AdvaMed called for more breakthrough devices, including diagnostics, to be eligible for the pathway, and for set timelines for national coverage determinations.

The CMS’ latest proposal follows several back-and-forth efforts to accelerate reimbursement for breakthrough medical devices. The FDA has granted breakthrough designation to nearly 1,300 devices, which may offer more effective treatment or diagnosis for life-threatening or debilitating conditions.

Under the first Trump administration, the CMS proposed automatic four-year coverage for breakthrough devices that receive FDA authorization. That plan was quickly scrapped, with CMS leadership finding “significant concerns” about clinical evidence for the Medicare population and instead implementing a pathway under the Biden administration to cover five new breakthrough technologies per year.

The latest proposal, called Regulatory Alignment for Predictable and Immediate Device, or RAPID, has a slightly narrower scope than the first Trump administration’s efforts. To be eligible, Class II devices must participate in the FDA’s Total Product Life Cycle Advisory Program, while Class III devices are eligible regardless of their participation. The CMS does not plan to cover in vitro diagnostics under RAPID. The CMS expects 40 new devices would currently qualify for the RAPID program, with the potential for about 20 more in the future.

AdvaMed pushed back on some of the restrictions in its comments. The lobbyist called for broader eligibility for breakthrough devices and for diagnostics participation in RAPID. The group wants firm timelines for national coverage determinations.

AdvaMed also called for transition protections for technologies that are already planned under prior CMS coverage pathways and for the RAPID program to receive adequate funding, be transparent and aligned with the FDA.

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