Medicare Compliance & Reimbursement

New recordkeeping requirements to go into effect Jan. 1.  The new three-year time limit for pharma companies to submit drug price recalculations to Medicaid won't go into effect until next year. In the Sept. 26 installment of the Federal Register, the Centers for Medicare & Medicaid Services says it's changing the effective date of its Aug. 29 regulation on the subject from Oct. 1, 2003 to Jan. 1, 2004. The agency says the originally published Oct. 1 date was incorporated into the rule by mistake. In addition to the price change limit, the rule also requires drugmakers to preserve data on pricing and rebates for a period of three years - as opposed to the apparently indefinite record retention period that currently applies. The only exception to the recordkeeping requirement involves instances when drug manufacturers are being audited or investigated by the feds. To see the notice, go to www.access.gpo.gov/su_docs/fedreg/a030926c.html. Lesson Learned: Drugmakers should watch for further regulatory developments connected with the Medicaid drug rebate program.