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In an effort to get evidenced-based treatment to more Americans with opioid use disorder, the Department of Health and Human Services (HHS) is releasing 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 for the Administration of Buprenorphine for Treating Opioid Use Disorder 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.

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, according to provisional data from the Centers for Disease Control and Prevention, and overdose deaths have continued to accelerate during the COVID-19 pandemic.

The alarming increase in overdose deaths underscores the need for more accessible treatment services, and studies have shown that medication-based treatment promotes long-term recovery from opioid use disorder.

"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, MD. "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). "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."

"Removing barriers to quality treatment is a top policy priority for the Biden-Harris Administration," said Office of National Drug Control Policy Acting Director Regina LaBelle. "Addiction treatment should be a routine part of healthcare, and this new guideline will make access to quality treatment for opioid use disorder more accessible. The guideline is another important step forward in our efforts to bend the curve of the overdose and addiction epidemic."

The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder provide an exemption from certain certification requirements under 21 U.S.C. § 823(g)(2)(B)(i)-(ii) of the Controlled Substances Act (CSA). Specifically, the Practice Guidelines provide that:

• With respect to the prescription of certain medications that are covered under applicable provisions of the CSA, such as buprenorphine, practitioners, defined as physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, who are licensed under state law, and who possesses 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.
• Under the exemption, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives are required to 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 opioid use disorder. 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.
• Practitioners who do not wish to practice under the exemption and its attendant 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 opioid use disorders.
• Before treating patients with buprenorphine for opioid use disorder, practitioners are required to obtain a waiver under the CSA by submitting a Notice of Intent to SAMHSA under established protocols.

Practitioners may find more information about the exemption at Quick Start Guide - PDF and FAQs. Reporters seeking more information should contact the SAMHSA press office at media@samhsa.hhs.gov.