

Indications: The therapy may be indicated for individuals who:

• Cannot tolerate active land-based or full-weight bearing therapeutic procedures;

• Require increased support in the presence of proprioceptive deficit;

• Are at risk of compression fracture due to decreased bone density;

• Have symptoms that are exacerbated in a dry environment;

• Have a higher probability of meeting active therapeutic goals than in a dry environment.

After the supervised aquatics program has been established, either a selfdirected aquatic program or a transition to a self-directed dry environment exercise program is recommended.

Evidence Statements Regarding Aquatic Therapy Aquatic exercise and land-based exercise show comparable outcomes for function and mobility among people with symptomatic osteoarthritis of the knee or hip.

Systematic Review and meta-analysis of Time Frames for Aquatic Therapy Frequency 3 to 5 times per week.

Maximum Duration 6 weeks.

c. Functional Activities: are well-established interventions which involve the use of therapeutic activity to enhance mobility, body mechanics, employability, coordination, and sensory motor integration.

Time Frames for Functional Activities Frequency 1 to 5 times per week.

Maximum Duration 8 weeks.

d. Gait Training: indications include the need to promote normal gait pattern with assistive devices and/or to reduce risk of fall or loss of balance. This may include instruction in safety and proper use of assistive devices and gait instruction on uneven surfaces and steps (with or without railings).

Time Frames for Gait Training Time to Produce Effect 1 to 6 sessions.

Optimum Duration 2 weeks. Could be needed intermittently as changes in functional status occur.

Maximum Duration 1 month.

e. Mirror Therapy - Graded Motor Imagery: is a several week program that is accomplished through patient participation. It usually begins with limb laterality recognition, imagined motion, and mirror movements. Each phase gradually increases the number of repetitions. Therapy visits are once a week in the last phases, and the treatment is performed at home at least 30 minutes per day.

There is some evidence that mirror box therapy 30 minutes per day for 4 weeks is likely to reduce pain in CRPS. Therapy usually lasts 4-6 weeks for training and oversight. Most of the program is accomplished through patient participation at home. Time to produce effect is not known.

Evidence Statements Regarding Mirror Therapy - Graded Motor Imagery Mirror box therapy 30 minutes per day for 4 weeks is likely to reduce pain in CRPS.

Randomized clinical trial, Systematic Review and Meta-Analysis Time Frames for Mirror Therapy – Graded Motor Imagery Training period 4 to 8 lessons.

Optimum Duration weeks with 2 follow-up visits.

f. Neuromuscular Re-education: is a generally accepted treatment. It is the skilled application of exercise with manual, mechanical, or electrical facilitation to enhance strength; movement patterns, neuromuscular response, proprioception, kinesthetic sense, coordination; education of movement, balance, and posture.

There is some evidence that there is a modest benefit from adding a back school to other treatments such as NSAIDs, massage, transcutaneous electrical nerve stimulation (TENS), and other physical therapy modalities. However, a recent adequate quality systematic review found no evidence for the effectiveness of back schools for treating chronic low back pain.

Indications include the need to promote neuromuscular responses through carefully timed proprioceptive stimuli, to elicit and improve motor activity in patterns similar to normal neurologically developed sequences, and to improve neuromotor response with independent control.

Evidence Statements Regarding Neuromuscular Re-education There is a modest benefit from adding a back school to other treatments such as NSAIDs, massage, transcutaneous electrical nerve stimulation (TENS), and other physical therapy modalities.

Systematic review of Time Frames for Neuromuscular Re-education Time to Produce Effect 2 to 6 treatments.

Optimum Duration 4 to 8 weeks.

Maximum Duration 8 weeks.

g. Stress Loading: is a generally accepted reflex and sensory integration technique involving the application of a compressive load and a carry load. It is carried out in a consistent, progressive manner and integrated as part of a home program. Use of this technique may increase symptoms initially, but symptoms generally subside with program consistency. This technique is used for upper as well as lower extremities Time Frames for Stress Loading Time to Produce Effect 3 weeks.

Frequency 2 to 3 times per week.

Optimum Duration 4 to 6 weeks and concurrent with an active daily home exercise program Maximum Duration 6 to 10 weeks.

h. Therapeutic Exercise: with or without mechanical assistance or resistance, may include isoinertial, isotonic, isometric, and isokinetic types of exercises. May also include alternative/complementary exercise movement therapy (with oversight of a physician or appropriate healthcare professional).

Indications include the need for cardiovascular fitness, reduced edema, improved muscle strength; improved connective tissue strength and integrity, increased bone density, promotion of circulation to enhance soft tissue healing, improvement of muscle recruitment, improved proprioception, and coordination, and increased range-of-motion are used to promote normal movement patterns.

Yoga may be an option for motivated patients with appropriate diagnoses.

Therapeutic exercise programs should be tissue specific to the injury and address general functional deficits as identified in the diagnosis and clinical assessment. Patients should be instructed in and receive a home exercise program that is progressed as their functional status improves. Upon discharge, the patient would be independent in the performance of the home exercise program and would have been educated in the importance of continuing such a program. Educational goals would be to maintain or further improve function and to minimize the risk for aggravation of symptoms in the future.

Available evidence supporting therapy mainly exists in the chronic low back literature.

Evidence Statements Regarding Therapeutic Exercise In the short, intermediate, and long-term, motor control exercises that emphasize the transversus abdominis and multifidi are at least as effective as other forms of exercise and manual therapy. They are possibly more effective than other minimal interventions in reducing pain and improving disability in patients for the treatment of chronic non-specific low back pain.

A 12 week course of treatment in the McKenzie method is at most modestly more effective than spinal manipulation of similar duration in reducing disability in patients with persistent (more than 6 weeks duration, mean = 95 weeks) nonspecific low back pain, although a clinically relevant difference was not apparent. The McKenzie method should not be utilized if there is severe nerve root involvement with motor, sensory, or reflex abnormality.

Pilates is more effective in reducing pain and improving disability compared with a minimal intervention at intermediate term follow-up, but Pilates is equally as effective as other forms of exercise in improving disability at short- or intermediate-term follow-up for the treatment of patients with chronic non-specific low back pain.

Exercise alone or part of a multi-disciplinary program results in decreased disability for workers with non-acute low back pain.

An unsupervised 12-week, periodized musculoskeletal rehabilitation program of weight training conducted 2, 3, or 4 days a week is effective at improving musculoskeletal strength and quality of life and at reducing pain and disability in untrained persons with chronic low back pain. The 4 days a week training volume is most effective. The volume (total number of reps) of PMR exercise prescribed is important.

Trunk balance exercises combined with flexibility exercises are more effective than a combination of strength and flexibility exercises in reducing disability and improving physical function in patients with chronic low back pain.

An exercise program which includes resistance training of the cervical and scapulothoracic muscles, combined with stretching of the same muscles, is likely to be beneficial for mechanical neck pain.

Cervicolscapular endurance exercises are beneficial for chronic cervicogenic headache.

General fitness exercises and upper extremity exercises are unlikely by themselves to be beneficial for mechanical neck pain and are therefore not recommended.

There is no significant difference in the effectiveness of an 12-week, 20 session comprehensive supervised exercise program and an unsupervised simple exercise program with advice for improvement in average pain intensity in the preceding week in people with a mild chronic whiplashassociated disorder even though both interventions resulted in small reductions of pain over 12 months.

A 4-month intervention for chronic neck pain patients containing pain education, specific exercises and graded activity training shows a significant effect, although clinically small, on improved physical and mental health related quality of life compared with controls receiving pain education alone. Good adherence increased the effect in favor of the exercise group. controlled superiority multicenter clinical 12 weeks of supervised high-dose exercise, spinal manipulative therapy, or low-dose home exercise with advice are all equally effective for reducing pain in the shortand long-term (one year) in those who have chronic low back pain. blinded randomized controlled trial Intensive exercise coupled with cognitive behavioral therapy is as effective for chronic un-operated low back pain as posterolateral fusion.

In the setting of non-specific chronic low back pain, patientcentered cognitive functional therapy from physical therapists produced superior outcomes for pain reduction and functional improvement compared with traditional manual therapy and exercise at post-intervention and at 12month follow-up.

There is no significant difference in the effectiveness of an 8-week supervised walking program, an evidence-based group exercise class, and usual physiotherapy for improvement in functional disability after 6 months for people with chronic low back pain even though all 3 interventions resulted in small, significant improvements in physical function, reduction of pain, quality of life, and fear avoidance over time.

Evidence Statements Regarding Yoga Yoga has small to moderate advantages over providing only a booklet in reducing low back pain and back-specific disability, but there is no evidence that yoga is superior to stretching and strengthening classes led by a licensed physical therapist.

In the setting of chronic low back pain, 8 weeks of 2 hour weekly group sessions of either mindfulness based stress reduction meditation program with yoga or Cognitive Behavioral Therapy results in small, significant improvements in physical function and reduction in pain compared to usual care at 26 weeks with no significant differences in outcomes between the 2 treatments.

Iyengar yoga, which avoids back bending, results in improved function and decreased chronic mechanical low back pain for up to 6 months. Instruction occurred 2 times per week for 24 weeks and was coupled with home exercise. One quarter of the participants dropped out.

In the setting of chronic pain, both an 8-week mindfulness based stress reduction meditation program with yoga and an 8-week multidisciplinary pain intervention program with exercise resulted in small, significant reductions in pain intensity and pain-related distress post intervention but with no significant differences in outcomes between the 2 programs.

Time Frames for Therapeutic Exercise Time to Produce Effect 2 to 6 treatments.

Frequency 2 to 5 times per week.

Optimum Duration 4 to 8 weeks and concurrent with an active daily home exercise program.

Maximum Duration 8 to 12 weeks of therapist oversight. Home exercise should continue indefinitely. Additional sessions may be warranted during periods of exacerbation of symptoms Yoga may be an option for motivated patients.

Time Frames for Yoga Time to Produce Effect 8 sessions Maximum Duration 48 sessions is the maximum expected duration i. Work Conditioning: This program is a work-related, outcome-focused, individualized treatment program. Objectives of the program include, but are not limited to, improvement of cardiopulmonary and neuromusculoskeletal functions (strength, endurance, movement, flexibility, postural control, and motor control functions), patient education, and symptom relief. The goal is for patients to gain full- or optimal-function and return-to-work. The service may include the timelimited use of modalities, both active and passive, in conjunction with therapeutic exercise, functional activities, general conditioning body mechanics, and lifting techniques re-training.

This program is usually initiated once re-conditioning has been completed but may be offered at any time throughout the recovery phase. It should be initiated when imminent return of a patient to modified- or full-duty is not an option, but the prognosis for returning the patient to work at completion of the program is at least fair to good.

Time Frames for Work Conditioning Time to Produce Effect 1 to 2 hours per day.

Frequency 2 to 5 visits per week.

Maximum Duration 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

j. Work Simulation: is a program where an individual completes specific workrelated tasks for a particular job and return to work. Use of this program is appropriate when modified duty can only be partially accommodated in the work place, when modified duty in the work place is unavailable, or when the patient requires more structured supervision. The need for work place simulation should be based upon the results of a functional capacity evaluation and/or jobsite analysis.

Time Frames for Work Simulation Time to Produce Effect 2 to 6 hours per day.

Frequency 2 to 5 visits per week.

Time Frames for Work Simulation Maximum Duration 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

16. THERAPY—PASSIVE: Most of the following passive therapies and modalities are generally accepted methods (unless otherwise noted) of care for a variety of work-related injuries. Passive therapy includes those treatment modalities that do not require energy expenditure on the part of the patient. They are principally effective during the early phases of treatment and are directed at controlling symptoms such as pain, inflammation and swelling and to improve the rate of healing soft tissue injuries. They should be used adjunctively with active therapies such as postural stabilization and exercise programs to help control swelling, pain, and inflammation during the active rehabilitation process.

Please refer to Section B.5, General Guideline Principles, Active Interventions. Passive therapies may be used intermittently as a practitioner deems appropriate or regularly if there are specific goals with objectively measured functional improvements during treatment; or if there are episodes of acute pain superimposed upon a chronic pain problem.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as "maximum”. Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care and co-morbidities may extend durations of care.

Having specific goals with objectively measured functional improvement during treatment can support extended durations of care. It is recommended that if after 6 to 8 visits no treatment effect is observed, alternative treatment interventions, further diagnostic studies or further consultations should be pursued.

The following passive therapies are listed in alphabetical order:

a. Continuous Passive Motion (CPM): is rarely indicated in CRPS but may occasionally be warranted if the patient shows signs of contracture despite active therapy.

Time Frames for Continuous Passive Motion Time to Produce Effect 4 to 6 treatments.

Frequency Varies, between 2 to 3 times per day and 1 time per week.

Optimum Duration 4 treatments.

Maximum Duration 6 treatments. Provide home unit with improvement.

b. Desensitization: is accomplished through sensory integration techniques.

Concurrent desensitization techniques are generally accepted as a treatment for CRPS. Home techniques using soft cloths of various textures, massage, and vibrators may be beneficial in reducing allodynia and similar sensory abnormalities.

Time Frames for Desensitization Time to Produce Effect 6 treatments.

Frequency 3 times per week and concurrent with home exercise program.

Optimum Duration 3 weeks with reinforcement of home program.

Maximum Duration 1 month.

c. Fluidotherapy: used primarily for desensitization and to facilitate increased active range-of-motion. Thermal heat conduction and convection is advantageous for vasodilation, muscle relaxation, and preparation for stress and activity (exercise).

Time Frames for Fluidotherapy Time to Produce Effect 3 treatments.

Frequency 3 times per week.

Optimum Duration 2 months.

Maximum Duration 2 months as a primary therapy or intermittently as an adjunct therapy to other procedures.

d. Paraffin Bath: Indications include the need to enhance collagen extensibility before stretching, reduce muscle guarding, and to prepare for functional restoration activities.

Time Frames for Paraffin Bath Time to Produce Effect 1 to 2 treatments.

Frequency 1 to 3 times per week as an adjunct treatment to other procedures. May use daily if available at home.

Optimum Duration 2 weeks.

Maximum Duration 3 to 4 weeks. If effective, purchase a home unit.

e. Superficial Heat Therapy: Superficial heat is a thermal agent applied to raise the body tissue temperature. It is indicated before exercise to elevate the pain threshold, alleviate muscle spasm, and promote increased movement. Heat packs can be used at home as an extension of therapy in the clinic setting.

Time Frames for Superficial Heat Therapy Time to Produce Effect Immediate.

Optimum Duration 2 weeks as primary or intermittently as an adjunct to other therapeutic procedures.

Maximum Duration 2 weeks. Home use as a primary modality may continue at the providers’ discretion.

I. THERAPEUTIC PROCEDURES – OPERATIVE

When considering operative intervention in CRPS management, the treating physician must carefully consider the inherent risk and benefit of the procedure. All operative intervention should be based on a positive correlation with clinical findings, the clinical course, and diagnostic tests. A comprehensive assessment of these factors should have led to a specific diagnosis of confirmed CRPS with positive identification of the pathologic condition. Operative treatment is indicated when the natural history of surgically treated lesions is better than the natural history for nonoperatively treated lesions.

Surgical procedures are seldom meant to be curative and should be employed in conjunction with other treatment modalities for maximum functional benefit. Functional benefit should be objectively measured and includes the following: ● Return-to-work or maintaining work status. ● Fewer restrictions at work or performing activities of daily living. ● Decrease in usage of medications prescribed for the work-related injury. ● Measurable functional gains, such as increased range-of-motion or a documented Education of the patient should include the proposed goals of the surgery, expected gains, risks or complications, and alternative treatment.

Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and be provided with appropriate counseling by the physician. If a treating physician recommends a specific smoking cessation program peri-operatively, this should be covered by the insurer. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels. The surgeon will make the final determination as to whether smoking cessation is required prior to surgery. Similarly, patients with uncontrolled diabetes are at increased risk of post-operative infection and poor wound healing. It is recommended that routine lab work prior to any surgical intervention include a hemoglobin A1c. If it is higher than the recommended range, the surgery should be postponed until optimization of blood sugars has been achieved.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work activities, and the patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partialand full-disability expected post-operatively.

1. NEUROSTIMULATION:

Spinal cord stimulation (SCS) is the delivery of low-voltage electrical stimulation to the spinal cord or peripheral nerves to inhibit or block the sensation of pain. The system uses implanted electrical leads and a battery powered implanted pulse generator (IPG).

Refer the Division’s Chronic Pain Disorder Medical Treatment Guideline for indications and evidence.

2. DORSAL ROOT GANGLION STIMULATOR:

Description: neurostimulator device implanted in the epidural space near to dorsal root ganglion – up to 4 leads may be placed. It is used for lower extremity CRPS pain.

There is good evidence that dorsal root ganglion (DRG) stimulation is non-inferior to conventional SCS with respect to pain relief for CRPS patients with lower extremity pain. There is some evidence that DRG stimulation is superior to SCS with respect to pain relief for up to 12 months after implantation. Neurological deficits related to stimulation with either device appear to be rare. 46% of the DRG patients had more serious complications compared to 26% for SCS.

Particular technical expertise is required to perform this procedure and is available in some neurosurgical, rehabilitation, and anesthesiology training programs and fellowships. Physicians performing this procedure must be trained in neurostimulation implantation and participate in ongoing training workshops on this subject, such as those sponsored by the Spine Intervention Society (SIS), North American Neuromodulation Society (NANS), or as sponsored by implant manufacturers.

Complications: Serious, extremely rare complications include spinal cord compression, paraplegia, epidural hematoma, and epidural hemorrhage. Other less serious complications / undesirable side effects include undesirable change in stimulation, seroma, CSF leakage, infection, erosion, allergic response, accidental dural puncture, hardware malfunction or equipment migration, pain at implantation site, loss of pain relief, chest wall stimulation, and other surgical risks. Neurological deficits related to stimulation with either device appear to be rare. 46% of the DRG patients had complications (mostly technical issues) compared to 26% for SCS.

Surgical Indications: Patients with established CRPS I or II with persistent, functionally limiting lower extremity pain. Candidates must have failed full conservative therapy including active therapy, medical management with at least 2 medications, and therapeutic injections. They must also have completed psychological treatment and evaluation and have a successful stimulator trial. Prior authorization is required. Habituation to opioid analgesics in the absence of a history of addictive behavior does not preclude the use of SCS. Patients with severe psychiatric disorders and issues of secondary gain or one or more primary risk factors are not candidates for the procedure, and the prognosis worsens as the number of secondary risk factors increases.

Approximately, one third to one half of patients who qualify for SCS can expect a substantial reduction in pain relief; however, it may not influence allodynia and hypesthesia. Patients’ expectations need to be realistic, and therefore, patients should understand that the intervention is not a cure for their pain but rather a masking of their symptomatology which might regress over time. Historically, there appears to be a likely benefit of up to 3 years with spinal cord stimulator. It may be similar with the DRG.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work, as well as possible complications. The patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

Informed decision making should be documented for all invasive procedures. This must include a thorough discussion of the pros and cons of the procedure and the possible complications as well as the natural history of the identified diagnosis. Since many patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and be provided with appropriate counseling by the physician. If a treating physician recommends a specific smoking cessation program peri-operatively, this should be covered by the insurer. Typically, the patient should show some progress toward cessation at about 6 weeks. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels. The surgeon will make the final determination as to whether smoking cessation is required prior to surgery. Patients with demonstrated success may continue the program up to 3 months or longer if needed based on the operative procedure. Refer to Section G.10.j, Smoking Cessation Medications and Treatment, in the Division’s Chronic Pain Disorder Medical Treatment Guideline for further details.

DRG may be indicated in a subset of patients who have confirmed CRPS, have burning pain in a distribution amenable to stimulation coverage, and have pain at night not relieved by position.

The extremity pain should account for at least 50% or greater of the overall leg and back pain experienced by the patient.

Prior to the stimulator trial, a comprehensive psychiatric or psychological evaluation, for a chronic pain evaluation. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for more information. This evaluation should include a standardized detailed personality inventory with validity scales (e.g., MMPI-2, MMPI-2-RF, or PAI); pain inventory with validity measures (e.g., BHI 2, MBMD); clinical interview and complete review of the medical records. The psychologist or psychiatrist performing these evaluations should not be an employee of the physician performing the implantation. This evaluation must be completed, with favorable findings, before the screening trial is scheduled. Before proceeding to a spinal stimulator trial, the evaluation should find the following:

• No indication of falsifying information;

• No indication of invalid results on testing;

• No primary psychiatric risk factors or “red flags” (e.g., psychosis, active suicidality, severe depression, or addiction). (Note that tolerance and dependence to opioid analgesics are not addictive behaviors and do not preclude implantation);

• A level of secondary risk actors or “yellow flags” (e.g., moderate depression, job dissatisfaction, dysfunctional pain conditions) judged to be below the threshold for compromising the patient’s ability to benefit from neurostimulation.

• The patient is cognitively capable of understanding and operating the neurostimulation control device;

• The patient is cognitively capable of understanding and appreciating the risks and benefits of the procedure;

• The patient is familiar with the implications of having an implant, can accept the complications, potential disfigurement, and effort it takes to maintain the device;

• The patient is cognitively capable of understanding the course of injury both with and without neurostimulation;

• The patient has demonstrated a history of motivation in and adherence to prescribed treatments;

• The patient understands the work related restrictions that may occur with placement of the stimulator. All reasonable surgical and non-surgical treatment has been exhausted;

• The topography of pain and its underlying pathophysiology are amenable to stimulation coverage (the entire painful area has been covered); and • A successful neurostimulation screening test of at least 5 to 7 days.

For a neurostimulation screening test, a temporary lead is implanted at the level of pain and attached to an external source to validate therapy effectiveness. A screening test is considered successful if the patient meets both of the following criteria: (a) experiences a 50% decrease radicular or CRPS in pain, which may be confirmed by visual analogue scale (VAS) or Numerical Rating Scale (NRS), and (b) demonstrates objective functional gains or decreased utilization of pain medications.

Objective, measurable, functional gains must be evaluated by an independent occupational therapist, not affiliated with the physician performing the screening or the implant of the stimulator, and/or physical therapist and the primary treating physician prior to and before discontinuation of the trial. Functional gains may include: standing, walking, positional tolerance, upper extremity activities, increased social participation, or decreased medication use.

Contraindications:

• Unsuccessful trial: inability to obtain objective, documented, functional improvement, or reduction of pain.

• Those with cardiac pacemakers should be evaluated on an individual basis as some may qualify for surgery.

• Patients who are unable to properly operate the system.

• Patients who are anti-coagulated and cannot be without anticoagulation for a few days (e.g., patients with artificial heart valves).

• Patients with frequent severe infections.

• Patients for whom a future MRI is likely.

Operative Treatment: Implantation of stimulating leads connected by extensions to either an implanted neurostimulator or an implanted receiver powered by an external transmitter. The procedure may be performed either as an open or a percutaneous procedure, depending on the presence of epidural fibrosis and the anatomical placement required for optimal efficacy. During the final procedure, the patient must be awakened to establish full coverage from the placement of the lead. One of the most common failures is misplaced leads. Functional improvement is anticipated for up to 3 years or longer when objective functional improvement has been observed during the time of neurostimulation screening exam based on spinal cord stimulator studies.

Post-operative Considerations: MRI may be contraindicated depending on the model and implant location.

Work restrictions postplacement include no driving when active paresthesias are present. Thus, use of potentially dangerous or heavy equipment while the simulator is active is prohibited. The physician may also limit heavy physical labor.

Post-operative Therapy: Active and/or passive therapy should be employed to improve function.

Implantable stimulators will require frequent monitoring such as adjustment of the unit and replacement of batteries. Estimated battery life of SCS implantable devices is usually 3 years; however, newer systems may last longer. For the DRG system, expected duration of the implanted batter is about 5 years.

Evidence Statements Regarding Dorsal Root Ganglion Stimulator Dorsal root ganglion stimulation is non-inferior to conventional spinal cord stimulation with respect to pain relief for CRPS patients with lower extremity pain.

Randomized noninferiority clinical trial Dorsal root ganglion stimulation is superior to spinal cord stimulation with respect to pain relief for up to 12 months after implantation. Neurological deficits related to stimulation with either device appear to be rare. 46% of the DRG patients had more serious complications compared to 26% for SCS.

Randomized noninferiority clinical trial 3. PERIPHERAL NERVE STIMULATION:

There are no randomized controlled studies for this treatment. This modality should only be employed with a clear nerve injury or when the majority of pain is clearly in a nerve distribution in patients who have completed 6 months of other appropriate therapy including the same pre-trial psychosocial evaluation and treatment as are recommended for spinal cord stimulation. A screening trial should take place over 3 to 7 days and is considered successful if the patient meets both of the following criteria: (a) experiences a 50% decrease in pain, which may be confirmed by Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) and (b) demonstrates objective functional gains or decreased utilization of pain medications. Objective, measurable, functional gains must be evaluated by an independent occupational therapist and/or physical therapist and the primary treating physician (who did not place the nerve stimulator) prior to and before discontinuation of the trial. It may be used for proven occipital, ulnar, median, and other isolated nerve injuries.

4. INTRATHECAL DRUG DELIVERY:

Not generally recommended. Requires prior authorization. Due to conflicting studies in this population and complication rate for long-term use, it may be considered only in very rare occasions when dystonia and spasticity are dominant features or when pain is not able to be managed using any other non-operative treatment.

Refer the Division’s Chronic Pain Disorder Medical Treatment Guideline for indications.

5. SYMPATHECTOMY: including use of phenol or radiofrequency.

Description: destruction of part of the sympathetic nervous system, which is not generally accepted or widely used. Long-term success with this pain relief treatment is poor. Expected duration of pain relief is 3 to 5 months. There is currently a lack of evidence supporting long-term pain relief, and increased pain can result. This procedure is generally not recommended and requires prior authorization. It may be considered for patients who are unable to return to normal activities of daily living when using the other non-operative treatments (as listed in Section G, Non-operative Procedures) and who meet the strict indications below.

The practice of surgical and chemical sympathectomy for neuropathic pain and CRPS is based on very little high quality evidence. Sympathectomy should be used cautiously in clinical practice, in carefully selected patients, and probably only after failure of other treatment options. In these circumstances, establishing a clinical register of sympathectomy may help to inform treatment options on an individual patient basis.

Indications: single extremity CRPS I with a significant amount of sympathetically mediated ischemia and distal pain only. The procedure should not be done if the proximal extremity is involved. Local anesthetic stellate ganglion block or lumbar sympathetic block consistently gives 90 to 100% relief each time a technically good block is performed and results in a temperature difference between the affected and the unaffected extremity of at least 1°C. The procedure may be considered for individuals who have limited duration of relief from blocks. Permanent neurological complications are common.

6. AMPUTATION:

Amputation is not recommended in CRPS except in cases of gangrene or frequent/recurrent limb infections with the risk for osteomyelitis or systemic sepsis.

J. MAINTENANCE MANAGEMENT

Successful management of chronic pain conditions results in fewer relapses requiring intense medical care. Failure to address long-term management as part of the overall treatment program may lead to higher costs and greater dependence on the health care system. Management of CRPS continues after the patient has met the definition of maximum medical improvement (MMI).

MMI is declared when a patient’s condition has plateaued and an authorized treating physician believes no further medical intervention is likely to result in improved function. Patients with either clinical or confirmed CRPS may qualify for an impairment when functional deficits exist related to CRPS physiology which are distinct from any other related conditions. When the patient has reached MMI, a physician must describe in detail the maintenance treatment.

Maintenance care in CRPS requires a close working relationship between the carrier, the providers, and the patient. Providers and patients have an obligation to design a cost-effective, medically appropriate program that is predictable and allows the carrier to set aside appropriate reserves. Carriers and adjusters have an obligation to assure that medical providers can design medically appropriate programs. Designating a primary physician for maintenance management is strongly recommended.

Maintenance care will be based on principles of patient self-management. When developing a maintenance plan of care, the patient, physician, and insurer should attempt to meet the following goals:

• Maximal independence will be achieved through the use of home exercise programs or exercise programs requiring special facilities (e.g., pool, health club) and educational programs;

• Modalities will emphasize self-management and self-applied treatment;

• Management of pain or injury exacerbations will emphasize initiation of active therapy techniques and may occasionally require anesthetic injection blocks;

• Dependence on treatment provided by practitioners other than an authorized treating physician will be minimized;

• Reassessment of the patient’s function must occur regularly to maintain daily living activities and work function; and • Patients will understand that failure to comply with the elements of the self-management program or therapeutic plan of care may affect consideration of other interventions.

1. FUNCTIONAL TESTS: It is recommended that valid functional tests are used with treatments to track efficacy. Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline for Specific Maintenance Interventions and Parameters, including home exercise programs and exercise equipment, exercise programs requiring special facilities, patient education management, psychological management, non-opioid medication management, therapy management, and purchase or rental of durable medical equipment.

2. VITAMIN C: There is some evidence that Vitamin C 500mg taken for 50 days after a wrist fracture may help to prevent CRPS. It may be useful to prescribe vitamin C to patients who historically have had or currently have CRPS if they suffer a fracture in order to prevent exacerbation of CRPS.

Evidence Statements Regarding Vitamin C Vitamin C 500mg taken for 50 days after a wrist fracture may help to prevent CRPS.

3. OPIOID MEDICATION MANAGEMENT: In very selective cases, scheduled opioids may prove to be the most cost effective means of ensuring the highest function and quality of life; however, inappropriate selection of these patients may result in a high degree of iatrogenic illness including addiction and drug overdose. A patient should have met the criteria in the opioids section of this guideline before beginning maintenance opioids.

Laboratory or other testing may be appropriate to monitor medication effects on organ function. The following management is suggested for maintenance opioids:

• The medications should be clearly linked to improvement of function, not just pain control. All follow-up visits should document the patient’s ability to perform routine functions satisfactorily. Examples include the abilities to perform: work tasks, drive safely, pay bills or perform basic math operations, remain alert and upright for 10 hours per day, or participate in normal family and social activities. If the patient is not maintaining reasonable levels of activity the patient should usually be tapered from the opioid and tried on a different long-acting opioid.

• A lower risk opioid medication regimen is defined as less than 50 MME per day.

This may minimally increase or decrease over time. Dosages will need to be adjusted based on side effects of the medication and objective function of the patient. A patient may frequently be maintained on non-opioid medications to control side effects, treat mood disorders, or control neuropathic pain; however, only one long-acting opioid and one short-acting opioid for rescue use should be prescribed. Buccally absorbed opioids other than buprenorphine are not appropriate for these non-malignant pain patients. Transdermal opioid medications are not recommended, other than buprenorphine.

• All patients on chronic opioid medication dosages need to sign an appropriate opioid contract with their physician for prescribing the opioids.

• The patient must understand that continuation of the medication is contingent on their cooperation with the maintenance program. Use of non-prescribed drugs may result in tapering of the medication. The clinician should order random drug testing at least annually and when deemed appropriate to monitor medication compliance.

• Patients on chronic opioid medication dosages must receive them through one prescribing physician.

Time Frames for Opioid Medication Management Maintenance Duration 12 visits within a 12 month period to review the opioid plan. Laboratory and other monitoring, as appropriate.

4. INJECTION THERAPY

a. Sympathetic Blocks: These injections are considered appropriate if they increase function for a minimum of 4 to 8 weeks. Maintenance blocks are combined with and are enhanced by the appropriate neuro-pharmacological medication(s) and an active self-management exercise program. It is anticipated that the frequency of the maintenance blocks may increase in the cold winter months or with stress.

Time Frames for Sympathetic Blocks Maintenance Duration Not to exceed 4 to 6 blocks in a 12 month period for a single extremity and to be separated by no less than 4 week intervals. Increased frequency may need to be considered for multiple extremity involvement or for acute recurrences of pain and symptoms. For treatment of acute exacerbations, consider 2 to 6 blocks with a short time interval between blocks. A positive result would include a return to baseline function as established at MMI, return to increased work duties, and measurable improvement in physical activity goals including return to baseline after an exacerbation. Injections may only be repeated when these functional and time goals are met and verified by the designated primary physician. Patient completed functional questionnaires such as those recommended by the Division as part of Quality Performance and Outcomes Payments (QPOP, see Rule 18-8) and/or the Patient Specific Functional Scale can provide useful additional confirmation. _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 18: Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 08 Rule 17, Exhibit 8 - CERVICAL SPINE INJURY MEDICAL TREATMENT GUIDELINES {#sec-7-ccr-1101-3-r17-ex-08 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 08}

DEPARTMENT OF LABOR AND EMPLOYMENT

WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

RULE 17, EXHIBIT 8 CERVICAL SPINE INJURY MEDICAL TREATMENT GUIDELINES 7 CCR 1101-3 Rule 17 - Exhibit 8 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

Section 1. Guidelines Introduction

Section 1.a. Context and Use This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of guidelines for physicians/providers treating individuals who qualify as injured workers with cervical spine injuries under the Colorado Workers’ Compensation Act.

Although the primary purposes of this document for practitioners are advisory and educational, these guidelines are enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from these guidelines, as individual cases dictate. Therefore, these guidelines are not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip or overlook any sections.

Section 1.b. Application of the Guidelines The Division provides procedures to implement medical treatment guidelines (MTGs) and to foster communication to resolve disputes among the provider, payer, and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the Office of Administrative Courts.

Section 1.c. Guidelines Recommendations and Inclusion of Medical Evidence All recommendations are based on available evidence and/or consensus judgment. A Division staff methodologist (MD, MSPH) researched and adopted literature critique criteria for certain study designs (e.g., randomized controlled trial [RCT]). Literature critiques were performed in a manner congruent with national standards and were completed independent of the multidisciplinary task force group that drafted initial recommendations. The methodology is described in detail on the Division's MTGs page at cdle.colorado.gov/medical-treatment-guidelines. Please also refer to the Division’s website for evidence tables and study critiques that provide details on the studies used to develop the evidence statements.

When possible, guidelines recommendations link to evidence tables that include the level of evidence supporting the treatment recommendation. An evidence summary is included in tables where multiple evidence statements address the same topic. Some of the evidence tables include literature on low back pain when there is a presumed physiologic similarity for neck pain. It is generally recognized that early reports of a positive treatment effect are frequently weakened or overturned by subsequent research.

When interpreting medical evidence statements in the guidelines, the following apply:

• “Some evidence” means the recommendation considered at least 1 adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the intervention’s effect.

• “Good evidence” means the recommendation considered the availability of multiple adequate scientific studies or at least 1 relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the intervention’s effect.

• “Strong evidence” means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the intervention’s effect.

Recommendations not linked to evidence tables are based on consensus; consensus means the judgment of experienced professionals based on general medical principles.

All recommendations in the guidelines are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guidelines as “not recommended.”

Section 1.d. Recommended Citation for This Document Colorado Division of Workers' Compensation. (2021). Cervical Spine Injury Medical Treatment Guidelines. Colorado Department of Labor and Employment. https://cdle.colorado.gov/medicalproviders/medical-treatment-guidelines.

Section 1.e. Glossary of Abbreviations • ACDF - Anterior cervical discectomy and fusion • ADLs - Activities of daily living • BBHI 2 - Brief Battery for Health Improvement, 2nd Edition • BCIA - Biofeedback Certification International Alliance • BDI-II - Beck Depression Inventory-II • BHI-MV - Behavioral Health Index-Multimedia Version • BMP - Bone morphogenetic protein • CBT - Cognitive behavioral therapy • CDA - Cervical disc arthroplasty • CES-D - Center for Epidemiological Studies Depression Scale • COX-2 - Cyclooxygenase-2 • CT - Computed tomography • DRAM - Distress and Risk Assessment Method • DSM - Diagnostic and Statistical Manual of Mental Disorders • ESI - Epidural steroid injection • FCE - Functional capacity evaluation • G6PD - Glucose-6-phosphate-dehydrogenase • GAD-7 - Generalized Anxiety Disorder Scale • GI - Gastrointestinal • H2-blocker - Histamine H2-receptor antagonists • MME - Morphine milligram equivalents • MMI - Maximum medical improvement • MRI - Magnetic resonance imaging • MTGs - Medical treatment guidelines • NMES - Neuromuscular electrical stimulation • NRS - Numeric rating scale • NSAIDs - Non-steroidal anti-inflammatory drugs • ODI - Oswestry Disability Index, or Oswestry Low Back Pain Disability Questionnaire • ORT - Opioid Risk Tool • PDMP - Prescription Drug Monitoring Program • PEEK - Polyetheretherketone • PENS - Percutaneous electrical nerve stimulation • PHQ - Patient Health Questionnaire • PRIME-MD - Primary Care Evaluation for Mental Disorders • QPOP - Quality Performance and Outcomes Payments • RCT - Randomized controlled trial • RF - Radiofrequency • rhBMP - Recombinant human bone morphogenetic protein • rhBMP-2 - Recombinant human bone morphogenetic protein-2 • ROM - Range of motion • SF-12 - 12-item Short Form Health Survey • SF-36 - 36-item Short Form Health Survey • SI - Sacroiliac • SNRI - Serotonin norepinephrine reuptake inhibitor • SSRI - Selective serotonin reuptake inhibitors • TDR - Total disc replacement • TENS - Transcutaneous electrical nerve stimulation • VAS - Visual analogue scale

Section 2. General Guidelines Principles This document should be interpreted within the parameters of the following guidelines principles that may lead to more optimal medical and functional outcomes for injured workers.

Section 2.a. Education Education of the individual and family and/or support system, as well as the employer, insurer, policy makers, and the community, should be the primary emphasis in the treatment of cervical spine injury and disability. Currently, practitioners often think of education last, after medications, manual therapy, and surgery. Practitioners must implement strategies to educate individuals with cervical spine injury, employers, insurance systems, policy makers, and the community as a whole. An education-based paradigm should always start with inexpensive communication that provides recovery, function-focused, patient-centered, and evidence-based information to the individual with cervical spine injury. More indepth education is currently a component of treatment regimens that employ functional, restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention. Facilitation through language interpretation, when necessary, is a priority and part of the medical care treatment protocol.

Section 2.b. Shared Decision Making Providers should implement shared decision making as a crucial element of a successful treatment plan.

Patients, with the assistance of their health care practitioner and support system, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, psychologists, physical therapists, and other members of the health care team play an integral role in shared decision making and achievement of functional goals. Patient education and shared decision making should facilitate selfmanagement of symptoms and prevention of further injury.

Section 2.c. Return to Work Return to work is therapeutic, assuming the work is not likely to aggravate the basic problem. The practitioner must provide specific written physical limitations, and the patient should never be released to work with non-specific and vague descriptions such as “sedentary” or “light duty.” The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, carrying, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, repetitive motion tasks, sustained grip, tool usage, and vibration factors. Even if there is residual chronic pain, return to work is not usually contraindicated. The practitioner should understand all of the physical demands of the patient’s job position before returning the patient to full duty and should request clarification of the patient’s job duties. Clarification should be obtained from the employer or, if necessary, including, but not limited to, an occupational health nurse, occupational therapist, vocational rehabilitation specialist, or an industrial hygienist.

Section 2.d. Treatment Parameter Duration Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Duration will be impacted by the individual’s adherence, as well as availability of services. Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

Section 2.e. Active Interventions Active interventions emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, are generally utilized over passive interventions, especially as treatment progresses.

Generally, passive interventions are viewed as a means to facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

Section 2.f. Active Therapeutic Exercise Program Exercise program goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

Section 2.g. Positive Patient Response Positive results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to: positional tolerances, range of motion (ROM), strength, endurance, activities of daily living (ADLs), ability to function at work, cognition and communication, psychological behavior, and efficiency/velocity measures that can be quantified. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation. Anatomic correlation must be based on objective findings. Patient completed functional questionnaires can provide useful additional confirmation, such as those recommended by the Colorado Division of Workers’ Compensation (Division) Quality Performance and Outcomes Payments program (QPOP, see Rule 18), the Patient-Specific Functional Scale, or other validated function scales.

Section 2.h. Re-evaluation of Treatment Effectiveness Re-evaluation should occur every 3 to 4 weeks or within the time to produce effect for a given treatment.

Treatment should be modified or discontinued if there is no evidence of positive results. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results. Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

Section 2.i. Surgical Interventions Surgery should be contemplated within the context of expected functional outcome and not purely for the

purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic conditions.

Section 2.j. 6-month Time Frame The prognosis drops precipitously for returning an injured worker to work once they have been temporarily totally disabled for more than 6 months. The emphasis within these guidelines is to move patients along a continuum of care and return to work within a 6-month time frame, whenever possible. It is important to note that time frames may be less pertinent for injuries that do not involve work-time loss or are not occupationally related.

Section 2.k. Delayed Recovery For patients who are failing to make expected progress 6 to 12 weeks after initiation of treatment of an injury, strongly consider a psychological evaluation, if not previously provided, as well as initiating interdisciplinary rehabilitation treatment and vocational goal setting. The Division recognizes that 3 to 10% of all industrially injured patients will not recover within the timelines outlined in this document, despite optimal care. Such individuals may require treatments beyond the timelines discussed within this document, but such treatment requires clear documentation by the authorized treating practitioner focusing on objective functional gains afforded by further treatment and impact upon prognosis.

Section 2.l. Post Maximum Medical Improvement (MMI) Care Maximum medical improvement (MMI) should be declared when a patient’s condition has plateaued to the point where the authorized treating physician no longer believes further medical intervention is likely to result in improved function. However, some patients may require treatment after MMI has been declared in order to maintain their functional state. The recommendations in these guidelines are for pre- MMI care and are not intended to limit post-MMI treatment.

Section 3. Overview of Care Introduction. Neck pain is a common condition in the adult population. Neck pain in the working population most commonly occurs from cervical strain injuries, whiplash associated disorder, or degenerative conditions aggravated by work. Most individuals with neck pain without neurological findings will recover with therapy and self-management without invasive measures. These guidelines outline a biopsychosocial approach to neck pain care and integrate biological, psychological, and social elements.

Significant trauma resulting in fractures and/or spinal cord dysfunction are not covered in these guidelines. Early imaging and surgical evaluation should be reserved for more severe issues outlined in recommendation 1. Most patients will respond to conservative care as outlined in recommendations 2 through 5 and will not require invasive treatment. Additional interventions, as indicated for less common cases, are covered by the remaining recommendations. Refer to the Mild Traumatic Brain Injury Medical Treatment Guidelines (MTGs) for information on cervicogenic headache.

Recommendation 1. Early imaging and surgical evaluation is required for patients with signs of myelopathy, progressive neurologic deficits, upper extremity weakness, or epidural abscess.

Recommendation 2. Initial conservative management without imaging is strongly recommended for neck pain patients who do not meet the criteria in recommendation 1, focusing on the following:

• education that prolonged periods of immobility are detrimental, • education on the positive impact of movement on recovery, • appropriate use of over the counter medications, and • application of ice or heat.

Recommendation 3. Cervical immobilization as the sole treatment is not recommended for nonspecific neck pain when there is no clinical concern for instability.

Recommendation 4. Close follow-up and subsequent neurologic examinations are required for patients with radicular neck pain who do not meet the criteria in recommendation 1 or recommendation 8.

Recommendation 5. Participation in self-directed exercise or an active therapy program that includes core stabilization, strengthening, and endurance is recommended as a principal neck pain treatment. See the Active Therapies section.

Recommendation 6. Individuals with barriers to functional recovery may benefit from an interdisciplinary approach to care. See the Diagnosis section.

Recommendation 7. Referral for epidural steroid injection (ESI) evaluation within 6 weeks of pain onset is permitted when all of the following criteria are met:

• function-limiting pain in arms greater than the neck that interferes with return to work, activities of daily living (ADLs), and/or participation in active therapy; and • positive correlation among clinical findings, the clinical course, and diagnostic tests.

See the Epidural Steroid Injection section.

Recommendation 8. Referral for discectomy evaluation within 6 weeks of pain onset is permitted when all of the following criteria are met:

• function-limiting pain in arms greater than the neck that interferes with return to work, ADLs, and/or participation in active therapy;

• physical exam findings of abnormal reflexes, motor weakness, or radicular sensory deficits;

• findings on magnetic resonance imaging (MRI) indicate impingement of nerves or the spinal cord corresponding to reproducible physical exam findings; and • the observed pathology is amenable to surgical intervention.

See the Discectomy section.

Recommendation 9. Referral for spinal injection is indicated when all of the following criteria are met:

• positive correlation among clinical findings, the clinical course, and diagnostic tests;

• positive functional response to a diagnostic injection, if required;

• persistent functional impairment despite engagement in 6 weeks of active therapy; and confounding psychosocial risk factors have been screened for and clinically addressed. See the See the Injections section.

Recommendation 10. Referral of patients with cervical radiculopathy for surgical evaluation is recommended when confirmatory imaging studies specifically correlate with clinical findings, demonstrating nerve root compression or spinal cord compromise, and any of the following are present:

• acute, incapacitating pain with progressive neurologic deficits;

• persistent or recurrent arm pain with functional limitations unresponsive to 6 weeks of treatment;

• progressive neurologic deficits; or • static neurologic deficit with significant radicular pain.

Evidence Tables. See related sections for evidence tables.

Section 4. Diagnosis Introduction. Initial and follow-up diagnostic evaluation of neck pain may include a clinical history, physical examination, laboratory studies, imaging studies, and electrodiagnostic studies. Please see specific sections for diagnostic injections.

Initial Diagnostic Studies Requirements.

Recommendation 11. A detailed history of pain onset, past medical history, and a detailed neurologic examination are required at the initial neck pain evaluation (tables 1, 2).

Recommendation 12. Medical causation must establish that neck pain is a result of a specific injury, an aggravation of an underlying condition, or a previously asymptomatic condition made symptomatic by a work-related exposure (table 3).

Recommendation 13. Initial functional assessment is strongly recommended. See the Appendix Functional Screens.

Recommendation 14. A psychological screen is encouraged as a routine part of clinical care and is required as soon as any of the following barriers to functional recovery are identified (Appendix Psychological Screens):

• limited patient engagement in recovery, • activity avoidance or catastrophization due to pain, • avoidance of essential recovery activities, • inappropriate expression of a sense of injustice, • exaggeration of symptoms/situation, • low expectations of recovery, • ineffective coping skills, or • loss of vocational connection.

Individuals with barriers to functional recovery may benefit from an interdisciplinary approach to care (table 4).

Recommendation 15. Imaging studies are recommended if the patient is 55 years or older, if there is a

history of significant trauma, if there is persistent or unexplained pain after 6 weeks, or if there is concern for any of the following:

• fracture, • instability, • occult cancer, • weakness, • pain worse at rest, • epidural abscess, or • myelopathy.

Documentation shall include the specific findings under investigation and how the imaging test will influence treatment.

Recommendation 16. Dynamic fluoroscopy is permitted in the initial or follow-up evaluation of cervical spine trauma and in select cases for comprehensive evaluation of neck and radicular pain.

Recommendation 17. When clinically indicated, early laboratory studies may be ordered to evaluate for systemic illness, infection, neoplasia, underlying rheumatologic, or connective tissue disorder.

Follow-Up Diagnostic Studies Requirements.

Recommendation 18. A formal psychological or psychosocial evaluation is required for patients not making expected progress within 6 weeks of injury and whose subjective symptoms do not correlate with objective signs and tests. See the Behavioral and Psychological Interventions section.

Recommendation 19. Magnetic resonance imaging (MRI) is indicated when there is concern for myelopathy, masses, infection, metastatic disease, or cord contusion. MRI is recommended for patients who have responded poorly to initial care and there is clinical suspicion for disc herniation or nerve root compression. Contrast MRI can be used when there is a history of cervical surgery or if there is possible infection, malignancy, or tumor (table 5).

Recommendation 20. Computed tomography (CT) scan is permitted to better visualize bone and to further evaluate masses and suspected fractures not clearly identified on radiographic evaluation.

Recommendation 21. Myelography is a diagnostic option when:

• CT or MRI are contraindicated or not available, and • when other tests have proven non-diagnostic in the surgical candidate.

Recommendation 22. Radioisotope bone scanning is permitted when there is clinical suspicion for metastatic or primary bone tumors, occult or stress fractures, osteomyelitis, infection, or other inflammatory lesions.

Recommendation 23. Discography is not recommended for use in evaluating cervical spine conditions.

See the Spinal Fusion section.

Recommendation 24. Electromyography and nerve conduction studies are recommended for patients with suspected neural involvement and persistent symptoms that are unresponsive to initial conservative treatment.

Recommendation 25. Somatosensory evoked potentials may be used to evaluate myelopathy, neurogenic bladder, and sexual dysfunction, but it is not recommended to identify radiculopathy.

Recommendation 26. Surface electromyography and current perception threshold evaluation are not recommended.

Table 1.

Evidence Table: Self-reported Body Pain Diagrams in Describing Neck Pain Pain diagrams, either manual or computerized, reliably identify pain location.

Using a computer program (electronic body surface estimation method) to measure pain distribution was found to have both high intra- and interexaminer reliability in patients with chronic nonmalignant pain.

A body diagram, in which the patients use a pencil to shade in painful areas of the body, has acceptable reliability for designating the regions in which their pain is felt.

Table 2.

Evidence Table: Physical Examination Findings and Neck Pain The findings on physical examination may be clinically suggestive of neurologic compression.

Spurling’s test, traction/neck distraction, and Valsalva demonstrate reasonable specificity. With high suspicion for nerve root compression, they are helpful to clinically rule in radiculopathy.

Table 2 continued.

Evidence Table: Physical Examination Findings and Neck Pain The upper limb tension test should be done with finger and wrist extension.

When performed in this manner and with a low index of clinical suspicion, a negative upper limb tension test may be helpful to rule out radiculopathy.

Table 3.

Evidence Table: Occupational Risk Factors for Neck Pain Neck pain is caused by a combination of workplace factors (e.g., poor workstation ergonomic design, work posture, and workplace activities) and personal factors (e.g., age, previous musculoskeletal pain, and low physical fitness). Prolonged neck flexion while performing repetitive or precision work and performing tasks that require sustained trapezium activity may result in neck pain.

Neck pain in the workplace is multifactorial, and a combination of workplace and individual factors is necessary to cause neck pain.

Repetitive or precision work, accompanied by prolonged neck flexion, are likely risk factors for neck pain in the workplace.

Sustained trapezius muscle activity predicts later neck and shoulder pain. Cohort Table 4.

Evidence Table: Interdisciplinary Neck Pain Care Interdisciplinary programs that include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability.

Table 5.

Evidence Table: Imaging Findings and Neck Pain Imaging findings occur frequently in asymptomatic patients and therefore are a poor indicator for clinically significant pathology.

Table 5 continued.

Evidence Table: Imaging Findings and Neck Pain The majority of workers over 60 show evidence of disc degeneration on cervical spine MRI, and posterior disc protrusions are present in the majority of asymptomatic workers over 40 years of age.

Asymptomatic subjects of all ages frequently show common degenerative changes in the cervical and lumbar spine as seen on MRIs. These changes are more common with increasing age. The cervical and lumbar spine are equally affected, suggesting that disc degeneration occurs in tandem in the lumbar and cervical spine.

Section 5. Return to Activity and Work Considerations Introduction. Return to activity and/or work-related activities is a primary therapeutic component of neck pain management and rehabilitation. There are special tests performed as a part of a skilled assessment of the patient’s capacity to return to work, their strength capacities, and/or physical work demand classifications and tolerance. Terminology relevant to the activity and return to work discussion includes the following:

• computer enhanced evaluations, • immobility, • functional capacity evaluation (FCE), • jobsite evaluation or analysis, and • work tolerance screenings.

Communication among the patient, treating provider, employer, and insurer is essential for successful return to work efforts. Refer to the Active Therapies section for work conditioning and work simulation.

Absolute and Relative Contraindications to Return to Work.

• Absolute and relative contraindications include performance of job activities that pose a medical risk to the recovering worker.

Side Effects and Adverse Events Related to Return to Work.

• Side effects and adverse events include a temporary increase in discomfort or muscle soreness when correcting deconditioning after time away from typical tasks.

Recommendation 27. A job history interview should be completed at the time of the initial evaluation. A thorough job history generally includes:

• duties and demands of job held at time of injury;

• duties and demands of current job, if different;

• stressors; and • cognitive and social issues, with treatment incorporated into the plan of care.

Recommendation 28. A formal job description for the injured worker is required to identify physical demands at work and to assist in the creation of modified duty.

Recommendation 29. Ergonomic or adaptive equipment, therapeutic breaks, and workplace interventions are recommended to maintain employment (table 6).

Recommendation 30. Nurse case management is recommended in medically complex cases to facilitate communication between the primary provider, referral providers, insurer, employer, and employee. The patient may decline nurse case management services.

Workplace Tests Requirements.

Recommendation 31. A jobsite evaluation is permitted to fully understand the physical demands of a working day; this information can be used when determining medical causation, the need for ergonomic changes, and/or ability to return to work.

Recommendation 32. A work tolerance screening is recommended to determine a patient’s tolerance for performing a specific job activity or task from a cardiovascular, postural tolerance, and physical fitness perspective.

Recommendation 33. An FCE may be used to determine an individual’s capacity to work. A formal job description and jobsite evaluation, if performed, should be made available to the FCE evaluator prior to having the FCE performed.

Recommendation 34. Follow-up evaluation with the treating therapist and/or the treating physician is required between 1 to 3 days after the FCE to assess the patient’s status.

Recommendation 35. FCEs are not recommended as the sole tool for the development of temporary or permanent work restrictions (table 7).

Recommendation 36. Performance during FCEs cannot be used as the sole criteria in diagnosing malingering.

Recommendation 37. Computer-enhanced strength evaluations or performance on FCEs cannot be used alone to determine return to work restrictions.

Return to Work Requirements.

Recommendation 38. It is strongly recommended that the patient return to work in a modified capacity as soon as it is medically appropriate.

Recommendation 39. Interdisciplinary services are permitted to assist the injured worker in return to work efforts (e.g., behavioral and/or psychological support, active therapy).

Recommendation 40. A graduated return to work strategy should be incorporated into a successful medical treatment plan and rehabilitation after injury with a goal of return to full duty, if medically feasible (e.g., nature and frequency of activities, and hours worked).

Recommendation 41. Permanent work restrictions should be developed based on objective information available, including:

• history;

• findings on physical examination and diagnostic testing; and • functional response to active therapy, work conditioning, and/or modified duty.

Timing of Tests.

Timing of Tests and Maximum Allowed FCE 1 time to determine baseline status, and 1 time to determine permanent work restrictions at case closure if it is clear that the patient cannot return to the position held at the time of injury.

Jobsite evaluations 1 time for initial evaluation, 1 for mid-treatment assessment, and 1 at final evaluation.

Computer enhanced evaluations 1 time for initial evaluation, 1 for mid-treatment assessment, and 1 at final evaluation.

Work tolerance screening 1 time for the initial screen. May monitor improvements in strength every 3 to 4 weeks up to a total of 6 visits.

Table 6.

Evidence Table: Return to Work and Spine Pain For workers with musculoskeletal conditions, including neck pain, workplace interventions such as ergonomic adjustments and work modification reduce the recurrence of further injury and reduce time away from work. These interventions involve the worker, employer, and an occupational physician.

For workers who have been absent from work due to musculoskeletal conditions, the cumulative time away from work in the first 12 months is likely to be reduced if there is a workplace intervention in which several stakeholders, including the workers, the employer, and an occupational physician, formulate a plan to reduce the recurrence of further injury; this generally will involve an ergonomic evaluation of the worksite and plans for work modification as needed.

Workplace interventions in which several stakeholders, including the workers, the employer, and an occupational physician formulate a plan to reduce the recurrence of further injury are also likely to shorten the time needed for a first return to work, and are likely to be beneficial in reducing the risk of a recurrence of sickness absence due to the underlying musculoskeletal condition.

An integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain.

Table 7.

Evidence Table: FCE FCEs are poor predictors of return to work, and there is no evidence that they predict re-injury. A short form FCE, designed for completion in 1 day, may have similar predictive value to standard FCEs.

Performance-based measures, such as those assessed in an FCE, are weakly predictive of return to work variables. Most of the variation in time for return to work is explained by factors other than the physical ability to perform specific tasks.

Time off work and gender are important predictors for return to work, and floorto-waist lifting may also help predict return to work, however, the strength of that relationship has not been determined.

A short form FCE reduced to a few tests produces a similar predictive quality compared to the longer 2-day version of the FCE regarding length of disability and recurrence of a claim after return to work.

Table 7 continued.

Evidence Table: FCE Lack of Lack of evidence statement Design There is a lack of evidence supporting the validity of FCE for prediction of reinjury following return to work.

Section 6. Essential First Line Treatment Introduction. Education about neck pain and associated disability may involve the patient, patient’s family, employer, insurer, policymakers, and community. Informed consent and shared decision making are 2 important components of patient education. Informed consent is an individual’s autonomous authorization of a medical intervention that has resulted from a conversation between a patient and provider. It is also a formal process that healthcare institutions require before permitting procedures.

Shared decision making involves an exchange of ideas between the patient and provider and collaboration in the decision itself.

Recommendation 42. Patient education is required as a primary component of neck pain treatment, beginning with the expected natural history of neck pain, with and without radicular symptoms (table 8).

Recommendation 43. In the setting of benign clinical examination, it is strongly recommended that the provider educates and reassures the patient that there is a high likelihood their condition will improve and that it is essential to self-manage their symptoms.

Recommendation 44. Patient education should include a thorough discussion of how behavioral health evaluation and treatment is an essential component to support recovery from physical injury.

Recommendation 45. Shared decision making is required when 2 or more medically reasonable treatment choices exist, regardless of whether the degree of risk is high or low. Elements of shared decision making for spine interventions must include the following:

• the patient’s experience with treatment;

• creation of individualized functional goals of treatment and anticipated barriers to success;

• documentation of expected results of diagnostic testing and possible plan of action in response to test results;

• a discussion of the continuum of treatment from the least invasive to the most invasive, with the intent of identifying a treatment along this continuum that most completely addresses the condition;

• expectation regarding the functional impact of the proposed treatment, including a discussion regarding return to work and expected timeframe for treatment;

• criteria for determining treatment success or failure;

• confirmation of the patient’s commitment to perform active therapy to optimize treatment outcomes; and • consideration of the patient’s unique risks and benefits based on comorbid medical conditions Shared decision making discussions should be tailored to the patient’s health literacy.

Recommendation 46. Informed consent is required when a high risk treatment is under consideration. It includes the following elements:

• discussion of the purpose of the proposed treatment;

• benefits and risks of the proposed treatment, alternative treatments, and nontreatment; and • explicit patient agreement or refusal.

Table 8.

Evidence Table: Education and Shared Decision Making Structured educational interventions, whether in the form of written material, oral instruction, or videos, are not expected to lead to significant clinical benefits for whiplash or other neck-associated disorders unless it is combined with exercise or individual advice from a physical therapist.

Section 7. Second Line Treatment

Section 7.a. Core Second Line Treatment

Section 7.a.i. Active Therapies Introduction. Active therapies are therapeutic exercises and/or activities that intend to restore flexibility, strength, endurance, function, and range of motion (ROM) and to alleviate discomfort. Given the anatomic proximity, active therapies for cervical conditions may also incorporate the shoulder. They require intrinsic motivation by the patient to complete a specific exercise or task. The following active therapies are common treatments:

• activities of daily living (ADLs) therapy, • functional activities therapy, • functional electrical stimulation or neuromuscular electrical stimulation (NMES), • neuromuscular re-education, • pilates, • tai chi, • therapeutic exercise, • yoga, • work conditioning, and • work simulation.

Active therapies also include developing functional goal-setting, maintaining or returning to usual activities and exercise in a graded fashion, and providing patient education and key recovery messages. Active therapies may coincide with pain neuroscience education. Pain neuroscience education involves educating patients about the biological and physiological processes involved in their pain experience and, importantly, deemphasizing the issues associated with anatomical structures, pain generators, and tissue damage.

Individual patients may benefit from additional education approaches. Education may include, but is not limited to: a favorable prognosis for recovery, the importance of continuing daily activities, promotion of self-efficacy, problem-solving, engagement of support systems, and relaxation techniques.

Contraindications / Side Effects and Adverse Events.

Relative Contraindications to Active Therapies.

• Motor, sensory, or reflex abnormalities are relative contraindications to the use of the McKenzie Method of Mechanical Diagnosis and Therapy.

• Pulmonary or cardiac conditions limiting participation are relative contraindications to active Side Effects and Adverse Events Related to Active Therapies.

• Exercise therapy may result in transient neck, shoulder, or thoracic muscle soreness. This side effect, within reasonable limits, should not deter continued active therapy.

Recommendation 47. Active interventions, including therapeutic exercise and/or functional treatment, are recommended in the treatment of neck pain (table 9).

Recommendation 48. Medical clearance is required prior to participation in active therapies if a patient has any of the following:

• angina/dyspnea on exertion or at rest, • paroxysmal nocturnal dyspnea and/or orthopnea, • syncope or presyncope, • arrhythmia or palpitations, or • cardiac murmur (see Contraindications to Active Therapies).

Recommendation 49. Patients in active therapy must:

• demonstrate functional progress that is documented through validated sequential functional assessment measures, • return to work with decreased restrictions, and/or • have improvement in clinical measures (e.g., strength, ROM, and ADLs)

If there is no documented evidence of functional progress after 6 treatments, the therapy will be discontinued and the patient must be referred back to their treating provider for further evaluation. Each patient is limited to a maximum of 4 discrete active therapy trials without documented functional progress (Appendix Functional Screens).

Recommendation 50. A patient is allowed up to 6 active therapy visits to advance their active home exercise program. These visits are contingent on documented demonstration of previously instructed exercises, performance of their home program at the recommended frequency, and progress in their exercise program.

Recommendation 51. Adjunct passive therapy can occur concurrently with active therapy and the frequency of passive therapies will decrease over time. See the Passive Therapies section.

Recommendation 52. Durations of care beyond those listed as “time to produce effect” and “maximum” are warranted in certain circumstances when treatment to date has resulted in measurable and clinically meaningful functional improvement. These circumstances include:

• re-injury;

• interrupted continuity of care;

• after surgery, particularly after multiple surgeries;

• injuries (e.g., fracture); or • comorbidities.

Recommendation 53. Functional electrical stimulation or NMES home units require prior authorization, documenting medical justification for home use.

Time Frames for Active Therapies Time to produce effect Frequency Optimum duration Maximum duration 6 treatments up to 4 times per week 6 weeks 8 weeks Table 9.

Evidence Summary: Active Therapies Active therapies may provide functional benefit and symptomatic relief in patients with neck pain. No evidence demonstrates that 1 form of active therapy is superior to any other, and the selection of an active therapy may be guided by local availability and the patient’s preference and capability. Patients with barriers to functional recovery may benefit from the incorporation of pain education into therapeutic exercise.

Table 10.

Evidence Table: Exercise and Neck Pain For patients with subacute and chronic neck pain, exercise provides symptomatic relief as compared to control interventions. For patients with neck pain, participation in active therapy in combination with passive therapy (e.g., manipulation, mobilization, stretching, muscle energy) results in reduced pain and disability as compared to either treatment alone, education alone, or other minimal intervention.

Adding exercise in combination with other interventions such as: 1) manipulation alone, or 2) manipulation and mobilization, or 3) mobilization, muscle energy, and stretching, is more effective than manipulation alone, mobilization alone, exercise alone, and other minimal intervention or education alone in reducing neck pain and disability.

In people with chronic neck pain, exercise with or without manipulation results in decreased pain and disability compared to home exercise and advice at 12 weeks but not 52 weeks. The percentage of patients with 2.5% decrease in pain at 1 year was 51% with manipulation and exercise, 57% with exercise only, and 41% with home exercise and advice. It is not clear that the expense is worth the outcome long-term.

A 12-week physiotherapist-led neck-specific exercise program (with or without a behavioral approach) consisting of 2 physiotherapy sessions weekly in addition to home-exercise of increasing intensity in terms of duration (or repetitions) was found to be more effective in reducing pain and disability than “prescription of physical activity.” The effect was sustained up to 6 months in both groups as well.

For patients with subacute to chronic mechanical neck disorders, a combination of scapulothoracic and upper extremity strength training decreased pain intensity compared to control interventions.

The programs ranged from 2 minutes to 2 hours per session, sessions ranged from 3 times/week to 6 times/week, and the programs lasted up to 20 weeks.

All programs included specific forms of scapulothoracic and upper extremity strength training.

For patients with chronic mechanical neck disorders a program consisting of repeated active cervical rotations, strength and flexibility exercises had a beneficial effect on reducing pain intensity.

The specific programs ranged from 3 to 6 months (the shorter-length program included a 3 month-self-directed follow-up), 18 to 24 sessions, and duration of sessions was 45 to 90 minutes. Exercise was monitored by a qualified physiotherapist.

Table 10 continued.

Evidence Table: Exercise and Neck Pain For patients with chronic mechanical neck disorders, a combination of cervicoscapulothoracic strengthening and stretching exercises improved function at the intermediate term follow-up (defined as 3 months up to, but not including, 1 year).

The specific programs ranged from 6 weeks to 11 weeks, the sessions ranged from 1 to 2 times/week, and the duration of sessions ranged from 20 minutes to 45 minutes.

In the setting of symptomatic cervical radiculopathy from herniated discs and/or osteophytes at 1 or 2 levels, it is reasonable to initiate a program of structured physical therapy before any surgical decisions are made, since many patients will experience significant improvement in pain and function.

However, a program of anterior cervical discectomy and fusion (ACDF) plus structured physical therapy is likely to be superior to physical therapy alone, and the improvements appear to continue for at least 5 to 8 years.

In a population of female office workers with “constant chronic neck pain and disability” and symptoms lasting greater than 6 months, a home exercise program consisting of either muscle endurance training (i.e., 3 sets of 20 reps, 3 times a week for 12 months) or muscle strength training (i.e., 1 set of 15 reps, 3 times a week for 12 months) was found to be effective in improving function in the short-term.

An exercise program that includes resistance training of the cervical and scapulothoracic muscles, combined with stretching of the same muscles, is likely to be beneficial for mechanical neck pain.

General fitness exercises and upper extremity exercises are unlikely by themselves to be beneficial for mechanical neck pain.

In patients with chronic mechanical neck pain, stabilization exercises with or without connective tissue massage are equally effective for reducing pain, anxiety and physical health while increasing the quality of life.

A 3-week program of twice weekly home neck exercises with manual physical therapy that includes joint mobilization, muscle energy, and stretching, reduces neck pain and disability compared with a minimal intervention for patients with chronic neck pain at 6 weeks follow-up, but it did not persist at 1 year follow-up.

In the setting of nonspecific acute or subacute neck pain that limits daily activities but is unaccompanied by radicular signs, weakness, or numbness in the arm, 3 treatment options include spinal manipulative therapy, prescription or nonprescription medication, and home exercise with advice. 12 weeks of spinal manipulative therapy is likely to be marginally more beneficial than medication, but is not more beneficial than home exercise with advice consisting of 2 hours of instruction by a physical therapist, focused on simple self-mobilization exercise of the neck and shoulder joints done 6 to 8 times per day.

A combination of exercise and spinal manipulation is more effective than manipulation alone in relieving chronic neck pain, and these advantages remain for more than 1 year after the end of treatment.

Multimodal care consisting of a 3-week program of twice weekly exercise with manual therapy with joint mobilization, muscle energy techniques, and home strengthening and ROM exercises, reduces neck pain and disability compared with a minimal intervention consisting of postural advice, ROM exercise, subtherapeutic ultrasound, and continuation of prescribed medication.

A program of 2 sessions of thoracic thrust manipulation followed by a cervical exercise program is more effective than a cervical exercise program alone.

Mobilization, manipulation, and exercise does not provide greater long-term pain relief when compared to exercise alone.

In patients with tension-type musculoskeletal neck pain with no neurological deficits, both individually applied physical therapy and a 7-week group course teaching relaxation and body awareness activities lead to improvements in pain and function after 20 weeks. However, the benefits are likely to be greater in patients who receive the group instruction in relaxation and body awareness exercises. A brief course in this intervention is needed for the physical therapists who will implement the intervention at their clinics.

Table 11.

Evidence Table: The McKenzie Method and Neck Pain The McKenzie approach provides similar outcomes in improving pain, disability, and ability to carry out work activities in comparison with cognitive behavioral therapy (CBT).

Table 12.

Evidence Table: Pilates and Tai Chi in Neck Pain Pilates exercise shows statistically and clinically significant reductions in pain and statistically significant improvements in function in the short-term (maximum follow up 15 weeks) compared with usual care, no exercise, education, or physical activity for the treatment of patients with chronic low back pain. 12 weeks of Tai Chi is more effective than no treatment to improve pain, disability, quality of life, and postural control in subjects with chronic nonspecific neck pain.

Table 13.

Evidence Table: Craniosacral Therapy and Neck Pain Craniosacral therapy for chronic nonspecific neck pain, performed by a physical therapist trained in the technique, is superior to sham treatment in reducing neck pain intensity at 8 weeks and probably at 20 weeks.

Table 14.

Evidence Table: Active Therapies with Education for Neck Pain Among patients with persistent grade I-II whiplash-associated disorders, the addition of a 10-week standardized progressive goal attainment program to a functional restoration physical therapy (2.5 hours/day, 3 times/week for 10 weeks or until return to work) improves the rate at which patients return to work.

A 2-day course focusing on the biopsychosocial model with an emphasis on the goals of returning to usual activities and fitness is as effective in reducing disability as 6 sessions of manual therapy sessions provided by physiotherapists and more limited patient education.

Table 15.

Evidence Table: Pain Neuroscience Education For patients with chronic musculoskeletal pain, including neck pain, active therapy with pain neuroscience education reduces pain and increases function as compared to active therapy alone.

Pain neuroscience education combined with a physical intervention is more effective in reducing pain, improving disability, and reducing healthcare utilization compared with either usual care, exercise, other education, or another control group for the treatment of patients with chronic musculoskeletal pain.

The difference between the pain-education and control group for patients with chronic neck or low back pain reaches clinical relevance for both physical and mental-health domains in the 36-item Short Form Health Survey (SF-36 scale) and persists at 12 months.

Section 7.a.ii. Behavioral and Psychological Interventions Introduction. Psychological therapeutic and diagnostic interventions have selected use in acute pain problems and more widespread use in sub-acute and chronic pain populations. Psychosocial interventions include psychotherapeutic treatments for mental health conditions, as well behavioral medicine treatments. Therapeutic psychological interventions include, but are not limited to, individual counseling and group therapy. Treatment can occur within an individualized model, a multi-disciplinary model, or a structured pain management program.

These interventions may similarly benefit patients without psychiatric conditions but who may need to make major life changes in order to cope with pain or adjust to disability. Health behavior assessment and intervention services are used to identify and address the psychological, behavioral, emotional, cognitive, and interpersonal factors important to the assessment, treatment, or management of physical health problems.

The following commonly used terminology appears in the context of addressing behavioral and psychological interventions:

• biofeedback training, including: o electromyogram, o skin temperature, o respiration feedback, o respiratory sinus arrhythmia, o heart rate variability, o electrodermal response, and o electroencephalograph, • cognitive behavioral therapy (CBT);

• mindfulness-based stress reduction;

• progressive relaxation;

• relaxation therapy; and • sleep hygiene training.

CBT is a psychological therapy that integrates theories of cognition and learning with treatment techniques derived from cognitive therapy and behavior therapy. It assumes that cognitive, emotional, and behavioral variables are functionally interrelated. Treatment is aimed at identifying and modifying the patient’s unproductive thought processes and behaviors through cognitive restructuring and behavioral techniques to achieve change. Variations of CBT methods can be used to treat a variety of conditions, including chronic pain, depression, anxiety, phobias, and post-traumatic stress disorder. For patients with multiple diagnoses, more than 1 type of CBT might be needed. A “manualized” approach to CBT follows a specific protocol in a manual. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for additional information on psychological evaluation.

Absolute and Relative Contraindications to Behavioral and Psychological Interventions.

• Contraindications include active suicidality, homicidality, active psychosis, or major untreated psychological comorbidity.

• Relative contraindication includes a lack of patient engagement despite interventions targeting initial resistance.

• Relative contraindications to CBT include literacy below the 6th grade level, lack of English language proficiency, and cognitive impairment.

Side Effects and Adverse Events Related to Behavioral and Psychological Interventions.

• Side effects and adverse events include emotional discomfort, cognitive dissonance, irritability, interpersonal difficulties, or temporary increase in stress.

Recommendation 54. Formal psychological or psychosocial evaluation is recommended as a component of the biopsychosocial approach to patient recovery from physical injury and should attempt to identify both primary psychological risk factors (e.g., psychosis and active suicidality) and secondary psychological risk factors (e.g., moderate depression and job dissatisfaction) (table 16). The evaluation should distinguish between pre-existing, aggravated, and/or purely causative psychological conditions.

Recommendation 55. Comprehensive psychological evaluation must be performed by a psychologist with PhD, PsyD, or EdD credentials or a physician with psychiatric MD/DO credentials.

Recommendation 56. Psychometric testing, distinct from screening psychological questionnaires, must be administered by a psychologist with a PhD, PsyD, or EdD or a health professional working under the supervision of a doctorate level psychologist. A physician with appropriate training may also administer such testing, but interpretation of the tests should be done by a properly credentialed mental health professional.

Recommendation 57. Evaluation for psychiatric medication is permitted if there is an established diagnosis consistent with the standards of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM). See the Medications section.

Recommendation 58. An initial assessment, ongoing assessment, and treatment plan with measurable and clinically meaningful behavioral goals, time frames, and specific planned interventions are required before initiating psychological/psychiatric interventions. Ongoing requirements include:

• a biweekly status report during initial, more frequent treatment and monthly thereafter, documenting progress toward functional recovery;

• a discussion of the psychosocial issues affecting the patient’s ability to participate in treatment; and • addressing pertinent issues such as pre-existing, aggravated, and/or causative issues, as well as realistic functional prognosis.

• Recommendation 59. The following is recommended when obtaining a psychological evaluation:

• a full release from the patient prior to evaluation acknowledging that information that may go to the employer, and • exclusion of sensitive health information not directly related to the work-related conditions in reports sent to the insurer is essential.

CBT Requirements.

Recommendation 60. CBT is recommended for cervical spine pain patients who catastrophize, cope ineffectively with pain, or avoid activity out of fear of re-injury (table 17).

Recommendation 61. A full psychological evaluation is required before CBT can be initiated.

Recommendation 62. A CBT provider must be a:

• psychologist with PhD, PsyD, or EdD credentials;

• psychiatric MD/DO; or • licensed mental health or licensed health care provider with training in CBT or certified as a CBT therapist with experience in treating chronic pain disorders who works in consultation with a psychologist with a PhD, PsyD, EdD, or psychiatric MD/DO.

Recommendation 63. A manualized approach to CBT is strongly recommended if being performed by a non-mental health professional, with appropriate supervision by a psychologist with a PhD, PsyD, EdD, or psychiatric MD/DO provider.

Recommendation 64. Candidates for CBT will have all of the following characteristics:

• adequate literacy level to complete homework used to teach inductive rational thinking, • adequate cognitive and education abilities to meet the requirements of a CBT protocol, and • otherwise stable social circumstances.

The selection of CBT methods should be based on the individual's literacy level, English proficiency, and cognitive capabilities, as assessed by the behavioral health provider. Individuals who are not candidates for CBT may benefit from other behavioral and psychological approaches.

Biofeedback Requirements.

Recommendation 65. Biofeedback as an adjunct to psychological therapy is recommended for patients who meet 1 of the following indications:

• musculoskeletal injury, in which muscle dysfunction or other physiological indicators of excessive prolonged stress response affects and/or delays recovery;

• a need for training to improve self-management of pain, anxiety, panic, anger or emotional distress, opioid withdrawal, insomnia, sleep disturbance, and/or other central and autonomic nervous system imbalances; and/or • motivation to learn and practice biofeedback and self-regulation techniques (table 18).

Recommendation 66. If biofeedback treatment is indicated, it must be done in conjunction with the patient’s other psychosocial or medical interventions.

Recommendation 67. Psychologists or psychiatrists who provide psycho-physiological therapy, which integrates biofeedback with psychotherapy, must be either Biofeedback Certification International Alliance (BCIA) certified or practicing within the scope of their training.

• Non-licensed health care providers of biofeedback for chronic pain patients must be BCIA certified and shall have their biofeedback treatment plan approved by the authorized treating psychologist or psychiatrist.

• Biofeedback can also be provided by health care providers who follow a set treatment and educational protocol. Such treatment may utilize standardized material, relaxation recordings, or app-based interventions. App-based interventions must meet the criteria in Rule 18.

Substance Use Disorder Requirements.

Recommendation 68. Patients with substance use disorder, high-dose opioid use, or use of other drugs of abuse may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs).

Time Frames for Behavioral and Psychological Interventions Time to produce effect (sessions)

Frequency (sessions/week)

Maximum duration Group CBT up to 8 (2-hours) up to 2 16 sessions Individual CBT up to 8 (1-hour) up to 2 16 sessions Biofeedback up to 4 sessions up to 2 12 sessions ᶷ Relaxation up to 4 sessions up to 2 12 sessions ᶷ Other psychological interventions up to 8 up to 2 6 months ᶷ Treatment beyond 12 sessions must be documented with respect to need, expectation, and ability to facilitate positive symptomatic and functional gains.

For the first 2 weeks of treatment, excluding hospitalization, if required; decreasing to weekly in the 2nd month of treatment and then 2-4 times per month (with the exception of exacerbations, which may require increased frequency of visits).

Longer supervised psychological/psychiatric treatment may be required, especially if there are ongoing medical procedures or complications. If counseling beyond 6 months is indicated, the management of psychosocial risks or functional progress must be documented.

Table 16.

Evidence Table: Psychological Assessments and Outcomes Psychological testing identifies patients most likely to benefit from surgery.

Psychometric testing can predict medical treatment outcomes. Cohort Interdisciplinary programs that include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability.

Psychological and medical risk factor assessment prior to surgery can identify patients unlikely to benefit from surgery.

Table 17.

Evidence Table: CBT CBT may reduce pain, disability, sick leave, health care utilization, and insomnia for patients with chronic pain.

CBT may reduce pain and disability in patients with chronic pain, but the magnitude of the benefit is uncertain.

CBT, but not behavioral therapy, shows weak to small effects in reducing pain, and small effects on improving disability, mood, and catastrophizing in the treatment of patients with chronic pain.

A stepped care program is more effective than usual care in veterans with chronic musculoskeletal pain. The stepped care program consisted of 12 weeks during which nurse case managers took a medication use history and adjusted medication dosage and scheduling through telephone contacts with patients every other week, followed by a 12-week step in which cognitive behavioral treatment was administered by 45 minute individual sessions by telephone every other week. Disability and pain interference with daily activity with stepped care were both superior to usual care in which patients were given printed handouts and were followed for all care by their primary treating physicians.

A 6-week program of cognitive-behavioral group intervention with or without physical therapy can reduce sick leave, health care utilization, and the risk for developing long-term sick leave disability (> 15 days) in workers with nonspecific low back or neck pain compared with simple verbal instruction by a physician.

CBT provided in seven 2-hour small group sessions can reduce the severity of insomnia in chronic pain patients.

The McKenzie approach provides similar outcomes in improving pain, disability, and ability to carry out work activities in comparison with CBT.

The benefits of CBT continue to be present 3 or more years after the initial intervention, although the differences between CBT and the control group are likely to become narrower with extended follow-up.

Behavioral modification, such as patient education and group or individual counseling with CBT, can be effective in reversing the effects of insomnia.

Table 18.

Evidence Table: Biofeedback and Relaxation Training Both biofeedback and relaxation therapy may reduce pain and disability for patients with chronic low back pain. While the literature in this table discusses chronic low back pain, there is presumed physiologic similarity for chronic neck pain.

Biofeedback or relaxation therapy is equal in effect to CBT for chronic low back pain.

Self-regulatory interventions, such as biofeedback and relaxation training, may be equally effective.

Progressive relaxation was the only psychological therapy associated with improvement in function as well as pain intensity compared to wait-list control in chronic low back pain.

Section 7.b. Adjunct Second Line Treatments, as Indicated

Section 7.b.i. Passive Therapies Introduction. Passive therapies include treatments that do not require a patient’s energy expenditure.

They are most helpful early in treatment, and they are directed at controlling symptoms and improving the rate of healing soft tissue injuries. They can be used adjunctively with active therapies to help control swelling, pain, and inflammation. The following passive therapies are common treatments: treatments:

• acupuncture, • acupuncture with electrical stimulation, • iontophoresis, • joint mobilization, • low level laser, • manipulation, • manual treatment, • manual traction, • massage, • mechanical or motorized traction, • phonophoresis, • soft tissue mobilization, • short-wave diathermy, • superficial heat and cold therapy, • trigger point dry needling, • ultrasound, and • unattended electrical stimulation (e.g., transcutaneous electrical nerve stimulation [TENS]).

Absolute and Relative Contraindications to Passive Therapies.

• High velocity / low amplitude manipulation is contraindicated in those with joint instability, fractures, severe osteoporosis, infection, metastatic cancer, active inflammatory arthritis, signs of progresssive neurologic deficits, myelopathy, vertebrobasilar insufficiency, or carotid artery disease.

• Relative contraindications to manipulation include spinal stenosis, spondylosis, and disc herniation.

• Manual traction is contraindicated in those with tumor, infection, fracture, or fracture dislocation.

• Non-oscillating inversion traction methods are contraindicated in patients with glaucoma or hypertension.

Complications of Passive Therapies.

• Rare complications of dry needling or acupuncture include pneumothorax, infection, or syncope.

• Cervical vertebral artery dissection can occur with high velocity neck manipulation.

Side Effects and Adverse Events Related to Passive Therapies.

• Acupuncture may result in treatment-related pain or bruising associated with needle insertion.

Recommendation 69. Patients in passive therapy must demonstrate functional progress through validated functional assessment measures. If there is no evidence of functional progress within the time to produce effect, the therapy shall be discontinued and the patient must be referred back to their treating provider for evaluation. Each patient is limited to a maximum of 4 discrete passive therapy trials.

Recommendation 70. Passive therapies must occur concurrently with self-directed exercise or formal active therapy programs (table 19).

Recommendation 71. The frequency of passive therapy must decrease over time.

Recommendation 72. Durations of care beyond those listed as “time to produce effect” and “maximum” are warranted in certain circumstances when treatment to date has resulted in measurable and clinically meaningful functional improvement. These circumstances include:

• re-injury;

• interrupted continuity of care;

• after surgery, particularly multiple surgeries;

• injuries (e.g., fracture); or • comorbidities.

Specific goals with objective measures of functional improvement must be cited to justify extended durations of care.

Recommendation 73. Manipulation under general anesthesia and manipulation under joint anesthesia are not recommended.

Recommendation 74. Mechanical traction is not generally recommended for neck pain patients with or without radicular symptoms.

Recommendation 75. Due to the absence of quality evidence supporting their use, ultrasound, phonophoresis, low level laser, kinesiotaping, iontophoresis, and motorized traction are not recommended for neck pain.

Time Frames for Passive Therapies Time to produce effect (sessions)

Frequency* (sessions/week)

Maximum duration Mobilization and Manipulation up to 6 up to 3 times/week 8 weeks Massage 1 up to 2 times/week 8 weeks Acupuncture up to 6 up to 3 times/week 15 treatments Heat/cold, short-wave diathermy, unattended electrical stimulation (e.g., TENS**) up to 4 up to 3 times/week 8 weeks Trigger point / dry needling up to 4 up to 2 times/week 8 weeks Traction (manual)*** up to 3 up to 3 times/week 4 weeks *See recommendation 71 regarding the expected decreasing frequency over time. **If TENS treatment results in documented functional benefit and is anticipated to extend beyond 4 treatments, consider purchase of a home TENS unit. ***If response is negative after 3 thirty minute treatments, discontinue.

Table 19.

Evidence Summary: Passive Therapies Passive therapies may provide functional benefit and symptomatic relief in patients with neck pain, especially when paired with an active intervention. The decision to refer a patient for 1 passive therapy over another should be based on patient preference and relative safety, not on the expectation of a greater treatment effect among passive therapy options.

Table 20.

Evidence Table: Manipulation and Mobilization for Neck Pain Manipulation and/or mobilization can reduce pain and improve function for patients with neck pain, especially when combined with exercise.

Manipulation alone or mobilization alone provides immediate, short-term, and intermediate-term relief for acute, subacute, and chronic neck pain.

Adding exercise in combination with other interventions such as: 1) manipulation alone, or 2) manipulation and mobilization, or 3) mobilization, muscle energy, and stretching, is more effective than manipulation alone, mobilization alone, exercise alone, and other minimal intervention or education alone in reducing neck pain and disability.

In patients with neck pain (with or without radicular findings), multiple sessions of thoracic manipulation was more effective in reducing intermediate-term chronic neck pain when compared with multiple sessions of a control.

In people with chronic neck pain, exercise with or without manipulation results in decreased pain and disability compared to home exercise and advice at 12 weeks but not 52 weeks.

The percentage of patients with 2.5% decrease in pain at 1 year was 51% with manipulation and exercise, 57% with exercise only, and 41% with home exercise and advice. It is not clear that the expense is worth the outcome longterm.

There is little difference in clinically significant benefit between high-velocity, low-amplitude cervical thrust manipulation and low velocity intervention, like mobilization, using techniques such as muscle energy, myofascial release, and sustained apophyseal natural glides.

Table 20 continued.

Evidence Table: Manipulation and Mobilization for Neck Pain In the setting of chronic neck pain, an intervention that mobilizes a nearby but asymptomatic spinal segment may be as beneficial as an intervention done directly at the symptomatic level. This may give the clinician additional options regarding the optimal treatment technique to be applied to the patient.

A 3-week program of twice weekly home neck exercises with manual physical therapy that includes joint mobilization, muscle energy, and stretching, reduces neck pain and disability compared with a minimal intervention for patients with chronic neck pain at 6 weeks follow-up, but it did not persist at 1 year follow-up.

Mobilization, manipulation, and exercise does not provide greater long-term pain relief when compared to exercise alone.

Thoracic thrust manipulation may improve pain and function for mechanical neck pain.

A combination of exercise and spinal manipulation is more effective than manipulation alone in relieving chronic neck pain, and these advantages remain for more than 1 year after the end of treatment.

Multimodal care consisting of a 3-week program of twice weekly exercise with manual therapy with joint mobilization, muscle energy techniques, and home strengthening and ROM exercises, reduces neck pain and disability compared with a minimal intervention consisting of postural advice, ROM exercise, subtherapeutic ultrasound, and continuation of prescribed medication.

A program of 2 sessions of thoracic thrust manipulation followed by a cervical exercise program is more effective than a cervical exercise program alone.

In the setting of nonspecific acute or subacute neck pain that limits daily activities but is unaccompanied by radicular signs, weakness, or numbness in the arm, 3 treatment options include spinal manipulative therapy, prescription or nonprescription medication, and home exercise with advice. 12 weeks of spinal manipulative therapy is likely to be marginally more beneficial than medication, but is not more beneficial than home exercise with advice consisting of 2 hours of instruction by a physical therapist, focused on simple self-mobilization exercise of the neck and shoulder joints done 6 to 8 times per day.

Table 21.

Evidence Table: Massage for Neck Pain In patients with chronic mechanical neck pain, stabilization exercises with or without connective tissue massage are equally effective for reducing pain, anxiety and physical health while increasing the quality of life.

Table 22.

Evidence Table: Trigger Point Dry Needling and Neck Pain 4 sessions of trigger point deep dry needling with passive stretching over 2 weeks was significantly more effective in reducing neck pain and improving neck disability than passive stretching alone in the short-term and at 6-month follow-up in people with chronic nonspecific neck pain.

Table 23.

Evidence Table: Acupuncture Acupuncture may reduce pain and improve function for patients with chronic neck pain.

Acupuncture is useful in the treatment of neck pain. Systematic Acupuncturists must be properly trained in aseptic technique. Systematic Patients with nonspecific chronic neck pain were randomly assigned to 12 acupuncture sessions or 20 one-to-one Alexander Technique lessons with equivalent overall contact time. Both were associated with a significant reduction in neck pain and decreased disability, per the Northwick Park Neck Pain Questionnaire (NPQ), at 12 months compared with usual care.

In the current study, participants with chronic neck pain received a 3-week phase of acupuncture, which included a total of 6 treatments, 3 times per week, each lasting 30 minutes. It was found that up to 12 weeks after treatment ended, those who received classic acupuncture improved significantly more with respect to disability and pain than those who received acupuncture at non-classical sites. Both groups had significant improvement.

Table 24.

Evidence Table: Acustimulation and Neck Pain There is no difference between the use of electroacupuncture and sham laser acupuncture on chronic neck pain at 3 months after 9 treatments and 6 months, although both groups improved.

A combination of electrical “acustimulation” to the wrist combined with neck stretching and strengthening exercises for 30 minutes 2 times per week for a period of about 4 weeks demonstrates more improvement in chronic neck pain and patient self-confidence in performing functional activities than neck exercises alone for up to 1 month.

Table 25.

Evidence Table: Traction and Neck Pain Intermittent cervical traction does not add therapeutic benefit to a brief course of individualized manual therapy combined with exercise for patients with cervical radiculopathy.

Section 7.b.ii. Durable Medical Equipment Introduction. Durable medical equipment includes devices that can be used repeatedly to serve a medical purpose. These include braces or splints for supporting, immobilizing, or treating muscles, joint, or skeletal parts that are weak, ineffective, deformed, or injured.

Complications / Side Effects and Adverse Events.

Complications of Durable Medical Equipment.

• Complications of durable medical equipment include deconditioning of the cervical musculature and associated fatigue or pain, and skin irritation resulting from contact with the orthotic.

Acute and Postoperative Treatment Time Frame Requirements.

Recommendation 76. Soft cervical collars are not recommended for an isolated cervical sprain (table 26).

Recommendation 77. Rigid cervical collars are permitted in the postoperative and emergency setting.

Documentation should include directions for duration and frequency of use.

Recommendation 78. Halo immobilization is recommended in the treatment of cervical fracture, dislocation, and instability, at the discretion of the treating surgeon.

Table 26.

Evidence Table: Cervical Collars for Neck Injury Patients encouraged to continue usual activity have less neck stiffness and headache than patients placed in cervical collars and placed on sick leave following motor vehicle crashes.

Semi-hard collars worn during the day for 3 weeks and then weaned over 3 weeks may hasten resolution of recent onset cervical radiculopathy.

Section 8. Third Line Treatment, as Indicated

Section 8.a. Injections - Diagnostic and Therapeutic Introduction. Spinal injections are considered when function remains limited despite appropriate nonoperative treatment options. Diagnostic spinal injections are used to localize a source of pain when the results would impact the course of treatment. Therapeutic injections are used to temporarily reduce functional impairment. Most individuals with neck pain will not need a spinal injection. See the Overview of Care section.

• See the specific injection section.

Recommendation 79. Spinal injections are indicated when all of the following criteria are met:

• positive correlation among clinical findings, the clinical course, and diagnostic tests;

• positive functional response to a diagnostic injection, if required;

• persistent functional impairment despite engagement in 6 weeks of active therapy; and • confounding psychosocial risk factors have been screened for and clinically addressed. See the Recommendation 80. All spinal injections should be preceded by magnetic resonance imaging (MRI) or computed tomography (CT) scan.

Recommendation 81. Informed consent is required before all invasive procedures. See the Essential First Line Treatment section.

Recommendation 82. Routine use of sedation is not recommended for diagnostic or therapeutic spinal injections. Minimal to moderate sedation and pain relief may be needed for some patients but are only permitted when there is documentation of extreme circumstances.

Recommendation 83. All injections must be accompanied by self-directed exercise or formal physical Recommendation 84. Multi-planar fluoroscopic imaging is required to create permanent images that confirm proper needle placement and contrast flow pattern. CT needle guidance may be required in rare circumstances.

Recommendation 85. Total steroid injections at all sites, including the extremities, should be limited to 4 per year to avoid side effects from steroids. Prior authorization is required for additional injections with appropriate documentation of medical reasoning and functional improvement.

Recommendation 86. Due to the absence of quality evidence supporting their use, the injection of substances other than steroids, anesthetic, or contrast solution is not recommended (e.g., orthobiologics such as platelet rich plasma, stem cells, or amniotic fluid; ozone; etc.).

Section 8.a.i. Epidural Steroid Injection (ESI) and Transforaminal Nerve Root Block Introduction. Epidural steroid injections (ESIs) are corticosteroid injections into the cervical epidural space by a transforaminal or interlaminar approach. A transforaminal nerve root block involves injecting steroid medication near where the nerve root exits the spinal column. The therapeutic goals of injections are to restore ROM and facilitate progress in active therapy programs by temporarily reducing pain and inflammation in the acute or subacute phases of injury.

Absolute and Relative Contraindications to ESI.

• Poorly controlled diabetes mellitus, systemic or localized bacterial infection, known anatomic abnormalities, and bleeding diathesis are absolute contraindications to ESI.

• Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive ESIs.

• Patients on medications that affect coagulation require special consideration prior to ESI.

• Allergy to contrast material, somatization disorder, poorly controlled congestive heart failure, and uncontrolled hypertension are relative contraindications to ESI.

• Significant spinal stenosis is a contraindication to an injection at that level. This applies to placing a needle at the spinal stenosis area, but it is acceptable to inject adjacent to the level.

Complications of ESI.

• Long-term morbidity can occur as a result of ESI, although complications that lead to long-term morbidity are rare.

• Permanent paresis, anaphylaxis, and arachnoiditis have been rarely reported with the use of epidural steroids.

• Cervical epidural injections carry additional risks of injury including death, spinal cord injury, and stroke when compared to lumbar injections.

• Headache, nerve injury, transient neurapraxia, vasovagal effects, infection, local pain, epidural hematoma, spinal cord injury, dural perforation, and cerebrospinal fluid leaks have been reported.

• Direct needle trauma is a reported complication (recommendation 90).

• Although major neurological complications are rare with fluoroscopically-guided ESIs, there is a much greater risk with injections above C5-C6 and with particulate steroid injections (recommendation 91; table 28).

• Osteoporotic fractures, Cushing’s syndrome, hypopituitarism, spinal epidural lipomatosis, and growth hormone deficiency have been associated with ESI.

Side Effects and Adverse Events Related to Injectate.

• Increased blood glucose levels, decreased plasma cortisol levels, and impaired bowel or bladder function are possible side effects of ESI.

• Dose-dependent suppression of the hypothalamic-pituitary-adrenal axis, leading to a transient secondary adrenal insufficiency in the first few weeks after ESI (table 27).

Recommendation 87. Interlaminar injections should not be performed above the level of C6-C7 nor at the level of any stenosis as demonstrated on pre-procedure imaging review.

Recommendation 88. For a patient to be a candidate for an ESI, the provider must document all of the following:

• subjective report of severe radicular pain that correlates with objective findings;

• positive neural compression test (e.g., dural tension, Spurling’s sign, traction/distraction, upper limb tension test) and/or reflex, motor, or sensory changes on examination specifically correlating with imaging findings; and • imaging findings that demonstrate impingement of nerve(s) or spinal cord.

Recommendation 89. ESI is not recommended for the treatment of axial neck pain in the absence of radicular symptoms.

Recommendation 90. Multi-planar fluoroscopic imaging is required to create permanent images confirming proper needle placement and contrast flow pattern.

Recommendation 91. Particulate corticosteroid preparations are not recommended for epidural injection (table 28).

Recommendation 92. A patient who meets the ESI indications can trial an epidural injection of local anesthetic alone as an alternative to an injection containing steroid (table 29).

Recommendation 93. All patients with diabetes must be instructed to monitor their glucose levels carefully over the 7 days after steroid injection. Clinicians can pursue diabetic screening tests for those who appear to be at risk for Type 2 diabetes (table 30).

Recommendation 94. A diagnostic response to a selective nerve root block must be documented to show its value, including:

• improvement in at least 3 objective functional measures (e.g., spinal ROM; tolerance and time limits for reaching and lifting); and • at least 80% radicular pain improvement as measured using an accepted pain scale (e.g., visual analog scale [VAS] or numeric rating scale [NRS]) that is consistent with: o the expected duration of the injected local anesthetic phase, and o a post-injection pain diary with at least 8 hourly response recordings and preferably for 1 week if local anesthetic is used. Documentation of pain response may be indicated for up to 3 weeks, depending on the nature of the injection.

A successful response to a diagnostic injection requires documentation of positive functional changes by trained personnel and may include nurses, physician assistants, medical assistants, therapists, or noninjectionist physicians. Functional progress supersedes pain improvement.

Acute Phase Requirements (Within 6 Weeks of Initial Care).

Recommendation 95. Early referral within 6 weeks for ESI is permitted when the provider documents all criteria in recommendation 88 and at least 1 of the following:

• radicular pain-related functional impairment prevents participation in active therapy and activities of daily living (ADLs); or • an opioid treatment is being considered.

Subacute and Chronic Phase Requirements (After 6 Weeks of Care).

Recommendation 96. ESI or referral for surgical consultation is permitted for patients who meet the criteria in recommendation 88 and both of the following:

• functional impairment despite 6 weeks of optimal medical management and participation in active therapy, and • confounding psychosocial risk factors have been screened for and are being clinically addressed.

See the Behavioral and Psychological Interventions section (table 31).

Repeat ESI Requirements.

Recommendation 97. Repeat ESI can occur as soon as 2 weeks after the first injection when the initial injection resulted in a sustained therapeutic response for 2 weeks or more and is characterized by the following:

• improvement in at least 3 objective functional measures (e.g., spinal ROM; tolerance and time limits for reaching and lifting), and • 80% radicular pain improvement as measured using an accepted pain scale (e.g., VAS or NRS).

Functional progress supersedes pain improvement. The third injection can then be repeated after a hiatus of 6 months (Appendix Functional Screens). See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for information on subsequent injections.

Recommendation 98. Ordering a “series” of ESIs is prohibited. If the first injection fails to result in functional gain and pain relief as outlined in recommendation 97, the injection cannot be repeated at that level with the same approach.

Recommendation 99. If the decision is made to proceed with a different type of injection, the specific criteria for that injection must be satisfied.

Recommendation 100. Testing morning cortisol levels is recommended prior to the third or fourth steroid injection.

Table 27.

Evidence Table: ESI and the Hypothalamic-Pituitary-Adrenal Axis In the setting of ESI given for low back pain with radiculopathy, there is a dose-dependent suppression of the hypothalamic-pituitary-adrenal axis leading to a transient secondary adrenal insufficiency in the first few weeks after the procedure, with an 80 mg dose of methylprednisolone acetate leading to secondary adrenal insufficiency in about 80% of patients the first week after the injection, and in about 50% of patients receiving a 40 mg dose.

The cortisol response to an injection of adrenocorticotropic hormone (ACTH) gradually returns to normal in the weeks after the injection, but secondary adrenal insufficiency remains detectable in some patients 4 weeks later.

Table 28.

Evidence Table: Risk of particulate ESI ESIs with particulate steroids, such as methylprednisolone and triamcinolone, have systemic absorption effects and a much higher risk of major neurological complications than ESIs of water soluble steroids, such as betamethasone and dexamethasone.

Although major neurological complications are rare with fluoroscopicallyguided cervical and lumbar ESIs, the risk is much greater with particulate steroid injections.

Some steroid preparations have a systemic absorption effect, which is reflected in suppression of morning cortisol measurements 3 and 6 weeks after the injection. This appears to be the case with the particulate steroids, methylprednisolone and triamcinolone, but not with the water soluble steroids, betamethasone and dexamethasone.

Particulate steroids offer no advantage over nonparticulate steroids in the setting of transforaminal or interlaminar ESIs for patients with lumbar or cervical radiculopathy, either with respect to pain relief or improvement of function.

Table 29.

Evidence Table: Use of Steroid in Epidural Injections The addition of a corticosteroid may not provide added improvement in function or pain over epidural injections with local anesthetic or saline alone. While the evidence does not support a benefit of adding steroids to local anesthetic spinal injections, steroids are routinely used in therapeutic spinal injections due to a presumed physiologic effect.

Evidence statement Design Epidural injections of solutions not containing steroids (such as normal saline or local anesthetic in saline) are likely to have therapeutic effects in the setting of radicular pain, possibly arising from lavage effects and other effects not depending on the steroid component of the injected solution. The interpretation of clinical trials in which epidural steroid and non-steroid injections appear to have similar effects should be influenced by this principle.

Results from transforaminal injections of anesthetic plus steroids is similar to injections with anesthetic only in the cervical spine.

Table 30.

Evidence Table: Corticosteroid-Containing ESI in Diabetic Patients In the setting of ESI for patients with adequately controlled diabetes mellitus, significant increases in fasting and postprandial blood glucose can be expected on the day of the procedure and for the first 3 days thereafter; however, the increase in blood glucose are less with a 20 mg than with a 40 mg dose of triamcinolone.

There is no difference in pain relief between the 2 steroid doses, making the 20 mg dose preferable to a 40 mg dose.

Table 31.

Evidence Table: Depression and Cervical ESI Among patients with cervical radiculopathy who are considered to be surgical candidates, for whom a trial of non-surgical treatment is an option, the presence of clinical depression, defined as a score greater than 33 on the Zung Depression scale, is an unfavorable predictor for a successful response to a cervical ESI, reducing the favorable response rate by more than 50%.

Section 8.a.ii. Zygapophyseal (Facet) Injection Introduction. Facet joint injection consists of the intra-articular or pericapsular injection of local anesthetic and corticosteroid. It has very limited uses.

Absolute and Relative Contraindications to Facet Joint Injection.

• Systemic or localized bacterial infection and bleeding diathesis are absolute contraindications to steroid injections. Poorly controlled diabetes is a contraindication if steroids are used.

• Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive steroid injections. It is unknown if facet joint injections contribute to increased risk of vertebral fractures, but appropriate precautions should be taken for at-risk patients.

• Patients on medications that affect coagulation require special consideration prior to these injections.

• Somatization disorder, poorly controlled congestive heart failure, and uncontrolled hypertension are relative contraindications to these injections. Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.

Complications of Facet Joint Injection.

• Complications include nerve injury, bleeding, infection, contrast allergy, localized pain, or irritation.

• Extravasation of local anesthetic to the associated spinal nerve may result in associated weakness and numbness of that level.

Side Effects and Adverse Events Related to Facet Joint Injection.

• Diabetic patients may notice a steroid-induced effect on blood glucose levels in the post-injection period.

Recommendation 101. Facet joint injections are of very limited use. One of the following requirements must be met prior to proceeding with a facet joint injection:

• at least 3 months of pain, unresponsive to 6 weeks of conservative therapies, including manual therapy; and • confounding psychosocial risk factors have been screened for and clinically addressed; and • physical examination findings are consistent with facet origin pain (e.g., pain on extension with lateral bending and referral patterns are consistent with the expected pathologic level) that is affecting activity;

• the patient has refused a rhizotomy despite facet origin pain on clinical exam;

• the patient has facet findings with a thoracic component.

Recommendation 102. Repeat facet joint injections are only recommended when the first injection results in a sustained therapeutic response for 3 months or more and is characterized by the following:

• improvement in at least 3 physical examination findings consistent with facet origin pain (e.g., pain on extension with lateral bending and referral patterns consistent with the expected pathologic level), and • at least 80% improvement in an accepted pain scale (e.g., VAS or NRS).

Functional progress supersedes pain improvement.

Recommendation 103. There is no indication for combined facet injection and medial branch block.

Intraarticular facet joint steroid injections are not of diagnostic utility in determining appropriateness for radiofrequency (RF) neurotomy.

Recommendation 104. Facet injections cannot be performed at more than 2 levels, unilaterally or bilaterally.

Time Frames for Facet Joint Injections Time to produce effect Maximum duration Approximately 30 minutes for local anesthetic; 48 to 72 hours for corticosteroid. 2 injections per level per year when at least 3 months of functional benefit is documented. Prior authorization must be obtained for injections beyond 2 levels.

Section 8.a.iii. Intradiscal Injection Introduction. Intradiscal steroid injection is a direct injection of a steroid-containing solution into an intervertebral disc.

Complications of Intradiscal Steroid Injections.

• Complications include infection, pain, bleeding, nerve injury, and allergic reaction to contrast dye.

Recommendation 105. Intradiscal injections are not recommended (table 32).

Table 32.

Evidence Table: Intradiscal Steroid Injection Intradiscal steroid injection is unlikely to relieve pain or provide functional benefit in patients with non-radicular back pain and therefore, they are not recommended.

Section 8.a.iv. Medial Branch Block and Radiofrequency (RF) Denervation Introduction. Medial branch blocks are diagnostic injections used to determine whether a patient is a candidate for radiofrequency (RF) medial branch neurotomy. Medial branch neurotomy, also known as facet rhizotomy, is a procedure designed to denervate the facet joint by ablating the corresponding sensory medial branches. Continuous thermal percutaneous RF is the method frequently used. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for information on the use of repeat RF neurotomy in chronic pain maintenance management.

Absolute and Relative Contraindications to Medial Branch Block or RF Neurotomy.

• Systemic or localized bacterial infection and bleeding diathesis are absolute contraindications to medial branch blocks and RF neurotomy. Poorly controlled diabetes is a relative contraindication if steroids are used post-neurotomy.

• Allergy to contrast material may be a contraindication if alternative contrast material is unavailable.

Complications of Medial Branch Block or RF Neurotomy.

• Complications of medial branch block or RF neurotomy include bleeding, infection, neural injury, localized neuritis, or rarely, a deafferentation centralized pain syndrome.

• Complications of repeat neurotomy include atrophy of spinal musculature with repeat RF neurotomy.

Side Effects and Adverse Events Related to Medial Branch Block or RF Neurotomy.

• Side effects and adverse events related to medial branch block or RF neurotomy include localized pain at the injection and/or RF site and post-injection dysesthesia.

Diagnostics Medial Branch Block Requirements.

Recommendation 106. Diagnostic medial branch blocks are recommended when all of the following are present:

• physical examination findings consistent with facet origin pain (e.g., pain on extension with lateral bending and referral patterns consistent with the expected pathologic level);

• at least 3 months of pain, unresponsive to 6 to 8 weeks of conservative therapies, including manual therapy; and • confounding psychosocial risk factors have been screened for and clinically addressed. See the Recommendation 107. Diagnostic medial branch blocks are limited to 2 anatomic facet joint levels or 3 medial branch levels. Bilateral controlled blocks are permitted, if performed in a way that preserves diagnostic accuracy.

Recommendation 108. A diagnostic response to medial branch blocks must be documented to show its value, including:

• improvement in at least 3 objective functional measures (e.g., spinal ROM; reaching and lifting); and • at least 80% improvement in an accepted pain scale (e.g., VAS or NRS) reported with postinjection provocative testing that is consistent with: o the expected duration of the injected local anesthetic phase, and o a post-injection pain diary with at least 8 hourly response recordings or until the block has clearly worn off.

A successful response to a diagnostic injection requires documentation of positive functional changes by trained personnel and may include nurses, physician assistants, medical assistants, therapists, or noninjectionist physicians. Functional progress supersedes pain improvement.

Recommendation 109. If the diagnostic response to the initial block is considered positive, then a separate confirmatory block using a local anesthetic of different duration on a different date must be performed to confirm the level of involvement prior to rhizotomy.

RF Neurotomy Requirements.

Recommendation 110. RF neurotomy is not recommended for patients with non-facetogenic pain generators or involvement of more than 3 levels of medial branch nerves per side.

Recommendation 111. RF neurotomy is only indicated for those with proven facetogenic joint pain who have met the criteria for a positive response to 2 controlled medial branch blocks, as defined in recommendation 108 (table 33). Intra-articular facet joint steroid injections are not considered diagnostic blocks for the purposes of this criteria.

Recommendation 112. Cooled RF denervation, pulsed RF, dorsal nerve root ganglion RF ablation, and transdiscal biacuplasty are not recommended for the cervical spine.

Repeat RF Neurotomy Requirements.

Recommendation 113. Repeat RF neurotomy may be indicated if the patient experiences sustained (6 months or more), measurable, and clinically meaningful improvement in at least 3 objective functional measures (e.g., spinal ROM; reaching and lifting) and improvement in an accepted pain scale (e.g., VAS or NRS) after initial RF neurotomy (Appendix Functional Scales). Functional progress supersedes pain improvement. The potential for atrophy of the spinal musculature should be factored into clinical decision making.

Recommendation 114. If the patient's pain presents differently than the initial rhizotomy, a confirmatory medial branch block, as outlined in recommendation 108, will be necessary.

Table 33.

Evidence Table: Cervical RF Neurotomy RF neurotomy relieves pain and restores function in patients whose neck pain arises from the facet joint but benefits beyond 1 year are not yet established.

This was determined by a methodologically carefully done study whose application as evidence is limited by the size of the patient sample.

Section 8.a.v. Prolotherapy Introduction. Prolotherapy, also known as sclerotherapy, consists of a series of injections of hypertonic dextrose, with or without glycerine and phenol, into the ligaments of the neck.

Side Effects and Adverse Events Related to Cervical Prolotherapy.

• Side effects and adverse events include a temporary increase in neck pain and stiffness postinjection.

Recommendation 115. Prolotherapy is not recommended for neck pain.

Evidence Tables. None. The above recommendation was based on consensus.

Section 8.a.vi. Trigger Point Injection Introduction. Trigger point injections consist of injection of local anesthetic, with or without corticosteroid, into highly localized, extremely sensitive bands of skeletal muscle fibers that produce local and referred pain when activated.

Absolute and Relative Contraindications to Trigger Point Injection.

• Contraindications include underlying structural issues that more reasonably account for myofascial pain or infection.

Complications of Trigger Point Injection.

• Complications include infection, pneumothorax, anaphylaxis, penetration of the viscera, neurapraxia, neuropathy, syncope, and/or local myopathy (when corticosteroid is injected).

Side Effects and Adverse Events Related to Trigger Point Injection.

• Side effects and adverse events include localized pain.

• If a patient experiences severe pain, there is a possibility of intraneural injection and the needle should be immediately repositioned.

Recommendation 116. Trigger point injections should be reserved for patients who meet all of the following criteria:

• consistent, well circumscribed trigger points with a local twitch response;

• characteristic radiation of pain pattern and local autonomic reaction (e.g., persistent hyperemia following palpation); and • trigger points are not responding to specific, noninvasive, myofascial interventions within a 6week time frame.

Recommendation 117. Concurrent participation in a therapeutic exercise program is required while undergoing myofascial interventions. See the Active Therapies section.

Recommendation 118. Conscious sedation is not recommended for patients receiving trigger point injections.

Time Frames for Trigger Point Injection Time to produce effect Frequency Optimum duration Maximum duration Local anesthetic - up to 30 mins No local anesthetic - up to 48 hrs Weekly 4 weeks 8 weeks No more than 4 injections per session per week to avoid significant post-injection soreness.

Occasional patients may require 2 to 4 repetitions of trigger point injections series over a 1 to 2 year period.

Section 8.a.vii. Botulinum Toxin Injection Introduction. Botulinum toxin injections are used to temporarily weaken or paralyze muscles. These injections may reduce muscle pain in conditions associated with spasticity or dystonia. See the Mild Traumatic Brain Injury MTGs for botulinum toxin injection use in the treatment of cervicogenic and migraine headaches.

Absolute Contraindications to Botulinum Toxin Injection.

• Absolute contraindications to botulinum toxin injection include: o hypersensitivity to any botulinum toxin preparation or any of the components in the formulation, o infection at the proposed injection site, and o motor neuropathy or neuromuscular junction disorders.

Complications of Botulinum Toxin Injection.

• Complications include infection at the injection site.

Side Effects and Adverse Events Related to Botulinum Toxin Injection.

• Side effects and adverse events include flu-like symptoms, dry mouth, dysphagia, weakening of the paracervical musculature, and localized muscular tenderness at the site of injection.

• Neutralizing antibodies develop in at least 4% of patients treated with botulinum toxin type A, rendering it ineffective. Several antigenic types of botulinum toxin have been described.

Botulinum type B appears to be effective in patients who have become resistant to the type A toxin. The immune responses to botulinum toxins type A and B are not cross-reactive, allowing type B toxin to be used when type A action is blocked by antibodies (table 34).

Recommendation 119. Botulinum trigger point injections are not recommended for nonspecific neck pain or myofascial trigger points (table 35).

Recommendation 120. Botulinum toxin injection may be used for centrally mediated spasticity, dystonia, or torticollis resulting in limited ROM.

Recommendation 121. After appropriate dose titration, repeat botulinum injections are only recommended when the first injection results in at least 80% improvement in an accepted pain scale (e.g., VAS or NRS) with associated improvement in currently impaired physical function. Functional progress supersedes pain improvement.

Time Frames for Botulinum Toxin Injections Time to produce effect Duration between injections Maximum duration 24 to 72 hours post-injection* > 3 months** Maximum 4 injections *Peak effect by 4 to 6 weeks. **Patient should be reassessed after each injection session.

Table 34.

Evidence Table: Botulinum Adverse Events Botulinum toxin injections commonly lead to adverse effects.

Cervical botulinum toxin A injections cause transient dysphagia and neck weakness. Allergic reaction to medications, dry mouth, and vocal hoarseness may also occur. Dry mouth and dysphagia occur 15% of the time after 1 injection of botulinum toxin type B.

Among those with cervical dystonia, treatment with botulinum toxin type A is more likely than placebo to lead to adverse effects such as local weakness and dysphagia.

In non-naive botulinum toxin populations, the occurrence of the specific adverse effect of “sore-throat/dry-mouth” was 36.2% higher in patients using botulinum toxin B as compared to patients using botulinum toxin A.

Table 35.

Evidence Table: Botulinum Injection Effectiveness For patients with cervical dystonia, botulinum toxin injections reduce dystonia and pain. They do not provide benefit for nonspecific cervical pain.

Table 35 continued.

Evidence Table: Botulinum Injection Effectiveness Botulinum toxin A has objective and symptomatic benefits over placebo for cervical dystonia.

A single injection of botulinum toxin type B is more effective than placebo in alleviating the severity and pain of idiopathic cervical dystonia. The duration of effect of botulinum toxin type B is not certain but appears to be approximately 12 to 18 weeks.

Botulinum toxin is not different from placebo for cervical pain. Meta

Section 8.b. Surgical Interventions Introduction. Operative treatments are considered when the natural history for surgically treated lesions is better than that of non-operatively treated lesions. Most individuals with neck pain will not need a surgical intervention. See the Overview of Care section • See specific surgical procedure section.

Core requirements.

Recommendation 122. Expedited surgical referral is required for patients with myelopathy, acute fracture, or dislocation or for patients with functional loss due to stenosis and instability and/or progressive neurologic deficits.

Recommendation 123. Surgical referral for patients with cervical radiculopathy is recommended when confirmatory imaging studies specifically correlate with clinical findings, demonstrating nerve root compression or spinal cord compromise and any of the following are present:

• acute, incapacitating pain with progressive neurologic deficits;

• persistent or recurrent arm pain with functional limitations unresponsive to 6 weeks of treatment;

• progressive neurologic deficits; or • static neurologic deficit with significant radicular pain.

Recommendation 124. Surgical referral for patients with persistent non-radicular cervical pain is recommended when frequent symptom recurrence results in functional limitations even if non-operative treatment provides temporary relief and all of the following are present:

• non-operative treatment fails to result in consistent functional improvement;

• diagnostic elimination of confounding psychological or physical conditions that may respond to non-surgical techniques but may be refractory to surgical intervention; and • symptomatic improvement has plateaued and residual functional disability is unacceptable at 6 months.

Recommendation 125. Continuation of exercise and/or active therapy while awaiting a surgical evaluation or surgical procedure is recommended to maintain and optimize physical conditioning.

Recommendation 126. Informed consent is required before all invasive procedures. See the Essential First Line Treatment section.

Recommendation 127. Participation in a postoperative active therapy program that includes core stabilization, strengthening, and endurance is strongly recommended. See the Active Therapies section.

Recommendation 128. Diabetes control and related routine lab work, including hemoglobin A1c, are recommended prior to surgery.

Recommendation 129. A multi-modal approach to postoperative pain management is recommended to avoid overuse and misuse of opioid medications. This approach may include any of the following:

• cognitive behavioral therapy (CBT) (see the Behavioral and Psychological Interventions section);

• pain neuroscience education (see the Active Therapies section);

• use of non-opioid medication strategies as adjunct to anesthesia and pre- or postoperative pain management (see the Medications section);

• use of peripheral regional analgesia; and/or • use of passive therapy for postoperative pain (see the Passive Therapies section).

Recommendation 130. Intraoperative neuromonitoring is permitted to evaluate spinal cord integrity and screw placement during the operative procedure.

Recommendation 131. Percutaneous RF disc decompression and intradiscal electrothermal therapy are not recommended.

Section 8.b.i Discectomy Introduction. Discectomy is a surgical treatment for ruptured or herniated discs of the cervical spine.

There are several procedures in use to decompress extruded disc material around nerve roots, including several minimally invasive techniques. Cervical discectomy is typically paired with fusion. Please see the Spinal Fusion section for additional information. This includes:

• microscopic discectomy, • percutaneous discectomy, • microdiscectomy, and • laser discectomy.

Complications of Cervical Discectomy.

• Complications of discectomy include nerve damage, spinal fluid leakage, esophageal injury, infection, vascular injury, and hemorrhage.

• Complications of percutaneous discectomy include nerve or vessel injury, infection, hematoma, and incomplete nerve root dissection.

Recommendation 132. A psychological screen with a follow-up psychological evaluation, if indicated, is required prior to proceeding with discectomy. If the surgery is being performed in an emergent or urgent situation, the screen is not necessary.

Recommendation 133. For a patient to be a candidate for an isolated cervical discectomy, the provider must document all of the following:

• subjective report of severe radicular pain;

• positive neural compression test (e.g., dural tension, Spurling’s sign, traction/distraction, upper limb tension test) and/or reflex, motor, or sensory changes on examination consistent with imaging findings; and • objective findings of neural compression on imaging studies that specifically correlate with the subjective report and examination findings.

Recommendation 134. ESIs can be trialed prior to surgery if the patient has a preference to avoid surgery, is unable to participate in therapy after the first 2 weeks post-injury, and meets the criteria for ESI outlined in recommendation 95.

Recommendation 135. The decision to proceed with an open or minimally invasive technique for cervical discectomy is left to the treating surgeon’s discretion, experience, and training in these techniques (table 36).

Acute Phase Requirements (Within 6 Weeks of Initial Care).

Recommendation 136. Early referral within 6 weeks for isolated cervical discectomy is permitted when the provider documents all criteria in recommendations 132 and 133 and at least 1 of the following:

• radicular pain-related functional impairment prevents participation in active therapy and ADLs;

• presence of progressive functional neurological deficits; or • an opioid treatment is being considered.

Subacute and Chronic Phase Requirements (After 6 Weeks of Care).

Recommendation 137. Referral for isolated cervical discectomy is permitted for patients who meet the criteria in recommendation 133 and both of the following:

• functional impairment despite 6 weeks of optimal medical management and participation in active therapy; and • confounding psychosocial risk factors have been screened for and clinically addressed (see the Behavioral and Psychological Interventions section).

Recommendation 138. Laser discectomy and percutaneous discectomy are not recommended.

Table 36.

Evidence Table: Effectiveness of Cervical Discectomy Minimally invasive discectomy has not been shown to improve function, extremity pain, or axial pain compared to open discectomy in the setting of cervical and lumbar primary discectomy.

Section 8.b.ii. Decompression for Central or Lateral Spinal Stenosis Introduction. Multiple procedures described in this section offer surgical access to decompress neural elements by partial or total removal of various parts of the spinal elements. These procedures include:

• laminotomy, • laminectomy, • foraminotomy, • facetectomy, • corpectomy, • discectomy, and • laminoplasty.

Absolute and Relative Contraindications to Decompressive Surgery.

• Unaddressed depression or cardiovascular comorbidity are relative contraindications.

• Documented radiographic instability is a contraindication for decompression alone.

• Scoliosis is a relative contraindication to decompression.

Complications of Decompressive Surgery.

• Complications include graft dislodgement, nerve injury, post-surgical instability, cerebrospinal fluid leakage, hematoma, hemorrhage, infection, spinal cord injury causing paralysis, perineural fibrosis, ROM loss, kyphosis, and incomplete decompression.

Recommendation 139. A psychological screen with a follow-up psychological evaluation, if indicated, is required prior to proceeding with decompression. If the surgery is being performed in an emergent or urgent situation, the screen is not necessary.

Recommendation 140. Surgical indications include all of the following:

• radicular symptoms or symptoms of neurogenic claudication, often with clinical evidence of radiculopathy that correlates with the patient’s pain and findings;

• evidence of nerve root or spinal compression on imaging studies; and • failure of non-surgical care, including a trial of 6 weeks of active therapy.

Recommendation 141. Cervical laminoplasty or laminectomy alone is recommended for patients with spinal stenosis or spondylotic myelopathy primarily related to posterior spinal compressive pathology in the absence of kyphosis.

Recommendation 142. Corpectomy or hemicorporectomy with fusion is recommended for patients with 1- or 2- level spinal stenosis, spondylolisthesis, or severe kyphosis and associated spinal cord compression.

Section 8.b.iii. Spinal Fusion Introduction. Spinal fusion is a procedure that unites 2 or more vertebral bodies together to restrict motion and removes a degenerative disc to relieve symptoms of coexistent nerve root compression. The procedure often involves the use of bone grafts, and sometimes instrumentation, to produce a rigid connection between 2 or more adjacent vertebrae.

Absolute and Relative Contraindications to Cervical Fusion.

Morbid obesity is a relative contraindication to fusion (table 37).

Complications of Cervical Fusion.

Complications include instrumentation failure, pseudoarthrosis, superficial or deep wound infection, incomplete decompression, in-hospital mortality, bone graft donor site pain graft extrusion, cerebrospinal fluid leak, laryngeal nerve damage, iatrogenic kyphosis, dysphonia, dysphagia, esophageal perforation, airway obstruction, and acceleration of adjacent segment disease (table 37).

Recommendation 143. Cervical fusion is not recommended in the first 6 months of symptoms, except for acute fracture, dislocation, or for some patients with functional loss due to stenosis and instability, myelopathy, and/or progressive neurologic deficits.

Recommendation 144. Psychological evaluation is required to assess suitability for a cervical fusion.

Documentation should include the following items with associated treatment recommendations:

• psychological factors that might influence elective surgical treatment outcomes; or • psychological factors that might complicate surgical recovery.

Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section (table 38).

Recommendation 145. Spinal fusion is reserved for patients who meet either of the following sets of criteria:

• cervical radiculopathy resulting in incapacitating pain; and • imaging studies (e.g., MRI) consistent with clinical findings, demonstrating nerve root or spinal cord compromise; and • one of the following: o progressive functional neurological deficit; or o persistent motor deficit; or o persistent or recurrent arm pain with functional limitations, unresponsive to conservative treatment after 6 weeks; or o static neurological deficit associated with significant radicular pain.

• persistent non-radicular cervical pain unrelieved by non-operative treatment; and • all pain generators are adequately defined and treated; and • all physical medicine and manual therapy interventions are completed; and • imaging studies demonstrate spinal stenosis with instability or disc pathology, requiring decompression; and • psychological evaluation, with confounding issues addressed as discussed in recommendation 144; and • one of the following: o improvement of symptoms has plateaued and the residual symptoms of pain and signs of functional disability are unacceptable at the end of 6 months of active treatment; or o frequent symptom recurrence causes serious functional limitations even if a nonoperative active treatment program provides satisfactory symptom relief and functional restoration at each occurrence (tables 39, 40).

Recommendation 146. In the absence of radiculopathy, fusion is limited to 2 spinal levels.

Recommendation 147. Discography is not recommended for use in evaluating cervical spine conditions.

Recommendation 148. Tobacco cessation for at least 6 weeks prior to fusion is required, unless the surgeon documents reasoning that the benefits of proceeding with surgery outweigh the risks.

Recommendation 149. Cervical application of recombinant human bone morphogenetic protein (rhBMP) is not recommended (table 37).

Recommendation 150. The choice of bone graft donor site, grafting substance, operative technique, and surgical approach are at the discretion of the treating surgeon (tables 41, 42).

Recommendation 151. Strategic perioperative medication use is recommended for pain management to minimize opioid use and optimize surgical outcome.

Recommendation 152. Postoperative participation in an active therapy program that includes core stabilization, strengthening, and endurance is recommended. See the Active Therapies section.

Recommendation 153. Cervical bracing is permitted following fusion.

Table 37.

Evidence Table: Complications Related to Cervical Fusion Recombinant human bone morphogenetic protein-2 (rhBMP-2) increases the risks of dysphagia, dysphonia, and other postoperative complications in the setting of anterior cervical fusion, but there is uncertainty regarding the risks of cancer associated with the use of bone morphogenetic protein (BMP) in spine fusion of any type and uncertainty about the comparative risks of retrograde ejaculation sometimes attributed to BMP.

Morbid obesity increases hospital length of stay, mortality, and postoperative complications after spinal fusion surgery, with concomitant increases in hospital costs.

Cross sectional Table 38.

Evidence Table: Factors Influencing Surgical Outcomes Depression at the time of surgery and in the early recovery period is associated with poorer functional recovery at 2 years, even though it does not appear to be associated with worse pain at 2 years.

Table 39.

Evidence Table: Anterior Cervical Discectomy and Fusion (ACDF)

Outpatient anterior cervical discectomy and fusion (ACDF) and inpatient ACDF both have low postoperative complication rates, and there is no difference in risks of commonly occurring complications for the procedure between the 2 settings, but there is insufficient evidence to compare the safety of the 2 settings for rare but potentially catastrophic events.

In the setting of symptomatic cervical radiculopathy from herniated discs and/or osteophytes at 1 or 2 levels, it is reasonable to initiate a program of structured physical therapy before any surgical decisions are made, since many patients will experience significant improvement in pain and function.

However, a program of ACDF plus structured physical therapy is likely to be superior to physical therapy alone, and the improvements appear to continue for at least 5 to 8 years.

Table 40.

Evidence Table: ACDF Versus Total Disc Arthroplasty Both cervical disc arthroplasty (CDA) and ACDF are safe and effective interventions for patients with cervical degenerative disc disease. CDA leads to greater improvements in pain and disability and fewer reoperations than ACDF.

For patients with cervical degenerative disc disease at 1 or 2 levels, both CDA and ACDF are safe and effective interventions leading to symptomatic relief and functional improvement.

In patients with single level radiculopathy or myelopathy, cervical artificial disc produces 2-year success rates at least equal to those of ACDF with allograft interbody fusion and an anterior plate.

For patients with single-level cervical degenerative disc disease, there is strong evidence that both CDA and ACDF are safe and effective interventions leading to symptomatic relief and functional improvement.

Overall success, ascertained by improvement in neck disability scores combined with favorable neurological outcome and no repeat surgery at the operated level, is better with CDA than with ACDF.

Table 40 continued.

Evidence Table: ACDF Versus Total Disc Arthroplasty In patients with stable 1 or 2 level cervical disc disease who have minimal facet joint degeneration and bone mineral density greater than a T-score of - 1.5, and who do not have axial neck pain as the sole presenting symptom, treatment with either total disc replacement (TDR) or ACDF are likely to alleviate pain and disability for at least 7 years, and that the TDR procedure is likely to confer greater benefit than fusion. Reoperation rates may be lower with disc replacement but this inference must be made with considerable caution.

CDA leads to slightly better outcomes than ACDF for improvements in neck and arm pain and cervical spine function.

CDA is associated with fewer repeat operations at adjacent spine levels than ACDF for the first several years after the surgery is performed.

In the setting of radiographically stable cervical degenerative disc disease from C3 to C7 at 2 adjacent levels, CDA is at least as safe and effective as fusion with an anterior plate and a ring allograft, and is likely to require fewer reoperations in the first 2 years after surgery.

In patients with single-level cervical radiculopathy, without signs of myelopathy and with preservation of at least 3mm of disc height, equally good improvements in neck disability are expected after 2 years with any of 3 operations: anterior cervical discectomy alone, anterior cervical discectomy with fusion and a polyetheretherketone (PEEK) cage, or anterior CDA.

Evidence is lacking to suggest that the development of adjacent segment degeneration is significantly different after 2 years with 1 or another of these 3 surgical options.

Cervical TDR requires fewer revision operations than ACDF after the first 2 years of treatment, and TDR slightly decreases neck pain at 5 years compared to ACDF. Half of the reoperations in the ACDF group were at adjacent levels.

Table 41.

Evidence Table: Cervical Fusion Graft Site In the setting of ACDF, P-15 (trademark name i-Factor), a 15 amino acid peptide, is noninferior to local bone autograft for achieving radiographic fusion, improvement in neck disability, and neurologic success, and has a safety profile similar to that of autograft.

Table 42.

Evidence Table: Cervical Fusion - Other Technical Issues In the setting of spine fusion surgery, the use of antifibrinolytics such as tranexamic acid reduces intraoperative blood loss and total blood loss, leading to lower transfusion requirements, while not being accompanied with significant adverse effects compared to no antifibrinolytic use.

In cervical fusion for degenerative disease, iliac crest autograft provides greater fusion rates, but cages are a valid alternative as cages result in fewer complications from surgery.

In the setting of ACDF, a zero-profile implant is less likely to lead to postoperative dysphagia than a conventional cervical plate for up to 1 year after the operation.

In the setting of ACDF, a PEEK cage filled with bone graft substitute in the form of calcium sulfate and demineralized bone matrix achieves similar rates of fusion and clinical success as a PEEK cage filled with iliac crest autograft, while eliminating morbidity related to the donor site.

Section 8.b.iv. Cervical Total Disc Replacement (TDR)

Introduction. Cervical total disc replacement (TDR) is a surgical procedure where a degenerated disc is replaced with a prosthetic device after decompression of the neural elements is completed. The endplates are positioned under intraoperative fluoroscopic guidance for optimal placement in the sagittal and frontal planes. The prosthetic device physiologically distributes the mechanical load of the vertebrae and maintains ROM.

Absolute and Relative Contraindications to Cervical TDR.

• Absolute and relative contraindications include: o significant spinal deformity and scoliosis; o symptomatic facet joint arthrosis; o osteopenia, osteoporosis, or any metabolic bone disease; o spinal instability at the pathologic level; o spinal instability at an adjacent level that is not appropriate for fusion; o deficient posterior elements; o infection; o previous compression or burst fracture; o spondylolisthesis > 3 mm; o spondylolysis; o chronic steroid or other medication use that interferes with bone or soft tissue healing; o allergy to device materials; o morbid obesity (e.g., body mass index > 40 kg/m2 or over 100 pounds overweight); o active malignancy; or o generalized chronic pain.

Complications of Cervical TDR.

• Complications include nerve and vascular injury, dural tears, malpositioning/suboptimal positioning of prosthesis, implant failure, complex regional pain syndrome, and need for reoperation.

Recommendation 154. Psychological evaluation is required to assess suitability for cervical disc replacement. Documentation should include the following items with associated treatment recommendations:

• psychological factors that might influence elective surgical treatment outcomes, or • psychological factors that might complicate surgical recovery.

Confounding depression or anxiety must be addressed prior to proceeding with surgery. Presurgical psychological evaluation should not be done by a psychologist employed by the physician performing the procedure. See the Behavioral and Psychological Interventions section.

Recommendation 155. Cervical TDR is reserved for patients who meet either of the following sets of criteria:

• symptomatic 1- or 2- level disc disease established by objective testing (e.g., CT scan or MRI) with established radiculopathy or myelopathy unrelieved after 6 weeks of active nonsurgical treatment; and • radiculopathy or myelopathy documented by electromyography or MRI with correlated objective findings;

• symptoms unrelieved after 6 months of active nonsurgical treatment; and • all pain generators are adequately defined and treated; and • all physical medicine and manual therapy interventions are completed; and • imaging studies demonstrate disc pathology requiring decompression; and • psychosocial evaluation as outlined in recommendation 154, with confounding issues addressed (table 43).

Recommendation 156. If there are signs suggestive of facet-mediated pain, the pain must be evaluated with medial branch blocks before proceeding with disc replacement.

Recommendation 157. A trial of multi-disciplinary therapy must occur prior to proceeding with surgery.

Recommendation 158. Surgeons performing total disc arthroplasty must have attended training courses or undergone disc replacement training in fellowship. It is highly recommended that the surgeon is mentored and proctored.

Table 43.

Evidence Table: Total Disc Arthroplasty Versus Spinal Fusion Both CDA and ACDF are safe and effective interventions for patients with cervical degenerative disc disease. CDA leads to greater improvements in pain and disability, and fewer reoperations, than ACDF.

For patients with cervical degenerative disc disease at 1 or 2 levels, both CDA and ACDF are safe and effective interventions leading to symptomatic relief and functional improvement.

Table 43 continued.

Evidence Table: Total Disc Arthroplasty Versus Spinal Fusion In patients with single level radiculopathy or myelopathy, cervical artificial disc produces 2-year success rates at least equal to those of ACDF with allograft interbody fusion and an anterior plate.

For patients with single-level cervical degenerative disc disease, there is strong evidence that both CDA and ACDF are safe and effective interventions leading to symptomatic relief and functional improvement.

CDA is associated with fewer repeat operations at adjacent spine levels than ACDF for the first several years after the surgery is performed.

CDA leads to slightly better outcomes than ACDF for improvements in neck and arm pain and cervical spine function.

In patients with stable 1 or 2 level cervical disc disease who have minimal facet joint degeneration and bone mineral density greater than a T-score of - 1.5, and who do not have axial neck pain as the sole presenting symptom, treatment with either TDR or ACDF are likely to alleviate pain and disability for at least 7 years, and that the TDR procedure is likely to confer greater benefit than fusion. Reoperation rates may be lower with disc replacement but this inference must be made with considerable caution.

Overall success, ascertained by improvement in neck disability scores combined with favorable neurological outcome and no repeat surgery at the operated level, is better with CDA than with ACDF.

In the setting of radiographically stable cervical degenerative disc disease from C3 to C7 at 2 adjacent levels, CDA is at least as safe and effective as fusion with an anterior plate and a ring allograft, and is likely to require fewer reoperations in the first 2 years after surgery.

Cervical TDR requires fewer revision operations than ACDF after the first 2 years of treatment, and TDR slightly decreases neck pain at 5 years compared to ACDF. Half of the reoperations in the ACDF group were at adjacent levels.

In patients with single-level cervical radiculopathy, without signs of myelopathy and with preservation of at least 3mm of disc height, equally good improvements in neck disability are expected after 2 years with any of 3 operations: anterior cervical discectomy alone, anterior cervical discectomy with fusion and a PEEK cage, or anterior CDA.

Evidence is lacking to suggest that the development of adjacent segment degeneration is significantly different after 2 years with 1 or another of these 3 surgical options.

Section 8.b.v. Spinal Cord Stimulators Introduction. Spinal cord stimulation is the delivery of low-voltage electrical stimulation to the spinal cord or peripheral nerves to inhibit or block the sensation of pain. The system uses implanted electrical leads and a battery powered implanted pulse generator. See the Chronic Pain Disorder MTGs.

Recommendation 159. Neurostimulation is reserved for patients who meet the criteria outlined in the Chronic Pain Disorder MTGs.

Evidence Tables. See the Chronic Pain Disorder MTGs for evidence.

Section 8.b.vi. Epiduroscopy with Epidural Lysis of Adhesions Introduction. Epiduroscopy and epidural lysis of adhesions involves the introduction of a fiberoptic endoscope into the epidural space. A saline irrigation is performed with or without epiduroscopy to distend the epidural space and result in lysis of adhesions.

Complications of Epiduroscopy.:

• Saline irrigation on epiduroscopy and lysis of adhesions is associated with risks of elevated pressures that may impede blood flow and venous return, possibly causing ischemia of the cauda equina and retinal hemorrhage.

• Other epiduroscopy complications associated with instrumented lysis include catheter shearing, need for catheter surgical removal, infection (including meningitis), hematoma, and possible severe hemodynamic instability during application.

Recommendation 160. Epiduroscopy and mechanical lysis of adhesions and epiduroscopy-directed steroid injections are not recommended.

Evidence Tables. See the Chronic Pain Disorder MTGs for evidence.

Section 9. Medications Introduction. Medications are used in the treatment of neck injuries to control acute pain, chronic pain, and inflammation. Use of medications will vary widely due to the spectrum of injuries. If medications are being considered for long-term chronic pain management, refer to the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) medication section.

• See the specific medication section. The medication lists within these sections do not provide complete information on side effects, potential complications, drug interactions, or drug monitoring. For more complete information, refer to the Chronic Pain Disorder MTGs medication

section or a medication reference text.

Recommendation 161. Medication reconciliation is required at the initial visit and periodically during treatment to avoid medication errors and to discuss side effects, drug interactions, and expected functional goals. Reconciliation includes the following elements:

• current medication name, dosage, frequency, and route;

• patient understanding of indication;

• potential interaction of prescription and over the counter medications;

• drug allergies;

• comorbid medical issues;

• history of substance abuse; and • checking the Colorado Prescription Drug Monitoring Program (PDMP).

The medications documented as a part of the reconciliation will reflect those that the provider deems directly relevant to the claim-related condition.

Recommendation 162. A therapeutic trial of medications is recommended to evaluate the effect on functional status. The length of a medication trial will depend on the individual medication, and the patient should be informed on the time to expected benefit. If no functional benefit is observed at that time, the medication should be discontinued.

Recommendation 163. Medications should be initiated at the lowest dose expected to result in functional improvement and then titrated based on clinical response.

Section 9.a. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Acetaminophen Introduction. Non-steroidal anti-inflammatory drugs (NSAIDs) are medications for neck pain and inflammation. Acetaminophen is an analgesic commonly used to treat mild pain.

Absolute and Relative Contraindications to Acetaminophen and NSAIDs.

• Acetaminophen o Concomitant use of other drug products containing acetaminophen exceeding the maximum recommended daily dose of acetaminophen. o Allergy to acetaminophen or any of the inactive ingredients. o Use with caution in patients with alcoholic liver disease, patients with hepatic impairment or active liver disease, and patients with known glucose-6-phosphate-dehydrogenase (G6PD) deficiency.

• NSAIDs (table 44) o Comorbid conditions that result in an increased risk for gastrointestinal (GI), renal, or cardiovascular adverse reactions. o Patients at risk for GI bleeding, including patients who use alcohol, smoke, are older than 65 years old, take corticosteroids or anti-coagulants, and patients on longer durations of o Celecoxib is contraindicated in sulfonamide allergic patients. o Contraindicated in patients with aspirin-exacerbated respiratory disease due to crossreactivity risk and potential for a severe asthma attack.

• Topical salicylate and non-salicylate medications may result in alterations in bleeding time; they should be used with caution in patients on warfarin therapy.

Side Effects and Adverse Events Related to Specific Classes of Acetaminophen and NSAIDs.

• Acetaminophen may result in hepatotoxicity, and chronic use may result in chronic kidney disease, hypersensitivity or anaphylactic reactions, serious and potentially fatal skin reactions, hypertension, chronic daily headaches, and peptic ulcer disease.

• NSAIDs may result in abnormal or worsening renal function, including renal failure; abnormal liver function; GI bleeding, particularly in patients at higher risk for a bleed; increased risk of cardiovascular events; gastric or duodenal perforation and ulceration; anaphylactoid reaction; platelet function abnormalities; and fluid retention and edema. Postoperative NSAIDs may increase the risk of nonunion at higher doses.

• Topical agents may result in localized skin reactions.

Recommendation 164. Acetaminophen or NSAIDs are recommended for initial analgesic treatment of uncomplicated neck pain (tables 45, 46).

Recommendation 165. Co-prescription of a proton pump inhibitor, histamine H2-receptor antagonists (H2-blockers), or prostaglandin analog with NSAIDs is recommended to reduce risk of duodenal or gastric ulceration in patients with concurrent antiplatelet or corticosteroid therapy.

Recommendation 166. Cyclooxygenase-2 (COX-2) inhibitors are not recommended as a first-line agent for short-term use in low-risk patients, but they can be used for patients who do not tolerate traditional NSAIDs.

Recommendation 167. Topical NSAIDs are recommended when oral NSAID use is contraindicated due to systemic side effects. It must be started with the lowest dose anticipated to achieve the desired clinical effect and then titrated until functional improvement is noted (table 47).

Recommendation 168. Perioperative use of acetaminophen and/or NSAIDs, either alone or in combination with other medications, to optimize analgesia is recommended.

Recommendation 169. See the Chronic Pain Disorder MTGs medication section if acetaminophen or NSAIDs are being considered for long-term use.

Time Frames for Medications Acetaminophen up to 10 days Extended use on a case-by-case basis NSAIDs 7 days 1 year Use of this substance long-term (for 3 days per week or greater) may be associated with rebound pain upon cessation.

Table 44.

Evidence Table: Adverse Events and NSAIDs Naproxen has a more favorable cardiovascular profile than other NSAIDs when used over a long period for chronic pain.

Celecoxib in a dose of 200 mg per day, administered over a long period, does not have a worse cardiovascular risk profile than naproxen at a dose of up to 1000 mg per day or ibuprofen at a dose of up to 2400 mg per day.

Celecoxib has a more favorable safety profile than ibuprofen or naproxen with respect to serious GI adverse events, and has a more favorable safety profile than ibuprofen with respect to renal adverse events.

Fewer adverse events occurred in NSAIDs treatment arms as compared to placebo in patients experiencing chronic low back pain.

Topical NSAIDs are associated with fewer systemic adverse events than oral NSAIDs.

Table 45.

Evidence Table: Acetaminophen In the setting of acute nonspecific low back pain, acetaminophen at a dose of up to 4 grams per day is no more effective than placebo for pain relief and for improvement of disability.

Table 46.

Evidence Table: NSAIDs NSAIDs may reduce acute low back pain and short term disability when compared to placebo, but the clinical benefit is small. Postoperative NSAIDs may increase the risk of nonunion at higher doses. While the literature in this table discusses low back pain, there is presumed physiologic similarity for neck pain.

For persistent low-back pain, oral NSAIDs are more effective than placebo or acetaminophen.

Table 46 continued.

Evidence Table: NSAIDs In the setting of lumbar spinal fusion, NSAIDs at an equivalence of no more than 120 mg of ketorolac for 14 days postoperatively do not appear to increase the risk of nonunion of the operated spinal segment.

In the setting of acute low back pain lasting less than 12 weeks, NSAIDs lead to a small reduction in short term pain intensity, approximately 10 points on a 100 point scale, compared to placebo.

NSAIDs are not more beneficial than placebo when evaluating pain-intensity and disability outcomes; the change in these scores does not reach a minimal clinical important difference in patients experiencing chronic low back pain.

In the setting of lumbar fusion without bone morphogenetic protein (BMP), postoperative NSAIDs with an equivalent dose of more than 300 mg of diclofenac are associated with an increased risk of nonunion of the operated spinal segment. There appears to be a dose-dependent effect of postoperative NSAIDs on the risk of nonunion.

Table 47.

Evidence Table: Topical NSAIDs for Analgesia Topical NSAIDs are more effective than placebo vehicles, such as gels or creams, in the setting of acute musculoskeletal injuries.

Section 9.b. Muscle Relaxants Introduction. Muscle relaxants are a heterogeneous class of medications with varying mechanisms of action used to treat muscle spasm associated with neck injury.

Absolute and Relative Contraindications to Muscle Relaxants.

• Cyclobenzaprine should not be used when a patient has a history of cardiac dysrhythmia or when there is concurrent use of monoamine oxidase inhibitors.

• Metaxalone should not be used when there is a history of significantly impaired renal or hepatic disease, pregnancy, and predisposition to drug induced hemolytic anemia.

• Methocarbamol should not be used when the patient has a hypersensitivity to the medication or there is possible renal compromise.

• Tizanidine should not be used when there is concurrent use of ciprofloxacin or fluvoxamine or hepatic disease.

Side Effects and Adverse Events Related to Muscle Relaxants.

• Cyclobenzaprine may cause sedation, anticholinergic reactions, and blurred vision. Patients should also be monitored for suicidal ideation and drug abuse.

• Metaxalone may cause sedation and hematologic abnormalities.

• Methocarbamol may cause decreased cognition, lightheadedness, and GI side effects.

• Tizanidine may cause hypotension, sedation, hepatotoxicity, hallucinations, psychosis, dry mouth.

Recommendation 170. Muscle relaxants may be used as an adjunct to rest and active therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions (table 48).

Recommendation 171. Tizanidine (alpha-2 adrenergic agonist) is only approved by the Food and Drug Administration (FDA) for the treatment of true centrally mediated spasticity associated with musculoskeletal disorders. Use for musculoskeletal conditions, such as neck or back pain, would be “off label.”

Recommendation 172. Benzodiazepines are not recommended for use in combination with opioids due to the elevated risk of death due to respiratory depression.

Recommendation 173. See the Chronic Pain Disorder MTGs medication section if muscle relaxants are being considered for long-term use.

Time Frames for Muscle Relaxants 1 week 2 weeks or longer, if only used at night.

Table 48.

Evidence Table: Muscle Relaxants For patients with spine pain, muscle relaxants provide greater short-term pain relief than placebo.

However, they do not provide additional benefit over NSAIDs alone, and they increase adverse events.

While the literature in this table discusses low back pain, there is presumed physiologic similarity for neck pain.

Non-benzodiazepine muscle relaxants are more effective than placebo for providing short-term pain relief in acute low back pain. They should be used with caution because of central nervous system side effects.

In patients with acute nontraumatic musculoskeletal low back pain who have optimized their use of NSAIDs such as naproxen, the addition of cyclobenzaprine 5mg to be taken as needed adds no significant functional benefit in the short term, but it does increase the frequency of adverse events such as dizziness, drowsiness, and GI side effects.

In the setting of acute nonradicular, nontraumatic musculoskeletal low back pain of 2 weeks duration or less, the addition of diazepam to naproxen adds no additional pain relief or reduction of functional disability beyond that of placebo.

Section 9.c. Oral Steroids Introduction. Oral steroids are used for pain and inflammation.

Absolute and Relative Contraindications to Oral Steroids.

• Absolute and relative contraindications include poorly controlled diabetes mellitus or hypertension; heart failure with peripheral edema; cataract or glaucoma; peptic ulcer disease; presence of injection; and low bone mineral density or osteoporosis.

Complications of Oral Steroids.

• Complications include gastritis, ulcer formation, and GI bleeding.

Side Effects and Adverse Events Related to Oral Steroids.

• Side effects and adverse events include fluid retention, mood disturbance, and hyperglycemia.

Recommendation 174. Oral steroids are generally not recommended for the treatment of acute neck pain with or without radiculopathy (table 49).

Table 49.

Evidence Table: Oral Steroids for Radicular Pain For patients with radicular pain, oral steroids do not provide clinically important improvements in function or pain, nor reductions in the rate of surgery. They also increase the risk for serious adverse effects. While the literature in this table discusses radicular low back pain, there is presumed physiologic similarity for radicular neck pain.

In patients with an acutely herniated lumbar disc with radicular symptoms, a 15-day course of tapering oral prednisone may produce a small improvement in spine function compared to placebo, but this improvement is of very uncertain clinical importance. Also, there is no evidence that oral prednisone reduces the rate of back surgery in the following year. The benefits of a small functional improvement should be weighed against the frequent occurrence of steroid-related adverse effects such as insomnia, nervousness, and increased appetite. There is no evidence that oral prednisone reduces sciatica pain compared to placebo.

In patients who have not taken oral steroids in the past year, short-term use of an oral steroid can increase the risk of fracture, sepsis, and venous thromboembolism in the subsequent 5 to 90 days, with the greatest increased risk occurring in the first 5-30 days after the prescription is filled.

(Waljee et al., 2017)

Among patients presenting to the emergency department with acute onset of musculoskeletal or radicular low back pain or acute exacerbation of chronic low back pain, a 5-day course of 50 mg oral prednisone results in similar pain reduction at 5 days post-discharge when compared to a placebo given over 5 days.

A short course of oral corticosteroids, lasting 14 days or fewer, is associated with an increased incidence of GI bleeding, sepsis, and heart failure in the period following their administration.

Table 50.

Evidence Table: Other Medications Bisphosphonates taken alone or in combination with calcium and/or vitamin D are more beneficial than placebo taken alone or with calcium and/or vitamin D for the prevention and treatment of spinal glucocorticoid induced osteoporosis, with data extending to 24 months of use.

Section 9.d. Gabapentinoids Introduction. Gabapentinoids are anticonvulsant and nerve pain medications that may be used to treat neuropathic symptoms. They include gabapentin and pregabalin.

Absolute and Relative Contraindications to Gabapentinoids.

• Renal insufficiency is a relative contraindication to gabapentin use, but dosage can be adjusted to accommodate use in the setting of renal dysfunction.

Side Effects and Adverse Events Related to Gabapentinoids.

• Gabapentinoids may cause dizziness, sedation, and respiratory depression in older patients who receive gabapentin along with other analgesics or sedatives.

• Coadministration of opioids and pregabalin or gabapentin may increase the risk of opioid related mortality.

• Gabapentinoids may be associated with an increased risk of mental health disturbance (e.g., depression, suicide), unintentional overdose, and motor vehicle accidents.

Recommendation 175. A trial of oral gabapentin, with a goal of using the lowest dose expected to result in functional improvement, can be used for patients with radicular cervical pain (table 51).

Recommendation 176. If a gabapentinoid is being considered for long-term, chronic pain management, refer to the Chronic Pain Disorder MTGs medication section.

Table 51.

Evidence Table: Gabapentinoids Gabapentin is more effective than placebo in the relief of painful diabetic neuropathy and postherpetic neuralgia.

Section 9.e. Antidepressants Introduction. Antidepressants are used for the treatment of pain, dysesthesias, sleep disorders, and depression. If medications are being considered for chronic pain management, refer to the Chronic Pain Disorder MTGs medication section.

Absolute and Relative Contraindications to Antidepressants.

