Thursday April 30, 2026 — Field Note
A deeper look at one story shaping medical device and health tech.
FIELD NOTE
The FDA and CMS Just Launched a New Breakthrough Device Coverage Pathway. Here’s What It Actually Covers.
For years, one of medtech’s most persistent frustrations has been the gap between FDA authorization and Medicare coverage. A device can clear the FDA’s most rigorous review, demonstrate clinical efficacy in a pivotal trial, and still wait a year or more — sometimes much longer — before CMS issues a National Coverage Determination. According to a 2022 survey from the Stanford Byers Center for Biodesign and the Duke-Margolis Center for Health Policy, the average time from FDA authorization to national Medicare and commercial coverage is five years.
On April 23rd, CMS and FDA announced a new attempt to close that gap. The Regulatory Alignment for Predictable and Immediate Device coverage pathway — RAPID — is designed to bring the two agencies into alignment earlier in the development process, so that evidence generated for FDA review can also satisfy Medicare coverage requirements. Under the pathway, CMS would issue a proposed NCD the same day an eligible device receives FDA marketing authorization. The 30-day public comment period would follow, and national coverage could take effect as soon as two months after authorization — down from a year or more today.
The agencies have tried versions of this before. The FDA’s Parallel Review Program launched as a pilot in 2011 and was fully implemented in 2016; as of late 2024, 97 devices had requested participation, and two had completed it. The first Trump administration’s MCIT rule offered four years of automatic Medicare coverage upon FDA authorization, but was scrapped by the Biden administration, which replaced it with the Transitional Coverage for Emerging Technologies pathway in 2024. TCET was capped at 5 devices per year, even though the FDA typically grants more than 100 breakthrough designations in that time. AdvaMed criticized TCET for exactly that reason. TCET is now paused as CMS shifts focus to RAPID.
The Eligibility Gap
This is where the announcement warrants careful reading. RAPID is not available to all breakthrough devices. Class III breakthrough devices qualify regardless of additional program participation. Class II breakthrough devices qualify only if they are enrolled in FDA’s Total Product Life Cycle Advisory Program, or TAP — an enhanced engagement program initiated under MDUFA V. All eligible devices must also be the subject of an Investigational Device Exemption study that enrolls Medicare beneficiaries and studies clinical outcomes agreed upon by both agencies. That IDE requirement alone excludes non-significant risk devices, which make up the majority of the Class II market.
A senior CMS official said on the day of the announcement that approximately 40 devices currently qualify, with another 20 potentially eligible. For context: as of December 30, 2025, FDA had granted 1,246 Breakthrough Device Designations, with 185 devices having received marketing authorization. More than 1,000 breakthrough-designated devices remain outside the pathway’s reach under the same coverage dynamics as before. As Jennifer Newberger of Hyman, Phelps & McNamara wrote in a post-announcement analysis, RAPID may function as “less a systemic solution than a targeted pilot for a narrow slice of the market.”
Industry Response and What to Watch
AdvaMed called RAPID a “positive step” but stopped short of an endorsement, with CEO Scott Whitaker noting that “without meaningful timelines, accountability, and effective management of this program, patients are unlikely to see the full benefits of new technologies.” Whitaker also flagged a complicating factor: CMS has separately proposed repealing the New Technology Add-on Payment alternative pathway for breakthrough devices, which provides temporary reimbursement supplements to hospitals offering procedures with newly authorized technologies. NTAP and RAPID serve different but complementary roles in the access equation, and industry is watching both simultaneously.
The proposed procedural notice will be published in the Federal Register, opening a 60-day public comment period. RAPID does not take formal effect until CMS issues a final notice in response to those comments. How the agencies respond to stakeholder input — particularly on whether TAP participation should remain a prerequisite for Class II eligibility — will determine whether RAPID stays narrow or expands its reach. For companies that do qualify, the most immediate implication is practical: trial design conversations with CMS should begin earlier than they have historically, and IDE protocols should be structured with Medicare outcomes in mind from the start.
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