CMS & FDA Announces RAPID: A New Pathway to Expedite Access to Innovative Medical Devices for Medicare Beneficiaries

The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway is designed to streamline communication from the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) to manufacturers in the early stages of product development, allowing Medicare beneficiaries to participate in review trials.

According to the CMS press release, the program specifically covers breakthrough devices for otherwise unmet medical needs. Devices must be Class II devices participating in the FDA’s Total Product Life Cycle Advisory Program (TAP) and Class II devices regardless of TAP participation.

The RAPID pathway could answer questions about the risks and benefits of Medicare paying for unproven technology, which STAT notes is seen within the industry as a critical precursor for coverage by other insurers. The FDA implemented a fast-track program of its own for breakthrough devices in 2016, which speeds up the process for investigational products that the FDA determines could provide for more effective treatment or diagnosis. But developers have maintained that it can take years to obtain reimbursement after authorization. From Scott Whitaker, president and CEO of device industry trade group AdvaMed:

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.

Participation will require tradeoffs, law firm McDermott+ explains. CMS carries a much higher bar than FDA authorization requires, so studies for devices in the RAPID program might be much larger and more costly, leading the risk of trial failure to be much higher, though CMS may adopt more flexible approaches to pre-market products on a case-by-case basis.