Patient Access to Innovative New Technologies Act of 2025

This bill aims to help Medicare patients get access to new, “breakthrough” medical devices faster. It lets Medicare give temporary extra payments to hospitals for these devices as soon as the device gets FDA approval within the fiscal year—even if the usual Medicare deadline was missed—so care isn’t delayed while payment rules catch up. The change must be budget neutral, meaning it won’t raise overall Medicare spending. It uses the FDA’s own definition of a “breakthrough device” and ties the faster payment to when the FDA clears or approves the device in that year.

It takes effect when signed into law and applies to devices approved on or after July 1, 2023, if they meet the breakthrough criteria and receive FDA clearance or approval before July 1 of the year the hospital seeks the add-on payment.

• Who is affected: Medicare patients needing cutting-edge devices; hospitals that treat them; companies with FDA-designated breakthrough devices.
• What changes: Medicare can grant conditional add-on payments for breakthrough devices sooner in the year, avoiding delays tied to prior deadlines; overall spending must stay the same.
• When: Starts on enactment; applies to eligible devices approved on or after July 1, 2023, with FDA action before July 1 of the payment year.