CMS Pauses TCET and Proposes Same-Day Coverage for Breakthrough Devices

On 11 August 2026 CMS published a notice with comment period setting out the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway — a process under which a proposed national coverage determination would be issued on the same day as FDA market authorisation, and finalised as little as 60 days later. The notice is at 91 FR 51710, file code CMS-3487-NC, docket CMS-2026-2674. Comments close 13 October 2026.

The sentence with the most immediate consequence is not about RAPID at all. It is this: the Transitional Coverage for Emerging Technologies (TCET) pathway is paused for new candidates on publication of this notice, while CMS concentrates on implementing RAPID. TCET was established only two years ago, on 12 August 2024 (89 FR 65724). Any manufacturer that was preparing a TCET nomination needs to reassess now.

What RAPID actually does

Today, the standard national coverage determination process has statutory timeframes and generally takes nine to twelve months to complete. That clock normally starts after FDA market authorisation, which is where the well-known coverage gap comes from: a device can be legally marketed and still have no Medicare coverage for the better part of a year.

RAPID attacks the gap by moving the evidence work forward rather than by shortening the review. Under the pathway, CMS and FDA agree with the manufacturer, at the IDE pre-submission stage, on the clinical health outcomes the investigational device exemption study will measure in Medicare beneficiaries. If the completed study demonstrates improvement in those outcomes, CMS posts a proposed NCD on the day FDA authorises the device — timed to coincide with public availability of the FDA Decision Summary or Summary of Safety and Effectiveness Data — and aims to finalise it:

60 days later for Class II devices

90 days later for Class III devices

CMS notes that interested parties told it a short 60-to-90-day delay is actually useful, since it gives manufacturers time to prepare for distribution.

The underlying problem CMS is trying to solve is stated plainly in the notice: FDA’s review does not require a focus on the Medicare population, and studies conducted for market authorisation are not required to enrol participants resembling Medicare beneficiaries. CMS cites research indicating roughly 50 percent of Medicare patients have two or more diseases, and notes that trials often exclude exactly those patients to make a device’s effect easier to isolate. The result is that at authorisation, CMS frequently has no evidence it can use. RAPID’s answer is to specify what CMS needs before the study is designed.

Who is eligible — and who is not

Participation is voluntary, and the eligibility gate is narrow. A device must meet all of the following:

Be a Class II FDA Breakthrough-designated device enrolled in FDA’s Total Product Life Cycle Advisory Program (TAP) and planning a De Novo request — which includes 510(k)-cleared devices whose primary predicate was authorised via De Novo no earlier than 18 months before acceptance — or a Class III Breakthrough-designated device planning a PMA, whether or not it is in TAP;

Be at the IDE pre-submission stage, with a planned IDE study that enrols Medicare beneficiaries and evaluates clinical outcomes FDA determines appropriate and CMS confirms would demonstrate improvement for the Medicare population;

Not be obviously outside a Medicare benefit category on the available information;

Not already be the subject of a controlling NCD;

Be separately payable and billable to Medicare if approved;

Not be otherwise excluded from coverage by law or regulation.

In vitro diagnostics are excluded outright. CMS notes that the statutory definition of “device” at section 201(h)(1) of the FD&C Act includes IVD products such as diagnostic laboratory tests, but states that IVDs “will not be accepted into the RAPID coverage pathway.” Its reasoning is that IVD coverage has historically been delegated to specialised MACs and should stay there. A manufacturer of a Breakthrough-designated diagnostic test that assumed RAPID would apply to it should read section II.C of the notice before doing anything else — the rare NCD route remains open via the request process at 78 FR 48164, but the accelerated pathway does not. This is a meaningful asymmetry for anyone tracking FDA regulation of laboratory developed tests.

Also excluded: devices already market-authorised, and devices already being studied under an IDE. CMS is explicitly soliciting comment on whether to create a temporary on-ramp for in-flight IDE studies that would otherwise have qualified, and on how long such a window should last. If your device is mid-study, that is the comment to file.

The three stages

RAPID runs in three stages: IDE pre-submission, formal IDE submission to FDA and CMS, and transition from IDE to coverage.

Entry happens through FDA, not CMS. After receiving Breakthrough designation (and TAP acceptance where applicable), a manufacturer emails FDA in advance of an IDE pre-submission; a TAP advisor then facilitates entry. FDA screens the candidate against the eligibility criteria and consults CMS on benefit category, statutory exclusions under 42 CFR part 411 subpart A, and whether a controlling NCD already exists. If the manufacturer proceeds, FDA works with it on a clinical study synopsis for a RAPID kick-off meeting attended by FDA, CMS and the manufacturer, at which CMS and FDA may give real-time comments on the protocol. CMS then provides FDA with written feedback on whether the proposed health outcomes are sufficient.

For teams accustomed to running device studies, the practical shift is that CMS becomes a party to protocol design rather than a downstream reviewer — which changes who needs to be in the room when endpoints and inclusion criteria are set. See IDE significant risk determinations for how the study classification interacts with this.

Coverage with evidence development is still on the table

RAPID does not guarantee unconditional coverage. CMS states that the improvement in health outcomes and the relative risk of the device determine whether coverage with evidence development forms part of the NCD. Lower-risk devices are more likely to have generated enough evidence by authorisation to be reasonable and necessary under section 1862(a)(1)(A) of the Act; higher-risk devices are more likely to have residual evidence gaps and to be covered under section 1862(a)(1)(E), the CED authority. Where CED is anticipated, CMS says it will engage with FDA and the manufacturer before market authorisation to align CED requirements with any FDA-required post-approval studies — which, if it works, removes one of the more expensive duplications in the current system.

