Medicaid Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program
medicaid · Centers for Medicare and Medicaid Services · Rule · Published 2004-11-26 · Effective 2005-01-01 · 69 FR 68815
Document
Document number
04-25969
Federal Register citation
69 FR 68815
CFR reference
42 CFR 447
Type
Rule
Action
Final rule.
Category
medicaid
Sub-agency
Centers for Medicare and Medicaid Services
Publication date
2004-11-26
Effective date
2005-01-01
HHS docket
CMS-2175-F
Abstract
This final rule finalizes 10-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. Manufacturers must retain records for 10 years from the date the manufacturer reports data to us for a rebate period. This final rule also finalizes the requirement that manufacturers must retain records beyond the 10-year period if the records are known by the manufacturer to be the subject of an audit or a government investigation. Furthermore, this final rule responds to public comments on the January 6, 2004 interim final rule with comment period and the proposed rule pertaining to the 10-year recordkeeping requirements, respectively.