New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices
Today, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.
“FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned sooner in that process,” said CMS Administrator Dr. Mehmet Oz. “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.”
“The American people deserve timely access to meaningful treatments without red tape or high costs," said FDA Commissioner Marty Makary, M.D., M.P.H. "In this administration, FDA and CMS are functioning as a single team to deliver life-saving Breakthrough Devices to American patients as soon as we know they work,” said FDA Commissioner Marty Makary, M.D., M.P.H.
The RAPID coverage pathway allows CMS and the FDA to work together, with innovators, earlier in the technology development lifecycle so that evidence generated for FDA review can also support Medicare coverage decisions. By aligning regulatory and coverage expectations in advance, the RAPID coverage pathway is designed to significantly reduce delays that have historically occurred between FDA market authorization and Medicare national coverage determinations. This is a critical first step towards delivering on the Trump Administration’s commitment to provide accelerated and more predictable coverage following FDA market authorization for Breakthrough technologies that clinically benefit the Medicare population.
Early Alignment on Evidence That Matters for Medicare
Through the RAPID coverage pathway, CMS will now be a part of the early and frequent engagement between the FDA and device innovators. The coverage pathway will link manufacturers to CMS experts early in development to understand what clinical outcomes are most relevant for Medicare beneficiaries.
The RAPID coverage pathway is for Breakthrough Devices that address unmet medical needs among Medicare beneficiaries and is available for certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices regardless of whether they are participating in TAP. To be eligible for the RAPID coverage pathway, devices must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by the FDA and CMS.
This coordinated approach allows CMS and the FDA to rely on premarket evidence to inform both the FDA premarket review and Medicare coverage processes. Aligning evidence expectations earlier reduces duplication, improves efficiency, and provides increased transparency to innovators.
A More Predictable Pathway for Coverage
The RAPID coverage pathway establishes a predictable timeline and process that can safely expedite national Medicare coverage for eligible Class II and Class III Breakthrough Devices by better synchronizing FDA market authorization with CMS’ National Coverage Determination (NCD) process.
Under the RAPID coverage pathway, CMS will issue a proposed NCD the same day an eligible device participating in this pathway receives FDA market authorization, triggering the statutorily required 30-day public comment period. This streamlined approach 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, helping Medicare beneficiaries access new technologies sooner while increasing transparency, predictability, and cost savings for innovators and clinicians.
Relationship with Other Medicare Coverage Pathways
CMS will continue to offer multiple pathways to support access to medical technologies, including the standard process for opening, deciding, or reconsidering national coverage determinations. The Transitional Coverage for Emerging Technologies (TCET) Pathway will be paused for new candidates as CMS focuses on the successful implementation of the RAPID coverage pathway. CMS will apply lessons learned across coverage pathways to strengthen and improve Medicare coverage processes over time.
A proposed procedural notice outlining the RAPID coverage pathway will soon be published in the Federal Register. The public will have 60 days to provide comments on the procedural notice. CMS will respond to public comments in a subsequent final notice. The effective date of the new pathway is expected to occur upon publication of the final notice in the Federal Register. Interested parties should look to the upcoming Federal Register publication for details on the RAPID coverage pathway and how to provide comments.
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