RAPID Device Coverage: A Narrow Bridge Over Medicare’s Coverage Gap

After being announced in April by FDA and CMS, the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway was released as a proposed procedural notice in the Federal Register on August 11, 2026, and is open for public comment.  Comments may be submitted for 60 days.

This coverage pathway is intended to provide an expedited Medicare national coverage decision (NCD) for new, innovative technologies, which is an important policy objective.  However, it is structured to “leverage existing processes,” specifically the processes for review of Investigational Device Exemption (IDE) studies, and in doing so, creates limitations to the number of devices that will be eligible.

As described in the notice as well as in an accompanying Fact Sheet, only devices that meet the following requirements are eligible for RAPID:

• Presumptive Class II FDA Breakthrough-designated devices participating in TAP [Total Product Life Cycle Advisory Program] planning to submit a De Novo request to FDA; 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.

The notice further limits eligibility to exclude in vitro diagnostics, including diagnostic laboratory tests, stating that these device types are currently reviewed by specialized Medicare Administrative Contractors (MACs), and should continue through this existing pathway.

As we blogged about previously, the RAPID requirements will significantly limit the devices that are able to take advantage of this pathway.  This Federal Register announcement includes another requirement that was not clear from FDA’s prior announcement—a device need not only be a Class II Breakthrough device in TAP with an IDE study, it must be a device that will go through the de novo authorization process rather than a 510(k), with limited exceptions for 510(k) devices relying on a primary predicate that was recently authorized through the de novo pathway.  Based on our review of FDA’s list of authorized Breakthrough devices, more than 40% came to market through the 510(k) process, but for those meeting the narrow exception for 510(k) devices, these would not have been eligible for RAPID.

Furthermore, the requirement for an IDE will limit eligible devices greatly.  For many, if not most, presumptive Class II devices that might otherwise be eligible, clinical studies will be non-significant risk and will not be required to submit an IDE to FDA.  Devices may also obtain Breakthrough designation by improving accessibility of technology that has already been proven clinically, so there may be instances where new clinical performance data are not needed, but differences introduced to improve accessibility result in the need for a new coverage determination.  Devices that are beyond the IDE pre-submission stage and already have an approved IDE are also currently excluded, although the notice does seek comments on whether a temporary process should be included to allow consideration of these devices.

In our review of RAPID, the need for an IDE was introduced to leverage an existing review process instead of developing a process that can be utilized to achieve the program’s bigger goal.  The Breakthrough Devices Program already includes processes for Data Development Plans and Clinical Protocol Agreements, and the TAP program’s primary goal is to “expedite patient access to innovative medical devices . . . by facilitating engagement with other key parties for developers of devices of public health importance.” It is not clear why the Agencies decided to insert IDE requirements for RAPID eligibility instead of building RAPID on the existing Breakthrough and TAP frameworks.

In its review, CMS needs to assess clinical outcomes (direct measures of how a patient feels, functions, or survives) in Medicare beneficiaries, and there are multiple ways to accomplish this in addition to conducting a clinical study under an approved IDE.  The RAPID coverage pathway has three stages: (1) IDE Pre-submission; (2) Formal IDE Submission to FDA and CMS; and (3) Transition from IDE to Coverage.  Stage 2 provides study design considerations from both FDA and CMS that could seemingly be provided using Breakthrough interactions or TAP amendments for devices that do not require an IDE study.  For those devices that make it through the process, a proposed NCD will be issued the same day as FDA market authorization—with a goal of finalization within 60 to 90 days.

The notice seems to recognize the limited scope of RAPID and devotes significant discussion to other existing coverage pathways that may be utilized for devices that are not eligible for RAPID, including Parallel Review (we note that only two devices have successfully utilized the Parallel Review program, calling into question the extent to which this is truly a viable option).  The notice indicates that CMS also intends to work with FDA to consider updates to the Parallel Review program and other initiatives to align procedures.

RAPID reflects an important effort by FDA and CMS to close the gap between market authorization and Medicare coverage for the small subset of devices that can meet its eligibility criteria.  But manufacturers should not overestimate RAPID’s reach.  The pathway will be unavailable to many Breakthrough devices whose studies are non-significant risk or otherwise do not require an IDE, to devices already past the IDE pre-submission stage, to in vitro diagnostics, to Class II devices that are not in TAP, and Class II devices that will proceed through the 510(k) pathway.  Manufacturers should assess RAPID eligibility, and the tradeoffs of pursuing an IDE study built around Medicare-relevant outcomes, as early as possible in development, ideally in tandem with any Breakthrough Devices Program and TAP interactions.