• Tricyclic antidepressants should be avoided in patients with the following: o at risk of unintentional overdose; o heart disease; o underlying cardiac conduction system disease; o dysrhythmia; o prostatic hypertrophy; o at risk for suicide; o uncontrolled hypertension or orthostatic hypotension; o those 65 years or older, particularly if a fall risk; and o seizure disorder.

• Serotonin norepinephrine reuptake inhibitors (SNRIs) should not be used in patients with seizures or eating disorders.

Complications of Antidepressants.

• Tricyclic antidepressants may cause acute hepatitis, neuroleptic malignant syndrome, and tardive dyskinesia.

• SNRIs may result in serotonin syndrome.

• Venlafaxine may cause hypertension, glaucoma, sexual dysfunction, and cardiac issues.

Side Effects and Adverse Events Related to Antidepressants • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline) may cause anticholinergic effects (e.g., sedation, dry mouth and associated periodontal conditions, orthostatic hypotension, constipation, urinary retention); decreased seizure threshold; sexual dysfunction; diaphoresis; tremor; antihistamine effects; alpha-1-adrenergic receptor blockade; and cardiac effects, including increasing intraventricular conduction, prolonged QT interval, prolonged conduction through the atrioventricular node.

• SNRIs (e.g., duloxetine, venlafaxine) may cause nausea, dizziness, sweating, loss of appetite, dry mouth, insomnia, drowsiness, constipation, abnormal bleeding, fatigue, sexual dysfunction, and suicidal ideation and attempts in adolescents and young adults.

Recommendation 177. Tricyclic antidepressants are the recommended first-line agent for neuropathic pain, particularly in the setting of insomnia, but they are not recommended as a first-line agent for depression.

Recommendation 178. SNRIs are recommended as a second-line agent for neuropathic pain if a tricyclic offers inadequate relief. However, duloxetine may be considered a first-line agent for a patient who is a candidate for pharmacologic treatment of both chronic pain and depression.

Recommendation 179. Selective serotonin reuptake inhibitors (SSRIs) are recommended for treating depression, but they are not recommended for neuropathic pain.

Recommendation 180. Evaluation and ongoing monitoring for suicidal ideation and mood swings are required for all patients being considered for antidepressant medications.

Recommendation 181. A screening electrocardiogram may be indicated for select patients prior to initiating treatment with a tricyclic or SNRI antidepressant to assess cardiovascular risk.

Time Frames for Antidepressant Medications up to 6 months up to 12 months, with monitoring

Section 9.f. Opioids Introduction. Opioids are powerful analgesics reserved for severe, acute pain associated with major trauma, burn, sickle cell disease, and end-of-life cancer pain. If opioid medications are being considered for chronic pain management, refer to the Chronic Pain Disorder MTGs medication section.

Absolute and Relative Contraindications to Opioids.

• Opioids should not be prescribed with benzodiazepines, antihistamines, or other central nervous system depressants or when the history is consistent with regular alcohol or other substance use.

• Tramadol should be used with caution in patients who have a history of seizures, are taking medications that lower the seizure threshold, or are taking medications that impact serotonin reuptake and could increase the risk for serotonin syndrome, such as monoamine oxidase inhibitors, SSRIs, selective serotonin agonists (triptans), tricyclic antidepressants, and alcohol.

Also use caution in patients who are taking medications that result in QT prolongation. Tramadol has been associated with death in those with an emotional disturbance or concurrent use of alcohol and other opioids. Significant renal and hepatic dysfunction requires dosage adjustment.

Side Effects and Adverse Events Related to Opioids.

• Opioid medications may commonly cause nausea, vomiting, drowsiness, unsteadiness, constipation, and confusion. Occasional side effects include dry mouth, sweating, pruritus, hallucinations, and myoclonus. Adverse events include opioid-induced hyperalgesia, respiratory depression, dependence, opioid use disorder, overdose, or death. Prolonged opioid use may result in hypogonadism (tables 52, 53). Abrupt discontinuation may precipitate withdrawal.

• Certain comorbid medical conditions can increase the risk for opioid overdose (e.g., obesity, pulmonary disease, obstructive sleep apnea, congestive heart failure, history of alcohol or substance use disorder, advanced age, renal or hepatic dysfunction).

Recommendation 182. Opioid medications are not generally recommended for the treatment of neck pain. Rare exceptions include either of the following:

• acute, severe functionally limiting pain in a patient for whom other non-opioid medications are contraindicated; or • acute, severe functionally limiting pain that is refractory to non-opioid medications and nonpharmacologic treatment and an absence of risk factors for potential misuse or abuse (table 54).

Recommendation 183. Long-acting opioids are not recommended for the treatment of acute, subacute, or postoperative pain.

Recommendation 184. Opioid medications, including tramadol, are not generally recommended for use in patients with a history of opioid dependence. However, if an opioid medication is deemed clinically appropriate, a referral to a pain specialist is permitted.

Short-term Prescribing Requirements.

Recommendation 185. Prior to dispensing an opioid medication, the following steps are required:

• documented results of a rapid risk assessment for developing opioid use disorder (e.g., Opioid Risk Tool [ORT]), • risk assessment of developing opioid related adverse events, • review data on the Colorado PDMP, • education on the short- and long-term risks and side effects of opioid therapy, • realistic goals of opioid therapy and the anticipated course of recovery, • establish the lowest effective dose and shortest duration of therapy, • education on the safe storage and disposal of opioid medications, and • develop a discontinuation plan for opioids prior to prescribing.

Prescribing Requirements Beyond 7 Days.

Recommendation 186. Whenever opioids are prescribed for more than 7 days, providers must follow all recommendations for screening and follow-up of chronic pain use. See the Chronic Pain Disorder MTGs.

Time Frames for Opioids ≤ 3 days 7 days Whenever there is use of opioids for > 7 days, providers should follow all recommendations for screening and follow-ups of chronic pain use.

Table 52.

Evidence Table: Risk of Initiating Opioid Medications Short-term opioid prescriptions increase the risk of disability and the risk of developing an opioid use disorder. The use of 50 morphine milligram equivalents (MME) or greater average daily dose or the use of long-acting opioids increases the risk of opioid-related death.

In the setting of common low back injuries, when baseline pain and injury severity are taken into account, a prescription for more than 7 days of opioids in the first 6 weeks is associated with an approximate doubling of disability 1 year after the injury.

In the setting of new onset chronic noncancer pain, there is a clinically important relationship between opioid prescription and subsequent opioid use disorder. Compared to no opioid use, short-term opioid use approximately triples the risk of opioid use disorder in the next 18 months. Use of opioids for over 90 days is associated with very pronounced increased risks of the subsequent development of an opioid use disorder, which may be as much as 100-fold when doses greater than 120 MME are taken for more than 90 days.

The absolute risk of these disorders is very uncertain but is likely to be greater than 6.1% for long duration treatment with a high opioid dose.

In generally healthy patients with chronic musculoskeletal pain, treatment with long-acting opioids, compared to treatments with anticonvulsants or antidepressants, is associated with an increased risk of death of approximately 69%, most of which arises from non-overdose causes, principally cardiovascular in nature. The excess cardiovascular mortality principally occurs in the first 180 days from starting opioid treatment.

Prescription opioids in excess of 200 MME average daily doses are associated with a near tripling of the risk of opioid-related death, compared to average daily doses of 20 MME. Average daily doses of 100-200 mg and doses of 50- 99 mg per day may be associated with a doubling of mortality risk, but these risk estimates need to be replicated with larger studies.

Compared to an opioid dose under 20 MME per day, a dose of 20-50 mg nearly doubles the risk of death, a dose of 50 to 100 mg may increase the risk more than fourfold, and a dose greater than 100 mg per day may increase the risk as much as sevenfold. However, the absolute risk of fatal overdose in chronic pain patients is fairly low, and may be as low as 0.04%.

Table 53.

Evidence Table: Adverse Effects of Opioid Medications Adverse events such as constipation, dizziness, and drowsiness are more frequent with opioids than with placebo.

Opioids produce significantly more adverse effects than placebo such as constipation, drowsiness, dizziness, nausea, and vomiting.

Table 54.

Evidence Table: Opioid Medications Effectiveness The majority of patients with musculoskeletal pain do not experience clinically meaningful pain relief or functional improvement with opioid treatment as compared to placebo. For patients with neuropathic pain, there is no evidence that opioid treatment improves function or quality of life. For neuropathic pain patients, opioid treatment is more likely to result in pain relief as compared to placebo, but there is no evidence that opioids are superior to gabapentin or nortriptyline for this indication. Opioids produce significantly more adverse effects than placebo. While the literature in this table discusses chronic low back pain, there is presumed physiologic similarity for neck pain.

In the setting of chronic nonspecific low back pain, the short and intermediate term reduction in pain intensity of opioids, compared with placebo, falls short of a clinically important level of effectiveness for a majority of patients, although some patients may experience a clinically meaningful analgesic benefit.

In patients with chronic low back pain, or chronic pain from osteoarthritis of the hip and knee, opioid therapy does not lead to better pain outcomes in terms of daily functioning or in pain intensity.

In patients with acute nontraumatic musculoskeletal low back pain who have optimized their use of NSAIDs such as naproxen, the addition of oxycodone 5 mg/acetaminophen 325 mg to be taken as needed adds no significant functional benefit in the short term, but it does increase the frequency of adverse events such as dizziness, drowsiness, and GI side effects.

Opioids are more efficient than placebo in reducing neuropathic pain by clinically significant amounts during the first 8 weeks of treatment.

Lack of Lack of evidence statement Design There is a lack of evidence that opioids improve function and quality of life more effectively than placebo.

There is a lack of evidence that opioids are superior to gabapentin or nortriptyline for pain reduction.

Section 9.g. Tobacco Cessation Introduction. Nicotine replacement therapy is used to relieve nicotine withdrawal symptoms by providing nicotine without the use of tobacco. The mechanism of bupropion in smoking cessation is not entirely understood, but it is believed to act by enhancing central nervous system noradrenergic and dopaminergic release. Varenicline reduces the symptoms of nicotine withdrawal by binding to the receptor that mediates the reinforcing effects of nicotine dependence.

Absolute and Relative Contraindications to Tobacco Cessation Therapies.

• Use nicotine replacement therapy with caution in patients with unstable cardiovascular disease.

• Bupropion is contraindicated in those with seizure disorders.

Side Effects and Adverse Events Related to Tobacco Cessation Therapies.

• Nicotine replacement therapy can cause GI symptoms, headache, and local irritation with topical products.

• Bupropion can cause insomnia, agitation, dry mouth, and headache.

• Varenicline can cause nausea, insomnia, neuropsychiatric disorders, and abnormal dreams.

• Review package insert for supplement contraindications and side effects.

Recommendation 187. Tobacco cessation, including medication and behavioral support, are recommended when tobacco use is expected to negatively impact claim-related medical outcomes.

Medications may include nicotine patches, gum, inhaler, lozenges or nasal spray, bupropion, or varenicline (table 55).

Table 55.

Evidence Table: Smoking and Non-Operative Spine Care Patients who smoke respond less favorably to non-operative spine care than nonsmokers, and quitting smoking during treatment results in greater improvement than patients who continue smoking during treatment.

Section 10. Interdisciplinary Rehabilitation Programs Introduction. These guidelines discuss an interdisciplinary approach to neck pain treatment in the acute and subacute timeframes. Interdisciplinary rehabilitation programs are the gold standard of treatment for individuals with chronic neck pain who have not responded to less intensive modes of treatment or individuals who require concurrent treatment for chemical dependency.

Appendix Functional Tests Name of Test Body Part Description Oswestry Low Back Pain Disability Questionnaire (ODI)

Lumbar Spine Functional questions with sleeping, lifting, walking, sitting, and standing Quebec Back Pain Disability Scale Spine Functional and emotional questions Neck Disability Index Cervical Spine 10 questions addressing pain, personal care, headaches, and functional deficits 36-Item Short Form Survey (SF-36) and 12-Item Short Form Survey (SF-12)

Physical Health Assesses activities of daily living (ADLs)

Dallas Pain Questionnaire Spine Chronic pain Brief Pain Inventory General Sleep, walking, ADLs Psychological Screens Name of Test Description Brief Battery for Health Improvement, 2 nd Edition (BBHI 2)

Measures pain, functioning, somatization, depression, anxiety, and defensiveness; brief measure of risk factors for delayed recovery Distress and Risk Assessment Method (DRAM)

Measures depression and somatic symptoms of anxiety, risk factors commonly associated with chronic pain Center for Epidemiological Studies Depression Scale (CES-D)

Measures depression, 20 items Beck Depression Inventory-II (BDI-II)

Measures depression, 21 items Primary Care Evaluation for Mental Disorders (PRIME-MD) Must be filled out by a provider 2 components: paper and pencil screen for patient and follow–up interview by physician.

Assesses mood, anxiety, somatoform tendencies, and alcohol and eating disorders Zung Depression Inventory Measures depression, brief measure Patient Health Questionnaire (PHQ) and PHQ-9 Self-administered version of the PRIME-MD.

Assesses mood, anxiety, somatoform tendencies, and alcohol and eating disorders Generalized Anxiety Disorder Scale (GAD-7)

Assesses generalized anxiety, 7 questions Behavioral Health Index-Multimedia Version (BHI- MV)

Screens for addiction _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011, and

rule history, are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the

History link that appears above the text in 7 CCR 1101-3. To view versions effective after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 18:

Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 09 Rule 17, Exhibit 9 - CHRONIC PAIN DISORDER MEDICAL TREATMENT GUIDELINES {#sec-7-ccr-1101-3-r17-ex-09 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 09}

DEPARTMENT OF LABOR AND EMPLOYMENT

WORKERS' COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

RULE 17, EXHIBIT 9 CHRONIC PAIN DISORDER MEDICAL TREATMENT GUIDELINES 7 CCR 1101-3 Rule 17, Exhibit 9 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ A. INTRODUCTION This document has been prepared by the Colorado Department of Labor and Employment, Division of Workers’ Compensation (Division) and should be interpreted within the context of guidelines for physicians/providers treating individuals qualifying under Colorado’s Workers’ Compensation Act as injured workers with chronic pain.

Although the primary purpose of this document is advisory and educational, these guidelines are enforceable under the Workers’ Compensation Rules of Procedure, 7 CCR 1101-3. The Division recognizes that acceptable medical practice may include deviations from these guidelines, as individual cases dictate. Therefore, these guidelines are not relevant as evidence of a provider’s legal standard of professional care.

To properly utilize this document, the reader should not skip nor overlook any sections.

B. GENERAL GUIDELINE PRINCIPLES

The principles summarized in this section are key to the intended implementation of all Division of Workers’ Compensation medical treatment guidelines and critical to the reader’s application of the guidelines in this document.

1. APPLICATION OF THE GUIDELINES The Division provides procedures to implement medical treatment guidelines and to foster communication to resolve disputes among the provider, payer, and patient through the Workers’ Compensation Rules of Procedure. In lieu of more costly litigation, parties may wish to seek administrative dispute resolution services through the Division or the office of administrative courts.

2. EDUCATION Education of the patient and family, as well as the employer, insurer, policy makers, and the community, should be the primary emphasis in the treatment of chronic pain and disability. Currently, practitioners often think of education last, after medications, manual therapy, and surgery. Practitioners must implement strategies to educate patients, employers, insurance systems, policy makers, and the community as a whole.

An education-based paradigm should always start with inexpensive communication providing reassuring and evidence-based information to the patient. More in-depth patient education is currently a component of treatment regimens which employ functional, restorative, preventive, and rehabilitative programs. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms and prevention. Facilitation through language interpretation, when necessary, is a priority and part of the medical care treatment protocol.

3. INFORMED DECISION MAKING Providers should implement informed decision making as a crucial element of a successful treatment plan. Patients, with the assistance of their health care practitioner, should identify their personal and professional functional goals of treatment at the first visit. Progress towards the individual’s identified functional goals should be addressed by all members of the health care team at subsequent visits and throughout the established treatment plan. Nurse case managers, physical therapists, and other members of the health care team play an integral role in informed decision making and achievement of functional goals. Patient education and informed decision making should facilitate self-management of symptoms and prevention of further injury.

4. TREATMENT PARAMETER DURATION Time frames for specific interventions commence once treatments have been initiated, not on the date of injury. Obviously, duration will be impacted by patient adherence, as well as availability of services. Clinical judgment may substantiate the need to accelerate or decelerate the time frames discussed in this document.

5. ACTIVE INTERVENTIONS Active interventions emphasizing patient responsibility, such as therapeutic exercise and/or functional treatment, are generally emphasized over passive modalities, especially as treatment progresses. Generally, passive interventions are viewed as a means to facilitate progress in an active rehabilitation program with concomitant attainment of objective functional gains.

6. ACTIVE THERAPEUTIC EXERCISE PROGRAM Exercise program goals should incorporate patient strength, endurance, flexibility, coordination, and education. This includes functional application in vocational or community settings.

7. POSITIVE PATIENT RESPONSE Positive results are defined primarily as functional gains that can be objectively measured. Objective functional gains include, but are not limited to: positional tolerances, range-of-motion (ROM), strength, endurance, activities of daily living, ability to function at work, cognition, psychological behavior, and efficiency/velocity measures that can be quantified. Subjective reports of pain and function should be considered and given relative weight when the pain has anatomic and physiologic correlation. Anatomic correlation must be based on objective findings. Patient completed functional questionnaires such as those recommended by the Division as part of Quality Performance and Outcomes Payments (QPOP, see Rule 18-8) and/or the Patient Specific Functional Scale can provide useful additional confirmation.

8. RE-EVALUATION OF TREATMENT NO LESS THAN EVERY 3 TO 4 WEEKS If a given treatment or modality is not producing positive results within 3 to 4 weeks or within the time to produce effect in the guidelines, the treatment should be either modified or discontinued. Before discontinuing the treatment, the provider should have a detailed discussion with the patient to determine the reason for failure to produce positive results.

Reconsideration of diagnosis should also occur in the event of a poor response to a seemingly rational intervention.

9. SURGICAL INTERVENTIONS Surgery should be contemplated within the context of expected functional outcome and not purely for the purpose of pain relief. The concept of “cure” with respect to surgical treatment by itself is generally a misnomer. All operative interventions must be based upon positive correlation of clinical findings, clinical course, and diagnostic tests. A comprehensive assimilation of these factors must lead to a specific diagnosis with positive identification of pathologic conditions.

10. SIX-MONTH TIME FRAME The prognosis drops precipitously for returning an injured worker to work once he/she has been temporarily totally disabled for more than six months. The emphasis within these guidelines is to move patients along a continuum of care and return to work within a six-month time frame, whenever possible. It is important to note that time frames may be less pertinent for injuries that do not involve work-time loss or are not occupationally related.

11. RETURN-TO-WORK A return-to-work is therapeutic, assuming the work is not likely to aggravate the basic problem or increase long-term pain. The practitioner must provide specific physical limitations, and the patient should never be released to non-specific and vague descriptions such as “sedentary” or “light duty.” The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, data entry and other repetitive motion tasks, sustained grip, tool usage, and vibration factors. Even if there is residual chronic pain, return-to-work is not necessarily contraindicated. The practitioner should understand all of the physical demands of the patient’s job position before returning the patient to full duty and should request clarification of the patient’s job duties. Clarification should be obtained from the employer or, if necessary, from including, but not limited to, an occupational health nurse, occupational therapist, vocational rehabilitation specialist, an industrial hygienist, or another professional.

12. DELAYED RECOVERY Strongly consider a psychological evaluation, if not previously provided, as well as initiating interdisciplinary rehabilitation treatment and vocational goal setting, for those patients who are failing to make expected progress 6 to 12 weeks after initiation of treatment of an injury. Therefore, all chronic pain patients should have a documented psychological evaluation and psychological treatment as appropriate to address issues of chronic pain. It is also appropriate to clinically reassess the patient, function goals, and differential diagnosis. The Division recognizes that 3 to 10% of all industrially injured patients will not recover within the timelines outlined in this document, despite optimal care. Such individuals may require treatments beyond the timelines discussed within this document, but such treatment requires clear documentation by the authorized treating practitioner focusing on objective functional gains afforded by further treatment and impact upon prognosis.

13. GUIDELINE RECOMMENDATIONS AND INCLUSION OF MEDICAL EVIDENCE All recommendations are based on available evidence and/or consensus judgment. When possible, guideline recommendations will note the level of evidence supporting the treatment recommendation. It is generally recognized that early reports of a positive treatment effect are frequently weakened or overturned by subsequent research. When interpreting medical evidence statements in the guideline, the following apply:

• Consensus means the judgment of experienced professionals based on general medical principles. Consensus recommendations are designated in the guidelines as “generally well-accepted,” “generally accepted,”

“acceptable/accepted,” or “well-established.”

• “Some evidence” means the recommendation considered at least one adequate scientific study, which reported that a treatment was effective. The Division recognizes that further research is likely to have an impact on the intervention’s effect.

• “Good evidence” means the recommendation considered the availability of multiple adequate scientific studies or at least one relevant high-quality scientific study, which reported that a treatment was effective. The Division recognizes that further research may have an impact on the intervention’s effect.

• “Strong evidence” means the recommendation considered the availability of multiple relevant and high-quality scientific studies, which arrived at similar conclusions about the effectiveness of a treatment. The Division recognizes that further research is unlikely to have an important impact on the intervention’s effect.

All recommendations in the guideline are considered to represent reasonable care in appropriately selected cases, irrespective of the level of evidence or consensus statement attached to them. Those procedures considered inappropriate, unreasonable, or unnecessary are designated in the guideline as “not recommended.”

Please refer to the Colorado Department of Labor and Employment’s website for evidence tables and study critiques which provide details on the studies used to develop the evidence statements.

14. TREATMENT OF PRE-EXISTING CONDITIONS The conditions that preexisted the work injury/disease will need to be managed under two circumstances: (a) A pre-existing condition exacerbated by a work injury/disease should be treated until the patient has returned to their objectively verified prior level of functioning or Maximum Medical Improvement (MMI); and (b) A pre-existing condition not directly caused by a work injury/disease but which may prevent recovery from that injury should be treated until its objectively verified negative impact has been controlled. The focus of treatment should remain on the work injury/disease.

The remainder of this document should be interpreted within the parameters of these guideline principles that may lead to more optimal medical and functional outcomes for injured workers.

C. OVERVIEW OF CHRONIC PAIN MANAGEMENT

It is estimated by the Institute of Medicine that approximately 100 million adults suffer from chronic pain in the United States. The World Health Organization’s survey found that 37% of adults in 10 developed countries have chronic pain conditions. This overview covers the biopsychosocial nature of chronic pain and a comprehensive plan of care including: functional assessment and goal setting, psychological assessment, medication management, sleep considerations, and active therapy.

Chronic pain may develop from persistent acute pain due to neuroplastic changes occurring in the central nervous system. All chronic pain appears to involve a central sensitization which changes the perception of pain. Thus, treatment patterns are aimed at a number of mechanisms contributing to chronic pain.

Chronic pain is recognized as a biopsychosocial disease process. Each treatment plan should be individualized with a patient-centered approach addressing the many available treatment combinations. Therefore, all areas of the chronic pain guideline should be considered when developing a treatment plan. This includes: the mandatory psychological evaluation; an active therapy plan; medications specific to the pain process for that patient; continuing functional assessment; complementary medication alternatives, when appropriate; and continued return to work/regular daily activity.

Once a patient has been identified as a chronic pain patient, usually 3 months after an injury when pain persists or when pain persists beyond a reasonable post-operative period, the physician should perform a complete re-evaluation. This will assist both the patient and the provider in developing an appropriate treatment plan. Although it is unusual to identify an unknown pathology at this point in the treatment, it is recommended that the provider acknowledge the full complement of patient symptoms and concerns. Repeating or ordering new imaging may be necessary; however, it is not usually recommended as the findings may add to the patient’s confusion regarding the work-related injury.

It is essential that the patient and provider understand the type of pain the patient is experiencing and how the pain affects day-to-day activities. Identifying the presence of neuropathic pain, as well as any sources of nocioceptive pain, will assist the patient and provider when choosing medication and other forms of treatment recommended in the guideline.

During the chronic pain assessment, it is suggested that all physicians review with the patient their usual activities over several different typical 24-hour periods. This will assist both parties in understanding what functions are not able to be performed by the patient, how significantly sleep is impacted, and whether pain is affecting social and family relationships. This information is also essential for establishing agreed upon functional goals.

All chronic pain patients should have psychological evaluations. Patients may merely need assistance with coping mechanisms, and/or anxiety or depression may be caused or exacerbated by chronic pain. Treatment in this area is essential for the chronic pain patient. A limited number of cognitive behavioral sessions are frequently effective for these conditions.

Review of the current prescribed and over-the-counter medications is an important part of this initial chronic pain evaluation. If the patient has been chronically on opioids, it is very likely that the full required opioid trial and review has not been performed. Thus, the physician will need to ensure that the proper steps have been taken if opioids are to be continued. It is also reasonable to taper opioids in order to determine the patient’s baseline and how other medications are actually affecting the pain.

Refer to Section G.10.g, Opioids, in this guideline for more details. The following is a general summary of the required elements. A number of other guidelines, including the Center for Disease Control and Prevent (CDC) and Colorado’s Board of Medical Examiners, have confirmed these steps.

1. An opioid trial shall be performed before chronic opioids are determined to be useful for patients. About 50% of patients will not be able to tolerate the side effects and/or not show a sufficient increase in function with opioid use. Patients should be aware that this is a trial and like any other medication trial, it will not be continued unless there is sufficient benefit. The average benefit is about a 30% decrease in pain. Thus, all other required treatment must be continued during the time period of the chronic opioid trial.

2. Long acting opioids should never be used for acute pain, post-operative pain, or before an opioid trial has been completed. There is no evidence they are more beneficial than short acting opioids, and the trial should began with short acting opioids.

3. A risk assessment tool, such as the Opioid Risk Tool (ORT) should be completed to assure the provider that there are no prior elements suggesting substance abuse or, when such elements are present, the physician may choose to refer to a provider with more expertise in substance abuse.

4. Urine drug testing should be done prior to the trial.

5. Check the Prescription Drug Monitoring Program (PDMP).

6. The psychological evaluation should have been completed and hopefully treatment as appropriate is being continued.

7. A functional history should be taken and functional goals should be set. This needs to be followed throughout all chronic pain treatment to determine if the patient is increasing or decreasing in function.

8. A provider physician agreement must be completed. This is extremely helpful as it reviews for the patient the expectations regarding his/her behavior as well as the expectations regarding when a physician would choose to taper or remove the patient from opioids and what other treatment is expected to continue during an opioid trial.

If the opioid trial is successful, the physician should continue to monitor with random drug testing and PDMP checks. In addition, the Current Opioid Misuse Measure (COMM) is a tool that can be used for patients on opioids to screen for possible abuse. It should be noted that current estimates suggest approximately 14 to 19 percent of chronic opioid users may become addicted to opioids.

The patient will need to be monitored for side effects. Constipation is anticipated. There may also be problems with sexual dysfunction. Opioids may increase or cause sleep apnea problems, and this should be monitored. At all visits, the functional status of the patient should be recorded. This can be accomplished with reliable, patient-reported functional status tools. Function is preferably validated by physical exam or by other objective measures from the provider.

Lack of sleep is a significant problem for patients with uncontrolled chronic pain. Taking a good

history in this area and promoting an appropriate sleep regime is essential for patients, if they are to establish a productive life-style.

Active therapy is one of the most important components. Regular exercise is shown to decrease depression as well as decrease chronic pain. Helping the patient choose appropriate physical activities and cognitive activities will be important for recovery.

Although treating chronic pain patients is challenging due to the many disciplines and treatment patterns available, the rewards are great when a patient with chronic pain is able to resume work and engage in satisfying life activities.

D. INTRODUCTION TO CHRONIC PAIN

The International Association for the Study of Pain (IASP) defines pain as "an unpleasant sensory and emotional experience with actual or potential tissue damage." Pain is a complex experience embracing physical, mental, social, and behavioral processes that often compromises the quality of life of many individuals.

Pain is an unpleasant subjective perception usually in the context of tissue damage. Pain is subjective and cannot be measured or indicated objectively. Pain evokes negative emotional reactions such as fear, anxiety, anger, and depression. People usually regard pain as an indicator of physical harm, despite the fact that pain can exist without tissue damage and tissue damage can exist without pain. Many people report pain in the absence of tissue damage or any likely pathophysiologic cause. There is no way to distinguish their experience from pain due to actual tissue damage. If they regard their experience as pain and they report it the same way as pain caused by tissue damage, it should be accepted as pain.

Pain can generally be classified as:

• Nociceptive, which includes pain from visceral origins or damage to other tissues.

Myofascial pain is a nociceptive type of pain characterized by myofascial trigger points limited to a specific muscle or muscles;

• Neuropathic, including pain originating from the brain, peripheral nerves, or both; and • Psychogenic, which originates in mood, characterological, social, or psychophysiological processes.

Recent advances in the neurosciences reveal additional mechanisms involved in chronic pain. In the past, pain was seen as a sensation arising from the stimulation of pain receptors by damaged tissue, initiating a sequence of nerve signals ending in the brain and there recognized as pain. A consequence of this model was that ongoing pain following resolution of tissue damage was seen as less physiological and more psychological than acute pain with identifiable tissue injury.

Current research indicates that chronic pain involves additional mechanisms that cause: 1) neural remodeling at the level of the spinal cord and higher levels of the central nervous system; 2) changes in membrane responsiveness and connectivity leading to activation of larger pain pathways; and 3) recruitment of distinct neurotransmitters.

Changes in gene function and expression may occur, with lasting functional consequences.

These physiologic functional changes cause chronic pain to be experienced in body regions beyond the original injury and to be exacerbated by little or no stimulation. The chronic pain experience clearly represents both psychologic and complex physiologic mechanisms, many of which are just beginning to be understood.

Chronic pain is defined as "pain that persists for at least 30 days beyond the usual course of an acute disease or a reasonable time for an injury to heal or that is associated with a chronic pathological process that causes continuous pain (e.g., Complex Regional Pain Syndrome)." The very definition of chronic pain describes a delay or outright failure to increase function and relieve pain associated with some specific illness or accident. Delayed recovery should prompt a clinical review of the case and a psychological evaluation by the health care provider. Consideration may be given to new diagnostic testing or a change in treatment plan. Referral to a specialist with experience in chronic pain management is recommended.

The term “chronic pain syndrome” has been incorrectly used and defined in a variety of ways that generally indicate a belief on the part of the health care provider that the patient's pain is inappropriate or out of proportion to existing problems or illness. Use of the term “chronic pain syndrome” should be discontinued because the term ceases to have meaning due to the many different physical and psychosocial issues associated with it. The IASP offers a taxonomy of pain, which underscores the wide variety of pathological conditions associated with chronic pain. This classification system may not address the psychological and psychosocial issues that occur in the perception of pain, suffering, and disability and may require referral to psychiatric or psychological clinicians. Practitioners should use the nationally accepted terminology indicated in the most current ICD system. Chronic pain can be diagnosed as F45.42 “Pain disorder with related psychological factors” when the associated body part code is also provided. Alternately, chronic pain can also be diagnosed as F54 “Psychological factors affecting physical conditions,” and this code should also be accompanied by the associated body part.

Injured patients generally initiate treatment with complaints of pain, which is generally attributable to a specific injurious event, but occasionally to an ostensible injury. Thus, the physician should not automatically assume that complaints of acute pain are directly attributable to pathophysiology at the tissue level. Pain is known to be associated with sensory, affective, cognitive, social, and other processes. The pain sensory system itself is organized into two parts, often called first and second pain. A-∂ nerve fibers conduct first pain via the neospinalthalamic tract to the somatosensory cortex and provide information about pain location and quality. In contrast, unmyelinated C fibers conduct second pain via the paleospinalthalamic tract and provide information about pain intensity. Second pain is more closely associated with emotion and memory neural systems than it is with sensory systems.

As a patient’s condition transitions through the acute, subacute, and chronic phases, the central nervous system (CNS) is reorganized. The temporal summation of second pain produces a sensitization or “windup” of the spinal cord, and the connections between the brain regions involved in pain perception, emotion, arousal, and judgment are changed by persistent pain.

These changes cause the CNS’s “pain neuromatrix” to become sensitized to pain. This CNS reorganization is also associated with changes in the volume of brain areas, decreased grey matter in the prefrontal cortex, and the brain appearing to age more rapidly. As pain continues over time, the CNS remodels itself so that pain becomes less closely associated with sensation, and more closely associated with arousal, emotion, memory, and beliefs. Because of these CNS processes, all clinicians should be aware that as the patient enters the subacute phase, it becomes increasingly important to consider the psychosocial context of the disorder being treated, including the patient’s social circumstances, arousal level, emotional state, and beliefs about the disorder. However, behavioral complications and physiological changes associated with chronicity and central sensitization may also be present in the acute phase, and within hours of the initial injury. It is the intent of many of the treatments in this guideline to assist in remodeling these CNS changes.

Chronic pain is a phenomenon not specifically relegated to anatomical or physiologic parameters.

The prevailing biomedical model (which focuses on identified disease pathology as the sole cause of pain) cannot capture all of the important variables in pain behavior. While diagnostic labels may pinpoint contributory physical and/or psychological factors and lead to specific treatment interventions that are helpful, a large number of patients defy precise taxonomic classification. Furthermore, such diagnostic labeling often overlooks important social contributions to the chronic pain experience. Failure to address these operational parameters of the chronic pain experience may lead to incomplete or faulty treatment plans. The concept of a "pain disorder" is perhaps the most useful term, in that it captures the multi-factorial nature of the chronic pain experience.

It is recognized that some health care practitioners have much greater expertise in the area of chronic pain evaluation and treatment than others by virtue of their experience, additional training, and/or accreditation by pain specialty organizations. Referrals for the treatment of chronic pain should be to such recognized specialists. Chronic pain treatment plans should be monitored and coordinated by physicians with expertise in pain management including specialty training and/or certification.

Most acute and some chronic pain problems are adequately addressed in other Division Medical Treatment Guidelines and are generally not within the scope of this guideline. However, because chronic pain is more often than not multi-factorial, involving more than one pathophysiologic or mental disorder, some overlap with other guidelines is inevitable. This guideline is meant to apply to any patient who fits the operational definition of chronic pain discussed at the beginning of this

section.

E. DEFINITIONS

1. AFTER SENSATION: refers to the abnormal persistence of a sensory perception provoked by a stimulus even though the stimulus has ceased.

2. ALLODYNIA: pain due to a non-noxious stimulus that does not normally provoke pain.

Mechanical Allodynia: refers to the abnormal perception of pain from usually non-painful mechanical stimulation.

Static Mechanical Allodynia: refers to pain obtained by applying a single stimulus such as light pressure to a defined area.

Dynamic Mechanical Allodynia: obtained by moving the stimulus such as a brush or cotton tip across the abnormal hypersensitive area.

Thermal Allodynia: refers to the abnormal sensation of pain from usually non-painful thermal stimulation such as cold or warmth.

3. ANALGESIA: absence of pain in response to stimulation that would normally be painful.

4. BIOPSYCHOSOCIAL: a term that reflects the multiple facets of any clinical situation; namely, the biological, psychological, and social situation of the patient.

5. CENTRAL PAIN: pain initiated or caused by a primary lesion or dysfunction in the central nervous system.

6. CENTRAL SENSITIZATION: the experience of pain evoked by the excitation of nonnociceptive neurons or of nerve fibers that normally relay non-painful sensations to the spinal cord. This results when non-nociceptive afferent neurons act on a sensitized central nervous system (CNS). Experimental data suggest that pathways normally carrying pain signals themselves become overstimulated and/or fail to respond to inhibitory influences causing increased pain. An example is ‘wind-up’ which occurs when cells in the dorsal horn of the spinal cord increase their rate of action potential discharge in response to repeated stimulation by nociceptors.

7. DYSESTHESIA: an abnormal sensation described by the patient as unpleasant. As with paresthesia, dysesthesia may be spontaneous or evoked by maneuvers on physical 8. HYPERALGESIA: refers to an exaggerated pain response from a usually painful stimulation.

8. HYPERESTHESIA (POSITIVE SENSORY PHENOMENA): includes allodynia, hyperalgesia, and hyperpathia. Elicited by light touch, pin prick, cold, warm, vibration, joint position sensation or two-point discrimination, which is perceived as increased or more.

9. HYPERPATHIA: a condition of altered perception such that stimuli which would normally be innocuous, if repeated or prolonged, result in severe explosive persistent pain.

10. HYPOALGESIA: diminished pain perception in response to a normally painful stimulus.

11. HYPOESTHESIA/HYPESTHESIA (NEGATIVE SENSORY PHENOMENA): diminished sensitivity to stimulation.

12. MALINGERING: intentional feigning of illness or disability in order to achieve external incentives such as recreational drugs or money.

13. MYOFASCIAL PAIN: a regional pain characterized by tender points in taut bands of muscle that produce pain in a characteristic reference zone.

14. MYOFASCIAL TRIGGER POINT: a physical sign in a muscle which includes a) exquisite tenderness in a taut muscle band; and b) referred pain elicited by mechanical stimulation of the trigger point. The following findings may be associated with myofascial trigger points: 1) Local twitch or contraction of the taut band when the trigger point is mechanically stimulated; 2) Reproduction of the patient’s spontaneous pain pattern when the trigger point is mechanically stimulated; 3) Weakness without muscle atrophy; 4)

Restricted range-of-motion of the affected muscle; and 5) Autonomic dysfunction associated with the trigger point such as changes in skin or limb temperature.

16. NEURALGIA: pain in the distribution of a nerve or nerves.

17. NEURITIS: inflammation of a nerve or nerves.

18. NEUROGENIC PAIN: pain initiated or caused by a primary lesion, dysfunction, or transitory perturbation in the peripheral or central nervous system.

19. NEUROPATHIC PAIN: pain due to an injured or dysfunctional central or peripheral nervous system.

20. NEUROPATHY: a disturbance of function or pathological change in a nerve: in one nerve (mononeuropathy), in several nerves (mononeuropathy multiplex), OR diffuse and bilateral (polyneuropathy). Neuropathy should be associated with objective findings such as consistent sensory abnormalities, consistent motor findings (e.g., weakness, atrophy, fasciculations, muscle cramping), and/or neuropathic abnormalities on EMG/nerve conduction testing.

21. NOCICEPTOR: a receptor preferentially sensitive to a noxious stimulus or to a stimulus which would become noxious if prolonged.

22. PAIN BEHAVIOR: the non-verbal actions (such as grimacing, groaning, limping, using visible pain relieving or support devices, and requisition of pain medications, among others) that are outward manifestations of pain and through which a person may communicate that pain is being experienced.

23. PAIN THRESHOLD: the smallest stimulus perceived by a subject as painful during laboratory testing. The term also loosely applies to the biological variation among human beings in sensing and coping with pain.

24. PARESTHESIA: an abnormal sensation that is not described as pain. It can be either a spontaneous sensation (such as pins and needles) or a sensation evoked from nonpainful or painful stimulation, such as light touch, thermal, or pinprick stimulus on physical 25. PERIPHERAL NEUROPATHIC PAIN: pain initiated or caused by a primary lesion or dysfunction in the peripheral nervous system.

25. SOMATIC DYSFUNCTION: somatic dysfunction is impaired or altered function of related components of the somatic (body framework) system which includes skeletal, arthrodial, and myofascial structures.

26. SUMMATION: refers to abnormally painful sensation to a repeated stimulus although the actual stimulus remains constant. The patient describes the pain as growing and growing as the same intensity stimulus continues.

27. SYMPATHETICALLY MAINTAINED PAIN (SMP): a pain that is maintained by sympathetic efferent pathways and is eliminated by blockade of these pathways. It is intensified by circulating catecholamines.

28. TENDER POINTS: tenderness on palpation at a tendon insertion, muscle belly, or over bone. Palpation should be done with the thumb or forefinger, applying pressure approximately equal to a force of 4 kilograms (blanching of the entire nail bed).

F. INITIAL EVALUATION & DIAGNOSTIC PROCEDURES

The Division recommends the following diagnostic procedures be considered, at least initially. It is the responsibility of the workers’ compensation carrier to ensure that an accurate diagnosis and treatment plan can be established. Standard procedures that should be utilized when initially diagnosing a work-related chronic pain complaint are listed below.

1. HISTORY TAKING AND PHYSICAL EXAMINATION (HX & PE): These are generally accepted, well-established, and widely used procedures that establish the foundation/basis for and dictate subsequent stages of diagnostic and therapeutic procedures. When findings of clinical evaluations and those of other diagnostic procedures are not complementing each other, the objective clinical findings should have preference. The medical records should reasonably document the following:

a. Medical History: As in other fields of medicine, a thorough patient history is an important part of the evaluation of chronic pain. In taking such a history, factors influencing a patient’s current status can be made clear and taken into account when planning diagnostic evaluation and treatment. It may be necessary to acquire previous medical records. One efficient manner in which to obtain historical information and patient reported functional status is by using a questionnaire. The questionnaire may be sent to the patient prior to the initial visit or administered at the time of the office visit. History should ascertain the following elements.

i. General Information: General items requested are name, sex, age, birth date, etc.

ii. Level of Education: The level of the patient’s education may influence response to treatment.

iii. Work History/Occupation: to include both impact of injury on job duties and impact on ability to perform job duties, work history, job description, mechanical requirements of the job, duration of employment, and job satisfaction.

iv. Current employment status.

v. Marital status.

vi. Family Environment: Is the patient living in a nuclear family or with friends? Is there, or were there, any family members with chronic illness or pain problems? Responses to such questions reveal the nature of the support system or the possibility of conditioning toward chronicity.

vii. Ethnic Origin: Ethnicity of the patient, including any existing language barriers, may influence the patient’s perception of and response to pain.

Literature indicates that providers may under-treat patients of certain ethnic backgrounds due to underestimation of their pain.

viii. Belief System: Patients should be asked about their value systems, including spiritual and cultural beliefs, in order to determine how these may influence the patient’s and family’s response to illness and treatment recommendations.

ix. Functional Assessment: Functional ability should be assessed and documented at the beginning of treatment. Periodic assessment should be recorded throughout the course of care to follow the trajectory of recovery. Functional measures are likely to be more reliable over time than pain measures.

Patient-reported outcomes, whether of pain or function, are susceptible to a phenomenon called response shift. This refers to changes in selfevaluation, which may accompany changes in health status. Patient selfreports may not coincide with objective measures of outcome, due to reconceptualization of the impact of pain on daily function and internal recalibration of pain scales. Response shift may obscure treatment effects in clinical trials and clinical practice, and it may lead to apparent discrepancies in patient-reported outcomes following treatment interventions. While methods of measuring and accounting for response shift are not yet fully developed, understanding that the phenomenon exists can help clinicians understand what is happening when some measures of patient progress appear inconsistent with other measures of progress.

x. Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs): Pain has a multidimensional effect on the patient that is reflected in changes in the ability to perform self-care tasks and usual daily vocational, social, recreational, and sexual activities.

xi. Past and present psychological problems.

xii. History of abuse: physical, emotional, sexual.

xiii. History of disability in the family.

xiv. Sleep disturbances: Poor sleep has been shown to increase patient’s self-perceived pain scores. Pre-injury and post-injury sleep should be recorded.

xv. Causality: How did this injury occur? Was the problem initiated by a work-related injury or exposure? Patient’s perception of causality (e.g., was it their fault or the fault of another).

b. Pain History: Characterization of the patient’s pain and of the patient’s response to pain is one of the key elements in treatment.

i. Site of Pain: Localization and distribution of the pain help determine the type of pain the patient has (i.e., central versus peripheral).

ii. Pain diagram drawings to document the distribution of pain.

iii. Visual Analog Scale (VAS): Current pain, highest pain level, and usual pain level may be recorded. Include a discussion of the range of pain during the day and how activities, use of modalities, and other actions affect the intensity of pain.

iv. Duration: including intermittent pain, activity related pain.

v. Place of onset: circumstances during which the pain began (e.g., an accident, an illness, a stressful incident, or spontaneous onset).

vi. Pain Characteristics: such as burning, shooting, stabbing, and aching.

Time of pain occurrence, as well as intensity, quality, and radiation, give clues to the diagnosis and potential treatment. Quality of pain can be helpful in identifying neuropathic pain which is normally present most of the day, at night, and is often described as burning.

vii. List of activities which aggravate or exacerbate, ameliorate, decrease, or have no effect on the level of pain.

viii. Associated Symptoms: Does the patient have numbness or paresthesia, dysesthesia, weakness, bowel or bladder dysfunction, altered temperature, increased sweating, cyanosis, or edema? Is there local tenderness, allodynia, hyperesthesia, or hyperalgesia? Does the patient have constitutional symptoms such as fevers, chills, night sweats, unexplained weight loss, or pain that awakes them from a deep sleep at night?

c. Medical Management History:

i. Diagnostic Tests: All previous radiological and laboratory investigations should be reviewed.

ii. Prior Treatment: chronological review of medical records including previous medical evaluations and response to treatment interventions. In other words, what has been tried and which treatments have helped?

iii. Prior Surgery: If the patient has had prior surgery specifically for the pain, he/she may be less likely to have a positive outcome.

iv. Medications: history of and current use of medications, including opioids, over-the-counter medications, cannabis products, and herbal/dietary supplements, to determine drug usage (or abuse) interactions and efficacy of treatment. Drug allergies and other side effects experienced with previous or current medication therapy and adherence to currently prescribed medications should be documented. Ideally, this includes dosing schedules as reported by the patient or patient representative.

Information should be checked against the Colorado Prescription Drug Monitoring Program (PDMP), offered by the Colorado Pharmacy Board.

v. Review of Systems Check List: Determine if there is any interplay between the pain complaint and other medical conditions.

vi. Psychosocial Functioning: Determine if any of the following are present: current symptoms of depression or anxiety; evidence of stressors in the workplace or at home; and past history of psychological problems. Other confounding psychosocial issues may be present, including the presence of psychiatric disease. Due to the high incidence of co-morbid problems in populations that develop chronic pain, it is recommended that all patients diagnosed with chronic pain should be referred for a full psychosocial evaluation.

vii. Pre-existing Conditions: Treatment of these conditions is appropriate when the pre-existing condition affects recovery from chronic pain.

viii. Family history pertaining to similar disorders.

d. Substance Use/Abuse:

i. Alcohol use.

ii. Smoking History and use of nicotine replacements.

iii. History of current and prior prescription and recreational drug use or iv. The use of caffeine or caffeine containing beverages.

v. Substance abuse information may be only fully obtainable from multiple sources over time. Patient self-reports may be unreliable. Patient selfreports should always be checked against medical records.

e. Other Factors Affecting Treatment Outcome:

i. Compensation/Disability/Litigation.

ii. Treatment Expectations: What does the patient expect from treatment: complete relief of pain or reduction to a more tolerable level?

iii. Other scales may be used to identify cases which are likely to require more complex care. Examples include:

A) Fear Avoidance Beliefs Questionnaire B) Tampa Scale of Kinesiophobia C) Pain Catastrophizing Scale f. Physical Examination:

i. Neurologic Evaluation: includes cranial nerves survey, muscle tone and strength, atrophy, detailed sensory examination (see ii-below), motor evaluation (station, gait, coordination), reflexes (normal tendon reflexes and presence or absence of abnormal reflexes such as frontal lobe release signs or upper motor neuron signs), cerebellar testing, signs suggestive of a sensory ataxia (positive Romberg, impaired proprioception, etc.), and provocative neurological maneuvers.

ii. Sensory Evaluation: A detailed sensory examination is crucial in evaluating a patient with chronic pain complaints. Quantitative sensory testing, such as Semmes-Weinstein, may be useful tools in determining sensory abnormalities. Ideally, the examination should determine if the following sensory signs are present and consistent on repeated A) Hyperalgesia.

B) Hyperpathia.

C) Paresthesia.

D) Dysesthesia.

E) Mechanical Allodynia – static versus dynamic.

F) Thermal Allodynia.

G) Hypoesthesia.

H) Hyperesthesia.

I) Summation.

iii. Musculoskeletal Evaluation: range-of-motion, segmental mobility, musculoskeletal provocative maneuvers, palpation, observation, and functional activities. All joints, muscles, ligaments, and tendons should be examined for asymmetry, swelling, laxity, and tenderness. A portion of the musculoskeletal evaluation is the myofascial examination. The myofascial examination includes palpating soft tissues for evidence of tightness, tenderness, and trigger points.

iv. Evaluation of non-physiologic findings:

A) Waddell’s Signs cannot be used to predict or diagnose malingering. It is not an appropriate test for assessing nonphysiologic causes of low back pain. The sole purpose of the Waddell’s signs is to identify low back pain patients who may need further psychosocial assessment prior to surgery. Refer to

Section F.2, Personality/Psychological/Psychosocial Evaluation.

B) Variability on formal exam including variable sensory exam, inconsistent tenderness, and/or swelling secondary to extrinsic sources.

C) Inconsistencies between formal exam and observed abilities of range-of-motion, motor strength, gait, and cognitive/emotional state should be noted in the assessment.

2. PERSONALITY/ PSYCHOLOGICAL/PSYCHOSOCIAL EVALUATIONS FOR PAIN

MANAGEMENT: These are generally accepted, well-established, and widely used diagnostic procedures not only with selected use in acute pain problems but also with more widespread use in subacute and chronic pain populations. Diagnostic evaluations should distinguish between conditions that are pre-existing, aggravated by the current injury, or work related.

Psychosocial evaluations should determine if further psychosocial or behavioral interventions are indicated for patients diagnosed with chronic pain. The interpretations of the evaluation should provide clinicians with a better understanding of the patient in his or her social environment, thus allowing for more effective rehabilitation. Psychosocial assessment requires consideration of variations in pain experience and expression resulting from affective, cognitive, motivational and coping processes, and other influences such as gender, age, race, ethnicity, national origin, religion, sexual orientation, disability, language, or socioeconomic status.

While there is some agreement about which psychological factors need to be assessed in patients with chronic pain, a comprehensive psychological evaluation should attempt to identify both primary psychiatric risk factors or “red flags” (e.g., psychosis, active suicidality) as well as secondary risk factors or “yellow flags” (e.g., moderate depression, job dissatisfaction). Significant personality disorders must be taken into account when considering a patient for spinal cord stimulation and other major procedures.

Psychometric Testing is a valuable component of a consultation to assist the physician in making a more effective treatment plan. There is good evidence that psychometric testing can have significant ability to predict medical treatment outcome. For example, one study found that psychometric testing exceeded the ability of discography to predict disability in patients with low back pain. Pre-procedure psychiatric/psychological evaluation must be done prior to diagnostic confirmatory testing for a number of procedures. Examples include discography for fusion, spinal cord stimulation, or intrathecal drug delivery systems, and they should not be done by a psychologist employed by the physician planning to perform the procedure.

In many instances, psychological testing has validity comparable to that of commonly used medical tests; for example, the correlation between high trait anger and blood pressure is equal to the correlation between reduced blood flow and the failure of a synthetic hemodialysis graft. Thus, psychometric testing may be of comparable validity to medical tests and may provide unique and useful diagnostic information.

All patients who are diagnosed as having chronic pain should be referred for a psychosocial evaluation, as well as concomitant interdisciplinary rehabilitation treatment.

This referral should be performed in a way so as to not imply that the patient’s claims are invalid or that the patient is malingering or mentally ill. Even in cases where no diagnosable mental condition is present, these evaluations can identify social, cultural, coping, and other variables that may be influencing the patient’s recovery process and may be amenable to various treatments including behavioral therapy. As pain is understood to be a biopsychosocial phenomenon, these evaluations should be regarded as an integral part of the assessment of chronic pain conditions.

a. Qualifications:

i. A psychologist with a PhD, PsyD, or EdD credentials or a physician with Psychiatric MD/DO credentials may perform the initial comprehensive evaluations. It is preferable that these professionals have experience in diagnosing and treating chronic pain disorders and/or working with patients with physical impairments.

ii. Psychometric tests should be administered by psychologists with a PhD, PsyD, or EdD or health professionals working under the supervision of a doctorate level psychologist. Physicians with appropriate training may also administer such testing, but interpretation of the tests should be done by properly credentialed mental health professionals.

b. Clinical Evaluation:

Special note to health care providers: most providers are required to adhere to the federal regulations under the Health Insurance Portability and Accountability Act (HIPAA). Unlike general health insurers, workers’ compensation insurers are not required to adhere to HIPAA standards. Thus, providers should assume that sensitive information included in a report sent to the insurer could be forwarded to the employer. The Colorado statute provides a limited waiver of medical information regarding the work-related injury or disease to the extent necessary to resolve the claim. It is recommended that the health care provider either 1) obtain a full release from the patient regarding information that may go to the employer or 2) not include sensitive health information not directly related to the work related conditions in reports sent to the insurer.

All chronic pain patients should have a clinical evaluation that addresses the following areas recalling that not all details should be included in the report sent to the insurer due to the HIPAA issue noted above:

i. History of Injury: The history of the injury should be reported in the patient’s words or using similar terminology. Caution must be exercised when using translators.

• Nature of injury.

• Psychosocial circumstances of the injury.

• Current symptomatic complaints.

• Extent of medical corroboration.

• Treatment received and results.

• Adherence with treatment.

• Coping strategies used, including perceived locus of control, catastrophizing, and risk aversion.

• Perception of medical system and employer.

• History of response to prescription medications.

ii. Health History:

• Nature of injury.

• Medical history.

• Psychiatric history: to include past diagnoses, counseling, medications, and response to treatment.

• Past, recent, and concurrent stressors.

• History of substance related and addictive disorders to include: ○ Alcohol ○ Cannabis products ○ Opioids ○ Sedative, hypnotic, and anxiolytic medications ○ Stimulants ○ Prescription drug abuse ○ Nicotine use ○ Other substances of abuse / dependence • Activities of daily living.

• Previous injuries, including disability, impairment, and compensation.

iii. Psychosocial History:

• Childhood history, including abuse/neglect.

• Educational history.

• Family history, including disability.

• Current living situation including roommates, family, intimate partners, and financial support.

• Marital history and other significant adulthood activities and events.

• Legal history, including but not limited to substance use related, domestic violence, criminal, and civil litigation.

• Employment history.

• Military duty: Because post-traumatic stress disorder (PTSD) might be an unacceptable condition for many military personnel to acknowledge, it may be prudent to screen initially for signs of depression or anxiety – both of which may be present in PTSD.

• Signs of pre-injury psychological dysfunction.

• Financial history.

• Prior level of function including self-care, community, recreational, and employment activities.

iv. Mental status exam including orientation, cognition, activity, speech, thinking, affect, mood, and perception. May include screening tests such as the mini mental status exam or frontal assessment battery if appropriate.

v. Assessment of any danger posed to self or others.

vi. Psychological test results, if performed.

vii. Current psychiatric diagnosis consistent with the standards of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders.

viii. Pre-existing psychiatric conditions: Treatment of these conditions is appropriate when the pre-existing condition affects recovery from chronic ix. Causality: to address medically probable cause and effect and to distinguish pre-existing psychological symptoms, traits, and vulnerabilities from current symptoms.

x. Treatment recommendations with respect to specific goals, frequency, time frames, and expected outcomes.

c. Tests of Psychological Functioning: Psychometric testing is a valuable component of a consultation to assist the physician in making a more effective treatment plan. Psychometric testing is useful in the assessment of mental conditions, pain conditions, cognitive functioning, treatment planning, vocational planning, and evaluation of treatment effectiveness. While there is no general agreement as to which psychometric tests should be specifically recommended for psychological evaluations of chronic pain conditions, standardized tests are preferred over those which are not for assessing diagnosis. Generally, it is helpful if tests consider the following issues: validity, physical symptoms, affective disorders, character disorders and traits, and psychosocial history.

Character strengths that support the healing/rehabilitative process should also be evaluated and considered with any dysfunctional behavior patterns or pathology to more accurately assess the patient’s prognosis and likely response to a proposed intervention.

In contrast, non-standardized tests can be useful for “ipsative” outcome assessment, in which a test is administered more than once and a patient’s current and past reports are compared.

It is appropriate for the mental health providers to use their discretion and administer selective psychometric tests within their expertise and within standards of care in the community. Use of screening psychometrics by nonmental health providers is encouraged, but mental health provider consultation should always be utilized for chronic pain patients in which invasive palliative pain procedures or chronic opiate treatment is being contemplated. Some of these tests are available in Spanish and other languages, and many are written at a 6 th grade reading level. Examples of frequently used psychometric tests performed include, but are not limited to, the tests identified below. (For a description of the psychometric tests listed in this section, refer to the Appendix, Description of Tests of Psychological Functioning.)

i. Comprehensive Inventories for Medical Patients:

A) Battery for Health Improvement, 2 Edition (BHI B) Millon Behavioral Medical Diagnostic (MBMD ).

ii. Comprehensive Psychological Inventories:

These tests are designed for detecting various psychiatric syndromes but in general are more prone to false positive findings when administered to medical patients.

A) Millon® Clinical Multiaxial Inventory® (MCMI®-IV).

B) Minnesota Multiphasic Personality Inventory®, 2 Edition (MMPI®-2).

C) Minnesota Multiphasic Personality Inventory®, 2 Edition Revised Form (MMPI®-2).

D) Personality Assessment Inventory (PAI®).

iii. Brief Multidimensional Screens for Medical Patients:

Treating providers may use brief instruments to assess a variety of psychological and medical conditions, including depression, pain, disability, and others. These instruments may also be employed as repeated measures to track progress in treatment or as one test in a more comprehensive evaluation. Brief instruments are valuable in that the test may be administered in the office setting and hand scored by the physician. Results of these tests should help providers distinguish which patients should be referred for a specific type of comprehensive evaluation.

A) Brief Battery for Health Improvement, 2nd Edition (BBHI B) Pain Patient Profile (P-3®).

C) SF-36®.

D) Sickness Impact Profile (SIP).

E) McGill Pain Questionnaire (MPQ).

F) McGill Pain Questionnaire – Short Form (MPQ-SF).

G) Oswestry Disability Questionnaire (ODQ).

H) Visual Analog Scales (VAS).

I) Numerical Rating Scales (NRS).

J) Chronic Pain Grade Scale (CPGS).

K) Pain Catastrophizing Scale (PCS).

iv. Brief Multidimensional Screens for Psychiatric Patients:

These tests are designed for detecting various psychiatric syndromes but in general are more prone to false positive findings when administered to medical patients.

A) Brief Symptom Inventory (BSI®).

B) Brief Symptom Inventory–18 (BSI®-18).

C) Symptom Check List - 90 Revised (SCL-90 R®).

v. Brief Specialized Psychiatric Screening Measures:

A) Beck Depression Inventory® (BDI®).

B) Center of Epidemiologic Studies – Depression Questionnaire (CES-D).

Note: Designed for assessment of psychiatric patients, not pain patients, which can bias results, and this should be a consideration when using.

C) Brief Patient Health Questionnaire from PRIME - MD®. (The PHQ-9 may also be used as a depression screen.)

D) Zung Depression Questionnaire.

Note: The Zung Depression Scale must be distinguished from the Modified Zung Depression scale used by the DRAM (a QPOP measure). The Zung Depression Scale has different items and a different scoring system than the Modified Zung Depression scale, making the cutoff scores markedly different.

The cutoff scores for one measure cannot be used for the other.

E) Generalized Anxiety Disorder 7-item scale (GAD-7).

Evidence Statements Regarding Psychometric Testing Psychometric testing can have significant ability to predict medical treatment outcome.

Prospective cohort study, Observational cohort study 3. DIAGNOSTIC STUDIES Imaging of the spine and/or extremities is a generally accepted, well-established, and widely used diagnostic procedure when specific indications, based on history and physical examination, are present. Practitioners should be aware of the radiation doses associated with various procedures and provide appropriate warnings to patients. Coloradans have a substantial background exposure to radiation, and unnecessary CT scans or X-rays increase the lifetime risk of cancer death. Physicians should refer to the Division’s Medical Treatment Guidelines on specific acute care for detailed information about specific testing procedures. Tests should be performed to rule in or out specific diagnoses.

a. Radiographic Imaging, MRI, CT, bone scan, radiography, and other special imaging studies may provide useful information for many musculoskeletal disorders causing chronic pain. It is probably most helpful in ruling out rare, significant diagnoses that may present with pain, such as metastatic cancer.

Most imaging is likely to demonstrate aging changes which are usually not pathologic. Refer to specific Division Medical Treatment Guidelines for details.

Before the test is performed, patients should be informed of the purpose of the exam (e.g., to rule out unsuspected cancer) and the likelihood of finding nonpathologic changes that are part of the normal aging process.

b. Electrodiagnostic studies may be useful in the evaluation of patients with suspected myopathic or neuropathic disease and may include Nerve Conduction Studies (NCS), Standard Needle Electromyography, or Somatosensory Evoked Potential (SSEP). The evaluation of electrical studies is complex and should be performed by specialists who are well trained in the use of this diagnostic procedure.

c. Special testing procedures may be considered when attempting to confirm the current diagnosis or reveal alternative diagnosis. Additional special tests may be performed at the discretion of the physician.

d. Testing for Complex Regional Pain Syndrome (CRPS I) or Sympathetically Maintained Pain (SMP) is described in the Division’s Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy Medical Treatment Guidelines.

4. LABORATORY TESTING Laboratory tests are generally accepted, well-established, and widely used procedures. Patients should be carefully screened at the initial exam for signs or symptoms of diabetes, hypothyroidism, arthritis, and related inflammatory diseases. For patients at risk for sleep apnea, testing may be appropriate depending on medication use and issues with insomnia. The presence of concurrent disease does not refute work-relatedness of any specific case. This frequently requires laboratory testing.

When a patient's history and physical examination suggest infection, metabolic or endocrinologic disorders, tumorous conditions, systemic musculoskeletal disorders (e.g., rheumatoid arthritis or ankylosing spondylitis), or problems potentially related to medication (e.g., renal disease and non-steroidal anti-inflammatory medications), then laboratory tests, including, but not limited to the following can provide useful diagnostic information:

a. Thyroid stimulating hormone (TSH) for hypothyroidism;

b. Diabetic screening: recommended for men and women with a BMI over 30, patients with a family history of diabetes, those from high risk ethnic groups, and patients with a previous history of impaired glucose tolerance. There is some evidence that diabetic patients with upper extremity disorders have sub-optimal control of their diabetes;

c. Serum protein electrophoresis;

d. Sedimentation rate and C-reactive protein (CRP) are nonspecific but elevated in infection, neoplastic conditions, and rheumatoid arthritis. Other screening tests to

rule out inflammatory or autoimmune disease may be added when appropriate;

e. Serum calcium, phosphorus, uric acid, alkaline, and acid phosphatase for metabolic, endocrine and neo-plastic conditions;

f. Complete blood count (CBC), liver, and kidney function profiles for metabolic or endocrine disorders or for adverse effects of various medications;

g. Bacteriological (microorganism) work-up for wound, blood, and tissue;

h. Vitamin B12 levels may be appropriate for some patients.

The Division recommends that the workers’ compensation carrier cover initial lab diagnostic procedures to ensure that an accurate diagnosis and treatment plan is established. When an authorized treating provider has justification for the test, insurers should cover the costs.

Laboratory testing may be required periodically to monitor patients on chronic medications.

5. INJECTIONS–DIAGNOSTIC

a. Spinal Diagnostic Injections:

Diagnostic spinal injections are not commonly used in chronic pain patients as usually they have been performed previously in the acute or subacute stage.

They may rarely be necessary for aggravations of low back pain. Refer to the Division’s Low Back Pain Medical Treatment Guideline for indications.

i. Steroid Associated Issues:

If steroids are injected, only non-particulate steroids should be used to avoid the risk of spinal infection.

The majority of diabetic patients will experience an increase in glucose following steroid injections. Average increases in one study were 125mg/dL and returned to normal in 48 hours, whereas in other studies, the increased glucose levels remained elevated up to 7 days, especially after multiple injections. All diabetic patients should be told to follow their glucose levels carefully over the 7 days after a steroid injection. For patients who have not been diagnosed with diabetes, one can expect some increase in glucose due to insulin depression for a few days after a steroid injection. Clinicians may consider diabetic screening tests for those who appear to be at risk for type 2 diabetes.

Intra-articular or epidural injections cause rapid drops in plasma cortisol levels which usually resolve in 1 to 4 weeks. There is some evidence that an intra-articular injection of 80 mg of methylprednisolone acetate into the knee has about a 25% probability of suppressing the adrenal gland response to exogenous adrenocortocotrophic hormone ACTH for four or more weeks after injection, but complete recovery of the adrenal response is seen by week 8 after injection. This adrenal suppression could require treatment if surgery or other physiologically stressful events occur.

There is good evidence that there are no significant differences between epidural injections with corticosteroid plus local anesthetic versus local anesthetic alone in patients with symptomatic spinal stenosis; however, there are measureable differences with respect to morning cortisol levels at 3 and 6 weeks after the injection, suggesting that the corticosteroid injection is capable of inducing suppression of the hypothalamic-pituitaryadrenal axis.

Case reports of Cushing’s syndrome, hypopituitarism and growth hormone deficiency have been reported uncommonly and have been tied to systemic absorption of intra-articular and epidural steroid injections.

Cushing’s syndrome has also been reported from serial occipital nerve injections and paraspinal injections.

Morning cortisol measurements may be ordered prior to repeating steroid injections or prior to the initial steroid injection when the patient has received multiple previous steroid injections.

The effect of steroid injections on bone mineral density (BMD) and any contribution to osteoporotic fractures is less clear. Patients on long-term steroids are clearly more likely to suffer from fractures than those who do not take steroids. However, the contribution from steroid injections to this phenomenon does not appear to be large. A well-controlled, large retrospective cohort study found that individuals with the same risk factors for osteoporotic fractures were 20% more likely to suffer a lumbar fracture if they had an epidural steroid injection. The risk increased with multiple injections. Other studies have shown inconsistent findings regarding BMD changes.

Thus the risk of epidural injections must be carefully discussed with the patient, particularly for patients over 60, and repeat injections should generally be avoided unless the functional goals to be reached outweigh the risk for future fracture. Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive epidural steroid Time Frame for Spinal Diagnostic Injections Maximum Given this information regarding increase in blood glucose levels, effects on the endocrine system, and possible osteoporotic influence, it is suggested that intra-articular and epidural injections be limited to a total of 3 to 4 per year [all joints combined].

ii. Specific Diagnostic Injections: In general, relief should last for at least the duration of the local anesthetic used and should significantly result in functional improvement and relief of pain. Refer to Section G.7, Injections – Spinal Therapeutic, for information on specific therapeutic A) Epidural injections: Diagnostic epidural injections are usually not necessary in chronic pain as herniated discs have already been treated. They may be used for spinal stenosis. Refer to the Division’s Low Back Pain Medical Treatment Guideline for indications.

B) Medial Branch Blocks: Diagnostic medical branch blocks are usually not necessary in chronic pain. Refer to the Division’s Low Back Pain Medical Treatment Guideline for indications.

C) Sacroiliac Joint Injection: Diagnostic sacroiliac joint injections are usually not necessary in chronic pain. Refer to the Division’s Low Back Pain Medical Treatment Guideline for indications.

D) Zygapophyseal (Facet) Blocks: Diagnostic zygapophyseal blocks are usually not necessary in chronic pain. Refer to the Division’s Low Back Pain Medical Treatment Guideline for indications.

E) Peripheral Nerve Blocks: These are diagnostic injections that may be used for specific nerve injury or entrapment syndromes.

Not all peripheral nerve blocks require fluoroscopy. On occasion, they are used for treatment in chronic pain or CRPS. Repeat injection for treatment should be based on functional changes.

These injections are usually limited to 3 injections per site per year.

Evidence Statements Regarding Diagnostic Spinal Injections and Steroid Associated Issues Epidural steroid injections (ESIs) have a small average short-term benefit for leg pain and disability for those with sciatica.

ESIs do not, on average, provide clinically meaningful long-term improvements in leg pain, back pain, or disability in patients with sciatica (lumbar radicular pain or radiculopathy).

ESIs have no short-term or long-term benefit for low back injection has a small effect on patient reported pain and Randomized clinical trials There are no significant differences between epidural injections with corticosteroid plus local anesthetic versus local anesthetic alone in patients with symptomatic spinal stenosis. However, there are measureable differences with respect to morning cortisol levels at 3 and 6 weeks after the injection, suggesting that the corticosteroid injection is capable of inducing suppression of the hypothalamic-pituitary-adrenal axis. injection may reduce the frequency of surgery in the first year after treatment in patients with neurologic compression and corresponding imaging findings who also are strong candidates for surgery and have completed 6 weeks of therapy without adequate benefit.

The benefits for the non-surgical group persisted for at least 5 years in most patients, regardless of the type of block given.

Evidence Statements Regarding Diagnostic Spinal Injections and Steroid Associated Issues After 6 weeks of conservative therapy for large herniated discs, an epidural injection may be attempted, as it does not compromise the results of a discectomy at a later date.

One half of the patients in this study who were randomized to ESIs did not have surgery and this benefit persisted. Because this study did not have a control group that received neither treatment nor a group which received injections without steroids, one cannot make definite conclusions regarding the efficacy of ESI injections in this setting.

An intra-articular injection of 80 mg of methylprednisolone acetate into the knee has about a 25% probability of suppressing the adrenal gland response to exogenous adrenocortocotrophic hormone ACTH for four or more weeks after injection, but complete recovery of the adrenal response is seen by week 8 after injection.

Evidence Against There is good evidence against the use of lumbar facet or epidural injections for relief of non-radicular low back pain.

6. SPECIAL TESTS are generally well-accepted tests and are performed as part of a skilled assessment of the patient’s capacity to return to work, his/her strength capacities, and/or physical work demand classifications and tolerance. The procedures in this subsection are listed in alphabetical order.

a. Computer-Enhanced Evaluations: These may include isotonic, isometric, isokinetic, and/or isoinertial measurements of movement; ROM; endurance; or strength. Values obtained can include degrees of motion, torque forces, pressures, or resistance. Indications include determining validity of effort, effectiveness of treatment, and demonstrated motivation. These evaluations should not be used alone to determine return-to-work restrictions.

Time Frames for Computer-Enhanced Evaluations Frequency One time for evaluation, one for mid-treatment assessment, and one at final evaluation.

b. Functional Capacity Evaluation (FCE): This is a comprehensive or modified evaluation of the various aspects of function as they relate to the worker’s ability to return to work. Areas such as endurance, lifting (dynamic and static), postural tolerance, specific ROM, coordination and strength, worker habits, employability, as well as psychosocial aspects of competitive employment may be evaluated.

Reliability of patient reports and overall effort during testing is also reported.

Components of this evaluation may include: (a) musculoskeletal screen; (b) cardiovascular profile/aerobic capacity; (c) coordination; (d) lift/carrying analysis;

(e) job-specific activity tolerance; (f) maximum voluntary effort; (g) pain assessment/psychological screening; and (h) non-material and material handling activities. Standardized national guidelines (such as National Institute for Occupational Safety and Health (NIOSH)) should be used as the basis for FCE recommendations.

Most studies of FCEs were performed on chronic low back cases. There is some evidence that an FCE fails to predict which injured workers with chronic low back pain will have sustained return to work. Another cohort study concluded that there was a significant relation between FCE information and return to work, but the predictive efficiency was poor. There is some evidence that time off work and gender are important predictors for return to work, and floor-to-waist lifting may also help predict return to work; however, the strength of that relationship has not been determined.

A full review of the literature reveals no evidence to support the use of FCEs to prevent future injuries. There is some evidence in chronic low back pain patients that (1) FCE task performance is weakly related to time on disability and time for claim closure, and (2) even claimants who fail on numerous physical performance FCE tasks may be able to return to work. These same issues may exist for lower extremity issues.

Full FCEs are rarely necessary. In many cases, a work tolerance screening or return to work performance will identify the ability to perform the necessary job tasks. There is some evidence that a short form FCE reduced to a few tests produces a similar predictive quality compared to the longer 2-day version of the FCE regarding length of disability and recurrence of a claim after return to work.

When an FCE is being used to determine return to a specific jobsite, the provider is responsible for fully understanding the physical demands and the duties of the job that the worker is attempting to perform. A jobsite evaluation is usually necessary. A job description should be reviewed by the provider and FCE evaluator prior to this evaluation. FCEs cannot be used in isolation to determine work restrictions. It is expected that the FCE may differ from both self-report of abilities and pure clinical exam findings in chronic pain patients. The length of a return to work evaluation should be based on the judgment of the referring physician and the provider performing the evaluation. Since return to work is a complicated multidimensional issue, multiple factors beyond functional ability and work demands should be considered and measured when attempting determination of readiness or fitness to return to work. FCEs should not be used as the sole criteria to diagnose malingering.

Evidence Statements Regarding Functional Capacity Evaluation An FCE fails to predict which injured workers with chronic low back pain will have sustained return to work.

Observational prognostic study In chronic low back pain patients, (1) FCE task performance is weakly related to time on disability and time for claim closure and (2) even claimants who fail on numerous physical performance FCE tasks may be able to return to work.

Time off work and gender are important predictors for return to work, and floor-to-waist lifting may also help predict return to work; however, the strength of that relationship has not been determined.

Retrospective Study A short form FCE reduced to a few tests produces a similar predictive quality compared to the longer 2-day version of the FCE regarding length of disability and recurrence of a claim after return to work.

Time Frames for Functional Capacity Evaluation Frequency Once when the patient is unable to return to the pre-injury position and further information is desired to determine permanent work restrictions.

Prior authorization is required for repeat FCEs.

c. Jobsite Evaluation and Alterations: A comprehensive analysis of the physical, mental, and sensory components of a specific job. The goal of the jobsite evaluation is to identify any job modification needed to ensure the safety of the employee upon return to work. These components may include but are not limited to: (a) postural tolerance (static and dynamic); (b) aerobic requirements;

(c) range-of-motion; (d) torque/force; (e) lifting/carrying; (f) cognitive demands;

(g) social interactions; (h) visual perceptual; (i) environmental requirements of a job; (j) repetitiveness; (k) essential functions of a job; and (l) ergonomic set up.

Job descriptions provided by the employer are helpful but should not be used as a substitute for direct observation.

Jobsite evaluation and alteration should include input from a health care professional with experience in ergonomics or a certified ergonomist, the employee, and the employer. The employee must be observed performing all job functions in order for the jobsite evaluation to be a valid representation of a typical workday. If the employee is unable to perform the job function for observation, a co-worker in an identical job position may be observed instead.

Periodic follow-up is recommended to assess the effectiveness of the intervention and need for additional ergonomic changes.

A jobsite evaluation may include observation and instruction of how work is done, what material changes (desk, chair) should be made, and determination of readiness to return to work.

Requests for a jobsite evaluation should describe the expected goals for the evaluation. Goals may include but are not limited to the following:

i. To determine if there are potential contributing factors to the person’s condition and/or for the physician to assess causality;

ii. To make recommendations for and to assess the potential for ergonomic changes;

iii. To provide a detailed description of the physical and cognitive job requirements;

iv. To assist patients in their return to work by educating them on how they may be able to do their job more safely in a bio-mechanically appropriate manner;

v. To give detailed work/activity restrictions.

Time Frames for Jobsite Evaluation and Alterations Frequency One time with additional visits as needed for follow-up per jobsite.

d. Vocational Assessment: Once an authorized practitioner has reasonably determined and objectively documented that a patient will not be able to return to his/her former employment and can reasonably prognosticate final restrictions, implementation of a timely vocational assessment can be performed. The vocational assessment should provide valuable guidance in the determination of future rehabilitation program goals. It should clarify rehabilitation goals which optimize both patient motivation and utilization of rehabilitation resources. If prognosis for return to former occupation is determined to be poor, except in the most extenuating circumstances, vocational assessment should be implemented within 3 to 12 months post-injury. Declaration of Maximum Medical Improvement (MMI) should not be delayed solely due to lack of attainment of a vocational assessment.

Time Frames for Vocational Assessment Frequency One time with additional visits as needed for follow-up.

e. Work Tolerance Screening (Fitness for Duty): is a determination of an individual's tolerance for performing a specific job based on a job activity or task.

It may include a test or procedure to specifically identify and quantify workrelevant cardiovascular, physical fitness, and postural tolerance. It may also address ergonomic issues affecting the patient’s return-to-work potential. May be used when a full FCE is not indicated.

Time Frames for Work Tolerance Screening Frequency One time for initial screen. May monitor improvements in strength every 3 to 4 weeks up to a total of 6 visits.

G. THERAPEUTIC PROCEDURES – NON-OPERATIVE

Non-operative therapeutic rehabilitation is applied to patients with chronic and complex problems of de-conditioning and functional disability. Treatment modalities may be utilized sequentially or concomitantly depending on chronicity, complexity of the problem, and anticipated therapeutic effect. Treatment plans should always be based on a diagnosis utilizing appropriate diagnostic procedures.

All treatment plans begin with shared decision making with the patient. Before initiation of any therapeutic procedure, an authorized treating physician, employer, and insurer must consider these important issues in the care of the injured worker: ● Patients undergoing therapeutic procedure(s) should be released or returned to modified or restricted duty during their rehabilitation at the earliest appropriate time. Refer to

Section G.17, Return-to-Work, in this section for detailed information. ● Reassessment of the patient’s status in terms of functional improvement should be documented after each treatment. If patients are not responding within the recommended time periods, alternative treatment interventions, further diagnostic studies, or consultations should be pursued. Continued treatment should be monitored using objective measures such as:

• Return-to-work or maintaining work status;

• Fewer restrictions at work or performing activities of daily living (ADL);

• Decrease in usage of medications related to the work injury; and • Measurable functional gains, such as increased range-of-motion, documented increase in strength, increased ability to stand, sit or lift, or patient completed functional evaluations. ● Clinicians should provide and document education to the patient. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms. ● Psychological or psychosocial screening should be performed on all chronic pain The following procedures are listed in alphabetical order.

1. ACUPUNCTURE

a. Overview: When acupuncture has been studied in randomized clinical trials, it is often compared with sham acupuncture and/or no acupuncture (usual care). The differences between true acupuncture and usual care have been moderate but clinically important. These differences can be partitioned into two components: non-specific effects and specific effects. Non-specific effects include patient beliefs and expectations, attention from the acupuncturist, administration of acupuncture in a relaxing setting, and other components of what is often called the placebo effect. Specific effects refer to any additional effects which occur in the same setting of expectations and attention, but they are attributable to the penetration of the skin in the specific, classic acupuncture points on the surface of the body by the needles themselves.

A sham procedure is intended as a non-therapeutic procedure that appears similar to the patient as the purported therapeutic procedure being tested. In most controlled studies, sham and classic acupuncture have produced similar effects. However, the sham controlled studies have shown consistent advantages of both true and sham acupuncture over no acupuncture when the studies have included a third comparison group that was randomized to usual medical care. Having this third comparison group has been advantageous in the interpretation of the non-specific effects of acupuncture since the third comparison group controls for some influences on study outcome. These influences include: more frequent contact with providers; the natural history of the condition; regression to the mean; the effect of being observed in a clinical trial; and for biased reporting of outcomes if the follow-up observations are done consistently in all three treatment groups. Controlling for these factors enables researchers to more closely estimate the contextual and personal interactive effects of acupuncture as it is generally practiced.

There is some evidence that in the setting of chronic joint pain arising from aromatase inhibitor treatment of non-metastatic breast cancer, the symptomatic relief from acupuncture is strongly influenced by the expectations with which patients approach treatment, and a patient who expects significant benefits from acupuncture is more likely to derive benefits from sham acupuncture than a patient with low expectations is to derive benefits from real acupuncture. On average, real and sham acupuncture do not lead to significantly different symptom responses, but different treatment expectations do lead to different symptom responses.

Clinical trials of acupuncture typically enroll participants who are interested in acupuncture and who may respond to some of the non-specific aspects of the intervention more than patients who have no interest in or desire for acupuncture.

The non-specific effects of acupuncture may not be produced in patients who have no wish to be referred for it.

There is a high quality study which does not support good evidence that true acupuncture is meaningfully superior to sham acupuncture with blunt needles in relieving the bothersomeness of nonspecific low back pain. The overall evidence from similar high quality studies does not support evidence of a treatment difference between true and sham acupuncture. In these studies, 5–15 treatments were provided. Comparisons of acupuncture and sham acupuncture have been inconsistent, and the advantage of true over sham acupuncture has been small in relation to the advantage of sham over no acupuncture.

Acupuncture is recommended for subacute or chronic pain patients who are trying to increase function and/or decrease medication usage and have an expressed interest in this modality. It is also recommended for subacute or acute pain for patients who cannot tolerate NSAIDs or other medications.

Acupuncture is not the same procedure as dry needling for coding purposes; however, some acupuncturists may use acupuncture treatment for myofascial trigger points. Dry needling is performed specifically on myofascial trigger points.

Refer to Section G.8.i, Trigger Point Injections, and Section G.19.n, Trigger Point Dry Needling Treatment.

Acupuncture should generally be used in conjunction with manipulative and physical therapy/rehabilitation.

Credentialed practitioners with experience in evaluation and treatment of chronic pain patients must perform evaluations prior to acupuncture treatments. The exact mode of action is only partially understood. Western medicine studies suggest that acupuncture stimulates the nervous system at the level of the brain, promotes deep relaxation, and affects the release of neurotransmitters.

Acupuncture is commonly used as an alternative or in addition to traditional Western pharmaceuticals. It may be used when pain medication is reduced or not tolerated; as an adjunct to physical rehabilitation and surgical intervention; and/or as part of multidisciplinary treatment to hasten the return of functional activity. Acupuncture must be performed by practitioners with the appropriate credentials in accordance with state and other applicable regulations. Therefore, if not otherwise within their professional scope of practice and licensure, those performing acupuncture must have the appropriate credentials, such as L.A.c.

R.A.c, or Dipl. Ac.

There is good evidence that the small therapeutic effects of needle acupuncture, active laser acupuncture, and sham acupuncture for reducing pain or improving function among patients older than 50 years with moderate to severe chronic knee pain from symptoms of osteoarthritis are due to non-specific effects similar to placebo.

The Agency for Healthcare Research and Quality (AHRQ) supports acupuncture as effective for chronic low back pain. There is good evidence that acupuncture is effective in the treatment of low back pain in patients with positive expectations of acupuncture. There is good evidence that acupuncture, true or sham, is superior to usual care for the reduction of disability and pain in patients with chronic nonspecific low back pain, but true and sham acupuncture are likely to be equally effective. There is some evidence that acupuncture is better than no acupuncture for axial chronic low back pain. In summary, there is strong evidence that true or sham acupuncture may be useful for chronic low back pain in patients with high expectations, and it should be used accordingly.

Indications: All patients being considered for acupuncture treatment should have subacute or chronic pain (lasting approximately 3-4 weeks depending on the condition) and meet the following criteria:

• they should have participated in an initial active therapy program; and • they should show a preference for this type of care or previously have benefited from acupuncture; and • they must continue to be actively engaged in physical rehabilitation therapy and return to work.

It is less likely to be successful in patients who are more focused on pain than return to function. Time to produce effect should clearly be adhered to.

b. Acupuncture: is the insertion and removal of filiform needles to stimulate acupoints (acupuncture points). Needles may be inserted, manipulated, and retained for a period of time. Acupuncture can be used to reduce pain, reduce inflammation, increase blood flow, increase range-of-motion, decrease the side effect of medication-induced nausea, promote relaxation in an anxious patient, and reduce muscle spasm.

Indications include joint pain, joint stiffness, soft tissue pain and inflammation, paresthesia, post-surgical pain relief, muscle spasm, and scar tissue pain.

c. Acupuncture with Electrical Stimulation: is the use of electrical current (microamperage or milli-amperage) on the needles at the acupuncture site. It is used to increase effectiveness of the needles by continuous stimulation of the acupoint.

Physiological effects (depending on location and settings) can include endorphin release for pain relief, reduction of inflammation, increased blood circulation, analgesia through interruption of pain stimulus, and muscle relaxation.

It is indicated to treat chronic pain conditions, radiating pain along a nerve pathway, muscle spasm, inflammation, scar tissue pain, and pain located in multiple sites.

d. Other Acupuncture Modalities: may include a combination of procedures to enhance treatment effect. Other procedures may include the use of heat, soft tissue manipulation/massage, and exercise. Refer to Section G.18, Active Therapy (Therapeutic Exercise), and Section G.19, Passive Therapy (Massage and Superficial Heat and Cold Therapy), for a description of these adjunctive acupuncture modalities and time frames.

Evidence Statements Regarding Acupuncture The small therapeutic effects of needle acupuncture, active laser acupuncture, and sham acupuncture for reducing pain or improving function among patients older than 50 years with moderate to severe chronic knee pain from symptoms of osteoarthritis are due to nonspecific effects similar to placebo.

Negative randomized Acupuncture is effective in the treatment of low back pain in patients with positive expectations of acupuncture.

Acupuncture, true or sham, is superior to usual care for the reduction of disability and pain in patients with chronic nonspecific low back pain, but true and sham acupuncture are likely to be equally effective.

In the setting of chronic joint pain arising from aromatase inhibitor treatment of non-metastatic breast cancer, the symptomatic relief from acupuncture is strongly influenced by the expectations with which patients approach treatment, and a patient who expects significant benefits from acupuncture is more likely to derive benefits from sham acupuncture than a patient with low expectations is to derive benefits from real acupuncture. On average, real and sham acupuncture do not lead to significantly different symptom responses, but different treatment expectations do lead to different symptom responses.

Acupuncture is better than no acupuncture for axial chronic low back Evidence Statements Regarding Acupuncture Summary of Evidence Regarding Acupuncture Based on the multiple studies with good and some evidence listed above, there is strong evidence that true or sham acupuncture may be useful for chronic low back pain in patients with high expectations, and it should be used accordingly.

e. Total Time Frames for Acupuncture and Acupuncture with Electrical Stimulation: are not meant to be applied to acupuncture and acupuncture with electrical stimulation separately. The time frames are to be applied to all acupuncture treatments regardless of the type or combination of therapies being provided.

Time Frames for Acupuncture and Acupuncture with Electrical Stimulation Time to Produce Effect 3 to 6 treatments.

Optimum Duration 1 to 2 months.

Maximum Duration 14 treatments within 6 months.

Any of the above acupuncture treatments may extend longer if objective functional gains can be documented and when symptomatic benefits facilitate progression in the patient’s treatment program. Treatment beyond 14 treatments must be documented with respect to need and ability to facilitate positive symptomatic or functional gains. Such care should be re-evaluated and documented with each series of treatments.

2. BIOFEEDBACK

a. Overview: Biofeedback is a form of behavioral medicine that helps patients learn self-awareness and self-regulation skills for the purpose of gaining greater control of their physiology, such as muscle activity, brain waves, and measures of autonomic nervous system activity. Stress-related psycho-physiological reactions may arise as a reaction to organic pain and in some cases may cause pain. Electronic instrumentation is used to monitor the targeted physiology and then displayed or fed back to the patient visually, auditorily, or tactilely, with coaching by a biofeedback specialist. There is good evidence that biofeedback or relaxation therapy is equal in effect to cognitive behavioral therapy for chronic low back pain. There is good evidence that cognitive behavioral therapy, but not behavioral therapy (e.g., biofeedback), shows weak to small effects in reducing pain and small effects on improving disability, mood, and catastrophizing in patients with chronic pain.

Indications for biofeedback include cases of musculoskeletal injury in which muscle dysfunction or other physiological indicators of excessive or prolonged stress response affects and/or delays recovery. Other applications include training to improve self-management of pain, anxiety, panic, anger or emotional distress, opioid withdrawal, insomnia/sleep disturbance, and other central and autonomic nervous system imbalances. Biofeedback is often utilized for relaxation training. Mental health professionals may also utilize it as a component of psychotherapy, where biofeedback and other behavioral techniques are integrated with psychotherapeutic interventions. Biofeedback is often used in conjunction with physical therapy or medical treatment.

Recognized types of biofeedback include the following:

b. EMG/Electromyogram (EMG): used for self-management of pain and stress reactions involving muscle tension.

c. Skin Temperature: used for self-management of pain and stress reactions, especially vascular headaches.

d. Respiration Feedback (RFB): used for self-management of pain and stress reactions via breathing control.

e. Respiratory Sinus Arrhythmia (RSA): used for self-management of pain and stress reactions via synchronous control of heart rate and respiration.

Respiratory sinus arrhythmia is a benign phenomenon which consists of a small rise in heart rate during inhalation and a corresponding decrease during exhalation. This phenomenon has been observed in meditators and athletes and is thought to be a psycho-physiological indicator of health.

f. Heart Rate Variability (HRV): used for self-management of stress via managing cardiac reactivity.

g. Electrodermal Response (EDR): used for self-management of stress involving palmar sweating or galvanic skin response.

h. Electroencephalograph (EEG, QEEG): used for self-management of various psychological states by controlling brainwaves.

The goal in biofeedback treatment is normalizing the physiology to the pre-injury status to the extent possible and involves transfer of learned skills to the workplace and daily life. Candidates for biofeedback therapy or training should be motivated to learn and practice biofeedback and self-regulation techniques. In the course of biofeedback treatment, patient stressors are discussed and selfmanagement strategies are devised. If the patient has not been previously evaluated, a psychological evaluation should be performed prior to beginning biofeedback treatment for chronic pain. The psychological evaluation may reveal cognitive difficulties, belief system conflicts, somatic delusions, secondary gain issues, hypochondriasis, and possible biases in patient self-reports, which can affect biofeedback. Home practice of skills is often helpful for mastery and may be facilitated by the use of home training tapes.

Psychologists or psychiatrists, who provide psycho-physiological therapy which integrates biofeedback with psychotherapy, should be either Biofeedback Certification International Alliance (BCIA) certified or practicing within the scope of their training. All non-licensed health care providers of biofeedback for chronic pain patients must be BCIA certified and shall have their biofeedback treatment plan approved by an authorized treating psychologist or psychiatrist. Biofeedback treatment must be done in conjunction with the patient’s psychosocial intervention. Biofeedback may also be provided by licensed health care providers who follow a set treatment and educational protocol. Such treatment may utilize standardized material, relaxation tapes, or smart phone apps.

Evidence Statements Regarding Biofeedback Biofeedback or relaxation therapy is equal in effect to cognitive behavioral therapy for chronic low back pain.

Meta-analysis of controlled Cognitive behavioral therapy, but not behavioral therapy e.g., biofeedback, shows weak to small effects in reducing pain and small effects on improving disability, mood, and catastrophizing in patients with chronic pain.

Meta-analysis of randomized clinical trials favoring cognitive behavioral therapy over biofeedback Time Frames for Biofeedback Time to Produce Effect 3 to 4 sessions.

Frequency 1 to 2 times per week.

Optimum Duration 5 to 6 sessions.

Maximum Duration 10 to 12 sessions. Treatment beyond 12 sessions must be documented with respect need, expectation, and ability to facilitate functional gains.

3. COMPLEMENTARY MEDICINE

a. Overview: Complementary Medicine, termed Complementary Alternative Medicine (CAM) in some systems, is a term used to describe a broad range of treatment modalities, a number of which are generally accepted and supported by some scientific literature and others which still remain outside the generally accepted practice of conventional Western Medicine. In many of these approaches, there is attention given to the relationship between physical, emotional, and spiritual well-being. While CAM may be performed by a myriad of both licensed and non-licensed health practitioners with training in one or more forms of therapy, credentialed practitioners should be used when available or applicable.

Although CAM practices are diverse and too numerous to list, they can be generally classified into five domains:

b. Alternative Medical Systems: These are defined as medical practices that have developed their own systems of theory, diagnosis, and treatment and have evolved independent of and usually prior to conventional Western Medicine.

Some examples are Traditional Chinese Medicine, Ayurvedic Medicine, Homeopathy, and Naturopathy.

c. Mind-body Interventions: These include practices such as hypnosis, meditation, bioenergetics, and prayer. Reflexology does not appear to relieve low back pain.

d. Biological-based Practices: These include herbal and dietary therapy as well as the use of nutritional supplements. To avoid potential drug interactions, supplements should be used in consultation with an authorized treating physician.

e. Body-based Therapy: This category includes Rolfing bodywork. For information on yoga, please refer to Section G.18.g, Therapeutic Exercise.

f. Energy-based Practices: Energy-based practices include a wide range of modalities that support physical as well as spiritual and/or emotional healing.

Some of the more well-known energy practices include Qi Gong, Tai Chi, Healing Touch, and Reiki. Practices such as Qi Gong and Tai Chi are taught to the patient and are based on exercises the patient can practice independently at home. Other energy-based practices such as Healing Touch and Reiki that involve a practitioner/patient relationship may provide some pain relief. Tai Chi may improve range-of-motion in those with rheumatoid arthritis. There is some evidence that a 10-week tai chi program was effective for improving pain symptoms and disability compared with usual care controls for those who have chronic low back pain symptoms. There is insufficient evidence that the results from Qi Gong are equivalent to exercise therapy.

Methods used to evaluate chronic pain patients for participation in CAM will differ with various approaches and with the training and experience of individual practitioners. A patient may be referred for CAM therapy when the patient’s cultural background, religious beliefs, or personal concepts of health suggest that an unconventional medical approach might assist in the patient’s recovery or when the physician’s experience and clinical judgment support a CAM approach.

The patient must demonstrate a high degree of motivation to return to work and improve his or her functional activity level while participating in therapy. Other more traditional conservative treatments should generally be attempted before referral to CAM. Treatment with CAM requires prior authorization.

All CAM treatments require prior authorization and must include agreed upon number of visits for time to produce functional effects.

Evidence Statements Regarding Complementary Medicine A 10-week tai chi program was effective for improving pain symptoms and disability compared with usual care controls for those who have chronic low back pain symptoms.

Time Frames for Complementary Medicine Time to Produce Effect Functional treatment goals and number of treatments for time to produce effect should be set with the practitioner and the patient before the beginning of treatment.

Frequency Per CAM therapy selected.

Optimum Duration Should be based upon the physician’s clinical judgment and demonstration by the patient of positive symptomatic and functional gains. Practitioner provided CAM therapy is not recommended on a maintenance basis.

4. DIRECT CORTICAL STIMULATION

There are several types of cortical stimulation to relieve pain. All of these are undergoing further investigation and are considered experimental at this time. The limited studies available do not allow translation to the workers’ compensation chronic pain population.

An invasive option is implantation in the epidural motor cortex. Given the invasive nature and lack of evidence applying to the working population, direct cortical stimulation is not 5. DISTURBANCES OF SLEEP a. Overview: Disturbances of sleep are common in chronic pain. An essential element of chronic pain treatment is restoration of normal sleep cycles. Although primary insomnia may accompany pain as an independent co-morbid condition, it more commonly occurs secondary to the pain condition itself. Exacerbations of pain often are accompanied by exacerbations of insomnia; the reverse can also occur. Sleep laboratory studies have shown disturbances of sleep architecture in pain patients. Loss of deep slow-wave sleep and an increase in light sleep occur.

Sleep efficiency, the proportion of time in bed spent asleep, is also decreased.

These changes are associated with patient reports of non-restorative sleep.

Sleep apnea may also occur as a primary diagnosis or be caused or exacerbated by opioid and hypnotic use. This should be investigated diagnostically. (Refer to

Section G.10.g, Medications and Medical Management, Opioids).

A recent systematic review explored the relationship between sleep and pain. It noted that studies of healthy individuals and those in pain from medical conditions both showed decreased pain thresholds after sleep deprivation. In this report some studies focusing on sleep continuity disruption showed a disruption of the natural pain inhibitory function. Sleep continuity disruption may be one of the most common sleep problems associated with pain. Thus, clinicians should strongly focus on assuring functional sleep for patients.

Many chronic pain patients develop behavioral habits that exacerbate and maintain sleep disturbances. Excessive time in bed, irregular sleep routine, napping, low activity, and worrying in bed are all maladaptive responses that can arise in the absence of any psychopathology. Relaxation training such as progressive relaxation, biofeedback, mindfulness meditation, or imagery training, and other forms of cognitive therapy can reduce dysfunctional beliefs and attitudes about sleep.

There is some evidence that behavioral modification, such as patient education and group or individual counseling with cognitive behavioral therapy, can be effective in reversing the effects of insomnia. Cognitive and behavioral interventions should be undertaken before prescribing medication solely for insomnia. Behavioral modifications are easily implemented and can include:

• Maintaining a regular sleep schedule; retiring and rising at approximately the same time on weekdays and weekends, regardless of the number of hours slept.

• Limiting naps to 30 minutes twice per day or less.

• Avoiding caffeinated beverages after lunchtime.

• Making the bedroom quiet and comfortable, eliminating disruptive lights, sounds, television sets, pets, and keeping a bedroom temperature of about 65 degrees Fahrenheit.

• Avoiding alcohol or nicotine within 2 hours of bedtime.

• Avoiding large meals within 2 hours of bedtime.

• Avoiding exposure to TV screens or computers within 2 hours of bedtime.

• Exercising vigorously during the day but not within 2 hours of bedtime since this may raise core temperature and activate the nervous system.

• Associating the bed with sleep and sexual activity only; using other parts of the home for television, reading, and talking on the telephone.

• Leaving the bedroom when unable to sleep for more than 20 minutes and returning to the bedroom when ready to sleep again.

• Reducing time in bed to estimated typical sleeping time.

• Engaging in relaxing activities until drowsy.

Behavioral modifications should be trialed before the use of hypnotics.

Reinforcing these behaviors may also decrease hypnotic use and overall medication costs. Some patients may use other medications to assist in sleep, such as: trazadone, amitriptyline, doxepin, or low doses of melatonin. There is some evidence that group cognitive behavioral therapy reduces the severity and daytime consequences of insomnia for at least six months. There is some evidence that ramelteon, while producing a small amount of reduction in sleep latency, does not appreciably increase total sleep time or daytime function. There is some evidence that a dietary supplement containing melatonin, magnesium, and zinc, conveyed in pear pulp, taken 1 hour before bedtime, results in significantly better quality of sleep and quality of life than a placebo treatment in long-term care facility residents aged 70 and older with primary insomnia.

Many medications used in chronic pain can affect the sleep cycle. There is some evidence that the following medications exert different effects with respect to sleep variables. Total sleep time and REM sleep duration are likely to be greater with pregabalin than with duloxetine or amitriptyline. However, pregabalin is likely to lead to dizziness and fatigue more frequently than the other drugs, and oxygen desaturation during sleep also appears to be greater with pregabalin.

Insomnia requires difficulty initiating or maintaining sleep, waking up early, or insufficient restorative sleep despite adequate opportunity for sleep, as well as, daytime symptoms of sleep deprivation. In general, recommendations for treatment of insomnia include Cognitive Behavioral Therapy.

Evidence Statements Regarding Disturbance of Sleep Group cognitive behavioral therapy reduces the severity and daytime consequences of insomnia for at least six Behavioral modification, such as patient education and group or individual counseling with cognitive behavioral therapy, can be effective in reversing the effects of insomnia.

Ramelteon, while producing a small amount of reduction in sleep latency, does not appreciably increase total sleep time or daytime function.

A dietary supplement containing melatonin, magnesium, and zinc, conveyed in pear pulp, taken 1 hour before bedtime, results in significantly better quality of sleep and quality of life than a placebo treatment in long-term care facility residents aged 70 and older with primary insomnia.

Double-blind placebo controlled randomized The following medications exert different effects with respect to sleep variables. Total sleep time and REM sleep duration are likely to be greater with pregabalin than with duloxetine or amitriptyline. However, pregabalin is likely to lead to dizziness and fatigue more frequently than the other drugs, and oxygen desaturation during sleep also appears to be greater with pregabalin.

Summary of Evidence Regarding Disturbance of Sleep Based on the multiple studies with some evidence listed above, there is good evidence supporting the use of cognitive behavioral therapy for sleep disturbances.

6. EDUCATION/INFORMED/SHARED DECISION MAKING: of the patient and family, as well as the employer, insurer, policy makers, and the community should be the primary emphasis to prevent disability. Unfortunately, practitioners often think of education and informed decision making last, after medications, manual therapy, and surgery.

Informed decision making is the hallmark of a successful treatment plan. In most cases, the continuum of treatment from the least invasive to the most invasive (e.g., surgery) should be discussed. The intention is to find the treatment along this continuum which most completely addresses the condition. Patients should identify their personal values and functional goals of treatment at the first visit. It is recommended that specific individual goals are articulated at the beginning of treatment as this is likely to lead to increased patient satisfaction above that achieved from improvement in pain or other physical function. Progress toward the individual functional goals identified should be addressed at follow-up visits and throughout treatment by other members of the health care team as well as an authorized physician.

Documentation of the informed decision process should occur whenever diagnostic tests or referrals from an authorized treating physician are contemplated. The informed decision making process asks the patients to set their personal functional goals of treatment and describe their current health status and any concerns they have regarding adhering to the diagnostic or treatment plan proposed. The provider should clearly describe the following:

• The expected functional outcomes from the proposed treatment or the expected results and plan of action if diagnostic tests are involved.

• Expected course of illness/injury without the proposed intervention.

• Any side effects and risks to the patient.

• Required post-treatment rehabilitation time and impact on work, if any.

• Alternative therapies or diagnostic testing.

Before diagnostic tests or referrals for invasive treatment take place, the patient should be able to clearly articulate the goals of the intervention, the general side effects and risks associated with it, and his/her decision regarding compliance with the suggested plan. There is some evidence that information provided only by video is not sufficient education.

Practitioners must develop and implement an effective strategy and skills to educate patients, employers, insurance systems, policy makers, and the community as a whole.

An education-based paradigm should always start with providing reassuring information to the patient and informed decision making. More in-depth education currently exists within a treatment regimen employing functional restoration, prevention, and cognitive behavioral techniques. Patient education and informed decision making should facilitate self-management of symptoms and prevention.

Evidence Statements Regarding Education / Informed Decision Making Information provided only by video is not sufficient education.

Prospective randomized controlled trial Time Frames for Education / Informed Decision Making Time to Produce Effect Varies with individual patient Frequency Should occur at every visit.

7. INJECTIONS–SPINAL THERAPEUTIC:

The following injections are considered reasonable treatment for chronic pain exacerbations when therapy is continuing and specific indications are met. Refer to the Division’s appropriate Medical Treatment Guideline for indications. For post-MMI care, refer to Section I.8, Injection Therapy Maintenance Management, in this guideline.

a. Steroid Associated Issues: If steroids are injected, only non-particulate steroids should be used to avoid the risk of spinal infarction.

The majority of diabetic patients will experience an increase in glucose following steroid injections. Average increases in one study were 125mg/dL and returned to normal in 48 hours, whereas in other studies, the increased glucose levels remained elevated up to 7 days, especially after multiple injections. All diabetic patients should be told to follow their glucose levels carefully over the 7 days after a steroid injection. For patients who have not been diagnosed with diabetes, one can expect some increase in glucose due to insulin depression for a few days after a steroid injection. Clinicians may consider diabetic screening tests for those who appear to be at risk for type 2 diabetes.

Intra-articular or epidural injections cause rapid drops in plasma cortisol levels which usually resolve in 1 to 4 weeks. There is some evidence that an intraarticular injection of 80 mg of methylprednisolone acetate into the knee has about a 25% probability of suppressing the adrenal gland response to exogenous adrenocortocotrophic hormone (ACTH) for 4 or more weeks after injection, but complete recovery of the adrenal response is seen by week 8 after injection. This adrenal suppression could require treatment if surgery or other physiologically stressful events occur.

There is good evidence that there are no significant differences between epidural injections with corticosteroid plus local anesthetic versus local anesthetic alone in patients with symptomatic spinal stenosis; however, there are measureable differences with respect to morning cortisol levels at 3 and 6 weeks after the injection, suggesting that the corticosteroid injection is capable of inducing suppression of the hypothalamic-pituitary-adrenal axis.

Case reports of Cushing’s syndrome, hypopituitarism, and growth hormone deficiency have been reported uncommonly and have been tied to systemic absorption of intra-articular and epidural steroid injections. Cushing’s syndrome has also been reported from serial occipital nerve injections and paraspinal Morning cortisol measurements may be ordered prior to repeating steroid injections or prior to the initial steroid injection when the patient has received multiple previous steroid injections.

The effect of steroid injections on bone mineral density (BMD) and any contribution to osteoporotic fractures is less clear. Patients on long-term steroids are clearly more likely to suffer from fractures than those who do not take steroids. However, the contribution from steroid injections to this phenomenon does not appear to be large. A well-controlled, large retrospective cohort study found that individuals with the same risk factors for osteoporotic fractures were 20% more likely to suffer a lumbar fracture if they had an epidural steroid injection. The risk increased with multiple injections. Other studies have shown inconsistent findings regarding BMD changes. Thus, the risk of epidural injections must be carefully discussed with the patient, particularly for patients over 60, and repeat injections should generally be avoided unless the functional goals to be reached outweigh the risk for future fracture. Patients with existing osteoporosis or other risk factors for osteoporosis should rarely receive epidural steroid injections.

Time Frames for Intra-Articular and Epidural Injections Maximum Duration Given this information regarding increase in blood glucose levels, effects on the endocrine system, and possible osteoporotic influence, it is suggested that intra-articular and epidural injections be limited to a total of 3 to 4 per year [all joints combined].

b. Epidural Steroid Injection (ESI): may include caudal, transforaminal, or interlaminar injections. Epidural injections are usually not necessary in chronic pain as herniated discs have already been treated. They may be used for spinal stenosis. Refer to the Division’s Low Back Pain Medical Treatment Guideline for indications of herniated disc.

For radicular pain due to disc herniation, refer to the Division’s Low Back Pain Medical Treatment Guideline as this condition is not usually treated in chronic Spinal Stenosis Patients: Refer to the Division’s Low Back Pain Medical Treatment Guideline for patients with radicular findings and claudication for indications.

For chronic radiculopathy, injections may be repeated only if a functional documented response lasts for 3 months. Patients should be reassessed after each injection session for an 80% improvement in pain (as measured by accepted pain scales) and evidence of functional improvement. A positive result would include a return to baseline function, return to increased work duties, and a measurable improvement in physical activity goals including return to baseline after an exacerbation.

c. Intradiscal Steroid Injections:

There is some evidence that intradiscal steroid injection is unlikely to relieve pain or provide functional benefit in patients with non-radicular back pain; therefore, they are not recommended.

Intradiscal injections of other substances such as bone marrow, stem cells, are not recommended at this time due to lack of evidence and possible complications.

d. Sacroiliac Joint Injection:

A generally accepted injection of local anesthetic in an intra-articular fashion into the sacroiliac joint under fluoroscopic guidance. May include the use of corticosteroids. Long-term therapeutic effect has not yet been established. Refer to the Division’s Low Back Pain Medical Treatment Guideline for indications.

e. Transforaminal Injection with Etanercept:

Transforaminal injection with a tumor necrosis factor alpha inhibitor is thought to decrease the inflammatory agents which may be associated with the pathophysiology of lumbar radicular pain from a herniated disc.

It is not recommended due to the results of a study which showed no advantage over steroids or saline injections.

f. Zygapophyseal (Facet) Injection:

This is an accepted intra-articular or pericapsular injection of local anesthetic and corticosteroid with very limited uses. There is no justification for a combined facet and medial branch block.

A high quality meta-analysis provides good evidence against the use of lumbar facet or epidural injections for relief of non-radicular low back pain. Facet injections have very limited use. Refer to the Division’s Low Back Pain Medical Treatment Guideline for indications.

Evidence Statements Regarding Therapeutic Spinal Injections and Steroid Associated Issues Epidural steroid injections (ESIs) have a small average short-term benefit for leg pain and disability for those with sciatica.

ESIs do not, on average, provide clinically meaningful long-term improvements in leg pain, back pain, or disability in patients with sciatica (lumbar radicular pain or radiculopathy).

ESIs have no short-term or long-term benefit for low back The additional of steroids to a transforaminal bupivacaine injection has a small effect on patient reported pain and Evidence Statements Regarding Therapeutic Spinal Injections and Steroid Associated Issues There are no significant differences between epidural injections with corticosteroid plus local anesthetic versus local anesthetic alone in patients with symptomatic spinal stenosis. However, there are measureable differences with respect to morning cortisol levels at 3 and 6 weeks after the injection, suggesting that the corticosteroid injection is capable of inducing suppression of the hypothalamic-pituitary-adrenal axis. injection may reduce the frequency of surgery in the first year after treatment in patients with neurologic compression and corresponding imaging findings who also are strong candidates for surgery and have completed 6 weeks of therapy without adequate benefit.

The benefits for the non-surgical group persisted for at least 5 years in most patients, regardless of the type of block given.

After 6 weeks of conservative therapy for large herniated discs, an epidural injection may be attempted, as it does not compromise the results of a discectomy at a later date.

One half of the patients in this study who were randomized to ESIs did not have surgery and this benefit persisted. Because this study did not have a control group that received neither treatment nor a group which received injections without steroids, one cannot make definite conclusions regarding the efficacy of ESI injections in this setting.

An intra-articular injection of 80 mg of methylprednisolone acetate into the knee has about a 25% probability of suppressing the adrenal gland response to exogenous adrenocortocotrophic hormone ACTH for 4 or more weeks after injection, but complete recovery of the adrenal response is seen by week 8 after injection.

Patients who smoke respond less well to non-operative spine care, and quitting smoking results in greater Translaminar steroid injections do not increase walking tolerance for those with spinal stenosis compared to local anesthetic.

Intradiscal steroid injection is unlikely to relieve pain or provide functional benefit in patients with non-radicular back pain.

Evidence Against There is good evidence against the use of lumbar facet or epidural injections for relief of non-radicular low back pain.

8. INJECTIONS – OTHER (INCLUDING RADIO FREQUENCY): The following are in alphabetical order:

a. Botulinum Toxin Injections:

Description: Used to temporarily weaken or paralyze muscles. These injections may reduce muscle pain in conditions associated with spasticity or dystonia.

Neutralizing antibodies develop in at least 4% of patients treated with botulinum toxin type A, rendering it ineffective. Several antigenic types of botulinum toxin have been described. Botulinum toxin type B, first approved by the Food and Drug Administration (FDA) in 2001, is similar pharmacologically to botulinum toxin type A. It appears to be effective in patients who have become resistant to the type A toxin. The immune responses to botulinum toxins type A and B are not cross-reactive, allowing type B toxin to be used when type A action is blocked by antibody. Experimental work with healthy human volunteers suggests that muscle paralysis from type B toxin is not as complete or as long lasting as that resulting from type A. The duration of treatment effect of botulinum toxin type B for cervical dystonia has been estimated to be 12 to 16 weeks. Electromyography (EMG) needle guidance may permit more precise delivery of botulinum toxin to the target area.

There is strong evidence that botulinum toxin A has objective and asymptomatic benefits over placebo for cervical dystonia. There is good evidence that a single injection of botulinum toxin type B is more effective than placebo in alleviating the severity and pain of idiopathic cervical dystonia. The duration of effect of botulinum toxin type B is not certain but appears to be approximately 12 to 18 weeks.

There is a lack of adequate evidence supporting the use of these injections to lumbar musculature for the relief of isolated low back pain. There is insufficient evidence to support its use for longer-term pain relief of other myofascial trigger points and it is likely to cause muscle weakness or atrophy if used repeatedly.

Examples of such consequences include subacromial impingement, as the stabilizers of the shoulder are weakened by repeated injections of trigger points in the upper trapezii. Therefore, it is not recommended for use for low back pain or other myofascial trigger points.

They may be used for chronic piriformis syndrome. There is some evidence to support injections for electromyographically proven piriformis syndrome. Prior to consideration of botulinum toxin injection for piriformis syndrome, patients should have had marked (80% or better) but temporary improvement, verified with demonstrated improvement in functional activities, from three separate trigger point injections. To be a candidate for botulinum toxin injection for piriformis syndrome, patients should have had symptoms return to baseline or near baseline despite an appropriate stretching program after trigger point injections.

Botulinum toxin injections of the piriformis muscle should be performed by a physician experienced in this procedure and utilize either ultrasound, fluoroscopy, or EMG needle guidance. Botulinum toxin should be followed by limb strengthening and reactivation.

Indications: for conditions which produce dystonia or piriformis syndrome. It is important to note that dystonia, torticollis, and spasticity are centrally mediated processes that are distinct from spasm, tightness, or myofascial pain. True dystonia is uncommon and consists of a severe involuntary contraction which results in abnormal postures or movements. Cervical dystonia or torticollis is the most common dystonia seen in the work related population. There should be evidence of limited range-of-motion prior to the injection. Refer to the Division’s Traumatic Brain Injury (TBI) Medical Treatment Guideline for indications regarding headache.

There is insufficient evidence to support its use in myofascial trigger points for longer-term pain relief, and it is likely to cause muscle weakness or atrophy if used repeatedly. Examples of such consequences include subacromial impingement, as the stabilizers of the shoulder are weakened by repeated injections of trigger points in the upper trapezii. Therefore, it is not recommended for use for other myofascial trigger points.

Complications: There is good evidence that cervical botulinum toxin A injections cause transient dysphagia and neck weakness. Allergic reaction to medications, dry mouth, and vocal hoarseness may also occur. Dry mouth and dysphagia occur 15% of the time after one injection. Rare systemic effects include flu-like syndrome and weakening of distant muscle. There is an increased risk of systemic effects in patients with motor neuropathy or disorders of the neuromuscular junction.

Evidence Statements Regarding Botulinum Toxin Injections for Cervical Dystonia Botulinum toxin A has objective and asymptomatic benefits over placebo for cervical dystonia.

A single injection of botulinum toxin type B is more effective than placebo in alleviating the severity and pain of idiopathic cervical dystonia. The duration of effect of botulinum toxin type B is not certain but appears to be approximately 12 to 18 weeks.

Evidence Statements Regarding Botulinum Toxin Injections for Piriformis Syndrome There is some evidence to support injections for electromyographically proven piriformis syndrome.

Time Frames for Botulinum Toxin Injections Time to Produce Effect 24 to 72 hours post injection with peak effect by 4 to 6 weeks.

Frequency No less than 3 months between re-administration. Patients should be reassessed after each injection session for approximately an 80% improvement in pain (as measured by accepted pain scales) and evidence of functional improvement for 3 months. A positive result would include a return to baseline function, return to increased work duties, and measurable improvement in physical activity goals including return to baseline after an exacerbation.

Optimum Duration 3 to 4 months.

Maximum Duration Currently unknown. Repeat injections should be based upon functional improvement and therefore used sparingly in order to avoid development of antibodies that might render future injections ineffective. In most cases, not more than 4 injections are appropriate due accompanying muscle atrophy.

b. Epiduroscopy and Epidural Lysis of Adhesions: is a controversial and investigational treatment of low back pain. It involves the introduction of a fiberoptic endoscope into the epidural space via the sacral hiatus. With cephalad advancement of the endoscope under direct visualization, the epidural space is irrigated with saline. Adhesiolysis may be done mechanically with a fiberoptic endoscope. The saline irrigation is performed with or without epiduroscopy and is intended to distend the epidural space in order to obtain an adequate visual field.

It is designed to produce lysis of adhesions, which are conjectured to produce symptoms due to traction on painful nerve roots. Saline irrigation is associated with risks of elevated pressures which may impede blood flow and venous return, possibly causing ischemia of the cauda equina and retinal hemorrhage. Other complications associated with instrumented lysis include catheter shearing, need for catheter surgical removal, infection (including meningitis), hematoma, and possible severe hemodynamic instability during application. Although epidural adhesions have been postulated to cause chronic low back pain, studies have failed to find a significant correlation between the level of fibrosis and pain or difficulty functioning. Studies of epidural lysis demonstrate no transient pain relief from the procedure. Given the low likelihood of a positive response, the additional costs and time requirement, and the possible complications from the procedure, epiduroscopy, or mechanical lysis, is not recommended.

Epiduroscopy-directed steroid injections are also not recommended because there is no evidence to support an advantage in using an epiduroscope with steroid injections.

c. Prolotherapy: Also known as sclerotherapy, prolotherapy consists of a series of injections of hypertonic dextrose, with or without glycerine and phenol, into the ligamentous structures of the low back. Its proponents claim that the inflammatory response to the injections will recruit cytokine growth factors involved in the proliferation of connective tissue, stabilizing the ligaments of the low back when these structures have been damaged by mechanical insults.

There is good evidence that prolotherapy alone is not an effective treatment for chronic low back pain. There is some evidence that prolotherapy of the sacroiliac (SI) joint is longer lasting, up to 15 months, than intra-articular steroid injections.

The study was relatively small and long-term blinding was unclear; however, all injections were done under fluoroscopic guidance. Indications included an 80% reduction in pain from an SI joint injection with local anesthetic, as well as physical findings of SI joint dysfunction. Lasting functional improvement has not been shown and approximately 3 injections were required. The injections are invasive, and may be painful to the patient. The use of prolotherapy for low back pain is generally not recommended, as the majority of patients with SI joint dysfunction will do well with a combination of active therapy and manipulation and not require prolotherapy. However, it may be used in select patients.

Prolotherapy is not recommended for other non-specific back pain.

Indications: insufficient functional progress after 6 months of an appropriate program that includes a combination of active therapy, manual therapy and psychological evaluation and treatment. There should be documented relief from previously painful maneuvers (e.g., Patrick’s or Faber’s test, Gaenslen, distraction or gapping, and compression test). A positive result from SI joint diagnostic block including improvement in at least 3 previously identified physical functions. Standards of evaluation should follow those noted in the diagnostic

section. Refer to Section F.5, Injections-Diagnostic.

At the minimum, manual therapy, performed on a weekly basis per guideline limits by a professional specializing in manual therapy (such as a doctor of osteopathy or chiropractor) would address any musculoskeletal imbalance causing sacroiliac joint pain such as lumbosacral or sacroiliac dysfunction, pelvic imbalance, or sacral base unleveling. This thorough evaluation would include identification and treatment to resolution of all causal conditions such as iliopsoas, piriformis, gluteal or hamstring tonal imbalance, leg length inequality, loss of motion of the sacrum, lumbar spine or pelvic bones, and ligamentous, visceral or fascial restrictions.

An active therapy program would consist of a functionally appropriate rehabilitation program which is advanced in a customized fashion as appropriate commensurate with the patient’s level of strength and core spinal stability. Such a program would include stretching and strengthening to address areas of muscular imbalance as noted above and neuromuscular re-education to address maintenance of neutral spine via core stabilization with concomitant inhibition of lumbar paravertebral muscles. Patients who demonstrate a directional preference are usually not candidates for this procedure and should receive a trial of directional preference therapy.

Informed decision making must be documented including a discussion of possible complications and the likelihood of success. It is suggested that the individual be evaluated by a non-injection specialist to determine whether all reasonable treatment has been attempted and to verify the physical findings.

Procedures should not be performed in patients who are unwilling to engage in the active therapy and manual therapy necessary to recover.

Evidence Statements Regarding Prolotherapy Prolotherapy alone is not an effective treatment for chronic low back pain.

Systematic reviews of Prolotherapy of the sacroiliac (SI) joint is longer lasting, up to 15 months, than intra-articular steroid injections.

The study was relatively small and long-term blinding was unclear; however, all injections were done under fluoroscopic guidance.

d. Radio Frequency Ablation – Dorsal Nerve Root Ganglion: Due to the combination of possible adverse side effects, time limited effectiveness, and mixed study results, this treatment is not recommended.

e. Radio Frequency Ablation – Genicular Nerves: Neurotomy – There is currently inadequate evidence to support radiofrequency neurotomy for knee osteoarthritis failing conservative therapy. The one randomized controlled study identified was inadequate to support this invasive procedure. No long-term follow up is available, and there is a risk of charcot’s joint. If an independent medical review is considering recommending it for functionally debilitation pain after failed knee arthroplasty, all of the usual criteria must be meet, including significant pain reduction and demonstrated objective functional improvement after diagnostic genicular injections.

f. Radio Frequency (RF) Denervation - Medial Branch Neurotomy/Facet Rhizotomy:

Description: a procedure designed to denervate the facet joint by ablating the corresponding sensory medial branches. Continuous percutaneous radiofrequency is the method generally used. Pulsed radiofrequency should not be used as it may result in incomplete denervation. Cooled radiofrequency is generally not recommended due to current lack of evidence.

There is good evidence in the lumbar spine that carefully selected patients who had 80% relief with medial branch controlled blinded blocks and then had RF neurotomy will have improved pain relief over 6 months and decreased impairment compared to those who had sham procedures. Pain relief was defined as one hour of 80% relief from the lidocaine injection and 2 hours of 80% relief with bupivacaine. Generally, pain relief lasts 7-9 months and repeat radiofrequency neurotomy can be successful and last longer. RF neurotomy is the procedure of choice over alcohol, phenol, or cryoablation. Precise positioning of the probe using fluoroscopic guidance is required because the maximum effective diameter of the device is a 5x8 millimeter oval. Permanent images should be recorded to verify placement of the device.

Needle Placement: Multi-planar fluoroscopic imaging is required for all injections.

Injection of contrast dye to assure correct needle placement is required to verify the flow of medication. Permanent images are required to verify needle Indications: those patients with proven, significant, facetogenic pain. A minority of low back patients would be expected to qualify for this procedure. This procedure is not recommended for patients with multiple pain generators or involvement of more than 3 levels of medial branch nerves or 2 facet levels unilateral or bilateral.

Individuals should have met all of the following indications:

• Physical exam findings consistent with facet origin pain; and • Positive response to controlled medial branch blocks; and • At least 3 months of pain, unresponsive to 6-8 weeks of conservative therapies, including manual therapy; and • A psychosocial screening (e.g., thorough psychosocial history, screening questionnaire) with treatment as appropriate has been undergone.

Since one study found 67% false positives with controlled medical branch blocks, it is reasonable to delay radiotherapy if a false positive is suspected or pain has not returned.

All patients should continue appropriate exercise with functionally directed rehabilitation. Active treatment, which patients will have had prior to the procedure, will frequently require a repeat of the sessions previously ordered (Refer to Section G.18, Therapy-Active).

It is obligatory that sufficient data be accumulated by the examiner performing this procedure such that the value of the medial branch block is evident to other reviewers. This entails documentation of patient response regarding the degree and type of response to specific symptoms. As recommended by the SIS guidelines, the examiner should identify 3 or 4 measurable physical functions, which are currently impaired and can be objectively reassessed 30 minutes or more after the injection. A successful block requires documentation of positive functional changes by trained medical personnel experienced in measuring range-of-motion or assessing activity performance. The evaluator should be acquainted with the patient, in order to determine pre and post values, and preferably unaffiliated with the injectionist’s office. Qualified evaluators include nurses, physician assistants, medical assistants, therapists, or non-injectionist physicians. To be successful, the results should occur within the expected time frame and there should be pain relief of approximately 80% demonstrated by pre and post Visual Analog Scale (VAS) scores. Examples of functional changes may include sitting, walking, and lifting. Additionally, a prospective patient completed pain diary must be recorded as part of the medical record that documents response hourly for a minimum requirement of the first 8 hours post injection or until the block has clearly worn off and preferably for the week following an injection. The diary results should be compared to the expected duration of the local anesthetic phase of the procedure. Responses must be identified as to specific body part (e.g., low back, leg). The practitioner must identify the local anesthetic used and the expected duration of response for assessment purposes.

In almost all cases, this will mean a reduction of pain to 1 or 2 on the 10-point Visual Analog Scale (VAS) correlated with functional improvement. The patient should also identify activities of daily living (ADLs) (which may include measurements of ROM) that are impeded by their pain and can be observed to document objective functional improvement in the clinical setting. Ideally, these activities should be assessed throughout the observation period for function. The observer should not be the physician who performed the procedure. It is suggested that this be recorded on a form similar to SIS recommendations.

A separate comparative block on a different date should be performed to confirm the level of involvement prior to the rhizotomy. A comparative block uses anesthetics with varying lengths of activity. Medial Branch blocks are probably not helpful to determine the likelihood of success for spinal fusion.

The success rate of RF neurotomy is likely to decrease with lower percentages of pain relief from a medial branch block.

Informed decision making should also be documented for injections and all invasive procedures. This must include a thorough discussion of the pros and cons of the procedure and the possible complications as well as the natural

history of the identified diagnosis. The purpose of spinal injections, as well as surgery, is to facilitate active therapy by providing short-term relief through reduction of pain. Patients should be encouraged to express their personal goals, outcome expectations and desires from treatment as well as any personal habits or traits that may be impacted by procedures or their possible side effects. All patients must commit to continuing appropriate exercise with functionally directed rehabilitation usually beginning within 7 days, at the injectionist’s discretion.

Since most patients with these conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment. All injections must be accompanied by active therapy.

i. Complications: bleeding, infection, or neural injury. The clinician must be aware of the risk of developing a localized neuritis, or rarely, a deafferentation centralized pain syndrome as a complication of this and other neuroablative procedures. Spinal musculature atrophy is likely to occur especially with repeat procedures as a rhizotomy denervates the multifidus-muscle in patients. For this reason, repeated rhizotomies and multiple level rhizotomies can be harmful by decreasing supportive spinal musculature. This is especially problematic for younger patients who may engage in athletic activities or workers with strenuous job requirements as the atrophy could result in increased injuries or pain, although this has not been documented.

ii. Post-Procedure Therapy -- Active therapy: implementation of a gentle aerobic reconditioning program (e.g., walking) and back education within the first post-procedure week, barring complications. Instruction and participation in a long-term, home-based program of ROM, core strengthening, postural or neuromuscular re-education, endurance, and stability exercises should be accomplished over a period of 4 to 10 visits post-procedure. Patients who are unwilling to engage in this therapy should not receive this procedure.

iii. Requirements for Repeat Radiofrequency Medial Branch Neurotomy: In some cases, pain may recur. Successful RF neurotomy usually provides from 6 to 18 months of relief.

Before a repeat RF neurotomy is done, a confirmatory medial branch injection should be performed if the patient’s pain pattern presents differently than the initial evaluation. In occasional patients, additional levels of RF neurotomy may be necessary. The same indications and limitations apply.

It is recommended the total number of RF neurotomy sessions not exceed 12 in a lifetime as continued degradation of muscle strength is likely to result in other painful conditions.

Evidence Statements Regarding Radio Frequency (RF) Denervation - Medial Branch Neurotomy/Facet Rhizotomy For the lumbar spine, carefully selected patients who had 80% relief with medial branch controlled blinded blocks and then had RF neurotomy will have improved pain relief over 6 months and decreased impairment compared to those who had sham procedures. Pain relief was defined as one hour of 80% relief from the lidocaine injection and two hours of 80% relief with bupivacaine.

a. Radio Frequency Denervation - Sacro-iliac (SI) Joint Cooled: This procedure requires neurotomy of multiple nerves, L5 dorsal ramus, and lateral branches of S1-S3 under C-arm fluoroscopy. There is good evidence that cooled RF neurotomy performed in a highly selected population results in better pain relief and functional gains than a sham procedure. The benefits persisted for 9 months.

Approximate half of the patients had benefits initially, and approximately half of those reported the pain was completely relieved.

i. Needle Placement: Multi-planar fluoroscopic imaging is required for all steroid injections. Injection of contrast dye to assure correct needle placement is required to verify the flow of medication. Permanent images are required to verify needle placement.

ii. Indications: The following three requirements must be fulfilled:

A) The patient has physical exam findings of at least 3 positive physical exam maneuvers (e.g., Patrick’s sign, Faber’s test, Ganslen distraction or gapping, or compression test). Insufficient functional progress after 6 months of an appropriate program that includes a combination of active therapy, manual therapy, and psychological evaluation and treatment.

At the minimum, manual therapy, performed on a weekly basis per guideline limits by a professional specializing in manual therapy (such as a doctor of osteopathy or chiropractor) would address any musculoskeletal imbalance causing sacroiliac joint pain such as lumbosacral or sacroiliac dysfunction, pelvic imbalance, or sacral base unleveling. This thorough evaluation would include identification and treatment to resolution of all causal conditions such as iliopsoas, piriformis, gluteal or hamstring tonal imbalance, leg length inequality, loss of motion of the sacrum, lumbar spine or pelvic bones, and ligamentous, visceral or fascial restrictions.

An active therapy program would consist of a functionally appropriate rehabilitation program which is advanced in a customized fashion as appropriate commensurate with the patient’s level of strength and stability. Such a program would include stretching and strengthening to address areas of muscular imbalance as noted above and neuromuscular reeducation to address maintenance of neutral spine via core stabilization with concomitant inhibition of lumbar paravertebral muscles. Patients who demonstrate a directional preference are usually not candidates for this procedure and should receive a trial of directional preference therapy. Patients with confounding findings suggesting zygapophyseal joint or intervertebral disc pain generators should be excluded.

B) Two fluoroscopically guided comparative blocks of the appropriate branches with differing anesthetics, 80% relief of pain for the appropriate time periods, and functional improvement must be documented to meet standards for control blocks. Refer to Section F.5, Injections-Diagnostic.

It is obligatory that sufficient data be accumulated by the examiner performing this procedure such that the value of the procedure is evident to other reviewers. This entails documentation of patient response regarding the degree and type of response to specific symptoms. The examiner should identify 3 or 4 measurable provocative physical exam maneuvers (e.g., Patrick’s sign, Faber’s test, Gaenslen, distraction or gapping, or compression test), and physical functions, which are currently impaired and can be objectively reassessed 30 minutes or more after the injection. A successful block requires documentation of positive functional changes by trained medical personnel experienced in measuring range-of-motion or assessing activity performance. The evaluator should be acquainted with the patient, in order to determine pre and post values, and preferably unaffiliated with the injectionist’s office.

Qualified evaluators include nurses, physician assistants, medical assistants, therapists, or non-injectionist physicians. To be successful the results should occur within the expected time frame and there should be pain relief of approximately 80% demonstrated by pre and post Visual Analog Scale (VAS) scores. Examples of functional changes may include sitting, walking, and lifting. Additionally, a prospective patient completed pain diary must be recorded as part of the medical record that documents response hourly for a minimum requirement of the first 8 hours post injection or until the block has clearly worn off and preferably for the week following an injection. The diary results should be compared to the expected duration of the local anesthetic phase of the procedure. Responses must be identified as to specific body part (e.g., low back, leg). The practitioner must identify the local anesthetic used and the expected duration of response for assessment purposes.

C) Informed decision making must be documented including a discussion of possible complications and the likelihood of success. It is suggested that the individual be evaluated by a non-injection specialist to determine whether all reasonable treatment has been attempted and to verify the physical findings.

Procedures should not be performed in patients who are unwilling to engage in the active therapy necessary to recover.

iii. Complications: damage to sacral nerve roots – issues with bladder dysfunction etc. Bleeding, infection, or neural injury. The clinician must be aware of the risk of developing a localized neuritis, or rarely, a deafferentation centralized pain syndrome as a complication of this and other neuroablative procedures.

iv. Post-Procedure Therapy -- Active Therapy: implementation of a gentle aerobic reconditioning program (e.g., walking) and back education within the first post-procedure week, barring complications. Instruction and participation in a long-term home-based program of ROM, core strengthening, postural or neuromuscular re-education, endurance, and stability exercises should be accomplished over a period of 4 to 10 visits post-procedure. Patients who are unwilling to engage in this therapy should not receive this procedure.

v. Requirements for Repeat Radiofrequency SI Joint Neurotomy: In some cases, pain may recur. Successful RF neurotomy usually provides from 6 to 18 months of relief. Repeat neurotomy should only be performed if the initial procedure resulted in improved function for 6 months.

Due to denervation of spinal musculature, repeated neurotomy should be limited.

Evidence Statements Regarding Radio Frequency Denervation - Sacro-iliac (SI) Joint Cooled Cooled RF neurotomy performed in a highly selected population results in better pain relief and functional gains than a sham procedure. The benefits persisted for 9 months. Approximate half of the patients had benefits initially, and approximately half of those reported the pain was completely relieved.

h. Transdiscal Biacuplasty:

Description: cooled radiofrequency procedure intended to coagulate fissures in the disc and surrounding nerves which could be pain generators.

It is not recommended due to lack of published data demonstrating effectiveness.

i. Trigger Point Injections:

Description: Trigger point injections are generally accepted treatments. Trigger point treatments can consist of the injection of local anesthetic, with or without corticosteroid, into highly localized, extremely sensitive bands of skeletal muscle fibers. These muscle fibers produce local and referred pain when activated.

Medication is injected in a four-quadrant manner in the area of maximum tenderness. Injection can be enhanced if treatments are immediately followed by myofascial therapeutic interventions, such as vapo-coolant spray and stretch, ischemic pressure massage (myotherapy), specific soft tissue mobilization and physical modalities. There is conflicting evidence regarding the benefit of trigger point injections. There is no evidence that injection of medications improves the results of trigger-point injections. Needling alone may account for some of the therapeutic response of injections. Needling must be performed by practitioners with the appropriate credentials in accordance with state and other applicable regulations.

There is no indication for conscious sedation for patients receiving trigger point injections. The patient must be alert to help identify the site of the injection.

Indications: Trigger point injections may be used to relieve myofascial pain and facilitate active therapy and stretching of the affected areas. They are to be used as an adjunctive treatment in combination with other treatment modalities such as active therapy programs. Trigger point injections should be utilized primarily for the purpose of facilitating functional progress. Patients should continue in an aggressive aerobic and stretching therapeutic exercise program, as tolerated, while undergoing intensive myofascial interventions. Myofascial pain is often associated with other underlying structural problems. Any abnormalities need to be ruled out prior to injection.

Trigger point injections are indicated in patients with consistently observed, wellcircumscribed trigger points. This demonstrates a local twitch response, characteristic radiation of pain pattern, and local autonomic reaction such as persistent hyperemia following palpation. Generally, trigger point injections are not necessary unless consistently observed trigger points are not responding to specific, noninvasive, myofascial interventions within approximately a 6-week time frame. However, trigger point injections may be occasionally effective when utilized in the patient with immediate, acute onset of pain or in a post-operative patient with persistent muscle spasm or myofascial pain.

Complications: Potential but rare complications of trigger point injections include infection, pneumothorax, anaphylaxis, penetration of viscera, neurapraxia, and neuropathy. If corticosteroids are injected in addition to local anesthetic, there is a risk of local myopathy. Severe pain on injection suggests the possibility of an intraneural injection, and the needle should be immediately repositioned.

Time Frames for Trigger Point Injections Time to Produce Effect Local anesthetic 30 minutes; 24 to 48 hours for no anesthesia.

Frequency No more than 4 injection sites per session per week for acute exacerbations only, to avoid significant post-injection soreness. 4 sessions per year. Injections may only be repeated when the above functional and time goals are met.

9. INTERDISCIPLINARY REHABILITATION PROGRAMS

a. Overview:

Interdisciplinary Rehabilitation Programs are the gold standard of treatment for individuals who have not responded to less intensive modes of treatment. There is good evidence that interdisciplinary programs that include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability. There is good evidence that multidisciplinary rehabilitation (physical therapy and either psychological, social, or occupational therapy) shows small effects in reducing pain and improving disability compared to usual care and that multidisciplinary biopsychosocial rehabilitation is more effective than physical treatment for disability improvement after 12 months of treatment in patients with chronic low back pain. Patients with a significant psychosocial impact are most likely to benefit. The Agency for Healthcare Research and Quality (AHRQ) supports multidisciplinary rehabilitation as effective for chronic low back pain. These programs should assess the impact of pain and suffering on the patient’s medical, physical, psychological, social, and/or vocational functioning.

The International Classification of Functioning, Disability and Health (ICF) model should be considered in patient program planning. The following factors should be addressed: body function and structures, activity expectations, participation barriers, and environmental and personal factors. In general, interdisciplinary programs evaluate and treat multiple and sometimes irreversible conditions, including but not limited to: painful musculoskeletal, neurological, and other chronic pain conditions and psychological issues; drug dependence, abuse, or addiction; high levels of stress and anxiety; failed surgery; and pre-existing or latent psychopathology. The number of professions involved on the team in a chronic pain program may vary due to the complexity of the needs of the person served. The Division recommends consideration of referral to an interdisciplinary program within 6 months post-injury in patients with delayed recovery, unless successful surgical interventions or other medical and/or psychological treatment complications intervene.

Chronic pain patients need to be treated as outpatients within a continuum of treatment intensity. Outpatient chronic pain programs are available with services provided by a coordinated interdisciplinary team within the same facility (formal) or as coordinated among practices by an authorized treating physician (informal).

Formal programs are able to provide a coordinated, high-intensity level of services and are recommended for most chronic pain patients who have received multiple therapies during acute management.

Patients with addiction problems, high-dose opioid use, or abuse of other drugs may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation.

Guidelines from the American Society of Addiction Medicine are available and may be consulted relating to the intensity of services required for different classes of patients in order to achieve successful treatment.

There is some evidence that a telephone-delivered collaborative care management intervention for primary care veteran patients produced clinically meaningful improvements in pain at 12-month follow-up compared with usual care by increasing non-opioid analgesic medications and without changing opioid usage for the management of chronic musculoskeletal pain. The management was directed by nurse case managers. Because the control group was usual care rather than an attention control, the non-specific effects of attention received in the intervention group could have contributed to the effectiveness of the intervention. If an attention control had been used as the control group, the effect size observed for improvement in pain in the intervention group may have been smaller. It is unknown how successful this would be with injured workers.

Informal interdisciplinary pain programs may be considered for patients who are currently employed, those who cannot attend all-day programs, those with language barriers, or those living in areas not offering formal programs. Before treatment has been initiated, the patient, physician, and insurer should agree on treatment approach, methods, and goals. Generally, the type of outpatient program needed will depend on the degree of impact the pain has had on the patient’s medical, physical, psychological, social, and/or vocational functioning.

When referring a patient for formal outpatient interdisciplinary pain rehabilitation, an occupational rehabilitation program, or an opioid treatment program, the Division recommends the program meets the criteria of the Commission on Accreditation of Rehabilitation Facilities (CARF).

Inpatient pain rehabilitation programs are rarely needed but may be necessary for patients with any of the following conditions: (a) high risk for medical instability, (b) moderate-to-severe impairment of physical/functional status, (c) moderate-to-severe pain behaviors, (d) moderate impairment of cognitive and/or emotional status, (e) dependence on medications from which he/she needs to be withdrawn, and (f) the need for 24-hour supervised nursing. Whether formal or informal programs, they should be comprised of the following dimensions:

i. Communication: To ensure positive functional outcomes, communication between the patient, insurer, and all professionals involved must be coordinated and consistent. Any exchange of information must be provided to all parties, including the patient. Care decisions should be communicated to all parties and should include the family and/or support system.

ii. Documentation: Thorough documentation by all professionals involved and/or discussions with the patient. It should be clear that functional goals are being actively pursued and measured on a regular basis to determine their achievement or need for modification. It is advisable to have the patient undergo objective functional measures.

iii. Risk assessments: The following should be incorporated into the overall assessment process, individual program planning, and discharge planning: aberrant medication related behavior, addiction, suicide, and other maladaptive behavior.

iv. Treatment Modalities: Use of modalities may be necessary early in the process to facilitate compliance with and tolerance to therapeutic exercise, physical conditioning, and increasing functional activities.

Active treatments should be emphasized over passive treatments. Active and self-monitored passive treatments should encourage self-coping skills and management of pain, which can be continued independently at home or at work. Treatments that can foster a sense of dependency by the patient on the caregiver should be avoided. Treatment length should be decided based upon observed functional improvement. For a complete list of active and passive therapies, refer to Section G.18, Therapy – Active, and Section G.19, Therapy – Passive. All treatment time frames may be extended based on the patient’s positive functional v. Therapeutic Exercise Programs: A therapeutic exercise program should be initiated at the start of any treatment rehabilitation. Such programs should emphasize education, independence, and the importance of an on-going exercise regimen. There is good evidence that exercise alone or as part of a multi-disciplinary program results in decreased disability for workers with non-acute low back pain. There is not sufficient evidence to support the recommendation of any particular exercise regimen over another exercise regimen.

vi. Return-to-Work: An authorized treating physician should continually evaluate the patients for their potential to return to work. For patients who are currently employed, efforts should be aimed at keeping them employed. Formal rehabilitation programs should provide assistance in creating work profiles. For more specific information regarding return to work, refer to Section G.17, Return-to-Work.

vii. Patient Education: Patients with pain need to re-establish a healthy balance in lifestyle. All providers should educate patients on how to overcome barriers to resuming daily activity, including pain management, decreased energy levels, financial constraints, decreased physical ability, and change in family dynamics.

viii. Psychosocial Evaluation and Treatment: Psychosocial evaluation should be initiated, if not previously done. Providers should have a thorough understanding of the patient’s personality profile, especially if dependency issues are involved. Psychosocial treatment may enhance the patient’s ability to participate in pain treatment rehabilitation, manage stress, and increase their problem-solving and self-management skills.

ix. Family/Support System Services as appropriate: The following should be considered in the initial assessment and program planning for the individual: ability and willingness to participate in the plan, coping, expectations, educational needs, insight, interpersonal dynamics, learning style, problem solving, responsibilities, and cultural and financial factors. Support would include counseling, education, assistive technology, and ongoing communication.

x. Vocational Assistance: Vocational assistance can define future employment opportunities or assist patients in obtaining future employment. Refer to Section G.17, Return-to-Work, for detailed information.

xi. Discharge Planning: Follow-up visits will be necessary to assure adherence to treatment plan. Programs should have community and/or patient support networks available to patients on discharge.

xii. Interdisciplinary Teams: Interdisciplinary programs are characterized by a variety of disciplines that participate in the assessment, planning, and/or implementation of the treatment program. These programs are for patients with greater levels of perceived disability, dysfunction, deconditioning, and psychological involvement. Programs should have sufficient personnel to work with the individual in the following areas: behavioral, functional, medical, cognitive, communication, pain management, physical, psychological, social, spiritual, recreation and leisure, and vocational. Services should address impairments, activity limitations, participation restrictions, environmental needs, and personal preferences of the worker.

b. Formal Interdisciplinary Rehabilitation Programs:

i. Interdisciplinary Pain Rehabilitation: An Interdisciplinary Pain Rehabilitation Program provides outcome-focused, coordinated, goaloriented interdisciplinary team services to measure and improve the functioning of persons with pain and encourage their appropriate use of health care system and services. The program can benefit persons who have limitations that interfere with their physical, psychological, social, and/or vocational functioning. The program shares information about the scope of the services and the outcomes achieved with patients, authorized providers, and insurers.

The interdisciplinary team maintains consistent integration and communication to ensure that all interdisciplinary team members are aware of the plan of care for the patient, are exchanging information, and are implementing the plan of care. The team members make interdisciplinary team decisions with the patient and then ensure that decisions are communicated to the entire care team.

Teams that assist in the accomplishment of functional, physical, psychological, social, and vocational goals must include: a medical director, pain team physician(s) who should preferably be board certified in an appropriate specialty, and a pain team psychologist. The Medical Director of the pain program and each pain team physician should be board certified in pain management or be board certified in his/her specialty area and have one of the following: 1) completed a one-year fellowship in interdisciplinary pain medicine or palliative care recognized by a national board, 2) two years of experience in an interdisciplinary pain rehabilitation program, or 3) if less than 2 years of experience, participate in a mentorship program with an experienced pain team physician. The pain team psychologist should have 1) one year’s fulltime experience in an interdisciplinary pain program, or 2) if less than 2 years of experience, participate in a mentorship program with an experienced pain team psychologist. Professionals from other disciplines on the team may include but are not limited to: a biofeedback therapist, an occupational therapist, a physical therapist, a registered nurse (RN), a case manager, an exercise physiologist, a psychologist, a psychiatrist, and/or a nutritionist. A recent French interdisciplinary functional spine restoration program demonstrated increased return to work at 12 Time Frames for Interdisciplinary Pain Rehabilitation Time to Produce Effect 3 to 4 weeks.

Frequency Full time programs – No less than 5 hours per day, 5 days per week; part-time programs – 4 hours per day, 2–3 days per week.

Optimum Duration 3 to 12 weeks at least 2–3 times a week. Follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

Maximum Duration 4 months for full-time programs and up to 6 months for part-time programs. Periodic review and monitoring thereafter for 1 year, and additional followup based on the documented maintenance of functional gains.

ii. Occupational Rehabilitation: This is a formal interdisciplinary program addressing a patient’s employability and return to work. It includes a progressive increase in the number of hours per day in which a patient completes work simulation tasks until the patient can tolerate a full work day. A full work day is case specific and is defined by the previous employment of the patient. Safe workplace practices and education of the employer and family and/or social support system regarding the person’s status should be included. This is accomplished by addressing the medical, psychological, behavioral, physical, functional, and vocational components of employability and return to work.

The following are best practice recommendations for an occupational rehabilitation program:

A) Work assessments including a work-site evaluation when possible (Refer to Section G.17, Return-To-Work).

B) Practice of component tasks with modifications as needed.

C) Development of strength and endurance for work tasks.

D) Education on safe work practices.

E) Education of the employer regarding functional implications of the worker when possible.

F) Involvement of family members and/or support system for the worker.

G) Promotion of responsibility and self-management.

H) Assessment of the worker in relationship to productivity, safety, and worker behaviors.

I) Identification of transferable skills of the worker.

J) Development of behaviors to improve the ability of the worker to return to work or benefit from other rehabilitation.

K) Discharge includes functional/work status, functional abilities as related to available jobs in the community, and a progressive plan for return to work if needed.

There is some evidence that an integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain. The occupational medicine rehabilitation interdisciplinary team should, at a minimum, be comprised of a qualified medical director who is board certified with documented training in occupational rehabilitation, team physicians having experience in occupational rehabilitation, an occupational therapist, and a physical therapist. As appropriate, the team may also include any of the following: a chiropractor, an RN, a case manager, a psychologist, a vocational specialist, or a certified biofeedback therapist.

Time Frames for Occupational Rehabilitation Time to Produce Effect 2 weeks.

Frequency 2 to 5 visits per week, up to 8 hours per day.

Maximum Duration 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

iii. Opioid/Chemical Treatment Programs: Refer to the Division’s Chronic Pain Disorder Medical Treatment Guideline. Recent programs which incorporate both weaning from opioids and interdisciplinary therapy appear to demonstrate positive long-term results.

c. Informal Interdisciplinary Rehabilitation Program: A coordinated interdisciplinary pain rehabilitation program is one in which an authorized treating physician coordinates all aspects of care. This type of program is similar to the formal programs in that it is goal-oriented and provides interdisciplinary rehabilitation services to manage the needs of the patient in the following areas:

(a) functional, (b) medical, (c) physical, (d) psychological, (e) social, and (f) vocational.

This program is different from a formal program in that it involves lower frequency and intensity of services/treatment. Informal rehabilitation is geared toward those patients who do not need the intensity of service offered in a formal program or who cannot attend an all-day program due to employment, daycare, language, or other barriers.

Patients should be referred to professionals experienced in outpatient treatment of chronic pain. The Division recommends an authorized treating physician consult with physicians experienced in the treatment of chronic pain to develop the plan of care. Communication among care providers regarding clear objective goals and progress toward the goals is essential. Employers should be involved in return to work and work restrictions, and the family and/or social support system should be included in the treatment plan. Professionals from other disciplines likely to be involved include: a biofeedback therapist, an occupational therapist, a physical therapist, an RN, a psychologist, a case manager, an exercise physiologist, a psychiatrist, and/or a nutritionist.

Time Frames for Informal Interdisciplinary Rehabilitation Program Time to Produce Effect 3 to 4 weeks.

Frequency Full-time programs – No less than 5 hours per day, 5 days per week; Part-time programs – 4 hours per day for 2–3 days per week.

Optimum Duration 3 to 12 weeks at least 2–3 times a week. Follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

Maximum Duration 4 months for full-time programs and up to 6 months for part-time programs. Periodic review and monitoring thereafter for 1 year, and additional followup based upon the documented maintenance of functional gains.

Evidence Statements Regarding Interdisciplinary Rehabilitation Programs Interdisciplinary programs that include screening for psychological issues, identification of fear-avoidance beliefs and treatment barriers, and establishment of individual functional and work goals will improve function and decrease disability.

Cluster randomized trial, Randomized Multidisciplinary rehabilitation (physical therapy and either psychological, social, or occupational therapy) shows small effects in reducing pain and improving disability compared to usual care, and multidisciplinary biopsychosocial rehabilitation is more effective than physical treatment for disability improvement after 12 months of treatment in patients with chronic low back pain. Patients with a significant psychosocial impact are most likely to benefit.

Exercise alone or as part of a multi-disciplinary program results in decreased disability for workers with non-acute Telephone-delivered collaborative care management intervention for primary care veteran patients produced clinically meaningful improvements in pain at 12-month follow-up compared with usual care by increasing nonopioid analgesic medications and without changing opioid usage for the management of chronic musculoskeletal pain. The management was directed by nurse case managers. Because the control group was usual care rather than an attention control, the non-specific effects of attention received in the intervention group could have contributed to the effectiveness of the intervention. If an attention control had been used as the control group, the effect size observed for improvement in pain in the intervention group may have been smaller. It is unknown how successful this would be with injured workers.

Single-blind An integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain.

10. MEDICATIONS AND MEDICAL MANAGEMENT

There is no single formula for pharmacological treatment of patients with chronic nonmalignant pain. A thorough medication history, including use of alternative and overthe-counter medications, should be performed at the time of the initial visit and updated periodically. The medication history may consist of evaluating patient refill records through pharmacies and the Physician Drug Monitoring Program (PDMP) to determine if the patient is receiving their prescribed regimen. Appropriate application of pharmacological agents depends on the patient’s age, past history (including history of substance abuse), drug allergies, and the nature of all medical problems. It is incumbent upon the healthcare provider to thoroughly understand pharmacological principles when dealing with the different drug families, their respective side effects, drug interactions, and primary reason for each medication’s usage. Patients should be aware that medications alone are unlikely to provide complete pain relief. In addition to pain relief, a primary goal of drug treatment is to improve the patient’s function as measured behaviorally. Besides taking medications, continuing participation in exercise programs and using self-management techniques such as biofeedback, cognitive behavioral therapy, and other individualized physical and psychological practices are required elements for successful chronic pain management. Management must begin with establishing goals and expectations, including shared decision making about risks and benefits of medications.

