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  • Washington Highlights

    HHS Issues New Guidelines to Expand Access to Buprenorphine


    Gayle Lee, Director, Physician Payment & Quality
    Tannaz Rasouli, Sr. Director, Public Policy & Strategic Outreach

    As part of its effort to address the opioid crisis, the Department of Health and Human Services issued new practice guidelines on April 27 that will expand access to buprenorphine, a drug used to treat opioid addiction, by enabling more clinicians to prescribe the treatment.

    Under these new guidelines, physicians will no longer need to take an eight-hour training course to prescribe buprenorphine if they are treating no more than 30 patients at a time. In addition, they will be exempt from certification requirements related to counseling and other ancillary services. These clinicians must be licensed under state law and have a valid Drug Enforcement Administration registration, and they will still be required to submit a notice of intent to the Substance Abuse and Mental Health Services Administration (SAMHSA) stating their intention to prescribe the drug to receive a federal waiver. Providers treating more than 30 patients will still need to meet the existing extra training requirements to obtain the waiver. The new exemptions also will apply to physician assistants, nurse practitioners, certified registered nurse anesthetists, and certified nurse midwives who prescribe buprenorphine.

    Many groups, including the AAMC, have advocated for the elimination of the waiver requirement because it has been a barrier to expanding the number of buprenorphine prescribers, despite the drug’s demonstrated effectiveness in treating opioid use disorder and saving lives [refer to Washington Highlights, June 5, 2020].

    Earlier this year, the bipartisan House and Senate sponsors of the Mainstreaming Addiction Treatment Act of 2021 (H.R. 1384, S. 445) reintroduced their bill to fully suspend the waiver requirement, which the AAMC praised in an April 21 letter. In advance of reintroducing the legislation, the bill’s authors sent a Feb. 8 letter urging President Biden to prioritize actions to make buprenorphine more accessible after his administration reversed a last-minute decision by the outgoing Trump administration to eliminate the waiver requirement [refer to Washington Highlights, Feb. 5].

    Sen. Maggie Hassan (D-N.H.), one of the bill’s lead authors, said in an April 27 statement that the Biden administration’s new guidelines are a “step forward in removing some of the barriers in accessing medication-assisted treatment” and that she “will continue working on a bipartisan basis to expand access to this life-saving treatment.”

    To learn more about the new practice guidelines, SAMHSA has published more information for providers about the exemption and an FAQ guide.