Coordination Between FDA And CMS: Strategic Considerations For Medicare Coverage And Payment, And The Growing Impact Of CMS In The Marketplace

Coordination Between FDA And CMS: Strategic Considerations For Medicare Coverage And Payment, And The Growing Impact Of CMS In The Marketplace was presented at the FDA Regulatory and Compliance Symposium at Harvard, August 22-25, 2006.

Medicare is the largest purchaser of health care in the U.S., and one of the largest in the world. As a result, Medicare has a significant influence on the adoption of medical products in the marketplace. After obtaining FDA approval or clearance for drugs, biologics or medical devices, many manufacturers have discovered that the Medicare coverage process, administered by the Centers for Medicare & Medicaid Services (CMS), presents many hurdles that must be overcome. Early planning for and understanding of the Medicare coverage process is important in order to design successful strategies that lead to Medicare payment for new products. Coordination Between FDA And CMS: Strategic Considerations For Medicare Coverage And Payment, And The Growing Impact Of CMS In The Marketplace explains the Medicare coverage process and highlights important strategic considerations for Medicare coverage and payment.