title-65•Title 65 W. Va. C.S.R.
Health Care Authority Health Care Authority
Series 01 Procedural Rules For Meetings Of The Health Care Cost Review Council
W. Va. Code R. § 65-1-1 General
1.1. Scope. -- The West Virginia Open Governmental Proceedings Law, section one, article nine-a, chapter six et seq. of the W. Va. Code of 1931, as amended (hereinafter referred to as "The Code"), requires in section three that governing bodies of state boards shall promulgate rules by which the time and the place of all regularly scheduled meetings and the time, place and purpose of all special meetings are made available, in advance, to the public and the news media, except in the event of an emergency requiring immediate official action.
1.2. Authority. -- W. Va. Code '6-9A-3, '29A-2-9 and '29B-1-3.
1.3. Filing Date. -- August 17, 1983.
1.4. Effective Date. -- September 16, 1983.
W. Va. Code R. § 65-1-2 Application And Enforcement
These procedural rules apply to the Board. The enforcement of these rules is vested with the chairperson of the Board.
W. Va. Code R. § 65-1-3 Definitions
3.1. Authority. -- The Health Care Cost Review Authority created under section five, article twenty-nine-b, chapter sixteen of the Code.
3.2. Board. -- The members of the governing body of the Health Care Cost Review Authority appointed by the Governor in accordance with section five, article twenty-nine-b, chapter sixteen of the Code.
3.3. Chairperson. -- The Board member appointed by the Governor under section five, article twenty-nine-b, chapter sixteen of the Code to serve as chairman of the Health Care Cost Review Authority.
3.4. Decision. -- Any determination, action, vote or final disposition of a motion, proposal, resolution, order or measure on which a vote of the Board is required at any meeting at which a quorum is present.
3.5. Meeting. -- The convening of the Board for which a quorum is required in order to make a decision or to deliberate toward a decision on any matter, but such term does not include (a) any meeting for the purpose of making an adjudicatory decision in any quasi-judicial administrative proceeding, or (b) any on-site inspection of any hospital or program.
3.6. Quorum. -- A simple majority of the constituent membership of the Board.
W. Va. Code R. § 65-1-4 Meetings
4.1. Meetings of the Board may be called by the chairperson, and the chairperson shall call a meeting upon the written request of two (2) Board members.
4.2. The chairperson shall notify Board members in writing at least seven (7) days in advance of a meeting setting forth the time and place of such meeting and the matters to be considered, except that such notice is not required if the time, the place and matters for consideration have been fixed in a meeting where all the members are present.
4.3. The chairperson shall notify the public and the news media by filing with the office of the Secretary of State a public notice of the meeting at least seven (7) days in advance. The public notice shall contain the time, the place and the matters to be considered.
4.4. The provisions of this section shall not apply in the event of an emergency requiring immediate official action by the Board.
4.5. Special meetings may be continued to a set time and place on the following workday by a majority vote of the Board members present and voting.
4.6. Special meetings may be canceled by the chairperson if no Board member objects.
W. Va. Code R. § 65-1-5 Proceeding To Be Open; Exceptions; Executive Session Permitted
5.1. All meetings of the Board shall be open to the public, except an executive session closed to the public may be held during a regular, special or emergency meeting, after the presiding officer has identified the authorization under section four, article nine-a, chapter six of the Code for the holding of such executive session and has presented it to the Board and to the general public, but no decision shall be made in such executive session.
5.2. An executive session may be held only upon a majority affirmative vote of the Board members present for the following (as from section four, article nine-a, chapter six of the Code):
(a) Matters of war, threatened attack from a foreign power, civil insurrection or riot; or (b) The appointment, employment, retirement, promotion, demotion, disciplining, resignation, discharge, dismissal or compensation of any public officer or employee, or other personnel matters, or for the purpose of conducting a hearing on a complaint against a public officer or employee, unless such public officer or employee requests an open meeting; or (c) The issuance, effecting, denial, suspension or revocation of a license, certificate or registration under the laws of this State or any political subdivision, unless the person seeking such license, certificate or registration or whose license, certificate or registration was denied, suspended or revoked requests an open meeting; or (d) The physical or mental health of any person, unless such person requests an open meeting; or (e) Matters which, if discussed in public, would be likely to affect adversely the reputation of any person; or (f) The development of security personnel or devices; or (g) Matters involving or affecting the purchase, sale or lease of property, advance construction planning, the investment of public funds or other matters involving competition which, if made public, might adversely affect the financial or other interest of the state or any political subdivision.
W. Va. Code R. § 65-1-6 Minutes
6.1. The Board shall provide for the preparation of written minutes of all its meetings. All such minutes shall be available to the public within a reasonable time after the meeting and shall include the following information:
(a) The date, time and place of the meeting;
(b) The name of each Board member present or absent;
(c) All motions, proposals, resolutions, orders, ordinances and measures proposed, the name of the person proposing the same and their disposition;
(d) The results of all votes and, upon request of a member, the vote of each member, by name.
6.2. Minutes of executive sessions may be limited to material the disclosure of which is not inconsistent with the provisions listed above of section four, article nine-a, chapter six of the Code.
W. Va. Code R. § 65-1-7 Majority Vote Required; Vote By Proxy Prohibited
The vote of a majority of all members present at any meeting of the Board shall be necessary to take any action. Proxy voting is prohibited.
W. Va. Code R. § 65-1-8 Records Of The Board - Public
Records of the Board are public records that may be inspected in accordance with section three, article one, chapter twenty-nine-b of the Code and copied at a charge of twenty-five cents ($.25) per page.
65CSR1
Series 06 Cooperative Agreement Approval and Compliance
W. Va. Code R. § 65-6-1 General
1.1. Scope. ‑- This legislative rule implements the provisions of the cooperative agreement approval and compliance requirements of W. Va. Code §16-29B-28.
1.2. Authority. ‑- W. Va. Code §§16-29B-28(g) and 16-29B-28(g)(1).
1.3. Filing Date. ‑- May 1, 2024.
1.4. Effective Date. ‑- May 1, 2024.
1.5. This rule shall terminate and have no further force or effect on August 1, 2029.
W. Va. Code R. § 65-6-2 Definitions
2.1. The defined terms in W. Va. Code §16-29B-28(a) are incorporated by reference.
2.2. The following terms are defined:
2.2.1. "Health Care Authority" means the Health Care Authority created and continued pursuant to W. Va. Code §16-29B-1 et seq.
2.2.2. “Secretary” means the Secretary of the Department of Health and Human Resources or his or her designee.
W. Va. Code R. § 65-6-3 Annual Report
The annual report required by W. Va. Code §16-29B-28(g)(1)(A) shall be submitted to the Secretary (a) on or before 120 days after the end of the fiscal year of the qualified hospital participating in the cooperative agreement or (b) upon written request of the qualified hospital participating in the cooperative agreement, annually on the anniversary date on which closing occurred on the merger, consolidation or acquisition.
W. Va. Code R. § 65-6-4 Approval of Applications
4.1. Before finalization of a cooperative agreement involving the merger, consolidation, or acquisition of a hospital located within 20 highway miles of the main campus of the qualified hospital, an application for approval of a proposed cooperative agreement shall be submitted to the Health Care Authority at least 30 days prior to finalization.
4.2. Cooperative agreements that are not implicated by §65-6-4.1 of this rule may be submitted to the authority either before or after finalization.
4.3. The application shall state in detail the nature of the proposed arrangement, including the goals and methods for achieving all the elements set forth in W. Va. Code §16-29B-28(d)(3). If an application is determined to be incomplete, the applicant will be notified in writing of the additional information required.
4.4. Expedited decisions may be requested by filing a motion with the authority. If the authority has published the required notice of completeness, any affected person may present public comments regarding the application in writing within 10 days of the date the review begins. The authority shall then determine whether cause exists to require the applicant to use the standard application process. Otherwise, the authority shall close the file on the 31st day of the expedited review and issue a written decision.
W. Va. Code R. § 65-6-5 Combination of Hospitals
Applicants approved to combine hospitals shall annually disclose a representative sample of the most recent quality metrics published by the Centers for Medicare and Medicaid Services selected by the authority for each hospital participating in the collaborative agreement on a form prescribed by the authority. This information shall be submitted at the same time as the annual report required by W. Va. Code §16-29B-28(g)(1)(A) for publication on the authority’s web site.
W. Va. Code R. § 65-6-6 Annual Report; Active Supervision
6.1. The authority shall utilize the Annual Report, as well as other information available to it, in performing the Active Supervision. The Annual Report shall include the following:
6.1.1. An explanation, with supporting documentation of its current compliance (or not) with each of the Terms and Conditions of the Cooperative Agreement Decision, that is certified by the Chief Executive Officer and Chief Financial Officer of the Applicant.
6.1.2. A summary of steps taken to reduce costs and improve efficiency;
6.1.3. An update on Population Health Plan and implementation achieved;
6.1.4. Any services that were consolidated during the year in review and the resulting cost savings in excess of $2,000,000;
6.1.5. Any material changes in volume or availability of any inpatient or outpatient services during the year in review;
6.1.6. A summary containing the number of approved resident positions for each residency program operated by the hospitals participating in the cooperative agreement and the number of such positions that are filled, along with copies of the relevant pages of the Medicare costs reports, as available, showing the number of full-time equivalent residents;
6.1.7. A description of any agreements moving resident “slots” from one hospital participating in a cooperative agreement to another pursuant to Medicare rules, resident programs moved from one hospital participating in a cooperative agreement to another, and new programs started;
6.1.8. A summary of the quality performance indicators of the hospitals participating in the cooperative agreement;
6.1.9. A comparison of the performance of hospitals participating in the cooperative agreement with the performance of similar health systems, along with a comparison to one or more rating agency indices for ratio of salaries and benefits to net patient revenue, ratio of operating EBITDA to net revenue, ratio of capital expenditures to depreciation, ratio of net income to net revenue (excess margin), days of cash on hand, days of net patient revenue outstanding, ratio of long-term debt to capitalization, ratio of unrestricted reserves to long term debt and debt service coverage ratio, along with a schedule of values for each component required to make the various ratio of calculations;
6.1.10. The total charity care; and
6.1.11. A current organizational chart.
W. Va. Code R. § 65-6-7 Corrective Action Plans
7.1. Where the average performance score of the parties to the cooperative agreement in any calendar year is below the 50th percentile for all U.S. hospitals in the selected quality metrics, the parties shall submit a corrective action plan to the authority pursuant to W. Va. Code §16-29B-28(g)(1)(C).
7.1.1. The authority will either accept, modify, or reject the corrective action plan within 30 days of receipt and notify the parties of the reasons for the action taken.
7.1.2. If the corrective action plan is modified or rejected, the parties shall submit a revised corrective action plan in accordance with the authority’s action within 15 days of notification of the modification or rejection.
W. Va. Code R. § 65-6-8 Rebates
8.1. The parties shall submit statistical information to the authority on an annual basis regarding all hospital inpatient and outpatient services.
8.1.1. The authority may order a party to issue rebates to health plans or insurers if either the hospital inpatient services or hospital outpatient services exceed the annual increase in the Consumer Price Index for all Urban Consumers by two percent.
8.1.2. The authority may waive the rebate if a party provides written justification of such excess satisfactory to the authority. Justification shall be submitted within 10 days of the authority’s rebate order.
W. Va. Code R. § 65-6-9 Investigations
9.1. The authority may take all actions necessary to adequately investigate whether parties comply with their cooperative agreements. Should the authority find that there is probable cause to believe that parties to the cooperative agreements previously approved by the authority have not complied with the provisions of W.Va. Code §16-29B-28(g), the authority shall provide written notice of such finding to the parties. The parties shall thereafter file a written response setting forth their position with respect to said violation and any corrective action plan which they desire to propose.
9.2. In the event the authority determines that the response is insufficient or that the corrective action plan is insufficient, it shall schedule and publish notice of a hearing before the authority at which the parties and affected parties may appear and offer evidence in accordance with the rules of the authority. A decision by the authority following such hearing shall be deemed a final decision subject to appeal under the Administrative Procedures Act.
W. Va. Code R. § 65-6-10 Penalties
If the parties to a cooperative agreement fail to comply with the provisions of W. Va. Code §16-29B-28(1)(F), the authority may revoke approval of an agreement or take other appropriate action.
W. Va. Code R. § 65-6-11 Administrative Due Process and Judicial Review
The authority may initiate any legal or disciplinary action available by law if the parties to a cooperative agreement have violated any applicable public policy, state rule, or law, and seek enforcement in circuit court.
W. Va. Code R. § 65-6-12 Fees
12.1. All applications for a cooperative agreement shall be accompanied by a non-refundable fee of $75,000 to be submitted to the authority. Application review will not commence until the fee is paid.
12.2. Approved applicants shall also submit an annual supervision fee not to exceed $75,000 to the authority until such time as the cooperative agreement is terminated.
Series 09 Critical Access Hospitals
W. Va. Code R. § 65-9-1 General
1.1. Scope. -- This legislative rule establishes specific standards and procedures to provide for the designation of a critical access hospital as a community outpatient medical center pursuant to W. Va. Code §16B-3-14.
1.2. Authority. -- W. Va. Code §16B-3-14.
1.3. Filing Date. -- May 9, 2025.
1.4. Effective Date. -- May 9, 2025.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2030.
W. Va. Code R. § 65-9-2 Definitions
2.1. “Critical Access Hospital” means a hospital that is:
2.1.1. A not-for-profit, for-profit, or public hospital that is located in a county in a rural area as defined in 42 U.S.C.A. § 1395.i.4(e);
2.1.2. Located more than a 35-mile drive from a hospital or another health care facility or is located more than a 15-mile drive from a hospital or another health care facility in the case of mountainous terrain or in areas where only secondary roads are available;
2.1.3. Designated by the state as being a necessary provider of health care services to residents in the area;
2.1.4. Makes available 24-hour emergency care services: Provided, That the state will determine necessary criteria for ensuring access to emergency care in each area served by the hospital;
2.1.5. Provides not more than 25 beds for inpatient care for a period not to exceed 96 hours for each hospitalization to be averaged annually, unless a longer period is required because transfer to a hospital is precluded because of inclement weather or other emergency conditions: Provided, That swing bed patients are not limited to the 96-hour requirement;
2.1.6. Has nursing services available on a 24-hour basis;
2.1.7. Provides basic services as required under the Critical Access Regulations 42 C.F.R. § 485.635; and
2.1.8. Meets the requirements of 42 U.S.C.A. § 1395, et seq., Emergency Medical Treatment and Active Labor Act (EMTALA).
2.2. “Department” means the West Virginia Department of Health.
2.3. “Licensed” when applied to an individual, means an individual practicing within his or her scope of practice as authorized by §30-1-1 et seq. of this Code and when applied to a community outpatient medical center means that the community outpatient medical center is licensed by the Department.
W. Va. Code R. § 65-9-3 Community Outpatient Medical Center
3.1. Eligibility requirements for a critical access hospital applying for a license designation change to a community outpatient medical center.
3.1.1. A critical access hospital may apply to be designated as a community outpatient medical center if:
3.1.1.a. It has been designated as a critical access hospital for at least one year;
3.1.1.b. It is designated as a critical access hospital at the time of application for a license designation change to a community outpatient medical center.
3.2. A community outpatient medical center shall:
3.2.1. Be open 24-hours a day, seven days a week;
3.2.2. Provide non-elective treatment and observation for periods continuing less than 24 hours;
3.2.3. If not otherwise subject to the federal Emergency Medical Treatment & Labor Act, 42 U.S.C. 1395dd, provide to each patient, without regard to the individual’s ability to pay, an appropriate medical screening examination to determine whether an emergency medical condition exists, and if so, shall provide stabilizing treatment within its capability. If the community outpatient medical center is unable to stabilize the patient within its capability, or if the patient requests, it shall implement a transfer of the patient to another facility that has the capability of stabilizing the patient;
3.2.4. Make all reasonable efforts to secure written agreement(s) with hospital(s) which include provisions for patient referral and transfer between the facilities, with the use of emergency and non-emergency transportation; and
3.2.5. Have operational policies developed with participation from one or more licensed physicians. The operational policies shall describe the patient care services the community outpatient medical center will provide directly and those that will be provided through contract or other arrangement.
3.3. A community outpatient medical center may:
3.3.1. Provide elective, out-patient surgical treatment and procedures for periods continuing less than 24 hours;
3.3.2. Provide basic obstetrics and gynecology treatment and procedures for periods continuing less than 24 hours; and
3.3.3. Provide elective endoscopy or other elective treatment and procedures which are not performed in an operating room environment.
W. Va. Code R. § 65-9-4 Designation as a Community Outpatient Medical Center
4.1. A community outpatient medical center shall be required to comply with all relevant provisions of the Hospital Licensure Rule, 64CSR12, as applicable to the scope of services offered by the community outpatient medical center.
4.2. The community outpatient medical center’s organization, scope of services to be offered, and availability of patient care services shall be defined and approved by the governing body of the critical access hospital seeking a license designation change to a community outpatient medical center.
Series 13 Financial Disclosure Rule
W. Va. Code R. § 65-13-1 General
1.1. Scope. ‑- This legislative rule implements the provisions of the financial reporting requirements of W. Va. Code §16-29B-1 et seq.
1.2. Authority. ‑- W. Va. Code §16-29B-8(b) and §16-29B-24.
1.3. Filing Date. ‑- March 30, 2023.
1.4. Effective Date. ‑- April 1, 2023.
1.5. This rule shall terminate and have no further force or effect on August 1, 2028.
W. Va. Code R. § 65-13-2 Definitions
2.1. The defined terms in W. Va. Code §16-29B-3 are incorporated by reference.
2.2. The following terms are defined:
2.2.a. "Annual financial report" means a complete audited financial statement for the preceding fiscal year, including all notes, schedules, and documents, prepared, and presented by an independent accountant or the auditor.
2.2.b. “Home health agency” means an organization primarily engaged in providing professional nursing services either directly or through contract arrangements and at least one of the following services:
2.2.b.1. Home health aide services;
2.2.b.2. Physical therapy;
2.2.b.3. Speech therapy;
2.2.b.4. Occupational therapy;
2.2.b.5. Nutritional services; or
2.2.b.6. Medical social services to persons in their place of residence on a part-time or intermittent basis.
2.3. “Statement of charges” means a document or file which contains the gross charges or amounts billed by the provider for services rendered commonly referred to as a chargemaster.
