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LUGPA Policy Update - CMS Proposes RAPID Pathway to Accelerate Medicare Coverage of Breakthrough Devices

September 2026

At a Glance

CMS has proposed a new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway designed to accelerate Medicare coverage of certain FDA-designated Breakthrough Devices.

The pathway would allow CMS to engage with manufacturers earlier in the FDA approval process and align clinical evidence requirements for FDA approval and Medicare coverage. For eligible devices that demonstrate improved health outcomes, CMS would issue a proposed National Coverage Determination (NCD) on the same day as FDA market authorization, with the goal of finalizing national Medicare coverage within 60 days for Class II devices and 90 days for Class III devices.

Key Provisions

  • Early CMS involvement: CMS would work with manufacturers during the IDE pre-submission stage to identify clinical outcomes important to Medicare beneficiaries.
  • Eligible devices: RAPID would generally apply to Class II Breakthrough Devices participating in FDA’s Total Product Life Cycle Advisory Program (TAP) and Class III Breakthrough Devices, regardless of TAP participation.
  • Faster coverage: CMS would begin the NCD process when the FDA grants market authorization, potentially significantly reducing the gap between FDA approval and Medicare coverage.
  • Additional evidence: Higher-risk devices may receive coverage with evidence development (CED) when additional clinical evidence is needed.

Why It Matters for LUGPA Members

The RAPID pathway could speed Medicare access to innovative urologic technologies by reducing the traditional delay between FDA authorization and national Medicare coverage.

For LUGPA members, a more predictable coverage pathway could:

  • Accelerate patient access to new devices and technologies that improve clinical outcomes.
  • Provide greater certainty for independent practices considering adoption of innovative technologies.
  • Reduce coverage delays that can limit the availability of newly approved treatments for Medicare patients.
  • Improve coordination between FDA approval and Medicare coverage, potentially making it easier for practices to integrate new technologies into clinical care.

The pathway could be particularly relevant to emerging urologic technologies that receive Breakthrough Device designation. However, eligibility is limited, and devices already beyond the IDE pre-submission stage generally would not qualify for RAPID. In vitro diagnostic products are also excluded.

Looking Ahead

LUGPA will continue to monitor implementation of the RAPID pathway and assess opportunities to support policies that provide timely and predictable Medicare coverage for new technologies that improve patient care.