Medication reconciliation is the process of comparing the medications that the patient is currently taking with those for which the patient has orders. This needs to include drug name, dosage, frequency, and route. The reconciliation can assist in avoiding medications errors such as omissions, duplications, dosing errors, or drug interactions.

The results can also be used to assist discussion with the patient regarding prescribing or changing medications and the likelihood of side effects, drug interactions, and achieving expected goals. At a minimum, medication reconciliation should be performed for all patients upon the initial visit and whenever refilling or prescribing new medications.

Control of chronic non-malignant pain is expected to frequently involve the use of medication. Strategies for pharmacological control of pain cannot be precisely specified in advance. Rather, drug treatment requires close monitoring of the patient’s response to therapy, flexibility on the part of the prescriber, and a willingness to change treatment when circumstances change. Many of the drugs discussed in the medication section were originally licensed for indications other than analgesia but are effective in the control of some types of chronic pain.

It is generally wise to begin management with lower cost non-opioid medications whose efficacy equals higher cost medications and medications with a greater safety profile.

Decisions to progress to more expensive, non-generic, and/or riskier products are made based on the drug profile, patient feedback, and improvement in function. The provider must carefully balance the untoward side effects of the different drugs with therapeutic benefits, as well as monitor for any drug interactions.

All medications should be given an appropriate trial in order to test for therapeutic effect.

The length of an appropriate trial varies widely depending on the individual drug. Certain medications may take several months to determine the efficacy, while others require only a few doses. It is recommended that patients with chronic nonmalignant pain be maintained on drugs that have the least serious side effects. For example, patients need to be tried or continued on acetaminophen and/or low dose generic antidepressant medications whenever feasible, as part of their overall treatment for chronic pain.

Patients with renal or hepatic disease may need increased dosing intervals with chronic acetaminophen use. Chronic use of NSAIDs is generally not recommended due to increased risk of cardiovascular events and GI bleeding.

The use of sedatives and hypnotics is not generally recommended for chronic pain patients. It is strongly recommended that such pharmacological management be monitored or managed by an experienced pain medicine physician. Multimodal therapy is the preferred mode of treatment for chronic pain patients whether or not these drugs were used acutely or sub-acutely.

Pharmaceutical neuropathic pain studies are limited. Diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN) are the two most frequently studied noncancer neuropathic pain conditions in randomized clinical trials of drug treatment. Some studies enroll only DPN or PHN patients, while other studies may enroll both kinds of patients.

There appear to be consistent differences between DPN and PHN with respect to placebo responses, with DPN showing greater placebo response than PHC. Thus, there is an increased likelihood of a “positive” trial result for clinical trials of drug treatment for PHN than for DPN.

Although many studies focus on mean change in pain, this may not be the most reliable result. It does not necessarily allow for subgroups that may have improved significantly.

Furthermore, the DPN and PHN studies do not represent the type of neurologic pain usually seen in workers’ compensation.

For these reasons, few pharmaceutical agents listed in this Guideline are supported by high levels of evidence, but the paucity of evidence statements should not be construed as meaning that medication is not to be encouraged in managing chronic pain patients.

General Order for Trial of Neuropathic Pain Medications Treating physician are encouraged to follow this sequence taking into consideration the patient’s individual tolerance for types of medications, their side effects, and their other medical conditions will guide pharmaceutical choices.

1. Tricyclic anti-depressants.

2. Gabapentin or pregabalin and/or serotonin norepinephrine reuptake inhibitors.

3. Other anticonvulsants as listed.

4. Opioids low dose including, tramadol, tapentadol.

It is advisable to begin with the lowest effective dose proven to be useful for neuropathic pain in the literature. If the patient is tolerating the medication and clinical benefit is appreciated, maximize the dose for that medication or add another second line medication with another mechanism of action. If a medication is not effective, taper off the medication and start another agent. Maintain goal dosing for up to 8 weeks before determining its effectiveness. Many patients will utilize several medications from different classes to achieve maximum benefit.

It is also useful to remember that there is some evidence that in the setting of uncomplicated low back pain lasting longer than 3 months, patients who were willing to participate in a trial of capsules clearly labelled as placebo experienced short-term reductions in pain and disability after the principles of the placebo effect had been explained to them.

The preceding principles do not apply to chronic headache or trigeminal neuralgia patients. These patients should be referred to a physician specializing in the diagnosis and treatment of headache and facial pain (refer to the Division’s Traumatic Brain Injury Medical Treatment Guideline).

For the clinician to interpret the following material, it should be noted that: (1) drug profiles listed are not complete; (2) dosing of drugs will depend upon the specific drug, especially for off-label use; and (3) not all drugs within each class are listed, and other drugs within the class may be appropriate for individual cases. Clinicians should refer to informational texts or consult a pharmacist before prescribing unfamiliar medications or when there is a concern for drug interactions.

Evidence Statements Regarding Medication Management In the setting of uncomplicated low back pain lasting longer than 3 months, patients who were willing to participate in a trial of capsules clearly labelled as placebo experienced short-term reductions in pain and disability after the principles of the placebo effect had been explained to them.

The following drug classes are listed in alphabetical order, not in order of suggested use, which is outlined above for neuropathic pain.

a. Alpha-Acting Agents: Noradrenergic pain-modulating systems are present in the central nervous system and the alpha-2 adrenergic receptor may be involved in the functioning of these pathways. Alpha-2 agonists may act by stimulating receptors in the substantia gelatinosa of the dorsal horn of the spinal cord, inhibiting the transmission of nociceptive signals. Spasticity may be reduced by presynaptic inhibition of motor neurons. Given limited experience with their use, they cannot be considered first-line or second-line analgesics for neurogenic pain, but a trial of their use may be warranted in some cases of refractory pain.

i. Clonidine (Catapres, Kapvay, Nexiclon)

A) Description – central alpha 2 agonist.

B) Indications – sympathetically mediated pain, treatment of withdrawal from opioids.

As of the time of this guideline writing, formulations of clonidine have been FDA approved for hypertension.

C) Major Contraindications – severe coronary insufficiency, renal impairment.

D) Dosing and Time to Therapeutic Effect – increase dosage weekly to therapeutic effect.

E) Major Side Effects – sedation, hypotension, sexual dysfunction, thrombocytopenia, weight gain, agitation, rebound hypertension with cessation.

F) Drug Interactions – beta adrenergics, tricyclic antidepressants.

G) Laboratory Monitoring – renal function, blood pressure.

b. Anticonvulsants: Although the mechanism of action of anticonvulsant drugs in neuropathic pain states remains to be fully defined, some appear to act as channel blocking agents. A large variety of sodium channels are present in nervous tissue, and some of these are important mediators of nociception, as they are found primarily in unmyelinated fibers and their density increases following nerve injury. While the pharmacodynamic effects of the various anticonvulsant drugs are similar, the pharmacokinetic effects differ significantly.

Gabapentin and pregablin, by contrast, are relatively non-significant enzyme inducers, creating fewer drug interactions. Because anticonvulsant drugs may have more problematic side-effect profiles, their use should usually be deferred until tricyclic-related medications have failed to relieve pain. All patients on these medications should be monitored for suicidal ideation. Many of these medications are not recommended for women of child bearing age due to possible teratogenic effects.

Gabapentin and pregabalin are commonly prescribed for neuropathic pain. There is an association between older anticonvulsants including gabapentin and nontraumatic fractures for patients older than 50; this should be taken into account when prescribing these medications.

Gabapentin and pregabalin have indirect (not GABA A or GABA B receptor mediated) GABA-mimetic qualities rather than receptor mediated actions. This can potentially result in euphoria, relaxation, and sedation. It is likely that they also affect the dopaminergic “reward” system related to addictive disorders.

Misuse of these medications usually involves doses 3-20 times that of the usual therapeutic dose. The medication is commonly used with alcohol or other drugs of abuse. Providers should be aware of the possibility and preferably screen patients for abuse before prescribing these medications. Withdrawal symptoms, such as insomnia, nausea, headache, or diarrhea, are likely when high doses of pregabalin have been used. Tolerance can also develop.

i. Gabapentin (Fanatrex, Gabarone, Gralise, Horizant, Neurontin)

A) Description: structurally related to gamma-aminobutyric acid (GABA) but does not interact with GABA receptors. Gabapentin affects the alpha-2-delta-1 ligand of voltage gated calcium channels, thus inhibiting neurotransmitter containing intra-cellular vesicles from fusing with the pre-synaptic membranes and reducing primary afferent neuronal release of neurotransmitters (glutamate, CGRP, and substance P). It may also modulate transient receptor potential channels, NMDA receptors, protein kinase C and inflammatory cytokines, as well as possibly stimulating descending norepinephrine mediated pain inhibition.

B) Indications: As of the time of this guideline writing, formulations of gabapentin have been FDA approved for post-herpetic neuralgia and partial onset seizures.

There is strong evidence that gabapentin is more effective than placebo in the relief of painful diabetic neuropathy and postherpetic neuralgia.

There is some evidence that gabapentin may benefit some patients with post-traumatic neuropathic pain. There is good evidence that gabapentin is not superior to amitriptyline. There is some evidence that nortriptyline (Aventyl, Pamelor) and gabapentin are equally effective for pain relief of postherpetic neuralgia. There is some evidence that the combination of gabapentin and morphine may allow lower doses with greater analgesic effect than the drugs given separately. There is strong evidence that gabapentin is more effective than placebo for neuropathic pain, even though it provides complete pain relief to a minority of patients. There is some evidence that a combination of gabapentin and nortriptyline provides more effective pain relief than monotherapy with either drug. Given the cost of gabapentin, it is recommended that patients who are medically appropriate receive a trial of tricyclics before use of gabapentin.

C) Relative Contraindications: renal insufficiency. Dosage may be adjusted to accommodate renal dysfunction.

D) Dosing and Time to Therapeutic Effect: Dosage should be initiated at a low dose in order to avoid somnolence and may require 4 to 8 weeks for titration. Dosage should be adjusted individually. It is taken 3 to 4 times per day, and the target dose is 1800 mg.

E) Major Side Effects: sedation, confusion, dizziness, peripheral edema. Patients should also be monitored for suicidal ideation and drug abuse.

F) Drug Interactions: antacids.

G) Laboratory Monitoring: renal function.

ii. Pregabalin (Lyrica)

A) Description: structural derivative of the inhibitory neuro transmitter gamma aminobutyric acid which inhibits calcium influx at the alpha-2-subunit of voltage-gated calcium channels of neurons. By inhibiting calcium influx, there is inhibition of release for excitatory neurotransmitters.

B) Indications: As of the time of this guideline writing, pregabalin is FDA approved for the treatment of neuropathic pain, postherpetic neuralgia, fibromyalgia, diabetic peripheral neuropathy, and partial-onset seizure in adults with epilepsy.

There is an adequate meta-analysis supporting strong evidence that in the setting of painful diabetic neuropathy, pregabalin as a stand-alone treatment is more effective than placebo in producing a 50% pain reduction, but this goal is realized in only 36% of patients treated with pregabalin compared with 24% of patients treated with placebo. There is an absence of published evidence regarding its effectiveness in improving physical function in this condition. There is also some evidence that pregabalin may be effective in treating neuropathic pain due to spinal cord injury. Unfortunately, most of the studies reviewed used pain as the primary outcome. Only one study considered function and found no improvement.

When pregabalin is compared with other first line medications for the treatment of neuropathic pain and diabetic peripheral neuropathy, such as amitriptyline and duloxetine, there is good evidence that it is not superior to these medications. Additionally, amitriptyline was found more effective compared to pregabalin for reducing pain scores and disability. Side effects were similar for the two medications. Therefore, amitriptyline is recommended as a first line drug for patients without contraindications, followed by duloxetine or pregabalin. This is based on improved effectiveness in treating neuropathic pain and a favorable side effect profile compared to pregabalin. Pregabalin may be added to amitriptyline therapy.

Pregabalin seems to be not effective and/or not well tolerated in a large percentage of patients. This is evident in several of the studies using run-in phases, enrichment, and partial enrichment techniques to strengthen the results. This analysis technique excludes placebo responders, non-responders, and adverse events prior to the treatment part of the study. This was done in the large meta-analysis, and one study had 60% of participants excluded in the run-in phase.

Duloxetine, pregabalin, and amitriptyline are approximately of equal benefit with respect to pain relief in the setting of diabetic peripheral neuropathy. There is some evidence that they exert different effects with respect to sleep variables. Total sleep time and REM sleep duration are likely to be greater with pregabalin than with duloxetine or amitriptyline. However, pregabalin is likely to lead to dizziness and fatigue more frequently than the other drugs, and oxygen desaturation during sleep also appears to be greater with pregabalin.

C) Relative Contraindications: Avoid use with hypersensitivity to pregabalin or other similar class of drugs, avoid abrupt withdrawal, avoid use with a CNS depressant or alcohol, and exercise caution when using:

• in the elderly, • with renal impairment, • with CHF class III/IV, • with a history of angioedema, • with depression.

D) Dosing and Time to Therapeutic Effect: Pregabalin comes in dosages ranging from 25mg to 300mg in 25mg and 50mg increments. For neuropathic pain, start at 75mg twice daily for one week and then increase to 150mg twice daily for 2 to 3 weeks if needed, with a possible final increase to 300mg twice daily with a max dose of 600mg/day. The full benefit may be achieved as quickly as 1 week, but it may take 6-8 weeks. To discontinue, taper the dose down for at least 1 week.

E) Major Side Effects: dizziness (≤ 45%), somnolence (≤ 36%), peripheral edema (≤ 16%), weight gain (≤ 16%), xerostomia (≤ 15%), headache (≤ 14%), fatigue (≤ 11%), tremor (≤ 11%), blurred vision/diplopia (≤ 12%), constipation (≤ 10%), confusion (≤ 7%), euphoria (≤ 7%), impaired coordination (≤ 6%), thrombocytopenia (≥ 1%). Patients should be monitored for hypersensitivity reactions, angioedema, suicidality, withdrawal symptoms, and seizures during abrupt discontinuation.

F) In regards to euphoria, pregabalin has higher rates compared to gabapentin in patients with history of substance misuse. Thus, prescribers should be aware that there is a potential for misuse.

G) Drug Interactions: Avoid use with antiepileptic agents and any CNS depression medications. Specifically avoid use with carbinoxamine, doxylamine, and gingko. Monitor closely when pregabalin is use with opioids.

H) Laboratory Monitoring: creatinine at baseline.

iii. Other Anticonvulsants with Limited Third Line Use:

It is recommended that a physician experienced in pain management be involved in the care when these medications are used.

A) Topiramate (Topamax, Topiragen): sulfamate substitute monosacchride. FDA approved for epilepsy or prophylaxis for migraines. Topiramate is without evidence of efficacy in diabetic neuropathic pain, the only neuropathic condition in which it has been adequately tested. The data we have includes the likelihood of major bias due to last observation carried forward imputation, where adverse event withdrawals are much higher with active treatment than placebo control. Despite the strong potential for bias, no difference in efficacy between topiramate and placebo was apparent. There is good evidence that topiramate demonstrates minimal effect on chronic lumbar radiculopathy or other neuropathic pain. If it is utilized, this would be done as a third or fourth line medication in appropriate B) Lamotrigine (Lamictal): This anti-convulsant drug is not FDA approved for use with neuropathic pain. Due to reported deaths from toxic epidermal necrolysis and Stevens Johnson syndrome, increased suicide risk, and incidents of aseptic meningitis, it is used with caution for patients with seizure or mood disorders.

There is insufficient evidence that lamotrigine is effective in treating neuropathic pain and fibromyalgia at doses of about 200 to 400 mg daily. Given the availability of more effective treatments including antiepileptics and antidepressant medicines, lamotrigine does not have a significant place in therapy based on the available evidence. The adverse effect profile of lamotrigine is also of concern. If it is utilized, this would be done as a third or fourth line medication in appropriate C) Zonisamide: There is insufficient evidence that zonisamide provides pain relief in any neuropathic pain condition. There are a number of drug interactions and other issues with its use. If it is utilized, this would be done as a third or fourth line medication in appropriate patients.

D) Carbamazepine: Has important effects as an inducer of hepatic enzymes and may influence the metabolism of other drugs enough to present problems in patients taking interacting drugs.

Dose escalation must be done carefully, since there is good evidence that rapid dose titration produces side-effects greater than the analgesic benefits. Carbamazepine is likely effective in some people with chronic neuropathic pain but with caveats. No trial was longer than 4 weeks, had good reporting quality, nor used outcomes equivalent to substantial clinical benefit. In these circumstances, caution is needed in interpretation, and meaningful comparison with other interventions is not possible.

Carbamazepine is generally not recommended; however, it may be used as a third or fourth line medication. It may be useful for trigeminal neuralgia.

E) Valproic Acid: There is insufficient evidence to support the use of valproic acid or sodium valproate as a first-line treatment for neuropathic pain. It should be avoided in women of child bearing age. There is more robust evidence of greater efficacy for other medications. However, some guidelines continue to recommend it. If it is utilized, this would be done as a third or fourth line medication in appropriate patients.

F) Levetiracetam: There is no evidence that levetiracetam is effective in reducing neuropathic pain. It is associated with an increase in participants who experienced adverse events and who withdrew due to adverse events. Therefore, this is not G) Lacosamide: Has limited efficacy in the treatment of peripheral diabetic neuropathy. Higher doses did not give consistently better efficacy but were associated with significantly more adverse event withdrawals. Where adverse event withdrawals are high with active treatment compared with placebo and when last observation carried forward imputation is used, as in some of these studies, significant overestimation of treatment efficacy can result. It is likely, therefore, that lacosamide is without any useful benefit in treating neuropathic pain; any positive interpretation of the evidence should be made with caution if at all. Therefore, this is not recommended.

Evidence Statements Regarding Anticonvulsants: Gabapentin (Fanatrex, Gabarone, Gralise, Horizant, Neurontin)

Gabapentin is more effective than placebo in the relief of painful diabetic neuropathy and post-herpetic neuralgia.

Gabapentin is more effective than placebo for neuropathic pain, even though it provides complete pain relief to a minority of patients.

Gabapentin is not superior to amitriptyline. Randomized crossover trial, Meta-analysis of Gabapentin may benefit some patients with posttraumatic neuropathic pain.

Nortriptyline (Aventyl, Pamelor) and gabapentin are equally effective for pain relief of post-herpetic neuralgia.

The combination of gabapentin and morphine may allow lower doses with greater analgesic effect than the drugs given separately.

A combination of gabapentin and nortriptyline provides more effective pain relief than monotherapy with either drug.

Evidence Statements Regarding Anticonvulsants: Pregabalin (Lyrica)

In the setting of painful diabetic neuropathy, pregabalin as a stand-alone treatment is more effective than placebo in producing a 50% pain reduction, but this goal is realized in only 36% of patients treated with pregabalin compared with 24% of patients treated with placebo.

When pregabalin is compared with other first line medications for the treatment of neuropathic pain and diabetic peripheral neuropathy, such as amitriptyline and duloxetine, it is not superior to these medications.

Additionally, amitriptyline was found more effective compared to pregabalin for reducing pain scores and disability. Side effects were similar for the two medications.

Open label parallel randomized clinical trial, Pregabalin may be effective in treating neuropathic pain due to spinal cord injury.

Randomized parallel group clinical trial Duloxetine, pregabalin, and amitriptyline exert different effects with respect to sleep variables. Total sleep time and REM sleep duration are likely to be greater with pregabalin than with duloxetine or amitriptyline.

However, pregabalin is likely to lead to dizziness and fatigue more frequently than the other drugs, and oxygen desaturation during sleep also appears to be greater with pregabalin.

Evidence Statements Regarding Anticonvulsants: Topiramate (Topamax, Topiragen)

Topiramate demonstrates minimal effect on chronic lumbar radiculopathy or other neuropathic pain. trial, Randomized clinical Evidence Statements Regarding Anticonvulsants: Carbamazepine Rapid dose titration produces side-effects greater than the analgesic benefits.

c. Antidepressants: Are classified into a number of categories based on their chemical structure and their effects on neurotransmitter systems. Their effects on depression are attributed to their actions on disposition of norepinephrine and serotonin at the level of the synapse; although these synaptic actions are immediate, the symptomatic response in depression is delayed by several weeks. When used for chronic pain, the effects may in part arise from treatment of underlying depression, but may also involve additional neuromodulatory effects on endogenous opioid systems, raising pain thresholds at the level of the spinal cord.

Pain responses may occur at lower drug doses with shorter times to symptomatic response than are observed when the same compounds are used in the treatment of mood disorders. Neuropathic pain, diabetic neuropathy, postherpetic neuralgia, and cancer-related pain may respond to antidepressant doses low enough to avoid adverse effects that often complicate the treatment of depression. First line drugs for neuropathic pain are the tricyclics with the newer formulations having better side effect profiles. SNRIs are considered second line drugs due to their costs and the number needed to treat for a response.

Duloxetine may be considered for first line use in a patient who is a candidate for pharmacologic treatment of both chronic pain and depression. SSRIs are used generally for depression rather than neuropathic pain and should not be combined with moderate to high-dose tricyclics.

All patients being considered for anti-depressant therapy should be evaluated and continually monitored for suicidal ideation and mood swings.

i. Tricyclics and Older Agents (e.g., amitriptyline, nortriptyline, doxepin (Adapin, Silenor, Sinequan), desipramine (Norpramin, Pertofrane), imipramine (Tofranil), trazodone (Desyrel, Oleptro)).

A) Description: Serotonergics, typically tricyclic antidepressants (TCAs), are utilized for their serotonergic properties as increasing CNS serotonergic tone can help decrease pain perception in non-antidepressant dosages. TCAs decrease reabsorption of both serotonin and norepinephrine. They also impact Na channels. Amitriptyline is known for its ability to repair Stage 4 sleep architecture, a frequent problem found in chronic pain patients and to treat depression, frequently associated with chronic pain. However, higher doses may produce more cholinergic side effects than newer tricyclics such as nortriptyline and desipramine. Doxepin and trimipramine also have sedative effects.

There is some evidence that in the setting of chronic low back pain with or without radiculopathy, amitriptyline is more effective than pregabalin at reducing pain and disability after 14 weeks of treatment. There is some evidence that in the setting of neuropathic pain, a combination of morphine plus nortriptyline produces better pain relief than either monotherapy alone, but morphine monotherapy is not superior to nortriptyline monotherapy, and it is possible that it is actually less effective than nortriptyline. There is insufficient low quality evidence supporting the use of desipramine to treat neuropathic pain.

Effective medicines with much greater supportive evidence are available. There may be a role for desipramine in patients who have not obtained pain relief from other treatments. There is no good evidence of a lack of effect; therefore, amitriptyline should continue to be used as part of the treatment of neuropathic pain.

Only a minority of people will achieve satisfactory pain relief.

Limited information suggests that failure with one antidepressant does not mean failure with all. There is insufficient evidence to support the use of nortriptyline as a first line treatment. However, nortriptyline has a lower incidence of anticholinergic side effects than amitriptyline. It may be considered for patients who are intolerant to the anticholinergic effects of amitriptyline. Effective medicines with greater supportive evidence are available, such as duloxetine and pregabalin.

There is some evidence that a combination of some gabapentin and nortriptyline provides more effective pain relief than monotherapy with either drug, without increasing side effects of either drug.

B) Indications: Some formulations are FDA approved for depression and anxiety. For the purposes of this guideline, they are recommended for neuropathic pain and insomnia. They are not recommended as a first line drug treatment for depression.

There is good evidence that gabapentin is not superior to amitriptyline. Given the cost of gabapentin, it is recommended that patients who are medically appropriate to undergo a trial of lower cost tricyclic before use of gabapentin.

C) Major Contraindications: cardiac disease or dysrhythmia, glaucoma, prostatic hypertrophy, seizures, high suicide risk, uncontrolled hypertension and orthostatic hypotension. A screening cardiogram may be done for those 40 years of age or older, especially if higher doses are used. Caution should be utilized in prescribing TCAs. They are not recommended for use in elderly patients 65 years of age or older, particularly if they are at fall risk.

D) Dosing and Time to Therapeutic Effect: varies by specific tricyclic. Low dosages, less than 100 mg are commonly used for chronic pain and/or insomnia. Lower doses decrease side effects and cardiovascular risks.

E) Major Side Effects: Side effects vary according to the medication used; however, the side effect profile for all of these medications is generally higher in all areas except GI distress, which is more common among the SSRIs and SNRIs. Anticholinergic side effects include, but not limited to, dry mouth, sedation, orthostatic hypotension, cardiac arrhythmia, urinary retention, and weight gain. Dry mouth leads to dental and periodontal conditions (e.g., increased cavities). Patients should also be monitored for suicidal ideation and drug abuse. Anticholinergic side effects are more common with tertiary amines (amitriptyline, imipramine, doxepin) than with secondary amines (nortriptyline and desipramine).

F) Drug Interactions: Tramadol (may cause seizures, both also increase serotonin/norepinephrine, so serotonin syndrome is a concern), clonidine, cimetidine (Tagemet), sympathomimetics, valproic acid (Depakene, Depakote, Epilim, Stavzor), warfarin (Coumadin, Jantoven, Marfarin), carbamazepine, bupropion (Aplezin, Budeprion, Buproban, Forfivo, Wellbutrin, Zyban), anticholinergics, quinolones.

G) Recommended Laboratory Monitoring: renal and hepatic function. EKG for those on high dosages, or with cardiac risk.

ii. Selective serotonin reuptake inhibitors (SSRIs) (e.g., citalopram (Celexa), fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra), paroxetine (Paxil, Pexeva), sertraline (Zoloft)) are not recommended for neuropathic pain. They may be used for depression.

iii. Selective Serotonin Nor-epinephrine Reuptake Inhibitor (SSNRI) /Serotonin Nor-epinephrine Reuptake Inhibitors (SNRI).

A) Description: Venlafaxine (Effexor), desvenlafaxine (Pristiq), duloxetine, and milnacipran (Savella).

There is strong evidence that duloxetine monotherapy is more effective than placebo in relieving the pain of diabetic peripheral neuropathy; however, monotherapy leads to a 50% pain reduction in only half of patients who receive a therapeutic dose.

AHRQ supports the use of duloxetine for chronic low back pain.

There is good evidence that in patients with painful diabetic neuropathy who have not had good responses to monotherapy with 60 mg of duloxetine or 300 mg of pregabalin, a clinically important benefit can be achieved by either of two strategies: doubling the dose of either drug, or combining both drugs at the same dose. It is likely that the strategy of combining the two drugs at doses of 60 and 300 mg respectively is more beneficial overall.

There was no evidence to support the use of milnacipran to treat neuropathic pain conditions, although it is used for fibromyalgia.

It is not generally recommended but may be used if patients cannot tolerate other medications.

There is insufficient evidence to support the use of venlafaxine in neuropathic pain. However, it may be useful for some patients who fail initial recommended treatments. Venlafaxine is generally reasonably well tolerated, but it can precipitate fatigue, somnolence, nausea, and dizziness in a minority of people. The sustained release formulations are generally more tolerable as inter-dose withdrawal symptoms can be avoided. They should be trialed if the patient cannot tolerate the immediate release formulation.

B) Indications: At the time of writing this guideline, duloxetine has been FDA approved for treatment of diabetic neuropathic pain and chronic musculoskeletal pain. Therefore, best evidence supports the use of duloxetine alone or with pregabalin if patients do not have sufficient relief from a tricyclic or cannot take a tricyclic.

C) Relative Contraindications: seizures, eating disorders.

D) Major Side Effects: depends on the drug, but commonly includes dry mouth, nausea, fatigue, constipation, and abnormal bleeding.

Serotonin syndrome is also a risk. GI distress, drowsiness, sexual dysfunction less than other classes. Hypertension and glaucoma with venlafaxine. Cardiac issues with venlafaxine and withdrawal symptoms unless tapered. Studies show increased suicidal ideation and attempts in adolescents and young adults.

Patients should also be monitored for suicidal ideation and drug E) Drug Interactions: drug specific.

F) Laboratory Monitoring: drug specific. Hepatic and renal monitoring, venlafaxine may cause cholesterol or triglyceride increases.

iv. Atypical Antidepressants/Other Agents. May be used for depression; however, are not appropriate for neuropathic pain.

Evidence Statements Regarding Antidepressants: Tricyclics and older agents (e.g., amitriptyline, nortriptyline, doxepin (Adapin, Silenor, Sinequan), desipramine (Norpramin, Pertofrane), imipramine (Tofranil), trazodone (Desyrel, Oleptro))

Gabapentin is not superior to amitriptyline. Randomized crossover trial, Meta-analysis of In the setting of chronic low back pain with or without radiculopathy, amitriptyline is more effective than pregabalin at reducing pain and disability after 14 weeks of treatment.

Open label parallel In the setting of neuropathic pain, a combination of morphine plus nortriptyline produces better pain relief than either monotherapy alone, but morphine monotherapy is not superior to nortriptyline monotherapy, and it is possible that it is actually less effective than nortriptyline.

Crossover randomized A combination of some gabapentin and nortriptyline provides more effective pain relief than monotherapy with either drug, without increasing side effects of either drug.

Evidence Statements Regarding Antidepressants: Selective Serotonin Nor-epinephrine Reuptake Inhibitor (SSNRI)/Serotonin Nor-epinephrine Reuptake Inhibitors (SNRI).

Duloxetine monotherapy is more effective than placebo in relieving the pain of diabetic peripheral neuropathy; however, monotherapy leads to a 50% pain reduction in only half of patients who receive a therapeutic dose.

In patients with painful diabetic neuropathy who have not had good responses to monotherapy with 60 mg of duloxetine or 300 mg of pregabalin, a clinically important benefit can be achieved by either of two strategies: doubling the dose of either drug, or combining both drugs at the same dose. It is likely that the strategy of combining the two drugs at doses of 60 and 300 mg respectively is more beneficial overall.

d. Cannabinoid Products:

At the time of writing, marijuana use is illegal under federal law and cannot be recommended for use in this guideline. The Colorado Constitution also states that insurers are not required to pay for marijuana.

Marijuana produces many cannabinoids. Only a few of these substances have been explored in detail. Cannabis is currently procured in Colorado through a registry program. Products are labeled for strength of tetrahydrocannabinol (THC) and cannabidiol (CBD). THC content increased from 2% in 1980 to 8.5% in 2007 and is likely higher in current products. Individual strains and products may have an even higher THC potency, thus making it difficult to correctly determine effects of a specific plant on an individual. Because smoked marijuana reaches its effect quickly, it is thought that most smokers titrate their dosage when using higher potency agents. Edible products increase the time to effect.

Generally, products with higher CBD are marketed for chronic pain, epilepsy, and sleep, while products with higher THC are used for the psychoactive effects.

Higher CBD products are believed to have better efficacy for chronic pain without creating the psychoactive effects of higher concentrated THC. It has been suggested that elevated THC in the presence of elevated CBD may be associated with less cognitive impairment.

There are a number of studies evaluating the health effects of cannabinoids.

Cannabis is associated with the subsequent development of psychosis in adolescents and can cause transient episodes of paranoia and psychotic symptoms in some individuals. It is not known whether or not the association with psychosis is causal. Cannabis increases heart rate in a dose related fashion and some studies suggest it may increase the risk for myocardial infarction and stroke in those less than 55 years. Because smoked marijuana contains many of the same carcinogens as smoked tobacco, it has been postulated that cancer risk may be increased in heavy marijuana smokers. However, the association has not been established epidemiologically. Cannabis dependence occurs in some users. In some individuals, withdrawal symptoms have been demonstrated after 20 days of high dose use and consist of decreased mood and appetite with irritability, insomnia, anxiety, and depression.

Unlike alcohol and many other sedating drugs of abuse, marijuana does not appear to be lethal for adults at any dose consumed by heavier users when used in isolation, probably because it is not a respiratory depressant. There is only one study that evaluated the use of marijuana in conjunction with chronic opioid management, thus no recommendations can be made to clinicians regarding this combination. Clinicians should keep in mind that there are an increasing number of deaths due to the toxic misuse of opioids with other medications and alcohol.

Drug screening is a mandatory component of chronic opioid management. It is appropriate to screen for alcohol and marijuana use and to have a contractual policy regarding both alcohol and marijuana use during chronic opioid management. A recent study of chronic pain patients in Michigan using marijuana found decreased use of opioids and other medication and increased quality of life. Another multi-state study of chronic pain patients on marijuana found a decrease in prescription drug use in states with legal marijuana.

There is good evidence that cannabinoids containing THC are associated with a small to moderate improvement in chronic pain compared to placebo; however, the dosage needed to produce an analgesic effect is undefined and uncertain.

Marijuana is likely to increase work-related driving accidents. It is recommended that less than weekly users wait 6 hours after smoking and 8 hours after eating to drive. Some studies have shown a decrease in reaction time and some association with motor vehicle accidents. However, the risk appears to be less than half the risk of driving under alcohol intoxication. A number of studies suggest that chronic use of THC results in some tolerance to effects on cognitive The contraindications and major side effects for cannabinoid are listed below. No laboratory monitoring is necessary.

i. Relative Contraindications: history of psychosis or risk factors for psychosis, seizure history, cardiovascular risk history, history of addiction, hypersensitivity to cannabinoids.

ii. Major Side Effects: dizziness or fatigue, rapid heart rate, dry mouth, euphoria. Less common effects: paranoia or hallucinations, seizures. A withdrawal reaction can occur when high doses are discontinued. It may include sweating and rhinorrhea with anorexia. Cyclic vomiting (cannabinoid hyperemesis) may occur with daily users.

iii. Psychological Reactions: Intoxication from cannabis frequently results in impaired motor coordination, euphoria, anxiety, sensation of slowed time, impaired judgment, social withdrawal, and hallucinations. Psychotic and anxiety disorders can occur from the use of cannabis. Paranoid ideation ranging from suspiciousness to frank delusions, hallucinations, and depersonalization or derealization has been reported. Use of THC cannabinoids in adolescents may create or unmask schizophrenia. Some of these findings may be related to the higher level of THC (delta-9tetrahydrocannabinol) found in the marijuana currently sold.

There are only two oral pharmaceutical cannabinoid products on the market. These medications were developed initially for nausea due to oncological drug therapy but have been trialed in other settings and are described below. A buccal spray is accepted in Europe and Canada and may be approved by the FDA for use with neuropathic pain. Initial studies were done on neuropathic pain associated with multiple sclerosis. The following pharmaceutical cannabinoid products are generally not recommended for pain, but providers may choose to prescribe them off-label.

i. Dronabinal (Marinol):

A) Description: Dronabinol is a synthetic delta-9tetrahydrocannabinol, which is also a naturally occurring component of Cannabis sativa L. (marijuana).

B) Indications: As of the time of writing this guideline, formulations of dronabinol have been FDA approved for nausea and vomiting with cancer therapy and weight loss associated with AIDS.

C) Dosing and Time to Therapeutic Effect: 2.5 mg twice a day titrated up to 20 mg total per day.

ii. Nabilone (Cesamet):

A) Description: Nabilone is a synthetic cannabinoid which is also a naturally occurring component of Cannabis sativa L. (marijuana).

B) Indications: As of the time of writing this guideline, formulations of nabilone have been FDA approved for nausea and vomiting with cancer therapy.

C) Dosing and Time to Therapeutic Effect: 1 to 2 mg twice a day titrated up to 6 mg per day.

iii. Nabiximols (Sativex):

A) Description: tetrahydrocannabinol (THC) and cannabidiol (CBD) in a one-to-one ratio, plus other components of cannabis extracts such as terpenoids and flavonoids mixed in a tincture. In the UK, nabiximols has just been approved for spasticity due to multiple sclerosis. In Canada, nabiximols is approved under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy for the relief of neuropathic pain and advanced cancer pain. It has not been approved in the United States as of the time of writing this guideline. This drug is not intended to provide the euphoria produced with smoking marijuana.

B) Indications: in other countries, for neuropathic pain and spasticity of multiple sclerosis (MS), cancer pain. There is some evidence that nabiximols can modestly decrease peripheral neuropathic pain with allodynia in some patients who were concomitantly treated with opioids or anticonvulsants; however, the drop-out rate for those who continued the medication longer term was high.

C) Dosing and Time to Therapeutic Effect: spray administered under the tongue. Up to 8 sprays every 3 hours with a maximum of 48 per day.

Evidence Statements Regarding Cannabinoid Products Cannabinoids containing THC are associated with a small to moderate improvement in chronic pain compared to placebo; however, the dosage needed to produce an analgesic effect is undefined and uncertain.

Nabiximols can modestly decrease peripheral neuropathic pain with allodynia in some patients who were concomitantly treated with opioids or anticonvulsants; however, the drop-out rate for those who continued the medication longer term was high.

e. Hypnotics and Sedatives: Sedative and hypnotic drugs decrease activity and induce drowsiness and may cause moderate agitation in some individuals. Many other medications, such as antihistamines and antidepressants also produce these side effects. Due to the addiction potential, withdrawal symptoms, and sedating side effects, benzodiazepines and other similar drugs found in this class, are not generally recommended to be initiated or continued if previously prescribed for another condition. There is an increased likelihood of death when opioids and benzodiazepines are used together; therefore, it is recommended that no more than 30 morphine milligram equivalents (MMEs) should be used when hypnotics or sedatives are prescribed. If a patient has been regularly taking these medications prior to the injury, they should be assessed by a psychiatrist to determine the need for continued treatment. When used, extensive patient education should be documented. Some of these medications have long halflives and sleep apnea can occur or be aggravated on these medications. Many unintentional drug deaths are related to concomitant opioid and benzodiazepine drug use. Retrograde amnesia can occur and is implicated in “sleep driving,”

“sleep eating,” and other activities. Nocturnal oximetry or other sleep studies may be appropriate to identify hypoxia.

Most insomnia in chronic pain patients should be managed primarily through behavioral interventions. Medications are a rare secondary measure (refer to

Section G.5, Disturbances of Sleep). Episodic use should be limited to 2 weeks.

i. Zaleplon (Sonata), Eszopiclone (Lunesta, Lunestar), Zolpidem (Ambien, Edluar, Intermezzo, Zolpimist).

A) Description: a nonbenzodiazepine hypnotic.

B) Indications: As of the time of this guideline writing, formulations of zaleplon, eszopiclonem, and zolpidem have been FDA approved for insomnia. There is some evidence that zolpidem does not appreciably enhance the effectiveness of Cognitive Behavioral Therapy.

C) Dosing and Time to Therapeutic Effect: time of onset is 30 to 60 minutes.

D) Major Side Effects: dizziness, dose-related amnesia.

E) Drug Interactions: increases sedative effect of other central nervous system (CNS) depressant drugs.

F) Laboratory Monitoring: none required, based on individual patient history.

ii. Benzodiazepine-based hypnotics include temazepam (Restoril, Temazepam, Gelthix), triazolam (Halcion), and flurazepam (Dalmane).

None are recommended because of habit-forming potential, withdrawal symptoms, and sedating side effects. Flurazepam has an active metabolite with a very long half-life, resulting in drug accumulation and next-day somnolence. These medications are not recommended for use in the working populations.

Evidence Statements Regarding Hypnotics and Sedatives Zolpidem does not appreciably enhance the effectiveness of Cognitive Behavioral Therapy.

f. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs):

NSAIDs are useful for pain and inflammation. In mild cases, they may be the only drugs required for analgesia. There are several classes of NSAIDs. The response of the individual injured worker to a specific medication is unpredictable. For this reason, a range of NSAIDs may be tried in each case, with the most effective preparation being continued. Patients should be closely monitored for adverse reactions. The FDA advises that many NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Administration of proton pump inhibitors, Histamine 2 Blockers, or prostaglandin analog misoprostol along with these NSAIDs may reduce the risk of duodenal and gastric ulceration in patients at higher risk for this adverse event (e.g., age > 60, concurrent antiplatelet or corticosteroid therapy). They do not impact possible cardiovascular complications. Due to the cross-reactivity between aspirin and NSAIDs, NSAIDs should not be used in aspirin-sensitive patients, and they should be used with caution in all asthma patients. NSAIDs are associated with abnormal renal function, including renal failure, as well as abnormal liver function. Patients with renal or hepatic disease may need increased dosing intervals with chronic use.

Chronic use of NSAIDs is generally not recommended due to increased risk of cardiovascular events and GI bleeding.

Topical NSAIDs may be more appropriate for some patients as there is some evidence that topical NSAIDs are associated with fewer systemic adverse events than oral NSAIDs.

NSAIDs may be associated with non-unions. Thus, their use with fractures is questionable.

Certain NSAIDs may have interactions with various other medications.

Individuals may have adverse events not listed above. Intervals for metabolic screening are dependent on the patient's age and general health status and should be within parameters listed for each specific medication. Complete Blood Count (CBC) and liver and renal function should be monitored at least every 6 months in patients on chronic NSAIDs and initially when indicated.

There is no evidence to support or refute the use of oral NSAIDs to treat neuropathic pain conditions.

AHRQ supports the use of NSAIDs for chronic low back pain.

i. Non-Selective Non-Steroidal Anti-Inflammatory Drugs: Includes NSAIDs and acetylsalicylic acid. Serious GI toxicity, such as bleeding, perforation, and ulceration can occur at any time, with or without warning symptoms, in patients treated with traditional NSAIDs. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur. Anaphylactoid reactions may occur in patients taking NSAIDs. NSAIDs may interfere with platelet function.

Fluid retention and edema have been observed in some patients taking NSAIDs.

Time Frames for Non-Selective Non-Steroidal Anti-Inflammatory Drugs Optimum Duration 1 week.

Maximum Duration 1 year. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

ii. Selective Cyclo-oxygenase-2 (COX-2) Inhibitors: COX-2 inhibitors differ from the traditional NSAIDs in adverse side effect profiles. The major advantages of selective COX-2 inhibitors over traditional NSAIDs are that they have less GI toxicity and no platelet effects. COX-2 inhibitors can worsen renal function in patients with renal insufficiency; thus, renal function may need monitoring.

There is good evidence that celecoxib (Celebrex) in a dose of 200 mg per day, administered over a long period, does not have a worse cardiovascular risk profile than naproxen at a dose of up to 1000 mg per day or ibuprofen at a dose of up to 2400 mg per day. There is good evidence that celecoxib has a more favorable safety profile than ibuprofen or naproxen with respect to serious GI adverse events, and it has a more favorable safety profile than ibuprofen with respect to renal adverse events. There is an absence of evidence concerning the relative safety of celecoxib at doses greater than 200 mg per day.

COX-2 inhibitors should not be first-line for low risk patients who will be using an NSAID short-term. COX-2 inhibitors are indicated in select patients who do not tolerate traditional NSAIDs. Serious upper GI adverse events can occur even in asymptomatic patients. Patients at high risk for GI bleed include those who use alcohol, smoke, are older than 65 years of age, take corticosteroids or anti-coagulants, or have a longer duration of therapy. Celecoxib is contraindicated in sulfonamide allergic patients.

Time Frames for Selective Cyclo-oxygenase-2 (COX-2) Inhibitors Optimum Duration 7 to 10 days.

Maximum Duration Chronic use is appropriate in individual cases. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

Evidence Statements Regarding Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Good Evidence Celecoxib in a dose of 200 mg per day, administered over a long period, does not have a worse cardiovascular risk profile than naproxen at a dose of up to 1000 mg per day or ibuprofen at a dose of up to 2400 mg per day. noninferiority trial Celecoxib has a more favorable safety profile than ibuprofen or naproxen with respect to serious GI adverse events, and it has a more favorable safety profile than ibuprofen with respect to renal adverse events.

Evidence Topical NSAIDs are associated with fewer systemic adverse events than oral NSAIDs.

g. Opioids: Opioids are the most powerful analgesics. Their use in acute pain and moderate-to-severe cancer pain is well accepted. Their use in chronic nonmalignant pain, however, is fraught with controversy and lack of scientific research. Deaths in the United States from opioids have escalated in the last 15 years. The CDC states the following in their 2016 guideline for prescribing opioids: Opioid pain medication use presents serious risk, including overdose and opioid use disorder. From 1999 to 2014, more than 165,000 persons died from overdose related to opioid pain medication in the United States. In the past decade, while the death rates for the top leading causes of death such as heart disease and cancer have decreased substantially, the death rate associated with opioid pain medication has increased markedly. Sales of opioid pain medication have increased in parallel with opioid-related overdose deaths. The Drug Abuse Warning Network estimated that >420,000 emergency department visits were related to the misuse or abuse of narcotic pain relievers in 2011, the most recent year for which data are available. Opioid poisoning has also been identified in work-related populations.

Effectiveness and Side Effects: Opioids include some of the oldest and most effective drugs used in the control of severe pain. The discovery of opioid receptors and their endogenous peptide ligands has led to an understanding of effects at the binding sites of these naturally occurring substances. Most of their analgesic effects have been attributed to their modification of activity in pain pathways within the central nervous system; however, it has become evident that they also are active in the peripheral nervous system. Activation of receptors on the peripheral terminals of primary afferent nerves can mediate anti-nociceptive effects, including inhibition of neuronal excitability and release of inflammatory peptides. Some of their undesirable effects on inhibiting GI motility are peripherally mediated by receptors in the bowel wall.

Most studies show that only around 50% of patients tolerate opioid side effects and receive an acceptable level of pain relief. Depending on the diagnosis and other agents available for treatment, the incremental benefit can be small.

There is strong evidence that in the setting of chronic nonspecific low back pain, the short and intermediate term reduction in pain intensity of opioids, compared with placebo, falls short of a clinically important level of effectiveness. There is an absence of evidence that opioids have any beneficial effects on function or reduction of disability in the setting of chronic nonspecific low back pain. AHRQ found that opioids are effective for treating chronic low back pain. However, the report noted no evidence regarding the long-term effectiveness or safety for chronic opioids.

There is good evidence that opioids are more efficient than placebo in reducing neuropathic pain by clinically significant amounts. There is a lack of evidence that opioids improve function and quality of life more effectively than placebo. There is good evidence that opioids produce significantly more adverse effects than placebo such as constipation, drowsiness, dizziness, nausea, and vomiting.

There is a lack of evidence that they are superior to gabapentin or nortriptyline for neuropathic pain reduction.

Patients should have a thorough understanding of the need to pursue many other pain management techniques in addition to medication use in order to function with chronic pain. They should also be thoroughly aware of the side effects and how to manage them. There is strong evidence that adverse events such as constipation, dizziness, and drowsiness are more frequent with opioids than with placebo. Common side effects are drowsiness, constipation, nausea, and possible testosterone decrease with longer term use.

There is some evidence that in the setting of chronic low back pain with disc pathology, a high degree of anxiety or depressive symptomatology is associated with relatively less pain relief in spite of higher opioid dosage than when these symptoms are absent. A study comparing Arkansas Medicaid and a national commercial insurance population found that the top 5% of opioid users accounted for 48-70% of total opioid use. Utilization was increased among those with mental health and substance use disorders and those with multiple pain conditions. Psychological issues should always be screened for and treated in chronic pain patients. Therefore, for the majority of chronic pain patients, chronic opioids are unlikely to provide meaningful increase in function in daily activities.

However, a subpopulation of patients may benefit from chronic opioids when properly prescribed and all requirements from medical management are followed.

Hyperalgesia: Administration of opioid analgesics leads not only to analgesia, but may also lead to a paradoxical sensitization to noxious stimuli. Opioid induced hyperalgesia has been demonstrated in animals and humans using electrical or mechanical pain stimuli. This increased sensitivity to mildly painful stimuli does not occur in all patients and appears to be less likely in those with cancer, clear inflammatory pathology, or clear neuropathic pain. When hyperalgesia is suspected, opioid tapering is appropriate.

Opioid Induced Constipation (OIC): Some level of constipation is likely ubiquitous among chronic opioid users. An observational study of chronic opioid users who also used some type of laxative at least 4 times per week noted that approximately 50% of the patients were dissatisfied and they continue to report stool symptoms. Seventy-one percent used a combination of natural and dietary treatment, 64.3% used over-the-counter laxatives, and 30% used prescription laxatives. Other studies report similar percentages. There are insufficient quality studies to recommend one specific type of laxative over others.

The easiest method for identifying constipation, which is also recommended by a consensus, multidisciplinary group, is the Bowel Function Index. It assesses the patient’s impression over the last 7 days for ease of defecation, feeling of incomplete bowel evacuation, and personal judgment re-constipation.

Stepwise treatment for OIC is recommended, and all patients on chronic opioids should receive information on treatment for constipation. Dietary changes increasing soluble fibers are less likely to decrease OIC and may cause further problems if GI motility is decreased. Stool softeners may be tried, but stimulant and osmotic laxatives are likely to be more successful. Osmotic laxatives include lactulose and polyethylene glycol. Stimulants include bisacodyl, sennosides, and sodium picosulfate, although there may be some concern regarding use of stimulants on a regular basis.

Opioid rotation or change in opioids may be helpful for some patients. It is possible that sustained release opioid products cause more constipation than short acting agents due to their prolonged effect on the bowel opioid receptors.

Tapentadol is a u-opioid agonist and norepinephrine reuptake inhibitor. It is expected to cause less bowel impairment then oxycodone or other traditional opioids. Tapentadol may be the preferred opioid choice for patients with OIC.

Other prescription medications may be used if constipation cannot adequately be controlled with the previous measures. Naloxegol is a pegylaped naloxone molecule that does not pass the blood brain barrier and thus can be given with opioid therapy. There is good evidence that it can alleviate OIC and that 12.5 mg starting dose has an acceptable side effect profile.

Methylnaltrexone does not cross the blood brain barrier and can be given subcutaneously or orally. It is specifically recommended for opioid induced constipation for patients with chronic non-cancer pain.

Misoprostol is a synthetic prostaglandin E1 agonist and has the side effect of diarrhea in some patients. It also has been tried for opioid induced constipation, although it is not FDA approved for this use.

Lubiprostone is a prostaglandin E1 approved for use in opioid constipation.

Most patients will require some therapeutic control for their constipation. The stepwise treatment discussed should be followed initially. If that has failed and the patient continues to have recurrent problems with experiencing severe straining, hard or lumpy stool with incomplete evacuation, or infrequent stools for 25% of the time despite the more conservative measures, it may be appropriate to use a pharmaceutical agent.

Evidence Statements Regarding Effectiveness and Side Effects of Opioids In the setting of chronic nonspecific low back pain, the short and intermediate term reduction in pain intensity of opioids, compared with placebo, falls short of a clinically important level of effectiveness. meta-analysis Adverse events such as constipation, dizziness, and drowsiness are more frequent with opioids than with placebo.

Opioids are more efficient than placebo in reducing neuropathic pain by clinically significant amounts.

Opioids produce significantly more adverse effects than placebo such as constipation, drowsiness, dizziness, nausea, and vomiting.

Naloxegol can alleviate opioid induced constipation and that 12.5 mg starting dose has an acceptable side effect profile.

Two identical and simultaneous multicenter randomized double-blind studies In the setting of chronic low back pain with disc pathology, a high degree of anxiety or depressive symptomatology is associated with relatively less pain relief in spite of higher opioid dosage than when these symptoms are absent.

Physiologic Responses to Opioids: Physiologic responses to opioids are influenced by variations in genes which code for opiate receptors, cytochrome P450 enzymes, and catecholamine metabolism. Interactions between these gene products significantly affect opiate absorption, distribution, and excretion.

Hydromorphone, oxymorphone, and morphine are metabolized through the glucuronide system. Other opioids generally use the cytochrome P450 system.

Allelic variants in the mu opiate receptor may cause increased analgesic responsiveness to lower drug doses in some patients. The genetic type can predict either lower or higher needs for opioids. For example, at least 10% of Caucasians lack the CYP450 2D6 enzyme that converts codeine to morphine. In some cases genetic testing for cytochrome P450 type may be helpful. When switching patients from codeine to other medications, assume the patient has little or no tolerance to opioids. Many gene-drug associations are poorly understood and of uncertain clinical significance. The treating physician needs to be aware of the fact that the patient’s genetic makeup may influence both the therapeutic response to drugs and the occurrence of adverse effects.

Adverse Events: Physicians should be aware that deaths from unintentional drug overdoses exceed the number of deaths from motor vehicle accidents in the US.

Most of these deaths are due to the use of opioids, usually in combination with other respiratory depressants such as alcohol or benzodiazepines. The risk for out of hospital deaths not involving suicide was also high. The prevalence of drug abuse in the population of patients undergoing pain management varies according to region and other issues. One study indicated that ¼ of patients being monitored for chronic opioid use have abused drugs occasionally, and ½ of those have frequent episodes of drug abuse. Eighty percent of patients admitted to a large addiction program reported that their first use of opioids was from prescribed medication.

There is good evidence that in generally healthy patients with chronic musculoskeletal pain, treatment with long-acting opioids, compared to treatments with anticonvulsants or antidepressants, is associated with an increased risk of death of approximately 69%, most of which arises from non-overdose causes, principally cardiovascular in nature. The excess cardiovascular mortality principally occurs in the first 180 days from starting opioid treatment.

There is some evidence that compared to an opioid dose under 20 MME per day, a dose of 20-50 mg nearly doubles the risk of death, a dose of 50 to 100 mg may increase the risk more than fourfold, and a dose greater than 100 mg per day may increase the risk as much as sevenfold. However, the absolute risk of fatal overdose in chronic pain patients is fairly low and may be as low as 0.04%.

There is good evidence that prescription opioids in excess of 200 MME average daily doses are associated with a near tripling of the risk of opioid-related death, compared to average daily doses of 20 MME. Average daily doses of 100-200 mg and doses of 50-99 mg per day may be associated with a doubling of mortality risk, but these risk estimates need to be replicated with larger studies.

Doses of opioids in excess of 120 MME have been observed to be associated with increased duration of disability, even when adjusted for injury severity in injured workers with acute low back pain. Higher doses are more likely to be associated with hypo-gonadism, and the patient should be informed of this risk.

Higher doses of opioids also appear to contribute to the euphoric effect. The CDC recommends limiting to 90 MME per day to avoid increasing risk of overdose.

In summary, there is strong evidence that any dose above 50 MME per day is associated with a higher risk of death and 100 mg or greater appears to significantly increase the risk.

Workers who eventually are diagnosed with opioid abuse after an injury are also more likely to have higher claims cost. A retrospective observational cohort study of workers’ compensation and short-term disability cases found that those with at least one diagnosis of opioid abuse cost significantly more in days lost from work for both groups and in overall healthcare costs for the short-term disability groups. About 0.5% of eligible workers were diagnosed with opioid abuse.

Evidence Statements Regarding Opioids and Adverse Events In generally healthy patients with chronic musculoskeletal pain, treatment with long-acting opioids, compared to treatments with anticonvulsants or antidepressants, is associated with an increased risk of death of approximately 69%, most of which arises from nonoverdose causes, principally cardiovascular in nature.

The excess cardiovascular mortality principally occurs in the first 180 days from starting opioid treatment.

Retrospective matched cohort study Prescription opioids in excess of 200 MME average daily doses are associated with a near tripling of the risk of opioid-related death, compared to average daily doses of 20 MME. Average daily doses of 100-200 mg and doses of 50-99 mg per day may be associated with a doubling of mortality risk, but these risk estimates need to be replicated with larger studies.

Nested case-control study with incidence density sampling Compared to an opioid dose under 20 MME per day, a dose of 20-50 mg nearly doubles the risk of death, a dose of 50 to 100 mg may increase the risk more than fourfold, and a dose greater than 100 mg per day may increase the risk as much as sevenfold. However, the absolute risk of fatal overdose of in chronic pain patients is fairly low, and may be as low as 0.04%.

Case-cohort study Summary of Evidence Regarding Opioids and Adverse Events Based on the studies with good evidence and some evidence listed above, there is strong evidence that any dose above 50 MME per day is associated with a higher risk of death and 100 mg or greater appears to significantly increase the risk.

Dependence versus Addiction: The central nervous system actions of these drugs account for much of their analgesic effect and for many of their other actions, such as respiratory depression, drowsiness, mental clouding, reward effects, and habit formation. With respect to the latter, it is crucial to distinguish between two distinct phenomena: dependence and addiction.

• Dependence is a physiological tolerance and refers to a set of disturbances in body homeostasis that leads to withdrawal symptoms, which can be produced with abrupt discontinuation, rapid reduction, decreasing blood levels, and/or by administration of an antagonist.

• Addiction is a primary, chronic, neurobiological disease, with genetic, psychological, and environmental factors influencing its development and manifestations. It is a behavioral pattern of drug craving and seeking which leads to a preoccupation with drug procurement and an aberrant pattern of use. The drug use is frequently associated with negative consequences.

Dependence is a physiological phenomenon, which is expected with the continued administration of opioids, and need not deter physicians from their appropriate use. Before increasing the opioid dose, the physician should review other possible causes for the decline in analgesic effect. Increasing the dose may not result in improved function or decreased pain. Remember that it is recommended for total morphine milligram equivalents (MME) per day to remain at 50 or below. Consideration should be given to possible new psychological stressors or an increase in the activity of the nociceptive pathways. Other possibilities include new pathology, low testosterone level that impedes delivery of opioids to the central nervous system, drug diversion, hyperalgesia, or abusive use of the medication.

Choice of Opioids: No long-term studies establish the efficacy of opioids over one year of use or superior performance by one type. There is no evidence that one long-acting opioid is more effective than another, or more effective than other types of medications, in improving function or pain. There is some evidence that long-acting oxycodone (Dazidox, Endocodone, ETH-oxydose, Oxycontin, Oxyfast, OxyIR, Percolone, Roxicodone) and oxymorphone have equal analgesic effects and side effects, although the milligram dose of oxymorphone (Opana) is ½ that of oxycodone. There is no evidence that long-acting opioids are superior to short-acting opioids for improving function or pain or causing less addiction. A number of studies have been done assessing relief of pain in cancer patients. A recent systematic review concludes that oxycodone does not result in better pain relief than other strong opioids including morphine and oxymorphone. It also found no difference between controlled release and immediate release oxycodone. There is some evidence that extended release hydrocodone has a small and clinically unimportant advantage over placebo for relief of chronic low back pain among patients who are able to tolerate the drug and that 40% of patients who begin taking the drug do not attain a dose which provides pain relief without unacceptable adverse effects. Hydrocodone ER does not appear to improve function in comparison with placebo. A Cochrane review of oxycodone in cancer pain also found no evidence in favor of the longer acting opioid. There does not appear to be any significant difference in efficacy between once daily hydromorphone and sustained release oxycodone. Nausea and constipation are common for both medications between 26-32%.

There is some evidence that in the setting of neuropathic pain, a combination of morphine plus nortriptyline produces better pain relief than either monotherapy alone, but morphine monotherapy is not superior to nortriptyline monotherapy, and it is possible that it is actually less effective than nortriptyline.

Long-acting opioids should not be used for the treatment of acute, sub-acute, or post-operative pain, as this is likely to lead to drug dependence and difficulty tapering the medication. Additionally, there is a potential for respiratory depression to occur. The FDA requires that manufacturers develop Risk Evaluation and Mitigation Strategies (REMS) for most opioids. Physicians should carefully review the plans or educational materials provided under this program.

Clinical considerations should determine the need for long-acting opioids given their lack of evidence noted above.

Addiction and abuse potentials of commonly prescribed opioid drugs may be estimated in a variety of ways, and their relative ranking may depend on the measure which is used. One systematic study of prescribed opioids estimated rates of drug misuse were estimated at 21-29% and addiction at 8-12%. There is good evidence that in the setting of new onset chronic non-cancer pain, there is a clinically important relationship between opioid prescription and subsequent opioid use disorder. Compared to no opioid use, short-term opioid use approximately triples the risk of opioid use disorder in the next 18 months. Use of opioids for over 90 days is associated with very pronounced increased risks of the subsequent development of an opioid use disorder, which may be as much as one hundredfold when doses greater than 120 MME are taken for more than 90 days. The absolute risk of these disorders is very uncertain but is likely to be greater than 6.1% for long duration treatment with a high opioid dose.

Hydrocodone is the most commonly prescribed opioid in the general population and is one of the most commonly abused opioids in the population. However, the abuse rate per 1000 prescriptions is lower than the corresponding rates for extended release oxycodone, hydromorphone (Dilaudid, Palladone), and methadone. Extended release oxycodone appears to be the most commonly abused opioid, both in the general population and in the abuse rate per 1000 prescriptions. Tramadol, by contrast, appears to have a lower abuse rate than for other opioids. Newer drug formulations such as oxymorphone, have been assumed to be relatively abuse-resistant, but their abuse potential is unknown and safety cannot be assumed in the absence of sound data.

Types of opioids are listed below:

i. Buprenorphine: (various formulations) is prescribed as an intravenous injection, transdermal patch, buccal film, or sublingual tablet due to lack of bioavailability of oral agents. Depending upon the formulation, buprenorphine may be indicated for the treatment of pain or for the treatment of opioid dependence (addiction).

Buprenorphine for Opioid Dependence (addiction): FDA has approved a number of buccal films including those with naloxone and a sublingual tablet to treat opioid dependence (addiction).

Buprenorphine for Pain: The FDA has approved specific forms of an intravenous and subcutaneous injectable, transdermal patch, and a buprenorphine buccal film to treat pain. However, by law, the transdermal patch and the injectable forms cannot be used to treat opioid dependence (addiction), even by DATA-2000 waivered physicians authorized to prescribe buprenorphine for addiction. Transdermal forms may cause significant skin reaction. Buprenorphine is not recommended for most chronic pain patients due to methods of administration, reports of euphoria in some patients, and lack of proof for improved efficacy in comparison with other opioids.

There is insufficient evidence to support or refute the suggestion that buprenorphine has any efficacy in any neuropathic pain condition.

There is good evidence transdermal buprenorphine is noninferior to oral tramadol in the treatment of moderate to severe musculoskeletal pain arising from conditions like osteoarthritis and low back pain. The population of patients for whom it is more appropriate than tramadol is not established but would need to be determined on an individual patient

basis if there are clear reasons not to use oral tramadol.

In a well done study, 63% of those on buccal buprenorphine achieved a 30% or more decrease in pain at 12 weeks compared to a 47% placebo response. Approximately 40% of the initial groups eligible for the study dropped out during the initial phase when all patients received the drug to test for incompatibility.

There is strong evidence that in patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine. There is strong evidence that buprenorphine is superior to placebo with respect to retention in treatment, and good evidence that buprenorphine is superior to placebo with respect to positive urine testing for opiates.

There is an adequate meta-analysis supporting good evidence that transdermal fentanyl and transdermal buprenorphine are similar with respect to analgesia and sleep quality, and they are similar with respect to some common adverse effects such as constipation and discontinuation due to lack of effect. However, buprenorphine probably causes significantly less nausea than fentanyl, and it probably carries a lower risk of treatment discontinuation due to adverse events. It is also likely that both transdermal medications cause less constipation than oral morphine.

Overall, due to cost and lack of superiority, buprenorphine is not a front line opioid choice. However, it may be used in those with a history of addiction or at high risk for addiction who otherwise qualify for chronic opioid use. It is also appropriate to consider buprenorphine products for tapering strategies and those on high dose morphine 90 MME ii. Codeine with Acetaminophen: Some patients cannot genetically metabolize codeine and therefore have no response. Codeine is not generally used on a daily basis for chronic pain. Acetaminophen dose per day should be limited to 2 grams.

iii. Fentanyl (Actiq, Duragesic, Fentora, Sublimaze): is not recommended for use with musculoskeletal chronic pain patients. It has been associated with a number of deaths and has high addiction potential.

Fentanyl should never be used transbuccally in this population. If it is being considered for a very specific patient population, it requires support from a pain specialist.

iv. Meperidine (Demerol): is not recommended for chronic pain. It and its active metabolite, normeperidine, present a serious risk of seizure and hallucinations. It is not a preferred medication for acute pain as its analgesic effect is similar to codeine.

v. Methadone: requires special precautions given its unpredictably long half-life and non-linear conversion from other opioids such as morphine.

It may also cause cardiac arrhythmias due to QT prolongation and has been linked with a greater number of deaths due to its prolonged half-life.

No conclusions can be made regarding differences in efficacy or safety between methadone and placebo, other opioids, or other treatments.

There is strong evidence that in patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine. Methadone should only be prescribed by those with experience in managing this medication. Conversion from another opioid to methadone (or the other way around) can be very challenging, and dosing titration must be done very slowly (no more than every 7 days).

Unlike many other opioids, it should not be used on an “as needed”

basis, as decreased respiratory drive may occur before the full analgesic effect of methadone is appreciated. If methadone is being considered, genetic screening is appropriate. CYP2B6 polymorphism appears to metabolize methadone more slowly than the usual population and may cause more frequent deaths.

vi. Morphine: may be used in the non-cancer pain population. A study in chronic low back pain suggested that individuals with a greater amount of endogenous opioids will have a lower pain relief response to morphine.

vii. Oxycodone and Hydromorphone: There is no evidence that oxycodone (as oxycodone CR) is of value in treating people with painful diabetic neuropathy, postherpetic neuralgia, or other neuropathic conditions.

There was insufficient evidence to support or refute the suggestion that hydromorphone has any efficacy in any neuropathic pain condition.

Oxycodone was not associated with greater pain relief in cancer patients when compared to morphine or oxymorphone.

viii. Propoxyphene (Darvon, Davon-N, PP-Cap): has been withdrawn from the market due to cardiac effects including arrhythmias.

ix. Tapentadol (Nucynta): is a mu opioid agonist which also inhibits serotonin and norepinephrine reuptake activity. It is currently available in an intermediate release formulation and may be available as extended release if FDA approved. Due to its dual activity, it can cause seizures or serotonin syndrome, particularly when taken with other SSRIs, SNRIs, tricyclics, or MAO inhibitors. It has not been tested in patients with severe renal or hepatic damage. It has similar opioid abuse issues as other opioid medication; however, it is promoted as having fewer GI side effects, such as constipation. There is good evidence that extended release tapentadol is more effective than placebo and comparable to oxycodone. In that study, the percent of patients who achieved 50% or greater pain relief was: placebo, 18.9%, tapentadol, 27.0%, and oxycodone, 23.3%. There is some evidence that tapentadol can reduce pain to a moderate degree in diabetic neuropathy, average difference 1.4/10 pain scale, with tolerable adverse effects. However, a high quality systematic review found inadequate evidence to support tapentadol to treat chronic pain. Tapentadol is not recommended as a first line opioid for chronic, subacute, or acute pain due to the cost and lack of superiority over other analgesics. There is some evidence that tapentadol causes less constipation than oxycodone. Therefore, it may be appropriate for patients who cannot tolerate other opioids due to GI side effects.

x. Tramadol (Rybix, Ryzolt, Ultram):

A) Description: an opioid partial agonist that does not cause GI ulceration or exacerbate hypertension or congestive heart failure.

It also inhibits the reuptake of norepinephrine and serotonin which may contribute to its pain relief mechanism. There are side effects similar to opioid side effects and may limit its use. They include nausea, sedation, and dry mouth.

B) Indications: mild to moderate pain relief. As of the time of this guideline writing, formulations of tramadol has been FDA approved for management of moderate to moderately severe pain in adults. This drug has been shown to provide pain relief equivalent to that of commonly prescribed NSAIDs. Unlike other pure opioids agonists, there is a ceiling dose to tramadol due to its serotonin activity (usually 300-400 mg per day). There is some evidence that it alleviates neuropathic pain following spinal cord injury. There is inadequate evidence that extended-release tramadol/acetaminophen in a fixed-dose combination of 75mg/650 mg is more effective than placebo in relieving chronic low back pain; it is not more effective in improving function compared to placebo. There is some evidence that tramadol yields a short-term analgesic response of little clinical importance relative to placebo in post-herpetic neuralgia which has been symptomatic for approximately 6 months. However, given the effectiveness of other drug classes for neuropathic pain, tramadol should not be considered a first line medication. It may be useful for patients who cannot tolerate tricyclic antidepressants or other medications.

C) Contraindications: use cautiously in patients who have a history of seizures, who are taking medication that may lower the seizure threshold, or taking medications that impact serotonin reuptake and could increase the risk for serotonin syndrome, such as monoamine oxidase inhibitors (MAO) inhibitors, SSRIs, TCAs, and alcohol. Use with caution in patients taking other potential QT prolonging agents. Not recommended in those with prior opioid addiction. Has been associated with deaths in those with an emotional disturbance or concurrent use of alcohol or other opioids. Significant renal and hepatic dysfunction requires dosage adjustment.

D) Side Effects: may cause impaired alertness or nausea. This medication has physically addictive properties, and withdrawal may follow abrupt discontinuation.

E) Drug Interactions: opioids, sedating medications, any drug that affects serotonin and/or norepinephrine (e.g., SNRIs, SSRIs, MAOs, and TCAs).

F) Laboratory Monitoring: renal and hepatic function.

Health care professionals and their patients must be particularly conscientious regarding the potential dangers of combining over-the-counter acetaminophen with prescription medications that also contain acetaminophen. Opioid and acetaminophen combination medication are limited due to the acetaminophen component. Total acetaminophen dose per day should not exceed 4 grams per any 24-hour period and is preferably limited to 2 grams per day to avoid possible liver damage.

Indications: The use of opioids is well accepted in treating cancer pain, where nociceptive mechanisms are generally present due to ongoing tissue destruction, expected survival may be short, and symptomatic relief is emphasized more than functional outcomes. In chronic non-malignant pain, by contrast, tissue destruction has generally ceased, meaning that central and neuropathic mechanisms frequently overshadow nociceptive processes. Expected survival in chronic pain is relatively long, and return to a high-level of function is a major goal of treatment. Therefore, approaches to pain developed in the context of malignant pain may not be transferable to chronic non-malignant pain. Opioids are generally not the best choice of medication for controlling neuropathic pain.

Tricyclics, SNRIs, and anticonvulsants should be tried before considering opioids for neuropathic pain.

In most cases, analgesic treatment should begin with acetaminophen, aspirin, and NSAIDs. While maximum efficacy is modest, they may reduce pain sufficiently to permit adequate function. When these drugs do not satisfactorily reduce pain, medications specific to the diagnosis should be used (e.g., neuropathic pain medications as outlined in Section G.10, Medications).

There is good evidence from a prospective cohort study that in the setting of common low back injuries, when baseline pain and injury severity are taken into account, a prescription for more than 7 days of opioids in the first 6 weeks is associated with an approximate doubling of disability one year after the injury.

Therefore, prescribing after 2 weeks in a non-surgical case requires a risk assessment. If prescribing beyond 4 weeks, a full opioid trial is suggested including toxicology screen. Best practice suggests that whenever there is use of opioids for more than 7 days, providers should follow all recommendations for screening and follow-ups of chronic pain use.

Consultation or referral to a pain specialist behavioral therapist should be considered when the pain persists but the underlying tissue pathology is minimal or absent and correlation between the original injury and the severity of impairment is not clear. Consider consultation if suffering and pain behaviors are present and the patient manifests risk behaviors described below, or when standard treatment measures have not been successful or are not indicated.

A psychological consultation including psychological testing (with validity measures) is indicated for all chronic pain patients as these patients are at high risk for unnecessary procedures and treatment and prolonged recovery.

Many behaviors have been found related to prescription-drug abuse patients.

None of these are predictive alone, and some can be seen in patients whose pain is not under reasonable control; however, the behaviors should be considered warning signs for higher risk of abuse or addiction by physicians prescribing chronic opioids. Refer to subsection ix, High Risk Behavior, below.

Recommendations for Opioid Use: When considering opioid use for moderate to moderately severe chronic pain, a trial of opioids must be accomplished as described below and the patient must have failed other chronic pain management regimes. Physicians should complete the education recommended by the FDA, risk evaluation and mitigation strategies (REMS) provided by drug manufacturing companies.

i. General Indications: There must be a clear understanding that opioids are to be used for a limited term as a trial (see trial indications below).

The patient should have a thorough understanding of all of the expectations for opioid use. The level of pain relief is expected to be relatively small, 2 to 3 points on a VAS pain scale, although in some individual patients it may be higher. For patients with a high response to opioid use, care should be taken to assure that there is no abuse or diversion occurring. The physician and patient must agree upon defined functional goals as well as pain goals. If functional goals are not being met, the opioid trial should be reassessed. The full spectrum of side effects should be reviewed. The shared decision making agreement signed by the patient must clarify under what term the opioids will be tapered. Refer to subsection vii.E, on the shared decision making agreement, below.

ii. Therapeutic Trial Indications: A therapeutic trial of opioids should not be employed unless the patient has begun multi-disciplinary pain management. The trial shall last one month. If there is no functional effect, the drug should be tapered.

Chronic use of opioids should not be prescribed until the following have been met:

A) The failure of pain management alternatives by a motivated patient including active therapies, cognitive behavioral therapy, pain self-management techniques, and other appropriate medical techniques.

B) Physical and psychological and/or psychiatric assessment including a full evaluation for alcohol or drug addiction, dependence or abuse, performed by two specialists including the authorized treating physician and a physician or psychologist specialist with expertise in chronic pain. The patient should be stratified as to low, medium, or high risk for abuse based on behaviors and prior history of abuse. High risk patients are those with active substance abuse of any type or a history of opioid abuse. These patients should generally not be placed on chronic opioids. If it is deemed appropriate to do so, physician addiction specialists should be monitoring the care. Moderate risk factors include a history of non-opioid substance abuse disorder, prior trauma particularly sexual abuse, tobacco use, widespread pain, poor pain coping, depression, and dysfunctional cognitions about pain and analgesic medications (see below). Pre-existing respiratory or memory problems should also be considered.

Patients with a past history of substance abuse or other psychosocial risk factors should be co-managed with a physician addiction specialist.

C) Risk Factors to Consider:

History of severe post-operative pain Opioid analgesic tolerance (daily use for months)

Current mixed opioid agonist/antagonist treatment (e.g., buprenorphine, naltrexone)

Chronic pain (either related or unrelated to the surgical site)

Psychological comorbidities (e.g., depression, anxiety, catastrophizing)

History of substance use disorder

History of “all over body pain”

History of significant opioid sensitivities (e.g., nausea, sedation)

History of intrathecal pump use or nerve stimulator implanted for pain control D) Employment requirements are outlined. The patient’s employment requirements should also be discussed as well as the need to drive. It is generally not recommended to allow workers in safety sensitive positions to take opioids. Opioid naïve patients or those changing doses are likely to have decreased driving ability. Some patients on chronic opioids may have nominal interference with driving ability; however, effects are specific to individuals. Providers may choose to order certified driver rehabilitation assessment.

E) Urine drug screening for substances of abuse and substances currently prescribed. Clinicians should keep in mind that there are an increasing number of deaths due to the toxic misuse of opioids with other medications and alcohol. Drug screening is a mandatory component of chronic opioid management. It is appropriate to screen for alcohol and marijuana use and have a contractual policy regarding both alcohol and marijuana use during chronic opioid management. Alcohol use in combination with opioids is likely to contribute to death.

F) Review of the Physician Prescription Drug Monitoring Program.

Informed, written, witnessed consent by the patient including the aspects noted above. Patients should also be counseled on safe storage and disposal of opioids.

G) The trial, with a short-acting agent, should document sustained improvement of pain control, at least a 30% reduction, and of functional status, including return-to-work and/or increase in activities of daily living. It is necessary to establish goals which are specific, measurable, achievable, and relevant prior to opioid trial or adjustment to measure changes in activity/function.

Measurement of functional goals may include patient completed validated functional tools such as those recommended by the Division as part of Quality Performance and Outcomes Payments (QPOP, see Rule 18-8) and/or the Patient Specific Frequent follow-up at least every 2 to 4 weeks may be necessary to titrate dosage and assess clinical efficacy.

iii. On-Going, Long-Term Management after a successful trial should include:

A) Prescriptions from a single practitioner;

B) Ongoing review and documentation of pain relief, functional status, appropriate medication use, and side effects; full review at least every 3 months;

C) Ongoing effort to gain improvement of social and physical function as a result of pain relief;

D) Review of the Physician Drug Monitoring Program (PDMP);

E) Shared decision making agreement detailing the following:

• Side effects anticipated from the medication;

• Requirement to continue active therapy;

• Need to achieve functional goals including return to work for most cases;

• Reasons for termination of opioid management, referral to addiction treatment, or for tapering opioids (tapering is usually for use longer than 30 days). Examples to be included in the contract include, but are not limited to:  Diversion of medication  Lack of functional effect at higher doses  Non-compliance with other drug use  Drug screening showing use of drugs outside of the prescribed treatment or evidence of non-compliant use of prescribed medication  Requests for prescriptions outside of the defined time frames  Lack of adherence identified by pill count, excessive sedation, or lack of functional gains  Excessive dose escalation with no decrease in use of short-term medications  Apparent hyperalgesia  Shows signs of substance use disorder (including but not limited to work or family problems related to opioid use, difficulty controlling use, craving)  Experiences overdose or other serious adverse event  Shows warning signs for overdose risk such as confusion, sedation, or slurred speech Patient Agreements should be written at a 6th grade reading level to accommodate the majority of patients.

F) Use of drug screening initially, randomly at least once a year and as deemed appropriate by the prescribing physician. Drug screening is suggested for any patients who have been receiving opioids for 8 to 90 days. A discussion regarding how screens positive for marijuana or alcohol will be handled should be included in the opioid contract. The concept of opioid misuse encompasses a variety of problems distinct from the development of addiction, such as nonmedical use, diversion, consultation with multiple prescribers, and unintentional overdose. In office only drug screening is insufficient as it does not identify metabolites of drugs prescribed.

Urine testing, when included as one part of a structured program for pain management, has been observed to reduce abuse behaviors in patients with a history of drug misuse. Clinicians should keep in mind that there are an increasing number of deaths due to the toxic misuse of opioids with other medications and alcohol. Drug screening is a mandatory component of chronic opioid management. Clinicians should determine before drug screening how they will use knowledge of marijuana use. It is appropriate to screen for alcohol and marijuana use and have a contractual policy regarding both alcohol and marijuana use during chronic opioid management. Alcohol use in combination with opioids is likely to contribute to death. From a safety standpoint, it is more important to screen for alcohol use than marijuana use as alcohol is more likely to contribute to unintended overdose.

Physicians should recognize that occasionally patients may use non-prescribed substances because they have not obtained sufficient relief on the prescribed regime.

Although drug screens done for chronic pain management should not be routinely available to employers, as screens are

part of the treatment record to which employers have limited access, patients should be aware that employers might obtain the records through attorneys or the insurer.

G) Chronic use limited to 2 oral opioids.

H) Transdermal medication use, other than buprenorphine, is generally not recommended.

I) Use of acetaminophen-containing medications in patients with liver disease should be limited, including over-the-counter medications. Acetaminophen dose should not exceed 4 grams per day for short-term use or 2-3 grams/day for long-term use in healthy patients. A safer chronic dose may be 1800mg/day.

J) Continuing review of overall therapy plan with regard to nonopioid means of pain control and functional status.

K) Tapering of opioids may be necessary for many reasons including the development of hyperalgesia, decreased effects from an opioid, lack of compliance with the opioid contract, or intolerance of side effects. Some patients appear to experience allodynia or hyperalgesia on chronic opioids. This premise is supported by a study of normal volunteers who received opioid infusions and demonstrated an increase in secondary hyperalgesia. Options for treating hyperalgesia include withdrawing the patient from opioids and reassessing their condition. In some cases, the patient will improve when off of the opioid. In other cases, another opioid may be substituted.

Tapering may also be appropriate by patient choice, to accommodate “fit-for-duty” demands, prior to major surgery to assist with post-operative pain control, to alleviate the effects of chronic use including hypogonadism, medication side effects, or in the instance of a breach of drug agreement, overdose, other drug use aberrancies, or lack of functional benefit. It is also appropriate for any of the tapering criteria listed in section E above.

Generally tapering can be accomplished by decreasing the dose 10% per week. This will generally take 6 to 12 weeks and may need to be done one drug class at a time. Behavioral support is required during this service. Tapering may occur prior to MMI or in some cases during maintenance treatment.

L) Medication assisted treatment with buprenorphine or methadone may be considered for opioid abuse disorder, in addition to behavioral therapy. Refer to Section G.12, Opioid Addiction Treatment.

M) Inpatient treatment may be required for addiction or opioid tapering in complex cases. Refer to Section G.9, Interdisciplinary Rehabilitation Programs, for detailed information on inpatient criteria.

iv. Relative Contraindications: Extreme caution should be used in prescribing controlled substances for workers with one or more “relative contraindications.” Consultation with a pain or addiction specialist may be useful in these cases.

A) History of alcohol or other substance abuse, or a history of chronic, benzodiazepine use.

B) Sleep apnea: If patient has symptoms of sleep apnea, diagnostic tests should be pursued prior to chronic opioid use.

C) Off work for more than 6 months with minimal improvement in function from other active therapy.

D) Severe personality disorder or other known severe psychiatric disease per psychiatrist or psychologist.

E) Monitoring of behavior for signs of possible substance abuse indicating an increased risk for addiction and possible need for consultation with an addiction specialist.

v. High Risk Behavior: The following are high risk warning signs for possible drug abuse or addiction. Patients with these findings may need a consultation by a physician experienced in pain management and/or addiction. Behaviors in the left hand column are warning signs, not automatic grounds for dismissal, and should be followed up by a reevaluation with the provider. Repeated behaviors in the left hand column may be more indicative of addiction. Behaviors in the right hand column should be followed by a substance abuse evaluation.

Less suggestive for addiction but are increased in depressed patients More suggestive of addiction and are more prevalent in patients with substance use disorder  Frequent requests for early refills; claiming lost or stolen prescriptions  Opioid(s) used more frequently, or at higher doses than prescribed  Using opioids to treat nonpain symptoms  Borrowing or hoarding  Using alcohol or tobacco to relieve pain  Requesting more or specific  Recurring emergency room visits for pain  Concerns expressed by family member(s)  Unexpected drug test results  Inconsistencies in the patient’s history  Buying opioids on the street; stealing or selling drugs  Multiple prescribers (“doctor shopping”)  Trading sex for opioids  Using illicit drugs, + urine drug tests for illicit drugs  Forging prescriptions  Aggressive demands for  Injecting oral/topical  Signs of intoxication (ETOH odor, sedation, slurred speech, motor instability, etc.)

Both daily and monthly users of nicotine were at least 3 times more likely to report non-medical use of opioid in the prior year. At least one study has demonstrated a prevalence of smokers and former smokers among those using opioids and at higher doses compared to the general population. It also appeared that smokers and former smokers used opioids more frequently and in higher doses than never smokers. Thus, tobacco use history may be a helpful prognosticator.

In one study, four specific behaviors appeared to identify patients at risk for current substance abuse: increasing doses on their own, feeling intoxicated, early refills, and oversedating oneself. A positive test for cocaine also appeared to be related.

One study found that half of patients receiving 90 days of continuous opioids remained on opioids several years later and that factors associated with continual use included daily opioid greater than 120 MME prior opioid exposure, and likely opioid misuse.

One study suggested that those scoring at higher risk on the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R), also had greater reductions in sensory low back pain and a greater desire to take morphine. It is unclear how this should be viewed in practice.

vi. Dosing and Time to Therapeutic Effect: Oral route is the preferred route of analgesic administration because it is the most convenient and costeffective method of administration. Transbuccal administration should be avoided other than for buprenorphine. A daily dosage above 50 MME may be appropriate for certain patients. However, when the patient’s dosage exceeds 50 MME per day and/or the patient is sedentary with minimal function, consideration should be given to lowering the dosage.

Some patients may require dosages above 90 MME per day. However, if the patient reaches a dosage above 90 MME per day, it is appropriate to taper or refer to a pain or addiction specialist. The provider should also adhere to all requirements in this guideline and closely monitor the patient as this is considered a high risk dosage. In some cases buprenorphine may be a preferred medication for pain control in those patients. Consultation may be necessary.

vii. Major Side Effects: There is great individual variation in susceptibility to opioid-induced side effects and clinicians should monitor for these potential side effects. Common initial side-effects include nausea, vomiting, drowsiness, unsteadiness, and confusion. Occasional sideeffects include dry mouth, sweating, pruritus, hallucinations, and myoclonus. Rare side effects include respiratory depression and psychological dependence. Constipation and nausea/vomiting are common problems associated with long-term opioid administration and should be anticipated, treated prophylactically, and monitored constantly.

Stool softeners, laxatives, and increased dietary fluid may be prescribed.

Refer to Section G.10.g, Opioid Induced Constipation. Chronic sustained release opioid use is associated with decreased testosterone in males and females and estradiol in pre-menopausal females. Patients should be asked about changes in libido, sexual function, and fatigue.

viii. Naloxone: may be prescribed when any risk factors are present. The correct use of Naloxone should be discussed with the patient and family.

ix. Benzodiazepines: should not be prescribed when opioids are used.

Refer to Section G.10.e, Hypnotics and Sedatives, for more information.

x. Sedation: driving and other tasks – Although some studies have shown that patients on chronic opioids do not function worse than patients not on medication, caution should be exerted, and patients should be counseled never to mix opioids with the use of alcohol or other sedating medication. When medication is increased or trials are begun, patients should not drive for at least 5 days. Chronic untreated pain and disordered sleep can also impair driving abilities.

xi. Drug Interactions: Patients receiving opioid agonists should not be given a mixed agonist-antagonist such as pentazocine (Talacen, Talwin) or butorphanol (Stadol) because doing so may precipitate a withdrawal syndrome and increase pain.

All sedating medication, especially benzodiazepines, should be avoided or limited to very low doses. Over-the-counter medications such as antihistamines, diphenhydramine, and prescription medications such as hydroxyzine (Anx, Atarax, Atazine, Hypam, Rezine, Vistaril) should be avoided except when being used to manage withdrawal during tapering of opioids. Alcohol should not be used.

xii. Recommended Laboratory Monitoring: Primary laboratory monitoring is recommended for acetaminophen/aspirin/NSAIDs combinations (renal and liver function, blood dyscrasia), although combination opioids are not recommended for long-term use. Morphine and other medication may require renal testing and other screening.

xiii. Sleep Apnea Testing: Both obstructive and central sleep apnea are likely to be exaggerated by opioid use or may occur secondary to higher dose chronic opioid use and combination medication use, especially benzodiazepines and sedative hypnotics. Patients should be questioned about sleep disturbance and family members or sleeping partners questioned about loud snoring or gasping during sleep. If present, qualified sleep studies and sleep medicine consultation should be obtained. Portable sleep monitoring units are generally not acceptable for diagnosing primary central sleep apnea. Type 3 portable units with 2 airflow samples and an 02 saturation device may be useful for monitoring respiratory depression secondary to opioids, although there are no studies on this topic.

xiv. Regular consultation of the Prescription Drug Monitoring Program (PDMP): Physicians should review their patients on the system whenever drug screens are done. This information should be used in combination with the drug screening results, functional status of the patient, and other laboratory findings to review the need for treatment and level of treatment appropriate for the patient. There is a separate billing code created by the DOWC to cover this service. Refer to Rule 18, Medical Fee Schedule.

xv. Addiction: If addiction occurs, patients will require treatment. Refer to

Section G.12, Opioid Addiction Treatment. After detoxification, they may need long-term treatment with naltrexone (Depade, ReVia), an antagonist which can be administered in a long-acting form or buprenorphine which requires specific education per the Drug Enforcement Agency (DEA).

xvi. Potentiating Agents: There is some evidence that dextromethorphan does not potentiate the effect of morphine opioids and therefore is not recommended to be used with opioids.

Evidence Statements Regarding Choice of Opioids, Indications, and Recommendations for Use In patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine.

Buprenorphine is superior to placebo with respect to retention in treatment.

Buprenorphine is superior to placebo with respect to positive urine testing for opiates.

In the setting of new onset chronic noncancer pain, there is a clinically important relationship between opioid prescription and subsequent opioid use disorder.

Compared to no opioid use, short-term opioid use approximately triples the risk of opioid use disorder in the next 18 months. Use of opioids for over 90 days is associated with very pronounced increased risks of the subsequent development of an opioid use disorder, which may be as much as one hundredfold when doses greater than 120 MME are taken for more than 90 days. The absolute risk of these disorders is very uncertain but is likely to be greater than 6.1% for long duration treatment with a high opioid dose.

Retrospective cohort study using claims data from a large health care database Extended release tapentadol is more effective than placebo and comparable to oxycodone. The percent of patients who achieved 50% or greater pain relief was: placebo, 18.9%, tapentadol, 27.0%, and oxycodone, 23.3%.

Transdermal buprenorphine is noninferior to oral tramadol in the treatment of moderate to severe musculoskeletal pain arising from conditions like osteoarthritis and low back pain. The population of patients for whom it is more appropriate than tramadol is not established but would need to be determined on an individual patient basis if there are clear reasons not to use oral tramadol.

Phase III noninferiority Evidence Statements Regarding Choice of Opioids, Indications, and Recommendations for Use Transdermal fentanyl and transdermal buprenorphine are similar with respect to analgesia and sleep quality, and they are similar with respect to some common adverse effects such as constipation and discontinuation due to lack of effect. However, buprenorphine probably causes significantly less nausea than fentanyl, and it probably carries a lower risk of treatment discontinuation due to adverse events.

It is also likely that both transdermal medications cause less constipation than oral morphine.

Network meta-analysis of randomized clinical In the setting of common low back injuries, when baseline pain and injury severity are taken into account, a prescription for more than seven days of opioids in the first 6 weeks is associated with an approximate doubling of disability one year after the injury.

Long-acting oxycodone (Dazidox, Endocodone, ETHoxydose, Oxycontin, Oxyfast, OxyIR, Percolone, Roxicodone) and oxymorphone have equal analgesic effects and side effects, although the milligram dose of oxymorphone (Opana) is ½ that of oxycodone.

Extended release hydrocodone has a small and clinically unimportant advantage over placebo for relief of chronic low back pain among patients who are able to tolerate the drug and that 40% of patients who begin taking the drug do not attain a dose which provides pain relief without unacceptable adverse effects.

Hydrocodone ER does not appear to improve function in comparison with placebo.

Randomized trial with a screening period of 7-14 days followed by an open-label titration period of up to 6 weeks followed by a double blind treatment period of up to 12 weeks In the setting of neuropathic pain, a combination of morphine plus nortriptyline produces better pain relief than either monotherapy alone, but morphine monotherapy is not superior to nortriptyline monotherapy, and it is possible that it is actually less effective than nortriptyline.

Crossover randomized Tapentadol can reduce pain to a moderate degree in diabetic neuropathy, average difference 1.4/10 pain scale, with tolerable adverse effects.

Tapentadol causes less constipation than oxycodone. Meta-analysis of Dextromethorphan does not potentiate the effect of morphine opioids and therefore is not recommended to be used with opioids.

Three randomized Evidence Statements Regarding Choice of Opioids, Indications, and Recommendations for Use Tramadol alleviates neuropathic pain following spinal cord injury.

Tramadol yields a short-term analgesic response of little clinical importance relative to placebo in postherpetic neuralgia which has been symptomatic for approximately 6 months.

h. Post-Operative Pain Management: Proper post-operative pain management may avoid overuse and misuse of opioids. A recent practice guideline strongly recommends a multi-modal approach to post-operative pain. Suggestions include use of TENS, cognitive behavioral therapy, use of oral medication over parenteral medication and patient controlled analgesia when parenteral medication is used, use of NSAIDS (for appropriate procedures) or acetaminophen, gabapentin or pregabalin may also be used, and peripheral regional anesthesia when appropriate. Ketamine is also suggested for major surgeries, patients with high opioid tolerance or those who have difficulty tolerating opioids. However, ketamine does have side effects such as hallucination and nightmares. It is not recommended as a first line medication for most patients.

Pre-operative psychological preparation or neuroscience education may improve post-operative pain management. Pre-operative cognitive-behavioral therapy or other psychological intervention likely improves in-hospital mobilization and analgesic use for lumbar spinal fusion patients and for other surgical patients.

One randomized study compared patients who received one session of preoperative pain neuroscience education from physical therapist prior to lumbar discectomy and those who did not. There was no change in the primary outcomes from surgery. However, significant changes occurred in secondary outcomes which included preparation for surgery, surgery meeting their expectations, and a 45% decrease in health expenditure for the follow up year.

Thus, pre-operative pain neuroscience education may prove a useful addition for any patient prior to surgical decisions. Refer to Section G.18, Therapy-Active, for a description of Pain Neuroscience Education. Optimal surgical outcomes are more likely when the patient commits to a post-operative active therapy program.

Generally, post-operative pain management is under the supervision of the surgeon and hospitalist with the goal of returning to the pre-operative level of pharmaceutical management. For a specific procedure’s post-operative management, refer to the related medical treatment guideline.

Surgical procedures may be necessary for patients already taking chronic opioids, and they may encounter difficulty with pain control post-operatively.

These patients will usually require higher doses of opioids during their postoperative phase and may benefit the most from multimodal therapy and/or ketamine as described in Section G.10.k., Topical Drug Delivery. It is strongly advised that physicians consult a pain specialist or addiction specialist when caring for post-operative patients with a history of substance abuse or previous addiction. Refer to Section G.10.h, Post-Operative Pain Management.

i. Skeletal Muscle Relaxants: are most useful for acute musculoskeletal injury or exacerbation of injury. Refer to Section G.10.e, Hypnotics and Sedatives, for benzodiazepines. Chronic use of benzodiazepines or any muscle relaxant is not recommended due to their habit-forming potential, seizure risk following abrupt withdrawal, and documented contribution to deaths of patients on chronic opioids due to respiratory depression.

i. Baclofen (intrathecal):

A) Description: may be effective due to stimulation of Gamma Aminobutyric Acid (GABA) receptors.

B) Indications: pain from muscle rigidity. As of the time of this guideline writing, formulations of baclofen injection have been FDA approved for the management of severe spasticity of a spinal cord or cerebral origin.

C) Side Effects: exacerbation of psychotic disorders, may precipitate seizures in epileptics, dry mouth, and sexual dysfunction.

D) Recommended Laboratory Monitoring: renal and hepatic E) Caution: Abrupt discontinuation of baclofen can precipitate a withdrawal syndrome and has been seen with both low and high doses. The most common side effects of baclofen withdrawal include pruritis, tremor, and mood disturbance. In extreme circumstances, seizures, muscle rigidity (resembling neuroleptic malignant syndrome), and even death can occur.

ii. Cyclobenzaprine (Amrix, Fexmid, Flexeril):

A) Description: structurally related to tricyclics.

B) Indications: acute exacerbated chronic pain associated with muscle spasm. As of the time of this guideline writing, formulations of this drug are FDA approved as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. It should only be used for short periods (less than 2 weeks) because of lack of evidence for effectiveness with prolonged use.

C) Major Contraindications: cardiac dysrhythmias.

D) Dosing and Time to Therapeutic Effect: variable, onset of action is 1 hour.

E) Major Side Effects: sedation, anticholinergic, blurred vision.

Patients should also be monitored for suicidal ideation and drug F) Drug Interactions: contraindicated for use with MAO inhibitors; interacts with tramadol, duloxetine, escitalopram, and fluoxetine.

Likely interactions with other SSRIs and SNRIs. Drug interactions are similar to those for tricyclics. Refer also to information on tricyclics in Section G.10, Medications.

G) Recommended Laboratory Monitoring: hepatic and renal iii. Carisoprodol (Soma, Soprodal, Vanadom): This medication should not be used in chronic pain patients due to its addictive nature secondary to the active metabolite meprobamate.

iv. Metaxalone (Skelaxin):

A) Description: central acting muscle relaxant.

B) Indications: acute exacerbated chronic pain associated with muscle spasm. As of the time of this guideline writing, formulations of this drug are FDA approved as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. It should only be used for short periods (less than 2 weeks) because of lack of evidence for effectiveness with prolonged use.

C) Major Contraindications: significantly impaired renal or hepatic disease, pregnancy, and disposition to drug induced hemolytic anemia.

D) Dosing and Time to Therapeutic Effect: 800 mg, 3 to 4 times per day, onset of action 1 hour.

E) Major Side Effects: sedation, hematologic abnormalities.

F) Drug Interactions: other sedating drugs (e.g., opioids, benzodiazepines).

G) Recommended Laboratory Monitoring:hepatic function, CBC.

v. Methocarbamol:

A) Description: central action muscle relaxant.

B) Indications: muscle spasm.

C) Major Contraindications: hypersensitivity, possible renal compromise.

D) Dosing and Time to Therapeutic Effect: 1500 mg. 4 times per day. Longer dosing 4000 to 4500 mg per day.

E) Major Side Effects: decreased cognition, light headedness, GI effects among other.

F) Drug Interactions: alcohol and other CNS depressants.

vi. Tizanidine (Zanaflex):

A) Description: alpha 2 adrenergic agonist.

B) Indications: true centrally mediated spasticity, musculoskeletal disorders. As of the time of this guideline writing, formulations of tizanidine have been FDA approved for the management of spasticity in spinal cord injury and multiple sclerosis.

C) Major Contraindications: concurrent use with ciprofloxacin (Cipro, Proquin) or fluvoxamine (Luvox); or hepatic disease.

D) Dosing and Time to Therapeutic Effect: 4 mg/day orally and gradually increase in 2-4 mg increments on an individual basis over 2 to 4 weeks; maintenance, 8 mg orally every 6 to 8 hr (max dose 36 mg/day).

E) Major Side Effects: hypotension, sedation, hepatotoxicity, hallucinations and psychosis, dry mouth.

F) Drug Interactions: Alcohol can increase sedation, and concurrent use with ciprofloxacin or fluvoxamine is contraindicated. Several other medications increase tizanidine plasma concentrations (e.g., oral contraceptives, verapamil, and cimetidine). Use with caution with other alpha agonists and other antihypertensives as they may increase the risk of hypotension.

G) Laboratory Monitoring: hepatic function, blood pressure.

j. Smoking Cessation Medications and Treatment: Tobacco dependence is chronic and may require repeated attempts to quit. All smoking cessation programs should be accompanied by behavioral support which may include practical counseling sessions and social support, which usually includes telephone follow-up. A variety of medications have been used including Bupropion SR, nicotine patches, gum, inhaler, lozenges or nasal spray, and varenicline. When nicotine supplements are used, cotinine testing will be positive. Urine anabasine or exhaled carbon monoxide 5 ppm or less may be used to check tobacco abstinence.

There is some evidence that among adults motivated to quit smoking, 12 weeks of open-label treatment including counseling and one of the following: nicotine patch, varenicline, or combination nicotine replacement therapy (nicotine patch and nicotine lozenge) are equally effective in assisting motivated smokers to quit smoking over a period of one year.

There is some evidence that among adults motivated to quit smoking, abrupt smoking cessation is the more effective method that leads to lasting abstinence over a period of 4 weeks to 6 months compared to gradual cessation, even for smokers who initially prefer to quit by gradual reduction.

Evidence Statements Regarding Smoking Cessation Medications and Treatment Among adults motivated to quit smoking, 12 weeks of open-label treatment including counseling and one of the following: nicotine patch, varenicline, or combination nicotine replacement therapy (nicotine patch and nicotine lozenge) are equally effective in assisting motivated smokers to quit smoking over a period of one year.

Among adults motivated to quit smoking, abrupt smoking cessation is the more effective method that leads to lasting abstinence over a period of 4 weeks to 6 months compared to gradual cessation, even for smokers who initially prefer to quit by gradual reduction. non-inferiority trial k. Topical Drug Delivery:

i. Description: topical creams and patches may be an alternative treatment of localized musculoskeletal and neuropathic disorders. If ordered compounded topicals are reviewed by the payer, the payer must evaluate and approve or deny each ingredient separately.

ii. Indications: neuropathic pain for many agents; episodic use of NSAIDs and salicylates for joint pain or musculoskeletal disorders. All topical agents should be used with strict instructions for application as well as maximum number of applications per day to obtain the desired benefit and avoid potential toxicity.

iii. Dosing and Time to Therapeutic Effect: all topical agents should be prescribed with clear instructions for application and maximum number of applications per day to obtain the desired benefit and avoid potential toxicity. For most patients, the effects of long-term use are unknown.

Thus, episodic use may be preferred for some agents.

iv. Side Effects: localized skin reactions may occur, depending on the medication agent used.

v. Topical Agents:

A) Capsaicin: As of the time of this guideline writing, formulations of capsaicin have been FDA approved for management of pain associated with post-herpetic neuralgia. Capsaicin offers a safe and effective alternative to systemic NSAID therapy. Although it is quite safe, effective use of capsaicin is limited by the local stinging or burning sensation that typically dissipates with regular use, usually after the first 7 to 10 days of treatment. Patients should be advised to apply the cream on the affected area with a plastic glove or cotton applicator and to avoid inadvertent contact with eyes and mucous membranes.

There is good evidence that low dose capsaicin (0.075%) applied 4 times per day will decrease pain up to 50%. There is strong evidence that a single application of 8% capsaicin is more effective than a control preparation of 0.04% capsaicin for up to 12 weeks. However, there may be a need for frequent application, and it is not known whether subsequent applications of capsaicin are likely to be as effective as the first application.

There is some evidence that in patients who are being treated with capsaicin 8% patches, two methods of pre-treatment are equally effective in controlling application pain and in enabling patients to tolerate the patch: topical 4% lidocaine cream applied to the area for one hour before placement of the capsaicin patch and 50 mg oral tramadol taken 30 minutes before patch B) Clonidine: There is good evidence that topical clonidine gel 0.1% is likely to alleviate pain from diabetic peripheral neuropathy in patients who display a nociceptive response to the application of 0.1% capsaicin applied to the pretibial area. It is likely that patients who do not display a pain response to pretibial capsaicin are not likely to have a clinically meaningful analgesic response to clonidine gel. It is unknown if this screening test applies to other types of neuropathic pain. Clonidine gel may be used for neuropathic pain.

C) Ketamine and Tricyclics: Topical medications, such as the combination of ketamine and amitriptyline, have been proposed as an alternative treatment for neuropathic disorders including CRPS. A study using a 10% concentration showed no signs of systemic absorption. This low-quality study demonstrated decreased allodynia at 30 minutes for some CRPS patients.

However, as of the time of this guideline writing, neither tricyclic nor ketamine topicals are FDA approved for topical use in neuropathic pain. Furthermore, there is good evidence that neither 2% topical amitriptyline nor 1% topical ketamine reduces neuropathic pain syndromes. Despite the lack of evidence, it is physiologically possible that topical tricyclics and a higher dose of ketamine could have some effect on neuropathic pain. Other less expensive topicals and compounds, including over-thecounter, should be trialed before more expensive compounds are ordered. The use of topical tricyclics and/or ketamine should be limited to patients with neuritic and/or sympathetically mediated pain with documented supporting objective findings such as allodynia and/or hyperalgesia. Continued use of these agents beyond the initial prescription requires documentation of effectiveness, including functional improvement, and/or decreased use of other medications, particularly decreased use of opioids or other habituating medications.

D) Lidocaine: As of the time of this guideline writing, formulations of lidocaine (patch form) have been FDA approved for pain associated with post-herpetic neuralgia. Evidence is mixed for long-term use of lidocaine topically. Physicians should always take into account the blood level that may be achieved with topical use as toxic levels have been reported and there is variability and systemic absorption among individuals. There is good evidence that lidocaine 5% plasters, applied for up to 12 hours to the lower extremities of patients with post-herpetic neuralgia and diabetic painful neuropathy, is non-inferior to pregabalin for the same indications. The topical lidocaine is associated with significantly fewer drug-related adverse events over 4 weeks of observation. There is some evidence that a 5% lidocaine patch may be used as a secondary option for patients with focal neuropathic pain. A 30 to 50% pain reduction may be achieved in those who tolerate the patch. Up to three patches may be used simultaneously for 12 hours per day. It should be applied only to intact skin. Metered dose 8% pump sprays have also been used and usually require a three times per day reapplication. There is some evidence that the 8% sprays are effective for short-term, 2 week use. However, the effects of long-term use are unknown.

E) Topical Salicylates and Nonsalicylates: have been shown to be effective in relieving pain in acute musculoskeletal conditions and single joint osteoarthritis. Topical salicylate and nonsalicylates achieve tissue levels that are potentially therapeutic, at least with regard to COX inhibition.

There is insufficient evidence to support the use of topical rubefacients containing salicylates for acute injuries or chronic conditions. They seem to be relatively well tolerated in the shortterm, based on limited data. The amount and quality of the available data mean that uncertainty remains about the effects of salicylate-containing rubefacients.

There is good evidence that diclofenac gel (Voltaren, Solaraze) reduces pain and improves function in mild-to-moderate hand osteoarthritis. There is good evidence that topical diclofenac and ketoprofen are more effective than placebo preparations for purposes of relieving pain attributable to knee osteoarthritis.

There is good evidence that topical NSAIDs probably reduce the risk of GI adverse effects by approximately 1/3 compared to oral NSAIDs. Topical diclofenac does not appear to affect the antiplatelet properties of aspirin unlike the oral version. The topical solution of 2% sodium diclofenac applied thrice a day is equal to 1.5% 4 times per day.

Diclofenac gel has been FDA approved for acute pain due to minor strains, pains, and contusions and for relief of pain due to osteoarthritis of the joints amenable to topical treatment, such as those of the knees and hands (refer to the Division’s Cumulative Trauma Conditions Medical Treatment Guideline). It is likely that other NSAIDs would also be effective topically. Thus, topical NSAIDs are permitted when patients show functional Other than local skin reactions, the side effects of therapy are minimal, although not non-existent. The usual contraindications to use of these compounds needs to be considered. Local skin reactions are rare and systemic effects are even less common.

Their use in patients receiving warfarin therapy may result in alterations in bleeding time. Overall, the low level of systemic absorption can be advantageous. This allows the topical use of these medications when systemic administration is relatively contraindicated, such as is the case in patients with hypertension, cardiac failure, or renal insufficiency (refer to the Division’s Cumulative Trauma Conditions Medical Treatment Guideline). Both topical salicylates and NSAIDs are appropriate for many chronic pain patients. However, in order to receive refills, patients should demonstrate increased function, decreased pain, or decreased need for oral medications.

F) Other Compounded Topical Agents: At the time of writing this guideline, no studies identified evidence for the effectiveness of compounded topical agents other than those recommended above. Therefore, other compounded topical agents are not generally recommended. In rare cases, they may be appropriate for patients who prefer a topical medication to chronic opioids or who have allergies or side effects from other more commonly used oral agents.

G) Prior authorization is required for all agents that have not been recommended above. Please refer to Rule 18-6(N), Prescription Strength Topical Compounds regarding requirements for reviewing, approving, denying, and refilling.

Evidence Statements Regarding Topical Drug Delivery: Capsaicin A single application of 8% capsaicin is more effective than a control preparation of 0.04% capsaicin for up to 12 weeks.

However, there may be a need for frequent application, and it is not known whether subsequent applications of capsaicin are likely to be as effective as the first application.

Low dose capsaicin (0.075%) applied 4 times per day will decrease pain up to 50%.

In patients who are being treated with capsaicin 8% patches, two methods of pre-treatment are equally effective in controlling application pain and in enabling patients to tolerate the patch: topical 4% lidocaine cream applied to the area for one hour before placement of the capsaicin patch and 50 mg oral tramadol taken 30 minutes before patch Evidence Statements Regarding Topical Drug Delivery: Clonidine Topical clonidine gel 0.1% is likely to alleviate pain from diabetic peripheral neuropathy in patients who display a nociceptive response to the application of 0.1% capsaicin applied to the pretibial area. It is likely that patients who do not display a pain response to pretibial capsaicin are not likely to have a clinically meaningful analgesic response to clonidine gel. It is unknown if this screening test applies to other types of neuropathic pain.

Evidence Statements Regarding Topical Drug Delivery: Ketamine and Tricyclics Neither 2% topical amitriptyline nor 1% topical ketamine reduces neuropathic pain syndromes.

Evidence Statements Regarding Topical Drug Delivery: Lidocaine Lidocaine 5% plasters, applied for up to 12 hours to the lower extremities of patients with post-herpetic neuralgia and diabetic painful neuropathy, is non-inferior to pregabalin for the same indications. The topical lidocaine is associated with significantly fewer drug-related adverse events over 4 weeks of observation.

Non-inferiority randomized trial A 5% lidocaine patch may be used as a secondary option for patients with focal neuropathic pain.

The 8% sprays are effective for short-term, 2 week use. Randomized crossover trial and open label study Evidence Statements Regarding Topical Drug Delivery: Topical Salicylates and Nonsalicylates Diclofenac gel (Voltaren, Solaraze) reduces pain and improves function in mild-to-moderate hand osteoarthritis.

Topical diclofenac and ketoprofen are more effective than placebo preparations for purposes of relieving pain attributable to knee osteoarthritis.

Topical NSAIDs probably reduce the risk of GI adverse effects by approximately 1/3 compared to oral NSAIDs.

l. Other Agents:

i. Glucosamine:

There is good evidence that glucosamine does not improve pain related disability in those with chronic low back pain and degenerative changes on radiologic studies; therefore, it is not recommended for chronic lower spinal or non-joint pain. For chronic pain related to joint osteoarthritis, see specific extremity guidelines. Glucosamine should not be combined with chondroitin as it is ineffective.

ii. Oral Herbals:

There is insufficient evidence due to low quality studies that an oral herbal medication, Compound Qishe Tablet, reduced pain more than placebo. There is also insufficient evidence that Jingfukang and a topical herbal medicine, Compound Extractum Nucis Vomicae, reduced pain more than Diclofenac Diethylamine Emulgel. Further research is very likely to change both the effect size and our confidence in the results.

Currently, no oral herbals are recommended.

iii. Vitamin D:

A large beneficial effect of vitamin D across different chronic painful conditions is unlikely. Therefore, it is not recommended.

iv. Alpha-Lipoic Acid:

An adequate meta-analysis shows that there is some evidence that alpha-lipoic acid at a dose of 600 mg per day may reduce the symptoms of painful diabetic neuropathy in the short term of 3 to 5 weeks. The effect of the intravenous route appears to be greater than that of the oral route, but the oral route may have a clinically relevant effect. Doses of 1200 or 1800 mg have not been shown to have additional therapeutic benefit. This medication may be used for neuropathic pain.

Evidence Statements Regarding Other Agents: Glucosamine Glucosamine does not improve pain related disability in those with chronic low back pain and degenerative changes on radiologic studies; therefore, it is not recommended for chronic lower spinal or non-joint Evidence Statements Regarding Other Agents: Alpha-Lipoic Acid Alpha-lipoic acid at a dose of 600 mg per day may reduce the symptoms of painful diabetic neuropathy in the short term of 3 to 5 weeks. The effect of the intravenous route appears to be greater than that of the oral route, but the oral route may have a clinically relevant effect.

11. NON-INVASIVE BRAIN STIMULATION: This has been proposed as a treatment for chronic pain. Varieties include repetitive transcranial magnetic stimulation (rTMS), cranial electrotherapy stimulation (CES), and transcranial direct current stimulation (tDCS).

Single doses of high-frequency rTMS of the motor cortex may have small short-term effects on chronic pain. It is likely that multiple sources of bias may exaggerate this observed effect. The effects do not meet the predetermined threshold of minimal clinical significance and multiple-dose studies do not consistently demonstrate effectiveness.

The available evidence suggests that low-frequency rTMS, rTMS applied to the prefrontal cortex, CES, and tDCS are not effective in the treatment of chronic pain.

Therefore, these devices are not recommended due to lack of evidence and safety concerns.

12. OPIOID ADDICTION TREATMENT:

The DSM-V renames opioid addiction as substance use disorder (SUD) and classifies opioid use disorder according to categories defined as mild (2 – 3 features of stated criteria), moderate (4 – 5 features of stated criteria), or severe (6 – 7 features of stated criteria).

Definitions:

• Opioid physical dependence: opioid withdrawal symptoms (withdrawals) which occur as a result of abrupt discontinuation of an opioid in an individual who became habituated to the medication or through administration of an antagonist.

Opioid physical dependency is not in and of itself consistent with the diagnosis of addiction/substance use disorder.

• Tolerance: a physiologic state caused by the regular use of an opioid in which increasing doses are needed to maintain the same affect. In patients with "analgesic tolerance," increased doses of the opioid may be needed to maintain pain relief.

• Opioid misuse: the utilization of opioid medications outside of the prescribing instructions for which it was originally prescribed. Misuse may be as innocuous as taking slightly more or less medications than prescribed to crushing or snorting an opioid.

• Opioid abuse: the use of any substance for a non-therapeutic purpose or the use of a medication for purposes other than those for which the agent is prescribed.

Abuse includes intentional use for altering a state of consciousness. Abuse frequently affects the individual’s ability to fulfill normal societal roles, resulting in difficulty with employment, or legal, or interpersonal problems.

• Pseudo-addiction: addiction-like behaviors consistent with overutilization of medications outside of the prescribing provider's instructions and recommendations for the express purpose of improved pain management. This occurs when a patient believes there is insufficient pain relief. Once pain is adequately managed with a higher dose of medications than initially prescribed or with improved therapy, the behaviors consistent with addiction are discontinued.

• Addiction: a primary chronic neurobiological disease influenced by genetic, psychosocial, and/or environmental factors. It is characterized by impaired control over drug use, compulsive drug use, and continued drug use despite harm and because of craving.

Substance use disorder/addiction in the workers’ compensation system can be encountered in three ways. First, the individual has an active substance use disorder at the time of injury. The party responsible for treatment of the substance use disorder may be outside of the workers’ compensation system. However, if there is no other paying party and the treatment is necessary in order to recover from the current workers’ compensation injury, treatment may be covered by the workers’ compensation payor.

The second possibility is that a patient with a substance use disorder, who is currently in recovery at the time of the workers’ compensation injury, relapses as a result of the medications which are prescribed by the treating provider. This patient may become readdicted and will manifest substance use disorder characteristics and symptoms consistent with the diagnosis. The third possibility is an individual with no history of substance use disorder who is injured as a result of an occupational accident. This particular individual becomes "addicted" to the medications as a result of the medications being prescribed. This is most likely to occur with the use of opioids but could possibly occur with use of other medications such as benzodiazepines or specific muscle relaxants such as carisoprodol.

If the treating provider is suspicious of a patient exhibiting opioid misuse, abuse, or addiction, the patient should preferably be evaluated by a specialist in the field of addiction medicine. It would be the responsibility of the specialist to identify medication misuse, abuse, addiction, or pseudo-addiction and to determine what additional treatment, if any, needs to be implemented.

During the initial injury evaluation, an authorized treating provider should obtain an addiction history as part of a complete history and physical. If it is determined at the time of the initial evaluation by the treating provider that there is the pre-existing condition of active SUD or history of opioid addiction/SUD, then it is prudent to consider an evaluation with an addiction medicine physician prior to issuing opioid treatments if possible. The addiction medication specialist will be able to counsel the patient accordingly, determine medication needs, and determine the appropriate follow-up to hopefully avoid aggravation or relapse of substance abuse disorders which will complicate the recovery process. Many patients exhibit opioid misuse, opioid abuse, and pseudo-addictive behaviors. These issues can be managed once the problem is identified and a discussion is carried out with the patient regarding these abnormal behaviors.

Once the diagnosis of SUD is confirmed, an addiction medicine specialist familiar with addiction treatment should assist in co-managing the patient's care and the problematic drug prescriptions. This co-management technique is critical for the injured worker with a SUD diagnosis during the initial injury phase, recovery, and stabilization phase until he/she has reached MMI. If it is determined during the active treatment and recovery phase that there is no longer a need for opioids, then the addiction medicine specialist will be in charge of the transition from use of opioids to safe taper/discontinuation of the opioids while monitoring for relapse of addiction.

Co-management is equally important for managing the chronic pain patient that has a concomitant opioid addiction/SUD with a legitimate need for analgesic medications. The addiction medicine specialist in all likelihood will monitor the patient more closely including judicious prescribing, PDMP reviews, urine drug testing, drug counts, and clarifying functional improvement as a result of the medications prescribed and frequent follow-ups which may initially seem excessive.

All abstinence addiction treatment begins with a discontinuation of the addicting substance; this is referred to as the detox phase of the treatment and can be performed in a number of ways. However, detoxification alone is not considered adequate addiction treatment. Detoxification is simply a method of discontinuing the medications in an effort to stabilize the patient prior to more extensive treatment.

Phase 1:

The methods of detoxification can include 1) abrupt discontinuation – not recommended due to high rate of relapse due to craving and withdrawal symptoms, 2) slow but progressive taper – 10% of total dosage per week as an outpatient treatment, 3) conversion to a different medication opioid (buprenorphine/naloxone) to enable a more stable and comfortable taper occasionally done as an outpatient but commonly done as

part of a more comprehensive treatment program, and 4) rapid detox under anesthesia – not recommended due to relatively high incidence of complications and high expense.

The methodology chosen for phase 1 detoxification is left up to the specialist and is simply the initial phase of stabilization prior to considering the need for a phase 2 of addiction treatment program.

Phase 2:

Once a patient is safely through the detoxification phase and the condition is stabilized regardless of the method chosen, then successful addiction treatment begins generally utilizing a number of techniques to prevent the return to active substance use and addiction. This phase of treatment generally involves teaching the patient to develop control over the compulsions, psychosocial factors, and associated mental health issues which are critical to maintain abstinence. This phase of treatment is generally managed in a 30 – 90 day non-hospital residential treatment program. The treatment prescribed in a residential treatment program generally includes individual and group therapy with certified addiction counselors and psychologists. Phase 2 of treatment may or may not be combined with opioid substitution therapy with medications such as buprenorphine/naloxone (partial agonist of the opioid receptor), methadone, or naltrexone. Injectable depot naltrexone may be used.

Buprenorphine/naloxone therapy utilizes a sublingual partial opioid receptor agonist which binds to the opioid receptor, reducing craving and resulting in analgesia when necessary. Due to its high affinity to the opioid receptor, it blocks the effect of nonapproved additional opioid use. The buprenorphine is administered either sublingually or, when FDA approved, as a subcutaneous implant. Naloxone was added to the sublingual drug formulation to discourage using this medication intravenously. With intravenous administration of buprenorphine/naloxone, the naloxone becomes absorbed neutralizing the effects of opioids. Buprenorphine/naloxone can be an excellent option in patients requiring analgesic medications with a prior history of opioid addiction because buprenorphine results in less sedation and euphoria then the other standard schedule II opioid medications. Prescribing Suboxone film (buprenorphine/naloxone) for addiction purposes can only be done by a physician and requires special training and certification.

Once special training is completed, an application is filed with the DEA to obtain a special DEA license referred to as an X-DEA number. This X–DEA number needs to accompany all prescription for Suboxone when delivered to the pharmacy and identifies the prescription is being issued specifically for the treatment of addiction/SUD.

Methadone may be an option if the patient is admitted to a federally licensed methadone treatment facility where a daily dose of medication is administered and the patient continues to utilize therapeutic treatments/cognitive behavioral therapies as noted above.

There is strong evidence that in patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine. The methodology and rationale for methadone treatment is to saturate the opioid receptors with methadone (a slow onset and prolonged duration opioid), reducing the opioid craving. The majority of the opioid receptors are bound by the methadone leaving very few unbound opioid receptors available in the event additional opioids are utilized in an attempt to achieve the euphoric effect. When the patient is stabilized on a methadone dose determined by the federally licensed methadone clinic and their associated physicians, the patient's drug-seeking, craving, legal issues, and attempts to utilize non-approved medications is reduced. Patients will frequently return to more productive lives free of the compulsions, cravings, and legal issues and are usually able to maintain jobs and improve family dynamics.

Other medications which may be useful and can be utilized during the phase 2 and 3 treatment include opioid receptor antagonists such as naltrexone (ReVia, Vivitrol) which produces no euphoria. The purpose of naltrexone therapy is to add an additional layer of protection and treatment for the patients by allowing them to receive a daily oral dose of naltrexone (ReVia) or a monthly injection of naltrexone (Vivitrol). Administration of naltrexone will bind with very high affinity to the opioid receptor resulting in the opioid receptors being non-responsive to other opioid utilization thereby preventing any euphoric response or reinforcement with unsanctioned opioid use. This treatment method can be problematic in an individual receiving intramuscular naltrexone therapy especially if that individual requires surgery and post-operative pain management because the analgesics needed for post-operative pain management will be significantly less effective because of the prolonged opioid antagonist properties of the naltrexone.

In Summary:

Medication assisted treatment for patients addicted to opioids is the treatment recommended by most experts. A Canadian evidence-based guideline recommends long-term treatment with buprenorphine/naloxone, or methadone for some patients, based on the high relapse rate without medication assistance. The likelihood of relapse in the workers’ compensation population for individuals who have become addicted through prescription drug use is unknown. Buprenorphine implants are likely equally effective as sublingual buprenorphine for preventing illicit opioid use. Implants are significantly more costly. Naltrexone treatment, an opioid agonist, has also been used to maintain abstinence. It can be provided in monthly injections or orally 3 times per week. Choice of these medications should be made by the addiction specialist.

Phase 3:

Aftercare begins after discharge from the non-hospital residential treatment program and is designed for long-term management of addiction. This phase is potentially the time when relapse is most likely to occur if the patient has not developed significant skills necessary to deal with the compulsions, cravings, and associated psychosocial factors contributing to SUD. Long-term strategies include 1) intense outpatient programs (IOP), 2) group therapy/meetings such as Narcotics Anonymous, and 3) residential communities (RC) which are groups of patients living together in a community for up to 6 months for the express purpose of maintaining abstinence from their drug of choice but at the same time transitioning and learning how to live in the general community. Residential communities are extremely useful to give patients an opportunity to be reintroduced to employment and psychosocial interactions with family and friends while maintaining contact with the community supporting their addiction recovery. In addition, phase 3 medication treatment may include utilization of opioid substitution therapy (buprenorphine/naloxone) or opioid receptor antagonist therapy as noted above.

It must be noted that relapse is common despite the utilization of intense cognitive behavioral therapy, addiction treatment strategies, and long-term phase 3 treatment and medication. Risk monitoring should be continued, including checking for behavioral aberrancies, checking the PDMP, and drug testing,. Additional treatment or readmission for repeat treatment is not uncommon.

Evidence Statements Regarding Opioid Addiction Treatment In patients being treated with opioid agonists for heroin addiction, methadone is more successful than buprenorphine at retaining patients in treatment. The rates of opiate use, as evidenced by positive urines, are equivalent between methadone and buprenorphine.

13. OPIOID/CHEMICAL TREATMENT PROGRAM REQUIREMENTS:

Chemical dependency for workers’ compensation issues will usually be related to opioids, anxiolytics, or hypnotics as prescribed for the original workers’ compensation injury.

Chemical dependency should be treated with specific programs providing medical and psychological assessment, treatment planning, and individual as well as group counseling and education. Established functional goals which are measurable, achievable, and time specific are required.

Inpatient or outpatient programs may be used, depending upon the level of intensity of services required. Formal inpatient treatment programs are appropriate for patients who have more intense (e.g., use extraordinarily excessive doses of prescription drugs to which they have developed tolerance) or multiple drug abuse issues (e.g., benzodiazepines and/or alcohol) and those with complex medical conditions or psychiatric issues related to drug misuse. A medical physician with appropriate training and preferably board certified in addiction medicine should provide the initial evaluation and oversee the program. Full primary assessment should include behavioral health assessment; medical history; physical examination; mental status; current level of functioning; employment history; legal history; history of abuse, violence, and risk taking behavior; education level; use of alcohol, tobacco and other drugs; and social support system. The initial medical exam should include appropriate laboratory testing such as liver function, screening for sexual diseases, etc.

Addiction specialists, alcohol and drug counselors, psychologists, psychiatrists, and other trained health care providers as needed, are involved in the program. Peer and group support is an integral part of the program and families are encouraged to attend. Peer support specialists should receive competency based training. A designated individual is assigned to each worker to assist in coordinating care. There should be good communication between the program and other external services, external health care providers, Al-Anon, Alcoholics Anonymous (AA), and pain medicine providers. Drug screening should be performed as appropriate for the individual, at least weekly during the initial detoxification and intensive treatment phases. At least 8 random drug screens per year should be completed for those on medication assisted treatment and drug diversion control methods should be in place.

Clear withdrawal procedures are delineated for voluntary, against medical advice, and involuntary withdrawal. Withdrawal programs must have a clear treatment plan and include description of symptoms of medical and emotional distress, significant signs of opioid withdrawal, and actions taken. All programs should have clear direction on how to deal with violence in order to assure safety for all participants. Transition and discharge should be carefully planned with full communication to outside resources. Duration of inpatient programs are usually 4 weeks while outpatient programs may take 12 weeks.

Drug detoxification may be performed on an outpatient or inpatient basis. Detoxification is unlikely to succeed in isolation when not followed by prolonged chemical dependency treatment. Isolated detoxification is usually doomed to failure with very high recidivism rates.

Both ultra-rapid and rapid-detoxification are not recommended due to possible respiratory depression and death and the lack of evidence for long range treatment success. Refer to Section G.12, Opioid Addiction Treatment, for more specific details on treatment plans.

Tapering opioids on an outpatient basis requires a highly motivated patient and diligent treatment team and may be accomplished by decreasing the current dose 10% per day or per week. Tapering programs under the supervision of physicians with pain expertise may proceed more aggressively. Tapering should be accompanied by addiction counseling. Failing a trial of tapering, a patient should be sent to a formal addiction program. When the dose has reached 1/3 of the original dose, the taper should proceed at half or less of the initial rate. Doses should be held or possibly increased if severe withdrawal symptoms, pain, or reduced treatment failure otherwise occurs. This method is tedious, time consuming, and more likely to fail than more rapid and formalized treatment programs.

Time Frames for Opioid / Chemical Treatment Programs Time to Produce Effect 3 to 4 weeks Frequency Full time programs - no less than 5 hours/day, 5 days/week;

part time programs - 4 hours/day for 2-3 days per week.

Optimum Duration 2 to 12 weeks at least 2-3 times a week. With follow-up visits weekly or every other week during the first 1 to 2 months after the initial program is completed.

Maximum Duration 4 months for full time programs and up to 6 months for parttime programs. Periodic review and monitoring thereafter for 1 year, additional follow-up based upon the documented maintenance of functional gains.

14. ORTHOTICS/PROSTHETICS/EQUIPMENT: Devices and adaptive equipment may be necessary in order to reduce impairment and disability, to facilitate medical recovery, to avoid re-aggravation of the injury, and to maintain maximum medical improvement.

Indications would be to provide relief of the industrial injury, prevent further injury, and control neurological and orthopedic injuries for reduced stress during functional activities.

In addition, they may be used to modify tasks through instruction in the use of a device or physical modification of a device. Equipment needs may need to be reassessed periodically. Refer to Section G.17, Return-to-work, for more detailed information.

Equipment may include high and low technology assistive devices, computer interface or seating, crutch or walker training, and self-care aids. It should improve safety and reduce risk of re-injury. Standard equipment to alleviate the effects of the injury on the performance of activities of daily living may vary from simple to complex adaptive devices to enhance independence and safety. Certain equipment related to cognitive impairments may also be required.

Ergonomic modifications may be necessary to facilitate medical recovery, to avoid reaggravation of the injury, and to maintain maximum medical improvement. Ergonomic evaluations with subsequent recommendations may assist with the patient’s return-towork. (Refer to Section F.6.c, Jobsite Evaluation and Alterations, for further information.)

For chronic pain disorders, equipment such as foot orthoses may be helpful. The injured worker should be educated as to the potential harm from using a lumbar support for a period of time greater than which it is prescribed. Harmful effects include de-conditioning of the trunk musculature, skin irritation, and general discomfort. Use of cervical collars is not recommended for chronic cervical myofascial pain. Special cervical orthosis and/or equipment may have a role in the rehabilitation of a cervical injury such as those injuries to a cervical nerve root resulting in upper extremity weakness, a spinal cord injury with some degree of paraparesis or tetraparesis, or post spinal fusion surgery. Use of such devices would be in a structured rehabilitation setting as part of a comprehensive rehabilitation program.

Fabrication/modification of orthotics, including splints, would be used when there is need to normalize weight-bearing, facilitate better motion response, stabilize a joint with insufficient muscle or proprioceptive/reflex competencies, to protect subacute conditions as needed during movement, and correct biomechanical problems. Orthotic/prosthetic training is the skilled instruction (preferably by qualified providers) in the proper use of orthotic devices and/or prosthetic limbs.

For information regarding specific types of orthotics/prosthetics/equipment, refer to individual medical treatment guideline.

15. PERSONALITY/PSYCHOLOGICAL/PSYCHOSOCIAL INTERVENTION

a. Introduction Psychosocial treatment is a well-established therapeutic and diagnostic intervention with selected use in acute pain populations and more widespread use in sub-acute and chronic pain populations. Psychosocial treatment is recommended as an important component in the total management of a patient with chronic pain and should be implemented as soon as the problem is identified.

Studies have noted that there is not a direct connection between impairment and disability nor is there a direct connection been lumbar imaging and pain. It appears that the lack of connections is likely accounted for by differences among individuals in level of depression, coping strategies, or other psychological distress.

There is some evidence that in the setting of chronic low back pain when disc pathology is present, a high degree of anxiety or depressive symptomatology is associated with relatively less pain relief in spite of higher opioid dosage than when these symptoms are absent. Therefore, psychological issues should always be screened for and treated in chronic pain patients.

Psychological treatments for pain can be conceptualized as having a neuropsychological basis. These treatments for pain have been shown to decrease physiological reactivity to stress, alter patterns of brain activation as demonstrated by functional MRI (fMRI), alter the volume of grey matter and other structures in the brain, and alter blood flow patterns in the brain. The most researched psychological treatment is Cognitive Behavioral Therapy (CBT) which is summarized in this section.

The screening or diagnostic workup should clarify and distinguish between preexisting, aggravated, and/or purely causative psychological conditions.

Therapeutic and diagnostic modalities include, but are not limited to, individual counseling and group therapy. Treatment can occur within an individualized model, a multi-disciplinary model, or a structured pain management program.

A psychologist with a PhD, PsyD, or EdD credentials or a psychiatric MD/DO may perform psychosocial treatments. The following professionals may also perform treatment in consultation with a psychologist with a PhD, PsyD, or EdD or psychiatric MD/DO: other licensed mental health providers, licensed health care providers with training in CBT, or providers certified as CBT therapists who have experience in treating chronic pain disorders in injured workers.

If a diagnosis consistent with the standards of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM) or most current ICD has been determined, the patient should be evaluated for the potential need for psychiatric medications. Use of any medication to treat a diagnosed condition may be ordered by an authorized treating physician or by the consulting psychiatrist. Visits for management of psychiatric medications are medical in nature and are not a component of psychosocial treatment. Therefore, separate visits for medication management may be necessary, depending on the patient and medications selected.

Psychosocial interventions include psychotherapeutic treatments for behavioral health conditions, as well as behavioral medicine treatments. These interventions may similarly be beneficial for patients without psychiatric conditions but who may need to make major life changes in order to cope with pain or adjust to disability. Examples of these treatments include Cognitive Behavioral Therapy (CBT), relaxation training, mindfulness training, and sleep hygiene psychoeducation.

CBT refers to a group of psychological therapies that are sometimes referred to by more specific names such as Rational Emotive Behavior Therapy, Rational Behavior Therapy, Rational Living Therapy, Cognitive Therapy, and Dialectic Behavior Therapy. Variations of CBT methods can be used to treat a variety of conditions, including chronic pain, depression, anxiety, phobias, and posttraumatic stress disorder (PTSD). For patients with multiple diagnoses, more than one type of CBT might be needed. The CBT used in research studies is often “manualized CBT,” meaning that the treatment follows a specific protocol in a manual. In clinical settings, CBT may involve the use of standardized materials, but it is also commonly adapted by a psychologist or psychiatrist to the patient’s unique circumstances. If the CBT is being performed by a non-mental health professional, a manual approach would be strongly recommended.

CBT must be distinguished from neuropsychological therapies used to teach compensatory strategies to brain injured patients, which are also called “cognitive therapy.” Many other clinical providers also provide a spectrum of cognitive interventions including: motivational interviewing, pain neuroscience education, and other interventions aimed at patient education and change in behavior. Refer to patient education in Section G.18, Therapy-Active, for details.

It should be noted that most clinical trials on CBT exclude subjects who have significant psychiatric diagnoses. Consequently, the selection of patients for CBT should include the following considerations. CBT is instructive and structured, using an educational model with homework to teach inductive rational thinking.

Because of this educational model, a certain level of cognitive ability and literacy is assumed for most CBT protocols. Patients who lack the cognitive and educational abilities required by a CBT protocol are unlikely to be successful.

Further, given the highly structured nature of CBT, it is more effective when a patient’s circumstances are relatively stable. For example, if a patient is about to be evicted, is actively suicidal, or is coming to sessions intoxicated, these matters will generally preempt CBT treatment for pain and require other types of psychotherapeutic response. Conversely, literate patients whose circumstances are relatively stable, but who catastrophize or cope poorly with pain or disability, are often good candidates for CBT for pain. Similarly, literate patients whose circumstances are relatively stable, but who exhibit unfounded medical phobias, are often good candidates for CBT for anxiety.

CBT is often combined with active therapy in an interdisciplinary program, whether formal or informal. It must be coordinated with a psychologist or psychiatrist. CBT can be done in a small group or individually, and the usual number of treatments varies between 8 and 16 sessions.

Before CBT or other psychological treatments are performed, the patient must have a full psychological evaluation. The CBT program must be done under the supervision of a psychologist with a PhD, PsyD, or EdD or a psychiatric MD/DO.

Psychological disorders associated with distress and dysfunction are common in chronic pain. One study demonstrated that the majority of patients who had failed other therapy and participated in an active therapy program also suffered from major depression. However, in a program that included CBT and other psychological counseling, the success rate for return to work was similar for those with and without an ICD diagnosis. This study further strengthens the argument for having some psychological intervention included in all chronic pain treatment plans.

b. Hypnosis i. The term hypnosis can encompass a number of therapy types including relaxation, imagery, focused attention, interpersonal processing, and suggestion. Hypnosis has been used in depression and for distress related to medical procedures.

ii. A number of studies support the use of hypnosis for chronic pain management. At least one pilot study suggested that hypnotic cognitive therapy assists recovery in chronic pain. Other imaging studies support the concept that hypnosis can actively affect cortical areas associated with pain. Thus, this therapy may be used at the discretion of the psychologist. A more recent meta-analysis was completed which purported to show evidence for hypnosis. However, the heterogeneity of the studies included prevents this study from meeting our standards for evidence.

For all psychological/psychiatric interventions, an assessment and treatment plan must be provided to the treating physician prior to initiating treatment. The treatment plan must include specific, measurable, achievable, and realistic behavioral goals, with specific interventions and time frames to achieve those goals. The report should also address pertinent issues such as pre-existing, exacerbated or aggravated, and/or causative issues, as well as a realistic functional prognosis.

Evidence Statements Regarding Psychosocial Intervention Good Evidence Cognitive behavioral therapy, but not behavioral therapy such as biofeedback, shows weak to small effects in reducing pain and small effects on improving disability, mood, and catastrophizing in the treatment of patients with chronic pain.

CBT may reduce pain and disability in patients with chronic pain, but the magnitude of the benefit is uncertain.

There are no clinically significant differences for pain and disability between physical versus behavioral/psychologically informed and combined interventions for nonspecific chronic spinal pain. meta-analyses of Psychological interventions, especially CBT, are superior to no psychological intervention for chronic low back pain.

Self-regulatory interventions, such as biofeedback and relaxation training, may be equally effective.

Six group therapy sessions lasting 90 minutes each focused on CBT skills improved function and alleviated pain in uncomplicated sub-acute and chronic low back pain patients.

Group randomized In the setting of chronic low back pain, 8 weeks of 2 hour weekly group sessions of either mindfulness based stress reduction meditation program with yoga or CBT results in small, significant improvements in physical function and reduction in pain compared to usual care at 26 weeks with no significant differences in outcomes between the 2 treatments.

Evidence Statements Regarding Psychosocial Intervention A stepped care program including CBT is more effective than usual care in veterans with chronic musculoskeletal pain. The stepped care program consists of (1) 12 weeks during which nurse case managers take a medication use history and adjust medication dosage and scheduling through telephone contacts with patients every other week, followed by (2) a 12 week step in which CBT is administered by 45 minute individual sessions by telephone every other week. Disability and pain interference with daily activity with stepped care were both superior to usual care in which patients were given printed handouts and were followed for all care by their primary treating physicians.

In the short-term, operant therapy focused on increasing function shows small effects in reducing pain compared to waiting list controls. Most studies demonstrated a positive effect. However, it was usually below the minimal clinical significant standard. There is good evidence that no specific type of behavioral therapy is more effective than another in the treatment of patients with chronic pain.

Some Evidence A 6-week program of cognitive-behavioral group intervention with or without physical therapy can reduce sick leave, health care utilization, and the risk for developing long-term sick leave disability (> 15 days) in workers with nonspecific low back or neck pain compared with simple verbal instruction by a physician.

Intensive exercise coupled with CBT is as effective as posterolateral fusion for chronic un-operated low back pain.

In the setting of chronic pain, both an 8-week mindfulness based stress reduction meditation program with yoga and an 8-week multidisciplinary pain intervention program with exercise resulted in small, significant reductions in pain intensity and pain-related distress post-intervention.

However, there were no significant differences in outcomes between the 2 programs.

CBT provided in 7 2-hour small group sessions can reduce the severity of insomnia in chronic pain patients.

In the setting of chronic low back pain for older adults (mean age 74.5 years), an 8-week mind-body program that taught mindfulness meditation methods resulted in significant, but clinically small improvements in (1) physical function in the short-term (8 weeks) and (2) current and most severe pain in the past week in the long term (6 months) compared to a healthy aging education program.

Additional Studies Not Resulting in Evidence Statements A study using functional magnetic imaging compared mindful practitioners with controls and found that mindfulness did not decrease pain but did decrease pain unpleasantness by 22% and anxiety by 23%.

Further studies would be needed to establish this as a recommendation.

Another recent Cochrane review found only low quality studies of cognitive behavioral therapy for chronic neck pain which suggested some benefit but with low clinical significance.

Summary of Evidence Regarding Psychosocial Intervention Based on the multiple studies with good evidence listed above, there is strong evidence supporting CBT, particularly in conjunction with other active therapy, to decrease pain and disability for chronic pain patients.

However, the magnitude of the change is not likely to be large.

Time Frames for Cognitive Behavioral Therapy (CBT) or Similar Treatment Time to Produce Effect 12-16 hours of treatment (1-hour individual sessions or alternately 1- to 2-hour group sessions).

Frequency 1 to 2 times weekly for the first 2 weeks, decreasing to 1 time per week thereafter.

Maximum Duration 24 1-hour sessions.

Note Before CBT or other psychological/psychiatric interventions are done, the patient must have a full psychological evaluation. The CBT program must be done under the supervision of a psychologist with a PhD, PsyD, or EdD, or a Psychiatric MD/DO.

Time Frames for Other Psychological/Psychiatric Interventions Time to Produce Effect 6 to 8 weeks.

Frequency 1 to 2 times weekly for the first 2 to 4 weeks (excluding hospitalization, if required), decreasing to 1 time per week for the second month. Thereafter, 2 to 4 times monthly with the exception of exacerbations, which may require increased frequency of visits. Not to include visits for medication management.

Optimum Duration 2 to 6 months.

Maximum Duration Commonly 6 months for most cases. Extensions under conditions as noted below.

(Not to include visits for medication management). For select patients (e.g., ongoing medical procedures or complications, medication dependence, diagnostic uncertainty, delays in care due to patient or systemic variables), less intensive but longer supervised psychological/psychiatric treatment may be required. If counseling beyond 6 months is indicated, the nature of the psychosocial risks being managed or functional progress must be documented. Progress notes for each appointment should include goal setting, with specific, measurable, achievable, and realistic goals, and a timetable with an expected end point. In complex cases, goal setting may include maintaining psychological equilibrium while undergoing invasive procedures.

16. RESTRICTION OF ACTIVITIES: Continuation of normal daily activities is the recommendation for most patients since immobility will negatively affect rehabilitation.

Prolonged immobility results in a wide range of deleterious effects, such as a reduction in aerobic capacity and conditioning, loss of muscle strength and flexibility, increased segmental stiffness, promotion of bone demineralization, impaired disc nutrition, and the facilitation of the illness role.

Some level of immobility may occasionally be appropriate which could include splinting/casting or as part of a structured schedule that includes energy conservation or intentional rest breaks between activities. While these interventions may occasionally have been ordered in the acute phase, the provider should be aware of their impact on the patient’s ability to adequately comply with and successfully complete rehabilitation.

Activity should be increased based on the improvement of core strengthening.

Patients should be educated regarding the detrimental effects of immobility versus the efficacious use of limited rest periods. Adequate rest allows the patient to comply with active treatment and benefit from the rehabilitation program. In addition, complete work cessation should be avoided, if possible, since it often further aggravates the pain presentation and promotes disability. Modified return to work is almost always more efficacious and rarely contraindicated in the vast majority of injured workers.

17. RETURN-TO-WORK: Return-to-work and/or work-related activities whenever possible is one of the major components in treatment and rehabilitation. Return to work is a subject that should be addressed by each workers’ compensation provider at the first meeting with the injured employee and updated at each additional visit. A return-to-work format should be part of a company’s health plan, knowing that return to work can decrease anxiety, reduce the possibility of depression, and reconnect the worker with society.

A prolonged time off work is likely to lead to chronic disability. In complex cases, experienced nurse case managers may be required to assist in return to work. Other services, including psychological evaluation and/or treatment, jobsite analysis, and vocational assistance, may be employed.

Two counseling sessions with an occupational physician, and work site visit if necessary, may be helpful for workers who are concerned about returning to work.

At least one study suggests that health status is worse for those patients who do not return to work than those who do. Self-employment and injury severity predict return to work. Difficulty with pain control, ADLs, and anxiety and depression were common among patients who did not return to work.

The following should be considered when attempting to return an injured worker with chronic pain to work.

a. Job History Interview: An authorized treating physician should perform a job

history interview at the time of the initial evaluation and before any plan of treatment is established. Documentation should include the worker’s job demands, stressors, duties of current job, and duties of job at the time of the initial injury. In addition, cognitive and social issues should be identified, and treatment of these issues should be incorporated into the plan of care.

b. Coordination of Care: Management of the case is a significant part of return to work and may be the responsibility of an authorized treating physician, occupational health nurse, risk manager, or others. Case management is a method of communication between the primary provider, referral providers including occupational and physical therapists, insurer, employer, and employee.

Because case management may be coordinated by a variety of professionals, the case manager should be identified in the medical record.

c. Communication: This is essential between the patient, authorized treating physician, employer, and insurer. Employers should be contacted to verify employment status, job duties and demands, and policies regarding injured workers. In addition, the availability and duration of temporary and permanent restrictions, as well as other placement options, should be discussed and documented. All communications in the absence of the patient are required to be documented and made available to the patient.

d. Establishment of Return-To-Work Status: Return to work for persons with chronic pain should be considered therapeutic, assuming that work is not likely to aggravate the basic problem or increase the discomfort. In some cases of chronic pain, the worker may not be currently working or even employed. The goal of return to work would be to return the worker to any level of employment with the current employer or to return him/her to any type of new employment.

Temporary restrictions may be needed while recommended ergonomic or adaptive equipment is obtained; employers should obtain recommended equipment in a timely manner.

e. Establishment of Activity Level Restrictions: A formal job description for the injured worker is necessary to identify physical demands at work and assist in the creation of modified duty. A jobsite evaluation may be utilized to identify applicable tasks such as pushing, pulling, lifting, reaching, grasping, pinching, sitting, standing, posture, and ambulatory distance and terrain. If applicable, a job site evaluation may also be utilized to assess temperature, air flow, noise, and the number of hours worked per day in a specific environment. Also refer to

Section F.6.c, Jobsite Evaluation and Alterations. Due to the lack of predictability regarding exacerbation of symptoms affecting function, an extended, occupationally focused functional capacity evaluation may be necessary to determine the patient’s tolerance for job type tasks over a continued period of time. Job requirements should be reviewed for the entire 8 hours or more of the working day. When prescribing the FCE, the physician must assess the probability of return to work against the potential for exacerbation of the work related condition. Work restrictions assigned by an authorized treating physician may be temporary or permanent. The case manager should continue to seek out modified work until restrictions become less cumbersome or as the worker’s condition improves or deteriorates. Ergonomic changes recommended by the worksite evaluation should be put in place.

Between 1 and 3 days after the evaluation, there should be a follow-up evaluation by the treating therapist and/or an authorized treating physician to assess the patient’s status. Patients should be encouraged to report their status post FCE.

f. Rehabilitation and Return-To-Work: As part of rehabilitation, every attempt should be made to simulate work activities so that an authorized treating physician may promote adequate job performance. The use of ergonomic or adaptive equipment, therapeutic breaks, and interventional modalities at work may be necessary to maintain employment.

g. Vocational Assistance: Formal vocational rehabilitation is a generally accepted intervention and can assist disabled persons to return to viable employment.

Assisting patients in identifying vocational goals will facilitate medical recovery and aid in the achievement of MMI by (1) increasing motivation towards treatment and (2) alleviating the patient’s emotional distress. Physically limited patients will benefit most if vocational assistance is provided during the interdisciplinary rehabilitation phase of treatment. To assess the patient’s vocational capacity, a vocational assessment utilizing the information from occupational and physical therapy assessments may be performed. This vocational assessment may identify rehabilitation program goals and optimize both patient motivation and utilization of rehabilitation resources. This may be extremely helpful in decreasing the patient’s fear regarding an inability to earn a living, which can add to his/her anxiety and depression.

Recommendations to Employers and Employees of Small Businesses:

Employees of small businesses who are diagnosed with chronic pain may not be able to perform any jobs for which openings exist. Temporary employees may fill those slots while the employee functionally improves. Some small businesses hire other workers, and if the injured employee returns to the job, the supervisor/owner may have an extra employee. Case managers may assist with resolution of these problems and with finding modified job tasks or jobs with reduced hours, etc., depending on company philosophy and employee needs.

Recommendations to Employers and Employees of Mid-sized and Large Businesses: Employers are encouraged by the Division to identify modified work within the company that may be available to injured workers with chronic pain who are returning to work with temporary or permanent restrictions. To assist with temporary or permanent placement of the injured worker, it is suggested that a program be implemented that allows the case manager to access descriptions of all jobs within the organization.

18. THERAPY—ACTIVE:

The following active therapies are widely used and accepted methods of care for a variety of work-related injuries. Active therapy is based on the philosophy that therapeutic exercise and/or activity can alleviate discomfort and are beneficial for restoring flexibility, strength, endurance, function, and range-of-motion. All active therapy plans should be made directly with patients in the interest of achieving long-term individualized goals.

Active therapy requires an internal effort by the individual to complete a specific exercise or task. This form of therapy requires supervision from a therapist or medical provider such as verbal, visual, and/or tactile instruction(s). Active therapy is intended to promote independence and self-reliance in managing the physical pain as well as to improve functional status in regard to the specific diagnosis, general conditioning, and well-being.

At times, a provider may help stabilize the patient or guide the movement pattern but the energy required to complete the task is predominately executed by the patient. Therapy in this section should not be merely a repeat of previous therapy but should focus specifically on the individual goals and abilities of the patient with chronic pain.

The goal of active therapy is to teach the patient exercises that they can perform regularly on their own. Patients should be instructed to continue active therapies at home as an extension of the treatment process in order to maintain improvement levels. Followup visits to reinforce and monitor progress and proper technique are recommended.

Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as "maximum.” Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care, need for post-operative therapy, and comorbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. It is recommended that, if no functional gain is observed after the number of treatments under “time to produce effect” has been completed, then alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

Pain Neuroscience Education (PNE): an educational strategy used by physical therapists and other practitioners that focuses on teaching people in pain more about the neurobiological and neurophysiological processes involved in their pain experience, versus a focus on anatomical and pathoanatomical education. PNE helps patients develop an understanding of various pain processes including central sensitization, peripheral sensitization, inhibition, facilitation, the brain’s processing of threat appraisal, and various biological systems involved in a pain experience. This reconceptualization of pain via PNE is then combined with various behavioral strategies including aerobic exercise, pacing, graded exposure, graded activity, and goal setting. PNE is likely to positively influence pain ratings, disability, fear-avoidance behaviors, pain catastrophization, and limitations in movement, pain knowledge, and healthcare utilization. PNE is recommended with active therapy for chronic pain patients.

Evidence Statements Regarding Patient Education Pain neuroscience education combined with a physical intervention is more effective in reducing pain, improving disability, and reducing healthcare utilization compared with either usual care, exercise, other education or another control group for the treatment of patients with chronic musculoskeletal pain.

Narrative systematic review of randomized A cognitive intervention consisting of 2 consultations lasting 1 hour each with a physical medicine specialist and a physical therapist covering coping strategies and patient education on motion produces short-term reductions in sub-acute back disability.

In the setting of non-specific chronic low back pain, patient-centered cognitive functional therapy from physical therapists produced superior outcomes for pain reduction and functional improvement compared with traditional manual therapy and exercise at postintervention and at 12-month follow-up.

The following active therapies are listed in alphabetical order:

a. Activities of Daily Living (ADL): instruction, active-assisted training, and/or adaptation of activities or equipment to improve a person's capacity in normal daily activities such as self-care, work re-integration training, homemaking, and driving.

Time Frames for Activities of Daily Living Frequency 1 to 5 times per week.

b. Aquatic Therapy: is a well-accepted treatment which consists of the therapeutic use of aquatic immersion for therapeutic exercise to promote strengthening, core stabilization, endurance, range-of-motion, flexibility, body mechanics, and pain management. Aquatic therapy is the implementation of active therapeutic procedures (individual or group) in a swimming or therapeutic pool heated to 88 to 92 degrees. The pool should be large enough to allow full extremity range-ofmotion and fully erect posture. Aquatic vests, belts, and other devices can be used to provide stability, balance, buoyancy, and resistance. The water provides a buoyancy force that lessens the amount of force of gravity applied to the body.

The decreased gravity effect allows the patient to have a mechanical advantage and more likely have a successful trial of therapeutic exercise. In addition, the compression of the water against the affected extremity and ability to move easier with decreased gravity allow for resulting muscular compression against vessels improving lymphatic drainage resulting in decreased edema. Aquatic Therapy may also provide an additional stimulus to assist with desensitization.

