White House relaxes buprenorphine prescribing requirements to expand access to opioid addiction treatment

The White House has released new guidelines to expand access to medication-based treatment by exempting physicians from certain certification requirements needed to prescribe buprenorphine to treat opioid use disorder. 

The Department of Health and Human Services (HHS) has implemented new buprenorphine practice guidelines that among other things, remove a longtime requirement tied to training, which some practitioners have cited as a barrier to treating more people.

Signed by HHS Secretary Xavier Becerra, the practice guidelines (PDF) exempt eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives from federal certification requirements related to training, counseling and other ancillary services that are part of the process for obtaining a waiver to treat up to 30 patients with buprenorphine, according to a press release issued Tuesday by HHS.

More than 90,000 drug overdose deaths are predicted to have occurred in the U.S. in the 12 months ending in September 2020, the highest number of overdose deaths ever recorded in a 12-month period, according to provisional data from the Centers for Disease Control and Prevention, and overdose deaths have continued to accelerate during the COVID-19 pandemic.

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“Increases in overdose deaths emphasize the need to expand access to evidence-based treatments, including buprenorphine that can be prescribed in office-based settings,” said Assistant Secretary for Health, Rachel Levine, M.D., in a statement. “These guidelines provide another tool to help communities respond to the evolving overdose crisis, equipping providers to save lives in their communities.”

“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.” said Acting Assistant Secretary for Mental Health and Substance Use Tom Coderre, who leads HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) in a statement.

“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.”

HHS, under the Trump administration, had previously announced Jan. 14, 2021, that the new guidelines would be issued, but the Biden administration hit the pause button, saying it wanted to evaluate all regulatory actions that were taken in the last few weeks of the previous administration before they go into effect. 

The American Medical Association (AMA) said the new guidelines support physicians to prescribe buprenorphine by "removing daunting regulatory barriers and easing stigma facing patients with opioid use disorder. " 

“Patients are struggling to find physicians who are authorized to prescribe buprenorphine; onerous regulations discourage physicians from being certified to prescribe it," said Patrice Harris, M.D., chair of the AMA Opioid Task Force and the association's immediate past president.

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"With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to separate, burdensome and stigmatizing requirements," Harris said.

She added, "Going forward, the AMA is supporting legislation to remove the waiver requirements altogether and will advocate for that in Congress."

The practice guidelines provide that practitioners who are licensed under state law, and who possess a valid DEA registration, may be exempt from the certification requirements related to training, counseling and other ancillary services.

Practitioners utilizing the exemption 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, according to the guidelines.

The exemption does not apply to the prescribing, dispensing, or use of Schedule II medications such as methadone for the treatment of opioid use disorders.

Before treating patients with buprenorphine for opioid use disorder, practitioners are required to obtain a waiver under the Controlled Substances Act by submitting a Notice of Intent to under established protocols.

SAMHSA developed a Quick Start Guide for practitioners to provide more information about the exemption.