Prescribing buprenorphine for opioid use disorder just got easier. The DATA-Waiver (X-Waiver) Program was eliminated on December 29, 2022, with President Biden’s signing of the Consolidated Appropriations Act of 2023, which contains the Mainstreaming Addiction Treatment Act (MAT Act). Now, practitioners with a current Drug Enforcement Administration (DEA) registration may prescribe buprenorphine for opioid use disorder if permitted by state law.
What does this new legislation mean for nurse practitioners, PAs, and other clinicians treating patients with opioid use disorder? In a letter to DEA registrants, DEA Administrator Anne Milgram highlighted practical aspects of the changes (Table).
Table. Summary of the Mainstreaming Addiction Treatment Act Changes
|An X-Waiver registration is no longer required to prescribe buprenorphine for opioid use disorder|
|All prescriptions for buprenorphine now only require a standard DEA registration number that includes Schedule III authority; previously used DATA-Waiver registration numbers are no longer needed|
|Limits or patient caps were eliminated on the number of patients a prescriber may treat for opioid use disorder with buprenorphine|
|The Act does not impact applicable state laws or regulations|
X-Waiver Removal Is a “Game Changer” for Opioid Use Disorder
American Academy of Physician Associates (AAPA) President Jennifer M. Orozco, DMSc, PA-C, DFAAPA, called the elimination of the decades-long X-Waiver requirement a “game changer” in addressing the nation’s opioid epidemic. “This law will save lives by empowering PAs and other providers to more effectively and efficiently treat patients struggling with addiction. I am proud of AAPA and our Advocacy Team’s work on behalf of PAs. Our persistence will have an immediate and sustained impact on the patients and communities that we serve every day,” said Dr Orozco, who attended the Removing Barriers to Addiction Treatment Event at the White House with American Association of Nurse Practitioners (AANP) President April Kapu, DNP, APRN, ACNP-BC, FAANP, FCCM, FAAN.
“Thank you to the many who have worked so hard to remove the outdated DATA Waiver,” said Dr Kapu. “Now our country has greater access to lifesaving treatment for opioid use disorder. It was a tremendous honor to represent AANP and the 355,000 NPs in the US at this White House event. Nurse practitioners are at the forefront of health care every day and will continue to be as we move forward in addressing this national health crisis.”
In response to the new legislation, the Substance Abuse and Mental Health Services Administration (SAMHSA) strongly encouraged all eligible practitioners to screen each patient for opioid use disorder and offer access to buprenorphine if permissible under state law. The MAT Act has the potential to prevent more than 30,000 overdose deaths annually and expand access to equitable care and long-term recovery, according to Fiscella et al. Only 1 in 10 Americans with opioid use disorders received medication-assisted treatment in the past year, according to data from the 2020 National Survey on Drug Use and Health.
What Was the Buprenorphine X-Waiver?
Previously, the federal government required practitioners with DEA licenses to also obtain a special waiver (known as an X-Waiver because the license number begins with an X) to prescribe medications such as buprenorphine for the treatment of opioid use disorder in office-based settings outside of federally-registered opioid treatment programs. The X-Waiver was not required if buprenorphine was prescribed for pain management. Health care providers were also restricted in the number of patients with opioid use disorder they could treat.
“X-waivered prescribers face heightened scrutiny by federal and state law enforcement officials, including periodic audits that are intended to minimize diversion and misuse,” as noted by Fiscella et al.
In France, the elimination of buprenorphine prescribing regulations led to increased use of this agent among people with opioid use disorders and a subsequent 79% reduction in opioid overdose deaths over 3 years. Researchers believe that the X-Waiver elimination in the US may lead to at least 30,000 fewer opioid overdose deaths each year.
New Training Requirements Issued for DEA Registration
New training requirements for DEA registration were also introduced in the Act and will not go into effect until June 21, 2023. The requirements are summarized as at least 8 hours of training on the treatment and management of patients with opioid use disorder.
The original version of this legislation required a 24-hour training requirement for nonphysician prescribers. The AAPA said it did not support the original training requirement and had significant engagement with Congressional lawmakers that persuaded Congress to establish a uniform training requirement of 8 hours.
“Given the urgency of the nation’s overdose crisis, the importance of having medical professionals equipped with such training cannot be overstated,” said SAMHSA.
The DEA and SAMHSA will provide further guidance on these requirements shortly, according to Milgram.
AAPA President Orozco Attends White House Event to Mark the End of Buprenorphine X-Waiver. American Association of Physician Associates. News release. January 24, 2023. Accessed January 24, 2023. https://www.aapa.org/news-central/2023/01/aapa-president-orozco-attends-white-house-event-to-mark-the-end-of-buprenorphine-x-waiver/
Milgram A. Letter. January 12, 2023. Accessed January 24, 2023. https://www.deadiversion.usdoj.gov/pubs/docs/A-23-0020-Dear-Registrant-Letter-Signed.pdf
Removal of DATA Waiver (X-Waiver) requirement. Substance Abuse and Mental Health Services Administration. Updated January 12, 2023. Accessed January 24, 2023. https://www.samhsa.gov/medication-assisted-treatment/removal-data-waiver-requirement