DEA Joins Health Care Organizations in Applauding Repeal of X-Waiver Program

The Drug Enforcement Administration (DEA) has joined the Director of the White House Office of National Drug Control Policy and multiple health care associations, including the American Society of Health-System Pharmacists (ASHP), in applauding the elimination of the DATA-Waiver or X-Waiver program.^1-3 The repeal became law when President Joe Biden signed the Consolidated Appropriations Act, 2023 (CAA 2023) into law on December 29, 2022.^4,5

The move comes at a time when the number of Americans living with substance use disorder continues to soar: a total of 110,236 people died due to an overdose during a 12-month period, according to CDC data reported by NPR on December 31, 2022.⁶

Section 1262 of the bipartisan Omnibus bill “removes the federal requirement for practitioners to submit a Notice of Intent (have a waiver) to prescribe medications, like buprenorphine, for the treatment of opioid use disorder (OUD),” according to an update posted by the Substance Abuse and Mental Health Services Administration (SAMHSA).⁷

The law also removes federal limits or patient caps impacting the number of patients a practitioner may treat with buprenorphine for OUD, according to a DEA letter.⁸ Health care providers, including pharmacists, with a DEA registration number that includes Schedule III authority “may not prescribe buprenorphine for opioid use disorder in accordance with their respective state scope of practice.³

“In this moment, when the United States is suffering tens of thousands of opioid-related drug opioid poisoning deaths every year, the DEA’s top priority is doing everything in our power to save lives,” said DEA Administrator Anne Milgram. “Medication for opioid use disorder helps those who are fighting to overcome substance use disorder by sustaining recovery and preventing overdoses…. DEA applauds the repeal of the X-Waiver and all it will do to expand access to buprenorphine for those who need it.”¹

New training requirements were also introduced for prescribers in Section 1263 of the CAA 2023, although these requirements do not go into effect until June 21, 2023.^2,6 Both the DEA and SAMHSA are “actively working on implementation” of this provision.^7,8 Under this section, “the one-time [substance use disorder] education requirement becomes a condition on a controlled medication prescriber’s DEA registration beginning with the first applicable registration,” according to a practice management statement by the American Society of Addiction Medicine (ASAM).⁴

The ASAM statement also noted that health care providers should remain aware of “applicable state laws or regulations that may still be in effect regarding the prescribing and dispensing of buprenorphine” for substance use disorder treatment.⁴ Additional guidance and clarification should be sought from state officials when necessary.

References

1. DEA applauds the repeal of the X-waiver. Drug Enforcement Administration. January 17, 2023. Accessed January 20, 2023. https://www.dea.gov/documents/2023/2023-01/2023-01-17/dea-applauds-repeal-x-waiver
2. Dr Gupta applauds removal of X-waiver in Omnibus, urges healthcare providers to treat addiction. News release. December 30, 2023. Accessed January 20, 2023. https://www.whitehouse.gov/ondcp/briefing-room/2022/12/30/dr-gupta-applauds-removal-of-x-waiver-in-omnibus-urges-healthcare-providers-to-treat-addiction/
3. DEA and SAMHSA eliminate X-Waiver requirements. News release. American Society of Health-System Pharmacists. January 13, 2023. Accessed January 20, 2023. https://www.ashp.org/News/2023/01/13/dea-and-samhsa-eliminate-x-waiver-requirements
4. Policies governing buprenorphine for opioid use disorder. American Society of Addiction Medicine. Accessed January 20, 2023. https://www.asam.org/advocacy/practice-resources/buprenorphine-management
5. Consolidated Appropriations Act, 2023, HR 2617, 117th Cong (2021-2022). Accessed January 20, 2023. https://www.congress.gov/bill/117th-congress/house-bill/2617/text
6. Mann B. 2022 was a deadly (but hopeful) year in America’s opioid crisis. NPR. Published December 31, 2022. Accessed January 20, 2023. https://www.npr.org/2022/12/31/1145797684/2022-was-a-deadly-but-hopeful-year-in-americas-opioid-crisis
7. Removal of DATA Waiver (X-Waiver) requirement. Substance Abuse and Mental Health Services Administration. Updated January 12, 2023. Accessed January 20, 2023. https://www.samhsa.gov/medication-assisted-treatment/removal-data-waiver-requirement
8. United States Department of Justice. Drug Enforcement Administration. Letter. January 12, 2023. Accessed January 20, 2023. https://www.deadiversion.usdoj.gov/pubs/docs/A-23-0020-Dear-Registrant-Letter-Signed.pdf