There is good evidence that aquatic exercise and land-based exercise show comparable outcomes for function and mobility among people with symptomatic osteoarthritis of the knee or hip.

Indications: The therapy may be indicated for individuals who:

• Cannot tolerate active land-based or full-weight bearing therapeutic procedures;

• Require increased support in the presence of proprioceptive deficit;

• Are at risk of compression fracture due to decreased bone density;

• Have symptoms that are exacerbated in a dry environment;

• Have a higher probability of meeting active therapeutic goals than in a dry environment.

Evidence Statements Regarding Aquatic Therapy Aquatic exercise and land-based exercise show comparable outcomes for function and mobility among people with symptomatic osteoarthritis of the knee or hip.

Systematic Review and Time Frames for Aquatic Therapy Frequency 3 to 5 times per week.

After the supervised aquatics program has been established, either a selfdirected aquatic program or a transition to a self-directed dry environment exercise program is recommended.

c. Functional Activities: are well-established interventions which involve the use of therapeutic activity to enhance mobility, body mechanics, employability, coordination, and sensory motor integration.

Time Frames for Functional Activities Frequency 1 to 5 times per week.

d. Functional Electrical Stimulation: is an accepted treatment in which the application of electrical current to elicit involuntary or assisted contractions of atrophied and/or impaired muscles. Indications include muscle atrophy, weakness, and sluggish muscle contraction secondary to pain, injury, neuromuscular dysfunction, peripheral nerve lesion, or radicular symptoms. This modality may be prescribed for use at home when patients have demonstrated knowledge of how to self-administer and are in an independent exercise program.

Time Frames for Functional Electrical Stimulation Frequency 3 times per week.

Optimum Duration 8 weeks.

Maximum Duration 8 weeks. If beneficial, provide with home unit.

e. Neuromuscular Re-education: is a generally accepted treatment. It is the skilled application of exercise with manual, mechanical, or electrical facilitation to enhance strength; movement patterns, neuromuscular response, proprioception, kinesthetic sense, coordination; education of movement, balance, and posture.

There is some evidence that there is a modest benefit from adding a back school to other treatments such as NSAIDs, massage, transcutaneous electrical nerve stimulation (TENS), and other physical therapy modalities. However, a recent adequate quality systematic review found no evidence for the effectiveness of back schools for treating chronic low back pain.

Indications include the need to promote neuromuscular responses through carefully timed proprioceptive stimuli, to elicit and improve motor activity in patterns similar to normal neurologically developed sequences, and to improve neuromotor response with independent control.

Evidence Statements Regarding Neuromuscular Re-education There is a modest benefit from adding a back school to other treatments such as NSAIDs, massage, transcutaneous electrical nerve stimulation (TENS), and other physical therapy modalities.

Time Frames for Neuromuscular Re-education f. Spinal Stabilization: is a generally well-accepted treatment. The goal of this therapeutic program is to strengthen the spine in its neutral and anatomic position. The stabilization is dynamic which allows whole body movements while maintaining a stabilized spine. It is the ability to move and function normally through postures and activities without creating undue vertebral stress.

Time Frames for Spinal Stabilization Time to Produce Effect 4 to 8 treatments.

g. Therapeutic Exercise: with or without mechanical assistance or resistance, may include isoinertial, isotonic, isometric, and isokinetic types of exercises. May also include alternative/complementary exercise movement therapy (with oversight of a physician or appropriate healthcare professional).

Indications include the need for cardiovascular fitness, reduced edema, improved muscle strength; improved connective tissue strength and integrity, increased bone density, promotion of circulation to enhance soft tissue healing, improvement of muscle recruitment, improved proprioception, and coordination, and increased range-of-motion are used to promote normal movement patterns.

Yoga may be an option for motivated patients with appropriate diagnoses.

Therapeutic exercise programs should be tissue specific to the injury and address general functional deficits as identified in the diagnosis and clinical assessment. Patients should be instructed in and receive a home exercise program that is progressed as their functional status improves. Upon discharge, the patient would be independent in the performance of the home exercise program and would have been educated in the importance of continuing such a program. Educational goals would be to maintain or further improve function and to minimize the risk for aggravation of symptoms in the future.

Available evidence supporting therapy mainly exists in the chronic low back literature.

In the short, intermediate, and long-term, motor control exercises that emphasize the transversus abdominis and multifidi are at least as effective as other forms of exercise and manual therapy. They are possibly more effective than other minimal interventions in reducing pain and improving disability in patients for the treatment of chronic non-specific Land-based exercise shows a small clinically important benefit for the relief of pain and improvement in function at the completion of a supervised exercise program and these benefits are sustained for at least another 3 to 6 months among people with symptomatic osteoarthritis of the hip.

A 12-week course of treatment in the McKenzie method is at most modestly more effective than spinal manipulation of similar duration in reducing disability in patients with persistent (more than 6 weeks duration, mean = 95 weeks) nonspecific low back pain, although a clinically relevant difference was not apparent. The McKenzie method should not be utilized if there is severe nerve root involvement with motor, sensory, or reflex abnormality.

Pilates is more effective in reducing pain and improving disability compared with a minimal intervention at intermediate term follow-up, but Pilates is equally as effective as other forms of exercise in improving disability at short- or intermediate-term follow-up for the treatment of patients with chronic non-specific low back pain.

Exercise alone or as part of a multi-disciplinary program results in decreased disability for workers with non-acute Supervised exercise therapy with added manual mobilization shows moderate, clinically important reductions in pain compared to non-exercise controls in people with osteoarthritis of the knee.

Land-based exercise shows a moderate clinically important benefit for the relief of pain and improvement in function at the completion of a supervised exercise program and shows that somewhat smaller benefits are sustained for at least another 2 to 6 months among people with symptomatic osteoarthritis of the knee.

An unsupervised 12-week, periodized musculoskeletal rehabilitation (PMR) program of weight training conducted 2, 3, or 4 days a week is effective at improving musculoskeletal strength and quality of life and at reducing pain and disability in untrained persons with chronic low back pain. The 4 days a week training volume is most effective. The volume (total number of reps) of PMR exercise prescribed is important.

Trunk balance exercises combined with flexibility exercises are more effective than a combination of strength and flexibility exercises in reducing disability and improving physical function in patients with chronic low back pain.

An exercise program which includes resistance training of the cervical and scapulothoracic muscles, combined with stretching of the same muscles, is likely to be beneficial for mechanical neck pain.

Cervicolscapular endurance exercises are beneficial for chronic cervicogenic headache.

General fitness exercises and upper extremity exercises are unlikely by themselves to be beneficial for mechanical neck pain and are therefore not recommended.

There is no significant difference in the effectiveness of an 12-week, 20 session comprehensive supervised exercise program and an unsupervised simple exercise program with advice for improvement in average pain intensity in the preceding week in people with a mild chronic whiplashassociated disorder even though both interventions resulted in small reductions of pain over 12 months.

A 4-month intervention for chronic neck pain patients containing pain education, specific exercises and graded activity training shows a significant effect, although clinically small, on improved physical and mental health related quality of life compared with controls receiving pain education alone. Good adherence increased the effect in favor of the exercise group. superiority multicenter 12 weeks of supervised high-dose exercise, spinal manipulative therapy, or low-dose home exercise with advice are all equally effective for reducing pain in the shortand long-term (1 year) in those who have chronic low back Intensive exercise coupled with cognitive behavioral therapy is as effective for chronic un-operated low back pain as posterolateral fusion.

In the setting of non-specific chronic low back pain, patientcentered cognitive functional therapy from physical therapists produced superior outcomes for pain reduction and functional improvement compared with traditional manual therapy and exercise at post-intervention and at 12month follow-up.

There is no significant difference in the effectiveness of an 8-week supervised walking program, an evidence-based group exercise class, and usual physiotherapy for improvement in functional disability after 6 months for people with chronic low back pain even though all 3 interventions resulted in small, significant improvements in physical function, reduction of pain, quality of life, and fear avoidance over time.

Twelve weeks of behavioral graded activity does not result in better long-term effectiveness in reducing pain or improving function at 5 years than usual exercise therapy in patients with osteoarthritis (OA) of the hip or knee.

Evidence Statements Regarding Yoga Yoga has small to moderate advantages over providing only a booklet in reducing low back pain and back-specific disability, but there is no evidence that yoga is superior to stretching and strengthening classes led by a licensed physical therapist.

In the setting of chronic low back pain, 8 weeks of 2 hour weekly group sessions of either mindfulness based stress reduction meditation program with yoga or CBT results in small, significant improvements in physical function and reduction in pain compared to usual care at 26 weeks with no significant differences in outcomes between the 2 treatments.

Iyengar yoga, which avoids back bending, results in improved function and decreased chronic mechanical low back pain for up to 6 months. Instruction occurred 2 times per week for 24 weeks and was coupled with home exercise. One quarter of the participants dropped out.

In the setting of chronic pain, both an 8-week mindfulness based stress reduction meditation program with yoga and an 8-week multidisciplinary pain intervention program with exercise resulted in small, significant reductions in pain intensity and pain-related distress post intervention but with no significant differences in outcomes between the 2 programs.

Time Frames for Therapeutic Exercise Frequency 2 to 5 times per week.

Optimum Duration 4 to 8 weeks and concurrent with an active daily home exercise program.

Maximum Duration 8 to 12 weeks of therapist oversight. Home exercise should continue indefinitely. Additional sessions may be warranted during periods of exacerbation of symptoms Yoga may be an option for motivated patients.

Time Frames for Yoga Time to Produce Effect 8 sessions Maximum Duration 48 sessions are the maximum expected duration h. Work Conditioning: This program is a work-related, outcome-focused, individualized treatment program. Objectives of the program include, but are not limited to, improvement of cardiopulmonary and neuromusculoskeletal functions (strength, endurance, movement, flexibility, postural control, and motor control functions), patient education, and symptom relief. The goal is for patients to gain full- or optimal-function and return to work. The service may include the timelimited use of modalities, both active and passive, in conjunction with therapeutic exercise, functional activities, general conditioning body mechanics, and lifting techniques re-training.

This program is usually initiated once re-conditioning has been completed but may be offered at any time throughout the recovery phase. It should be initiated when imminent return of a patient to modified- or full-duty is not an option but the prognosis for returning the patient to work at completion of the program is at least fair to good.

Time Frames for Work Conditioning Time to Produce Effect 1 to 2 hours per day.

Frequency 2 to 5 visits per week.

Maximum Duration 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

i. Work Simulation: is a program where an individual completes specific workrelated tasks for a particular job and return to work. Use of this program is appropriate when modified duty can only be partially accommodated in the work place, when modified duty in the work place is unavailable, or when the patient requires more structured supervision. The need for work place simulation should be based upon the results of a functional capacity evaluation and/or jobsite analysis.

Time Frames for Work Simulation Time to Produce Effect 2 to 6 hours per day.

Frequency 2 to 5 visits per week.

Maximum Duration 6 weeks. Participation in a program beyond 6 weeks must be documented with respect to need and the ability to facilitate positive symptomatic and functional gains.

19. THERAPY—PASSIVE:

Most of the following passive therapies and modalities are generally accepted methods of care for a variety of work-related injuries. Passive therapy includes those treatment modalities that do not require energy expenditure on the part of the patient. They are principally effective during the early phases of treatment and are directed at controlling symptoms such as pain, inflammation and swelling and to improve the rate of healing soft tissue injuries. They should be used adjunctively with active therapies such as postural stabilization and exercise programs to help control swelling, pain, and inflammation during the active rehabilitation process. Please refer to Section B.5, General Guideline Principles, Active Interventions. Passive therapies may be used intermittently as a practitioner deems appropriate or regularly if there are specific goals with objectively measured functional improvements during treatment; or if there are episodes of acute pain superimposed upon a chronic pain problem.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as "maximum.” Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care and co-morbidities may extend durations of care.

Having specific goals with objectively measured functional improvement during treatment can support extended durations of care. It is recommended that if after 6 to 8 visits no treatment effect is observed, alternative treatment interventions, further diagnostic studies or further consultations should be pursued.

The following passive therapies are listed in alphabetical order:

a. Electrical Stimulation (Unattended): low frequency transcutaneous muscle stimulator - electrical stimulation, once applied, requires minimal on-site supervision by the practitioner. Indications include pain, inflammation, muscle spasm, atrophy, decreased circulation, and the need for osteogenic stimulation.

A home unit should be purchased if treatment is effective and frequent use is Time Frames for Electrical Stimulation Time to Produce Effect 2 to 4 treatments.

Frequency Varies, depending upon indication, between 2 to 3 times per day to 1 time per week. A home unit should be purchased if treatment is effective and frequent use is recommended.

Time Frames for Electrical Stimulation Optimum and Maximum 4 treatments for clinic use.

b. Iontophoresis: is an accepted treatment which consists of the transfer of medication into superficial tissue, including, but not limited to, steroidal antiinflammatories and anesthetics, through the use of electrical stimulation.

Indications include pain (lidocaine), inflammation (hydrocortisone, salicylate, dexamethasone sodium phosphate), edema (mecholyl, hyaluronidase, and salicylate), ischemia (magnesium, mecholyl, and iodine), muscle spasm (magnesium, calcium), calcific deposits (acetate), scars and keloids (chlorine, iodine, acetate).

Time Frames for Iontophoresis Time to Produce Effect 1 to 4 treatments.

Frequency 3 times per week with at least 48 hours between treatments.

c. Low Level Laser: Not recommended as there is no proven benefit for this intervention due to lack of studies of sufficient quality. There is not enough research at this time to support this modality in the treatment of chronic pain.

Results of low level laser have been mixed and often of poor quality.

d. Manual Treatment including Manipulation: is defined as osteopathic manipulative treatment, chiropractic manipulative treatment, manual therapy, manipulation, or mobilization. Manual treatments may be applied by osteopathic physicians (DOs), chiropractors (DCs), physical therapists (PTs), occupational therapists (OTs), or medical doctors (MDs). Some popular and useful techniques include but are not limited to: high velocity, low amplitude (HVLA); muscle energy (ME) or hold-relax; strain-counterstrain (SCS); a balanced ligamentous tension (BLT); and myofascial release (MFR). Under these different types of manipulation, many subsets of different techniques that can be described as a) direct - a forceful engagement of a restrictive/pathologic barrier, b) indirect - a gentle/non-forceful disengagement of a restrictive/pathologic barrier, c) the patient actively assists in the treatment, and d) the patient relaxing, allowing the practitioner to move and balance the body tissues. When the proper diagnosis is made and coupled with the appropriate technique, manipulation has no contraindications and can be applied to all tissues of the body, including muscles, tendons, ligaments, joints, fascia, and viscera. This may consist of a variety of techniques. Pre-treatment assessment should be performed as part of each manual treatment visit to ensure that the correct diagnosis and correct treatment is employed.

The decision to refer a patient for spinal manipulation rather than for other treatments should be made on the basis of patient preference and relative safety, not on an expectation of a greater treatment effect. It may be the first line of treatment, in combination with active therapy for some patients, and should strongly be considered for patients with positive provocative testing for SI joint dysfunction or facet dysfunction who are not recovering in the first few weeks.

Manipulation may be indicated in patients who have not had an evaluation for manual medicine or who have not progressed adequately in an exercise program.

Contraindications to HVLA manipulation include joint instability, fractures, severe osteoporosis, infection, metastatic cancer, active inflammatory arthritis, aortic aneurysm, and signs of progressive neurologic deficits.

AHRQ supports use of spinal manipulation for chronic low back pain. In addition, based on multiple studies with some and good levels of evidence, there is good evidence supporting the use of manual therapy for treating chronic low back pain and chronic neck pain. There is also good evidence that supervised exercise therapy with added manual mobilization shows moderate, clinically important reductions in pain compared to non-exercise controls in people with osteoarthritis of the knee. There is not sufficient evidence to reliably determine whether manual muscle energy technique (MET) is likely to be effective in practice. See the evidence listed below for more detail on individual studies and their comparison groups.

Evidence Statements Regarding Manual Treatment for Neck Multiple sessions of thoracic manipulation was more effective in reducing short- and intermediate-term chronic neck pain and improving function and quality of life when compared with multiple sessions of an inactive control for the treatment of patients with chronic neck pain. trials and quasi RCTs A three week program of twice weekly home neck exercises with manual physical therapy that includes joint mobilization, muscle energy, and stretching, reduces neck pain and disability compared with a minimal intervention for patients with chronic neck pain at 6 weeks follow-up. It did not persist at one year follow-up.

Combination of exercise and spinal manipulation is more effective than manipulation alone in relieving chronic neck pain and that these advantages remain for more than 1 year after the end of treatment.

Craniosacral therapy for chronic nonspecific neck pain, performed by a physical therapist trained in the technique, is superior to sham treatment in reducing neck pain intensity at 8 weeks and probably at 20 weeks.

Evidence Statements Regarding Manual Treatment for Neck 12 weeks of supervised high-dose exercise, 20 sessions 1-2 times per week, with or without spinal manipulative therapy, resulted in significantly greater pain reduction in the short-term (12 weeks) compared to low-dose home exercise with advice, in people with chronic neck pain.

Disability reduction was also significantly greater.

However, the low dose group had only 2 visits with a provider which would generally be expected to diminish the outcome measurements. The effect decreased at one year follow-up.

Evidence Statements Regarding Manual Treatment for Low Back Spinal manipulative therapy (SMT) is comparable to exercise, standard medical care, and physiotherapy in reducing chronic low back pain, and SMT does not provide a clinically important superior pain relief over these interventions.

Two sessions of thrust manipulation of the thoracolumbar spine followed by an exercise regimen leads to better low back function at 6 months than oscillatory non-thrust manipulation in patients with subacute low back pain.

The study found patients with the following characteristics were likely to benefit from the program: segmental hypomobility, no symptoms distal to the knee, low fear-avoidance scores, and preservation of at least 35 degrees of internal rotation in at least one hip.

Spinal manipulation/mobilization, followed by active exercises, may be effective for the reduction of disability from nonspecific low back pain lasting more than 12 weeks. 12 sessions of spinal manipulation in 6 weeks from a chiropractor yields the most favorable pain reduction and functional disability improvement compared to a handson control in the short-term (12 weeks) for chronic nonspecific LBP. There was little difference in pain and disability scores and no clinically important differences between spinal manipulation dose groups of 6, 12, or 18 manipulations, making it difficult to recommend one treatment dose over another.

Evidence Statements Regarding Manual Treatment for Low Back 12 weeks of supervised high-dose exercise, spinal manipulative therapy, or low-dose home exercise with advice are all equally effective for reducing pain in the short- and long-term (1 year) in those who have chronic low back pain A combination of spinal manipulation and exercise is more effective than exercise alone in reducing pain and improving function of low back pain for 1 year.

Evidence Statements Regarding Manual Treatment for Knee Supervised exercise therapy with added manual mobilization shows moderate, clinically important reductions in pain compared to non-exercise controls in people with osteoarthritis of the knee.

Time Frames for Manual Treatment Including Manipulation Time to Produce Effect 6 to 9 treatments.

Frequency 1 to 3 times per week for the first 2 weeks as indicated by the severity of the condition. Treatment may continue at 1 treatment per week for the next 6 weeks.

Optimum Duration 4-6 weeks.

Maximum Duration 8 weeks. At week 8, patients should be re-evaluated.

Care beyond 8 weeks may be indicated for certain chronic pain patients in whom manipulation is helpful in improving function, decreasing pain and improving quality of life. In these cases, treatment may be continued at 1 treatment every other week until the patient has reached MMI and maintenance treatments, using the accompanying post MMI guideline, have been determined. Refer to Section I, Maintenance Management. Extended durations of care beyond what is considered “maximum” may be necessary in cases of reinjury, interrupted continuity of care, exacerbation of symptoms, and in those patients with comorbidities.

e. Manipulation Under General Anesthesia (MUA): refers to manual manipulation of the lumbar spine in combination with the use of a general anesthetic or conscious sedation. It is intended to improve the success of manipulation when pain, muscle spasm, guarding, and fibrosis appear to be limiting its application in patients otherwise suitable for their use.

There have been no high quality studies to justify its benefits given the risks of general anesthetic and conscious sedation. It is not recommended.

f. Manipulation Under Joint Anesthesia (MUJA): refers to manipulation of the lumbar spine in combination with a fluoroscopically guided injection of anesthetic with or without corticosteroid agents into the facet joint at the level being manipulated.

There are no controlled clinical trials to support its use. It is not recommended.

g. Massage—Manual or Mechanical: Massage is manipulation of soft tissue with broad ranging relaxation and circulatory benefits. This may include stimulation of acupuncture points and acupuncture channels (acupressure), application of suction cups, and techniques that include pressing, lifting, rubbing, pinching of soft tissues by or with the practitioners’ hands. Indications include edema (peripheral or hard and non-pliable edema), muscle spasm, adhesions, the need to improve peripheral circulation and range-of-motion, or to increase muscle relaxation and flexibility prior to exercise.

Evidence Statements Regarding Massage Massage therapy in combination with exercise reduces pain and improves function short-term for patients with subacute low back pain. controlled clinical trials, 10 weeks of either relaxation massage or structural massage are more effective than usual care and equally effective in improving functional disability and reducing symptoms of pain in people with chronic low back pain with benefits lasting at least 6 months.

Single-blind parallel group trial.

In the setting of chronic neck pain, 4 weeks of weekly hour-long massage leads to benefits with both pain and function, and there are incremental benefits from multiple massage sessions per week (up to 3 sessions) over a single massage session. with six intervention arms.

Time Frames for Massage Frequency 1 to 2 times per week.

Optimum Duration 6 weeks.

h. Mobilization (Soft Tissue): is a generally well-accepted treatment. Mobilization of soft tissue is the skilled application of muscle energy, strain/counter strain, myofascial release, manual trigger point release, and manual therapy techniques designed to improve or normalize movement patterns through the reduction of soft tissue pain and restrictions. Soft tissue mobilization can also use various instruments to assist the practitioner. These are typically labeled “instrument assisted soft-tissue techniques”. These can be interactive with the patient participating or can be with the patient relaxing and letting the practitioner move the body tissues. Indications include muscle spasm around a joint, trigger points, adhesions, and neural compression. Mobilization should be accompanied by active therapy.

Time Frames for Mobilization (Soft Tissue)

Time to Produce Effect 4 to 9 treatments.

Frequency Up to 3 times per week.

i. Percutaneous Electrical Nerve Stimulation (PENS): Needles are used to deliver low-voltage electrical current under the skin. Theoretically this therapy prevents pain signals traveling through small nerve fibers from reaching the brain, similar to the theory of TENS.

There is good evidence that PENS produces improvement of pain and function compared to placebo; however, there is no evidence that the effect is prolonged after the initial 3 week treatment episode. There are no well done studies that show PENS performs better than TENS for chronic pain patients. PENS is more invasive, requires a trained health care provider and has no clear long-term effect; therefore it is not generally recommended.

Time Frames for Percutaneous Electrical Nerve Stimulation (PENS)

Time to Produce Effect 1 to 4 treatments.

Optimum Duration 9 sessions.

Maximum Duration 12 sessions per year.

j. Superficial Heat and Cold Therapy (Including Infrared Therapy): is a generally accepted treatment. Superficial heat and cold are thermal agents applied in various manners that lower or raise the body tissue temperature for the reduction of pain, inflammation, and/or effusion resulting from injury or induced by exercise. Includes application of heat just above the surface of the skin at acupuncture points. Indications include acute pain, edema and hemorrhage, need to increase pain threshold, reduce muscle spasm, and promote stretching/flexibility. Cold and heat packs can be used at home as an extension of therapy in the clinic setting.

Time Frames for Superficial Heat & Cold Therapy (Including Infrared Therapy)

Frequency 2 to 5 times per week.

Optimum Duration 3 weeks as primary or intermittently as an adjunct to other therapeutic procedures up to 2 months.

k. Traction—Manual: is an accepted treatment and an integral part of manual manipulation or joint mobilization. Indications include decreased joint space, muscle spasm around joints, and the need for increased synovial nutrition and response. Manual traction is contraindicated in patients with tumor, infection, fracture, or fracture dislocation.

Time Frames for Manual Traction Time to Produce Effect 1 to 3 sessions. 1 month.

l. Traction—Mechanical: Mechanical traction is indicated for decreased joint space, muscle spasm around joints, and the need for increased synovial nutrition and response. Traction modalities are contraindicated in patients with tumor, infections, fracture, or fracture dislocation. Non-oscillating inversion traction methods are contraindicated in patients with glaucoma or hypertension.

There is some evidence that mechanical traction, using specific, instrumented axial distraction technique, is not more effective than active graded therapy without mechanical traction. Therefore, mechanical traction is not recommended for chronic axial spine pain.

Time Frames for Mechanical Traction Time to Produce Effect 1 to 3 sessions up to 30 minutes. If response is negative after 3 treatments, discontinue this modality. 1 month.

m. Transcutaneous Electrical Nerve Stimulation (TENS): should include least one instructional session for proper application and use. Indications include muscle spasm, atrophy, and decreased circulation and pain control. Minimal TENS unit parameters should include pulse rate, pulse width, and amplitude modulation.

One double-blinded, placebo-controlled study, found that low frequency TENS induces analgesia which is detected on functional MRI with change in brain activity in multiple regions. There was no functional follow-up. High-frequency TENS may be more effective than low frequency for patients on opioids.

Time Frames for Transcutaneous Electrical Nerve Stimulation (TENS)

Frequency Variable.

Optimum Duration 3 sessions. If beneficial, provide with home unit.

Maximum Duration 3 sessions. Purchase if effective.

n. Trigger Point Dry Needling (TDN): Description: TDN is a skilled intervention performed by physical therapists that utilizes a solid filament needle to penetrate the skin and underlying tissues to treat relevant muscular, neural, and other connective tissues for the evaluation and management of neuromusculokeletal conditions, pain, movement impairments, and disability. The technique can be done with or without electrical stimulation. It has been used for tendinopathies, headaches and occipital neuralgia, plantar fasciitis, shoulder pain, lateral epicondylalgia, spinal pain, hip and knee pain. The goal of dry needling is to improve overall function and disability by decreasing pain and improving rangeof-motion, strength, and/or muscle firing patterns. It is a technique that is utilized in conjunction with other physical therapy treatments including therapeutic exercise, manual therapy, stretching, neuromuscular re-education, postural education, and pain neuroscience education.

Indications: Trigger point dry needling is indicated when myofascial trigger points are identified in muscles in conjunction with decreased range-of-motion, decreased strength, altered muscle firing patterns, and/or pain which negatively affect a patient’s overall function.

Complications: Potential but rare complications of dry needling include infection and pneumothorax. Severe pain on injection suggests the possibility of an intraneural injection, and the needle should be immediately repositioned.

There is some evidence that the inclusion of 2 sessions of trigger point dry needling into a twice daily 5-week exercise program was significantly more effective in improving shoulder pain-related disability than an exercise program alone at 3, 6, and 12 month follow-ups in people with chronic subacromial pain syndrome. Both interventions were equally effective in reducing pain over 12 There is some evidence that 4 sessions of trigger point deep dry needling with passive stretching over 2 weeks was significantly more effective in reducing neck pain and improving neck disability than passive stretching alone in the short-term and at 6-month follow-up in people with chronic nonspecific neck pain.

Based on a number of meta-analysis and systematic reviews, studies have shown some advantage for dry needling. However, there are also a number of studies with negative results. Because of the low quality of studies and heterogeneity, no form of evidence can be drawn from these reviews, which include a number of anatomic sites.

Time Frames for Trigger Point Dry Needling (TDN)

Time to Produce Effect Immediately or up to 4 visits.

Frequency 1 to 2 sessions/week normally limited to 4 muscle groups.

Optimum Duration 4 treatments.

Maximum Duration 8 treatments.

o. Ultrasound (Including Phonophoresis): is an accepted treatment which uses sonic generators to deliver acoustic energy for therapeutic thermal and/or nonthermal soft tissue effects. Indications include scar tissue, adhesions, collagen fiber, and muscle spasm, and the need to extend muscle tissue or accelerate the soft tissue healing. Ultrasound with electrical stimulation is concurrent delivery of electrical energy that involves dispersive electrode placement. Indications include muscle spasm, scar tissue, pain modulation, and muscle facilitation.

Phonophoresis is the transfer of medication to the target tissue to control inflammation and pain through the use of sonic generators. These topical medications include, but are not limited to, steroidal anti-inflammatory, and anesthetics.

There is no high quality evidence to support the use of ultrasound for improving pain or quality of life in patients with non-specific chronic low back pain.

Time Frames for Ultrasound (Including Phonophoresis)

Time to Produce Effect 6 to 15 treatments.

Frequency 3 times per week.

p. Vertebral Axial Decompression (VAX-D)/DRX, 9000: Motorized traction devices which purport to produce non-surgical disc decompression by creating negative intradiscal pressure in the disc space include devices with the trade names of VAX-D and DRX 9000.

There are no good studies to support their use. They are not recommended.

H. THERAPEUTIC PROCEDURES – OPERATIVE

When considering operative intervention in chronic pain management, the treating physician must carefully consider the inherent risk and benefit of the procedure. All operative intervention should be based on a positive correlation with clinical findings, the clinical course, and diagnostic tests. A comprehensive assessment of these factors should have led to a specific diagnosis with positive identification of the pathologic condition. Operative treatment is indicated when the natural history of surgically treated lesions is better than the natural history for non-operatively treated lesions.

Surgical procedures are seldom meant to be curative and should be employed in conjunction with other treatment modalities for maximum functional benefit. Functional benefit should be objectively measured and includes the following:

• Return-to-work or maintaining work status.

• Fewer restrictions at work or performing activities of daily living.

• Decrease in usage of medications prescribed for the work-related injury.

• Measurable functional gains, such as increased range-of-motion or a documented increase in strength.

Education of the patient should include the proposed goals of the surgery, expected gains, risks or complications, and alternative treatment.

Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and be provided with appropriate counseling by the physician. If a treating physician recommends a specific smoking cessation program peri-operatively, this should be covered by the insurer. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels. The surgeon will make the final determination as to whether smoking cessation is required prior to surgery. Similarly, patients with uncontrolled diabetes are at increased risk of post-operative infection and poor wound healing. It is recommended that routine lab work prior to any surgical intervention include a hemoglobin A1c. If it is higher than the recommended range, the surgery should be postponed until optimization of blood sugars has been achieved.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work activities, and the patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partialand full-disability expected post-operatively.

1. NEUROSTIMULATION

a. Description: Spinal cord stimulation (SCS) is the delivery of low-voltage electrical stimulation to the spinal cord or peripheral nerves to inhibit or block the sensation of pain. The system uses implanted electrical leads and a battery powered implanted pulse generator (IPG).

There is some evidence that SCS is superior to reoperation in the setting of persistent radicular pain after lumbosacral spine surgery, and there is some evidence that SCS is superior to conventional medical management in the same setting. Success was defined as achieving 50% or more pain relief. However, the study could not demonstrate increased return to work. Some functional gains have been demonstrated. These findings may persist at 3 years of follow-up in patients who had an excellent initial response and who are highly motivated.

There is some evidence that a high-frequency, 10 KHz spinal cord stimulator is more effective than a traditional low frequency 50 Hz stimulator in reducing both back pain and leg pain in patients who have had a successful trial of an external stimulator. Two-thirds of the patients had radiculopathy and one-half had predominant back pain. The high frequency device appears to lead to greater patient satisfaction than the low frequency device, which is likely to be related to the fact that the high frequency device does not produce paresthesias in order to produce a pain response. In contrast to the low frequency stimulator, which requires recharging about twice per month, the high frequency stimulator is recommended for daily recharging for 30 to 45 minutes. A United Kingdom study of cost effectiveness for high frequency spinal cord stimulators found high cost effectiveness compared to traditional non-rechargeable or rechargeable stimulators, re-operation, or medical management.

Some evidence shows that SCS is superior to re-operation and conventional medical management for severely disabled patients who have failed conventional treatment and have Complex Regional Pain Syndrome (CRPS I) or failed back surgery with persistent radicular neuropathic pain.

A recent randomized trial found that patients with spinal cord stimulators for CRPS preferred different types and levels of stimulation for pain relief. No difference was found between 40,500 and 1200 Hz levels or burst stimulation.

SCS can be used for patients who have CRPS II. Spinal cord stimulation for spinal axial pain has traditionally not been very successful. It is possible that future technological advances such as high frequency and burst stimulation may demonstrate better results for axial spine pain. Currently, traditional spinal cord stimulators are not recommended for axial spine pain.

SCS may be most effective in patients with CRPS I or II who have not achieved relief with oral medications, rehabilitation therapy, or therapeutic nerve blocks, and in whom the pain has persisted for longer than 6 months.

It is particularly important that patients meet all of the indications before a permanent neurostimulator is placed because several studies have shown that workers’ compensation patients are less likely to gain significant relief than other patients. As of the time of this guideline writing, spinal cord stimulation devices have been FDA approved as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral and bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.

Particular technical expertise is required to perform this procedure and is available in some neurosurgical, rehabilitation, and anesthesiology training programs and fellowships. Physicians performing this procedure must be trained in neurostimulation implantation and participate in ongoing training workshops on this subject, such as those sponsored by the Spine Intervention Society (SIS), North American Neuromodulation Society (NANS), or as sponsored by implant manufacturers. Permanent electrical lead and IPG placement should be performed by surgeons (orthopedic or neurosurgery) with fellowship training in spine based surgical interventions or other physicians who have completed an Accreditation Council for Graduate Medical Education (ACGME) accredited pain medicine fellowship and have completed the required number of supervised implantations during fellowship.

b. Complications: Serious, less common complications include spinal cord compression, paraplegia, epidural hematoma, epidural hemorrhage, undesirable change in stimulation, seroma, CSF leakage, infection, erosion, and allergic response. Other complications consist of dural puncture, hardware malfunction or equipment migration, pain at implantation site, loss of pain relief, chest wall stimulation, and other surgical risks. In recent studies, device complication rates have been reported to be 25% at 6 months, 32% at 12 months, and 45% at 24 months. The most frequent complications are reported to be electrode migration (14%) and loss of paresthesia (12%), up to 24% required additional surgery. In a recent review of spinal stimulation, 34.6% of all patients reported a complication, most of them being technical equipment-related issues or undesirable stimulation.

c. Surgical Indications: Patients with established CRPS I or II or a failed spinal surgery with persistent functionally limiting radicular pain greater than axial pain who have failed conservative therapy including active and/or passive therapy, pre-stimulator trial psychiatric evaluation and treatment, medication management, and therapeutic injections. Traditional SCS is not recommended for patients with the major limiting factor of persistent axial spine pain. High frequency stimulators may be used for patients with predominantly axial back pain. Traditional or other SCS may be indicated in a subset of patients who have a clear neuropathic radicular pain (radiculitis) with or without previous surgery.

The extremity pain should account for at least 50% or greater of the overall back and leg pain experienced by the patient. Prior authorization is required.

Habituation to opioid analgesics in the absence of a history of addictive behavior does not preclude the use of SCS. Patients with severe psychiatric disorders, issues of secondary gain, and one or more primary risk factors are not candidates for the procedure. The prognosis worsens as the number of secondary risk factors increases. Approximately, one third to one half of patients who qualify for SCS can expect a substantial long-lasting pain relief; however, it may not influence allodynia and hypesthesia. Patients’ expectations need to be realistic, and therefore, patients should understand that the SCS intervention is not a cure for their pain but rather a masking of their symptomatology which might regress over time. There appears to be a likely benefit of up to 3 years, although some practitioners have seen benefits persist for longer periods.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work, as well as possible complications. The patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

Informed decision making should be documented for all invasive procedures.

This must include a thorough discussion of the pros and cons of the procedure and the possible complications as well as the natural history of the identified diagnosis. Since many patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and be provided with appropriate counseling by the physician. If a treating physician recommends a specific smoking cessation program peri-operatively, this should be covered by the insurer. Typically the patient should show some progress toward cessation at about 6 weeks. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels. The surgeon will make the final determination as to whether smoking cessation is required prior to surgery. Patients with demonstrated success may continue the program up to 3 months or longer if needed based on the operative procedure. Smoking cessation should continue throughout the post-operative period. Refer to Section G.10.j, Smoking Cessation Medications and Treatment, for further details.

Patients must meet the following criteria in order to be considered for neurostimulation:

i. Traditional or other SCS may be indicated in a subset of patients who have a clear neuropathic radicular pain (radiculitis); are not candidates for surgical intervention on the spine; have burning pain in a distribution amenable to stimulation coverage and have pain at night not relieved by position. The extremity pain should account for at least 50% or greater of the overall leg and back pain experienced by the patient. High frequency stimulators may be used for patients with predominantly axial back pain.

ii. Prior to the stimulator trial, a comprehensive psychiatric or psychological evaluation, for a chronic pain evaluation. Refer to Section F.2, Personality/Psychological Evaluation for Pain Management, for more information. This evaluation should include a standardized detailed personality inventory with validity scales (e.g., MMPI-2, MMPI-2-RF, or PAI); pain inventory with validity measures (e.g., BHI 2, MBMD); clinical interview and complete review of the medical records. The psychologist or psychiatrist performing these evaluations should not be an employee of the physician performing the implantation. This evaluation must be completed, with favorable findings, before the screening trial is scheduled. Before proceeding to a spinal stimulator trial, the evaluation should find the following:

• No indication of falsifying information.

• No indication of invalid results on testing; and • No primary psychiatric risk factors or “red flags” (e.g., psychosis, active suicidality, severe depression, or addiction). (Note that tolerance and dependence to opioid analgesics are not addictive behaviors and do not preclude implantation); and • A level of secondary risk actors or “yellow flags” (e.g., moderate depression, job dissatisfaction, dysfunctional pain conditions) judged to be below the threshold for compromising the patient’s ability to benefit from neurostimulation.

• The patient is cognitively capable of understanding and operating the neurostimulation control device; and • The patient is cognitively capable of understanding and appreciating the risks and benefits of the procedure; and • The patient is familiar with the implications of having an implant, can accept the complications, potential disfigurement, and effort it takes to maintain the device; and • The patient is cognitively capable of understanding the course of injury both with and without neurostimulation; and • The patient has demonstrated a history of motivation in and adherence to prescribed treatments; and • The patient understands the work related restrictions that may occur with placement of the stimulator. All reasonable surgical and non-surgical treatment has been exhausted; and • The topography of pain and its underlying pathophysiology are amenable to stimulation coverage (the entire painful area has been covered); and • A successful neurostimulation screening test of at least 5 to 7 days.

iii. For a spinal cord neurostimulation screening test, a temporary lead is implanted at the level of pain and attached to an external source to validate therapy effectiveness. A screening test is considered successful if the patient meets both of the following criteria: (a) experiences a 50% decrease radicular or CRPS in pain, which may be confirmed by visual analogue scale (VAS) or Numerical Rating Scale (NRS), and (b) demonstrates objective functional gains or decreased utilization of pain medications.

Objective, measurable, functional gains must be evaluated by an independent occupational therapist, not affiliated with the physician performing the screening or the implant of the stimulator, and/or physical therapist and the primary treating physician prior to and before discontinuation of the trial. Functional gains may include: standing, walking, positional tolerance, upper extremity activities, increased social participation, or decreased medication use.

d. Contraindications:

• Unsuccessful SCS test: inability to obtain objective, documented, functional improvement, or reduction of pain.

• Those with cardiac pacemakers should be evaluated on an individual

basis as some may qualify for surgery.

• Patients who are unable to properly operate the system.

• Patients who are anti-coagulated and cannot be without anticoagulation for a few days (e.g., patients with artificial heart valves).

• Patients with frequent severe infections.

• Patients for whom a future MRI is planned unless the manufacturer has approval for the body part that will be the subject of the MRI.

e. Operative Treatment: Implantation of stimulating leads connected by extensions to either an implanted neurostimulator or an implanted receiver powered by an external transmitter. The procedure may be performed either as an open or a percutaneous procedure, depending on the presence of epidural fibrosis and the anatomical placement required for optimal efficacy. During the final procedure for non-high frequency devices, the patient must be awakened to establish full coverage from the placement of the lead. One of the most common failures is misplaced leads. Functional improvement is anticipated for up to 3 years or longer when objective functional improvement has been observed during the time of neurostimulation screening exam.

f. Post-operative Considerations:

• MRI may be contraindicated depending on the model and implant location.

• Work restrictions postplacement include no driving when active paresthesias are present. This does not apply to high frequency stimulators as no paresthesia is present. Thus, use of potentially dangerous or heavy equipment while the simulator is active is prohibited.

The physician may also limit heavy physical labor.

g. Post-operative Therapy: Active and/or passive therapy should be employed to improve function. Implantable stimulators will require frequent monitoring such as adjustment of the unit and replacement of batteries. Estimated battery life of SCS implantable devices is usually 5 – 10 years depending on the manufacturer.

Evidence Statements Regarding Neurostimulation SCS is superior to reoperation in the setting of persistent radicular pain after lumbosacral spine surgery. Success was defined as achieving 50% or more pain relief.

SCS is superior to conventional medical management in the setting of persistent radicular pain after lumbosacral spine surgery. Success was defined as achieving 50% or more pain relief. However, the study could not demonstrate increased return to work.

Evidence Statements Regarding Neurostimulation A high-frequency, 10 KHz spinal cord stimulator is more effective than a traditional low frequency 50 Hz stimulator in reducing both back pain and leg pain in patients who have had a successful trial of an external stimulator.

Two-thirds of the patients had radiculopathy and one-half had predominant back pain. The high frequency device appears to lead to greater patient satisfaction than the low frequency device, which is likely to be related to the fact that the high frequency device does not produce paresthesias in order to produce a pain response. In contrast to the low frequency stimulator, which requires recharging about twice per month, the high frequency stimulator is recommended for daily recharging for 30 to 45 minutes.

The study was designed as a non-inferiority study for the experimental SCS system, and testing for superiority was done if the non-inferiority margins were met for the outcomes under consideration.

SCS is superior to re-operation and conventional medical management for severely disabled patients who have failed conventional treatment and have CRPS I or failed back surgery with persistent radicular neuropathic pain.

2. DORSAL ROOT GANGLION STIMULATOR

There are currently no studies qualifying for evidence regarding chronic pain patients.

Please refer to the Division’s CRPS Medical Treatment Guideline for more information.

3. PERIPHERAL NERVE STIMULATION

There are no randomized controlled studies for this treatment. This modality should only be employed with a clear nerve injury or when the majority of pain is clearly in a nerve distribution in patients who have completed 6 months of other appropriate therapy including the same pre-trial psychosocial evaluation and treatment as are recommended for spinal cord stimulation. A screening trial should take place over 3 to 7 days and is considered successful if the patient meets both of the following criteria: (a) experiences a 50% decrease in pain, which may be confirmed by Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) and (b) demonstrates objective functional gains or decreased utilization of pain medications. Objective, measurable, functional gains must be evaluated by an independent occupational therapist and/or physical therapist and the primary treating physician prior to and before discontinuation of the trial. The primary treating doctor is not the doctor who placed the nerve stimulator. It may be used for proven occipital, ulnar, median, and other isolated nerve injuries.

4. INTRATHECAL DRUG DELIVERY

Not generally recommended. Requires prior authorization. Due to conflicting studies in this population and complication rate for long-term use, it may be considered only in very rare occasions when dystonia and spasticity are dominant features or when pain is not able to be managed using any other non-operative treatment. Specific brands of infusion systems have been FDA approved for the following: chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of baclofen for the management of severe spasticity.

Due to lack of proven efficacy and safety, the following medications are not recommended: magnesium, benzodiazepines, neostigmine, tramadol, and ketamine.

a. Description: This mode of therapy delivers small doses of medications directly into the cerebrospinal fluid.

b. Complications: Intrathecal delivery is associated with significant complications, such as infection, catheter disconnects, CSF leak, arachnoiditis, pump failure, nerve injury, and paralysis.

Typical adverse events reported with opioids (i.e., respiratory depression, tolerance, and dependence) or spinal catheter-tip granulomas that might arise during intrathecal morphine or hydromorphone treatment have not currently been recorded for ziconotide. The most common presentation of an intraspinal mass is a sudden increase in dosage required for pain relief, with new neurologic defects secondary to a mass effect. Technical errors can lead to drug overdose which can be life-threatening.

Surveys have shown technical problems requiring surgical correction in 18% to 40% of patients. CSF leakage may occur with multiple dural punctures. Since the needle is larger than the spinal catheter, there may be incomplete tissue sealing around the catheter. The function of the pump depends on its electronic power source, which may be disrupted by the magnet of an MRI; therefore, after the patient has an MRI, the pump should be checked to ensure that it does not need to be restarted. The delivery rate can be affected by atmospheric pressure and body temperature.

c. Indications: Clinical studies are conflicting, regarding long-term, effective pain relief in patients with non-malignant pain. The Division does not generally recommend the use of intrathecal drug delivery systems in injured workers with chronic pain. Due to the complication rate for long-term use, it may be considered only in very rare occasions when dystonia and spasticity are dominant features or when pain is not able to be managed using any other nonoperative treatment. This treatment must be prior authorized and have the recommendation of at least one physician experienced in chronic pain management in consultation with the primary treating physician. The procedure should be performed by physicians with documented experience.

Prior to surgical intervention, the patient and treating physician should identify functional operative goals and the likelihood of achieving improved ability to perform activities of daily living or work, as well as possible complications. The patient should agree to comply with the pre- and post-operative treatment plan including home exercise. The provider should be especially careful to make sure the patient understands the amount of post-operative therapy required and the length of partial- and full-disability expected post-operatively.

Informed decision making should be documented for all invasive procedures.

This must include a thorough discussion of the pros and cons of the procedure and the possible complications as well as the natural history of the identified diagnosis. Since many patients with the most common conditions will improve significantly over time, without invasive interventions, patients must be able to make well-informed decisions regarding their treatment.

Smoking may affect soft tissue healing through tissue hypoxia. Patients should be strongly encouraged to stop smoking and be provided with appropriate counseling by the physician. If a treating physician recommends a specific smoking cessation program peri-operatively, this should be covered by the insurer. Typically the patient should show some progress toward cessation at about 6 weeks. Physicians may monitor smoking cessation with laboratory tests such as cotinine levels. The surgeon will make the final determination as to whether smoking cessation is required prior to surgery. Patients with demonstrated success may continue the program up to 3 months or longer if needed based on the operative procedure. Refer to Section G.10.j, Smoking Cessation Medications and Treatment, for further details.

This small eligible sub-group of patients must meet all of the following indications:

i. A diagnosis of a specific physical condition known to be chronically painful has been made on the basis of objective findings; and ii. All reasonable surgical and non-surgical treatment has been exhausted including failure of conservative therapy including active and/or passive therapy, medication management, or therapeutic injections; and iii. Pre-trial psychiatric or psychological evaluation has been performed (same as for SCS); and iv. There is no evidence of current addictive behavior. (Tolerance and dependence to opioid analgesics are not addictive behaviors and do not preclude implantation); and v. It is recommended that most patients be tapered off of opioids before the trial; and vi. A successful trial of continuous infusion by a percutaneous spinal infusion pump for a minimum of 24 hours or by bolus infusion. A screening test is considered successful if the patient (a) experiences a 50% decrease in pain, which may be confirmed by VAS, and (b) demonstrates objective functional gains or decreased utilization of pain medications. Functional gains should be evaluated by an occupational therapist and/or physical therapist prior to and before discontinuation of the trial.

d. Contraindications: Infection, body size insufficient to support the size and weight of the implanted device. Patients with other implanted programmable devices should be given these pumps with caution since interference between devices may cause unintended changes in infusion rates.

5. NEUROABLATION WITH RHIZOTOMY AS THE EXCEPTION

Neuroablation or neuro-destructive procedures are not commonly used in the management of non-malignant pain. These techniques require specific expertise to perform, have erratic results, and high rates of complication. Therefore, the use of neuroablative procedures is not recommended, except medial branch nerve rhizotomy, for injured workers with chronic pain.

6. DORSAL NERVE ROOT RESECTION

This procedure is not recommended. There exists the possibility of complications including unintended extensive nerve damage causing significant motor or sensibility changes from larger than anticipated lesioning of the ganglia at the dorsal ganglia level.

For radio-frequency ablation refer to Section G.8.d, Radio Frequency Ablation - Dorsal Nerve Root Ganglion.

I. MAINTENANCE MANAGEMENT

Successful management of chronic pain conditions results in fewer relapses requiring intense medical care. Failure to address long-term management as part of the overall treatment program may lead to higher costs and greater dependence on the health care system. Management of CPD continues after the patient has met the definition of maximum medical improvement (MMI).

MMI is declared when a patient’s condition has plateaued and an authorized treating physician believes no further medical intervention is likely to result in improved function. When the patient has reached MMI, a physician must describe in detail the maintenance treatment.

Maintenance care in CPD requires a close working relationship between the carrier, the providers, and the patient. Providers and patients have an obligation to design a cost-effective, medically appropriate program that is predictable and allows the carrier to set aside appropriate reserves. Carriers and adjusters have an obligation to assure that medical providers can design medically appropriate programs. Designating a primary physician for maintenance management is strongly recommended.

Maintenance care will be based on principles of patient self-management. When developing a maintenance plan of care, the patient, physician, and insurer should attempt to meet the following goals:

• Maximal independence will be achieved through the use of home exercise programs or exercise programs requiring special facilities (e.g., pool, health club) and educational programs;

• Modalities will emphasize self-management and self-applied treatment;

• Management of pain or injury exacerbations will emphasize initiation of active therapy techniques and may occasionally require anesthetic injection blocks.

• Dependence on treatment provided by practitioners other than an authorized treating physician will be minimized;

• Reassessment of the patient’s function must occur regularly to maintain daily living activities and work function;

• Patients will understand that failure to comply with the elements of the self-management program or therapeutic plan of care may affect consideration of other interventions.

It is recommended that valid functional tests are used with treatments to track efficacy. The following are Specific Maintenance Interventions and Parameters:

1. HOME EXERCISE PROGRAMS AND EXERCISE EQUIPMENT: Most patients have the ability to participate in a home exercise program after completion of a supervised exercise rehabilitation program. Programs should incorporate an exercise prescription including the continuation of an age-adjusted and diagnosis-specific program for aerobic conditioning, flexibility, stabilization, and strength. Many patients will benefit from several booster sessions per year, which may include motivational interviewing and graded activity.

Some patients may benefit from the purchase or rental of equipment to maintain a home exercise program. Determination for the need of home equipment should be based on medical necessity to maintain MMI, compliance with an independent exercise program, and reasonable cost. Before the purchase or long-term rental of equipment, the patient should be able to demonstrate the proper use and effectiveness of the equipment.

Effectiveness of equipment should be evaluated on its ability to improve or maintain functional areas related to activities of daily living or work activity. Home exercise programs are most effective when done 3 to 5 times a week. Prior to purchasing the equipment a therapist and/or exercise specialist who has treated the patient should visit a facility with the patient to assure proper use of the equipment. Occasionally, compliance evaluations may be made through a 4 week membership at a facility offering similar equipment.

2. EXERCISE PROGRAMS REQUIRING SPECIAL FACILITIES: Some patients may have higher compliance with an independent exercise program at a health club versus participation in a home program. All exercise programs completed through a health club facility should focus on the same parameters of an age-adjusted and diagnosis-specific program for aerobic conditioning, flexibility, stabilization, and strength. Prior to purchasing a membership, a therapist and/or exercise specialist who has treated the patient should visit a facility with the patient to assure proper use of the equipment. Selection of health club facilities should be limited to those able to track attendance and utilization, and provide records available for physician and insurer review.

Time Frames for Exercise Programs Requiring Special Facilities Maximum 3 months. Continuation beyond 3 months should be based on functional benefit and patient compliance. Health club membership should not extend beyond 3 months if attendance drops below 2 times per week on a regular

basis.

3. PATIENT EDUCATION MANAGEMENT: Educational classes, sessions, or programs may be necessary to reinforce self-management techniques. This may be performed as formal or informal programs, either group or individual Time Frames for Patient Education Management 2 to 6 educational visits during one 12 month period.

4. PSYCHOLOGICAL MANAGEMENT: An ideal maintenance program will emphasize management options implemented in the following order: (a) individual self-management (pain control, relaxation, and stress management, etc.), (b) group counseling, (c) individual counseling by a psychologist or psychiatrist, and (d) inpatient treatment.

Exacerbation of the injury may require psychological treatment to restore the patient to baseline. In those cases, use treatments and time frame parameters listed in the Biofeedback and Psychological Evaluation or Intervention sections.

Time Frames for Psychological Management 6 to 10 visits during the first year and 4 to 6 visits per year thereafter. In cases of significant exacerbation or complexity, refer to Section G.15, on psychological treatment.

5. NON OPIOID MEDICATION MANAGEMENT: In some cases, self-management of pain and injury exacerbations can be handled with medications, such as those listed in the Medication section. Physicians must follow patients who are on any chronic medication or prescription regimen for efficacy and side effects. Laboratory or other testing may be appropriate to monitor medication effects on organ function.

Time Frames for Non Opioid Medication Management Usually, 4 medication reviews within a 12 month period. Frequency depends on the medications prescribed. Laboratory and other monitoring as appropriate.

6. OPIOID MEDICATION MANAGEMENT: In very selective cases, scheduled opioids may prove to be the most cost effective means of ensuring the highest function and quality of life; however, inappropriate selection of these patients may result in a high degree of iatrogenic illness including addiction and drug overdose. A patient should have met the criteria in the opioids section of this guideline before beginning maintenance opioids.

Laboratory or other testing may be appropriate to monitor medication effects on organ function. The following management is suggested for maintenance opioids:

• The medications should be clearly linked to improvement of function, not just pain control. All follow-up visits should document the patient’s ability to perform routine functions satisfactorily. Examples include the abilities to perform: work tasks, drive safely, pay bills or perform basic math operations, remain alert and upright for 10 hours per day, or participate in normal family and social activities. If the patient is not maintaining reasonable levels of activity the patient should usually be tapered from the opioid and tried on a different long-acting opioid.

• A lower risk opioid medication regimen is defined as less than 50 MME per day.

This may minimally increase or decrease over time. Dosages will need to be adjusted based on side effects of the medication and objective function of the patient. A patient may frequently be maintained on non-opioid medications to control side effects, treat mood disorders, or control neuropathic pain; however, only one long-acting opioid and one short-acting opioid for rescue use should be prescribed. Buccally absorbed opioids other than buprenorphine are not appropriate for these non-malignant pain patients. Transdermal opioid medications are not recommended, other than buprenorphine.

• All patients on chronic opioid medication dosages need to sign an appropriate opioid contract with their physician for prescribing the opioids.

• The patient must understand that continuation of the medication is contingent on their cooperation with the maintenance program. Use of non-prescribed drugs may result in tapering of the medication. The clinician should order random drug testing at least annually and when deemed appropriate to monitor medication compliance.

• Patients on chronic opioid medication dosages must receive them through one prescribing physician.

Time Frames for Opioid Medication Management Maintenance Duration 12 visits within a 12 month period to review the opioid plan. Laboratory and other monitoring, as appropriate.

7. THERAPY MANAGEMENT: Some treatment may be helpful on a continued basis during maintenance care if the therapy maintains objective function and decreases medication use. With good management, exacerbations should be uncommon; not exceeding 2 times per year and using minimal or no treatment modality beyond self-management. On occasion, exacerbated conditions may warrant durations of treatment beyond those listed below. Having specific goals with objectively measured functional improvement during treatment can support extended durations of care. It is recommended that if after 6 to 8 visits no treatment effect is observed, alternative treatment interventions should be pursued.

Time Frames for Therapy Management Maintenance Duration Active therapy, acupuncture, or manipulation: 10 visits [for each treatment] during the first year and then decreased to 5 visits per year thereafter.

8. INJECTION THERAPY:

a. Trigger Point Injections and Dry Needling: These injections or dry needling may occasionally be necessary to maintain function in those with myofascial problems.

Time Frames for Injection Therapy: Trigger Point Injections and Dry Needling Maintenance Duration Not more than 4 injections per session not to exceed 4 sessions per 12 month period.

b. Epidural and Selective Nerve Root Injections: Patients who have experienced functional benefits from these injections in the past may require injection for exacerbations of the condition. Recall that the total steroid injections at all sites, including extremities, should be limited to 4 per year to avoid side effects from steroids.

Time Frames for Epidural and Selective Nerve Root Injections Maintenance Duration 2 to 4 injections per 12 month period. For chronic radiculopathy, injections may be repeated only when a functional documented response lasts for 3 months. A positive result would include a return to baseline function as established at MMI, return to increased work duties, and measurable improvement in physical activity goals including return to baseline after an exacerbation. Injections may only be repeated when these functional and time goals are met and verified by the designated primary physician. Patient completed functional questionnaires such as those recommended by the Division as part of QPOP and/or the Patient Specific Functional Scale can provide useful additional confirmation.

Time Frames for Zygapophyseal (Facet) Injections Maintenance Duration 2 injections per year and limited to 3 joint levels either unilaterally or bilaterally. Injections may be repeated only when a functional documented response lasts for 3 months. A positive result would include a return to baseline function as established at MMI, return to increased work duties, and a measurable improvement in physical activity goals including return to baseline after an exacerbation. Injections may only be repeated when these functional and time goals are met and verified by the designated primary physician. Patient completed functional questionnaires such as those recommended by the Division as part of QPOP and/or the Patient Specific Time Frames for Sacro-iliac Joint Injections Maintenance Duration 2 per year injections may be repeated only if a functional documented response lasts for 3 months. A positive result would include a return to baseline function as established at MMI, return to increased work duties, and a measurable improvement in physical activity goals including return to baseline after an exacerbation. Injections may only be repeated when these functional and time goals are met and verified by the designated primary physician. Patient completed functional questionnaires such as those recommended by the Division as part of QPOP and/or the Patient Specific Time Frames for Radiofrequency Medial Branch Neurotomy/ Facet Rhizotomy Maintenance Duration: 1 time per year not exceeding 3 levels, up to 12 total in a lifetime. The patient must meet the criteria as described in Section G.8.f, Radio Frequency Denervation. The initial indications including repeat blocks and limitations apply. The long-term effects of repeat rhizotomies, especially on younger patients are unknown. There is a possibility that repeated denervation could result in premature degenerative changes. In addition the patient should always reconsider all of the possible permanent complications before consenting to a repeat procedure. There are no studies addressing the total number of RF neurotomies that should be done for a patient. Patient should receive at least 6 to 18 months minimum improvement in order to qualify for repeat procedures.

Maintenance Duration Twice in the first year after the initial rhizotomy and once a year after up to 12 total.

9. PURCHASE OR RENTAL OF DURABLE MEDICAL EQUIPMENT (DME): It is recognized that some patients may require ongoing use of self-directed modalities for the

purpose of maintaining function and/or analgesic effect. Purchase or rental of modality based equipment should be done only if the assessment by the physician and/or physical/occupational therapist has determined the effectiveness, compliance, and improved or maintained function by its application. It is generally felt that large expense purchases such as spas, whirlpools, and special mattresses are not necessary to maintain function.

Refer to Rule 18-6(H) for DME rental time frames.

APPENDIX: DESCRIPTION OF TESTS OF PSYCHOLOGICAL FUNCTIONING

Refer to Section F.2.c, Tests of Psychological Functioning, for more information. Examples of frequently used psychometric tests performed include, but are not limited to, the following:

1. Comprehensive Inventories for Medical Patients:

a. Battery for Health Improvement, 2 Edition (BHI What it measures – Depression, anxiety, and hostility; violent and suicidal ideation; borderline, dependency, chronic maladjustment, substance abuse, conflicts with work, family and physician, pain preoccupation, somatization, perception of functioning, catastrophizing and kinesiophobia, and risk assessment for surgery, physical rehabilitation, and abuse of prescription medication. substantially to the design of interventions and to the understanding of psychosocial factors underlying pain reports, perceived disability, and somatic preoccupation. Serial administrations can track changes in a broad range of variables during the course of treatment and assess outcome.

Characteristics – Standardized test normalized on patients with chronic pain or injury and on community members, with reference groups for six other subcategories of injured patients.

b. Millon Behavioral Medical Diagnostic (MBMD ).

What it measures – Updated version of the Millon Behavioral Health Inventory (MBHI). Provides information on coping styles (introversive, inhibited, dejected, cooperative, sociable, etc.), health habits (smoking, drinking, eating, etc.), psychiatric indications (anxiety, depression, etc.), stress moderators (illness apprehension vs. illness tolerance, etc.), treatment prognostics (interventional fragility vs. interventional resilience, medication abuse vs. medication competence, etc.), and other factors. substantially to the understanding of psychosocial factors affecting medical patients. Understanding risk factors and patient personality type can help to optimize treatment protocols for a particular patient.

Characteristics – Standardized test normalized on medical patients with various diseases, and bariatric population. Chronic pain/presurgical analysis cites a chronic pain reference group but the analysis is based on a general medical population.

2. Comprehensive Psychological Inventories:

These tests are designed for detecting various psychiatric syndromes but in general are more prone to false positive findings when administered to medical patients.

a. Millon® Clinical Multiaxial Inventory®, (MCMI®-IV).

What it measures – Has scales to assess 15 types of maladaptive personality types, and 10 clinical syndromes including bipolar spectrum, depression, anxiety, drug/alcohol abuse, somatic symptom, post-traumatic stress and psychosis.

Benefits – When used as a part of a comprehensive evaluation, can screen for a broad range of ICD psychiatric diagnoses.

Characteristics – Standardized test normalized on psychiatric patients.

b. Minnesota Multiphasic Personality Inventory®, 2nd Edition (MMPI®-2).

What it measures – Original scale constructs, such as hysteria and psychasthenia are archaic but continue to be useful. Newer content scales include depression, anxiety, health concerns, bizarre mentation, social discomfort, low self-esteem, and almost 100 others.

Benefits – When used as a part of a comprehensive evaluation, measure a number of factors that have been associated with poor treatment outcome.

Characteristics – Standardized test normalized on community members c. Minnesota Multiphasic Personality Inventory®, 2 Edition Revised Form (MMPI®-2).

What it measures – 50 scales assess a wide range of psychiatric disorders and personality traits, plus 8 validity scales, critical items.

Benefits – new version of MMPI-2 has undergone extensive revision to correct perceived MMPI-2 deficiencies. Has advantages over the original MMPI-2 in psychiatric assessment, but may be less capable when assessing patients with chronic pain.

Characteristics – Standardized test normalized on community members, with multiple other reference groups including chronic pain and spine surgery candidate.

d. Personality Assessment Inventory (PAI®).

What it measures – A measure of general psychopathology that assesses depression, anxiety, somatic complaints, stress, alcohol and drug use reports, mania, paranoia, schizophrenia, borderline, antisocial, suicidal ideation, and more than 30 others. substantially to the identification of a wide variety of risk factors that could potentially affect the medical patient.

3. Brief Multidimensional Screens for Medical Patients:

Treating providers may use brief instruments to assess a variety of psychological and medical conditions, including depression, pain, disability, and others. These instruments may also be employed as repeated measures to track progress in treatment or as one test in a more comprehensive evaluation. Brief instruments are valuable in that the test may be administered in the office setting and hand scored by the physician. Results of these tests should help providers distinguish which patients should be referred for a specific type of comprehensive evaluation.

a. Brief Battery for Health Improvement, 2nd Edition (BBHI What it measures – Depression, anxiety, somatization, pain, function, and defensiveness.

Benefits – Can identify patients needing treatment for depression and anxiety and identify patients prone to somatization, pain magnification, and selfperception of disability. Can compare the level of factors above to other pain patients and community members. Serial administrations can track changes in measured variables during the course of treatment and assess outcome.

Characteristics – Standardized test normalized on patients with chronic pain or injury and on community members, with reference groups for six subcategories of injured patients.

b. Pain Patient Profile (P-3®).

What it measures – Assesses depression, anxiety, and somatization.

Benefits – Can identify patients needing treatment for depression and anxiety and patients prone to somatization. Can compare the level of depression, anxiety, and somatization to other pain patients and community members. Serial administrations can track changes in measured variables during the course of treatment and assess outcome.

Characteristics – Standardized test normalized on patients with chronic pain and on community members.

c. SF-36.

What it measures – A survey of general health, well-being, and functional states.

Benefits – Assesses a broad spectrum of patient disability reports. Serial administrations could be used to track patient perceived functional changes during the course of treatment and assess outcome.

d. Sickness Impact Profile (SIP).

What it measures – Perceived disability in the areas of sleep, eating, home management, recreation, mobility, body care, social interaction, emotional behavior, and communication.

Benefits – Assesses a broad spectrum of patient disability reports. Serial administrations could be used to track patient perceived functional changes during the course of treatment and assess outcome.

e. McGill Pain Questionnaire (MPQ).

What it measures – Cognitive, emotional, and sensory aspects of pain.

Benefits – Can identify patients prone to pain magnification. Repeated administrations can track progress in treatment for pain.

f. McGill Pain Questionnaire – Short Form (MPQ-SF).

What it measures – Emotional and sensory aspects of pain.

Benefits – Can identify patients prone to pain magnification. Repeated administrations can track progress in treatment for pain.

g. Oswestry Disability Questionnaire (ODQ).

What it measures – Disability secondary to low back pain.

Benefits – Can measure patient’s self-perceptions of disability. Serial administrations could be used to track changes in self-perceptions of functional ability during the course of treatment and assess outcome.

h. Visual Analog Scales (VAS).

What it measures – Graphical measure of patient’s pain report, in which the patient makes a mark on a line to represent pain level.

Benefits – Quantifies the patient’s pain report, most-commonly using a 10 centimeter horizontal line. Serial administrations could be used to track changes in pain reports during the course of treatment and assess outcome.

Characteristics – Non-standardized test without norms. Some patients may have difficulty with this conceptual test format, depending on perceptual, visuomotor, cultural orientation, or other factors.

i. Numerical Rating Scales (NRS).

What it measures – Numerical report of patient’s pain.

Benefits – Quantifies the patient’s pain report, typically on a 0-10 scale. Serial administrations could be used to track changes in pain reports during the course of treatment and assess outcome.

Characteristics – Recommended by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Non-standardized test without norms. May be more easily understood than the VAS.

j. Chronic Pain Grade Scale (CPGS):

What it measures - The CPGS is a multidimensional measure that assesses two dimensions of overall chronic pain severity: pain intensity and pain-related Benefits – Among patients with moderate to severe chronic musculoskeletal pain, the CPGS has been shown to be modestly responsive to change.

k. Brief Multidimensional Screens for Psychiatric Patients:

These tests are designed for detecting various psychiatric syndromes but in general are more prone to false positive findings when administered to medical l. Brief Symptom Inventory (BSI®).

What it measures: Somatization, obsessive-compulsive, depression, anxiety, phobic anxiety, hostility, paranoia, psychoticism, and interpersonal sensitivity. track changes in measured variables during the course of treatment and assess outcome.

m. Brief Symptom Inventory – 18 (BSI®-18).

What it Measures: Depression, anxiety, and somatization. track patient perceived functional changes during the course of treatment and assess outcome.

Characteristics – Standardized test normalized on patients with chronic pain associated with cancer.

n. Symptom Check List – 90 Revised (SCL-90R®).

What it measures: Somatization, obsessive-compulsive, depression, anxiety, phobic anxiety, hostility, paranoia, psychoticism, and interpersonal sensitivity. track changes in measured variables during the course of treatment and assess outcome.

4. Brief Specialized Psychiatric Screening Measures:

a. Beck Depression Inventory® (BDI®).

Benefits: Can identify patients needing referral for further assessment and treatment for depression and anxiety and identify patients prone to somatization.

Repeated administrations can track progress in treatment for depression, anxiety, and somatic preoccupation. Requires a professional evaluation to verify diagnosis.

Characteristics – Standardized test without norms, uses cutoff scores.

b. Center of Epidemiologic Studies – Depression Questionnaire (CES-D).

Note: Designed for assessment of psychiatric patients, not pain patients, which can bias results, and this should be a consideration when using.

c. Brief Patient Health Questionnaire from PRIME - MD®. (The PHQ-9 may also be used as a depression screen.)

What it measures: Depression, panic disorder.

Characteristics – Non-standardized test without norms, keyed to diagnostic criteria, uses cutoff scores.

d. Zung Depression Questionnaire.

Note: The Zung Depression Scale must be distinguished from the Modified Zung Depression scale used by the DRAM (a QPOP measure). The Zung Depression Scale has different items and a different scoring system than the Modified Zung Depression scale, making the cutoff scores markedly different. The cutoff scores for one measure cannot be used for the other. _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 18: Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R17 Ex 10 Rule 17, Exhibit 10 - [Repealed and repromulgated as Rule 17, Exhibit 2 eff. 01/30/2019] {#sec-7-ccr-1101-3-r17-ex-10 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R17 Ex 10}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Workers’ Compensation WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES

RULE 17 EXHIBIT 10 TRAUMATIC BRAIN INJURY MEDICAL TREATMENT GUIDELINES - Repealed and repromulgated as Rule 17 Exhibit 2 7 CCR 1101-3 Rule 17 - Exhibit 10 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

Editor's Notes

History Entire rule repealed and repromulgated as Rule 17 Exhibit 2 eff. 01/30/2019.

7 CCR 1101-3 Rule 18 Rule 18 Fee Schedule and Exhibits {#sec-7-ccr-1101-3-rule-18 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 Rule 18}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Workers' Compensation WORKERS' COMPENSATION RULES OF PROCEDURE MEDICAL FEE SCHEDULE 7 CCR 1101-3 Rule 18 (Rule 18 exhibits published separately) [Editor's Notes follow the text of the rules at the end of this CCR Document.] ______________________________________________________________________ 18-1 INTRODUCTION Pursuant to § 8-42-101(3)(a)(I) and § 8-47-107, the Director promulgates this Medical Fee Schedule to review and establish maximum fees for healthcare services falling within the purview of the Workers’ Compensation Act of Colorado. This Rule applies to services rendered on or after January 1, 2026. All other bills shall be reimbursed in accordance with the fee schedule in effect on the date of service. This Rule shall be read together with Rule 16, Utilization Standards, and Rule 17, the Medical Treatment Guidelines (MTGs).

The unofficial copies of Rule 18, other Colorado Workers' Compensation Rules of Procedure, and Interpretive Bulletins are available on the Division’s website. The rules also may be purchased from LexisNexis. An official copy of this Rule is available on the Colorado Secretary of State’s webpage, 7 CCR 1101-3.

18-2 INCORPORATION BY REFERENCE

The Director adopts and incorporates by reference the following materials:

(A) National Physician Fee Schedule Relative Value file (RBRVS-Resource Based Relative Value Scale), as modified and published by Medicare in April 2025.

(B) The Current Procedural Terminology CPT® 2025, Professional Edition, published by the American Medical Association (AMA). All CPT® modifiers are adopted, unless otherwise specified in this Rule.

(C) Medicare Severity Diagnosis Related Groups (MS-DRGs) Definitions Manual, Version 42.1 using MS-DRGs from CMS-1808-F Table 5. MS- DRGs Definitions Manual may be purchased from 3M Health Information Systems.

(D) Hospital Outpatient Prospective Payment System (OPPS) Addenda A and B, April 2025; 2025 NFRM OPPS Addendum J; Table 6 (OPPS Imaging Families and Multiple Imaging Procedure Composite APCs of the 2025 OPPS Final Rule); and Table 2 of the 2025 NFRM OPPS Claims Accounting.

(E) Medicare Part B April 2025 Average Sales Price (ASP) Pricing File.

(F) Health Care Common Procedure Coding System (HCPCS) Level II Professional 2025, published by the AMA.

(G) Medicare’s Clinical Laboratory Fee Schedule File, CY 2025 Q2.

(H) The Current Dental Terminology, CDT® 2025, published by the American Dental Association.

(I) Medicare’s 2022 Anesthesia Base Units by CPT® Code.

(J) Medicare’s DMEPOS fee schedule for rural (R) or non-rural (NR) areas, January 2025 and Medicaid’s Health First Colorado Fee Schedule, January 1, 2025.

(K) Standard formats for electronic billing, remittance, and acknowledgments adopted by the U.S. Department of Health and Human Services (45 CFR Parts 160 and 162) pursuant to Health Insurance Portability and Accountability Act of 1996 (HIPAA).

All guidelines and instructions in the referenced materials are adopted, unless otherwise specified in this Rule. The incorporation is limited to the specific editions named and does not include later revisions or editions.

The Division shall make available for public review and inspection the copies of all materials incorporated by reference in Rule 18. Please contact the Medical Services Manager, 707 17th Street, Denver, Colorado 80202. These materials also are available at any state publications depository library. All users are responsible for the timely purchase and use of these materials.

18-3 GENERAL POLICIES

(A) BILLING CODES AND FEE SCHEDULE

(1) The Division establishes the Medical Fee Schedule based on RBRVS, as modified by Rule 18 and its Exhibits.

(2) The Division incorporates CPT®, HCPCS, CDT® and National Drug Code (NDC) codes and values, unless otherwise specified in Rule 18. Providers may use CPT® Category III codes listed in the RBRVS with Payer agreement. Payment for the Category III codes shall comply with Rule 16 policy for unpriced codes.

(3) Division-created codes and values (DoWC ZXXXX) supersede CPT®, HCPCS, CDT®, and NDC codes and values. The CPT® mid-point rule for attaining a unit of time applies to these codes, unless otherwise specified in this Rule.

(4) Codes listed with values of “BR” (by report), not listed, or listed with a zero value and not included by Medicare in another procedure(s), require prior authorization.

(B) PLACE OF SERVICE CODES

The table below lists the place of service codes corresponding to the RBRVS facility RVUs. All other maximum fee calculations shall use the non-facility RVUs listed in the RBRVS.

Place of Service Code Place of Service Code Description 21 Inpatient Hospital 22 On Campus - Outpatient Hospital 23 Emergency Room-Hospital 24 Ambulatory Surgery Center (ASC) 26 Military Treatment Facility 31 Skilled Nursing Facility 34 Hospice 41 Ambulance - Land 42 Ambulance - Air or Water 51 Inpatient Psychiatric Hospital 52 Psychiatric Facility-Partial Hospitalization 53 Community Mental Health Center 56 Psychiatric Residential Treatment Center Place of Service Code Place of Service Code Description 61 Comprehensive Inpatient Rehabilitation Facility (C) CORRECT REPORTING AND PAYMENT POLICIES (1) Providers shall report codes and number of units based on all applicable code descriptions and this Rule. In addition, Providers shall document all services/ procedures in the medical record.

(2) Providers shall report the most comprehensive code that represents the entire service.

(3) Providers shall report only the primary services and not the services that are integral to the primary services.

(4) Providers shall document the time spent performing all time-based services or procedures in accordance with applicable code descriptions.

(5) Providers shall apply modifiers to clarify services rendered and/or adjust the maximum allowances as indicated in this Rule. When correcting a modifier, Payers shall comply with Rule 16.

18-4 PROFESSIONAL FEES AND SERVICES

(A) GENERAL INSTRUCTIONS

(1) Conversion Factors (CFs):

Maximum allowances are determined by multiplying the following CFs by the established facility or non-facility total relative value units (RVUs) found in the corresponding CPT® sections:

CPT® SECTION CF

Anesthesia $43.23 Surgery/Radiology/Pathology/Medicine (SRPM) $64.70 Physical Medicine and Rehabilitation $48.53 (Includes Medical Nutrition Therapy and Acupuncture)

Evaluation & Management (E/M) $56.61 (2) Maximum Allowance:

(a) Maximum allowance for most Providers shall be 100% of the Medical Fee Schedule unless otherwise specified in this

Rule.

(b) The maximum allowance for Physician Assistants (PAs) and Nurse Practitioners (NPs) shall be 85% of the Medical Fee Schedule. However, PAs and NPs are allowed 100% of the Medical Fee Schedule if the requirements of Rule 16 have been met and one of the following conditions applies:

(i) The service is provided in a rural area. Rural area means: ● a county outside a Metropolitan Statistical Area (MSA) or ● a Health Professional Shortage Area, located either outside of an MSA or in a rural census tract, as determined by the Office of Rural Health Policy, Health Resources and Services Administration, United States Department of Health and Human Services.

(ii) The PA or NP is Level I Accredited.

(c) The Payer may negotiate reimbursement of travel expenses not addressed in the fee schedule (including transit time) with Providers traveling to a rural area to serve an injured worker. A rural area is defined in subsection (2)(b)(i) above.

This reimbursement shall be in addition to the maximum allowance for services addressed in the fee schedule.

(3) The Division adopts the following RBRVS attributes or modifies them as follows:

(a) Modifiers – CPT® and HCPCS Level II, as necessary to provide additional information about reported procedures, services, and supplies.

(b) Description – short description as listed in the file and long description as specified in CPT®.

(c) Status Codes:

Status Meaning A Separately Payable B & P Bundled Code C Priced per Rule 16-10-1 E HCPCS J0120 to J9999 and CPT® 90296-90750 are payable.

HCPCS Q4074-Q4255 require prior authorization for I HCPCS A0021-A0998 and S0012-S0199 are payable.

Dental codes are paid per Exhibit #3; specified in this Rule. There may be another code for reporting and payment of these services.

J Anesthesia Code M & Q Measurement or Functional Information Codes - No Value Status Meaning N HCPCS A4210-A9300 are payable when dispensed for home use. Providers other than DMEPOS Suppliers shall append modifier SQ.

Dental codes are paid per Exhibit #3.

HCPCS V2025-V5290 are payable per section 18- 6(A). There may be another code for reporting and payment of services associated with V-codes.

Codes found in the Medicine Section of CPT® with an assigned RBRVS value (section 18-2) are payable.

R Dental codes are paid per Exhibit #3.

All other codes require prior authorization for payment unless otherwise specified in this Rule.

T Paid when it is the only payable service performed.

X Codes with an assigned RBRVS or DMEPOS value (section 18-2) are payable.

(d) Increment of Service/Billable (when specified).

(e) Anesthesia Base Unit(s), see section 18-4(C).

(f) Non-Facility (NF) Total RVUs.

(g) Facility (F) Total RVUs.

(h) Professional Component/Technical Component Indicators. 0 Physician Service Codes – professional component/ technical component (PC/TC) distinction does not 1 Diagnostic Radiology Tests - may be billed with or without modifiers 26 or TC. 2 Professional Component Only Codes – standalone professional service code (no modifier is appropriate because the code description dictates the service is professional only). 3 Technical Component Only Codes - standalone technical service code (no modifier is appropriate because the code description dictates the service is technical only). 4 Global Test Only Codes - modifiers 26 and TC cannot be used because the values equal to the sum of the total RVUs (work, practice expense, and malpractice). 5 Incident To Codes - do not apply. 6 Laboratory Physician Interpretation Codes – separate payments may be made (these codes represent the professional component of a clinical laboratory service and cannot be billed with modifier TC). 7 Physical Therapy Service – not recognized. 8 Physician Interpretation Codes – separate payments may be made only if a Physician interprets an abnormal smear for a hospital inpatient. 9 Concept of PC/TC distinction does not apply.

(i) Global Days: a period of time starting with the preoperative period of a surgical procedure and ending some period of time after the procedure was performed. 000 Endoscopies or some minor surgical procedures, typically a zero day post-operative period. E/M visits on the same day as procedures generally are included in the procedure, unless a separately identifiable service is reported with an appropriate modifier. 010 Other minor procedures, 10-day post-operative period. E/M visits on the same day as procedures and during the 10-day post-operative period generally are included in the procedure, unless a separately identifiable service is reported with an appropriate modifier. 090 Major surgeries, 90-day post-operative period. E/M visits the day before and on same day as procedures, as well as during the 90-day postoperative period generally are included in the procedure, unless a separately identifiable service is reported with an appropriate modifier.

MMM Global service days concept does not apply (see Medicare’s Global Maternity Care reporting rule).

XXX Global concept does not apply.

YYY Identifies primarily “BR” procedures where “global days” need to be determined by the Payer.

ZZZ Code is related to another service and always included in the global period of the other service.

Identifies “add-on” codes.

(j) Pre-Operative Percentage Modifier: percentage of the global surgical package payable when pre-operative care is rendered by a Provider other than the surgeon. % The Physician shall append modifier 56 when performing only the pre-operative portion of any with either modifier 54 or 55, but not both. This (k) Intra-Operative Percentage Modifier: percentage of the global surgical package payable when the surgeon renders only intra-operative care. % The surgeon shall append modifier 54 when performing only the intra-operative portion of a with either modifier 55 or 56, but not both. This (l) Post-Operative Percentage Modifier: percentage of the global surgical package payable when post-operative care is rendered by a Provider other than the surgeon. % The surgeon shall append modifier 55 when performing only the post-operative portion of a with either modifier 54 or 56, but not both. This (m) Multiple Procedure Modifier: the maximum allowance for the highest-valued procedure is 100% of the fee schedule, even if the Provider appends modifier 51. The maximum allowance for the lesser-valued procedures performed in the same operative setting is 50% of the fee schedule. 0 No payment adjustment for multiple procedures applies. These codes are generally identified as “addon” codes in CPT®. 1, 2, or 3 Standard payment reduction applies (100% for the highest-valued procedure and 50% for all lesservalued procedures performed during the same operative setting). 4, 5, 6, or Not subject to the multiple procedure adjustments. 9 Multiple procedure concept does not apply.

(n) Bilateral Procedure Modifier. 0 Not eligible for the bilateral payment adjustment. Either the procedure cannot be performed bilaterally due to the anatomical constraints or another code more adequately describes the procedure. 1 Eligible for bilateral payment adjustment and shall be reported on one line with modifier 50 and one unit of service.

Providers performing the same bilateral procedure during the same operative setting on multiple sites shall report the second and subsequent procedures with modifiers 50 and 59. Report on one line with one unit for each bilateral procedure performed. The maximum allowance is increased to 150%.

If Provider performs multiple bilateral procedures during the same setting, Payer shall apply the bilateral payment adjustment

rule first, and then apply other applicable payment adjustments (e.g., multiple surgery). 2 Not eligible for the bilateral payment adjustment. These procedure codes are already bilateral. 3 Not eligible for the bilateral payment adjustment. Report these codes on two lines with RT and LT modifiers. There is one payment per line. 9 Not eligible for the bilateral payment adjustment because the concept does not (o) Assistant Surgeon, Modifiers 80, 81, 82, or AS: the designation of “almost always” for a surgical code in the Physicians as Assistants at Surgery: 2023 Update (February 2023), published by the American College of Surgeons shall indicate that separate payment for an assistant surgeon is allowed for that code. If that publication does not make a recommendation on a surgical code or lists it as “sometimes” or “almost never,” then RBRVS indicators shall determine whether separate payment for assistant surgeons is allowed. 0 Documentation of medical necessity and prior authorization is required to allow an assistant at surgery. 1 No assistant at surgery is allowed. 2 Assistant at surgery is allowed. 9 Concept does not apply.

No separate assistant surgeon or minimum assistant fee shall be paid if a co-surgeon is paid for the same operative procedure during the same surgical episode. See section 18- 4(D)(1) for additional payment policies.

(p) Co-Surgeon, Modifier 62. 1 or 2 Indicators may require two primary surgeons performing two distinct portions of a procedure.

Modifier 62 is used with the procedure and maximum allowance is increased to 125% of the fee schedule value.

The payment is apportioned to each surgeon in relation to the individual responsibilities and work, or it is apportioned equally between the co-surgeons. 0 or 9 Not eligible for co-surgery fee allowance adjustment.

These procedures are either straightforward or only one surgeon is required, or the concept does not (q) Team Surgeon, Modifier 66. 0 Team surgery adjustments are not allowed. 1 Prior authorization is required for team surgery adjustments. 2 Team surgery adjustments may occur as a “BR.” Each team surgeon must bill modifier 66. Payer must adjust the values in consultation with the billing surgeon(s). 9 Concept does not apply.

(r) Endoscopy base codes are not recognized for payment adjustments except when other modifiers apply.

(s) All other fields are not recognized.

(B) EVALUATION AND MANAGEMENT (E/M)

(1) E/M codes may be billed by Physicians, NPs, and PAs, as defined in Rule 16. To justify the billed level of E/M service, medical records shall utilize CPT® E/M Services Guidelines and Exhibit #1.

To justify the level of E/M service billed based on time, the Provider shall exclude the time spent on other reportable codes.

(2) New or Established Patients:

An E/M visit shall be billed as a “new” patient service for each new injury or new Colorado workers’ compensation claim even if the Provider has seen the injured worker within the last three years.

Any subsequent E/M visits for the same injury billed by the same Provider or another Provider of the same specialty or subspecialty in the same group practice shall be billed as an “established patient” visit.

Transfer of care from one Physician to another with the same tax ID and specialty or subspecialty shall be billed as an “established patient” regardless of location.

(3) Number of Office Visits:

All Providers are limited to one office visit per injured worker, per day, per workers’ compensation claim, unless prior authorization is obtained.

(4) Treating Physician Telephone or On-line Services: Minimum required documentation elements include:

(a) Total time spent on medical discussion and date;

(b) The injured worker or family member spoken with; and (c) Specific discussion and/or decision(s) made during the discussion.

Telephone or on-line services may be billed even if performed within the one day and seven day timelines listed in CPT®.

(5) Consultations/Referrals/Transfers of Care/Independent Medical Examinations:

A consultation occurs when a treating Physician seeks an opinion from another Physician regarding an injured worker’s diagnosis and/or treatment beyond the treating Physician’s expertise. CPT® 99242 - 99245 are payable codes.

To bill for a consultation, the Physician must document the following:

(a) Identity of the Physician requesting the opinion;

(b) The need for a consultant’s opinion;

(c) Statement that the report was submitted to the requesting Physician.

A transfer of care occurs when one Physician turns over the responsibility for the comprehensive care of an injured worker to another Physician.

An independent medical exam (IME) occurs when a Physician is requested to evaluate an injured worker by any party or party’s representative and is billed in accordance with section 18-7(G).

(6) Prolonged Services:

Providers shall document the medical necessity of prolonged services utilizing patient-specific information. Providers shall comply with all applicable CPT® requirements and the following additional requirements.

(a) Physicians or other qualified healthcare professionals (MDs, DOs, DCs, DMPs, NPs, and PAs) billing for extensive record review shall document the names of Providers and dates of service reviewed, as well as briefly summarize each record reviewed.

(b) Prolonged clinical staff services (RNs or LPNs) with Physician or other qualified healthcare professional supervision:

(i) The supervising Physician or other qualified healthcare professional may not bill for the time spent supervising clinical staff.

(ii) Clinical staff services cannot be provided in an urgent care or emergency department setting.

When the above requirements are met, the status code for CPT® 99417 and 99418 converts to A (see section 18- 4(A)(3)(c)).

(C) ANESTHESIA

(1) All anesthesia base values are set forth in Medicare’s Anesthesia Base Units by CPT® code, as incorporated by section 18-2.

Anesthesia services are only reimbursable if the anesthesia is administered by a Physician, a Certified Registered Nurse Anesthetist (CRNA), or an Anesthesiologist Assistant (AA) who remains in constant attendance during the procedure for the sole

purpose of rendering anesthesia.

When a CRNA or AA administers anesthesia:

(a) Under the medical direction of an Anesthesiologist, the service shall be reimbursed 50% of the maximum anesthesia value. The other 50% is payable to the Anesthesiologist providing the medical direction to the CRNA or AA;

(b) Medical direction for administering anesthesia means the Anesthesiologist performs the following:

(i) examines and evaluates the injured worker before administering anesthesia;

(ii) prescribes the anesthesia plan;

(iii) personally participates in the most demanding procedures in the anesthesia plan including, if applicable, induction and emergence;

(iv) ensures that any procedure in the anesthesia plan is performed by a qualified anesthetist;

(v) monitors anesthesia administration at frequent intervals;

(vi) remains physically present and available for immediate diagnosis and treatment of emergencies; and (vii) provides indicated post-anesthesia care.

(2) HCPCS Level II modifiers are required when billing for anesthesia services. Modifier AD shall be used when an Anesthesiologist supervises more than four concurrent (occurring at the same time) anesthesia service cases. Maximum allowance for supervising multiple cases is calculated using three base anesthesia units for each case, regardless of the number of base anesthesia units assigned to each specific anesthesia episode of care.

(3) Physical status modifiers are reimbursed as follows, using the Anesthesia CF:

P-1 Healthy patient 0 RVUs P-2 Patient with mild systemic disease 0 RVUs P-3 Patient with severe systemic disease 1 RVU P-4 Patient with severe systemic disease that is a constant threat to life 2 RVUs P-5 A moribund patient who is not expected to survive without the operation 3 RVUs P-6 A declared brain-dead patient whose organs are being removed for donor purposes 0 RVUs (4) Qualifying circumstance codes are reimbursed using the Anesthesia CF:

Anesthesia complicated by extreme age (under one or over 70 yrs)

1 RVU

Anesthesia complicated by utilization of total body hypothermia Anesthesia complicated by utilization of controlled hypotension Anesthesia complicated by emergency conditions (specify)

(5) Multiple procedures are billed in accordance with CPT®. When more than one surgical procedure is performed during a single episode, only the highest-valued base anesthesia procedure value is added to the total anesthesia time for all procedures.

(6) Total minutes are reported for reimbursement. Each 15 minutes of anesthesia time equals one additional RVU. Five minutes or more is considered significant time and adds one RVU to the payment calculation.

(7) Calculation of Maximum Allowance for Anesthesia:

(a) Add the anesthesia base units, one unit for each 15 minutes of anesthesia time, and any physical status modifier units to calculate total relative value anesthesia units;

(b) Multiply the total relative value anesthesia units by the Anesthesia CF to calculate the total maximum anesthesia allowance.

(8) Non-time based anesthesia procedures shall be billed with modifier 47.

(D) SURGERY

(1) Assistant Surgeons Payment Policies and Modifiers:

(a) The use of assistant surgeons shall be limited according to the American College of Surgeons' Physicians as Assistants at Surgery: 2023 Update (February 2023), available from the American College of Surgeons, Chicago, IL, or from its web page.

Provider shall document the medical necessity for any assistant surgeon in the operative report.

(b) Payment for more than one assistant surgeon or minimum assistant surgeon requires prior authorization.

(c) Maximum allowance for an assistant surgeon reported by a Physician, as indicated by modifier 80, 81, or 82 is 20% of the fee schedule allowance.

(d) Maximum allowance for a minimum assistant surgeon, reported by a Non-Physician, as indicated by modifier AS is 10% of the fee schedule allowance (the 85% adjustment in

section 18-4(A)(2)(b) does not apply).

(e) The services performed by registered surgical technologists are bundled fees and are not separately payable.

See section 18-4(A)(3) for additional payment policies applicable to assistant surgeons.

(2) Global Package:

(a) Global surgical package rules apply in any setting, including inpatient and outpatient hospitals, ambulatory surgical centers, and physicians’ offices. The payment rules for global surgical packages apply to surgical procedure codes with global surgery indicators of 000, 010, 090, and sometimes YYY. In addition to the services included pursuant to CPT®, the following services, when provided within the global period by a Provider with the same specialty reporting the same Federal Employer Identification Number (FEIN), are included in the global surgical package:

(i) Pre-operative services performed within the global period (the day before surgery for procedures with global surgery indicators of 090, and the day of the surgery for all other procedures);

(ii) Complications following a procedure that require services of the Physician, but not a return trip to the operating room;

(iii) Post-operative visits, including follow-up E/Ms, related to the patient recovery;

(iv) Post-surgical pain management;

(v) Supplies related to the procedure, unless otherwise addressed in this Rule;

(vi) Miscellaneous services related to the procedure such as dressing changes; local incision care; removal of operative pack; removal of cutaneous sutures, staples, lines, wires, tubes, drains, casts, and splints; insertion, irrigation, and removal of urinary catheters, routine peripheral intravenous lines, and nasogastric and rectal tubes; and changes/removal of tracheostomy tubes.

(b) Services not included in the global surgical package:

(i) Services by a Provider who is not the same specialty unless the surgeon and the other Provider agree on the transfer of care (for transfers of care, see pre-, intra-, and post- operative percentage modifiers);

(ii) The E/M service that resulted in the initial decision to perform the surgery. billed with modifier 57;

(iii) Visits that are unrelated to the diagnosis for which the procedure was performed, billed with modifier 24 or 25;

(iv) Diagnostic tests and procedures (including lab and xray);

(v) Staged or related procedures or services that occur on the same day or staged over a couple of days, billed with modifier 58. The maximum allowance is 100% of the fee schedule.

(vi) Clearly distinct procedures during the post-operative period that are not re-operations or treatment for complications;

(vii) Treatment for post-operative complications requiring a return trip to the operating room or another place of service specifically equipped and staffed for the sole

purpose of performing procedures, billed with modifier 78. The maximum allowance is the intra-operative value of the procedure(s) performed only and the original post-operative global days continue from the initial surgical procedure(s).

(viii) Increased procedural services (the work required to provide a service is substantially greater than typically required), billed with modifier 22. The Payer and Provider shall negotiate the value based on the fee schedule and the amount of additional work.

(ix) Significant and separately identifiable services, billed with modifier 24 or 25. These services are not considered part of the surgical procedure, but may be necessary to stabilize the patient for the procedure.

These services may involve unusual circumstances, complications, exacerbations, or recurrences; and/or unrelated diseases or injuries. This category also includes an E/M visit by an ATP for disability management. Disability management for the same diagnosis requires the Physician to identify specific disability management detail performed during that visit.

(x) Casting supplies if a related fracture or surgical care code is not billed. The HCPCS Level II “Q” code(s) are used for reporting any associated DMEPOS fees.

(xi) Immunosuppressive therapy for organ transplants.

(3) General Surgical Payment Policies:

(a) Exploration of a surgical site is not separately payable except in cases of a traumatic wound or an exploration performed in a separate anatomic location.

(b) An arthroscopy performed as a “scout” procedure to assess the surgical field or extent of disease is bundled into the surgical procedure performed on the same body part during the same surgical encounter and is not separately payable.

(c) An arthroscopy converted to an open procedure is bundled into the open procedure and is not separately payable. In this circumstance, Providers shall not report either a surgical arthroscopy or a diagnostic arthroscopy code.

(d) Only the joints/compartments listed in subsections (4) through (6) below are recognized for separate payment purposes.

(e) Providers shall report only one removal code for removal of implants through the same incision, same anatomical site, or a single implant system during the same episode of care.

(4) Knee Arthroscopies:

(a) Medial, lateral, and patella are the knee compartments recognized for purposes of separate payment of debridement and synovectomies.

(b) Chondroplasty is separately payable with another knee arthroscopy only if performed in a different knee compartment or to remove a loose/foreign body during a meniscectomy. The separate payment must comply with all applicable CPT® guidelines.

(c) Limited synovectomy involving one knee compartment is not separately payable with another arthroscopic procedure on the same knee.

(d) Separate payment for a major synovectomy procedure requires a synovial diagnosis and two or more knee compartments without any other arthroscopic surgical procedures performed in the same compartment.

(5) Shoulder Arthroscopies:

CPT® 29822 is not separately payable when another shoulder arthroscopy procedure is billed and paid on the same shoulder at the same encounter. CPT® 29823 is bundled with CPT® 29806 and 29807.

(6) Spine and Nervous System:

(a) Spinal manipulation is integral to spinal surgical procedures and is not separately payable.

(b) Surgeon performing a spinal procedure shall not report intraoperative neurophysiology monitoring/testing codes.

(c) If multiple procedures from the same CPT® code family are performed at contiguous vertebral levels, Provider shall append modifier 51 to all lesser-valued primary codes. See

section 18-4(A)(3) for applicable payment policies.

(d) Fluoroscopy is separately payable with spinal procedures only if indicated by a specific CPT® instruction.

(e) Lumbar laminotomies and laminectomies performed with arthrodesis at the same interspace are separately payable if the surgeon identifies the additional work performed to decompress the thecal sac and/or spinal nerve(s). If these procedures are performed at the same level, Provider shall append modifier 51 to the lesser-valued procedure(s). If procedures are performed at different interspaces, Provider shall append modifier 59 to the lesser-valued procedure(s).

See section 18-4(A)(3) for applicable payment policies.

(f) Only one anterior or posterior instrumentation performed through a single skin incision is payable.

(g) Anterior instrumentation performed to anchor an inter-body biomechanical device to the intervertebral disc space is not (h) Anterior instrumentation unrelated to anchoring the device is separately payable with modifier 59 appended.

(7) Venipuncture maximum fee allowance is addressed in section 18- 4(F)(2).

(8) Platelet Rich Plasma (PRP) Injections:

The maximum allowance includes and applies to all body parts, imaging guidance, harvesting, preparation, the injection itself, kits, and supplies.

CPT® 0232T non-facility RVU is 11.38, facility RVU is 4.12 (9) Functional Assessments:

If all requirements of the Medical Treatment Guidelines for pre- and post-injection functional assessments have been met and documented, the billing codes and maximum allowances are as follows:

DOWC Z0811, $65.54, per episode for the initial functional assessment of pre-injection care, related to spinal or SI joint injections (may be performed by injectionist or non-injectionist no more than seven days prior to the injection).

DOWC Z0812, $36.00, for a subsequent visit of therapeutic postinjection care (preferably done by a non-injectionist and at least seven days after the injection), billed along with the appropriate E/M code, related to follow-up care of spinal or SI joint injections.

The injured worker should provide post injection data.

DOWC Z0814, $36.00, for post-diagnostic injection care (repeat functional assessment within the time period for the effective agent given).

(E) RADIOLOGY

(1) Payments:

(a) The Division recognizes the value of accreditation for quality and safe radiological imaging. Only offices/facilities that have attained accreditation from American College of Radiology (ACR), Intersocietal Accreditation Commission (IAC), RadSite, or The Joint Commission (TJC) may bill the technical component for Advanced Diagnostic Imaging (ADI) procedures (magnetic resonance imaging (MRI), computed tomography (CT), and nuclear medicine scan. Providers reporting technical or total component of these services certify accreditation status. The Provider shall supply proof of accreditation upon Payer request.

(b) The cost of dye and contrast materials shall be reimbursed in accordance with the ASP pricing file, when applicable.

(c) Copying charges for X-rays and MRIs shall be $15.30/film regardless of the size of the film.

(d) Providers using film instead of digital X-rays shall append the FX modifier. The allowance is 80% of the Maximum Fee Schedule.

If a Physician interprets the same radiological image more than once, or if multiple Physicians interpret the same radiological image, only one interpretation shall be reimbursed.

If an X-ray consultation is requested, the consultant’s report shall include the name of the requesting Provider, the reason for the request, and documentation that the report was sent to the requesting Provider.

The maximum allowance for an X-ray consultation shall be no greater than the maximum allowance for the professional component of the original X-ray.

The time a Physician spends reviewing and/or interpreting an existing radiological image is considered a part of the Physician’s E/M service code.

(2) Thermography:

(a) The Provider supervising and interpreting the thermographic evaluation shall be certified by the examining board of one of the following national organizations and follow their recognized protocols, or have equivalent documented training:

(i) American Academy of Thermology;

(ii) American Chiropractic College of Infrared Imaging; or (iii) American Academy of Infrared Imaging.

(b) Thermography Billing Codes:

DoWC Z0200 Upper Body w/Autonomic Stress Testing $980.00 DoWC Z0201 Lower Body w/Autonomic Stress Testing $980.00 (c) Documentation must include:

(i) Method of stress thermography supporting it was accomplished in a guideline-consistent fashion (cold water stress test, warm water stress test, or whole body thermal stress);

(ii) Temperature readings via infrared thermography and their locations on the affected and contralateral extremity and/or copies of any pictures or graphics obtained; and (iii) Interpretation of the results.

(F) PATHOLOGY

(1) Clinical Laboratory Improvement Amendments (CLIA):

Only laboratories with a CLIA certificate of waiver may perform tests cleared by the Food and Drug Administration (FDA) as waived tests. Laboratories with a CLIA certificate of waiver, or other Providers billing for services performed by these laboratories, shall bill using the QW modifier.

Laboratories with a CLIA certificate of compliance or accreditation may perform non-waived tests. Laboratories with a CLIA certificate of compliance or accreditation, or other Providers billing for services performed by these laboratories, do not append the QW modifier.

(2) Payments:

All clinical pathology laboratory tests, except as allowed by this

Rule, are reimbursed at 170% of the RBRVS values, as incorporated by section 18-2.

Technical or professional component maximum split is not separately payable and therefore should be negotiated between billing parties when applicable.

When a Physician clinical pathologist is required for consultation and interpretation, and a separate written report is created, the maximum allowance is determined by using RBRVS values and the SRPM CF. The SRPM CF also determines the maximum allowance when the CPT® code description includes “interpretation” and “report” or when billing CPT® codes for the following services:

(a) physician blood bank services;

(b) cytopathology and cell marker study interpretations;

(c) cytogenics or molecular cytogenics interpretation and report;

(d) surgical pathology gross and microscopic and special stain groups 1 and 2 and histochemical stain, blood or bone marrow interpretations; and (e) skin tests for unlisted antigen each, coccidioidomycosis, histoplasmosis, TB intradermal.

When ordering automated laboratory tests, the ordering Physician may seek verbal consultation with the pathologist in charge of the laboratory’s policy, procedures and staff qualifications. The consultation with the ordering Physician is not payable unless the Physician requested additional medical interpretation, judgment, and a separate written report. Upon such a request, the pathologist may bill using the appropriate CPT® code, not DoWC Z0755.

The maximum allowance for CPT® 80050 is $39.95 (equal to the total allowance for CPT® 80053, 85004, and 85027).

(3) Clinical Drug Screening and Testing:

Clinical drug screening and testing may be appropriate for therapeutic drug monitoring, to assess compliance, or to identify illicit or non-prescribed drug use.

(a) Billing requirements for clinical drug testing:

(i) documentation of medical necessity by the ordering Physician.

(ii) the ordering Physician shall specify which drugs require definitive testing to meet the injured worker’s medical needs.

(iii) a Physician order for quantification of illicit or nonprescribed drugs or drug classes.

(b) Presumptive Tests:

All drug class immunoassays or enzymatic methods are considered presumptive. Payers shall only pay for one presumptive test per date of service, regardless of the number of drug classes tested.

(c) Definitive qualitative or quantitative tests identify specific drug(s) and any associated metabolites, providing sensitive and specific results expressed as a concentration in ng/mL or as the identity of a specific drug.

• These tests may be billed using G0480-G0483.

• Providers may only bill one definitive HCPCS Level II code per day.

A Physician must order definitive quantitative tests. The reasons for ordering a definitive quantification drug test may include:

• Unexpected positive presumptive or qualitative test results inadequately explained by the injured worker.

• Unexpected negative presumptive or qualitative test results and suspected medication diversion.

• Differentiate drug compliance:

· Buprenorphine vs. norbuprenorphine · Oxycodone vs. oxymorphone and noroxycodone • Need for quantitative levels to compare with established benchmarks for clinical decision-making, such as tetrahydro-cannabinol quantitation to document discontinuation of a drug.

• Chronic opioid management:

· Drug testing shall be done prior to the implementation of the initial long-term drug prescription and randomly repeated at least annually.

· While the injured worker receives chronic opioid management, additional drug screens with documented justification may be conducted (see

section 18-9(A) for examples).

CPT® lists definitive drug classes and examples of individual drugs within each class. Each class of drug can only be billed once per day.

(G) MEDICINE

(1) Biofeedback:

Licensed medical and mental health professionals who provide biofeedback must practice within the scope of their training. Nonlicensed biofeedback providers must hold Clinical Certification from the Biofeedback Certification International Alliance (BCIA), practice within the scope of their training, and receive prior approval of their biofeedback treatment plan from the injured worker’s authorized treating Physician, or Psychologist. Professionals integrating biofeedback with any form of psychotherapy must be a Psychologist, a Clinical Social Worker, a Marriage and Family Therapist, or a Professional Counselor.

All biofeedback providers shall document biofeedback instruments used during each visit (including, but not limited to, surface electromyography (SEMG), heart rate variability (HRV), electroencephalogram (EEG), or temperature training), placement of instruments, and patient response if sufficient time has passed.

The modified RVUs for biofeedback are:

CPT® 90901 non-facility RVU is 1.75, facility RVU is 1.73 CPT® 90875 non-facility RVU is 2.07, facility RVU is 1.85 Psychophysiological therapy incorporating biofeedback is not subject to a reduction when performed by Non-Physician Providers.

(2) Appendix J of CPT® identifies mixed, motor, and sensory nerve conduction studies and applicable billing requirements. For purposes of Appendix J, each nerve branch listed in that appendix counts as a separate nerve. Electromyography (EMG) and nerve conduction velocity values generally include an E/M service.

However, an E/M service may be separately payable if the requirements listed in Appendix A of CPT® for billing modifier 25 have been met.

(3) Manipulation -- Chiropractic (DC), Medical (MD) and Osteopathic (DO):

(a) Prior authorization shall be obtained before billing for more than four body regions in one visit.

(b) Osteopathic Manipulative Treatment and Chiropractic Manipulative Treatment codes include manual therapy techniques, unless the Physician performs manual therapy in a separate region and meets modifier 59 requirements.

(c) The modified RVUs for chiropractic spinal manipulative treatment are:

CPT® 98940 non-facility RVU is 1.03, facility RVU is 0.83 CPT® 98941 non-facility RVU is 1.48, facility RVU is 1.26 (4) Psychiatric/Psychological Services:

(a) The maximum allowance for services performed by a Psychologist is 100% of the Medical Fee Schedule. The maximum allowance for psychological/psychiatric services performed by other Non-Physician Providers is 85% of the Medical Fee Schedule.

(b) Psychological diagnostic evaluation code(s) are limited to one per Provider, per admitted claim, unless it is authorized by the Payer or is necessary for the ATP to complete an impairment rating.

Documentation shall include:

• A comprehensive analysis of symptoms/lack of symptoms and diagnoses, or a reference to previously completed evaluations;

• Cognitive functioning, including potential impairments in setting goals and performing activities on a schedule;

• Assessment of the activities of daily living, including functional descriptions and impact;

• The nature, purpose, and content of any communication with family members, caregivers, or other relevant sources involved in the individual’s care or assessment, when applicable;

• Any psychotropic or related medications prescribed during the evaluation and intended treatment goals;

• Any laboratory tests or other diagnostic studies that are ordered or reviewed as part of the diagnostic formulation or to rule out medical causes contributing to the psychological presentation;

• Review of treatment history and future care recommendations; and • If used to complete an impairment rating, functional deficits pertaining to scoring and, if applicable, recommendations and rationale for maintenance.

(c) Central Nervous System (CNS) Assessments/Tests:

When testing, evaluation, administration, and scoring services are provided across multiple dates of service, all codes should be billed on the last date of service when the evaluation process is completed. A base code shall be billed only for the first unit of service of the evaluation process, and add-on codes shall be used to capture services provided during subsequent dates of service. The limit for these services is 16 hours unless the Provider obtains prior authorization.

Documentation shall include the total time and the approximate time spent on each of the following activities, when performed:

• face-to-face time with the patient;

• reviewing and interpreting standardized test results and clinical data;

• integrating patient data;

• clinical decision-making and treatment planning;

• report preparation.

If there is a delay in scheduling the feedback session, the Provider may incorporate feedback into the first psychotherapy session.

The modified RVUs for psychological and neuropsychological services are:

CPT® 96116 non-facility RVU is 3.29, facility RVU is 2.83 CPT® 96127 non-facility and facility RVUs are 0.17 CPT® 96130 non-facility RVU is 4.36, facility RVU is 3.94 CPT® 96131 non-facility RVU is 3.07, facility RVU is 2.69 CPT® 96132 non-facility RVU is 4.64, facility RVU is 3.82 CPT® 96133 non-facility RVU is 3.47, facility RVU is 2.70 CPT® 90791 non-facility RVU is 10.32, facility RVU is 8.84 CPT® 90792 non-facility RVU is 11.62, facility RVU is 10.12 CPT® 96127 is not separately payable when billed with psychotherapy.

(d) The limit for psychotherapy services is 60 minutes per visit, unless the Provider obtains prior authorization. The time for internal record review/ documentation is included in this limit.

Psychotherapy for work-related conditions continuing for more than three months after the initiation of therapy requires prior authorization unless the MTGs recommend a longer duration.

(e) When billing an E/M code in addition to psychotherapy:

(i) both services must be separately identifiable;

(ii) the level of E/M must be based on history, exam, and medical decision-making;

(iii) time may not be used as the basis for the E/M code selection; and (iv) the Provider must use add-on psychotherapy codes to indicate both services were provided.

Non-medical disciplines cannot bill most E/M codes.

(f) A Provider billing for any stored clinical or physiological data analysis must obtain prior authorization.

(g) Upon request of a party to a workers’ compensation claim and pursuant to HIPAA regulations, a psychiatrist, psychologist or other qualified healthcare professional may generate a separate report and bill for that service as a special report.

(h) In the event an injured worker cannot be seen face-to-face due to the emergent nature of the crisis, CPT® 90839 and 90840 may be provided by telephone, billed with modifier 93, and reimbursed using the facility RVUs for these codes.

(5) Telephone or On-Line Services:

Reimbursement for coordination of care between medical professionals is limited to professionals outside of the Provider’s practice.

Telephone services, including those listed in Appendix T and Telephone Services section of CPT®, shall be billed with a modifier 93.

Telephone and on-line services (CPT® 98008-98016, 98966- 98968, and 99421-99423) shall be reimbursed using facility RVUs, regardless of the place of service.

For reimbursement of face-to-face or telephonic meetings by a treating Physician or Psychologist with employer, claim representative, or attorney, see section 18-7(A)(1).

(6) Quantitative Autonomic Testing Battery (ATB) and Autonomic Nervous System Testing:

(a) Quantitative Sudomotor Axon Reflex Test (QSART) is a diagnostic test used to diagnose Complex Regional Pain Syndrome. This test is performed on a minimum of two extremities and encompasses the following components:

(i) Resting Sweat Test;

(ii) Stimulated Sweat Test;

(iii) Resting Skin Temperature Test; and (iv) Interpretation of clinical laboratory scores. Physician must evaluate the patient specific clinical information generated from the test and quantify it into a numerical scale. The data from the test and a separate report interpreting the results of the test must be documented.

(b) DoWC Z0401 QSART, $1,066.00, is billed when all the services outlined above are completed and documented.

This code may only be billed once per workers’ compensation claim, regardless of the number of limbs tested.

(7) Intra-Operative Monitoring (IOM):

IOM identifies compromise to the nervous system during certain surgical procedures. Evoked responses are constantly monitored for changes that could imply damage to the nervous system.

(a) Clinical Services:

(i) Technical staff: A qualified technician shall set up the monitoring equipment in the operating room. The technician shall be in constant attendance in the operating room with the physical or electronic capacity for real-time communication with the supervising neurologist or other Physician trained in neurophysiology. The technician shall be specifically trained in/registered with:

• the American Society of Neurophysiologic Monitoring; or • the American Society of Electrodiagnostic Technologists (ii) Professional/Supervisory/Interpretive:

A Physician trained in neurophysiology shall monitor the patient’s nervous system throughout the surgical procedure. The monitoring Physician’s time is billed based upon the actual time the Physician devotes to the individual patient, even if the Physician is monitoring more than one patient. The monitoring Physician’s time does not have to be continuous for each patient and may be cumulative. The Physician shall not monitor more than three surgical patients at one time. The Physician shall provide constant neuromonitoring at critical points during the surgical procedure as indicated by the surgeon or any unanticipated testing responses. There must be a neurophysiology-trained Physician backup available to continue monitoring the other two patients if one of the patients being monitored has complications and/or requires the monitoring Physician’s undivided attention. There is no additional payment for the backup neuro-monitoring Physician, unless utilized.

(b) Procedures and Time Reporting:

Physicians shall include an interpretive written report for all primary billed procedures.

(c) Billing Restrictions:

Intra-operative neurophysiology codes do not have separate professional and technical components. However, certain tests performed in conjunction with these services have separate professional and technical components, which may be separately payable if documented and otherwise allowed in this Rule.

The neuromonitoring Physician is the only party allowed to report these codes.

The maximum allowance for CPT® 95941 is equal to the maximum allowance for CPT® 95940.

(8) Speech-language therapy/pathology or any care rendered under a speech-language therapy/pathology plan of care shall be billed with a GN modifier.

(9) Hearing and vision services are separately payable with a code from the Medicine Section of CPT®, in addition to the supplies payable per section 18-6(A)(1)(f). The maximum allowances for the following codes are as follows:

CPT® 92590 non-facility value is $169.22, facility value is $95.68 CPT® 92591 non-facility value is $253.76, facility value is $143.37 CPT® 92592 non-facility value is $61.52, facility value is $34.75 CPT® 92593 non-facility value is $92.27, facility value is $52.13 CPT® 92594 non-facility value is $61.52, facility value is $34.75 CPT® 92595 non-facility value is $92.27, facility value is $52.13 (10) Vaccines, toxoids, immune globulins (including those with status “I”), serums, or recombinant products shall be billed using the appropriate J code or CPT® code listed in the ASP pricing file, as incorporated by section 18-2, unless an ASP value does not exist or the Provider’s actual cost exceeds the ASP value. In these circumstances, the Provider may request reimbursement based on the actual cost, after taking into account any discounts/rebates the Provider may have received.

The maximum allowance for CPT® 90371 is $816.

(11) IV infusion therapy performed in a Physician’s office or sent home with the injured worker shall be billed under the “Therapeutic, Prophylactic, and Diagnostic Injections and Infusions” and the “Chemotherapy and Other Highly Complex Drug or Highly Complex Biologic Agent Administration” in the Medicine Section of CPT®.

The maximum allowance for infused therapeutic drugs shall be at cost to the billing Provider.

Maximum allowance for supplies and medications provided by a Physician's office for self-administered home care infusion therapy are covered in section 18-6(B).

(12) Moderate (Conscious) Sedation:

Providers billing for moderate sedation services shall comply with all applicable CPT® billing instructions. The maximum allowance is determined using the Medicine CF.

(H) PHYSICAL MEDICINE AND REHABILITATION (PM&R)

(1) General Policies:

(a) Modifiers:

(i) Physical therapy or any care provided under a Physical Therapist’s plan of care shall be billed with a GP modifier. Occupational therapy or any care provided under an Occupational Therapist’s plan of care shall be billed with a GO modifier.

(ii) Services provided in whole or in part by a Physical Therapist Assistant shall be billed with a CQ modifier.

Services provided in whole or in part by an Occupational Therapist Assistant shall be billed with a CO modifier. “In part” is defined as exceeding the CPT® mid-point. The CQ and CO modifiers shall be billed in addition to the GP or GO modifiers.

(b) Each PM&R billed service must be clearly identifiable. The Provider must clearly document the time spent performing each service and the beginning and end time for each session.

(c) Functional objectives shall be included in the PM&R plan of care for all injured workers. Any request for additional treatment must be supported by evidence of positive objective functional gains or PM&R treatment plan changes.

The ordering ATP must also agree with the PM&R continuation or changes to the treatment plan.

(d) The injured worker shall be re-evaluated by the prescribing Provider within 30 calendar days from the initiation of the prescribed treatment and at least once every month thereafter.

(2) Medical nutrition therapy requires prior authorization.

(3) Interdisciplinary Rehabilitation Programs:

As defined in the MTGs, interdisciplinary rehabilitation programs may include, but are not limited to: chronic pain, spinal cord, or brain injury programs.

All billing Providers shall detail the services, frequency of services, duration of the program, and proposed fees for the entire program.

The billing Provider and Payer shall attempt to agree upon billing code(s) and fee(s) for each interdisciplinary rehabilitation program.

If there is a single billing Provider for the entire interdisciplinary rehabilitation program and a daily per diem rate is mutually agreed upon, use code Z0500.

Individual professionals billing separately for their participation in an interdisciplinary rehabilitation program shall use the applicable CPT® codes.

(4) Procedures and Modalities:

(a) Definitions:

(i) Procedure is any treatment listed in the Medicine/Physical Medicine and Rehabilitation

section of CPT® under the sub-heading “Therapeutic Procedures.” For purposes of this Rule, the term “procedure” also includes acupuncture and dry needling.

The billing maximums listed below are per discipline per day, unless medical necessity is documented and prior authorization is obtained. The total amount of time spent performing the procedures shall determine the appropriate number of time based units for a particular visit.

(ii) Modality is any treatment listed in the Medicine/Physical Medicine and Rehabilitation

section of CPT® under the sub-heading “Modalities.”

(b) Billing Restrictions:

(i) Provider may bill no more than two separate modality codes and no more than 60 minutes or four units of procedure codes on the same visit. This restriction does not apply to Special Tests referenced in subsection (6) below.

(ii) The maximum allowance for services billed by a Massage Therapist shall be 67% of the fee schedule.

(iii) The maximum allowance for services billed with a CQ or CO modifier shall be 85% of the fee schedule.

(iv) If a Provider performs another service concurrently with a time-based service, the time associated with the concurrent service shall not be included in the time used for reporting the time-based service.

(v) Electrical stimulation is not payable when billed with dry needling and performed on the same body part.

(vi) Providers shall specify all unlisted treatment in the medical record.

CPT® 97139 non-facility and facility RVUs are 0.89 CPT® 97039 non-facility and facility RVUs are 0.43 (c) Acupuncture:

(i) All Non-Physician acupuncture Providers must be Licensed Acupuncturists (L.Ac). Both Physician and L.Acs must provide evidence of training, and licensure upon request of the Payer.

(ii) New or established patient evaluation services are payable if the medical record specifies the appropriate

history, physical examination, treatment plan, or evaluation of the treatment plan. Only evaluation services directly performed by a Physician or a L.Ac are payable. All evaluation notes or reports must be written and signed by the Physician or the L.Ac.

L.Ac new patient visit: DOWC Z0800, $105.92 L.Ac established patient visit: DOWC Z0801, $71.74 (5) Evaluation Services for Physical Therapists (PTs), Occupational Therapists (OTs) and Athletic Trainers (ATs):

(a) All evaluation services must be supported by the appropriate

history, physical examination documentation, treatment goals, and treatment plan or re-evaluation of the treatment plan, as outlined in CPT®. The Provider shall clearly state the reason for the evaluation, the nature and results of the physical examination, and the reason for recommending the continuation or adjustment of the treatment protocol. The reevaluation codes shall not be billed for routine pre-treatment patient assessment.

If a new problem or abnormality is encountered that requires a new evaluation and treatment plan, the Provider may perform and bill for another initial evaluation. A new problem or abnormality may be caused by a surgical procedure being performed after the initial evaluation has been completed.

A re-examination, re-evaluation, or re-assessment is different from a progress note. Providers shall not bill these codes for a progress note. Providers may bill a re-evaluation code only if:

(i) professional assessment indicates a significant improvement or decline or change in the injured worker’s condition or a functional status that was not anticipated in the plan of care for that time interval;

(ii) new clinical findings become known; or (iii) the injured worker fails to respond to the treatment outlined in the current plan of care.

(b) A PT or OT may utilize a Rehabilitation Communication Form (WC 196) in addition to a progress note no more than every two weeks for the first six weeks, and once every four weeks thereafter.

The WC 196 Form shall not be used for an evaluation, reevaluation, or re-assessment. The Form must be completed and specify which validated functional tool was used for assessing the injured worker. The Form shall be sent to the referring Physician before or at the injured worker's follow-up appointment with the Physician.

DoWC Z0817 $15.92 (c) Only evaluation services directly performed by a PT, OT, or AT are payable. All evaluation notes or reports must be written and signed by the PT, OT, or AT.

(d) An injured worker may be seen by more than one healthcare professional on the same day. Each professional may charge an evaluation service with appropriate documentation per patient, per day.

(e) The RVU for evaluation services performed by ATs shall be equal to the RVU for evaluation services performed by PTs.

(6) Special Tests:

(a) The following are considered special tests:

(i) Job Site Evaluation (ii) Functional Capacity Evaluation (iii) Assistive Technology Assessment (iv) Speech (v) Physical performance test or measurement (b) Billing Restrictions:

(i) The following services require prior authorization: Job site evaluations exceeding two hours; Assistive Technology Assessments and Work Tolerance Screenings for more than four hours per test or more than three tests per claim; and Functional Capacity Evaluations for more than four hours per test or two tests per claim.

(ii) The Provider shall specify the time required to perform the test in 15-minute increments.

(iii) The analysis and the written report is included in the code’s value.

(iv) No E/M services or PT, OT, or acupuncture evaluations shall be charged separately for these tests.

(v) Data from computerized equipment shall always include the supporting analysis developed by the PM&R professional before it is payable as a special test.

(c) All special tests must be fully supervised by a Physician, PT, OT, CCC-SLP, or Audiologist. Final reports must be written and signed by the Physician, PT, OT, CCC-SLP, or Audiologist.

(7) Non-Medical Facility Fees:

Gyms, pools, etc., and training or supervision by non-medical providers require prior authorization and a written negotiated fee for every three month period.

(8) Work Hardening, Conditioning and Simulation:

These programs and recommendations for coverage are defined in the MTGs. All procedures must be performed by or under the onsite supervision of a Physician, Psychologist, PT, OT, CCC-SLP, or Audiologist. When the above requirements are met, the status code for CPT® 97545 and 97546 converts to A (see section 18- 4(a)(3)(c)).

CPT® 97545 non-facility and facility RVUs are 3.39 CPT® 97546 non-facility and facility RVUs are 1.7 (9) Wound Care:

Wound care is separately payable only when devitalized tissue is debrided using a recognized method (chemical, water, vacuums).

(I) TELEMEDICINE

(1) In addition to the healthcare services listed in Appendix P of CPT®, and Division Z-codes (when appropriate), services aligning with the following codes may be provided via telemedicine: G0396, G0397, G0406-G0408, G0425-G0427, G0447, G0459, G0508, G0509, 97129, 97130, 97150, 97542, and 97763. Additional services may be provided via telemedicine with prior authorization. The Provider shall append modifier 95 to the appropriate code(s) to indicate synchronous telemedicine service rendered via a real-time interactive audio and video telecommunications system.

All treatment provided through telemedicine shall comply with the applicable requirements found in the Colorado Medical Practice Act and Colorado Mental Health Practice Act, as well as the rules and policies adopted by the Colorado Medical Board and the Colorado Board of Psychologist Examiners, and shall follow applicable laws, rules, and regulations for informed consent.

(2) HIPAA privacy and electronic security standards are required for the originating site and the rendering Provider.

(3) Reimbursement:

(a) The rendering Provider may be the only Provider involved in the provision of telemedicine services. The rendering Provider shall bill place of service (POS) code 02 or 10.

Maximum allowance is the appropriate code’s non-facility relative weight from RBRVS multiplied by the appropriate CF, unless only a facility weight is established.

(b) An originating site fee may only be billed when the injured worker is receiving services at an authorized originating site.

The originating site is responsible for verifying the injured worker and rendering Provider’s identities. Originating site must bill with the appropriate facility POS code. Authorized originating sites include:

• A Hospital (inpatient or outpatient)

• A Critical Access Hospital (CAH)

• A Rural Health Clinic (RHC)

• A federally qualified health center (FQHC)

• A hospital based renal dialysis center (including satellites)

• A Skilled Nursing Facility (SNF)

• A community mental health center (CMHC)

Maximum allowance for Q3014 is $35.70 per 15 minutes.

(Equipment, supplies, and professional fees of supporting Providers at the originating site are not separately payable.)

(4) Documentation:

Documentation requirements are the same as for a face-to-face encounter and shall also include the location of both the rendering Provider and the injured worker at the time of service, and a statement on how the treatment was rendered through telemedicine (such as secured video).

18-5 FACILITY FEES

(A) INPATIENT FACILITY FEES

(1) Billing:

(a) Inpatient facility fees shall be billed using an 837I file or a UB-04 Form and require summary level billing by revenue code. The Provider must submit itemized bills.

(b) Hospitals reimbursed based on MS-DRGs shall maintain documentation on file showing how the MS-DRG was determined. The hospital shall determine the MS-DRG using the MS-DRGs Definitions Manual in effect per section 18-2 at the time of discharge. The attending Physician shall not be required to validate the MS-DRG unless a dispute arises between the hospital and the Payer regarding MS-DRG assignment. The Payer may deny payment for services until the appropriate MS-DRG code is supplied.

(2) Reimbursement:

(a) The following types of inpatient facilities, as defined in Rule 16, are allowed a reasonable charge as negotiated by the Provider and Payer:

(i) Children’s Hospitals (ii) Veterans Administration Hospitals (iii) State-run Psychiatric Hospitals (iv) Psychiatric Hospitals The Provider has the burden of proving reasonableness of reimbursement sought. Veterans Administration Hospital payments must comply with applicable rules promulgated by the United States Department of Veterans Affairs.

(b) The following inpatient facilities, as defined in Rule 16, are allowed a daily rate:

(i) Skilled Nursing Facilities (SNFs) are allowed $676.26 per day.

(ii) Rehabilitation Hospitals are allowed $1,508.58 per day.

(iii) Long Term Acute Care Hospitals (LTACHs) are allowed $3,485.34 per day.

Each of the daily rates listed above is all-inclusive for services related to the injured worker’s compensable conditions. Physician’s professional services, ambulance services, and chemotherapy drugs or radioisotopes may be billed separately. In the rare case extraordinary medical care is required, or for treatment of traumatic brain injuries or spinal cord injuries, there shall be an additional payment of $312.12 on a per day basis.

All charges shall be submitted on a final bill unless the parties agree on interim billing. The rate in effect on the last date of service covered by an interim or final bill shall determine payment.

The total length of stay includes the date of admission but not the date of discharge. Typically, bed hold days or temporary leaves are not subtracted from the total length of stay.

(c) All other inpatient facilities:

The maximum allowance is determined by the relative weights for the assigned MS-DRG from Table 5 in effect per

section 18-2 at the time of discharge and the individual hospital base rate in Exhibit #2, calculated as follows:

(MS-DRG relative weight x individual hospital base rate x 160%) + (trauma center activation allowance) + (organ acquisition, when appropriate)

(i) For trauma center activation allowance, (revenue codes 680-684) see subsection (B)(8)(c);

(ii) For organ acquisition allowance, (revenue codes 810- 819) see subsection (A)(2)(g).

Table 5 establishes the maximum length of stay (LOS) using the “arithmetic mean LOS.” However, there is no additional allowance for exceeding this LOS, other than through the cost outlier criteria.

An admission requiring the use of both an acute care hospital (admission/discharge) and its Rehabilitation Hospital (admission/discharge) is considered as one admission and MS-DRG.

(d) Outliers for inpatient hospitals identified in Exhibit #2:

Outliers are admissions with extraordinary cost warranting additional reimbursement beyond the maximum allowance.

To calculate the additional reimbursement, if any:

(i) Determine the hospital’s cost by multiplying total billed charges (excluding any trauma center activation or organ acquisition billed charges) by the hospital’s cost-to-charge ratio located in Exhibit #2;

(ii) The difference = hospital’s cost – maximum allowance excluding any trauma center activation or organ acquisition allowance;

(iii) If the difference is greater than $73,843, additional reimbursement is warranted. The additional allowance is determined by multiplying the difference by .80.

(e) If an injured worker is admitted to a hospital through the emergency department (ED), the ED fee is included in the inpatient allowance.

(f) If an injured worker is admitted to one hospital and is subsequently transferred to another hospital, the payment to each hospital will be based upon a per diem value of the MS-DRG maximum allowance. The per diem value is calculated based upon the individual hospital’s MS-DRG relative weight multiplied by the hospital’s specific base rate divided by the MS-DRG geometric mean LOS established in Table 5. This per diem amount is multiplied by the actual LOS. If the patient is admitted and transferred on the same day, or transferred and discharged on the same day, the actual LOS equals one. If the LOS is greater than or equal to the geometric mean LOS for the MS-DRG, then the maximum MS-DRG is allowed for that hospital.

(g) The Payer shall compare each billed charge type:

(i) The MS-DRG adjusted billed charges to the MS-DRG allowance (including any outlier allowance);

(ii) The trauma center activation billed charge to the trauma center activation allowance; and (iii) The organ acquisition billed charges to the organ acquisition allowance.

The MS-DRG adjusted billed charges are determined by subtracting the trauma center activation billed charge and the organ acquisition billed charges from the total billed charges. The final payment is the sum of the lesser of each of these comparisons.

The organ acquisition allowance is calculated using the most recent filed computation of organ acquisition costs and charges for hospitals that are certified transplant centers (CMS Worksheet D-4 or subsequent form) plus 20%.

(B) OUTPATIENT FACILITY FEES

(1) Provider Restrictions:

(a) All non-emergency outpatient surgeries require prior authorization unless the MTGs recommend a surgery for the particular condition. All outpatient surgical procedures performed in an ASC shall warrant performance at an ASC level.

(b) A facility fee is payable only if the facility is licensed as a hospital or an ASC by the Colorado Department of Public Health and Environment (CDPHE) or applicable out of state governing agency or statute.

(2) Types of Bills for Service:

(a) Outpatient facility fees shall be billed using an 837I file or a UB-04 Form and require summary level billing by revenue code. The Provider must submit itemized bills.

(b) All professional charges (professional services including, but not limited to, PT, OT, CCC-SLP, anesthesia, etc.) are subject to the RBRVS and Dental Fee Schedules as incorporated by this Rule. These fee schedules apply to professional services performed in all facilities.

(c) Outpatient hospital facility bills include all outpatient surgery, ED, clinics, Urgent Care, and diagnostic testing in the Radiology, Pathology or Medicine Section of CPT®/RBRVS.

(3) General Reimbursement Instructions:

(a) The following outpatient facilities, as defined in Rule 16, are allowed a reasonable charge, as negotiated by the Provider and Payer, except for any associated professional fees that are reimbursed per section 18-4:

(i) Children’s Hospitals (ii) Veterans Administration Hospitals (iii) State-run Psychiatric Hospitals The Provider has the burden of proving reasonableness of reimbursement sought. Veterans Administration Hospital payments must comply with applicable rules promulgated by the United States Department of Veterans Affairs.

(b) The maximum allowance for Ambulatory Payment Classifications (APC) is calculated at the following percentages of the payment rates listed in Medicare’s OPPS Addendum A, as incorporated by 18-2:

(i) Outpatient hospital is 160% (ii) CAH is 200% (iii) ASC is 150% To identify which APC grouper is aligned with a CPT® code and dollar value, use Medicare’s Addendum B, as incorporated by 18-2. For comprehensive APCs (C-APCs), see 18-5(B)(6).

(c) CPT® codes listed with a “C” status indicator in Medicare’s Addendum B shall align to the APC codes as listed in Exhibit #4. The status indicator assigned to the Exhibit #4 APC code, as identified in Medicare’s Addendum A, shall apply.

These codes are not eligible for complexity-adjusted APC payments.

(d) Facilities receive the lesser of the actual charge or the fee schedule allowance. A line-by-line comparison of charges is not appropriate.

(4) APC values include the services and revenue codes listed in Table 2 of the 2025 NFRM OPPS Claims Accounting, as incorporated by

Rule 18-2; therefore, these are generally not separately payable.

Drugs and devices having a status indicator of G and H receive a pass-through payment. In some instances, the procedure code may have an APC code assigned. These are separately payable based on APC values, if given, or at cost to the facility.

Services and items included in the APC value:

(a) nursing, technician, and related services;

(b) use of the facility where the surgical procedure(s) was performed;

(c) drugs and biologicals for which separate payment is not allowed;

(d) medical and surgical supplies, durable medical equipment and orthotics not listed as a “pass through”;

(e) surgical dressings;

(f) equipment;

(g) splints, casts and related devices;

(h) radiology services for which separate payment is not allowed;

(i) administrative, record keeping, and housekeeping items and services;

(j) materials, including supplies and equipment for the administration and monitoring of anesthesia;

(k) supervision of the services of an anesthetist by the operating surgeon;

(l) post-operative pain blocks; and (m) implanted items.

(5) Status Indicators from Medicare’s Addendum B apply as follows:

A Use another fee schedule instead of Addendum B, such as CFs listed in section 18-4, RBRVS RVUs, Ambulance Fee Schedule, or section 18-4(F)(2).

B Is not recognized for Outpatient Hospital Services bill type (12x and 13x) and therefore is not separately payable unless separate fees are applicable under another section of this Rule.

C The Division recognizes these procedures on an outpatient basis with prior authorization.

E Not generally reimbursable when submitted on any outpatient bill type. However, services could still be reasonable and necessary, thus requiring hospital or ASC level of care. The billing party shall submit documentation to substantiate the billed service codes and any similar established codes with fees in Addendum A, as incorporated by 18-2.

F Corneal tissue acquisition, certain CRNA services, and Hepatitis B vaccines are allowed at a reasonable cost to the facility. The facility must provide a separate invoice identifying its cost.

G “Pass-Through Drugs and Biologicals”; separate APC H “Pass-Through Device”; separate APC payment based on cost to the facility.

J1 or J2 The services are paid through a comprehensive APC.

K “Nonpass-Through Drug or Biological or Device” for therapeutic radiopharmaceuticals, brachytherapy sources, blood and blood products; separate APC L Influenza Vaccine/Pneumococcal Pneumonia Vaccine and therefore is generally considered to be unrelated to work injuries.

M Not separately payable.

N Items and services packaged into APC rates; not P Partial hospitalization paid based on observation fees outlined in this section.

Q1-Q4 Packaged services subject to separate payment criteria.

R Blood and blood products; separate APC payment.

S Significant procedure, not discounted when multiple.

T Significant procedure, multiple procedure reduction applies.

U Brachytherapy source; separate APC payment.

V Clinic or an ED visit; separate APC payment.

Y Non-implantable Durable Medical Equipment paid pursuant to Medicare’s Durable Medical Equipment Regional Carrier fee schedule for Colorado.

(6) Multiple Procedures (a) A comprehensive APC treats all individually reported codes as representing components of the comprehensive service, resulting in a single prospective payment.

As defined by status indicator J1, all covered outpatient services on the claim are packaged with the primary J1 service for payment, except services with a status indicator of F, G, H, L, or U; ambulance services; diagnostic and screening mammography; rehabilitation therapy services reported on a separate claim; new technology services; and self-administered drugs.

When multiple codes with J1 status indicators are included on the claim, services are packaged with the primary (highest APC value) J1 code. Certain J1 codes, when billed together, may be eligible for a complexity adjusted APC payment listed on Medicare’s Addendum J, as incorporated by 18-2.

Services with a status indicator J2 are assigned to a comprehensive APC (8011) when specific combinations of services are reported on the claim. All levels of emergency department (ED) and clinic visits, if billed in combination with observation time, can trigger this comprehensive composite rate. Payment of APC 8011 requires a minimum of eight units of G0378 hospital observation service, per hour; no status T procedure on the claim; and either an E/M visit on the same day or day before the G0378 date of service; or G0379 direct admit to observation.

All covered services on the claim shall be considered adjunct to APC 8011 and packaged into a single payment, except those items excluded by rule. Other excluded services include covered screening procedures, preventative services, pass-through drugs and devices (status indicator G or H), PT, OT, and SLP services reported on a separate claim, certain vaccines (status indicator L or F), corneal tissue acquisition, and new technology APCs with status indicator S. If the claim contains a J1 primary service, the J1 C- APC will be the composite under which the services will be paid. There is no complexity adjustment for J2 occurring on the same claim as J1.

If services with a J2 status indicator are provided during an extended assessment and management encounter, including observation care, and do not meet all the requirements for APC 8011 listed above, the outpatient status indicator converts to V and usual APC logic will apply.

(b) Codes with a status Q1 indicator are packaged with the APC assigned status indicator J1, J2 (APC 8011), S, T, or V.

Otherwise, payment is made through a separate APC.

Codes with a Q2 indicator are packaged with the APC assigned status indicator T, J1 or J2 (APC 8011). Otherwise, payment is made through a separate APC. When multiple codes with status Q1 or Q2 are billed together, only one unit of the highest-valued Q1 or Q2 code is payable.

Codes with a status Q3 indicator may be paid through a composite APC if billed with another code in the same family listed in Table 6 (OPPS Imaging Families and Multiple Imaging Procedure Composite APCs of the 2025 OPPS Final Rule. The five multiple imaging composite APCs are:

• APC 8004 (Ultrasound Composite);

• APC 8005 (CT and CTA without Contrast Composite);

• APC 8006 (CT and CTA with Contrast Composite);

• APC 8007 (MRI and MRA without Contrast Composite); and • APC 8008 (MRI and MRA with Contrast Composite).

Each imaging composite APC is defined as having two or more imaging procedures from the same family performed on the same date of service. If a “without contrast” procedure is performed during the same session as a “with contrast” procedure from the same family, payment would be based on the “with contrast” composite APC. Standard APC assignments apply for single imaging procedures and multiple imaging procedures performed across families.

Codes with a status Q4 indicator are packaged with the APC assigned status indicator J1, J2 (APC 8011), S, T, V, Q1, Q2, or Q3. Otherwise, these codes are reimbursed using laboratory or therapy fee schedule, as applicable.

(c) The maximum allowance for multiple procedures with a T status indicator is limited to four procedure codes per episode. The highest valued APC code is allowed at 100% of the maximum allowance, plus 50% of the maximum allowance for the following three highest valued codes.

(i) The use of modifier 51 is not a factor in determining which codes are subject to multiple procedure reductions.

(ii) Bilateral procedures require each procedure to be billed on separate lines using RT and LT modifier(s).

(iii) When a code is billed with multiple units, multiple procedure reductions apply to the second through fourth units as appropriate. Units may also be subject to other maximum frequency per day policies.

(7) Other surgical payment policies:

(a) All surgical procedures performed in one operating room, regardless the number of surgeons, are considered one outpatient surgical episode of care for payment purposes.

(b) Discontinued surgeries require the use of modifier 73 (discontinued prior to the administration of anesthesia) or modifier 74 (discontinued after administration of anesthesia).

Modifier 73 results in an allowance of 50% of the APC value for the primary procedure only. Modifier 74 allows 100% of the primary procedure value only. If a comprehensive APC procedure is discontinued or reduced and modifier 52, 73 or 74 is reported, complexity adjustment will not apply to the claim.

(c) Facilities shall report G0260 when billing for sacroiliac joint injections, not CPT® 27096.

(8) Emergency Department (ED) Visits:

(a) Types of ED Visits:

(i) Hospitals billing type “A” ED visits must be physically located within a hospital licensed by the CDPHE as a general hospital or meet the out-of-state facility’s state’s licensure requirements, and be open 24 hours a day, seven days a week. These EDs bill using revenue code 450 and applicable CPT® codes;

(ii) Hospitals billing type “B” ED visits must have operations and staffing equivalent to a licensed ED, be physically located inside a hospital, and meet Emergency Medical Treatment and Active Labor Act (EMTALA) regulations. All type “B” outpatient ED visits must be billed using revenue code 456 with level of care HCPCS codes G0380-G0384, even though the facility may not be open 24 hours a day, seven days a week.

(b) ED level of care is identified based upon one of five levels of care for either a type “A” or type “B” ED visit. The level of care is defined by CPT® E/M code descriptions and internal level of care guidelines developed by the hospital in compliance with Medicare regulations. The hospital’s guidelines should establish an appropriate gradation of hospital resources (ED staff and other resources) as the level of service increases. Upon request, the Provider shall supply a copy of its level of care guidelines to the Payer.

(Only the higher one of any ED levels or critical care codes shall be paid).

(c) Trauma activation means a trauma team has been activated, not just alerted. Trauma activation is billed with 068X revenue codes. The level of trauma activation shall be determined by CDPHE’s assigned hospital trauma level designation. Trauma activation fees are in addition to ED and inpatient fees and are not paid for alerts. APC 5045, Trauma Response with Critical Care, is not recognized for separate payment.

Trauma activation allowances are as follows:

Revenue Code 681 $5,645 Revenue Code 682 $2,344 Revenue Code 683 $1,315 Revenue Code 684 $973 (9) Ancillary Services:

(a) Any diagnostic testing, clinical labs, or therapies with a status indicator of “A” shall be reimbursed using section 18- 4(F)(2) or the appropriate CF to the unit values for the specific CPT® code as listed in the RBRVS. Hospital bill types 13x are allowed payment for any clinical laboratory services (even if the SI is “N” for the specific clinical laboratory CPT® code) when these laboratory services are unrelated to any other outpatient services performed that day. Off-campus freestanding imaging centers are reimbursed using the RBRVS TC value(s).

(b) Professional fees are reimbursed in accordance with section 18-4 regardless of the facility type. Additional reimbursement is payable for the following services not included in the APC values, as incorporated by 18-2:

(i) ambulance services (revenue code 540), see section 18-6(D)

(ii) blood, blood plasma, platelets (revenue codes 380X)

(iii) physician or physician assistant services (iv) nurse practitioner services (v) licensed clinical psychologist (vi) licensed social workers (vii) rehabilitation services (PT, OT, respiratory or CCC- SLP, revenue codes 420, 430,440)

(c) Any prescription for a drug supply to be used for longer than 24 hours, filled at any clinic, shall be reimbursed in accordance with section 18-6(C).

(d) Clinic facility fees are not separately payable unless otherwise specified in this Rule.

(e) IV infusion therapy performed in an outpatient hospital facility is separately payable in accordance with this section.

(10) Rural Health Clinics:

Rural Health Clinics are allowed a single separate clinic facility fee at 80% of billed charges per date of service.

Allowed revenue codes for clinic fees are 521 for physical health services and 900 for behavioral health services.

(C) URGENT CARE FACILITIES

(1) Provider Restrictions:

Facility fees are only payable if the facility qualifies as an Urgent Care facility. All Urgent Care facilities shall be accredited or certified by the Urgent Care Association (UCA) or accredited by the Joint Commission to be recognized for a separate facility payment for the initial visit.

(2) Billing and Maximum Allowances:

(a) Facility Fees:

(i) No separate facility fees are allowed for follow-up care. To receive a separate facility fee, a subsequent diagnosis shall be based on a new acute care situation and not the initial diagnosis.

(ii) No facility fee is appropriate when the injured worker is sent to the employer's designated Provider for a non-urgent episode of care during regular business hours of 8 am to 5 pm, Monday through Friday.

(iii) Hospital and non-hospital based urgent care facilities may bill one unit of the facility fee, HCPCS code S9088, $78.03, using an 837P file or the CMS-1500 Form with professional services. All other services and procedures provided in an urgent care facility, including a freestanding facility, are allowed according to the appropriate CPT® code relative weight from RBRVS multiplied by the appropriate CF.

(b) All professional fees shall be billed using an 837P file or the CMS-1500 Form with a Place of Service Code 20 and reimbursed in accordance with section 18-4.

(c) All supplies are included in the facility fee.

(d) Any prescription for a drug to be used for longer than 24 hours, filled at any clinic, shall be reimbursed in accordance with section 18-6(C).

18-6 ANCILLARY SERVICES

(A) DURABLE MEDICAL EQUIPMENT, PROSTHETICS, ORTHOTICS, AND

SUPPLIES (DMEPOS)

(1) Durable Medical Equipment (DME):

DME equipment withstands repeated use and allows injured workers accessibility in the home, work, and community. DME can be categorized as:

(a) Purchased Equipment/Capped Rental:

Items that cost $100.00 or less may not be rented.

Rented items must be purchased or discontinued after ten months of continuous use or once the total fee schedule allowance has been reached.

The monthly rental rate cannot exceed 10% of the DMEPOS fee schedule, or if not available, the cost of the item to the Provider or the supplier (after taking into account any discounts/rebates the supplier or the Provider may have received). When the item is purchased, all rental fees shall be deducted from the total fee scheduled price. If necessary, the parties should use an invoice to establish the purchase price.

Purchased items may require maintenance/servicing agreements or fees. The fees are separately payable.

Rented items typically include these fees in the monthly rental rates.

The Division recognizes modifiers NU, UE, and RR. Modifier UE shall be appended for used purchased items and modifier RR for rented items.

(b) Take Home Exercise Equipment:

Items with a total invoice cost of $50 or less may be billed using A9300 at no more than 120% of actual cost, without an invoice. Reimbursement shall be based on billed charges.

Payers reserve the right to retroactively review invoices to validate the Provider’s cost, per Rule 16. Home exercise supplies can include, but are not limited to the following items: therabands, theratubes, band/tube straps, theraputty, bow-tie tubing, fitness cables/trainers, overhead pulleys, exercise balls, cuff weights, dumbbells, ankle weight bands, wrist weight bands, hand squeeze balls, flexbars, digiflex hand exercisers, power webs, plyoballs, spring hand grippers, hand helper rubber band units, ankle stretchers, rocker boards, balance paws, and aqua weights.

(c) Electrical Stimulators:

Electrical stimulators are bundled kits that include the portable unit(s), two to four leads and pads, initial battery, electrical adapters, and carrying case. Kits that cost more than $300.00 shall be rented for the first month of use and require documentation of effectiveness prior to purchase (effectiveness means functional improvement and decreased pain).

TENS (Transcutaneous Electric Nerve Stimulator) machines/kits, IF (Interferential) machines/kits, and any other type of electrical stimulator combination kits: E0720 for a kit with two leads or E0730 for a kit with four leads.

Electrical Muscle Stimulation machines/kits: E0744 for scoliosis; or E0745 for neuromuscular stimulator, electric shock unit.

Osteogenesis electrical stimulators (E0747-E0760) are not required to be rented before purchase when used in accordance with MTG recommendations.

Replacement supplies are limited to once per month and are not eligible with a first month rental.

A4595 - electrical stimulator supplies, two leads.

A4557 - lead wires, pair (reimbursable once every 12 months).

Conductive Garments: E0731.

(d) Continuous Passive Motion Devices (CPMs):

These devices are bundled into the facility fees and are not separately payable, unless the MTGs recommend their use after discharge for the particular condition.

E0935 – continuous passive motion exercise device for use on the knee only.

E0936 – continuous passive motion exercise device for use on body parts other than knee.

(e) Intermittent Pneumatic Devices:

These devices (including, but not limited to, cold with compression) are bundled into facility fees and are not separately payable. The use of these devices after discharge requires prior authorization.

E0650-E0676 – Codes based on body part(s), segmental or not, gradient pressure and cycling of pressure, and purpose of use.

A4600 – Sleeve for intermittent limb compression device, replacement only, per each limb.

(f) Hearing and Vision Supplies:

These items are purchased. The maximum allowance is 120% of the cost to the Provider as indicated by invoice. The maximum allowance for V2623 (prosthetic eye) and L8045 (auricular prosthesis) shall be based on 120% of the cost of the item as indicated by invoice.

(2) Orthotics:

Maximum allowance for any orthotic created using casting materials shall be determined using Medicare’s Q codes and values listed under Medicare’s DMEPOS fee schedule. The therapist time necessary to create the orthotic shall be billed using CPT® 97760.

Payment for professional services associated with the fabrication and/or modification of orthotics, custom splints, adaptive equipment, and/or adaptation and programming of communication systems and devices shall be paid in accordance with the Colorado Medicare HCPCS Level II values.

(3) Supplies:

Supplies necessary to perform a service or procedure are not separately reimbursable. Only supplies that are not an integral part of a service or procedure are considered to be over and above those usually included in the service or procedure. Allowances for supplies to facilities shall comply with the appropriate section of this

Rule.

(4) Reimbursement:

Unless other limitations exist in this Rule, the maximum allowance for DMEPOS suppliers and medical Providers shall be based on Medicare’s HCPCS Level II codes, RBRVS status codes as incorporated by section 18-4(A)(3)(c), and DMEPOS fee schedule as incorporated by section 18-2. If the non-rural fee schedule lists a value for a payable code but the rural fee schedule lists $0, the non-rural value shall be used.

If no Medicare value exists, the maximum allowance shall be based on the total allowable amount listed in Medicaid’s fee schedule, as incorporated by section 18-2.

If no Medicaid fee schedule value exists, the maximum allowance is based on 120% of the cost of the item as indicated by invoice. For inventorial items, “invoice” means a statement given to the Provider by its supplier showing the Provider’s cost of obtaining the item. For fabricated/customized items, “invoice” means a statement prepared by the Provider showing the amount due after accounting for fabrication and necessary customization. The invoice must be dated 24 months or less from the date of service. Shipping and handling charges and sales tax are not separately payable. Payers shall not recognize the KE modifier.

Auto-shipping of monthly DMEPOS is not allowed. An affirmative request by the injured worker or prescribing Provider is required.

(5) Complex Rehabilitation Technology dispensed and billed by Non- Physician DMEPOS Suppliers:

(a) Complex rehabilitation technology (CRT) items, including complex rehabilitation power wheelchairs, highly configurable manual wheelchairs, adaptive seating and positioning systems, standing frames, and gait trainers enable individuals to maximize their function and minimize the extent and costs of their medical care.

(b) Complex Rehabilitation Technology products must be provided by suppliers who are specifically accredited by a Center for Medicare and Medicaid Services (CMS) deemed accreditation organization as a supplier of CRT and licensed as a DMEPOS Supplier with the Colorado Secretary of State.

(B) HOME CARE SERVICES

Prior authorization is required for all home care services, unless otherwise specified. All skilled home care service Providers shall be licensed by the Colorado Department of Public Health and Environment (CDPHE) as Type A or B Providers. The Payer and the home health entity should agree in writing on the type of care, the type and skill level of Provider, frequency of care, duration of care at each visit, and any financial arrangements to prevent disputes.

(1) Home Infusion Therapy:

The per day or refill rates for home infusion therapy shall include all reasonable and necessary products, equipment, IV administration sets, supplies, supply management, and delivery services necessary to perform the infusion therapy. Per diem rates are only payable when licensed professionals (RNs) are providing “reasonable and necessary” skilled assessment and evaluation services in the injured worker’s home.

Skilled Nursing fees are separately payable when the nurse travels to the injured worker’s home to perform initial and subsequent evaluation(s), education, and coordination of care.

