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HHS Loosens X-waiver Training Requirement for Clinicians Treating Fewer than 30 Patients

Issue Brief

April 29, 2021

To increase patient access to medication-assisted treatment, the U.S. Department of Health & Human Services (HHS) has reissued guidelines exempting some physicians from the X-waiver (or DATA waiver) requirement. Originally issued in the last days of Trump Administration, the Biden Administration initially pulled the regulations for additional review.

Currently, in order to provide MAT, physicians and other clinicians must undergo additional training to qualify for an X-waiver, allowing them to provide buprenorphine and other forms of MAT. Pursuant to the new guidelines, physicians and other X-waiver eligible clinicians with fewer than 30 patients may provide buprenorphine and Schedule III, IV, and V forms of MAT (methadone treatment is prohibited) without completing the X-waiver required training for certification. It is important to note that clinicians treating fewer than 30 patients are still required to submit a Notice of Intent (NOI) to the Substance Abuse and Mental Health Services Administration (SAHMSA) and receive approval prior to providing MAT. HHS has published an informative Frequently Asked Questions document with additional details regarding implementation and limitations.

HHS’s new guidelines are an important step toward expanded MAT access, but given the volume limitations, additional steps are needed substantially increase the number of clinicians offering MAT. ASHP appreciates HHS’s steps to reduce the X-waiver burden, but we believe bolder action is necessary to ensure that patient needs are met.

Specifically, ASHP has been actively working to ensure that pharmacists can provide MAT. Pharmacists cannot currently quality for an X-waiver due to statutory limitations on the list of eligible providers. Efforts to add pharmacists as X-waiver eligible providers through regulatory changes have been unsuccessful because HHS believes that list can be revised only through a statutory change. ASHP supports legislation that would remove the X-waiver requirement entirely – a position supported by a number of other physician and clinician groups. We will continue to update members on the status of this legislation, as well as other policy developments related to increasing access to MAT services.