Proposed Procedural Notice — Expedited Medicare Device Pathway
Article Publication Date
Summary
CMS and the FDA issued a proposed procedural notice outlining the process the agency will use to expedite approval of new devices covered by Medicare. Announced in April 2026, the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway applies to Food and Drug Administration (FDA) Breakthrough-designated devices that address unmet medical needs for Medicare beneficiaries. To 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.
CMS and FDA will use existing programs and coverage frameworks to analyze and approve devices that demonstrate positive clinical health outcomes in a timelier and more predictable way during the premarket phase. By aligning CMS and FDA evidence expectations in advance, the RAPID coverage pathway is designed to significantly reduce the review times that have historically occurred between FDA market authorization and Medicare national coverage determinations (NCDs). Comments must be received by October 13.
CMS and FDA will use existing programs and coverage frameworks to analyze and approve devices that demonstrate positive clinical health outcomes in a timelier and more predictable way during the premarket phase. By aligning CMS and FDA evidence expectations in advance, the RAPID coverage pathway is designed to significantly reduce the review times that have historically occurred between FDA market authorization and Medicare national coverage determinations (NCDs). Comments must be received by October 13.