Health Care Law Blog

New Rule on Exceptions to "Bona Fide Relationship" Requirement for Controlled Substance Prescribing

The statutes governing controlled substance prescribing, which were enacted in 2018, require a physician or other prescriber to establish a “bona fide prescriber-patient relationship” before prescribing any controlled substances.

To have a “bona fide” relationship, there must be a treatment or counseling relationship between the prescriber and patient. In addition, the prescriber (1) must review the patient's relevant medical or clinical records and complete 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) must create and maintain records of the patient's condition in accordance with medically accepted standards.

Numerous groups quickly raised concerns and questions about how this requirement would apply in settings common in everyday practice, such as covering for another physician or providing emergency care. The statute’s effective date was delayed to allow the Michigan Department of Licensing and Regulatory Affairs (LARA) time to issue rules dealing with exceptions to bona fide prescriber-patient relationship requirement.

LARA has issued a new rule, with an effective date of January 4, 2019. Now that LARA has promulgated the rule, the statutory requirement has taken effect.

Under the new rule, a physician or other prescriber does not have to perform the tasks required to establish a bona fide prescriber-patient relationship in the following circumstances:

On-call or cross-coverage

A physician, nurse practitioner, or physician assistant may prescribe a controlled substance if another physician or prescriber has already established a bona fide prescriber-patient relationship.  The prescriber providing on-call or cross-coverage must review the patient’s relevant medical or clinical records, medical history, and any change in medical condition. All prescriptions must be documented in the patient’s medical record.

Patients in hospitals, hospices, or nursing care facilities

Controlled substances may be prescribed if a physician or other 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. All prescriptions must be documented in the patient’s medical record.

Controlled substances may also be prescribed as part of the post-admission examination required for a patient admitted to a licensed nursing care facility or a hospice. The physician or other prescriber must review the relevant medical records and history and either follow or modify orders issued by a prior prescriber. All prescriptions must be documented in the patient’s medical record.

Reliance on review by other licensees

A prescriber may prescribe a controlled substance when the review of a patient’s medical records, history, and changed condition has been performed by another licensed health care professional. The prescriber must document any controlled substance prescriptions in the patient’s record.

Medical emergencies

A controlled substance may be prescribed when treating a patient in a medical emergency, which is 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 controlled substance prescription is being prescribed.”

While the new rule modifies the bona fide relationship requirement to accommodate common practice settings, there are many questions and details that remain. Nevertheless, physicians and other prescribers should carefully review the new rule and promptly implement its requirements whenever controlled substances are prescribed without personally establishing a bona fide relationship.

If you have questions about the current requirements for prescribing controlled substances, please contact Richard Kraus.

Categories: Pharmacy, Physicians