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Details for CMS-2188-P

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File Name	CMS-2188-P
Subject	Medicaid Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program
Publication/Implementation Date	01/06/2004
Quarterly Release Date	01/01/2004
Provider Type	Suppliers
Type of Regulation	Regulations This Quarter
Regulation Summary	On August 29, 2003, we published a final rule with comment period in the Federal Register that finalized two specific provisions: it established new 3-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program and set a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announced the pressing need for codification of fundamental recordkeeping requirements. On September 26, 2003, we issued a correction notice to change the effective date of the August 29, 2003 rule from October 1, 2003 to January 1, 2004. In this proposed rule, we propose removing the 3-year recordkeeping requirements and replacing them with 10-year recordkeeping requirements. We also propose that manufacturers must retain records beyond the 10-year period if the records are the subject of an audit or a government investigation.
Additional Information	N/A


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CMS-2188-P [PDF, 47KB]
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