Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (CMS-3487-NC) Procedural Notice Inviting Comment

The Centers for Medicare & Medicaid Services (CMS) issued a proposed procedural notice outlining a faster way for manufacturers to get new devices covered by Medicare: the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. First announced by CMS and the Food and Drug Administration (FDA) on April 23, 2026, this new Medicare coverage pathway will accelerate beneficiary access to eligible Class II FDA-designated Breakthrough Devices participating in FDA’s Total Product Life Cycle Advisory Program (TAP) and to eligible Class III FDA-designated Breakthrough Devices (regardless of TAP participation).

Under the RAPID coverage pathway, CMS and FDA will use existing programs and coverage frameworks to analyze and approve in a more timely and predictable way those devices that demonstrate positive clinical health outcomes in the premarket phase. Specifically, RAPID leverages FDA’s existing process to assess clinical outcomes in proposed Investigational Device Exemption (IDE) studies to facilitate a more efficient and streamlined process for manufacturers seeking Medicare coverage after FDA market authorization.

Through the RAPID coverage pathway, CMS will join early and frequent engagement opportunities between FDA and device manufacturers — linking manufacturers to CMS experts early in development to understand what clinical outcomes are most relevant for Medicare beneficiaries. By aligning CMS and FDA evidence expectations in advance, the RAPID coverage pathway is designed to significantly reduce the review times that have historically occurred between FDA market authorization and Medicare national coverage determinations (NCDs). For devices completing the RAPID coverage pathway, a proposed NCD will be issued the same day as FDA market authorization, meaning that national Medicare coverage could begin as soon as 60 days after FDA market authorization.

The public will have 60 days to comment on the procedural notice. CMS will respond to public comments in a subsequent final notice.

Background

Stakeholders have long sought a better way to cover new, innovative technologies. Today’s announcement is a critical step toward fulfilling the Trump administration’s commitment to provide accelerated and more predictable Medicare coverage for Breakthrough technologies that clinically benefit the Medicare population.

RAPID Coverage Pathway at a Glance

Device Eligibility

Only devices that meet the following requirements are eligible for RAPID:

- Presumptive Class II FDA Breakthrough-designated devices participating in TAP planning to submit a De Novo request to FDA; 1 or Class III FDA Breakthrough-designated devices planning to submit a premarket approval application (PMA) regardless of whether they are participating in TAP;