FDA and CMS Launch RAPID Pathway for Faster Medicare Coverage of Breakthrough Devices
The U.S. Food and Drug Administration and Centers for Medicare & Medicaid Services jointly launched the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway on April 23, 2026, to expedite Medicare coverage for breakthrough medical devices. According to agency officials, the initiative allows simultaneous FDA premarket review and Medicare coverage decisions, significantly reducing delays between market authorization and coverage determinations.
The RAPID pathway enables Medicare national coverage and payment decisions to occur as soon as two months after FDA market authorization, a significant acceleration compared to the current timeline of approximately one year or more, according to CMS Deputy Administrator John Brooks. The initiative allows the FDA and CMS to work collaboratively with device innovators earlier in the technology development lifecycle, aligning regulatory and coverage expectations to reduce delays between FDA market authorization and Medicare coverage determinations.
Brooks said coverage can be provided “within 60 to 90 days of FDA approval across the Medicare population for new devices.”
To qualify for the RAPID pathway, devices must carry the FDA’s Breakthrough Device designation, which is granted to products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, according to FDA records. Devices classified as Class II must participate in the FDA’s Total Product Life Cycle Advisory Program (TAP), while Class III devices are eligible regardless of TAP participation. Additionally, devices must address unmet medical needs among Medicare beneficiaries and be subject to an Investigational Device Exemption (IDE) study enrolling Medicare patients with clinical health outcomes agreed upon by both FDA and CMS.
The RAPID pathway is designed to synchronize evidence generation during the investigational stage, allowing the same data to support both FDA premarket review and Medicare national coverage decisions. This coordinated approach aims to reduce duplication of evidence requirements and improve efficiency, officials said. Historically, separate evidence packages were generated for FDA review and Medicare coverage determination, contributing to delays. The new pathway establishes a predictable timeline and process for synchronizing FDA market authorization with CMS’s National Coverage Determination (NCD) process.
Devices approved through the RAPID pathway would receive permanent Medicare coverage, according to CMS and FDA officials. The program is intended to accelerate access to certain FDA-designated Class II and Class III Breakthrough Devices for Medicare beneficiaries by reducing administrative barriers and bringing predictability to coverage decisions. Coverage determinations under the pathway rely on evidence generated during the investigational phase rather than waiting until after market authorization, providing greater transparency to innovators regarding coverage expectations.
The FDA’s Breakthrough Devices Program, which replaced the Expedited Access Pathway and Priority Review for medical devices, is a voluntary program that requires devices to meet rigorous standards for safety and effectiveness before marketing authorization. As of December 31, 2025, the FDA had granted 1,246 Breakthrough Device designations across its Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), with 1,226 designations from CDRH and 20 from CBER, according to FDA data.
The announcement of the RAPID pathway reflects the Trump administration’s commitment to providing accelerated and more predictable coverage following FDA market authorization, agency officials said. The initiative is described as a “critical first step” toward fulfilling administration priorities for breakthrough technologies and supporting clinical benefit for the Medicare population. The program represents a coordinated effort between two major federal health agencies to streamline access pathways for innovative medical devices.
A proposed procedural notice outlining the RAPID pathway will be published in the Federal Register, followed by a 60-day public comment period, according to CMS and FDA statements. The pathway will become effective upon publication of the final notice. This procedural step is intended to formalize the alignment between FDA market authorization and CMS’s National Coverage Determination process, ensuring a transparent and predictable framework for device innovators and Medicare beneficiaries alike.
