HHS Loosens Restrictions on Buprenorphine for Opioid Use Disorder

Caroline Cassels

April 27, 2021

New practice guidelines released by the US Department of Health & Human Services (HHS) remove long-time barriers to buprenorphine for the treatment of opioid use disorder (OUD).

Specifically, the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder exempts eligible physicians, physician assistants, nurse practitioners, and others from federal certification requirements related to training, counseling, and other ancillary services that are part of the current process to obtain a waiver to treat up to 30 patients with the drug.

"Increases in overdose deaths emphasize the need to expand access to evidence-based treatments, including buprenorphine that can be prescribed in office-based settings," Assistant Secretary for Health Rachel Levine, MD, said in a release.

"These guidelines provide another tool to help communities respond to the evolving overdose crisis, equipping providers to save lives in their communities," she added.

With respect to the prescription of certain medications covered under applicable provisions of the Controlled Substances Act (CSA), such as buprenorphine, practitioners licensed under state law who possess a valid Drug Enforcement Administration (DEA) registration, may be exempt from the certification requirements related to training, counseling, and other ancillary services.

Under the exemption, practitioners are limited to treating no more than 30 patients at any one time. Time spent practicing under the exemption will not qualify the practitioner for a higher patient limit.

In addition, under the exemption practitioners must be supervised by, or work in collaboration with, a DEA-registered physician if required by state law to work in collaboration with, or under the supervision of, a physician when prescribing medications for the treatment of OUD.

Record Number of Overdose Deaths

This requirement does not apply to practitioners who are employees or contractors of a department or agency of the United States acting within the scope of such employment or contract.

Under the guidelines, practitioners who do not wish to practice under the exemption and the 30-patient limit may seek a waiver per established protocols.

The exemption applies only to the prescription of Schedule III, IV, and V drugs or combinations of such drugs, covered under the CSA, such as buprenorphine. It does not apply to the prescribing, dispensing, or the use of Schedule II medications such as methadone for the treatment of OUD, the HHS notes.

Before treating patients with buprenorphine for OUD, practitioners must obtain a waiver under the CSA by submitting a Notice of Intent to the HHS's Substance Abuse and Mental Health Services Administration (SAMHSA) under established protocols.

Provisional data from the Centers for Disease Control and Prevention show that more than 90,000 drug overdose deaths are predicted to have occurred in the United States in the 12 months ending in September 2020, the highest number of overdose deaths ever recorded in a 12-month period and such deaths have continued to accelerate during the COVID-19 pandemic.

"The spike we've seen in opioid-involved deaths during the COVID-19 pandemic requires us to do all we can to make treatment more accessible," Acting Assistant Secretary for Mental Health and Substance Use Tom Coderre, who leads SAMHSA, said in a release.

"Americans with this chronic disease need and deserve readily available access to life-saving, evidence-based treatment options. These new guidelines are an important step forward in reducing barriers to treatment and will ultimately help more people find recovery."

Support From AMA

In a statement, the American Medical Association (AMA) applauded the move and noted that it will remove "daunting regulatory barriers and eas[e] stigma facing patients with opioid use disorder."

The AMA noted that patients with OUD struggle to find physicians authorized to prescribe buprenorphine and expressed hope that these new guidelines, which remove "onerous" regulations, will help them get the treatment they need.

"Treatment with buprenorphine allows patients with opioid use disorder to lead satisfying, productive lives. The policy announced today is a critically important step in making that happen. Going forward, the AMA is supporting legislation to remove the waiver requirements altogether and will advocate for that in Congress," the release said.

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