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

Administration Share 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 Download the RAPID Coverage Pathway Infographic (PDF) 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; Devices in the IDE pre-submission stage, and the manufacturer plans to conduct an IDE study that enrolls Medicare beneficiaries and evaluates clinical outcomes that FDA determines are appropriate for the device and that CMS confirms evidence showing that the device achieves those outcomes in the Medicare beneficiary population would demonstrate that the device improves health outcomes for Medicare beneficiaries; Based on the information available, there is no evidence that immediately makes clear that the device will not fall under a Medicare benefit category; Not already the subject of a controlling Medicare NCD; Separately payable devices that can, if approved, be billed to Medicare; and Not otherwise excluded from coverage through law or regulation. FDA’s statutory definition of “device” includes in vitro diagnostic (IVD) products, such as diagnostic laboratory tests. IVDs, including diagnostic laboratory tests, are a highly specific area of coverage policy development, and CMS has historically delegated the review of many of these products to specialized Medicare Administrative Contractors (MACs). CMS believes that the majority of coverage determinations for IVDs granted Breakthrough Device designation should continue to be determined by the MACs through existing pathways. Therefore, IVD products will not be accepted into RAPID. Devices beyond the IDE pre-submission stage (such as those market authorized or with an IDE study underway) are not appropriate for RAPID. Under RAPID, CMS and FDA will leverage their early involvement in IDE pre-submission during the premarket phase. CMS National Coverage Determination Analysis and Timing After completing the IDE study, a manufacturer of a device in the RAPID coverage pathway will follow several steps to get national Medicare coverage, including submitting an NCD request letter and receiving FDA market authorization. If the device has demonstrated improved health outcomes, then CMS will initiate the NCD process by posting a tracking s