Federal Policy
CMS Opens Comment Period for RAPID Device Coverage Pathway, Due October 10
CMS released a notice with comment period on August 7, 2026, establishing the framework for the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. The pathway aims to accelerate Medicare coverage for innovative medical devices following FDA market authorization. Comments are due October 10, 2026. The pathway creates a streamlined process that shortens the gap between FDA approval and national Medicare coverage for qualifying devices.
Why it mattersWhile focused on Medicare device coverage, the pathway may influence Medicaid coverage policies for innovative medical devices, particularly for states that tie coverage determinations to Medicare or FDA decisions.