HHS Exemptions for Buprenorphine (but not Methadone) Prescribers

For the year ending August 2020, provisional data from the Centers for Disease Control and Prevention shows that opioid overdose deaths increased 26.8 percent compared to the previous 12 months, with opioid overdoses resulting in more than 88,000 deaths. The Department of Health and Human Services (HHS) has observed that these deaths disproportionately affect working Americans with families, with the highest rates of opioid overdose deaths occurring in individuals between the ages of 25 and 54.

Buprenorphine, used in medication-assisted treatment for opioid dependence, has been the subject of significant regulatory restrictions. HHS Secretary Xavier Becerra issued new guidance that reduces certain of these legal requirements that are a reported barrier to prescribing and dispensing buprenorphine for patients receiving substance abuse maintenance treatment or detoxification treatment. 

This new guidance specifically exempts certain providers from needing to certify that they meet the statutory requirements related to training, counseling, and other ancillary services (e.g., psychosocial services) under federal law to receive a Drug Enforcement Administration (DEA) registration to dispense Schedule III, IV, and V drugs or combinations of such drugs, such as buprenorphine.¹

Who Is impacted?

Physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment are all impacted by the new guidance. Certain of these practitioners are required by state law to be supervised by, or work in collaboration with, a DEA-registered physician when prescribing medications for the treatment of opioid use disorder.  

How to Claim the Exemption

To claim an exemption, a practitioner must submit a notice of intent (NOI) to the Substance Abuse and Mental Health Services Administration (SAMHSA).² The NOI must select a patient limit of 30, in which case the practitioner would not need to certify as to the training, counseling, or other ancillary services requirements listed at 21 U.S.C. § 823(g)(2)(B)(i)–(ii). However, the waiver only applies to practitioners treating patients who are located in the same states where the practitioner is licensed to treat patients, unless the practitioner is an employee of a contractor of the United States, acting within the scope of his or her employment/contract.

SAMHSA reviews applications within 45 days of receipt. Once the application process is complete and the application is approved, SAMHSA will email an approval letter to the practitioner indicating the practitioner’s waiver level, certification date, and information regarding receipt of the practitioner’s X-designation from the DEA, which should occur within seven to 10 business days. The exemption applies only to Schedule III, IV, and V drugs or combinations of such drugs covered under 21 U.S.C. § 823(g)(2)(C), such as buprenorphine. It does not apply to the prescribing, dispensing, or use of Schedule II medications, such as methadone, for the treatment of opioid use disorders. SAMSHA’s webpage also notes that there are “federal laws and regulations [that] permit physicians and other qualifying practitioner[s] to administer medications approved by the Food and Drug Administration (FDA) for the treatment of OUD under special circumstances without a buprenorphine waiver.”³

How Long Will the Exemption Tied to the NOI Last?

If approved, the practitioner’s exemption from needing to satisfy the certification requirements related to psychosocial services at 21 U.S.C. § 823(g)(2)(B)(i)–(ii) will remain in place for one year.

Recommendations From HHS

Providers who avail themselves of this exemption are strongly encouraged by HHS to use the HHS Buprenorphine Quick Start Guide.⁴ They are also encouraged to provide patients with access to psychological services, such as counseling, or other ancillary services or to refer patients, as appropriate, to licensed behavioral health care practitioners. In addition, the guidance recognizes the need for core curriculum training on substance use disorders, and therefore, attention is directed to the SAMHSA Providers Clinical Support System as a suggested resource for technical assistance.⁵