By Fisher, JD, CHC, CCEP
Establishing Bona-Fide Prescriber-Patient Relationships for Schedule 2 to 5 Controlled Substances
Introduction
Overview of Michigan’s Opioid Prescribing Framework
The opioid epidemic has prompted the state of Michigan to implement robust legislative measures to regulate the prescribing of controlled substances. These statutory frameworks are designed to strengthen oversight of the prescriber-patient relationship and ensure responsible dispensing of schedule 2 to 5 controlled substances. Legal professionals and healthcare providers must understand and comply with these requirements to avoid regulatory penalties and contribute to mitigating opioid misuse.
Michigan has enacted several separate pieces of legislation to address the opioid epidemic, most of which are directed at controlling the prescribing relationship between a physician and a patient.
Generally, Michigan requires a controlled substance license to prescribe controlled substances in the state. A holder of a controlled substance license may administer or dispense schedule 2 to 5 controlled substances without obtaining a separate controlled substance license for each substance. Additional requirements may apply to the prescribing relationship at different points in time.
Beginning on the earlier of March 31, 2019, or the date implementing regulations are issued, a licensed prescriber must have a “bona-fide prescriber-patient relationship” before prescribing a schedule 2 to 5 controlled substance. To satisfy that standard, the prescriber must review relevant medical or clinical records, complete a full assessment of the patient’s medical history and current medical condition, conduct a relevant medical evaluation either in person or through telehealth, and maintain records of the patient’s condition in accordance with medically accepted standards.
The discussion below explains the licensing baseline, defines the bona-fide prescriber-patient relationship requirement, and outlines practical compliance steps for prescribers and healthcare organizations.
Controlled Substance Licensing Baseline
Michigan law requires practitioners who prescribe controlled substances to hold a valid controlled substance license. That license authorizes the holder to administer or dispense schedule 2 to 5 substances without obtaining additional, substance-specific licenses. Prescribers should maintain current licensure and monitor renewal and regulatory requirements, because noncompliance may result in disciplinary action, including suspension or revocation.
Bona-Fide Prescriber-Patient Relationship Requirement
Effective March 31, 2019, or upon the issuance of relevant regulations, Michigan requires the establishment of a bona-fide prescriber-patient relationship as a prerequisite for prescribing schedule 2 to 5 controlled substances. The criteria for this relationship are clearly delineated:
Required Elements of a Bona-Fide Relationship
- Medical Record Review: The prescriber must review all pertinent medical and clinical records to understand the patient’s health history and treatment needs.
- Comprehensive Patient Assessment: A thorough assessment of the patient’s medical history and current condition is required, ensuring that the prescriber is fully informed before issuing any prescription.
- Medical Evaluation: The prescriber must conduct a relevant medical evaluation, which may be performed either in person or through telehealth modalities. This evaluation must be tailored to the patient’s specific condition and the substance being prescribed.
- Recordkeeping: Detailed records of the patient’s condition and the prescriber’s evaluation must be maintained in accordance with medically accepted standards. These records should be comprehensive, accurate, and readily accessible for regulatory review.
Practical Compliance Controls for Prescribers
Prescribers can support compliance with Michigan’s controlled substance prescribing requirements by adopting practical controls that document the prescribing relationship, preserve licensure status, and prepare the practice for regulatory review:
- Maintain a current controlled substance license and track renewal deadlines before issuing schedule 2 to 5 controlled substance prescriptions.
- Establish protocols for thorough medical record review and patient assessment prior to prescribing controlled substances.
- Utilize secure telehealth platforms when conducting remote evaluations, ensuring all interactions are documented.
- Develop and maintain robust recordkeeping systems that adhere to medical and legal standards, facilitating audit readiness.
- Educate staff about the legislative requirements and the importance of adherence to all compliance measures.
Effective Date and Ongoing Regulatory Monitoring
Prescribers are required to comply with the bona-fide relationship mandate starting on the earlier of March 31, 2019, or the date that implementing regulations are issued. It is critical to monitor regulatory updates to ensure timely compliance and avoid inadvertent violations.
Key Compliance Takeaways
- Michigan’s opioid legislation establishes specific requirements for prescribers of schedule 2 to 5 controlled substances.
- A documented bona-fide prescriber-patient relationship must be in place before a prescriber issues a schedule 2 to 5 controlled substance prescription.
- Compliance depends on consistent medical record review, patient assessment, relevant medical evaluation, and accurate recordkeeping.
- Prescribers should maintain current licensure, monitor regulatory updates, and use internal controls that support audit readiness.
Conclusion: Maintaining Compliance and Responsible Care
Michigan’s opioid legislation requires prescribers to pair valid controlled substance licensure with a documented bona-fide prescriber-patient relationship before prescribing schedule 2 to 5 controlled substances. By maintaining clear review, evaluation, and recordkeeping practices, prescribers can support compliance while promoting responsible patient care.
