CMS, FDA Announce RAPID Coverage Pathway for Faster Medical Device Access

The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) today announced a new pathway that aims to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for Medicare recipients.

The the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway enables 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 will attempt to significantly reduce delays that have historically occurred between FDA market authorization and Medicare national coverage determinations. This is a critical first step towards providing accelerated and more predictable coverage after FDA market authorization for Breakthrough technologies that clinically benefit the Medicare population.

“The American people deserve timely access to meaningful treatments without red tape or high costs,” FDA Commissioner Marty Makary, M.D., said. “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.”

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 which specific 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, medical 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. 

“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,” CMS Administrator Dr. Mehmet Oz stated. “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.”

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.

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.

“It is important to remember who is on the receiving end of these statutorily defined ‘breakthrough’ medical technologies that have gone through the rigorous FDA review process: patients in need who currently lack medical options for the conditions from which they are suffering—and their expert doctors and care teams seeking the best medicine has to offer in order to alleviate that suffering,” Advamed President/CEO Scott Whitaker said in prepared remarks.

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.

While he expressed cautious optimism about the pathway, Whitaker noted the importance of implementing it in a timely manner.

“Today’s announcement is a positive step toward expanding Medicare beneficiaries’ access to the FDA-authorized, safe, and effective breakthrough medtech they desperately need. As Dr. Oz and Dr. Makary have said publicly, more can and must be done for these patients who lack options and are suffering,” he stated. “While we appreciate this first step toward improving coverage, it is critical that the implementation of such a proposal is effective. Without meaningful timelines, accountability, and effective management of this program, patients are unlikely to see the full benefits of new technologies. We look forward to continuing our work with CMS to ensure Medicare beneficiaries have full, timely access to all the lifesaving, life-changing benefits breakthrough medtech offers—as soon as possible after FDA clearance.”

“We also remain concerned about CMS’s recent proposal to repeal the New Technology Add-on Payments (NTAP) to hospitals that cannot afford to offer patients procedures involving FDA-authorized breakthrough medtech without these already-modest, temporary payments,” Whitaker said. “We will continue to work closely with CMS to shore up the NTAP program and its critical role in serving Medicare beneficiaries.”