Search For:

This bulletin is to alert the provider community about the recent practice guideline issued by the United States Department of Health and Human Services (HHS) announcing enhanced flexibilities around eligibility to prescribe buprenorphine to up to thirty (30) patients for treatment of opioid use disorder (OUD), effective April 28, 2021.

In order to expand access to buprenorphine for OUD treatment, the April 28, 2021  Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (OUD), under 21 U.S.C. 823(f)(2)(B)(i)-(ii), provides eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, (hereinafter collectively referred to as “practitioners”) an exemption from certain statutory requirements that allows them to treat up to thirty (30) patients for OUD using buprenorphine without having to meet any training-related certifications and without certifying their capacity to provide counseling and ancillary services.

Practitioners seeking to leverage these flexibilities must still meet the following conditions:

• Practitioners must be state licensed and obtain (and maintain) a valid Drug Enforcement Agency (DEA) registration under 21 U.S.C. 823(f).
• Practitioners must submit a Notice of Intent (NOI) in accordance with current procedures in order to receive a waiver, specifying a patient limit of 30 (allowing them to circumvent training, counseling or other ancillary services requirements otherwise applied under 21 U.S.C. 823(g)(2)(B)(i)-(ii)).
• Practitioners utilizing this exemption are limited to treating no more than 30 patients at any one time. Time spent practicing under this exemption will not qualify the practitioner for a higher patient limit under 21 U.S.C. 823(g)(2)(b)(iii).
• Physicians 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.  Note in Virginia, the Board of Medicine and Nursing has authority to issue a nurse practitioner that meets certain requirements in §54.1-2957 a new license that includes a designation indicating that the nurse practitioner is authorized to practice without a practice agreement.

Guidelines can be referenced here: https://www.federalregister.gov/documents/2021/04/28/2021-08961/practice-guidelines-for-the-administration-of-buprenorphine-for-treating-opioid-use-disorder. In conjunction with these guidelines, HHS also offered recommendations around training, education, and psychosocial treatment to practitioners who treat patients under this exemption, found in the HHS Buprenorphine Quick Start Guide. Practitioners are also encouraged to provide access to psychosocial services, such as counseling or other ancillary services, or refer as appropriate to licensed behavioral health practitioners in their communities.

Practitioners not wishing to practice under the exemption may continue to seek a waiver per established protocols for the customary NOI. More information about how to treat more than 30 patients may be found here: https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner.

*************************************************************************************