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.
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.
Richard Kraus has 30 years of experience in the area of health care law, with special emphasis on licensing investigations and disciplinary actions. His representation of individual health care professionals as well as hospitals, health systems, long term care facilities and multi-practitioner clinics, provides an understanding of clinical and business realities in health care as well as legal and regulatory requirements.View All Posts by Author ›
- HITECH Act
- Electronic Health Records
- Did you Know?
- Accountable Care Organizations
- 6th Circuit Court of Appeals
- Health Insurance Exchange
- Digital Assets
- Employee Benefits
- Fraud & Abuse
- Affordable Care Act
- News & Events
- Health Care Reform
- Department of Labor
- Labor Relations
Best Lawyers® 2020
Congratulations to the attorneys of the Health Care practice group at Foster Swift Collins & Smith, PC for their inclusion in the Best Lawyers in America 2020 edition. Firm-wide, 42 lawyers were listed. Best Lawyers lists are compiled based on an exhaustive peer-review evaluation and as lawyers are not required or allowed to pay a fee to be listed; inclusion in Best Lawyers is considered a singular honor. Health Care practice group members listed in Best Lawyers are as follows:
- Gilbert M. Frimet, Southfield
- Richard C. Kraus, Lansing
- Gary J. McRay, Lansing
- Jack A. Siebers, Grand Rapids/Holland
- Jennifer B. Van Regenmorter, Holland
To see the full list of Foster Swift attorneys listed in Best Lawyers 2020, click here.