W. Va. Code R. § 65-13-3 Reports to be Filed with Authority
3.1. Annually and within 120 days after the end of its fiscal year, unless an extension be granted by the authority, a covered facility shall file with the authority its annual financial report prepared by an accountant or auditor. If an audited financial report is not prepared by a covered facility or related organization, then that facility or organization shall provide the authority:
3.1.b. A statement of income;
3.1.c. A statement of changes in retained earnings;
3.1.d. A statement of cash flows;
3.1.e. A balance sheet for the reporting period; and
3.1.f. Other statement as required by generally accepted accounting principles.
3.2. A nonprofit, community based primary care center providing primary care services without regard to ability to pay shall provide the authority with a year-end audited financial statement prepared in accordance with generally accepted auditing standards and with governmental auditing standards issued by the Comptroller General of the United States. 3.3 Annually and within 120 days after the end of its fiscal year, a hospital shall submit:
3.3.a. A statement of charges for services rendered;
3.3.b. The Health Care Authority Financial Report, through the Uniform Reporting System;
3.3.c. Uniform Bill form in effect for inpatients. A hospital may not submit hard copies of the Uniform Bill data without the prior approval of the authority. A hospital may submit the uniform bill form monthly or quarterly.
3.4. Annually and within 120 days after the end of its fiscal year, a behavioral health facility shall submit the gross rates for its top 30 services by utilization.
3.5. Annually and within 60 days of receipt of service, a home health agency shall submit a utilization survey to determine utilization of existing providers on a county basis by age cohort. The authority may, for good cause shown, extend the time for filing.
3.6. A covered facility not expressly provided for in this section shall submit upon request of the authority the information from section three for itself or from a related organization.
3.7. The information required to be filed pursuant to this section shall be filed for a related organization and not for the aggregate of the covered facility or related organization. An organization is considered to be related to a covered facility if one of the following conditions is met:
3.7.a. The organization controls or is controlled by a covered facility through contracts or other legal documents that allow the organization the authority to direct any of the covered facility's activities, management, or policies, or allows the covered facility to direct any of the organization's activities, management or policies;
3.7.b. The organization has solicited funds in the name of the covered facility with the express or implied approval of the covered facility, and a substantial portion of the funds was intended by the contributor, or was otherwise required, to be used for the benefit of the covered facility;
3.7.c. The covered facility has transferred resources to the organization and a substantial portion of the organization's resources is held for the benefit of the covered facility;
3.7.d. The organization has transferred resources to the covered facility and a substantial portion of the covered facility's resources is held for the benefit of the organization;
3.7.e. The covered facility has assigned certain of its functions to the organization, which is operating primarily for the benefit of the covered facility;
3.7.f. The organization is wholly-owned or was created by the covered facility, and the covered facility receives any of the profits of the organization;
3.7.g. The covered facility is wholly-owned or was created by the organization, and the organization receives any of the profits of the covered facility; or
3.7.h. In the event of the dissolution of the related entity, substantially all of the assets of the entity would become the property of the creating entity.
3.8. If the authority is able to obtain the information required by this section from another source, the covered facility is not subject to the penalty established in section six.
W. Va. Code R. § 65-13-4 Additional Information
The authority may request additional information to verify the accuracy of the information submitted pursuant to this rule.
W. Va. Code R. § 65-13-5 Public Access to Information
5.1. The information submitted pursuant to this rule is subject to the provisions of the Freedom of Information Act provided in Chapter 29B of the West Virginia Code.
5.2. Uniform Bill data is confidential. The authority may, however, release statistical data or reports based upon the Uniform Bill data subject to the signing of a data use agreement,
5.3. The authority may not charge a fee to a covered entity which submits information to obtain data submitted pursuant to this rule from the authority.
5.4. The authority shall publish the results of the home health utilization survey on the authority’s web page at http://www.hca.wv.gov.
W. Va. Code R. § 65-13-6 Administrative Penalty
The authority shall notify a covered facility or related organization that fails to submit to the authority any information required by this rule by certified mail, return receipt requested. If the failure continues for more than 10 days after receipt of the notice, the delinquent facility or organization is subject to a penalty of $1,000.00 for each day thereafter that the failure continues. The authority shall pay any penalty received or recovered into the state treasury to the account of the general fund.
W. Va. Code R. § 65-13-7 Exemption
The provisions of this rule do not apply to the legally authorized practice of medicine by any one or more persons in the private office of any health care provider.
Series 29 Exemption from Certificate of Need
W. Va. Code R. § 65-29-1 General
1.1. Scope. -- This legislative rule establishes the general criteria and procedures for applying for an exemption from Certificate of Need.
1.2. Authority. -- W. Va. Code §16-2D-4(a)(2), §16-2D-11 and §16-29B-8(a)(1).
1.3. Filing Date. -- April 13, 2026.
1.4. Effective Date. -- April 13, 2026. 1.5 Sunset Date. -- This rule shall terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 65-29-2 Definitions
As used in this legislative rule, all terms that are defined in W. Va. Code §16-2D-2 have those same meanings which are in some cases further clarified in this rule. All terms not defined in W. Va. Code §16-2D-2 have the following meanings unless the context expressly requires otherwise.
2.1.a. “Authority” means the West Virginia Health Care Authority which is designated to administer the Certificate of Need program by W. Va. Code §16-2D-3(a)(1).
2.1.b. “Medically underserved population” is defined on a county-by-county basis. Applicants seeking an exemption for a proposed new end-stage renal disease treatment facility under this rule shall identify the service area as the county where the new facility is proposed to be located. For purposes of this rule only, a county service area with fewer than 50,000 residents is deemed to be a medically underserved population if there is no kidney disease treatment center located less than six driving miles from the location provided in the exemption application.
2.1.c. “Statute” means the West Virginia Health Care Authority Certificate of Need statute, W. Va. Code §16-2D-1 et seq.
2.1.d. “Verification” means a statement made under oath before a notary public that the information is knowingly provided and is true and correct.
W. Va. Code R. § 65-29-3 General Requirements
3.1. A health service exempt from certificate of need review by W.Va. Code § 16-2D-11 may not be acquired, offered, or developed within this state unless notification of the performance of the exemption is provided to the Authority.
3.2. A person or health care facility may not knowingly charge or bill for a health service exempted from certificate of need review by W. Va. Code §16-2D-11 without first submitting a notification of performance of the exemption to the Authority.
W. Va. Code R. § 65-29-4 Application
An application for an exemption shall, at a minimum, include the following:
4.1.a. Name, address, and contact information for the applicant;
4.1.b. Name, address, and contact information for the person making the application;
4.1.c. Verifications from the person making the application and the CEO of the applicant entity;
4.1.d. A copy of the governing body’s written authorization empowering the CEO or his or her designee to authorize specified individuals to sign the application and to act on its behalf; and
4.1.e. A detailed description of the project, including but not limited to:
4.1.e.1. The location of the proposal;
4.1.e.2. A detailed statement of the services to be provided;
4.1.e.3. The exemption for which the applicant is applying with the appropriate Code citation;
4.1.e.4. A statement of the circumstances justifying approval of the exemption; and
4.1.e.5. A timetable for implementation of the project. In the case of a kidney disease treatment center, the facility must be operational within one year of the approval or the exemption will expire after one year.
4.1.f. In the case of an exemption of a kidney disease treatment center, the application shall also contain:
4.1.f.1. The address of the proposed facility and a copy of the executed lease or option to lease or option to purchase agreement for the facility; and
4.1.f.2. Evidence that there is adequate water and other utilities at the site to support the facility.
W. Va. Code R. § 65-29-5 Expiration of Exemption
If a kidney disease treatment facility is not operational within one year from the date of the decision on exemption, the exemption will expire unless good cause can be demonstrated.
W. Va. Code R. § 65-29-6 Appeals
6.1. An appeal of the Authority’s decision may be filed with the Office of Judges in accordance with W.Va. Code §16-2D-16.
6.2. In lieu of an appeal, the applicant may refile an application with the Authority.
W. Va. Code R. § 65-29-7 Notification of Completion of Project
The applicant shall notify the Authority in writing upon the completion of the project. The notification shall contain a brief description of the project, the assigned case file number, the date of the completion of the project and the date that the project became or will become operational.
Series 32 Certificate of Need
W. Va. Code R. § 65-32-1 General
1.1. Scope. -- This legislative rule implements the provisions of the Certificate of Need program found at W. Va. Code §16-2D-1, et seq. as administered by the West Virginia Health Care Authority.
1.2. Authority. -- W. Va. Code §16-2D-4(a) and §16-29B-8(a)(1).
1.3. Filing Date. -- May 1, 2024.
1.4. Effective Date. -- May 1, 2024.
1.5. Sunset Date. -- This rule shall terminate and have no further force or effect August 1, 2029.
W. Va. Code R. § 65-32-2 Definitions
2.1. As used in this legislative rule, all terms that are defined in W. Va. Code §16-2D-2 have those same meanings which are in some cases further clarified in this section. Terms not defined in the statute have the following meanings unless the context expressly requires otherwise.
2.1.a. "Acquire a Health Care Facility" means to obtain by purchase, donation, lease, stock transfer or comparable arrangement a health care facility's assets used in the provision of health services or a majority of stock, including the transfer of a health care facility from a subsidiary corporation to its parent corporation or vice versa or including a change or transfer of the licensee of the health care facility.
2.1.b. "Authority" means the West Virginia Health Care Authority established pursuant to W. Va. Code §16-29B-5 and which is designated to administer the certificate of need program by W. Va. Code §16-2D-3(a)(1).
