Last week, CMS issued more details on a new pathway it is establishing to speed up Medicare coverage for innovative medical devices.
The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, first announced in April, seeks to align FDA and CMS review processes. The pathway would make it so the same clinical evidence used to win FDA approval can also be used to secure Medicare coverage, instead of starting that process from scratch afterward.
To qualify, a device needs to have the FDA’s breakthrough device designation, which is reserved for products that treat serious conditions and offer a meaningful improvement over existing options. The device also has to still be in the early stages of testing, before the company has started the clinical study that will support its FDA application. Once a device enters the pathway, CMS said it will work together with the FDA from the outset to agree on what kind of clinical results would justify Medicare coverage.
The industry reaction has been largely positive. Andrew Ibrahim, chief clinical officer at healthcare AI platform Viz.ai, said medical devices often “sit in coverage purgatory” for years.
“Getting these agencies into the same room earlier in the development lifecycle is genuinely good policy,” he declared.
In his eyes, the gap between FDA authorization and Medicare coverage has been one of the most persistent structural inefficiencies in medical innovation.
Prior administrations recognized this, Ibrahim pointed out. CMS and FDA launched a parallel review program in 2011, which was meant to let the two agencies work side by side — though in practice, few devices ever went through it.
“It was an earnest attempt to address it, but RAPID represents something more intentional — not just working in parallel, but actually aligning on evidence expectations early, before the pivotal trial is even designed,” Ibrahim stated.
What excites him the most is the longer arc this points toward. He pointed out that the FDA is already piloting infrastructure for real-time clinical trial data, and if that matures alongside the RAPID pathway, there could be a future where real-time data feeds directly into both the approval and coverage determination process.
That would significantly compress the timeline from trial enrollment and evidence generation to approval and coverage in ways that haven’t been possible before, Ibrahim said.
Josh Makower, a Stanford professor and director of the university’s center for biodesign, has been studying this exact problem for years. His research found that the average gap between FDA authorization and even the most minimal Medicare coverage for breakthrough devices is 5.7 years.
“This is too long for Medicare beneficiaries to wait, and this delay is also having devastating effects on the medical technology innovation ecosystem as well,” Makower stated.
He thinks the proposal has potential not only to improve patient care, but also provide “a very-much needed boost” to maintain the US’ competitiveness in medical technology.
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