Alabama Administrative Code Chapter 540-X-20 — Limited Purpose Schedule II Permit (LPSP)

540 Alabama Board of Medical Examiners

Ala. Admin. Code r. 540-X-20-.01 General Requirements

(1) The Alabama Board of Medical Examiners is the certifying board which may issue, renew, deny, limit, restrict, suspend or revoke a Limited Purpose Schedule II Permit (LPSP) for qualified Physician Assistants (PAs), qualified Certified Registered Nurse Practitioners (CRNPs), and qualified Certified Nurse Midwives (CNMs).

(2) The Board of Medical Examiners may decline to consider an application when the PA, CRNP, CNM, or collaborating or supervising physician is under investigation by the Board for a potential violation of the Code of Ala. 1975, Sections 20-2-54 or 34-24-360, or any rule of the Alabama Board of Medical Examiners or Medical Licensure Commission of Alabama.

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed October 16, 2014; effective November 20, 2014. Amended: Published August 31, 2022; effective October 15, 2022.

Ala. Admin. Code r. 540-X-20-.02 Requirements For Issuance Of Limited Purpose Schedule II Permit (LPSP)

To qualify for an LPSP, an individual must meet requirements which are the following:

(1) A PA shall have a current, active and unrestricted Alabama license to practice as a physician assistant, shall be registered to practice with a supervising physician, and shall have a current, active and unrestricted Qualified Alabama Controlled Substances Certificate (QACSC) for Schedules III, IV and V.

(2) A CRNP or a CNM shall have a current collaborative practice agreement with a collaborating physician and shall have a current, active and unrestricted QACSC for Schedules III, IV and V.

(3) The applicant shall submit an application on forms provided by the Board.

(4) The applicant shall pay the application fee required by the Board.

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed October 16, 2014; effective November 20, 2014.

Ala. Admin. Code r. 540-X-20-.03 Issuance Of A Limited Purpose Schedule II Permit

(LPSP) {#sec-540-x-20-.03 omnilex-key=us-al-regs-official--chapter-540-x-20--540-X-20-.03}

(1) Effective January 1, 2015, the Board may issue an LPSP to a PA, a CRNP, or a CNM when all of the requirements for issuance have been met.

(2) Every LPSP issued shall have a unique LPSP number which identifies the particular applicant as a PA, a CRNP, or a CNM with a valid LPSP.

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed October 16, 2014; effective November 20, 2014.

Ala. Admin. Code r. 540-X-20-.04 Renewal Of A Limited Purpose Schedule II Permit

(LPSP) {#sec-540-x-20-.04 omnilex-key=us-al-regs-official--chapter-540-x-20--540-X-20-.04}

(1) Renewal of an LPSP shall be annually on or before Jan. 1 of each year.

(2) An application for annual renewal of an LPSP shall be received by the Board on or before December 31 and shall be accompanied by the required LPSP renewal fee.

(3) Before renewing an LPSP, the applicant shall have a current QACSC for Schedules III, IV and V, a current United States Drug Enforcement Administration (DEA) registration for Schedules II through V, and a current registration to access the Controlled Substances Prescription Database established and maintained by the Alabama Department of Public Health.

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed October 16, 2014; effective November 20, 2014.

Ala. Admin. Code r. 540-X-20-.05 Fees

(1) The application fee for an initial LPSP is Twenty-Five Dollars ($25.00), which shall be submitted to the Board.

(2) An applicant for annual renewal of an LPSP submitted on or before the renewal deadline of December 31 shall submit to the Board an LPSP renewal fee in the amount of Ten Dollars ($10.00).

(3) An applicant for annual renewal of an LPSP submitted after the renewal deadline of December 31 and prior to January 31 shall submit to the Board an LPSP renewal fee in the amount of Ten Dollars ($10.00) and a late fee in the amount of Fifty Dollars ($50.00).

(4) An applicant for annual renewal of an LPSP submitted after January 31 shall submit to the Board an LPSP renewal fee in the amount of Ten Dollars ($10.00) and a penalty fee in the amount of Ninety-Five Dollars ($95.00).

(5) An applicant for annual renewal of an LPSP submitted after January 31 who has also prescribed Schedule II controlled substances between January 1 and the date of application shall submit to the Board an LPSP renewal fee in the amount of Ten Dollars ($10.00) and a penalty fee in the amount of One Hundred Twenty-Five Dollars ($125.00).

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed October 16, 2014; effective November 20, 2014. Amended: Published August 31, 2022; effective October 15, 2022.

Ala. Admin. Code r. 540-X-20-.06 Prescription Guidelines

(1) When prescribing controlled substances, a PA, CRNP, or CNM shall use a prescription form which includes all of the following:

(a) The name, medical practice site address and telephone number of the supervising/collaborating physician.

(b) The full name of the PA, CRNP, or CNM;

(c) The medical practice site address and telephone number of the PA, CRNP, or CNM, if different from that of the supervising/collaborating physician;

(d) The license number of the PA, CRNP, or CNM.

