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The Centers for Medicare & Medicaid Services is following through on a concept issued in April for faster approval of breakthrough medical devices, formally issuing a proposed procedural notice for the RAPID coverage pathway CMS first outlined earlier this year.
How the RAPID Coverage Pathway CMS Actually Works
CMS has outlined a faster way for manufacturers to get new devices covered by Medicare under the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway. RAPID aligns CMS and Food & Drug Administration evidence in advance to reduce the review time for the FDA to issue market authorization and for Medicare to give a national coverage determination.
The Timeline This Pathway Enables
This means a proposed NCD could be issued the same day as the FDA market authorization, CMS said. Medicare coverage could begin as soon as 60 days after FDA market authorization, a dramatic compression compared to the often lengthy separate review timelines that have traditionally applied to FDA approval and Medicare coverage determinations.
The Formal Process Behind This RAPID Coverage Pathway CMS Notice
Friday’s announcement outlines operational mechanics and initiates a 60-day public comment period. This formal notice moves the pathway from the conceptual joint press release CMS and FDA issued in April into an actionable regulatory proposal that stakeholders can now formally weigh in on.
Which Devices Qualify for RAPID
The RAPID coverage pathway applies to FDA-designated Breakthrough Devices that address unmet medical needs for Medicare beneficiaries. Eligible products include all Class III devices and certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program, or TAP.
What Breakthrough Devices Typically Look Like
The FDA Breakthrough Devices Program is designed to accelerate the development, assessment and review of novel devices with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, according to Health Affairs. Examples of breakthrough devices include continuous glucose monitors, pulsed field ablation systems, AI-powered diagnostic software and robotic surgical platforms.
Why This Pathway Matters to Stakeholders
Stakeholders have long sought a better way to cover new, innovative technologies, CMS said, suggesting this formal notice addresses a documented gap between how quickly breakthrough devices could receive FDA authorization and how long Medicare beneficiaries have historically had to wait for corresponding coverage decisions.
What’s Excluded From This RAPID Coverage Pathway CMS Notice
In vitro diagnostic, or IVD, products will not be accepted into RAPID, as CMS said they fall into a highly specific area of coverage policy development. CMS has historically delegated the review of many of these products to specialized Medicare Administrative Contractors and said it will continue to do so, keeping IVD review outside the scope of this new streamlined pathway.
The Program’s Origins
The FDA Breakthrough Devices Program was created by Congress in the 21st Century Cures Act of 2016. As of March 31, the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research had granted 1,284 Breakthrough Device designations, giving a sense of the scale of devices potentially eligible for this expedited RAPID pathway.
What This RAPID Coverage Pathway CMS Notice 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 that 1,284 devices have already received Breakthrough Device designations as of March, a substantial pool of existing and future products could become eligible for this accelerated same-day NCD and 60-day coverage timeline once RAPID is finalized.
What to Watch Going Forward
As the comment period progresses, industry observers will likely watch how CMS refines the pathway’s eligibility criteria and operational details in response to stakeholder feedback, particularly given the pathway’s explicit exclusion of in vitro diagnostic products. 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 closely monitor this RAPID coverage pathway CMS process as a potential new route to faster patient access and reimbursement.
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