|To:||Chief Medical Officers, Chief Nursing Officers, Pharmacy Leads, and Government Relations Staff|
|Please forward to applicable clinic leaders and staff|
|From:||David Streeter, MPA, Policy Director- Clinical and Data
DavidS@wsha.org |(206) 216-2508
|Subject:||New Federal Buprenorphine Guidelines Reduce Barriers to Treatment|
The purpose of this bulletin is to inform hospitals about the new buprenorphine practice guidelines issued by the Department of Health and Human Services (HHS), effective April 28, 2021. The new guidance removes a key barrier to obtaining an X-Waiver for prescribing buprenorphine by exempting covered practitioners from certain requirements. This regulatory change will make it easier for practitioners to obtain an X-Waiver to prescribe buprenorphine to patients with opioid use disorder (OUD).
The new guidelines apply to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives who treat 30 or fewer patients with OUD. The new guidelines do not apply to practitioners treating more than 30 patients for OUD.
Hospital leaders should review the new buprenorphine guidelines and share this bulletin with practitioners who treat patients with OUD.
Current law requires practitioners who want to prescribe buprenorphine for OUD to submit a Notice of Intent (NOI) to the Substance Abuse and Mental Health Services Administration (SAMHSA). Once approved by SAMHSA, the Drug Enforcement Administration (DEA) issues an X-Waiver identification number to the practitioner, who is then eligible to treat patients with buprenorphine.
Prior to HHS’ new guidelines, practitioners needed to meet certification requirements related to training, counseling, and other ancillary services as specified in 21 USC § 823(g)(2)(B)(i)-(ii). This requirement served as a barrier to obtaining the X-Waiver, which prevented many practitioners from prescribing buprenorphine.
HHS’ new guidelines remove the certification requirements for training, counseling, and other ancillary services for practitioners seeking an X-Waiver to treat 30 or fewer patients. All other items required for an X-Waiver remain in place. SAMHSA’s buprenorphine waiver webpage reflects this change and provides instructions for filling out the NOI.
Practitioners who treat more than 30 patients with buprenorphine are still required to complete the certifications for training, counseling, and other ancillary services. Information about these requirements can still be found on SAMHSA’s buprenorphine waiver webpage.
Covered practitioners treating 30 or fewer patients with OUD should submit their NOI to SAMHSA to receive their X-Waiver. The NOI form is available on SAMHSA’s buprenorphine waiver webpage.
The opioid crisis remains an ongoing issue across the United States. Prior to these guidelines, many practitioners were ineligible to prescribe buprenorphine to treat OUD patients. This policy is a welcome change and WSHA will continue to advocate for federal policy changes to address the opioid crisis.
Federal Register Document – “Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder,” 86 FR 22439, April 28, 2021.
HHS Press Release – “HHS Releases New Buprenorphine Practice Guidelines, Expanding Access to Treatment for Opioid Use Disorder, April 27, 2021.
SAMHSA Website – “FAQs About the New Buprenorphine Practice Guidelines.”
SAMHSA Website – “Become a Buprenorphine Waivered Practitioner.” (Contains the X-Waiver NOI form)
SAMHSA Buprenorphine Quick Start Guide (pdf)
21 USC § 823 – Registration Requirements