(e) The words "Product Selection Permitted" printed on one side of the prescription form directly beneath a signature line;

(f) The words "Dispense as written" printed on one side of the prescription form directly beneath a signature line.

(g) The date that the prescription is issued to the patient.

(h) The patient's full name and address.

(i) The QACSC and LPSP registration numbers of the PA, CRNP, or CNM.

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et seq.; 20-2-260; 34-24-53
• New Rule: Published December 30, 2022; effective February 13, 2023.

Ala. Admin. Code r. 540-X-20-.07 Limitations On Utilization Of A Limited Purpose Schedule II Permit (LPSP)

(1) The authority of a PA, a CRNP, or a CNM to prescribe, administer or authorize for administration a Schedule II controlled substance pursuant to an LPSP shall be practice specific.

(2) Only those Schedule II controlled substances which are generally and customarily used in the specialty practice of the supervising physician with whom the PA is registered or the specialty practice of the collaborating physician with whom the CRNP/CNM has a collaborative agreement will be approved by the Board to be prescribed, administered or authorized for administration pursuant to the LPSP.

(3) A specific practice formulary listing the specific Schedule II controlled substances to be prescribed, administered or authorized for administration by the PA, CRNP, or CNM shall be submitted with the application for the LPSP and shall be approved by the Board prior to issuance of the LPSP. The authority of the PA, CRNP, or CNM to prescribe, administer, or authorize for administration a Schedule II controlled substance shall be limited to the Schedule II controlled substances which are listed in the specific practice formulary and approved by the Board.

(4) A PA, CRNP or CNM shall not utilize the LPSP for the purchasing, obtaining, maintaining, or ordering of any stock supply or inventory of any controlled substance in any form.

(5) A PA, CRNP or CNM is prohibited from utilizing an LPSP to prescribe, administer or authorize for administration a controlled substance to his or her own self, spouse, child or parent.

(6) If the Alabama Controlled Substances Certificate of the supervising or collaborating physician under whose supervision the PA, CRNP, or CNM utilizes an LPSP becomes inactive, revoked, suspended, restricted, or placed on probation, then the LPSP of the PA, CRNP, or CNM shall be administratively terminated by operation of law.

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed October 16, 2014; effective November 20, 2014. Amended: Published February 28, 2020; effective April 13, 2020.
• Editor's note: Previous Rule .06 was renumbered to .07 per new rule .06 published December 30, 2022; effective February 13, 2023.

Ala. Admin. Code r. 540-X-20-.08 Grounds For Denial, Restriction, Limitation, Suspension Or Revocation – Limited Purpose Schedule II (LPSP)

The Board may deny, restrict, limit, suspend or revoke an LPSP based on the following grounds:

(1) Fraud or deceit in applying for, procuring or attempting to procure an LPSP.

(2) Conviction of a crime under any state or federal law relating to any controlled substance.

(3) Conviction of a crime or offense which affects the ability of the PA, CRNP or CNM to practice with due regard for the health or safety of his or her patients.

(4) Prescribing a drug or utilizing an LPSP in such a manner as to endanger the health of any patient of the PA, CRNP or CNM or any patient of the supervising, collaborating, or covering physician.

(5) Suspension or revocation of a DEA registration issued to the PA, CRNP or CNM.

(6) Unfitness or incompetence due to the use of or dependence on alcohol, chemicals or any mood-altering drug to such an extent as to render the PA, CRNP or CNM unsafe to prescribe or administer drugs.

(7) Any violation of the requirements of Code of Ala. 1975, §20-2-260 or this Chapter 540-X-20.

(9) Prescribing any Schedule II controlled substance without a current LPSP.

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed October 16, 2014; effective November 20, 2014. Amended: Published August 31, 2022; effective October 15, 2022.
• Editor's note: Previous Rule .07 was renumbered to .08 per certification published December 30, 2022; effective February 13, 2023.

Ala. Admin. Code r. 540-X-20-.09 Due Process Proceedings – Limited Purpose Schedule II Permit (LPSP)

(1) Any hearings concerning the LPSP shall be before the Board.

(2) Any hearing before the Board shall be considered a contested case under the Alabama Administrative Procedure Act, Code of Ala. 1975, §41-22-1, et seq., and shall be conducted in accordance with the requirements of that Act.

(3) Hearings related to the LPSP are to be governed by and conducted in accordance with the applicable provisions of Board Rules, Chapter 540-X-6.

(4) Appeals from an adverse ruling by the Board following a due process hearing are to be conducted in accordance with the provisions of the Alabama Administrative Procedure Act, Code of Ala. 1975, §41-22-1, et seq.

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed October 16, 2014; effective November 20, 2014.
• Editor's note: Previous Rule .08 was renumbered to .09 per certification published December 30, 2022; effective February 13, 2023.

Ala. Admin. Code r. 540-X-20-.10 Risk And Abuse Mitigation Strategies

(1) The Board recognizes that all controlled substances, including but not limited to, opiates, benzodiazepines, stimulants, anticonvulsants, and sedative hypnotics, have a risk of addiction, misuse, and diversion. It is the opinion of the Board that the best practice when prescribing controlled substances shall include medically appropriate risk and abuse mitigation strategies, which will vary from patient to patient. Additional care should be used by practitioners when prescribing medication to a patient from multiple controlled substance drug classes.

