Opportunity
Federal Register #CMS3487NC
CMS Solicits Public Comment on RAPID Coverage Pathway for Breakthrough Medical Devices
Buyer
Centers for Medicare & Medicaid Services
Posted
August 11, 2026
Respond By
October 13, 2026
Identifier
CMS3487NC
This opportunity is a public comment solicitation from the Centers for Medicare & Medicaid Services (CMS), part of the Department of Health and Human Services, regarding the proposed RAPID Coverage Pathway for medical devices. - Government Buyer: - Department of Health and Human Services (HHS) - Centers for Medicare & Medicaid Services (CMS) - Purpose: - Seeks public input on the RAPID Coverage Pathway, which aims to expedite national Medicare coverage for innovative medical devices. - Products/Services Requested: - No specific products, part numbers, or vendors are listed. - The focus is on Class II and Class III medical devices that have received FDA Breakthrough Device designation. - OEMs and Vendors: - No specific OEMs or vendors are named in the notice. - Unique/Notable Requirements: - The RAPID pathway is voluntary and only applies to eligible FDA-designated Breakthrough Devices. - The process leverages existing FDA and CMS frameworks, such as the Investigational Device Exemption (IDE) and National Coverage Determination (NCD). - The goal is to align the timing of Medicare coverage with FDA market authorization for qualifying devices. - Public comments are requested on the proposed process and requirements.
Description
This notice with comment period provides information on the process CMS will use to provide accelerated Medicare coverage through the RAPID coverage pathway for new innovative technologies. The RAPID pathway leverages existing processes to provide expedited national Medicare coverage for eligible Class II and Class III FDA Breakthrough-designated Devices. It aims to align with FDA market authorization timing and provide a proposed National Coverage Determination (NCD) on the same day as FDA market authorization, with final NCDs issued approximately 60 days later for Class II devices and 90 days later for Class III devices. The notice solicits public comments by October 13, 2026.