(a) Parenteral Nutrition:

Code Quantity Max Bill Frequency Daily Rate S9364 <1 Liter once per day $163.20 S9365 1 liter once per day $177.48 S9366 1.1 - 2.0 liter once per day $240.00 S9367 2.1 - 3.0 liter once per day $272.40 S9368 > 3.0 liter once per day $304.80 The daily rate includes the standard total parenteral nutrition (TPN) formula. Lipids, specialty amino acid formulas, and drugs other than those in standard formula are separately payable under section 18-6(C).

(b) Antibiotic Therapy is allowed a daily rate by professional + drug cost at Medicare’s Average Sale Price (ASP), as incorporated by Rule 18-2. If ASP is not available, use Average Wholesale Price (AWP) (see section 18-6(C)).

Code Time Max Bill Frequency Daily Rate S9494 Per diem once per day $161.16 S9497 once every 3 once per day $155.04 S9500 every 24 hrs. once per day $98.94 S9501 once every 12 once per day $112.20 S9502 once every 8 once per day $124.44 S9503 once every 6 once per day $136.68 S9504 once every 4 once per day $148.92 (c) Chemotherapy is allowed a daily rate + drug cost at ASP, as S9329 Administrative Services once per day $0.00 S9330 Continuous (24 hrs. or more) chemotherapy once per day $92.82 S9331 Intermittent (less than 24 hrs.) once per day $105.06 (d) Enteral nutrition (enteral formula and nursing services are separately payable):

S9341 Via Gravity once per day $44.97 S9342 Via Pump once per day $24.71 S9343 Via Bolus once per day $24.71 (e) Pain Management per day or refill + drug cost at ASP, as Continuous (24 hrs. or more) once per day $80.58 Intermittent (less than 24 hrs.) once per day $105.06 Implanted pump per diem $118.32/ref ill (f) Fluid Replacement is allowed a daily rate + drug cost at ASP, as incorporated by Rule 18-2. If ASP is not available, use A W P.

Code Quantity Max Bill Frequency Daily Rate S9373 < 1 liter per day once per day $62.22 S9374 1 liter per day once per day $86.70 S9375 >1 but <2 liters per day once per day $86.70 S9376 >2 liters but <3 liters once per day $86.70 S9377 >3 liters per day once per day $86.70 (g) Multiple Therapies:

Highest cost per day or refill only + drug cost at ASP, as (2) Nursing Services are limited to two hours without prior authorization, unless otherwise indicated in the MTGs:

Code Type of Nurse Max Bill Frequency Hourly Rate S9123 RN 2 hours $130.05 S9124 LPN 2 hours $130.05 S9122 CNA/Home Health Aide The amount of time spent with the injured worker must be specified in the medical records and on the bill. $51.00 (3) Physical medicine procedures are payable in accordance with

section 18-4(H).

(4) Mileage:

The parties should agree upon travel allowances and the mileage rate shall not exceed 63 cents per mile, portal to portal. DoWC Z0772.

(5) Travel Time:

Travel is typically included in the fees listed. Travel time for distances 50 miles or greater is allowed additional reimbursement not to exceed $36.08 per hour. DoWC Z0773.

(6) Drugs/Supplies/DME/Orthotics/Prosthetics Used for At-Home Care:

As defined in section 18-6(A), any drugs/supplies/DME/ Orthotics/Prosthetics integral to a professional’s service are not The maximum allowance for non-integral drugs/supplies/DME/ Orthotics/Prosthetics used during a professional’s home care visits are listed in section 18-6(A). All IV infusion supplies are included in the per diem or refill rates listed in this Rule.

(C) DRUGS AND MEDICATIONS

(1) All medications must be reasonably needed to cure and relieve the injured worker from the effects of the injury. Prior authorization is required for:

(a) Medications “not recommended” in the MTGs for a particular diagnosis; or (b) Any non-steroidal anti-inflammatory drug (NSAID), muscle relaxant, or topical agent for which a significantly lower-cost therapeutic equivalent is available, including commercially or over-the-counter (OTC), even in a different strength/dosage.

Significantly lower cost means the therapeutic equivalent costs at least $100 less, for the same number of days’ supply. For example, prior authorization would be required to dispense diclofenac gel 1.5% at an average wholesale price (AWP) of $689 when diclofenac 1% is available OTC for $10, or to dispense more than one unit of lidocaine 4.5%-menthol 5% patch at an AWP of $49 when a lidocaine 4%-menthol 5% patch can be obtained OTC for $2.

(2) Prescription Writing:

(a) This Rule applies to all pharmacies, whether located in or out of state.

(b) Physicians shall indicate on the prescription form that the medication is related to a workers’ compensation claim.

(c) All prescriptions shall be filled with bio-equivalent generic drugs unless the Physician indicates "Dispense as Written"

(DAW) on the prescription. In addition to the Rule 16 requirements, Providers prescribing a brand name with a DAW indication shall provide a written medical justification explaining the reasonableness and necessity of the brand name over the generic equivalent.

(d) The Provider shall not exceed a 60-day supply per prescription.

(e) Controlled substances and gabapentin shall only be provided through a pharmacy. The prescriber shall comply with applicable provisions of Title 12 and other statutes and rules.

(3) Non-Pharmacy Dispensing:

(a) Drugs name (brand or generic) shall be reported on bills using the applicable identifier from the National Drug Code (NDC) Directory as published by the Food and Drug Administration (FDA).

(b) Dispensing Provider shall bill by using the metric quantity (number of tablets, grams, or mls) in segment SV104 or item 24.G and shall specify the NDC number of the drug being dispensed or, if one does not exist, the HCPCS supply code. For repackaged drugs, dispensing Provider shall list the “repackaged” and the “original” NDC numbers in segment SV101 or item 24. The dispensing Provider shall list the “repackaged” NDC number of the actual dispensed medication first and the “original” NDC number second, with the prefix ‘ORIG’ appended. Billing Providers shall include the units and days supply for all dispensed medications in segment PWK or item 19, example: ‘60UN/30DY.’ (c) Dispensing Provider shall keep a signature on file indicating the injured worker or the injured worker’s authorized representative has received the prescription.

(4) Average Wholesale Price (AWP):

(a) AWP for brand name and generic pharmaceuticals may be determined using such monthly publications as Red Book Online or Medispan. In case of a dispute on AWP values for a specific NDC, the parties shall take the lower of their referenced published values.

(b) If published AWP data becomes unavailable, substitute Wholesale Acquisition Cost (WAC) + 20% for AWP everywhere in this Rule.

(5) Reimbursement for Prescription Drugs & Medications:

(a) For prescription medications, except topical compounds, reimbursement shall be AWP + $4.00. If drugs have been repackaged, use the original AWP and NDC that was assigned by the source of the repackaged drugs to determine reimbursement.

(b) The entity packaging two or more products together makes an implied claim that the products are safe and effective when used together and shall be billed as individual line items identified by their original AWP and NDC. This original AWP and NDC shall be used to determine reimbursement.

Supplies are considered integral to the package are not separately reimbursable.

(c) Reimbursement for an opiate antagonist prescribed or dispensed under §12-30-110 to an injured worker at risk of experiencing an opiate-related drug overdose event, or to a family member, friend, an employee or volunteer of a harm reduction organization, or other person in a position to assist the injured worker shall be AWP plus $4.00.

(d) Injectables shall be reimbursed at Medicare’s Part B Drug Average Sale Price (ASP), as incorporated by Rule 18-2, unless the ASP value does not exist for the drug or the Provider’s actual cost exceeds the ASP. In this circumstance, Provider may request reimbursement based on the actual cost, after taking into account any discounts/rebates the Provider may have received.

(e) The Provider may bill for the discarded portion of drug from a single use vial or a single use package, appending the JW modifier to the HCPCS Level II code. The Provider shall bill for the discarded drug amount and the amount administered to the injured worker on two separate lines. The Provider must document the discarded drug in the medical record.

(6) Prescription-Strength Topical Compounds:

In order to qualify as a compound under this section, the medication must require a prescription; the ingredients must be combined, mixed, or altered by a licensed pharmacist or a pharmacy technician being overseen by a licensed pharmacist, a licensed Physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist; and it must create a medication tailored to the needs of an individual patient. All topical compounds shall be billed using the DoWC Z code corresponding with the applicable category as follows:

Category I Z0790, $84.89 per 30 day supply of any antiinflammatory medication or any local anesthetic single agent.

Category II Z0791, $169.79 per 30 day supply of any antiinflammatory agent or agents in combination with any local anesthetic agent or agents.

Category III Z0792, $281.22 per 30 day supply of any single agent other than anti-inflammatory agent or local anesthetic, either alone, or in combination with anti-inflammatory or local anesthetic agents.

Category IV Z0793, $392.65 per 30 day supply of two or more agents that are not anti-inflammatory or local anesthetic agents, either alone or in combination with other anti-inflammatory or local anesthetic agents.

All ingredient materials must be listed by quantity used per prescription. If the MTGs approve some but not all of the active ingredients for a particular diagnosis, the insurer shall count only the number of the approved ingredients to determine the applicable category. In addition, initial prescription containing the approved ingredients shall be reimbursed without a medical review.

Continued use (refills) may require documentation of effectiveness including functional improvement.

Category allowances include materials, shipping and handling, and time. Regardless of how many ingredients or what type, compounded drugs cannot be reimbursed higher than the Category IV allowances. The 30 day maximum allowance value shall be fractioned down to the prescribed and dispensed amount given to the injured worker. Automatic refilling is not allowed.

(7) Over-the-Counter Medications:

(a) Medications that are available for purchase by the general public without a prescription and listed as over-the-counter in publications such as RedBook Online or Medispan, are reimbursed at NDC/AWP and are not eligible for dispensing fees. If drugs have been repackaged, use the original AWP and NDC that was assigned by the source of the repackaged drugs to determine reimbursement.

(b) The maximum allowance for any topical agent containing only active ingredients available without a prescription shall be at cost to the billing Provider up to $31.21 per 30 day supply for any application (excludes patches). The maximum allowance for a patch is cost to the billing Provider up to $72.83 per 30 day supply. When less than a 30 day supply is prescribed, these allowances shall be pro-rated to the amount dispensed to the injured worker.

(8) Dietary Supplements, Vitamins, and Herbal Medicines:

Reimbursement for outpatient dietary supplements, vitamins, and herbal medicines is authorized only by prior agreement of the Payer or if specifically indicated in the MTGs. Reimbursement shall be at cost to the injured worker (see subsection (9) below).

(9) Injured Worker Reimbursement:

In the event the injured worker has directly paid for authorized medications (prescription or over-the-counter), the Payer shall reimburse the injured worker for the amount actually paid within 30 days after submission of the injured worker’s receipt. See Rule 16.

(D) AMBULANCE TRANSPORTATION

(1) Maximum Allowance:

The maximum allowance for medical transportation consists of a base rate and a payment for mileage. Both the transport of the injured worker and all items and services associated with such transport are included in the base rate and mileage rate.

(2) General Claims Submission:

(a) All hospitals billing for ground or air ambulance services shall bill using an 837I file or a UB-04 Form. All other Providers shall bill using an 837P file or the CMS-1500 Form.

(b) Providers shall use HCPCS codes and origin/destination modifiers.

(c) Providers shall list their name, complete address, and NPI number.

(d) Providers shall list the zip code for the place of origin with an “AO” code. If billing for multiple trips and the zip code for each origin is the same, services can be submitted on the same claim. If the zip codes are different, a separate claim must be submitted for each trip.

(3) Ground Ambulance Services Billing Codes and Fees:

The selection of the base code is based upon the condition of the injured worker at the time of transport, not the vehicle used, and includes services and supplies used during the transport.

HCPCS URBAN

BASE RATE/

URBAN

RURAL BASE

RATE/

RURAL BASE

RATE/ SUPER

GROUND MILES 1- 17

A0425 $18.30 $18.48 n/a $27.72 A0426 $708.28 $715.22 $876.86 n/a A0427 $1,121.44 $1,132.44 $1,388.38 n/a A0428 $590.24 $596.02 $730.72 n/a A0429 $944.38 $953.64 $1,169.16 n/a A0432 $1,032.90 $1,043.04 n/a n/a A0433 $1,623.14 $1,639.06 $2,009.48 n/a A0434 $1,918.26 $1,937.06 $2,374.84 n/a The “urban” base rate(s) and mileage rate(s) shall apply to all relevant/applicable ambulance services unless the zip code range area is “Rural” or “Super Rural.” Medicare MSA zip code grouping is listed on Medicare’s webpage with an “R” indicator for “Rural” and “B” indicator for “Super Rural.” See Medicare’s Zip Code to Carrier Locality File, revised May 2025.

(4) Modifiers:

HCPCS modifiers identify place of origin and destination of the trip.

The modifier is to be placed next to the HCPCS code billed. Each of the modifiers may be utilized to make up the first and/or second half of a two-letter modifier. The first letter describes the origin of the transport, and the second letter describes the destination.

(5) Mileage:

Charges for mileage must be based on loaded mileage only, i.e., from pickup to destination.

18-7 DIVISION-ESTABLISHED CODES AND VALUES

(A) FACE-TO-FACE OR TELEPHONIC MEETINGS

(1) Face-to-face or telephonic meeting by a treating Physician or a Psychologist with an employer, claim representative, or any attorney, and with or without the injured worker. Claim representatives include physicians or other qualified medical personnel performing Payer-initiated medical treatment reviews, but this Rule does not apply to Provider-initiated requests for prior authorization. The Physician or Psychologist may bill for the time spent attending the meeting and preparing the report (no travel time or mileage is separately payable). The fee includes the cost of the report for all parties, including the injured worker.

Before a meeting is separately payable, the following requirements must be met:

(a) Each meeting (including the time to document) shall be a minimum of 8 minutes.

(b) A report or written record signed by the Physician or Psychologist is required and shall include the following:

(i) Who was present at the meeting and their role at the meeting;

(ii) Purpose of the meeting;

(iii) A brief statement of recommendations and actions at the conclusion of the meeting;

(iv) Documented time (both start and end times).

(c) DoWC Z0701, $45.10, is payable in 8-minute increments.

The CPT® mid-point rule for attaining a unit of time does not apply to this code. The Physician or Psychologist may bill multiple units of this code per date of service.

(d) For reimbursement to qualified non-Physician Providers for coordination of care with medical professionals, see section 18-4(H).

(2) Face-to-face or telephonic meeting by a non-treating Physician with the employer, claim representatives, or any attorney in order to provide a medical opinion on a specific workers’ compensation case, which is not accompanied by a specific report or written record.

DoWC Z0601, $78.53 per 15 minutes billed to the requesting party.

(3) Face-to-face or telephonic meeting by a non-treating Physician with the employer, claim representatives, or any attorney to provide a medical opinion on a specific workers’ compensation case, which is accompanied by a report or written record, shall be billed as a special report (see section 18-7(G)(4)).

(4) (1) Peer-to-peer review by a treating Physician with a medical reviewer, following the treating Physician’s complete prior authorization request pursuant to Rule 16.

DoWC Z0602, $78.53 per 15 minutes billed to the requesting party.

(B) CANCELLATION FEES FOR PAYER-MADE APPOINTMENTS

(1) A cancellation fee is payable only when a Payer schedules an appointment the injured worker fails to keep, and the Payer has not canceled five days prior to the appointment.

The Payer shall pay one-half of the usual fee for the scheduled services, or $191.02, whichever is less:

DoWC Z0720. The Provider shall indicate the code corresponding to the service that has been cancelled in segment PWK in an 837P file or item 19 of the CMS-1500 Form.

For Payer-made appointments scheduled for four hours or longer, the Payer shall pay one-half of the usual fee for the scheduled service.

DoWC Z0740. The Provider shall indicate the code corresponding to the service that has been cancelled in segment PWK in an 837P file or item 19 of the CMS-1500 Form.

(2) Missed Appointments:

When an injured worker fails to keep a scheduled appointment, the Provider should contact the Payer within five days. Upon reporting the missed appointment, the Provider may inquire if the Payer wishes to reschedule the appointment for the injured worker. If the injured worker fails to keep the Payer’s rescheduled appointment, the Provider may bill for a cancellation fee according to this section.

(C) REQUESTS FOR MEDICAL RECORDS AND COPYING FEES

The Payer, Payer's representative, injured worker, and injured worker's representative shall pay a reasonable fee for the reproduction of the injured worker's medical record. Copying charges do not apply for the initial submission of records that are part of the required documentation for billing. If records are readily producible electronically and appropriate security is in place, including but not limited to compatible encryption, the Provider shall provide the requestor with an electronic copy (e.g., email). If the requester and Provider agree, the copy may be provided by fax, on paper, or by disc. Provider may not charge a fee for a records search and retrieval. All records shall be provided no later than 30 days from the date the request is received.

Copying Fee Billing Codes and Maximum Fees:

DoWC Z0721, $18.90 for first 10 or fewer paper page(s), including faxed documents DoWC Z0725, $0.88 per paper page for the next 11-40 paper page(s), including faxed documents DoWC Z0726, $0.58 per paper page for remaining paper page(s), including faxed documents DoWC Z0727, $1.53 per microfilm page DoWC Z0728, $14.28 per computer disc DoWC Z0729, $6.50 per electronic copy DoWC Z0802, actual postage paid (D) DEPOSITION AND TESTIMONY FEES (1) If the parties cannot agree upon lesser fees for the deposition or testimony services, or cancellation time periods and/or fees, the deposition and testimony rules and fees listed below shall be used.

If a party shows good cause to an Administrative Law Judge (ALJ) for exceeding the Medical Fee Schedule allowance, that ALJ may allow a greater fee.

(2) Preparation Time:

By prior agreement, the Provider may charge for preparation time for a deposition or testimony, for reviewing and signing the deposition, or for preparation time for testimony.

Treating or non-treating Physician or Psychologist:

DoWC Z0730, $194.55, billed in half-hour increments. Other Providers are allowed 85% of this fee.

(3) Deposition:

Payment for testimony at a deposition shall not exceed $194.55, billed in half-hour increments, for a treating or non-treating Physician or a Psychologist. DoWC Z0734, calculating the Provider’s time from "portal to portal." Other Providers are allowed 85% of this fee.

If requested, the Provider is entitled to a full hour deposit in advance in order to schedule the deposition.

If the Provider is notified of the cancellation of the deposition at least ten days prior to the scheduled deposition, the Provider shall be paid the number of hours that have been reasonably spent in preparation, less any deposit paid by the deposing party. DoWC Z0731, $194.55, in half-hour increments.

If the Provider is notified less than ten days in advance of a cancellation or rescheduling, or the deposition is shorter than the time scheduled, the Provider shall be paid the number of hours that have been reasonably spent in preparation and have been scheduled for the deposition. DoWC Z0733, $194.55 in half-hour increments.

(4) Testimony:

Treating or non-treating Physician or Psychologist:

DoWC Z0738, $269.46, billed in half-hour increments. Other Providers are allowed 85% of this fee.

Calculation of the Provider’s time shall be "portal to portal” (includes travel time and mileage in both directions).

For testifying at a hearing, if requested, the Provider is entitled to a four-hour deposit in advance in order to schedule the testimony.

If the Provider is notified of the cancellation of the testimony at least ten days prior to the scheduled testimony, the Provider shall be paid the number of hours that have been reasonably spent in preparation, less any deposit paid by the requesting party. DoWC Z0735, $269.46, in half-hour increments.

If the Provider is notified less than ten days in advance of a cancellation or rescheduling, or the testimony is shorter than the time scheduled, the Provider shall be paid the number of hours that have been reasonably spent in preparation and has scheduled for the testimony. DoWC Z0737, $269.46, in half-hour increments.

(E) INJURED WORKER TRAVEL EXPENSES

The Payer shall advance or reimburse the injured worker for reasonable and necessary mileage expenses for travel to and from medical appointments. The injured worker shall submit a request to the Payer showing the date(s) of travel and mileage, incurred or anticipated, and explain any other reasonable and necessary travel expenses. The number of miles shall be in whole numbers and calculated using the most direct route available on the date of service. Advance mileage is available for eligible travel greater than 100 miles round trip, and shall be approved when requested by the injured worker at least seven days in advance.

Mileage Pre-paid Expense: DoWC Z0722, 63 cents per mile Mileage Expense: DoWC Z0723, 63 cents per mile Other Travel Expenses: DoWC Z0724, actual paid (F) PERMANENT IMPAIRMENT RATING (1) The Payer is only required to pay for one combined whole-person permanent impairment rating per claim, except as otherwise provided in the Workers' Compensation Rules of Procedures.

Exceptions that may require payment for an additional impairment rating include, but are not limited to, reopened cases, as ordered by the Director or an Administrative Law Judge, or a subsequent request to review apportionment. The ATP is required to submit in writing all permanent restrictions and future maintenance care related to the injury or occupational disease.

(2) Provider Restrictions:

The Physician determining the permanent impairment rating must be Level II accredited and comply with Rule 5 as applicable.

(3) Maximum Medical Improvement (MMI) Determined Without any Permanent Impairment:

If a Physician determines the injured worker is at MMI and has no permanent impairment, the Physician should be reimbursed for the examination at the appropriate level of E/M service. The ATP managing the total workers’ compensation claim should complete the Physician’s Report of Workers’ Compensation Injury (Closing Report), WC 164 (see section 18-7(G)(2)).

(4) MMI Determined with a Calculated Permanent Impairment Rating (a) Calculated Impairment: The total fee includes the office visit, a complete physical examination, complete history, review of all medical records except when the amount of medical records is extensive (see below), determining MMI, completing all required measurements, referencing all tables used to determine the rating, using all report forms from the AMA's Guide to the Evaluation of Permanent Impairment, Third Edition (Revised), (AMA Guides), and completing the Physician's Report of Workers’ Compensation Injury (Closing Report) WC 164.

Extensive medical records take longer than one hour to review and require a separate report. The separate report must document each record reviewed, specific details of the records reviewed, and the dates represented by the records reviewed. The separate record review can be billed as a special report and requires prior authorization.

(b) Impairments Requiring Multiple Providers:

All Physicians and Psychologists (including Level II Accredited Physicians) providing consulting services for the completion of a whole person impairment rating shall bill using the appropriate E/M consultation code, or psychological diagnostic evaluation code, and shall forward their portion of the rating to the Physician determining the combined whole person rating.

A return visit for a range of motion (ROM) validation shall be billed with the appropriate code in the Medicine Section of CPT®.

The date the Physician sees the injured worker shall be the date of service billed.

DoWC Z0759, $624.24, for the Level II Accredited Authorized Treating Physician providing primary care.

DoWC Z0760, $838.56, for the Referral, Level II Accredited Authorized Physician (the claimant is not a previously established patient to that Physician for that workers’ compensation injury).

DoWC Z0764, If the injured worker fails to attend the impairment rating appointment or if the parties notify the Physician of a cancellation or rescheduling five days or less prior to the appointment, the Physician shall be paid one-half of the fee for the scheduled service. The Physician shall indicate the code corresponding to the scheduled service in segment PWK in an 837P file or item 19 of the CMS-1500 Form.

(G) REPORT PREPARATION

(1) Routine Reports:

Providers shall submit routine reports free of charge as directed in

Rule 16 and by statute. Requests for additional copies of routine reports and for reports not in Rule 16 or statute are reimbursable under the copying fee section of this Rule. Routine reports include:

(a) Diagnostic testing (b) Procedure reports (c) Progress notes (d) Office notes (e) Operative reports (f) Supply invoices, if requested by the Payer (2) Completion of the Physician’s Report of Workers’ Compensation Injury:

(a) Initial Report WC 164:

The ATP and ED/urgent care Physician, when applicable, shall complete the first report of injury. Items 1-7 and 11 must be complete. However, item 2 may be omitted if not known by the Provider. If completed by a PA or NP, the ATP must countersign the Form.

DoWC Z0750 Initial Report $50.00 (b) Closing Report WC 164:

The ATP managing the workers’ compensation claim must complete the WC 164 closing report when the injured worker is at maximum medical improvement (MMI) for all covered injuries or diseases, with or without a permanent impairment.

Items 1-5, 6 B-C, 7 (if applicable), and 8-11 must be complete. If completed by a PA or NP, the ATP must countersign the Form.

DoWC Z0752 Closing Report $50.00 If the injured worker has sustained a permanent impairment, the following additional information must be attached to the bill when MMI is determined:

(i) All necessary permanent impairment rating reports, medical reports, and narrative relied upon by the ATP, when the ATP managing the workers’ compensation claim is Level II Accredited; or (ii) The name of the Level II Accredited Physician requested to perform the permanent impairment rating when a rating is necessary and the ATP managing the workers’ compensation claim is not determining the permanent impairment rating.

Initial and Closing Report WC 164 completed on the same Form for the same date of service: DoWC Z0753 $50.00 (c) Progress Report WC 164:

Any request from the Payer or the employer for the information provided on this Form is deemed authorization for payment. The Provider shall document the name of the person who made the request and the date of the request on the WC 164; complete items 1, 2, 4-7, and 11; and send it to all parties within five days of the request. If completed by a PA or NP, the ATP must countersign the Form.

DoWC Z0751 Progress Report $50.00 (3) Form Completion:

The requesting party shall pay for its request for a Physician to complete additional forms requiring 15 minutes or less, including forms sent by a Payer or an employer. This code also may be billed when completing the requirements outlined in § 8-43-404(10)(a) or Desk Aid 15 for a non-medical discharge.

DoWC Z0754 Form Completion $50.00 (4) Special Reports:

The term special report includes any form, questionnaire, letter, or report with variable content not otherwise addressed in Rule.

Examples include:

(a) treating or non-treating medical reviewers or evaluators producing written reports not otherwise addressed in this

Rule, or (b) meeting with and reviewing another Provider’s written record, and amending or signing that record.

The content and total payment shall be agreed upon by the Provider and the report's requester before the Provider begins the report.

Advance Payment: If requested, the Provider is entitled to a two hour deposit in advance in order to schedule a patient exam associated with a special report.

DoWC Z0755 Written Report, $97.28 billable in 15 minute increments DoWC Z0757 Lengthy Form, $97.28 billable in 15 minute increments DoWC Z0758 Meeting and Report with Non-treating Physician, $97.28 billable in 15 minute increments In cases of cancellation for special reports not requiring a scheduled patient exam, the Provider shall be paid for the time reasonably spent in preparation up to the date of cancellation.

DoWC Z0761 Report Preparation with Cancelled Patient Exam, $97.28 billable in 15 minute increments (5) Independent Medical Examinations (IMEs):

An IME is an objective medical examination of an injured worker performed by a Physician who has not previously treated the injured worker, in order to evaluate prior, current, or proposed treatment, or current condition. The Physician may refer a psychological component of the IME to a Psychologist and incorporate that evaluation into the IME report. In some circumstances, the IME Physician must be Level I or Level II accredited.

RIME: Respondent-requested Independent Medical Examination DoWC Z0756 RIME Report with patient exam, $97.28 billable in 15 minute increments

Section 8-43-404 requires RIMEs to be recorded in audio in their entirety and retained by the examining Physician for 12 months and made available by request to any party to the case.

DoWC Z0766 RIME Audio Recording, $36.41 per exam DoWC Z0767 RIME Audio Copying Fee, $24.97 per copy CIME: Claimant-requested Independent Medical Examination, $97.28 billable in 15 minute increments to the injured worker, DoWC Z0770 DIME: Division Independent Medical Examination, $97.28 billable in 15 minute increments, DoWC Z0768.

All IME reports must be served concurrently to all parties no later than 20 days after the examination. All IME reports must include an attestation that the billed charges comply with § 8-42-101(3)(a)(I) and Rule 16-8, as well as document the total time spent.

Cancellations:

In cases of a cancelled or rescheduled RIME or CIME, the Provider shall be paid the following fees:

If the Provider is notified of the cancellation of the RIME or CIME at least fourteen days prior to the scheduled examination, the Provider shall be paid the number of hours reasonably spent in preparation, less any deposit paid by the requesting party. DoWC Z0762, $97.28 billable in 15 minute increments.

If the Provider is notified less than fourteen days in advance of a cancelled or rescheduled RIME or CIME, the Provider shall be paid the number of hours reasonably spent in preparation and scheduled for the examination. DoWC Z0763, $97.28 billable in 15 minute increments.

(H) USE OF AN INTERPRETER

(1) Payers shall reimburse for the services of an interpreter when interpretation is reasonable and necessary to provide access to medical benefits. Interpreter services provided in a hospital or ambulatory surgery center are included in the facility reimbursement and are not separately payable.

An interpreter may be provided on-site or via video or audio remote interpreting service, based on availability and the preference of the treating Provider.

(2) Providers are prohibited from relying on minor children and should refrain from using adult family members and friends as interpreters, except in an emergency.

(3) Payment requirements:

(a) Interpreters for certifiable languages must be listed as certified on the Certification Commission for Healthcare Interpreters or National Board of Certification for Medical Interpreters website directory. Certifiable languages are:

• Spanish • Cantonese • Mandarin • Russian • Korean • Vietnamese • Arabic (b) For certifiable languages other than Spanish, Qualified interpreters may be used if a Certified interpreter is unavailable.

(c) For non-certifiable languages, the interpreter shall be qualified. Qualified means the interpreter has documentation showing completion of at least 40 hours of healthcare interpreter training.

(d) When a Certified Spanish interpreter is unavailable for the requested date and time, either on-site or via video or audio remote, the Provider may supply non-certified language assistance services in compliance with section 1557 of the Affordable Care Act. In this circumstance, interpreter services would not be eligible for separate reimbursement.

(e) Prior authorization is required for on-site interpreters except for initial and emergency treatment.

(4) Interpreters shall submit claims using the Interpreter Invoice Form or an 837P. The Invoice Form or electronic transaction shall include the individual interpreter’s NPI number at the line level. The codes and maximum allowances are:

(a) DoWC Z0710, Certified Spanish Interpreter, on-site, $15.00, billable in 15 minute increments with a minimum of one hour;

(b) DoWC Z0712, Interpreter for languages other than Spanish, on-site, rates shall be negotiated;

(c) HCPCS T1013, Sign Language, rates shall be negotiated;

(d) DoWC Z0713, On-Demand Video or Audio Remote Interpreting, all languages, $1.35 per minute, with no minimum.

(e) DoWC Z0773, Travel time for distances 50 miles or greater one-way is separately payable to on-site interpreters and shall not exceed $36.08 per hour.

(f) DoWC Z0772, Mileage is separately payable to on-site interpreters and shall not exceed 63 cents per mile. The reimbursement shall be calculated based on the actual number of miles driven portal to portal or the most direct route available on the date of service, whichever is less.

(g) If a prior authorized interpreter receives a cancellation notice less than 24 hours prior to the scheduled service, the Payer shall pay one-half of the usual fee for the scheduled service, or $191.02, whichever is less. DoWC Z0720, plus full reimbursement for incurred mileage and eligible travel time.

(h) The CPT® mid-point rule for attaining a unit of time applies to these codes, as well as the documentation requirements outlined in section 18-3(C)(4). Overlapping time may not be billed twice for the same injured worker. For example, if an interpreter attends a 15 minute chiropractic appointment, followed by a one hour physical therapy appointment, only 75 minutes is billable.

(I) GUARDIAN AD LITEM AND CONSERVATOR SERVICES

When reasonably necessary for employees who are legally incapacitated as a result of a work-related injury or occupational disease, the following services are allowed reasonable fees and costs as agreed upon by the parties:

Guardian ad litem Conservator Attorney/Paralegal The parties may submit an invoice or other agreed upon form for these services. If the parties are unable to agree on a reasonable fee, the parties may bring the matter before the Director for resolution.

18-8 DENTAL FEE SCHEDULE

The dental fee schedule is adopted using the American Dental Association’s CDT® as incorporated by section 18-2. However, surgical treatment for dental trauma and subsequent related procedures shall be billed using medical codes from RBRVS. If billed using RBRVS, reimbursement shall be in accordance with the values listed in the Surgery/Anesthesia section and the corresponding CF.

See Exhibit #3 for the listing and maximum allowance for CDT® codes.

Regarding prosthetic appliances, the Provider may bill and be reimbursed for 50% of the allowed fee at the time the master casts are prepared for removable prosthodontics or the final impressions are taken for fixed prosthodontics. The remaining 50% may be billed on insertion of the final prosthesis.

18-9 QUALITY INITIATIVES

(A) OPIOID MANAGEMENT

(1) Codes and maximum allowances are payable to the prescribing ATP for a written report with all the following opioid review services completed and documented:

(a) ordering and reviewing drug tests for subacute or chronic opioid management;

(b) ordering and reviewing Colorado Prescription Drug Monitoring Program (PDMP) results;

(c) reviewing the medical records;

(d) reviewing the injured worker’s current functional status;

(e) evaluating the risk of misuse and abuse initially and periodically; and (f) determining what actions, if any, need to be taken.

In determining the prescribed levels of medications, the ATP shall review and integrate the drug screening results required for subacute and chronic opioid management, as appropriate; the PDMP and its results; an evaluation of compliance with treatment and risk for addiction or misuse; as well as the injured worker’s past and current functional status. A written report also must document the ATP’s assessment of the injured worker’s past and current functional status of work, leisure, and activities of daily living.

The injured worker should initially and periodically be evaluated for risk of misuse or addiction. The ATP may consider whether the injured worker experienced an opiate-related drug overdose event that resulted in an opiate antagonist being prescribed or dispensed pursuant to § 12-30-110. If the injured worker is deemed to be at risk for an opiate overdose, an opioid antagonist may be prescribed (see section 18-6(C)(5)(c)).

Opioid Management Billing Codes:

Acute Phase: DoWC Z0771, $88.43, per 15 minutes, maximum of 30 minutes per report Subacute/Chronic Phase: DoWC Z0765, $88.43, per 15 minutes, maximum of 30 minutes per report (2) Definitions:

(a) Acute opioid use refers to the prescription of opioid medications (single or multiple) for duration of 30 days or less for non-traumatic injuries, or six weeks or less for traumatic injuries or post-operatively.

(b) Subacute opioid use refers to the prescription of opioid medications for longer than 30 days for non-surgical cases and longer than six weeks for traumatic injuries or postoperatively.

(c) Chronic opioid use refers to the prescription of opioid medications for longer than 90 days.

(3) Acute opioid prescriptions generally should be limited to three to seven days and 50 morphine milliequivalents (MMEs) per day.

Providers considering repeat opioid refills at any time during treatment are encouraged to perform the actions in this section and bill accordingly.

(4) When long-term opioid treatment is prescribed, the ATP shall comply with the Division’s Chronic Pain Disorder MTG (Rule 17, Exhibit #9), and review the Colorado Medical Board Policy #40-26, “Policy for Prescribing and Dispensing Opioids.”

(5) Urine drug tests are required for subacute and chronic opioid management and shall employ testing methodologies that meet or exceed industry standards for sensitivity, specificity, and accuracy.

The testing methodology must be capable of identifying and quantifying the parent compound and relevant metabolites of the opioid prescribed. In-office screening tests designed to screen for drugs of abuse are not appropriate for subacute or chronic opioid compliance monitoring. Refer to section 18-4(F)(3) for clinical drug screening testing codes and values.

(a) Drug testing shall be done prior to the initial long-term drug prescription being implemented and randomly repeated at least annually.

(b) While the injured worker is receiving opioid management, additional drug screens with documented justification may be conducted. Examples of documented justification include:

(i) Concern regarding the functional status of the injured worker;

(ii) Abnormal results on previous testing;

(iii) Change in management of dosage or pain; and (iv) Chronic daily opioid dosage above 50 MMEs.

(B) QUALITY PERFORMANCE AND OUTCOMES PAYMENTS (QPOP)

(1) Providers who are Level I or II Accredited and have successfully completed the QPOP training may bill separately for documenting functional progress made by the injured worker. Providers must utilize both a Division-approved psychological screen and a Division-approved functional tool. The psychological screen and the functional tool are approved by the Division and are validated for the specific purpose for which they have been created. Provider also must document whether the injured worker’s perception of function correlates with clinical findings. The documentation of functional progress should assist the Provider in preparing a successful plan of care, including specific goals and expected time frames for completion, or for modifying a prior plan of care. The documentation must include:

(a) Specific testing that occurred, interpretation of testing results, and the weight given to these results in forming a reasonable and necessary plan of care;

(b) Explanation of how the testing goes beyond the evaluation and management (E/M) services typically provided by the Provider;

(c) Meaningful discussion of actual or expected functional improvement between the Provider and the injured worker.

(2) Billing codes and maximum fees:

DOWC Z0815, $84.89, for the initial assessment during which the injured worker provides functional data and completes the validated psychological screen, which the Provider considers in preparing a plan of care. This code also may be used for the final assessment that includes review of the functional gains achieved during the course of treatment and documentation of MMI.

DOWC Z0816, $42.45, for subsequent visits during which the injured worker provides follow-up functional data that could alter the treatment plan. The Provider may use this code if the analysis of the data leads to a modification of the treatment plan. The Provider should not bill this code more than once every two to four weeks.

(3) QPOP for post-MMI patients requires prior authorization based on clearly documented functional goals.

(C) APP-BASED INTERVENTIONS

Providers may write an order for app-based interventions for the purpose of patient education and training to aid in curing and/or relieving the injured worker from the effects of the work injury. A duration for use shall be designated on the order and may be reordered as clinically indicated.

The app must be payable by invoice and billed directly to the Payer.

Providers who write such orders are not permitted to receive any remuneration from the service Provider for the referral. The maximum allowable charge is $25.50 per month and may be billed for a maximum duration of three months, or $76.50 per order. App-based interventions that exceed this allowance require prior authorization. Examples of appbased interventions include apps that utilize artificial intelligence to educate the user about pain neuroscience, chronic pain management, weight loss, mental well-being, glucose management, and home exercise routines.

(D) PILOT PROGRAMS

Payers may submit a proposal to conduct a pilot program(s) to the Director for approval. Pilot programs authorized by this Rule shall be designed to improve quality of care, determine the efficacy of clinical or payment models, and provide a basis for future development and expansion of such models.

The proposal for a pilot program shall meet the minimum standards set forth in § 8-43-602 and shall include:

(1) beginning and end date for the pilot program;

(2) population to be managed (e.g. size, specific diagnosis codes);

(3) Provider group(s) participating in the program;

(4) proposed codes and fees; and (5) process for evaluating the program’s success.

Participating Payers must submit data and other information as required by the Division to examine such issues as the financial implications for Providers and injured workers, enrollment patterns, utilization patterns, impact on health outcomes, system effects and the need for future health planning.

18-10 LIST OF EXHIBITS

Exhibit #1 - Evaluation and Management (E/M)

Exhibit #2 - Hospital Base Rates and Cost to Charge Ratios (CCRs)

Exhibit #3 - Dental Fee Schedule Exhibit #4 – APCs for Procedures with Status Indicator C When Performed in an OP Hospital or ASC ______________________________________________________________________

Editor's Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 17, Exhibit 1.

History [For history of this section, see Editor's Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R18 Ex 01 Rule 18, Exhibit 1 [Repealed eff. 01/01/2021] {#sec-7-ccr-1101-3-r18-ex-01 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R18 Ex 01}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Workers’ Compensation WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES MEDICAL FEE SCHEDULE 7 CCR 1101-3 Rule 18 - Exhibit 1 - Repealed eff. 01/01/2021 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 17, Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R18 Exhibits Rule 18, Exhibits {#sec-7-ccr-1101-3-r18-exhibits omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R18 Exhibits}

DEPARTMENT OF LABOR AND EMPLOYMENT

WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT

GUIDELINES

RULE 18 MEDICAL FEE SCHEDULE 7 CCR 1101-3 Rule 18, Exhibits [Editor’s Notes follow the text of the rules at the end of this CCR Document.] ______________________________________________________________________ Exhibit #1 Evaluation and Management - Medical Decision Making – Effective 1/1/2026 Number/Complexity of Problems Addressed (Chart A)

Only problems directly related to the injury and pertinent to the visit or treatment are counted. ⬜ 1 Self-limited / minor problem Self-limited or Minor Problem – A problem that runs a definite and prescribed course, is temporary in nature, and is not likely to permanently affect health status.

Stable, Chronic Illness - A problem with an expected duration of at least one year or until the death of the patient. For the purpose of defining chronicity, conditions are treated as chronic whether or not the stage or the severity changes (e.g., uncontrolled diabetes and controlled diabetes are a single chronic condition). ‘Stable’ for the purposes of categorizing MDM is defined by the specific treatment goals for an individual patient. A patient who is not at their treatment goal is not stable, even if the condition has not changed and there is no short- term threat to life or bodily function. For example, a patient with persistently poorly controlled blood pressure for whom better control is a goal is not stable, even if the pressures are not changing and the patient is asymptomatic. The risk of morbidity without treatment is significant.

Acute, Uncomplicated Illness or Injury - A recent or new short-term problem with low risk of morbidity for which a treatment is considered. There is little to no risk of mortality with treatment, and full recovery without functional impairment is expected. A problem that is normally self-limited or minor but is not resolving consistent with a definite and prescribed course is an acute, uncomplicated illness.

Chronic Illness with Exacerbation, Progression or Side Effects of Tx - A chronic illness that is actually worsening, poorly controlled or progressing with an intent to control progression and requiring additional supportive care or attention to treatment for side effects but that does not require consideration of hospital level care.

Undiagnosed New Problem with Uncertain Prognosis - A problem in the differential diagnosis that represents a condition likely to result in a high risk of morbidity without medical intervention.

Acute Illness with Systemic Symptoms - An illness that causes systemic symptoms and has a high risk of morbidity without treatment. For systemic general symptoms such as fever, body aches, or fatigue in a minor illness that may be treated to alleviate symptoms, shorten the course of illness or to prevent complications, see the definitions for ‘self-limited or minor’ or ‘acute, uncomplicated.’ Systemic symptoms may not be general, but may be a single ⬜ 2+ Self-limited/minor problems; or ⬜ 1 Stable chronic illness; or ⬜ 1 Acute uncomplicated illness/injury; may or may not require hospital level care �� 1 Stable acute illness Moderate ⬜ 1+ Chronic illness w/ exacerbation, progression, or Tx side effects; or ⬜ 2+ Stable chronic illnesses; or ⬜ Undiagnosed new problem w/ uncertain prognosis; or ⬜ Acute illness w/ systemic symptoms; or ⬜ Acute complicated injury system.

Acute, Complicated Injury – An injury which requires treatment that includes evaluation of other body systems that are not directly related to the injured organ, the injury is extensive, or the treatment options are multiple and/or associated with risk of morbidity.

Chronic Illness with Severe Exacerbation, Progression, or Side Effects of Treatment – The severe exacerbation or progression of a chronic illness or severe side effects of treatment that have significant risk of morbidity and may require hospitalization.

Acute or Chronic Illness or Injury that Poses a Threat to Life or Bodily Function - An acute illness with systemic symptoms (symptoms affecting one or more organ systems), an acute complicated injury, or a chronic illness or injury with exacerbation and/or progression or side effects of treatment, that poses a threat to life or bodily function in the shortterm without treatment.

High �� Chronic illness w/ severe exacerbation, progression, or Tx side effects; or �� Acute/chronic illness/injury that poses threat to life or bodily function Amount and/or Complexity of Data to be Reviewed and Analyzed (Chart B)

Tests & Documents (T&D) T&D pts Level of Data Review of prior external note(s) from each unique source* x 1 = ❏ 2 pts from at least 2 T&D or ❏ 1 pt from IHX If at least 1 box is checked, the level of data is LIMITED If not, the level of data is MINIMAL or NONE Review of the result(s) of each unique test* x 1 = Ordering of each unique test* or Discussion with the patient of possible test alternatives (documented) x 1 = Assessment requiring an independent historian(s)(IHx) IHx pts An individual who provides a history in addition to patient 0 or 1 max = Independent interpretation of tests (Intpr) Intpr pts Independent interpretation of a test performed by another physician/ other qualified health care professional (not separately reported); 0 or 1 max = ❑ 3 pts from 3 T&D/IHX or ❑ 1 pt from Intpr or ❑ 1 pt from DISC If at least 1 box is checked, the level of data is MODERATE If not, the level of data is LIMITED or MINIMAL/NONE Discussion of management or test interpretation (DISC) DISC pts Discussion of management or test interpretation with external physician/other qualified health care professional/appropriate source (not separately reported) 0 or 1 max = If at least 2 of the 3 boxes above are checked, the level of data is EXTENSIVE *Each unique test, order, or document contributes to the combination of T&D category below. If the test is being billed on the same date, T&D does not apply Test – Laboratory services, diagnostic imaging, psychometric, or physiologic data. A clinical laboratory panel (e.g., basic metabolic panel [80047]) is a single test. The differentiation between single or multiple unique tests is defined in accordance with the CPT® code set.

External – External records, communications and/or test results are from an external physician, other qualified health care professional, facility or health care organization.

External Physician or Other Qualified Healthcare Professional - An individual who is in a different group practice or who is of a different specialty or subspecialty. It includes licensed professionals that are practicing independently (e.g. PT, OT, nurse case manager.) It may also be a facility or organizational provider such as a hospital, nursing facility, or home health care agency.

Independent Historian(s)- An individual such as a parent, guardian, surrogate, spouse, caregiver, witness, supervisor, or co-worker who provides a

history in addition to a history provided by the patient who is unable to provide a complete or reliable history due to developmental stage of the patient, or another mental condition(s) or because a confirmatory history is determined to be necessary. In the case where there may be conflict or poor communication between multiple historians and more than one historian(s) is needed, the independent historian(s) requirement is met.

Independent Interpretation - The interpretation of a test for which there is a CPT® code and an interpretation or report is expected. This does not apply when the provider is reporting the service or has previously reported the service for the patient. A form of interpretation should be documented, but need not conform to the usual standards of a complete report for the test.

Appropriate Source – Individuals who are not health care professionals, but may be involved in the management of the patient (e.g., lawyer, parole officer, power of attorney, case manager, clergy, teacher). It does not include discussion with family or informal caregivers.

Risk of complications and/or Morbidity or Mortality of Patient Management (Chart C) see examples on following page �� Minimal risk of morbidity from additional Risk – The probability and/or consequences of an event (an event is the medical intervention or treatment). The assessment of the level of risk is affected by the nature of the event under consideration. For example, a low probability of death may be high risk, whereas a high chance of a minor, self-limited adverse effect of treatment may be low risk. Definitions of risk are based upon the usual behavior and thought processes of a provider in the same specialty. Trained clinicians apply common language usage meanings to terms such as ‘high’, ‘medium’, ‘low’, or ‘minimal’ risk and do not require quantification for these definitions, (though quantification may be provided when evidencebased medicine has established probabilities). For the purposes of calculating medical decision making, level of risk is based upon consequences of the problems(s) addressed at the visit when appropriately treated. Risk also includes medical decision making related to the need to initiate or forego further testing, treatment and/or hospitalization.

Morbidity – A state of illness or functional impairment that is expected to be long-term duration in which function is limited, quality of life is impaired, or there is organ damage that may not be temporary despite treatment. �� Low risk of morbidity from additional Moderate �� Moderate risk of morbidity from additional diagnostic testing or Treatment High �� High risk of morbidity from additional 99202/99212 99203/99213 Level of the Presenting Problem (from Chart A) ________________________ Level of Data (from Chart B) ________________________________________ Level of Risk (from Chart C) _________________________________________ Overall level of MDM-two of three categories above must be at a specific level in order to claim overall MDM at that level __________________ Examples of patient management or conditions Level of Risk ❑ Rest ❑ Gargles ❑ Insect bite ❑ Contusion ❑ Bruise ❑ Elastic bandages ❑ Superficial dressings ❑ Minor non-sutured laceration ❑ Abrasion MINIMAL ❑ Over-the-counter drugs ❑ IV fluids w/o additives ❑ Vaccine injection ❑ PT/OT ❑ Stable chronic low back pain ❑ Minor surgery w/o identified risk factors ❑ Superficial burn ❑ Simple sprain/strain (Grade 1) ❑ Simple laceration repair ❑ Superficial foreign body LOW ❑ Prescription drug management (new, increase, decrease, discontinue, decision to refill) ❑ IV fluids w/ additive(s) ❑ Therapeutic nuclear medicine ❑ Chronic pain w/ exacerbation &/or side effects of tx ❑ New neurologic complaints in extremity (numbness, tingling) ❑ Disability counseling &/or work restrictions ❑ Inability to return to work, requiring detailed functional improvement plan ❑ Dx/ tx significantly limited by social determinants of health ❑ Minor surgery w/ identified risk factors ❑ Elective major surgery w/o identified risk factors ❑ Partial thickness burn < 10% total body surface area ❑ Moderate sprain/strain (Grade 2) ❑ Torn ligament ❑ Closed fracture(s) or dislocation(s) w/o manipulation ❑ Intermediate laceration repair ❑ Deep foreign body ❑ Head injury w/ brief loss of consciousness MODERATE ❑ Drug therapy requiring intensive monitoring for toxicity ❑ Parenteral controlled substances ❑ Tx plan for symptoms causing severe functional deficits w/o supporting physiological findings or verified related dx ❑ Potential for significant permanent work restrictions or total disability ❑ Decision not to resuscitate, or to de-escalate care due to poor prognosis ❑ Management of addiction behavior or other significant psychiatric condition ❑ Emergency major surgery or trauma ❑ Elective major surgery w/ identified risk factors ❑ Full-thickness burn ❑ Partial thickness burn > 10% total body surface areas ❑ Complex sprain/strain (Grade 3) ❑ Initial treatment of open fracture ❑ Complex laceration repair ❑ Initial loss of limb/digit ❑ Head injury w/ prolonged loss of consciousness ❑ Abrupt change in neurological status HIGH Time-Based Coding Total Time on the Date of the Visit – (99202-99205, 99212-99215) - For calculation purposes, time for these services is the total time on the date of the visit. It includes both the face-to-face and non-face-to-face time personally spent by the provider(s) on the day of the visit and includes time in activities that require the provider but does not include time in activities normally performed by clinical staff.

Provider time includes the following activities, when performed Provider time does not include: and documented:

• Preparing to see the patient such as reviewing the pt’s record • Completing a WC-164 • Obtaining and/or reviewing separately obtained history • Activities related to QPOP • Performing a medically appropriate history and examination • Activities not included in the documentation • Counseling and educating the patient, family, and/or caregiver • Time associated with any other billed code • Ordering prescription medications, tests, or procedures • Referring and communicating with other health care providers when not separately reported during the visit • Documenting clinical information in the electronic or other health record • Independently interpreting and communicating results to the patient/family/caregiver • Coordinating the care of the patient (case manager; discharge; instructions for post-op care)

• Time spent communicating with patient, family and/or caregiver through an interpreter • Time spent on causation or apportionment analysis Code Time Code Time 99202 15-29 99212 10-19 99203 30-44 99213 20-29 99204 45-59 99214 30-39 99205 60-74 99215 40-54 Exhibit # 2 - Effective 1/1/2026 Base Rates and Cost-to-Charge Ratios Source: Medicare FY 2025 IPPS Impact File Provider Number Name Total CCR Individual Hospital Base Rate 060001 Banner North Colorado Medical Center 0.297 $8,272 060003 Longmont United Hospital 0.326 $7,495 060004 Intermountain Health Platte Valley Hospital 0.340 $7,423 060006 Montrose Regional Health 0.363 $7,423 060008 San Luis Valley Health 0.433 $7,423 060009 Lutheran Medical Center 0.192 $7,477 060010 Poudre Valley Hospital 0.247 $7,780 060011 Denver Health Medical Center 0.264 $9,458 060012 St Mary-Corwin Hospital 0.272 $8,542 060013 Mercy Hospital 0.233 $9,415 060014 Presbyterian/St Luke's Medical Center 0.101 $7,925 060015 St Anthony Hospital 0.185 $7,544 060020 Parkview Medical Center, Inc 0.132 $8,425 060022 University Colo Health Memorial Hospital Central 0.181 $7,603 060023 St Mary's Regional Hospital 0.260 $8,202 060024 University Of Colorado Hospital Authority 0.156 $9,466 060027 Foothills Hospital 0.182 $7,375 060028 Saint Joseph Hospital 0.198 $8,346 060030 Banner Mckee Medical Center 0.447 $7,307 060031 Penrose Hospital 0.176 $7,552 060032 Rose Medical Center 0.096 $7,713 060034 Swedish Medical Center 0.081 $7,928 060044 St Elizabeth Hospital 0.396 $7,764 060049 Uchealth Yampa Valley Medical Center 0.406 $11,373 060054 Community Hospital 0.233 $7,423 060064 Adventhealth Porter 0.204 $7,450 060065 North Suburban Medical Center 0.090 $7,805 060071 Delta County Memorial Hospital 0.421 $7,352 060075 Valley View Hospital Association 0.379 $9,732 060076 Sterling Regional Medcenter 0.586 $9,233 060096 Vail Health Hospital 0.513 $14,250 Provider Number Name Total CCR Individual Hospital Base Rate 060100 Medical Center Of Aurora, The 0.086 $8,026 060103 Adventhealth Avista 0.214 $7,540 060104 St Anthony North Hospital 0.169 $8,410 060107 National Jewish Health 0.183 $7,222 060112 Sky Ridge Medical Center 0.076 $8,366 060113 Adventhealth Littleton 0.198 $7,327 060114 Adventhealth Parker 0.198 $7,344 060116 Intermountain Health Good Samaritan Hospital 0.195 $7,300 060117 Animas Surgical Hospital, Llc 0.277 $7,222 060118 St Anthony Summit Hospital 0.313 $11,308 060119 Medical Center Of The Rockies 0.230 $7,338 060124 Orthocolorado Hosp At St Anthony Med Campus 0.159 $7,222 060125 Adventhealth Castle Rock 0.205 $7,288 060126 Banner Fort Collins Medical Center 0.434 $7,423 060128 Longs Peak Hospital 0.196 $7,408 060129 Uchealth Broomfield Hospital 0.292 $7,423 060130 Uchealth Grandview Hospital 0.309 $7,310 060131 Uchealth Greeley Hospital 0.312 $7,433 060132 Uchealth Highlands Ranch Hospital 0.211 $7,222 * Critical Access Hospitals 0.513 $14,250 069999 Any New Hospital 0.253 $6,567 * A list of Critical Access Hospitals is available at www.ruralcenter.org/resource-library/cahlocations.

Exhibit #3 Dental Fee Schedule – Effective 1/1/2026 D0120 PERIODIC ORAL EVALUATION - EST PATIENT 84.44 D0140 LIMITED ORAL EVALUATION - PROBLEM FOCUSED 141.56 D0145 ORAL EVAL PT UND 3 YR AGE CNSL W/PRIM CAREGIVER 131.62 D0150 COMP ORAL EVALUATION - NEW OR EST PATIENT 149.01 D0160 DTL&EXT ORAL EVALUATION - PROBLEM FOCUSED REPORT 298.02 D0170 RE-EVALUATION - LIMITED PROBLEM FOCUSED 99.34 D0171 RE-EVALUATION POST-OPERATIVE OFFICE VISIT 99.34 D0180 COMP PERIODONTAL EVALUATION - NEW OR EST PATIENT 161.42 D0190 SCREENING OF A PATIENT 84.44 D0191 ASSESSMENT OF A PATIENT 59.60 D0210 INTRAORAL COMPREHENSIVE SERIES RADIOGPHIC IMAGES 224.53 D0220 INTRAORAL - PERIAPICAL FIRST RADIOGRAPHIC IMAGE 44.91 D0230 INTRAORAL-PERIAPICAL-EACH ADDITIONAL IMAGE 40.42 D0240 INTRAORAL - OCCLUSAL RADIOGRAPHIC IMAGE 69.60 D0250 EXTRAORAL 2D PRJECTN RAD IMG BY RAD SRCE/ DTECTR 85.32 D0251 EXTRAORAL POSTERIOR DENTAL RAD IMAGE 78.59 D0270 BITEWING - SINGLE RADIOGRAPHIC IMAGE 43.38 D0272 BITEWINGS - TWO RADIOGRAPHIC IMAGES 69.40 D0273 BITEWINGS - THREE RADIOGRAPHIC IMAGES 84.58 D0274 BITEWINGS - FOUR RADIOGRAPHIC IMAGES 97.60 D0277 VERTICAL BITEWINGS - 7 TO 8 RADIOGRAPHIC IMAGES 147.48 D0310 SIALOGRAPHY 574.09 D0320 TEMPOROMANDIBULAR JOINT ARTHROGRAM INCL INJ 1,014.22 D0321 OTHER TEMPOROMANDIBULAR JOINT IMAGES BY REPORT 0.00 D0322 TOMOGRAPHIC SURVEY 822.86 D0330 PANORAMIC RADIOGRAPHIC IMAGE 177.97 D0340 2D CEPHLOMTRIC RAD IMG - ACQSTN MEASRE& ANALYSIS 200.93 D0350 2D ORAL/FACIAL PHOTOGRAPHIC IMAGES 95.68 D0364 CNE BEAM CAPTR & INTREP LESS THAN WHL JAW 319.58 D0365 CNE BEAM CAPTR INTERP W FLD VIEW 1 ARCH MNDBL 407.60 D0366 CNE BEAM CAPTR INTERP W FLD VIEW 1 ARCH MAXL 407.60 D0367 CNE BEAM CAPTR INTERP W FLD VIEW BTH JAWS 459.27 D0368 CNE BEAM CAPTR INTERP FR TMJ 2 OR MORE 472.67 D0369 MAXILLOFACIAL MRI CAPTURE AND INTERPRETATION 267.91 D0370 MAXLFCL US IMAGE CAPTR AND INTRP 153.09 D0371 SIALOENDOSCOPY CAPTURE AND INTERPRETATION 0.00 D0372 INTRAORAL TOMOSYNTHESIS COMPLETE SERIES RAD IMGS 0.00 D0373 INTRAORAL TOMOSYNTHESIS BITEWING RADIOG IMAGE 0.00 D0374 INTRAORAL TOMOSYNTHESIS PERIAPICAL RADIOG IMAGE 0.00 D0380 CNE BEAM CAPTR LMTD FLD <1 WHL JAW 329.14 D0381 CNE BEAM CAPTR W FLD VIEW 1 ARCH MNDBL 445.88 D0382 CNE BEAM CAPTR W FLD VIEW 1 ARCH MAXL 445.88 D0383 CNE BEAM CAPTR W FLD VIEW BTH JAWS 445.88 D0384 CNE BEAM CAPTR FR TMJ 2 OR MORE 478.41 D0385 MAXILLOFACIAL MRI IMAGE CAPTURE 2,937.42 D0386 MAXILLOFACIAL ULTRASOUND IMAGE CAPTURE 734.83 D0387 INTRAORAL TOMOSYNTHESIS CMPL SERIES RAD IMG CAPT 0.00 D0388 INTRAORAL TOMOSYNTHESIS BITEWING RAD IMAGE CAPTR 0.00 D0389 INTRAORAL TOMOSYNTHESIS PERIAPICAL RAD IMGE CAPT 0.00 D0391 INTERPRETATION OF DIAGNOSTIC IMAGE 0.00 D0393 VIRTL TREMNT SIM USING 3D IMG VOL OR SURF SCAN 0.00 D0394 DIGITAL SUBTR OF 2 > IMAGES OF THE SAME MODALITY 0.00 D0395 FUSION OF 2/> 3D IMAGE VOLUMES OF 1/> MODALITIES 0.00 D0396 3D PRINTING OF A 3D DENTAL SURFACE SCAN 0.00 D0411 HBA1C IN-OFFICE POINT OF SERVICE TESTING 0.00 D0412 BLOOD GLCSE LVL TST - IN-OFFICE USING GLCSE MTR 0.00 D0414 LAB MICRBAL SPEC CULTRE/SENS/REPORT PREP TRNSMSN 97.98 D0415 COLLECTION MICROORGANISMS CULTURE & SENSITIVITY 71.03 D0416 VIRAL CULTURE 105.33 D0417 CLCT & PREP SALIVA SAMPLE FOR LAB DX TESTING 95.53 D0418 ANALYSIS OF SALIVA SAMPLE 97.98 D0419 ASSESSMENT OF SALIVARY FLOW BY MEASUREMENT 0.00 D0422 COLLECT/PREP GENETIC SAMPLE FOR LAB ANALYSIS 71.03 D0423 GENETIC TEST SUSCEPT TO DSEASE SPECIMEN ANLYS 0.00 D0425 CARIES SUSCEPTIBILITY TESTS 61.24 D0431 ADJUNCTIVE PREDX TST NOT INCL CYTOLOGY/BX PROC 97.98 D0460 PULP VITALITY TESTS 97.98 D0470 DIAGNOSTIC CASTS 215.55 D0472 ACCESSION OF TISSUE GROSS EXAMINATION PREP/REPRT 134.72 D0473 ACCESS TISSUE GR&MIC EXAMINATION PREP/REPRT 284.14 D0474 ACCESS TISS GR&MIC EX ASSESS SURG MARG PREP/RPT 318.43 D0475 DECALCIFICATION PROCEDURE 171.46 D0476 SPECIAL STAINS FOR MICROORGANISMS 166.56 D0477 SPECIAL STAINS NOT FOR MICROORGANISMS 227.80 D0478 IMMUNOHISTOCHEMICAL STAINS 208.20 D0479 TISSUE INSITU HYBRIDIZATION INCL INTERPRETATION 318.43 D0480 ACESS EXFOLIATIVE CYTOL SMEAR MIC EXAM PREP/REPT 195.96 D0481 ELECTRON MICROSCOPY 734.83 D0482 DIRECT IMMUNOFLUORESCENCE 244.94 D0483 INDIRECT IMMUNOFLUORESCENCE 244.94 D0484 CONSULTATION ON SLIDES PREPARED ELSEWHERE 367.42 D0485 CONSULT INCL PREP SLIDES BX MATL SPL REF SRC 507.03 D0486 ACCESSION TRANSEPITHELIAL CYTOLOG SAMPL MIC EXAM 235.15 D0502 OTHER ORAL PATHOLOGY PROCEDURES BY REPORT 0.00 D0600 DX PX QUANT/MNITR/RECRD CHNGS ENAML/DENTN/CEMNTM 0.00 D0601 CARIES RISK ASSESS DOCU FINDING OF LOW RISK 17.56 D0602 CARIES RISK AX AND DOCU WITH A FNDNG OF MOD RISK 17.56 D0603 CARIES RISK AX AND DOCU WITH FNDNG OF HIGH RISK 17.56 D0604 ANTIGEN TEST PUB HLTH PATHOGEN INCL CORONAVIRUS 11.42 D0605 ANTIBODY TEST PUB HLTH PATHOGEN INCL CORONAVIRUS 8.49 D0606 MOLECULAR TEST PUB HEALTH PATHOGEN-CORONAVIRUS 0.00 D0701 PANORAMIC FILM - IMAGE CAPTURE ONLY 177.97 D0702 2-D CEPHALOMETRIC FILM - IMAGE CAPTURE ONLY 200.93 D0703 2-D ORAL/FACIAL FILM - IMAGE CAPTURE ONLY 95.68 D0705 EXTRA-ORAL POSTERIOR FLM - IMAGE CAPTURE ONLY 78.59 D0706 INTRAORAL OCCLUSAL FILM - IMAGE CAPTURE ONLY 69.60 D0707 INTRAORAL PERIAPICAL FLM - IMAGE CAPTURE ONLY 44.91 D0708 INTRAORAL BITEWING - IMAGE CAPTURE ONLY 43.38 D0709 INTRAORAL CMPRHNSV SERIES RAD IMAGE CAPT ONLY 224.53 D0801 3D INTRAORAL SURFACE SCAN DIRECT 0.00 D0802 3D DENTAL SURFACE SCAN INDIRECT 0.00 D0803 3D FACIAL SURFACE SCAN DIRECT 0.00 D0804 3D FACIAL SURFACE SCAN INDIRECT 0.00 D0999 UNSPECIFIED DIAGNOSTIC PROCEDURE BY REPORT 0.00 D1110 PROPHYLAXIS - ADULT 143.61 D1120 PROPHYLAXIS - CHILD 99.11 D1206 TOPICAL APPLICATION OF FLUORIDE VARNISH 66.31 D1208 TOPICAL APPLICATION OF FLUORIDE EXCL VARNISH 44.21 D1301 IMMUNIZATION COUNSELING 0.00 D1310 NUTRITIONAL COUNSELING CONTROL OF DENTAL DISEASE 76.64 D1320 TOBACCO CNSL CONTROL&PREVENTION ORAL DISEASE 83.21 D1321 COUNSEL ADVRSE EFFECTS HI RISK SUBSTNCE ABUSE 105.11 D1330 ORAL HYGIENE INSTRUCTIONS 105.11 D1351 SEALANT - PER TOOTH 85.40 D1352 PREV RSN REST MOD HIGH CARIES RISK PT-PERM TOOTH 109.49 D1353 SEALANT REPAIR PER TOOTH 109.49 D1354 INTERIM CARIES ARRESTING MEDICATION APPLICATION 85.40 D1355 CARIES PREVENTIVE MEDICAMENT APP - PER TOOTH 85.40 D1510 SPACE MAINTAINER - FIXED - UNILATERAL 541.40 D1516 SPACE MAINTAINER - FIXED - BILATERIAL MAXILLARY 757.96 D1517 SPACE MAINTAINER - FIXED - BILATERIAL MANDIBULAR 757.96 D1520 SPACE MAINTAINER - REMOVABLE - UNILATERAL 595.54 D1526 SPACE MAINTAINER - REMOVABLE - BILATERAL MAXILRY 920.38 D1527 SPACE MAINTAINER - REMOVABLE - BILATERAL MNDBULR 920.38 D1551 RECMT/REBND BILAT SPACE MAINTAINER MAXILLARY 116.94 D1552 RECMT/REBND BILAT SPACE MAINTAINER MANDIBULAR 116.94 D1553 RECMT/REBND UNI SPACE MAINTAINER PER QUADRANT 77.96 D1556 REMOVAL FIXED UNI SPACE MAINTAINER PER QUADRANT 75.80 D1557 REMOVAL FIXED BILAT SPACE MAINTAINER MAXILLARY 112.61 D1558 REMOVAL FIXED BILAT SPACE MAINTAINER MANDIBULAR 112.61 D1575 DISTAL SHOE SPACE MAINTANR - FIXED - UNILATERIAL 595.54 D1701 COVID-19 VACCINE ADMIN-PFIZER-1ST DOSE 0.00 D1702 COVID-19 VACCINE ADMIN-PFIZER-2ND DOSE 0.00 D1703 COVID-19 VACCINE ADMIN-MODERNA-1ST DOSE 0.00 D1704 COVID-19 VACCINE ADMIN-MODERNA-2ND DOSE 0.00 D1705 COVID-19 VACCINE ADMIN-ASTRAZENECA-1ST DOSE 0.00 D1706 COVID-19 VACCINE ADMIN-ASTRAZENECA-2ND DOSE 0.00 D1707 COVID-19 VACCINE ADMIN-JANSSEN 0.00 D1708 PFIZER-BIONTECH COVID VACC ADMIN THIRD DOSE 0.00 D1709 PFIZER-BIONTECH COVID VACC ADMIN BOOSTER DOSE 0.00 D1710 MODERNA COVID VACCINE ADMINISTRATION THIRD DOSE 0.00 D1711 MODERNA COVID VACCINE ADMINISTRATON BOOSTER DOSE 0.00 D1712 JANSSEN COVID VACCINE ADMINISTRATON BOOSTER DOSE 0.00 D1713 PFIZER-BIONTECH COVID VAC ADM TRISCRSE PED FIRST 0.00 D1714 PFIZER-BIONTECH COVID VAC ADM TRISCRSE PED SECND 0.00 D1781 VACCINE ADMINSTR HUMAN PAPILLOMAVIRUS DOSE 1 0.00 D1782 VACCINE ADMINSTR HUMAN PAPILLOMAVIRUS DOSE 2 0.00 D1783 VACCINE ADMINSTR HUMAN PAPILLOMAVIRUS DOSE 3 0.00 D1999 UNSPECIFIED PREVENTIVE PROCEDURE BY REPORT 0.00 D2140 AMALGAM - ONE SURFACE PRIMARY OR PERMANENT 262.41 D2150 AMALGAM - TWO SURFACES PRIMARY OR PERMANENT 339.59 D2160 AMALGAM - THREE SURFACES PRIMARY OR PERMANENT 410.59 D2161 AMALGAM-FOUR/MORE SURFACES PRIMARY/PERMANENT 500.12 D2330 RESIN-BASED COMPOSITE - ONE SURFACE ANTERIOR 238.80 D2331 RESIN-BASED COMPOSITE - TWO SURFACES ANTERIOR 304.75 D2332 RESIN-BASED COMPOSITE - THREE SURFACES ANTERIOR 372.98 D2335 RESIN BASED COMPOSITE 4/> SURFACES ANTERIOR 441.20 D2390 RESIN-BASED COMPOSITE CROWN ANTERIOR 488.96 D2391 RESIN-BASED COMPOSITE - ONE SURFACE POSTERIOR 279.73 D2392 RESIN-BASED COMPOSITE - TWO SURFACES POSTERIOR 366.15 D2393 RESIN-BASED COMPOSITE - THREE SURFACES POSTERIOR 454.85 D2394 RESIN COMPOS - FOUR OR MORE SURFACES POSTERIOR 557.19 D2410 GOLD FOIL - ONE SURFACE 528.17 D2420 GOLD FOIL - TWO SURFACES 880.28 D2430 GOLD FOIL - THREE SURFACES 1,525.82 D2510 INLAY - METALLIC - ONE SURFACE 1,396.71 D2520 INLAY - METALLIC - TWO SURFACES 1,584.51 D2530 INLAY - METALLIC - THREE OR MORE SURFACES 1,826.29 D2542 ONLAY - METALLIC - TWO SURFACES 1,791.08 D2543 ONLAY - METALLIC - THREE SURFACES 1,873.24 D2544 ONLAY - METALLIC - FOUR OR MORE SURFACES 1,948.36 D2610 INLAY - PORCELAIN/CERAMIC - ONE SURFACE 1,643.19 D2620 INLAY - PORCELAIN/CERAMIC - TWO SURFACES 1,734.74 D2630 INLAY - PORCELAIN/CERAMIC - THREE/MORE SURFACES 1,847.42 D2642 ONLAY - PORCELAIN/CERAMIC - TWO SURFACES 1,795.78 D2643 ONLAY - PORCELAIN/CERAMIC - THREE SURFACES 1,936.62 D2644 ONLAY - PORCELAIN/CERAMIC - 4 OR MORE SURFACES 2,053.99 D2650 INLAY - RESIN-BASED COMPOSITE - ONE SURFACE 1,079.81 D2651 INLAY - RESIN-BASED COMPOSITE - TWO SURFACES 1,286.39 D2652 INLAY RESIN BASED COMPOSITE 3 OR MORE SURFACES 1,352.11 D2662 ONLAY - RESIN-BASED COMPOSITE - TWO SURFACES 1,173.71 D2663 ONLAY - RESIN-BASED COMPOSITE - THREE SURFACES 1,380.28 D2664 ONLAY RESIN BASED COMPOSIT FOUR OR MORE SURFACES 1,478.87 D2710 CROWN - RESIN-BASED COMPOSITE (INDIRECT) 706.21 D2712 CROWN 3/4 RESIN-BASED COMPOSITE (INDIRECT) 706.21 D2720 CROWN - RESIN WITH HIGH NOBLE METAL 1,740.65 D2721 CROWN - RESIN WITH PREDOMINANTLY BASE METAL 1,631.23 D2722 CROWN - RESIN WITH NOBLE METAL 1,667.04 D2740 CROWN - PORCELAIN/CERAMIC 1,786.40 D2750 CROWN - PORCELAIN FUSED TO HIGH NOBLE METAL 1,762.53 D2751 CROWN - PORCELAIN FUSED PREDOMINANTLY BASE METAL 1,641.18 D2752 CROWN - PORCELAIN FUSED TO NOBLE METAL 1,680.97 D2753 CROWN-PORCELAIN FUSED TITANIUM AND ALLOYS 1,641.18 D2780 CROWN - 3/4 CAST HIGH NOBLE METAL 1,690.91 D2781 CROWN - 3/4 CAST PREDOMINANTLY BASE METAL 1,591.45 D2782 CROWN - 3/4 CAST NOBLE METAL 1,643.17 D2783 CROWN - 3/4 PORCELAIN/CERAMIC 1,738.66 D2790 CROWN - FULL CAST HIGH NOBLE METAL 1,700.86 D2791 CROWN - FULL CAST PREDOMINANTLY BASE METAL 1,611.34 D2792 CROWN - FULL CAST NOBLE METAL 1,641.18 D2794 CROWN - TITANIUM 1,740.65 D2799 PROVISIONAL CROWN 706.21 D2910 RECMNT/REBND INLAY/ONLAY/VNR/PART CVRGE RESTRATN 157.42 D2915 RECMNT/REBND INDRCT OR PREFAB POST AND CORE 157.42 D2920 RE-CEMENT OR RE-BOND CROWN 159.61 D2921 REATTACHMENT OF TOOTH FRAG INCISAL EDGE/CUSP 229.57 D2928 PREFAB PORCELAIN/CERAMIC CROWN-PERM TOOTH 631.87 D2929 PREFABR PORC CROWN - PRIMARY TOOTH 631.87 D2930 PREFABR STAINLESS STEEL CROWN - PRIMARY TOOTH 435.09 D2931 PREFABR STAINLESS STEEL CROWN - PERMANENT TOOTH 491.94 D2932 PREFABRICATED RESIN CROWN 524.73 D2933 PREFABR STAINLESS STEEL CROWN W/RESIN WINDOW 601.26 D2934 PREFAB ESTHETIC COAT STNLESS STEEL CROWN PRIM 601.26 D2940 PLACEMENT OF INTERIM DIRECT RESTORATION 166.17 D2941 INTERIM THERAPEUTIC RESTORATION PRIM DENTITION 166.17 D2949 RESTOR FOUNDATION FOR INDIR RESTOR 166.17 D2950 CORE BUILDUP INCLUDING ANY PINS WHEN REQUIRED 415.41 D2951 PIN RETENTION - PER TOOTH ADDITION RESTORATION 94.01 D2952 POST AND CORE ADDITION TO CROWN INDIRECTLY FAB 655.92 D2953 EACH ADDITIONAL INDIRECTLY FAB POST SAME TOOTH 327.96 D2954 PREFABRICATED POST AND CORE IN ADDITION TO CROWN 524.73 D2955 POST REMOVAL 404.48 D2956 REMOVAL INDIRECT RESTORATION NATURAL TOOTH 0.00 D2957 EACH ADDITIONAL PREFABRICATED POST - SAME TOOTH 262.37 D2960 LABIAL VENEER (RESIN LAMINATE) - CHAIRSIDE 1,268.11 D2961 LABIAL VENEER (RESIN LAMINATE) - LABORATORY 1,438.64 D2962 LABIAL VENEER (PORCELAIN LAMINATE) - LABORATORY 1,563.27 D2971 ADD PROC CUST CRWN UND XST PART DENTUR FRMEWRK 251.43 D2975 COPING 765.24 D2976 BAND STABILIZATION PER TOOTH 0.00 D2980 CROWN REPAIR MATERIAL FAILURE 306.09 D2981 INLAY REPAIR BY REPORT 306.09 D2982 ONLAY REPAIR BY REPORT 306.09 D2983 VENEER REPAIR BY REPORT 306.09 D2989 EXCAVATON TOOTH RESULT IN DETERM NON-RESTRABLTY 0.00 D2990 RESIN INFILT OF INCIPIENT LESIONS 109.32 D2991 APPLCATON HYDROYAPATITE REGEN MEDICMNT PER TOOTH 85.27 D2999 UNSPECIFIED RESTORATIVE PROCEDURE BY REPORT 0.00 D3110 PULP CAP - DIRECT (EXCLUDING FINAL RESTORATION) 157.56 D3120 PULP CAP - INDIRECT(EXCLUDING FINAL RESTORATION) 126.05 D3220 TX PULP-REMV PULP CORONAL DENTINOCEMENTL JUNC 323.00 D3221 PULPAL DEBRIDEMENT PRIMARY AND PERMANENT TEETH 354.52 D3222 PART PULPOTOMY FOR APEXOGENEIS PERM TOOTH 328.26 D3230 PULPAL THERAPY - ANTERIOR PRIMARY TOOTH 313.81 D3240 PULPAL THERAPY - POSTERIOR PRIMARY TOOTH 386.23 D3310 ENDODONTIC THERAPY ANTERIOR TOOTH 1,231.10 D3320 ENDODONTIC THERAPY PREMOLAR TOOTH 1,508.71 D3330 ENODODONTIC THERAPY MOLAR 1,870.80 D3331 TREATMENT RC OBSTRUCTION; NON-SURGICAL ACCESS 482.79 D3332 INCOMPLETE ENDO TX; INOP UNRESTORABLE/FX TOOTH 917.29 D3333 INTERNAL ROOT REPAIR OF PERFORATION DEFECTS 422.44 D3346 RETREATMENT PREVIOUS RC THERAPY - ANTERIOR 1,641.47 D3347 RETREATMENT PREVIOUS RC THERAPY - PREMOLAR 1,931.14 D3348 RETREATMENT PREVIOUS ROOT CANAL THERAPY - MOLAR 2,389.79 D3351 APEXIFICATION/RECALCIFICAT INIT VST 679.31 D3352 APEXIFICAT/RECALCIFICAT INT MED REPL 304.52 D3353 APEXIFICATION/RECALCIFICATION - FINAL VISIT 936.98 D3355 PULPAL REGENERATION - INITIAL VISIT 679.31 D3356 PULPAL REGEN - INTERIM MED RPLCMNT 304.52 D3357 PULPAL REGENERATION - COMPLETION OF TREATMENT 0.00 D3410 APICOECTOMY - ANTERIOR 1,346.91 D3421 APICOECTOMY - PREMOLAR (FIRST ROOT) 1,499.17 D3425 APICOECTOMY - MOLAR (FIRST ROOT) 1,698.28 D3426 APICOECTOMY (EACH ADDITIONAL ROOT) 573.90 D3428 BG IN CONJ PERIRADICULAR SURG/TOOTH SINGLE SITE 1,775.58 D3429 BG IN CONJ PERIRADICUL SURG EACH CONTIG TH SSS 1,693.60 D3430 RETROGRADE FILLING - PER ROOT 421.64 D3431 BIO MAT SFT OSS REGE CONJ PERIR SUR 2,084.79 D3432 GTR RESORB BRRER PER SITE IN CONJ PERIRAD SURG 1,791.98 D3450 ROOT AMPUTATION - PER ROOT 878.42 D3460 ENDODONTIC ENDOSSEOUS IMPLANT 3,279.44 D3470 INTENTIONAL REIMPLANTATION W/NECESSARY SPLINTING 1,674.86 D3471 SURGICAL REPAIR ROOT RESORPTION - ANTERIOR 2,084.79 D3472 SURGICAL REPAIR ROOT RESORPTION - PREMOLAR 2,084.79 D3473 SURGICAL REPAIR ROOT RESORPTION - MOLAR 2,084.79 D3501 SRG EXP ROOT WO APICO/RPR ROOT RESORPTN - ANT 1,218.08 D3502 SRG EXP ROOT WO APICO/RPR ROOT RESORPTN-PREMOLAR 1,218.08 D3503 SRG EXP ROOT WO APICO/RPR ROOT RESORPTN-MOLAR 1,218.08 D3910 SURGICAL PROCEDURE ISOLATION TOOTH W/RUBBER DAM 0.00 D3911 INTRAORIFICE BARRIER 0.00 D3920 HEMISECTION NOT INCLUDING ROOT CANAL THERAPY 667.60 D3921 DECORONATION OR SUBMERGENCE ERUPTED TOOTH 667.60 D3950 CANAL PREPARATION&FITTING PREFORMED DOWEL/POST 304.52 D3999 UNSPECIFIED ENDODONTIC PROCEDURE BY REPORT 0.00 D4210 GINGIVECT/PLSTY 4/>CNTIG/TOOTH BOUND SPACES-QUAD 1,274.38 D4211 GINGIVECT/PLSTY 1-3 CNTIG/TOOTH BOUND SPACE-QUAD 566.39 D4212 GINGIVECT/PLSTY FOR ACCESS RESTORATION PER TOOTH 453.11 D4230 ANAT CROWN EXP 4/> CONTIGUOUS TEETH PER QUAD 1,784.13 D4231 ANATOMICAL CROWN EXPOSURE 1-3 TEETH PER QUADRANT 849.59 D4240 GINGL FLP PROC 4/> CONTIG/TOOTH BOUND SPACE-QUAD 1,614.22 D4241 GINGL FLP PROC 1-3 CONTIG/TOOTH BOUND SPACE-QUAD 934.55 D4245 APICALLY POSITIONED FLAP 1,189.42 D4249 CLINICAL CROWN LENGTHENING - HARD TISSUE 1,769.98 D4260 OSSEOUS SURG 4/> CNTIG TEETH QUAD 2,690.36 D4261 OSSEOUS SURG 1-3 CNTIG TEETH QUAD 1,444.30 D4263 BONE REPLACEMENT GRAFT - FIRST SITE IN QUADRANT 962.87 D4264 BONE REPLACEMENT GRAFT - EA ADD SITE QUADRANT 821.27 D4265 BIOLOGIC MATERIALS AID SOFT&OSSEOUS TISSUE REGEN 0.00 D4266 GUID TISS REGEN NAT TETH RESORB BARRIER PER SITE 991.19 D4267 GUID TISS REGEN NAT TETH NONRESORB BARR PER SITE 1,274.38 D4268 SURGICAL REVISION PROCEDURE PER TOOTH 0.00 D4270 PEDICLE SOFT TISSUE GRAFT PROCEDURE 1,911.57 D4273 AUTOGNS CONECTIVE TISSUE GRFT 1ST TOOTH/IMPLANT 2,336.37 D4274 MESIAL OR DISTAL WEDGE PROCEDURE 1,325.36 D4275 NONAUTGNS CONECTV TISSUE GRFT 1ST TOOTH/IMPLANT 1,755.82 D4276 COMB CNCTIVE TISSUE & PEDICLE GRAFT PER TOOTH 2,619.56 D4277 FREE SOFT TISSUE GRAFT, 1ST TOOTH/ IMPLANT 1,982.37 D4278 FREE SOFT TISSUE GRAFT, E/ADNL TOOTH, IMPLNT 651.35 D4283 AUTO CNNCTV TISSUE GRFT PROC E/A TOOTH, IMPLANT 1,990.87 D4285 NON-AUTO CNNCTV TSSUE GRFT PROC E/A TOOTH/IMPLNT 1,498.11 D4286 REMOVAL OF NON-RESORBABLE BARRIER 339.84 D4322 SPLINT INTRACORONAL NATURAL TEETH OR PROS CROWN 705.37 D4323 SPLINT EXTRACORONAL NATURAL TEETH OR PROS CROWN 641.24 D4341 PRDONTAL SCALING&ROOT PLANING 4/MORE TEETH-QUAD 406.12 D4342 PRDONTAL SCALING&ROOT PLANING 1-3 TEETH-QUAD 235.12 D4346 SCALNG GNGIVAL INFLAMM FULL MOUTH AFTR ORAL EVAL 235.12 D4355 FULL MOUTH DEBRID ENABLE COMP PERIO EVAL & DX 277.87 D4381 LOC DEL ANTIMICROBL AGTS CREVICULR TISS TOOTH BR 0.00 D4910 PERIODONTAL MAINTENANCE 250.08 D4920 UNSCHEDULED DRESSING CHANGE 181.68 D4921 GINGIVAL IRRIGATION MEDICINAL AGENT PER QUADRANT 0.00 D4999 UNSPECIFIED PERIODONTAL PROCEDURE BY REPORT 0.00 D5110 COMPLETE DENTURE - MAXILLARY 2,965.66 D5120 COMPLETE DENTURE - MANDIBULAR 2,965.66 D5130 IMMEDIATE DENTURE - MAXILLARY 3,233.54 D5140 IMMEDIATE DENTURE - MANDIBULAR 3,233.54 D5211 MAXILLARY PARTIAL DENTURE - RESIN BASE 2,502.95 D5212 MANDIBULAR PARTIAL DENTURE - RESIN BASE 2,908.83 D5213 MAX PART DENTUR-CAST METL FRMEWRK W/RSN BASE 3,276.83 D5214 MAND PART DENTUR- CAST METL FRMEWRK W/RSN BASE 3,276.83 D5221 IMMED MAXILLARY PARTIAL DENTURE RESIN BASE 2,730.24 D5222 IMMED MANDIBULAR PARTIAL DENTURE RESIN BASE 3,171.30 D5223 IMMED MAXIL PART DENTURE CAST METL FRAME W/RESIN 3,571.77 D5224 IMMED MAND PART DENTURE CAST METL FRAME W/RESIN 3,571.77 D5225 MAXILLARY PARTIAL DENTRUE FLEXIBLE BASE 2,502.95 D5226 MANDIBULAR PARTIAL DENTURE FLEXIBLE BASE 2,908.83 D5227 IMMED MAXILLARY PARTIAL DENTURE FLEXIBLE BASE 2,732.95 D5228 IMMED MANDIBULAR PARTIAL DENTURE FLEXIBLE BASE 3,165.89 D5282 RMVBL UNIL PRTL DNTR CST MTL INCL CLSP TTH MXLRY 1,910.36 D5283 RMVBL UNIL PRTL DNTR CST MTL INCL CLSP TTH MNDBL 1,910.36 D5284 RMVABLE UNI PRTL DNTURE 1 PC FLEX BASE PER QDRNT 1,458.47 D5286 RMVABLE UNI PRTL DNTURE 1 PC RESIN PER QDRNT 1,458.47 D5410 ADJUST COMPLETE DENTURE - MAXILLARY 162.35 D5411 ADJUST COMPLETE DENTURE - MANDIBULAR 162.35 D5421 ADJUST PARTIAL DENTURE - MAXILLARY 162.35 D5422 ADJUST PARTIAL DENTURE - MANDIBULAR 162.35 D5511 REPAIR BROKEN COMPLETE DENTURE BASE, MANDIBULAR 324.71 D5512 REPAIR BROKEN COMPLETE DENTURE BASE, MAXILLARY 324.71 D5520 REPLACE MISSING/BROKEN TEETH - COMPLETE DENTURE 270.59 D5611 REPAIR RESIN PARTIAL DENTURE BASE, MANDIBULAR 351.77 D5612 REPAIR RESIN PARTIAL DENTURE BASE, MAXILLARY 351.77 D5621 REPAIR CAST FRAMEWORK, MANDIBULAR 378.82 D5622 REPAIR CAST FRAMEWORK, MAXILLARY 378.82 D5630 REPAIR OR REPLACE BROKEN CLASP PER TOOTH 460.00 D5640 REPLACE BROKEN TEETH - PER TOOTH 297.65 D5650 ADD TOOTH TO EXISTING PARTIAL DENTURE 405.88 D5660 ADD CLASP TO EXISTING PARTIAL DENTURE PER TOOTH 487.06 D5670 REPLACE ALL TEETH&ACRYLIC CAST METAL FRMEWRK MAX 1,190.59 D5671 REPLACE ALL TEETH&ACRYLIC CAST METL FRMEWRK MAND 1,190.59 D5710 REBASE COMPLETE MAXILLARY DENTURE 1,204.12 D5711 REBASE COMPLETE MANDIBULAR DENTURE 1,150.00 D5720 REBASE MAXILLARY PARTIAL DENTURE 1,136.47 D5721 REBASE MANDIBULAR PARTIAL DENTURE 1,136.47 D5725 REBASE HYBRID PROSTHESIS 1,204.12 D5730 RELINE COMPLETE MAXILLARY DENTURE (CHAIRSIDE) 679.18 D5731 RELINE COMPLETE MANDIBULAR DENTURE (CHAIRSIDE) 679.18 D5740 RELINE MAXILLARY PARTIAL DENTURE (CHAIRSIDE) 622.35 D5741 RELINE MANDIBULAR PARTIAL DENTURE (CHAIRSIDE) 622.35 D5750 RELINE COMPLETE MAXILLARY DENTURE (LABORATORY) 906.47 D5751 RELINE COMPLETE MANDIBULAR DENTURE (LABORATORY) 906.47 D5760 RELINE MAXILLARY PARTIAL DENTURE (LABORATORY) 892.94 D5761 RELINE MANDIBULAR PARTIAL DENTURE (LABORATORY) 892.94 D5765 SOFT LINER COMPL/PART DENTURE REMOVAL INDIRECT 906.47 D5810 INTERIM COMPLETE DENTURE (MAXILLARY) 1,434.12 D5811 INTERIM COMPLETE DENTURE (MANDIBULAR) 1,542.36 D5820 INTERIM PARTIAL DENTURE (MAXILLARY) 1,109.41 D5821 INTERIM PARTIAL DENTURE (MANDIBULAR) 1,177.06 D5850 TISSUE CONDITIONING MAXILLARY 284.12 D5851 TISSUE CONDITIONING MANDIBULAR 284.12 D5862 PRECISION ATTACHMENT BY REPORT 0.00 D5863 OVERDENTURE COMPLETE MAXILLARY 3,138.83 D5864 OVERDENTURE PARTIAL MAXILLARY 4,140.01 D5865 OVERDENTURE COMPLETE MIBULAR 3,138.83 D5866 OVERDENTURE PARTIAL MIBULAR 4,302.37 D5867 REPLACEMENT REPL PART SEMI-PRCISN/PRCISN ATTCH 0.00 D5875 MODIFICATION REMV PROSTH AFTER IMPLANT SURGERY 0.00 D5876 ADD MTL SUBSTRUCTR TO ACRYLIC FULL DNTR PER ARCH 0.00 D5899 UNS REMOVABLE PROSTHODONTIC PROCEDURE REPORT 0.00 D5911 FACIAL MOULAGE (SECTIONAL) 752.24 D5912 FACIAL MOULAGE (COMPLETE) 752.24 D5913 NASAL PROSTHESIS 15,840.28 D5914 AURICULAR PROSTHESIS 15,840.28 D5915 ORBITAL PROSTHESIS 21,436.06 D5916 OCULAR PROSTHESIS 5,717.55 D5919 FACIAL PROSTHESIS 0.00 D5922 NASAL SEPTAL PROSTHESIS 0.00 D5923 OCULAR PROSTHESIS INTERIM 0.00 D5924 CRANIAL PROSTHESIS 0.00 D5925 FACIAL AUGMENTATION IMPLANT PROSTHESIS 0.00 D5926 NASAL PROSTHESIS REPLACEMENT 0.00 D5927 AURICULAR PROSTHESIS REPLACEMENT 0.00 D5928 ORBITAL PROSTHESIS REPLACEMENT 0.00 D5929 FACIAL PROSTHESIS REPLACEMENT 0.00 D5931 OBTURATOR PROSTHESIS SURGICAL 8,528.97 D5932 OBTURATOR PROSTHESIS DEFINITIVE 15,951.22 D5933 OBTURATOR PROSTHESIS MODIFICATION 0.00 D5934 MANDIBULAR RESECTION PROSTHESIS W/GUIDE FLANGE 14,538.75 D5935 MANDIBULAR RESECTION PROSTHESIS W/O GUIDE FLANGE 12,650.04 D5936 OBTURATOR PROSTHESIS INTERIM 14,208.63 D5937 TRISMUS APPLIANCE (NOT FOR TMD TREATMENT) 1,785.89 D5951 FEEDING AID 2,321.65 D5952 SPEECH AID PROSTHESIS PEDIATRIC 7,538.61 D5953 SPEECH AID PROSTHESIS ADULT 14,316.86 D5954 PALATAL AUGMENTATION PROSTHESIS 13,266.98 D5955 PALATAL LIFT PROSTHESIS DEFINITIVE 12,271.21 D5958 PALATAL LIFT PROSTHESIS INTERIM 0.00 D5959 PALATAL LIFT PROSTHESIS MODIFICATION 0.00 D5960 SPEECH AID PROSTHESIS MODIFICATION 0.00 D5982 SURGICAL STENT 1,204.12 D5983 RADIATION CARRIER 2,705.89 D5984 RADIATION SHIELD 2,705.89 D5985 RADIATION CONE LOCATOR 2,705.89 D5986 FLUORIDE GEL CARRIER 270.59 D5987 COMMISSURE SPLINT 4,058.84 D5988 SURGICAL SPLINT 811.77 D5991 VESICULOBULLOUS DISEASE MEDICAMENT CARRIER 311.18 D5992 ADJUST MAXILLOFACIAL PROSTH APPLIANCE BY REPORT 0.00 D5993 MAINT / CLEAN MAXILLOFACIAL PROSTH BY REPORT 0.00 D5995 PERIO MEDIC CARRIER PERIPH SEAL LAB PRCESSD MAX 1,488.24 D5996 PERIO MEDIC CARRIER PERIPH SEAL LAB PRCESSD MAN 1,488.24 D5999 UNSPECIFIED MAXILLOFACIAL PROSTHESIS BY REPORT 0.00 D6010 SURG PLACEMENT IMPLANT BODY: ENDOSTEAL IMPLANT 3,931.66 D6011 SECOND STAGE IMPLANT SURGERY 0.00 D6012 SURG PLCMT INTERIM IMPL TRNSITIONL PROS: ENDOS 4,681.19 D6013 SURGICAL PLACEMENT OF MINI IMPLANT 4,954.48 D6040 SURGICAL PLACEMENT: EPOSTEAL IMPLANT 17,047.11 D6050 SURGICAL PLACEMENT: TRANSOSTEAL IMPLANT 12,717.68 D6051 INTERIM IMPLANT ABUTMENT 0.00 D6055 CONNECTING BAR IMPLANT OR ABUTMENT SUPPORTED 1,488.24 D6056 PREFABRICATED ABUTMENT INCLUDES PLACEMENT 1,028.24 D6057 CUSTOM FABRICATED ABUTMENT INCLUDES PLACEMENT 1,271.77 D6058 ABUTMENT SUPPORTED PORCELAIN/CERAMIC CROWN 2,852.01 D6059 ABUT SUPP PORCELAIN TO METL CROWN HI NOBLE METL 2,814.13 D6060 ABUT SUPP PORCELAIN TO MTL CROWN PREDOM BASE MTL 2,659.89 D6061 ABUT SUPP PORCELAIN TO METAL CROWN NOBLE METAL 2,714.01 D6062 ABUTMENT SUPP CAST METAL CROWN HIGH NOBLE METAL 2,703.18 D6063 ABUTMENT SUPP CAST METAL CROWN PREDOM BASE METAL 2,354.12 D6064 ABUTMENT SUPP CAST METAL CROWN NOBLE METAL 2,462.36 D6065 IMPL SUPP PORCELAIN/CERAMIC CROWN 2,806.01 D6066 IMPL SUPP PORCLN FUSED METL CRWN TITNM/HIGH NOBL 2,732.95 D6067 IMPL SUPP METAL CROWN TITIANM/HIGH NOBLE METL 2,651.77 D6068 ABUT SUPP RETAINER PORCELAIN/CERAMIC FPD 2,827.66 D6069 ABUT RETAINR PORCELN TO METL FPD HI NOBL METL 2,814.13 D6070 ABUT RETN PORCELN TO METL FPD PREDOM BASE METL 2,659.89 D6071 ABUT SUPP RETN PORCELN FUSD METAL FPD NOBLE METL 2,714.01 D6072 ABUT SUPP RETN CAST METL FPD HIGH NOBLE METL 2,746.48 D6073 ABUT RTNR CAST METL FPD PREDOM BASE METL 2,508.36 D6074 ABUTMENT RTNR CAST METAL FPD NOBLE METAL 2,665.30 D6075 IMPLANT SUPPORTED RETAINER FOR CERAMIC FPD 2,806.01 D6076 IMPL SUPP RTNR PORCLN FUSED METL FPD TITNM/HIGH 2,732.95 D6077 IMPL SUPP RTNR CST METL FPD TITNM/HIGH NOBLE 2,651.77 D6080 IMPL MAINT PROC REMV CLEAN PROSTH & ABUT REINSRT 232.71 D6081 SCALNG/DBRDMNT IMPLNT WO FLAP ENTRY/CLOS 119.06 D6082 IMPL SUPP CROWN PORCLN FUSED BASE ALLOY 2,732.95 D6083 IMPL SUPP CROWN PORCLN FUSED TO NOBLE ALLOYS 2,732.95 D6084 IMPL SUPP CROWN PORCLN FUSED TO TITANIUM ALLOYS 2,732.95 D6085 PROVISIONAL IMPLANT CROWN 817.18 D6086 IMPLANT SUPPORTED CROWN PREDOM BASE ALLOYS 2,651.77 D6087 IMPLANT SUPPORTED CROWN NOBLE ALLOYS 2,651.77 D6088 IMPLNT SUPRTD CROWN TITANIUM AND ALLOYS 2,651.77 D6089 ACCESS AND RETORQU LOOSE IMPLNT SCREW PER SCREW 0.00 D6090 REPAIR IMPLANT/ABUTMENT SUPPORTED PROSTHESIS 0.00 D6091 REPL ATTACHMNT IMPL/ABUT SUPP PROS PER ATTACHMNT 1,122.94 D6092 RECEMENT / REBOND IMPLANT/ABUTMENT SUPP CROWN 219.18 D6093 RECMNT/REBOND IMPL/ABUTMNT SUPP FIX PART DENTURE 343.65 D6094 ABUTMENT SUPPORTED CROWN TITANIUM 2,232.36 D6095 REPAIR IMPLANT ABUTMENT BY REPORT 0.00 D6096 REMOVE BROKEN IMPLANT RETAINING SCREW 0.00 D6097 ABUT SUPP CROWN PORCLN FUSED TO TITANIUM ALLOYS 2,732.95 D6098 IMPL SUPP RETAINER PORCELAIN FUSED TO BASE ALLOY 2,659.89 D6099 IMPL SUPP RETAINR FPD PORCLN FUSED NOBLE ALLOYS 2,714.01 D6100 SURGICAL REMOVAL IMPLANT BODY 0.00 D6101 DBRDMNT OF SNGL PERI-IMPLANT DEFECT/S 803.65 D6102 DBRDMNT AND OSSEOUS CNTUR OF PERI-IMPLANT DEFECT 1,104.00 D6103 BONE GRFT RPR PERIIMPLNT DFCT W/O FLAP ENTR/CLSE 920.00 D6104 BONE GRAFT AT TIME OF IMPLANT PLACEMENT 920.00 D6105 RMVL IMPLANT NO BONE REMOVAL OR FLAP ELEVATION 294.94 D6106 GIDED TISS REGENRATION RESORB BARRIER PER IMPLNT 947.06 D6107 GIDED TISS REGENRATION NONRESORB BARRIER PER IMP 1,217.65 D6110 IMPL/ABUTMENT SUPPORTED RD - MAXILLARY 3,698.95 D6111 IMPL/ABUTMENT SUPPORTED RD - MANDIBULAR 3,698.95 D6112 IMPL/ABUTMENT SUPPORTED RPD - MAXILLARY 3,698.95 D6113 IMPLANT / ABUTMENT SUPPORTED RPD - MANDIBULAR 3,698.95 D6114 IMPLANT / ABUTMENT SUPPORTED FD - MAXILLARY FULL 11,364.74 D6115 IMPLANT/ABUTMENT SUPPORTED FD - MANDIBULAR FULL 11,364.74 D6116 IMPL/ABUTMENT SUPPORTED FD - MAXILLARY - PARTIAL 4,968.01 D6117 IMPL/ABUT SUPPORTED FD - MANDIBULAR - PARTIAL 4,968.01 D6118 IMP/ABUT SPRTD INTRM FIXED DENTR EDENTLS MANDBLR 3,368.83 D6119 IMP/ABUT SPRTD INTRM FIXED DENTR EDENTLS MAXLARY 3,368.83 D6120 IMPL SUPP RETAINR PORCLN FUSED TITNM AND ALLOYS 2,659.89 D6121 IMPL SUPP RETAINER METAL FPD BASE ALLOYS 2,508.36 D6122 IMPL SUPP RETAINER METAL FPD NOBLE ALLOYS 2,665.30 D6123 IMPL SUPP RETAINR METAL FPD TITNM AND ALLOYS 2,508.36 D6180 IMP MAINT, FULL ARCH HYBRID, PRSTHSIS & ABUTS 0.00 D6190 RADIOGRAPHIC/SURGICAL IMPLANT INDEX BY REPORT 500.59 D6191 SEMI-PRECISION ABUTMENT - PLACEMENT 2,099.77 D6192 SEMI-PRECISION ATTACHMENT - PLACEMENT 1,122.94 D6193 REPLACEMENT OF AN IMPLANT SCREW 0.00 D6194 ABUTMENT SUPPORTED RETAINER CROWN FOR FPD-TITANM 2,300.01 D6195 ABUT SUPP RETAINR PORCLN FUSED TITANIUM ALLOYS 2,708.60 D6197 RPLC RSTRTV MAT CLOS ACES OPN IPLNT SUPP PRSTSIS 284.12 D6198 REMOVE INTERIM IMPLANT COMPONENT 500.59 D6199 UNSPECIFIED IMPLANT PROCEDURE BY REPORT 0.00 D6205 PONTIC - INDIRECT RESIN BASED COMPOSITE 1,075.54 D6210 PONTIC - CAST HIGH NOBLE METAL 1,644.33 D6211 PONTIC - CAST PREDOMINANTLY BASE METAL 1,540.91 D6212 PONTIC - CAST NOBLE METAL 1,602.96 D6214 PONTIC - TITANIUM 1,654.67 D6240 PONTIC - PORCELAIN FUSED TO HIGH NOBLE METAL 1,623.65 D6241 PONTIC - PORCELN FUSED PREDOMINANTLY BASE METAL 1,499.55 D6242 PONTIC - PORCELAIN FUSED TO NOBLE METAL 1,582.28 D6243 PONTIC PORCELAIN FUSED TO TITANIUM AND ALLOYS 1,499.55 D6245 PONTIC - PORCELAIN/CERAMIC 1,675.36 D6250 PONTIC - RESIN WITH HIGH NOBLE METAL 1,602.96 D6251 PONTIC - RESIN WITH PREDOMINANTLY BASE METAL 1,478.86 D6252 PONTIC - RESIN WITH NOBLE METAL 1,526.43 D6253 PROVISIONAL PONTIC 690.83 D6545 RETAINER - CAST METAL RESIN BONDED FIX PROSTH 614.46 D6548 RETAINER - PORCELN/CERAMIC RSN BONDED FIX PROSTH 675.91 D6549 RESIN RETAINER FOR RESIN BONDED FIXED PROSTHESIS 443.16 D6600 RETAINER INLAY - PORCELAIN/CERAMIC TWO SURFACES 1,219.62 D6601 RETAINER INLAY - PORC/CERAMIC 3 OR MORE SURFACES 1,279.20 D6602 RETAINER INLAY CAST HIGH NOBLE METAL 2 SURFACES 1,303.41 D6603 RETAINR INLAY - CAST HI NOBLE METAL 3/MORE SURFS 1,433.75 D6604 RETAINER INLAY - CAST PREDOM BASE METAL 2 SURFS 1,277.34 D6605 RTAINR INLAY - CAST PREDOM BASE MTL 3/MORE SURFS 1,353.68 D6606 RETAINER INLAY - CAST NOBLE METAL TWO SURFACES 1,256.86 D6607 RETNR INLAY CAST NOBLE METAL 3 OR MORE SURFACES 1,394.65 D6608 RETAINER ONLAY - PORCELAIN/CERAMIC TWO SURFACES 1,325.75 D6609 RETAINER ONLAY PORCELAIN/CERAMIC 3/MORE SURFACES 1,383.47 D6610 RETAINER ONLAY - HIGH NOBLE METAL TWO SURFACES 1,405.82 D6611 RETAINER ONLAY HIGH NOBLE METAL 3/MORE SURFACES 1,538.02 D6612 RETAINER ONLAY CAST PREDOM BASE METAL 2 SURFACES 1,398.37 D6613 RETNR ONLAY CAST PREDOM BASE METAL 3/MORE SURFS 1,461.68 D6614 RETAINER ONLAY - CAST NOBLE METAL TWO SURFACES 1,368.58 D6615 RETNR ONLAY CAST NOBLE METAL 3 OR MORE SURFACES 1,422.58 D6624 RETAINER INLAY - TITANIUM 1,303.41 D6634 RETAINER ONLAY - TITANIUM 1,368.58 D6710 RETAINER CROWN - INDIRECT RESIN BASED COMPOSITE 1,396.51 D6720 RETAINER CROWN - RESIN WITH HIGH NOBLE METAL 1,629.26 D6721 RETAINER CROWN - RESIN WITH PREDOM BASE METAL 1,545.47 D6722 RETAINER CROWN - RESIN WITH NOBLE METAL 1,573.40 D6740 RETAINER CROWN - PORCELAIN/CERAMIC 1,713.05 D6750 RETNR CROWN PORCELAIN FUSED TO HIGH NOBLE METAL 1,668.36 D6751 RETNR CROWN PORCELAIN FUSED PREDOM BASE METAL 1,556.64 D6752 RETAINER CROWN - PORCELAIN FUSED TO NOBLE METAL 1,593.88 D6753 RETAINR CROWN PORCLN FUSED TO TITANIUM AND ALLOY 1,556.64 D6780 RETAINER CROWN - 3/4 CAST HIGH NOBLE METAL 1,573.40 D6781 RETAINER CROWN 3/4 CAST PREDOMINANTLY BASE METAL 1,573.40 D6782 RETAINER CROWN - 3/4 CAST NOBLE METAL 1,461.68 D6783 RETAINER CROWN - 3/4 PORCELAIN/CERAMIC 1,619.95 D6784 RETAINER CROWN-3/4 TITANIUM AND ALLOYS 1,573.40 D6790 RETAINER CROWN - FULL CAST HIGH NOBLE METAL 1,610.64 D6791 RETAINER CROWN FULL CAST PREDOM BASE METAL 1,526.85 D6792 RETAINER CROWN - FULL CAST NOBLE METAL 1,582.71 D6793 PROVISIONAL RETAINER CROWN 661.01 D6794 RETAINER CROWN - TITANIUM 1,582.71 D6920 CONNECTOR BAR 472.95 D6930 RECEMENT / REBOND FIXED PARTIAL DENTURE 275.89 D6940 STRESS BREAKER 625.35 D6950 PRECISION ATTACHMENT 1,208.65 D6980 FIXED PARTIAL DENTURE REPAIR MATERIAL FAILURE 0.00 D6985 PEDIATRIC PARTIAL DENTURE FIXED 1,051.00 D6999 UNSPECIFIED FIXED PROSTHODONTIC PROCEDURE REPORT 0.00 D7111 EXTRACTION CORONAL REMNANTS - PRIMARY TOOTH 216.86 D7140 EXTRACTION ERUPTED TOOTH OR EXPOSED ROOT 288.26 D7210 EXTRACTION ERUPTED TOOTH REMV BONE ELEV FLAP 450.35 D7220 REMOVAL OF IMPACTED TOOTH - SOFT TISSUE 564.69 D7230 REMOVAL OF IMPACTED TOOTH - PARTIALLY BONY 751.37 D7240 REMOVAL OF IMPACTED TOOTH - COMPLETELY BONY 882.04 D7241 REMV IMP TOOTH - CMPL BONY W/UNUSUAL SURG COMPS 1,108.38 D7250 SURGICAL REMOVAL OF RESIDUAL TOOTH ROOTS 476.02 D7251 CORONECTMY INTNTNAL PART TOOTH REMOV IMPCTD OLY 933.38 D7252 PARTIAL TOOTH EXT IMMEDIATE IMPLANT PLACEMENT 0.00 D7259 NERVE DISSECTION 0.00 D7260 OROANTRAL FISTULA CLOSURE 3,554.21 D7261 PRIMARY CLOSURE OF A SINUS PERFORATION 1,480.92 D7270 TOOTH REIMPL &/OR STBL ACC EVULSED/DISPLCD TOOTH 1,110.69 D7272 TOOTH TRANSPLANTATION 1,480.92 D7280 EXPOSURE OF AN UNERUPTED TOOTH 1,036.64 D7282 MOBILIZ ERUPTED/MALPOSITIONED TOOTH AID ERUPTION 518.32 D7283 PLCMT DEVICE FACILITATE ERUPTION IMPACTED TOOTH 444.28 D7284 EXCISIONAL BIOPSY OF MINOR SALIVARY GLANDS 1,777.10 D7285 BIOPSY OF ORAL TISSUE HARD 2,073.29 D7286 BIOPSY OF ORAL TISSUE SOFT 888.55 D7287 EXFOLIATIVE CYTOLOGICAL SAMPLE COLLECTION 355.42 D7288 BRUSH BIOPSY - TRANSEPITHELIAL SAMPLE COLLECTION 355.42 D7290 SURGICAL REPOSITIONING OF TEETH 888.55 D7291 TRANSSEPTAL FIBEROT/SUPRA CRESTAL FIBEROT BR 0.00 D7292 SURG PLCMT: TEMP ANCHORAGE SCREW RET PLATE FLAP 1,421.68 D7293 SURG PLCMT: TEMP ANCHORAGE DEVICE RQR SURG FLAP 888.55 D7294 SURG PLCMT: TEMP ANCHORAGE DEVICE W/O SURG FLAP 740.46 D7295 HARVEST BONE FOR USE AUTOGENOUS GRAFTING PROC 0.00 D7296 CORTICOTOMY 1 - 3 TEETH OR TOOTH SPACES PER QUAD 0.00 D7297 CORTCTMY 4 OR MORE TEETH OR TOOTH SPCES PER QUAD 0.00 D7298 REMOVAL SCREW RETAINED PLATE WITH FLAP 0.00 D7299 REMOVAL TEMPORARY ANCHORAGE DEVICE WITH FLAP 0.00 D7300 REMOVAL TEMPORARY ANCHORAGE DEVICE WITHOUT FLAP 0.00 D7310 ALVEOLOPLASTY W/EXTRACTION 4/> TEETH/SPACE QUAD 589.53 D7311 ALVEOLOPLSTY CONJNC XTRACT 1-3 TEETH/SPACES QUAD 515.84 D7320 ALVEOLOPLASTY NOT W/EXTRACTIONS 4/> TEETH/SPACE 957.99 D7321 ALVEOLOPLSTY NOT CNJNC XTRCT 1-3 TEETH/SPCE QUAD 810.61 D7340 VESTIBULOPLASTY RIDGE EXT SEC EPITHELIALIZATION 4,053.03 D7350 VESTIBULOPLASTY RIDGE EXT W/SOFT TISS GRAFTS 11,790.64 D7410 EXCISION OF BENIGN LESION UP TO 1.25 CM 1,768.60 D7411 EXCISION OF BENIGN LESION GREATER THAN 1.25 CM 2,800.28 D7412 EXCISION OF BENIGN LESION COMPLICATED 3,095.04 D7413 EXCISION OF MALIGNANT LESION UP TO 1.25 CM 2,063.36 D7414 EXCISION OF MALIGNANT LESION > 1.25 CM 3,095.04 D7415 EXCISION OF MALIGNANT LESION COMPLICATED 3,463.50 D7440 EXC MALIG TUMOR-LESION DIAMETER UP TO 1.25 CM 2,800.28 D7441 EXC MALIG TUMOR-LESION DIAM GREATER THAN 1.25 CM 4,126.72 D7450 REMOVL BENIGN ODONTOGENC CYST/TUMR-UP T0 1.25 CM 1,768.60 D7451 REMOVAL BENIGN ODONTOGENIC CYST/TUMOR- > 1.25 CM 2,417.08 D7460 REMOVAL BEN NONODONTOGENIC CYST/TUMR- UP 1.25 CM 1,768.60 D7461 REMOVAL BEN NONODONTOGENIC CYST/TUMOR > 1.25 CM 2,417.08 D7465 DESTRUCTION LESION PHYSICAL/CHEM METHOD BY REPRT 957.99 D7471 REMOVAL OF LATERAL EXOSTOSIS 2,190.11 D7472 REMOVAL OF TORUS PALATINUS 2,602.78 D7473 REMOVAL OF TORUS MANDIBULARIS 2,455.40 D7485 REDUCTION OF OSSEOUS TUBEROSITY 2,190.11 D7490 RADICAL RESECTION OF MAXILLA OR MANDIBLE 17,685.96 D7509 MARSUPIALIZATION OF ODONTOGENIC CYST 957.99 D7510 INCISION & DRAINAGE ABSCESS-INTRAORAL SOFT TISS 633.75 D7511 I & D ABSCESS INTRAORAL SOFT TISSUE COMPLICATED 957.99 D7520 INCISION & DRAINAGE ABSCESS-EXTRAORAL SOFT TISS 3,018.40 D7521 I & D ABSCESS EXTRAORAL SOFT TISSUE COMPLICATED 3,316.12 D7530 REMOVAL FB FROM MUCOSA SKIN/SUBCUT ALVEOL TISSUE 1,087.69 D7540 REMV REACT-PRODUC FOREIGN BODIES-MUSCULOSKEL SYS 1,205.59 D7550 PART OSTEC/SEQUESTRECTOMY REMOVAL NON-VITAL BONE 751.65 D7560 MAXILLARY SINUSOTOMY REMOVAL TOOTH FRAGMENT/FB 5,969.01 D7610 MAXILLA-OPEN REDUCTION 9,653.59 D7620 MAXILLA-CLOSED REDUCTION 7,239.45 D7630 MANDIBLE-OPEN REDUCTION 12,551.14 D7640 MANDIBLE-CLOSED REDUCTION 7,964.58 D7650 MALAR AND/OR ZYGOMATIC ARCH - OPEN REDUCTION 6,033.86 D7660 MALAR AND/OR ZYGOMATIC ARCH - CLOSED REDUCTION 3,557.83 D7670 ALVEOLUS-CLOSED REDUCTION W/STABILIZATION TEETH 2,776.70 D7671 ALVEOLUS-OPEN REDUCTION W/STABILIZATION TEETH 5,232.10 D7680 FACE BONES-COMP RDUC W/FIX&MX SURG APPRCHES CPT 18,101.58 D7710 MAXILLA - OPEN REDUCTION 11,345.54 D7720 MAXILLA - CLOSED REDUCTION 7,964.58 D7730 MANDIBLE - OPEN REDUCTION 16,412.57 D7740 MANDIBLE - CLOSED REDUCTION 8,120.80 D7750 MALAR AND/OR ZYGOMATIC ARCH - OPEN REDUCTION 10,328.60 D7760 MALAR AND/OR ZYGOMATIC ARCH - CLOSED REDUCTION 4,144.41 D7770 ALVEOLUS - OPEN REDUCTION STABILIZATION OF TEETH 5,615.29 D7771 ALVEOLUS CLOSED REDUCTION STABILIZATION OF TEETH 4,333.06 D7780 FACIAL BONES-COMP RDUC FIX & MULT APPROACHES 24,135.44 D7810 OPEN REDUCTION OF DISLOCATION 10,617.47 D7820 CLOSED REDUCTION OF DISLOCATION 1,739.12 D7830 MANIPULATION UNDER ANESTHESIA 996.31 D7840 CONDYLECTOMY 14,473.01 D7850 SURGICAL DISCECTOMY WITH/WITHOUT IMPLANT 12,498.08 D7852 DISC REPAIR 14,310.89 D7854 SYNOVECTOMY 14,767.78 D7856 MYOTOMY 10,478.93 D7858 JOINT RECONSTRUCTION 29,868.64 D7860 ARTHROTOMY 12,730.94 D7865 ARTHROPLASTY 20,515.71 D7870 ARTHROCENTESIS 677.96 D7871 NON-ARTHROSCOPIC LYSIS AND LAVAGE 1,355.92 D7872 ARTHROSCOPY - DIAGNOSIS WITH OR WITHOUT BIOPSY 7,236.51 D7873 ARTHROSCOPY: LAVAGE & LYSIS ADHESIONS 8,713.28 D7874 ARTHROSCOPY: DISC REPSTN & STABILIZATION 12,498.08 D7875 ARTHROSCOPY: SYNOVECTOMY 13,691.88 D7876 ARTHROSCOPY: DISCECTOMY 14,761.88 D7877 ARTHROSCOPY: DEBRIDEMENT 13,028.66 D7880 OCCLUSAL ORTHOTIC DEVICE BY REPORT 1,627.11 D7881 OCCLUSAL ORTHOTIC DEVICE ADJUSTMENT 176.86 D7899 UNSPECIFIED TMD THERAPY BY REPORT 0.00 D7910 SUTURE OF RECENT SMALL WOUNDS UP TO 5 CM 966.83 D7911 COMPLICATED SUTURE - UP TO 5 CM 2,414.13 D7912 COMPLICATED SUTURE - GREATER THAN 5 CM 4,344.85 D7920 SKIN GRAFT 7,118.60 D7921 COLL APPL AUTOLOGOUS BLD CNCNTRT PRODUCT 657.33 D7922 PLACEMENT INTRASOCKET BIO DRESSING PER SITE 0.00 D7939 INDEX OSTEOTOMY USING DYNMIC ROBO ASSIST NAVI 0.00 D7940 OSTEOPLASTY - FOR ORTHOGNATHIC DEFORMITIES 0.00 D7941 OSTEOTOMY - MANDIBULAR RAMI 18,128.11 D7943 OSTEOT-MANDIB RAMI W/BONE GRFT;INCL OBTAIN GRAFT 16,654.28 D7944 OSTEOTOMY - SEGMENTED OR SUBAPICAL 14,841.47 D7945 OSTEOTOMY - BODY OF MANDIBLE 19,749.32 D7946 LEFORT I (MAXILLA - TOTAL) 24,465.58 D7947 LEFORT I (MAXILLA - SEGMENTED) 20,574.67 D7948 LEFORT II/LEFORT III - W/O BONE GRAFT 26,705.80 D7949 LEFORT II OR LEFORT III - WITH BONE GRAFT 34,782.39 D7950 OSSEOUS OSTEOPERIOSTEAL/CARTILAGE GRAFT MAND/MAX 0.00 D7951 SINUS AUG WITH BONE OR BONE SUBSTITUTES-LAT APP 0.00 D7952 SINUS AUGMENTATION VIA A VERTICAL APPROACH 0.00 D7953 BONE REPLCMT GRAFT RIDGE PRESERVATION PER SITE 1,002.20 D7955 REPAIR MAXLOFACIAL SOFT &/ HARD TISSUE DEFECT 0.00 D7956 GIDED TISS REGENRATION EDENT RESORB BARR PR SITE 1,031.68 D7957 GIDED TISS REGENRATION EDENT NONRESORB BARR SITE 1,326.45 D7961 BUCCAL/LABIAL FRENECTOMY (FRENULECTOMY) 810.61 D7962 LINGUAL FRENECTOMY (FRENULECTOMY) 810.61 D7963 FRENULOPLASTY 1,326.45 D7970 EXCISION OF HYPERPLASTIC TISSUE - PER ARCH 1,179.06 D7971 EXCISION OF PERICORONAL GINGIVA 442.15 D7972 SURGICAL REDUCTION OF FIBROUS TUBEROSITY 1,650.69 D7979 NON-SURGICAL SIALOLITHOTOMY 0.00 D7980 SURGICAL SIALOLITHOTOMY 1,857.03 D7981 EXCISION OF SALIVARY GLAND BY REPORT 0.00 D7982 SIALODOCHOPLASTY 4,392.01 D7983 CLOSURE OF SALIVARY FISTULA 4,215.15 D7990 EMERGENCY TRACHEOTOMY 3,625.62 D7991 CORONOIDECTOMY 8,842.98 D7993 SURGICAL PLCMNT CRANIOFACIAL IMPLANT-EXTRA ORAL 0.00 D7994 SURGICAL PLACEMENT ZYGOMATIC IMPLANT 0.00 D7995 SYNTHETIC GRAFT-MANDIBLE/FACIAL BONES BY REPORT 0.00 D7996 IMPLANT-MANDIBLE AUGMENTATION PURPOSES BY REPORT 0.00 D7997 APPLIANCE REMOVAL INCLUDES REMOVAL OF ARCHBAR 677.96 D7998 INTRAORAL PLCMT FIX DEVICE NOT CONJUNCTION W/FX 2,947.66 D7999 UNSPECIFIED ORAL SURGERY PROCEDURE BY REPORT 0.00 D8010 LIMITED ORTHODONTIC TREATMENT PRIMARY DENTITION 0.00 D8020 LTD ORTHODONTIC TREATMENT TRANSITIONAL DENTITION 0.00 D8030 LTD ORTHODONTIC TREATMENT ADOLESCENT DENTITION 0.00 D8040 LIMITED ORTHODONTIC TREATMENT ADULT DENTITION 0.00 D8070 COMP ORTHODONTIC TX TRANSITIONAL DENTITION 0.00 D8080 COMPREHENSIVE ORTHODONTIC TX ADOLES DENTITION 0.00 D8090 COMPREHENSIVE ORTHODONTIC TX ADULT DENTITION 0.00 D8091 COMP ORTHO TX WITH ORTHOGNATHIC SURG 0.00 D8210 REMOVABLE APPLIANCE THERAPY 0.00 D8220 FIXED APPLIANCE THERAPY 0.00 D8660 PREORTHODONTIC TREATMENT VISIT 0.00 D8670 PERIODIC ORTHODONTIC TREATMENT VISIT 0.00 D8671 PERIODIC ORTHO VISIT WITH ORTHOGNATHIC SURG 0.00 D8680 ORTHODONTIC RETENTION 0.00 D8681 REMOVABLE ORTHODONTIC RETAINER ADJUSTMENT 0.00 D8695 REMOVAL OF FIXED ORTHO APPLIANCES TX NOT COMPLT 0.00 D8696 REPAIR ORTHODONTIC APPLIANCE MAXILLARY 0.00 D8697 REPAIR ORTHODONTIC APPLIANCE MANDIBULAR 0.00 D8698 RE-CEMENT OR RE-B0ND FIXED RETAINER MAXILLARY 0.00 D8699 RE-CEMENT OR RE-BOND FIXED RETAINER MANDIBULAR 0.00 D8701 REPAIR FIXED RETAINER, WITH REATTACH, MAXILLARY 0.00 D8702 REPAIR FIXED RETAINER, WITH REATTACH, MANDIBULAR 0.00 D8703 REPLACE LOST OR BROKEN RETAINER MAXILLARY 0.00 D8704 REPLACE LOST OR BROKEN RETAINER MANDIBULAR 0.00 D8999 UNSPECIFIED ORTHODONTIC PROCEDURE BY REPORT 0.00 D9110 PALLIATIVE TREATMENT OF DENTAL PAIN PER VISIT 203.10 D9120 FIXED PARTIAL DENTURE SECTIONING 229.48 D9130 TMJ JOINT DYSFUNCTION - NON-INVASIVE PHYSL THERP 0.00 D9210 LOCAL ANES-NOT CONJUNCTION W/OP/SURGICAL PROC 77.08 D9211 REGIONAL BLOCK ANESTHESIA 85.05 D9212 TRIGEMINAL DIVISION BLOCK ANESTHESIA 132.89 D9215 LOCAL ANESTHESIA CONJUCTION OPERATIVE/SURG PROC 63.79 D9219 EVALUATION FOR MOD OR DEEP SEDATION / GA 151.50 D9222 DEEP SEDATION / GENERAL ANESTHESIA FIRST 15 MIN 451.83 D9223 DEEP SEDATION/ GEN ANESTH EACH 15 MIN INCREMENT 345.52 D9230 INHALATION OF NITROUS OXIDE/ANXIOLYSIS ANALGESIA 127.57 D9239 IV MOD (CONSCIOUS) SEDTION/ANALGSIA FIRST 15 MIN 372.09 D9243 IV MOD (CONSCIOUS) SEDATION EACH 15 MIN INCRMENT 292.36 D9248 NON-INTRAVENOUS CONSCIOUS SEDATION 186.05 D9310 CONSULT DX SERV DENT/PHY NOT REQUESTING DENT/PHY 280.67 D9311 CONSULT WITH A MEDICAL HEALTHCARE PROFESSIONAL 280.67 D9410 HOUSE/EXTENDED CARE FACILITY CALL 321.01 D9420 HOSPITAL OR AMBULATORY SURGICAL CENTER CALL 519.23 D9430 OFFICE VISIT OBSERVATION NO OTHER SRVC PERFORMED 0.00 D9440 OFFICE VISIT - AFTER REGULARLY SCHEDULED HOURS 175.42 D9450 CASE PRESENTATION AFTER DETL&EXTN TREATMENT PLAN 87.71 D9610 THERAPEUTIC PARENTERAL DRUG SINGL ADMINISTRATION 0.00 D9612 TX PARENTERAL DRUGS 2/> ADMINISTRATIONS DIFF MED 0.00 D9613 INFLTRN SUSTND RELSE THRPTIC DRG PER QUADRANT 0.00 D9630 DRUGS AND/OR MEDICAMENTS BY REPORT, HOME USE 0.00 D9910 APPLICATION OF DESENSITIZING MEDICAMENT 108.03 D9911 APPLIC DESENZT RSN CERV &OR ROOT SURF-TOOTH 151.24 D9912 PRE-VISIT PATIENT SCREENING 104.94 D9913 ADMINISTRATION OF NEUROMODULATORS 0.00 D9914 ADMINISTRATION OF DERMAL FILLERS 0.00 D9920 BEHAVIOR MANAGEMENT BY REPORT 0.00 D9930 TX COMPLICATIONS - UNUSUAL CIRCUMSTANCES REPORT 0.00 D9932 CLEAN/INSPECT REMOVBL COMPLETE MAXILLARY DENTURE 151.24 D9933 CLEAN INSPECT REMVBL COMPLETE MANDIBULAR DENTURE 151.24 D9934 CLEAN/ INSPECT REMVBL PARTIAL MAXILLARY DENTURE 151.24 D9935 CLEAN INSPECT REMVBL PARTIAL MANDIBULAR DENTURE 151.24 D9938 FABR CUST REMVBLE CLER PLAST TEMP ASTHETC APLNCE 0.00 D9939 PLACE CUST REMVBLE CLER PLAST TEMP ASTHTC APLNCE 0.00 D9941 FABRICATION OF ATHLETIC MOUTHGUARD 308.64 D9942 REPAIR AND/OR RELINE OF OCCLUSAL GUARD 370.37 D9943 OCCLUSAL GUARD ADJUSTMENT 185.19 D9944 OCCLUSAL GUARD - HARD APPLIANCE, FULL ARCH 895.07 D9945 OCCLUSAL GUARD - SOFT APPLIANCE, FULL ARCH 895.07 D9946 OCCLUSAL GUARD HARD APPLIANCE PARTIAL ARCH 895.07 D9947 CUSTOM SLEEP APNEA APPLIANCE FABRCATION/PLACEMNT 0.00 D9948 ADJUSTMENT CUSTOM SLEEP APNEA APPLIANCE 0.00 D9949 REPAIR CUSTOM SLEEP APNEA APPLIANCE 0.00 D9950 OCCLUSION ANALYSIS - MOUNTED CASE 586.42 D9951 OCCLUSAL ADJUSTMENT - LIMITED 262.35 D9952 OCCLUSAL ADJUSTMENT - COMPLETE 1,234.58 D9953 RELINE CUSTOM SLEEP APNEA APPLIANCE (INDIRECT) 1,018.53 D9954 FABRIC AND DELIV OAT MORNING REPOSITION DEVICE 0.00 D9955 ORAL APPLIANCE THERAPY (OAT) TITRATION VISIT 0.00 D9956 ADMINISTRATION OF HOME SLEEP APNEA TEST 0.00 D9957 SCREENING FOR SLEEP RELATED BREATHING DISORDERS 0.00 D9959 UNSPECIFIED SLEEP APNEA SERV PROC BR 0.00 D9961 DUPLICATE/COPY PATIENT'S RECORDS 0.00 D9970 ENAMEL MICROABRASION 138.89 D9971 ODONTOPLASTY 1-2 TEETH; INCL REMOVAL ENAMEL PROJ 179.01 D9972 EXTERNAL BLEACHING - PER ARCH 617.29 D9973 EXTERNAL BLEACHING - PER TOOTH 101.85 D9974 INTERNAL BLEACHING - PER TOOTH 540.13 D9975 EXTERNAL BLEACHING - PER ARCH (HOME) 617.29 D9985 SALES TAX 0.00 D9986 MISSED APPOINTMENT 0.00 D9987 CANCELLED APPOINTMENT 0.00 D9990 CERT TRNSLATION OR SIGN LANGUAGE SRVCS PER VISIT 0.00 D9991 DENTAL CASE MGMT ADDRESS APPNTMNT COMPL BARRIERS 0.00 D9992 DENTAL CASE MANAGEMENT - CARE COORDINATION 108.03 D9993 DENTAL CASE MGMT - MOTIVATIONAL INTERVIEWING 0.00 D9994 DENTAL CASE MGMT - PATIENT EDU IMPRV ORAL HEALTH 0.00 D9995 TELEDENTISTRY - SYNCHRONOUS; REAL TIME ENCOUNTER 493.83 D9996 TELDENTRY ASYNCHRNS INFO FWD DENTIST SBSQNT REVW 370.37 D9997 DENTAL CASE MANAGEMENT SPECIAL HEALTH CARE NEEDS 0.00 D9999 UNSPECIFIED ADJUNCTIVE PROC BY REPORT (01/25) By Report Exhibit #4 – Effective 1/1/2026 APCs for Procedures with a Status Indicator C When Performed in an OP Hospital or ASC 0202T Post vert arthrplst 1 lumbar 5115 0219T Plmt post facet implt cerv 5115 0220T Plmt post facet implt thor 5115 20802 Replantation arm complete 5116 20805 Replant forearm complete 5116 20808 Replantation hand complete 5116 20816 Replantation digit complete 5114 20824 Replantation thumb complete 5114 20827 Replantation thumb complete 5114 20838 Replantation foot complete 5116 20955 Fibula bone graft microvasc 5114 20956 Iliac bone graft microvasc 5114 20957 Mt bone graft microvasc 5114 20962 Other bone graft microvasc 5114 20969 Bone/skin graft microvasc 5114 20970 Bone/skin graft iliac crest 5114 21045 Extensive jaw surgery 5165 21145 Lefort i-1 piece w/ graft 5165 21146 Lefort i-2 piece w/ graft 5165 21147 Lefort i-3/> piece w/ graft 5165 21151 Lefort ii w/bone grafts 5165 21154 Lefort iii w/o lefort i 5165 21155 Lefort iii w/ lefort i 5165 21159 Lefort iii w/fhdw/o lefort i 5165 21160 Lefort iii w/fhd w/ lefort i 5165 21179 Reconstruct entire forehead 5165 21180 Reconstruct entire forehead 5165 21182 Reconstruct cranial bone 5165 21183 Reconstruct cranial bone 5165 21184 Reconstruct cranial bone 5165 21188 Reconstruction of midface 5165 21247 Reconstruct lower jaw bone 5165 21268 Revise eye sockets 5165 21343 Open tx dprsd front sinus fx 5165 21344 Open tx compl front sinus fx 5165 21348 Opn tx nasomax fx w/graft 5165 21423 Treat mouth roof fracture 5165 21431 Treat craniofacial fracture 5165 21432 Treat craniofacial fracture 5165 21433 Treat craniofacial fracture 5165 21435 Treat craniofacial fracture 5165 21436 Treat craniofacial fracture 5165 21510 Drainage of bone lesion 5114 21602 Exc ch wal tum w/o lymphadec 5114 21603 Exc ch wal tum w/lymphadec 5114 21615 Removal of rib 5114 21616 Removal of rib and nerves 5114 21620 Partial removal of sternum 5114 21627 Sternal debridement 5114 21630 Extensive sternum surgery 5114 21705 Revision of neck muscle/rib 5114 21740 Reconstruction of sternum 5114 21750 Repair of sternum separation 5114 21825 Treat sternum fracture 5114 22010 I&d p-spine c/t/cerv-thor 5114 22015 I&d abscess p-spine l/s/ls 5114 22110 Remove part of neck vertebra 5114 22112 Remove part thorax vertebra 5114 22114 Remove part lumbar vertebra 5114 22206 Incis spine 3 column thorac 5114 22207 Incis spine 3 column lumbar 5114 22210 Incis 1 vertebral seg cerv 5114 22212 Incis 1 vertebral seg thorac 5114 22214 Incis 1 vertebral seg lumbar 5114 22220 Osteot dsc ant 1 vrt sgm crv 5114 22222 Osteot dsc ant 1vrt sgm thrc 5114 22224 Osteot dsc ant 1vrt sgm lmbr 5114 22318 Treat odontoid fx w/o graft 5115 22319 Treat odontoid fx w/graft 5115 22325 Treat spine fracture 5115 22326 Treat neck spine fracture 5115 22327 Treat thorax spine fracture 5115 22532 Arthrd lat xtrcvtry tq thrc 5116 22533 Arthrd lat xtrcvtry tq lmbr 5116 22548 Arthrd ant toral/xoral c1-c2 5116 22556 Arthrd ant ntrbd min dsc thc 5116 22558 Arthrd ant ntrbd min dsc lum 5116 22586 Arthrd pre-sac ntrbdy l5-s1 5116 22590 Arthrd pst tq craniocervical 5116 22595 Arthrd pst tq atlas-axis 5116 22600 Arthrd pst tq 1ntrspc crv 5116 22610 Arthrd pst tq 1ntrspc thrc 5116 22800 Arthrd pst dfrm<6 vrt sgm 5116 22802 Arthrd pst dfrm 7-12 vrt sgm 5116 22804 Arthrd pst dfrm 13+ vrt sgm 5116 22808 Arthrd ant dfrm 2-3 vrt sgm 5116 22810 Arthrd ant dfrm 4-7 vrt sgm 5116 22812 Arthrd ant dfrm 8+ vrt sgm 5116 22818 Kyphectomy 1-2 segments 5116 22819 Kyphectomy 3 or more 5116 22830 Exploration of spinal fusion 5115 22849 Reinsert spinal fixation 5116 22850 Remove spine fixation device 5115 22852 Remove spine fixation device 5115 22855 Remove spine fixation device 5115 22857 Tot disc arthrp ant lumbar 5116 22861 Revise cerv artific disc 5116 22862 Revise lumbar artif disc 5116 22864 Remove cerv artif disc 5115 22865 Remove lumb artif disc 5115 23200 Resect clavicle tumor 5114 23210 Resect scapula tumor 5114 23220 Resect prox humerus tumor 5114 23335 Shoulder prosthesis removal 5073 23474 Revis reconst shoulder joint 5115 23900 Amputation of arm & girdle 5115 23920 Amputation at shoulder joint 5115 24900 Amputation of upper arm 5115 24920 Amputation of upper arm 5115 24930 Amputation follow-up surgery 5114 24931 Amputate upper arm & implant 5115 24940 Revision of upper arm 5115 25900 Amputation of forearm 5115 25905 Amputation of forearm 5115 25915 Amputation of forearm 5114 25920 Amputate hand at wrist 5114 25924 Amputation follow-up surgery 5114 25927 Amputation of hand 5113 26551 Great toe-hand transfer 5114 26553 Single transfer toe-hand 5114 26554 Double transfer toe-hand 5114 26556 Toe joint transfer 5114 26992 Drainage of bone lesion 5114 27005 Incision of hip tendon 5114 27025 Incision of hip/thigh fascia 5114 27030 Drainage of hip joint 5114 27036 Excision of hip joint/muscle 5114 27054 Removal of hip joint lining 5113 27070 Part remove hip bone super 5114 27071 Part removal hip bone deep 5114 27075 Resect hip tumor 5114 27076 Resect hip tum incl acetabul 5114 27077 Resect hip tum w/innom bone 5115 27078 Rsect hip tum incl femur 5115 27090 Removal of hip prosthesis 5073 27091 Removal of hip prosthesis 5073 27120 Reconstruction of hip socket 5115 27122 Reconstruction of hip socket 5115 27125 Partial hip replacement 5115 27132 Total hip arthroplasty 5115 27134 Revise hip joint replacement 5115 27137 Revise hip joint replacement 5115 27138 Revise hip joint replacement 5115 27140 Transplant femur ridge 5115 27146 Incision of hip bone 5114 27147 Revision of hip bone 5114 27151 Incision of hip bones 5114 27156 Revision of hip bones 5114 27158 Revision of pelvis 5114 27161 Incision of neck of femur 5114 27165 Incision/fixation of femur 5114 27170 Repair/graft femur head/neck 5114 27175 Treat slipped epiphysis 5114 27176 Treat slipped epiphysis 5115 27177 Treat slipped epiphysis 5114 27178 Treat slipped epiphysis 5114 27181 Treat slipped epiphysis 5114 27185 Revision of femur epiphysis 5114 27187 Reinforce hip bones 5114 27226 Treat hip wall fracture 5114 27227 Treat hip fracture(s) 5114 27228 Treat hip fracture(s) 5114 27232 Treat thigh fracture 5112 27236 Treat thigh fracture 5114 27240 Treat thigh fracture 5112 27244 Treat thigh fracture 5114 27245 Treat thigh fracture 5114 27248 Treat thigh fracture 5114 27253 Treat hip dislocation 5113 27254 Treat hip dislocation 5113 27258 Treat hip dislocation 5113 27259 Treat hip dislocation 5113 27268 Cltx thigh fx w/mnpj 5113 27269 Optx thigh fx 5112 27280 Fusion of sacroiliac joint 5116 27282 Fusion of pubic bones 5115 27284 Fusion of hip joint 5116 27286 Fusion of hip joint 5116 27290 Amputation of leg at hip 5116 27295 Amputation of leg at hip 5116 27303 Drainage of bone lesion 5114 27365 Resect femur/knee tumor 5114 27445 Revision of knee joint 5115 27448 Incision of thigh 5114 27450 Incision of thigh 5114 27454 Realignment of thigh bone 5114 27455 Realignment of knee 5114 27457 Realignment of knee 5114 27465 Shortening of thigh bone 5114 27466 Lengthening of thigh bone 5114 27468 Shorten/lengthen thighs 5114 27470 Repair of thigh 5114 27472 Repair/graft of thigh 5114 27486 Revise/replace knee joint 5115 27487 Revise/replace knee joint 5115 27488 Removal of knee prosthesis 5114 27495 Reinforce thigh 5114 27506 Treatment of thigh fracture 5114 27507 Treatment of thigh fracture 5114 27511 Treatment of thigh fracture 5114 27513 Treatment of thigh fracture 5114 27514 Treatment of thigh fracture 5114 27519 Treat thigh fx growth plate 5114 27535 Treat knee fracture 5114 27536 Treat knee fracture 5114 27540 Treat knee fracture 5114 27556 Treat knee dislocation 5114 27557 Treat knee dislocation 5114 27558 Treat knee dislocation 5114 27580 Fusion of knee 5115 27590 Amputate leg at thigh 5116 27591 Amputate leg at thigh 5116 27592 Amputate leg at thigh 5116 27596 Amputation follow-up surgery 5114 27598 Amputate lower leg at knee 5115 27645 Resect tibia tumor 5114 27646 Resect fibula tumor 5114 27703 Reconstruction ankle joint 5115 27712 Realignment of lower leg 5115 27715 Revision of lower leg 5115 27724 Repair/graft of tibia 5114 27725 Repair of lower leg 5114 27727 Repair of lower leg 5114 27880 Amputation of lower leg 5116 27881 Amputation of lower leg 5114 27882 Amputation of lower leg 5114 27886 Amputation follow-up surgery 5114 27888 Amputation of foot at ankle 5115 28800 Amputation of midfoot 5113 35372 Rechanneling of artery 5184 35800 Explore neck vessels 5184 37182 Insert hepatic shunt (tips) 5193 37617 Ligation of abdomen artery 5183 38562 Removal pelvic lymph nodes 5362 43840 Repair of stomach lesion 5331 44300 Open bowel to skin 5302 44345 Revision of colostomy 5341 44346 Revision of colostomy 5341 44602 Suture small intestine 5303 49010 Exploration behind abdomen 5341 49255 Removal of omentum 5341 51840 Attach bladder/urethra 5415 56630 Extensive vulva surgery 5415 61624 Transcath occlusion cns 5194 G0412 Open tx iliac spine uni/bil 5114 G0414 Pelvic ring fx treat int fix 5115 G0415 Open tx post pelvic fxcture 5115 ______________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 17, Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R18 Ex 02-06 Rule 18, Exhibits 2-6 [Repealed eff. 01/01/2021] {#sec-7-ccr-1101-3-r18-ex-02-06 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R18 Ex 02-06}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Workers’ Compensation WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES MEDICAL FEE SCHEDULE 7 CCR 1101-3 Rule 18 - Exhibits 2-6 - Repealed eff. 01/01/2021 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 17, Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R18 Ex 07 Rule 18, Exhibit 7 [Repealed eff. 01/01/2021] {#sec-7-ccr-1101-3-r18-ex-07 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R18 Ex 07}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Workers’ Compensation WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES MEDICAL FEE SCHEDULE 7 CCR 1101-3 Rule 18 - Exhibit 7 - Repealed eff. 01/01/2021 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 17, Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R18 Ex 08 Rule 18, Exhibit 8 [Repealed eff. 01/01/2021] {#sec-7-ccr-1101-3-r18-ex-08 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R18 Ex 08}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Workers’ Compensation WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES MEDICAL FEE SCHEDULE 7 CCR 1101-3 Rule 18 - Exhibit 8 - Repealed eff. 01/01/2021 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 17, Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-3 R18 Ex 09 Rule 18, Exhibit 9 [Repealed eff. 01/01/2021] {#sec-7-ccr-1101-3-r18-ex-09 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-3 R18 Ex 09}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Workers’ Compensation WORKERS’ COMPENSATION RULES OF PROCEDURE WITH TREATMENT GUIDELINES MEDICAL FEE SCHEDULE 7 CCR 1101-3 Rule 18 - Exhibit 9 - Repealed eff. 01/01/2021 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Editor’s Notes 7 CCR 1101-3 has been divided into smaller sections for ease of use. Versions prior to 01/01/2011 and

rule history are located in the first section, 7 CCR 1101-3. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 01/01/2011, select the desired part of the rule, for example 7 CCR 1101-3 Rules 1-17, or 7 CCR 1101-3 Rule 17, Exhibit 1.

History [For history of this section, see Editor’s Notes in the first section, 7 CCR 1101-3]

7 CCR 1101-4 Rules Governing the Issuance of Self-Insurance Permits Under the Workers' Compensation Act {#sec-7-ccr-1101-4 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-4}

DEPARTMENT OF LABOR AND EMPLOYMENT

RULES GOVERNING THE ISSUANCE OF SELF-INSURANCE PERMITS UNDER THE WORKERS'

COMPENSATION ACT

7 CCR 1101-4 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

PART 1 INTRODUCTION

(A) STATEMENT OF BASIS AND PURPOSE

The specific right of the Executive Director to issue and revoke permits which allow employers to fulfill their insurance requirements under the Workers’ Compensation Act of Colorado by the self-insured method is found under §8-44-201. C.R.S.

The following rules set forth procedures for applying for a self-insurance permit, submission of periodic reports for retention of self-insured status, approval or denial of applications and revocation of a permit.

Also set forth by these rules are the security deposit and insurance requirements of self-insurers and the

authority of the Executive Director to perform audits to determine adequacy of reserves and security or require an audit and certified statement by an independent source.

PART 2 DEFINITIONS

"Act" means the "Workers’ Compensation Act of Colorado".

"Executive Director" means the "Executive Director of Labor and Employment".

"Permit" means the instrument issued to an approved employer by the Executive Director authorizing such employer the privilege to insure its risk under the Act as a self-insurer.

"Permit Holder" means that employer who has qualified under the rules of the Executive Director and has been granted the authority to self-insure its risks under the Act.

"Self-Insurer" means a permit holder.

"Specific Excess Insurance" means insurance purchased from either an insurer or a non-admitted surplus line company licensed by or approved by the Insurance Commissioner of Colorado that is liable for payment of any amount of a claim in excess of a retained predetermined value paid by the self-insured.

"Aggregate Excess Insurance" means insurance purchased from either an insurer or a non-admitted surplus line company licensed or approved by the Insurance Commissioner of Colorado that is liable for payment of the aggregate of all self-insured claims in excess of a retained predetermined aggregate value paid by the self-insured.

PART 3 APPLICATION PROCESS AND PERMIT REQUIREMENTS

(A) Employer Self-Insurance; Application.

(1) An employer seeking to insure its risk under the Act as a self-insurer pursuant to § 8-44-201, C.R.S., shall apply to the Executive Director on a form prescribed and furnished by the Executive Director titled "Application for Self-Insurance".

(2) All questions on the Application for Self-Insurance must be answered under oath by an authorized agent of the applicant.

(3) Only those applications submitted by employers who regularly employ at least three hundred (300) employees in Colorado will be considered by the Executive Director. In his/her discretion, the Executive Director may waive the 300 employee limitation for corporations, division(s) of a corporation, or subsidiaries of a corporation who can affirmatively demonstrate to the Executive Director their continued ability to meet all obligations under the Workers' Compensation Act at all times. In considering whether any waiver should be allowed, the Executive Director may consider factors such as, but not limited to:

(a) Total assets of at least $100,000,000;

(b) The ratio of current assets to current liabilities of 1.5:1; or more (c) The ratio of long term debt to tangible net worth of 1:1.5; or less (d) Accounting ratios which equal or exceed industry standards.

(4) In addition to the application, a favorable applicant must comply with all of the following:

(a) Submission of the applicant's most recent certified financial statement and certified financial statements for the immediate preceding four consecutive years.

(b) Evidence that the employer has been in business for a period of not less than five (5) years and can demonstrate sufficient financial strength and liquidity to assure that all obligations will be met promptly. An employer in business less than five (5) years may be considered if liability is guaranteed by a parent corporation with a business history of no less than five (5) years. If the applicant is an entity which has formed through merger, bifurcation or divestiture, the Executive Director may consider business history created prior to the applicants present formation as well as pro forma financial information.

(c) An insurance policy of specific excess insurance with policy limits and retention amounts acceptable to the Executive Director shall be required of each self-insured. Aggregate excess insurance may be required as a condition of approval of any self-insured program.

(d) An applicant for a permit shall provide security in the amount and in a manner prescribed by the Executive Director to insure payment of all workers' compensation claims required by the Act. The minimum amount of such security shall be $300,000. The Executive Director may consider, but is not limited to, the following forms of security:

1. Cash, government bonds, certificate of deposit or other forms of liquid security that are deemed acceptable by the Executive Director. All such security under this provision shall be bound in trust by proper agreement as approved by the Executive Director and duly executed by all parties to said trust.

2. A surety bond of the form prescribed by the Executive Director. When a surety bond is used, the following criteria shall apply:

(a) The Executive Director will not accept a surety bond unless it is issued by a surety company authorized by the Colorado Insurance Commissioner to transact such business in Colorado.

(b) A surety bond shall be issued on a prescribed form. A replacement surety bond must be on a prescribed replacement form, be of the current coverage amount and contain inclusive dates of surety coverage. The Executive Director must be advised immediately of such a change.

(c) The bond must include a statement that the bonding company must give ninety (90) days' notice of its intent to terminate liability to both the principal and the Executive Director.

3. The Executive Director may consider an irrevocable letter of credit of a form prescribed by the Executive Director at his/her discretion.

(e) All forms of security shall name the Executive Director as beneficiary and may be held by the Office of Treasurer of the State of Colorado. Upon discontinuance of self-insured status, for any reason, the Executive Director shall claim such security of that permit holder as reserves for all outstanding workers' compensation liabilities. The Executive Director shall retain such security until he/she is satisfied that all liabilities have been met; or the Executive Director or his/her agent shall oversee the appropriate disbursements of such security. In all forms of security such proceeds may be used in any manner to include payment of administrative or other costs necessitated in discharging any workers' compensation liability on the part of the employer under the act.

(5) All parent companies (permit holders) shall make application on behalf of their subsidiaries and provide a guarantee of liability for payment of compensation claims on the prescribed Division form. Changes subsequent to the initial application that pertain to acquisitions, mergers, spin-offs, creation of new subsidiaries, changes with Federal Employer identification number(s) must be reported a minimum of 30 days, prior to the effective date of the change, to the Executive Director or his/her agent for coverage approval if the self-insured permit holder’s intention is to continue self-insurance coverage and/or add coverage under the existing self-insurance permit.

(6) Each permit holder shall have within its own organization ample facilities and competent personnel to service its own program with respect to claims and administration or shall contract with a service company competent to provide these services.

PART 4 ADDITIONAL INSURANCE REQUIREMENTS

(A) SPECIFIC EXCESS INSURANCE AND AGGREGATE EXCESS INSURANCE

(1) The contract or policy of specific excess insurance and/or aggregate excess insurance shall comply with all of the following:

(a) Is issued from either an insurer or a non-admitted surplus line company licensed or approved by the Insurance Commissioner of Colorado.

(b) Is not cancelable or nonrenewable unless written notice by registered or certified mail is given to the other party to the policy and to the Executive Director not less than ninety (90) days before termination by the party desiring to cancel or not renew the policy.

(c) Any contract or policy containing any type of commutation clause shall provide that any commutation effected thereunder shall not relieve the underwriter or underwriters of further liability in respect to claims and expenses unknown at the time of such commutation or in regard to any claim apparently closed at the time of initial commutation which is subsequently reopened by or through a competent authority. If the underwriter proposes to settle a liability for future payments payable as compensation for accidents occurring during the term of the policy by the payment of a lump sum to the employer to be fixed as provided in the commutation clause of the policy, then not less than thirty (30) days prior notice to such commutation shall be given by the underwriter(s) or its (their) agent by registered or certified mail to the Executive Director. If any commutation is effected, the Executive Director shall have the right to direct that such sum be placed in trust for the benefit of the injured employee(s) entitled to such future payments of compensation.

(d) If a permit holder becomes insolvent and is unable to make benefit payments, the excess carrier shall make such payments as would have been made by the excess carrier to the employer, after it has been determined that the retention level has been reached on the excess contract, as directed by the Executive Director.

(e) All of the following shall be applied toward the reaching of retention level in the specific excess contract and/or the aggregate excess contract:

(1) Payments made by the employer;

(2) Payments due and owing to claimant by the employer;

(3) Payments made on behalf of the employer by any surety bond under a bond required by the Executive Director or from other security, as defined in Part 3(A)(4)(d).

