WASHINGTON, D.C. — The Centers for Medicare & Medicaid Services proposed a new pathway to shorten the lag between Food and Drug Administration authorization and national Medicare coverage for certain breakthrough medical devices, potentially allowing coverage to begin about 60 days after FDA authorization for eligible Class II products.
The Regulatory Alignment for Predictable and Immediate Device, or RAPID, pathway would bring CMS into the device-development process earlier, allowing the agency and FDA to align evidence expectations before manufacturers complete clinical studies and seek market authorization.
Under the proposal, CMS would issue a proposed national coverage determination, or NCD, on the same day an eligible device receives FDA market authorization if the device has demonstrated improved health outcomes. A 30-day public comment period would follow.
CMS is targeting a final NCD approximately 60 days after FDA authorization for eligible Class II devices and 90 days for Class III devices. The approach is intended to reduce delays between regulatory authorization and Medicare coverage decisions without creating a new FDA approval process or Medicare benefit category.
The pathway, initially disclosed by CMS and FDA in April, would be available to certain Class II devices with FDA Breakthrough Device designation that participate in the agency’s Total Product Life Cycle Advisory Program, known as TAP. Class III Breakthrough Devices could participate regardless of whether they are enrolled in TAP.
Eligibility would be limited to devices still in the Investigational Device Exemption pre-submission stage. Manufacturers would need to plan an IDE study that includes Medicare beneficiaries and evaluates clinical outcomes that FDA considers appropriate and CMS determines could demonstrate improved health outcomes for the Medicare population.
Devices already authorized for sale or with an IDE study underway would not qualify because RAPID depends on CMS and FDA involvement before pivotal evidence is generated.
The pathway would also exclude devices already governed by a controlling Medicare NCD, products barred from coverage by law or regulation and devices that cannot be separately billed to Medicare.
In vitro diagnostic products, including diagnostic laboratory tests, would be excluded. CMS indicated that coverage decisions for most IVDs receiving Breakthrough Device designation should continue to be handled through existing processes administered by specialized Medicare Administrative Contractors.
The proposal could give device manufacturers greater clarity about the evidence Medicare will require before they commit resources to clinical development. CMS would participate in early discussions between FDA and manufacturers to identify outcomes relevant to Medicare beneficiaries and determine whether evidence generated for FDA review could also support Medicare coverage.
The amount of evidence required after authorization would depend in part on a device’s risk and the strength of its clinical results. CMS indicated that lower-risk products may be more likely to satisfy Medicare’s “reasonable and necessary” standard at authorization, while higher-risk devices may require additional evidence.
In those cases, CMS could use coverage with evidence development, or CED, which permits Medicare coverage while additional clinical evidence is collected. When CED appears necessary, CMS intends to work with FDA and manufacturers before authorization to align Medicare evidence requirements with any FDA-mandated post-approval studies.
RAPID national coverage determinations would remain effective until reconsidered. CMS emphasized that determinations using CED should be time-limited rather than continue indefinitely, with additional evidence ultimately used to support a longer-term Medicare coverage decision.
The procedural notice does not itself establish coverage for any device. Manufacturers participating in RAPID would still have to complete the applicable FDA process, demonstrate improved health outcomes and formally request an NCD from CMS.
The public has 60 days to comment on the proposed pathway. CMS will address comments in a subsequent final notice.
More information is available at: https://www.federalregister.gov/public-inspection/current
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