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 a schedule II through V controlled substance without a separate controlled substance license covering those substances. Additional requirements will attach to the prescribing relationship commencing at various intervals.

This article covers the new requirement regarding the establishment of a bona-fide prescriber-patient relationship.  A licensed prescriber will be required to have a “bona-fide prescriber-patient relationship” in order to prescribe a schedule II through V controlled substance commencing on March 31, 2019 or the date the regulations are issued, whichever is sooner.  In order to be considered a “bona-fide prescriber” the prescriber must review relevant medical/clinical records, complete a full assessment of 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 to medically accepted standards.

All of the above factors should be supported by the patient’s medical record.  There are a lot of loose ends on the definitions applicable to each of these requirements.  It is possible that additional details will be forthcoming when regulations are finalized.  In the meantime, providers should take a proactive, risk averse approach to complying with the new laws.  This approach will require interpreting the law broadly and expansively and creating standards to implement that approach.  Standards can always be adjusted back if regulations provide more concise guidance in the future.

Because these requirements create a condition precedent to being able to prescribe schedule II through V controlled substance, it is critical physicians and other prescribers review their documentation standards to be certain these requirements are reflected in the patient’s chart in each instance.  Provider entities will need to consider adopting policies and procedures setting the standards for documentation and integrating the other requirements of Michigan’s new laws.  Appropriate training should also be conducted to ensure prescribers and their support staff are aware of the detailed documentation requirements.  Additionally, appropriate monitoring and auditing should be conducted to ensure prescribers are meeting the requirements.

Stay tuned for additional coverage of Michigan’s new opioid prescription laws as well as other opioid related compliance issues.