The U.S. Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) have aligned toward a new payment pathway that for an eligible medical device receiving breakthrough status immediately establishes a proposed Medicare national coverage determination.
Called the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, the process will also trigger a 30-day public comment period, according to the agencies. RAPID could shorten the time to national Medicare coverage and payment to two months after FDA market authorization, compared with approximately a year or more under the current pathway, CMS and the FDA said.
CMS plans to engage early and often between the FDA and device innovators, the agencies said.
To be eligible for RAPID, devices must address unmet medical needs among Medicare beneficiaries, be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries, and study clinical health outcomes agreed upon by both agencies. Certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices regardless of TAP participation are eligible, the agencies said.
In October 2024, the American College of Radiology (ACR) announced its participation in the FDA's TAP pilot. The program facilitates strategic input in the areas of patient engagement, clinical evidence development, clinical practice and new technology adoption, and reimbursement from non-FDA parties such as the ACR to TAP innovators such as AI-enabled software device manufacturers. The Society of Interventional Radiology is also participating in TAP.
AdvaMed called RAPID the "first step" toward improving coverage but urged meaningful timelines, accountability, and effective management.
As part of the announcement, CMS said it will pause the Transitional Coverage for Emerging Technologies (TCET) pathway for new candidates while it focuses on RAPID implementation.
A proposed procedural notice will be published in the Federal Register, with a 60-day public comment period.
Find the full announcement here.
