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The Centers for Medicare and Medicaid Services is asking for public comment on a plan that would significantly shorten the timeframe between FDA authorization and Medicare coverage for some breakthrough medical devices, formally opening comment on the RAPID pathway breakthrough devices proposal for 60 days.
The Scale of the Delay Behind the RAPID Pathway Breakthrough Devices Proposal
It can take nearly five years on average for a medical device to get national Medicare and commercial insurance coverage after receiving FDA authorization, according to a survey by the Stanford Byers Center for Biodesign and the Duke-Margolis Institute for Health Policy. This lengthy gap between market authorization and reimbursement has long been a central frustration for device manufacturers seeking to bring innovative technologies to Medicare beneficiaries.
How RAPID Would Compress This Timeline
Under the new Regulatory Alignment for Predictable and Immediate Device coverage pathway, a proposed national coverage determination for certain devices would be issued the same day as FDA market authorization, meaning national Medicare coverage could begin as soon as 60 days afterward, CMS said.
Which Devices Qualify for the RAPID Pathway Breakthrough Devices Program
The RAPID pathway proposal, first unveiled in April, is intended to help Medicare beneficiaries gain quicker access to eligible Class II breakthrough devices in the FDA’s Total Product Life Cycle Advisory Program and eligible Class III breakthrough devices regardless of TAP participation.
Why Speed to Reimbursement Has Long Frustrated the Device Industry
The FDA’s breakthrough device program was designed to prioritize market authorization reviews for devices that offer more effective treatment or diagnosis for life-threatening or debilitating medical conditions. However, the device industry has long been concerned about the length of time it takes for new technologies to gain Medicare reimbursement, a gap this proposal directly targets.
How RAPID Would Streamline Coverage Decisions
RAPID would use the FDA’s existing process for assessing clinical outcomes in proposed investigational device exemption studies to streamline Medicare coverage decisions after market authorization. The plan would connect CMS experts with device manufacturers early in the development process, rather than beginning the coverage conversation only after FDA authorization is secured.
How Evidence Development Requirements Would Be Determined
Improvement shown in study outcomes and the device’s relative risk will determine if further evidence development is needed for the NCD, CMS said. If the agency finds coverage with evidence development is necessary, it will communicate with the FDA and manufacturer before FDA market authorization to align those needs with any post-approval studies the FDA requires.
What’s Excluded From the RAPID Pathway Breakthrough Devices Program
In vitro diagnostic products will not be accepted into RAPID. CMS has historically delegated review of many laboratory tests to specialized Medicare administrative contractors, and the agency said it believes most coverage determinations for IVDs granted breakthrough designation should continue to be set by the MACs. Devices beyond the IDE pre-submission stage also are not appropriate for RAPID, CMS said.
Why These Exclusions Matter for Manufacturers
Device manufacturers whose products have already progressed beyond the IDE pre-submission stage, or whose products fall into the IVD category, will need to continue navigating the traditional coverage determination process rather than benefiting from RAPID’s accelerated timeline, making early engagement with CMS a prerequisite for eligibility under this program.
What This RAPID Pathway Breakthrough Devices Proposal Means Going Forward
With the 60-day public comment period now underway, device manufacturers, health systems, and industry groups have a formal opportunity to shape the pathway’s operational mechanics before CMS finalizes the program. Given the nearly five-year average gap the Stanford Byers Center and Duke-Margolis survey identified between FDA authorization and Medicare coverage, RAPID represents one of the most significant proposed reductions in device reimbursement timelines in recent memory if implemented as designed.
What to Watch Going Forward
As the comment period progresses, industry observers will likely watch how CMS refines the pathway’s eligibility criteria in response to stakeholder feedback, particularly given the pathway’s explicit exclusion of in vitro diagnostic products and devices beyond the IDE pre-submission stage. Given the potential for dramatically compressed timelines between FDA market authorization and Medicare coverage, medical device manufacturers developing Class III or TAP-eligible Class II breakthrough technologies may want to engage CMS early in their development process to position their products for this RAPID pathway breakthrough devices program once finalized.
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