Medical organizations comment on CMS RAPID coverage pathway

Medical organizations and patient advocacy groups have submitted formal comments to the Centers for Medicare & Medicaid Services (CMS) regarding the proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway.

The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) expressed support for aligning RAPID eligibility with the FDA Breakthrough Devices Program and the Total Product Life Cycle Advisory (TAP) Program. They advocated for a transition pathway for devices moving beyond the Investigational Device Exemption (IDE) stage and requested that CMS establish mechanisms for devices supported by Non-Significant Risk (NSR) studies to participate in the program.

The National Health Council (NHC) also provided feedback, noting that the RAPID pathway aims to reduce delays between FDA market authorization and Medicare coverage. The pathway is designed to allow for earlier CMS engagement in the development process and provides the possibility of a proposed National Coverage Determination (NCD) concurrent with FDA authorization, with final determinations following within 60 to 90 days depending on the device class.