(f) Copies of a certificate of the excess insurance and aggregate insurance shall be filed, on an annual basis, with the Executive Director together with a certification that such policy fully complies with the rules of the Workers’ Compensation Act.

PART 5 APPROVAL OR DISAPPROVAL OF THE APPLICATION

(A) EVALUATING APPLICANT; FACTORS FOR APPROVAL, DENIAL, OR REVOCATION OF A

PERMIT

(1) An applicant or a self-insurance permit holder at the time of its annual review shall, if the Executive Director requests, pay the fees of a consultant approved by the Executive Director to determine if the employer has the financial ability to become self-insured or to have its selfinsurance permit remain in force.

(2) The Executive Director will deny an application for self-insurance or revoke the self-insurance privilege if the applicant/permit holder is unable to demonstrate that the employer will be able to meet all obligations under the Act. The Executive Director may use but shall not be limited to the following factors in determining if the applicant/permit holder can meet those obligations:

(a) Ratio of tangible net worth to maximum of all of the self-insured’s retention limits;

(b) Ratio of current assets to current liabilities;

(c) Ratio of debt to tangible net worth;

(d) Profit and loss history for the current year and previous four years;

(e) Organizational structure and management background;

(f) Compensation loss history for the current year and previous four years.

(g) Number of employees;

(h) Excess insurance;

(i) Guarantee by parent company;

(j) Surety bond or other security based upon approved level of security as determined by the Executive Director;

(k) Claims administration, efficiency and effectiveness;

(l) Safety engineering program.

(B) ACTION OF EXECUTIVE DIRECTOR UPON DENIAL OF APPLICATION FOR SELF-

INSURANCE OR REVOCATION OF SELF-INSURANCE PERMIT

(1) Notice of denial of an application or revocation of self-insured status will be mailed to the employer at the address on file at the Division. The notice will include the grounds for denial or revocation. Within fifteen (15) days of issuance of notification of denial of an application, the employer may request reconsideration by the Executive Director of the denial. The employer shall furnish with such request all information and documentation it wishes to submit for Executive Director consideration.

(2) When the Executive Director revokes a self-insured permit, the Director of the Division of Workers’ Compensation shall promptly implement § 8-43-409, C.R.S., if necessary.

(3) The holder of a permit revoked by the Executive Director may not reapply for self-insured status for a minimum period of five (5) years from the effective date of revocation.

(4) The holder of a permit revoked by the Executive Director must continue to provide annual financial and/or claims data to the Executive Director until he/she is satisfied that all liabilities have been met.

(C) EMPLOYER INDIVIDUAL SELF-INSURANCE, COMPLIANCE WITH REQUIREMENTS

NOTICE, ADDITIONAL TIME, AND CERTIFICATION

(1) After considering the application and all supportive data, the Executive Director may grant approval, deny approval, or advise the employer of the requirements to be met before approval is granted. In the latter instance the employer shall be given thirty (30) days from the mailing of notice in which to comply with the requirements. Self-insurance authority is not effective until all requirements for self-insured approval have been met and a permit has been issued.

(2) The applicant may be granted additional time to meet the requirements of a self-insured. A request for an extension of time shall be made in writing by the applicant within the thirty (30) day compliance period. Failure of the applicant to meet the requirements as advised by the Executive Director within the time prescribed shall cause the application to be denied.

(3) Upon meeting the requirements, an applicant will receive a formal certificate approving its status as a self-insured employer and will be issued a block number. The certificate will be considered to be in force unless it is revoked at the Executive Director's discretion or discontinued at the request of the applicant/permit holder. Compliance with the annual review requirements as set forth by the Executive Director in Part 6 is a prerequisite to retaining a permit.

PART 6 ANNUAL REVIEW PROCESS

(A) EACH PERMIT HOLDER WILL SUBMIT TO THE EXECUTIVE DIRECTOR WITHIN SIXTY (60)

DAYS FOLLOWING THE ANNIVERSARY DATE OF ITS PERMIT A REPORT CONTAINING

THE FOLLOWING INFORMATION:

(1) A copy of the permit holder's most recent certified financial statement;

(2) A copy of the permit holder's payroll statement submitted to the Division of Workers’ Compensation for Premium Surcharge Assessment purposes;

(3) Total number of workers’ compensation claims for the current year and all preceding years;

(4) Total payments and reserves on claims for the current year and all preceding years;

(5) Evidence by certificate that the required insurance is currently in force and the bond, if a bond(s) had been tendered for security, is currently in force.

(6) Other annual data as requested by the Executive Director or his/her agent.

(B) EXECUTIVE DIRECTOR EVALUATION OF THE DATA

(1) Upon review of the annual report the Executive Director will enter an order only when a change in self-insured status is necessary.

(2) The Executive Director or his/her agent, will notify a permit holder of any required change in security or when change in insurance requirements is necessary.

(3) Revocation as a result of the review shall be pursuant to Part 5(A).

(C) EXECUTIVE DIRECTOR RESPONSIBILITY FOR NON-SCHEDULED REVIEWS

The Executive Director may request information similar to that developed at the time of the annual review at any time in order to examine the financial status of the permit holder. Such an interim examination of status shall be conducted after a written request to the permit holder. Such a request by the Executive Director shall not reduce or delay the obligation of the permit holder to file the reports required hereunder.

(D) EXECUTIVE DIRECTOR RIGHT TO AUDIT CLAIMS

The Executive Director, or his/her agent, has the right to perform on site audits/reviews of claim files to determine workers' compensation liability and security needs. The audits/reviews will also evaluate efficiency, effectiveness and competency of the claims administration. The Executive Director, or his/her agent will give ten (10) days notice of the audit, unless in the opinion of the Executive Director, an immediate audit is necessary. The Executive Director, in lieu of an audit by his/her agent may require a certified statement by an approved independent source evaluating such liability.

PART 7 [Emergency rule expired 07/23/2020] _________________________________________________________________________ Editor’s Notes

History

Part 7 emer. rule eff. 03/25/2020; expired 07/23/2020.

7 CCR 1101-6 Premium Cost Containment Certificates {#sec-7-ccr-1101-6 omnilex-key=us-co-regs-official--department-10--7 CCR 1101-6}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Workers’ Compensation PREMIUM COST CONTAINMENT CERTIFICATES 7 CCR 1101-6 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

PART 1

(A) STATEMENT OF BASIS AND PURPOSE

(1) These rules are amended by the Workers' Compensation Cost Containment Board of the Division of Workers' Compensation under authority pursuant to §8-14.5-105(1)(h), C.R.S. The Amendment brings the wording of the rules into conformity with existing legislation and more accurately reflects existing practices under the rules and regulations governing the Workers” Compensation Cost Containment Board.

(2) The amendment to these rules follows a public hearing held in accordance with §24-4-103, C.R.S. to codify procedures and conform to existing legislation.

PART 2 DEFINITIONS

"Approved Program" means a cost containment or risk management program which includes all of the elements listed in Part 3 (A)(2) a. through g.

"Board" means the Workers' Compensation Cost Containment Board established pursuant to §8-14.5- 104, C.R.S.

"Cost Containment Certification" under § 8-14.5-107, C.R.S., requires a cost containment or risk management program which has been in place for one (1) year, conforms to the specific standards of an approved program, and is certified by the Board.

"Division" means the Division of Workers' Compensation in the Department of Labor and Employment.

"Initial Renewal" means extending a year old certificate for one year.

“New Certification” means a risk management program that has been in place for one year, conforms to the specific standards of an approved program and is initially certified by the Board for one year.

"Subsequent Renewal" means extending an initial or ensuing renewal for three years.

PART 3 APPLICATION PROCESS AND CERTIFICATION REQUIREMENTS

(A) PROGRAM EVALUATION AND CERTIFICATION

(1) An employer seeking certified status pursuant to § 8-14.5-107, C.R.S. must furnish to the Board affirmative verification that all requirements of the approved program have been, or will have been, in force for at least one year at the time of certification. In order for a certificate to be issued to the employer the application for certification, as well as further information the Board may require as described in Section (A)(3), must be received in the offices of the Board on or before the 20th day of the month prior to the next Board meeting.

(2) In evaluating the application for certification the Board shall consider the following specifications plus loss history:

(a) Formal declaration of a company-wide loss prevention and loss control policy including designation of a representative responsible for overseeing the policy.

(b) Formal creation of a documented safety committee and/or coordinator.

(c) Clearly defined and conspicuously posted loss prevention rules.

(d) All employees undergo initial and ongoing job/task training.

(e) A cost containment program in cooperation with a designated medical provider who has knowledge of work injuries, fee schedules, employer’s operations, and is decisive on maximum-medical-improvement determinations, and communicates with the employer.

(f) Written policies and procedures on claims management which include accident investigation and an early return to work/modified duty program.

(g) A copy of the insurance carrier's loss reports covering the last three full policy years and the current policy year-to-date together with the total number of hours worked by all employees during each of those policy years.

(3) In consideration of the applicant's loss and payroll information, the Board may require further information from those employers showing a poor or deteriorating history of accidents and costs, and may hold in abeyance the decision of granting or renewal of cost containment certification status until such time as the applicant employer has responded. Upon receipt of the applicant's response, the application will then be considered at the next regularly scheduled Board meeting, whereupon the Board may decide by majority vote to approve or deny certification. The Board reserves the right to direct on-site employer inspections to verify compliance.

(4) Cost containment certification shall remain in force for an initial certification period of one year, an initial renewal period of one year, and upon subsequent renewals for a period of three years unless revoked by the Board, or cancelled, by the request of the employer or by ownership transfer.

PART 4 RENEWAL REQUIREMENTS

In the cost containment renewal process, compliance with the seven requirements for certification as set forth in Part 3 must be confirmed by the Board, with loss records for the last three full policy years and the current policy year-to-date being presented for consideration as part of that compliance. A signed affidavit by the employer stating that all of the program requirements remain in force may be considered by the Board in lieu of a new submission of program documentation. In order to process the renewal in a timely manner, the Request for Recertification shall be submitted 30 days prior to the expiration of the Cost Containment certificate.

PART 5 DENIAL OF CERTIFICATION

If an employer or other entity is denied cost containment certification or recertification, they may appeal, in writing, to the Board within 30 days of the date of denial by the Board. Appeals shall be made by the employer before the Board at the next regularly scheduled Board meeting, whereupon the Board may decide by majority vote to approve or deny certification. If the employer does not appeal the denial or if denied by the Board on appeal, a one-year waiting period, from the date the employer was denied, shall be imposed upon the employer. At the end of the waiting period the employer must meet the requirements in Part 3 of these rules before re-applying for certification. Under §24-4-106, C.R.S the appeal decision by the Board is final agency action.

PART 6 TRANSFER OF OWNERSHIP

When there is an ownership transfer of a certified employer which necessitates a change in workers' compensation coverage to a new policyholder, who does not have cost containment certification, certified status is not transferable. The new policyholder may, however, apply for certification immediately if no changes affecting compliance with the requirements in Part 3(A)(2)(a) through (g) have been made to the existing risk management/cost containment program.

PART 7 CERTIFICATION REVOCATION

The Board, by majority vote, may revoke an employer's certification at any time for good cause.

Revocation may be appealed in writing to the Board within 30 days of the date of revocation by the Board.

Appeals shall be made by the employer before the Board at the next regularly scheduled Board meeting, whereupon the Board may decide by majority vote whether to uphold the revocation. If the employer does not appeal the revocation of if the revocation is upheld by the Board on appeal, a one-year waiting period from the date the employer was revoked shall be imposed upon the employer. At the end of the waiting period the employer must meet the requirements in Part 3 of these rules before re-applying for certification. Under §24-4-106, C.R.S. the appeal decision by the Board is final agency action. _________________________________________________________________________ Editor’s Notes

History

1104 Workforce Development Programs

7 CCR 1104-1 The Colorado Nonimmigrant Agricultural Seasonal Worker Pilot Program {#sec-7-ccr-1104-1 omnilex-key=us-co-regs-official--department-10--7 CCR 1104-1}

DEPARTMENT OF LABOR AND EMPLOYMENT

Division of Employment and Training, Workforce Development Programs THE COLORADO NONIMMIGRANT AGRICULTURAL SEASONAL WORKER PILOT PROGRAM 7 CCR 1104-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

CHAPTER 1 GENERAL PROVISIONS

Rule 1-1 Authority This regulation is adopted pursuant to the authority in Sections 8-3.5-104 and 8-3.5-112, C.R.S. and is intended to be consistent with the requirements of the State Administrative Procedures Act, Section 24-4- 101, et seq. (the “APA” ), C.R.S. and the Colorado Nonimmigrant Agricultural Seasonal Worker Pilot Program Act, Section 8-3.5-101 et seq. (the “Act”), C.R.S.

Rule 1-2 Statement of Basis and Purpose These regulations are promulgated by the Division of Employment and Training, Workforce Development Programs to establish uniform rules for the implementation of the Act.

The main purpose of these regulations is to establish requirements for participation in the Colorado Nonimmigrant Agricultural Seasonal Worker Pilot Program (the “Program”) and ensure implementation of the Program complies with applicable state and federal law.

These regulations establish minimum requirements to expedite the federal labor certification application and approval process for the issuance of H-2A visas by the United States government. The purpose of the Program is to ensure that Colorado agricultural employers have labor sufficient to meet the seasonal demands of the agriculture industry.

Rule 1-3 Scope This regulation shall govern procedures used to implement the Nonimmigrant Agricultural Seasonal Worker Pilot Program. This regulation shall not apply, replace, or in any way supersede the responsibilities of the Division of Employment and Training, Workforce Development Programs, in its administration of the foreign labor certification program.

Rule 1-4 Effective Date This regulation is effective March 2, 2009.

Rule 1-5 Definitions A. “Agent” means a person or entity in the business of:

(1) Developing and submitting appropriate application materials to the state employment security agency and the department responsible for issuing labor certifications for a specific employer and job; and (2) Coordinating local recruitment with the employer and state employment security agency; and (3) Developing appropriate documentation of employer requirements and employment terms for use in selecting foreign workers; and (4) Filing for visa petition approval and coordinating visa issuance by the United States consulate or embassy in the worker’s country of origin.

B. “Application Filing Date” means the date an employer submits to the implementing agency an Employer Assurance Form and the Employer Petition Form. If these forms are submitted on different dates, the “Application Filing Date” shall be the later date.

C. “Department” means the Colorado Department of Labor and Employment.

D. “Director” means the Executive Director of the Colorado Department of Labor and Employment.

E. “Director’s Designee” means the Department of Labor and Employment, Deputy Executive Director; or, the Department of Labor and Employment, Division of Employment and Training, Division Director.

F. “Division” means the Division of Employment and Training.

G. “Employee” means a person who works for an employer and is an active participant in the program.

H. “Employer Assurance Form” means the Division form submitted and signed by the employer whereby the employer agrees to comply with Section 8-3.5-105(5), C.R.S.

I. “Employer Petition Form” means the Division form submitted and signed by the employer whereby the employer requests participation in the Program.

J. “Implementing Agency” means the Workforce Development Programs, within the Department of Labor and Employment, Division of Employment and Training.

K. “Pilot Program Year” means the twelve-month period beginning October 1 and ending September 30 of each year. The Pilot Program Year shall be expressed in terms of overlapping calendar years.

For example, Pilot Program Year 2008-09 shall equal calendar period of October 1, 2008, to September 30, 2009. The Pilot Program Year shall be used exclusively by the Department to set program fees and the annual number of allowable workers under the Program, and for no other

purpose.

L. “Program” means the Nonimmigrant Agricultural Seasonal Worker Pilot Program.

CHAPTER 2 AGENTS

Rule 2-1 Requirements The implementing agency may retain Agents for the Program. The implementing agency shall establish requirements for Agents that intend to participate in the Program. These requirements shall include a list of services that must be provided to an employer by participating Agents. Any person or entity interested in providing Agent services for the Program shall submit appropriate application materials to the implementing agency for consideration. The implementing agency will review application materials and will identify the Agent(s) that meet the specific application requirements. Agents that meet the application requirements shall be required to certify compliance with all Program statutes, rules, policies, and procedures.

Rule 2-2 Recruitment Fees Agents participating in the Program shall not charge or receive payments (either direct or indirect) from prospective workers pursuant to requirements set forth in 20 CFR 655.105 and 8 CFR 214.2. Any Agent found to have violated this rule shall be subject to the penalties listed in Rule 5-1 of this rule.

Rule 2-3 Affidavit Agents wishing to participate in the Program shall sign an affidavit with the implementing agency. An Agent who signs the affidavit declares under penalty of perjury, and any other penalty authorized under law, that he or she is not barred by any state or federal agency from filing H-2A applications or from operating as a licensed Farm Labor Contractor and that he or she agrees to:

A. Honor the prices provided to the implementing agency for employers that retain the Agent services as

part of the Program;

B. Comply with all federal and state laws, rules, regulations, executive orders, and agency policies concerning the administration of H-2A visas and the Program;

C. Complete all services described in the contract between the Agent and the Employer in a timely manner;

D. Inform the Employer of the Employer’s responsibility to reimburse Employees for transportation and subsistence as required by federal and state law;

E. Inform the Employer in writing of all applicable federal and state laws, rules, regulations, and policies governing administration of H-2A visas and the Program;

F. Report to the implementing agency in writing the date an Employee has returned to his or her country origin pursuant to requirements found at 8-3.5-105(3), C.R.S.;

G. Report to the implementing agency any information the Department deems necessary to evaluate, track, monitor, or assess the Program; and H. Refrain from charging fees to Employees that are prohibited by Rule 2-2 and 20 CFR 655.105.

Rule 2-4 References Agents wishing to participate in the Program shall submit a minimum of three professional references to the implementing agency. The professional references will be from Employers that have retained the Agent for H-2A services within 36 months of the date an Agent applies for participation in the Program.

Rule 2-5 Relationship with Employers Employers seeking Agents through the Program shall contact the implementing agency for a listing of Agents that have been determined to comply with Program requirements. Employers shall select and contact the Agent for assistance in obtaining workers for the Program. The employer and Agent may enter into an agreement for services but the Department, Division, and implementing agency shall not be a party to such agreements.

Rule 2-6 Compliance Listed Agents who do not meet specific Program requirements or who do not comply with all Program statutes, rules, policies, and procedures as determined by the implementing agency shall be removed from the implementing agency’s Agent listing and shall be barred from participation in the Program for a period of time determined by the Director or the Director’s Designee.

CHAPTER 3 EMPLOYERS

Rule 3-1 Program Eligibility Pursuant to 8-3.5-104, C.R.S., participation in the Program for Pilot Program Year 2008-09 shall include all sectors of “agriculture” as defined in 29 U.S.C. 203(f) and 20 CFR 655.100.

Rule 3-2 Applications Each employer that intends to participate in the Program shall apply with the implementing agency. An application shall be considered filed when an employer signs and submits to the implementing agency the “Employer Petition Form” and the “Employer Assurance Form” provided by the Division.

Rule 3-3 Employer Petition Form The implementing agency shall designate and make available an Employer Petition Form. An employer that intends to participate in the Program shall sign and submit the Employer Petition Form to the implementing agency.

Rule 3-4 Employer Assurance Form In addition to the Employer Petition Form, an employer shall sign and submit an “Employer Assurance Form” . The employer’s signature on the form signifies that the employer agrees to comply with the provisions of Section 8-3.5-105(4), C.R.S. and any federal, state, and local employment laws.

Rule 3-5 Notifications The implementing agency shall notify an employer if an employer is approved or denied participation in the Program. If an employer is approved, the implementing agency shall also notify the employer of the approved total number of workers and the total program fees in accordance with Chapter 4 of this rule.

CHAPTER 4 FEES

Rule 4-1 Application Fees The Director of the Division shall charge an employer an application processing fee to cover the actual, reasonable, and necessary expenses to administer this program. The application processing fee will be calculated based on the number of workers approved by the implementing agency. For Pilot Program Year 2008-09, the fee for each approved worker is one hundred dollars ($100). On or before September 30 of each year, the Director of the Division will adjust the fee, if necessary, based on anticipated program expenditures and the total number workers allowable statewide in the Program for the ensuing Pilot Program Year.

CHAPTER 5 ENFORCEMENT

Rule 5-1 Penalty to Employer for Failure to Report a Worker Who Has Absconded If an employee absconds his or her employment and the employer, with reckless disregard, fails to notify the Department within the timeframe specified in Rule 8 CFR 214.2(h) the Director of the Division may deny the employer future participation in the program or may impose a fine of up to two hundred dollars per day for each day of violation.

Rule 5-2 Violation of Statute Pursuant to Section 8-3.5-110, C.R.S, the Director or the Director’s Designee may take enforcement actions against any person who, with reckless disregard, is believed to have violated or assisted in the violation of any provision of the Act except for violations covered by Rule 5-1. Such enforcement actions may include assessment of a fine of up to five thousand dollars per violation.

Rule 5-3 Procedures Within thirty days after the date of issuance of a Notice of Violation, persons subject to enforcement actions and fines may file a written request for a hearing with the Director. If the alleged violator fails to timely request a hearing, all provisions of the notice of violation shall become final and not subject to further administrative review.

If the alleged violator fails to pay an assessment after it has become final, or after a court of competent jurisdiction has entered final judgment in favor of the Department, the Director or the Director’s Designee shall refer the matter to the State Controller and the State Attorney General, who shall recover the amount assessed by action in the appropriate court of competent jurisdiction, and the appropriateness of the final order imposing the penalty shall not be subject to review.

Rule 5-4 Reckless Disregard For purposes of Chapter 5 of this rule, “reckless disregard” means the knowing and willful failure of an Agent, employer, employee, or other person to comply with the requirements of this Act; or the knowing and willful failure of an Agent, employer, employee, or other person to cause another person to fail to comply with this act. _____________________________________________________ Editor’s Notes

History Entire rule emer. rule eff. 12/19/2008; expired 03/19/2009.

Entire rule eff. 03/30/2009.

1105 Division of Vocational Rehabilitation

7 CCR 1105-1 Division of Vocational Rehabilitation {#sec-7-ccr-1105-1 omnilex-key=us-co-regs-official--department-10--7 CCR 1105-1}

DEPARTMENT OF LABOR AND EMPLOYMENT

REHABILITATION SERVICES (STAFF MANUAL VOLUME 9)

7 CCR 1105-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ 9.100 VOCATIONAL REHABILITATION PROGRAM 9.101 LEGAL AND OPERATIONAL BASIS [Rev. eff. 3/17/17]

The Department of Labor and Employment is the sole designated State agency that administers the vocational rehabilitation services program in Colorado, and the Division of Vocational Rehabilitation (DVR) is the sole designated State unit primarily concerned with the vocational rehabilitation of individuals with disabilities. Individuals with disabilities who receive services from DVR are referred to in general as “recipients” of services and include:

A. Students with disabilities who are potentially eligible for vocational rehabilitation (VR) services for the purposes of Pre-Employment Transition Services B. Individuals who have applied to DVR C. Individuals who have been determined to be eligible for DVR services 9.101.1 Blind and Low Vision Services (BLVS) [Rev. eff. 3/1/20]

A. DVR shall establish and maintain a specialized unit, BLVS, focused on providing services to individuals who are blind or have low vision. The BLVS unit shall have a dedicated manager reporting directly to the DVR Director, with oversite for personal adjustment training services, vocational rehabilitation services, the Business Enterprise Program (BEP), the Older Individuals Who are Blind (OIB) program, and other programs serving individuals who are blind or have low vision as appropriate.

B. In addition to other performance metrics for which DVR is accountable, BLVS shall demonstrate success through timely eligibility determinations, timely plan development, employment, and earnings. For purposes of evaluating performance, Program Year 2018 (July 1, 2018 – June 30, 2019) will establish a baseline of performance and ongoing performance evaluation will consider the impact of overall economic conditions.

C. BLVS shall conduct a minimum of biannual stakeholder meetings to ensure ongoing input from the community. Invited representatives shall include, but not be limited to:

1. National Federation of the Blind of Colorado;

2. American Council of the Blind of Colorado;

3. Colorado Optometric Association;

4. Colorado Center for the Blind;

5. Colorado School for the Deaf and Blind;

6. Anchor Center for Blind Children;

7. A Shared Vision;

8. BEP Operators;

9. Older Individuals Who are Blind Program Grantees;

10. BLVS Clients; and 11. The community at large. 9.102 PERSONNEL STANDARDS [Rev. eff. 3/17/17]

A. Federal law requires state vocational rehabilitation agencies to establish qualified personnel standards and education and experience requirements for rehabilitation personnel, including rehabilitation counselors. DVR has established minimum qualifications through the Department of Personnel and Administration that are consistent with the minimum educational requirements established by the Commission on Rehabilitation Counselor Certification. Other positions within the rehabilitation counselor series such as orientation and mobility (O&M) specialists and vision rehabilitation therapists are also required to meet the minimum educational standards of appropriate national level certifying bodies. DVR shall ensure counselors providing services to individuals who are blind or have low vision have the necessary training and experience to support successful competitive integrated employment outcomes for this population.

B. DVR shall take reasonable steps to ensure the safety of recipients of services and safeguard individuals from abuse or exploitation while participating in the VR program. As demonstrated by other state programs serving children, youth, and adults with disabilities, such steps shall include the requirement of criminal background checks for personnel engaged in direct care and services to, or accessing the confidential information of, this population. 9.103 PROTECTION, USE, AND RELEASE OF PERSONAL INFORMATION [Eff. 4/1/13] 9.103.1 Confidential Information [Rev. eff. 3/17/17]

All potentially eligible students and applicants (or their authorized representatives) shall be informed about DVR's need to collect personal information and the principal purposes for which DVR will use that information. Any information secured by or made available to DVR and/or its employees or representatives concerning referrals or recipients of the vocational rehabilitation program is considered confidential. Use of such information, current or stored, is limited to purposes directly connected to the administration of the Vocational Rehabilitation Program as identified in Sections 9.103.2 and 9.103.3 and is not to be otherwise disclosed, directly or indirectly. Individuals shall be notified of the confidential nature of their case records and the conditions for release of such information at the time of application or program involvement for a potentially eligible student with a disability. 9.103.2 Release to Recipients [Rev. eff. 3/17/17]

Information acquired or maintained by the Division of Vocational Rehabilitation (DVR) will be available upon written request, for inspecting and copying by a recipient or, as appropriate, the individual's representative, in accordance with the Colorado Open Records Act (Section 24 72-201, et. seq., C.R.S.), unless release of such information is prohibited by state or federal statutes, case law, or rules and regulations.

Medical, psychological, or other information which the counselor determines may be harmful to the individual shall not be released directly to the individual, rather such information shall be provided through a third party chosen by the individual. Any employee of DVR shall not disclose the information listed below to the recipient and/or his or her authorized representative:

A. Social Security Administration (SSA) information except when requested by the Client Assistance Program on behalf of the recipient;

B. Information from the U.S. Department of Veterans Affairs;

C. Medical or psychological information when the service provider states in writing that disclosure to the individual is prohibited. Applicants and eligible individuals requesting such information shall be referred to the originating source of the information. 9.103.3 Release to Other Programs or Authorities [Rev. eff. 3/17/17]

A. Confidential information may be released to other agencies or organizations when necessary for their program purposes only after DVR receives informed written consent from the recipient of DVR services or, if appropriate, the individual’s representative, and under assurances that the agency or organization shall manage the information in a manner to safeguard its confidentiality in accordance with the confidentiality regulations governing vocational rehabilitation programs.

B. Information may be released to other programs or authorities without a recipient’s written authorization when:

1. The information is directly connected with the administration of the Vocational Rehabilitation Program used only by persons officially connected with an audit or evaluation, and the final report contains no identifying information;

2. Sharing of the information, including pertinent medical and other data received from SSA, is necessary to establish an individual's eligibility for rehabilitation services and/or for the provision of such services under an Individualized Plan for Employment (IPE);

3. The information is required by federal law;

4. The information is necessary to respond to an investigation in connection with law enforcement, fraud, or abuse, unless expressly prohibited by Federal or State laws or regulations, and in response to a judicial order;

5. The information is necessary in order to protect the individual or others when the individual poses a threat to their own safety or to the safety of others;

6. The information is requested by the Social Security Administration (SSA); or, 7. The Director of the Division of Vocational Rehabilitation approves release to an organization or individual engaged in research.

9.104 RIGHTS TO REVIEW AND APPEAL 9.104.1 Review of DVR Determinations [Rev. eff. 3/17/17]

A. A recipient who is dissatisfied with any determination made by the Division of Vocational Rehabilitation (DVR) that affects the provision of vocational rehabilitation services may request a review of that decision through an informal or formal process. The individual may also utilize the mediation process to resolve disputes. If appropriate, any request for review or mediation may be made through the individual’s authorized representative.

B. A recipient shall be notified, in writing, of their appeal rights, established procedures for review of determinations, and the availability of the Client Assistance Program each time the following occur:

1. At the time of program involvement for a potentially eligible student with a disability;

2. At the time of application for services;

3. At the time of placement into an Order of Selection (OOS) priority for services category;

4. At the time of Individualized Plan for Employment (IPE) development and any time the IPE is amended;

5. Any time that DVR makes a decision to reduce, suspend or terminate planned services;

6. At the time a case is closed for reasons of ineligibility; and, 7. At the time a case is closed from a deferred services wait list.

C. A recipient shall be responsible for their personal costs (including, but not limited to, legal representation and copying fees) associated with the individual’s review, appeal or mediation unless otherwise ordered.

D. An applicant's or eligible individual's appeal shall not result in suspension, reduction or termination of vocational rehabilitation services pending resolution of their appeal unless:

1. A recipient or, if appropriate, the individual's representative requests a suspension, reduction or termination of services; or, 2. There is evidence that fraud has occurred or that the vocational rehabilitation services were obtained through misrepresentation, collusion or criminal conduct. 9.104.2 Mediation of Disputes [Eff. 3/17/17]

A. An applicant or eligible individual may seek mediation by a qualified and impartial mediator as a means to resolve a dispute with the Division of Vocational Rehabilitation (DVR). The goal of mediation is to achieve consensus between the individual and DVR. The individual may bring an authorized representative to assist them during the mediation process.

1. The request for mediation shall be submitted, in writing, to the DVR administrative office at any time during the review process and no later than the 60th day from the date the formal hearing is requested. The request shall identify the decision or action that is being disputed, why it is being disputed and what solution is requested. A qualified and impartial mediator arranged through the state shall be provided at no cost to the individual.

2. If the recipient requests mediation, DVR shall participate unless:

a. It is not possible to resolve the dispute without placing the Department in clear violation of state or federal law, rules, policy or the approved State Plan;

b. A mediated outcome is not possible based on documented evidence from previous experience with the individual concerning the issue under dispute;

c. The individual has committed acts of violence, has threatened acts of violence or has engaged in other forms of harassment against Department staff or any other individuals involved in the provision of vocational rehabilitation services; or, d. The individual has failed to fulfill their responsibilities under a previous mediation agreement with DVR concerning the issue under dispute.

B. DVR may seek mediation by a qualified and impartial mediator as a means to resolve a dispute with a recipient before the individual requests an informal review or a formal appeal if the individual agrees to participate.

C. Mediation shall commence within twenty-one (21) days of the request for mediation and shall not delay conduct of the formal appeal unless both parties agree additional time is necessary.

Mediation is limited to a maximum of six (6) hours of mediation session(s) unless both parties and the mediator agree that additional hours may provide a resolution. Mediation shall be completed within one (1) calendar month of the initial request unless both parties and the impartial mediator agree that additional time is necessary.

D. If mediation is successful, the consensus reached by both parties shall be documented in writing by the mediator and provided to both parties within seven (7) calendar days. Each party shall sign the agreement, which indicates agreement with its terms and a commitment to fulfill each party’s respective responsibilities. If agreement on all issues is reached, the parties shall withdraw any pending informal review or formal appeal request. DVR shall not agree to any provision that it believes is contrary to state and federal law, rules, and policy or the approved State Plan.

E. If mediation is not successful, the individual may initiate, or proceed with, an informal review or a formal appeal of the issue under dispute.

F. Failure of the individual to honor their commitment under the terms of the mediation agreement shall void the mediation agreement. 9.104.3 Informal Review [Rev. eff. 3/17/17]

The recipient may request an informal review to resolve the issue(s) under dispute without mediation or conduct of a formal appeal. The informal resolution process will result in a decision by DVR regarding the issue under dispute. An individual shall not be required to go through an informal review prior to or instead of a formal appeal. An informal review shall be conducted within thirty (30) calendar days of the initial request unless both parties agree that additional time is necessary. Informal review shall not delay a formal appeal if one has been requested. If the informal review does not resolve the issue(s), and the formal appeal process has not been requested, the individual may request a formal appeal.

A. Informal review begins with a request for the applicable DVR Supervisor to review a decision concerning the provision of vocational rehabilitation services.

B. If the applicant or eligible individual is not satisfied with the decision made by the Supervisor, the applicant or eligible individual may take the next step and submit a written request for review to the Deputy of Field Services (or designee) to review the decision. 9.104.4 Formal Appeal Process [Rev. eff. 3/17/17]

An applicant or eligible individual may initiate a formal appeal regarding a determination to resolve the issue(s) under dispute without mediation or conduct of an informal review.

A. A written request for a formal appeal must be submitted to the Colorado Department of Personnel and Administration, Office of Administrative Courts (OAC), within ninety (90) calendar days of the subject determination made by the DVR counselor or other DVR staff that affects a provision of pre-employment transition services or vocational rehabilitation services.

B. The written request must be a statement detailing the basis of appeal, including a description of the determination made by DVR staff that the individual is appealing. The statement should include a description of what the individual wants from the appeal.

C. A recipient and DVR may voluntarily participate in mediation through the OAC. Mediation may not be used to deny or delay an individual’s right to pursue resolution of the dispute through the formal appeal process unless both parties agree that additional time is necessary for mediation. 9.104.5 Formal Appeal before the Office of Administrative Courts [Rev. eff. 3/17/17]

A. When the Office of Administrative Courts (OAC) receives a request for a formal appeal, the OAC shall notify DVR and the Attorney General’s Office, Labor and Employment Unit, that the request has been docketed and send a copy of the formal appeal request to DVR and the Attorney General’s Office.

B. A representative from the Attorney General’s office, on behalf of DVR, shall serve a notice to set an informal pre-hearing conference within ten (10) calendar days of receipt of the formal appeal request from the OAC. The purpose of the informal pre-hearing conference shall be to:

1. Identify the issues for appeal.

2. Set a date for DVR to provide a written statement summarizing the background and

history of services for the appeal.

3. Set a date for a response from the appellant to respond to the summary and identify specific issues for the appeal. The appellant should identify specific remedies being sought, if known.

4. Set the date for hearing within sixty (60) days, unless both parties agree that more time is needed and agree to extend beyond the sixty days.

5. Set dates for an exchange of witness and exhibit list, as well as exchanging exhibits or other evidence.

C. The Administrative Law Judge shall conduct the hearing within sixty (60) calendar days of an individual's request for formal appeal unless both parties agree additional time is necessary.

D. The Administrative Law Judge shall conduct the hearing on formal appeal in accordance with the Administrative Procedure Act, Section 24-4-105, C.R.S. The rights of the parties include:

1. Each party shall have the right to present his or her case or defense by oral and documentary evidence, to submit rebuttal evidence, and to conduct cross-examination.

2. Subject to these rights and requirements, where a hearing will be expedited and the interest of the parties will not be subsequently prejudiced thereby, the Administrative Law Judge may receive all or part of the evidence in written form or by oral stipulations.

3. Hearings will be conducted at a site convenient to the appellant. A telephonic hearing may be conducted as an alternative to a face-to-face hearing if requested by either party.

If either party requests a face-to-face hearing, the written request for a face-to-face hearing must be filed with the OAC and the other party at least ten (10) calendar days before the scheduled hearing.

E. At the conclusion of the hearing, unless the Administrative Law Judge allows additional time to submit documentation, the Administrative Law Judge shall take the matter under advisement.

After considering all the relevant evidence presented by the parties, the Administrative Law Judge shall render an initial decision.

F. The initial decision shall uphold, modify or reverse DVR's determination affecting the provision of pre-employment transition services or vocational rehabilitation services to a recipient or the decision regarding eligibility for services.

G. The initial decision shall be rendered within thirty (30) calendar days of the completion of the hearing.

H. When an appellant fails to appear at a duly scheduled hearing, having been given proper notice, without having given timely advance notice to the Administrative Law Judge of acceptable good cause for inability to appear at the hearing at the time, date and place specified in the notice of hearing, then the appeal shall be considered abandoned and the Administrative Law Judge shall enter an initial decision dismissing appeal. 9.104.6 Further Appeal [Eff. 3/17/17]

A. The initial decision rendered by the Administrative Law Judge shall become the final decision of the agency in absence of an exception filed by either party within thirty days after service of the initial decision, unless extended by the agency.

B. If a timely exception to the initial decision is filed by the appellant, the agency shall issue a final decision and advise the individual of his/her right to seek judicial review in the State District Court, City and County of Denver.

C. Any recipient who wishes to challenge the final agency decision may also bring a civil action for review of such decision (i.e. judicial review per CRS 24-4-105). The final agency decision shall be implemented pending the results of the review under a civil action. The civil action may be brought in any State court or in a district court of the United States, regardless of the amount in controversy. All records relating to the hearing shall be provided to the court in which the civil action shall be heard. Additional evidence may be provided upon request of the individual or the Director of DVR. The decision of the court and any relief granted as a result of the civil action shall be deemed final and binding. 9.104.7 Grievance of Discrimination on the Basis of Disability [Eff. 3/02/19]

An individual who believes they have experienced discrimination in violation of the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act of 1973, as amended, or the Colorado Anti- Discrimination Act (CADA) is entitled to due process and may file a grievance.

A. Informal Resolution: An individual who believes they have experienced discrimination on the

basis of disability may seek informal resolution by contacting the Deputy for Field Services, or their designee, as soon as possible to explain the concern and propose a solution. Informal review shall be conducted in a timely manner that shall not delay a formal grievance. If the informal review does not resolve the issue(s), and the formal grievance has not already been filed, the individual may seek resolution through the formal grievance procedures.

B. Formal Grievance Procedures: An individual, or the individual’s authorized representative, may initiate a formal grievance in lieu of seeking an informal resolution or if the informal resolution process did not satisfactorily resolve the concern.

1. Formal Written Complaint: A written complaint shall be considered when submitted to the ADA and Section 504 Coordinator of the Colorado Department of Labor and Employment within thirty (30) calendar days of the alleged offense or incident. The complaint shall include the name, address, and telephone number of the person filing the complaint; a description of the incident or alleged offense with as much information as possible; the date and location of the incident or alleged offense; and a proposed agency response that would resolve the issue(s) to the satisfaction of the complainant.

Within thirty (30) calendar days of receipt of the complaint, the ADA and Section 504 Coordinator shall conduct an investigation of the circumstances involved. At the conclusion of the investigation, the ADA and Section 504 Coordinator shall respond in writing or, as appropriate, in a format accessible to the complainant, explaining the position of the Department.

2. Additional Action: If the response of the written complaint by the ADA and Section 504 Coordinator does not satisfactorily resolve the concern, the complainant, or the complainant’s authorized representative, may contact the Colorado Civil Rights Division (CCRD) or the United States Department of Education’s Office of Civil Rights (OCR) within sixty (60) days of the Department’s decision. An individual does not need to seek resolution through DVR’s information resolution or written complaint processes prior to filing a discrimination complaint with CCRD or OCR. A complaint directly to CCRD must be filed within sixty (60) days of the alleged incident of discrimination. A complaint directly to OCR must be filed within 180 days of the alleged incident of discrimination. 9.105 APPLICATION AND ELIGIBILITY [Eff. 3/17/17] 9.105.1 Application [Eff. 3/17/17]

A. An applicant is an individual who has applied for DVR services. Authorized representatives shall be involved in pertinent issues in the same manner as the applicant or client. DVR shall provide assistance and/or accommodations throughout the application process.

Application criteria for vocational rehabilitation services:

1. An individual or, as appropriate, the individual’s authorized representative, signs and dates DVR’s application for services; and 2. The individual is available to complete the assessment process; and 3. Information necessary to initiate the eligibility determination process is provided. 9.105.2 Eligibility [Rev. eff. 3/17/17]

A. DVR will work with each applicant to obtain existing records and documents, and when necessary, conduct additional assessments needed to determine eligibility. The length of time between application and eligibility shall not exceed sixty (60) calendar days unless a period of trial work experience is required or exceptional and unforeseen circumstances beyond the agency’s control preclude determining eligibility within sixty calendar days and the counselor and applicant agree to a specific extension of time.

Eligibility criteria for vocational rehabilitation services requires that:

1. The individual has a physical or mental impairment documented by qualified personnel.

For purposes of this eligibility criteria, DVR considers “qualified personnel” to be individuals or practitioners that are licensed and regulated by the Colorado Department of Regulatory Agencies to determine the existence of an impairment for their specific area of medical or psychological practice, or who otherwise meet established state or national licensing and certification requirements for that area of practice. In addition, the Social Security Administration and education officials responsible for the public education of students with disabilities are considered by DVR to be qualified personnel for this eligibility criterion;

2. The impairment constitutes or results in a substantial impediment to employment that is consistent with the individual's abilities and capabilities;

3. The individual requires vocational rehabilitation services to prepare for, secure, retain, advance in, or regain employment consistent with their unique strengths, resources, priorities, concerns, abilities, capabilities, interests and informed choice; and, 4. The Division of Vocational Rehabilitation (DVR) presumes that an applicant who meets all other eligibility criteria can benefit in terms of an employment outcome from the provision of vocational rehabilitation services. If DVR questions whether the individual’s disability is too severe for them to benefit from services in terms of an employment outcome, clear and convincing evidence shall be obtained through the provision of trial work experiences.

B. Presumptive Eligibility An applicant who is determined to be eligible for Supplemental Security Income (SSI) and/or Social Security Disability Insurance (SSDI) benefits (based on their own disability, including blindness) is presumed to meet the eligibility requirements. Verification of eligibility for SSI/SSDI benefits is sufficient to establish that DVR eligibility criteria are met unless the presumption of benefit in terms of an employment outcome is questionable due to the severity of the disability(ies), which may require trial work experiences. 9.106 SEVERITY OF DISABILITY [Rev. eff. 3/17/17]

The assessment for determining eligibility and identifying vocational rehabilitation needs shall establish an individual’s priority for services, based upon whether the individual’s disability is most significant, significant, or an individual with a disability.

A. An individual with a most significant disability is defined as an eligible individual (including presumptively eligible) who has a severe physical or mental impairment that seriously limits three or more functional capacities (communication, interpersonal skills, mobility, motor skills, self-care, self-direction, work skills, or work tolerance) in terms of an employment outcome; and, whose vocational rehabilitation can be expected to require the provision of two or more vocational rehabilitation services for at least five months.

B. An individual with a significant disability is defined as an eligible individual who has been verified to be presumptively eligible or who has a severe physical or mental impairment that seriously limits one or two functional capacity areas (communication, interpersonal skills, mobility, motor skills, self-care, self-direction, work skills, or work tolerance) in terms of an employment outcome; and, whose vocational rehabilitation can be expected to require the provision of two or more vocational rehabilitation services for at least five months.

C. An individual with a disability is defined as an eligible individual who does not meet the criteria for most significant or significant. 9.107 PROVISION OF VOCATIONAL REHABILITATION SERVICES [Rev. eff. 3/17/17]

A. Pre-employment transition services must be made available statewide to all students with disabilities, regardless of whether the student has applied or been determined eligible for vocational rehabilitation services.

1. Pre-employment transition services are:

a. Job exploration counseling;

b. Work-based learning experiences that are provided in an integrated environment in the community to the maximum extent possible;

c. Counseling on opportunities for enrollment in comprehensive transition or postsecondary educational programs and institutions of higher education;

d. Workplace readiness training to develop social skills and independent living; and e. Instruction in self-advocacy, which may include peer mentoring.

B. All other vocational rehabilitation services shall be provided to:

1. Applicants to determine eligibility and severity of disability.

2. Eligible individuals to determine a vocational goal and identify the nature and scope of the services necessary to reach that vocational goal.

3. Under an Individualized Plan for Employment (IPE) to assist an individual in preparing for, securing, retaining, advancing in, or regaining an employment outcome.

Services shall be necessary, appropriate, and purchased at least possible cost. A service is considered necessary only if it is essential to assess an individual’s eligibility and severity of disability, to establish the individual’s vocational rehabilitation needs, to overcome or circumvent an identified vocational impediment(s), and to attain the individual’s chosen employment outcome. A service is considered appropriate if it is of sufficient quality to fully meet the individual’s particular needs and circumstances. Least possible cost is considered only after the determination of necessary and appropriate. All services shall be provided in the most integrated settings possible. 9.107.1 Engagement and Contact [Rev. eff. 3/17/17]

An effective vocational rehabilitation program requires the active participation of each eligible individual. A DVR staff member shall contact every eligible individual at least once every two months and document this in the client record.

9.108 UTILIZATION OF REHABILITATION FUNDS 9.108.1 Expenditure of Rehabilitation Funds [Rev. eff. 9/30/2019]

A. Payment for Services Necessary and appropriate services provided to applicants and eligible individuals shall be procured at the least possible cost to the Division of Vocational Rehabilitation (DVR). All services and goods shall be authorized prior to, or at the initiation of, the delivery of the service or good unless the service record documents that prior written authorization is not possible. All goods shall be procured in compliance with state purchasing procedures.

B. Estimation of Costs All completed Individualized Plans for Employment (IPE) shall contain estimates of anticipated agency costs and contributions for goods and services listed.

C. Regardless of the vocation chosen, DVR excludes supporting a business that does not comply with all relevant state, federal, and local laws and regulations.

D. Fee Schedule Services must be authorized and payments approved in accordance with current agency fee schedules. Fees exceeding the established maximum may be authorized and paid only when the specific service is not available at the established rate or when the service available at the established rate is not adequate to meet the individual's rehabilitation needs.

E. Provider Standards Vocational goods and services are purchased only from providers who meet minimum standards and possess sufficient knowledge of disability and disability-related barriers to effectively meet the needs of recipients of DVR services. Minimum standards are identified in DVR’s fee schedule.

1. DVR shall take reasonable steps to ensure the safety of recipients of services and safeguard individuals from abuse or exploitation while participating in the VR program and interacting with providers of services purchased by DVR. DVR shall establish and maintain policies and procedures specifying the manner in which criminal background checks will be utilized prior to registering providers or approving contracts which will require direct contact with recipients of services or access to confidential information.

2. Additional training and certification requirements apply to Supported Employment service providers.

a. Supported Employment service providers shall possess either a nationally recognized Supported Employment certification (Certification) approved by the Department of Health Care Policy and Financing (HCPF) and DVR or complete a nationally recognized training certificate (Training Certificate) approved by HCPF and DVR. Approved Certifications and Training Certificates shall align with the following core competencies:

i. Core values and principles of Supported Employment. These include the priority of employment for all working-age persons with disabilities, and the belief that all people are capable of full participation in employment and community life. These values and principles are essential to successfully providing Supported Employment services.

ii. Person-centered process. The process identifies the strengths, preferences, needs (clinical and support), and desired outcomes of the individual and individually identified goals and preferences related to relationships, community participation, employment, income and savings, healthcare and wellness, and education. The Person-centered approach includes working with a team where the individual chooses the people involved on the team and receives necessary information and support to ensure he or she is able to direct the process to the maximum extent possible; effective communication; and appropriate assessment.

iii. Individualized career assessment and planning. This process is used to determine the individual’s strengths, needs, and interests to support career exploration and leads to effective career planning, including the consideration of necessary accommodations and benefits planning.

iv. Individualized job development. Identifying and creating individualized competitive integrated employment opportunities for individuals with significant disabilities, which meet the needs of both the employer and the individual. This competency includes negotiation of necessary disability accommodations.

v. Individualized job coaching. Providing necessary workplace supports to individuals with significant disabilities to ensure success in competitive integrated employment and resulting in a reduction in the need for paid workplace supports over time.

b. Supported Employment service providers employed by a provider agency or registered as a vendor with DVR on or before July 1, 2019, shall obtain Certification or a Training Certificate no later than July 1, 2024.

c. Supported Employment service providers hired by a provider agency or registered as a vendor with DVR after July 1, 2024, shall obtain Certification or a Training Certificate within two years of employment.

i. Beginning July 1, 2024, Supported Employment service providers who are not fully qualified shall receive supervision from a Supported Employment service provider who is fully qualified (Supervisor) until he or she becomes fully qualified.

ii. Supervision shall include, at a minimum, one-on-one meetings (in person or virtually) between the Supported Employment service provider and the Supervisor at least twice each month, and onsite job shadowing at least twice each year (12 month period of time).

d. Supported Employment service providers obtaining Certification and/or Training Certificate shall be eligible to receive reimbursement for the training and/or Certification costs, as applicable. Reimbursement is limited to $300 per Certification and $1,200 per Training Certificate. Reimbursement amounts are inclusive of all associated costs, such as registration fees, travel, and wages.

i. Supported Employment service providers seeking reimbursement for Training Certificate and/or Certification costs shall obtain pre-approval and request reimbursement from HCPF in accordance with 10 CCR 25.5-10 §8.500.14.H.

F. Payment for Transportation Transportation is provided to an individual if necessary to participate in DVR services. Public transportation is encouraged unless the individual’s impairment-related limitations prevent use of public transportation. If the individual chooses to use their own vehicle when public transportation is available and accessible, reimbursement for mileage may be provided up to the cost of public transportation.

To receive reimbursement, the individual or the individual’s driver shall have a valid driver’s license, possess an active insurance policy to drive the automobile, and use an automobile that is appropriately licensed and registered. Appropriate documentation shall be provided to DVR to support the reimbursement is related to services necessary for eligibility determination or in connection with the provision of services.

G. State Property Goods purchased for use by an eligible individual in a training program, trade, or business remain the property of the State of Colorado until successful closure from DVR occurs. DVR may choose to recover purchased equipment per established policy and/or procedure. 9.108.2 Applicant or Eligible Individual Financial Participation [Rev. eff. 3/17/17]

Payment for most services or goods for individuals other than SSI/SSDI recipients is based upon the economic need of the individual and the finances of the family unit. DVR shall conduct a determination of the individual's economic need prior to the preparation and approval of an Individualized Plan for Employment or a Business Exploration Agreement whenever the plan contains a vocational rehabilitation service that is not specifically exempted from financial participation. An individual who receives Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) is exempt from the determination of economic need and from participating financially in their rehabilitation plan.

A. Re-determinations of the individual's economic need shall be conducted within forty-five (45) days of a change to the individual's financial circumstances.

B. All economic need determinations shall be documented and require an individual’s proof of financial status. Documentation accepted as proof of financial status shall be defined in writing by DVR. The applicant or eligible individual shall provide proof of financial status unless the service record documents that there is no proof of financial status available and/or it cannot be obtained.

If proof of financial status cannot be obtained, the statement of the applicant or eligible individual and/or member of his/her family shall establish data used to complete economic need determinations.

C. The family unit consists of the applicant or eligible individual, the spouse of the individual, and any other persons whom the individual claims as a dependent for income tax purposes. When the individual is dependent upon their parents, the parents and persons for whom the parents are financially responsible shall be considered part of the family unit. An individual who is living with his/her parents is considered a dependent unless the parents have not claimed the individual as a dependent for income tax purposes for the tax year previous to the financial need determination and do not intend to claim the individual as a dependent in current and future years.

Exceptions to the family unit may occur if the service record documents a clear indication that the individual is not receiving financial support from the family unit. When this occurs, he/she may be considered his/her own family unit regardless of dependent status for income tax purposes.

D. The financial need analysis shall determine economic need and consider income and net resources as well as the allowable monthly deductions of the entire family unit. Standardized allowances for normal living costs are determined by the size of the family unit.

E. Financial participation of the individual or completion of a financial need analysis is not required for the following vocational rehabilitation services:

1. Diagnostic and related assessment services that are required to determine eligibility and vocational rehabilitation needs, including transportation necessary to obtain the assessment.

2. Vocational rehabilitation counseling and guidance;

3. Referral services;

4. Professional fees to providers of vocational adjustment and personal adjustment training, independent living skills training, job coaching, on-the-job training, job seeking skills training, training in the use of rehabilitation technology, and business consultation services provided through a Business Exploration Agreement;

5. Interpreter services and note-taking services for individuals who are deaf;

6. Reader services and note-taking services for individuals who are blind;

7. Personal assistance services;

8. Auxiliary aids needed for an individual with a disability to participate in the vocational rehabilitation program;

9. Job-related services;

10. Occupational goods & services;

11. Self-Employment goods & services;

12. Any service or good furnished to an individual for whom the DVR counselor has evidence of current eligibility for SSI and/or SSDI benefits for disability or blindness; and 13. Pre-employment transition services. 9.109 CASE CLOSURE [Rev. eff. 3/17/17]

The DVR counselor may close a case record for an applicant or eligible individual when it is determined vocational rehabilitation services are no longer necessary or appropriate for the individual to achieve an employment outcome. The case record of an individual who receives services that lead to an employment outcome shall be closed when the individual achieves the criteria for successful closure. If it is determined that an applicant is ineligible for services or the individual receiving services is no longer eligible for services, the case record shall be closed. 9.110 REGULATORY CITATION [Eff. 3/17/17] 9.100 is developed in accordance with 34 CFR 361 (August 2016). No amendments or later editions are incorporated. Copies are available for purchase at the Government Bookstore, Federal Office Building, 1961 Stout Street, Denver, Colorado 80294. A copy is available for inspection during regular business hours at the Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of the Director, 633 17th Street, Suite 1501, Denver, Colorado 80205; or any state publications depository library.

9.200 INDEPENDENT LIVING (IL) SERVICES

9.201 GENERAL PROVISIONS

The purpose of the program authorized by Title 8. Article 85.INDEPENDENT LIVING SERVICES, Colorado Revised Statutes, is to promote a philosophy of independent living (IL), including consumer control, peer support, self-help, self-determination, equal access, individual and system advocacy, and transitions to maximize the leadership, empowerment, independence, and productivity of individuals with significant disabilities, and to promote and maximize the integration and full inclusion of individuals with significant disabilities into the mainstream of American society.

9.202 DEFINITIONS

“CIL” means a Center for Independent Living.

“Code of Federal Regulations” means Code of Federal Regulations, Title 2 – Grants and Agreements, Subtitle A – Office of Management and Budget Guidance for Grants and Agreements, Chapter II – Office of Management and Budget Guidance, Part 200 – Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (http://www.ecfr.gov/cgi-bin/text idx?tpl=/ecfrbrowse/Title02/2cfr200_main_02.tpl)

“Consumer Service Record (CSR)” means a complete record which includes eligibility determination, intake information, a signed Independent Living Plan (ILP) or waiver, specific goals, a description of services, Client Assistance Program (CAP) information, a confidentiality agreement, a grievance policy, and a record of whether goals were achieved.

“Director” means the Director of the Division of Vocational Rehabilitation.

“DVR” means the Division of Vocational Rehabilitation.

“Federal Act” means Title VII of the Federal Rehabilitation Act of 1973, as amended and codified in 29 U.S.C. 71 1(c) and Section 796. This rule does not contain any later editions of those parts. Copies of these regulations are available from: Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library.

“Network” means the Network of Certified Colorado Centers for Independent Living.

“OIL” means the Office of Independent Living Services “Provider association” means the Association of Colorado Centers for Independent Living (ACCIL).

“Service area” means the community, county, or groups of counties a CIL serves.

“SILC” means Statewide Independent Living Council.

“SILS” means State Independent Living Services Program, in accordance with 34 CFR 365.1. No later editions are incorporated. Copies of these federal regulations are available from the Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library.

“State” means the State of Colorado.

“Verification team” means a team designated by the Director, which consists of DVR/OIL Staff and a representative of the CILs network.

9.203 SERVICES PROVIDED

A. Independent living services includes the independent living core services which consist of information and referral services, IL skills training, peer counseling, (including cross-disability peer counseling), individual and systems advocacy; and transition services; and B. Other services, such as:

1. Counseling services, including psychological, psychotherapeutic, and related services;

2. Services related to securing housing or shelter, including services related to community group living, that are supportive of the purposes of the federal Act, and adaptive housing services, including appropriate accommodations to and modifications of any space used to serve, or to be occupied by, individuals with significant disabilities;

3. Rehabilitation technology;

4. Mobility training;

5. Services and training for individuals with cognitive and sensory disabilities, including life skills training and interpreter and reader services;

6. Personal assistance services, including attendant care and the training of personnel providing these services;

7. Surveys, directories, and other activities to identify appropriate housing, recreation opportunities, and accessible transportation, and other support services;

8. Consumer information programs on rehabilitation and IL services available under the Federal Act, especially for minorities and other individual with significant disabilities who have traditionally been unserved or underserved by programs under the Federal Act;

9. Education and training necessary for living in a community and participation in community activities;

10. Supported living;

11. Transportation, including referral and assistance for transportation;

12. Physical rehabilitation;

13. Therapeutic treatment;

14. Provision of needed prostheses and other appliances and devices;

15. Individual and group social and recreational services;

16. Training to develop skills specifically designed for youths who are individuals with significant disabilities to promote self-awareness and esteem, develop advocacy and selfempowerment skills, and explore career options;

17. Services for children;

18. Services under other federal, state, or local programs designed to provide resources, training, counseling, or other assistance of substantial benefit in enhancing the independence, productivity, and quality of life of individuals with significant disabilities:

19. Appropriate preventive services to decrease the need of individuals with significant disabilities assisted under the Federal Act for similar services in the future;

20. Community awareness programs to enhance the understanding and integration into society of individuals with significant disabilities; and, 21. Any other services that may be necessary to improve the ability of an individual with a significant disability to function, continue functioning, or move toward functioning independently in the family or community or to continue in employment and that are not inconsistent with any other provisions of the Federal Act. 9.203.1 DISCONTINUATION OF SERVICES [Eff. 4/1/13]

Section 51 of 34 CFR 364 under the authority of 29 U.S.C. 796-796f-5 which do not include amendments to or editions of said regulations later than August 15, 1994, provides requirements for determinations of eligibility or ineligibility, in accordance with all parts, incorporated herein by reference. Copies of these regulations are available from: Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library.

A CIL shall discontinue Independent Living (IL) services to an individual if the individual is no longer eligible to receive IL services. An individual is no longer eligible to receive IL services when the delivery of IL services will no longer improve the individual’s ability to function, ability to continue functioning, or move toward functioning independently in the community. If the CIL intends to discontinue services to an individual receiving IL services under an IL plan or an individual receiving services after they have waived their right to a plan, the CIL shall follow the requirements that apply to determinations of ineligibility and review of ineligibility determinations. 9.203.2 APPEAL PROCEDURES [Eff. 4/1/13]

Section 58 of 34 CFR 364 requires each CIL to establish consumer appeal procedures; Section 30 of CFR 364 requires each center to provide notice of the Client Assistance Project in accordance with all parts, under the authority of 29 U.S.C. 796-796f-5 which do not include amendments to or editions of said regulations later than August 15, 1994 of those parts and incorporated herein by reference. Copies of these regulations are available from: Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library A. Each CIL must establish policies and procedures that an individual may use to obtain review of decisions made by the CIL concerning the individual’s request for IL services or the provision of IL services to the individuals; and, B. Use formats that are accessible to inform each individual who seeks or is receiving IL services from the center about the procedures required by paragraph A of this section;

C. Establish policies and procedures that require that the individual is notified of the Client Assistance Program (CAP);

D. Establish a policy that the center shall continue services to the consumer while the decision is being reviewed, unless continuation of services is deemed harmful to the consumer or otherwise. 9.203.3 APPLICATION, CERTIFICATION AND RE-CERTIFICATION OF CENTERS [Eff. 4/1/13]

A. Application Process An organization that intends to become a Center for Independent Living must apply to the Director of the Division of Vocational Rehabilitation to become certified as a CIL and eligible for funding under the SILS program.

B. For an organization that DVR previously certified to operate as a certified CIL or was decertified, the organization must provide to DVR/OIL evidence that it is currently operating in accordance with all parts, incorporated herein by reference, of Title VII, Section 725 of the Federal Act, as defined in 34 CFR 366.60 under the authority of 20 U.S.C. 796f-4 and 34 CFR 366.63 under the

authority of 29 U.S.C. 711(c), 796d-1(b), and 796f-4, which do not include amendments to or editions of said regulations later than August 1, 1995 of those parts and incorporated herein by reference. Copies of these regulations are available from: Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library.

C. Requirements of Certification and Re-Certification The organization must comply with the standards and assurances for independent living in accordance with all parts, incorporated herein by reference, of Title VII, Section 725 of the Federal Act, the center evaluation standards in accordance with all parts, incorporated herein by reference of 34 CFR 366.60, under the authority of 20 U.S.C. 796f-4 and 34 CFR 366.63 under the authority of 29 U.S.C. 711(c), 796d-1(b), and 796f-4, which do not include amendments to or editions of said regulations later than August 1, 1995 of those parts. Copies of these regulations are available from: Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library. Prior to certifying an organization as a center, DVR/OIL may conduct on-site verification procedures based on the evaluation standards previously cited and may include verifying the accuracy of the information in the organization’s annual report. If DVR/OIL determines that the organization qualifies to operate as a center, DVR/OIL shall provide written certification for up to thirty-six months from the date of the on-site verification. 9.203.4 CERTIFICATION OF CENTERS AND VERIFICATION OF INFORMATION [Eff. 4/1/13]

A. DVR/OIL shall verify the accuracy of the information in the CIL's annual performance report through information obtained by a Verification Team during an onsite review in locations that a CIL operates. A Verification Team will evaluate a CIL at least once every thirty-six months to determine certification status.

B. The Verification Team will notify the CIL at least ten working days prior to the verification team's onsite evaluation. DVR/OIL reserves the right to monitor all or part of the evaluation standards.

Included in the notification to CILs will be a list of evaluation standards.

C. Minimal compliance means that the CIL provides at least one type of evidence for each evaluation standard. The DVR Verification Team obtains evidence to verify the accuracy of the information in the annual performance report and establish minimal compliance, as outlined in 34 CFR 366.60 under the authority of 20 U.S.C. 796f-4 which does not include amendments to or editions of said regulations later than August 15, 1994, and incorporated herein by reference, and with DVR contracts and procedures. Copies of these regulations are available from: Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library.

D. The CIL must comply with the evaluation standards defined in 34 CFR 366.60 to 366.63 under the authority of and all parts, incorporated herein by reference incorporated herein by reference of 34 CFR 366.60, under the authority of 20 U.S.C. 796f-4 and 34 CFR 366.63 under the authority of 29 U.S.C. 711(c), 796d-1(b), and 796f-4 which do not include amendments to or editions of said regulations later than August 1, 1995 of those parts. Copies of these federal regulations are available from the Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library.

Prior to certifying an organization as a CIL DVR/OIL may verify the accuracy of the information in the organization’s annual performance report following the on-site verification process outlined in this section and a DVR/OIL procedural. If DVR/OIL determines that the organization qualifies to operate as a CIL, DVR/OIL shall provide a written certification. DVR/OIL may certify an organization for up to thirty-six months from the date of the on-site verification.

E. DVR/OIL may conduct additional on site evaluation visits, without prior notification, if the Verification Team needs additional documentation or information in regards to compliance indicators. 9.204 (NONE) [Rev. eff. 4/1/13] 9.205 ASSURANCE TO RECEIVE FUNDING UNDER THE SILS PROGRAM [Rev. eff. 4/1/13]

A. To be eligible for funding under the SILS program, an eligible agency shall comply with all parts, incorporated herein by reference, of Title VII, Section 725, 34 CFR 366.60, under the authority of 20 U.S.C. 796f-4 and 34 CFR 366.63 under the authority of 29 U.S.C. 711(C), 796D-1(B), and 796F-4, which do not include amendments to or later editions of regulations later than August 1, 1995 of those parts. Copies of these regulations are available from: Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library.

B. A CIL must obtain an annual independent fiscal audit conducted by a certified public accountant and provide documentation that demonstrates the CILs’ board of directors’ review of the CILs monthly financial statements.

C. A CIL must comply with all state and federal contract requirements in terms of proper financial reporting, accountability, transparency and documentation; and agree to the terms and conditions of such contract. Funds allocated under the SILS program must only be used to provide Independent Living services or to pay associated costs, as described in the contract exhibits. 9.206 PAYMENT TO CILS [Rev. eff. 4/1/13]

A. A CIL may invoice DVR/OIL according to specific requirements in a contract or procedures set forth by DVR/OIL. To receive payment, a CIL must have all supporting documentation for services and allowable costs and be able to provide documentation of such record if requested.

B. A CIL must adhere to contract requirements in order to receive payment for services provided. 9.207 ALLOCATION OF FUNDS FOR SILS [Rev. eff. 4/1/13] 9.207.1 STATE ALLOCATION [Rev. eff. 4/1/13]

The State shall allocate funds to CILs that participate in the SILS program. Funds to be allocated include funds appropriated in both Federal and State appropriations. The allocation represents the maximum amount of funds that a CIL may be reimbursed under the SILS program. DVR/OIL shall set forth specific procedures that allocate funds to all eligible CILs.

The allocation of funding to CILs is subject to periodic review by the Independent Living Allocations Committee. A review of allocations will:

A. Align with the State Plan for Independent Living (SPIL); or, B. Occur if there is a change in the number of CILs eligible to receive funding.

C. DVR/OIL reserves the right to evaluate and/or change the allocation of funding if special, unforeseen, circumstances occur. 9.207.2 INDEPENDENT LIVING ALLOCATIONS COMMITTEE [Rev. eff. 4/1/13]

A. The SILC, CIL Network, and DVR shall participate in an Independent Living Allocation Committee. The Chairperson of the SILC shall make the appointment of two members who are advocates for individuals with disabilities and are not affiliated with CILs. The CILs Network shall appoint two individuals. The Director of DVR will appoint two individuals. The total number of allocation committee members shall equal six, two from each group.

B. The Independent Living Allocations Committee will work to establish criteria for allocating funds from the State General Fund for Independent Living and Federal Part B funds.

C. All funding formulas submitted by the allocation committee shall be in compliance with State fiscal rules and regulations, current Federal and State laws and regulations, including annotations and footnotes in appropriations, and the State Plan for Independent Living.

D. DVR/OIL will ensure that the Independent Living Allocations Committee participates in any change of funding allocation that is in DVR/OIL procedures. The final decision of how to allocate funds is the responsibility of DVR/OIL.

9.207.3 STATE ALLOCATION FOR DELIVERY OF INDEPENDENT LIVING SERVICES

A. The Block Distribution of state moneys to independent living centers.

(A) A base amount of not less than six hundred thousand dollars; and (B) Other factors agreed to by the independent living centers, which may include a per capita adjustment, a per county adjustment, or other adjustments.

B. Certified Centers for Independent Living will be allocated General Funds in addition to their base amount of General Funds with a weighted formula that divides County disability population, plus County population, and Land Area by population to determine for each County. The resulting figure is the amount which each CIL will receive.

Specific calculations of the formula are:

A. 1st assign each Colorado County a score of: 40% x (County 16-64 Disability Population/State 1664 Disability Population)

B. 2nd add the weighted score of: 20% x (County 65+ Population/State 65+ Population)

C. 3rd add the weighted score of: 40% x (County Quantile Average of Land Area/Population)

D. 4th multiply this score of each County by the available funds;

E. 5th divide it by 100.

F. 6th sum up all the County scores from within each CIL’s catchment area.

CILS whose catchment areas share a County shall report to the Department, how they will allocate County scores between them. If these CILS do not reach an agreement, the Department shall determine and document the allocation of County scores between the CILS. 9.208 RECORDS [Rev. eff. 4/1/13]

In addition to complying with applicable EDGAR record keeping requirements, centers that receive financial assistance from the SILS program will maintain records that fully disclose and document:

A. The amount and disposition by the center of that funding;

B. The total cost of the IL services;

C. The amount of that portion of the cost of the IL services supplied by other sources; and, D. Compliance with regulations pertaining to the SILS program; and, 1. Records that the Director, Division of Vocational Rehabilitation or the Secretary of the Federal Department of Health and Human Services determines to be appropriate to facilitate an effective audit.

2. Access to Records For the purpose of conducting audits, examinations, compliance reviews and verification of information in the annual performance report, centers that receive funding from the SILS program will provide access to the Director, the Secretary of the federal Department of Education, and the Comptroller General, or any of their duly authorized representatives, to these records; and, a. Any other books, documents, papers, and records of the recipients that are pertinent to the financial assistance received to provide IL services; and, b. All consumer service records for individuals served with funds received from the SILS program, including names, addresses, and records of evaluation included in those consumer service records. 9.209 EVALUATION OF CENTERS: ENFORCEMENT PROCEEDINGS [Rev. eff. 7/1/12]

With regards to enforcement proceedings, DVR/OILS shall comply with all federal rules and regulations, incorporated herein by reference, including 45 CFR 1329.7 September 1, 2017. This rule does not contain any later editions of those parts. Copies of these regulations are available from: Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living SERVICES, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publications Depository Library. 9.209.1 Modification of Enforcement Proceedings [Rev. eff. 7/1/12]

If the funds received by the CIL under the SILS program include federal funds administered by the Colorado Department of Labor and Employment in accordance with, and incorporated herein by reference, Section 723 Title VII of the Federal Act, as defined in Section 9.202, the enforcement procedures required by 45 CFR 1329.7 under the authority of 29 U.S.C. Section 711(c) and 796F-2 (g) and (i), as defined in Section 9.202, will be included in enforcement proceedings with respect to the

Section 723 federal funds only, as defined in Section 9.202 (Federal Act) September 1, 2017. This rule does not contain any later editions of those parts. Copies of these regulations are available from:

Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living Services, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library. 9.209.2 TERMINATION OF FUNDS [Rev. eff. 4/1/13]

A CIL’s funds may be terminated for:

A. Failure to meet the requirements of 45 CFR 1329.7 September 1, 2017. This rule does not contain any later editions of those parts. Copies of these regulations are available from: Colorado Department of Labor and Employment, Division of Vocational Rehabilitation, Office of Independent Living Services, 633 17th Street, 15th Floor, Denver, CO 80202 or at any State Publication Depository Library.

B. Failure to meet contract requirements within the statement of work and its exhibits including, but not limited to, general and special provisions.

C. A decision to terminate funding will also terminate the organization’s certification as a center.

Refer to Section 9.203.3 for clarification on re-certification. 9.400 BUSINESS ENTERPRISE PROGRAM [Rev. eff. 7/1/08]

AUTHORITY: 20 U.S.C. § 107 et seq. 34 CFR Part 395 et seq. 8-84-201, C.R.S. et seq.

9 CCR 2503-1 § 3.850.72 - 3.850.73

6 CCR 1010-2 § 2-201

The purpose of the Colorado Business Enterprise Program is to provide blind persons with remunerative employment, enlarging the economic opportunities of the blind, and stimulating the blind to greater efforts in striving to make themselves self-supporting.

Colorado may implement a mission and vision statement, which may evolve with the era.

Colorado shall approach any gaps in information in 8-84-201, C.R.S. et seq. by applying the interpretation and intent (in federal buildings) of 20 U.S.C. § 107 et seq. and 34 CFR Part 395 et seq. to State, private, and other property.

The Colorado Business Enterprise Program carries out the Colorado State Licensing Agency responsibilities, under the Division of Vocational Rehabilitation, as applied for in accordance with 34 CFR

Part 395.2. 9.400.1 Definitions [Rev. eff. 7/1/08]

The Colorado Business Enterprise Program recognizes the terms as defined in 34 CFR Part 395.1.

Additional terms are defined as follows:

“Active Participation” means an ongoing process of negotiations and collaboration between the State Licensing Agency and the Committee of Licensed Blind Operators to participate in major administrative decisions and policy and Program development decisions affecting the overall administration of the Program.

“Bad Debt” means a Debt that is 30 days or more past due and does not have an associated, accepted, repayment plan.

“Blind Operator” means all Program Participants, including Licensed Blind Operators, Certified Blind Operators, and Trainees.

“Blind Operator Agreement” means a contract or other legal document executed between a Blind Operator and the State Licensing Agency, delineating the arrangement accepted by both parties, identifying all rights and obligations specific to the operation of a Business Enterprise Location as subcontracted to any awarded Blind Operator.

“Business Enterprise Location” is considered to be one-in-the-same as “Vending facility” as defined in 34 CFR Part 395.1 and includes vending machines as defined in this §, and other business as described in C.R.S. 8-84-201, including like Business Enterprise Locations being managed by Certified Blind Operators prior to licensure.

“Colorado Elected Committee” means the State Committee of Blind Vendors per 34 CFR Part 395.14 and/or Committee of Blind Vendors per 20 U.S.C § 107 b-1.

“Debt” means an obligation or liability to pay an amount of money due.

“Individual Business Enterprise Location” means the entire identity and complete parameters that are established by the State Licensing Agency for a single Business Enterprise Location, which may be established and reestablished at the State Licensing Agency's discretion when it is in the best interest of The Business Enterprise Program.

“Licensed Blind Operator” means a “vendor” as defined in 34 CFR Part 395.1(aa), regardless of status of award of an active Business Enterprise Location.

“State Licensing Agency” means the Business Enterprise Program, housed within the Division of Vocational Rehabilitation Services, which administers the Randolph-Sheppard Vending Facility Program and issues licenses to blind persons in accordance with 34 CFR Part 395.2.

“Unassigned vending machine income” is considered to be one-in-the-same as “Vending machine income” as defined in 34 CFR Part 395.1 and is income that accrues to the State Licensing Agency from commissions that vending or other companies pay on proceeds where there is no on-site Blind Operator.

This applies to vending machines, commission income (CRS 8-84-205) and other businesses operated on Federal, State, or other property.

“Vending machine” is considered to be one-in-the-same as “Vending machine” as defined in 34 CFR Part 395.1 and includes all types of automated vending equipment which dispenses goods or services, automated teller machines or similar, or such equipment which provides recreational or other services.

“Vending machine income” is considered to be one-in-the-same as “Vending machine income” as defined in 34 CFR Part 395.1, except that it applies to income that accrues to a Blind Operator, or the State Licensing Agency.

“Vendor Debt” means a Debt found to be legitimately owed by the Blind Operator to an industry vendor (i.e. food or beverage manufacturer or distributor, or other vendor to the Blind Operator). 9.401 ELIGIBILITY [Rev. eff. 7/1/08]

Pursuant to 20 U.S.C. § 107a.(b) and 34 CFR Part 395.7, in selecting persons to be Blind Operators of the Business Enterprise Program, preference shall be given to persons who are in need of employment and who have been determined to be:

A. Blind as defined by 20 U.S.C. § 107e and 8-84-202(1), C.R.S.;

B. Citizens of the United States;

C. Able to successfully pass all State and Federal background investigations;

D. Free from infectious diseases as defined by the Department of Public Health and Environment for food handling (6 CCR 1010-2, § 2-201);

E. Free from any felony conviction or pattern of misdemeanor convictions;

F. Successful in the completion of Business Enterprise Program Training Program;

G. Reasonably possess the physical and mental aptitude to successfully manage a Business Enterprise Location as deemed by the State Licensing Agency and further defined in policy;

H. Eighteen (18) years of age or older; and, I. In possession of a high school diploma or GED.

J. The State Licensing Agency may develop policy prescribing methods which verify that eligibility standards are met through the entire period that a participant is granted licensure, to include initial and subsequent eligibility verification. 9.402 LICENSURE AND LEVELS OF BLIND OPERATORS [Rev. eff. 7/1/08]

This Part is administered in accordance with 20 U.S.C. § 107b and 34 CFR Part 395.7.

A. The State Licensing Agency shall provide for the issuance of licenses for an indefinite period.

Licenses are subject to Probation, Suspension, or Termination.

B. Upon satisfactory completion of training and subsequently operating an awarded Business Enterprise Location for ninety (90) calendar days, an evaluation will be conducted by the State Licensing Agency to determine whether the applicant is qualified for the award of a license, or if the applicant must continue training, or if it is the recommendation that the applicant seek another occupation.

C. The award of a license by the State Licensing Agency is contingent upon stabilized operation of a Business Enterprise Location for a minimum of ninety (90) calendar days and is determined to be successful jointly by the State Licensing Agency and Division of Vocational Rehabilitation delegates.

Description of status differentiation among Blind Operators.

A. “Trainee” means a blind person who has been accepted into the Business Enterprise Program and is participating in the formal Business Enterprise Program training course, including any preliminary training offered through the Division of Vocational Rehabilitation, but are not yet certified. Trainees are:

1. Clients of the Division of Vocational Rehabilitation and are subject to all rights and obligations as such.

2. Not eligible for any benefits afforded to Licensed Blind Operators, financial, legal, or otherwise.

B. “Certified Blind Operator” means a Trainee who has successfully completed the formal Business Enterprise Program training course and has been certified to manage a Business Enterprise Location, prior to licensure. Certified Blind Operators are:

1. Clients of the Division of Vocational Rehabilitation and are subject to all rights and obligations as such.

2. Not eligible for any benefits afforded to Licensed Blind Operators, financial, legal, or otherwise.

3. Eligible to bid on available Business Enterprise Locations and apply for associated beginning operating cash loan.

C. “Licensed Blind Operator” means a blind person who has been awarded a license by the State Licensing Agency. Licensed Blind Operators whose licenses are not in a probationary, suspended, or terminated status are:

1. Protected by all rights and benefits afforded to Blind Operators in accordance with the Federal Randolph-Sheppard Act, 20 U.S.C. § 107 et seq., and implementing regulations, 2. Eligible:

a. To apply for beginning operating cash loan associated with an awarded Business Enterprise Location b. To bid on available Business Enterprise Location c. To run for Colorado Elected Committee membership d. To apply for fair minimum return e. For grievance and appeal rights in accordance with § 9.413 f. For any health, medical, or retirement benefits as adopted by the body g. For quarterly unassigned vending machine income disbursement h. To be a voting member of the body of Blind Operators D. “Blind Operator” means any participant of The Business Enterprise Program at any stage identified above.

E. “Probationary License Status” means a License that is associated with a SMART action plan, or other corrective action plan, and the associated Licensed Blind Operator activities are being closely monitored for progression. This temporary status is assigned when a Licensed Blind Operator must work with their assigned Business Consultant to fulfill prescribed requirements, or face additional consequences. Licensed Blind Operators who are in a Probationary License Status:

1. Are protected by all rights and benefits afforded to Blind Operators in accordance with the Federal Randolph-Sheppard Act, 20 U.S.C. § 107 et seq., and implementing regulations, 2. Retain the same rights and eligibility as a Licensed Blind Operator as described in § 9.402 – 3, with the exception that they 3. Are not eligible to bid on an available Business Enterprise Location or run for Colorado Elected Committee membership if the reason they are on probation is because of bad Debt owed to the Business Enterprise Program F. “Suspended License Status” means a Licensed that is associate with a Blind Operator who must return to training and fulfill additional requirements in order to return to a Licensed Blind Operator or Probationary License Status. Licensed Blind Operators who are in a Suspended License Status:

2. Are protected by all rights and benefits afforded to Blind Operators in accordance with the Federal Randolph-Sheppard Act, 20 U.S.C. § 107 et seq., and implementing regulations, 2. Do not have any of the same rights and eligibility as a Licensed Blind Operator as described in § 9.402 – 3, with the exception that they 3. Do retain grievance and appeal rights in accordance with § 9.413 G. “Terminated License Status” means a Blind Operator who has had their license completely revoked, cancelled, or otherwise separated. Licensed Blind Operators who are in a Terminated License Status:

3. Are protected by all rights and benefits afforded to Blind Operators in accordance with the Federal Randolph-Sheppard Act, 20 U.S.C. § 107 et seq., and implementing regulations, 34 CFR 395 et. seq. for a full 30 calendar days after termination, if no appeal is in progress.

4. Do not have any of the same rights and eligibility as a Licensed Blind Operator as described in § 9.402 – 3, with the exception that they 3. Do retain grievance and appeal rights in accordance with § 9.413 4. May not receive quarterly unassigned vending machine income disbursement 5. May not bid on available Business Enterprise Locations 6. May not serve on the Colorado Elected Committee 7. May utilize grievance and appeals processes The State Licensing Agency shall be free to develop other levels of distinction or classes of licensing.

Issuance and conditions of licenses. 9.402.1 Property Right [Rev. eff. 7/1/08]

A license shall not create any property right for the licensee to whom it is issued and shall be deemed only to inform the public and other interested parties that the licensee has successfully earned licensure as described herein. 9.402.2 Enforcement, Removal, and Termination of a License [Rev. eff. 7/1/08]

The enforced removal of any Blind Operator from a Business Enterprise Location may occur prior to licensure or be in conjunction with the Suspension or Termination of a license and will be managed in accordance with written policies of the program.

Individuals committing illegal acts may also be subject to civil or criminal penalties.

A license issued to a Blind Operator for the operation of a Business Enterprise Location may be placed on probation, suspension, or terminated when:

A. If the Licensed Blind Operator does not abide by any part of these Rules or provisions covered by Blind Operator Agreement, including all obligations and Debt.

B. The Blind Operator Agreement has not been fully executed or is no longer in effect.

C. The State Licensing Agency finds that the Business Enterprise Location is not being managed in accordance with the laws, rules and regulations, the terms and conditions governing the Blind Operator Agreement, contract or applicable permit terms for the particular Business Enterprise Location, or other written agreement with the Blind Operator.

D. Program Eligibility, as delineated in section 9.401, is no longer met, including if there is proof of improvement of vision so that the Blind Operator no longer meets the definition of blindness, for which the State Licensing Agency may require proof periodically and by vendors selected according to Colorado, department, and division procurement rules and source selection methods.

E. There is an extended illness with medically documented diagnosis of prolonged incapacity of the Licensed Blind Operator to manage the Business Enterprise Location in a manner consistent with the needs of the Business Enterprise Location or other available Business Enterprise Locations in the Business Enterprise Program. The Blind Operator may return to The Business Enterprise Program if they provides documentation that their physician deems improved physical condition that they may “return to work” and the State Licensing Agency is in agreement.

F. The Licensed Blind Operator withdraws from The Business Enterprise Program by notice to The Business Enterprise Program.

G. A Licensed Blind Operator elects not to accept any Business Enterprise Location and fail to request for an available Business Enterprise Location to be put out for bid, and then successfully bid on it. They will be considered to have a Terminated License after ninety (90) calendar days and all program re-entry rules and practices shall apply.

H. Falsification of records by the Blind Operator, as validated by the State Licensing Agency or other State entity, will result in the Termination or Suspension of a License without placing the Blind Operator on probation.

Program Re-entry When any former Licensed Blind Operator requests to return to The Business Enterprise Program, they must:

A. Meet all eligibility requirements in § 9.401 B. Be free of bad Debt to the Business Enterprise Program C. Be free of bad Debt to industry vendors which may impact their success in managing a Business Enterprise Location D. Be subject to existing application and review process for new applicants E. Be required to fulfill training as prescribed by the State Licensing Agency, in order to become recertified and licensed 9.403 COLORADO ELECTED COMMITTEE: ELECTION AND PURPOSE OF A COMMITTEE OF LICENSED BLIND OPERATORS This entire Part is managed in accordance with 20 U.S.C. § 107b-1 and 34 CFR Part 395.14.

The Colorado Elected Committee is not regulated by the Governor’s Office of Boards and Commissions or equivalent and is provided in accordance with 20 U.S.C. § 107b-1 through the State Licensing Agency, with Active Participation by the Colorado Elected Committee.

The Colorado Elected Committee bylaws are developed by the entire body of Blind Operators, with oversight and acceptance by the State Licensing Agency. 9.403.1 Elections [Rev. eff. 7/1/08]

The State Licensing Agency shall provide for an election among the Licensed Blind Operators to establish a committee that, to the extent possible, will be representative of:

A. All Business Enterprise Location types B. All areas of the State Members shall be elected to serve a two-year term.

Participation by any Blind Operator in any election shall not be conditioned upon the payment of dues or any other fees in accordance with 34 CFR Part 395.14(a). Dues or fees do not mean Debt or bad Debt. 9.403.2 Purpose of the Colorado Elected Committee [Rev. eff. 7/1/08]

The Colorado Elected Committee shall perform the following functions:

A. The Colorado Elected Committee is responsible for Active Participation with the State Licensing Agency and perform functions in accordance with 20 U.S.C. §107b-1(3) and 34 CFR Part 395.7(c), 395.9, 395.14 et. seq., and 395.36(a), as defined in these rules, §9.400.1 related to:

1. Major administrative decisions, to include:

a. Setting out the method for determining budget line items for expenditure of setaside (these rules, § 9.411.2).

2. Policy, to include those in accordance with these rules, §9.404 which govern the Blind Operators’:

a. Duties b. Supervision c. Transfer and promotion d. Financial participation 3. Program development decisions which affect the overall administration of the State's Business Enterprise program, to include:

a. Development and administration of a State system for the transfer and promotion of Blind Operators b. Development of training and retraining programs for Blind Operators B. Receive and transmit to the State Licensing Agency grievances at the request of Licensed Blind Operators and serve as advocates for such Licensed Blind Operators in connection with such grievances;

C. Sponsor, with the assistance of the State Licensing Agency, meetings and instructional conferences for Blind Operators within the State. 9.404 RESPONSIBILITIES [Rev. eff. 7/1/08]

STATE LICENSING AGENCY

The State Licensing Agency must act as prescribed in 20 U.S.C. § 107 et seq. and 34 CFR Part 395 et seq. and responsibilities are further delineated as follows and in policy.

The State Licensing Agency shall have the ultimate responsibility for the Business Enterprise Program.

When the State Licensing Agency does not adopt written recommendations of the Colorado Elected Committee, it shall notify the Colorado Elected Committee. The State Licensing Agency will maintain operational procedures to secure the day to day function of the State Licensing Agency.

The following are responsibilities of the State Licensing Agency: The State Licensing Agency shall:

A. Cooperate with the Federal Secretary of Education in applying the requirements of the Randolph- Sheppard Act in a uniform manner (20 U.S.C. § 107 et seq.)

B. Take effective action to carry out full responsibility for the supervision and collaborative management of each Business Enterprise Location in the program in accordance with its established rules and regulations, this part, and the terms and conditions governing the contracts, agreements, permits and Blind Operator Agreements. This includes the removal of a Blind Operator from their awarded Business Enterprise Location, Probation, Suspension, or Termination of Licenses in accordance with § 9.402.2.

C. Take diligent action to enforce Blind Operator responsibilities, performance, and overall mission compliance to include systematic analysis of financial and other performance through evaluations and/or audits.

D. Submit promptly to the Secretary of Education for approval a description of any changes in 1. The legal authority of the State Licensing Agency, 2. Its rules and regulations, 3. Blind Operator Agreements, 4. Schedules for the setting aside of funds, 5. Contractual arrangements for the furnishing of services by a nominee, 6. Arrangements for carrying general liability and product liability insurance, and 7. Any other matters which form a part of the application (34 CFR Parts 395.2 and 395.3);

E. Survey sites in order to identify whether they are satisfactory for a Business Enterprise Location in accordance with 20 U.S.C. § 107a(d) and provide a waiver to the agency which has a nonsatisfactory site, limiting the term and defining the conditions of the waiver.

F. Provide and train on documents provided upon request to any Blind Operator at any time.

G. Submit to an arbitration panel those grievances of any Licensed Blind Operator unresolved after a full evidentiary hearing in accordance with 20 U.S.C. §§ 107b(6) and 107d-1(a), upon written receipt of such request by the Licensed Blind Operator or their representative.

H. For each Business Enterprise Location and for the entire Business Enterprise Program, adopt accounting procedures and maintain financial and other records in a manner necessary to provide detail as is sufficient to 1. Enable evaluation of performance and 2. Comply with Secretary of Education requirements I. Provide financial reporting relevant to Business Enterprise Program on at least a quarterly and annual basis, pursuant to 20 U.S.C. § 1071b-1.1.

J. Protect and manage all State Assets assigned to the Business Enterprise Program including purchase, transition, and tracking.

K. Only use set-aside funds for appropriate purposes, as identified in 20 U.S.C. § 1071b-3 and 34 CFR Part 395.8(c), and manage set-aside in accordance with these rules §9.405.

L. Notify Blind Operators of the set-aside schedule in accordance with these rule § 9.405.2.

M. Ensure any training services related to any Blind Operator, which have been incorporated into the standardized or individualized training curriculum, are provided to Blind Operators as vocational rehabilitation services under the Rehabilitation Act of 1973 (Pub. L. 93-112), as amended. This is not limited to, but includes personal and vocational adjustment, books, tools, and other training materials.

N. Ensure the opportunity for Active Participation in accordance with these rules §9.403.

O. Attempt to resolve day to day problems with Permit on-site official informally with awarded Blind Operator of the Individual Business Enterprise Location (34 CFR Part 395.36(a)).

P. Be solely authorized to initiate repair calls.

Q. Further establish in writing and maintain policies which have been developed with the Active Participation in accordance with § 9.403.2 of these rules.

R. Establish additional procedures as necessary to assure that rules and policies have been explained to each Blind Operator.

S. Determine procedures through an internal document.

The following are responsibilities of the Blind Operator. The Blind Operator Shall:

A. Not assume duties exclusive to the State Licensing Agency as listed in these Rules, § 9.404.

B. Conduct all business in a just and truthful manner.

C. Be responsive to communications received through modern means in order to responsibly manage business. For example, electronic mail, delivered mail, phone recordings, and other methods reasonably accessible to the blind.

D. Notify Business Enterprise Program of 1. Any litigations in which they is a party defendant in a case that involves any services provided as a result of participation in the Business Enterprise Program.

2. Complaints of alleged violations or legal issues that could jeopardize a Business Enterprise Location permit or agreement with property management, or jeopardize Business Enterprise Program’s priority under the Randolph-Sheppard Act.

3. Facility and personal emergency and contact information, especially for legal correspondence 4. Preferred electronic and hard-copy reading format.

E. Submit a request for a full evidentiary hearing in accordance with these rules, § 9.413, or after such hearing, file a complaint with the Secretary in order to initiate an arbitration panel if so desired, in accordance with 20 U.S.C. § 107d-1(a);

BLIND OPERATORS WHO ARE ASSIGNED/AWARDED BUSINESS ENTERPRISE LOCATION/S

SHALL:

A. Abide by all rules and regulations and program policies governing the operation of the Business B. Impress upon their employees the importance of these Rules and the Blind Operator Agreement and shall be responsible for the actions of their employees concerning relative to the Business Enterprise Program.

C. Actively engage in the management of the Business Enterprise Location.

D. Be available for all necessary visits to the facility and cannot assign, delegate, or subcontract the totality of the Blind Operator duties to subcontractors or any other third party.

E. Appear and manage, or arrange for the management of, the Business Enterprise Location, or request an exception in writing, and receive, prior approval by the State Licensing Agency and approved by the State Licensing Agency.

F. Provide excellent service to the facility and its customers, maintain a professional appearance, and act in a professional manner while managing a Business Enterprise Program facility, or engaging in related activities.

G. Perform within any contract, permit, or agreement, as authorized or required by the Business Enterprise Location’s property management, franchise agreement, management services agreement, state interagency agreement, or other. The Blind Operator will actively initiate full understanding of such terms and conditions and will communicate any developments which may have a negative impact on professional relationships, the Business Enterprise Location, the reputation of Business Enterprise Program, or the reputation of the Body of Blind Operators.

H. Not engage in any conduct that is detrimental to Business Enterprise Program’s interest in the Business Enterprise Location, its statutory priority, its permits or agreements, or its equipment or other inventory.

I. Be responsible and financially liable for the accurate and proper reporting of all 1. Sales transacted through the Business Enterprise Location 2. Business Enterprise Program assets entrusted to the Blind Operator J. Ensure compliance with all laws applicable in the operation of the associated business at all times.

K. Not engage in or permit harassment, violent behavior, threat of violent behavior, intimidation, or other disruptive behavior directed towards another Blind Operator, Business Enterprise Program staff member, subordinate, client, customer, or property. Possession of weapons is prohibited in or on any state or federal facility, including in vehicles.

L. Self-report any felony or misdemeanor arrest or charge.

M. Comply with the provisions of CRS 8-17.5-101 et seq. and shall not knowingly employ or contract with an illegal alien to perform work or enter into a contract with a subcontractor that knowingly employs or contracts with an illegal alien.

N. Acquire and maintain all appropriate records and business licenses applicable to the Business O. Allow Business Enterprise Program, the State, the federal government, access to perform semiannual evaluations, audits and/or inspections of records at any time, to assure compliance with the State or federal government’s rules and regulations or to evaluate the Blind Operator’s performance.

P. Comply with all reasonable requests made in the course of an investigation by the Colorado Department of Labor and Employment Q. Furnish and give access to all documents and reports for business operations at the Business Enterprise Location, which are required by State or Federal governments.

R. Implement, or assist in the implementation of, the necessary systems, methods and controls for tracking, monitoring, and reporting of vending machine sales.

S. Acquire merchandise, utensils, and consumables as determined by Business Enterprise Program to be sufficient to satisfactorily maintain the facility (beyond initial inventory), in accordance with the Business Enterprise Program Inventory Policy and Process and with CRS § 24-30 202.4 regarding State Collections.

T. Not neglect, abuse, or relocate State owned equipment and manage it according to manufacturer recommendations.

U. Be responsible for the payment of required business licenses, business insurances, communications products, and consumable inventory (beyond initial inventory), and business needs not otherwise provided for.

V. Submit, in accordance with the prescribed schedule and method per these rules §§ 9.405.2 and 9.406 1. The standardized monthly financial turn-in Report (“Turn-in”) to the Business Enterprise Program.

2. The set-aside payment to the Business Enterprise Program per these rules.

3. Timely payments to repay the services established by Business Enterprise Program on behalf of the Blind Operator.

4. Items which must be returned upon the transition out of the Business Enterprise Location according to the Blind Operator Agreement.

W. Pay all Debts associated with participation in the Business Enterprise Program (including to vendors of the facility/business operation), timely.

X. Give a minimum 30 day notice to the Business Enterprise Program of intention to vacate or discontinue managing the awarded/assigned Business Enterprise Location on a daily business.

Y. Understand that if they vacate, discontinue managing, or are the subject of an enforced removal, they may be held responsible for costs incurred as a result of the transition.

Z. Vacate facilities in an acceptable condition, conducive to an immediate transition between Blind Operators with no closure time required solely due to the physical condition of the Business 9.405 SET-ASIDE FUND [Rev. eff. 7/1/08]

A set-aside fund shall be established and managed, pursuant to 20 U.S.C. § 107b(3) and 34 CFR Part 395.3(a)(11)(iv) and 395.9(a).

A. Pursuant to 34 CFR Part 395.9(b), set-aside funds may expended only for the purposes of:

1. Maintenance and replacement of equipment;

2. Purchase of new equipment;

3. Management services;

4. Assuring a fair minimum of return to Licensed Blind Operators; or, 5. Retirement or pension plans, health insurance, and other specified benefits after a vote of the entire body B. The State Licensing Agency shall:

5. Utilize the Colorado, department, and division procurement rules and source selection methods in order to prevent a greater charge for any purpose than is reasonably required for that purpose.

6. Maintain adequate records to support the reasonableness of the charges for each of the purposes listed in this §, including any reserves necessary to assure that such purposes can be achieved on a consistent basis. 9.405.1 Set-Aside Assessment [Rev. eff. 7/1/08]

A. The set-aside assessment (or administrative fee) is a charge levied against the net proceeds of each Business Enterprise Location, which represents a certain percentage of the net proceeds realized as a result of the facility's operation.

B. The Blind Operator is responsible for the payment of this assessment to the State Licensing Agency each month.

C. Net proceeds are determined from net sales, less merchandise cost and other allowable business expenses, plus commissions, vending machine income remitted to the Licensed Blind Operator, and rebates and bonuses paid to the Licensed Blind Operator.

D. The amount of set-aside assessment may not be deducted as an expense in computing net proceeds.

E. The set-aside (percentage of net proceeds) to be paid to the State Licensing Agency by each Blind Operator is predicated upon a schedule negotiated between the State Licensing Agency and the Colorado Elected Committee, and determined to be sufficient for the operation of the State Licensing Agency. The set-aside schedule must 1. Allow for the retention of reasonable reserves by the State Licensing Agency.

2. Not exceed a maximum of thirteen percent (13%) per Business Enterprise Location 3. Be approved by the U.S. Rehabilitation Services Administration prior to implementation 9.405.2 Schedule [Rev. eff. 7/1/08]

In accordance with current accounting schedule, Blind Operators shall remit payments plus business expenses determined reasonable at the discretion of the State Licensing Agency, as reasonably notified. 9.406 FINANCIAL REPORTING [Rev. eff. 7/1/08]

A. Each Blind Operator who is awarded a Business Enterprise Location must file with the agency a monthly financial report of their business operation.

B. The report (turn-in) and the payment of set-aside assessments currently due the State Licensing Agency shall be determined according to written policy.

C. If the State Licensing Agency's technology permits, the Blind Operator may be afforded the opportunity to file their reports and pay fees on-line according to the deadline in written policy.

D. Each Blind Operator must maintain and provide itemization and documentation according to the Blind Operator Agreement.

E. Only the assigned Blind Operator for a Business Enterprise Location, or Blind Operator designee, may have an economic interest in that Business Enterprise Location. No employee of the State Licensing Agency, it's contractors or subcontractors, or other Blind Operator shall have any personal or economic interest whatsoever in the Business Enterprise Location. Notwithstanding the foregoing, economic interest may be held by an authorized third party, as signified by a separate written agreement with the State Licensing Agency.

F. Each Blind Operator shall be permitted access to all financial data of the State Licensing Agency relevant to the operation of the Business Enterprise Program, including reasonable alternative formats and media acceptable to the Blind Operator and in compliance with current HIPAA and Division of Vocational Rehabilitation rules (34 CFR Part 395.12). 9.407 UNASSIGNED VENDING MACHINE INCOME [Rev. eff. 7/1/08]

Unassigned vending machine income shall be accrued and disbursed in accordance with 20 U.S.C. § 107d-3. Colorado applies references to “federal” in the Code to State and other Business Enterprise Locations as well.

A. Unassigned vending machine income shall be disbursed to each Licensed Blind Operator in accordance with policy, which shall observe:

1. The disbursement of unassigned vending machine income to each individual Licensed Blind Operators shall be in an amount not to exceed the average net income of the total number of Blind Operators within Colorado or average net income of the total number of Blind Operators in the United States. Excess unassigned vending machine income, per this § shall be retained by the State Licensing Agency.

2. The State Licensing Agency shall disburse unassigned vending machine income to Blind Operator within the State on at least a quarterly basis.

3. Any unassigned vending machine income not necessary for such purposes shall be used by the State Licensing Agency in accordance with 34 CFR Part 395.9(b) and these Rules §9.405.

4. Any assessment charged to Blind Operators by a State Licensing Agency shall be reduced pro rata in an amount equal to the total of such remaining unassigned vending machine income.

5. Distributions are based on unassigned vending machine income, accounted for and managed collectively from every type of Business Enterprise Location and collectively from federal, State, and other property types.

B. Individual Blind Operators shall only receive disbursement after it has been determined by the State Licensing Agency that the Blind Operator is in good standing and free of bad Debt to the Business Enterprise Program.

C. All unassigned vending machine income disbursement 1. Shall be calculated so that the final total disbursed has been offset by any set-aside due on the gross commission income of each Blind Operator.

2. May be applied to existing Debt of a Blind Operator.

3. Shall be applied to existing bad Debt of any Blind Operator.

9.409 BLIND OPERATOR AGREEMENTS, RESPONSIBILITIES, AND BUSINESS ENTERPRISE

LOCATION [Rev. eff. 7/1/08] 9.409.1 Blind Operator Agreement [Rev. eff. 7/1/08]

A. Each Blind Operator and the State shall enter into an agreement concerning operation of any Business Enterprise Location.

B. The agreement shall not be effective until signed by the Blind Operator and the delegated

authority on behalf of the State of Colorado.

C. The execution of such agreement must occur for each Blind Operator in each Business Enterprise Location, prior to any Blind Operator performance or transition into such Business D. The State Licensing Agency may develop further policy governing agreements for true emergency transitions, as approved by the Colorado Department of Labor and Employment, Procurement and Contracts Services Division.

E. Unless otherwise specified within governing Laws, Regulations, or these Rules, the State of Colorado views all Blind Operators as contractors for the purpose of carrying out any executed contract or agreement, including for the enforcement of rights and obligations.

F. The Blind Operator Agreement will:

1. Identify each party’s full legal name, business address, and legal notification address.

2. Identify the transition in/start date.

3. Identify the Individual Business Enterprise Location;

4. Define the nature, scope and, responsibilities of the Blind Operator concerning the operation of the Individual Business Enterprise Location;

5. Describe management services offered by the State Licensing Agency and direct to resources which further define;

6. Identify allowable business expenses in accordance with § 9.405.1.

7. Identify items which must be returned upon the transition out of the Business Enterprise Location.

G. Execution of the Blind Operator Agreement The Blind Operator Agreement must be signed prior to the Blind Operator's acceptance of an Individual Business Enterprise Location. A Blind Operator's failure to execute the Blind Operator's agreement, within the allotted time period designated by the State Licensing Agency, shall result in the Blind Operator surrendering their opportunity to manage the Individual Business Enterprise Location for which the agreement was prepared. A new agreement must be signed each time the Blind Operator accepts the opportunity to manage any Individual Business Enterprise Location, whether permanent or temporary.

Signature of the Blind Operator Agreement signifies their receipt of all information necessary to fully understand their responsibilities at the respective Business Enterprise Location, in compliance with 34 CFR Part 395.3(a)(11)(vi).

The Blind Operator Agreement will expire annually or periodically in accordance with the written policies of the program. The Blind Operator Agreement may be renegotiated prior to expiration. 9.409.2 Business Enterprise Location Transfer and Promotion [Rev. eff. 7/1/08]

This rule is written in accordance with §9.403.2 of these rules.

The transfer or promotion of a Blind Operator to a new Business Enterprise Location will be through a Transfer and Promotion process, policy, or procedure, which will include provisions for:

A. Definitions specific to transfer and promotion, if applicable.

B. Temporary Business Enterprise Location management and prescribed minimum or maximum period of time.

C. Length of time a Blind Operator may maintain their former Business Enterprise Location upon award of a new permanent Business Enterprise Location.

A Blind Operator shall be transferred to a Business Enterprise Location, or from their assigned Business Enterprise Location only when the transfer will directly benefit the Blind Operator or will be in the best interest of the Business Enterprise Program, giving preference to the Blind Operator having demonstrated the most ability in management of a Business Enterprise Location.

For the purposes of this Section, the following may each be considered to be Individual Business A. A vending route B. Premises as defined by legal agreement - wherein the agreement premises encompass an entire campus, base, installation, or other pairing/clustering of physical sites, the State Licensing Agency may change the established parameters of the Individual Business Enterprise Location to reflect the entire premises as defined in the Federal or State contract.

No limitation shall be imposed on vending machine income, combined to create a Business Enterprise Location, when such facility is maintained, serviced, or managed by a Blind Operator.

An Individual Business Enterprise Location shall only be assigned to one Blind Operator, unless the State Licensing Agency approves an exception through written documentation. 9.410 BLIND OPERATOR INDEBTEDNESS [Rev. eff. 7/1/08]

Blind operators participating in the Business Enterprise Program must pay any and all Debt on time. A present or past Blind Operator’s indebtedness to the Business Enterprise Program that becomes past due shall include any and all collection charges, attorney fees, court costs and all expenditures directly or indirectly incurred due to that Debt.

It is solely the responsibility of the Blind Operator to pay their Debt. If it becomes necessary for the Business Enterprise Program to become an intermediary to satisfy vendor Debt:

A. The State Licensing Agency will put the Blind Operator license on probation, suspension, or termination.

B. The State will pay the Debt.

C. The State will invoice the Blind Operator for the full amount of Debts paid to the Vendors.

D. An administrative fee will be added to the invoice and the Debt will become the Blind Operator’s Debt to the State, which will be managed as bad Debt in accordance with this § 9.410 and § 9.407.

These actions in this § 9.410 may also be initiated if any Blind Operator:

A. Acts independently of the State in order to assume responsibilities of the State, including but not limited to authorizations or requests which are the duty of a State Licensing Agency staff member as identified in these rules section 9.404.

B. Vacates the Business Enterprise Location in an unsatisfactory manner, per these rules section 9.404.

State agencies refer all Debt to State Collections, once the payment becomes 30 days past due and no payment arrangement is agreed upon, in accordance with CRS § 24-30 202.4.The State Licensing Agency may refer any bad Debt amount to collections in accordance with Colorado Department of Personnel and Administration, Office of the Executive Director, Accounts Receivable Collections Administrative Rule 1.37.

Impact of Bad Debt Owed to the Business Enterprise Program If a Blind Operator is referred to collections for Bad Debt:

A. The State Licensing Agency has the right to remove the Blind Operator from any assigned/awarded Business Enterprise Location(s).

B. Monies due to Blind Operator shall be offset against existing bad Debt, without the prior approval of the Blind Operator. This includes quarterly unassigned vending machine income disbursements in accordance with § 9.407.

C. The Blind Operator is not eligible to bid on an available Business Enterprise Location.

D. The Blind Operator is not eligible to run for Colorado Elected Committee membership. If they are already on the Colorado Elected Committee, it will be managed by policy or on a case by case

basis if none exists. 9.411 EQUIPMENT AND INITIAL MERCHANDISE INVENTORY [Rev. eff. 7/1/08] 9.411.1 Furnishing Equipment and Initial Merchandise Inventory [Rev. eff. 7/1/08]

All furnishing of equipment and initial merchandise inventory will be managed in accordance with 20 U.S.C. § 107b-2, 34 CFR Parts 395.3 and 395.6, and subject to availability of funds. Policies, procedures, and processes may be written to further identify methods for the management of State equipment and consumable inventory establishment and transfer.

A. The State Licensing Agency will furnish an adequate initial stock of merchandise for resale, and other related inventory items for the successful initial operation of the Business Enterprise Location for newly established Business Enterprise Locations and for incoming Blind Operators in established Business Enterprise Locations previously managed by another Blind Operator or program operated stands.

B. The State Licensing Agency shall purchase or cause to be furnished suitable equipment, utensils, and supplies for initial operation; and shall provide for the maintenance and repair of equipment and replacement of worn out or obsolete equipment for each Individual Business Enterprise Location as required to assure its continued successful operation.

C. The Blind Operator shall be responsible for routine day to day care of the equipment and items considered disposable by the State Licensing Agency.

D. The State Licensing Agency may require the Blind Operator to conduct a physical inventory of all merchandise and supplies; schedule to be determined by the State Licensing Agency. 9.411.2 Right, Title to, and Interest in Business Enterprise Location Equipment and Merchandise Inventory [Rev. eff. 7/1/08]

The right, title to, and interest and equity in all Business Enterprise Location equipment shall be held by the Business Enterprise Program of the State of Colorado with the exception of Blind Operator ownership per 34 CFR Part 395.6.

In order to satisfy these rules § 9.403.2(a)1(a), Each fiscal year, in anticipation of receiving spending

authority, the State Licensing Agency shall seek Active Participation from the Colorado Elected Committee in order to designate a representative subcommittee to collaborate with the State Licensing Agency in order to establish the amount of equipment expenditures.

All resulting decisions are contingent upon receipt of actual funding and spending authority and are subject to applicable procurement rules and regulations. 9.412 TRAINING PROGRAM [Rev. eff. 7/1/08]

This Part is written pursuant to 20 U.S.C. § 107d-4, 34 CFR Part 395.11, and these rules §§ 9.403.2(3)(b) and 9.404, to achieve maximum vocational potential through the Division of Vocational Rehabilitation.

A training program shall be afforded to Trainees to certify them to manage a Business Enterprise Location in accordance with accepted business practices. After any necessary personal and vocational adjustment training, Trainees must complete established training programs within a twelve (12) month period, unless special circumstances are approved by the State Licensing Agency. Upon completion of the training program, the State Licensing Agency may assign the Trainee any Business Enterprise Location deemed to be suitable to the abilities of the Trainee, or the Trainee may participate in the transfer and promotion process, with the potential to compete and be awarded a Business Enterprise Location. The State Licensing Agency may develop policy to encourage, promote, or make mandatory continuing education and/or upward mobility.

Training and curriculum shall include the following to Blind Operators with the capacity to operate a vending facility, as needed.

A. Personal and vocational adjustment B. Training:

1. All aspects of a Business Enterprise Location 2. On the job 3. Upward mobility 4. Post-employment C. Training materials D. Follow-along services Prior to becoming Certified, each Trainee shall be provided a hard or electronic copy of or link to:

A. 20 U.S.C. § 107 et seq.

B. 34 CFR Part 395 et seq.

C. 8-84-201, C.R.S. et seq.

D. These rules E. The standardized Blind Operator Agreement A description of the arrangements for providing services and training on each of these documents shall be provided through classroom training and associated documentation, which shall include a signed acknowledgement. 9.413 RIGHTS OF APPEAL AND FORMAL APPEAL PROCESS [Rev. eff. 7/1/08]

Trainees and Certified Blind Operators may seek council of a Colorado Elected Committee member for a grievance in accordance with these Rules, § 9.403.2(b) and shall refer to the DVR Policy Manual for any mediation, informal appeal, or formal appeal of a State Licensing Agency decision.

Licensed Blind Operators whose license is in any status, who wish to pursue a grievance or appeal, shall act in accordance with the following. 9.413.1 Right of Appeal [Rev. eff. 7/1/08]

A. A Licensed Blind Operator who is dissatisfied with any determination made by the Business Enterprise Program staff and/or Division of Vocational Rehabilitation agency representative, which concerns the provision of Business Enterprise Program services, may request a:

1. Grievance in accordance with these Rules, § 9.403.2(b) and/or;

2. An informal review in accordance with this § 9.413 et seq. and/or;

3. A formal appeal in accordance with this § 9.413 et seq.

B. A Licensed Blind Operator is responsible for costs associated with their appeal.

C. NOTIFICATION OF RIGHTS TO REVIEW AND REQUEST MEDIATION

All Blind Operators through the Business Enterprise Program training, shall be notified of Licensed Blind Operator appeal rights.

D. PROVISION OF BUSINESS ENTERPRISE PROGRAM SERVICE(S) DURING REVIEWS AND

MEDIATION

When a review request is made, all Business Enterprise Program services being provided under a current plan shall continue as specified until the review and/or appeal is completed, unless an Licensed Blind Operator or, as appropriate, the individual’s representative requests a suspension, reduction, or termination of services, or if there is a risk to public safety or stability of The Business Enterprise Program. If the disputed service(s) and/or good(s) was obtained through proven misrepresentation, fraud, collusion, or criminal conduct by the individual or the individual’s representative, the good or service shall be terminated immediately.

E. ADDITIONAL SERVICES DURING APPEALS

When an informal review or formal appeal request concerns an issue which may impact determination of ineligibility for Business Enterprise Program services and/or Transfer and Promotion, new or additional service(s) or good(s) shall not be provided.

F. DOCUMENTATION OF REVIEWS AND MEDIATION

The Blind Operator record shall contain documentation concerning actions and decisions relating to requests by Blind Operators for an informal review or formal appeal of Business Enterprise Program staff determinations.

G. INFORMAL REVIEW

The Licensed Blind Operator may request an informal review by the Program Manager in order to resolve the issue(s) under dispute with or without the conduct of a formal appeal. Informal review begins with a request for the Program Manager to review a decision concerning the provision of Business Enterprise Program services. If the individual is not satisfied with the decision made by the Program Manager, the individual may then submit a written request for review to the Blind and Low Vision Services Manager to review the decision. Informal review shall be conducted in a timely manner that shall not delay a formal appeal and within thirty (30) days of the initial request unless both parties agree that additional time is necessary. If the informal review does not resolve the issue(s), and the formal appeal process has not been requested, the individual may request a formal appeal.

When a formal appeal has been requested and the informal review does not resolve the dispute within the time established through mutual agreement, the formal appeal shall be conducted within the time frames outlined for the formal appeal process. An individual is not required to go through an informal review prior to or instead of a formal appeal.

H. FORMAL APPEAL: FULL EVIDENTIARY HEARING

1. This is written pursuant to 20 U.S.C. § 107d-1 and 34 CFR Part 395.13.

2. An individual, or, as appropriate, his or her authorized representative, may initiate a formal appeal regarding Business Enterprise Program staff determinations by requesting an impartial due process hearing with an administrative law judge (ALJ).

3. The request shall be submitted, in writing, to the Colorado Department of Personnel and Administration, Office of Administrative Courts within ninety (90) calendar days of the decision that affects provision of a Business Enterprise Program service. The written request shall be a statement identifying the basis of the appeal, including a description of the determination made by the Business Enterprise Program staff that the individual is appealing. The statement should include a description of what the individual wants from the appeal.

4. Hearing Timelines A hearing shall be held within sixty (60) calendar days of the informal pre-hearing conference, unless both parties agree additional time is necessary for good cause. There may be situations when a time extension is necessary to allow either party or the administrative law judge sufficient time to prepare for the hearing following an informal review. Even at those times, all parties must agree to the extension.

5. Additional Evidence and Witnesses The individual, or, as appropriate, his or her authorized representative may present additional evidence, information, and witnesses to support the individual’s position during the hearing.

6. Findings and Decision The administrative law judge shall render a decision and provide a written report of the findings and the grounds for this decision to the individual, or, as appropriate, his or her authorized representative, and the Business Enterprise Program within thirty (30) calendar days of completion of the hearing.

7. Federal Arbitration The State Licensing Agency or the Licensed Blind Operator who wishes to challenge the final decision made by the administrative law judge may submit a request for review of such decision to the Secretary of Education pursuant to and 20 U.S.C. § 107d-2 and 34 CFR Part 395.13. The final decision of the administrative law judge shall be implemented pending the results of the review of the Secretary of Education. 9.414 CONFIDENTIALITY [Rev. eff. 7/1/08]

The Business Enterprise Program shares business and logistical information as it is operationally required. As an eligibility program, it is considered common knowledge and is openly shared that participants are legally blind, along with meeting all other eligibility requirements.

The Business Enterprise Program shall develop further policy or process for the effective and consistent management of information. _________________________________________________________________________ Editor’s Notes

History Entire rule recodified from 12 CCR 2513-1 eff. 03/17/2017.

Rules 9.207.3, 9.209, 9.209.1, 9.209.2 A eff. 03/30/2018.

Rule 9.100 eff. 03/02/2019.

Rule 9.108.1 E.2 eff. 09/30/2019.

Rules 9.101.1, 9.102 A eff. 03/01/2020.

Rules 9.103.3-9.108.2 eff. 11/30/2022.

1106 Colorado Uninsured Employers Board

7 CCR 1106-1 Colorado Uninsured Employers Fund {#sec-7-ccr-1106-1 omnilex-key=us-co-regs-official--department-10--7 CCR 1106-1}

DEPARTMENT OF LABOR AND EMPLOYMENT

COLORADO UNINSURED EMPLOYERS FUND

7 CCR 1106-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________

Rule 1 General Provisions 1-1 The following definitions shall apply unless otherwise indicated in these rules: 1-2 Meetings (A) The Board shall meet four times per year or more often if a majority of the board determines it is necessary. Meetings shall be noticed as required by law.

(B) All meetings of the Board shall be open to the public and conducted on the record except as permitted by the Colorado Open Meetings Act.

(C) Travel reimbursement to Board members shall be paid in accordance with the rules promulgated by the Colorado State Controller’s Office and guidance issued by the CDLE. 1-3 The Board is not an insurer or employer for purposes of the Colorado Workers’ Compensation Act or Workers’ Compensation Rules of Procedure. 1-4 [Expired 05/15/2020 per House Bill 20-1179] 1-5 Financial records of the cue fund will be maintained by the division of workers’ compensation in accordance with all applicable statutory authority, rules and regulations.

Rule 2 Claims 2-1 Notice to the Board (A) The CUE Board shall be notified by the Division monthly of any claim deemed or appearing to be uninsured.

(B) Any Application for Hearing or Response to Application for Hearing filed in a claim in which the issue of insurance coverage is endorsed or which is considered uninsured by the Division or which has been accepted by the Board for payment of benefits shall be served upon the Board or its designated representative at the time of filing.

(C) At the discretion of the board, an order issued without proper notice to the board may be accepted for purposes of an application for benefits.

(D) The Board may notify all parties of its intent to join the claim by filing a Response to the Application for Hearing or upon motion and order to join the claim. If the deadline for filing a response to the application for hearing has expired, an extension shall be granted by a prehearing administrative law judge upon good cause shown. 2-2 Initial Application (A) Application for payment of benefits from the Fund may only be made after issuance of a final order finding the claim to be compensable and the employer to be uninsured. Any such application shall be made within 90 days of the order becoming final. The Board shall notify the claimant of the 90 day deadline for application.

(B) Where the Board participated in the hearing, the application for benefits may not be rejected unless the Fund is closed pursuant to 3-2(B).

(C) Where the Board received notice and did not participate in the hearing, it is bound by the final order with regard to compensability of the claim. Applications for benefits may only be denied if:

(1) The Board or its agents determine an insured entity such as a statutory employer is responsible for payment of benefits.

(2) The application for benefits appears to be fraudulent.

(3) The Fund has been temporarily closed pursuant to the Board’s authority under

Rule 3-2 (D) Upon rejection of an initial application for entry into the Fund the Applicant may file an application for hearing to contest the determination of the Board. Any such application for hearing shall be filed within 90 days of the date the Board issues notice the application for benefits was rejected. Notice shall include a statement of the right to apply for hearing within 90 days. Failure to file an application for hearing within the time provided shall be deemed a waiver of the right to appeal. 2-3 Benefits (A) At the time of initial acceptance into the Fund a Claimant shall be entitled to receive payment for all benefits which accrued prior to the date of acceptance, subject to the benefit levels set by the Board in the annual report required by Rule 3-1 which were applicable at the time the benefits accrued.

(B) At the time of initial acceptance into the Fund all reasonable and necessary medical provider bills which remain unpaid will be paid pursuant to Workers’ Compensation Rule of Procedure 16. The injured worker will be reimbursed for any such payments made out of pocket. Any medical bills more than three years old at the time of application must be reviewed by the Board and will be paid only upon a majority vote.

(C) Following acceptance into the Fund, benefits shall be paid in the same manner as workers’ compensation benefits paid pursuant to the Workers’ Compensation Act, except that:

(1) The Board may modify, terminate or suspend payments from the CUE Fund pursuant to 8-67-107(1)(b).

(2) For any period where payments are so modified, terminated or suspended, the Claimant shall have no claim to accrued payments from the Fund other than medical benefits.

(a) Nothing in this section shall be construed as reducing the liability of the non-insured employer to pay the full amount of benefits as required by the Workers’ Compensation Act.

(b) Any bills for medical services which accrue during a period of reduced benefits shall have first priority upon any subsequent increase or resumption of benefits.

(D) Any claimant seeking benefits from the cue fund must file a notice of entitlement to such benefits with the board for benefits between February 1 and April 1 of each year.

(1) The Board shall send each claimant that received benefits the prior year a notice form to complete.

(2) Failure to properly file the required notice will result in the suspension of payment of indemnity benefits from the Fund.

(E) Any medical bills authorized and approved and not paid due to a limitation of funds shall be retained by the Board and paid first in the following fiscal year. 2-4 Adjusting Procedures (A) At any point after acceptance into the Fund the Board may take any action permitted by the Workers’ Compensation Act on behalf of the employer.

(1) The employer may object to any action by following the same procedure set forth by statute for claimant to object. Where statute does not provide a procedure for objecting, the employer may request a prehearing conference.

(2) Nothing in this section shall be construed so as to prohibit or prevent the uninsured employer from filing an application for hearing on any contested issues.

(B) The Board will be the only entity permitted to file admissions of liability for accepted claims with the Division of Workers’ Compensation (C) Any admissions filed by the Board shall represent the benefits to which the injured worker is legally entitled under the Workers’ Compensation Act, without regard to restrictions on payments from the Fund imposed by the Board due to funding.

(D) Twice a year the Board shall provide the injured worker and Division, on a form designated by the Division, a statement of benefits actually paid by the Board and owed by the employer.

Rule 3 Funding and Review 3-1 Annual Review (A) On an annual basis the Board shall review funding received the previous year, anticipated funding for the upcoming year as well as actual expenditures for the prior year and anticipated expenditures for the upcoming fiscal year.

(B) On or before June 1 of each year the Board shall release an annual report identifying the benefit level that will be paid for the upcoming fiscal year subject to the Board’s authority to lower benefits based on funding levels as set forth in §8-67-107(1)(b). The report shall also include the total number of uninsured claims filed with the Division, the number of claims for which benefits were paid in the previous year, the total amount paid from the Fund to injured workers listed by category of benefit as well as information regarding efforts at recovery from uninsured employers. 3-2 Interim reviews (A) The Board may at any time review funding levels and issue a modified report.

(B) If funding levels are insufficient to continue paying benefits at the benefit level announced in the annual report the Board may, at its discretion, lower benefit levels for the remainder of the year and/or close the Fund to new applicants.

(1) Any claimant denied access to the Fund upon initial application because of lack of funding may reapply the following fiscal year, provided said claimant is still entitled to receive benefits.

(2) Any claimant admitted to the fund on reapplication pursuant to this section will be entitled to have their outstanding medical bills paid dating back to the date of injury subject to the limitations in rule 2-3(b).

(3) Upon admission following reapplication, non-medical benefits will be paid in accordance with the priority set forth in §8-67-107(1)(b) and the funding levels otherwise established by the board.

(c) The board may include contingencies in the annual report to adjust the benefit level based on remaining balance in the fund without the need to issue an interim report.

Rule 4 Medical Providers 4-1 Upon notice of designation a new authorized treating physician, Claimant shall schedule an appointment with the new provider within 30 days or request that the Board or its agent schedule the appointment. The Board may schedule a demand appointment at any time after designation. 4-2 The Board or its agent shall forward all medical reports available, and identifying information for the claimant being referred, to the newly designated physician within 7 days of designation 4-3 The Board or its agent shall include a request to the provider that the claimant be contacted within 7 days to schedule an initial appointment.

Rule 5 Actions Against Uninsured Employers 5-1 The board may utilize third-party attorneys and collections services to pursue recovery of benefits from uninsured employers. 5-2 Referral of cases for collection may be made by the board itself, by third-party vendors contracted to adjust claims and by staff of the division of workers’ compensation specifically delegated to make such referrals. _________________________________________________________________________ Editor’s Notes

History New rule eff. 10/30/2018.

Rules 1-4, 1-5, 2-1(C)-(D), 2-3(D), 3-2(B)-(C), Rule 5 eff. 03/30/2019.

Annotations

Rule 1-4 (adopted 02/05/2019) was not extended by House Bill 20-1179 and therefore expired 05/15/2020.

1107 Division of Family and Medical Leave Insurance

7 CCR 1107-1 Regulations Concerning Premiums and Individuals Electing Coverage {#sec-7-ccr-1107-1 omnilex-key=us-co-regs-official--department-10--7 CCR 1107-1}

DEPARTMENT OF LABOR AND EMPLOYMENT

REGULATIONS CONCERNING PREMIUMS AND INDIVIDUALS ELECTING

COVERAGE

7 CCR 1107-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _____________________________________________________________________ 1.1 Statements of Authority, Purpose, and Incorporation by Reference 1. This regulation is adopted pursuant to the authority in section C.R.S. § 8-13.3- 501 et seq. and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24-4-101 et seq. (the “APA”), and the Paid Family and Medical Leave Insurance Act, C.R.S. § 8-13.3-501 through 524 (the “FAMLI Act”).

2. The general purpose of these rules is to exercise the authority of this Division to enforce and implement the Paid Family and Medical Leave Insurance Act (C.R.S. § 8-13.3-501 et seq.) with regard to premiums and individuals electing coverage.

3. 7 CCR 1103-1 (2025) and U.S. Department of Labor, Unemployment Insurance Program Letter No. 20-04 (May 10, 2004) are hereby incorporated by reference.

Earlier versions of such laws and regulations may apply to events that occurred in prior years. Such incorporation excludes later amendments to or editions of the statutes and regulations. These statutes and regulations are available for public inspection at the Colorado Department of Labor and Employment, Division of Family and Medical Leave Insurance, 707 17th Street, Denver, CO 80202.

Copies may be obtained from this Division at a reasonable charge, or can be accessed electronically from the website of the Colorado Secretary of State.

Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of the statutes and regulations incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Division Rules are available to the public at famli.colorado.gov.

4. If any part of these rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 1.2 Definitions and Clarifications 1. Unless otherwise indicated, terms used here that are defined in the FAMLI Act have the same definition as they do under the FAMLI Act.

5. “Calendar Quarter” has the same definition as C.R.S. § 8-70-103(6).

6. “Gross income from self-employment” means all gross income derived by an individual from any trade or business carried on by such individual, as reportable on IRS Schedule SE, plus all payments the individual receives from their trade or business that are reportable on IRS Form W-2 or Schedule E Part II, Section 28, including but not limited to S corporation earnings.

7. “Individual electing coverage” means either an employee of a local government that has declined participation in the family and medical leave insurance program or a self-employed person, who elects family and medical leave insurance coverage pursuant to C.R.S. § 8-13.3-514.

8. “My FAMLI+ Employer” means the online portal through which employers and individuals electing coverage will interact with the FAMLI Division. Activities completed through this portal include, but are not limited to, electing coverage, declining coverage, reporting wages, remitting premiums, receiving important information for tax compliance, and maintaining their accounts pursuant to the FAMLI Act and its implementing regulations.

9. “Premium” is defined as the money payments required pursuant to C.R.S. § 8- 13.3-507 to finance the payment of family and medical leave insurance benefits and administer the family and medical leave insurance program.

10. “Self-employed person” or “self-employed individual” means a Colorado resident who either: (1) carries on a trade or business as a sole proprietor or an independent contractor; (2) is a member of a partnership that carries on a trade or business; or (3) is otherwise in business for himself or herself (including a parttime business or a “gig worker”). An individual who does not meet the FAMLI Act’s two-prong exception to the definition of “employee” at C.R.S. § 8-13.3- 503(7) is not a self-employed person or individual. The Division will presume that an individual is not self-employed with regard to any business of which they own less than twenty-five (25) percent. An individual can overcome this presumption by proving that they are primarily free from control and direction in the performance of the labor or services, both under the individual's contract for the performance of the labor or services and in fact, and are customarily engaged in an independent trade, occupation, profession, or business related to the labor or services performed.

11. “Tax transcript” means a full copy of the individual's “record of account transcript” from the Internal Revenue Service (“IRS”).

12. “Wages” as used in the FAMLI Act and its implementing regulations means “gross wages,” and includes monetary compensation described by C.R.S. § 8-4- 101(14)(a), employer-provided paid leave pursuant to 7 CCR 1107-4 Section 4.2.2., and leave from a separate bank of time off solely for the purpose of paid family and medical leave as described by 7 CCR 1107-4 Section 4.2.5., if such leave is paid to the employee by the employer and not by a third party. “Wages” does not include compensation described by C.R.S. § 8-4-101(14)(b), compensation described by C.R.S. § 8-4-103(3), or any non-monetary payment except for the portion of any non-monetary payment used as credit toward the minimum wage pursuant to 7 CCR 1103-1 Sections 6.2.1 and 6.2.2. “Wages” for self-employed individuals who elected coverage means “gross income from selfemployment” as defined in these rules.

13. Throughout the FAMLI Act and its implementing regulations, unless otherwise stated, entities that are employers and have different Federal Employer Identification Numbers (“FEIN”) are different employers with separate rights and obligations. This does not impact the ability of private plan administrators to report aggregate data pursuant to 7 CCR 1107-5, Section 5.12. 1.3 Individuals Electing Coverage 1. Individuals electing coverage may elect coverage under C.R.S. § 8-13.3-514 for an initial period of coverage of three years.

A. The individual electing coverage must create a My FAMLI+ Employer account and must submit their notice of election of coverage via My FAMLI+ Employer. For self-employed individuals, the notice of election must include a copy of their most recent tax transcript, as well as copies of any IRS Form W-2 issued to the individual by the individual’s business or businesses for the same tax year reflected by the tax transcript. No communication from a self-employed individual will constitute a notice of election without the required tax transcript and W-2 forms.

B. Elective coverage becomes effective on the date the individual files the notice of election, and not sooner. While elective coverage does provide for leave for a qualifying condition, it does not guarantee an award of wage replacement benefits. Benefits calculations are limited by the FAMLI Act and its implementing regulations, including but not limited to multiemployer scenarios described by C.R.S. § 8-13.3-506(2), leave thresholds described by C.R.S. § 8-13.3-505(3), the definition of “wages subject to premiums” at 7 CCR 1107-3, Section 3.2, and average weekly wage calculations pursuant to 7 CCR 1107-3, Section 3.5.

C. A period of coverage is a minimum of:

1. Three years following the date that the individual files the notice of election, and ends on the effective date of a notice of withdrawal.

No period of coverage may be shorter than three years, regardless of whether an individual has had a prior period of coverage. A period of coverage beyond three years will continue indefinitely unless the covered individual submits a notice of withdrawal.

D. Any individual who has elected coverage may file a notice of withdrawal at any time.

E. The notice of withdrawal must include an effective date of the withdrawal, which must be no sooner than both the end of the coverage period and thirty days after the filing of the notice of withdrawal.

F. A notice of withdrawal from coverage must be submitted to the Division online or in another format approved by the Division.

G. Upon termination of coverage, due and unpaid premiums must be paid, as well as any interest or fines assessed.

H. Throughout a period of coverage, individuals electing coverage as a selfemployed individual, and individuals electing coverage as an employee of a local government that has declined participation pursuant to C.R.S. § 8- 13.3-522, must report wages, pay premiums, and otherwise comply with the FAMLI Act and its implementing regulations. This includes submitting wage reports for quarters in which no relevant wages are paid and submitting documentation as required by the FAMLI Act, its implementing regulations, or the Division. Premiums liability for individuals electing coverage is limited to wages paid to the individual during the elective coverage period, and the Division may not hold any wages paid to an individual outside of their coverage period to be subject to premiums.

Wages paid outside of the elective coverage period are not “wages subject to premiums” as defined in 7 CCR 1107-3, Section 3.2, and shall not be used to calculate benefits.

I. If, during a period of coverage, an individual becomes no longer employed by a local government that has declined participation pursuant to C.R.S. § 8- 13.3-522, or becomes no longer self-employed in Colorado, their coverage period does not end, and they must still comply with the FAMLI Act and its implementing regulations with regard to elective coverage.

However, they may contact the Division and request a waiver of their quarterly wage reporting obligations, and the Division in its sole discretion may grant the waiver. The Division may revoke the waiver at any time.

J. Awards of paid family and medical leave with a benefit start date occurring during a period of coverage will be paid through the duration approved or until a recertification is required, regardless of the date that the period of coverage ends.

2. Provisions specific to self-employed individuals electing coverage:

A. Starting with the second calendar quarter of 2025, self-employed individuals must submit supporting documentation with their quarterly wage reports except for quarters in which they receive no gross income from self-employment. The supporting documentation must substantiate the amount of wages reported. Supporting documentation may include bank account statements, invoices, pay statements, reports, receipts, or other relevant documentation. Wage reports without supporting documentation may be considered untimely and subject to fines.

B. If the documentation submitted does not clearly support the reported wages, or if other information available to the Division undermines the reliability of the reported wages, then the Division may revise the wage amount to reflect the Division’s reasonable estimate of gross income from self-employment. A reasonable estimate may be, but is not limited to:

1. A prior quarter’s wages; or 2. A prorated amount of gross income from self-employment reflected by the individual’s tax transcripts and W-2 forms.

C. If the Division revises a wage amount pursuant to Section 1.3.2.B above, and the self-employed individual wants to challenge that revision, they must first request a reconsideration of that revision within forty-nine (49) days of the date of the revision. The deadline to request a reconsideration may be extended by up to a maximum of forty-nine (49) days for good cause. The self-employed individual may appeal the outcome of the reconsideration pursuant to 7 CCR 1107-9.

D. In addition to the tax transcript required in the notice of election, a selfemployed individual electing coverage must annually submit to the Division the prior year’s tax transcript and W-2 forms by December 1, if the self-employed individual had coverage during the prior tax year.

1. If the transcript and W-2 forms–prorated as appropriate–show a total amount of gross income from self-employment that is lower than the total the self-employed individual reported for that year, then the Division may evenly decrease each of that year’s quarterly wage reports proportionate to the difference and adjust premium obligations and benefits payments accordingly.

2. If the transcript and W-2 forms–prorated as appropriate–show a total amount of gross income from self-employment that is higher than the total the self-employed individual reported for that year, then the self-employed individual may request the Division to evenly increase each of that year’s quarterly wage reports proportionate to the difference and adjust premium obligations and benefits payments accordingly. Such a request must be received by December 1 of the following year. The Division may increase quarterly earnings pursuant to this rule regardless of whether it received a request to do so.

3. If the self-employed individual fails to submit complete and accurate tax transcripts and W-2 forms by December 1 as required by these rules, then the Division may:

a. Remove their gross income from self-employment from any active claim;

b. Exclude gross income from self-employment from new claims for the entire period of time the tax transcripts and W- 2 forms are due and absent; and c. Assess a fine against the individual in an amount up to $500.00.

4. If the Division imposes a consequence described in Section 1.3.2.D.3 above, it shall withdraw that consequence if it receives the required tax transcripts and W-2 forms by December 1 of the following year.

5. All individuals electing coverage must report wages and remit premium payments quarterly, no later than the last day of the month immediately following the end of the calendar quarter for which the premiums have accrued. The Division may require additional information or documentation from any individual electing coverage in order to determine or verify wages or other information. 1.4 Premiums 1. Premiums must be paid not less than quarterly in the form and manner determined by the Division. Quarterly payments must include all premiums with respect to wages paid during the calendar quarter.

6. Premiums must be paid no later than the last day of the month immediately following the end of the calendar quarter for which the premiums have accrued.

Payment will be considered timely if postmarked or received electronically on or before the due date. If the due date of premiums falls on a Saturday, Sunday, or legal holiday, payment will be considered timely if postmarked or received in person or electronically on the next business day. If an employer or an individual electing coverage wants to challenge a premiums assessment, they must first request a reconsideration of that determination within forty-nine (49) days after the due date. The deadline to request a reconsideration may be extended by up to a maximum of forty-nine (49) days for good cause. The employer or individual electing coverage may appeal the outcome of the reconsideration pursuant to 7 CCR 1107-9.

3. If an individual electing coverage owes unpaid premiums, fines, penalties, or interest to the Division, the Division may recoup that amount via benefits offset.

4. If, as a result of an incorrect notification or computation by the Division of premiums due, an employer is required to make an additional payment of premiums, such additional payment will not accrue interest until thirty days after notification by the Division that such additional payments are due.

5. Unless stated otherwise by exemption:

A. The first premium payment of any person or entity that becomes an employer subject to C.R.S. § 8.13.3-501 et seq., at any time during a calendar year must be paid on or before the last day of the month immediately following the calendar quarter in which such person or entity becomes an employer.

B. Said payment must include premiums with respect to wages paid beginning the first day the person or entity becomes an employer.

6. An employer required to remit premiums pursuant to C.R.S. § 8-13.3-507 may not deduct more than the maximum allowable employee share of the premium from wages paid for a pay period. If an employer deducts more than the amount authorized by the FAMLI Act and its implementing regulations, the Division may assess a fine of up to $25.00 per employee per instance. Such excessive deductions also constitute a violation of C.R.S. § 8-4-105. If the Division issues a written determination concluding that the employer deducted more than the amount authorized by the FAMLI Act and its implementing regulations, such a determination may constitute a written demand pursuant to C.R.S. § 8-4-101(15).

A. If an employer fails to deduct the maximum allowable employee share of the premium from wages paid for a pay period, the employer is considered to have elected to pay that portion of the employee share under C.R.S. § 8- 13.3-507, and the employer cannot deduct this amount from a future paycheck of the employee for a different pay period. However, where there is a lack of sufficient employee wages to cover the employee share of premiums for a pay period, the employer may deduct the uncollected portion of the employee share from one or more paychecks for future pay periods.

B. In the payment of any premiums to the Division, and in the collection of any premium contributions from an employee, a fractional part of a cent will be disregarded unless it amounts to one-half cent or more, in which case it will be increased to one cent.

7. Premium payments to the Division will be applied in the following order, starting with the oldest quarter to the most recent past calendar quarter in which a balance is owed:

A. Fines;

B. Fees;

C. Interest; and D. Premiums.

8. If the Division receives payment in an amount that exceeds the total of any premiums, fines, interest, or other debt owed to the Division, then the Division will notify the payor and:

A. If the amount in excess is less than $50.00, it will be credited to future payments due; and B. If the amount in excess is $50.00 or more, it may be refunded to the employer at the employer's request. Otherwise, it will be credited to future payments due.

9. If an employer or an individual electing coverage fails to remit premiums by the due dates described in these rules, the Division may assess upon the employer or individual a fine of up to $50.00 per individual whose premiums were not timely paid.

10. Premiums will not be required for wages, including wages from self-employment, above the limit described by C.R.S. § 8-13.3-507(6).

11. If the Division issues a reimbursement of premiums to an employer, the employer must return to its employees any portion of the reimbursed amount that it collected from its employees. If the employer fails to do so within sixty (60) days of a reimbursement of premiums, the Division may assess a fine against the employer in an amount up to $50.00 per employee owed a reimbursement, per day that the employer fails to do so. 1.5 Calculating Employer Size 1. For determining employer size for the purpose of determining premium liability pursuant to C.R.S. § 8-13.3-507(5), an employee counts toward the total number of employees if they are employed in any state of the United States, the District of Columbia, or any territory or possession of the United States during 20 or more workweeks in the preceding calendar year. A person is considered “employed” during a workweek for the purpose of determining premium liability if:

(1) they perform any work for the employer during the workweek; or (2) they are on any type of paid or unpaid leave during the workweek, and the employer has a reasonable expectation that the employee will later return to active employment, including any protected military leave.

2. An employer's size for purposes of this rule will be calculated upon registration with the My FAMLI+ Employer portal and annually thereafter during the first calendar quarter of the year. It is the employer’s responsibility to notify the Division of its size upon registration and annually thereafter, and if the employer fails to do so, the Division may presume that the employer has ten or more employees. The FAMLI Division may, on its own initiative, determine an employer’s size based on a preponderance of evidence. If the Division changes an employer’s size pursuant to this rule, it shall notify the employer. Any Division decision regarding an employer’s size constitutes a determination, and the effective date of that determination is the date that additional premiums associated with that change are due. An employer may request a reconsideration of such a change pursuant to Section 1.4 of these rules. The Division will not adjust an employer size based on fluctuations throughout the year.

3. If the Division determines the employer's status has changed as it relates to premium liability, the Division will notify the employer as to their premium liability. 1.6. Colorado Localization of Employees 1. An employee is localized to Colorado, and their wages will be subject to premiums, if A. The employee’s entire service is performed within Colorado;

B. The employee’s service is performed both within and outside of Colorado, but the service performed outside the state is incidental to the employee’s work within Colorado or, for example is, temporary or transitory in nature and consists of isolated transactions; or C. Services are not localized in any state, but some of the services are performed in Colorado, and 1. The employee’s base of operations is in Colorado, or if the employee has no base of operations, then the place from which such services are directed or controlled is in Colorado as established in C.R.S. § 8-70-117, or 2. The employee’s base of operations, or place from which some part of the service is directed or controlled by the employer is not in any state in which part of the service is performed, but the employee’s residence is in Colorado.

2. An employer who has paid to another jurisdiction an amount as premiums properly payable to Colorado will not be delinquent if premiums properly payable to Colorado are paid within thirty days of the date on which the Division determines that such premiums are payable to Colorado.

3. Services are performed where the worker is physically located. For example, if an individual works from their Colorado home for a Nevada employer, the work is performed in Colorado.

4. In determining whether an employee is localized to Colorado, the Division is guided by Unemployment Insurance Program Letter No. 20-04 and its attachments, issued by the United States Department of Labor’s Employment & Training Administration on May 10, 2004.

5. An employee’s status as a military spouse has no impact on an employee’s localization under these rules. 1.7 Assessments and Recomputations of FAMLI Premiums 1. If the report of wages included in an employer’s premium report is incomplete or in error, the Division may require a further report, may examine the employer’s relevant books and records, or may use other reasonable measures to the extent necessary to obtain an accurate report.

6. If an employer is delinquent in filing a wage report within the time prescribed by the Division, or fails to provide the Division with additional records needed to make a proper determination of an amount of indebtedness, the Division may, in its discretion:

A. Use the information and knowledge available to the Division to estimate the wages paid by an employer during the premium period or periods. The amount of wages so determined will be deemed to have been paid by the employer;

B. Assess the employer for premiums calculated on the basis of the estimated wages; and C. Issue a subpoena duces tecum to compel an employer to release books and records to the Division for use in obtaining the required information.

3. The Division will notify an employer who is delinquent in filing reports or paying premiums by sending a determination letter to the employer’s correct address.

Any outstanding premiums past due shall accrue interest pursuant to C.R.S. § 5- 12-102.

4. The Division may correct errors of computation whenever such erroneous computations are found or brought to the Division's attention. _____________________________________________________________________ Editor’s Notes

History New rule eff. 01/01/2022.

Entire rule eff. 12/30/2022.

New rule eff. 01/01/2024.

Entire rule eff. 01/01/2025.

Rules 1.1 3, 1.3 2.D.3, 1.6 5 eff. 07/01/2025.

Rules 1.1 3, 1.2 3, 1.2 5, 1.3 1, 1.3 2.D, 1.4 2, 1.4 10, 1.5, 1.6 5 eff. 01/01/2026.

7 CCR 1107-2 Regulations Concerning Local Government Participation with the Paid Family Medical Leave Program {#sec-7-ccr-1107-2 omnilex-key=us-co-regs-official--department-10--7 CCR 1107-2}

DEPARTMENT OF LABOR AND EMPLOYMENT

REGULATIONS CONCERNING LOCAL GOVERNMENT PARTICIPATION WITH THE

PAID FAMILY MEDICAL LEAVE PROGRAM

7 CCR 1107-2 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] ______________________________________________________________________ 2.1 Statements of Authority, Purpose, and Incorporation by Reference 1. This regulation is adopted pursuant to the authority in section C.R.S. § 8-13.3- 501 et seq. and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24-4-101 et seq. (the “APA”), and the Paid Family and Medical Leave Insurance Act, C.R.S. § 8-13.3-501 through 524 (the “FAMLI Act”).

2. The general purpose of these rules is to exercise the authority of this Division to enforce and implement the FAMLI Act with regard to local governments.

3. If any part of these rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 2.2 Definitions and Clarifications 1. Unless otherwise indicated, terms used here that are defined in the FAMLI Act have the same definition as they do under the FAMLI Act.

4. “Governing Body” has the same meaning as in C.R.S. § 29-1-102(12).

5. “Local Government” has the same meaning as defined at C.R.S. § 8-13.3- 503(14), and is limited to Colorado local governments. "Local government" does not include: (1) a governmental entity with one or more employees in the state personnel system pursuant to Art. XII Section 13 of the Colorado Constitution and the State Personnel System Act, C.R.S. § 24-50-101 et seq.; or (2) a governmental entity for which premiums were paid pursuant to C.R.S. § 8-13.3- 518(4)(b).

6. “Premium” has the same meaning as in 7 CCR 1107-1 Section 1.2.6. 2.3 Process and Notification of Program Declination 1. Local government employers are permitted to decline participation in the family and medical leave insurance program after a written notice has been delivered to the Division memorializing the decision by an affirmative vote of the local government’s governing body to decline participation in the program. Such a vote must follow the local government’s procedures for other votes of the governing body for similar decisions.

A. If a local government participates in the family and medical leave program on or after January 1, 2024, and later votes to decline participation, the declination will not take effect until at least 180 days after the vote, to allow individual employees the opportunity to opt into the benefits program pursuant to C.R.S. § 8-13.3-514, should individuals choose to elect coverage.

B. Public notice must be given in the same manner as any similar business before the governing body, and the local government must take/hear public comment prior to the vote if the local government has established procedures for public comment for similar business. The local government’s employees must also be notified in writing prior to the vote and provided both information regarding the vote process and the opportunity to submit comments through a public process to the governing body.

C. Within 30 days following a local government declination vote, the local government must provide its local government employees with a written individual notice of the local government’s declination vote and the impact toward coverage under the FAMLI Act, or other paid family and leave insurance coverage. The written notice, must at a minimum, explain the differences between benefits offered by the state program and any other paid leave plan offered by the local government. The notice must also state which employees, if any, are eligible for job protection under the federal Family and Medical Leave Act (FMLA) benefits or other local provisions where applicable. The notice must also be delivered to all new employees hired after the date of the declination vote.

D. The written notice described at Section 2.3.1.C must contain information regarding the right of local government employees to voluntarily elect coverage pursuant to C.R.S. § 8-13.3-514, and the contact information for the Division. In addition to providing written notices to individual employees in accordance with Section 2.3.1.C of this rule, local government employers must also post a notice containing the information in a conspicuous and accessible place in each establishment where employees are employed; provided, however, in cases where the local government employer does not maintain a physical workplace, or an employee teleworks or performs work through a web-based or app-based platform, notification must be sent via electronic communication or through a conspicuous posting in the web-based or app-based platform. The individual and posted notices required in Sections 2.3.1.C and 2.3.1.D must be in English and in any language representing the first language spoken by at least five percent of the local government employer's workforce. The Division will create and make available to local government employers posters and notices containing the information required in this regulation, and local government employers may use the posters and notices to comply with the requirements of this section.

1. It is the responsibility of the local government employer to request printed materials from the Division. Local government employers may be responsible for the printing and mailing costs of such materials.

2. It is the responsibility of the local government to provide written notification to the Division of the local government employers interpretation needs of printed notices for languages other than English or Spanish.

3. Local governments without employees are not employers, and as such, do not need to register, vote, decline coverage, or otherwise participate in the family and medical leave insurance program.

4. The Division may presume that an entity is not a local government if the entity does not appear on a public list of local governments published by the Office of the State Auditor’s Local Government Audit Division, the Colorado Department of Local Affairs, or the Colorado Department of Education. An entity not on those lists may overcome the presumption by submitting documentation sufficient to establish that it is a local government. 2.4 Local Government Employer Participation 1. Local government employers are required to formally notify the Division in writing and provide both the date of the vote, and the local government’s decision to decline participation in the family and medical leave insurance program.

A. Local governments which have previously declined participation in the family and medical leave insurance program pursuant to C.R.S. § 8-13.3- 522, may subsequently elect coverage at any time by a vote of the governing body.

B. A local government may not decline participation in the family and medical leave insurance program in part. Any declination by a local government is a full declination of family and medical leave insurance program participation for that local government employer, except such an employer may enter into an agreement with an employee who elects coverage pursuant to C.R.S. § 8-13.3-514, whereby the employer agrees to provide administrative support to the employee with regard to the employee’s program obligations, including but not limited to deducting premiums from the employee’s wages and remitting premiums and wage reports to the Division on behalf of the employee.

2. A vote to decline coverage is not permanent. A local government which has previously declined coverage may vote to renew the declination no later than every eight years. The Division will notify the local government of the end of the eight-year declination period one year in advance. In the absence of a vote further declining coverage, the local government will become a covered employer immediately after the end of the eight-year declination period. The local government must inform the Division of a declination vote in writing which includes the date the vote was taken.

3. When a local government employer returns to coverage pursuant to these rules, the employer will be covered and subject to premium liability beginning on the earlier of: (1) the effective date specified by the local government employer in its notification to the Division; or (2) the first day after the local government employer’s deadline to renew its declination has passed.

4. Local government employers that have previously declined participation and then subsequently elect or otherwise return to coverage under the family and medical leave insurance program pursuant to these regulations must remain in the program and pay premiums for a minimum of twelve complete calendar quarters after the elected coverage begins. If such an employer chooses to again decline participation, notice of such declination must be delivered in writing to the Division at least one complete calendar quarter in advance of the end of the twelve calendar quarter cycle pursuant to this regulation.

5. Employees must also be notified directly in writing, and at least 180 days before the pending or upcoming return to or withdrawal of coverage pursuant to this

regulation.

A. Local government employers must display a notice containing the information required in this regulation in a conspicuous and accessible place in each establishment where employees are employed; provided, however, in cases where the local government employer does not maintain a physical workplace, or an employee teleworks or performs work through a web-based or app-based platform, notification must be sent via electronic communication or through a conspicuous posting in the web-based or app-based platform.

B. The written notice and posting must contain an explanation of employee rights under the FAMLI program including but not limited to program requirements, benefits, claims process, payroll deductions and premiums, the right to job protection and benefit continuation under C.R.S. § 8-13.3- 509, protection against retaliatory personnel actions or other discrimination, relevant contact information for the Division, and other pertinent information.

C. The notice and poster required by this regulation must be in English and in any language representing the first language spoken by at least five percent of the local government employer's workplace. The Division will create and make available to local government employers posters and notices containing information required in this regulation, and local government employers may use the posters and notices to comply with the requirements of this section.

6. Local governments that decline participation in the family and medical leave insurance program are not subject to obligations or prohibitions contained in the FAMLI Act or its implementing regulations, except where otherwise expressly provided in the FAMLI Act or its implementing regulations. Local governments that decline participation in the family and medical leave insurance program are not entitled to any rights or protections contained in the FAMLI Act or its implementing regulations, except where otherwise expressly provided in the FAMLI Act or its implementing regulations. 2.5 Overpayments In the event of an overpayment of premiums by a local government employee whose employer elects coverage after having previously declined coverage, any overpaid premiums will be repaid to the employee by the Division. The Division will ensure a continuation of coverage for local government employees who have individually opted into the benefits program pursuant to C.R.S. § 8-13.3-514, and ensure there is not a lapse in coverage prior to the local government’s reinstatement of coverage. ______________________________________________________________________ Editor’s Notes

History New rule eff. 03/17/2022.