Manufacturers may withdraw at any point up to the issuance of a proposed NCD; CMS gives insufficient data, or a judgement that local coverage would be more advantageous, as legitimate reasons. FDA and CMS may also remove a manufacturer from the pathway where it fails to supply requested information or is “found to be falsifying or omitting pertinent information.”

Two proposals with consequences beyond RAPID participants

First, queue priority. CMS proposes to prioritise opening RAPID NCDs over non-RAPID NCDs from the NCD Wait List when it cannot address the total volume within available resources. It commits to continuing to apply the prioritisation circumstances described in its August 2013 notice for everything else. In plain terms: if you have a topic on the NCD Wait List and no Breakthrough designation, RAPID candidates go ahead of you.

Second, disclosure. CMS proposes to make the identity of manufacturers and devices in the RAPID pathway publicly available, giving the CMS Approved IDE Studies web page and the NCD Dashboard as examples. That is a real change in posture for pre-market device programmes and is worth a comment from anyone who regards pipeline participation as confidential.

How this fits the history

This is the third attempt at the same problem in six years. The Medicare Coverage of Innovative Technology (MCIT) final rule, issued in January 2021, was repealed on 15 November 2021 (86 FR 62944). TCET was established on 12 August 2024 (89 FR 65724) and is now paused for new candidates. Parallel Review, announced as a pilot in 2010 (75 FR 57045) and fully implemented in 2016 (81 FR 73113), survives — and CMS says its scope is broader than RAPID’s and could support expedited review of non-Breakthrough devices, adding that it intends to work with FDA on updates to Parallel Review to align procedures.

CMS states that RAPID reflects feedback gathered after the MCIT repeal and during TCET’s establishment. It was announced on 23 April 2026, and CMS says FDA and CMS have already begun engaging with potentially eligible manufacturers since then.

What to do before 13 October

If you were preparing a TCET nomination, stop and reassess. The pause applies to new candidates from publication. CMS’s advice for manufacturers past IDE initiation who believe they have sufficient evidence is to contact CMS about available mechanisms, including a conventional NCD request under 78 FR 48164.

If you have an IDE study already running, comment on the temporary on-ramp. CMS asked for input on whether to create one and how long it should last. That question is live and unresolved.

If you make IVDs, read the exclusion carefully and comment if you disagree with it. CMS gave a reason — MAC specialisation — rather than a statutory bar, which makes it the kind of position that responds to evidence.

If you hold a place on the NCD Wait List, the prioritisation proposal affects you and is expressly open for comment.

Frequently asked questions

Is RAPID in effect now?

This is a notice with comment period, not a final rule. CMS describes the process it will use and simultaneously solicits comment on it. The TCET pause, however, is stated as taking effect upon publication of the notice.

Does RAPID change the “reasonable and necessary” standard?

No. CMS states explicitly that RAPID “will not alter the existing standards” for the current coverage mechanisms. The statutory tests at section 1862(a)(1)(A) and, for CED, section 1862(a)(1)(E) of the Act are unchanged. What changes is when the evidence is generated and when the determination is issued.

Does FDA market authorisation now mean Medicare coverage?

No, and the notice is emphatic on the point: “FDA market authorization alone does not entitle that technology to Medicare coverage.” The two agencies apply different statutory standards. RAPID aligns the timing, not the tests.

Are diagnostic laboratory tests eligible?

No. IVD products, which under section 201(h)(1) of the FD&C Act include diagnostic laboratory tests, will not be accepted into RAPID. CMS intends coverage for Breakthrough-designated IVDs to continue through the MACs.

What happens to devices already in TCET?

The notice states the pause applies to new candidates. It does not describe termination of existing TCET participation. Manufacturers already in TCET should confirm their status with CMS rather than infer it from the notice.

When and where do comments go?

By 13 October 2026, electronically at regulations.gov under docket CMS-2026-2674, or by mail to CMS marked with file code CMS-3487-NC. All comments received before the close of the period are posted publicly, including any confidential business information they contain — CMS says so directly.

Primary source: Centers for Medicare & Medicaid Services, “Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway,” notice with comment period, 91 FR 51710 (11 August 2026), file code CMS-3487-NC, docket CMS-2026-2674, comments due 13 October 2026. Cited within: 86 FR 62944 (15 November 2021, MCIT repeal); 89 FR 65724 (12 August 2024, TCET); 75 FR 57045 (17 September 2010) and 81 FR 73113 (24 October 2016) (Parallel Review); 78 FR 48164 (NCD request process); section 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-3); sections 1862(a)(1)(A), 1862(a)(1)(E), 1862(m), 1869(f)(4) and 1142 of the Social Security Act; 42 CFR 405.212 and 42 CFR part 411, subpart A.

Further reading: IDE Studies Medicare Coverage — FDA assigns every Investigational Device Exemption (IDE) study a Category A (experimental) or Category B (nonexperimental/investigational) classification, and that classification — not the trial phase — decides whether.

Related reading: CED CMS — How CMS’s Coverage with Evidence Development (CED) mechanism conditions Medicare payment on registry or clinical-study participation, and what it means for research administration and billing.