“Authorized” Generic Could Be Added To Brand’s “Best Price,” HHS Clarifies
This article was originally published in The Pink Sheet Daily
Executive Summary
HHS assures Sen. Schumer (D-N.Y.) that administrative revision of “best price” reporting requirements is possible, provided the Centers for Medicare & Medicaid Services follows formal rulemaking procedures.
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The Centers for Medicare & Medicaid Services could make "authorized" generics part of Medicaid rebate calculations for the corresponding brand drug, provided the agency followed formal rulemaking procedures, HHS clarified in a statement to Sen. Charles Schumer (D-N.Y.) Feb. 17. During a Senate Finance Committee hearing one day earlier, HHS Secretary Leavitt indicated that CMS lacks administrative authority to change how authorized generics affect Medicaid rebate reporting requirements for manufacturers of brand drugs (1 (Also see "CMS Lacks Authority To Include "Authorized" Generic In A Brand's "Best Price"" - Pink Sheet, 16 Feb, 2005.)). A clarification issued by HHS states that CMS would be able to revise the definition of Medicaid best price to account for authorized generics if it issued a proposed rule and accepted public comments. The change in the treatment of Medicaid rebate reporting for brand drugs with authorized generics is a priority for many generic manufacturers. The industry is attempting to combat the impact of authorized generics on the value of the 180-day exclusive marketing period (2 (Also see "GPhA Talking To CMS About Medicaid "Best Price" For "Authorized" Generics" - Pink Sheet, 28 Sep, 2004.)). - Andrew Dove |