FDA and CMS have been working together on many initiatives related to the review and use of FDA-regulated drugs, medical devices, and biologics. During this webinar, panelists will provide a background and overview of the links between FDA regulatory approval and the Medicare Part A and Part B coverage process. The endpoints that both agencies consider in their decision-making process and the ways in which the two agencies coordinate their efforts will also be addressed.
Rochelle Fink, Senior Health Science Project Specialist, CDRH, FDA
Linda Gousis, Senior Advisor, Coverage and Analysis Group, Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services (CMS)
Moderated by David R. Zook, Partner, Faegre Baker Daniels LLP