Thomas Celerier
CMS’s RAPID pathway puts a proposed Medicare NCD (National Coverage Determination) on the day of FDA market authorization for eligible Breakthrough Devices, with a final NCD 60 to 90 days later. Entry closes at IDE pre-submission, in vitro diagnostics are excluded, and the NCD may cover the device only inside a study. The first device to finish the pathway will most likely do so after 2030.
Every reimbursement leader I speak with had the same first reaction to RAPID, and it was not excitement. It was, “we have seen this before, twice.”
They are right. Medicare Coverage of Innovative Technology (MCIT) arrived in January 2021, would have granted Breakthrough-designated devices automatic national coverage, and was repealed that November. Transitional Coverage for Emerging Technologies (TCET) followed in August 2024. It took five devices a year, against more than a hundred Breakthrough designations annually, and is now paused for new candidates so CMS can stand up RAPID.
So it’s not whether RAPID is faster. On paper it plainly is. What a manufacturer should change on the strength of it, given the pathway asks for commitments today and delivers its first result years from now, is the big one. My answer is narrower than the headline: read RAPID as a reform of how Medicare evidence gets designed, not as a coverage promise you can plan a launch around.
What CMS's RAPID pathway actually committed to
CMS and the FDA announced RAPID (Regulatory Alignment for Predictable and Immediate Device) on April 23, 2026, and published the CMS-3487-NC procedural notice in the Federal Register on August 11. The two agencies engage manufacturers during premarket development, agree which clinical outcomes matter for Medicare beneficiaries, and let the evidence from the Investigational Device Exemption study carry into the National Coverage Determination.
If an eligible device reaches authorization having shown improvement in those agreed outcomes, CMS posts a proposed NCD the same day. A 30-day comment period follows, and CMS aims to finalize about 60 days after authorization for Class II devices, 90 for Class III. The conventional NCD process, by CMS’s own account, runs 9 to 12 months, and in practice devices have waited roughly five years from authorization to national coverage. Against those numbers, the compression is real.
The mechanism worth paying attention to, though, is upstream. CMS officials told MedTech Dive that manufacturers have repeatedly reached authorization only to discover the evidence built for FDA did not answer Medicare’s questions, sometimes forcing an entirely new study. RAPID fixes it at protocol design. For most companies, avoiding a second pivotal program is worth more than months off an NCD calendar. Clinical evidence is expensive, nearly impossible to amend late, and wired straight into launch timing and capital planning.
Will RAPID survive where MCIT and TCET didn't?
Standard eligibility opens only at IDE pre-submission, which means RAPID begins with studies that have not started. Add protocol design, enrollment, follow-up, FDA review, then coding and payment, and the arithmetic is unavoidable. One independent analysis of that full sequence puts the first same-day NCD after 2030, and a device holding both coverage and a workable payment route closer to 2031 or 2032. CMS has published no estimate of its own, so treat those as informed estimates rather than agency forecasts. But the shape of the timeline is not in dispute.
Which means the administration that launched this pathway will be out of office before it produces its first outcome. MCIT did not survive a transition. TCET did not survive its successor. A manufacturer being asked to design a pivotal trial around RAPID is being asked to bet on institutional continuity, not just on regulatory alignment.
The bet is safer than it looks because RAPID is better built than either predecessor. It changes what evidence gets generated rather than bolting coverage onto the end. And the evidence outlives the pathway. A study designed to answer Medicare's questions still supports a conventional NCD, a local coverage determination, or a commercial payer conversation, whether or not RAPID survives to 2031. Any company can take that hedge without betting on the pathway itself.
Hence, the calculation I would put to a board is to adopt the evidence discipline and stay agnostic about the vehicle.
Who is eligible for RAPID?
Eligibility is tighter than the coverage suggests. Two groups qualify. The first is presumptive Class II Breakthrough devices heading to a De Novo request, provided they are enrolled in FDA’s Total Product Life Cycle Advisory Program (TAP). The second is Class III Breakthrough devices heading to a premarket approval application (PMA), which may take part whether or not they are in TAP. Either way, the device must sit at IDE pre-submission. The planned study must also enroll Medicare beneficiaries and measure outcomes both agencies agree are relevant to that population. A senior CMS official put the currently qualifying population at about 40 devices, with roughly 20 more that might qualify.
Three further screens get less attention than they deserve. The technology must not present an obvious Medicare benefit-category problem or already fall under a controlling NCD, and must be separately payable (billable to Medicare if approved). CMS is also explicit that its early benefit-category read is preliminary, not a final determination. A company can satisfy every clinical requirement and still not know where its technology lands in Medicare’s coding and payment architecture. For a reimbursement lead, “separately payable” warrants nearly the scrutiny Breakthrough designation gets.
Then the timing bar. Devices already authorized, or already being studied under an IDE, are outside RAPID today. CMS has asked for comment on whether to create a temporary process letting devices past pre-submission in, and how long it should run. This single question determines whether RAPID is relevant to this pipeline or only to the next one for anyone with a device currently in the clinic.
Same-day NCD is not necessarily full coverage
A second layer sits beneath the headline. The notice ties the kind of coverage to the device’s risk and to how much the study has already settled. Lower-risk devices arriving with sufficient evidence can be covered outright. Higher-risk devices with remaining gaps are more likely to be covered under Coverage with Evidence Development. Under CED, Medicare pays only for beneficiaries enrolled in an approved study, which is intended to be time-limited and is subject to later reconsideration.
