The disconnect between the subjects enrolled in prospective clinical trials and patients in the real world has been an issue of concern for years. Dr. Marissa Carter and I first published on this in 2009 Advances in Skin & Wound Care. To over-simplify the problem – the Food and Drug Administration (FDA) requires efficacy studies in a carefully-controlled environment while payers like the Centers for Medicare and Medicaid Services (CMS) need to understand effectiveness among real world patients. The disconnect is no one’s fault – the FDA and CMS have entirely different mandates. However, it has created serious problems for patient access and it has hindered the development of new treatments. Manufacturers may spend millions on the clinical trials needed to bring a novel product to market and then begin an entirely separate (and unclear) process for Medicare coverage of their novel treatment. Both the Alliance of Wound Care Stakeholders and the Wound Care Collaborative Community have advocated for a better path forward, but aligning two very differently focused government organizations (CMS and the FDA) is a massive undertaking. However, there is exciting news on that front!
On April 23, CMS and FDA announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, a new mechanism designed to better align FDA authorization with Medicare coverage. The details are complex, so I asked Joe Rolley to break it down. Thank you, Joe for taking the time to write this insightful article.
–Caroline
RAPID Isn’t Just Faster Coverage: It’s a Fundamental Reset for Device Evidence and Access
On April 23, CMS and FDA announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway1, a new mechanism designed to better align FDA authorization with Medicare coverage. RAPID is more than a faster coverage process; it reflects a structural shift in how the U.S. evaluates and pays for breakthrough medical technologies.
For years, innovators have operated in a fragmented system: FDA determines whether a technology works, while CMS determines whether it gets used. The result has been delayed access, duplicative evidence requirements, and persistent uncertainty for developers and clinicians alike. RAPID represents strong attempt to close that gap.
At first glance, the program appears to be about speed. CMS notes that synchronized processes could enable Medicare coverage as soon as two months after FDA authorization. However, focusing only on speed misses the larger point; the real change is structural.
From Sequential to Parallel Decision Making
RAPID shifts the system from sequential to parallel decision making. CMS is now embedded earlier in the development process, participating alongside FDA as evidence strategies are defined rather than after pivotal trials are complete. Coverage is no longer a downstream administrative step; it becomes part of the development pathway itself.
This has immediate implications for how technologies are designed, studied, and positioned. It also reduces a long standing inefficiency in the system: the need to retrofit evidence generated for FDA into something that can satisfy CMS after the fact.
A Higher Bar for Evidence in Wound Care
For wound care innovators, RAPID is not simply an opportunity to move faster. It signals a shift in what counts as “sufficient evidence.” Because RAPID requires Medicare relevant outcomes and early CMS involvement, clinical trials will need to reflect the patients who drive utilization and cost; that is, older adults with chronic, complex wounds and multiple comorbidities. This represents a meaningful departure from the narrowly defined study populations that have characterized parts of the wound care evidence base.
Endpoints will also need to evolve. Binary wound closure, while still important, is unlikely to be sufficient on its own. CMS will increasingly expect to see evidence of durability, reductions in infection and complications, functional improvement, and whether a technology can meaningfully reduce high cost interventions such as hospitalization or amputation.
At the same time, the Breakthrough designation itself is likely to be interpreted more rigorously. RAPID is limited to FDA designated Breakthrough Devices addressing unmet need, which means many incremental innovations which are common in wound care may not qualify. The implication is clear that clinical differentiation, not product iteration, will determine access to accelerated pathways.
This shift also elevates the importance of evidence generated outside traditional clinical trials. As CMS becomes involved earlier, the focus expands from whether a technology can work under controlled conditions to how it performs in real world settings. Registries, longitudinal datasets, and digital wound measurement platforms are no longer peripheral but instead are becoming central to the evidence strategy.
The Missing Piece: Infrastructure for Adaptive Evidence
While RAPID establishes a framework for alignment, it also exposes a practical challenge. Generating Medicare relevant, real world–reflective evidence across the product lifecycle is not something most innovators are equipped to do on their own.
Organizations such as the Wound Care Collaborative Community (WCCC), an FDA recognized collaborative community, are beginning to fill this gap by developing shared, pre competitive evidence frameworks for wound care. Through initiatives like the Adaptive Evidence Program, WCCC is working to standardize clinical and patient reported outcomes, support longitudinal data collection across care settings, and integrate real world evidence into regulatory and coverage decision making. Because these frameworks are not tied to any single product, they create a common foundation that reduces duplication, improves comparability across technologies, and helps align expectations among regulators, payers, clinicians, and innovators. As RAPID evolves, this type of infrastructure may become essential for technologies seeking both timely authorization and predictable coverage.
Speed Comes with Trade-Offs
RAPID introduces the possibility of faster national coverage through the NCD process, but that acceleration comes with trade offs. National coverage brings broader scrutiny, including public comment and expectations that a technology’s benefits are generalizable across diverse patient populations and care settings.
This stands in contrast to the more flexible, and sometimes more variable, pathways associated with Local Coverage Decisions (LCDs). In effect, CMS is offering a clearer and potentially faster route to coverage, but only for technologies that can withstand more transparent and comprehensive evaluation.
A Broader Policy Signal
RAPID should not be viewed in isolation. Pausing TCET (Transitional Coverage for Emerging Technologies) while advancing this new pathway signals a broader CMS shift toward fewer, more structured coverage pathways, greater reliance on premarket evidence, and deeper alignment with FDA from the outset. For innovators, this reinforces a point that has often been underappreciated: market access strategy can no longer follow regulatory strategy. The two must be developed in tandem.
What Clinicians Should Expect
For clinicians, RAPID has the potential to accelerate access to meaningful innovations, but it may also narrow the field. Fewer technologies are likely to qualify for this pathway, but those that do should arrive with stronger evidence, clearer value propositions, and more predictable coverage. In that sense, RAPID may improve not only the speed of access, but the signal quality of the technologies entering clinical practice.
Bottom Line
RAPID is not just a new pathway; it is a redefinition of the evidence to access continuum. It introduces the possibility of faster coverage, but only in exchange for earlier alignment with CMS, more relevant study designs, stronger and more generalizable evidence, and increasingly, the infrastructure required to support continuous evidence generation over time.
For wound care innovators and clinicians alike, the message is straightforward: the era of developing for FDA first and figuring out coverage later is ending.
References:
Joseph Rolley, MSIA
Principal, JTR Business Consulting, LLC
Member of the Board and Treasurer, Wound Care Collaborative Community
JTR.BusinessConsulting@gmail.com
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
