A couple months ago, CMS announced it would nix the TCET program for rapid NCDs with Coverage with Evidence Development. And replace it with RAPID. However, details only appeared late Friday, August 7, in the Federal Register.
"Regulatory Alignment for Predictable and Immediate Device" RAPID coverage pathway.
Find it here:
(This is advance-text, Fed Reg typeset version to appear August 11.)
There's also a new press release.
Despite the ironic fact that two major, early, prominent Parallel Review case studies were diagnostics - Cologuard 2014 and FMI 2018 - diagnostics (IVD) are excluded from RAPID.
This posture of IVD exclusion may be a mistake. The output of new diagnostics LCDs at Novitas in recent years was mainly noncoverage of 9/9 oncology tests in 2025. The output of new Dx LCDs at NGS MAC (Wellpoint federal) in several years is about N of 1 - Renalytix KidneyIntel. The MolDx program is great at follow-on tests (for MRD or CGP) but it's a rare day when MolDx issues an entirely new LCD, and they follow a 2 to 3 year delay queue, easily enough to bankrupt a startup. In short, CMS may need to take a 360 view of their proposed exclusion of IVDs from rapid coverage.
Here's a fast and early read by AI.
RAPID: Medicare's Latest Attempt to Solve the FDA-to-Coverage Gap
CMS has now produced another special pathway intended to shorten the sometimes painfully long interval between FDA authorization of an innovative medical device and Medicare coverage.
The newest acronym is RAPID — Regulatory Alignment for Predictable and Immediate Device Coverage. CMS and FDA first announced RAPID on April 23, 2026; on August 7 CMS released a detailed proposed procedural notice, scheduled for Federal Register publication August 11.
If the history seems familiar, it should. Medicare has been trying versions of this problem for quite a while.
There was Parallel Review, announced as a pilot in 2010 and formally implemented in 2016. FDA and CMS could meet with a manufacturer during development and later review the pivotal evidence concurrently, reducing the gap between FDA authorization and a CMS proposed NCD. Its most memorable early successes included Cologuard and, later, FoundationOne CDx. CMS itself describes Parallel Review as having two stages: early feedback on the pivotal trial followed by concurrent FDA/CMS review of the results.
Then came MCIT — Medicare Coverage of Innovative Technology, finalized during the first Trump administration in January 2021. MCIT was the bold version: FDA Breakthrough Device authorization would essentially open the door to immediate nationwide Medicare coverage, potentially lasting four years.
But MCIT never really got to govern. The incoming Biden administration first delayed and then repealed it in November 2021. The central objection was that FDA's determination of safety and effectiveness was not necessarily enough to establish Medicare's separate statutory requirement that an item be “reasonable and necessary” for Medicare beneficiaries—an older population with more comorbidities than many FDA trial populations.
Biden-era CMS eventually produced TCET — Transitional Coverage for Emerging Technologies, finalized in August 2024. TCET kept the FDA Breakthrough Device idea but restored a recognizably CMS-style evidence process: premarket engagement, an Evidence Preview, identification of evidence gaps, potentially an Evidence Development Plan, and an NCD that might employ Coverage with Evidence Development. CMS describes TCET as intended for Breakthrough Devices whose evidence may still be limited or developing for Medicare purposes.
And now TCET itself is being pushed aside.
CMS states that TCET will be paused for new candidates while CMS focuses on RAPID.
One begins to think of the late Roman Empire: Parallel Review, MCIT, TCET, RAPID—each new emperor arriving with a new acronym and a solution to the succession problem.
So What Is Different About RAPID?
RAPID actually has a fairly clear and interesting idea behind it.
The fundamental FDA/CMS problem has always been that the agencies ask somewhat different questions.
FDA asks whether the device satisfies the applicable regulatory standards for safety and effectiveness. CMS asks whether the item or service is reasonable and necessary for Medicare beneficiaries. FDA clinical trials do not necessarily contain enough older patients, patients with multiple chronic conditions, or outcomes that CMS considers decisive for Medicare coverage. FDA authorization therefore does not automatically imply Medicare coverage. CMS spends several pages emphasizing precisely this distinction.
Under the traditional sequence, a manufacturer could therefore spend years conducting a beautiful FDA program, obtain approval, walk across town to Medicare—and discover that CMS wanted somewhat different evidence.
RAPID tries to prevent that problem before the pivotal trial starts.
