Medtech lobby seeks broader device eligibility

Medtech lobby AdvaMed is seeking broader device eligibility for the Centers for Medicare and Medicaid Services’ (CMS) proposed RAPID pathway. The pathway aims to provide faster Medicare coverage for certain breakthrough devices upon Food and Drug Administration (FDA) authorization.

The CMS unveiled plans for the RAPID pathway earlier this year, which would give breakthrough devices a proposed national coverage determination. AdvaMed praised the pathway as a positive step toward expanding access to breakthrough devices.

AdvaMed has urged the CMS to broaden the RAPID program’s eligibility to include more breakthrough devices, particularly diagnostic tools, and to establish clear deadlines for coverage decisions. The public currently has until October 13 to submit feedback on the proposal.

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To date, the FDA has identified roughly 1,300 devices as breakthrough technologies, many of which could significantly improve outcomes for patients with severe or life-altering illnesses. The CMS estimates that around 40 devices would now meet RAPID’s criteria, with another 20 potentially qualifying in the near future.

In its formal comments, AdvaMed criticized certain limitations of the RAPID framework, arguing that more devices, including diagnostics, should be included and that the program must set firm deadlines for coverage approvals. The group also stressed the need for safeguards to protect devices already in development under older CMS policies.

The latest proposal has a slightly narrower scope than the first Trump administration’s efforts, with Class II devices required to participate in the FDA’s Total Product Life Cycle Advisory Program to be eligible, while Class III devices are eligible regardless of their participation.