FDA, CMS unveil accelerated Medicare coverage pathway for breakthrough devices

The Centers for Medicare and Medicaid Services (CMS) and FDA are debuting a new Medicare coverage pathway that “cuts red tape” and accelerates access to certain breakthrough devices.

The new Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway is meant to synchronize FDA market authorization with the CMS National Coverage Determination (NCD) process and significantly reduce the time between regulatory approval and coverage determination.

CMS also said it is pausing the Transitional Coverage for Emerging Technologies (TCET) pathway for new candidates to focus on implementing the RAPID pathway.

“The American people deserve timely access to meaningful treatments without red tape or high costs,” FDA Commissioner Dr. Marty Makary said in a news release. “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.”

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With RAPID, the two federal health agencies will work with device innovators early in their product development lifecycles to generate data and evidence needed for FDA review, which could also be used to support Medicare coverage decisions.

“This coordinated approach allows CMS and the FDA to rely on premarket evidence to inform both the FDA premarket review and Medicare coverage processes,” CMS said. “Aligning evidence expectations earlier reduces duplication, improves efficiency, and provides increased transparency to innovators.”

The pathway connects device makers with CMS experts early in product development to understand which clinical outcomes are most relevant for Medicare beneficiaries.

“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,” CMS said.

In the new pathway, CMS will issue a proposed NCD on the same day an eligible device in the RAPID pathway receives FDA market authorization, triggering a statutorily required 30-day public comment period, the agency said.

This streamlined approach could enable Medicare national coverage and payment as soon as two months after market authorization, compared to approximately a year or more under the current pathway, CMS said.

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AdvaMed President and CEO Scott Whitaker called the move “a positive step toward expanding Medicare beneficiaries’ access to the FDA-authorized, safe, and effective breakthrough medtech they desperately need.”

“While we appreciate this first step toward improving coverage, how it will be implemented is critical,” he later continued. “Without meaningful timelines, accountability, and effective management of this program, patients are unlikely to see the full benefits of new technologies.”

The new coverage pathway is for products with Breakthrough Device designation that address unmet medical needs among Medicare beneficiaries, certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices, regardless of whether they’re participating in TAP.

To be eligible for the RAPID pathway, the 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. said in the release. “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 said it will continue offering multiple pathways to support access to medical technologies, including the standard process for opening, deciding or reconsidering national coverage determinations.

A proposed procedural notice outlining the RAPID coverage pathway will soon be published in the Federal Register, CMS said. The public will then have 60 days to provide comments on the procedural notice and the agency 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.