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.

The RAPID pathway is available for certain Class II and Class III Breakthrough Devices, with eligibility requiring participation in an Investigational Device Exemption (IDE) study that includes Medicare beneficiaries and agreed-upon clinical outcomes.

CMS will issue a proposed National Coverage Determination (NCD) the same day as FDA market authorization for eligible devices, starting a 30-day public comment period and potentially enabling Medicare coverage as soon as two months after market authorization.  

CMS plans to pause the Transitional Coverage for Emerging Technologies (TCET) Pathway for new candidates while focusing on RAPID implementation, while continuing other Medicare coverage pathways.      

A proposed procedural notice outlining the RAPID pathway will be published in the Federal Register, with a 60-day public comment period before finalization and implementation. 

More on This Topic:

CMS Press Release 
FDA Press Release