Legislation & Regulation

AMCP Regulatory NewsBreaks

Regulatory NewsBREAK: CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices

On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway to accelerate Medicare coverage for certain FDA-designated Breakthrough Devices by aligning evidence requirements and coverage decisions earlier in development.
Legislation & Regulation