As CMS summarizes it in the new fact sheet, the agency will join the FDA/manufacturer process through early and frequent engagement, allowing CMS experts to identify the clinical outcomes most relevant to Medicare beneficiaries while the device is still in development.
Thus, schematically:
Old model:
FDA trial → FDA authorization → CMS review → “Where are the Medicare data?”
RAPID model:
FDA + CMS + manufacturer agree on Medicare-relevant outcomes → pivotal IDE trial → FDA authorization + virtually simultaneous CMS NCD process.
That may be the most important conceptual difference between RAPID and MCIT.
MCIT tried to eliminate the FDA-Medicare gap by treating FDA authorization as sufficient to trigger coverage. RAPID tries to eliminate the gap by making sure the FDA development program generates the evidence CMS will need.
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You Have to Get Into RAPID Very Early
RAPID is not a rescue program for a device that has already received FDA approval and suddenly discovers it has a Medicare problem.
Quite the opposite.
The device generally must enter RAPID at the IDE pre-submission stage. The manufacturer must plan an IDE study that enrolls Medicare beneficiaries and evaluates clinical outcomes that FDA considers appropriate and CMS agrees would demonstrate improved health outcomes for Medicare beneficiaries.
CMS's August fact sheet makes the point especially plainly: devices already market authorized—or even devices for which an IDE study is already underway—are generally too late for RAPID.
CMS does ask for comments on whether there should be a temporary transition mechanism for some devices whose IDE studies are already underway. That may be important for companies caught between TCET and RAPID, but it is not the basic design of the program.
RAPID therefore pushes Medicare reimbursement strategy remarkably far upstream.
For an eligible company, Medicare coverage planning becomes part of pivotal clinical-trial design.
That is probably RAPID's most consequential feature.
Who Is Eligible?
The pathway is deliberately narrow.
For Class II devices, RAPID generally requires an FDA Breakthrough-designated device enrolled in FDA's Total Product Life Cycle Advisory Program (TAP) (link) and proceeding toward a De Novo request.
For Class III devices, RAPID requires Breakthrough designation and a planned PMA; TAP participation is not required.
The product must also fit, or at least not obviously fail to fit, within a Medicare benefit category; it cannot already be controlled by an existing NCD; it must be separately payable; and it cannot otherwise be excluded from Medicare coverage.
RAPID is voluntary. A manufacturer can also withdraw before CMS issues the proposed NCD—for example, if the evidence disappoints or if local MAC coverage looks strategically preferable.
The Payoff: FDA Authorization and the NCD Nearly Converge
If everything works, the payoff is dramatic.
Once the IDE study is completed, FDA provides CMS with the relevant study information. If the manufacturer proceeds with RAPID and the study has satisfactorily demonstrated improvement in the agreed clinical outcome, CMS plans to post the NCD tracking sheet and proposed NCD on the same day FDA grants market authorization.
There will then be a 30-day public comment period.
CMS's goal is a final NCD approximately:
60 days after FDA authorization for Class II devices, and
90 days after FDA authorization for Class III devices.
CMS's August fact sheet translates that into unusually plain English: national Medicare coverage could therefore begin as soon as 60 days after FDA authorization.
That is a striking contrast with the ordinary NCD process, which CMS itself says generally takes nine to twelve months.
It is also more aggressive than TCET's approximately six-month post-FDA target.
Notice, however, that RAPID is not literally MCIT-style instantaneous coverage. What is simultaneous with FDA authorization is the proposed NCD. Final coverage follows roughly two or three months later.
“Immediate” in the acronym therefore deserves a small Medicare asterisk.
RAPID Is Not Necessarily the End of Evidence Development
RAPID also doesn't mean every successful device automatically gets an unconditional §1862(a)(1)(A) NCD.
CMS says the amount of demonstrated improvement in clinical outcomes and the risk profile of the device will affect whether additional evidence development is required.
A lower-risk device may arrive at FDA authorization with sufficient evidence to support conventional “reasonable and necessary” coverage.
A higher-risk device may still have evidence gaps and receive coverage through CED — Coverage with Evidence Development. In that case CMS intends to coordinate, as much as possible, its evidence requirements with FDA-required post-approval studies rather than create duplicative research programs.
So RAPID isn't really eliminating CMS evidence review. It is moving much of it earlier.
That's an important distinction.
And Now the Bad News for Diagnostics
For readers in molecular diagnostics, there is one remarkably explicit paragraph.
