Federal Policy
CMS Proposes RAPID Pathway for Breakthrough Device Coverage Under Medicare
On August 7, 2024, CMS issued a notice with comment period proposing the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. The pathway would accelerate Medicare coverage for medical devices receiving FDA breakthrough designation by aligning CMS coverage review with FDA premarket review before market authorization. The proposal aims to reduce the gap between FDA approval and Medicare coverage determinations for qualifying devices. Comments are due following standard notice procedures.
Why it mattersThis pathway could accelerate Medicaid access to innovative medical devices in states that follow Medicare coverage policies or reference Medicare determinations in their own coverage frameworks.