2.1.c. "Batching" means the consideration of completed certificate of need applications which are grouped by the date they are deemed complete. There are two batches each month: one on the fifteenth day of the month and one on the last day of the month. If either of these dates fall on a Saturday, Sunday or legal holiday, the applications will be batched on the next business day.
2.1.d. "Certificate of Need" means a document issued by the Authority which indicates that a proposed new health service is in compliance with the intent, purposes, and provisions of W. Va. Code §16-2D-1, et seq., and that a need exists for the proposed new health service.
2.1.e. "Consistent With The State Health Plan" means a determination made by the Authority that the preponderance of the evidence supports the achievement of the applicable provisions of the State Health Plan unless the Plan is in conflict with any statute or rule.
2.1.f. "Emergency Circumstances That Pose A Threat To Public Health" means those circumstances proclaimed by the Secretary of the Department of Health to be an emergency which pose a threat to public health or those circumstances upon which a state of emergency is declared pursuant to W. Va. Code §15-5-6.
2.1.g. “Health Care Facility" has the same meaning as contained in W. Va. Code §16-2D-2(16) but does not include state homes for qualified veterans as defined in W. Va. Code §9A-2-1, or any institution operated by or on behalf of the West Virginia Division of Corrections.
2.1.h. "Private Office Practice" means the independent practice of one or more health professionals that meets the following requirements:
2.1.h.1. The independent practice of one or more health professionals consists of one profession and is licensed, authorized, or organized pursuant to the provisions of Chapter 30 of the West Virginia Code in one of the following ways:
2.1.h.1.A. As a sole proprietorship wholly owned and operated by a health professional who is duly licensed pursuant to the provisions of Chapter 30 of the West Virginia Code;
2.1.h.1.B. As a partnership wholly owned and operated by two or more health professionals who are duly licensed pursuant to the provisions of Chapter 30 of the West Virginia Code;
2.1.h.1.C. As a professional corporation duly registered with or certified by the appropriate health professional licensure board; or
2.1.h.1.D. As a professional limited liability company duly registered with or certified by the appropriate health professional licensure board.
2.1.h.2. Practice composition:
2.1.h.2.A. If the practice is a for-profit entity, the entity must be owned exclusively by health professionals, all of whom are duly licensed to practice in the State of West Virginia.
2.1.h.2.B. If the practice is a non-profit entity and has a membership, all of the members of the entity must be health professionals, all of whom are duly licensed to practice in the State of West Virginia.
2.1.h.2.C. If the practice is a non-profit entity and does not have a membership, the governing body of the entity must be composed exclusively of health professionals, all of whom are duly licensed to practice in the State of West Virginia.
2.1.h.3. The independent practice of health professionals is not controlled directly or indirectly, in whole or part, by any third person or entity. That control can be manifested in one or more of the following ways:
2.1.h.3.A. The ability of a third person or entity to nominate, appoint, elect, or remove one or more members of the practice’s governing Authority or committee, or the ability of a third person or entity to exercise the voting power of one or more members of the governing Authority or committee by means of a voting trust, a voting agreement, proxy, or any other arrangement;
2.1.h.3.B. The ability of a third person or entity to require its approval of an action that would otherwise be within the sole purview of the practice’s governing Authority or committee, or the ability of a third person or entity to veto an action that would otherwise be within the sole purview of the governing Authority or committee, regardless of whether the approval or veto power is granted by the practice’s organizational documents (partnership agreement, articles of incorporation, articles of organization, bylaws, policies, etc.), by contract, or by any other means;
2.1.h.3.C. The ability of a third person or entity to require the practice’s governing Authority or committee to amend or restate its organizational documents; to incur or refinance indebtedness; to assign, sell, lease, mortgage, encumber, or otherwise transfer interests in the practice’s assets; to merge, consolidate, or dissolve the practice; or to otherwise direct or require any other significant action that would otherwise be within the sole purview of the practice’s governing Authority or committee; or
2.1.h.3.D. The agreement of any third person or entity (other than the lender or an insurer) to guarantee, pay, or otherwise discharge any indebtedness, liability, or other financial obligation of the practice.
2.1.h.4. For purposes of this definition, the term “third person or entity” shall not include any person who is a health professional duly licensed pursuant to the provisions of Chapter 30 of the West Virginia Code, and who is participating in the practice as either the owner of a sole proprietorship, a partner of a partnership, a shareholder of a proprietary professional corporation, a member of a nonprofit professional corporation or a professional limited liability company, or an employed provider of professional health services to patients of the practice. All other persons constitute a “third person or entity”.
2.1.h.5. Notwithstanding anything to the contrary, a management services organization’s provision of administrative services to a practice shall not constitute control, either direct or indirect, of the practice.
2.1.h.6. Notwithstanding anything to the contrary, any practice granted a determination of nonreviewability as a private office practice by the Authority on or before July 1, 2010, is and shall remain a private office practice under the statute; provided there has been no material change in the facts and circumstances provided in the original request for determination of reviewability.
2.1.i. "Project" means a proposed new health service.
2.1.j. "Proposed New Health Service" means:
2.1.j.1. The construction, development, acquisition, or other establishment of a new health care facility including the acquisition of a health care facility which is not currently in operation or is not currently being operated as a health care facility, but which has been operated as one in the past;
2.1.j.2. The partial or total closure of a health care facility with which a capital expenditure is associated;
2.1.j.3. Any obligation for a capital expenditure incurred by or on behalf of a health care facility in excess of the expenditure minimum or any obligation for a capital expenditure incurred by any person to acquire a health care facility. An obligation for a capital expenditure is considered to be incurred by or on behalf of a health care facility:
2.1.j.3.A. When a contract, enforceable under state law, is entered into by or on behalf of the health care facility for the construction, acquisition, lease, or financing of a capital asset;
2.1.j.3.B. When the health care facility takes formal action to commit its own funds for a construction project undertaken by the health care facility as its own contractor; or
2.1.j.3.C. In the case of donated property, on the date on which the gift is completed under state law;
2.1.j.4. A substantial change to the bed capacity of a health care facility with which a capital expenditure is associated;
2.1.j.5. The addition of any health service specified in section 20 of this rule and which was not offered on a regular basis within the twelve-month period prior to the time the services would be offered;
2.1.j.6. The addition of ventilator services by a hospital;
2.1.j.7. The elimination of one or more health services, previously offered on a regular basis by or on behalf of a health care facility when the elimination is associated with a capital expenditure;
2.1.j.8. A substantial change to the bed capacity or health services offered by or on behalf of a health care facility, whether or not the change is associated with a proposed capital expenditure, if the change is associated with a previous capital expenditure for which a certificate of need was issued and if the change will occur within two years after the date the activity which was associated with the previously approved capital expenditure was undertaken;
2.1.j.9. The acquisition of major medical equipment;
2.1.j.10. A substantial change in an approved new health service for which a certificate of need is in effect;
2.1.j.11. An expansion of the service area for hospice or home health agency, regardless of the time period in which the expansion is contemplated or made; or
2.1.j.12. The addition of health services which were not offered on a regular basis by or on behalf of the health care facility within the 12-month period prior to the time the services would be offered.
2.1.k. "Statute" means the certificate of need statute, W. Va. Code §16-2D-1 et seq.
2.1.l. "Undertaken," when used to describe an activity for which a certificate of need has been issued or for which an exemption was granted, means the first use of the new health service for its intended purpose.
2.1.m. "Verification" means a signed statement made under oath before a notary public that the information is knowingly provided and is true and correct.
W. Va. Code R. § 65-32-3 Certificate of Need Requirements
3.1. A new health service as defined by W. Va. Code §16-2D-8 may not be acquired, offered, or developed within this state unless the Authority has issued a certificate of need for the new health service, subject to the exemptions in W. Va. Code §16-2D-9, §16-2D-10, and §16-2D-11.
3.2. A person or health care facility may not knowingly charge or bill for a health service as defined by W. Va. Code §16-2D-8 without first obtaining a certificate of need from the Authority.
3.3. Any charge or bill for a defined health service for which a certificate of need has not been issued by the Authority is void and legally unenforceable.
3.4. A transfer of equipment or facilities for less than fair market value is a new health service if a transfer of the equipment or facilities at fair market value would be subject to review by the Authority.
3.5. The Authority may determine a series of expenditures, each less than the expenditure minimum, which, when taken together, are in excess of the expenditure minimum, to be a single expenditure subject to the review of the Authority. In making that determination, the Authority shall consider the following:
3.5.a. Whether the expenditures are for components of a system which is required to accomplish a single purpose;
3.5.b. Whether the expenditures are to be made over a two-year period and are directed towards the accomplishment of a single goal; or
3.5.c. Whether the expenditures are to be made within a two-year period within a single department and constitute a significant modernization of the department.
W. Va. Code R. § 65-32-4 Certificate of Need Application
4.1. An application for a certificate of need shall be on forms approved by the Authority. The forms may be located on the Authority’s website, www.hca.wv.gov. The applicant shall submit the original and one paper copy to the Authority. The applicant may also submit the application electronically. The application shall have a verification signed by the chief executive officer and the person or persons who prepared the application. Any application received after 4:30 p.m., Eastern Standard Time, on a business day or on a weekend or holiday shall be deemed received on the next business day.
