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Bona Fide Prescriber-Patient Relationship Requirement for Controlled Substance Prescribing Effective January 4, 2019

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Bona Fide Prescriber-Patient Relationship Requirement for Controlled Substance Prescribing Effective January 4, 2019

Bona Fide Relationship Requirement LawPublic Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”). The Michigan legislature delayed the effective date of the bona fide prescriber-patient relationship requirement to the earlier of (a) March 31, 2019, or (b) the date administrative rules describing the exceptions to the requirement are promulgated. Public Act 247 also requires the prescriber to provider certain follow-up care to the patient to monitor the efficacy of the CS in treating the patient’s medical condition. Failure to comply with the bona fide relationship requirement is considered professional misconduct and may subject the prescriber to professional discipline.

Effective DateThe Michigan Department of Licensing and Regulatory Affairs (“LARA”) has now published a rule, effective January 4, 2019, describing exceptions to the bona fide prescriber-patient relationship requirement. Promulgation of this rule means that the bona fide prescriber-patient relationship requirement of MCL § 333.7303a is in effect as of January 4, 2019, for all practitioners who prescribe schedule 2-5 CS.

Bona Fide Relationship DefinitionThe law defines a bona fide prescriber-patient relationship as a treatment or counseling relationship between a prescriber and a patient in which both of the following are present:

  1. The prescriber has reviewed the patient’s medical or clinical records and completed a full assessment of the patient’s medical history and current medical condition, including a relevant medical evaluation of the patient conducted in person or via telehealth; and
  2. The prescriber has created and maintained records of the patient’s condition in accordance with medically accepted standards.

Exceptions to the Bona Fide RelationshipThe new rule, promulgated as Mich. Admin. Code R 338.3161a, states that a licensed prescriber may prescribe a schedule 2-5 CS without first establishing a bona fide prescriber-patient relationship in the following five circumstances:

  1. On-Call Prescribing. The prescriber is providing on-call coverage or cross-coverage for another prescriber who is not available and who has established a bona fide prescriber-patient relationship with the patient for whom the on-call or covering prescriber is prescribing the CS. The prescriber, or an individual licensed under article 15 of the Michigan Public Health Code (“Code”), must review the patient’s medical or clinical records, medical history, and any change in medical condition, and provide documentation in the patient’s medical record in accordance with the medically accepted standards of care.
  2. Modifying Orders for Hospital Inpatients, Hospice Patients and Nursing Facility Residents. The prescriber is following or modifying the orders of a prescriber who has established a bona fide prescriber-patient relationship with a hospital inpatient, hospice patient, or nursing facility resident and provides documentation in the patient’s medical record in accordance with the medically accepted standards of care.
  3. Admitting Orders for Hospice Patients and Nursing Facility Residents. When prescribing for an individual who has been admitted to a licensed nursing care facility or a hospice, the prescriber need not have a bona fide prescriber-patient relationship with the patient prior to prescribing CS on admission. Instead, the prescriber must complete the tasks listed in requirements (a) and (b) of the bona fide prescriber-patient relationship described above in compliance with requirements for the timing of medical examinations by physicians for individuals admitted to a nursing home or hospice, as described in nursing home and hospice administrative rules. The prescriber must also provide documentation in the patient’s medical record in accordance with the medically accepted standard of care.
  4. Required Assessment and Review Done by Another Licensed Individual. The prescriber is prescribing for a patient for whom the tasks listed in requirements (a) and (b) of the bona fide prescriber-patient relationship described above have been performed by an individual licensed under article 15 of the Code, and the prescriber provides documentation in the patient’s medical record in accordance with the medically accepted standard of care.
  5. Medical Emergency. The prescriber is treating a patient in a medical emergency, defined as a situation that, in the prescriber’s good faith professional judgment, creates an immediate threat of serious risk to the life or health of the patient for whom the CS is being prescribed.

On January 7, 2019, LARA issued a notice by email advising prescribers of the effective date of the bona fide prescriber-patient relationship requirement and updated its Opioid FAQs, found at: https://www.michigan.gov/documents/lara/LARA_DHHS_Opioid_Laws_FAQ_05-02-2018_622175_7.pdf with information about the new rule.

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