CMS Final Rule on the Drug Rebate Program

On July 17, 2007, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule with comment period to implement the Medicaid Drug Rebate Program. With certain notable exceptions, which are discussed in the referenced memorandum, the final rule is largely consistent with the proposed rule published by CMS in December 2006. This memorandum summarizes the final rule, noting where it differs from the proposed rule and prior policy or guidance issued by CMS. We also identify issues that would benefit from further clarification from CMS.