DEA’s “X” Waiver Eliminated by Congress

On December 29, 2022, the Consolidated Appropriations Act of 2023 (Public Law No. 117-328) (the “Legislation”) was signed into law, which, under Section 1262 of the Legislation, contains the Mainstreaming Addiction Treatment Act (the “MAT Act”). The MAT Act repeals and eliminates the Drug Enforcement Administration's (DEA) “X” waiver registration requirement, which was historically required for a DEA registration in order for a practitioner registrant to prescribe buprenorphine (e.g. Suboxone, Subutex) for the treatment of Opioid Use Disorder (“OUD”). While Section 1262 eliminated the “X” waiver, Section 1263 of the Legislation imposes certain statutory training requirements for prescriber registrants, which are broadly summarized as requiring prescribers to receive not less than eight (8) hours of training on the treatment and management of patients with OUD. The training requirements will go into effect on June 21, 2023; however, in advance of that deadline, DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) are expected to publish guidance for compliance, which Quarles will continue to monitor.

In response to the Legislation, the DEA Administrator published a notice to all registrants acknowledging the elimination of the “X” waiver and noting DEA’s support for the MAT Act, while specifically informing prescribers of the following:

1. “A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.
2. Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.
3. There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
4. The Act does not impact existing state laws or regulations that may be applicable.”

SAMHSA issued a similar statement acknowledging the impact of the MAT Act.

The "X" waiver was a source of political football between the Trump and Biden administrations as we previously discussed in client alerts on 3/10/22 (Ninth Circuit Ruling Expands Nursing Home COVID-19 Venue Fight) and 3/14/22 (Biden Administration Signals Even Harsher Regulation of Long-Term Care Industry). The elimination of the "X" waiver is viewed in the substance use disorder (SUD) treatment industry as a major move toward battling the nation's OUD epidemic. This national change follows significant moves by state agencies throughout the United States toward a more clinical, MAT-focused approach to battling OUD.

For clients involved in behavioral medicine, MAT practices and the SUD/OUD specialties, Quarles has a Behavioral Health subgroup led by Nick Meza, Kirti Reddy and Jaya White. For more information on "X" waiver developments and the Consolidated Appropriations Act of 2023 please contact your local Quarles Pharmacy attorney or:

• Edward L. Holloran, III: (317) 399-2892 / ed.holloran@quarles.com
• Edward Rickert: (312) 715-5139 / ed.rickert@quarles.com
• Hunter DeKoninck: (317) 399-2868 / hunter.dekoninck@quarles.com