For this pathway, that is not an edge case. RAPID is open to Class III devices going to PMA and novel Class II devices going to De Novo. Those are exactly the risk profiles most likely to reach authorization with open questions about older patients carrying several comorbidities. So a company can run RAPID as designed, receive its proposed NCD on the day of authorization, and find the NCD covers the device only inside a study it now has to fund. CMS signals this before authorization, which is one more reason the coverage conversation belongs in the protocol.
Does coverage mean getting paid?
An NCD answers whether Medicare covers something. A provider still needs a way to bill it. CMS states plainly that HCPCS Level II coding decisions are independent of coverage and payment; a code neither establishes coverage nor guarantees payment. For non-drug items, those applications run on two cycles a year. Apply by the first business day of January, and the code takes effect that October. Apply by the first business day of July, and it takes effect the following April. Miss a window and the application waits for the next cycle, which can push a usable code more than a year past the point it was needed in the first place.
RAPID does not touch those calendars. So “reimbursement readiness” cannot mean a coverage date. It has to mean the point at which a provider can identify the right code, understand the payment methodology, submit a claim, and adopt the technology without absorbing unresolved financial risk. RAPID accelerates one milestone in that sequence.
What should device companies do before comments close?
Comments close October 13, 2026, and two items are worth a formal position rather than an internal opinion.
The first is the transitional on-ramp. If CMS builds it, companies mid-study can amend protocols or show that existing endpoints already satisfy Medicare’s requirement, and the pathway could produce output years earlier than 2030. If CMS does not, the manufacturers closest to commercialization watch from outside while the first eligible cohort starts several stages behind them. Anyone with a qualifying device in the clinic has a direct commercial interest in that answer, and CMS has invited it.
The second is how much weight the preliminary benefit-category read can bear. CMS offers an early assessment and warns it is not final. Teams need to know how much they can rely on that feedback before committing a study design and a commercial model to it. It is a fair thing to ask for in a comment, and difficult to obtain later.
CMS excludes in vitro diagnostics (IVD) outright and expects Breakthrough-designated IVD coverage to continue through Medicare Administrative Contractors, with a conventional NCD available only in narrow cases. The stated reasoning is that IVD coverage is specialized and already delegated. But diagnostics companies face the same evidence-alignment failure RAPID was built to solve, and if early coordination reduces uncertainty for devices, the case for an equivalent mechanism is straightforward. Unless diagnostics companies make that argument in this comment period, it won’t get made. And the organizational implication runs deeper than any of it.
RAPID asks a manufacturer to settle what Medicare will need to see before the protocol is written. In practice, it means clinical development, regulatory, health economics, market access, and coding, all agreeing on one evidence plan while it can still change. A market access function that activates near launch arrives after every decision that mattered. That is a sequencing problem more than a regulatory one, and no notice from CMS can fix it for you.
What I am seeing across device and diagnostics programs is that companies whose reimbursement teams already sit in on protocol design reviews are better positioned for RAPID than those with the most advanced pipelines.
Before the protocol locks
Although getting reimbursement into protocol design is the manufacturer's call, making it hold is a systems problem, and that is where Coditas works with MedTech and Life Sciences teams. We integrate the clinical data, build the evidence and workflow systems that keep a program on one plan as the study runs, and keep the decision record a manufacturer needs to defend its choices to FDA and CMS years later.
The comment window closes October 13, the last moment the pathway's rules are open to influence. Weigh in now, while a program in the clinic can still shape the on-ramp that decides whether it qualifies at all. If your regulatory and reimbursement teams are working out where they stand, I'd value comparing notes. Find me at HLTH in Las Vegas this November, Booth 4051, Level 2, Exhibit Hall, AI Zone.
FAQs
What is the RAPID coverage pathway?
RAPID, or Regulatory Alignment for Predictable and Immediate Device, is a CMS and FDA pathway proposed under CMS-3487-NC. For eligible Class II and Class III Breakthrough Devices, the agencies coordinate during premarket development so evidence from the IDE study can support Medicare coverage, and CMS intends to post a proposed NCD on the day of FDA market authorization.
Does a same-day NCD mean full Medicare coverage?
Not necessarily. Depending on the device’s risk and the strength of the evidence at authorization, CMS may issue the NCD under Coverage with Evidence Development, which pays only for patients enrolled in an approved study and is reconsidered later, rather than granting full national coverage.
Are diagnostics eligible for RAPID?
No. CMS excludes in vitro diagnostic products, including diagnostic laboratory tests, and expects most Breakthrough-designated IVD coverage to continue through Medicare Administrative Contractors. An IVD may pursue a conventional NCD in limited circumstances.
When will the first RAPID coverage decision happen?
CMS has not named a year. Because standard eligibility begins at IDE pre-submission, an independent analysis estimates the first same-day RAPID NCD is unlikely before 2030, with coverage plus a workable payment route closer to 2031 or 2032. CMS is taking comment on a temporary process for active IDE studies, which could materially move that.
How is RAPID different from MCIT and TCET?
MCIT would have granted automatic coverage after authorization, but it was repealed in 2021. TCET, established in 2024, expedited NCDs for a small number of devices a year and is now paused for new candidates. RAPID differs by intervening before the pivotal study, aligning FDA and CMS evidence expectations at protocol design rather than adjudicating coverage afterward.
