Open CMS/FDA Medical Device Coverage Pathway
The Centers for Medicare & Medicaid Services (CMS) has issued the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway, file code CMS-3487-NC. The August 11, 2026 Federal Register notice proposes an expedited Medicare national coverage process for certain FDA Breakthrough-designated Class II and Class III devices. This is not a grant, cooperative agreement, procurement, contract award, or funding award.
Comment Deadline and Submission
Public comments must be received by October 13, 2026. The Federal Register notice does not publish a clock time or time zone. Electronic comments may be submitted through Regulations.gov under docket CMS-2026-2674. The notice also provides mail and express-delivery options.
Who Can Qualify for RAPID
CMS proposes a voluntary pathway for certain devices that meet specific conditions. The notice describes presumptive Class II FDA Breakthrough-designated devices participating in FDA’s Total Product Life Cycle Advisory Program (TAP) and planning a De Novo submission, and Class III FDA Breakthrough devices planning a Premarket Approval application. The device must be at the IDE pre-submission stage, the planned IDE study must enroll Medicare beneficiaries and evaluate clinical outcomes agreed to be relevant by FDA and CMS, there must be no clear Medicare benefit-category exclusion or controlling national coverage determination, and the device must be separately payable if approved. In vitro diagnostic devices are excluded.
What RAPID Would Do
CMS proposes issuing a national coverage determination for qualifying devices on the same day as FDA market authorization, followed by evidence review and a final national coverage determination on an accelerated schedule. CMS states that the Transitional Coverage for Emerging Technologies pathway is paused for new candidates while RAPID is implemented.
N9+ and Dr. Miltie Relevance
Potential N9+ relevance is conditional. Atlas has not verified that N9+, QC Healthcare, or Dr. Miltie currently holds the FDA Breakthrough designation, applicable TAP participation, IDE-stage status, separate-payability pathway, Medicare benefit-category fit, or other regulatory and evidentiary prerequisites described by CMS. No device-participation application should be advanced unless those requirements are independently verified. Dr. Miltie may submit public comments as an interested stakeholder.
Official Controlling Sources
CMS RAPID Coverage Pathway fact sheet
Federal Register notice, CMS-3487-NC
Regulations.gov docket CMS-2026-2674