Entire rule eff. 12/30/2022.

Entire rule eff. 01/01/2024.

Entire rule eff. 01/01/2025.

Rule 2.1 3 eff. 07/01/2025.

Rules 2.1 3, 2.4 5.C eff. 01/01/2026.

7 CCR 1107-3 Regulations Concerning Benefits and Employer Participation Requirements {#sec-7-ccr-1107-3 omnilex-key=us-co-regs-official--department-10--7 CCR 1107-3}

Department of Labor and Employment REGULATIONS CONCERNING BENEFITS AND EMPLOYER PARTICIPATION REQUIREMENTS 7 CCR 1107-3 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] 3.1 Statements of Authority, Purpose, and Incorporation by Reference 1. This regulation is adopted pursuant to the authority in section C.R.S. § 8-13.3- 501. et seq., and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24-4-101 et seq. (the “APA”), and the Paid Family and Medical Leave Insurance Act, C.R.S. §§ 8-13.3-501 through 524 (the “Act”).

2. The general purpose of these rules is to exercise the authority of this Division to enforce and implement the Paid Family and Medical Leave Insurance Act (C.R.S. § 8-13.3-501 et seq.) with regard to benefits and employer participation.

3. 29 C.F.R. §§ 825.102, 825.113, 825.114, 825.115, and 825.119(a) (2025) are hereby incorporated by reference. Earlier versions of such laws and regulations may apply to events that occurred in prior years. Such incorporation excludes later amendments to or editions of the statutes and regulations. These statutes and regulations are available for public inspection at the Colorado Department of Labor and Employment, Division of Family and Medical Leave Insurance, 707 17th Street, Denver, CO 80202. Copies may be obtained from this Division at a reasonable charge, or can be accessed electronically from www.ecfr.gov.

Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of the statutes and regulations incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Division Rules are available to the public at famli.colorado.gov.

4. If any part of these rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 3.2 Definitions and Clarifications 1. Unless otherwise indicated, terms used here that are defined in the FAMLI Act have the same definition as they do under the FAMLI Act.

5. “Application year” as used at C.R.S. § 8-13.3-505(1), and “benefit year” as used at C.R.S. § 8-13.3-521(1)(b) are both defined as “application year” under C.R.S. § 8-13.3-503(1). The 12-month period is measured forward from the date the claim is filed. Under this ‘‘measured forward” method, an employee would be entitled to the leave amounts described at C.R.S. § 8-13.3-505(1) during the year beginning on the first date a claimant files for paid family and medical leave, and the next 12-month period would begin the first time the claimant files for paid family and medical leave after the completion of any 12-month period. Solely for the purpose of determining the application year, the date the claim is filed is the benefit start date.

6. “Benefit start date” means the first day the covered individual is unable to work for which benefits are approved.

7. “Benefit year,” for purposes of applying the definitions of “base period” at C.R.S. § 8-70-103(2) and “alternative base period” at C.R.S. § 8-70-103(1.5), means “application year” as defined at Section 3.2.2 of these rules.

8. “Business Days” means Monday, Tuesday, Wednesday, Thursday, and Friday, and excludes any Colorado state holidays, as listed in C.R.S. § 24-11-101.

9. “Calendar week” means any period of seven consecutive days.

10. “Claimant” means a person who has filed a claim for paid family and medical leave insurance benefits, regardless of whether the person is a covered individual pursuant to C.R.S. § 8-13.3-503(3).

11. “Continuous leave” means one non-recurring, uninterrupted period of leave.

12. “Days” means calendar days unless otherwise specified as a business day, as defined by these rules.

13. “Designated Representative” means a person legally authorized to make decisions on behalf of a claimant, with regard to the FAMLI program. That legal authorization may be through written designation from the claimant or through legal status as a parent, guardian, conservator, or power of attorney. If the claimant is unable to file a claim or authorize a designated representative due to the claimant’s medical incapacitation, a claimant’s family member may serve as a designated representative without prior authorization from the claimant. For safe leave applications, the alleged perpetrator of domestic violence, stalking, sexual assault, or sexual abuse may not be the claimant’s designated representative. An entry of appearance by an attorney who is licensed and in good standing shall be sufficient to establish the attorney’s status as a designated representative. A claimant may revoke an individual’s designated representative status at any time.

14. “Good cause” means that a reasonably prudent individual under the same or similar circumstances would have been prevented from complying with deadlines established by the FAMLI Act and its implementing regulations. Good cause exceptions to requirements in these rules are limited to those requirements that expressly allow for a good cause exception. In determining whether good cause exists, all relevant factors may be considered, including but not limited to:

A. Whether the requestor received timely and adequate notice of the need to act;

B. Administrative error by the Division or its representatives, or the failure of the Division or its representatives to discharge its responsibilities;

C. Factors outside the control of the requestor which prevented a timely action;

D. The requestor's physical or mental impairment, particularly if the impairment is related to the request for paid leave;

E. Whether the requestor acted diligently in submitting the request once the reason for the late request no longer existed;

F. The total length of time that the action was untimely;

G. Whether the delay affects the ability of the Division or private plan administrator to determine the validity of the request for paid family and medical leave insurance benefits; and H. Good faith error, provided that in determining whether good faith error constitutes good cause, the Division or private plan administrator shall consider any prior history of such errors, whether the request is excessively late, and whether the requestor otherwise acted with due diligence.

12. “Health care provider” as defined by C.R.S. § 8-13.3-503(13) is limited to an individual licensed, certified, or registered under Colorado law to provide medical or emergency services or an individual with a National Provider Identifier (“NPI”) number issued by the National Plan and Provider Enumeration Service (“ NPPES”) who is licensed, certified, or registered to provide medical or emergency services. A health care provider may only certify the need for FAMLI leave if such certification is within the diagnostic scope of their licensure, certification, or registration. “Medical or emergency services” means treatment for any physical or mental condition giving rise to a serious health condition.

13. “In loco parentis” means a relationship in which a person puts himself or herself in the situation of a parent by assuming and discharging the obligations of a parent to a child. Although no legal or biological relationship is necessary, grandparents or other relatives, such as siblings, may stand in loco parentis to a child as long as the relative satisfies the in loco parentis requirements. Persons who are in loco parentis include those with day-to-day responsibilities to care for or financially support a child. In determining in loco parentis status, the Division will consider the age of the child; the degree to which the child is dependent on the person; the amount of financial support, if any, provided; and the extent to which duties commonly associated with parenthood are exercised. The fact that a child has a biological parent in the home, or has both a mother and a father, does not prevent an employee from standing in loco parentis to that child. The FAMLI Act does not restrict the number of parents a child may have. The specific facts of each situation will determine whether an individual stands in loco parentis to a child.

14. “Intermittent leave” means leave taken in separate blocks of time due to a single qualifying reason.

15. “Material fact” means any fact that could substantially impact the outcome of an individual’s entitlement to family and medical leave insurance benefits.

16. “Neonatal intensive care unit” means a hospital-based unit designated by the inpatient facility as a neonatal intensive care unit and equipped to provide continuous, specialized medical care for critically ill or medically fragile infants.

This definition excludes well-baby nurseries, pediatric intensive care units (PICUs), and any other inpatient setting not classified explicitly by the treating facility as a neonatal intensive care unit, except that this definition does include other intensive care units into which the infant was transferred directly after birth or from the unit classified as a neonatal intensive care unit if the transfer was due to an escalation in the infant’s medical needs.

17. “Neonatal care leave” means a separate and distinct leave entitlement under C.R.S. § 8-13.3-505(1)(b) that provides up to twelve (12) additional weeks of paid family and medical leave benefits to a covered individual who is providing care for their infant receiving inpatient treatment in a neonatal intensive care unit. The leave is available only for the duration that the infant remains admitted to a neonatal intensive care unit. The leave is available for qualifying absences from work on or after January 1, 2026, and neither the fact that an infant was receiving inpatient treatment in a neonatal intensive care unit prior to that date, nor the fact that a covered individual took FAMLI leave to care for that infant prior to that date, precludes an award of neonatal care leave.

18. “Reduced leave schedule” means a fixed and specific leave schedule that reduces an employee's usual number of working hours per workweek, or hours per workday. A reduced leave schedule is a fixed and specific change in the employee's schedule for a period of time, normally from full-time to part-time.

19. “Regular work schedule” means the number of weekly hours an individual works at any job, plus the number of weekly hours they would have worked but for any paid holidays and other paid leave, including paid family and medical leave. If the number of weekly hours cannot be determined, the average number of weekly hours worked over the four weeks prior to the benefit start date may be used.

The individual’s regular work schedule is calculated for each job individually and then aggregated to determine their aggregate regular work schedule for each week. For the purpose of calculating the individual’s regular work schedule, “job” means any arrangement where an individual is paid for their services, including self-employment, gig work, and all employment, regardless of whether it is covered under the FAMLI Act.

20. “Self-employed individual” has the same meaning as in 7 CCR 1107-1.

21. “Wage replacement benefit” means the monetary weekly benefit amount described at C.R.S. § 8-13.3-506.

22. “Wages” has the same meaning as “wages” as defined in 7 CCR 1107-1. Wages are “earned” pursuant to C.R.S. § 8-13.3-503(3)(a)(I) on the date that they are paid or payable to the employee.

23. “Wages subject to premiums” as used in C.R.S. § 8-13.3-503(3)(a) include wages paid to an employee by an employer with an approved private plan, wages paid to an employee by an employer under the state plan, and wages paid from either self-employment or local government employment to individuals after such individuals elect coverage pursuant to C.R.S. § 8-13.3-514. Selfemployment and local government wages earned by individuals who have elected coverage pursuant to C.R.S. § 8-13.3-14 are not considered wages subject to premiums if they are paid outside of the individual’s elective coverage period, and will not be used to calculate benefits if they are paid outside of the individual’s elective coverage period.

24. “Willful” or “willfully” as used in the FAMLI Act or its implementing regulations means the employer or individual knew or showed reckless disregard for whether its conduct was prohibited by the FAMLI Act or its implementing regulations. 3.3 Employer Participation Requirements 1. Employers, including local government employers that decline participation in the FAMLI program, and employers who meet their obligations under the FAMLI Act through an approved private plan, must register with the FAMLI Division via “MyFAMLI+ Employer” by January 1, 2023, or when they become an employer, whichever occurs later. If the Division determines that an employer has violated this section, it may assess upon the employer a fine of up to $500.00.

A. Any entity that registers one or more accounts with the FAMLI Division via “My FAMLI+ Employer” on behalf one or more employers is prohibited from registering unnecessary accounts, including but not limited to accounts for fake or illegitimate employers, and accounts for employers with no employees whose work is localized to Colorado pursuant to 7 CCR 1107-1, Section 1.6. If the Division determines that an entity registered unnecessary accounts, the Division may assess upon the entity a fine of up to $500.00 per violation.

B. Within seven (7) days of a request by the Division, any entity that bulk registers multiple accounts with the FAMLI Division via “My FAMLI+ Employer” on behalf of multiple employers must submit to the FAMLI Division a document describing the methods by which it (1) determines that a registrant is a legitimate employer, and not a fraudulent, fake, or illegitimate entity; and (2) determines that the employer needs to register an account with My FAMLI+ Employer in accordance with the FAMLI Act and its implementing regulations. If the entity does not provide the Division with the requested verification document within seven (7) days, the Division may assess upon the entity a fine of up to $500.00 per violation.

2. Employers participating in the state plan must submit accurate wage reports to the Division on the same quarterly schedule as they must submit premiums to the Division pursuant to 7 CCR 1107-1.

A. If an employer fails to timely submit reasonably accurate wage reports, the Division may assess upon the employer a fine of up to $50.00 per employee whose wages were not reported timely or accurately, and per employee whose wages were unnecessarily reported.

B. If an employer submits an amended wage report after the due date to submit premiums pursuant to 7 CCR 1107-1, and the amended wage report increases premiums owed by twenty-five (25) percent or more, then the wage report shall not be considered timely regarding those employees whose wages were amended.

3. An employer must notify the Division within 10 business days if it ceases business operations in Colorado or otherwise ceases to employ Colorado employees, in accordance with the provisions of 7 CCR 1107-1 regarding localization of employees. An employer with no Colorado employees will not be required to remit premiums, submit wage reports, or otherwise participate in the FAMLI program. If the employer later resumes business operations or again employs workers in Colorado, it must register with the FAMLI Division via “MyFAMLI+ Employer.” If the Division determines that an employer has violated this section, it may assess upon the employer a fine of up to $250.00.

4. The My FAMLI+ portal, the My FAMLI+ Employer portal, and the contact information therein provided by employers, individuals electing coverage, and claimants are the official methods by which the Division communicates with such individuals and entities in order to deliver important benefits, premiums, and tax information. Employers, individuals electing coverage, and claimants must provide current accurate contact information to the Division, and must update that contact information to reflect any changes. Individuals are encouraged to contact the Division via telephone if they need assistance in updating information in either the My FAMLI+ or My FAMLI+ Employer portals. If the Division incurs any tax liability as a result of an employer’s failure to register an account with My FAMLI+ Employer or to maintain accurate contact information within My FAMLI+ Employer, the Division may assess upon the employer a fee, per benefits payment to a covered individual, up to the amount of tax liability incurred for that benefits payment.

5. The Division may allow a third-party administrator to satisfy an employer’s registration and wage reporting obligations without the employer's prior authorization if the Division determines that: (1) the third-party administrator is legitimate, active, and in good standing with the industry; (2) the third-party is acting within the authority granted to it by the employer; and (3) the third-party is acting on behalf of an employer in good standing. In making this determination, the Division may require the third-party administrator to submit contract documents, Colorado Secretary of State filings, or any other necessary documentation. 3.4 Clarifications Regarding Use of Paid Family and Medical Leave Insurance Benefits 1. The use of paid family and medical leave insurance benefits is restricted to absences caused by a qualifying condition described at C.R.S. § 8-13.3-504(2). If the absence is caused by a reason other than a qualifying condition described at C.R.S. § 8-13.3-504(2), paid family and medical leave insurance benefits are not available. Except for holiday absences during continuous leave as described in these rules, an absence is caused by a qualifying condition only if it would not have occurred but for the qualifying condition.

A. If a covered individual is awarded continuous leave or any neonatal care leave for an absence caused by a qualifying condition described at C.R.S. § 8-13.3-504(2), the awarded leave is not impacted by a subsequent separation from employment, except when the individual receives unemployment benefits in accordance with 7 CCR 1107-4, Section 4.4, or when the Division determines that the individual is ineligible for benefits in accordance with the FAMLI Act and its implementing regulations, in either which case the benefits award ends.

B. If a covered individual is awarded intermittent leave or reduced leave schedule for an absence caused by a qualifying condition described at C.R.S. § 8-13.3-504(2) other than neonatal care leave, and subsequently becomes unemployed or changes employers, the awarded leave terminates upon unemployment or the change in employment, and the covered individual may apply for benefits upon reemployment. An individual becomes unemployed within the meaning of this rule if they are terminated, they resign, or no work is available to them due to a cessation in operations, the end of seasonal employment, the end of a temporary work assignment, or any other reason that causes the cessation of available work.

2. For purposes of determining the amount of leave used by an employee, the fact that a holiday may occur within a period of continuous leave has no effect; the time is counted as FAMLI leave and the employee will receive wage replacement benefits for that time. However, if an employee is using FAMLI leave in the form of intermittent leave or reduced leave schedule, the holiday will not count against the employee's FAMLI entitlement–and the employee will not receive wage replacement benefits for the holiday—unless the employee was otherwise scheduled and expected to work during the holiday. Similarly, if for some reason the employer's business activity or the employee’s position have temporarily ceased and the employee is not expected to report for work for one or more weeks, the days the employer's activities or the employee’s position have ceased do not count against the employee's FAMLI leave entitlement and the employee will not receive wage replacement benefits for them, unless they are on continuous leave that began before the cessation in operations.

3. Paid family and medical leave insurance benefits are available to an individual while taking paid family and medical leave from employment if the individual meets the definition of “covered individual” under C.R.S. § 8-13.3-503(3) and has a qualifying condition described at C.R.S. § 8-13.3-504(2).

A. To determine whether an individual has met the $2,500.00 threshold described at C.R.S. § 8-13.3-503(3)(a)(I), the Division will rely on wages reported to the Division by the employer pursuant to these rules. If a claim for benefits is denied because the reported wages do not establish that the individual has met the $2,500.00 threshold, the individual may request a reconsideration pursuant to Section 3.11 of these rules.

B. An individual claimant can meet the $2,500.00 threshold described at C.R.S. § 8-13.3-503(3)(a)(I) by earning wages subject to premiums from any combination of employers, and a claimant need not earn $2,500.00 from their current employer to meet the threshold C. An individual meets the $2,500.00 threshold described at C.R.S. § 8-13.3- 503(3)(a)(I) if the individual has been paid that amount of wages during either the individual’s base period, as defined at C.R.S. § 8-70-103(2), or the individual’s alternative base period, as defined at C.R.S. § 8-70- 103(1.5).

4. Paid family and medical leave insurance benefits are available for absences occurring on or after January 1, 2024 caused by a qualifying condition described at C.R.S. § 8-13.3-504(2), regardless of the onset date of the qualifying condition.

5. “Serious health condition” determinations by the Division will be in accordance with 29 C.F.R. §§ 825.102, 825.113, 825.114, 825.115, and 825.119(a), except where those regulations conflict with the FAMLI Act or its implementing regulations.

6. “Care” for a family member includes assistance with basic medical, hygienic, nutritional, safety, transportation needs, physical care, or psychological comfort.

7. To determine whether an individual is a family member under C.R.S. § 8-13.3- 503(11)(e) because the individual is someone with whom the covered individual has a significant personal bond that is or is like a family relationship, the Division will look to the totality of the circumstances surrounding the relationship, including, but not limited to, the following non-dispositive factors:

A. Shared financial responsibility, including shared leases, common ownership of real or personal property, joint liability for bills, or beneficiary designations;

B. Emergency contact designations;

C. The expectation of care created by the relationship and/or the prior provision of care;

D. Cohabitation and the duration thereof; and E. Geographical proximity.

8. Clarifications regarding “caring for a new child” under C.R.S. § 8-13.3-504(2)(a):

A. “Caring” includes bonding with and providing basic needs for a new child.

B. “Child” means a person who is either under the age of 18, or between the ages of 18 and 21 and remains under the jurisdiction of a juvenile court.

C. Benefits under C.R.S. § 8-13.3-504(2)(a) are limited to 12 weeks per qualifying condition, and are limited to biological parents, adoptive parents, foster parents, step-parents, individuals standing in loco parentis to the child, and domestic partners of any of the individuals listed in this

Section 3.4.7.C.

D. If a person has received benefits under C.R.S. § 8-13.3-504(2)(a) to care for a new child placed through foster care, and the person later adopts the child, the person is not entitled to again receive benefits under C.R.S. § 8- 13.3-504(2)(a) in relation to the adoption of the same child.

9. Clarifications regarding “safe leave” under C.R.S. § 8-13.3-503(18) and 504(2)(e):

A. To determine whether an individual is the victim of domestic violence, the victim of stalking, or the victim of sexual assault or abuse, for purposes of determining eligibility for safe leave, an individual need not prove that a court has determined that the individual was the victim of domestic violence, stalking, sexual assault, or sexual abuse.

B. Benefits may be awarded based on the victim’s good-faith attestation that the circumstances giving rise to the safe leave satisfy the elements of the offense.

C. If an individual is granted safe leave based on their good-faith attestations, and is later found by a court not to have been a victim of domestic violence, stalking, sexual assault, or sexual abuse, benefits paid for the leave will not be considered an overpayment unless a court’s findings show that the attestations were not in good faith.

10. Clarifications regarding “neonatal care leave” under C.R.S. § 8-13.3-505(1)(b):

A. Neonatal care leave is only available for parents of the infant and individuals standing in loco parentis to the infant.

B. Benefits under C.R.S. § 8-13.3-505(1)(b) are limited to a maximum of twelve (12) weeks per infant.

C. For the purposes of satisfying the eligibility requirements of C.R.S. § 8- 13.3-504(2) and triggering concurrency described at C.R.S. § 8-13.3- 510(1), neonatal care leave constitutes leave to care for a family member with a serious health condition.

D. Neonatal care leave is distinct from leave to care for a new child under C.R.S. § 8-13.3-504(2)(a), and does not reduce or limit the claimant’s entitlement to other types of paid leave under the FAMLI Act.

E. Neonatal care leave may be taken for as much or as little of an individual’s regular work schedule as the individual chooses, and the individual’s choice may change from day to day or from week to week. Covered individuals must report their neonatal care leave weekly.

F. A covered individual taking neonatal care leave may miss a whole day of work for any day that the infant is in the neonatal intensive care unit, regardless of how much time the infant was in the neonatal intensive care unit that day.

G. Claimants must notify the Division via My FAMLI+ when their neonatal care leave has ended because the infant is no longer receiving care in a neonatal intensive care unit, because the claimant has exhausted their available neonatal care leave, because the claimant has become ineligible for neonatal care leave, or because of any other reason communicated by the claimant. Within fourteen (14) days of such notification, the claimant must submit to the Division documentation from the treating facility confirming either: (1) discharge of the infant from the neonatal intensive care unit; or (2) continued inpatient treatment in the neonatal care unit.

H. If the claimant has not ended their neonatal care leave at the end of the twelfth (12th) calendar week following the benefit start date, the Division may require the claimant to submit discharge or continuing treatment documentation within fourteen (14) days of the Division's request. If the claimant submits documentation of continuing treatment at this time, has not utilized twelve (12) weeks of neonatal care leave, and their neonatal care leave continues beyond the twelfth (12th) calendar week following the benefit start date, the claimant remains obligated to notify the Division when their neonatal care leave has ended and to timely submit the required discharge or continuing treatment documentation. If the claimant has not closed the claim within six (6) months after the benefit start date, the Division will end the claim and will require the claimant to provide discharge or continuing treatment documentation within fourteen (14) days.

I. Failure to provide timely documentation of discharge or continuing treatment may result in a retroactive denial of the claim for neonatal care leave, and the claimant may request a reconsideration of such a denial in accordance with Section 3.11 of these rules. If the claimant provides sufficient documentation of discharge or continuing treatment, the Division will modify or reverse the retroactive denial.

11. Pursuant to CRS 8-13.3-503(15), paid family and medical leave is leave taken from employment. If a claimant is not employed at the outset of their leave, then leave from employment is not possible and the claim for benefits will be denied.

Examples of such denials include, but are not limited to, applications for leave to begin after the claimant has separated from their employer, applications for leave to begin during an off-season period in which a seasonal employee is not engaged in seasonal employment, and applications for leave to begin during periods of time between temporary placements by a staffing agency. A claimant must notify the Division if they become separated from employment before their benefit start date.

12. An additional four weeks of leave per benefit year for leave due to a serious health condition related to pregnancy complications or childbirth complications available under C.R.S. § 8-13.3-505(1) may not exceed four weeks per pregnancy.

13. Covered individuals are not eligible for benefits for any period in which they are not localized to Colorado pursuant to 7 CCR 1107-1, Section 1.6.

14. Paid family and medical leave includes travel time reasonably necessary to satisfy a qualifying leave reason under C.R.S. § 8-13.3-504(2). 3.5 Amount, Duration, and Format of Benefits 1. The Division will calculate a covered individual’s average weekly wage in accordance with C.R.S. § 8-13.3-503(2) and 506(2) based on their wages subject to premiums. Wages from a current job will be excluded from the average weekly wage calculation only if the covered individual is not taking any paid family and medical leave from that job as of the benefit start date.

15. The Division will calculate the covered individual’s weekly benefit in accordance with C.R.S. § 8-13.3-506(1)(a). The covered individual shall receive their weekly benefit amount multiplied by their FAMLI weekly usage for each week of leave, subject to limitations under C.R.S. § 8-13.3-505(3) and Section 3.5.5 of these rules.

16. FAMLI weekly usage shall be determined by dividing the number of hours of family and medical leave the individual takes per week by their aggregate regular work schedule for that week.

A. The hours of family and medical leave taken for any job cannot exceed the regular work schedule for that job.

B. If a covered individual is unable to provide the Division with the number of scheduled or worked hours for any job during their leave, the Division may, at its discretion and based on previous work schedules or other information available to it, assign a reasonably approximate regular work schedule.

C. If an individual’s regular work schedule increases or decreases during their leave, the Division shall make any adjustments to benefit awards made necessary by that increase or decrease.

D. If the individual’s work schedule for a job from which they are taking continuous family and medical leave decreases to zero (e.g. termination, resignation, suspension of position, scheduled academic break), the Division will not make adjustments to benefit awards based on that decrease.

E. Regular work schedule must be calculated as of the first date of the leave and, if applicable, upon notification from the claimant that their regular work schedule has changed.

4. To determine an individual’s average weekly wage in accordance with C.R.S. § 8- 13.3-503(2), the Division will rely on earnings reported to the Division pursuant to these rules. If the Division believes that earnings were incorrectly reported to the Division pursuant to these rules, the Division may request from the individual and/or the individual’s current employer or employers documentation of the individual’s earnings during the individual’s base period or alternative base period, and may rely on that documentation and any other information that is reasonable or reliable in order to calculate benefits in accordance with wages that should have been reported.

5. Absences of less than 8 hours may be approved, but wage replacement benefits will be paid in accordance with C.R.S. § 8-13.3-505(3). The 8-hour threshold must be met with each claim and each recertification period.

6. The Division will recalculate wage replacement benefit awards for in-progress awards of paid family and medical leave if the state average weekly wage changes, a change in regular work schedule triggers a recalculation in accordance with these rules, or the outcome of an appeal results in a change in awarded benefits. If the recalculation increases or decreases the wage replacement benefit amount, the Division will notify the covered individual and will adjust future payments accordingly. If the covered individual’s employer has made a valid request for benefit amounts in accordance with Section 3.8.9 of these rules, the Division will notify the employer of any increases or decreases in the covered individual’s wage replacement benefit amount.

7. The Division will award benefits for a reasonable duration in accordance with the details in the application, the documentation submitted, and where applicable, known standards of care. The awarded benefits must not exceed the duration limits described at C.R.S. § 8-13.3-505(1).

8. The duration of leave taken for any week for the purpose of C.R.S. § 8-13.3-505 shall be equal to FAMLI weekly usage for that week. 100% FAMLI weekly usage shall count as one week of duration used.

9. Approved leave may be taken in increments of one hour or less, in accordance with C.R.S. § 8-13.3-505(3).

10. Approved leave for any qualifying condition may be in the form of continuous leave, intermittent leave, or reduced leave schedule, except that neonatal care leave may be used flexibly and in accordance with the daily and weekly needs of the covered individual, as described in Section 3.4 of these rules. Prior employer approval is not needed to access any particular form of leave.

11. The amount and duration of family and medical leave benefits may be impacted by the receipt of workers’ compensation benefits or unemployment insurance benefits, as detailed in 7 CCR 1107-4.

12. Benefit awards for approved leave are not impacted by the end of the claimant’s benefit year that occurs during the approved leave.

13. Claimants, employers, and private plan administrators must provide the Division with any information necessary for the Division to calculate benefits.

14. A claimant is not eligible for paid family and medical leave benefits for continuous leave from an employer during any period for which they have already been awarded benefits on a separate claim for leave from that same employer.

However, a claimant may end a continuous leave claim for one qualifying reason early and begin any type of claim for another qualifying reason, regardless of whether they remain eligible for leave for the initial qualifying reason.

15. Family and medical leave approved by the Division and taken by the claimant is considered taken as part of the individual’s maximum annual allotment of leave under C.R.S. § 8-13.3-505(1), and protected under C.R.S. § 8-13.3-509 and 7 CCR 1107-7, regardless of the benefit amount the covered individual is entitled to pursuant to the FAMLI Act and its implementing regulations.

16. From January 1, 2026 through December 31, 2026, the Division will withhold and remit to the Internal Revenue Service (“IRS”) federal income tax from all benefits at a rate of 10% upon the claimant's election. For benefits paid on or after January 1, 2027, the Division will withhold and remit to the IRS Federal Insurance Contributions Act (“FICA”) taxes and federal income taxes from benefits for leave to care for a covered individual’s own serious health condition in accordance with IRS Rev. Rul. 2025-4 (Jan. 15, 2025). The Division does not determine an employer’s tax liability, but starting January 1, 2027, the Division will deliver to the employer information sufficient to transfer any tax liability incurred as a result of any benefits being considered wages under Notice 2015-6, IRB 2015-5. Tax withholding represents the Division’s compliance with federal law and does not constitute a determination that may be appealed pursuant to 7 CCR 1107-9. Employers and employees may raise any federal tax-related dispute with the IRS using the appropriate channels and forms. 3.6 Applying for Benefits 1. To request paid family and medical leave insurance benefits, the claimant or the claimant’s designated representative must apply to the Division for benefits.

17. Applications may be submitted up to thirty (30) days prior to the benefit start date.

18. The claimant must provide any information necessary for the Division or private plan administrator to calculate benefits.

19. The Division will notify the claimant’s employer of the application submission within five (5) business days.

20. Applications may be submitted up to thirty (30) days after the leave has begun. If the Division receives an application after thirty (30) days, but before ninety (90) days, the Division will consider the application if it includes evidence establishing good cause for the claimant’s failure to submit the application within thirty (30) days.

21. Additional Documentation Requirements A. For leave necessary to care for a child because of birth, the claimant must submit the following documentation with their application:

22. Proof of birth, which may include a birth certificate, documentation from a health care provider who provided care during the birth or recovery, or other vital records showing birth;

23. Proof of parental status or in loco parentis status, which may include a birth certificate, documentation from a health care provider who provided care during the birth or recovery, other vital records showing parenthood, or a written statement establishing in loco parentis status;

24. Documentation confirming the child’s discharge from, or continued treatment in, a neonatal intensive care unit, if the claimant previously took neonatal care leave and has not yet submitted such documentation as required by Section 3.4 of these rules; and 4. Any other reasonable information or documentation necessary to B. For leave necessary to care for a child because of adoption, the claimant must submit the following documentation with their application:

25. Proof of adoption placement, which may include documentation from a court or an adoption agency; and 2. Any other reasonable information or documentation necessary to C. For leave necessary to care for a child because of placement through foster care, the claimant must submit the following documentation with their application:

26. Either:

a. Proof that the claimant is either a licensed or certified foster parent and the child has been placed in their care; or b. Documentation from a child placement agency as defined in C.R.S. § 26-6-903(6), the state department of human services, a county department of human services, or a court indicating a kinship or emergency placement was necessary to provide for the immediate care and safety of a minor child, and the person will be standing in loco parentis through a power of attorney or other legal designation; and 2. Any other reasonable information or documentation necessary to D. For leave necessary to care for a family member with a serious health condition, the claimant must submit the following documentation with their application:

1. A “Serious Health Condition Certification - Family Member Form” completed and signed by the family member’s health care provider; and 2. Any other reasonable information or documentation necessary to E. For leave necessary because of the claimant’s own serious health condition, the claimant must submit the following documentation with their application:

2. A “Serious Health Condition Certification - Self Form” completed and signed by the health care provider; and 2. Any other reasonable information or documentation necessary to F. For leave due to a need for qualifying exigency leave, the claimant must submit the following documentation with their application:

3. A “Military Exigency Leave Attestation Form” completed by the claimant; and 2. Any other reasonable information or documentation necessary to G. For leave due to a need for safe leave, the claimant must submit the following documentation with their application:

4. A “Safe Leave Attestation Form” completed by the victim or a family member of the victim; and 2. Any other reasonable information or documentation necessary to H. For neonatal care leave, the claimant must submit the following:

5. Documentation confirming the infant’s admission to a neonatal intensive care unit, issued by the treating facility;

6. Documentation establishing parental status or in loco parentis status, which may include but is not limited to: neonatal intensive care unit admission forms listing the claimant, a birth certificate, records from a health care provider who provided care during the birth or recovery, other vital records verifying parenthood, or a signed written statement attesting to in loco parentis status; and 3. Any other reasonable information or documentation requested bv the Division that is necessary to adjudicate the claim.

7. In addition to the above documentation required with the application for benefits, the claimant must also submit documentation in accordance with Section 3.4.10 of these rules.

8. For applications for benefits requiring certification by a health care provider, the health care provider may not be the claimant or a family member of the claimant.

9. Applications may be submitted using My FAMLI+, the FAMLI Division’s online benefits portal. Individuals are encouraged to contact the Division via telephone if they need assistance submitting an application.

10. Requirements for an application to be considered filed:

A. Upon receipt of an application for benefits, the Division will promptly review the application. If the Division needs more information or documentation to adjudicate the claim for benefits, it will make a reasonable effort to promptly obtain the additional information or documentation. If the Division needs additional information or documentation from the claimant, it will make a reasonable effort to obtain it using the claimant’s preferred language and method of contact. The Division will promptly review any additional information it receives.

B. An application will not be considered filed until all required information and documentation has been received by the Division, and the Division has been notified that the paid family and medical leave has begun.

C. If an application is not properly filed within sixty (60) days after the Division receives it, the application will be closed and the Division will take no further action on it, absent a finding of good cause based on evidence submitted by the claimant. The Division will notify the claimant prior to any such closure in their preferred language and method of contact, and will describe the claimant’s opportunity to establish good cause to keep the application open.

D. Once an application is properly filed, the Division will notify the claimant and the employer of the proper filing within five (5) business days.

E. The FAMLI Division may at any time determine that it needs more information or documentation to adjudicate a claim, thereby rendering the claim not properly filed. The two-week (14-day) deadline described in C.R.S. § 8-13.3-505(2) and Section 3.9.1 below, does not begin until the claimant has responded to all Division requests for information and documentation, and the Division has been notified that the paid family and medical leave has begun. If the claimant has responded to all Division requests for information and documentation, it is presumed that the claimant has provided all necessary information and documentation to adjudicate the claim unless the Division requests additional information or documentation. 3.7 Requirements Regarding Notice to Employees 1. Employers participating in the state plan must display the program notice described by C.R.S. § 8-13.3-511 in a conspicuous and accessible place in each establishment where employees are employed; provided, however, in cases where the employer does not maintain a physical workplace, or an employee teleworks or performs work through a web-based or app-based platform, notification must be sent via electronic communication or through a conspicuous posting in the web-based or app-based platform.

2. In addition to displaying the program notice described by C.R.S. § 8-13.3-511, employers participating in the state plan must individually deliver the program notice to employees upon hiring or transfer to Colorado and, absent extenuating circumstances, within five days after either learning of an employee experiencing an event that triggers eligibility pursuant to C.R.S. § 8-13.3-504, or receiving from the employee a request for protected leave under other family and medical leave laws. The employer shall deliver the program notice to the employee in the first language spoken by the employee if the employer is aware of the first language spoken by the employee; otherwise, the employer shall deliver the program notice in the first language spoken by the employee, upon the employee’s request.

3. The program notice must be in English, Spanish, and in any language representing the first language spoken by at least five percent of the employer's workplace.

4. The Division will make a reasonable effort to provide a program notice in any language upon request from an employer.

5. If the Division determines that an employer has not posted or delivered the program notice in accordance with the FAMLI Act and its implementing regulations, the Division may assess upon the employer a fine of up to $500.00 per violation. Each day that an employer fails to post or deliver the program notice constitutes a separate violation. 3.8 Requirements Regarding Notice to Employers 1. A claimant must schedule leave in accordance with C.R.S. § 8-13.3-505(4), and must notify their employer or employers of the need for leave in accordance with C.R.S. § 8-13.3-505(5). For individuals on intermittent leave, these scheduling and notice requirements apply to each absence. Notification need not include any specific terms or reference specific provisions of the FAMLI Act or its implementing regulations, but must reasonably implicate qualifying leave under the FAMLI Act to satisfy the notification requirement at C.R.S. § 8-13.3-505(5).

6. If the need for leave is foreseeable, a claimant must consult with the employer and make a reasonable effort to schedule leave so as not to unduly disrupt the employer’s operations. If the claimant does not do so, the employer may initiate discussions with the employee and require the employee to attempt to make such arrangements, subject, where applicable, to the approval of the health care provider. An undue disruption requires significant difficulty or expense in relation to the resources and specific circumstances of the employer.

7. If the necessity for leave is not foreseeable, or providing 30 days’ notice is not possible, the individual shall provide the notice as soon as practicable. As soon as practicable means as soon as both possible and practical, taking into account all of the facts and circumstances in the individual case. When an employee becomes aware of a need for leave less than 30 days in advance, it should be practicable for the employee to provide notice of the need for leave either the same day or the next business day. In all cases, however, the determination of when an employee could practicably provide notice must take into account the individual facts and circumstances.

8. A claimant’s failure to schedule leave in accordance with C.R.S. § 8-13.3-505(4) or properly notify their employer or employers of the need for leave in accordance with C.R.S. § 8-13.3-505(5) does not change the Division’s obligations to pay benefits on an approved claim within two weeks after the claim is filed under C.R.S. § 8-13.3-505(2) and these rules.

9. The Division shall not deny a claimant benefits for a failure to comply with C.R.S. § 8-13.3-505(4) or (5).

10. Employers may require the notice to contain the anticipated start time, anticipated duration, and where applicable, anticipated frequency of leave.

11. Such notification must be in the same manner as the claimant and employer typically communicate work availability, and absent unusual circumstances, must comply with the employer’s usual and customary notice and procedural requirements for leave, unless those requirements are contrary to rights, benefits, or protections afforded to the claimant under the FAMLI Act and its implementing regulations.

12. If an employer fails to post and deliver the program notice in accordance with C.R.S. § 8-13.3-511 and these rules, the employer may not punish or discipline an employee for failing to provide notice in accordance with C.R.S. § 8-13.3- 505(5).

13. By submitting an application for benefits, the claimant consents to the Division sharing with the employer limited information necessary for the employer to comply with federal or state tax laws or tax regulations, or to coordinate FAMLI benefits with other benefits for which the claimant is eligible, including the wage replacement amount and the reason for leave. The employer shall not request or access information that is not absolutely necessary for such tax law compliance or benefit coordination, and accessing or requesting information not absolutely necessary for such purposes may constitute discrimination, retaliation, and/or interference in violation of C.R.S. § 8-13.3-509. The employer must store and maintain the confidentiality of such information in accordance with all applicable federal, state, and local laws and regulations, and failure to do so may constitute discrimination, retaliation, and/or interference in violation of C.R.S. § 8-13.3-509.

14. Records and documents relating to medical certifications, recertifications, or medical histories of employees or employees' family members created for purposes of the FAMLI must be maintained as confidential medical records in separate files/records from the usual personnel files. If the Division determines that an employer has not maintained such records confidentially and separately from usual personnel files, the Division may assess upon the employer a fine of up to $500.00 per violation. If the Genetic Information Nondiscrimination Act of 2008 (GINA) is applicable, records and documents created for purposes of FAMLI containing family medical history or genetic information as defined in GINA shall be maintained in accordance with the confidentiality requirements of Title II of GINA (see 29 CFR 1635.9). If the Americans with Disabilities Act (ADA) is also applicable, such records should be maintained in conformance with ADA confidentiality requirements, except that:

A. Supervisors and managers may be informed regarding necessary restrictions on the work or duties of an employee and necessary accommodations;

B. First aid and safety personnel may be informed if the employee's physical or medical condition might require emergency treatment; and C. Division and/or other government officials investigating compliance with the FAMLI Act should be provided relevant information upon request.

11. Consistent with the timeframes set forth in C.R.S. § 8-13.3-505(5), a claimant must notify the employer from which they are taking leave whether they will take continuous leave, intermittent leave, and/or a reduced leave schedule.

Notification need not use the terms continuous leave, intermittent leave, or reduced leave schedule, but must reasonably implicate the type of leave they are taking. Consistent with the timeframes set forth in C.R.S. § 8-13.3-505(5), a claimant must also give the employer reasonable details about their work and leave schedule.

12. A claimant must take reasonable steps to notify the employer in advance of any change in their planned work and leave schedule, which include following employer policies to request or change leave, unless those policies are contrary to rights, benefits, or protections afforded to the claimant under the FAMLI Act and its implementing regulations. 3.9 Division Review of Applications 1. After an application is properly filed, the Division will adjudicate the claim within two weeks after filing.

13. The Division will contemporaneously notify the claimant and the employer of the outcome of the adjudication, and will provide information on how the claimant can appeal the outcome.

A. If the outcome is a denial of benefits, the Division will send separate notices to the claimant and to the claimant’s employer or employers. The notice to the claimant will explain the reason for the benefits denial and will identify information or documentation necessary to perfect their claim for benefits. The notice to the claimant’s employer or employers will state that the claim for benefits has been denied, include the date of the denial, and include a description of the claimant’s appeal rights.

B. If the outcome of the adjudication is to award benefits, the Division will send separate notices to the claimant and to the claimant’s employer or employers. Both notices will include the leave start date, the leave duration, any denied segments of requested leave, the claimant’s regular work schedule upon which benefits were based, and where applicable, a description of any approved reduced leave schedule or intermittent leave.

The notice to the claimant will also include the benefit amount. Upon the employer’s valid request, the Division will share with the employer the benefit amount and reason for leave, in accordance with Section 3.8.9 of these rules.

3. If the Division awards benefits, it will issue payment for the benefits within two weeks after the application is filed, and where applicable, at least every two weeks thereafter.

4. For applications approved in advance of the needed leave, the claimant must notify the Division once the leave begins.

5. A claimant may appeal an adverse claim determination pursuant to 7 CCR 1107- 9.

6. An award of benefits does not preclude future investigation or oversight by the Division.

7. It is the individual’s burden to prove by preponderance of the evidence that they are eligible for paid family and medical leave benefits. 3.10 Covered Individual Obligations During Leave 1. A covered individual or their designated representative must notify the FAMLI Division within ten (10) days after the occurrence of any event, or the foreseeability of any event, that could change the amount or duration of approved leave, including but not limited to the following:

A. A change in the covered individual’s need to care for a new child, including death of the child, placement of the child in another home, or a caregiving arrangement whereby someone other than the covered individual provides care;

B. A change in the covered individual’s own serious health condition or need to care for a family member with a serious health condition, including death of the family member or any increase or decrease in the care the covered individual must provide;

C. A change in the covered individual’s need for exigency leave;

D. A change in the covered individual’s need for safe leave;

E. Any event resulting in the covered individual no longer being localized to Colorado, pursuant to 7 CCR 1107-1 and its provisions regarding in-state status of employees;

F. An addition or loss of one or more jobs;

G. A change in the covered individual’s regular work schedule;

H. Any change in employment, including unemployment, retirement, or any gained or lost source of employment or self-employment; or I. Any filing or termination of a claim for family and medical leave insurance benefits with a private plan during a period of paid family and medical leave under the state plan.

2. If a covered individual notifies the Division of an event that would increase the amount, duration, or frequency of benefits, the Division may require the covered individual to submit additional documentation in support of their claim.

3. If information reported to the Division results in an increase or decrease in the duration or frequency of leave awarded to a covered individual, the Division will promptly and contemporaneously notify the employer and the covered individual of the change.

4. If a covered individual receives a reduced leave schedule or intermittent leave, the covered individual must submit documentation sufficient to recertify their need for leave every six months, or as requested by the Division for claim management purposes. Upon recertification, the Division will notify the covered individual and the employer or employers from which the covered individual is taking leave, and will include in that notification any changes in the duration or frequency of the approved leave. If an individual fails to recertify, the approval for the leave will expire and the Division will notify the employer or employers from which the covered individual was taking leave.

5. A covered individual receiving reduced leave schedule or intermittent leave must notify the Division of their regular work schedule and individual absences on a weekly basis in order to receive wage replacement benefits for the absences. If the individual does not report their regular work schedule by the deadline established by the Division, the Division will accept this as communication from the individual that their regular work schedule has not changed from the most recently reported regular work schedule. If the individual does not report absences for a week by the deadline established by the Division, the Division will accept this as communication from the individual that no approved absences occurred in that week. The Division may deny a claimant’s request to modify a past notification of their regular work schedule or individual absences unless the claimant provides both good cause for their failure to provide timely notifications, and evidence supporting the modification.

6. A covered individual receiving continuous leave must notify the Division of any hours worked in any employment for which they are taking continuous leave within seven (7) days of performing that work. 3.11 Benefits Reconsiderations 1. A claimant or an employer from which a claimant is taking leave may request a reconsideration of a decision to award or deny paid family and medical leave benefits if they have a good-faith belief, supported by evidence, that the Division has granted and/or paid family and medical leave insurance benefits to a claimant in an amount, duration, or frequency not authorized by the FAMLI Act and its implementing regulations.

7. Requests for reconsiderations must be submitted within 49 days of the date of the original determination. The deadline to request a reconsideration may be extended by up to a maximum of forty-nine (49) days for good cause. If a deadline falls on a weekend or State holiday, the deadline shall become the next business day.

8. The claimant and all employers from which the claimant has applied to take paid family and medical leave will be notified of the request for reconsideration. Any party may submit additional documents, statements, or other evidence in support of their request.

9. Upon receiving a request for a reconsideration, the Division may request any reasonably necessary evidence.

10. After receiving the request for reconsideration and gathering any reasonably necessary evidence, the Division will issue a reconsideration of the claimant’s eligibility for paid family and medical leave benefits as soon as is practicable. The reconsideration will be sent to both the claimant and all employers from which the claimant has applied to take paid family and medical leave.

11. A request for a reconsideration of an initial benefits determination must be made before the Division will accept an appeal of such a determination pursuant to 7 CCR 1107-9.

12. No party may request a reconsideration of any determination made by the Division other than an initial benefits determination, unless otherwise provided by the FAMLI Act and its implementing regulations. All other determinations may only be challenged by filing an appeal pursuant to 7 CCR 1107-9.

13. Frivolous, unsubstantiated, or bad-faith requests for a reconsideration from an employer may constitute discrimination, interference, or retaliation in violation of C.R.S. § 8-13.3-509.

14. The Division may issue a reconsideration of an initial benefits determination on its own volition regardless of whether a reconsideration has been requested.

15. To initiate the Division’s review of a private plan’s initial benefits determination, a claimant must file an appeal pursuant to 7 CCR 1107-9. 3.12 Fitness for Duty Nothing in the FAMLI Act or its implementing regulations prohibits an employer from requiring a covered individual to provide certification of his or her fitness for duty prior to returning to work from a FAMLI-approved absence, so long as such a requirement does not constitute discrimination, retaliation, or interference in violation of C.R.S. § 8-13.3- 509. 3.13 Disqualification from Benefits 1. If the Division determines that a covered individual has willfully made a false statement or misrepresentation regarding a material fact in order to obtain family and medical leave insurance benefits, or has willfully failed to report a material fact in order to obtain family and medical leave insurance benefits, the covered individual will be disqualified from family and medical leave insurance benefits for one year after the effective date of the disqualification.

16. The Division will notify the claimant of any disqualification of benefits by issuing a determination to the claimant, and the claimant may appeal the disqualification in accordance with 7 CCR 1107-9.

17. If the claimant does not appeal the disqualification, the effective date of the disqualification shall be the earlier of:

A. The day after the appeal deadline; or B. The day the Division receives notification from the claimant of the claimant’s decision not to contest the disqualification.

4. If the claimant does not appeal the disqualification, or if the Division upholds the claimant’s disqualification upon appeal, the Division will notify the claimant’s employer or employers of the disqualification.

5. If the Division or a court upholds the claimant’s disqualification upon appeal, the effective date of the disqualification shall become the date of the decision or order upholding the initial disqualification 6. If a claimant is disqualified from family and medical leave insurance benefits, the claimant’s employer or employers remain obligated to remit premiums for the claimant in accordance with the FAMLI Act, and remain entitled to require premium contributions from the employee in accordance with the FAMLI Act. 3.14 Benefit Underpayments If the Division identifies a benefit underpayment, it will make a reasonable effort to obtain accurate contact information from the underpaid individual, and will issue the underpaid amount to the individual as soon as practicable. If the Division cannot obtain accurate contact information from the underpaid individual, the Division will remit the underpaid amount to the Colorado Department of Treasury in accordance with the Colorado Revised Uniform Unclaimed Property Act, C.R.S. § 38-13-101 et seq. 3.15 Language Accessibility The Division will make reasonable efforts to make forms and communications under these rules available in an individual’s primary language, subject to the Division’s sole discretion based on available resources.

Editor’s Notes

History New rule eff. 10/15/2022.

Entire rule eff. 01/01/2024.

Entire rule eff. 01/01/2025.

Rules 3.1 3, 3.6 6.A.2, 3.7 2 eff. 07/01/2025.

Entire rule eff. 01/01/2026.

Rule 3.5 16 emer. rule eff. 01/01/2026.

Rules 3.1 3, 3.5 16 eff. 04/30/2026.

Rules 3.1 3, 3.4 1 eff. 07/01/2026.

7 CCR 1107-4 Regulations Concerning Coordination of Benefits and Reimbursement of Advance Payments {#sec-7-ccr-1107-4 omnilex-key=us-co-regs-official--department-10--7 CCR 1107-4}

DEPARTMENT OF LABOR AND EMPLOYMENT

REGULATIONS CONCERNING COORDINATION OF BENEFITS AND REIMBURSEMENT OF

ADVANCE PAYMENTS

7 CCR 1107-4 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ 4.1 Statements of Authority, Purpose, and Incorporation by Reference 1. This regulation is adopted pursuant to the authority in section C.R.S. § 8-13.3-501 et seq., and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24-4-101 et seq. (the “APA”), and the Paid Family and Medical Leave Insurance Act, C.R.S. § 8-13.3-501 through 524 (the “FAMLI Act”).

2. The general purpose of these rules is to exercise the authority of this Division to enforce and implement the Paid Family and Medical Leave Insurance Act (C.R.S. § 8-13.3-501 et seq.) with regard to coordination of benefits and reimbursement of advance payments.

3. If any part of these rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 4.2 Definitions and Clarifications 1. Unless otherwise indicated, terms used here that are defined in the FAMLI Act have the same definition as they do under the FAMLI Act.

4. “Employer-provided paid leave” means vacation leave, paid sick leave, paid personal leave, and any other employer-paid time off. Employer-provided paid leave does not include benefits under a short-term disability policy, long-term disability policy, or a separate bank of time off solely for the

purpose of paid family and medical leave.

3. “Health care benefits” as used at C.R.S. § 8-13.3-509(2) means benefits provided to an employee by an employer related to the improvement or maintenance of the employee’s health or the employee’s family members’ health, including but not limited to:

A. Health insurance;

B. Dental insurance;

C. Vision insurance; and D. Mental health, counseling, and addiction services.

4. “Paid sick leave” has the same meaning as in C.R.S. § 8-13.3-402(8).

5. “Separate bank of time off solely for the purpose of paid family and medical leave” means time off provided by an employer which may only be used for a purpose listed in C.R.S. § 8-13.3-504(2), including but not limited to, paid parental leave, and paid leave under C.R.S. § 24-34-402.7, and is separate from employer-provided paid leave defined in Section 4.2.2 of these rules.

6. No benefits received by an individual impact their eligibility for family and medical leave insurance benefits except for unemployment insurance benefits and workers’ compensation benefits, as described in this rule.

7. An employer may require an employee to exhaust any available FAMLI leave as a condition to access short term disability benefits, long term disability benefits, or any other separate bank of leave for the purpose of family and medical leave. Whether an employer does require any such exhaustion is governed by the terms of the benefits policy. However, an employer cannot require the employee to exhaust available FAMLI leave or begin FAMLI leave as a condition to access leave that it is otherwise required to provide, like leave under the federal "Family and Medical Leave Act," paid sick leave mandated by the Colorado Healthy Families and Workplaces Act, or any other leave to which the employee is entitled under the terms of its policy. 4.3 FAMLI Benefits and Workers’ Compensation Benefits 1. Benefits under the FAMLI Act and its implementing regulations are separate benefits claims from benefits under the Workers’ Compensation Act of Colorado, C.R.S. § 8-40-101 et seq. or its implementing regulations (the “Workers’ Compensation Act”). Regardless of an individual’s status as a covered individual, if an absence from work is due to circumstances that would entitle an individual to temporary total or partial indemnity benefits under the Workers’ Compensation Act, the individual is not entitled to family and medical leave insurance benefits for that absence.

8. An individual applying for family and medical leave insurance benefits must disclose whether their serious health condition was caused by or otherwise related to a workplace injury or illness.

9. Health care providers, in completing a “Serious Health Condition Certification - Self Form,” must disclose any information or belief that the individual’s serious health condition was caused by or otherwise related to a workplace injury.

10. If either the individual applying for family and medical leave insurance benefits or the health care provider completing the “Serious Health Condition Certification - Self Form” indicates that the individual’s serious health condition was caused by or otherwise related to a workplace injury, then the application for benefits will be denied unless the individual submits proof that they are either ineligible or no longer eligible for temporary total or partial indemnity benefits under the Workers’ Compensation Act. The Division will accept and review the following documents as evidence an individual is not eligible or is no longer eligible for temporary total or partial indemnity Workers’ Compensation benefits:

A. A Final Admission of Liability with a mailing date that is at least 30 days prior to the benefit start date;

B. A Final Order by an Administrative Law Judge showing temporary total or partial indemnity benefits under Workers Compensation Act have been denied or are no longer being paid; or C. A Notice of Contest issued to the claimant by a Workers’ Compensation insurer.

5. An individual must notify the FAMLI Division if they receive any benefits under the Workers’ Compensation Act during a period of family and medical leave and may be required to complete a release for records relating to the workers’ compensation injury.

6. If an individual is paid or entitled to receive any temporary total or partial indemnity benefits under the Workers’ Compensation Act during a period of family and medical leave, then any wage replacement benefits paid or owed to the individual in association with the same job and the same time missed as the temporary indemnity benefits under the Workers’ Compensation Act will be considered an overpayment of family and medical leave insurance benefits.

7. The Division may recover an overpayment of paid family and medical leave insurance benefits due to an individual’s entitlement to receive temporary total or partial indemnity benefits under the Workers’ Compensation Act during a period of family and medical leave from either the individual overpaid or directly from the Workers’ Compensation insurer that awarded the benefits.

8. An individual’s failure to disclose either a workplace injury related to an application for family and medical leave insurance benefits, or the receipt of benefits under the Workers’ Compensation Act related to an injury that is related to the receipt of family and medical leave insurance benefits, may constitute grounds for disqualification of benefits pursuant to C.R.S. § 8-13.3-513. 4.4 FAMLI Benefits and Unemployment Insurance Benefits 1. Benefits under the FAMLI Act and its implementing regulations do not run concurrently with benefits under the Colorado Employment Security Act, C.R.S. § 8-70-101 et seq., or its implementing regulations (“CESA”).

9. Regardless of an individual’s status as a covered individual, the individual is not entitled to family and medical leave insurance benefits for any hours the individual receives unemployment benefits pursuant to CESA for the same job.

10. An individual must notify the FAMLI Division if they apply for or receive any benefits under CESA during a period of family and medical leave.

11. If an individual is paid any benefits under CESA during a period of family and medical leave, then any family and medical leave wage replacement benefits paid to the individual for the same job during the same period of leave as the benefits received under CESA will be considered an overpayment.

12. An individual’s failure to disclose either the application for or the receipt of benefits under CESA during any period of family and medical leave may constitute grounds for disqualification of benefits pursuant to C.R.S. § 8-13.3-513. 4.5 FAMLI Benefits and Employer-provided Paid Leave 1. The FAMLI Act and its implementing regulations do not entitle an employee to receive both wage replacement benefits under the FAMLI Act and employer-provided paid leave for the same hours absent, except that pursuant to C.R.S. § 8-13.3-510(1)(c), an employer and an employee may mutually agree that the employee may use any accrued employer-provided leave as a supplement to family and medical leave insurance benefits in an amount not to exceed the difference between the individual’s wage replacement benefits under the FAMLI Act and the individual’s average weekly wage.

A. If employer-provided paid leave is used to supplement FAMLI wage replacement benefits, the employer may: (1) convert the dollar amount of the supplement into the corresponding number of employer-provided paid leave hours; and (2) subtract those hours from the employee’s balance of accrued and unused employer-provided leave.

B. The use of employer-provided paid leave to supplement FAMLI wage replacement benefits requires mutual agreement between the employer and the employee. If either the employer or the employee does not so mutually agree, employer-provided paid leave may not be used to supplement FAMLI wage replacement benefits. Any such agreement must be in writing and must be retained by the employer. The employer may rely on one written agreement per employee that covers all future supplements, so long as the terms of the agreement expressly provide that it is revocable by the employee.

C. Mutual agreement between the employer and the employee is not necessary in order for an employee to use paid sick leave prior to receiving family and medical leave insurance benefits.

2. If an individual receives both wage replacement benefits under the FAMLI Act and employerprovided paid leave for the same hours absent, and the employer and the employee have mutually agreed to supplement FAMLI wage replacement benefits with employer-provided leave, then any employer-provided paid leave in excess of the amount authorized by Section 4.5.1 of these rules is an overpayment that the employer may recoup.

3. If an individual receives both wage replacement benefits under the FAMLI Act and employerprovided paid leave for the same hours absent, and the employer and the employee have not mutually agreed to supplement FAMLI wage replacement benefits with employer-provided leave, then any employer-provided paid leave for the same hours absent is an overpayment that the employer may recoup.

4. In the event of an overpayment pursuant to either Sections 4.5.2 or 4.5.3 of these rules:

A. The employer may recoup the overpayment by any legal means, including via one or more lawful deductions in accordance with C.R.S. § 8-4-105;

B. The employer must replenish the employee’s bank of accrued employer-provided paid leave in an amount equal to the overpayment amount if the employee requests it or if the employer chooses to recoup the overpayment; and C. If the employer-provided paid leave so recouped as an overpayment is paid sick leave, an employer’s failure to replenish the employee’s bank of paid sick leave in accordance with Section 4.5.4.B of these rules shall constitute a violation of the Healthy Families and Workplaces Act, C.R.S. § 8-13.3-401 et seq (“HFWA”).

5. To the extent possible, the FAMLI Act and its implementing regulations shall not be read to reduce rights under HFWA and its implementing regulations, and HFWA and its implementing regulations shall not be read to reduce rights under the FAMLI Act and its implementing regulations.

6. If the Division determines that an employer has violated C.R.S. § 8-13.3-510(1)(c) or Section 4.5 of these rules, the Division may assess upon the employer a fine of up to $50.00 per employee per day. 4.6 Employer-provided benefits during paid family and medical leave 1. The FAMLI Act and its implementing regulations only require an employer to maintain health care benefits in accordance with C.R.S. § 8-13.3-509(2), and do not entitle an employee to the continued accrual of employer-provided leave or any other benefits during a period of family and medical leave.

7. With regard to a covered individual’s obligation to pay their share of the cost of health benefits pursuant to C.R.S. § 8-13.3-509(2), the employer may collect such payment via:

A. Lawful deductions from employer-provided paid leave used to supplement FAMLI wage replacement benefits, in accordance with C.R.S. § 8-4-105;

B. Lawful deductions from wages paid upon the employee’s return to work, in accordance with C.R.S. 8-4-105;

C. A repayment plan entered into by the employer and the employee; or D. Any other legal means.

3. Pursuant to C.R.S. § 8-13.3-509(8), if a local government employer has declined coverage pursuant to C.R.S. § 8-13.3-522, FAMLI does not require the local government employer to maintain health care benefits during a period of family and medical leave for its employees who elect coverage pursuant to C.R.S. § 8-13.3-514.

4. If an employer and an employee mutually agree to supplement FAMLI wage replacement benefits with paid sick leave, then the extent to which the employer must maintain benefits beyond the requirements in C.R.S. § 8-13.3-509(2) and Rules 4.6.1 and 4.6.2 is governed by HFWA.

5. If the Division determines that an employer has violated C.R.S. § 8-13.3-509(2) or Section 4.6 of these rules, the Division may assess upon the employer a fine of up to $500.00 per employee, per day the employer failed to maintain health care benefits. 4.7 FAMLI Benefits, short-term disability benefits, long-term disability benefits, and benefits from a separate bank of time off solely for the purpose of paid family and medical leave 1. If family and medical leave is taken for a reason that also qualifies for benefits from a short-term disability policy, long-term disability policy, or a separate bank of time off solely for the purpose of paid family and medical leave offered by the employer, then so long as the employer satisfies the notice requirement of C.R.S. § 8-13.3-510(1)(b), the employer may count both the wage replacement amount and the duration of the family and medical leave against the remaining benefit amounts and leave duration provided under such policy or bank of time. The employer or policy may not count either the wage replacement amount or duration of the paid family and medical leave taken under FAMLI against past or future balances under such policy or bank of time.

6. If the employer requires family and medical leave insurance benefits to run concurrent with its short-term or long-term disability benefits, then the terms of the short-term or long-term disability policy shall govern whether the employer, the employee, or both must notify the policy’s program administrator of concurrent paid family and medical leave insurance benefits received by the employee.

7. If the employer and the employee mutually agree that the employee may use short-term disability benefits, long-term disability benefits, and benefits from a separate bank of time off solely for the

purpose of paid family and medical leave as a supplement to family and medical leave insurance benefits, the same rights and requirements described in Section 4.5 of these rules shall apply.

4. No individual is required to apply for or exhaust short-term disability benefits, long-term disability benefits, or benefits from a separate bank of time off solely for the purpose of paid family and medical leave as a condition to access paid family and medical leave benefits under either the state plan or an approved private plan. Any action by an employer, insurer, or leave administrator requiring behavior contrary to this rule is a violation of this rule and constitutes unlawful interference.

5. If the Division determines that an employer has violated C.R.S. § 8-13.3-510(1)(b) or Section 4.7 of these rules, the Division may assess upon the employer a fine of up to $500.00 per violation. 4.8 FAMLI Benefits and the FMLA and the Family Care Act 1. As provided in C.R.S. § 8-13.3-510(1)(a), leave taken with wage replacement under the FAMLI Act that also qualifies as leave under the "Family and Medical Leave Act," as amended, Pub. L. 103-3, codified at 29 U.S.C. sec. 2601 et. seq., or part 2 of article 13.3 of title 8 runs concurrently with leave taken under the "Family and Medical Leave Act" or part 2 of article 13.3 of title 8, as applicable.

6. If the qualifying reason for family and medical leave does not constitute a qualifying reason for leave under the Family and Medical Leave Act, then the extent to which family and medical leave runs concurrently with leave taken under the Family and Medical Leave Act, if at all, is governed by the Family and Medical Leave Act and its implementing regulations.

7. If an employee requests leave under the Family and Medical Leave Act, the employer must notify the employee that they may be eligible for leave under the FAMLI Act. 4.9 Benefit Coordination Between Plans Providing Paid Family and Medical Leave Benefits 1. To allow for continuity of benefits for individuals covered under FAMLI or a private plan, when an employer changes plans, the previous plan is required to continue paying all leave (continuous, intermittent and reduced leave schedules) with a benefit start date prior to the date an employer changes plans through the duration previously approved or until a recertification is required, after which the claimant may reapply for benefits with their new plan. The previous plan must also adjudicate and pay any approved claims submitted retroactively within the application and filing timeframes set forth in 7 CCR 1107-3, Section 3.6. However, the previous plan does not have to pay pre-approved claims that did not have a benefit start date before the change in plans, and does not have to continue to pay benefits where the provisions of 7 CCR 1107-3, Section 3.4.1 provide for the termination of approved leave.

8. If an individual has multiple jobs and is covered under multiple plans, each plan must calculate benefits based on leave taken under that plan, but proportionate to the covered individual's aggregate regular work schedule pursuant to 7 CCR 1107-3 so that total benefits do not exceed the maximum weekly benefit provided by C.R.S. § 8-13.3-506(1)(b), and total duration does not exceed the number of weeks provided by C.R.S. § 8-13.3-505(1). 4.10 Reimbursement of Advance Payments by Employers 1. An employer may qualify for a reimbursement of advance payments made to an employee when:

A. The employer pays FAMLI wage replacement benefits in advance of an adjudication decision without using any employer-provided paid leave;

B. The employee applies for family and medical leave insurance benefits; and C. The employer requests reimbursement from the Division prior to the Division’s payment of benefits to the employee.

2. Any wage replacement benefits awarded pursuant to such an application are paid directly to the employer, not to the employee.

3. An employer assumes the risk that an employee for whom it paid FAMLI wage replacement benefits in advance will not apply for family and medical leave insurance benefits, that the FAMLI Division will award wage replacement benefits in an amount less than that which the employer advanced to the employee, or that the FAMLI Division will award no wage replacement benefits.

4. If an employer is not reimbursed, or is reimbursed an amount less than that which it paid an employee, it may not recoup from the employee the difference between the amount it paid and the amount it was reimbursed.

5. An employer’s prepayment of benefits does not modify the appeal rights or procedures described in 7 CCR 1107-9.

6. An employer must verify to the Division that it proactively paid the employee a payment designated as a family and medical leave benefit consisting of partial or full wage replacement prior to receiving reimbursement. 4.11 Language Accessibility The Division will make reasonable efforts to make forms and communications under this rule available in English and Spanish. If an individual’s primary language is neither English nor Spanish, the Division will make a reasonable attempt to accommodate that individual’s language needs, subject to the Division’s sole discretion based on available resources. _________________________________________________________________________ Editor’s Notes

History New rule eff. 12/30/2022.

Rules 4.2-4.9 eff. 07/15/2023.

Entire rule eff. 01/01/2024.

Rules 4.1-4.7 eff. 01/01/2025.

Rule 4.1 3 eff. 07/01/2025.

Rule 4.1, 4.2 7, 4.3 1, 4.7, 4.9 1 eff. 01/01/2026.

7 CCR 1107-5 Regulations Concerning Private Plans {#sec-7-ccr-1107-5 omnilex-key=us-co-regs-official--department-10--7 CCR 1107-5}

DEPARTMENT OF LABOR AND EMPLOYMENT

REGULATIONS CONCERNING PRIVATE PLANS

7 CCR 1107-5 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] ______________________________________________________________________ 5.1 Statements of Authority, Purpose, and Incorporation by Reference 1. This regulation is adopted pursuant to the authority in section C.R.S. § 8-13.3- 501 et seq., and is intended to be consistent with the requirements of the State Administrative Procedures Act, section 24-4-101 et seq. (the “APA”), C.R.S. and the Paid Family and Medical Leave Insurance Act, sections C.R.S. § 8-13.3-501 et seq. (the “FAMLI Act”).

2. The general purpose of these rules is to exercise the authority of this Division to enforce and implement the Paid Family and Medical Leave Insurance Act (C.R.S. § 8-13.3-501 et seq.) with regard to private plans.

3. 7 CCR 1101-2 (2025) is hereby incorporated by reference. Earlier versions of such laws and regulations may apply to events that occurred in prior years. Such incorporation excludes later amendments to or editions of the statutes and regulations. These statutes and regulations are available for public inspection at the Colorado Department of Labor and Employment, Division of Family and Medical Leave Insurance, 707 17th Street, Denver, CO 80202. Copies may be obtained from this Division at a reasonable charge, or can be accessed electronically from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of the statutes and regulations incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Division Rules are available to the public at famli.colorado.gov.

4. If any part of these rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 5.2 Definitions and Clarifications 1. Unless otherwise indicated, terms used here that are defined in the FAMLI Act have the same definition as they do under the FAMLI Act.

5. These rules govern employees who are localized to Colorado pursuant to 7 CCR 1107-1, and govern employers and private plan administrators with regard to employees who are localized to Colorado pursuant to 7 CCR 1107-1. These rules do not govern employees who are not localized to Colorado pursuant to 7 CCR 1107-1, and do not govern employers or private plan administrators with regard to employees who are not localized to Colorado pursuant to 7 CCR 1107- 1.

6. “Additional conditions or restrictions” as used in C.R.S. § 8-13.3-521(1)(i) means material conditions or restrictions, and does not include incidental conditions or restrictions that do not interfere with, restrict, or lessen an employee’s rights under FAMLI Act.

7. “Adverse determination” means either a complete denial of benefits, or a determination to award a claimant benefits in a frequency or duration less than the claimant requested, or a determination to award a wage replacement amount less than what the claimant believes they are entitled to under the FAMLI Act and its implementing regulations.

8. “Insurer approved by the state” as used in C.R.S. § 8-13.3-521(2)(c) and these rules means an insurance provider licensed by the Division of Insurance within the Colorado Department of Regulatory Agencies, and in good standing with the Division of Insurance in accordance with its regulations.

9. “Private plan administrator” means an entity or individual tasked with the administration of an approved private plan, and can include without limitation the employer, a third-party administrator, a labor union, and/or an insurer approved by the state.

10. “Rights, protections, and benefits provided to employees under this part 5” as used in C.R.S. § 8-13.3-521(1) includes any rights, protections, and benefits conferred by rules promulgated under the FAMLI Act and its implementing 8. “Wages” has the same meaning as in 7 CCR 1107-1, Section 1.2.9. 5.3 Private Plan Requirements 1. An employer may comply with the FAMLI Act by providing an approved private plan that provides all of the same rights, protections and benefits provided to employees by the FAMLI Act and its implementing regulations, including but not limited to:

A. Allowing family and medical leave insurance benefits to be taken for all purposes specified in C.R.S. § 8-13.3-504(2);

B. Providing family and medical leave insurance benefits to a covered individual for any of the purposes, including multiple purposes in the aggregate, as set forth in C.R.S. § 8-13.3-504(2), for the maximum number of weeks required in C.R.S. § 8-13.3-505(1) in a benefit year as defined in 7 CCR 1107-3 Section 3.2.4;

C. Allowing family and medical leave insurance benefits under C.R.S. § 8- 13.3-504(2)(b) to be taken to care for any family member as defined under C.R.S. § 8-13.3-503(11) and 7 CCR 1107-3 Section 3.4.6;

D. Allowing family and medical leave insurance benefits under C.R.S. § 8- 13.3-504(2)(c) to be taken by a covered individual with any serious health condition;

E. Allowing family and medical leave insurance benefits under C.R.S. § 8- 13.3-504(2)(e) to be taken for any safe leave purposes;

F. Providing a wage replacement rate for all family and medical leave insurance benefits of at least the amount required by C.R.S. § 8-13.3- 506(1)(a), and issuing payments no less frequently than required by C.R.S. § 8-13.3-505(2);

G. Providing a maximum weekly benefit for all family and medical leave insurance benefits of at least the amount specified in C.R.S. § 8-13.3- 506(1)(b);

H. Allowing a covered individual to take intermittent leave as authorized by C.R.S. § 8-13.3-505(3) or a reduced leave schedule pursuant to 7 CCR 1107-3;

I. Imposing no additional conditions or restrictions on family and medical leave insurance benefits, or paid family and medical leave taken in connection therewith, beyond those explicitly authorized by the FAMLI Act or regulations issued pursuant to the FAMLI Act;

J. Allowing any employee covered under the private plan who is eligible for family and medical leave insurance benefits under the FAMLI Act to receive benefits and take paid family and medical leave under the private plan; and K. Providing that the cost to employees covered by a private plan shall not be greater than the cost charged to employees under the state plan under C.R.S. § 8-13.3-507.

2. Subject to the limitations described at Section 5.5.3 of these rules, an approved private plan shall be in the form of either self-insurance or a policy obtained through an insurer approved by the state. An insurer shall not allow coverage for an employer under its policy to become effective earlier than thirty (30) days after the employer has received private plan approval from the FAMLI Division.

3. Private plans must offer benefits to all covered individuals employed by the employer. Nothing prohibits a private plan from covering multiple employers’ workforces; however, if an employer intends to meet its obligations under the FAMLI Act and its implementing regulations with an approved private plan, it must apply for private plan approval, pay the administrative fee described in these rules, pay the maintenance fee described in these rules, and otherwise comply with these rules regardless of how many other employers use or intend to use the same private plan to meet their obligations under the FAMLI Act and its 4. Private plans must not impede the ability of an employer, an employee, or a private plan administrator to comply with the provisions of the FAMLI Act or its 5. The earnings requirement necessary to be a “covered individual” pursuant to C.R.S. § 8-13.3-503(3)(a)(I) is not “per-employer” and private plans may not deny or otherwise limit benefits to which the covered individual would otherwise be entitled. However, if the private plan administrator does not have verified wages from other employers, the private plan administrator may determine a claimant’s wage replacement amount based on the private plan employer’s wages, so long as the employee is able to appeal the benefit decision to provide accurate wage information for their other employment.

4. Employers who are approved to provide FAMLI benefits under a self-insured plan must establish and maintain a separate account for their localized Colorado employees: (1) into which all localized employee contributions are deposited and kept; and (2) from which all benefits for localized employees must be paid, and from which private plan administrative costs may be paid. Employers may not withdraw from the account except to pay benefits and private plan administrative costs. Upon any voluntary or involuntary termination of a self-insured plan, the employer must remit the remaining balance of the account to the Division.

5. All private plans must provide for the confidentiality of employee information related to FAMLI benefits, and such information must be kept separate from all other employment records.

6. By submitting an application for benefits to a private plan administrator, the claimant consents to the private plan administrator sharing with the employer limited information necessary for the employer to comply with federal or state tax laws or tax regulations, or to coordinate FAMLI benefits with other benefits for which the claimant is eligible, in accordance with the information-sharing provisions of 7 CCR 1107-4, including the wage replacement amount and the reason for leave. The employer shall not request, and the private plan administrator shall not provide, information that is not absolutely necessary for such tax law compliance or benefit coordination. An employer's request for information not absolutely necessary for such purposes, or a private plan administrator's provision of information not absolutely necessary for such purposes, may constitute discrimination, retaliation, and/or interference in violation of C.R.S. § 8-13.3-509. The employer must store and maintain the confidentiality of such information in accordance with all applicable federal, state, and local laws and regulations, and failure to do so may constitute discrimination, retaliation, and/or interference in violation of C.R.S. § 8-13.3-509.

7. All private plans must provide that an employee shall be provided, upon request and free of charge, reasonable access to, and copies of, all documents, records, and other information relevant to the employee’s claim for benefits within seven (7) days of the request. If the Division determines that an employee was not granted access and copies in violation of this section, the Division may assess upon the private plan administrator a fine of up to $250.00 per violation.

8. With regard to forms that claimants and/or health care providers will be required to complete in relation to a claim for benefits, all private plans shall either utilize the forms provided by the Division, or utilize forms that are no more onerous than the forms provided by the Division. If a private plan administrator makes changes to an approved form, they may submit the revised form to the Division for review and approval. If the Division determines that an employee had to, as a condition to access benefits, use a form more onerous than the forms provided by the Division, the Division may assess upon the private plan administrator a fine of up to $500.00 per violation, except that the Division shall not assess a fine for a form that it has approved.

9. Private plans must determine whether an application for benefits is properly filed, and must do so in a manner consistent with 7 CCR 1107-3 Section 3.6.9.

10. In accordance with C.R.S. § 8-13.3-521(7), in addition to the initial administration fee described in these rules, starting in 2025, an employer with an approved private plan must pay the Division an annual maintenance fee to cover amounts expended by the division for costs arising out of the administration of private plans.

A. Maintenance fees will be due by December 31 of each year and will reflect approximate costs incurred by the Division during the prior fiscal year beginning July 1 and ending June 30. The Division may extend the deadline to pay a maintenance fee for good cause.

B. Approximate costs will equal the sum of:

1. Midrange annual salaries of the positions tasked with the administration and oversight of private plans, as set forth in the State of Colorado Basic Pay Plan issued by the Department of Personnel and Administration for that fiscal year; and;

2. The cost of any contracts entered into by the FAMLI Division with another entity for the administration and oversight of private plans.

C. Maintenance fees shall only be due from employers who had private plan coverage throughout the relevant fiscal year, and shall be calculated by first dividing approximate costs by the number of such employers, and then rounding that amount to the nearest dollar. No maintenance fee will be due from an employer who did not have private plan coverage throughout the entire relevant fiscal year.

D. For 2025, the maintenance fee will be $142.00. Starting in 2026, maintenance fees will be calculated and published on the Division’s website by July 31.

E. In no event shall the maintenance fee increase more than 10% from the prior year’s maintenance fee.

F. Employers may request a reconsideration of their maintenance fee within forty-nine (49) days after its due date. That deadline may be extended by an additional forty-nine (49) days for good cause. The outcome of a maintenance fee reconsideration may be appealed pursuant to 7 CCR 1107-9. A hearing officer shall only overturn a maintenance fee assessment upon a finding that the employer did not have private plan coverage for the entire fiscal year, or upon a finding that the Division abused its discretion.

G. Employers who are members of a professional employer organization (“ PEO”) certified pursuant to C.R.S. § 8-70-114 do not have to pay an annual maintenance fee if the PEO has an approved private plan that covers all the employer's Colorado employees. The certified PEO counts as one employer and will be assessed a maintenance fee.

13. Private plans must make reasonable efforts to make forms and communications under these rules available in an individual’s primary language.

14. The internal reconsideration and appeals procedures under a private plan need not be equivalent or better than those procedures under the state plan, so long as the private plan provides for appeals to the Division and any court of competent jurisdiction, in accordance with C.R.S. § 8-13.3-521(5). However, all determinations under a private plan are appealable directly to the Division pursuant to 7 CCR 1107-9, and a private plan may not require a claimant to go through any internal review, reconsideration, or appeal before appealing a private plan determination to the FAMLI Division.

15. Private plans will not be reviewed or approved for any local government, or for any individual electing coverage pursuant to C.R.S. § 8-13.3-514.

16. An insurer approved by the state shall send notification to the Division within fourteen (14) days after any lapse in or end of coverage under the policy. The notification shall include:

A. The effective date of the lapse in or end of coverage;

B. The cause of the lapse in or end of coverage;

C. Whether the employer may reinstate the policy;

D. If eligible for reinstatement, the time period during which the employer has to reinstate; and E. If eligible for reinstatement, the requirements for reinstatement.

17. An insurer approved by the state shall send notification to the Division within three (3) business days after the employer is sent notification of reinstatement.

The reinstatement notification shall include:

A. The effective date of the reinstatement;

B. Whether there was a lapse in coverage; and C. If there was a lapse in coverage, the dates coverage lapsed. 5.4 Application Requirements and Effective Date of New Private Plans 1. Private plans must be approved by the Division prior to implementation. Private plans in the form of an insurance policy issued by an insurer approved by the state must first be submitted to the Colorado Division of Insurance for approval.

2. To obtain approval of a private plan, an employer must first submit a complete private plan application for private plan approval to the Division. Entities with separate federal employer identification numbers (FEINs) must submit separate applications and pay separate application fees, except that employers who are members of a professional employer organization (“PEO”) certified pursuant to C.R.S. § 8-70-114 do not have to pay an application fee if they are covered by their PEO’s private plan and their PEO has paid an application fee. Applications may be submitted at any time, and the Division will review complete private plan applications as they are received.

3. A complete private plan application for private plan approval must include:

A. The employer’s federal employer identification number (“EIN”);

B. The employer’s name;

C. The employer’s business address;

D. The employer’s mailing address;

E. A designated contact person, with that person’s name and contact information;

F. A copy of the employer’s self-insured private plan, or if the private plan is in the form of an insurance policy provided by an insurer approved by the state, a copy of that insurance policy form;

G. If the private plan is in the form of self-insurance, a surety bond, issued by a surety company authorized to transact business in Colorado, in an amount equal to one year of total premiums calculated pursuant to C.R.S. § 8-13.3-507, along with payroll documentation supporting the surety bond calculation;

H. If the private plan is in the form of self-insurance, attestation that the employer has complied with the separate account requirements at Section 5.3.6 of these rules;

I. An attestation, completed by the employer, that the employer understands, and the private plan satisfies, the requirements set forth in the FAMLI Act and its implementing regulations;

J. An attestation, completed by the employer, that the forms used by the employees and/or health care providers will be no more onerous than the forms used by employees and/or health care providers under the state plan;

K. A copy of the posted notice required by Section 5.9.4 of these rules;

L. Other information as required on the application form; and M. An administration fee of:

1. $500.00 for private plan applications received through 2024; and 2. For private plan applications received in 2025 and later, the amount determined by the Director pursuant to C.R.S. § 8-13.3-521(7), and published on the Division’s website.

2. Approved private plans must take effect no earlier than sixty days after the date the Division receives a complete private plan application so that the Division has sufficient time to review the application, and the employer has sufficient time to provide notice to employees in accordance with Section 5.9 of these rules.

3. The employer must submit to the Division any forms to be used by employees and/or health care providers under the approved private plan at least thirty (30) days prior to making them available to employees for usage.

4. Employers remain liable to the FAMLI Division for premiums on wages paid until the effective date of the approved private plan, and remain entitled under C.R.S. § 8-13.3-507(5) to withhold the employees’ share of premiums from wages paid until the effective date of the approved private plan. Throughout the duration of an approved private plan, employers may withhold premiums deductions from employees in an amount not to exceed the amount authorized by C.R.S. § 8-13.3-507(5), if such a deduction is pursuant to the terms of the approved private plan.

5. Employees remain eligible for benefits under the FAMLI Act until the effective date of the approved private plan.

6. Benefits awarded to an employee must be paid by the plan that awarded the benefits for the full duration of the employee’s approved FAMLI benefits claim, pursuant to 7 CCR 1107-4 Section 4.9.1.

A. In the event of an approved private plan failing to pay benefits due to an insurance carrier’s insolvency, if the policy is covered by an insurance guaranty association, the claims will be paid by the insurance guaranty association pursuant to their rules and procedures. If the policy is not covered by a guaranty association, then the employer will become responsible for paying all claims approved by the private plan prior to the date of insolvency. In either event, the employer shall immediately notify the FAMLI Division of the insolvency, the notice requirements under Section 5.14 of these rules are waived, and the employer will be deemed covered under the state system.

B. If a self-insured employer fails to pay benefits as awarded and private plan approval is withdrawn pursuant to Section 5.16 of these rules, the Division shall execute upon the surety bond and use the proceeds and the remaining funds in the separate account established pursuant to Section 5.3.6 of these rules to pay benefits due for claims arising prior to the date of termination.

C. If an employer fails to pay benefits as required by 5.4.8.A, or if the surety bond and remaining funds are insufficient to pay the benefits under 5.4.8.B, those claims shall be paid by the FAMLI Division. The employer is indebted to the Division for such amounts, and the Division may pursue all legal means to collect such amounts from the employer. 5.5 Review of Private Plan Applications 1. If the Division does not approve an application for a private plan, the Division shall notify the employer in writing of any issues that must be addressed in order for the private plan application to be approved.

2. The employer may request to meet and confer with the Division to discuss the issues and how they can be addressed, and the Division shall make a good faith effort to schedule a prompt meeting with the employer at a convenient time and in a convenient manner.

3. For applications for self-insured private plans received by the Division on or after January 1, 2025, the employer must use the self-insurance private plan template approved by the FAMLI Division and published on its website. If the Division makes changes to the self-insured private plan template, it will deliver an addendum to the employer with a self-insured private plan that shall function as an approved amendment to the previously approved self-insured private plan. An employer must incorporate the addendum into the self-insured private plan by the effective date provided in the addendum. If an employer needs to incorporate more than four (4) addendums to an approved self-insured private plan, the employer shall submit an amended private plan using the self-insured template approved by FAMLI, which will incorporate any previously approved addendums, to the Division for approval at least thirty (30) days prior to the required effective date of the restated self-insured private plan. Failure to amend a self-insured private plan template by the effective date provided by the Division may result in the involuntary withdrawal of private plan approval.

4. The employer may submit another application for private plan approval after sufficiently addressing any identified issues.

5. No additional administrative fee will be assessed for an application received within one year of the initial application for private plan approval.

6. Each application is a separate application for purposes of determining the effective date of an approved private plan.

7. The Division may deny a private plan application based on a record of prior noncompliance with federal or state laws or regulations by the legal entity, its owners, or its officers, where that record of prior noncompliance gives rise to a reasonable concern of future noncompliance with the FAMLI Act and its 8. The outcome of a private plan application is subject to an appeal, in accordance with 7 CCR 1107-9. 5.6 Surety Bond Requirement for Employer Self-Insured Private Plan 1. The Division will only accept a surety bond issued by a surety company authorized by the Colorado Insurance Commissioner to transact such business in Colorado.

8. The bond amount must be an amount equal to one year of total premiums calculated pursuant to C.R.S. § 8-13.3-507.

9. The bond amount must be based on four quarters of projected wages, as represented by:

A. The previous four quarters of wages reported by the employer to the Division, in accordance with 7 CCR 1107-3 Section 3.3.2; or B. If the employer has not reported wages to the Division for four quarters, the previous four quarters of wages paid to its employees; or C. If none of the above is possible, a reasonable estimate of one year of projected wages supported by documentation.

4. The Division may disapprove a private plan if an employer fails to provide documentation the Division deems necessary for purposes of calculating an appropriate surety bond amount. This disapproval is a determination subject to appeal pursuant to 7 CCR 1107-9.

5. If an employer has reason to believe that the amount calculated pursuant to

Section 5.6.3 of this rule does not accurately reflect its projection of the next year of wages, the employer must notify the Division and provide an explanation as to why, along with any supporting documentation.

6. A surety bond shall be issued on a form prescribed by the Division.

7. The bond must include a statement that the bonding company must give ninety (90) days’ notice of its intent to terminate liability to both the principal and the Division, except that if the bonding company is terminating liability because it is issuing a replacement bond, it may do so without providing prior notice. In the event of a replacement bond, the surety company and the employer must notify the Division no later than fourteen (14) days after its effective date.

8. The employer must maintain surety bond coverage for the duration of its approved self-insured private plan.

9. The Division will review the bond annually to ensure that the amount corresponds with the wage projections as described in this rule. The employer must provide the Division with any documentation necessary to review the bond amount. If the Division determines that the bond amount must be increased, the employer must do so to maintain private plan approval. If the Division determines that the bond amount exceeds the projected wages as described in Section 5.6.3 of this rule, the employer may reduce the bond amount to match such projected wages.

10. The Division may execute on and collect the bond amount if the employer’s private plan approval is terminated, voluntarily or involuntarily, pursuant to these rules.

A. The Division may execute on and collect the entire bond amount, less any funds received from the employer within 30 days after the effective date of the termination of the private plan approval or as agreed upon by the employer and the Division.

B. Funds so received by the Division from the employer and/or the surety, as well as funds received by the Division pursuant to Section 5.3.6 of these rules, will be deposited into the fund, and if applicable, will be credited toward the employer’s obligations under Section 5.17 of this rule, and will not be refunded pursuant to 7 CCR 1107-1, Section 1.4.8.B. 5.7 Duration of Private Plan Approval; Renewal Requirements 1. Unless otherwise authorized by the Division pursuant to these rules, private plan approval expires after eight years from the date that the private plan went into effect.

2. Employers seeking renewal of their private plan approval must submit an application for renewal at least sixty (60) days before the expiration of their private plan approval. The Division will send to the employer’s email address an expiration notice at least ninety (90) days before the expiration of the private plan’s approval. 5.8 Partial Colorado Workforce Coverage Prohibited If an employer meets its obligations under the FAMLI Act and its implementing regulations with an approved private plan, it must cover all of the employer’s employees localized in Colorado in accordance with 7 CCR 1107-1. 5.9 Notice to Employees of Private Plan Benefits and Administration 1. No later than thirty (30) days before the effective date of an approved private plan, an employer must deliver to each of its employees a written notice of its election and approval by the Division to offer a private plan in lieu of participating in the state plan. For an employee whose start date or Colorado transfer is later than thirty (30) days before the effective date of an approved private plan, an employer must deliver the written notice to the employee immediately upon hire or transfer. Additionally, the employer must deliver the private plan notice to an employee within five days after either learning of an employee experiencing an event that triggers eligibility pursuant to C.R.S. § 8-13.3-504, or receiving from the employee a request for leave under the Family and Medical Leave Act at 29 U.S.C. § 2601 et seq., absent extenuating circumstances.

3. The written notice may be delivered to the individual employee electronically, in person, or via mail.

4. The written notice must include:

A. The effective date of the approved private plan;

B. A description of the private plan’s wage replacement benefits;

C. A description of the private plan’s leave and employment protection benefits;

D. A description of how employee eligibility is determined;

E. A description of how any employee contributions are calculated and collected;

F. A description of how and when an employee may file a claim for benefits under the approved private plan;

G. A notification to the employee of the employee’s appeal rights pursuant to the FAMLI Act, and if applicable, of the employee’s optional alternative to appeal a benefits determination to the private plan administrator;

H. Contact information for the FAMLI Division and the plan administrator; and I. A notification to the employee of the employee’s rights under C.R.S. § 8- 13.3-509.

4. In addition to delivering the written notice to each of its employees localized in Colorado, an employer must post a notice containing the same information.

A. The notice must be posted in a conspicuous and accessible place in each establishment where employees are employed.

B. The notice must be in English, Spanish, and any language that is the first language spoken by at least five percent of the employer’s Colorado workforce.

C. If the employer does not maintain a physical workplace, or an employee works remotely, the employer may satisfy the posting requirement by sending the notice via email or through a conspicuous posting in a webbased or app-based platform that the employee regularly uses.

5. If the Division determines that an employer has violated any part of Section 5.9 of these rules, the Division may assess upon the employer a fine of up to $500.00. 5.10 Collection of Employee Contributions Authorized Where an employer lawfully deducts premium contributions from an employee’s wages pursuant to C.R.S. § 8-13.3-507(5) or the terms of an approved private plan, then for the purposes of compliance with C.R.S. § 8-4-105, premium contributions are considered wages paid for the benefit of the employee, and collecting such premium contributions does not violate C.R.S. § 8-4-105(2). If an employer deducts premium contributions from an employee’s wages, and subsequently receives a refund of premiums paid from the private plan, the employer must distribute the refund proportionately and in accordance with how it was collected. If an employee terminates employment with the employer, any premiums previously deducted remain part of the employer’s approved private plan. 5.11 Calculation of Benefits Under Private Plans Private plans must provide a wage replacement rate for all family and medical leave insurance benefits of at least the amount required by 7 CCR 1107-3 Section 3.5. Private plan benefits are not subject to Colorado income tax. 5.12 Recordkeeping and Reporting Requirements; Division Access to Records 1. A private plan administrator must keep and maintain documentation of the following for a minimum of six years:

A. Applications for benefits;

B. Benefits paid, including payment dates and amounts;

C. Adverse determinations of benefits applications;

D. Internal appeals received;

E. The outcome of internal appeals received; and F. Documents, including wage data, containing the information upon which benefits determinations were based.

2. An employer must keep and maintain documentation of the following for a minimum of six years:

A. Records of any premium contributions it collected from employees.

B. Wage records.

3. A private plan administrator must, on a quarterly basis, submit to the Division a private plan administration summary of the previous calendar quarter. The private plan administration summary must be submitted no later than the last day of the month immediately following the end of the calendar quarter addressed by the summary. After a private plan administrator has submitted timely quarterly administration summaries for three years, the private plan administrator may, unless otherwise directed by the Division, submit its private plan administration summary annually, which will be due on January 30 of each year. Information received by the Division in the private plan administration summary will be aggregated so that the Division can comply with its reporting obligations at C.R.S. § 8-13.3-519. The private plan administration summary must include aggregate summaries of the following:

A. Total number of benefits applications received;

B. Total number of benefit applications approved, pending, denied, or closed.

C. Total benefit amounts paid;

D. Total number of employees covered under the private plan;

E. The purposes for approved leave;

F. The reported gender of individuals for whom leave was approved, and for whom leave was denied in whole or in part;

G. The average weekly wage of individuals for whom leave was approved;

H. If leave was taken to care for a family member, the relationship of that family member to the beneficiary;

I. Total number of appeals received; and J. Total number of appeals affirmed, reversed, modified, or withdrawn.

4. For private plan administrators who administer private plans for multiple employers, the aggregate summaries included in the private plan administration summaries may be aggregated across employers.

5. Within twenty-eight (28) days of the Division’s written request, a private plan administrator or an employer with an approved private plan shall provide any documentation either is obligated to maintain pursuant to Section 5.12 of these rules. If the employer or private plan administrator requests an extension and provides good cause for the extension, the Division may extend the 28-day deadline. If the employer or private plan administrator does not provide the requested documentation by the deadline, the Division may withdraw its approval of the private plan. 5.13 Modification of a Private Plan 1. An employer shall notify the Division, in writing, of any material change to an approved private plan at least sixty (60) days before the change is to take effect.

However, if an employer is changing from one approved private plan to another approved insurance carrier’s private plan, the employer must notify the Division, in writing, of the change at least thirty-five (35) days before the change is to take effect. The notification shall include:

A. A detailed explanation of all material changes; and B. For self-insured private plans, a statement describing how any material changes do not reduce benefits or impose new requirements on covered employees beyond what would be provided and required under the state plan.

2. The Division will review the material change to the approved private plan, and will determine whether the material change impacts private plan approval. The Division will make a good faith effort to confer with the employer regarding any impact to continued private plan approval, and to notify the employer of its determination within thirty (30) days of the employer’s notification to the Division.

In no event may an employer make a material change without first obtaining Division approval and providing at least thirty (30) days’ notice to its employees.

3. Material changes to an approved private plan include, but are not limited to:

A. Changing from one private plan to another;

B. Changing the private plan to reduce benefits or leave types;

C. Changing the private plan to increase claims adjudication timeframes;

D. Changing the private plan to increase benefits payment timeframes; or E. Changing the private plan to increase the information collected from employees to apply for or receive benefits.

4. Material changes to an approved private plan do not include:

A. Updating the private plan benefits application form in a way that does not make the form more onerous than the state’s benefits application form;

B. Changing business or contact information;

C. Correcting typographical errors;

D. Increasing benefits or leave types; or E. Updating the private plan to align with regulatory changes.

5. A change to an approved private plan will not extend the duration of its approval.

6. If the Division determines that an employer has not notified the Division of a material change in accordance with Section 5.13 of these rules, the Division may assess upon the employer a fine of up to $250.00. If the Division determines that an employer has not notified its employees of a material change in accordance with Section 5.13 of these rules, the Division may assess upon the employer a fine of up to $100 per employee per day. 5.14 Voluntary Termination of an Approved Private Plan by an Employer 1. Before terminating coverage under an approved private plan as part of a transition to the state plan, an employer must provide at least thirty (30) days advance written notice to its employees and to the Division. Coverage termination as part of a transition from one private plan to another is governed by

Section 5.13 of this rule.

2. The Division will withdraw approval of an employer’s private plan, effective the date coverage under the private plan was terminated.

3. If the employer terminates coverage under an approved private plan without providing thirty (30) days advance notice to its employees, the Division may assess upon the employer a fine of up to $500.00 per employee who did not receive timely advance notice. If the Division awards benefits to an employee with a benefit start date occurring during the thirty days after their employer delivers notice to the Division pursuant to Section 5.14.1 of these rules, the Division may assess upon the employer separate fines of up to $500.00 per employee who received such benefits. 5.15 Expiration of an Approved Private Plan If an employer does not renew its private plan in accordance with Section 5.7 of these rules, the employer will be deemed to have voluntarily terminated its private plan, and will be subject to the requirements in Section 5.14 of these rules. 5.16 Involuntary Termination of a Private Plan by the Division 1. The Division will withdraw approval for a private plan when the terms or conditions of the plan have been violated. Causes for plan termination shall include, but not be limited to, the following:

A. Failure to pay benefits in the amount and duration required by the FAMLI Act and its implementing regulations;

B. Failure to pay benefits in the amount and duration required by the private plan, where the private plan provides benefits in a greater amount or duration than is required by the FAMLI Act and its implementing regulations;

C. Failure to pay benefits within the timeframes and in the manner specified by the FAMLI Act and its implementing regulations;

D. Failure to maintain an adequate surety bond in accordance with the FAMLI Act and its implementing regulations;

E. Misuse of private plan money, including the use of private plan funds for anything other than paying out and administering benefits, or transferring private plan funds from an account established pursuant to Section 5.3.6 of these rules to any account not exclusively for holding private plan funds;

F. Failure to submit reports or comply with other compliance requirements as required by the FAMLI Act and/or its implementing regulations;

G. Failure to pay the annual maintenance fee;

H. Failure to maintain private plan coverage; or I. Failure to otherwise comply with the FAMLI Act and its implementing 2. The Division will conclude that the terms or conditions of the plan have been violated, and therefore withdraw approval of the private plan, if the Division determines that the employer or the private plan administrator has repeatedly violated the private plan’s terms and/or the FAMLI Act and its implementing rules, has willfully or recklessly violated the private plan’s terms and/or the FAMLI Act or its implementing rules, or has otherwise violated the private plan’s terms and/or the FAMLI Act or its implementing rules in such a way that indicates a widespread compliance concern.

3. If the Division withdraws approval of an employer’s private plan, the Division will issue to the employer and the private plan administrator a Notice of Withdrawal of Private Plan Approval. The employer may appeal that withdrawal to the Division pursuant to 7 CCR 1107-9. If the employer does not appeal the withdrawal, the effective date is the day following the opportunity for a good cause extension to the appeal deadline specified by 7 CCR 1107-9, except that if the Division withdraws approval because the employer failed to maintain private plan coverage, the effective date is the date coverage ended. The Division will stay the withdrawal of approval during an appeal unless the Division withdrew approval because the employer failed to maintain private plan coverage. 5.17 Employer Obligations After Termination of Private Plan Approval 1. Within seven (7) days of the effective date of a voluntary or involuntary termination of private plan approval, the employer must notify all Colorado employees of the termination, notify all Colorado employees that they are under the state plan as a result of the termination, and deliver to all Colorado employees the information contained in the program notice described at C.R.S. § 8- 13.3-511.

4. If an employer’s workforce becomes covered by the state plan because the employer’s private plan approval was voluntarily or involuntarily terminated, the employer must remain covered by the state plan and pay premiums to the state for a period of at least three (3) years and deliver to the Division all remaining amounts in the account established pursuant to Section 5.3.6 of these rules.

5. If the employer returns to coverage under an approved private plan before the end of three (3) years, the employer must pay to the state the amount of premiums it would have been required to remit pursuant to C.R.S. § 8-13.3- 507(5) through the remainder of the three-year period. The employer may choose to either remit the remainder as a lump sum based on a projection determined by the Division, or may continue to remit premiums based on actual wage data on a quarterly basis through the remainder of the three-year period.

6. If the Division determines that an employer has violated Section 5.17 of these rules, the Division may assess upon the employer a fine of up to $100.00 per employee per day. 5.18 Division Oversight of Private Plans 1. The Division may, at any time at its sole discretion, initiate a review of a private plan and its administration to determine whether the private plan and its administration are in accordance with the FAMLI Act and its implementing 2. Upon initiation of a review and request by the Division, the private plan administrator and the employer shall provide all information and documentation necessary to conduct the review.

7. The Division will ensure confidentiality of records.

8. Information and documentation requested by the Division must be provided within fourteen (14) days after the request. The Division may extend the deadline where good cause for such an extension exists.

9. Failure to provide information and documentation necessary for the Division’s review of a private plan and its administration may result in the Division’s withdrawal of the private plan’s approval, and may result in a fine of up to $250.00 per employee whose information is requested, per day that it is late.

10. Upon determination that a private plan administrator is not administering private plans in accordance with the FAMLI Act and its implementing regulations, the Division may withdraw its approval of private plans administered by that private plan administrator, and may deny approval of future private plans administered by that private plan administrator. If the Division withdraws approval pursuant to this rule, it will make a reasonable effort to do so in a way that ensures employers can maintain consistent coverage for their employees. All withdrawals of private plan approval may be appealed pursuant to 7 CCR 1107-9. 5.19 Appeals 1. Claimants under an approved private plan may appeal any adverse determination made by the private plan administrator pursuant to 7 CCR 1107-9, including but not limited to:

A. A private plan administrator’s failure to issue a determination within two weeks of filing;

B. A private plan’s adverse determination of a claim for benefits;

C. A private plan’s failure to pay the full claim it approved;

D. A private plan’s closure of a claim based on its determination that the claim was not properly filed in accordance with 7 CCR 1107-3 Section 3.6.9;

E. A private plan’s determination that an employee is disqualified from benefits due to its conclusion that the employee willfully made a false statement or misrepresentation regarding a material fact, or willfully failed to report a material fact, to obtain benefits;

F. A private plan’s identification and/or collection of an overpayment; or G. A private plan’s failure to issue payments in accordance with C.R.S. § 8- 13.3-505(2).

2. A claimant under an approved private plan may file an appeal with the Division, or may choose to file an appeal with the private plan administrator if the private plan allows for a discretionary internal appeal mechanism. Regardless of whether there is an internal private plan appeal process, a claimant under an approved private plan may choose to file an appeal directly to the FAMLI Division in accordance with 7 CCR 1107-9.

3. If a claimant chooses to file an appeal with the private plan administrator, the claimant may appeal the outcome of that appeal to the Division in accordance with 7 CCR 1107-9.

4. If a covered individual appeals a benefit determination under an approved private plan, and the Division determines that the covered individual is entitled to additional payment, the Division will notify the private plan administrator, and the private plan administrator must pay the additional amount within the same time frames the Division would have to pay additional amounts pursuant to 7 CCR 1107-9.

5. The Division will specify the benefit amount due and when such additional payments are due in its determination.

6. If the Division overturns or modifies a benefits determination under an approved private plan, and the private plan administrator seeks judicial review of the Division’s decision, the private plan administrator must still pay the additional amount within the timeframes above. However, if the Division’s determination is overturned or modified by a court upon judicial review, the private plan administrator may:

A. Deduct any overpayment from an employee’s wages in accordance with C.R.S. § 8-4-105, if the private plan administrator is the employee’s employer;

B. Enter into a repayment plan with the employee; or C. File suit against the employee in a court of competent jurisdiction to recover the overpayment. 5.20 Fines 1. If, upon appeal or judicial review, the Division or a court determines that the private plan administrator owes additional payments to a covered individual, and the private plan administrator fails to issue payment of the benefits by the date or dates specified by the Division or the court in its determination, then the Division may assess fines upon the private plan administrator.

2. Each day after the due date that additional payments owed by a private plan to an individual claimant go unpaid constitutes a separate violation.

3. The Division may assess fines as follows:

A. For the first day of nonpayment after the due date, a fine of up to $100.00 per individual claimant;

B. For the second day of nonpayment after the due date, a fine of up to $200.00 per individual claimant;

C. For the third day of nonpayment after the due date, a fine of up to $300.00 per individual claimant;

D. For the fourth day of nonpayment after the due date, a fine of up to $400.00 per individual claimant; and E. For the fifth day of nonpayment after the due date, and for every additional day thereafter, separate fines of up to $500.00 per day per individual claimant. ______________________________________________________________________ Editor’s Notes

History New rule eff. 12/30/2022.

Rules 5.1-5.6, 5.9-5.14, 5.16-5.19 eff. 01/01/2024.

Rules 5.1 3, 5.3-5.6, 5.9, 5.12-5.19 eff. 01/01/2025. Rule 5.21 repealed eff. 01/01/2025.

Rules 5.1 3, 5.5 1-4, 5.9 1, 5.14 2-3, 5.16 1.H-I, 5.16 3 eff. 07/01/2025.

Entire rule eff. 10/30/2025.

Rules 5.1 3, 5.3 1.F, 5.3 8, 5.3 11, 5.4 2-4, 5.5 3, 5.5 7-8, 5.6 3, 5.7, 5.11, 5.12 3, 5.19 1.G eff. 01/01/2026.

7 CCR 1107-6 Regulations Concerning Program Integrity {#sec-7-ccr-1107-6 omnilex-key=us-co-regs-official--department-10--7 CCR 1107-6}

DEPARTMENT OF LABOR AND EMPLOYMENT

REGULATIONS CONCERNING PROGRAM INTEGRITY

7 CCR 1107-6 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ 6.1 Statements of Authority, Purpose, and Incorporation by Reference 1. This regulation is adopted pursuant to the authority in section C.R.S. § 8-13.3-501 et seq. and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24-4-101 et seq. (the “APA”), and the Paid Family and Medical Leave Insurance Act, C.R.S. § 8-13.3-501 through 524 (the “Act” or “FAMLI”).

2. The general purpose of these rules is to exercise the authority of this Division to enforce and implement the Paid Family and Medical Leave Insurance Act (C.R.S. § 8-13.3-501 et seq.) with regard to program integrity.

3. If any part of these rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 6.2 Definitions and Clarifications 1. Unless otherwise indicated, terms used here that are defined in the Act have the same definition as they do under the Act.

4. “Benefit Overpayment” means a payment in excess of the amount authorized by the Act and its implementing regulations.

5. “Claimant” has the same definition as 7 CCR 1107-3, Section 3.2.7.

6. “Correct Address” has the same definition as 7 CCR 1107-8, Section 8.2.6.

7. “Determination” has the same meaning as defined in 7 CCR 1107-9, Section 9.2.8.

8. “Equity and Good Conscience” means fairness as applied to each individual case after considering the totality of the circumstances. When determining whether an individual or entity shall pay an amount owed to the Fund (e.g. benefit overpayment, fines or interest), the Division or private plan administrator may consider the following factors to determine equity and good conscience, including, but not limited to:

A. The individual’s financial condition required that the amount owed be spent on reasonable and necessary living expenses;

B. The individual’s household income is below 200% of the federal poverty income guidelines;

C. The individual or entity lacks the ability to pay the amount owed based on prior income level, current income and assets, and future earnings potential;

D. Requiring repayment will cause extraordinary financial hardship by depriving the individual of the ability to provide for basic necessities that cannot be deferred such as food, shelter, clothing, utilities, and medical costs;

E. The individual detrimentally changed their position in reliance on the receipt of the overpaid benefits including, but not limited to, entering into a financial and/or contractual obligation that they would not have entered except for the receipt of the overpaid benefits;

F. The individual relinquished a valuable right in reliance on the receipt of the overpaid benefits, including the receipt of other governmental benefits for which they would have been entitled except for the receipt of the overpaid benefits. Although the individual is not required to apply for governmental benefits and be rejected from receiving them, they may be required to prove eligibility for such benefits by establishing their economic situation at the time family and medical leave insurance benefits were received as well as the requirements for receiving said benefits;

G. The individual’s knowledge or lack of knowledge regarding an employer’s incorrect reporting of wages; and/or H. The individual’s knowledge or lack of knowledge with regard to a provider who fails to meet the definition of health care provider, or who has provided a diagnosis or treatment outside of their licensed scope of practice, or has a license that has been suspended or revoked at the time the provider completes documentation regarding the individual’s need for family and medical leave.

7. “Fees” means any additional charge by a private plan added to an outstanding amount owed.

8. “Party” or “Parties” means a claimant, employee, employer, or individual electing coverage involved in a proceeding.

9. “Qualifying Condition” means a reason for leave described at C.R.S. § 8-13.3-504(2). 6.3 Benefits Overpayments 1. A claimant who receives family and medical leave insurance benefits they are not entitled to receive shall be liable for repayment of the amount overpaid, unless otherwise relieved pursuant to section 6.3.7. Circumstances giving rise to a benefits overpayment include, but are not limited to a(n):

A. Division miscalculation that occurs without any fault from the claimant or is caused by a claimant’s omission, willful misrepresentation, or fraud;

B. Determination by the Division that the claimant does not qualify for family and medical leave insurance benefits because they are not localized in Colorado pursuant to the instate status provisions of 7 CCR 1107-1, are not a covered individual, do not have a qualifying condition, or are disqualified from receiving family and medical leave insurance benefits because of a willful false statement or misrepresentation pursuant to C.R.S. § 8- 13.3-513;

C. Claimant’s failure to notify the Division of an event that causes benefit payments to change pursuant to 7 CCR 1107-3, Section 3.10.1;

D. Claimant who, during time designated as FAMLI leave, performs work for the employer from which they are taking FAMLI leave;

E. Claimant who is receiving family and medical leave insurance benefits, continuous or intermittent, during a period of unemployment, except as described in 7 CCR 1107-3

Section 3.4.1.A;

F. Claimant receiving family and medical leave insurance benefits for an absence from work that is caused by circumstances that would entitle the claimant to temporary indemnity benefits under the Colorado Workers’ Compensation Act in violation of 7 CCR 1107-4,

Section 4.3;

G. Claimant receiving family and medical leave insurance benefits during any week the individual receives unemployment benefits for the same job pursuant to the Colorado Employment Security Act in violation of 7 CCR 1107-4, Section 4.4;

H. Claimant receiving family and medical leave insurance benefits when their family and medical insurance leave benefits have been exhausted;

I. Modification of reported wages that results in a recalculation of benefits; or J. Health care provider who fails to meet the definition of “health care provider” as defined by C.R.S. § 8-13.3-503(13), has provided a diagnosis, treatment, or leave certification outside of their licensed or certified scope of practice, or has a license or certification that has been suspended or revoked at the time the provider completes documentation regarding the individual’s need for family and medical leave.

2. Benefit overpayments may be identified through any lawful means, including but not limited to Division audits, Division investigations, or external tips.

3. The Division will notify claimants of any determination of benefit overpayment by sending the claimant a determination letter to the claimant’s correct address. If the claimant has provided an email address, the Division shall send the determination via email, and such delivery via email will satisfy the requirement to send the determination letter to the claimant’s correct address.

4. The claimant may appeal a determination of benefit overpayment as detailed in 7 CCR 1107-9.

5. Any outstanding benefit overpayment owed to the Fund by the claimant is subject to recovery pursuant to 7 CCR 1107-8, Section 8.8.

6. Any outstanding balance past due shall accrue interest pursuant to 7 CCR 1107-8, Section 8.9 7. At its discretion, the Division may waive, in whole or in part, any amount of benefit overpayment owed to the Fund where such recovery would be against equity and good conscience, unless the overpayment resulted from the individual’s willful misrepresentation or willful failure to disclose a material fact to the Division. A request to waive an overpayment is not an appeal, and waiver requests must be submitted through the benefits system. The Division’s determination of equity and good conscience and its determination of whether and the degree to which to waive an overpayment shall only be overturned upon a finding that the Division abused its discretion. 6.4 Premium Underpayments, Fines, and Interest.

7. An employer or individual electing coverage shall be liable for a premium underpayment.

Circumstances giving rise to a premium underpayment include, but are not limited to a(n):

A. Mistake in billing by the Division caused by a technical error;

B. Employer who has incorrectly identified employees localized in Colorado, underreported the number of employees they have, misclassified employees as non-employees, or failed to register with FAMLI and pay premiums; or C. Individual electing coverage who has underreported their income or has failed to report their income.

2. A fine may be imposed for any violation, including a failure to undertake an action specifically required by the Act and its implementing rules, or by engaging in any activity specifically prohibited by the Act and its implementing rules.

3. Premium underpayments are identified through any lawful means including Division audits, investigations, and external tips.

4. The Division will notify an individual electing coverage or employer of any determination of premium underpayment or fine by sending a determination letter to the individual electing coverage or employer’s correct address.

5. The party may appeal a determination of premium underpayment or fine pursuant to 7 CCR 1107-9.

6. Any outstanding premium underpayment fine or interest owed to the Fund by the party is subject to recovery pursuant to 7 CCR 1107-8, Section 8.8.

7. Any outstanding balance past due shall accrue interest pursuant to 7 CCR 1107-8, Section 8.9.

8. At its discretion, the Division may waive, in whole or in part, any fine or interest owed to the Fund where such recovery would be against equity and good conscience. 6.5 Private Plans and Benefit Overpayments 1. A claimant who receives benefits under a private plan that they are not entitled to receive shall be liable for repayment of the amount overpaid, unless otherwise relieved pursuant to this section.

Circumstances giving rise to a benefits overpayment include, but are not limited to a(n):

A. Private plan miscalculation that occurs without any fault from the claimant or is caused by a claimant’s omission, willful misrepresentation, or fraud;

B. Determination by the private plan that the claimant does not qualify for benefits because they are not localized in Colorado pursuant to the in-state status provisions of 7 CCR 1107-1, are not a covered individual, do not have a qualifying condition, or are disqualified from receiving benefits because of a willful false statement or misrepresentation pursuant to C.R.S. § 8-13.3-513;

C. Claimant’s failure to notify the private plan of an event that causes benefit payments to change pursuant to 7 CCR 1107-3, Section 3.10.1;

D. Claimant who has not taken a leave of absence from the employment from which they are receiving benefits;

E. Claimant who is receiving benefits, continuous or intermittent, during a period of unemployment, except as provided by 7 CCR 1107-3, Section 3.4.1.A;

F. Claimant receiving benefits for an absence from work that is caused by circumstances that would entitle the claimant to temporary indemnity benefits under the Colorado Workers’ Compensation Act in violation of 7 CCR 1107-4, Section 4.3;

G. Claimant receiving benefits during any week the individual receives unemployment benefits under the Colorado Employment Security Act for the same job in violation of 7 CCR 1107-4, Section 4.4;

H. Claimant receiving family and medical leave insurance benefits when their family and medical insurance leave benefits have been exhausted;

I. Employer who incorrectly reports wages for the claimant, causing the claimant to receive benefits in an amount greater than their actual wages would provide; or J. Health care provider who fails to meet the definition of “health care provider” as defined by C.R.S. § 8-13.3-503(13), has provided a diagnosis or treatment outside of their licensed scope of practice, or has a license that has been suspended or revoked at the time the provider completes documentation regarding the claimant’s need for family and medical leave.

2. The private plan administrator shall notify the claimant of any determination of benefit overpayment by sending a determination letter to the claimant’s correct address. If the claimant has provided an email address, the private plan administrator shall send the determination via email, and such delivery via email will satisfy the requirement to send the determination letter to the claimant’s correct address. For determinations of benefit overpayments totaling $25 or more, the private plan administrator shall additionally notify the Division by sending copies of such determination letters to the Division’s correct address in accordance with the private plan administrator’s reporting schedule as described in 7 CCR 1107-5, Section 5.12.3. If the Division determines that a private plan administrator did not notify the Division of an overpayment in accordance with these rules, the Division may assess upon the private plan administrator a fine of up to $50.00.

3. The claimant may appeal a determination of benefit overpayment by a private plan as detailed in 7 CCR 1107-9.

4. Any outstanding benefit overpayment owed to the private plan by the claimant is subject to recovery by any legal means available to the private plan.

5. A private plan shall exercise its discretion to waive, in whole or in part, any amount of benefit overpayment owed where recovery would be against equity and good conscience.

6. Any outstanding benefit overpayment owed to the private plan is subject to interest pursuant to C.R.S. § 5-12-101.

7. A private plan shall not subject an employee to any additional fees in addition to any outstanding benefit overpayment amounts owed. 6.6. Language Accessibility The Division will make forms and communications under this rule available in English and Spanish. If an individual’s primary language is neither English nor Spanish, the Division will make a reasonable attempt to accommodate that individual’s language needs, subject to the Division’s sole discretion based on available resources. 6.7 Subrogation The Division has no subrogation rights and will not attempt to exercise subrogation rights absent express

authority to do so in statute or in rule. _________________________________________________________________________ Editor’s Notes

History New rule eff. 07/15/2023.

Entire rule eff. 01/01/2024.

Rules 6.1 3, 6.2 5, 6.3 1.D, 6.3 7, 6.5 2 eff. 01/01/2025.

Rule 6.1 3 eff. 07/01/2025.

Rules 6.1 3, 6.3 1.I-J, 6.3 7, 6.7 eff. 01/01/2026.

7 CCR 1107-7 Rules Concerning Employee Job Protection, Anti-Retaliation and Anti-Interference {#sec-7-ccr-1107-7 omnilex-key=us-co-regs-official--department-10--7 CCR 1107-7}

DEPARTMENT OF LABOR AND EMPLOYMENT

REGULATIONS CONCERNING EMPLOYEE JOB PROTECTION, ANTI-RETALIATION AND ANTI-

INTERFERENCE

7 CCR 1107-7 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ 7.1 Statements of Authority, Purpose, and Incorporation by Reference 1. This regulation is adopted pursuant to the authority in section C.R.S. § 8-13.3-509 and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24-4-101 et seq. (the “APA”), and the Paid Family and Medical Leave Insurance Act, sections 8-13.3-501 et seq. (the “FAMLI Act”), C.R.S.

2. The general purpose of these Employee Job Protection and Anti-Retaliation and Anti-Interference rules is to exercise the authority of this Division to enforce and implement Colorado legislative enactments and accompanying rules protecting against retaliation for, or interference with, the exercise of protected rights, and requiring that employees receive various forms of notification of their rights under the Paid Family and Medical Leave Insurance Act (C.R.S. Title 8, Article 13.3,

Part 5). These Rules are adopted pursuant to Division authority in C.R.S. § 8-13.3-509(7).

3. 29 C.F.R. § 825.215(c)(2) (2025) is hereby incorporated by reference. Earlier versions of such laws and regulations may apply to events that occurred in prior years. Such incorporation excludes later amendments to or editions of the statutes and regulations. These statutes and regulations are available for public inspection at the Colorado Department of Labor and Employment, Division of Family and Medical Leave Insurance, 707 17th Street, Denver, CO 80202. Copies may be obtained from this Division at a reasonable charge or can be accessed electronically from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24-4- 103(12.5)(b), the agency shall provide certified copies of the statutes and regulations incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Division Rules are available to the public at famli.colorado.gov.

4. If any part of these rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 7.2 Definitions and Clarifications 1. Unless otherwise indicated, terms used here that are defined in the FAMLI Act have the same definition as they do under the FAMLI Act.

5. “Complaint” has the same meaning as 7 CCR 1107-8, Section 8.2.5.

6. “Eligible employee” means an employee entitled to the protections described at C.R.S. § 8-13.3- 509(1).

7. "Equivalent position" means a position that is nearly identical to the employee's former position as if the employee did not take paid family and medical leave. This includes pay, benefits and working conditions, privileges, perks, location, and status. It must involve the same or substantially similar duties and responsibilities, which must entail substantially equivalent skill, effort, responsibility, and authority.

8. “Protected activity” means any activity described under C.R.S. § 8-13.3-509(4).

9. “Retaliation” means, and is synonymous with, discrimination based on or for protected activity, and it encompasses any act (whether an affirmative act, an omission, or a statement) that is intended to, and could, deter a reasonable person from engaging in, or impose consequences for, protected activity. Examples of unlawful retaliation may include, but are not limited to:

A. Subjecting an employee to intimidation, threat, reprisal, harassment, or discrimination;

B. Subjecting an employee to an adverse employment action, including discipline, discharge, suspension, transfer, or assignment to a lesser position in terms of job classification, job security, or another term or condition of employment;

C. Reducing the pay or hours of work of an employee or denying an employee additional hours of work;

D. Failing to hire an individual because they engaged in protected activity;

E. Failing to reinstate an employee following a return from leave, in accordance with Section 7.3 of these rules;

F. Failing to store and maintain the confidentiality of employee information related to requests for leave under the FAMLI Act or its implementing regulations, in accordance with all applicable federal, state, and local laws and regulations, and as provided by 7 CCR 1107-3, Section 3.8.9 and 7 CCR 1107-5, Section 5.3.8.

G. Initiating an eviction proceeding or evicting an employee from employer-provided housing because they engaged in protected activity.

H. Engaging in conduct that would reasonably have the effect of discouraging a reasonable employee from accessing family and medical leave insurance benefits;

I. Enacting or enforcing an employer attendance policy that counts leave taken under the FAMLI Act as an absence that may lead to or result in discipline, demotion, or suspension. Such an attendance policy shall constitute per se retaliation under C.R.S. § 8-13.3-509. An employee working under this policy is entitled to appropriate legal and equitable relief under the FAMLI Act.

J. Taking any effort to use a person’s immigration status to negatively impact the rights, responsibilities, or proceedings of any person or entity under the FAMLI Act. Such efforts shall constitute per se retaliation and/or extortion, based on statutory provisions including but not limited to the following that make it unlawful: for any person to “threaten[] to report to law enforcement officials the immigration status of the threatened person or another person” to “induce another person” to give up money “or another item of value” (C.R.S. § 18-3-207(1.5)), including inducing the surrender of any “tangible and intangible personal property, contract rights, choices in action, [or] services, and any rights of use or enjoyment connected therewith” (C.R.S. § 18-1-901).

7. “Interference” means any act or omission that, regardless of intent, interferes with any right or protected activity under the FAMLI Act or its implementing regulations. Interference includes but is not limited to:

A. Intimidating or threatening conduct intended to discourage an employee from accessing family and medical leave insurance benefits or family and medical leave, or which has the effect of discouraging an employee from accessing such benefits or leave;

B. Providing false or misleading information intended to interfere with an employee's ability to access family and medical leave insurance benefits or paid family and medical leave, or which has the effect of interfering with an employee's ability to access such benefits or leave;

C. Failing to provide notice, as required by C.R.S. § 8-13.3-511;

D. Failing to reinstate an eligible employee to their position upon returning from leave as required under C.R.S. § 8-13.3-509(1) and Section 7.3;

E. Information requests prohibited by 7 CCR 1107-3, Section 3.8.9 or 7 CCR 1107-5,

Section 5.3.8;

F. Requiring the production of information defined as confidential under federal or state laws or regulations;

G. Failing to cooperate with the Division in processing a request for family and medical leave insurance benefits;

H. Failing to cooperate with the Division’s compliance activities that implicate an individual’s rights under the FAMLI Act and its implementing regulations;

I. Inducing or attempting to induce an individual to prospectively waive a right under the FAMLI Act or its implementing regulations;

J. Taking any effort to use a person’s immigration status to negatively impact the rights, responsibilities, or proceedings of any person or entity under the FAMLI Act; or K. Requiring an individual to perform work during a period of paid family and medical leave.

8. Except where expressly provided by the Act and its implementing regulations, these rules do not apply to local governments that have declined participation in the FAMLI program. 7.3 Clarifications Regarding Job Reinstatement 1. Pursuant to C.R.S. § 8-13.3-509(1), Any covered individual who has been employed with the covered individual's current employer for at least 180 days prior to the commencement of the covered individual's family and medical leave who exercises the covered individual's right to family and medical leave insurance benefits shall be entitled, upon return from that leave, to be restored by the employer to the position held by the covered individual when the leave commenced, or to be restored to an equivalent position with equivalent employment benefits, pay and other terms and conditions of employment.

A. An individual is considered employed on any day they work, on their days off, and during any leave, paid or unpaid, where the employer reasonably believes the individual will return to work. Where employment is seasonal, an individual is not considered employed between seasons.

B. The 180 days need not be consecutive. However, if a gap in employment exceeds 365 days, then the number of days employed resets to zero.

C. A change in the employee’s status with their current employer does not reset or negate the number of days the employee was employed prior to the change in status (e.g., fulltime to part-time, seasonal to full-time).

D. Military leave protected by federal or state laws or regulations is considered “employment.”

E. The replacement of an employer by a “successor employer,” as defined by C.R.S. § 8- 13.3-503(8)(b)(II), does not interrupt an employee’s accumulation of days employed.

F. Leave is considered to have “commenced” whenever an employee leaves work and utilizes paid family and medical leave.

1. Continuous leave commences once at the outset of the leave. This means that if a covered individual has not been employed with their current employer for at least 180 days before the beginning of the leave, they will not become entitled to the rights described at C.R.S. § 8-13.3-509(1) with regard to that employer during their continuous leave, regardless of whether their 180th day of employment occurs during their continuous leave.

2. Intermittent leave and reduced leave schedule commence upon each covered absence. This means that if a covered individual has not been employed with their current employer for at least 180 days before their first covered absence, but their 180th day of employment occurs before a subsequent covered absence, they will become entitled to the rights described at C.R.S. § 8-13.3-509(1) with regard to covered absences from that employer occurring after their 180th day.

3. An employer is not obligated to reinstate an employee:

A. Where the covered individual has not been employed with the current employer for at least 180 days prior to the commencement of the covered individual's family and medical leave;

B. Where the covered individual’s family and medical leave extends beyond the maximum benefit duration provided by C.R.S. § 8-13.3-505;

C. Where the employee’s return from family and medical leave coincides with an employer’s scheduled cessation of operations for the season (e.g., ski resorts, waterparks) and the employer can show that the employee would not otherwise have been employed at the time of reinstatement;

D. Where the employee’s written contract for employment with the employer has ended pursuant to its terms;

E. Where an employee’s position is eliminated due to legitimate downsizing or reorganization;

F. Where the employee cannot perform the essential functions of their job any longer following the period of leave. An employee may be eligible to request reasonable accommodation under the Americans with Disabilities Act ("ADA"), C.R.S. § 24-34-402.3, or other applicable state or federal law;

G. Where the Division or a private plan administrator has made a determination that the employee applied for or was approved for family and medical leave insurance benefits based on a fraudulent certification;

H. Where the employee fails to provide notice pursuant to C.R.S. § 8-13.3-505(5) and CCR 7 CCR 1107-3, Section 3.8, unless the need for leave was not foreseeable and unusual circumstances justify the failure to comply; or I. Where an employee on family and medical leave provides written notice of resignation.

3. An employer that chooses to deny reinstatement under this subsection to an employee on family and medical leave must notify the employee in writing as soon as the employer decides to deny reinstatement. The employer must serve this notice to the employee either in person or by certified mail. The notice must include:

A. A statement that the employer intends to deny employment reinstatement when the leave has ended;

B. The reasons behind the decision to deny reinstatement and the grounds for denying reinstatement as provided by subsection (2) of this rule;

C. An explanation that health benefits will still be paid for the duration of the leave; and D. The date on which eligibility for employer-provided health benefits ends.

4. Under this Rule, an “equivalent position” as defined in Section 7.2 of these rules includes, but is not limited to:

A. Base pay - Providing an employee with equivalent base pay upon returning from family and medical leave. Base pay includes bonuses as described by 29 C.F.R. § 825.215(c)(2). Base pay does not include overtime or tips unless such overtime was regular or consistent. If an employee departed from a position averaging ten hours of overtime (and corresponding overtime pay) each week, an employee is ordinarily entitled to such a position on return from family and medical leave.

B. Benefits - Providing an employee with equivalent benefits upon returning from family and medical leave. Benefits include all benefits provided or made available to employees by an employer, including group life insurance, health insurance, disability insurance, sick leave, annual leave, educational benefits, and pensions, regardless of whether such benefits are provided by a practice or written policy of an employer through an employee benefit plan.

C. Proximate location - Permitting an employee to return to an equivalent location as worked prior to taking family and medical leave. If it is not possible to return the employee to the exact location, an employer may offer to return the employee to a proximate location or site where work is performed for and/or in connection with the employer’s business. If the employer offers a position at a location different from the employee’s original worksite, the employee must be reinstated to a geographically proximate worksite (i.e., one that does not involve a significant increase in commuting time or distance).

D. Approximate shift times - Providing an employee with a schedule that is equivalent to the employee’s schedule prior to taking family and medical leave. Material changes to an employee’s schedule upon return from leave may raise an adverse inference of retaliation (e.g., scheduling a historically day shift working employee to graveyard shifts, etc.). In returning a covered employee to their equivalent position, employers may be required to remove an employee temporarily working the covered employee’s shift in order to comply with this section.

E. Approximate hours per week - An employee returning to work from family and medical leave shall be permitted to work the equivalent number of hours per week as was worked prior to the employee taking leave. Material changes to an employee’s working hours that change the employment status of an employee may raise an adverse inference of retaliation (e.g., reducing an employee’s hours from 40 hours per week to 25 hours per week, changing the employee’s status from full-time to part-time).

5. Nothing in these Rules shall be construed to require an employer to extend or offer permanent or indefinite employment to a temporary or seasonal employee.

6. Employers shall not be prohibited from disciplining or terminating employees who have attendance issues unrelated to protected leave under the FAMLI Act (e.g., excessive tardiness), or employees who have violated company policies that comply with applicable local, state, and federal laws.

7. Nothing in these Rules requires an employer to ignore an employee’s performance or retain an underperforming employee.

8. No employer shall be required to postpone or avoid legitimate layoffs or downsizing of a business solely to restore an eligible employee to their prior position upon returning from approved leave under the FAMLI Act.

9. An employee who is approved for and takes leave on an intermittent or reduced leave schedule and who fails to work during hours scheduled in accordance with that leave may be subject to employer discipline. In the event that an employee's utilization of intermittent leave or reduced leave schedule is inconsistent with the Division’s or private plan administrator’s approval, it shall not be considered retaliation under C.R.S. § 8-13.3-509(3) for an employer to request additional information related to the use of leave.

10. An employee’s reinstatement to a position slated for elimination due to legitimate downsizing or reorganization would not meet the requirements of an equivalent position when the employee's original position is not slated for elimination due to downsizing or reorganization.

11. An employee is entitled to reinstatement even if the employee has been replaced or the employee's position has been restructured to accommodate the employee's absence unless the employer can demonstrate the circumstances fall within Sections 7.3.2 or 7.3.3.

12. Leave and employment protection provided by C.R.S. § 8-13.3-509(1) is limited to the benefit duration provided by C.R.S. § 8-13.3-505. An employer may not treat an absence that is subject to appeal or judicial review as an absence not protected by the FAMLI Act unless and until the leave is denied and the claimant exhausts any right to appeal or judicial review. However, if the outcome of an appeal or judicial review is pending outside of the benefits duration provided by C.R.S. § 8-13.3-505, it does not extend the duration of the leave available to the employee beyond the period approved by the Division or a private plan administrator. 7.4 Employment Agencies 1. When an employee is employed by an employment agency and the employment agency’s client (“client employer”), both employers are responsible for compliance with the FAMLI Act.

13. Employees who are employed by both an employment agency and a client employer must be counted by both employers to determine employer status, and premium liability under the FAMLI Act and its implementing regulations, regardless of whether the employee is maintained on one or both of the employers’ payrolls. However, only one of these parties need pay premiums pursuant to the agreement between the employment agency and the client employer.

14. Under these Rules, employment agencies are responsible for the following:

A. Providing the required notice under C.R.S. § 8-13.3-511 to its employees;

B. Maintaining any health care benefits during the family and medical leave benefit period as described by section C.R.S. § 8-13.3-509(2);

C. Restoring an eligible employee to an equivalent position upon return from family and medical leave; and D. Maintaining all records by the FAMLI Act and its implementing regulations with respect to their employees.

4. Under these Rules, client employers are responsible for the following:

A. Keeping basic payroll and personnel records with respect to any such employees; and B. Complying with the anti-retaliation and anti-interference provisions of C.R.S. § 8-13.3- 509(4).

5. Employment agencies shall meet all of their obligations under the FAMLI Act even when their client employer is not in compliance with the law or does not provide support to the employment agency in meeting these responsibilities.

6. For purposes of calculating 180 days of employment pursuant to C.R.S. 8-13.3-509(1), an employment agency shall not include as part of its calculation any days on which a covered individual was awaiting a work assignment in a staffing pool. 7.5 Fines and Interest 1. In addition to any remedies available under C.R.S. § 8-13.3-509(6), the Division will assess a fine of $500 per covered individual, per each violation under C.R.S. § 8-13.3-509.

7. Awards for damages and equitable relief under C.R.S. § 8-13.3-509(6) will accrue interest from the date of the award pursuant to C.R.S. § 5-12-102. 7.6 Language Accessibility The Division will make reasonable efforts to make forms and communications under these rules available in an individual’s primary language, subject to the Division’s sole discretion based on available resources. _________________________________________________________________________ Editor’s Notes

History New rule eff. 07/15/2023.

Entire rule eff. 01/01/2024.

Entire rule eff. 01/01/2025.

Rules 7.1 3, 7.2 1, 7.3 1.F, 7.3 4.A eff. 07/01/2025.

Rules 7.1 3, 7.2 1, 7.1 7.F, 7.3 1.D eff. 01/01/2026.

7 CCR 1107-8 Regulations Concerning Investigations {#sec-7-ccr-1107-8 omnilex-key=us-co-regs-official--department-10--7 CCR 1107-8}

Department of Labor and Employment REGULATIONS CONCERNING INVESTIGATIONS 7 CCR 1107-8 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] 8.1 Statement of Authority, Purpose, and Incorporation by Reference 1. This regulation is adopted pursuant to the authority in section C.R.S. § 8-13.3- 501 et seq., and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24-4-101 et seq. (the “APA”), and the Paid Family and Medical Leave Insurance Act, C.R.S. § 8-13.3-501 through 524 (the “FAMLI Act”).

2. The general purpose of these rules is to exercise the authority of this Division to enforce and implement the Paid Family and Medical Leave Insurance Act (C.R.S. § 8-13.3-501 et seq.) with regard to investigating and making determinations for violations of the FAMLI Act and its implementing regulations.

3. If any part of these rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 8.2 Definitions and Clarifications 1. “Aggrieved party” means a person who alleges that their rights under the FAMLI Act or its implementing regulations have been violated.

4. “Authorized representative” means a person designated by a party to an agency action or investigation to represent the party during any Division proceeding, including an investigation, hearing, or appeal. An authorized representative may be, but does not have to be, an attorney. To designate or change an authorized representative, the party must comply with the requirements of Section 8.3.8.

5. “Certified copy” means a copy of a final division decision (issued by a Division investigator or hearing officer) signed by the director of the division, or his or her designee, certifying that the document is a true and accurate copy of the final decision. A Division decision (issued by a Division investigator or hearing officer) will not be certified unless: either (1) all appeal deadlines have passed and no appeal has been filed or (2) if an appeal was timely filed, the decision was not superseded on appeal.

6. “Charging Party” means an aggrieved party who files a complaint alleging violations arising under C.R.S. § 8-13.3-509.

7. “Complaint” means the official form submitted to the FAMLI Division by a named aggrieved party alleging a violation of C.R.S. § 8-13.3-509.

8. “Correct address” can include, but is not limited to, an email address reported to the Division or posted on a party’s website, an address on file with the Colorado Secretary of State, the address of a registered agent on file with the Colorado Secretary of State, or an address provided to the Division by the party. “Correct address” includes the My FAMLI+ portal, the My FAMLI+ Employer portal, and any contact information provided to the Division through that portal. Individuals may contact the Division via telephone to ensure contact information is correct. A notice is deemed sent to a party when placed in the U.S. mail, sent by electronic means, personally delivered to a party or a party’s representative, or personally delivered to a party’s correct address.

9. “Determination” has the same meaning as defined in 7 CCR 1107-9, Section 9.2.8.

10. “Determination letter” means a letter detailing a decision by a Division compliance investigator upon the conclusion of an investigation.

11. “Good cause” has the same meaning as 7 CCR 1107-3, Section 3.2.11.

12. “Investigator” means a member of the Division staff tasked with the collection and discovery of factual information concerning the potential violations of the FAMLI Act and its implementing regulations. Investigators may also prepare determinations or dismissals arising out of an investigation.

13. “Motivating factor” means a standard that requires the Charging Party to show that the protected activity engaged in under the FAMLI Act and its implementing regulations was a motivating factor in the employer's adverse action. This does not mean it was the sole factor, but it must be one of the factors that influenced the Respondent’s decision to take adverse action. This legal standard is applicable in cases where the Charging Party claims that FAMLI was one of the reasons for the Respondent’s adverse action. Even if other legitimate reasons were also present, as long as protected activity under the FAMLI Act and its implementing regulations was a motivating factor, the Respondent could be found in violation of the law.

14. “Notice of Dismissal” under this Section means a written notification provided to a Charging Party and Respondent by the Division dismissing the complaint in part or in its entirety. A Notice of Dismissal may be issued at any time during the proceedings.

15. “Notice of Investigation” means a notice to an employer that identifies potential violations under investigation and includes an initial request for documentation and records.

16. “Notice of Investigation Termination” means a notice to an employer that no further action is contemplated by the Division regarding the potential violations described in the Notice of Investigation.

17. “Other protected party,” as to the rights and responsibilities under the FAMLI Act, means a person who has, or is perceived as having, any relationship protected against retaliation under the FAMLI Act, including but not limited to:

A. a “family member” of an employee, as defined at C.R.S. § 8-13.3-503(11).

B. a “workplace relationship” with a covered employee which encompasses any person with whom the employee has interacted repeatedly in the scope of their employment, regardless of the person’s employer or employment status.

16. “Party” has the same meaning as 7 CCR 1107-9, Section 9.2.15.

17. “Position Statement” means a responsive statement to the Division that addresses all of the allegations in a Charging Party’s Complaint, provides relevant evidence to support the Respondent's position, and asserts any defenses that the Respondent believes are applicable and can help the Division accelerate the investigation and tailor its requests for additional information.

18. “Respondent” means an individual or entity against whom a complaint has been filed.

19. “Subject of an investigation'' means an individual or entity whose conduct has given rise to a Division-initiated investigation of potential violations of the FAMLI Act and its implementing regulations.

20. Except where explicitly provided by the FAMLI Act or its implementing regulations, these rules do not apply to local governments that have declined participation in the FAMLI program. 8.3 Filing a Complaint 1. Any person who alleges that their rights under the FAMLI Act or its implementing regulations have been violated may file a complaint with the Division by using the Division-approved form(s). The Charging Party shall comply with any other Division instructions as to information or submissions required by the Division.

21. If the Division receives written communication from a person alleging a violation of the FAMLI Act or its implementing regulations, and the contents of the communication suggest that the person would like the Division to initiate an investigation, the Division will send the person a complaint form and invite them to complete and return the complaint form. If the person returns a completed complaint form within thirty-five (35) days after the Division sends it, the complaint will be deemed to have been received on the date of the initial written communication. If the person returns a completed complaint form later than thirty-five (35) days after the Division sends it, the complaint will be deemed to have been received on the date the Division receives the completed complaint form.

22. A complaint shall include the Charging Party’s signature and contact information, Respondent’s contact information, and basis for the complaint. Failure to comply with this Rule may result in dismissal of the complaint without prejudice.

Anonymous complaints will be accepted; however, the Division may choose to independently address anonymous complaints at its discretion. An anonymous complaint does not need to contain the complaining person’s contact information or signature.

4. The failure of a Charging Party to respond in a timely manner to informational or investigatory requests by the Division may result in dismissal of the complaint without prejudice. If the Division issues a Notice of Dismissal for failure to comply with this Rule, and the Charging Party provides the information within thirty-five (35) days of receipt of the notice, the Division may at its discretion reopen the complaint. A Charging Party may be required to file a new complaint if the Division receives their response more than thirty-five (35) days after the Division’s request for information. Nothing in this subsection shall be construed to extend the deadlines described at C.R.S. § 8-13.3-509(6)(c)-(d).

5. A Charging Party under this section may pursue relief for any violation arising under C.R.S. § 8-13.3-509 through either the court system or the Division’s established procedures and processes.

6. Aggrieved parties under C.R.S. § 8-13.3-509 are not required to first pursue the Division’s administrative remedies prior to initiating a lawsuit in the court system.

7. The Division does not have jurisdiction over any violation arising under this

section that has been adjudicated or is currently being adjudicated by the court system or by another government administrative body. If the Charging Party files a civil action in a court of competent jurisdiction against an employer or any other individual or entity named as a Respondent to a pending complaint before the Division, and one or more of the alleged violations arise from the same facts or issues in both the civil action complaint and the Charging Party’s Division complaint, the Division will dismiss the complaint pending before the Division in

part or in its entirety. 8 Any party to a complaint may designate an authorized representative to represent the party during the Division’s investigative, enforcement, and/or appeals process.

A. The party may designate an authorized representative by filing the Division-approved form with the Division.

B. The party may revoke the authorized representative’s authority by contacting the Division in writing.

9. In any Division investigation, proceeding, or other action initiated for a reason other than the receipt of a named complaint, if information is provided to the Division by a source requesting confidentiality, and that information is used only as a basis for procuring other evidence, not offered as evidence itself, then the source shall remain confidential. Any such confidential source is unlawful to disclose (unless the source consents) in any administrative or judicial proceeding, in response to any records or information request, or in any other manner.

10. Within ninety (90) days of a complaint being filed (or within ninety (90) days of the effective date of these Rules, whichever is later), the Division will assess whether it will exercise its discretion to either investigate or dismiss the complaint. The Division will inform the parties of its decision in writing. 8.4 Filing, Notification, and Deadlines 1. A complaint to the Division is considered “filed” with the Division when it is sent via mail or online submission. Complaints shall be filed within the time limits specified by the Act and its implementing regulations. If the last date upon which a timely complaint may be filed falls upon a Saturday, Sunday, or State of Colorado legal holiday, the complaint shall be deemed timely if filed with the Division on the next regular business day. Any complaint received after 11:59 p.m. Mountain Standard Time is considered filed the next business day.

11. A complaint to the Division is considered “signed,” or to have a “signature,” if it has either an ink signature, a scanned signature, an electronically drawn or generated signature, a mark, or a typed name entered by the Charging Party in the signature area. By signing in any such fashion, the person is deemed to have agreed and assented that the document is signed by them.

12. Deadlines in these Rules may be extended a maximum of ninety [90] days for good cause. 8.5 Investigations 1. Generally A. The Division has the authority and discretion to initiate investigations, audits, or any other compliance oversight activities related to any provision of the FAMLI Act and its implementing regulations upon its own initiative or upon the receipt of a complaint filed by an aggrieved party or their authorized representative. Nothing in the FAMLI Act or its implementing regulations limits the Division’s authority to conduct pre-investigation factfinding, facilitate settlements, or make referrals to other criminal or civil enforcement agencies.

B. Investigations initiated by the FAMLI Division may include potential violations of the FAMLI Act and its implementing regulations by any person, entity, or private plan.

C. The Division may utilize the following as part of an investigation:

1. Interviews of parties or witnesses;

2. Information gathering, fact-finding, and reviews of written submissions; and 3. Any other lawful techniques that enable the Division to assess compliance with the FAMLI Act and its implementing regulations.

D. Upon receipt of a Notice of Complaint or Notice of Investigation, the subject or Respondent shall preserve all personnel records relevant to the charge or action until final disposition of the charge or the action. For purposes of complaints arising under C.R.S. § 8-13.3-509, relevant “personnel records” include but are not limited to:

1. Records related to paid family and medical leave insurance benefits;

2. Records related to other benefits that relate to, impact, or are impacted by paid family and medical leave insurance benefits;

3. Requests or statements by the person that are claimed to be protected activity;

4. Responses to, or analyses of, such request(s) or statement(s);

5. Records related to the “equivalent position” factors described in 7 CCR 1107-7, Section 7.3.4; and 5. Policies or decisions, formal or informal, that may apply to such request(s) or statements(s).

E. All parties to an investigation are responsible for ensuring the Division has current contact information.

1. All parties must promptly notify the Division of any change in contact information, including mailing address, email address, and phone number.

2. Parties should not rely on the U.S. Postal Service to forward mail.

Failure to respond to a notice because mail was not forwarded to a new address will not be excused.

F. The Division may exercise its discretion to consolidate complaints, or to have an investigation sequenced and/or divided into two or more stages on discrete questions of liability or relief (e.g., bifurcation), yielding two or more determinations and/or phases of the investigation.

2. Investigations Initiated by the Division A. Whenever the Division initiates an investigation, it shall send a Notice of Investigation to the subject of an investigation at their correct address.

B. The subject of an investigation may designate an authorized representative to represent it during the investigation.

C. Upon the receipt of a Notice of Investigation, the subject of an investigation or the subject’s representative must submit a complete response to the Notice of Investigation within fourteen (14) calendar days of the date of the notice. The Division may extend the deadline upon a showing by the subject or their representative of good cause.

D. The Division may issue a determination against the subject of the investigation if it determines that a violation of the FAMLI Act or its implementing regulations occurred. If the subject of the investigation does not respond to the Notice of Investigation, then the Division may rely on any available, undisputed evidence.

E. If the Division initiates an investigation, then it will end the investigation by issuing either a determination or a Notice of Investigation Termination.

3. Investigations Initiated by a Job Protection & Retaliation Complaint Form A. Investigations into complaints arising under C.R.S. § 8-13.3-509 shall include a thorough review of the circumstances under which the alleged violations occurred and any policies and/or practices that may appear to constitute retaliatory personnel action or interference with the Charging Party’s rights under the FAMLI Act and its implementing regulations, even though they may not have not been expressly cited by the Charging Party in their Complaint.

B. Anytime the Division selects a Complaint for investigation, and prior to the commencement of an investigation into a complaint, the Division will send a Notice of Complaint to the Respondent at the Respondent’s correct address. The Notice of Complaint will include a citation to each potential violation of the FAMLI Act and its implementing regulations. The Charging Party’s complaint and non-confidential attachments will be provided with the Notice of Complaint. A Respondent must provide a Position Statement responding to the allegations contained within the Charging Party’s complaint within thirty (30) days after a complaint is sent to them, unless an extension is granted for good cause.

1. If the Notice of Complaint cannot be delivered, a Division investigation cannot be commenced. If a correct address is located or provided, the Division will resend the Notice of Complaint, and the Respondent’s deadline to respond will be calculated from the date of the subsequent notice.

2. If the Division cannot determine the Respondent’s correct address, it may contact the Charging Party to request the Respondent’s correct address. The Division may dismiss the complaint without prejudice if neither the Charging Party nor the Division can determine the Respondent’s correct address.

C. Failure to respond to the Division’s request for a Position Statement may result in a default judgment in favor of the Charging Party based solely on the undisputed allegations set forth in the Complaint.

D. Upon receipt of the Respondent’s Position Statement, the Division shall review all of the documentation received. The Division will provide the Charging Party with a copy of the Position Statement and all evidence submitted in support thereof, unless information provided by the Respondent has been designated as confidential. The position statement itself cannot be marked as confidential in its entirety. It is the responsibility of the Respondent to ensure appropriate redactions and designations are made to the position statement before submission. The Division will review these attachments marked as confidential and assess the provided justification, as blanket or unsupported claims of confidentiality will not be accepted.

E. A Charging Party may provide a rebuttal disputing the Respondent’s position within fourteen (14) days of the date the Division sent the Position Statement to the Charging Party. The Division may extend the deadline for good cause.

F. Subject to the approval of the Division, complaints arising under C.R.S. § 8- 13.3-509 may be amended under certain circumstances. Amendments to the complaints may include but are not limited to: amendments to cure technical defects and errors or omissions, including failure to sign a complaint; to clarify or amplify the allegations therein; or to allege additional violations arising from the subject matter of the original complaint. Amendments related to or growing out of the subject matter of the original complaint will relate back to the date the complaint was first filed. If the Division uncovers additional potential violations during the course of a retaliation and interference investigation, it may unilaterally amend the complaint and add the additional violations to the investigation.

G. Amendments shall be filed in the same manner as provided by these Rules for the filing of the original complaint. If a complaint is amended, the Division will send a revised Notice of Complaint to the Respondent, and the Respondent must provide a Position Statement responding to the additional allegations contained within the amended complaint within thirty (30) days after the amended complaint is sent to them, unless an extension is granted for good cause.

H. An aggrieved party under C.R.S. § 8-13.3-509 may withdraw the complaint, or their participation in the complaint filed on their behalf, at any time prior to the issuance of a determination by notifying the Division in writing.

I. Complaints arising under C.R.S. § 8-13.3-509 may be settled at any time during the investigation. Any settlement reached shall be in writing and signed by both parties and shall identify the claims resolved.

J. Upon conclusion of an investigation under C.R.S. § 8-13.3-509, the Division will issue and deliver to the parties a written determination with appeal rights or a notice of dismissal. A Charging Party may not withdraw a complaint once a determination has been issued by the Division. A Notice of Dismissal is not a determination and does not prohibit a Charging Party from filing a civil complaint in a court of competent jurisdiction.

K. The Division shall keep a full and complete record of all proceedings in connection with any investigation for six (6) years after the completion of the investigation. 8.6 Burdens of Proof 1. The party seeking an award of benefits or damages, the imposition of a fine, penalty, fee or interest, or any other relief, has the burden of proof to show the relief should be granted by a preponderance of the evidence. Where the Division proves the grounds for imposing fines, penalties, or fees, the amount of such fines, penalties, or fees shall be overturned or modified only if the employer or private plan proves that the Division abused its discretion.

2. Complaints alleging retaliatory personnel action under C.R.S. § 8-13.3-509 are analyzed as follows, with the preponderance of the evidence standard applying to all burdens of proof.

A. The Charging Party has the burden of proving all elements of a claim, including that an unlawful retaliatory personnel action occurred. The Respondent must explain which, if any, allegations it disputes. Any evidence probative of a relevant issue may be submitted or considered. If an employer takes an adverse employment action, as described in 7 CCR 1107-7, Section 7.2.6.B, against an employee who engaged in protected activity or an other protected party within ninety (90) days of the employee engaging in protected activity, such adverse employment action creates a rebuttable presumption of retaliation.

B. If the Charging Party proves unlawful retaliation or discrimination was a motivating factor for the complained-of practice, then a violation is proven.

If the Charging Party cannot demonstrate that unlawful retaliation or discrimination was a motivating factor for the complained-of practice, then a violation has not been proven. However, if a violation is proven but the Respondent proves by a preponderance of the evidence that the complained-of practice would have occurred for another lawful reason, then the Division shall not award any damages as of the date the practice would have occurred.

C. In determining whether a violation occurred or whether the complained-of practice would have occurred for another lawful reason, evidence the Division may consider includes, but is not limited to:

1. Emails, written records, performance reviews, and other documentation that can be objectively evaluated;

2. Comparing the treatment of the Charging Party with similarly situated employees who did not engage in the protected activity;

3. Testimonies and statements from managers, supervisors, and other witnesses;

4. Explicit statements or actions indicating discriminatory intent;

5. Patterns of behavior, timing of adverse actions relative to the protected activity;

6. Contradictory, inconsistent, or false statements made by the Respondent or its agents;

7. An absence of contemporaneous or supporting evidence of the alleged basis for the adverse action.

8. Complaints alleging interference under C.R.S. § 8-13.3-509 are analyzed as follows, with the preponderance of the evidence standard applying to all burdens of proof.

A. The Charging Party has the burden of proving all elements of a claim, including that unlawful interference occurred. The Respondent must explain which, if any, allegations it disputes. Any evidence probative of a relevant issue may be submitted or considered. Interference is established when a Charging Party shows the Respondent engaged in conduct that tends to or does result in at least slight harm to rights guaranteed by the FAMLI Act.

