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B-330938 1 (2019-04-22)

handle is hein.gao/gaobadzez0001 and id is 1 raw text is: GAO U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 B-330938 April 22, 2019 The Honorable Chuck Grassley Chairman The Honorable Ron Wyden Ranking Member Committee on Finance United States Senate The Honorable Frank Pallone, Jr. Chairman The Honorable Greg Walden Ranking Member Committee on Energy and Commerce House of Representatives The Honorable Richard Neal Chairman The Honorable Kevin Brady Ranking Member Committee on Ways and Means House of Representatives Subject: Department of Health and Human Services, Centers for Medicare and Medicaid Services: Medicaid Program; Covered Outpatient Drug; Line Extension Definition; and Change to the Rebate Calculation for Line Extension 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 and Medicaid Services (CMS) entitled Medicaid Program; Covered Outpatient Drug; Line Extension Definition; and Change to the Rebate Calculation for Line Extension Drugs (RIN: 0938-AT09). We received the rule on April 5, 2019. It was published in the Federal Register as a final rule and interim final rule with comment period on April 1, 2019. 84 Fed. Reg. 12130. The effective date of the rule is April 1, 2019. According to CMS, the interim final rule revises the regulatory text to reflect the applicable statutory language describing the rebate calculation for the line extension drugs which was revised by the Bipartisan Budget Act of 2018. See Bipartisan Budget Act of 2018, Pub. L. No. 115-123, 132 Stat. 64 (2018). Additionally, the final rule responds to comments on the definition and identification of line extension drugs for which CMS requested additional comments in the Covered Outpatient Drugs final rule with comment period published in the February 1, 2016, Federal Register.

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