CMS Moves RAPID Coverage Pathway Forward for Breakthrough Medical Devices

The Centers for Medicare & Medicaid Services (CMS) is moving forward with a new approach designed to shorten the gap between FDA authorization and Medicare coverage for certain breakthrough medical devices.

On August 11, 2026, CMS published a procedural notice with comment period outlining its proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. The proposal moves RAPID closer to implementation and gives manufacturers and other stakeholders until October 13, 2026, to submit comments.

From FDA Authorization to Medicare Coverage

RAPID was first announced by CMS and the FDA in April, and seeks to address the fact that FDA market authorization does not automatically result in Medicare coverage. If enacted, RAPID would bring CMS into the process earlier. Eligible manufacturers would work with FDA and CMS during device development to generate clinical evidence relevant to both FDA review and Medicare coverage. The pathway would apply to certain FDA-designated Class II and Class III Breakthrough Devices addressing unmet needs among Medicare beneficiaries.

For qualifying devices, CMS proposes issuing a proposed National Coverage Determination (NCD) on the same day as FDA market authorization. Presumably, this would allow national Medicare coverage as soon as approximately two months after FDA authorization.

RAPID Represents a Shift Away From TCET

RAPID builds on CMS's Transitional Coverage for Emerging Technologies (TCET) pathway, which sought to provide more predictable Medicare coverage for certain breakthrough devices. CMS has now paused acceptance of new TCET candidates while it focuses on implementing RAPID.

Stakeholders should take interest because the implementation of RAPID would move Medicare considerations further upstream, encouraging manufacturers to address CMS evidence expectations while clinical studies are still being designed rather than waiting until after FDA authorization. This, however, does not necessarily solve every reimbursement challenge. The RAPID notice focuses primarily on Medicare coverage and does not itself guarantee appropriate coding or payment for participating technologies. Manufacturers will still need a broader reimbursement strategy.

Why This Matters for MedTech

For companies serving Medicare populations, decisions about trial populations, clinical endpoints and evidence generation could increasingly influence both regulatory authorization and the speed of Medicare coverage.

The current comment period also gives manufacturers, investors, providers and other stakeholders an opportunity to influence how CMS structures the pathway before it becomes final.

If RAPID works as intended, it could significantly reduce the delay between receiving FDA authorization and obtaining national Medicare coverage.

For MedTech companies, the emerging question is no longer simply how to secure FDA authorization. It is how to build an evidence strategy that supports FDA authorization and Medicare coverage at the same time.

Comments on the RAPID procedural notice are due October 13, 2026.