Securing a Breakthrough Device designation from the FDA is significant, but it is only the beginning of a long, uncertain road to getting your device to patients. The device also needs to obtain FDA marketing authorization and market access through CMS. Gaining market access is difficult because CMS demands clinical outcomes data that the FDA’s Breakthrough Device Program is unlikely to generate, particularly given the program’s tendency to narrow the indications of devices.
FDA and CMS have tried instituting several programs over the last 15 years to bridge the gap between their processes and accelerate market access. But so far only two devices have successfully completed these various programs. In April 2026, CMS and FDA announced a new such program, called the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. Its success remains to be seen, and its ambitious goals may backfire.
The Difficulty of Satisfying Both the FDA and CMS
It is difficult to create clinical trials and generate data that satisfy both the FDA and CMS because the agencies have different objectives. The FDA seeks to determine whether a medical device is safe and effective, while CMS tests clinical utility, specifically whether the device alters patient management and improves health outcomes.
Additionally, CMS routinely rejects theoretical, economic models predicting long-term benefits of breakthrough devices, particularly when the device company pays for those studies. Instead, CMS demands prospective, real-world studies utilizing a statistically meaningful cohort of actual patients. This makes it even harder for studies focused on satisfying the FDA to simultaneously satisfy CMS.
The Breakthrough Device Program’s Narrow Indication Trap
The Breakthrough Device Program often adds to this difficulty by trapping devices in overly narrow indications for use. To be eligible for the program, a device must meet innovation requirements like representing breakthrough technology or having no approved or cleared alternatives. Very narrow indications or patient subpopulations are more likely to meet such criteria. The FDA also may favor narrow indications because doing so leaves the door open for other breakthrough devices to enter the program under different niches. This tactical narrowing can lock a device company into a highly specific clinical trial protocol that makes it even harder to generate the robust, real-world clinical utility data that CMS demands.
Prior Coverage Pathways for Breakthrough Devices
Recognizing this disconnect, the FDA and CMS have instituted a series of programs to align their processes. In 2011, the agencies introduced the Parallel Review program to encourage simultaneous FDA and CMS review of clinical data, but only two devices successfully went through that program. The Medicare Coverage of Innovative Technology (MCIT) rule would have granted automatic, national Medicare coverage for up to four years from FDA authorization, but it was repealed months after being instituted. In 2024, CMS finalized the Transitional Coverage for Emerging Technologies (TCET) pathway to provide transitional coverage while the device company collaborates with CMS on an Evidence Development Plan. But no more than five devices were eligible for TCET each year, and no devices completed the program before it was paused in April 2026 in favor of the new RAPID coverage pathway.
New RAPID Coverage Pathway
The new RAPID coverage pathway aims to solve the shortcomings of these prior programs by synchronizing FDA premarket review with CMS’s National Coverage Determination (NCD) process from the beginning of the Investigational Device Exemption (IDE) stage. For eligible Class II and Class III devices, CMS and the FDA will jointly guide the pivotal trial design to simultaneously satisfy the evidence standards of both agencies, including by capturing CMS-acceptable prospective, real-world data from the beginning. This approach expands program capacity to roughly 40 to 60 qualifying devices and targets providing a proposed NCD the same day the device receives FDA marketing authorization.
The prospects of the RAPID program are uncertain. On the one hand, its ambitious goal of providing a proposed NCD the same day as FDA marketing authorization could very quickly get breakthrough devices to patients who need them nationwide. On the other hand, this ambitious goal also means that regulators will scrutinize a device’s clinical utility from the beginning, potentially making it even more expensive and time-consuming to navigate the FDA and CMS processes and obtain market access.
The HcFocus Market Access Team
HcFocus takes clients from strategy through execution, with decades of experience and deep payor and physician relationships across reimbursement, coding, coverage, and policy. Whether a product is in early-stage development, preparing for launch, or already facing a reimbursement cutback, we build the client-specific strategy and hands-on execution needed to secure and defend coverage. Reach out to schedule a strategy call.