CMS and FDA Announce RAPID Pathway to Speed Medicare Coverage of Designated Devices

The Centers for Medicare & Medicaid Services and the US Food and Drug Administration on April 23 announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, which the agencies said is designed to expedite Medicare access to certain FDA-designated class II and class III devices with breakthrough device designation, according to a joint announcement posted by the FDA.

Under the pathway, CMS will issue a proposed national coverage determination the same day an eligible device receives FDA marketing authorization, triggering the statutorily required 30-day public comment period. The agencies said this "could enable predictable Medicare national coverage and payment as soon as two months after market authorization, compared to approximately a year or more under the current pathway."

"The RAPID coverage pathway brings our two agencies together earlier, cutting red tape for innovators, and helping beneficiaries access new, life-changing health technology faster," CMS Administrator Mehmet Oz said in the announcement. FDA Commissioner Marty Makary said the two agencies "are functioning as a single team."

Who is eligible

The pathway is for devices with breakthrough device designation that address unmet medical needs among Medicare beneficiaries. It is open to certain class II devices participating in FDA's Total Product Life Cycle Advisory Program (TAP), and to class III devices whether or not they participate in TAP. Devices must be the subject of an investigational device exemption study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by FDA and CMS, according to the announcement.

The agencies said CMS will join FDA's early engagement with device makers, linking manufacturers with CMS experts during development to identify which clinical outcomes matter most for Medicare beneficiaries, so that evidence generated for FDA review can also support the coverage decision.

About 40 devices would qualify for the pathway now, with about 20 more that could potentially qualify, a senior CMS official said on a press call, Healthcare Dive reported. The official said the agencies will work with companies as they design pivotal trials, because some companies previously did not generate the evidence needed for Medicare coverage and had to run new trials, according to the report.

TCET paused, notice to follow

CMS will pause its Transitional Coverage for Emerging Technologies (TCET) pathway for new candidates while it focuses on implementing RAPID, the announcement said. Healthcare Dive noted that TCET, created in 2024, considers five devices with breakthrough device designation a year for Medicare coverage. CMS said it will continue to offer the standard process for opening, deciding or reconsidering national coverage determinations.

The pathway is not yet in effect. A proposed procedural notice will be published in the Federal Register with a 60-day comment period, CMS will respond to comments in a final notice, and the pathway is expected to take effect when that final notice is published, according to the announcement.

AdvaMed called the pathway a "positive step," according to Healthcare Dive. "While we appreciate this first step toward improving coverage, it is critical that the implementation of such a proposal is effective," CEO Scott Whitaker said in an emailed statement to MedTech Dive. "Without meaningful timelines, accountability, and effective management of this program, patients are unlikely to see the full benefits of new technologies."