Medicare works to speed up coverage for ‘breakthrough’ radiology devices

Medicare is moving forward with plans to grant faster coverage for “breakthrough” medical devices in radiology and other specialties.

The federal payment program for seniors on Aug. 7 released a new fact sheet with details about its Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway. First outlined in April, Medicare is collaborating with the Food and Drug Administration to help boost patient access to certain Class 2 and 3 devices. 

Experts have noted there often is a lag—at a median of nearly six years—between the FDA authorizing new products and Medicare granting payment. The RAPID pathway aims to allow the two agencies to collaborate earlier in product life cycles, generating evidence to more rapidly support decisions. 

“By aligning CMS and FDA evidence expectations in advance, the RAPID coverage pathway is designed to significantly reduce the review times that have historically occurred between FDA market authorization and Medicare national coverage determinations,” the Centers for Medicare & Medicaid Services said in its new fact sheet. 

For devices completing the pathway, a coverage determination would be issued the same day as FDA market authorization, CMS noted. This means that national Medicare coverage would begin as soon as 60 days after the Food and Drug Administration made its decision. 

The public has 60 days to comment on the policy notice, with CMS planning to respond to feedback in the subsequent final notice. Authorities outlined further details on which devices will be eligible for RAPID payment. These include certain Class 2 breakthrough devices partaking in the FDA’s Total Product Life Cycle Advisory Program. Same for Class 3 ones, regardless of their participation. 

The American College of Radiology also highlighted the fact sheet in a news update to its members, released on Aug. 13. ACR notes that RAPID would not apply to in-vitro diagnostic tests, which would continue to follow existing Medicare coverage pathways. 

This builds on CMS’ broader efforts to streamline coverage for new emerging technologies, ACR added. RAPID aims to move imaging stakeholder engagement to earlier in the development process, helping to support faster and more predictable coverage decisions. With the related Transitional Coverage for Emerging Technologies (TCET) framework paused for new candidates, RAPID could become CMS’ “primary accelerated coverage pathway” for eligible breakthroughs. 

“ACR urges members to review the proposal and consider its potential impact on access to innovative medical technologies and future Medicare coverage policy,” ACR said in its Thursday news update. “The college will provide a detailed summary of the new coverage pathway and its implications.”