CMS, FDA Propose New Path for Breakthrough Devices

Published by Medmarc Insurance on May 12, 2026

The Centers for Medicare & Medicaid Services and the FDA recently announced a new program that will create a more predictable route for adoption of innovative medical devices. The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway requires the two agencies to collaborate with manufacturers early in the development cycle and could enable Medicare coverage within months of FDA approval, compared to significantly longer timelines under current processes.

The RAPID pathway is set aside for class II and class III devices that are admitted to the FDA breakthrough devices program. May 2026 Blog CMS, FDA Propose New Path for Breakthrough Devices 1200x625 px The concept calls on both agencies to work with innovators early enough in the product development cycle to allow the developer to devise an evidence generation plan that can satisfy both agencies’ requirements.

The RAPID program is intended to synchronize the FDA premarket review process with the CMS national coverage determination (NCD) process with the expectation that CMS will issue a draft NCD the same date on which the FDA approves or clears the device. CMS administrator Mehmet Oz said the structure of the program would cut red tape and bring life-saving technologies to patients more quickly. FDA commissioner Marty Makary said the two agencies would function as a single team to bring breakthrough devices to patients “as soon as we know they work.”

Class II devices, which are those going through the 510(k) or de novo premarket programs, would be eligible for RAPID only if they are taking part in both the breakthrough devices program and the Total Product Life Cycle Advisory Program (TAP). All class III devices that are in the breakthrough devices program would be eligible, assuming they are not already part of an established coverage pathway.

CMS is generally required to issue a draft coverage determination within six to nine months of receipt of the request, although there is a backlog of such requests. After factoring in the comment period, the NCD process is ordinarily expected to span nine to 12 months, an expectation the agency may struggle at times to meet.

CMS intends to suspend the Transitional Coverage for Emerging Technologies (TCET) program while the RAPID program is established, although other programs for bringing new devices into Medicare coverage will continue. The two agencies will publish a draft edition of the RAPID framework in the Federal Register, after which interested parties will have 60 days to comment.

The announcement for the RAPID program prompted the Advanced Medical Technology Association (AdvaMed) to post an April 23 press release stating that AdvaMed has historically favored a shorter timeline to Medicare coverage for breakthrough devices. AdvaMed said the gap between regulatory approval and payer coverage of these devices has a median length of nearly six years.

Scott Whitaker, AdvaMed President and CEO, said the announcement “is a positive step toward expanding Medicare beneficiaries’ access to the FDA-authorized, safe and effective breakthrough medtech they desperately need.” However, Whitaker stated also that an appropriate implementation of RAPID is critical to the program’s success, emphasizing meaningful timelines and program accountability.

Whitaker stated further that AdvaMed is concerned about CMS’s proposal to repeal one of the pathways under the new technology add-on payment (NTAP) program under the Medicare inpatient prospective payment system. He said AdvaMed will continue to work with CMS “to shore up the NTAP program and its critical role in serving Medicare beneficiaries.”

Last updated on May 19, 2026

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