4.2. The application shall, at a minimum, include the following:
4.2.a. The identification of the applicant;
4.2.b. A copy of the governing body's approval of the proposal and also a written authorization empowering specified individuals to sign the application and to act on its behalf. One authorization is sufficient for multiple applications provided the individual empowered to sign the application and to act on the applicant’s behalf has not changed. This must be clearly stated in the written authorization and a copy provided in each application;
4.2.c. A description of the project;
4.2.d. A timetable for implementation of the project, including the projected date for incurring the obligation for any capital expenditure;
4.2.e. A documented analysis of the need of the population to be served by the project, including the medically underserved, and the extent to which the proposed service will be accessible to the population;
4.2.f. Policies for patient admission and provision of fully or partially uncompensated care;
4.2.g. A documented analysis of alternatives considered by the applicant;
4.2.h. A documented analysis of the proposal's relationship to the existing health care system, including providers of direct, ancillary, and support services and health professional training programs in the area in which services are to be provided, and, when applicable, the extent to which the proposal will meet the needs of those training programs;
4.2.i. A documented analysis of the proposal's relationship to the state health plan;
4.2.j. An analysis of the relationship of the proposal to the most recent statements of deficiencies and plans of corrections from surveys conducted by accreditation organizations and other federal, state and local inspection agencies, as well as copies of those survey reports or portions of the reports as may be required by the Authority;
4.2.k. Documentation of the availability of resources, including health care providers, management personnel and funds for capital and operating needs;
4.2.l. A preliminary financial feasibility study which includes an analysis of historical and projected utilization, charges, sources of revenue, statements of revenues and expenses, a statement of changes in fund balance, a statement of cash flows, balance sheets, and a statement of the specific assumptions upon which the feasibility study was based; and.
4.2.m. If applicable, a documented analysis of the needs and circumstances of research projects.
W. Va. Code R. § 65-32-5 Access to Information and Facilities
5.1. Upon proper notice, and when reasonable and necessary in the performance of the Authority's responsibilities in administering the certificate of need program, the Authority shall have access to any information, records, meetings, sites and/or facilities pertinent to an application under review by the Authority.
W. Va. Code R. § 65-32-6 Additional Information or Amendments to Application
6.1. After the review of an application has begun, the Authority may require the applicant to submit additional information. If no hearing is requested upon the application, and the applicant fails to submit the information within the time directed or if the applicant submits a substantial amendment to its application, the Authority may extend the review cycle for fifteen days at the request of the applicant.
6.2. If the additional information requested is not sufficient to satisfy the Authority’s request or not timely received, the Authority may deny the application.
6.3. The Authority may examine the extent of additional information provided or any amendment made by the applicant regarding the application currently under consideration by the Authority and determine the application to be a new proposal subject to a new review cycle. The Authority shall notify the applicant of the determination, in writing, and further advise the applicant of the dates in the new review cycle. The Authority shall also publish notice of its action on its website.
W. Va. Code R. § 65-32-7 Application Withdrawal
7.1. An applicant may withdraw an application under consideration by the Authority at any time prior to the issuance of a final written decision. The withdrawal of the application is without prejudice.
7.2. The applicant shall file with the Authority a written notice withdrawing the application before the issuance of a final written decision.
W. Va. Code R. § 65-32-8 Application Review Procedure
8.1. Any person proposing a new health service shall file with the Authority a letter of intent 10 days before the submission of an application. The letter of intent shall contain sufficient information to advise the Authority of the nature, scope, cost, and timing of the project, as well as the location and name of the proposed applicant.
8.2. Notification of receipt of the letter of intent shall be published in a newspaper of general circulation in the area where the health service is being proposed. The newspaper notice shall contain a statement that further information regarding the application is on the Authority’s website. The notification in the newspaper shall be provided within five days of receipt of the letter of intent. A copy of the letter of intent shall be placed on the Authority’s website.
8.3. A certificate of need application must be filed 10 days after the letter of intent.
8.4. The application must be accompanied by the appropriate fees as defined in W. Va. Code §16-2D-13(b)(2). An application will not be accepted without the appropriate fee.
8.5. A copy of the application must be submitted to the Director of the Office of Insurance Consumer Advocacy.
8.6. Upon receipt of a certificate of need application, the Authority shall determine whether the application is complete or whether additional information is required. A declaration by the Authority that an application is complete means that there is sufficient information contained in the application for the Authority to make an informed decision. It does not mean that the approval of the application is warranted. Except in emergency situations that pose a threat to the public health, the Authority shall not declare an application complete if:
8.6.a. The applicant is a health care facility subject to the financial disclosure provisions of W. Va. Code §16-29B-24, et seq. or W. Va. Code §16-29B-1, et seq., and the health care facility has failed to file with the Authority all reports, records, data, or other information required by the code and the rules promulgated pursuant to the code.
8.6.b. Information provided in the application differs from information provided in the letter of intent; and
8.6.c. The application is not timely filed as provided in subsection 8.3. of this rule.
8.7. The Authority shall make a determination of completeness within 10 days of its receipt of the application. If the Authority determines that the application is not complete, it may request additional information or ask additional questions. Upon receipt of the additional information, the Authority has 10 days within which to determine if the application is complete. If the applicant fails to respond within 45 days, the application is considered withdrawn. If the applicant later desires to pursue the project, the applicant shall file a new letter of intent and an application.
8.8. Upon a determination by the Authority that an application is complete, the Authority shall notify the applicant in writing.
8.9. The Authority may batch completed application for review on the 15th day of the month or the last day of the month in which the application was deemed complete. The Authority shall publish on its website a notice of review for each batch. The notice shall, at a minimum, contain the following:
8.9.a. The name of the applicant;
8.9.b. A description of the proposed project;
8.9.c. The date the review cycle begins;
8.9.d. The last date for an affected person to request a public hearing;
8.9.e. The file closing date if no public hearing is requested; and
8.9.f. The last date upon which the Authority will issue a decision.
8.10. When a determination of completeness is made by the Authority and the notice specified in subsection 8.9. of this rule is published, affected persons may request a public hearing within 30 days from the batch date. A request for a public hearing shall be in writing and shall be addressed to: General Counsel, West Virginia Health Care Authority, Certificate of Need Program, 100 Dee Drive, Suite 201, Charleston, West Virginia 25311.
8.11. The Authority shall hold a public hearing on an application if it is requested within the time period specified by subsection 8.14. of this rule by any affected person. The Authority shall conduct the public hearing in accordance with the requirements for administrative hearings found in W. Va. Code §29A-5-1, et seq.
8.12. A hearing order shall be entered by the Authority within 15 days from the last date an affected person may request an administrative hearing on a certificate of need application.
8.13. The hearing order shall contain, at a minimum, the following:
8.13.a. The date of the hearing;
8.13.b. The date of the prehearing conference;
8.13.c. The last date to submit replacement pages;
8.13.d. The last date to file motions for discovery;
8.13.e. The completion date for discovery;
8.13.f. The last date to file all motions which must be a minimum of three days prior to the prehearing conference; and
8.13.g. The last date to file requests for subpoenas or subpoenas duces tecum, or both.
8.14. The hearing shall be conducted no later than three months from the date the hearing order is entered by the Authority and in accordance with the administrative hearing requirements in W. Va. Code §29A-5-1, et seq.
8.15. When a public hearing is scheduled to be conducted upon an application, the Authority shall, prior to the hearing, provide notice to all parties and publish notice on its website. The notice shall, at a minimum, contain the following:
8.15.a. The name of the applicant;
8.15.b. A description of the proposed project;
8.15.c. The date of the public hearing; and
8.15.d. The date of any prehearing conference.
8.16. Whenever a public hearing is scheduled upon any application, the Authority may direct the parties to appear for a prehearing conference. The prehearing conference may be held before any member of the board or before a hearing examiner appointed by the board. The board or its designee shall designate parties to the public hearing at the prehearing conference. The Authority may designate affected persons as parties after the prehearing conference only for good cause shown.
8.17. Parties shall file all prehearing motions with the Authority a minimum of three days prior to the prehearing conference or in accordance with the date established by the time frame order entered in the case, whichever is sooner. The Authority or its designee may consider motions at the prehearing conference.
8.18. Parties shall exchange a list of all witnesses and copies of all documents to be presented or introduced at a public hearing with all other parties to the hearing. The witness lists and the copies of the documents shall be filed by the parties with the Authority or its designee during or prior to the prehearing conference unless a different date is established by the Authority or its designee. Failure to comply with this section is sufficient grounds for the Authority or its designee to disallow the testimony of a proposed witness or disallow the introduction of any exhibit.
8.19. Parties shall file the original and one copy of all communications concerning a pending application with the Authority. A standard certificate of service shall be attached to each written communication which shows that copies have been sent by the regular United States Mail, postage prepaid, to all other parties to the matter. A list of all parties to a matter may be obtained from the Authority. The Authority or its designee may strike a written communication from the record if it does not comply with the requirements of this section.
8.20. The Authority may subpoena witnesses, papers, records, documents and any other information or data it considers necessary for its determination. The Authority shall issue all subpoenas and subpoenas duces tecum in the name of the Authority. Any party requesting a subpoena or subpoena duces tecum is responsible for seeing that they are properly served. Service of subpoenas or subpoenas duces tecum issued at the instance of the Authority is the responsibility of the Authority.
8.21. All requests for subpoenas and subpoenas duces tecum shall be in writing and shall contain a statement acknowledging that the requesting party agrees to pay all fees for the attendance and travel of witnesses.
8.22. Every subpoena or subpoena duces tecum issued at the request of a party shall be served by the party at least five days before the return date, either by personal service by a person over 18 years of age or by registered or certified mail, return receipt requested. If service is by mail, the five-day notice period shall not begin until the date the person or entity receives the subpoena or subpoena duces tecum.
8.23. Fees for the attendance of witnesses are the same as for witnesses before the circuit court of this State and shall be paid by the party requesting the issuance of the subpoena or subpoena duces tecum.
8.24. In any case of disobedience or neglect of any subpoena or subpoena duces tecum issued by the Authority, or any refusal of a witness to testify to any matter regarding which he or she may be lawfully interrogated, the Authority may apply to the Circuit Court of Kanawha County, and the court shall compel obedience through the same manner as a subpoena or subpoena duces tecum is enforced in Kanawha County Circuit Court.
8.25. The affected parties may engage in discovery as provided by the West Virginia Rules of Civil Procedure. The scope of discovery is limited to relevant and admissible evidence. Affected parties engaging in discovery are required to file a copy of the certificate of service attached to the discovery request or response with the Authority. Affected parties shall not file copies of the actual discovery and responses with the Authority.
8.26. In a public hearing, any party may be represented by counsel and may present oral or written arguments and evidence relevant to the matter which is the subject of the hearing. Any party may conduct reasonable cross-examination of persons who testify at the proceeding.
8.27. All witnesses who testify during a hearing are first subject to oath or affirmation.
8.28. The Authority shall maintain a verbatim record of the public hearing.
8.29. After the commencement of a public hearing on an application, and before a decision is rendered by the Authority, there shall be no ex parte contacts between the applicant, any person acting on behalf of the applicant or any person opposed to the application with the Authority or any of its employees or agents who exercise any responsibility regarding the application.
8.30. If a public hearing is not conducted during the review of an application, the Authority shall close the file on the thirty-fifth day after the batch date. After this date, no other factual information or evidence may be considered by the Authority unless the file closing date is extended by the Authority.
8.31. The Authority shall review an uncontested certificate of need application within 60 days from the date the application is batched. An uncontested application is deemed approved if the Authority does not issue a decision within this time period unless an extension, up to 15 days is requested by the applicant as provided in section 9 of this rule.
8.32. In the event a hearing is conducted on the certificate of need application, the Authority shall issue a decision within 45 days of the closing of the file in the administrative proceedings.
8.33. At any time prior to the file closing date, the Authority shall, upon request, provide a detailed itemization of the documents in the Authority's file on a proposed new health service.
8.34. The Authority may, after the publication of a notice on its website and allowing 30 days after the publication for public comment, adopt population projections for use in certificate of need decisions.
W. Va. Code R. § 65-32-9 Extensions of Review Periods; Denials
9.1. At any time during the Authority's review of an application, the Authority may grant the applicant's request that the running of the review period be extended for 15 days.
9.2. If the Authority issues an extension of the review period, or for good cause, it may extend the file closing date.
9.3. Upon a finding by the Authority that it would not be practicable to complete the review of an application within the time provided by this rule, the Authority may deny the application.
9.4. Situations which would make it impracticable for the Authority to complete its review within the time provided by this rule include, but are not limited to the following:
9.4.a. The Authority has requested additional information from the applicant and the applicant has failed to provide all of the information to the Authority in the time frame directed by the Authority;
9.4.b. Weather conditions or other natural disasters have prevented the review process from taking place in a timely manner; and
9.4.c. Any of the circumstances listed in subsection 8.6. of this rule.
W. Va. Code R. § 65-32-10 Decision
10.1. Except as provided later in this section, the Authority shall issue a certificate of need only if it makes the following written findings:
10.1.a. That the proposed new health service is needed;
10.1.b. With the exception of emergency circumstances that pose a threat to the public health, that the new health service is consistent with the State Health Plan. If the proposed new health service is not discussed in the State Health Plan, the Authority shall not disapprove the application solely for that reason;
10.1.c. That superior alternatives to the services in terms of cost, efficiency and appropriateness do not exist and that the development of alternatives is not practicable;
10.1.d. Existing facilities providing similar services to those proposed are using those services in an appropriate and efficient manner;
10.1.e. In the case of new construction, alternatives to new construction have been considered and have been implemented to the maximum extent possible, including modernization and sharing arrangements;
10.1.f. Patients will experience serious problems in obtaining care of the type proposed in the absence of the proposed new service; and
10.1.g. In the case of a proposal for the addition of beds for the provision of skilled nursing or intermediate care services, the addition will be consistent with the plans of other agencies of the state responsible for the provision and financing of long-term care facilities or services including home health services.
10.2. If the Authority finds that the facility or service with respect to which a capital expenditure is proposed by the applicant is required to eliminate or prevent imminent safety hazards as defined by federal, state or local fire, building or life safety codes or rules and regulations, to comply with state licensure requirements, or to comply with accreditation or certification standards, and that the obligation of the capital expenditure is consistent with the State Health Plan, then the Authority shall approve the application to the extent that the capital expenditure is required to eliminate the hazards or meet the standards of accreditation or certification.
10.3. If the Authority disapproves a proposed new health service for its failure to meet the needs of medically underserved populations, the finding shall be in writing.
10.4. The final decision of the Authority upon an application shall be in the form of an approval, a denial or an approval with conditions. If the approval is with conditions, the Authority shall not impose upon the applicant a new health service not originally proposed by the applicant. The Authority may only issue a certificate of need with conditions if the conditions directly relate to the criteria found in the statute or any rule promulgated by the Authority. Conditions may be imposed upon the operations of the applicant for a period not exceeding three years.
10.5. The Authority shall send its decision by certified mail to the applicant and to any affected party. The Authority shall also make the decision available to other persons upon request. The Authority shall also publish notice on its website.
10.6. An applicant shall not file any application for a new health service for which a certificate of need has been denied by the Authority for a period of 90 days from the date that the case has reached a final resolution. This prohibition does not apply if the State Health Plan standards relating to the new health service are amended after the date of the decision to the extent that an approval of the application would be required by the Authority.
W. Va. Code R. § 65-32-11 Appeal of Certificate of Need Decision
11.1. Decisions issued by the Authority prior to June 30, 2022, relating to the issuance, denial, or withdrawal of a certificate of need, shall be appealed by an affected person to the Office of Judges, West Virginia Office of the Insurance Commissioner. Affected persons shall address or deliver a request for review to West Virginia Health Care Authority/Office of Judges, P.O. Box 3585, Charleston, West Virginia 25328.
11.2. For the purpose of administrative review of the Authority’s decision, the Office of Judges shall conduct its proceedings in conformance with the West Virginia Rules of Civil Procedure and the Local Rules for the Circuit Court of Kanawha County, and its review of appeals in accordance with the provisions governing the judicial review of contested administrative cases in W. Va. Code §29A-5-4.
11.3. The Authority may stay the effect of the Authority’s decision pending review. The stay shall be in writing and at the request of the person appealing the Authority’s decision or the applicant seeking a certificate of need.
11.4. The person requesting a review of the Authority decision shall, as part of the request, include assignment(s) of error.
11.5. If a person requesting the review of the Authority’s decision fails to appear at the date, time and place of the hearing, the Office of Judges shall, unless good cause is shown, dismiss the request for review.
11.6. The Office of Judges shall send its written findings to the person who requested the review, the person proposing the new health service, all other affected parties and the Authority. The Authority shall make copies of the decision available to others upon request.
11.7. If the Office of Judges remands the matter to the Authority, the remand order may establish a date by which the Authority shall complete further action. The order shall also state whether any findings of rulings of the Authority have been reversed or revised.
11.8. The Office of Judges may grant a continuance of a hearing upon a showing of good cause. If a request for a general continuance is made, and neither the person requesting the review or the applicant seeking the certificate of need for a new health service object, the Office of Judges may grant the request for a general continuance. The Office of Judges may dismiss the appeal with prejudice if the continuance continues for an unreasonable period of time and for good cause shown.
W. Va. Code R. § 65-32-12 Judicial Review
12.1. Decisions issued by the Authority after June 30, 2022, relating to the issuance, denial, or withdrawal of a certificate of need, shall be appealed by an affected person to the West Virginia Intermediate Court of Appeals, pursuant to the provisions governing the judicial review of contested administrative cases found in W. Va. Code, §29A-5-1, et seq. Pursuant to W. Va. Code §51-11-7(b), all appeals shall be filed with the Clerk of the Supreme Court of Appeals.
12.2. The Authority may stay the effect of the Authority’s decision pending review. The stay shall be in writing and at the request of the person appealing the Authority’s decision or the applicant seeking a certificate of need.
12.3. The person requesting a review of the Authority decision shall, as part of the request, include assignment(s) of error.
W. Va. Code R. § 65-32-13 Progress Reports/Extension of Certificate of Need
13.1. Any person holding a certificate of need shall submit to the Authority, in writing, a report on the progress being made toward completion of the approved project according to the timetable contained in the application. The progress report must contain a verification signed by the Chief Executive Officer and shall be submitted at least 45 days prior to the expiration of the certificate of need, or at any other time directed by the Authority. The report shall include, at a minimum, the following:
13.1.a. The current status of the project in relation to the timetable in the application;
13.1.b. The projected date of completion;
13.1.c. The cause or causes of any delays encountered;
13.1.d. Changes in the project, including any proposed changes for which a request is made for the Authority to determine whether the proposed change is reviewable as a substantial change or that an exemption previously granted should be withdrawn and the applicant be required to obtain a certificate of need for failure to meet the requirements of the exemption;
13.1.e. The projected total cost; and
13.1.f. Compliance with any conditions of certification.
