Thursday, April 2, 2026 
12:00–1:00 p.m. via Zoom 
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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