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GAO-03-1157R 1 (2003-09-15)

handle is hein.gao/gaobadwjg0001 and id is 1 raw text is: im Accountability * Integrity * Reliability United States General Accounting Office Washington, DC 20548 B-292824 September 15, 2003 The Honorable Charles E. Grassley Chairman The Honorable Max Baucus Ranking Minority Member Committee on Finance United States Senate The Honorable W.J. Billy Tauzin Chairman The Honorable John D. Dingell Ranking Minority Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services, Centers for Medicare and Medicaid Services: Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program 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; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program (RIN: 0938-AM20). We received the rule on September 4, 2003. It was published in the Federal Register as a final rule on August 29, 2003. 68 Fed. Reg. 51912. The final rule establishes new recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program and sets a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to CMS. The final rule has an announced effective date of October 1, 2003. The Congressional Review Act 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). As noted above, the rule was published on August 29, 2003, and was received by Congress on September 4, 2003. Therefore, the rule does not have the required delay in its effective date. GAO-03-1157R

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