ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA and CMS announce a new aligned pathway to accelerate Medicare coverage after HHS Secretary Kennedy hints about the work ; Kenya publishes a forward-leaning AI guidance; Europe updates its guides on risk classifications and borderline products; and more from South Korea and US policy groups.
[Editor’s note: Updated April 23 to add news on the FDA-CMS RAPID coverage pathway. Pathways Picks will not be published on April 29. Look for the next edition on May 6.]
RAPID Over TCET?
CMS and FDA co-announced (as Secretary Robert F. Kennedy signaled last week, see brief below) a new pathway promising to align regulatory authorization and Medicare coverage to accelerate market access to new innovative devices. Under the Regulatory Alignment for Predictable and Immediate Device Coverage (RAPID) pathway, the two agencies say that manufacturers with FDA-designated Breakthrough Devices—including Class III devices and a select group of Class II devices enrolled in the TPLC Advisory Program (TAP) pilot—can benefit from a collaborative process resulting in FDA authorization and a proposed National Coverage Determination on the same day, and final coverage within 60-90 days. Participating firms will engage with FDA and CMS at the time pivotal trial is being designed.
Officials said the current Transitional Coverage for Emerging Technologies (TCET) program will be paused once RAPID is launched (following a short comment period). The difference between TCET and RAPID, according to officials, is the companies will engage much earlier with both agencies in the new program to help ensure that the premarket study, and postmarket data requirements, align with both regulatory and Medicare coverage demands. CMS also says it will be able to work with significantly more than the five devices per year that have been promised for TCET. An agency official. “Right now, we think that there are 40 devices that would qualify for the rapid pathway and then we estimate about 20 additional devices could participate and could gain coverage through that pathway,” the official said on background.
Another program RAPID resembles is the FDA-CMS Parallel Review Program, which has been in place since 2011 with very limited participation due to resource challenges for CMS and participating companies, among other issues. CMS hasn’t responded to a question from Market Pathways about the differences between RAPID and Parallel Review.
RFK Jr. on the Hill
“Announcement soon” on breakthrough devices?
Breakthrough coverage rule coming? HHS Secretary Robert F. Kennedy Jr. says CMS will “have an announcement soon” related to the agency’s efforts to rethink the Medicare coverage pathway for FDA-designated Breakthrough Devices. He made the statement during an April 16 appearance before the House Ways and Means Committee, though didn’t confirm whether active rulemaking was in process or whether the agency supported a more streamlined path to coverage compared to the existing Transitional Coverage for Emerging Technologies (TCET) pathway. The device industry complains TCET doesn’t go far enough to expedite access to new technologies.
The topic was raised by Rep. Blake Moore (R-Utah), who co-sponsors the Ensuring Patient Access to Critical Breakthrough Products Act, which would establish automatic coverage for breakthrough devices for a four-year period starting upon FDA authorization, but hasn’t been able to get through Congress after years of work. Rep. Moore asked Kennedy if the agency was working to implement a similar policy via rulemaking, referencing the first Trump administration’s Medicare Coverage of Innovative Technology (MCIT) pathway (repealed during the Biden administration), which serves as the model for the automatic coverage path proposed in the legislation. Kennedy appeared unsure if rulemaking was in progress, but after deliberating with advisors in the room, he told lawmakers to look out for more soon and that “we’re happy to work with you on it.”
