The Centers for Medicare & Medicaid Services has posted a draft version of the Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (RAPID), a program first announced by CMS and the FDA in April 2026. CMS said RAPID will use existing coverage mechanisms to provide faster market access for qualifying medical devices, primarily the national coverage determination (NCD) process.
Medmarc previously highlighted what was known about RAPID when the FDA and CMS first announced the program in April
2026, a point at which few details were available. CMS stated in the Aug. 7, 2026, press release that in vitro diagnostics will generally be ineligible for RAPID, a limitation that also applied to the Transitional Coverage for Emerging Technologies (TCET) pathway finalized in August 2024. The two agencies stated in April 2026 that TCET would be suspended when RAPID becomes an operational program.
CMS recommends that manufacturers interested in RAPID approach the agency when the device is still in the pre-submission stage and prior to enrollment of an investigational device exemption (IDE) study. The IDE study should be designed to enroll Medicare beneficiaries to provide evidence that the device improves health outcome for beneficiaries.
There are several other eligibility criteria for RAPID, including that the device is a high-risk, class III device. Class II devices may be eligible so long as they are enrolled in the FDA’s Total Product Life Cycle Advisory Program (TAP), a requirement that does not apply to class III devices. Class II devices that are under FDA review under the de novo pathway are eligible, but class II devices that will be reviewed as 510(k) devices will be eligible only if they recite a de novo device as the primary or sole predicate.
This assumes that the reference de novo device was approved by FDA within 18 months of the 510(k) device’s application for entry into RAPID. CMS added that a device would be eligible only if “there is no evidence that immediately makes clear that the device will not fall under a Medicare benefit category.”
Other limitations are that the device is not already the subject of an existing NCD and is not otherwise excluded from Medicare coverage via law or regulation. CMS said it will issue a draft NCD for RAPID devices upon FDA marketing authorization, which will be followed by a 30-day comment period. The agency would finalize the NCD within another 30 days for class II devices for a total of 60 days after FDA authorization. For class III devices, the timeline is issuance of a final NCD 60 days after the draft NCD is posted for a total elapsed time of 90 days after FDA approval or clearance.
Under this proposal, some devices may be fully and immediately covered if the evidence unambiguously demonstrates that the device and related services meet the reasonable and necessary standard. Otherwise, the NCD may include a coverage with evidence development (CED) requirement. CMS said it would strive to align such a requirement with any FDA-mandated post-approval studies, but offered no specific time limit for the CED study.
However, CMS reassured device makers that CED studies are not intended to be open-ended requirements, suggesting that the agency will be vigilant in not allowing the CED requirement to continue past the point at which the evidence suffices to determine whether the device meets the reasonable and necessary standard. The agency is taking comment through Oct. 13, 2026.