HHS Eliminates X-Waiver Requirement for DEA-Registered Physicians

January 15, 2021

MEMORANDUM

UPDATE: On Jan. 27, HHS reversed the DATA-Waiver exemption for physicians detailed in this memo. IHA has summarized the reversal here.

On Jan 14, the U.S. Department of Health and Human Services (HHS) published Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, exempting state-licensed physicians with a DEA registration from certain certification requirements under 21 U.S.C. § 823(g)(2) of the Controlled Substances Act (CSA) to prescribe buprenorphine for opioid use disorder (OUD) treatment.  The new exemption applies only to physicians, not other qualifying waivered practitioners under 21 U.S.C. § 823(g)(2)(G)(iii).  All qualifying prescribers, including physicians and other practitioners, may continue to seek a Drug Addiction Treatment Act (DATA)-waiver under existing protocols, not subject to the specific prescribing limitations of physicians using the new exclusion.

Physicians must treat patients located in states where they are authorized to practice and are limited to treating no more than 30 patients at one time without a waiver.  Hospital-based physicians who may initiate treatment but do not engage in a long term treatment relationship with the patient, such as emergency department physicians, are exempt from the 30 patient treatment limitation.

The exemption applies only to the prescription of drugs covered under the X-waiver of the CSA, including buprenorphine, and does not apply to methadone.  Physicians who use the exemption must place an "X" on the prescription and clearly identify that the prescription is being written for OUD and maintain corresponding patient charts.

The implementation and results of the new practice guidelines will be monitored by an interagency working group chaired by a representative from the immediate office of the HHS Secretary, meeting at least semi-annually.  The guidelines strongly encourage colleges of medicine to continue implementing comprehensive training in substance use disorder diagnosis and management as a component of their core, required curriculum.

For more information, see the HHS press release.  For IHA questions or comments, please contact IHA.