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GAO-16-822R 1 (2016-07-25)

handle is hein.gao/gaobadskc0001 and id is 1 raw text is: GA U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 B-328267 July 25, 2016 The Honorable Lamar Alexander Chairman The Honorable Patty Murray Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable Fred Upton Chairman The Honorable Frank Pallone, Jr. Ranking Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services: Medication Assisted Treatment for Opioid Use Disorders 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 (HHS) entitled Medication Assisted Treatment for Opioid Use Disorders (RIN: 0930-AA22). We received the rule on July 7, 2016. It was published in the Federal Register as a final rule on July 8, 2016. 81 Fed. Reg. 44,712. The final rule increases access to medication-assisted treatment (MAT) with buprenorphine and the combination buprenorphine/naloxone (hereinafter referred to as buprenorphine) in the office- based setting as authorized under the United States Code. Section 303(g)(2) of the Controlled Substances Act (CSA) allows individual practitioners to dispense or prescribe Schedule Ill, IV, or V controlled substances that have been approved by the Food and Drug Administration (FDA). Section 303(g)(2)(B)(iii) of CSA allows qualified practitioners who file an initial notification of intent (NOI) to treat a maximum of 30 patients at a time. After 1 year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. This final rule will expand access to MAT by allowing eligible practitioners to request approval to treat up to 275 patients under section 303(g)(2) of CSA. The final rule also includes requirements to ensure that patients receive the full array of services that comprise evidence- based MAT and minimize the risk that the medications provided for treatment are misused or diverted. The Congressional Review Act (CRA) requires a 60-day delay in the effective date of a major rule from the date of publication in the Federal Register or receipt of the rule by Congress, whichever is later. 5 U.S.C. § 801(a)(3)(A). This final rule has a stated effective date of August 8, 2016. The rule was received by GAO on July 7, 2016, and was published in the GAO-16-822R

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