CMS proposes RAPID device coverage: a proposed NCD on FDA approval day, final in 60 to 90 days, and TCET paused

Sixty days. That is how long CMS says it wants Medicare national coverage to take after FDA authorizes an eligible Class II Breakthrough Device, under a pathway the agency formally proposed in the Federal Register on August 11 [1]. For Class III devices the target is about 90 days [1, 2]. A conventional national coverage determination (NCD), the decision that sets Medicare coverage for an item across the country, generally takes 9 to 12 months [1].

What changed

The notice, CMS-3487-NC, sets out the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, which CMS and FDA first announced April 23 [1, 2]. CMS Administrator Mehmet Oz approved it August 7, and comments are due October 13, 2026 [1].

The mechanics: FDA and CMS agree, before the main clinical trial starts, on the health outcomes the trial must measure in Medicare beneficiaries. If the results show improvement, CMS posts a proposed NCD on the day of FDA market authorization, opens a 30-day comment period and aims to finalize about 60 or 90 days later [1, 2]. The proposed NCD depends on FDA’s Decision Summary or Summary of Safety and Effectiveness Data being public that same day, and coverage is limited to the FDA-authorized indications [1].

The notice also pauses the Transitional Coverage for Emerging Technologies (TCET) pathway for new candidates as of publication [1]. CMS finalized TCET on August 12, 2024, and said then it did not expect to accept more than five candidates a year based on its resources [3]. Under TCET, CMS aimed for a proposed NCD within 6 months of opening the review and a final one within 90 days after that [3].

Who it affects

Eligibility is narrow by design. A device must be one of the following [1, 2]:

• a Class II Breakthrough Device enrolled in FDA’s Total Product Life Cycle Advisory Program (TAP) that plans a De Novo request, or
• a Class III Breakthrough Device planning a premarket approval application, in TAP or not.

It must also be at the investigational device exemption (IDE) presubmission stage, with a planned IDE study that enrolls Medicare beneficiaries. It cannot already be under a controlling NCD, must be separately payable and must plausibly fit a Medicare benefit category [1]. A footnote extends eligibility to certain 510(k) devices whose main predicate was authorized through De Novo within the prior 18 months [1].

In vitro diagnostics are out. CMS says most coverage decisions for Breakthrough-designated tests should stay with the Medicare Administrative Contractors (MACs) [1]. Devices already on the market or already in an IDE study are also excluded, though CMS asks whether a temporary on-ramp should exist for devices in ongoing IDE trials [1].

The pool is small. A senior CMS official told reporters in April that about 40 devices would qualify now and about 20 more could, according to Healthcare Dive [4]. FDA typically grants Breakthrough status to more than 100 devices a year, the outlet reported [4].

Clinicians touch the pathway at two points: as investigators in IDE trials that must now enroll Medicare patients, and as the people who bill for the device after coverage begins.

Why does Medicare coverage lag FDA approval for new devices?

Because the two agencies answer different questions. FDA decides whether a device is safe and effective; CMS decides whether it is “reasonable and necessary” for Medicare beneficiaries under section 1862(a)(1)(A) of the Social Security Act [1]. FDA market authorization “alone does not entitle that technology to Medicare coverage,” the notice says [1].

CMS’s recurring problem is the patient mix in device trials. About half of Medicare patients have two or more diseases, the notice says, and trial exclusion criteria often screen such patients out, leaving CMS without outcome data for the population it covers [1]. RAPID tries to fix that upstream, by writing Medicare-relevant outcomes into the IDE protocol.

Without an NCD, coverage falls to the MACs, either through a local coverage determination (LCD) or claim by claim. MACs usually finalize an LCD within a year of proposing it [1]. A survey by the Stanford Byers Center for Biodesign and the Duke-Margolis Center for Health Policy found devices take an average of five years after FDA authorization to win national Medicare and commercial coverage, Healthcare Dive reported [4].

Earlier fixes have struggled to scale. Parallel Review, launched as a pilot in 2011, had received 97 requests and seen two devices complete the program as of December 2024, according to RAPS [5]. CMS says Parallel Review stays open and may be updated [1].

What it means for your practice

Coverage could arrive with the device. For a RAPID device, your practice would no longer wait for a MAC to write an LCD or decide claims one at a time. A final NCD would set the coverage terms nationally within months of launch [1, 2]. Note what the notice covers and what it doesn’t: it addresses coverage, and it says nothing about coding or payment rates.

Coverage may come with strings. Higher-risk devices are more likely to get an NCD under Coverage with Evidence Development (CED), where Medicare pays only when the patient is in an approved study or registry [1]. CED decisions are meant to be time-limited, and coverage can start once a CED study is approved [1]. If you adopt a CED-covered device, your documentation will need to show study participation.

Off-label use stays outside. RAPID coverage tracks the FDA-authorized indications [1]. Using the device for anything else puts you back into local or claim-level review.

Other NCD requests could wait longer. CMS proposes to open RAPID NCDs ahead of non-RAPID topics on its NCD Wait List when it lacks the staff to handle both [1]. If your specialty society has a pending national coverage request for an older technology, that queue matters.

Your trial site will see new demands. Sponsors in the pathway must enroll Medicare beneficiaries and measure outcomes FDA and CMS have agreed on [1, 2]. Category B IDE studies approved by CMS can already carry premarket coverage of the device itself [1].

What to do now

1. Comment by October 13. Use docket CMS-2026-2674 on regulations.gov and cite file code CMS-3487-NC [1]. CMS asks specifically about the temporary on-ramp for devices already in IDE trials [1].
2. Map the coverage route before you buy. For any new device, check whether it is under an NCD, an LCD or neither. Devices outside RAPID keep using those routes [1].
3. Track the participant lists. CMS proposes to name RAPID manufacturers and devices on its Approved IDE Studies page and NCD Dashboard [1].
4. Ask sponsors about Medicare enrollment. If you run trials, ask whether a study is a RAPID study and which outcomes it must capture [1].

The policy fight

The agencies pitch RAPID as cutting delay. “The American people deserve timely access to meaningful treatments without red tape or high costs,” FDA Commissioner Marty Makary said in April [4]. Oz said the pathway “brings our two agencies together earlier, cutting red tape for innovators” [4].

Industry groups welcomed it with conditions. AdvaMed CEO Scott Whitaker said “it is critical that the implementation of such a proposal is effective” and warned against a program without “meaningful timelines, accountability, and effective management” [4, 5]. Mark Leahey, CEO of the Medical Device Manufacturers Association, said it “holds significant promise to alleviate the problem of delayed access for Medicare beneficiaries” [5]. AdvaMed had criticized TCET for how few devices it could take [4].

The notice itself names the trade-offs commenters will weigh. Only devices that have not yet started their main IDE trials qualify, so products already in IDE studies wait for a possible transition process [1]. Lab tests stay with the MACs [1]. And faster RAPID decisions could push other NCD topics down the queue when staff are short [1]. Whether a final notice keeps those limits depends on comments due October 13.