CMS Unveils the RAPID Coverage Pathway: What Medtech Innovators Need to Know
A new voluntary pathway aims to close the gap between FDA market authorization and Medicare coverage, and the comment period is open now.
On August 11, 2026, CMS published a notice with comment period introducing the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. By getting CMS involved during the investigational device exemption (IDE) stage, rather than after FDA authorization, RAPID aims to let eligible breakthrough devices post a proposed National Coverage Determination the same day FDA authorizes the device, a sharp contrast to the 9 to 12 month timeline of a conventional NCD.
FDA and CMS operate under different legal standards. FDA asks whether a device is safe and effective. CMS asks whether it is reasonable and necessary for Medicare beneficiaries specifically, a population that is older, more likely to have multiple comorbidities, and often underrepresented in the clinical trials that support FDA authorization.
That mismatch has historically meant a lag, sometimes a long one, between the day a device hits the market and the day Medicare decides whether, and how, it will pay for it. This lag has been a persistent source of frustration since the short-lived Medicare Coverage of Innovative Technology (MCIT) rule was repealed in 2021, and it is a big part of what the 2024 Transitional Coverage for Emerging Technologies (TCET) pathway tried to address. RAPID is CMS's next attempt to close that gap, this time by getting involved much earlier, during the IDE stage, rather than waiting until after FDA authorization to start the coverage conversation.
RAPID is built around a simple idea: if Medicare relevant health outcomes are built into a device's pivotal IDE study from the start, CMS can move in parallel with FDA instead of starting from scratch after authorization. The pathway unfolds in three stages.
IDE Presubmission. A manufacturer with Breakthrough Device designation expresses interest to FDA before submitting its IDE. FDA screens eligibility and loops in CMS for a preliminary benefit category check. If aligned, a RAPID kick-off meeting shapes the clinical study protocol, specifically which health outcomes will need to be demonstrated in the Medicare population.
Formal IDE Submission. The manufacturer submits the IDE to FDA. Once FDA issues its decision letter, CMS reviews it too and works directly with the manufacturer on any study design considerations needed to keep the device eligible for RAPID.
Transition from IDE to Coverage. After the IDE study wraps and the manufacturer submits its marketing application to FDA, CMS reviews the same clinical data to confirm the agreed upon health outcomes were met. CMS then posts a proposed NCD the same day as FDA market authorization, aiming to finalize it 60 days later for Class II devices and 90 days later for Class III devices.
RAPID is not for every device. Eligibility is narrow and specific.
| Criterion | Detail |
|---|---|
| Class II devices | FDA Breakthrough designated, enrolled in FDA's Total Product Life Cycle Advisory Program (TAP), planning a De Novo request, or a 510(k) whose predicate cleared via De Novo no more than 18 months before RAPID acceptance |
| Class III devices | FDA Breakthrough designated, planning a PMA submission, whether or not enrolled in TAP |
| Stage requirement | Must still be at the IDE presubmission stage; devices already market authorized or already under an active IDE do not qualify |
| Benefit category | CMS must not already see a clear reason the item would fall outside a Medicare benefit category |
| Coverage status | Not already covered by a controlling NCD, separately payable, and not otherwise excluded from coverage by law or regulation |
| Excluded category | In vitro diagnostics are carved out entirely; CMS intends to keep routing IVD coverage decisions through the Medicare Administrative Contractors (MACs) as it does today |
Participation is voluntary throughout. A manufacturer can withdraw at any point up until CMS issues a proposed NCD, for example if the evidence is not panning out, or if pursuing coverage at the local level through an LCD or claim by claim adjudication starts to look like the better option.
RAPID NCDs are expected to be more streamlined than conventional NCDs, since the evidence supporting them will have been shaped collaboratively with CMS from the IDE stage forward. But coverage under RAPID is explicitly limited to the FDA authorized indication or indications for use. There is no room to expand coverage scope beyond what FDA has cleared.
CMS also draws a clear line based on risk: lower risk devices that generate sufficient outcomes evidence during the IDE phase are more likely to get straightforward coverage under the standard reasonable and necessary authority. Higher risk devices with lingering evidence gaps are more likely to land in Coverage with Evidence Development (CED), meaning coverage continues, but conditioned on further data collection through a postmarket study.
CMS is pausing new candidates into the TCET pathway as of this notice's publication, so it can focus resources on standing up RAPID. Manufacturers who were eyeing TCET should take a close look at whether their device might instead fit RAPID's narrower, but faster, criteria, or whether Parallel Review or a standard NCD request remains the better route.
CMS publishes the notice with comment period in the Federal Register (91 FR 51710, Docket CMS-2026-2674), introducing RAPID.
CMS has specifically invited comment on whether a temporary transition process should let devices already past the IDE presubmission stage become eligible after the fact, and if so, for how long, along with general feedback on the eligibility criteria, procedures, and overall design of the pathway.
Comment deadline. Comments can be submitted electronically through Regulations.gov (docket CMS-2026-2674), by regular mail, or by express or overnight mail to CMS's Baltimore office. As of this writing, nine comments have already been posted to the docket.
Why This Matters for Medtech and SaMD Companies
RAPID represents a real opportunity to shorten the gap between FDA clearance and Medicare reimbursement, but it requires engaging with CMS years before market authorization, not after.
Build Medicare relevant health outcomes into IDE study design from day one, not retrofitted later.
Coordinate FDA and CMS touchpoints early, ideally before IDE presubmission, rather than treating them as sequential conversations.
Weigh honestly whether your device's risk profile and evidence base make it a good fit for RAPID's tight, same-day NCD posture, versus a more traditional path.
The comment period is a genuine opportunity to shape how workable RAPID turns out to be, particularly on the proposed transition process for devices already mid-IDE.
Not sure if your device is a fit for RAPID, or want help thinking through your reimbursement strategy? Prevara's team is ready to help.
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