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New Medicare medical device coverage pathway cuts reimbursement timelines from over a year to just 60-90 days, benefiting manufacturers and patients seeking faster access to breakthrough treatments.
The Centers for Medicare & Medicaid Services and the Food and Drug Administration unveiled the RAPID coverage pathway to streamline coverage determinations for medical devices. The program shortens Medicare coverage timelines to 60 to 90 days from FDA clearance, compared to traditional timelines exceeding one year. This new medical device coverage pathway aims to address the problem of delayed Medicare reimbursement, which deters innovation and investment.
CMS plans to publish a national coverage determination for these covered devices on the same day eligible devices receive FDA approval, with a 30-day comment period. The program focuses on FDA-designated Class II and Class III breakthrough devices such as artificial heart valves and cardiac rhythm devices. There are around 40 devices that meet the criteria currently. John Brooks, deputy administrator of the CMS, stressed that manufacturers will know "exactly what targets they need to hit to get Medicare coverage."
Device makers hailed this move with much satisfaction. Medtronic, which posted revenue of $33.5 billion in 2025, was hopeful for "rapid and predictable coverage pathways." The firm Johnson & Johnson, which earns $33.8 billion from medtech sales, backs better access for patients. Industry heavyweights have always pushed for shorter reimbursement cycles to keep their competitive edge. Business Honor notes that the advent of the RAPID program is a breakthrough that will ensure better access to innovative devices for patients.
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