ARTICLE SUMMARY:
The two agencies are rolling out a new path for manufacturers of Breakthrough Devices to collaborate on pivotal trial design and better align FDA authorization to Medicare coverage timelines. This is not the first go-around by FDA and CMS on this type of program, and whether it offers advantages over previous efforts remains to be seen, according to some industry observers.
CMS and FDA are launching the latest pathway promising to align regulatory authorization and Medicare coverage. For now, however, industry players are taking a wait-and-see attitude about whether it will meaningfully differ from past attempts by the two agencies to accelerate market access for innovative devices.
Under the Regulatory Alignment for Predictable and Immediate Device Coverage (RAPID) pathway, announced April 23, 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 (NCD) on the same day, and final coverage within 60-90 days following FDA’s decision.