IVDs are excluded.
FDA's legal definition of “device” includes in vitro diagnostic products, including laboratory tests. Thus, conceptually, an FDA Breakthrough-designated IVD might seem like an obvious RAPID candidate.
CMS says no.
CMS explains that IVDs and diagnostic laboratory tests constitute a specialized area of Medicare coverage policy and that CMS has historically delegated many such decisions to specialized Medicare Administrative Contractors. CMS therefore says that most Breakthrough IVD coverage decisions should continue through those MAC pathways.
The conclusion could hardly be clearer:
“IVD products will not be accepted into the RAPID coverage pathway.”
The August CMS fact sheet repeats the exclusion almost word for word.
An IVD manufacturer isn't forbidden from pursuing an ordinary NCD. CMS notes that in the unusual case where CMS and a manufacturer agree an NCD is appropriate, the manufacturer can use the normal NCD request process.
But RAPID itself is closed to diagnostics.
There is an historical irony here. Two of the landmark products associated with the older FDA-CMS Parallel Review program were diagnostics—Cologuard and FoundationOne CDx. The newest FDA/CMS coordination pathway now expressly sends IVDs back toward the MAC system.
Four Generations of the Same Problem
The lineage can now be summarized fairly simply:
| Program | Approx. era | Basic idea |
|---|---|---|
| Parallel Review | 2010– | FDA and CMS engage and review in parallel |
| MCIT | 2021 | FDA Breakthrough authorization essentially triggers temporary Medicare coverage |
| TCET | 2024 | CMS evaluates evidence gaps and develops transitional NCD/CED coverage |
| RAPID | 2026 | Design the pivotal FDA evidence program up front to satisfy CMS too |
The programs overlap conceptually more than the succession of acronyms suggests. In fact, RAPID contains a substantial amount of Parallel Review DNA.
Parallel Review already allowed FDA and CMS to provide feedback on a proposed pivotal trial and later evaluate the resulting evidence concurrently.
What RAPID adds is a much more formalized pathway around Breakthrough designation, TAP, IDE development, Medicare-specific clinical outcomes, and a commitment to synchronize the proposed NCD with FDA market authorization.
RAPID may therefore be viewed less as an entirely new species than as an ambitious, highly structured descendant of Parallel Review.
To Sum Up
There is a sensible policy idea here.
MCIT attacked the coverage lag at the back end: FDA has approved it, so Medicare should cover it.
TCET tried to manage the gap during the transition between FDA and Medicare.
RAPID attacks the problem at the front end: before you design your pivotal study, CMS tells you what it will need. Then one evidence-generation program has a fighting chance of satisfying both agencies.
If RAPID works as advertised, the great achievement won't really be turning a nine-month NCD into a 60-day NCD.
It will be avoiding the situation in which a manufacturer reaches FDA approval after years of product development and only then discovers that the evidence needed for Medicare coverage was never collected.
That is genuinely useful regulatory alignment.
Whether enough devices can satisfy RAPID's narrow eligibility rules—and whether CMS has the manpower to provide this degree of early engagement—is another question.
And for diagnostics, the question is largely academic.
RAPID may be the latest emperor in Medicare's revolving door of innovative-technology pathways, but IVDs aren't being invited into the palace.
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Sidebar: What Is FDA’s TAP Program?
FDA’s Total Product Life Cycle Advisory Program (TAP) is a voluntary CDRH program launched as a pilot in 2022 to give selected device developers unusually early, frequent, and strategic interaction with FDA—and to help connect them with other parties important to eventual adoption and patient access. FDA describes TAP as a “medical device accelerator,” with dedicated TAP advisers helping sponsors identify and resolve development and market-access issues earlier in the product life cycle. (U.S. Food and Drug Administration)
The program is now fairly substantial: as of July 1, 2026, FDA reported 133 devices enrolled in the TAP Pilot. On that date FDA also expanded TAP across all of CDRH’s Offices of Health Technologies for eligible Breakthrough-designated and Safer Technologies Program (STeP) devices. (U.S. Food and Drug Administration)
TAP matters directly to RAPID because eligible Class II RAPID devices generally must be enrolled in TAP. In effect, RAPID plugs CMS into an FDA infrastructure that was already designed for intensive, early-stage coordination—now adding Medicare evidence and coverage requirements to that conversation. (U.S. Food and Drug Administration)
