CMS Proposes RAPID Pathway for Faster Device Coverage

CMS proposed a new Medicare coverage pathway that could speed beneficiary access to certain FDA-designated Breakthrough Devices. The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway would allow CMS and the FDA to work together earlier in the device development process, helping align evidence requirements before FDA approval.

Under the proposal, CMS could release a proposed national coverage determination (NCD) the same day as the FDA authorizes an eligible device. Medicare coverage could begin as soon as 60 days after FDA authorization for some Class II devices, significantly reducing delays between FDA approval and Medicare coverage decisions. CMS put together an infographic with more details about the proposal.

RAPID would apply to eligible FDA Breakthrough Devices but would not include in vitro diagnostic tests, which would continue to follow existing Medicare coverage pathways administered by Medicare Administrative Contractors.

The proposal builds on CMS’ broader effort to streamline coverage for innovative technologies and follows the agency’s Transitional Coverage for Emerging Technologies (TCET) framework. While TCET focuses on coverage with evidence development for selected Breakthrough Devices after FDA authorization, RAPID moves engagement earlier in the development process to help support faster and more predictable national coverage decisions. With TCET paused for new candidates, RAPID would become CMS’s primary accelerated coverage pathway for eligible Breakthrough Devices.

CMS is accepting public comments about the proposed procedural notice until Oct. 13. CMS will respond to public comments in subsequent final notice. ACR® urges members to review the proposal and consider its potential impact on access to innovative medical technologies and future Medicare coverage policy.

The College will provide a detailed summary of the new coverage pathway and its implications.

For more information, contact Alicia Blakey, ACR Manager of Economic Policy.