Patrick Haddad and Kathleen Westfall Co-Author Article to be published in Oakland County Medical Society Publication entitled: "New Michigan Administrative Rules: Bona Fide Prescriber-Patient Relationships and Controlled Substances Awareness Training"
As part of the 10-bill package of Michigan legislation enacted in late 2017 to combat Michigan’s opioid crisis, Public Act 247 of 2017 prohibits a licensed prescriber from prescribing a schedule 2 to 5 controlled substance to a patient after March 31, 2018, unless the prescriber is in a “bona fide prescriber-patient relationship” with the patient for whom the controlled substance was being prescribed. However, in response to wide concerns voiced on the impact that the bona fide prescriber-patient relationship requirement would have on patient care and prescriber liability, on April 2, 2018 the Michigan legislature enacted Public Act 101 of 2018. This legislation delays the effective date of the bona fide prescriber-patient relationship requirement until the earlier of March 31, 2019 or the date on which administrative rules providing exceptions to the a bona fide prescriber-patient relationship take effect. Although Public Act 247 establishes by statute specific standards that prescribers will be required to comply with when the definition of “bona fide prescriber-patient relationship” takes effect, Michigan’s professional licensing boards and the U.S. Drug Enforcement Administration each have always required that prescribers may prescribe controlled substances only for legitimate medical purposes.
Public Act 247 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 relevant 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.
Public Act 247 provides that exceptions to the “bona fide prescriber-patient relationship” may be established by administrative rules. The legislation authorizes the Michigan Department of Licensing and Regulatory Affairs (“LARA”), in consultation with the Michigan Board of Medicine, the Michigan Board of Osteopathic Medicine and Surgery, the Michigan Board of Dentistry, the Michigan Board of Podiatric Medicine and Surgery, the Michigan Board of Optometry, the Michigan Task Force on Physician’s Assistants, and the Michigan Board of Nursing to promulgate rules describing the circumstances under which a bona fide prescriber-patient relationship is not required for purposes of prescribing a schedule 2 to 5 controlled substance under the legislation. Public Act 247 authorizes the rules to include an alternative requirement for prescribing a schedule 2 to 5 controlled substance when a bona fide prescriber-patient relationship is not required.
When the bona fide prescriber-patient relationship requirement takes effect, Public Act 247 additionally will require a prescriber to provide follow-up care to the patient to monitor the efficacy of the use of the controlled substance as a treatment of the patient’s medical condition. If the prescriber is unable to provide follow-up care, the prescriber must refer the patient to the patient’s primary care provider for follow-up care or, if the patient does not have a primary care provider, the prescriber must refer the patient to another licensed prescriber who is geographically accessible to the patient for follow-up care.
Bona Fide Prescriber-Patient Relationship Rules
On August 31, 2018, LARA filed proposed administrative rules with the Joint Committee on Administrative Rules (“JCAR”). The proposed rules are anticipated to take effect in early December, 2018.
Under the proposed rules, a licensed prescriber may prescribe a controlled substance listed in schedules 2 to 5 without first establishing a bona fide prescriber-patient relationship in the following circumstances:
- When the 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 for whom the on-call or covering prescriber is prescribing a controlled substance, the prescriber, or an individual licensed under Article 15 of the Michigan Public Health Code, 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 in accordance with medical accepted standards of care.
- 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 in accordance with medically accepted standards of care.
- When the prescriber is prescribing for a patient who has been admitted to a licensed nursing care facility or a hospice, completes the tasks required to establish a bona fide prescriber-patient relationship in compliance with Michigan Administrative Code Rule 325.20602 or Rule 325.13302, as applicable, and provides documentation in the patient’s medical record in accordance with medically accepted standards of care.
- When the prescriber is prescribing for a patient for whom the tasks required to establish a bona fide prescriber-patient relationship have been performed by an individual licensed under Article 15 of the Michigan Public Health Code, and the prescriber provides documentation in the patient’s medical record in accordance with medically accepted standards of care.
- When the prescriber is treating a patient in a medical emergency. “Medical emergency” means 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.
Opioid and Controlled Substances Awareness Training
The proposed rules additionally will require individuals seeking a controlled substance license or who is licensed to prescribe or dispense controlled substances to comply a one-time training in opioids and controlled substances awareness training. The training must cover all of the following topics:
- Use of opioids and other controlled substances;
- Integration of treatments;
- Alternative treatments for pain management;
- Counseling patients on the effects and risks associated with using opioids and other controlled substances;
- The stigma of addiction;
- Utilizing the Michigan Automated Prescription System (MAPS);
- State and federal laws regarding prescribing and dispensing controlled substances; and
- Security features and proper disposal requirements for prescriptions.
The training may be obtained from more than one program. Acceptable providers or methods of training include training offered by a nationally or state recognized health related organization; offered by or in conjunction with a state or federal agency; offered by an approved continuing education program accepted by a licensing board established under Article 15 of the Michigan Public Health Code; or training obtained in an educational program that has been approved by a board established under Article 15 of the Michigan Public Health Code for initial licensure or registration, or by a college or university. Acceptable modalities of training include (1) teleconference or webinar, (2) online presentation, (3) live presentation, or (4) printed or electronic media.
A prescriber or dispenser shall not delegate or order the prescribing, dispensing or administering of a controlled substance to an advanced practice registered nurse, registered professional nurse, or licensed practical nurse, unless the nurse has completed the awareness training.
The awareness training requirement will apply to controlled substance license renewals beginning with the first renewal cycle after the promulgation of the proposed rules and for initial licenses issued after September 1, 2019.
New Schedule 5 Controlled Substance
Finally, the proposed rules will add the anticonvulsant prescription drug Gabapentin to the list of schedule 5 controlled substances in order to reduce the abuse of the drug. Upon the effective date of the rules, prescribers must comply with all requirements applicable to schedule 5 controlled substances, including, but not limited to, obtaining and reviewing a MAPS report before prescribing a quantity which exceeds a 3-day supply, in order to continue to prescribe gabapentin.
Effective Date of “Bona Fide Prescriber-Patient Relationship” Required by Public Act 247
It is important for physicians and other licensed prescribers to monitor the effective date of the proposed administrative rules. The effective date of the proposed administrative rules will be the same date on which on which prescribers must begin to comply with the bona fide prescriber-patient relationship and follow-up care requirements established by Public Act 247. Prescribers who fail to comply with the applicable requirements of Public Act 247 and the proposed administrative rules, when they take effect, will be subject to licensing actions and discipline.