The U.S. Department of Health and Human Services (HHS) published a proposed rule to expand access to buprenorphine, one of three medications currently approved by the Food and Drug Administration (FDA) for treatment of opioid dependence which is open for comments for 60 days starting Wednesday, March 30, 2016.
Major proposed changes include:
- The proposed rule would revise the existing patient limit of 100 patients to allow qualified practitioners to treat up to 200 patients. To be eligible, practitioners must have an active waiver to treat up to 100 patients for one year and either: 1) possess subspecialty board certification in addiction medicine or addiction psychiatry or 2) practice in a qualified practice setting, as defined in the NPRM.
- Practitioners seeking the higher patient limit must attest that they will: adhere to evidence-based treatment guidelines, provide patients with or connect patients to necessary behavioral health services, provide appropriate releases of information to permit care coordination, use patient data to inform the improvement of outcomes, adhere to a diversion control plan, consider how to assure continuous access to care in the event of practitioner incapacity or an emergency situation, and notify patients in the event that a request for the higher limit is not renewed. Practitioners must also reaffirm their eligibility every three years.
- Additionally, during emergency situations likely to exacerbate or be exacerbated by untreated substance use disorder, (e.g., natural or human-caused disaster, practitioner incapacity, or a local disease outbreak associated with drug use), practitioners with a 100-patient limit in good standing may be allowed the higher limit for up to six months.
See related Federal Register Notice available at: https://www.federalregister.gov/articles/2016/03/30/2016-07128/medication-assisted-treatment-for-opioid-use-disorders
See related HHS Blog Improving Access to Treatment: Expanding reach of Buprenorphine available at: