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GAO-16-412R 1 (2016-02-16)

handle is hein.gao/gaobadrxp0001 and id is 1 raw text is: G A O U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 B-327762 February 16, 2016 The Honorable Orrin G. Hatch Chairman The Honorable Ron Wyden Ranking Member Committee on Finance United States Senate The Honorable Fred Upton Chairman The Honorable Frank Pallone, Jr. Ranking Member Committee on Energy and Commerce House of Representatives The Honorable Kevin Brady Chairman The Honorable Sander M. Levin Ranking Member Committee on Ways and Means House of Representatives Subject: Department of Health and Human Services, Centers for Medicare & Medicaid Services: Medicaid Program; Covered Outpatient Drugs 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, Centers for Medicare & Medicaid Services (CMS) entitled Medicaid Program; Covered Outpatient Drugs (RIN: 0938- AQ41). We received the rule on January 27, 2016. It was published in the Federal Register as a final rule with comment period February 1, 2016. 81 Fed. Reg. 5170. The final rule implements provisions of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, pertaining to Medicaid reimbursement for covered outpatient drugs (CODs). This final rule also revises other requirements related to CODs, including key aspects of their Medicaid coverage and payment and the Medicaid drug rebate program. Enclosed is our assessment of CMS's compliance with the procedural steps required by section 801 (a)(1)(B)(i) through (iv) of title 5 with respect to the rule. Our review of the procedural steps taken indicates that CMS complied with the applicable requirements. GAO-16-412R

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