News & Media

New Controlled Substance Prescribing Rules in Effect

Wednesday, January 09, 2019

Michigan prescribers and patients have experienced the implementation of several legislative and regulatory actions intended to address Michigan's opioid crisis over the past year. Most recently, revisions to the Michigan Board of Pharmacy's Controlled Substance rules were finalized and took effect immediately upon filing with the Office of the Great Seal on January 4, 2019.

There were three important changes to the rules; perhaps most notable of which is the identification of exceptions to the "bona fide prescriber-patient relationship" requirement in MCL 333.7303a.

On April 2, 2018, the Legislature responded to stakeholder concerns by delaying the effective date of the bona fide relationship provision to March 31, 2019, or upon the promulgation of rules carving out exceptions, whichever was sooner. Because the rule establishing these exceptions was finalized with immediate effect, the requirement of a bona fide prescriber-patient relations prior to prescribing a controlled substance to patients also took effect on January 4, 2019. MSMS and many other health care stakeholders collectively advocated for exceptions that allow prescribers to provide timely, appropriate and non-duplicative care to patients. MSMS Legal Counsel has prepared a Legal Alert detailing the statutory bona fide prescriber-patient relationship requirement, the administrative rule exceptions, and suggested best practices for compliance. The related rule change is as follows:

  • R 338.3161a - Prescribers must be in a "bona fide prescriber-patient relationship" before prescribing a controlled substance listed in schedules 2 to 5. Exceptions allowing a prescriber to prescribe a controlled substance listed in schedules 2 to 5 without first establishing a bona fide prescriber-patient relationship are recognized in the following circumstances:
     
    • When a prescriber is providing on-call coverage or cross-coverage for another prescriber who is not available and has established a bona fide prescriber-patient relationship with the patient, as long as the prescriber or an individual licensed under article 15 of the act, reviews the patient's relevant medical or clinical records, medical history, and any change in medical condition, and provides documentation in the patient's medical record.
       
    • When the prescriber is following or modifying the orders of a prescriber who has established a bona fide prescriber-patient relationship with a hospital in-patient, hospice patient, or nursing care facility resident and provides documentation in the patient's medical record.
       
    • When the prescriber is prescribing for a patient that has been admitted to a licensed nursing care facility or a hospice and completes the tasks required in subrule (2)(a) and (2)(b) in accordance with the nursing care facility or hospice admitting rules and provides documentation in the patient's medical record.
       
    • When the prescriber is prescribing for a patient, and the tasks required in subrule (2)(a) and (2)(b) are complied with by an individual licensed under article 15 of the Public Health Code and the prescriber provides documentation in the patient's medical record.
       
    • When the prescriber is treating a patient in a medical emergency, as defined in the rule.

In addition, prescribers need to be aware of two other important changes as follows:

  • R 338.3125 - Gabapentin has been added to the schedule 5 drug list as a controlled substance. As a result of this change, any prescribers prescribing gabapentin must be registered with the Michigan Automated Prescription System (MAPS). Prescribers must also obtain and review the patient's MAPS report if prescribing a quantity that exceeds a 3-day supply, unless dispensed and administered to a patient within a hospital or freestanding surgical outpatient facility.
      
  • R 338.3135 - Licensees applying for or holding a controlled substance license, as well as delegates who prescribe, administer, or dispense on behalf of a licensee, will be required to complete a one-time opioid and other controlled substances awareness training. This requirement does not take effect until September 1, 2019, for initial licenses and the first renewal cycle after the promulgation of this rule for controlled substance license renewals. More details will be forthcoming from the MSMS Education Department as the compliance deadline nears.

An MSMS legal alert titled "Michigan's Bona Fide Prescriber-Patient Relationship Requirement When Prescribing Schedule 2-5 Controlled Substances" is available by visiting MSMS.org/Alerts; then click to expand "Legal" (login required).

A complete copy of the new Pharmacy - Controlled Substances Rule Set is available on the Michigan Department of Licensing and Regulatory Affairs website at www.michigan.gov/bpl.

If you have additional questions, please contact Stacey P. Hettiger, MSMS Director of Medical and Regulatory Policy at 517-336-5766.