Article
How RAPID works
On Aug. 7, CMS released a procedural notice for the Regulatory Alignment for Predictable and Immediate Device coverage pathway, known as RAPID, which CMS and the FDA first announced on April 23. The goal is to shorten the gap between FDA market authorization and a Medicare national coverage determination.
Under the process, CMS would post a proposed coverage decision on the same day the FDA authorizes a device. The public would have 30 days to comment. CMS aims to finalize coverage about 60 days after authorization for Class II devices and about 90 days for Class III devices.
Which devices qualify
- Class III breakthrough devices headed for premarket approval.
- Certain Class II breakthrough devices in the FDA’s TAP program that plan De Novo requests, plus some 510(k) devices that rely on a recent De Novo predicate.
- Devices must be at the investigational device exemption pre-submission stage, with a planned study that enrolls Medicare beneficiaries.
- Devices must be separately payable and not already covered by a national coverage determination. Diagnostic lab tests are excluded.
Evidence will still matter. Lower-risk devices with strong study results are more likely to be covered outright. Higher-risk devices may be covered with evidence development, which is time-limited and would be aligned with any FDA post-approval study. CMS is taking comments on the notice for 60 days after it appears in the Federal Register.
What it means for hospitals
Faster national coverage could shorten the period in which hospitals must decide whether to adopt a new device before Medicare payment is clear. That is good for access, but it compresses the time hospitals have to evaluate clinical value, train staff and set up supply contracts. Coverage with evidence development can also bring registry or data reporting duties for the sites that use the device.
Preparing for faster adoption
- Watch the pipeline: Ask service-line leaders and value analysis committees to track breakthrough devices in development for cardiology, neurology, orthopedics and other high-volume areas.
- Join studies early: Because RAPID requires studies that enroll Medicare beneficiaries, participating as a trial site can build clinical experience before launch.
- Plan for evidence duties: Confirm that registry reporting capacity exists before adopting devices covered with evidence development.
- Model the economics: National coverage does not guarantee adequate payment. Review coding and add-on payment options alongside coverage.
Archive entry for Aug 10, 2026, added Nov. 11, 2026.