CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices

The Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) have introduced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway to accelerate patient access to innovative medical technologies. This initiative aims to reduce the historical delay between FDA authorization and Medicare national coverage from over a year to as little as two months for qualifying Breakthrough Devices. By aligning regulatory and reimbursement evidence requirements early in the development process, the program seeks to provide a more predictable commercialization path for manufacturers of Class II and Class III devices.

On April 23, 2026, federal agencies officially launched the RAPID program, targeting Class II and Class III medical devices that have received the FDA’s Breakthrough Device designation. This designation is reserved for novel technologies that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The RAPID pathway is designed to address the longstanding reimbursement gap by allowing manufacturers to engage with both the FDA and CMS simultaneously during the premarket phase, ensuring that the clinical evidence generated satisfies the requirements of both agencies for safety, effectiveness, and Medicare coverage.

Under the new framework, the National Coverage Determination (NCD) process is synchronized with the FDA’s review timeline. Unlike previous proposals that suggested automatic coverage, RAPID facilitates the issuance of a proposed NCD on the same day a device receives FDA authorization. Following a 60-day public comment period, CMS targets a final coverage decision within 60 to 90 days of the initial authorization. This coordination is expected to drastically shorten the timeframe for Medicare payment, which often serves as a benchmark for commercial insurance providers and informs broader market access.

While the RAPID program offers a faster route to coverage, a separate proposal from CMS could change how these devices are reimbursed at the hospital level. On April 10, 2026, CMS proposed repealing the alternative New Technology Add-On Payment (NTAP) pathway for Breakthrough Devices in both inpatient and outpatient settings. If finalized, this would require breakthrough technologies to meet the same substantial-clinical-improvement standard as standard medical devices to qualify for additional payments. This shift introduces new financial risks for device makers and healthcare providers, as it may affect the total compensation hospitals receive for utilizing high-cost innovative technologies.