By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting
Earlier this year, in April 2026, FDA and the Centers for Medicare and Medicaid Services (CMS) announced the proposed establishment of the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new program aimed at helping Sponsors of novel medical devices temporally align their regulatory authorization through the FDA with reimbursement coverage by CMS. At the time, very little information was available detailing the particulars of RAPID enrollment and benefit. As such, the MedTech field, including our team at Mittal Consulting, generally accepted this news with hopeful optimism about the potential benefits for Sponsors of novel medical devices to avoid the “valley of death” that awaits in the period between FDA authorization and successful establishment of reimbursement streams. In August, CMS finally released the full details of this program, opening a 60-day comment period for MedTech stakeholders to weigh in. Equipped with a clearer picture of what FDA and CMS have in store for RAPID, while the purpose and potential benefits of the program are coming from the right place, significant concerns with the eligibility criteria and implementation as currently written call into question the utility of the program for a large swath of device Sponsors.
In April, FDA and CMS introduced the RAPID pathway and identified its objective to involve both FDA and CMS in planning clinical validation packages still in development for eligible devices. The goal is that the agreed upon clinical data can support an FDA premarket authorization on the same day as a preliminary proposed CMS national coverage determination (NCD), which is the key determinant of whether Medicare will pay for a medical device.
FDA and CMS’ August notice clarifies two major components of RAPID: enrollment eligibility and program timelines. To be considered an appropriate candidate for RAPID, the device should either be a Class II Breakthrough-designated device participating in FDA’s Total Product Lifecycle Advisory Program (TAP) and planning a De Novo premarket submission, or a Class III Breakthrough-designated device planning to submit a PMA (but not necessarily enrolled in TAP). The devices should be at the “IDE pre-submission” stage, referring to the period where a device Sponsor is planning a clinical study expected to be of significant risk and is discussing their clinical plan with FDA but has not yet submitted a formal Investigational Device Exemption (IDE) submission to gain FDA approval to proceed with the study. The clinical study must target enrollment of Medicare beneficiaries, and the device should not already be the subject of a Medicare National Coverage Determination (NCD), the prize awaiting RAPID-enrolled devices.
Eligible devices can initiate into RAPID immediately after FDA Breakthrough Device Designation and enrollment in TAP through an email request and preliminary consideration and benefit category analysis by both FDA and CMS. If all parties agree on the eligibility, a kick-off meeting with FDA, CMS, and the Sponsor will be held to walk through a preliminary clinical study synopsis and gain feedback before submitting the next Pre-Submission that will discuss the details of the study. Using the written feedback from both FDA and CMS on the Pre-Submission, the Sponsor should then submit an IDE application for FDA review. Importantly, FDA conducts the IDE review independently and provides their decision to approve the IDE to both the Sponsor and CMS at the same time. At that point, CMS has the opportunity to provide feedback that may trigger an amended protocol for FDA review, and the IDE review process continues until all parties are satisfied. After the Sponsor conducts the IDE study, FDA shares the study report with CMS, and an FDA premarket authorization and a proposed NCD are delivered on the same day. CMS states that a full coverage determination can arrive as early as 60 days later, but also reserves the right to ask for additional evidence collection, making this timeline a minimum, not a maximum.
In Mittal Consulting’s initial analysis of the RAPID pathway in April, our main concerns centered around the accessibility of the program based on the narrow eligibility requirements, necessarily limiting the utility for devices that didn’t or can’t gain Breakthrough Designation or enroll in TAP and for devices that aren’t conducting significant risk clinical studies as part of their premarket authorization submission. Now, with much more information than was present in the initial announcement, these concerns remain – and may have in fact worsened with the more granular eligibility criteria. We share the sentiment with other industry voices that have utilized the open comment period from the August notice to express support for a CMS coverage pathway that provides for more predictable access to a crucial step of reimbursement and endorses early communication between FDA and CMS to proactively design a clinical validation package that satisfies both regulatory and reimbursement targets. However, there are significant restrictions that decrease the value of the program. The criteria prohibit enrollment for a large number of device categories, including Class I devices that are Breakthrough-designated, Class II devices that are Breakthrough-designated but unable to enroll in TAP, Class II devices appropriately pursuing the 510(k) pathway, devices that are the subject of clinical studies that are appropriately considered non-significant risk for which an FDA IDE approval is not required, and in vitro diagnostic (IVD) devices.
AdvaMed, the leading advocacy group representing the interests of medical device company members, emphasizes in their public comment the risk of such narrow eligibility for companies that are desperate to avoid the valley of death. Sponsors working on devices that were accurately classified as low-risk, that are pursuing the comparatively less burdensome 510(k) pathway for marketing authorization, or are conducting clinical studies of “non-significant risk” which, correctly, do not require FDA approval before study start may artificially upclassify their device and clinical program’s risk level, claiming more risk or intentionally designing a device to increase the risk level unnecessarily. This would not only greatly increase the burden on the Sponsor, but also antithetically increase the workload on an already overburdened FDA, who must now review a potentially much greater number of IDE submissions and lengthy De Novo premarket applications for devices that simply don’t fit into those categories. CMS should not indirectly dictate regulatory decisions made by Sponsor with the FDA.
Further, several comments, including AdvaMed’s response, emphasize that there must be a transition period as RAPID takes effect. There are many companies that do fit the criteria – Class II or III Breakthrough devices with TAP enrollment – that have already started clinical data collection and are no longer at the “pre-IDE” stage that may still require the support and collaboration that RAPID is intended to provide.
This is especially important as the new RAPID details and conclusion of the open comment period come at a particularly precarious time for reimbursement of novel devices. First, when FDA and CMS announced RAPID in April, CMS also announced the pause of the Transitional Coverage for Emerging Technologies (TCET) pathway that served to accelerate NCDs before RAPID. Though the concept behind RAPID is to helpfully shift CMS and FDA collaboration earlier in the evidence generation timeline than TCET, TCET included broader eligibility criteria, potentially leaving companies designing their development program for TCET but now ineligible for RAPID in the lurch. Additionally, on the payment side of reimbursement, an August announcement from CMS repealed the alternative pathway for access to new technology add-on payment (NTAP) and transitional pass-through payment (TPT) programs, making it immensely more difficult for novel technologies to apply for payment support through the valley of death, which our team at Mittal Consulting saw as a direct blow to medical device innovation. For these reasons, medical device stakeholders are particularly conscious of changes to the reimbursement schemes meant to support successful transfer of important medical innovation to patients.
Now at the conclusion of the public comment period for RAPID, FDA and CMS will review the recommendations provided by industry stakeholders and consider amendments as necessary. Until the final notice of the RAPID pathway is ready, it isn’t clear whether the eligibility requirements will be loosened to provide the opportunity of benefit to more novel device Sponsors. Companies working on truly impactful devices are still encouraged to pursue FDA Breakthrough Designation and TAP enrollment as applicable to accelerate device development programs. Importantly, there is still not a known implementation date for RAPID. Sponsors, especially those nearing the start of FDA interactions regarding clinical studies that might fit into RAPID’s eligibility requirements, should remain vigilant for any updates from FDA and CMS.