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On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the US Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for certain FDA-designated Breakthrough Devices. RAPID is expected to provide predictable national Medicare coverage at or soon after a device’s launch.
Under most national Medicare coverage pathways, CMS requires FDA authorization before starting the national coverage determination (NCD) process. This process typically takes nine to 12 months from the time CMS chooses to take up a topic. However, the gap between FDA authorization and Medicare national coverage is frequently longer because of the large number of requests and limited CMS resources in this area. Thus, many new technologies come to market without predictable coverage, placing beneficiaries and healthcare systems at financial risk.
RAPID is CMS and FDA’s latest effort to close the gap (an earlier effort, the Parallel Review pathway, is still available). Under RAPID, CMS and FDA will collaborate during the FDA review process to provide input to medical device companies about the evidence needed for both regulatory authorization and national Medicare coverage. Participation in RAPID will not change or reduce FDA’s standards for approval, authorization, or clearance. However, early CMS involvement may influence study design, including endpoint selection, patient population, and patient size, which in turn may shape the evidentiary package submitted to FDA.
The RAPID coverage pathway will be available to Class III devices and certain Class II devices that participate in the FDA Total Life Cycle Advisory Program (TAP). Devices must be FDA-designated Breakthrough Devices that address unmet medical needs among Medicare beneficiaries. Devices must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and with clinical health outcomes agreed upon by FDA and CMS. TAP is open to ophthalmic, cardiovascular, neurological and physical medicine, orthopedic, and radiologic health devices. Later in 2026, TAP will expand to other types of devices.
Once in RAPID, MedTech companies must decide whether to accept likely higher evidentiary standards needed by CMS and potentially increased trial size, length, and cost in return for predictable coverage. Depending on CMS’s requirements, the risk of trial failure also may increase. On the other hand, conducting a successful, more rigorous trial will result in near-immediate national Medicare coverage and may improve the likelihood of faster coverage by commercial payers and more favorable treatment in clinical guidelines.
Participation in RAPID will involve strategic trade-offs. Because CMS’s (and other payers’) evidentiary bar is higher than FDA authorization needs, IDE studies for devices in the RAPID program may be more robust, with greater participation by Medicare beneficiaries, more patient-outcomes-based endpoints, and longer follow-up times than most studies supporting devices solely for FDA authorization. Your risk of trial failure may consequently be higher, depending on the circumstances.
The following questions may be helpful to consider:
CMS may in some cases adopt a more flexible approach to pre-market evidence generation and opt to require evidence generation through post-market studies, leveraging either any FDA-required post-market approval studies or other post-market surveillance. In such cases, the CMS coverage determination could take the form of an NCD with continuing evidence generation requirements.
If you accept CMS and FDA’s evidence generation strategy, CMS will issue a proposed NCD on the same day as FDA authorization. CMS will then accept public comments on the proposed coverage decision for 30 days. CMS notes that this approach could result in a coverage decision in as little as two months, a marked contrast with the much lengthier current process.
An NCD will ensure consistent national coverage for all Medicare beneficiaries in fee-for-service (FFS) coverage. In addition, all Medicare Advantage (MA) plans are required to follow NCDs, so MA plans will not be able to issue noncoverage policies that conflict with FFS policy (although MA plans may still impose prior authorization requirements). Your customers will be able to assure their Medicare patients that Medicare will cover the new technology. Your sales teams will be able to assure your customers that they will be reimbursed for using your new technology following the requirements in the NCD.
Many questions remain to be answered. For example:
FDA and CMS likely will start to provide answers to these and other questions in the forthcoming Federal Register notice. The notice will be open for public comments for 60 days.
Once the notice is published, McDermott+ and McDermott Will & Schulte can support your analysis and assist in developing comments to FDA and CMS.
