A breakthrough device that clears the FDA waits an average of 5.7 years before Medicare will pay for it. That number comes from Stanford research by Josh Makower, and it belongs on the wall of any company about to design a pivotal trial. Market authorization is not the day you get paid. It is the day a second review begins, run by an agency asking a different question from the one you spent four years answering.
In April, CMS and the FDA announced a pathway built to close that gap. They call it RAPID, for Regulatory Alignment for Predictable and Immediate Device coverage. The mechanism fits in a sentence: CMS issues a proposed national coverage determination the same day the FDA grants market authorization, then targets a final decision within 60 to 90 days. A device that would have spent a year or more in what Andrew Ibrahim of Viz.ai calls “coverage purgatory” can be covered in about two months.
The entry gate is a trial-design decision
In August, CMS filled in the part that changes how you plan. The two agencies start working together before the pivotal trial is designed, and a device has to be in early testing to get in. Eligibility runs through Breakthrough Device designation: all Class III breakthrough devices meeting the criteria, and Class II breakthrough devices also enrolled in the FDA’s Total Product Life Cycle Advisory Program. The investigational study has to enroll Medicare beneficiaries and measure outcomes both agencies agreed to in advance.
That last requirement is where the work is. The population you enroll to satisfy the FDA and the population that answers CMS are not automatically the same people. Medicare beneficiaries are 65 and older, and they show up with everything else that comes with being 65 and older. A trial built around a healthier cohort can produce a clean safety and effectiveness story and still leave CMS holding no evidence about the patients it covers. Under the old sequence you could find that out after authorization and go run a second study. Under RAPID you’ve already spent your one shot.
Who owns the coverage decision
The instinct is to hand this to a reimbursement consultant. That is the wrong seat. Deciding which patients your device is for, and what outcome you will claim it produces, is the same decision that sets your indication, your predicate logic, your study population, and your labeling. Framing the indication is the regulatory strategy, and it’s the argument I make first when a founder asks me where regulatory work goes wrong. The device you build and the product you define are two different things, and only one of them goes through review. RAPID stretches that same framing decision to cover who pays for it. The person who owns the product owns that call.
A scale check is worth running before anyone rebuilds a roadmap around this. CMS estimates roughly 40 devices qualify today, with about 20 more expected. That’s a real number and a small one. It’s also bigger than what came before it: the Parallel Review program the two agencies launched in 2011 and made permanent in 2016 capped participation at five candidates a year, and very few devices ever completed it. Letting more companies in is the easy half. Getting them to use it is the half that killed the last attempt.
For everyone outside the breakthrough lane, none of the underlying math moved. Hospitals cannot fund science experiments anymore. Margins are tight enough that a promising capital purchase with an unproven payback does not get budget, and the buyer runs that arithmetic long before your first system reaches a loading dock. Coverage is one input to that calculation. RAPID makes the input arrive sooner for a few dozen companies. It does not make the number close.
The speed is what gets the headlines. What matters more is that RAPID drags the question of who pays into the room while the protocol is still editable, and that is the only moment when answering it is cheap. If your pivotal trial is already enrolling, you missed that window. Plan for the wait.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for product companies. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →