Patient Access to Innovative New Technologies Act of 2025

The Patient Access to Innovative New Technologies Act of 2025 aims to speed Medicare beneficiaries’ access to cutting-edge medical devices by allowing certain “breakthrough devices” to qualify for the Medicare New Technology Add-On Payment (NTAP) program on a conditional basis, even if they have not yet received full FDA approval, clearance, or authorization by a specified deadline. If a device reaches what the bill calls “breakthrough device” status and meets the outlined FDA criteria for its indication, it could receive NTAP for a particular fiscal year for discharges that begin in the first quarter after conditional approval. The policy is designed to be budget-neutral and would take effect upon enactment, applying to breakthrough devices that are approved under FDA pathways on or after July 1, 2023. In short, the bill expands NTAP eligibility to accelerate coverage for breakthrough devices while they continue through the FDA approval process, with safeguards to ensure the device is still tied to the specified indication and that the approach does not increase net federal spending.