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B-335969 Feb 20, 2024 1 (2024-02-20)

handle is hein.gao/gaopxi0001 and id is 1 raw text is: U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 B-335969 February 20, 2024 The Honorable Bernard Sanders Chairman The Honorable Bill Cassidy Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable Cathy McMorris Rodgers Chair The Honorable Frank Pallone, Jr. Ranking Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services, Office of the Secretary: Medications for the Treatment of Opioid Use Disorder Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Office of the Secretary (HHS) entitled Medications for the Treatment of Opioid Use Disorder (RIN: 0930-AA39). We received the rule on January 31, 2024. It was published in the Federal Register as a final rule on February 2, 2024. 89 Fed. Reg. 7528. The effective date of this final rule is April 2, 2024, and the compliance date is October 2, 2024. HHS states that the final rule modifies and updates certain provisions of 42 C.F.R. part 8 related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder (OUD) with Medications for Opioid Use Disorder (MOUD) in OTPs. HHS also states that the final rule makes flexibilities put forth during the COVID-19 Public Health Emergency (PHE) permanent, as well as expands access to care and evidence-based treatment for OUD. Finally, HHS states that the final rule removes all language and rules pertaining to the Drug Addiction and Treatment Act (DATA) Waiver from 42 C.F.R. part 8 pursuant to the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 136 Stat. 4459 (Dec. 29, 2022). Enclosed is our assessment of HHS's compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule. If you have any questions about this report or wish to contact GAO officials responsible for the evaluation work relating to the subject matter of the rule, please contact Shari Brewster, Assistant General Counsel, at (202) 512-6398. Shirley A. Jones Managing Associate General Counsel

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