CMS Puts RAPID Device Coverage Plan Out for Comment, Pausing TCET Intake

The Centers for Medicare & Medicaid Services published its proposed procedure for the RAPID coverage pathway in the Federal Register on Tuesday, setting out how Medicare would issue a proposed national coverage determination on the same day the FDA authorizes an eligible device that holds breakthrough device designation.

The notice with comment period (CMS-3487-NC, 91 FR 51710) describes the Regulatory Alignment for Predictable and Immediate Device pathway, which CMS and the FDA first announced on April 23. Comments are due October 13, 2026. CMS Administrator Mehmet Oz approved the document on August 7, the day the agency posted a fact sheet on the proposal.

How the pathway would work

According to the notice, the pathway is meant to align FDA and CMS evidence expectations before a pivotal study begins, so that an investigational device exemption (IDE) study can support both FDA market authorization and Medicare coverage. CMS would post a tracking sheet and proposed national coverage determination (NCD) when the FDA authorizes the device, open a 30-day comment period, and aim to finalize the NCD about 60 days after authorization for Class II devices and 90 days after for Class III devices.

The notice says the NCD process generally takes 9 to 12 months to complete. In the April announcement, CMS said the new approach could enable national coverage and payment as soon as two months after market authorization, compared with approximately a year or more under the current pathway.

Eligibility is narrow. The fact sheet lists these requirements, among others:

• The device is a presumptive Class II device with breakthrough device designation that participates in the FDA's Total Product Life Cycle Advisory Program (TAP) and plans a De Novo request, or a Class III device with the designation that plans a premarket approval application, whether or not it is in TAP.
• The device is still at the IDE pre-submission stage, and the planned IDE study enrolls Medicare beneficiaries and measures clinical outcomes the FDA considers appropriate and CMS confirms are relevant.
• The device is not already the subject of a controlling NCD, is separately payable and is not excluded from coverage by law or regulation.

In vitro diagnostics will not be accepted, the fact sheet says; CMS wrote that coverage for most diagnostics with breakthrough device designation should continue to be decided by Medicare Administrative Contractors. Devices that are already authorized or whose IDE study is underway are also excluded, although the notice asks for comment on whether CMS should set up a temporary process that would let devices currently being studied under an IDE become eligible.

TCET paused, evidence development kept

The notice also halts intake for the Transitional Coverage for Emerging Technologies (TCET) pathway, which CMS established on August 12, 2024. "The TCET pathway will be paused for new candidates upon publication of this notice with comment period as CMS focuses on the successful implementation of the RAPID coverage pathway," the notice states. It directs manufacturers already past the start of their IDE study to contact CMS about other coverage mechanisms, including a standard NCD request. Parallel Review, a joint FDA-CMS program with broader eligibility, remains available, the notice says.

Not every RAPID decision would be unconditional coverage. The fact sheet says the improvement shown in the IDE study and the device's relative risk will determine whether an NCD requires coverage with evidence development (CED), and that higher-risk devices are more likely to have remaining evidence gaps. CMS said CED coverage under RAPID should be time-limited and that it would try to align any CED requirements with FDA-required post-approval studies.

CMS also proposes to open RAPID coverage reviews ahead of other topics on its NCD wait list if it cannot handle the full volume of requests, and to publish the names of manufacturers and devices accepted into the pathway. CMS said it will respond to comments in a subsequent final notice; the April announcement said the pathway is expected to take effect when that final notice is published.