KnobbeMedical.com

On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced “a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.” The FDA announcement for the pathway, titled Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, can be found here.

The announcement indicates Class II devices may be eligible for the new pathway if they are participating in the FDA Total Product Life Cycle Advisory Program (TAP), and Class III devices may be eligible regardless of participation in TAP. The FDA announcement also indicates that “[t]o be eligible for the RAPID coverage pathway, 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.”

The RAPID coverage pathway is intended to accelerate access to breakthrough devices by (1) promoting early alignment between the CMS, FDA, and innovators, and (2) establishing a predictable timeline and process.

The FDA announcement states:

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

The FDA expects early coordination between the relevant parties will allow for alignment of premarket evidence for both FDA premarket review and Medicare coverage processes. “Aligning evidence expectations earlier reduces duplication, improves efficiency, and provides increased transparency to innovators,” the announcement states.

The RAPID coverage pathway intends to provide benefits to all parties involved, including “increasing transparency, predictability, and cost savings” for innovators of the breakthrough devices.

For those interested in the RAPID coverage pathway, be on the lookout for a procedural notice in the Federal Register. Once published, the notice will allow the public 60 days to provide comments.