Medicare Program; Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals

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On April 6, 2004, we published an interim final rule in the Federal Register implementing the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) related to the calculation and submission of manufacturer's average sales price (ASP) data on certain Medicare Part B drugs and biologicals by manufacturers. This final rule responds to the public comments received on the interim final rule concerning the methodology for estimating price concessions associated with manufacturers' ASP reporting requirements. Other issues and comments relating to the interim final rule will be addressed at a future time.