The Centers for Medicare and Medicaid Services is requesting public feedback on a proposal designed to shorten the timeframe between Food and Drug Administration authorization and Medicare coverage for breakthrough medical devices. The proposed pathway, known as Regulatory Alignment for Predictable and Immediate Device coverage (RAPID), attempts to fix a persistent delay in the healthcare system.
Currently, patients often wait years for insurance coverage on newly approved technology. A survey conducted by the Stanford Byers Center for Biodesign and the Duke-Margolis Institute for Health Policy found that it takes nearly five years on average for a medical device to secure national Medicare and commercial insurance coverage after receiving FDA authorization.
Under the RAPID model, a proposed national coverage determination would be issued the same day as FDA market authorization. This timing would allow national Medicare coverage to potentially begin as soon as 60 days after authorization, a significant reduction from the status quo.
Targeting Breakthrough Technology
The proposal focuses on devices that treat serious conditions. It is intended to help Medicare beneficiaries gain quicker access to eligible Class II breakthrough devices participating in the FDA’s Total Product Life Cycle Advisory Program.
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It also covers eligible Class III breakthrough devices, regardless of their participation in that program. The FDA’s breakthrough device program was created to prioritize market authorization reviews for devices that provide more effective treatment or diagnosis for life-threatening conditions.
While the FDA process speeds up approval for these high-need devices, the industry has long voiced concern over the length of time required to secure Medicare reimbursement. The RAPID pathway, first unveiled in April, seeks to bridge that gap.
The fundamental challenge has been a regulatory disconnect where safety clearance and payment coverage operate on completely separate tracks. This proposal acknowledges that for patients facing life-threatening illnesses, access is defined not just by regulatory permission but by the ability to pay for the treatment. Aligning these tracks removes a major barrier that prevents innovative technology from reaching the market in a functional way.
Streamlining Evidence Review
To achieve this, RAPID would utilize the FDA’s existing process for assessing clinical outcomes in proposed investigational device exemption studies. The plan intends to connect CMS experts with device manufacturers early in the development process, rather than waiting until after approval to begin coverage discussions.
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Improvement shown in study outcomes and the device’s relative risk will determine if further evidence development is needed for the national coverage determination, the CMS said. If the agency finds that coverage with evidence development is necessary, it will communicate with the FDA and the manufacturer before FDA market authorization occurs.
This early communication is meant to align the evidence needs of CMS with any post-approval studies that the FDA might require. This approach ensures that data collection efforts are not duplicated. If the FDA requires a post-approval study for safety, CMS can use that same data to satisfy coverage requirements, which reduces the administrative burden on manufacturers.
However, not all devices will fit into this new framework. In vitro diagnostic products will specifically be excluded from the RAPID pathway. CMS has historically delegated the review of many laboratory tests to specialized Medicare administrative contractors, known as MACs.
The agency stated it believes most coverage determinations for IVDs granted breakthrough designation should continue to be set by the MACs rather than through this national process. Additionally, devices that have already advanced beyond the IDE pre-submission stage are not appropriate for the RAPID pathway. Comments on the procedural notice will be accepted for 60 days.