B. If the Charging Party meets its burden of proof, then a violation is proven.

However, if a violation is proven but the Respondent proves by a preponderance of the evidence the violation resulted from circumstances beyond its control and that no alternative course of action was available, then the Division shall not award any damages.

4. Determinations must include a finding of fact on which the determination is based, the relevant section or sections of the law, and the date the determination was issued. 8.7 Remedies 1. Upon conclusion of an investigation, the Division will issue and deliver to the parties a written determination or a notice of dismissal.

5. Determinations issued by the Division may include the following remedies, depending on which, if any, the Division’s findings support:

A. Monetary or other relief authorized by the FAMLI Act or its implementing regulations, including any remedies under C.R.S. § 8-13.3-509(6)(b)-(7);

B. An assessment of an amount owed (fines and interest); and/or C. Orders to cease non-compliance, effectuate compliance, and/or otherwise redress direct or indirect consequences of violations of the FAMLI Act.

3. For the purpose of determining damages pursuant to C.R.S. § 8-13.3-509(6)(b), the value of paid family and medical leave benefits that an individual was unable to access because of unlawful retaliation or interference is considered other compensation denied or lost to the individual by reason of the violation.

4. For any monetary award imposed under these rules, the Division shall issue a determination and Notice of Assessment and Requirement to Report Payments Made which will include:

A. Total damages owed to the Charging Party with calculations and a narrative explaining the Division’s justifications for an award of damages;

B. Total fines owed to the Division and the relevant statutory or regulatory citations;

C. Total interest owed, including a description of the calculation and citations to the relevant statute and/or regulations.

D. Instructions for remittance of payment to the Charging Party and/or Division;

E. Instructions for the reporting to the Division payments made to the Charging Party; and F. Deadlines to remit payment to the Charging Party and/or Division.

5. The person awarded relief or remedies under this section shall be issued a certified copy of the final Division decision imposing relief or remedies, signed by the Director of the Division, or their designee, certifying that the document is a true and accurate copy of the final decision. The person awarded relief or remedies may file the certified copy with the clerk of a court having jurisdiction over the parties, and such a filing will thereby have the effect of a judgment from which execution may be issued. Where practicable, the Division shall make reasonable efforts to assist in the filing of the certified copy.

6. An aggrieved party is not entitled to appeal a determination of the Division to a court of competent jurisdiction until the aggrieved party has exhausted all administrative remedies, including appeal to a Division hearing officer. 8.8 Recovery 1. Any outstanding amount owed to the Division as determined by a final agency action may be collected by the Division through any and all legal means available, including, but not limited to benefit offsets, garnishments, liens, or the Federal Treasury Offset Program.

7. The Division may share information with other criminal or civil enforcement authorities if it believes that a violation implicating their enforcement authority has occurred. However, the Division will not voluntarily provide any person or entity information concerning immigration status. 8.9 Interest Any outstanding balance past due shall accrue interest at the rate allowed pursuant to C.R.S. § 5-12-102, until payment is received in full. 8.10 Determinations 1. What constitutes a “Determination” is defined in 7 CCR 1107-9, and includes determinations pursuant to the FAMLI Act or any of its implementing regulations.

8. The Division will issue and deliver determinations by U.S. first class mail or electronically to the parties at their correct addresses and include a statement regarding appeal rights.

9. The date of issuance of the Division's determination is the date the Division's determination is sent to the parties by mail or electronically to the parties, as indicated in the determination. Any reconsideration or appeal deadlines are calculated from the Division's date of issuance.

10. Determinations shall be deemed final, and any information contained in any document or notice issued by the Division shall be deemed correct unless a party requests a reconsideration, the Division issues a reconsideration on its own volition, or a party files a timely request for appeal according to these regulations.

11. No party can appeal a Division decision to a Division hearing officer unless the decision constitutes a determination. No party can appeal a determination of the Division to a court of competent jurisdiction until such party has exhausted all administrative remedies provided in these rules, including appeal to a Division hearing officer.

12. Determinations must include some explanation of the facts forming the basis for the determination, citation to relevant provisions of the law, and the date the determination was issued and a notice of reconsideration or appeal rights. 8.11 Language Accessibility The Division will make reasonable efforts to make forms and communications under these rules available in an individual’s primary language, subject to the Division’s sole discretion based on available resources.

Editor’s Notes

History New rule eff. 07/15/2023.

Entire rule eff. 01/01/2024.

Entire rule eff. 01/01/2025.

Rules 8.1 3, 8.2 5, 8.2 12, 8.3 7, 8.5 3.F-G, 8.6 2.A, 8.7 3-6 eff. 07/01/2025.

Rules 8.1 3, 8.2 6, 8.7 3 eff. 01/01/2026.

Rules 8.5 2.D, 8.10 6 eff. 07/01/2026.

7 CCR 1107-9 Regulations Concerning Appeals {#sec-7-ccr-1107-9 omnilex-key=us-co-regs-official--department-10--7 CCR 1107-9}

Department of Labor and Employment REGULATIONS CONCERNING APPEALS 7 CCR 1107-9 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] 9.1 Statement of Authority, Purpose, and Incorporation by Reference 1. This regulation is adopted pursuant to the authority in section C.R.S. § 8-13.3- 501 et seq., and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24-4-101 et seq. (the “APA”), and the Paid Family and Medical Leave Insurance Act, C.R.S. § 8-13.3-501 through 524 (the “FAMLI Act”).

2. The general purpose of these rules is to exercise authority of the Colorado Department of Labor and Employment’s FAMLI Division (the “Division”) to enforce and implement the Paid Family and Medical Leave Insurance Act (C.R.S. § 8-13.3-501 et seq.) with regard to administrative determinations and hearing appeals.

3. If any part of these rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 9.2 Definitions 1. Unless otherwise indicated, terms used here that are defined in the FAMLI Act have the same definition as they do under the FAMLI Act.

4. “Administrative Decision” means a written decision made by the Division’s administrative staff other than the hearings officers.

5. “Appeal” means a written statement challenging any part of a determination and submitted to the Appeals Unit for review by a FAMLI hearing officer after internal review has occurred, if required by statute or State regulation.

6. “Appellant” means the party making the request for a FAMLI hearing officer to review a determination or reconsideration, as those terms are defined in this

Rule.

5. “Authorized representative” has the same meaning as 7 CCR 1107-8, Section 8.2.2.

6. “Claimant” means a person who has filed a FAMLI Claim, regardless of whether the person is a covered individual pursuant to C.R.S. § 8-13.3-503(3). If that person has a “designated representative,” as defined in 7 CCR 1107-3, Section 3.2.10, the designated representative is subject to the same deadlines and obligations as the claimant with regard to these regulations.

7. “Correct address” has the same meaning as 7 CCR 1107-8, Section 8.2.6.

8. “Determination” means an administrative decision or a private plan decision that is designated as a “determination” or is a written decision that adversely affects the rights of parties if it, by example only, (1) explicitly or effectively approves or denies all or part of a FAMLI Claim, or changes the status of a FAMLI premiums account, (2) imposes fines, fees, penalties, or any other monetary liability, (3) identifies an overpayment or requires repayment of benefits, or denies a request to waive an overpayment, (4) awards damages, or other remedies, (5) denies or grants all or part of the relief requested in an accepted grievance, investigation, or complaint, or (6) withdraws the approval of a private plan or finds that a private plan committed a violation of the FAMLI Act or its implementing regulations.

“Determination” includes a Division assessment of premiums. “Determination” does not include a Division notice that only informs a claimant or applicant that an application is incomplete or requests additional information.

9. “Division” means the Paid Family and Medical Leave Insurance Division of the Department of Labor and Employment created pursuant to C.R.S. § 8-13.3-508.

10. “Documents” means any designated documents or electronically stored information — including writings, drawings, graphs, charts, photographs, sound recordings, images, computer screenshots, and other data or data compilations — stored in any medium from which information can be obtained either directly, or any designated tangible things.

11. “FAMLI Appeals Unit” or “Appeals Unit” means the work unit presently within the Policy and Appeals Branch of the FAMLI Division, authorized to resolve appeals of determinations and reconsiderations.

12. “FAMLI Claim” means a claim for “benefits” and “paid family and medical leave” as those terms are defined under the FAMLI Act, C.R.S. § 8-13.3-501 et seq.

13. “Good cause” has the same meaning as 7 CCR 1107-3, Section 3.2.11.

14. “Hearing officer” includes an administrative law judge within the Appeals Unit.

15. “Parties of record” means the appellant, the Division, parties listed on a notice of hearing, and any person added as a party by a hearing officer after a notice of hearing is issued.

16. “Party” means a person explicitly identified as a “party” in these rules or who has a right or a legally cognizable interest potentially affected by the outcome of an appeal. The Division is a party to any appeal of Division determinations filed with the Appeals Unit, and more than one person may attend appeal proceedings as “the Division.” A “private plan administrator,” as defined in 7 CCR 1107-5, is a party to any appeal involving a private plan.

17. “Person” includes natural persons and entities with a recognized legal status in Colorado.

18. “Reconsideration” is a decision that replaces a prior Division-issued determination following an internal review process. 9.3 Filing Appeals of Determinations 1. Any party adversely affected by a determination may appeal it to the Appeals Unit. Where required by statute or State regulation, a party must request a reconsideration by the Division before filing an appeal.

19. The Division does not have jurisdiction over any matter that has been adjudicated or is currently being adjudicated by the court system or by another government administrative body having jurisdiction over such matter. If a party has filed a civil action in a court of competent jurisdiction pertaining to the same subject matter as a determination previously issued by the Division, the Appeals Unit will dismiss the appeal of that determination.

20. An appeal is procedurally valid only if it: (a) is timely filed with the Appeals Unit;

(b) includes a copy of the determination or reconsideration at issue or sufficiently identifies the determination or reconsideration appealed and the date of issuance; and (c) has been signed or electronically verified by the party or the party's authorized representative.

4. The Appeals Unit will only consider appeals filed within forty-nine (49) days of the date the Division issued the determination or reconsideration in question unless an extension of time is granted consistent with Rule 9.3.7.

5. A document is considered “filed” with the Appeals Unit when the appeal is properly sent by U.S. first class mail or via an Appeals Unit-approved electronic filing system. Any appeal to the Appeals Unit sent after 11:59 p.m. (Mountain Time Zone) is considered filed the next business day.

6. An appeal to the Appeals Unit is considered “signed,” or to have a “signature,” if it has either an ink signature, a scanned signature, an electronically drawn or generated signature, a unique mark belonging to a specific person, a typed name entered by the party or authorized representative in the signature area, or a completed electronic attestation.

7. Unless otherwise specified, “day” means calendar day. Deadlines in this rule may be extended up to a maximum of forty-nine (49) days for good cause. If a deadline falls on a weekend or State holiday, the deadline shall become the next business day. 9.4 Preliminary Issues for Filed Appeals 1. Upon receiving an appeal, the Appeals Unit will determine as soon as practicable whether the appeal meets the requirements for a procedurally valid appeal. If the appeal is not procedurally valid, including if the appeal is untimely, the Appeals Unit will send a notice of the procedural deficiency and an order to show cause providing the appellant seven (7) days to respond. The Appeals Unit can take any action it deems appropriate to address the deficiency, including dismissal of an untimely appeal. For good cause, the Appeals Unit may grant an extension of time not exceeding fourteen (14) days for a response to the notice of deficiency.

8. Once an appeal is determined to be procedurally valid, the Appeals Unit will send a notice to the appellant and the Division that the appeal has been accepted. The notice of acceptance will also be sent to any person that has received a notice of a determination or claim that is the subject of an appeal. The Appeals Unit will assign a hearing officer who will oversee the manner in which the appeal will be handled, including scheduling and sending a notice of any necessary proceedings. A hearing, if necessary, will be scheduled to occur within thirty-five (35) days after an appeal is accepted as procedurally valid unless an extension of time is granted consistent with Rule 9.3.7. The filing of an appeal will not suspend or terminate a FAMLI Claim award unless and until a hearing officer modifies or overturns a determination at issue in an appeal.

9. Upon a request by a party of record or the hearing officer’s own initiative, the hearing officer may convene a prehearing conference to discuss the issues on appeal, questions related to party status, the evidence to be presented, requests for language interpretation or other reasonable accommodations, and any other relevant matters that may simplify the proceedings, including resolving issues without a hearing if the material facts are undisputed. Genuine disputes of any material fact must be resolved at an evidentiary hearing or by stipulation of all the parties of record.

10. Motions to disqualify a hearing officer must be made and addressed at the earliest opportunity consistent with the provisions of C.R.S. § 24-4-105(3), including the requirement of a good faith affidavit explaining the alleged disqualifying reasons. An unreasonable delay in requesting a disqualification can be considered a waiver of any objection to the assignment of an appeal to a hearing officer. Previous adverse rulings will not be considered as a valid basis for disqualification. A hearing officer may recuse themselves in a manner consistent with C.R.S. § 24-4-105(3). 9.5 Discovery, Subpoenas, and Evidence for Hearings 1. Within seven (7) days after the parties have been notified that an appeal has been accepted and assigned to a hearing officer for review, the Division or private plan shall file with the Appeals Unit an initial disclosure of information and/or documents supporting the determination at issue unless such evidence cannot be sent to a party consistent with C.R.S. § 8-13.3-516 and 7 CCR 1107-3,

Section 3.8.10. Failure to timely provide such disclosure may result in the hearing officer taking remedial action under Rule 9.6.1. Confidential documents and information shall not lose any protections from disclosure solely because an appeal was filed. The hearing officer may take any action the hearing officer deems necessary to ensure confidentiality consistent with C.R.S. § 8-13.3-516 and 7 CCR 1107-3.

2. Evidence to be presented at a hearing must be submitted to the hearing officer and all other parties of record at least ten (10) days before the hearing begins or as otherwise directed by the hearing officer.

3. Whenever a party files any other documents with the Appeals Unit, the party must also provide the documents simultaneously to all parties of record. Failure to timely provide documents to all other parties of record may be grounds for the hearing officer to limit issues or the presentation of evidence or both as determined by the hearing officer’s sound discretion in the totality of circumstances. Only parties of record and their authorized representatives shall have the right to access documents submitted for that appeal, subject to the confidentiality requirements referenced in Rule 9.5.1. Parties are responsible to provide relevant documents to their own witnesses.

4. No party may seek discovery, including an order for production of documents or evidence from a party opponent, without approval from the hearing officer and only upon a clear showing that the discovery is appropriate and necessary. To establish a clear showing, the party seeking discovery must (1) present sufficient evidence of a legitimate dispute of a material fact and (2) clearly articulate the need for and appropriateness of the requested discovery to resolve the factual dispute.

5. The hearing officer shall have the power to issue, on the request of a party, subpoenas to compel the attendance of witnesses or the production of documents deemed appropriate and necessary to resolve the pending appeal.

The requesting party is responsible for service of process served by a noninterested party and subject to the requirements of C.R.C.P. Rule 45.

6. If a party or witness fails to obey a subpoena issued by the hearing officer, a party may apply to any district court of this state to order compliance with the subpoena. The court may exercise its power to issue a contempt citation to a person who fails to obey the order. 9.6 Hearings 1. The hearing officer shall have the power and authority to schedule, preside at, conduct hearings, and ensure the appeal process is fair to all parties on a caseby-case basis. Hearings will be conducted virtually with internet and telephone access. The hearing officer has the power to administer oaths and affirmations, take depositions, certify to official acts, issue procedural orders, preclude or limit evidence or legal arguments as a reasonable remedy or sanction for a party’s willful non-compliance, and to take any other reasonable steps the hearing officer deems necessary to resolve the pending appeal and control the hearing.

7. The hearing officer shall not communicate with a party unless all parties are present or simultaneously receive the hearing officer’s verbal or written communication. If such a communication occurs, the hearing officer shall immediately disclose it to all parties.

8. Hearings shall be conducted informally with as few technical requirements as possible. Only parties of record to the appeal, and authorized representatives, may participate in hearings and other appeal proceedings, and present evidence, including calling witnesses. The hearing officer shall control the evidence taken during a hearing in a manner consistent with the due process rights of all the parties and to provide a fair hearing.

9. A hearing officer may make a finding of fact based on hearsay evidence only if it is reliable, trustworthy, and probative. When deciding whether to accept hearsay as evidence, the hearing officer may consider some or all of the following nonexclusive factors:

A. Whether the statement was written and signed;

B. Whether the statement was sworn to by the declarant;

C. Whether the declarant was a disinterested witness or had a potential bias;

D. Whether the hearsay statement is denied or contradicted by other evidence;

E. Whether the declarant is credible;

F. Whether there is corroboration for the hearsay statement;

G. Whether the case turns on the credibility of the witnesses;

H. Whether the party relying on the hearsay offers an adequate explanation for the failure to call the declarant to testify; and I. Whether the party against whom the hearsay is used had access to the statements prior to the hearing or the opportunity to subpoena the declarant.

5. The hearing officer must preside impartially over administrative proceedings and hearings. The hearing officer may provide limited procedural guidance to parties so long as the hearing officer does not become an advocate for any of the parties.

6. Parties of record are entitled to at least fourteen (14) days advance notice of any hearing where parties will offer witness testimony and/or documentary evidence (an “evidentiary hearing”), and advance notice of the issues that may be considered at an evidentiary hearing according to the schedule ordered by the hearing officer. In setting an evidentiary hearing date, the hearing officer shall ensure that the parties of record have had reasonably sufficient opportunity to submit exhibits and prepare for hearing. Upon mutual agreement of all the parties, the hearing officer can set an evidentiary hearing to occur with less than fourteen (14) days notice. The hearing officer shall not permit a party of record to present evidence on issues at a hearing that have not been disclosed to all other parties of record before the hearing except to prevent obvious injustice. The hearing officer has reasonable discretion to control the administrative proceedings and ensure that the parties of record receive a fair hearing, including postponing hearings and granting additional time to the parties of record where appropriate.

7. Only the hearing officer is authorized to record appeal proceedings, and that recording shall be the official recording of the proceeding. A transcription of the recording may also be made by the Appeals Unit if the hearing officer’s decision is appealed to the District Court. All testimony at a hearing or other proceeding must be recorded by the Appeals Unit and provided to a party upon the party’s request. 9.7 Appeal Decisions and Burdens of Proof 1. After conducting appeal proceedings as necessary, the hearing officer shall decide each relevant issue properly raised during the proceedings and necessary to resolve the appeal. The hearing officer shall issue a written decision based solely on the evidence presented during the hearing and include findings of fact, conclusions of law, and an order. In deciding disputed issues of fact, the hearing officer shall not give deference to the Division’s factual determinations except where otherwise provided in rule. In deciding disputed issues of law, the hearing officer shall adhere to the plain language of both the Division’s regulations and the Division’s interpretations of the FAMLI Act and its implementing regulations that it has published on its website as a formal interpretation or has adopted as a

statement of basis and purpose for a regulation in accordance with the Colorado Administrative Procedures Act. The hearing officer shall not conclude that a rule adopted by the Division is outside of the Division’s statutory or constitutional

authority. No rule shall be construed as being ambiguous unless it is reasonably susceptible to more than one interpretation. If a hearing officer determines that a

rule is ambiguous, the hearing officer must identify multiple reasonable interpretations of that rule. If a party files a motion to reconsider in accordance with Section 9.7.7 of these rules asserting a lack of alternative interpretations, the hearing officer may either grant the motion and amend the final order as appropriate or, if the motion is denied, include reasons and bases for the hearing officer’s ruling on the motion.

2. Unless stated otherwise in rule, the burden of proof before the Appeals Unit is “by a preponderance of the evidence.”

A. The burden of proof rests with:

1. The party seeking to overturn or change a Division or private plan decision on a FAMLI claim award, or 2. The party seeking damages, the imposition of a fine, disqualification, penalty, fee or interest, or 3. The party seeking any other relief.

B. Where the Division proves the grounds for imposing monetary fines, penalties, or fees on a party, the amount of such fines, penalties, or fees shall be overturned or modified only if the party proves that the Division abused its discretion.

C. Determinations resulting from the Division’s discretion in accordance with the FAMLI Act and its implementing regulations shall be overturned or modified only if the party proves that the Division abused its discretion.

3. The hearing officer’s decision shall be made as soon as practicable after a hearing and constitutes a final agency action pursuant to C.R.S. § 24-4-106. The decision shall be binding on the Division unless it is withdrawn by a hearing officer, postponed pursuant to C.R.S. § 24-4-106(5), overturned by a court, or made obsolete by a statute or rule amendment. The Appeals Unit shall promptly serve a copy of the hearing officer’s decision to each party of record.

4. The hearing officer will issue written decisions in compliance with C.R.S. § 8- 13.3-516 and will not disclose protected health information, the reason for leave, and wage replacement benefit amounts beyond the information necessarily and appropriately disclosed to the parties during an appeal proceeding.

5. Any party of record in the administrative proceeding may appeal the hearing officer’s decision only by commencing an action for judicial review in a district court of competent jurisdiction within thirty-five (35) days after the date the decision was served to the party. Judicial review is limited to appeal briefs and the record designated on appeal.

6. If the hearing officer or a court reverses or modifies a denial of a FAMLI claim, the Division or private plan will pay the benefits as soon as practicable but no later than five (5) business days after the order awarding benefits. However, the Division or private plan need not pay benefits within five (5) business days if a hearing officer reverses or modifies the denial of a FAMLI claim, and a party files a motion to reconsider with the hearing officer within five (5) business days.

7. A hearing officer, on their own initiative or the motion of a party, may reconsider a decision within five (5) business days of issuance when it appears that a clear procedural or substantive error has been made or that obvious injustice would result. If the Division or a private plan owes benefits upon the resolution of a motion to reconsider, such benefits must be paid as soon as practicable but no later than five (5) business days after the resolution of the motion. 9.8 Withdrawal and Dismissal of Appeals 1. If the party that filed the appeal does not participate in the appeal proceedings, the appeal may be dismissed if the hearing officers deems the appeal abandoned.

8. The appellant may request to withdraw their appeal at any time, and such request will be granted if no party files a meritorious objection. If the appellant withdraws their appeal, they may not appeal the determination again unless the appellant demonstrates that denying the right to appeal will result in an obvious injustice in light of the totality of circumstances. If the appellant withdraws their appeal during the hearing, the hearing officer shall inform the appellant that withdrawal of their appeal will render the determination final.

Editor’s Notes

History New rule eff. 01/01/2024.

Entire rule eff. 01/01/2025.

Rules 9.1 3, 9.2 8, 9.3 4, 9.4 2 eff. 07/01/2025.

Entire rule eff. 01/01/2026.

Rules 9.7 1, 9.7 6, 9.7 7 eff. 07/01/2026.

1108 Office of the Future of Work

7 CCR 1108-1 Colorado State Apprenticeship Agency Rules {#sec-7-ccr-1108-1 omnilex-key=us-co-regs-official--department-10--7 CCR 1108-1}

DEPARTMENT OF LABOR AND EMPLOYMENT

COLORADO STATE APPRENTICESHIP AGENCY RULES

7 CCR 1108-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted May 10, 2023; effective June 30, 2023. 1.1 Statement of Authority.

This regulation is adopted pursuant to the authority in section C.R.S. § 8-15.7-102 and 8-15.7-108 and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24- 4-101 et seq. (the “APA”) and in conformity with regulations promulgated by the Secretary of Labor under the National Apprenticeship Act, 29 U.S.C. 50. 1.2 Purpose and Incorporation by Reference.

A. The general purpose of these Colorado State Apprenticeship Agency Rules (“Rules”) is to exercise the authority of the Director of the State Apprenticeship Agency to enforce and implement rules affecting the registration, performance, and legal compliance of apprenticeship programs.

B. Article 15.7 of C.R.S. Title 8 is hereby incorporated by reference. Earlier versions of such laws may apply to events that occurred in prior years. These statutes and regulations are available for public inspection at the Colorado Department of Labor and Employment, Office of the Future of Work, 633 17th Street, Denver CO 80202. Copies may be obtained from this Office at a reasonable charge, or can be accessed electronically from the website of the Colorado Secretary of State. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of the statutes and regulations incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Office of the Future of Work (OFW) rules are available to the public at https://apprenticeship.colorado.gov/about/apprenticeship-legislation-policy. Where these Rules have provisions different from or contrary to any incorporated or referenced material, the provisions of these Rules govern so long as these are consistent with Colorado statutory and constitutional provisions and in conformity with regulations promulgated by the Secretary of Labor under the National Apprenticeship Act, 29 U.S.C. 50.

C. If any part of these Rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 1.3 Definitions.

“Administrator” means the Administrator of the Office of Apprenticeship, or any person specifically designated by the Administrator.

“Apprentice” means a worker at least 16 years of age, except where a higher minimum age standard is otherwise fixed by law, who is employed to learn an apprenticeable occupation as provided in article 15.7, title 8 of the C.R.S. and 29 CFR 29.4 under standards of apprenticeship fulfilling the requirements of 29 CFR 29.5.

“Apprenticeship Agreement” means a signed written agreement, complying with 29 CFR 29.7, between an apprentice and either the apprentice's program sponsor, or an apprenticeship committee acting as agent for the program sponsor(s), which contains the terms and conditions of the employment and training of the apprentice.

“Apprenticeship committee” means those persons designated by the sponsor to administer the program.

A committee may be either joint or non-joint, as follows:

• A joint committee is composed of an equal number of representatives of the employer(s) and of the employees represented by a bona fide collective bargaining agent(s).

• A non-joint committee, which may also be known as a unilateral or group non-joint (which may include employees) committee, has employer representatives but does not have a bona fide collective bargaining agent as a participant.

“Apprenticeable Occupation” means an occupation specified by an industry that involves the progressive attainment of skills, competencies, and knowledge that are:

• clearly identified and commonly recognized throughout the relevant industry or occupation;

• customarily learned or enhanced in a practical way through a structured, systematic program of on-the-job, supervised learning and related instruction to supplement the learning; and • offered through a time-based, competency-based, or hybrid model that the Director has determined meets the requirements of article 15.7, title 8 of the C.R.S. and 29 CFR Parts 29 and 30.

“Apprenticeship program” is a plan containing all terms and conditions for the qualification, recruitment, selection, employment and training of apprentices, that meets the requirements of article 15.7, title 8 of the C.R.S. and 29 CFR Parts 29 and 30, such as the requirement for a written Apprenticeship Agreement.

“Cancellation” means the termination of the registration or approval status of a program at the request of the sponsor, or termination of an Apprenticeship Agreement at the request of the apprentice.

“Certification” or “Certificate” means documentary evidence that:

• The Office of Apprenticeship has approved a set of National Guidelines for Apprenticeship Standards developed by a national committee or organization, joint or unilateral, for policy or guideline use by local affiliates, as conforming to the standards of apprenticeship set forth in 29 CFR 29.5; or • The SAA has established that an individual is eligible for the probationary period as an apprentice under a registered apprenticeship program.

“Certificate of Registration” means documentary evidence that the SAA has registered an apprenticeship program pursuant to article 15.7, title 8 of the C.R.S. and federal guidelines as evidenced by a Certificate of Registration or other written indicia.

“Certificate of Completion” means documentary evidence that the SAA has determined that an individual has successfully completed apprenticeship.

“CFR” means Code of Federal Regulations.

“Competency” means the attainment of manual, mechanical or technical skills and knowledge, as specified by an occupational standard and demonstrated by an appropriate written and hands-on proficiency measurement.

“Completion rate” means the percentage of an apprenticeship cohort who receive a certificate of apprenticeship completion within 1 year of the projected completion date. An apprenticeship cohort is the group of individual apprentices registered to a specific program during a one (1) year time frame, except that a cohort does not include the apprentices whose Apprenticeship Agreement has been canceled during the probationary period.

“Creed” means all aspects of religious beliefs, observances or practices, as well as sincerely-held moral and ethical beliefs as to what is right and wrong, and/or addresses ultimate ideas or questions regarding the meaning of existence, as well as the beliefs or teachings of a particular religion, church, denomination or sect. A creed does not include political beliefs, association with political beliefs or political interests, or membership in a political party.

“Department” means the Colorado Department of Labor and Employment.

“Director” means the director of the SAA.

“Direct threat” means a significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation. The determination that an individual poses a “direct threat” must be based on an individualized assessment of the individual’s present ability to safely perform the essential functions of the job. This assessment must be based on a reasonable medical judgment that relies on the most current medical knowledge and/or on the best available objective evidence. In determining whether an individual would pose a direct threat, the factors to be considered include:

• The duration of the risk;

• The nature and severity of the potential harm;

• The likelihood that the potential harm will occur; and • The imminence of the potential harm.

“Disability” means, with respect to an individual:

• A physical or mental impairment that substantially limits one or more major life activities of such individual;

• A record of such an impairment; or • Being regarded as having such an impairment.

“EEO” means equal employment opportunity.

“Effective date” means July 1, 2023, unless otherwise noted. Sponsors must comply with the terms of these Rules by the effective date.

“Electronic media” means media that utilize electronics or electromechanical energy for the end user (audience) to access the content; and includes, but is not limited to, electronic storage media, transmission media, the Internet, extranet, lease lines, dial-up lines, private networks, and the physical movement of removable/transportable electronic media and/or interactive distance learning.

“Employer” means any person or organization employing an apprentice, whether or not such person or organization is a party to an Apprenticeship Agreement with the apprentice.

“Ethnicity”, for purposes of recordkeeping and affirmative action, has the same meaning as under the Office of Management and Budget’s Standards for the Classification of Federal Data on Race and Ethnicity, or any successor standards. Ethnicity thus refers to the following designations:

• Hispanic or Latino—A person of Cuban, Mexican, Puerto Rican, Cuban, South or Central American, or other Spanish culture or origin, regardless of race.

• Not Hispanic or Latino “Executive Director” means the Executive Director of the Colorado Department of Labor & Employment.

“Gender expression” means an individual's way of reflecting and expressing the individual's gender to the outside world, typically demonstrated through appearance, dress, and behavior. C.R.S. § 24-34-301 “Gender identity” means an individual's innate sense of the individual's own gender, which may or may not correspond with the individual's sex assigned at birth. C.R.S. § 24-34-301 “Genetic information” means information about:

• An individual’s genetic tests;

• The genetic tests of that individual’s family members;

• The manifestation of disease or disorder in family members of the individual (family medical

history);

• An individual’s request for, or receipt of, genetic services, or the participation in clinical research that includes genetic services by the individual or a family member of the individual; or • The genetic information of a fetus carried by an individual or by a pregnant woman who is a family member of the individual and the genetic information of any embryo legally held by the individual or family member using an assisted reproductive technology.

• Genetic information does not include information about the sex or age of the individual, the sex or age of family members, or information about the race or ethnicity of the individual or family members that is not derived from a genetic test.

“Interim credential” means an optional credential issued by the SAA, upon request of the appropriate sponsor, as certification of competency attainment by an apprentice.

“Journeyworker” means a worker who has attained a level of skill, abilities and competencies recognized within an industry as having mastered the skills and competencies required for the occupation. (Use of the term may also refer to a mentor, technician, specialist or other skilled worker who has documented sufficient skills and knowledge of an occupation, either equal to or greater than formal apprenticeship or through practical on-the-job experience and formal training.)

“Major life activities” include, but are not limited to: Caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, sitting, reaching, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, interacting with others, and working. A major life activity also includes the operation of a major bodily function, including but not limited to, functions of the immune system, special sense organs and skin; normal cell growth; and digestive, genitourinary, bowel, bladder, neurological, brain, respiratory, circulatory, cardiovascular, endocrine, hemic, lymphatic, musculoskeletal, and reproductive functions. The operation of a major bodily function includes the operation of an individual organ within a body system.

“Office of Apprenticeship” or “OA” means the federal office designated by the Employment and Training Administration of the U.S. Department of Labor to administer the National Apprenticeship System or its successor organization.

“Physical or mental impairment” means:

• Any physiological disorder or condition, cosmetic disfigurement, or anatomical loss affecting one or more body systems, such as neurological, musculoskeletal, special sense organs, respiratory (including speech organs), cardiovascular, reproductive, digestive, genitourinary, immune, circulatory, hemic, lymphatic, skin, and endocrine; or • Any mental or psychological disorder, such as intellectual disability (formerly termed “mental retardation”), organic brain syndrome, emotional or mental illness, and specific learning disabilities.

“Probationary period” means a period of the apprenticeship during which either the apprentice or the sponsor may cancel the apprenticeship agreement at-will, without stated cause, without an adverse impact on the sponsor’s completion rate. The probationary period may not exceed 25% of the length of the program, or 1 year, whichever is shorter. Full credit must be given for the probationary period toward completion of the apprenticeship.

“Provisional registration” means the 1-year initial provisional approval of newly registered programs that meet the required standards for program registration, after which program approval may be made permanent, continued as provisional, or rescinded following a review by the SAA, as provided for in the criteria described in 29 CFR 29.3(g) and (h).

“Quality assurance assessment” means a comprehensive review conducted by the SAA regarding all aspects of an apprenticeship program's performance, including but not limited to, determining if apprentices are receiving: on-the-job learning in all phases of the apprenticeable occupation; scheduled wage increases consistent with the registered standards; related instruction through appropriate curriculum and delivery systems; and that the SAA is receiving notification of all new registrations, cancellations, and completions as required in this Rule.

“Qualified applicant or apprentice” is an individual who, with or without reasonable accommodation, can perform the essential functions of the registered apprenticeship program for which the individual applied or is enrolled.

“Qualified intermediary” means an entity that demonstrates expertise in connecting employers or apprenticeship program participants to registered apprenticeship programs or in convening stakeholders to develop registered apprenticeship programs and serves employers and apprenticeship program participants by:

• connecting employers to programs under the National Apprenticeship System;

• assisting in the design and implementation of registered apprenticeship programs, including curriculum development and delivery for related instruction;

• supporting entities, sponsors, or registered apprenticeship program administrators in meeting and reporting the requirements of title 8, article 15.7;

• providing professional development activities, such as training to mentors;

• supporting the recruitment, retention, and apprenticeship program completion of potential registered apprenticeship program participants, including nontraditional participants and apprenticeship populations and individuals with barriers to employment;

• developing and providing personalized apprenticeship program participant supports, including partnering with organizations to provide access to or referrals for supportive services and financial advising;

• providing services, resources, and supports for the development, delivery, expansion, or improvement of apprenticeship programs under the National Apprenticeship System; or • serving as a registered apprenticeship program sponsor.

“Quality pre-apprenticeship program”, for state purposes, is a training model that meets, at a minimum, the federal definition of quality pre-apprenticeship, and any additional criteria established by the SAA for state recognition. Quality pre-apprenticeships are designed to assist individuals who may not currently possess the minimum requirements for selection into a registered apprenticeship program to meet the minimum selection criteria established in a program sponsor’s apprenticeship standards.

“Race”, for purposes of recordkeeping and affirmative action, has the same meaning as under the Office of Management and Budget’s Standards for the Classification of Federal Data on Race and Ethnicity, or any successor standards. Race thus refers to the following designations:

• White—A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

• Black or African American—A person having origins in any of the black racial groups of Africa.

• Native Hawaiian or Other Pacific Islander—A person having origins in any of the peoples of Hawaii, Guam, Samoa, or other Pacific Islands.

• Asian—A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian Subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.

• American Indian or Alaska Native—A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment.

• Per C.R.S. § 24-34-301, race includes hair texture, hair type, or a protective hairstyle that is commonly or historically associated with race.

“Reasonable accommodation” means:

• Modifications or adjustments to a job application process that enable a qualified applicant with a disability to be considered for the position such qualified applicant desires; or • Modifications or adjustments to the work environment, or to the manner or circumstances under which the position held or desired is customarily performed, that enable a qualified individual with a disability to perform the essential functions of that position; or • Modifications or adjustments that enable a sponsor’s apprentice with a disability to enjoy equal benefits and privileges of registered apprenticeship as are enjoyed by its other similarly situated apprentices without disabilities.

• Reasonable accommodation may include but is not limited to the following based on disability, religious belief or practice, pregnancy or a condition related to pregnancy or childbirth, or speaking a first language other than English:

• Making existing facilities used by apprentices readily accessible and usable; and • Job restructuring; part-time or modified work schedules; reassignment to a vacant position; acquisition or modifications of equipment or devices; appropriate adjustment or modifications of examinations, training materials, or policies; the provision of qualified readers or interpreters; and other similar accommodations.

• To determine the appropriate reasonable accommodation it may be necessary for the sponsor to initiate an informal, interactive process with the qualified individual in need of the accommodation.

This process should identify the precise limitations resulting from the disability and potential reasonable accommodations that could overcome those limitations.

“Registration agency” means the State Apprenticeship Agency in the Colorado Department of Labor and Employment, USDOL’s Office of Apprenticeship, or another recognized State Apprenticeship Agency.

“Registration of an Apprenticeship Agreement” means the acceptance and recording of an Apprenticeship Agreement by a Registration Agency as evidence of the apprentice's participation in a particular registered apprenticeship program.

“Registered apprenticeship program” means an apprenticeship program that is registered by a Registration Agency.

“Registration of an apprenticeship program” means the acceptance and recording of such program by the Office of Apprenticeship, or registration and/or approval by the SAA or a recognized State Apprenticeship Agency, as meeting the basic standards and requirements of the OA for approval of such program for Federal purposes. Approval is evidenced by a Certificate of Registration or other written indicia.

“Related instruction” or “related technical instruction” means an organized and systematic form of instruction designed to provide the apprentice with the knowledge of the theoretical and technical subjects related to the apprentice's occupation. Such instruction may be given in a classroom, through occupational or industrial courses, or by correspondence courses of equivalent value, electronic media, or other forms of self-study approved by the SAA.

“Secretary” means the Secretary of Labor or any person designated by the Secretary.

“Selection procedure” means any measure, combination of measures, or procedure used as a basis for any decision in registered apprenticeship. Selection procedures include the full range of assessment techniques from traditional paper and pencil tests, performance tests, training programs, or probationary periods and physical, educational, and work experience requirements through informal or casual interviews and unscored application forms.

“Sponsor” means any employer, association, committee, organization, education and training provider or qualified intermediary, or person operating a registered apprenticeship program and in whose name the program is (or is to be) registered or approved.

“State Apprenticeship Agency” or “SAA” means the State Apprenticeship Agency created in C.R.S. §8- 15.7-102 unless otherwise noted.

“State Apprenticeship Council” or “SAC” means an entity established to provide advice and guidance to the State Apprenticeship Agency as defined in 29 CFR 29.2.

“State office” means that individual office or division of State government designated as the point of contact for the State Apprenticeship Agency. In Colorado, this is the Office of the Future of Work in the Colorado Department of Labor and Employment.

“Technical assistance” means guidance provided by Registration Agency staff in the development, revision, amendment, or processing of a potential or current program sponsor's Standards of Apprenticeship, Apprenticeship Agreements, or advice or consultation with a program sponsor to further compliance with this Rule or guidance.

“Transfer” means a shift of apprenticeship registration from one program to another or from one employer within a program to another employer within that same program, where there is agreement between the apprentice and the affected apprenticeship committees or program sponsors. This agreement may include a similar related instruction provided by institutions of higher education that may have additional enrollment criteria from the original apprenticeship program.

“Undue hardship”— 1. In general. Undue hardship means, with respect to the provision of an accommodation, significant difficulty or expense incurred by a sponsor, when considered in light of the factors set forth in part 2. of this definition.

2. Factors to be considered. In determining whether an accommodation would impose an undue hardship on a sponsor, factors to be considered include:

• The nature and net cost of the accommodation needed under this plan, taking into consideration the availability of tax credits and deductions, and/or outside funding;

• The overall financial resources of the facility or facilities involved in the provision of the reasonable accommodation, the number of persons employed at such facility, and the effect on expenses and resources;

• The overall financial resources of the sponsor, the overall size of the registered apprenticeship program with respect to the number of apprentices, and the number, type and location of its facilities;

• The type of operation or operations of the sponsor, including the composition, structure and functions of the workforce of such entity, and the geographic separateness and administrative or fiscal relationship of the facility or facilities in question to the sponsor; and • The impact of the accommodation upon the operation of the facility, including the impact on the ability of other apprentices to perform their duties and the impact on the facility’s ability to conduct business. 1.4 Duties of the Colorado State Apprenticeship Agency and the State Apprenticeship Council A. The State Apprenticeship Agency is the state Registration Agency and has the responsibility for registering apprenticeship programs, apprenticeship agreements, and apprentices.

B. The State Apprenticeship Agency or SAA shall perform its duties as set forth in C.R.S. § 8-15.7- 102 and this 7 CCR 1108-1 in conformity with the regulations published in 29 CFR Parts 29 and 30, specifically:

1. Secure recognition as a Registration Agency with the OA;

2. Establish the State Apprenticeship Council, which operates under the direction of the SAA, to provide advice and guidance;

3. Register and oversee apprenticeship programs, apprenticeship agreements, and apprentices, including the cancellation and deregistration of apprenticeship programs and agreements;

4. Conduct reviews of registered apprenticeship programs and quality assurance assessments for compliance with federal regulations and state policies, including equal opportunity in apprenticeship;

5. Establish the Colorado State Apprenticeship Agency State Plan for Equal Opportunity in Apprenticeship to ensure equal opportunity for apprentices and applicants;

6. Provide reciprocal approval to apprentices, apprenticeship programs and standards that are registered in other states by OA or another recognized Registration Agency;

7. Provide technical assistance to current and prospective sponsors on the development or revision of standards of apprenticeship, apprenticeship agreements, or other guidance to comply with federal regulations and state policies on registered apprenticeship; and 8. Maintain requirements pursuant to 29 CFR 29.13 for recognition as a Registration Agency.

C. C.R.S. § 8-15.7-103 to 8-15.7-105 establish the membership requirements and duties of the State Apprenticeship Council (SAC) and its subcommittees to advise the SAA on the operation of the state's apprenticeship system.

D. The SAC may convene additional Subcommittees as needed to fulfill its duties. 1.5 Standards, Criteria, and Requirements for Apprenticeship Program Registration and/or Approval A. Eligibility and procedure for registration of an apprenticeship program.

1. Sponsor duties and submission. Any person or organization seeking to register an apprenticeship program shall submit all required documents to the SAA for consideration and approval.

a. A sponsor may apply to register an apprenticeship with the SAA. A sponsor is responsible for meeting the eligibility requirements outlined in this Section 1.5(A)(2).

b. A sponsor of a registered apprenticeship is responsible for the administration and supervision of on-the-job learning and related instruction for each apprentice in the registered apprenticeship.

2. Program Eligibility. To be eligible for SAA registration, an apprenticeship program or agreement must meet all of the following:

a. Conform with the standards set forth in 29 CFR 29.5 and article 15.7, title 8 of the C.R.S. and the Department's regulations and applicable state employment and training laws and regulations.

b. Conform with the Equal Employment Opportunity in Apprenticeship and Training in 29 CFR Part 30, as amended, Colorado’s State Plan for Equal Opportunity in Apprenticeship in this Rule 1.6, and applicable state laws and regulations impacting Equal Employment Opportunity.

c. Be in an apprenticeable occupation having the characteristics set forth in 29 CFR 29.4 and Section B. of this Rule.

3. Application Components. The SAA may provide technical assistance to all potential sponsors upon their request in compiling any or all elements of their application. Each application for a registered apprenticeship program shall provide, at a minimum:

a. Verification of the company's existing workforce b. Apprentice supervision. Each registered apprenticeship program shall identify a numeric ratio of apprentices to journeyworkers for the workforce that complies with 29 CFR 29.5(b)(7).

c. Apprenticeable occupation. Verification of the training is in an apprenticeable occupation having the criteria and requirements set forth in Section B. of this

Rule d. On-the-job Learning and Related Instruction. An organized plan for meeting each of the program standards required by Section C. of this Rule.

e. Apprenticeship Agreement. A copy of the Apprenticeship Agreement defined in

Rule 1.3.

f. The SAA may, in partnership with relevant state agencies, incorporate additional elements into the application to reduce duplication of postsecondary program approval.

g. The SAA may incorporate additional elements into the application for state purposes to align requirements to ease administrative burden or coordinate with partner programs where appropriate, as long as any additions conform with 29 CFR Parts 29 and 30.

i. The option to participate in the Eligible Training Provider List.

ii. The option to express interest in GI Bill ™ Benefits for referral to the Office of Veterans Education and Training.

iii. The option for referral and communications with federal, state, and local partners to align registered apprenticeship related grants, funding, and related federal and state partner programs.

iv. The option to coordinate with appropriate state partners, institutions of higher education, local education agencies, and/or relevant qualified intermediaries regarding credit for prior learning, related instruction plans, finding additional related instruction partners, and credentialing.

v. The option for referral to Equal Employment Opportunity partners and/or qualified intermediaries for assistance with recruitment services.

h. Sponsor intent to file as one of the following:

i. Single employer, participating in a collective bargaining agreement (joint);

ii. Single employer, not participating in a collective bargaining agreement (non-joint);

iii. Multi-employer, joint; or iv. Multi-employer, non-joint.

4. Apprentice Registration. Apprentices must be individually registered under a registered program. Such individual registration may be triggered by:

a. Filing copies of each individual Apprenticeship Agreement with the SAA; or b. Subject to prior OA or recognized SAA approval, filing a master copy of such agreement followed by a listing of the name, and other required data, of each individual when apprenticed.

5. Probationary Period. Names of apprentices in the probationary period must be submitted within 45 days of the program start date to the SAA for certification to establish the apprentice as eligible for such probationary period.

6. Changes to Apprenticeship Agreements. The SAA must be notified by the sponsor within 45 days of apprentices who have successfully completed apprenticeship programs, or transfers, suspensions, and cancellations of Apprenticeship Agreements and a statement of the reasons.

7. Program Certification a. The SAA may conduct a worksite analysis prior to any decision to approve a registered apprenticeship program. The analysis shall identify any prior or existing state or federal violations that affect workers.

b. Each registered apprenticeship program shall set forth in writing: a statement that the program will be conducted in compliance with Equal Employment Opportunity in Apprenticeship Training, adopted pursuant to 29 CFR Part 30; an equal opportunity pledge: and when applicable, an affirmative action program and selection method that complies with 29 CFR Part 30.

c. The SAA may, in partnership with relevant state agencies, incorporate additional elements into the certification process to reduce duplication of postsecondary program approval.

d. Group (multi-employer programs) have an additional review prior to registration:

i. Multi-employer programs must demonstrate an alignment between their on-the-job learning component, employer demand, and apprentice enrollment prior to registration.

ii. Programs participating in Collective Bargaining Agreements (Single or Multi-employer Joint Programs). Under a program proposed for registration by an employer or employers' association, where the standards, collective bargaining agreement or other instrument provides for participation by a union in any manner in the operation of the substantive matters of the registered apprenticeship program, and such participation is exercised, written acknowledgement of union agreement or no objection to the registration is required. Where no such participation is evidenced and practiced, the employer or employers' association must simultaneously furnish to an existing union, which is the collective bargaining agent of the employees to be trained, a copy of its application for registration and of the apprenticeship program. The SAA must provide for receipt of union comments, if any, within 45 days before final action on the application for registration and/or approval.

iii. Multi-employer programs without a Collective Bargaining Agreement (Non-Joint). Where the employees to be trained have no collective bargaining agreement, an apprenticeship program may be proposed for registration by an employer or group of employers, or an employer association.

e. The SAA will issue certificates of registration to approved sponsors of operating (active) registered apprenticeship programs.

8. Provisional Approval.

a. All new registered apprenticeship programs shall be under provisional approval for a period of one (1) year. A quality assessment review of the program shall be conducted by the SAA after the one-year mark to determine conformity. At that time, the registration approval of the program in conformity may be made permanent or continue to be provisionally approved through the first full training cycle. A program not in operation or not conforming during the provisional approval period may be recommended for deregistration procedures.

b. Programs in provisional status upon the transition to the SAA will remain in provisional status and have one (1) year from the date of July 1, 2023 for a provisional review to determine conformity. At that time, the registration approval of the program in conformity may be made permanent or continue to be provisionally approved through the first full training cycle. A program not in operation or not conforming during the provisional approval period may be recommended for deregistration procedures.

c. The SAA may, in partnership with relevant state agencies, incorporate additional elements into the provisional quality assurance process for the purposes of reducing duplication of postsecondary program approval.

9. Permanent registration. The SAA must review all programs for quality and for conformity with this rule at the end of the first full training cycle. A satisfactory review of a provisionally approved program will result in conversion of provisional approval to permanent registration. Programs in permanent status upon the transition to the SAA will have two (2) years from the date of July 1, 2023 for an initial review to determine conformity. Subsequent reviews must be conducted no less frequently than every 5 years. Programs not in operation or not conforming to the regulations must be recommended for deregistration procedures.

10. Program Modifications.

a. Any sponsor proposals or applications for modification(s) or change(s) to registered programs must be submitted to the SAA.

b. To meet the standards for review, any modifications must meet the same standards as new programs established under this Rule and subsequent Standards set by federal and state law or guidance.

i. If the change is an addition of employers, the SAA may conduct a worksite analysis to identify any prior or existing state or federal violations that affect workers. If not approved, the sponsor must be notified of the disapproval and the reasons therefore and provided the appropriate technical assistance.

ii. If the modification impacts the related instruction, the related instruction must meet the minimum requirements for related instruction providers and instruction.

iii. If the modifications impact interim credentials or certificate of completion, the sponsor must review the work process and related instruction to meet the competencies and/or hours to meet the requirements of the credential, and any state or federal regulations regarding registered apprenticeship credentialing.

iv. Wage schedule modifications.

I. Voluntary wage schedule modifications will not be approved if they violate federal, state, or local wage laws.

II. Mandatory modifications to wage schedules based on changes to state and local wage laws. The SAA is responsible for notifying sponsors of changes to federal state and local policies, initiating the wage schedule adjustment process for impacted programs, and providing technical assistance. Sponsors are required to adjust the wage schedule for new and existing employers to comply with updated standards. The SAA must follow state and local guidance on the timeline for modification of wage standards regarding impacted programs.

c. The SAA must make a determination on whether to approve such submissions within 90 days from the date of receipt. If approved, the modification(s) or change(s) will be recorded and acknowledged within 90 days of approval as an amendment to such program. If not approved, the sponsor must be notified of the disapproval and the reasons therefore and provided the appropriate technical assistance.

d. The state Office is responsible for coordinating internal review of functions within the Department impacting minimal Standards of Apprenticeship quality assurance, inclusive of state and federal policies regarding labor standards.

B. Criteria for apprenticeable occupations.

1. An apprenticeable occupation is one specified by an industry that involves the progressive attainment of skills, competencies, and knowledge that are:

a. clearly identified and commonly recognized throughout the relevant industry or occupation;

b. customarily learned or enhanced in a practical way through a structured, systematic program of on-the-job, supervised learning and related instruction to supplement the learning; and c. offered through a time-based, competency-based, or hybrid (blend of time-based and competency-based) model that the Director has determined meets the requirements of title 8, article 15.7 of the C.R.S. and 29 CFR Parts 29 and 30.

2. A time-based model requires the completion of at least 2,000 hours of on-the-job learning.

C. Colorado Standards of registered apprenticeship.

An apprenticeship program, to be eligible for approval and registration by the SAA, must conform to the following standards:

1. The program must have an organized, written plan (program standards) embodying the terms and conditions of employment, training, and supervision of one or more apprentices in an apprenticeable occupation and subscribed to by a sponsor who has undertaken to carry out the apprentice training program.

2. The program standards must contain provisions that address:

a. The employment and training of the apprentice in a skilled occupation.

b. The term of registered apprenticeship, which for an individual apprentice may be measured either through the completion of the industry standard for on-the-job learning (at least 2,000 hours) (time-based approach), the attainment of competency (competency-based approach), or a blend of the time-based and competency-based approaches (hybrid approach).

i. The time-based approach measures skill acquisition through the individual apprentice's completion of at least 2,000 hours of on-the-job learning as described in a work process schedule.

ii. The competency-based approach measures skill acquisition through the individual apprentice's successful demonstration of acquired skills and knowledge, as verified by the program sponsor. Programs utilizing this approach must still require apprentices to complete an on-the-job learning component of registered apprenticeship. The program standards must address how on-the-job learning will be integrated into the program, describe competencies, and identify an appropriate means of testing and evaluation for such competencies.

iii. The hybrid approach measures the individual apprentice's skill acquisition through a combination of specified minimum number of hours of on-the-job learning and the successful demonstration of competency as described in a work process schedule.

iv. The determination of the appropriate approach for the program standards is made by the program sponsor, subject to approval by the SAA of the determination as appropriate to the apprenticeable occupation for which the program standards are registered.

c. An outline of the work processes in which the apprentice will receive supervised work experience and training on the job, and the allocation of the approximate amount of time to be spent in each major process.

d. Provision for organized, related instruction in technical subjects related to the occupation. A minimum of 144 hours for each year of registered apprenticeship is recommended. Related instruction may be delivered in a live classroom, or in a virtual or hybrid format using electronic media provided:

i. The delivery of related instruction to all apprentices enrolled in the program via electronic means is administratively feasible ii. The use of electronic media by the program sponsor to deliver related instruction is not inconsistent with the current version of the program’s Standards or its Work Process Schedule (WPS);

e. Every apprenticeship instructor must:

i. Meet the Colorado Department of Education's requirements for a technical education instructor in the State of registration, or be a subject matter expert, which is an individual, such as a journeyworker, who is recognized within an industry as having expertise in a specific occupation; and ii. Have training in teaching techniques and adult learning styles, which may occur before or after the apprenticeship instructor has started to provide the related instruction.

iii. If applicable, the instructor must meet the instructor requirements of state recognized institutions of higher education, which may also include additional requirements through the Colorado Community College System and the Colorado Department of Education. Institutions of higher education must be authorized to operate in the state by the Colorado Department of Higher Education, and meet the institutional or program accrediting standards, as required by law. Sponsors partnering with approved programs do not need to seek additional approval of individual instructors, unless institutional partners change.

f. A progressively increasing schedule of wages to be paid to the apprentice consistent with the skill acquired. The entry wage must not be less than the highest applicable minimum wage prescribed by the Fair Labor Standards Act, by Colorado or (to the extent applicable) local statutes or rules, or by collective bargaining agreement.

g. Periodic review and evaluation of the apprentice's performance on the job and in related instruction; and the maintenance of appropriate progress records.

h. A numeric ratio of apprentices to journeyworkers consistent with proper supervision, training, safety, and continuity of employment, and applicable provisions in collective bargaining agreements, except where such ratios are expressly prohibited by the collective bargaining agreements . The ratio language must be specific and clearly described as to its application to the job site, workforce, department or plant.

i. A probationary period reasonable in relation to the full apprenticeship term, with full credit given for such period toward completion of registered apprenticeship.

The probationary period cannot exceed 25 percent of the length of the program, or 1 year, whichever is shorter. During the probationary period, either party may cancel the Apprenticeship Agreement without stated cause, and such cancellation will not have an adverse effect on the sponsor's completion rate.

j. Adequate and safe equipment and facilities for training and supervision, and relevant safety training for apprentices on the job and in related instruction.

k. Each registered apprenticeship program shall provide for the placement of each apprentice under a written registered Apprenticeship Agreement that meets the requirements of this document and is approved by the SAA. The agreement must directly or by reference incorporate the standards of the program as part of the agreement.

i. The names of persons in the probationary period as an apprentice under an apprenticeship program registered by the Office of Apprenticeship or the SAA, if not individually registered under such program, must be submitted within 45 calendar days of the program start date to the SAA for certification to establish the apprentice as eligible for such probationary period.

ii. For programs for which the on-the-job learning occurs first, the sponsor is responsible for:

I. Ensuring the apprentice is under an Apprenticeship Agreement within 45 days of the start of employment.

iii. For programs for which related instruction occurs first, the sponsor is responsible for:

I. Securing adequate on-the-job learning placements prior to enrolling apprentices;

II. Ensuring that before the time of enrollment and incurring costs associated with the program, the apprentice has a copy of the Apprenticeship Standards, information on available on-the-job learning placements, and understands any provisions related to continuing to on-the-job learning (e.g. successful completion of coursework); and III. Ensuring the apprentice is under an Apprenticeship Agreement or in probationary status within 45 days of the start of related instruction.

l. The granting of advanced standing or credit for demonstrated competency, acquired experience, training, or skills for all applicants equally, with commensurate wages for any progression step so granted.

m. The transfer of an apprentice between apprenticeship programs and within a registered apprenticeship program must be based on agreement between the apprentice and the affected apprenticeship committees or program sponsors, and must comply with the following requirements:

i. The transferring apprentice must be provided a transcript of related instruction and on-the-job learning by the committee or program sponsor;

ii. Transfer must be to the same occupation or, if not the same occupation, through a reasonable transcript analysis for equivalency of related instruction, interim credentials and/or on-the-job learning; and iii. A new Apprenticeship Agreement must be executed when the transfer occurs between program sponsors.

n. Assurance of qualified training personnel and adequate supervision on the job.

o. In licensed occupations, apprentices in registered apprenticeship programs shall be employed by licensed contractors. Apprenticeships in licensed occupations must prepare the apprentice for qualifications for licensure and maintain the administrative requirements of the appropriate oversight body of that occupation.

The SAA may coordinate with the appropriate agencies in the quality assurance review process to reduce employer or sponsor administrative burden and maintain worker protections.

p. Each apprenticeship program shall provide recognition of successful completion of a registered apprenticeship to the apprentices as evidenced by the appropriate certificate issued by the SAA.

q. Program standards that utilize the competency-based or hybrid approach for progression through a registered apprenticeship and that choose to issue interim credentials must clearly identify the interim credentials, demonstrate how these credentials link to the components of the apprenticeable occupation, and establish the process for assessing an individual apprentice's demonstration of competency associated with the particular interim credential. Further, interim credentials must only be issued for recognized components of an apprenticeable occupation, thereby linking interim credentials specifically to the knowledge, skills, and abilities associated with those components of the apprenticeable occupation.

r. Each registered apprenticeship program shall identify the Colorado SAA as the Registration Agency.

s. Apprenticeship program sponsors must promptly submit and obtain the approval of the SAA for any modification or amendment to a registered program and provide for the registration, cancellation, and deregistration of the program. The SAA will make a determination on whether to approve such modifications or changes within 90 calendar days from the date of receipt. If approved, the modifications or changes will be recorded and acknowledged within 90 calendar days of approval as an amendment to the program. If not approved, the sponsor will be notified of the disapproval and the reasons and provided with the appropriate technical assistance.

t. Providing notice to the SAA of persons who have successfully completed the registered apprenticeship program, and notice of transfers, suspensions and cancellations of Apprenticeship Agreements and a statement of the reasons.

u. Authority for the cancellation of an Apprenticeship Agreement during the probationary period by either party without stated cause; cancellation during the probationary period will not have an adverse impact on the sponsor's completion rate.

v. Compliance with 29 CFR Part 30, including the equal opportunity pledge prescribed in 29 CFR 30.3(c); an affirmative action program complying with 29 CFR 30.4; and a method for the selection of apprentices complying with 29 CFR 30.10, or compliance with parallel requirements contained in the State plan for equal opportunity in apprenticeship adopted under 29 CFR Part 30 and approved by the OA. The apprenticeship standards must also include a statement that the program will be conducted, operated and administered in conformity with applicable provisions of 29 CFR part 30, as amended, or if applicable, an approved State plan for equal opportunity in apprenticeship.

w. Each registered apprenticeship program shall provide contact information (name, address, telephone number, and e-mail if appropriate) for the appropriate individual with authority under the program to receive, process and make disposition of complaints.

x. Each registered apprenticeship program shall provide that the sponsor shall maintain all records concerning registered apprenticeship as may be required by the SAA and other applicable law, including appropriate progress records, for not less than five (5) years, and that the sponsor shall make such records available to the SAA upon request.

y. Each registered apprenticeship program sponsor shall identify a point of contact and complete disclosure regarding information to be publicly released in the annual Apprenticeship Resource Directory required by C.R.S. 8-83-308, as amended.

D. Registered Apprenticeship Program Performance Standards.

1. Every registered apprenticeship program must have at least one registered apprentice, except for the following specified periods of time, which may not exceed 1 year:

a. Between the date when a program is registered and the date of registration for its first apprentice(s); or b. Between the date that a program graduates an apprentice and the date of registration for the next apprentice(s) in the program.

2. The SAA must evaluate performance of registered apprenticeship programs.

a. The tools and factors to be used must include, but are not limited to:

i. Quality assurance assessments;

ii. Equal Employment Opportunity (EEO) Compliance Reviews; and iii. Completion rates.

b. Any additional tools and factors used by the SAA in evaluating program performance must adhere to guidance issued by the SAA and in conformity with regulations promulgated by the Secretary under the National Apprenticeship Act, 29 U.S.C. 50.

c. The SAC may advise the SAA on administrative policies that ensure the safety and quality of registered apprenticeship programs and address, as warranted, the related needs of Colorado’s businesses, the labor workforce, and communities.

3. In order to evaluate completion rates, the SAA must review a program's completion rates in comparison to the national average for completion rates. Based on the review, the SAA must provide technical assistance to programs with completion rates lower than the national average.

4. Cancellation of Apprenticeship Agreements during the probationary period will not have an adverse impact on a sponsor's completion rate. 1.6 The Colorado SAA State Plan for Equal Opportunity in Apprenticeship A. Purpose, applicability, and relationship to other laws 1. Purpose. The purpose of this plan is to promote equal opportunity for apprentices and applicants for apprenticeship in registered apprenticeship programs by prohibiting discrimination based on the following protected bases: race, color, religion, national origin, sex, sexual orientation, age (40 or older), genetic information, disability, creed, gender identity, gender expression, ancestry, pregnancy or childbirth (or related conditions), and any other basis protected by federal, state, or local law. This plan also prescribes affirmative action efforts sponsors must take to ensure equal opportunity for apprentices and applicants for registered apprenticeship. This plan sets forth the equal opportunity obligations of sponsors, the contents of affirmative action programs, procedures for the filing and processing of complaints, and enforcement procedures. This plan also establishes procedures for deregistration of an apprenticeship program in the event of noncompliance with this plan.

5. Applicability. The plan applies to all sponsors of apprenticeship programs registered with the Colorado SAA.

6. Relationship to other laws. This plan does not invalidate or limit the remedies, rights, and procedures under any Federal law or the law of any State or political subdivision of any State or jurisdiction that provides greater or equal protection for individuals based on the protected bases listed in (A)(1) than are afforded by this plan. It may be a defense to a charge of a violation of this plan that a challenged action is required or necessitated by a Federal law or regulation, or that a Federal law or regulation prohibits an action that would otherwise be required by this plan.

B. Equal opportunity standards applicable to all sponsors 1. Discrimination prohibited. It is unlawful for a sponsor of a registered apprenticeship program to discriminate against an apprentice or applicant for apprenticeship on the

basis of the protected bases listed in (A)(1) with regard to:

a. Recruitment, outreach, and selection procedures;

b. Hiring and/or placement, upgrading, periodic advancement, promotion, demotion, transfer, layoff, termination, right of return from layoff, and rehiring;

c. Rotation among work processes;

d. Imposition of penalties or other disciplinary action;

e. Rates of pay or any other form of compensation and changes in compensation;

f. Conditions of work;

g. Hours of work and hours of training provided;

h. Job assignments;

i. Leaves of absence, sick leave, or any other leave; and j. Any other benefit, term, condition, or privilege associated with registered apprenticeship.

2. Discrimination standards and defenses.

a. Race, color, religion, national origin, sex, or sexual orientation. In implementing this section, the SAA will look to the legal standards and defenses applied under title VII of the Civil Rights Act of 1964, 42 U.S.C. 2000 et seq, Executive Order 11246, and C.R.S. § 24-34-301 as applicable, in determining whether a sponsor has engaged in a practice prohibited under Section (B)(1) of this Rule.

b. Disability. With respect to discrimination based on a disability, the SAA will apply the same standards, defenses, and exceptions to the definition of disability as those set forth in title I of the Americans with Disabilities Act (ADA), 42 U.S.C. 12112 and 12113, as amended, and the implementing regulations promulgated by the Equal Employment Opportunity Commission (EEOC) at 29 CFR Part 30, which include, among other things, the standards governing reasonable accommodation, medical examinations and disability-related inquiries, qualification standards, and direct threat defense. The Interpretive Guidance on title I of the ADA set out as an appendix to part 1630 issued pursuant to title I may be relied upon for guidance in complying with the nondiscrimination requirements of this plan with respect to the treatment of individuals with disabilities.

c. Age. The SAA will apply the same standards and defenses for age discrimination as those set forth in the Age Discrimination in Employment Act (ADEA), 29 U.S.C. 623, the implementing regulations promulgated by the EEOC at 29 CFR

Part 1625, and in the Colorado Anti-Discrimination Act, C.R.S. § 24-34-402.

d. Genetic information. The SAA will apply the same standards and defenses for discrimination based on genetic information as those set forth in the Genetic Information Nondiscrimination Act (GINA), 29 U.S.C. 2000ff et seq., and the implementing regulations promulgated by the EEOC at 29 CFR Part 1635.

e. Creed, gender identity, gender expression, or ancestry. The SAA will apply the same standards, defenses, and exceptions for discrimination based on creed, gender identity, gender expression, or ancestry as those set forth in the Colorado Anti-Discrimination Act, C.R.S. § 24-34-402.

f. Pregnancy, childbirth, and related conditions. The SAA will apply the same standards, defenses, and exceptions for discrimination based on pregnancy, childbirth, and related conditions as those set forth in the Colorado Anti- Discrimination Act, C.R.S. 24-34-402.5.

C. General duty to engage in affirmative action. For each registered apprenticeship program, a sponsor is required to take affirmative steps to provide equal opportunity in apprenticeship. These steps must include:

1. Assignment of responsibility. The sponsor will designate an individual or individuals with appropriate authority under the program, such as an apprenticeship coordinator, to be responsible and accountable for overseeing its commitment to equal opportunity in registered apprenticeship, including the development and implementation of an affirmative action program as required by Section (D)(2) and 29 CFR 30.4(b). The individual(s) must have the resources, support of, and access to the sponsor leadership to ensure effective implementation. The individual(s) will be responsible for:

a. Monitoring all registered apprenticeship activity to ensure compliance with the nondiscrimination and affirmative action obligations required by this plan;

b. Maintaining records required under this plan; and c. Generating and submitting reports as may be required by the SAA.

2. Internal dissemination of equal opportunity policy. The sponsor must inform all applicants for apprenticeship, apprentices, and individuals connected with the administration or operation of the registered apprenticeship program of its commitment to equal opportunity and its affirmative action obligations. In addition, the sponsor must require that individuals connected with the administration or operation of the registered apprenticeship program take the necessary action to aid the sponsor in meeting its nondiscrimination and affirmative action obligations under this plan. A sponsor, at a minimum, is required to:

a. Publish its equal opportunity pledge—set forth in Section (C)(5)(a) of this Rule— in the apprenticeship standards required under Rule 1.5(C), and in appropriate publications, such as apprentice and employee handbooks, policy manuals, newsletters, or other documents disseminated by the sponsor or that otherwise describe the nature of the sponsorship;

b. Post its equal opportunity pledge from (C)(5)(a) of this Rule on bulletin boards, including through electronic media, such that it is accessible to all apprentices and applicants for registered apprenticeship;

c. Conduct orientation and periodic information sessions for individuals connected with the administration or operation of the registered apprenticeship program, including all apprentices and journeyworkers who regularly work with apprentices, to inform and remind such individuals of the sponsor’s equal employment opportunity policy with regard to registered apprenticeship, and to provide the training required by Rule 1.6(C)(4)(a); and d. Maintain records necessary to demonstrate compliance with these requirements and make them available to the SAA upon request.

3. Universal outreach and recruitment. The sponsor will implement measures to ensure that its outreach and recruitment efforts for apprentices comply with all federal, state, and local laws as to job postings, outreach, and recruitment, and that they extend to all persons available for apprenticeship within the sponsor’s relevant recruitment area without regard to race, color, religion, national origin, sex, sexual orientation, age (40 or older), genetic information, disability, creed, gender identity, gender expression, ancestry, pregnancy or childbirth (or related conditions), and any other basis protected by federal, state, or local law. In furtherance of this requirement, the sponsor must:

a. Develop and update annually a list of current recruitment sources that will generate referrals from all demographic groups within the relevant recruitment area. Examples of relevant recruitment sources include: The public workforce system’s workforce centers and local workforce development boards; community-based organizations; community colleges; career and technical colleges; pre-apprenticeship programs; and Federally funded, youth job training programs such as YouthBuild and Job Corps or their successors;

b. Identify a contact person, mailing address, telephone number, and email address for each recruitment source; and c. Provide recruitment sources advance notice, preferably 30 calendar days, of registered apprenticeship openings so that the recruitment sources can notify and refer candidates. Such notification must also include documentation of the sponsor’s equal opportunity pledge specified in Section (C)(5)(a) of this Rule.

4. Maintaining apprenticeship programs free from harassment, intimidation, and retaliation.

The sponsor must develop and implement procedures to ensure that its apprentices are not harassed because of the protected bases listed in (A)(1) and to ensure that its registered apprenticeship program is free from intimidation and retaliation as prohibited by C.R.S. § 24-34-402(1)(f). To promote an environment in which all apprentices feel safe, welcomed, and treated fairly, the sponsor must ensure the following steps are taken:

a. Providing anti-harassment training to all individuals connected with the administration or operation of the registered apprenticeship program, including all apprentices and journeyworkers who regularly work with apprentices. This training must not be a mere transmittal of information, but must include participation by trainees, such as attending a training session in person or completing an interactive training online. The training content must include, at a minimum, communication of the following:

i. That harassing conduct will not be tolerated;

ii. The definition of harassment and the types of conduct that constitute unlawful harassment on the basis of the protected bases listed in (A)(1); and iii. The right to file a harassment complaint under 29 CFR 30.14.

b. Making all facilities and registered apprenticeship activities available without regard to the protected bases listed in (A)(1) except that if the sponsor provides restrooms or changing facilities, the sponsor must provide separate or singleuser restrooms and changing facilities to assure privacy between the sexes.

c. Establishing and implementing procedures for handling and resolving complaints about harassment and intimidation based on the protected bases listed in (A)(1), as well as complaints about retaliation for engaging in protected activity described in 29 CFR 30.17.

d. Compliance with Federal and State equal employment opportunity laws. The sponsor must comply with all other applicable Federal and State laws and regulations that require equal employment opportunity without regard to the protected bases in (A)(1) and any other bases protected under limited circumstances in the Colorado Anti-Discrimination Act (C.R.S. § 24-34-402 through 402.7). Failure to comply with such laws if such noncompliance is related to the equal employment opportunity of apprentices and/or graduates of such a registered apprenticeship program under this plan is grounds for deregistration or the imposition of other enforcement actions in accordance with Section O. of this

Rule.

5. Equal opportunity pledge.

a. Each sponsor of a registered apprenticeship program must include in its Standards of Apprenticeship and registered apprenticeship opportunity announcements the following equal opportunity pledge: [Name of sponsor] will not discriminate against registered apprenticeship applicants or apprentices based on race, color, religion, creed, national origin, ancestry, sex (including pregnancy and gender identity), gender expression, childbirth and related conditions, sexual orientation, genetic information, or because they are an individual with a disability or a person 40 years old or older. [Name of sponsor] will take affirmative action to provide equal opportunity in apprenticeship and will operate the registered apprenticeship program as required under Title 29 of the Code of Federal Regulations, part 30.

b. The nondiscrimination bases listed in this pledge may be broadened to conform to consistent local requirements. Sponsors may include additional protected bases but may not exclude any of the bases protected by this Rule.

6. Compliance.

a. Current sponsors: A sponsor that has a registered apprenticeship program as of the effective date of this Rule must comply with all obligations of this section by the effective date of this Rule.

b. New sponsors: A sponsor registering after the effective date of this Rule shall comply with all obligations of this section upon registration.

D. Affirmative action programs.

1. Definition and purpose. As used in this plan:

a. An affirmative action program is designed to ensure equal opportunity and prevent discrimination in registered apprenticeship programs. An affirmative action program is more than mere passive nondiscrimination. Such a program requires the sponsor to take affirmative steps to encourage and promote equal opportunity, to create an environment free from discrimination, and to address any barriers to equal opportunity in registered apprenticeship. An affirmative action program is more than a paperwork exercise. It includes those policies, practices, and procedures, including self-analyses, that the sponsor implements to ensure that all qualified applicants and apprentices are receiving an equal opportunity for recruitment, selection, advancement, retention and every other term and privilege associated with registered apprenticeship. An affirmative action program should be a part of the way the sponsor regularly conducts its registered apprenticeship program.

b. A central premise underlying affirmative action is that, absent discrimination, over time a sponsor’s registered apprenticeship program, generally, will reflect the sex, race, ethnicity, and disability profile of the labor pools from which the sponsor recruits and selects. Consistent with this premise, affirmative action programs contain a diagnostic component which includes quantitative analyses designed to evaluate the composition of the sponsor’s registered apprenticeship program and compare it to the composition of the relevant labor pools. If women, individuals with disabilities, or individuals from a particular minority group, for example, are not being admitted into registered apprenticeship at a rate to be expected given their availability in the relevant labor pool, the sponsor’s affirmative action program must include specific, practical steps designed to address any barriers to equal opportunity that may be contributing to this underutilization.

c. Effective affirmative action programs include internal auditing and reporting systems as a means of measuring the sponsor’s progress toward achieving a registered apprenticeship program that would be expected absent discrimination.

d. An affirmative action program also ensures equal opportunity in registered apprenticeship by incorporating the sponsor’s commitment to equality in every aspect of the registered apprenticeship program. Therefore, as part of its affirmative action program, a sponsor must monitor and examine its employment practices, policies and decisions and evaluate the impact such practices, policies and decisions have on the recruitment, selection and advancement of apprentices. It must evaluate the impact of its employment and personnel policies on minorities, women, and persons with disabilities, and revise such policies accordingly where such policies or practices are found to create a barrier to equal opportunity.

e. The commitments contained in an affirmative action program are not intended and must not be used to discriminate against any qualified applicant or apprentice on the basis of the protected bases listed in (A)(1).

2. Adoption of affirmative action programs. Sponsors other than those exempted in (D)(4) of this section must develop and maintain an affirmative action program, setting forth that program in a written plan. The components of the written plan, as detailed in Sections E. through I. of this Rule, must be developed in accordance with the respective compliance dates and made available to the SAA any time thereafter upon request.

3. Contents of affirmative action programs. An affirmative action program must include the following components in addition to those required of all sponsors by Section B of this

Rule:

a. Utilization analysis for race, sex, and ethnicity, as described in Section E. and 29 CFR 30.5;

b. Establishment of utilization goals for race, sex, and ethnicity, as described in

Section F. and 29 CFR 30.6;

c. Utilization goals for individuals with disabilities, as described in Section G. and 29 CFR 30.7;

d. Targeted outreach, recruitment, and retention, as described in Section H. and 29 CFR 30.8;

e. Review of personnel processes, as described in Section I. and 29 CFR 30.9; and f. Invitations to self-identify, as described in Section J. and 29 CFR 30.11 4. Exemptions— a. Programs with fewer than five apprentices. A sponsor is exempt from the requirements of Sections (D)(2) and (D)(3) of this Rule if the sponsor’s registered apprenticeship program has fewer than five apprentices registered, unless such a program was adopted to circumvent the requirements of this plan.

b. Programs subject to approved equal employment opportunity programs. A sponsor is exempt from the requirements of Sections (D)(2) and (D)(3) of this plan if the sponsor both submits to the SAA satisfactory evidence that it is in compliance with an equal employment opportunity program providing for affirmative action in apprenticeship, including the use of goals for any underrepresented group or groups of individuals, which has been approved as meeting the requirements of either title VII of the Civil Rights Act of 1964, as amended (42 U.S.C. 2000e et seq.) and agrees to extend such program to include individuals with disabilities, or if the sponsor submits to the SAA satisfactory evidence that it is in compliance with an equal employment opportunity program providing for affirmative action in apprenticeship, including the use of goals for any underrepresented group or groups of individuals, which has been approved as meeting the requirements of both Executive Order 11246, as amended, and section 503 of the Rehabilitation Act, as amended (29 U.S.C. 793), and their implementing regulations at title 41 of the Code of Federal Regulations, Chapter 60. Provided that programs approved, modified or renewed subsequent to the effective date of this Rule will qualify for this exception only if the goals for any underrepresented group for the selection of apprentices provided for in such programs are likely to be equal to or greater than the goals required under this plan.

5. Written affirmative action plans. Sponsors required to undertake an affirmative action program must create and update a written document memorializing and discussing the contents of the program set forth in Section (D)(3) of this plan.

a. Compliance— i. Current sponsors. The initial written affirmative action plan for such programs must be completed within two years after the effective date of this Rule. The written affirmative action plan for such programs must be updated every time the sponsor completes workforce analyses required by Sections E. and G.

ii. Registered apprenticeship programs registered after the effective date of this Rule. The initial written affirmative action plan for such programs must be completed within two years of registration. The written affirmative action plan for such programs must be updated every time the sponsor completes workforce analyses required by Sections E. and G.

E. Utilization analysis for race, sex, and ethnicity.

1. Purpose. The purpose of the utilization analysis is to provide sponsors with a method for assessing whether possible barriers to registered apprenticeship exist for particular groups of individuals by determining whether the race, sex, and ethnicity of apprentices in a sponsor’s registered apprenticeship program is reflective of persons available for apprenticeship by race, sex, and ethnicity in the relevant recruitment area. Where significant disparity exists between availability and representation, the sponsor will be required to establish a utilization goal pursuant to Section (F)(1) and 29 CFR 30.6.

2. Analysis of apprenticeship program workforce— a. Process. Sponsors must analyze the race, sex, and ethnic composition of their apprentice workforce. This is a two-step process. First, each sponsor must group all apprentices in its registered apprenticeship program by occupational title.

Next, for each occupation represented, the sponsor must identify the race, sex, and ethnicity of its apprentices within that occupation.

b. Schedule of analyses. Each sponsor is required to conduct an apprenticeship program workforce analysis at each compliance review, and again if and when three years have passed without a compliance review. This updated workforce analysis should be compared to the utilization goal established at the sponsor’s most recent compliance review to determine if the sponsor is underutilized, according to the process in Section (E)(2)(a) of this plan.

c. Compliance date.

i. Current sponsors: A sponsor that has a registered apprenticeship program as of the effective date of this Rule must conduct its first workforce analysis, pursuant to this section, no later than two years after the effective date of this Rule.

ii. New sponsors: A sponsor registering with the SAA after the effective date of this Rule must conduct its initial workforce analysis pursuant to this section no later than two years after the date of registration.

3. Availability analysis— a. The purpose of the availability analysis is to establish a benchmark against which the demographic composition of the sponsor’s registered apprenticeship program can be compared in order to determine whether barriers to equal opportunity may exist with regard to the sponsor’s registered apprenticeship program.

b. Availability is an estimate of the number of qualified individuals available for apprenticeship by race, sex, and ethnicity expressed as a percentage of all qualified persons available for apprenticeship in the sponsor’s relevant recruitment area.

c. In determining availability, the following factors must be considered for each major occupation group represented in the sponsor’s registered apprenticeship program standards:

i. The percentage of individuals who are eligible for enrollment in the registered apprenticeship program within the sponsor’s relevant recruitment area broken down by race, sex, and ethnicity; and ii. The percentage of the sponsor’s employees who are eligible for enrollment in the registered apprenticeship program, broken down by race, sex, and ethnicity.

d. In determining availability, the relevant recruitment area is defined as the geographical area from which the sponsor usually seeks or reasonably could seek apprentices. The sponsor must identify the relevant recruitment area in its written affirmative action plan. The sponsor may not draw its relevant recruitment area in such a way as to have the effect of excluding individuals based on race, sex, or ethnicity from consideration, and must develop a brief rationale for selection of that recruitment area.

e. Availability will be derived from the most current and discrete statistical information available. Examples of such information include census data, data from local job service offices, and data from colleges or other training institutions.

f. Sponsors, working with the SAA, will conduct availability analyses at each compliance review.

4. Rate of utilization. To determine the rate of utilization, the sponsor, working with the SAA, must group each occupational title in its apprenticeship workforce by major occupation group and compare the racial, sex, and ethnic representation within each major occupation group to the racial, sex, and ethnic representation available in the relevant recruitment area, as determined in Section (E)(3) of this plan. When the sponsor’s utilization of women, Hispanics or Latinos, or a particular racial minority group is significantly less than would be reasonably expected given the availability of such individuals for apprenticeship, the sponsor must establish a utilization goal for the affected group in accordance with the procedures set forth in Section F. of this plan.

Sponsors are not required or expected to establish goals where no significant disparity in utilization rates has been found.

F. Establishment of utilization goals for race, sex, and ethnicity 1. Where, pursuant to Section (E)(4) and 29 CFR 30.5, a sponsor is required to establish a utilization goal for a particular racial, sex, or ethnic group in a major occupation group in its registered apprenticeship program, the sponsor, working with the SAA, must establish a percentage goal at least equal to the availability figure derived under 29 CFR 30.5(c) for that major occupation group.

2. A sponsor’s determination under 29 CFR 30.5 that a utilization goal is required constitutes neither a finding nor an admission of discrimination.

3. Utilization goals serve as objectives or targets reasonably attainable by means of applying every good faith effort to make all aspects of the entire affirmative action program work. Utilization goals are used to measure the effectiveness of the sponsor’s outreach, recruitment, and retention efforts.

4. In establishing utilization goals, the following principles apply:

a. Utilization goals may not be rigid and inflexible quotas, which must be met, nor are they to be considered either a ceiling or a floor for the selection of particular groups as apprentices. Quotas are expressly forbidden.

b. Utilization goals may not provide a sponsor with a justification to extend a preference to any individual, select an individual, or adversely affect an individual’s status as an apprentice, on the basis of that person’s race, sex, or ethnicity.

c. Utilization goals do not create set-asides for specific groups, nor are they intended to achieve proportional representation or equal results.

d. Utilization goals may not be used to supersede eligibility requirements for registered apprenticeship. Affirmative action programs prescribed by this Rule do not require sponsors to select a person who lacks qualifications to participate in the registered apprenticeship program successfully, or select a less-qualified person in preference to a more qualified one.

G. Utilization goals for individuals with disabilities.

1. Utilization goal. The Administrator of OA has established a utilization goal of 7 percent for employment of qualified individuals with disabilities as apprentices for each major occupation group within which the sponsor has an apprenticeship program.

2. Purpose. The purpose of the utilization goal established in Section (G)(1) of this plan is to establish a benchmark against which the sponsor must measure the representation of individuals with disabilities in the sponsor’s apprentice workforce by major occupation group. The goal serves as an equal opportunity objective that should be attainable by complying with all of the affirmative action requirements of this Rule.

3. Periodic review of goal. The Administrator of OA will periodically review and update, as appropriate, the utilization goal established in Section (G)(1) of this plan.

4. Utilization analysis— a. Purpose. The utilization analysis is designed to evaluate the representation of individuals with disabilities in the sponsor’s apprentice workforce grouped by major occupation group. If individuals with disabilities are represented in the sponsor’s apprentice workforce in any given major occupation group at a rate less than the utilization goal, the sponsor must take specific measures outlined in

Section (H) of this plan.

b. Apprentice workforce analysis— i. Process. Sponsors are required to analyze the representation of individuals with disabilities within their apprentice workforce by occupation. This is a two-step process. First, as required in 29 CFR 30.5, each sponsor must group all apprentices in its registered apprenticeship program according to the occupational titles represented in its registered apprenticeship program. Next, for each occupation represented, the sponsor must identify the number of apprentices with disabilities.

ii. Schedule of evaluation. The sponsor must conduct its apprentice workforce analysis at each compliance review, and again if and when three years have passed without a compliance review. This updated workforce analysis, grouped according to major occupation groups, should then be compared to the utilization goal established under

Section (G)(1) of this plan.

iii. Compliance.

I. Sponsors registered as of the effective date of this Rule: A sponsor must conduct its first workforce analysis, pursuant to this section, no later than two years after the effective date of this

Rule.

II. New sponsors: A sponsor registering after the effective date of this Rule must conduct its initial workforce analysis pursuant to this section no later than two years after the date of registration.

5. Identification of problem areas. When the sponsor, working with the SAA, determines that the percentage of individuals with disabilities in one or more major occupation groups within which a sponsor has apprentices is less than the utilization goal established in

Section (G)(1) of this plan, the sponsor must take steps to determine whether and/or where impediments to equal opportunity exist. When making this determination, the sponsor must look at the results of its assessment of personnel processes required by

Section I. and 29 CFR 30.9 and the effectiveness of its outreach and recruitment efforts required by Section H. and 29 CFR 30.8, if applicable.

6. Action-oriented programs. The sponsor must undertake action-oriented programs, including targeted outreach, recruitment, and retention activities identified in 29 CFR 30.8, designed to correct any problem areas that the sponsor identified pursuant to its review of personnel processes and outreach and recruitment efforts.

7. Utilization goal relation to discrimination. A determination that the sponsor has not attained the utilization goal established in Section (G)(1) of this plan in one or more major occupation groups does not constitute either a finding or admission of discrimination in violation of this rule.

8. Utilization goal not a quota or ceiling. The utilization goal established in Section (G)(1) of this plan must not be used as a quota or ceiling that limits or restricts the employment of individuals with disabilities as apprentices.

H. Targeted outreach, recruitment, and retention.

1. Minimum activities required. Where a sponsor has found underutilization and established a utilization goal for a specific group or groups pursuant to Section F. and 29 CFR 30.6 and/or where a sponsor has determined pursuant to Section (G)(5) that there are problem areas resulting in impediments to equal employment opportunity, the sponsor must undertake targeted outreach, recruitment, and retention activities that are likely to generate an increase in applications for registered apprenticeship and improve retention of apprentices from the targeted group or groups and/or from individuals with disabilities, as appropriate. In furtherance of this requirement, the sponsor must:

a. Set forth in its written affirmative action plan the specific targeted outreach, recruitment, and retention activities it plans to take for the upcoming program year. Such activities must include at a minimum:

i. Dissemination of information to organizations serving the underutilized group regarding the nature of registered apprenticeship, requirements for selection for registered apprenticeship, availability of registered apprenticeship opportunities, and the equal opportunity pledge of the sponsor. These organizations may include: Community-based organizations; local high schools; local community and technical colleges; local Career and Technical Education providers; and local workforce system partners including Colorado Workforce Centers;

Human Services providers; Division of Vocational Rehabilitation (DVR) centers;

ii. Advertising openings for registered apprenticeship opportunities by publishing advertisements in appropriate media which have wide circulation in the relevant recruitment areas;

iii. Cooperation with local school boards and Career and Technical Education providers to develop and/or establish relationships with preapprenticeship programs targeting students from the underutilized group to prepare them to meet the standards and criteria required to qualify for entry into registered apprenticeship programs; and iv. Establishment of linkage agreements or partnerships enlisting the assistance and support of pre-apprenticeship programs, communitybased organizations, advocacy organizations, or other appropriate organizations, in recruiting qualified individuals for registered apprenticeship.

b. Evaluate and document after every selection cycle for registering apprentices the overall effectiveness of such activities;

c. Refine its targeted outreach, recruitment, and retention activities as needed; and d. Maintain records of its targeted outreach, recruitment, and retention activities and records related to its evaluation of these activities.

2. Other activities. In addition to the activities set forth in Section (H)(1) of this plan, as a matter of best practice, sponsors are encouraged but not required to consider other outreach, recruitment, and retention activities that may assist sponsors in addressing any barriers to equal opportunity in registered apprenticeship. Such activities include but are not limited to:

a. Enlisting the use of journeyworkers from the underutilized group or groups to assist in the implementation of the sponsor’s affirmative action program;

b. Enlisting the use of journeyworkers from the underutilized group or groups to mentor apprentices and to assist with the sponsor’s targeted outreach and recruitment activities; and c. Conducting exit interviews of each apprentice who leaves the sponsor’s registered apprenticeship program prior to receiving a certificate of completion to understand better why the apprentice is leaving the program and to help shape the sponsor’s retention activities.

I. Review of personnel processes.

1. As part of its affirmative action program, the sponsor must, for each registered apprenticeship program, engage in an annual review of its personnel processes related to the administration of the apprenticeship program to ensure that the sponsor is operating an apprenticeship program free from discrimination based on the protected bases listed in (A)(1). This annual review is required regardless of whether the sponsor is underutilized as described in Section (E)(4). The review must be a careful, thorough, and systematic one and include review of all aspects of the registered apprenticeship program at the program, industry and occupation level, including, but not limited to, the qualifications for registered apprenticeship, application and selection procedures, wages, outreach and recruitment activities, advancement opportunities, promotions, work assignments, job performance, rotations among all work processes of the occupation, disciplinary actions, handling of requests for reasonable accommodations, and the program’s accessibility to individuals with disabilities (including to the use of information and communication technology). The sponsor must make any necessary modifications to its program to ensure that its obligations under this Rule are met.

2. Compliance.

a. Current sponsors: A sponsor that has a registered apprenticeship program as of the effective date of this Rule must comply with the obligations of paragraph (1) of this section within two years of the effective date of this Rule.

b. New sponsors: A sponsor registering with the SAA after the effective date of this

rule shall comply with the obligations of paragraph (1) of this section within two years after the date of registration.

c. The sponsor must include a description of its review in its written affirmative action plan and identify in the written plan any modifications made or to be made to the program as a result of its review.

J. Selection of apprentices.

1. A sponsor’s procedures for selection of apprentices must be included in the written plan for Standards of Apprenticeship submitted to and approved by the SAA, as required under Rule 1.5(C).

2. Sponsors may utilize any method or combination of methods for selection of apprentices, provided that the selection method(s) used meets the following requirements:

a. The use of the selection procedure(s) must comply with the Uniform Guidelines on Employee Selection Procedures (UGESP) (41 CFR part 60–3), including the requirements to evaluate the impact of the selection procedure on race, sex, and ethnic groups (Hispanic or Latino/non–Hispanic or Latino) and to demonstrate job-relatedness and business necessity for those procedures that result in adverse impact in accordance with the requirements of UGESP.

b. The selection procedure(s) must be uniformly and consistently applied to all applicants and apprentices within each selection procedure utilized.

c. The selection procedure(s) must comply with title I of the ADA and EEOC’s implementing regulations at Part 1630. This procedure(s) must not screen out or tend to screen out an individual with a disability or a class of individuals with disabilities, on the basis of disability, unless the standard, test or other selection criteria, as used by the program sponsor, is shown to be job-related for the position in question and is consistent with business necessity.

d. The selection procedure(s) must be facially neutral in terms of the protected bases listed in Section (A)(1).

K. Invitation to self-identify as an individual with a disability.

1. Pre-offer.

a. A sponsor adopting an affirmative action program pursuant to Section D. must invite applicants for registered apprenticeship to inform the sponsor whether the applicant believes that he or she is an individual with a disability as defined in

Rule 1.3. This invitation must be provided to each applicant when the applicant applies or is considered for registered apprenticeship. The invitation may be included with the application materials for registered apprenticeship, but must be separate from the application.

b. The sponsor must invite an applicant to self-identify as required in paragraph (a) of this section using the voluntary disclosure form prescribed by the Administrator and published on the OA Web site.

2. Post offer.

a. At any time after acceptance into the registered apprenticeship program, but before the applicant begins their registered apprenticeship, the sponsor must invite the applicant to inform the sponsor whether the applicant believes that he or she is an individual with a disability as defined in Rule 1.3.

b. The sponsor must invite an applicant to self-identify as required in paragraph (a) of this section using the voluntary disclosure form prescribed by the Administrator and published on the OA Web site.

3. Apprentices.

a. Within the timeframe specified in paragraph (8) below, the sponsor must make a one-time invitation to each current apprentice to inform the sponsor whether he or she is an individual with a disability as defined in Rule 1.3. The sponsor must make this invitation using the voluntary disclosure form prescribed by the Administrator and published on the OA Web site.

b. Thereafter, the sponsor must remind apprentices at least yearly that they may voluntarily update their disability status.

4. Voluntary self-identification for apprentices. The sponsor may not compel or coerce an individual to self-identify as an individual with a disability.

5. Confidentiality. The sponsor must keep all information on self-identification confidential and must maintain it in a data analysis file (rather than the medical files of individual apprentices) as required under 29 CFR 30.12(e). The sponsor must provide selfidentification information to the SAA upon request. Self-identification information may be used only in accordance with this Rule.

6. Affirmative action obligations. Nothing in this section may relieve the sponsor of its obligation to take affirmative action with respect to those applicants and apprentices of whose disability the sponsor has knowledge.

7. Nondiscrimination obligations. Nothing in this section may relieve the sponsor from liability for discrimination in violation of this Rule.

8. Compliance dates.

a. Sponsors registered as of the effective date of this Rule: A sponsor must begin inviting applicants and apprentices to identify as individuals with disabilities, pursuant to this section, no later than the effective date of this Rule. A sponsor must also invite each of its current apprentices to voluntarily inform the sponsor whether the apprentice believes that he or she is an individual with a disability, as defined in 29 CFR 30.2, no later than the effective date of this Rule.

b. New sponsors: A sponsor registering after the effective date of this Rule must begin inviting applicants and apprentices to identify as individuals with disabilities, pursuant to this section, no later than two years after the date of registration. A sponsor covered by this subparagraph must also invite each of its current apprentices to voluntarily inform the sponsor whether the apprentice believes that he or she is an individual with a disability, as defined in Rule 1.3, no later than two years after the date of registration.

L. Recordkeeping.

1. General obligation. Each sponsor must collect such data and maintain such records as the SAA finds necessary to determine whether the sponsor has complied or is complying with the requirements of this Rule. Such records must include, but are not limited to records relating to:

a. Selection for registered apprenticeship, including applications, tests and test results, interview notes, bases for selection or rejection, and any other records required to be maintained under the Uniform Guidelines on Employee Selection Procedures (UGESP) at 41 CFR part 60-3;

b. The invitation to self-identify as an individual with a disability;

c. Information relative to the operation of the registered apprenticeship program, including but not limited to job assignments in all components of the occupation as required under Rule 1.5(C)(2)(c), promotion, demotion, transfer, layoff, termination, rates of pay, other forms of compensation, conditions of work, hours of work, hours of training provided, and any other personnel records relevant to EEO complaints filed with the SAA under Section N. or with other enforcement agencies;

d. Compliance with the requirements of Section B. and 29 CFR 30.3;

e. Requests for reasonable accommodation; and f. Any other records pertinent to a determination of compliance with these regulations, as may be required by the SAA.

2. Sponsor identification of record. For any record the sponsor maintains pursuant to this

Rule, the sponsor must be able to identify the race, sex, ethnicity (Hispanic or Latino/non- Hispanic or Latino), and when known, disability status of each apprentice, and where possible, the race, sex, ethnicity, and disability status of each applicant to apprenticeship and supply this information upon request to the SAA.

3. Affirmative action programs. Each sponsor required under Section D. to develop and maintain an affirmative action program must retain both the written affirmative action plan and documentation of its component elements set forth in Sections E, F, G, H, I, and J.

4. Maintenance of records. The records required by this Rule and any other information relevant to compliance with this Rule must be maintained for 5 years from the date of the making of the record or the personnel action involved, whichever occurs later, and must be made available upon request to the SAA or other authorized representative in such form as the SAA may determine is necessary to enable it to ascertain whether the sponsor has complied or is complying with this Rule. Failure to preserve complete and accurate records as required by paragraphs (a), (b), and (c) of this section constitutes noncompliance with this Rule.

5. Confidentiality and use of medical information.

a. Any information obtained pursuant to this Rule regarding the medical condition or

history of an applicant or apprentice must be collected and maintained on separate forms and in separate medical files and treated as a confidential medical record, except that:

i. Supervisors and managers may be informed regarding necessary restrictions on the work or duties of the applicant or apprentice and necessary accommodations;

ii. First aid and safety personnel may be informed, when appropriate, if the disability might require emergency treatment; and iii. Government officials engaged in enforcing this Rule, the laws administered by the USDOL Office of Federal Contract Compliance Programs, or the ADA, must be provided relevant information on request.

b. Information obtained under this Rule regarding the medical condition or history of any applicant or apprentice may not be used for any purpose inconsistent with this Rule.

6. Access to records. Each sponsor must permit access during normal business hours to its places of business for the purpose of conducting on-site EEO compliance reviews and complaint investigations and inspecting and copying such books, accounts, and records, including electronic records, and any other material the SAA deems relevant to the matter under investigation and pertinent to compliance with this EEO plan. The sponsor must also provide the SAA access to these materials, including electronic records, off-site for purposes of conducting EEO compliance reviews and complaint investigations. Upon request, the sponsor must provide the SAA information about all format(s), including specific electronic formats, in which its records and other information are available.

Information obtained in this manner will be used only in connection with the administration of this plan or other applicable EEO laws.

M. Equal employment opportunity compliance reviews.

1. Conduct of compliance reviews. The SAA will regularly conduct EEO compliance reviews to determine if the sponsor maintains compliance with this EEO plan and will also conduct EEO compliance reviews when circumstances warrant. An EEO compliance review may consist of, but is not limited to, comprehensive analyses and evaluations of each aspect of the registered apprenticeship program through off-site reviews, such as desk audits of records submitted to the SAA, and on-site reviews conducted at the sponsor’s establishment that may involve examination of records required under this

Rule; inspection and copying of documents related to recordkeeping requirements of this

Rule; and interviews with employees, apprentices, journeyworkers, supervisors, managers, and hiring officials.

2. Notification of compliance review findings. Within 45 business days of completing an EEO compliance review, the SAA must present a written Notice of Compliance Review Findings to the sponsor’s contact person through registered or certified mail, with return receipt requested. If the compliance review indicates a failure to comply with this rule, the SAA will so inform the sponsor in the Notice and will set forth in the Notice the following:

a. The deficiency(ies) identified;

b. How to remedy the deficiency(ies);

c. The timeframe within which the deficiency(ies) must be corrected; and d. Enforcement actions may be undertaken if compliance is not achieved within the required timeframe.

3. Compliance.

a. When a sponsor receives a Notice of Compliance Review Findings that indicates a failure to comply with this Rule, the sponsor must, within 30 business days of notification, either implement a compliance action plan and notify the SAA of that plan or submit a written rebuttal to the Findings. Sponsors may also seek to extend this deadline one time by up to 30 days for good cause shown. If the SAA upholds the Notice after receiving a written response, the sponsor must implement a compliance action plan within 30 days of receiving the notice from the SAA upholding its Findings. The compliance action plan must include, but is not limited to, the following provisions:

i. A specific commitment, in writing, to correct or remediate identified deficiency(ies) and area(s) of noncompliance;

ii. The precise actions to be taken for each deficiency identified;

iii. The time period within which the cited deficiency(ies) will be remedied and any corrective program changes implemented; and iv. The name of the individual(s) responsible for correcting each deficiency identified.

b. Upon the SAA’s approval of the compliance action plan, the sponsor may be considered in compliance with this rule provided that the compliance action plan is implemented.

4. Enforcement actions. Any sponsor that fails to implement its compliance action plan within the specified timeframes may be subject to an enforcement action under Section O.

N. Complaints.

1. Requirements for individuals filing complaints— a. Who may file. Any individual who believes that they have been or are being discriminated against on the basis of race, color, religion, national origin, sex, sexual orientation, age (40 or older), genetic information, disability, creed, gender identity, gender expression, ancestry, pregnancy or childbirth (or related conditions) with regard to registered apprenticeship, or who believe they have been retaliated against as described in Section Q, may, personally file a written complaint with the SAA or the Registration Agency with whom the apprenticeship program is registered.

b. Time period for filing a complaint. Generally, a complaint must be filed within 300 days of the alleged discrimination or specified failure to follow the equal opportunity standards. However, for good cause shown, the SAA may extend the filing time. The time period for filing is for the administrative convenience of the SAA and does not create a defense for the respondent.

c. Contents of the complaint. Each complaint must be made in writing and must contain the following information:

i. The complainant’s name, address, email address and telephone number, or other means for contacting the complainant;

ii. The identity of the respondent (the individual or entity that the complainant alleges is responsible for the discrimination);

iii. A short description of the events that the complainant believes were discriminatory, including but not limited to when the events took place, what occurred, and why complainant believes the actions were discriminatory (for example, because of their race, color, religion, national origin, sex, sexual orientation, age (40 or older), genetic information, disability, creed, gender identity, gender expression, ancestry, pregnancy or childbirth (or related conditions)); and iv. The complainant’s signature.

2. Requirements of sponsors. Sponsors must provide written notice to all applicants for registered apprenticeship and all apprentices of their right to file a discrimination complaint and the procedures for doing so. The notice must include the address, phone number, and other contact information for the SAA that will receive and investigate complaints filed under this EEO plan. The notice must be provided in the application for registered apprenticeship and must also be displayed in a prominent, publicly available location where all apprentices will see the notice. The notice must contain the following specific wording:

Your Right to Equal Opportunity It is against the law for a sponsor of an apprenticeship program registered for Federal purposes to discriminate against an apprenticeship applicant or apprentice based on race, color, religion, creed, national origin, ancestry, sex (including pregnancy and gender identity), gender expression, childbirth and related conditions, sexual orientation, genetic information, age (40 or older), or disability. The sponsor must ensure equal opportunity with regard to all terms, conditions, and privileges associated with registered apprenticeship. If you think that you have been subjected to discrimination, you may file a complaint within 300 days from the date of the alleged discrimination or failure to follow the equal opportunity standards with:

Colorado Department of Labor & Employment Attention: State Apprenticeship Agency Director 633 17th Street, Suite 201 (720) 204-8608 apprenticeship@state.co.us You may also be able to file complaints directly with the EEOC, or State fair employment practices agency. If those offices have jurisdiction over the sponsor/employer, their contact information is listed below.

Colorado Civil Rights Division 1560 Broadway, Suite 825 Phone: 303-894-2997 (para español, oprima dos)

Toll Free: 800-886-7675 DORA_CCRD@state.co.us Equal Employment Opportunity Commission (EEOC) 950 17th St, Suite 300 Phone: 800-669-4000 TTY: 800-669-6820 ASL Video Phone: 844-234-5122 Attention: EEOC Director https://publicportal.eeoc.gov Each complaint filed must be made in writing and include the following information:

a. Complainant’s name, address, email address and telephone number, or other means for contacting the complainant;

b. The identity of the respondent (i.e. the name, address, and telephone number of the individual or entity that the complainant alleges is responsible for the discrimination);

c. A short description of the events that the complainant believes were discriminatory, including but not limited to when the events took place, what occurred, and why the complainant believes the actions were discriminatory (for example, because of their race, color, religion, national origin, sex, sexual orientation, age (40 or older), genetic information, disability, creed, gender identity, gender expression, ancestry, pregnancy or childbirth (or related conditions));

d. The complainant’s signature.

3. Requirements of the SAA a. Conduct investigations. The investigation of a complaint filed under this Rule will be undertaken by the SAA, and will proceed as expeditiously as possible. In conducting complaint investigations, the SAA must:

i. Provide written notice to the complainant acknowledging receipt of the complaint;

ii. Contact the complainant, if the complaint form is incomplete, to obtain full information necessary to initiate an investigation;

iii. Initiate an investigation upon receiving a complete complaint;

iv. Complete a thorough investigation of the allegations of the complaint and develop a complete case record that must contain, but is not limited to, the name, address, and telephone number of each person interviewed, the interview statements, copies, transcripts, or summaries (where appropriate) of pertinent documents, and a narrative report of the investigation with references to exhibits and other evidence which relate to the alleged violations; and v. Provide written notification of the SAA’s findings to both the respondent and the complainant.

b. Seek compliance. Where a report of findings from a complaint investigation indicates a violation of the nondiscrimination requirements of this EEO plan, the SAA should attempt to resolve the matter quickly at the SAA level whenever appropriate. Where a complaint of discrimination cannot be resolved at the SAA level to the satisfaction of the complainant, the SAA shall refer the complaint to other Federal, State or local EEO agencies, as appropriate.

c. Referrals to other EEO agencies. The SAA, at its discretion, may choose to refer a complaint immediately upon its receipt or any time thereafter to:

i. The EEOC;

ii. The United States Attorney General;

iii. The U.S. Department of Labor’s Office of Federal Contract Compliance Programs; or iv. The Colorado Civil Rights Division O. Enforcement actions.

1. Where the SAA, as a result of a compliance review, complaint investigation, or other reason, determines that the sponsor is not operating its registered apprenticeship program in accordance with this Rule, the SAA shall notify the sponsor in writing of the specific violation(s) identified and may:

a. Offer the sponsor technical assistance to promote compliance with this EEO plan.

b. Suspend the sponsor’s right to register new apprentices if the sponsor fails to implement a compliance action plan to correct the specific violation(s) identified within 30 business days from the date the sponsor is so notified of the violation(s), or, if the sponsor submits a written response to the findings of noncompliance, fails to implement a compliance action plan within 30 days of receiving the SAA’s notice upholding its initial noncompliance findings. If the sponsor has not implemented a compliance action plan within 30 business days of notification of suspension, the SAA may institute proceedings to deregister the program in accordance with the deregistration proceedings set forth in 29 CFR

Part 29, or if the SAA does not institute such proceedings within 45 days of the start of the suspension, the suspension is lifted.

c. Take any other action authorized by law. These other actions may include, but are not limited to:

i. Referral to the EEOC;

ii. Referral to the Colorado Civil Rights Division; or iii. Referral to the U.S. Department of Labor’s Office of Federal Contract Compliance Programs.

P. Reinstatement of program registration.

1. An apprenticeship program that has been deregistered pursuant to this Rule may be reinstated by the SAA upon presentation of adequate evidence that the apprenticeship program is operating in accordance with this Rule.

Q. Intimidation and retaliation prohibited.

1. A participant in a registered apprenticeship program may not be intimidated, threatened, coerced, retaliated against, or discriminated against because the individual has:

a. Filed a complaint alleging a violation of this Rule;

b. Opposed a practice prohibited by the provisions of this Rule or any other Federal or State equal opportunity law;

c. Furnished information to, or assisted or participated in any manner, in any investigation, compliance review, proceeding, or hearing under this Rule or any Federal or State equal opportunity law; or d. Otherwise exercised any rights and privileges under the provisions of this Rule.

2. Any sponsor that permits such intimidation or retaliation in its registered apprenticeship program, including by participating employers, and fails to take appropriate steps to prevent such activity will be subject to enforcement action under 29 CFR 30.15.

3. Requests for exemption from this Rule, or any part thereof, must be made in writing to the SAA and must contain a statement of reasons supporting the request. Exemptions may be granted for good cause by the SAA upon approval by the OA Administrator to grant an exemption. 1.7 Apprenticeship Agreement Contents and Approval Process A. Required Individual Apprenticeship Agreements 1. No apprentice shall be employed under a registered apprenticeship program unless an individual Apprenticeship Agreement for that apprentice has been registered with the SAA.

4. Registration of the individual apprentice must be entered into the SAA management system by one of the following mechanisms:

a. direct entry of the sponsor, or their designee (preferred)

b. providing a .CSV of secure data elements 3. The names of persons in the probationary period as an apprentice under a registered apprenticeship program certified by the SAA if not registered individually must be submitted within 45 days of the program start date to the SAA for certification to establish the apprentice as eligible for such probationary period.

B. Individual Apprenticeship Agreements 1. Contents. The Apprenticeship Agreement must contain, explicitly or by reference:

a. Names and signatures of the contracting parties (apprentice, and the program sponsor or employer), and the signature of a parent or guardian if the apprentice is a minor.

b. The apprentice’s date of birth.

c. A Social Security number, Individual Taxpayer Identification Number, or other unique identifier of the apprentice, unless a state policy or established agreement with the SAA protects the inclusion of such a field.

d. Contact information of the Program Sponsor and SAA:

Colorado Department of Labor and Employment Attention: State Apprenticeship Agency Director 633 17th St., Suite 201 e. A statement of the occupation in which the apprentice is to be trained, and the beginning date and term (duration) of registered apprenticeship.

f. A statement showing:

i. The number of hours to be spent by the apprentice in work on the job in a time-based program; or a description of the skill sets to be attained by completion of a competency-based program, including the on-the-job learning component; or the minimum number of hours to be spent by the apprentice and a description of the skill sets to be attained by completion of hybrid program; and ii. The number of hours to be spent in related instruction in technical subjects related to the occupation, which is recommended to be not less than 144 hours per year.

g. A statement setting forth a schedule of the work processes in the occupation or industry divisions in which the apprentice is to be trained and the approximate time to be spent at each process.

h. A statement of the graduated scale of wages to be paid to the apprentice and whether or not the required related instruction is compensated.

i. Statements providing:

i. For a specific probationary period during which the Apprenticeship Agreement may be canceled by either party to the agreement upon written notice to the SAA, without adverse impact on the sponsor.

ii. That, after the probationary period, the agreement may be:

a. Canceled at the request of the apprentice, or b. Suspended or canceled by the sponsor, for good cause, with due notice to the apprentice and a reasonable opportunity for corrective action, and with written notice to the apprentice and to the SAA of the final action taken.

j. A reference incorporating as part of the agreement the standards of the registered apprenticeship program as they exist on the date of the agreement and as they may be amended during the period of the agreement.

k. A statement that the apprentice will be accorded equal opportunity in all phases of registered apprenticeship employment and training, without discrimination because of race, color, religion, creed, national origin, ancestry, sex (including pregnancy and gender identity), gender expression, childbirth and related conditions, sexual orientation, genetic information, age (40 or older), or disability.

l. Contact information (name, address, phone, and e-mail if appropriate) of the appropriate authority designated by the registered apprenticeship program to receive, process and make disposition of controversies or differences arising out of the Apprenticeship Agreement when the controversies or differences cannot be adjusted locally or resolved in accordance with the established procedure or applicable collective bargaining provisions.

m. Option for the apprentice to disclose demographic data, including the apprentice's race, sex, and ethnicity, and disability status.

2. The SAA will use the USDOL Appendix B (ETA 671 or subsequent form) Apprenticeship Agreement for registering apprentices as the preferred standard agreement for all new and existing programs.

a. New and existing programs have the option to create a state-approved Apprenticeship Agreement that meets, at minimum, the requirements of this part, for purposes of reducing administrative burden, enhancing their program, increasing equity, or complying with industry or employer/human resources standards or regulations impacting effective and equitable apprenticeship administration.

i. The SAA, as part of the registration process, will require programs to indicate whether or not they will be using the ETA 671, an alternative state-approved agreement, or, in the case of multi-employer programs, a combination.

ii. During the approval process, the SAA will indicate to the sponsor which elements of their agreement ensure compliance with federal and state standards and the policy on apprentice agreement review.

b. Sponsors must notify the SAA prior to issuing new agreements if they change the method of Apprenticeship Agreements.

i. The sponsor may make changes to the agreement that do not impact the elements required in federal and SAA requirements. If the sponsor makes adjustments that impact registered apprenticeship elements that are related to compliance, they must notify the SAA for approval of the new form prior to issuing new agreements.

c. Existing programs with alternative Apprenticeship Agreements on file with the USDOL will have the option to continue to use these agreements, provided they conform with this Rule.

i. The SAA will receive a copy of this Apprenticeship Agreement in the transition from the OA to the SAA to ease sponsor burden.

ii. Existing sponsors are responsible as part of quality assurance to maintain individual agreements both prior to and after the transition to the SAA, regardless of the format of the transition.

iii. After the transition to an SAA, the quality assurance team of the SAA will reach out to existing sponsors providing them with the opportunity to transition to the ETA 671, or conduct a review of their agreement for conformance with the requirements of this Rule. The SAA will provide technical assistance to sponsors seeking a transition to the ETA 671.

d. The SAA will offer training to all new programs on the ETA 671 Apprenticeship Agreement and indicate their option to generate an alternative form that at minimum, meets the standards of this part and is state-approved.

3. The SAA Director, or their designee, shall register individual Apprenticeship Agreements, which will meet the requirements of this section. 1.8 Policies Related to Reciprocal Approval for Federal purposes by the SAA to Apprentices, Apprenticeship Programs and Standards that are Registered in Other States A. Reciprocity of registered apprenticeship programs.

4. Reciprocity for programs at the request of the sponsor. Colorado may grant reciprocal approval to a registered apprenticeship program which has been registered by the Office of Apprenticeship or a recognized SAA for state and federal purposes if the below criteria are met:

a. Meet Colorado (including lawful local government) wage, hour, and other labor statutes and rules, and apprentice ratio standards;

b. The program sponsor seeking reciprocity must attest that the program and individual apprentices who will work in Colorado are properly registered with the OA or SAA; and.

c. If in a licensed occupation, the standards must prepare the apprentice to meet or exceed the minimum requirements of CO state or local licensure in that occupation.

B. Reciprocity for apprentices and journeyworkers. Colorado may grant reciprocal approval to active apprentices and grant recognition of completers of registered apprenticeship in other states.

1. Reciprocity for completers of a registered apprenticeship. The occupational certificate of completion is a recognized credential in the state of Colorado for occupational proficiency. Completers of registered apprenticeship programs in licensed occupations may require additional licensure requirements in the occupation.

2. Reciprocity for active apprentices. Apprentices who have completed some portion of their registered apprenticeship program in another state are eligible for recognition in the state of Colorado. Apprentices must coordinate with the sponsor for transfer into Colorado programs. The Colorado sponsor shall ensure that any/all credit being awarded results in the apprentice receiving all education and on the job training in accordance with Colorado licensing laws and/or regulations for relevant occupations. 1.9 Policies Regulating the Cancellation and/ or Deregistration of Registered Apprenticeship Programs, and for the Temporary Suspension, Cancellation, and/or Deregistration of Apprenticeship Agreements A. Deregistration of a registered program.

3. Deregistration at the request of the sponsor. At the sponsor's request of a registered apprenticeship program, the SAA has the authority to deregister an apprenticeship program by giving written notice to the sponsor indicating that:

a. The program is canceled at the sponsor's request or deregistration by the SAA upon reasonable cause and giving the effective date of such action;

b. Within 15 days of the date of acknowledgment, the sponsor will notify all apprentices of such cancellation and the effective date;

c. Such cancellation automatically deprives the apprentice of individual registration;

d. Deregistration of a registered program removes the apprentice from coverage for federal purposes which require the Secretary’s approval of an apprenticeship program;

e. Deregistration of a state registered apprenticeship program removes the apprentice from coverage for state purposes which will require approval from the SAA Director; and f. All apprentices are referred to the SAA for information concerning the deregistration and potential transfer to other registered apprenticeship programs.

2. Deregistration by the SAA upon reasonable cause. The SAA has the authority to deregister an apprenticeship program after a hearing pursuant to this Rule when an apprenticeship program is not conducted, operated, or administered in accordance with the programs' registered provisions or requirements of this plan, or any conditions and rules established by the SAA, including but not limited to:

a. Failure to provide on-the-job learning;

b. Failure to provide related instruction;

c. Failure to pay the apprentice a progressively increasing schedule of wages consistent with the apprentice’s skills acquired; or d. Persistent and significant failure to perform successfully.

3. Persistent and significant failure defined. As it relates to potential cause for deregistration, persistent and significant failure to perform occurs when a program sponsor:

a. Consistently fails to register at least one apprentice b. Shows a pattern of poor-quality assessment results over a period of several years c. Demonstrates an ongoing pattern of very low completion rates over a period of several years d. Shows no indication of improvement in the areas identified by the SAA during a review process as requiring corrective action.

4. Where it appears the program is not being operated in accordance with the registered standards or with the requirements of this section, the SAA must notify in writing of a preliminary notice of involuntary deregistration, by registered or certified mail. The correspondence must:

a. State the shortcoming(s) and the corrective action required b. State that a determination of reasonable cause for deregistration will be made unless corrective action is taken within thirty (30) calendar days from the date of the notice.

c. The SAA has the authority to extend the period for corrective action for up to thirty (30) additional calendar days for good cause and the SAA shall assist the sponsor in every reasonable way to achieve conformity.

5. If the required correction is not effected within the allotted time, the SAA must send a final written notice, by registered or certified mail, of involuntary deregistration to the sponsor, stating:

a. That the notice is sent under this section;

b. That the deficiency and the remedial action required were called to the sponsor's attention (enumerating them and the remedial measures requested with the dates of such occasions and letters);

c. That the sponsor has failed or refused to affect the correction; and d. That based upon the stated deficiencies and failure to remedy them, a determination has been made that there is reasonable cause to deregister the program and the program may be deregistered unless, within 15 business days of the receipt of this notice, the sponsor requests a hearing with the SAA.

6. Every order of voluntary or involuntary deregistration must contain a provision that the sponsor must, within 30 calendar days of the effective date of the order:

a. notify all registered apprentices of the deregistration of the program; the effective date thereof; that such cancellation automatically deprives the apprentice of individual registration;

b. that the deregistration removes the apprentice from coverage for Federal purposes which require the Secretary’s approval of an apprenticeship program or removes the apprentice from coverage for State purposes which require the SAA’s approval, and c. that all apprentices are referred to the SAA for information about potential transfer to other registered apprenticeship programs.

7. Deregistration proceedings for violation of equal employment opportunity requirements must be processed in accordance with the provisions of the State’s Equal Employment Opportunity in Apprenticeship Plan pursuant to Rule 1.6.

B. Reinstatement of apprenticeship programs.

1. An apprenticeship program that has been deregistered pursuant to this Rule may be reinstated by the SAA upon presentation of adequate evidence that the apprenticeship program is operating in accordance with this Rule.

a. No earlier than one (1) year after issuance of the deregistration order;

b. If the SAA determines that the apprenticeship program has an acceptable set of standards and is in compliance with all requirements for registered apprenticeship programs; and c. If the apprenticeship program is prepared to immediately enroll one or more apprentices.

2. Upon request to the SAA, a sponsor may reverse a voluntary deregistration within six months after its effective date if on that date the SAA had no current grounds to initiate involuntary deregistration proceedings.

C. Hearings for deregistration.

1. The SAA shall conduct hearings for the purpose of resolving compliance issues or deregistration issues with a registered apprenticeship program in conformity with regulations promulgated by the Secretary under the National Apprenticeship Act, 29 U.S.C. 50.

2. The determination of the SAA is a final agency action that is subject to judicial review pursuant to C.R.S. section 24-4-106.

3. Sponsors have the right to appeal the SAA’s determination to the OA for a final determination in conformity with regulations promulgated by the Secretary of Labor under the National Apprenticeship Act, 29 U.S.C. 50.

D. Limitations.

1. Nothing in this subpart or in any Apprenticeship Agreement will operate to invalidate:

a. Any apprenticeship provision in any collective bargaining agreement between employers and employees establishing higher apprenticeship standards; or b. Any special provision for veterans, minority persons, or women in the standards, apprentice qualifications or operation of the program, or in the Apprenticeship Agreement, which is not otherwise prohibited by law, Executive Order, or authorized regulation.

E. Complaints.

1. Complaints related to equal employment opportunity requirements must be submitted, processed and resolved in accordance with the provisions of the State’s Equal Employment Opportunity in Apprenticeship Plan, adopted pursuant to 29 CFR Part 30.

2. The SAA Director may promulgate rules to implement grievance procedures for complaints not under the jurisdiction of the United States Equal Employment Opportunity Commission, including complaints concerning apprentices not moving through a registered apprenticeship program in a timely manner and insufficient on-the-job learning or related instruction time.

3. Except for matters related to Equal Employment Opportunity requirements, any controversy or difference arising under an Apprenticeship Agreement which cannot be adjusted locally and which is not covered by a collective bargaining agreement, may be submitted by an apprentice to the SAA which has registered and/or approved the program in which the apprentice is enrolled, for review.

4. Matters covered by a collective bargaining agreement are not subject to such review.

5. The complaint must be in writing and signed by the complainant and must be submitted within 60 days of the final local decision. It must set forth the specific matter(s) complained of, together with relevant facts and circumstances. Copies of pertinent documents and correspondence must accompany the complaint.

6. The SAA will render an opinion within 90 days after receipt of the complaint, based upon such investigation of the matters submitted as may be found necessary, and the record before it. During the 90-day period, the SAA will make reasonable efforts to effect a satisfactory resolution between the parties involved. If so resolved, the parties will be notified that the case is closed. Where an opinion is rendered, copies will be sent to all interested parties.

7. The SAA shall notify all parties of the decision, which shall be a final administrative action.

8. Nothing in this section precludes an apprentice from pursuing any other remedy authorized under another Federal, State, or local law. _________________________________________________________________________ Editor’s Notes

History New rule eff. 06/30/2023.

7 CCR 1108-2 Colorado Apprenticeship Tax Credit Rules {#sec-7-ccr-1108-2 omnilex-key=us-co-regs-official--department-10--7 CCR 1108-2}

DEPARTMENT OF LABOR AND EMPLOYMENT

COLORADO APPRENTICESHIP TAX CREDIT RULES

7 CCR 1108-2 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted November 27, 2024; effective January 14, 2025. 1.1 Statement of Authority.

This regulation is adopted pursuant to the authority in C.R.S. §§ 39-22-562 and 8-15.7-102 and is intended to be consistent with the requirements of the State Administrative Procedures Act, C.R.S. § 24- 4-101 et seq. (the “APA”) and in conformity with 7 CCR 1108-1 and regulations promulgated by the Secretary of Labor under the National Apprenticeship Act, 29 U.S.C. 50. 1.2 Purpose and Incorporation by Reference.

A. The general purpose of these Colorado Apprenticeship Tax Credit Rules (“Rules”) is to exercise the authority of the Director of the State Apprenticeship Agency to enforce and implement rules establishing the standards for issuing apprenticeship tax credit certificates.

B. 29 C.F.R. § 29 (2024) is hereby incorporated by reference. These regulations are available for public inspection at the Colorado Department of Labor and Employment, Office of the Future of Work, 633 17th Street, Denver CO 80202. Copies may be obtained from this Office at a reasonable charge, or can be accessed electronically from the Apprenticeship.gov website.

Certified copies of these regulations are available from the U.S. Government Publishing Office Online Bookstore. Pursuant to C.R.S. § 24-4-103(12.5)(b), the agency shall provide certified copies of the statutes and regulations incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency originally issuing the statutes. All Office of the Future of Work (OFW) rules are available to the public on the State Apprenticeship Agency Policy & Legislation webpage. Where these Rules have provisions different from or contrary to any incorporated or referenced material, the provisions of these Rules govern so long as these are consistent with Colorado statutory and constitutional provisions and in conformity with regulations promulgated by the Secretary of Labor under the National Apprenticeship Act, 29 U.S.C. 50.

C. If any part of these Rules is held invalid, the remainder shall remain valid, and if any part is held not wholly invalid, but in need of narrowing, it will be retained in narrowed form. 1.3 Definitions.

“Apprentice” means a worker at least 16 years of age, except where a higher minimum age standard is otherwise fixed by law, who is employed to learn an apprenticeable occupation as provided in article 15.7, title 8, C.R.S. and 29 CFR 29.4 under standards of apprenticeship fulfilling the requirements of 29 CFR 29.5.

“Apprenticeship Agreement” means a signed written agreement, complying with 29 CFR 29.7, between an apprentice and either the apprentice's program sponsor, or an apprenticeship committee acting as agent for the program sponsor(s), which contains the terms and conditions of the employment and training of the apprentice.

“Certificate of registration” means documentary evidence that the State Apprenticeship Agency has registered an apprenticeship program pursuant to article 15.7, title 8, C.R.S. and federal guidelines as evidenced by a Certificate of Registration or other written indicia.

“Credit" means the credit against income tax created in C.R.S. § 39-22-562.

“Employee" means and includes every individual who is a resident or domiciled in the state of Colorado performing services for an employer, either within or without or both within and without the state of Colorado, or any individual performing services within the state of Colorado, the performance of which services constitutes, establishes, and determines the relationship between the parties as that of employer and employee, and includes officers of corporations and individuals, including elected officials, performing services for the United States government or any agency or instrumentality thereof or the state of Colorado or any county, city or municipality, or political subdivision thereof, except that “employee” includes only those individuals who perform services for the taxpayer for at least 1,040 hours per income tax year.

“New and emerging industry” does not include the building and construction trades as described in C.R.S. § 8-15.7-105 (4). The State Apprenticeship Council defines the jurisdiction of the building and construction trades and new and emerging industries.

“Qualified taxpayer" or "taxpayer" means a person subject to tax pursuant to article 22, title 39, C.R.S., that is doing business in this state and that employs an apprentice in the relevant tax year.

“Registered apprenticeship program” means an apprenticeship program that is registered by the State Apprenticeship Agency as provided in C.R.S. § 8-15.7-101(13). An apprenticeship program may be registered by the SAA if it directly registers with the SAA, or if it is an apprenticeship program registered by the US DOL’s Office of Apprenticeship, or another State Apprenticeship Agency to which the SAA must accord reciprocal approval of apprentices, apprenticeship programs and standards under federal law if the program sponsor requests such reciprocity be granted.

“Small business" means a business with fewer than fifty employees.

"State Apprenticeship Agency" or "SAA" means the State Apprenticeship Agency created in C.R.S. § 8- 15.7-102.

“State apprenticeship council” or “SAC” means the state apprenticeship council created in C.R.S. § 8- 15.7-105. 1.4 Requirements for Apprenticeship Tax Credit A. Reserving a Tax Credit.

1. The taxpayer must submit an application to the SAA to reserve a tax credit for a given tax year beginning in 2025. The application requirements will be specified on the Apprenticeship Colorado website.

2. The SAA shall review the application to determine whether it meets the minimum requirements for a tax credit reservation and may reserve for the benefit of the qualified taxpayer all or part of the credit amount requested. The SAA shall notify the taxpayer of its decision whether to reserve a tax credit and, if a reservation is made, the amount reserved.

3. The reservation of a tax credit does not entitle the taxpayer to the issuance of a tax credit certificate until the SAA has verified that the taxpayer has met all the requirements in Sections 1.4(B) and 1.5 and C.R.S. § 39-22-562.

B. Claiming a Tax Credit.

1. In order to claim an apprenticeship tax credit, an employer must submit an application for reservation of a tax credit and must meet the following requirements.

a. Qualified taxpayer. A qualified taxpayer is a person subject to tax pursuant to

article 22, title 39, C.R.S. that is doing business in this state (must file a Colorado income tax return) and that employs an apprentice in Colorado in the relevant tax year. In addition, a qualified taxpayer must either:

i. have established a registered apprenticeship program in good standing with the SAA and received a certificate of registration from the SAA, USDOL’s Office of Apprenticeship, or another State Apprenticeship Agency; or ii. be an employer partner of a registered apprenticeship program in good standing with the SAA as verified by the qualified taxpayer's inclusion on the Colorado State Apprenticeship Directory pursuant to C.R.S. § 8-83- 308. Inclusion on the Colorado State Apprenticeship Directory requires the registered apprenticeship program sponsor to add the qualified taxpayer as an employer partner in the Registered Apprenticeship Partners Information Database System (RAPIDS) or any successor data management system.

b. Apprentice. The apprentice(s) that the employer claims the tax credit for must be:

i. An employee of the qualified taxpayer for a minimum of six months in the tax year, and ii. Registered with the SAA, USDOL’s Office of Apprenticeship, or another State Apprenticeship Agency, as evidenced by a current Apprenticeship Agreement on file in the Registered Apprenticeship Partners Information Database System (RAPIDS) or any successor data management system.

c. New and emerging industry. The apprentice must participate in a registered apprenticeship program in an occupation defined as “new and emerging”. The SAC defines the jurisdiction of the building and construction trades and new and emerging industries. The SAC shall review occupations on an annual basis and publish a list to the SAA website.

C. Credit Amounts.

1. The credit is equal to up to $6,300 for six months of employment, plus up to $1,050 for each additional month of employment, for a maximum of $12,600 per apprentice per tax year.

D. Limitations.

1. The taxpayer shall not claim a credit for:

a. More than ten apprentices per income tax year;

b. The same apprentice for more than two consecutive income tax years; and c. An apprentice for months when the apprentice did not receive wages from the taxpayer. 1.5 Standards of Apprenticeship Program Quality A. As required by article 15.7, title 8, C.R.S., registered apprenticeship programs must conform to the standards located at 7 CCR 1108-1(1.5) and federal regulations published in 29 CFR Parts 29 and 30 in order to be eligible for approval and registration by the SAA.

B. The SAA shall perform its duties as set forth in C.R.S. §8-15.7-102 and 7 CCR 1108-1. Related to program quality, the SAA conducts reviews of registered apprenticeship programs and quality assurance assessments for compliance with federal and state regulations and state policies, including equal opportunity in apprenticeship, at the end of the first full training cycle. Subsequent reviews occur at least every five years.

C. Registered apprenticeship programs not in conformity with applicable state and federal law, regulations, and guidance shall not be considered in good standing for purposes of claiming the tax credit for apprentices. _________________________________________________________________________ Editor’s Notes

History New rule eff. 01/14/2025.

1109 Office of New Americans (ONA)

7 CCR 1109-1 Regulations Concerning the Colorado Refugee Services Program (crsp) {#sec-7-ccr-1109-1 omnilex-key=us-co-regs-official--department-10--7 CCR 1109-1}

Department of Labor and Employment REGULATIONS CONCERNING THE COLORADO REFUGEE SERVICES PROGRAM (CRSP)

7 CCR 1109-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] 1.1. Program Summary The Colorado Refugee Services Program (CRSP) is housed within the Office of New Americans (ONA) at the Colorado Department of Labor and Employment (CDLE).

CRSP is responsible for the overall supervision and coordination of the refugee services program in Colorado, and for the development and supervision of the annual state plan for Colorado. CRSP operates under the Refugee Act of 1980 and Title IV of the Immigration and Nationality Act (INA), as amended.

CRSP serves eligible populations (see General Definitions in section 1.3) who are residents of Colorado for up to sixty (60) months after their date of entry into the United States or the date status was granted. These eligible populations are considered qualified non-citizens and are exempt from the five-year bar for public assistance, with exceptions. These populations may also access public assistance programs provided by the State of Colorado. CRSP services are primarily funded by the Office of Refugee Resettlement (ORR) housed within the U.S. Department of Health and Human Services’ (HHS) Office of the Administration for Children and Families (ACF). CRSP’s service model is delivered in alignment with 45 CFR 400.

If not eligible for the assistance of TANF/Colorado Works, individuals meeting a definition for ORR eligibility in section 1.4 below may be eligible for Refugee Cash Assistance (RCA) through CRSP if income and program eligibility criteria are met. Per 45 CFR § 400.56, Colorado operates a Public/Private RCA program, requiring individuals interested in applying for RCA to apply for those benefits at a local resettlement agency located in Colorado.

For Unaccompanied Refugee Minors (URM), CRSP may serve this population through the URM program until the youth turns twenty-one (21) years of age. If needed, a URM who is no longer in the URM program may receive ORR-funded services through CRSP for up to sixty (60) months after receiving a status that makes them eligible. 1.2. General Definitions “45 CFR 400” refers to the part of the Code of Federal Regulations governing refugee resettlement programming and assistance.

“Household” means an individual adult, married individuals without children, or parents, or custodial relatives, with minor children who live in the same household.

“Lawful Permanent Resident” means a non-citizen legally admitted into the United States to reside on a permanent basis.

“Office of Refugee Resettlement” means the office within the U.S. Department of Health and Human Services authorized to manage federal assistance for the resettlement of refugees in the United States per the Refugee Act of 1980.

“Qualified non-citizen” means an individual who meets the specific definition of “qualified alien” as defined by the Personal Responsibility and Work Opportunity Reconciliation Act of 1996.

“Refugee Cash Assistance (RCA)” means cash assistance provided to ORR-eligible populations in accordance with Colorado’s State Plan for refugee resettlement.

“Refugee Medical Assistance (RMA)” means medical assistance provided to ORReligible populations in accordance with Colorado’s State Plan for refugee resettlement.

“Temporary Assistance for Needy Families (TANF) or Colorado Works (CW)” means the cash assistance program also known as Title IV-A of the Social Security Act.

“Verification” means confirmation of a household’s statements through written, verbal, or electronic means. 1.3. Office of Refugee Resettlement (ORR) Eligible Populations 1.3.1. The following categories of people are eligible for ORR-funded services.

A. A “refugee” means the same as in 8 U.S.C. § 1101(a)(42) and accompanying notes to 8 U.S.C § 1101.

B. An “asylee” is a person who has been granted asylum by the U.S. Citizenship and Immigration Service (USCIS) while residing in the United States. An asylee meets the same definition as a refugee and has been granted asylum status.

Individuals admitted to the United States who are classified by USCIS as “applicants for asylum” are not eligible for CRSP benefits unless they are a Cuban or Haitian Entrant (refer to Sections 1.4.C and 1.5.C). Family members who obtain derivative status from an individual granted asylum are also eligible for both benefits and services.

C. “Cuban and Haitian Entrants” are:

1. Any individual granted parolee status by the U.S. Department of Homeland Security (DHS) as a Cuban/Haitian Entrant (status pending) or granted any other special status subsequently established under the immigration laws for nationals of Cuba or Haiti, regardless of the status of the individual at the time assistance or services provided.

2. A national of Cuba or Haiti who was paroled into the United States and has not acquired any other status under the Immigration and Nationality Act (INA), and with respect to whom a final, nonappealable, and legally enforceable order of removal, deportation, or exclusion has not been entered.

3. A national of Cuba or Haiti who is the subject of removal, deportation, or exclusion proceedings under the INA and with respect to whom a final, nonappealable, and legally enforceable order of removal, deportation, or exclusion has not been entered.

4. A national of Cuba or Haiti who has an application for asylum pending with DHS, USCIS, or the U.S. Department of Justice (DOJ)/Executive Office for Immigration Review (EOIR) and with respect to whom a final, nonappealable, and legally enforceable order of removal, deportation, or exclusion has not been entered.

D. “Certain Amerasians from Vietnam” are certain persons from Vietnam who:

1. Are admitted to the United States as immigrants and were born in Vietnam after January 1, 1962, and before January 1, 1976; and, 2. Were fathered by a citizen of the United States.

E. “Victims of Severe Forms of Trafficking” are persons who have been certified as such by the U.S. Department of Health and Human Services (HHS), and are eligible for benefits and services to the same extent as refugees. Eligible individuals may be adults or minors. Family members who obtain derivative status from the trafficked person are also eligible for both benefits and services.

F. “Iraqi and Afghan Special Immigrant Visa Recipients” (SIVs) are Iraqi and Afghan citizens or nationals who have been employed by, or on behalf of, the U.S. military, or the U.S. government during hostilities in their countries. Eligible individuals have been admitted to the United States under a Special Immigrant Visa (SIV) due to a well-founded fear of remaining in their respective countries due to their employment with, or on behalf of the U.S. military or the U.S. government. Spouses and unmarried children under the age of 21 of principal SIVs may also be admitted under a Special Immigrant Visa and are considered ORR-eligible SIVs. Upon admission to the U.S., SIVs are granted Legal Permanent Residency (LPR or “green card”).

G. “Afghan Humanitarian Parolee” (AHP) refers to Afghan citizens or nationals who:

1. Were paroled into the United States under section 212(d)(5) of the INA between July 31, 2021, and September 30, 2023; or, 2. Are a spouse or child of an individual described in section G.1 who is paroled into the United States after September 30, 2023; or, 3. Are a parent or legal guardian of an individual described in section G.1 who is determined to be an unaccompanied child as defined by 6 U.S.C. § 279(g)(2), and is paroled into the United States after September 30, 2023.

H. “Afghan Special Immigrant Parolee” refers to Afghan citizens or nationals who have been paroled in the United States under Public Law 117-43, § 2502 (Sept. 30, 2021) on or after July 31, 2021.

I. “Afghan Special Immigrant Conditional Permanent Resident” refers to Afghan citizens or nationals who have been granted conditional permanent residency in the United States under Public Law 117-43, § 2502 (Sept. 30, 2021) on or after July 31, 2021.

J. “Ukrainian humanitarian parolee (UHPs)” refers to Ukrainian citizens or nationals of Ukraine who:

1. Were paroled into the United States under section 212(d)(5) of the INA between February 24, 2022, and September 30, 2024; or, 2. Are non-Ukrainian individuals who last habitually resided in Ukraine and who DHS has paroled into the United States between February 24, 2022, and September 30, 2024; or, 3. Are a spouse or child of an individual described in section J.1 or J.2 who was paroled into the United States after September 30, 2023; or, 4. Are a parent, legal guardian, or primary caregiver of an unaccompanied refugee minor or an unaccompanied child described in section J.1 or J.2 who was paroled into the United States after September 30, 2023.

K. “Unaccompanied refugee minors” (URMs) are minors with eligible immigration statuses who do not have a parent or legal guardian to care for them in the United States. Refugee minors are identified overseas and are eligible for resettlement in the United States, but do not have a parent or a relative available who is committed to providing for the minor’s long-term care. Upon arrival in the United States, these refugee youth are placed into the URM program and receive refugee foster care services and benefits. Other eligible unaccompanied minors may enter the URM program if they have a qualifying immigration status and are approved by ORR for the URM program. These youth often arrive in the URM program through ORR shelters for unaccompanied minors.

L. Lawful Permanent Residents (LPR or “green card”) who were granted a status outlined in this section prior to being granted legal permanent residency. 1.4. Verification of Status for ORR Eligibility 1.4.1. The following documents are acceptable for verification of eligibility for ORR-funded services and must be reviewed/verified prior to delivery of any ORRfunded services.

A. Acceptable documents for individuals admitted as refugees:

1. I-94 arrival/departure record noting admission under § 207 of the INA or one of the following admission codes: RE-1, RE-2, RE-3, RE-4, RE-5; or 2. Employment Authorization Document with codes A03 or A04; or 3. DHS form I-571; or 4. I-730 approval letter of refugee status; or 5. Visa 93 on the I-94 arrival/departure card, which may contain the words “Section 207”.

B. Acceptable documents for individuals granted asylee status:

1. I-94 arrival/departure record noting § 208 of the INA or one of the following admission codes: AS-1, AS-2, AS-3; or 2. DHS form I-571; or 3. I-766 Employment Authorization Document with the code A05; or 4. An order of an Immigration Judge granting asylum under § 208 of the INA;

2. An Asylum Approval Letter from a USCIS Asylum Office, noting § 208 of the INA; or 6. A written decision from the Board of Immigration Appeals (BIA) noting § 208 of the INA; or 7. I-730 Approval Letter; or 8. Visa 92 on the I-94 arrival/departure record, which may contain the words “Section 208”

C. Acceptable documentation for Cuban and Haitian Entrants:

1. I-94 arrival/departure record with a stamp showing parole at any time as a “Cuban/Haitian Entrant (Status Pending),” and may reference § 212(d)(5);

2. I-94 arrival/departure record showing parole into the U.S. on or after April 21, 1980 (Cubans only) or on or after October 10, 1980 (both Cubans and Haitians), and may reference § 212(d)(5); or 3. A Cuban or Haitian passport with a stamp dated on or after October 10, 1980, referencing § 212(d)(5); or 4. I-94 arrival/departure record showing parole into the U.S. and referencing § 212(d)(5), or humanitarian or public interest parole; or 5. I-766 Employment Authorization Document with one of the following codes: A04, A10, C8, C10, C11; or 6. One of the following DHS forms issued to a Cuban or Haitian national: I- 1221, I-862, I-220A, I-122, I-1221S; or 7. I-589 application for asylum and withholding of removal stamped by the Executive Office for Immigration Review (EOIR); or 8. I-485 application to register permanent residence stamped by EOIR; or 9. EOIR-26 notice of appeal from a Decision of an Immigration Judge, stamped by EOIR; or 10. Other applications for relief that have been date-stamped by EOIR; or 11. Other documentation pertaining to an applicant’s removal, exclusion, or deportation proceedings.

a. There may be other possible documents presented by Cuban or Haitian Entrants, parolees, or asylum seekers. If you have questions regarding documents presented by Cuban or Haitian Entrants/parolees, you may call the Colorado Refugee Services office for additional information and guidance on eligibility determination.

D. Acceptable documentation for certain Amerasians:

1. I-94 arrival/departure record noting one of the following admission codes:

AM-1, AM-2, AM-3; or 2. Form I-551, noting one of the following admission codes: AM-6, AM-7, AM-8; or 3. Vietnamese Exit Visa noting one of the following admission codes: AM-1, AM-2, AM-3, and may have a temporary I-551 stamp; or 4. Vietnamese passport noting one of the following admission codes: AM-1, AM-2, AM-3, and may have a temporary I-551 stamp; or, 5. United States passport noting one of the following admission codes: AM-1, AM-2, AM-3.

E. Acceptable documentation for Victims of a Severe form of Trafficking:

1. Certification letter, Eligibility Letter, or Interim Assistance Letter from the ACF Office on Trafficking in Persons (OTIP). Validity of the letter must be confirmed by calling the trafficking verification line at (866) 401-5510; or 2. I-797 Notice of Action form with one of the following codes: T-2, T-3, T-4, T- 5, or T-6; or 3. I-94 arrival/departure record with one of the following codes: T-2, T-3, T-4, T- 5, or T-6; or 4. A foreign passport with a DHS-issued visa noting one of the following codes: T-2, T-3, T-4, T-5, or T-6; or 5. I-766 Employment Authorization Document with one of the following codes: A16, C25 F. Acceptable documentation for Iraqi and Afghan Special Immigrant Visa Recipients (SIVs):

2. Iraqi or Afghan passport with an immigrant visa stamp noting that the individual has been classified under Immigrant Visa Category SI1, SI2, SI3, SQ1, SQ2, SQ3, SW1, SW2, SW3, along with a DHS stamp or notation on passport or I-94 arrival/departure record showing date of admission; or 2. Form I-551 noting one of the following Immigrant visa codes: SI6, SI7, SI8, SQ6, SQ7, SQ8, SW1, SW2, SW3; or 3. DHS/CBP temporary Form I-551 Alien Documentation Identification and 4. DHS/USCIS temporary Form I-551 Alien Documentation Identification and 5. I-765 Employment Authorization Document receipt notice with one of the following codes: SQ1, SQ2, SQ3, SQ6, SQ7, SQ8, or 6. I-766 Employment Authorization Document with one of the following codes: SQ1, SQ2, SQ3, SQ6, SQ7, SQ8.

G. Acceptable documentation for Afghan Humanitarian Parolees:

1. I-94 arrival/departure record noting one of the following: “OAR”, “OAW”, “PAR”, “DT”, “PAROLED”, or Humanitarian Parole (per INA section 212(d)(5)(A)); or 2. A foreign passport with DHS/CBP admission stamp noting “OAR, “OAW”, “PAR”, “DT”, “PAROLED”, or Humanitarian Parole (per INA section 212(d)(5)(A)); or 3. Interim Notice Authorizing Parole (INAP) noting parole under INA 212(d)(5)(A); or 4. I-765 Employment Authorization Document receipt notice with code C11;

2. I-766 Employment Authorization Document with the code C11.

H. Acceptable documentation for Afghan Special Immigrant Parolees:

1. I-94 arrival/departure record noting SI or SQ parole (per section 602(B)(1)

AAPA/Sec 1059(a) NDAA 2006); or 2. I-765 Employment Authorization Document receipt notice with code C11;

3. I-766 Employment Authorization Document with code C11.

I. Acceptable documentation for Afghan Special Immigrant Conditional Permanent Residents:

1. Foreign passport with Machine Readable Immigrant Visa (MRIV) with code CQ1, CQ2, or CQ3; or 2. Foreign passport with DHS/CBP admission stamp noting that the individual has been classified under Immigrant Visa category CQ1, CQ2, or CQ3; or 3. I-551 with an Immigrant Visa category code of CQ1, CQ2, or CQ3; or 4. DHS/CBP temporary Form I-551 Alien Documentation Identification and 5. DHS/USCIS temporary Form I-551 Alien Documentation Identification and 6. I-765 Employment Authorization Document receipt notice with code C11;

2. I-766 Employment Authorization Document with code C11.

J. Acceptable documentation for Ukrainian Humanitarian Parolees:

1. I-94 arrival/departure record noting humanitarian parole (per INA section 212(d)(5) or 8 U.S.C. § 1182(d)(5)); or 2. Foreign passport with DHS/CBP admission stamp noting one of the following: “DT”, “U4U”, or “UHP”; or 3. I-765 Employment Authorization Document receipt notice with code C11;

2. I-766 Employment Authorization Document with code C11; or 5. Any other immigration documentation with a notation of parole under INA § 212(d)(5); or 6. Any one of the forms or stamps listed above for UHPs, and documentation of the last habitual residence in Ukraine, including Crimea.

K. Unaccompanied Refugee Minors (URMs) who meet the definition above will have one of the following statuses: refugee, asylee, Cuban/Haitian entrant, victim of trafficking, Afghan Humanitarian Parolee, Ukrainian Humanitarian Parolee, Special Immigrant Juvenile Status (SIJS), U visa holder, or has legal permanent resident status that previously held one of the statuses mentioned.

1. If the URM has SIJS status, the documentation presented will be one of the following:

a. I-797, notice of action indicating status (i.e., evidence of approved I- 360, or evidence of approved I-360 and approved I-485); or b. Immigration Visa indicating SIJS status with SL class of admission;

c. I-1551 indicating SIJS status with SL class of admission; and d. Evidence that at the time a Dependency Order was issued, was either in the custody of the ORR Unaccompanied Children’s (UC)

Program or receiving federal benefits or services as a Cuban/Haitian Entrant.

2. If the URM has a U-visa, documentation presented will be one of the following:

a. I-797 notice of action indicating U status;

b. U-visa; or c. I-94 arrival/departure record showing admission in U status.

3. Please note: U-visa holders are not considered “qualified non-citizens” for federal public benefits. It does qualify the person to be “lawfully present” for potential state benefits.

4. If the URM is a Victim of Human Trafficking, they will have an Office of Trafficking in Persons (OTIP) letter.

L. Acceptable documentation for Lawful Permanent Residents who previously held an eligible status:

1. I-551 form (“green card”, permanent resident card or resident alien card) with one of the following class of admission codes: RE6, RE7, RE8, RE9, AS6, AS7, AS8, CH6, HA6, HB6, GA6, GA7, GA8, ST6, ST7, ST8, ST0, ST9, SI6, SI7, SI8, SQ6, SQ7, SQ8, AM-6, AM-7, AM-8.

2. Foreign passport with an unexpired, temporary I-551 stamp and one of the following classes of admission codes: RE6, RE7, RE8, RE9, AS6, AS7, AS8, AM-1, AM-2, AM-3, GA6, GA7, GA8, SY6, SY7, SY8.

Individuals admitted to the United States who are classified by USCIS as "applicants for asylum" are not eligible for CRSP benefits. Once granted asylum, those individuals are eligible. The exception to this rule is Cuban and Haitian individuals applying for asylum; however, they must produce documents as described above.

CRSP follows the federal guidance on eligible populations, status, and documentation in the Office of Refugee Resettlement State Letter # 16-01, dated 10/02/2015, located on the federal government website at: https://www.acf.hhs.gov/orr/policy-guidance/statusand-documentation-requirements- orr-refugee-resettlement-program No later editions or amendments are incorporated. Copies may be reviewed during normal business hours by contacting the State Refugee Coordinator in the Office of New Americans, Colorado Refugee Services Program, 707 17th St., Ste. 2700, Denver, Colorado 80202. If there is an eligibility question, please contact CRSP for assistance. 1.5. Refugee Medical Assistance (RMA) 1.5.1. Overview Each individual member of a household that applies for medical assistance must first be screened for eligibility under the State Medicaid/Health First Colorado Program. If the individual is determined ineligible for Medicaid/Health First Colorado, then a determination of eligibility under the Refugee Medical Assistance (RMA) Program must be made. For Medicaid/Health First Colorado, the determination of what constitutes a “household” is based on 10 CCR 2505-10-8.100.4.E.

Any individual member of a household who is not eligible for Medicaid/Health First Colorado shall be considered for Refugee Medical Assistance (RMA). Per 45 CFR § 400.211(a), RMA is limited to a time period to be determined by the Director of the ORR each year, based on appropriated funds available for the fiscal year (refer to section 1.5 for verification of status for program eligibility). Please contact CRSP for applicable RMA eligibility time periods.

Persons applying for RMA will use the State-prescribed application for Medicaid/Health First Colorado. Applicants will first be screened for State Medicaid/Health First Colorado programs in accordance with the Colorado Department of Health Care Policy and Financing’s Medical Assistance Manual (10 CCR 2505-10). In accordance with federal law, in providing RMA to ORR-eligible populations, Colorado will provide at least the same services in the same manner and to the same extent as under the state’s Medicaid/Health First Colorado program. 1.5.2. Initial Refugee Medical Assistance Determination, Eligibility, and Definitions Initial RMA income eligibility determination (where the applicant was not previously eligible for Medicaid/Health First Colorado) is based on two hundred percent (200%) of the federal poverty level.

A. In determining eligibility for and receipt of RMA, the following are not considered: in-kind services and shelter provided to an applicant by a sponsor or local resettlement agency. Payments, such as refugee cash assistance, matching grant, or ORR Program of Initial Resettlement, received from the refugee resettlement agency are exempt from RMA income determinations.

B. Determination of RMA eligibility will be based on an applicant’s income on the date of application.

C. Denial or termination of RCA does not cause denial or termination of RMA benefits.

ORR-eligible populations who are within the applicable RMA eligibility time period established by the ORR Director, and who lose their eligibility for Medicaid/Health First Colorado because of earnings from employment, will be transferred to RMA without an eligibility determination, and the two hundred percent (200%) of poverty rule shall not be applied. The increased earnings from employment shall not affect the ORR-eligible individual’s continued RMA eligibility while within the applicable RMA eligibility period.

Copies of the Colorado Code of Regulations referenced are available for public inspection by contacting the Colorado State Refugee Coordinator during regular business hours at the Office of New Americans, Colorado Refugee Services Program, 707 17th St., Ste. 2700, Denver, CO 80202; or at a state publications depository library.

No later editions or amendments are incorporated.

Editor’s Notes

History New rule eff. 06/02/2026.