Changes to Buprenorphine Prescriber Limits

Two weeks ago, the Department of Health and Human Services (DHHS) announced changes in buprenorphine treatment regulations that would allow certain licensed physicians to provide buprenorphine to up to 275 patients. This is an increase from the 100 patient limit set forth by the Office of National Drug Control Policy (ONDCP) Reauthorization Act of 2006. The change comes after growing concern about the increase in prescription opioid misuse and heroin use in the United States. By increasing the patient limit, DHHS hopes to increase access to medication assisted opioid agonist treatment.

According to federal regulations, physicians must take an eight hour training course and apply for a waiver from registration requirements of the Controlled Substances Act and a license from the United State Drug Enforcement Agency in order to prescribe buprenorphine in an office based setting. During the first year, waivered physicians can only prescribe buprenorphine to a maximum of 30 patients, but in the subsequent years they can now apply to treat as many as 275 patients. Unfortunately, fewer than 32,000 physicians have received the waiver and many of those do not prescribe near the legal limit.

Another approach to increase access to medication-assisted opioid agonist treatment is to allow trained non-physician health professionals to prescribe the medication. The Comprehensive Addiction and Recovery Act (CARA) recently passed in both the House of Representatives and the Senate grants physician assistants (PAs) and nurse practitioners (NPs) the ability to prescribe buprenorphine. PAs and NPs will need to undergo 24 hours of training and education to become waivered to prescribe buprenorphine for up to 30 patients in the first year and 100 patients in the following year. It is unclear whether this limit will also change to 275. The legislation requires the physician who supervises or collaborates with the PA or NP to also obtain a waiver. The authorization for PAs and NPs to become waivered is for a five-year period, expiring in 2021.  This presents an opportunity for policy-relevant research to compare the health outcomes, service utilization, and cost of patients treated by PAs and NPs versus other prescribers to inform decisions about whether to extend the authorization beyond 2021.