13.2. Any person holding a certificate of need shall submit any additional information relating to the certificate of need requested by the Authority.
13.3. The creation of shelled in space shall not be considered completion of the project unless explicitly permitted in the Authority's decision granting the certificate of need.
13.4. The Authority may not impose new conditions which are unrelated to the representations made by the applicant.
13.5. Any failure to submit a complete and timely progress report is sufficient grounds for the Authority to determine that any future certificate of need application is not complete.
13.6. The applicant shall incur an obligation for a capital expenditure associated with an approved project within 12 months of issuance of the certificate of need unless the Authority has approved a timetable for the obligation of a series of obligations for capital expenditures for discrete components to be incurred over a period longer than 12 months. If the Authority has approved a timetable for the obligation of a series of obligations for capital expenditures for discrete components to be incurred over a period longer than 12 months, the applicant shall incur the obligation for the first component within 12 months after the issuance of the certificate of need.
13.7. Upon good cause shown, the Authority may extend the duration of a certificate of need for up to six months. If the obligation required to be incurred by subsection 13.6. of this rule is not incurred within 18 months of the issuance of the certificate of need, the certificate automatically expires.
13.8. If the obligation required to be incurred by subsection 13.6. of this rule is incurred within the prescribed time period, the applicant may request a renewal of the certificate of need in order to complete the project.
13.9. If a renewal review is underway, the Authority shall automatically extend the old certificate of need until the completion of the renewal review.
13.10. The Authority may grant a renewal of the certificate of need for time periods that are determined appropriate.
13.11. If a request for renewal of a certificate of need is not made before its expiration, the certificate automatically expires. For good cause shown, the Authority may waive the effect of this subsection and permit the extension of the certificate of need during the renewal review period.
W. Va. Code R. § 65-32-14 Substantial Changes to Project After Issuance of Certificate of Need
14.1. In determining whether changes proposed to an approved project for which a certificate of need has been issued are substantial, the Authority shall consider the following as prima facie evidence of a substantial change.
14.1.a. A change in the location of the approved project which reduces the accessibility of patients who otherwise have no alternative to the services reasonably available or the change in location would adversely affect or impact an existing health care facility;
14.1.b. A change in the service area of the approved project;
14.1.c. A change in the location of the approved project to a county that was not significantly impacted by the proposal when it was originally approved;
14.1.d. An addition in the number of beds or a change in the types of beds;
14.1.e. The acquisition of major medical equipment not described in the application as part of the project or a capital expenditure for major medical equipment in excess of 10 percent over the approved capital expenditure for medical equipment;
14.1.f. The addition of health services;
14.1.g. An increase or decrease in square footage in excess of 10 percent of the originally approved footage or 1,000 square feet, whichever is greater; and
14.1.h. An unapproved capital expenditure, or an increase in the approved capital expenditure which is in excess of the expenditure minimum or in excess of 20 percent of the originally approved capital expenditure, whichever is less.
14.2. An applicant shall not make a proposed substantial change to a previously approved project until the Authority has made a determination of the need for review. The Authority shall issue its decision on whether a new certificate of need review is required. The Authority shall issue its decision within 15 days of its receipt of the request from the applicant or, if additional information is requested by the Authority, within 15 days of its receipt of the additional information.
14.3. Any failure to inform the Authority of a proposed substantial change to a previously approved project may result in the Authority withdrawing the certificate of need.
W. Va. Code R. § 65-32-15 Transferability
15.1. A certificate of need is nontransferable. A transfer includes the sale, lease, transfer of stock or partnership shares, or other comparable arrangement which has the effect of transferring the control of the owner of the certificate of need.
15.2. If the Authority finds that a certificate of need has been transferred, the Authority shall withdraw the certificate.
W. Va. Code R. § 65-32-16 Substantial Compliance Review
16.1. The Authority shall conduct a substantial compliance review of all new health services for which it has issued a certificate of need. No later than 45 days prior to licensure or the undertaking of the activity for which a certificate of need was issued, or an exemption granted, the applicant shall request, in writing, that the Authority undertake a substantial compliance review. The request shall contain a verification signed by the Chief Executive Officer.
16.2. The Authority shall issue its findings as to substantial compliance within 45 days of its receipt of a request for the review. If the Authority finds that the project is not in substantial compliance with its certificate of need, the Authority may withdraw the certificate and the Authority may direct that any license to operate the new service be revoked or denied, or the Authority may impose appropriate fines and/or seek an injunction against the use or operation of the new service.
16.3. If the Authority determines that it would be impracticable for the applicant to prepare and submit final cost figures for the project prior to the time the project is ready to be licensed or ready to undertake the activity for which a certificate of need was issued, the Authority may issue a conditional notice of substantial compliance, authorizing the licensure or the undertaking of the activity, for up to 12 months. The applicant shall prepare and submit documented final cost figures within the time designated by the Authority in its notice of substantial compliance. The Authority may withdraw a certificate of need if the applicant fails to submit the final cost figures within the time designated by the Authority. The Authority may impose appropriate fines and seek an injunction against the further use or operation of the new service.
W. Va. Code R. § 65-32-17 Withdrawal of Certificate of Need
17.1. The Authority may withdraw a certificate of need for any of the following reasons:
17.1.a. Insufficient progress in meeting the timetable specified in the approved application for the certificate and for not making a good faith effort to meet it in developing the project;
17.1.b. Noncompliance with any conditions of certification;
17.1.c. A substantial change in an approved new health service for which the Authority has not issued a certificate of need;
17.1.d. A material misrepresentation by an applicant upon which the Authority relied in making its decision; or
17.1.e. Other reasons contained in the statute or this rule.
17.2. After the commencement of a hearing on the Authority's proposal to withdraw a certificate of need, and before a final decision is issued, there may be no ex parte contacts between the holder of the certificate, any person acting on behalf of the holder, or any person in favor of or in opposition to the withdrawal of the certificate and any member of the Authority or its staff or agents who exercise responsibility respecting the withdrawal of the certificate.
17.3. In the case of a proposed withdrawal of a certificate, the Authority shall follow the notification of review provisions, the public hearing provisions, the notification of the status of review and finding provisions, the annual report provisions, the conditional decision provisions and the notification of decision and findings provisions of the statute and this rule.
17.4. An applicant may appeal the withdrawal of a certificate of need pursuant to section 11 of this rule.
W. Va. Code R. § 65-32-18 Declaratory Ruling or Ruling of Reviewability
18.1. A health care facility, health care provider or other entity regulated by the statute, or any person planning to acquire, offer or develop any new health service may apply to the Authority for a declaratory ruling on any matter regulated by the statute or any rule promulgated under the statute.
18.2. Any person acquiring, offering or developing a health service may apply to the Authority for a ruling regarding reviewability of the proposed health service. The request must be accompanied by a nonrefundable $100 fee.
18.3. Persons who request a declaratory ruling or a ruling regarding reviewability shall make the request in writing. They shall address the request to: Chairman, West Virginia Health Care Authority, 100 Dee Drive, Suite 201, Charleston, West Virginia 25311. The request shall contain a verification signed by the Chief Executive Officer.
18.4. Upon receipt of a request for declaratory ruling or a ruling regarding reviewability, the Authority shall issue its ruling within 45 days of its receipt of the request if all of the necessary information has been provided to the Authority in a timely manner. The Authority shall serve the ruling upon the person requesting the ruling and shall make the ruling available to any other person upon request and on payment of the cost set out in the fee schedule adopted by the Authority.
18.5. The Authority shall publish notice of its declaratory ruling or ruling regarding reviewability on its website.
W. Va. Code R. § 65-32-19 Public Access to Information
19.1. The Authority shall make available for public inspection and examination all applications filed with the Authority and all other pertinent written materials filed with the Authority and essential to its review process. The Authority shall make copies of the applications or documents available to the public upon request. The Authority may charge its reasonable and customary fees for making the copies.
W. Va. Code R. § 65-32-20 Addition of Health Services
20.1. The following health services are subject to certificate of need review pursuant to section W. Va. Code §16-2D-8(b), subject to the exemptions contained in W. Va. Code §16-2D-9, §16-2D-10, and §16-2D-11.
20.1.a. Providing radiation therapy;
20.1.b. Providing computed tomography;
20.1.c. Providing positron emission tomography;
20.1.d. Providing cardiac surgery;
20.1.e. Providing fixed magnetic resonance imaging;
20.1.f. Providing comprehensive medical rehabilitation;
20.1.g. Establishing an ambulatory care center;
20.1.h. Establishing an ambulatory surgical center;
20.1.i. Providing diagnostic imaging;
20.1.j. Providing cardiac catheterization services;
20.1.k. Constructing, developing, acquiring, or establishing of kidney disease treatment centers, including freestanding hemodialysis units;
20.1.l. Providing megavoltage radiation therapy;
20.1.m. Providing surgical services;
20.1.n. Establishing operating rooms;
20.1.o. Adding acute care beds;
20.1.p. Providing intellectual developmental disabilities services;
20.1.q. Providing organ and tissue transplants;
20.1.r. Establishing an intermediate care facility for individuals with intellectual disabilities;
20.1.s. Providing inpatient services;
20.1.t. Providing hospice services;
20.1.u. Establishing a home health agency; and
20.1.v. Providing personal care services.
20.2. The services listed in subsection 20.1. of this rule are subject to certificate of need review regardless of the expenditure associated with the proposal.
