CMS proposes faster Medicare coverage for breakthrough devices

CMS has released a draft procedural notice aimed at accelerating approval for breakthrough medical devices. The notice describes an expedited route for makers to secure Medicare coverage of new products under this RAPID coverage pathway, as intended by the program, facilitating quicker patient access nationwide through streamlined processes.

CMS has aligned its evidence with the Food & Drug Administration (FDA) in advance to reduce the review time for the FDA to issue market authorization and for Medicare to give a national coverage determination (NCD). A proposed NCD could be issued the same day as the FDA market authorization, and Medicare coverage could begin as soon as 60 days after FDA market authorization.

The RAPID coverage pathway applies to FDA-designated Breakthrough Devices that address unmet medical needs for Medicare beneficiaries. Eligible products include all Class III devices and certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP). They include continuous glucose monitors and robotic surgical platforms as examples of breakthrough devices.

CMS and the FDA first announced the new RAPID Medicare coverage pathway in April. As of March 31, the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) had granted 1,284 Breakthrough Device designations. The FDA Breakthrough Devices Program was created by Congress in the 21st Century Cures Act of 2016.

The announcement outlines operational mechanics and initiates a 60-day public comment period. Stakeholders have long sought a better way to cover new, innovative technologies, CMS said. However, in vitro diagnostic (IVD) products will not be accepted into RAPID, as CMS said they fall into a highly specific area of coverage policy development.