(2) Every practitioner shall provide his or her patient with risk education prior to initiating controlled substances therapy and prior to continuing the controlled substances therapy initiated by another practitioner.

(3) Every practitioner shall utilize medically appropriate risk and abuse mitigation strategies when prescribing controlled substances. Examples of risk and abuse mitigation strategies include, but are not limited to:

(a) Pill counts;

(b) Urine drug screening;

(c) PDMP checks;

(d) Consideration of abuse-deterrent medications;

(e) Monitoring the patient for aberrant behavior;

(f) Using validated risk-assessment tools, examples of which shall be maintained by the Board; and

(g) Co-prescribing naloxone to patients receiving opioid prescriptions when determined to be appropriate in the clinical judgment of the treating practitioner.

(4) The Board recognizes that the best available research demonstrates that the risk of adverse events occurring in patients who use controlled substances to treat pain increases as dosage increases. The Board adopts the "Morphine Milligram Equivalency" ("MME") daily standard as set out by the Centers for Disease Control and Prevention ("CDC") for calculating the morphine equivalence of opioid dosages. The Board further adopts the “Lorazepam Milligram Equivalency” (“LME”) daily standard for calculating sedative dosing when using the Alabama Prescription Drug Monitoring Program.

(5) For the purpose of preventing controlled substance diversion, abuse, misuse, addiction, and doctor-shopping, the Board sets forth the following requirements for the use of Alabama's Prescription Drug Monitoring Program (PDMP):

(a) For controlled substance prescriptions totaling less than 30 MME or 3 LME per day, practitioners are expected to use the PDMP in a manner consistent with good clinical practice.

(b) When prescribing to a patient-controlled substances of more than 30 MME or 3 LME per day, practitioners shall review that patient's prescribing history through the PDMP at least two (2) times per year, and each practitioner is responsible for documenting the use of risk and abuse mitigation strategies in the patient’s medical record.

(c) Practitioners shall query the PDMP to review a patient's prescribing history every time a prescription for more than 90 MME or 5 LME per day is written, on the same day the prescription is written.

(6) Exemptions: The Board's PDMP requirements do not apply to practitioners writing controlled substance prescriptions for:

(a) Nursing home patients;

(b) Hospice patients, where the prescription indicates hospice on the physical prescription;

(c) When treating a patient for active, malignant pain; or

(d) Intra-operative patient care.

(7) Due to the heightened risk of adverse events associated with the concurrent use of opioids and benzodiazepines, practitioners should reconsider a patient's existing benzodiazepine prescriptions or decline to add one when prescribing an opioid and consider alternative forms of treatment.

(8) Effective January 1, 2018, each holder of an Alabama Controlled Substances Certificate (ACSC) shall acquire two (2) credits of AMA PRA Category 1™ continuing medical education (CME) in controlled substance prescribing every two (2) years as part of the licensee's yearly CME requirement. The controlled substance prescribing education shall include instruction on controlled substance prescribing practices, recognizing signs of the abuse or misuse of controlled substances, or controlled substance prescribing for chronic pain management.

(9) A violation of this rule is grounds for the assessment of a fine and for the suspension, restriction, or revocation of a practitioner's Alabama Controlled Substances Certificate or license to practice medicine.

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed June 24, 2014; effective November 20, 2019.
• Editor's note: Previous Rule .09 was renumbered to .10 per certification published December 30, 2022; effective February 13, 2023.

Ala. Admin. Code r. 540-X-20-AA Appendix A Application For Limited Purpose Schedule II Permit (LPSP) (Repealed 2/13/23)

ALABAMA BOARD OF MEDICAL EXAMINERS ADMINISTRATIVE CODE

APPENDIX A APPLICATION FOR LIMITED PURPOSE SCHEDULE II PERMIT (LPSP) (REPEALED 2/13/23)

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-259.
• New Rule: Filed October 16, 2014; effective November 20, 2014. Repealed and New Rule: Filed April 13, 2018; effective May 28, 2018. Amended: Filed August 23, 2018; effective October 7, 2018. Repealed: Published December 30, 2022; effective February 13, 2023.

Ala. Admin. Code r. 540-X-20-AB Appendix B LPSP Renewal Application (Repealed 2/13/23)

ALABAMA BOARD OF MEDICAL EXAMINERS ADMINISTRATIVE CODE

APPENDIX B LIMITED PURPOSE SCHEDULE II PERMIT (LPSP) RENEWAL APPLICATION (REPEALED 2/13/23)

History

• Author: Alabama Board of Medical Examiners
• Authority: Code of Ala. 1975, §§20-2-50, et. seq.; 20-2-260; 34-24-53.
• New Rule: Filed October 16, 2014; effective November 20, 2014. Repealed: Published December 30, 2022; effective February 13, 2023.