The FDA Approval and Medicare Coverage Processes

Originally Published MX November/December 2002

GOVERNMENTAL & LEGAL AFFAIRS

Part 2: Striving toward Harmonization

Bradley Merrill Thompson

Although distinct by both authorizing statute and controlling agency, the processes that the U.S. government uses to ensure the safety and effectiveness of medical technologies are in many ways interconnected with the processes used to approve coverage for such products under the federal Medicare program. The first installment of this article (MX, September/October 2002) discussed the interconnections between the FDA approval and Medicare coverage processes, comparing the regulatory procedures and criteria employed by FDA and by the Centers for Medicare and Medicaid Services (CMS; Baltimore). That installment highlighted the overlap that exists between those processes, which includes considerations of safety and effectiveness that underpin both FDA approval and Medicare coverage decisions (see Figure 1).