Devices and Clinical Research: A Refresher on Billing and Regulatory Requirements

Session Description:
   -An overview of FDA and CMS regulatory framework for investigational devices, including key distinctions among device types
   -Coverage analysis considerations
   -Regulatory requirements, with particular emphasis on Investigational Device Exemptions (IDEs) for Categories A and B

Presenters:
   Sara Kuhl, M.S
   CRSO Clinical Trials Coverage Analysis Team Lead
   
   Kate Applegate, M.A.
   CRSO Senior Clinical Trials Coverage Analyst
   
   Renee Hensley
   UK Healthcare Senior Manager, Governmental, Payer Administration