by Wendy C. Goldstein, Kathleen A. Peterson, Benjamin S. Martin, and Constance A. Wilkinson
On September 3, 2010, the Centers for Medicare & Medicaid Services ("CMS") issued a proposed rule withdrawing regulations governing the determination of "Average Manufacturer Price" ("AMP"), the definition of "Multiple Source Drug," and the application of federal upper reimbursement limits ("FULs") for Multiple Source Drugs (the "Proposed Rule"). This withdrawal would impact the applicable regulations finalized by CMS in 2007 and 2008 but would leave intact other sections of the 2007 regulations, including, for example, the "Best Price" provisions and certain "definitions" (including the definition of "bona fide service fee"). Comments may be submitted to CMS until 5:00 p.m. EDT on October 4, 2010. We recommend that organizations consider commenting on the impact of the withdrawn regulations, as well as on the open items that have not been addressed under the recent "health reform" legislation.