CMS and FDA propose same-day coverage decisions for breakthrough devices

MedDevice Startups Staff · Apr 23 · 2 min read · Via FDA press announcement

CMS and FDA announced the RAPID coverage pathway on April 23, 2026. Under it CMS issues a proposed national coverage determination on the same day FDA grants marketing authorization, triggering a public comment period rather than starting a fresh evidence review. Coverage and payment could follow roughly two months after authorization. Today that gap runs a year or longer, and for a startup it is usually the difference between a clearance and revenue.

Eligibility runs through the Breakthrough Devices Program. A Class III breakthrough device qualifies on its own. A Class II breakthrough device must be enrolled in TAP, the Total Product Life Cycle Advisory Program, which as of July 1, 2026 accepts requests across all Offices of Health Technologies and holds 133 enrolled devices. Either way the device needs an IDE study enrolling Medicare beneficiaries and measuring outcomes both agencies agreed to in advance. That last condition is the real work: it means bringing CMS into trial design years before submission.

CMS and FDA put roughly 40 devices in scope now, with about 20 more potentially eligible, against the five a year TCET handles. AdvaMed CEO Scott Whitaker was measured: "Without meaningful timelines, accountability, and effective management of this program, patients are unlikely to see the full benefits." A proposed procedural notice with a 60-day comment period comes before implementation.

Questions & Answers

What is the RAPID coverage pathway announced by CMS and FDA?

RAPID, or Regulatory Alignment for Predictable and Immediate Device coverage, was announced April 23, 2026. CMS would issue a proposed national coverage determination the same day FDA grants marketing authorization, which could put Medicare coverage in place about two months after authorization instead of a year or more.

Which devices qualify for the RAPID coverage pathway?

FDA-designated Breakthrough Devices that address an unmet need for Medicare patients. Class II devices must be enrolled in FDA's Total Product Life Cycle Advisory Program, Class III devices need not be, and the device must have an IDE study enrolling Medicare beneficiaries with outcomes agreed by both agencies.

How does RAPID differ from the TCET pathway?

TCET accepts about five devices a year. CMS and FDA said roughly 40 devices would qualify for RAPID today with another 20 potentially eligible, and RAPID aligns evidence expectations during development rather than after authorization.

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