W. Va. Code R. § 65-32-21 Applicability
21.1. The Authority shall consider any application for which a review cycle has been established prior to the effective date of this rule under the rules in effect at the time the review cycle was established.
Series 34 Uniform Bill Database
W. Va. Code R. § 65-34-1 General
1.1. Scope. -- This rule establishes procedures for the collection, retention, use, and disclosure of data from the uniform bill (UB) database, including provisions and safeguards to protect the privacy, integrity, confidentiality, and availability of any data; procedures for the collection of required data elements, required data format, code tables, edit specifications, thresholds required for a submission to be deemed complete, methods for submitting data, and submission schedules; and fees for data requests payable by users of the data, if any.
1.2. Authority. – W. Va. Code §16-29B-24.
1.3. Filing Date. – March 30, 2023.
1.4. Effective Date. – April 1, 2023.
1.5. Sunset Provision. – This rule shall terminate and have no further force or effect on August 1. 2028.
W. Va. Code R. § 65-34-2 Definitions
2.1. De-identified data means all of the data elements listed in subsection 4.1. of this rule are omitted.
2.2. Health oversight agency means an agency or authority of the United States, a State, a territory, a political subdivision of a State or territory, or an Indian tribe, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is authorized by law to oversee the health care system (whether public or private) or government programs in which health information is necessary to determine eligibility or compliance, or to enforce civil rights laws for which health information is relevant.
2.3. Limited data set means one in which none of the data elements listed in subsection 5.9. of this rule are included.
2.4. Public health surveillance means the ongoing systematic collection, analysis, and interpretation of health-related data essential to planning, implementation, and evaluation of public health practices.
§64-34-3. Data Collection and Retention.
3.1. Pursuant to W. Va. Code §16-29B-30, and notwithstanding any other provision of the code to the contrary, as of July 1, 2017, and any and all functions of the West Virginia Health Care Authority (Authority) were transferred to the Department of Health and Human Resources (Department). This includes the responsibility for coordinating and overseeing health data collection and leading state agencies’ efforts to make the best use of emerging technology to facilitate the expedient and appropriate exchange of health care data.
3.2. In some instances, the Department may hire a data discharge vendor to collect and analyze UB data directly from all non-federal acute care hospitals. The policies, procedures, schedules, specifications, and definitions of the West Virginia Hospital Data Submission System (HDSS) are found at “Appendix A” to this rule.
3.3. The data discharge vendor maintains the master database for the HDSS and provides copies of the data to the Department at least quarterly for storage in a data warehouse under the control of the Department. Since this data may, in some instances, contain identifiers that may, when linked with other sources or standing alone, lead to the identity of an individual, steps are taken to protect this data, to limit use of this data, and to restrict disclosure of this data.
W. Va. Code R. § 65-34-4 Data Published on the Internet
4.1. Generally, data published on the internet will be de-identified in accordance with HIPAA privacy standards and will contain a cell size of at least 30. In order to de-identify data the following variables must be omitted:
4.1.1. Names;
4.1.2. All geographic subdivisions smaller than a state, including street address, city, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if according to the current publicly available data from the Bureau of Census the initial geographic unit formed by combining all zip codes with the same three initial contains more than 20,000 and the initial three digits of a zip code for all such geographic units containing 20,000 or fewer is changed to 000;
4.1.3. All elements of dates (except year) for dates directly related to an individual, including birth date, date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of 90 or older;
4.1.4. Telephone numbers;
4.1.5. Fax numbers;
4.1.6. Electronic mail addresses;
4.1.7. Social security numbers;
4.1.8. Medical record numbers;
4.1.9. Health plan beneficiary numbers;
4.1.10. Account numbers;
4.1.11. Certificate/license numbers;
4.1.12. Vehicle identifiers and serial numbers, including license plate numbers;
4.1.13. Device identifiers and serial numbers;
4.1.14. Web Universal Resource Locators (URLs);
4.1.15. Internet Protocol (IP) address numbers;
4.1.16. Biometric identifiers, including finger and voice prints;
4.1.17. Full face photographic images and any comparable images; and
4.1.18. Any other unique identifying number, characteristic, or code.
W. Va. Code R. § 65-34-5 Data Use and Disclosure
5.1. The Department utilizes hospital discharge data for public health surveillance, to inform health care policy, and to evaluate the effectiveness of programs. The Department also recognizes the legitimate needs of citizens, providers, policy makers, researchers, and others to access discharge data. Every effort is made to satisfy legitimate requests for data while protecting patient data.
5.2. If a party requests more than a de-identified data set or a de-identified data set with a cell size of less than 30, then the party must submit a complete application for its request to be considered.
5.3. Once this application is received, the analyst will determine if the data request has value and utility, whether the data is available from other sources, if the minimum data necessary to accomplish the research project has been requested and whether an IRB with Federal Wide Assurance has approved the request.
5.4. A hospital submitting UB data may obtain the full set of UB data that it has submitted without restriction.
5.5. The Authority may exchange data available in a limited data set with a public health oversight agency.
5.6. If a state agency needs UB data to perform an essential function of that agency, the data may be produced if a data use agreement is obtained and the minimum necessary data is provided.
5.7. If an internal source requests data for use before a state agency, the Legislature, or any other public body, the Director of Data and Analysis must determine if the data requested has a public mission, value and utility and supports the greater good of the community.
5.8. If a government agency requests data for an articulated public health surveillance purpose and the government agency certifies that its request complies with the minimum necessary restrictions, the data can be produced without a data use agreement and as requested by the government agency once the Director of Data and Analysis approves this disclosure.
5.9. If the request is approved and a data use agreement signed, then a limited data set may be provided. In no event may any limited data set include the following:
5.9.1. Names;
5.9.2. Postal address information, other than town or city, state, and zip codes;
5.9.3. Telephone numbers;
5.9.4. Fax numbers;
5.9.5. Electronic mail addresses;
5.9.6. Social security numbers;
5.9.7. Medical record numbers;
5.9.8. Health plan beneficiary numbers;
5.9.9. Account numbers;
5.9.10. Certificate/license numbers;
5.9.11. VIN and serial numbers, including license plates;
5.9.12. Device identifiers and serial numbers;
5.9.13. Web universal resource locators (URL);
5.9.14. Internet protocols (IP) address numbers;
5.9.15. Biometric identifiers, including finger and voice prints; and
5.9.16. Full face photographic images and any comparable images.
5.10. All requests for UB data from members of the press must be submitted directly to the DHHR Division of Communications.
5.11. Requests for data from data vendors who are going to resell the data must be referred to the Healthcare Cost and Utilization Project (H-CUP) sponsored by the Agency for Healthcare Research and Quality (AHRQ) of the U.S. Department of Health & Human Services. Data from West Virginia, along with data from several other states, is available for comparison in an interactive query system which is freely available to the public at the following link: https://datatools.ahrq.gov/hcupnet. Alternatively, these requests may be directed to the de-identified data on the web or the facility.
5.12. The Department reserves the right not to provide any or all of the data requested in its sole discretion. In addition, the Authority reserves the right not to provide any or all data requested by parties that have previously violated the terms of a data use agreement or otherwise misused any of the Authority’s data.
W. Va. Code R. § 65-34-6 Fees
6.1. The following fee structure has been established for certain types of reports and data in order to reasonably reimburse the Department for its costs in making copies of the reports available and in fulfilling custom requests:
6.1.1. Standard reports of financial and utilization statics: Paper copies are 50 cents per page; $10 per electronic file. Some reports may be retrieved electronically and free of charge from the Health Care Authority online archive at http://www.hcawv.org/vs5FileNet/.
6.1.2. Standard reports based upon hospital discharge uniform billing data: $50 per report. Some data may be retrieved electronically and free of charge using the Health IQ query tool at https://hca.gov/data/Pages/default.aspx; and from the AHRQ H-CUP query tool at https://hcupnet.ahrq.gov/#setup.
6.1.3. Custom reports based upon financial and utilization data or hospital uniform billing data sets: $50 per report. Additional fees may apply for excessive programming time.
6.1.4. Annual hospital discharge uniform billing data sets: Annual files are available for purchase from the AHRQ H-CUP central distributor at http://www.hcup-us.ahrq.gov/tech_assist/centdist.jsp.
6.1.5. Shipping: Additional shipping costs will be applied for costs above $1 or if signature confirmation of delivery is required by policy. No additional shipping cost will be incurred for certified mail delivery. Overnight delivery will be billed at the standard rate or charged to requestor’s FedEx account.
6.1.6. Retrieval of paper reports from archival storage: $15 per box accessed to retrieve a document. This is the actual cost of document retrieval.
W. Va. Code R. § 65-34-7 Requesting Data
7.1. Internal or external users may request a limited data set by submitting a data request form: https://docs.google.com/forms/d/e/1FAIpQLSeBN9qaAyg5PYBYLGZIuEspIHu50gVp5vsDvPqeSPyBEKn0Eg/viewform to the DHHR Office of Management Information Services, Data and Analytics.
7.1.1. Forms can be mailed, emailed to Michael.J.Morris@wv.gov or faxed to (304) 558-4775.
7.1.2. Requests may be approved as submitted or additional justification or modification may be required. Requests may also be denied.
7.1.3. External entities may be required to sign a Data Use Agreement at the discretion of the Department.
7.1.4. If a request is approved, an encrypted report will be sent to the requester within 30 days via Secure File Transfer Protocol.
APPENDIX A
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