May 3, 2021

On April 27, 2021, the Department of Health and Human Services (“HHS”) issued new practice guidelines for the administration of buprenorphine for the treatment of opioid use disorder (“OUD”). As the number of overdose deaths continues to rise, these guidelines are intended to remove barriers and make treatment more accessible. Previously, the process to become a buprenorphine waivered practitioner to treat OUD required a qualifying practitioner to submit a Notice of Intent (“NOI”) to the Substance Abuse and Mental Health Services Administration, complete the required training activities and obtain a waiver number from the Drug Enforcement Administration (“DEA”). Additionally, practitioners were responsible for providing, either directly or by referral, appropriate counseling and other ancillary psychosocial services. The new guidelines eliminate the training, counseling, and psychosocial services requirements for qualifying practitioners. Providers are still required to submit an NOI and obtain approval in order to use buprenorphine in the treatment of patients with OUD.  

The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder provide the following:

  • An exemption to eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives who are licensed under state law, and who possess a valid DEA registration, from the certification requirements related to training, counseling, and other ancillary services (i.e., psychosocial services) under 21 U.S.C. 823(g)(2)(B)(i)-(iii).
  • Practitioners utilizing the exemption are limited to treating no more than 30 patients at any one time.
  • Practitioners who wish to prescribe above the 30-patient limit are required to submit a new NOI that satisfies all existing statutory certification requirements related to training and psychosocial services.
  • The exemption applies only to the prescription of Schedule III, IV, and V drugs or combinations of such drugs, covered under the Controlled Substances Act, such as buprenorphine. It does not apply to the prescribing, dispensing or the using of Schedule II medications, such as methadone.

For questions on this or other substance abuse/addiction treatment related issues, please contact a member of Hancock Daniel’s Substance Abuse/Addiction Treatment Services team.

Click here for a full PDF of this advisory.

The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.

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