Patient Access to Innovative New Technologies Act of 2025
Sponsored By: Representative Carey
Introduced
Summary
Conditional Medicare payments to speed patient access to breakthrough medical devices. This bill would let Medicare's New Technology Add-On Payment (NTAP) program grant conditional NTAP status when a device has an FDA breakthrough designation even if it misses the normal approval deadline.
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- Patients and families: Patients could get earlier access to breakthrough technologies because hospitals could receive NTAP for devices that begin discharges in the first quarter after FDA clearance.
- Hospitals and providers: Hospitals could claim NTAP only if the device's approval is granted before July 1 of the fiscal year and the device starts discharges in the first quarter after approval.
- Device manufacturers: Manufacturers of devices designated under the FDA breakthrough pathway and later cleared under 510(k), 513(f)(2), or 515 could be eligible for conditional NTAP, creating a clearer path to temporary Medicare reimbursement after meeting the designation and timing rules.
*This provision would be implemented in a budget-neutral manner and is designed not to change net Medicare spending.*
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Faster Medicare access to breakthrough devices
This bill would let hospitals get a temporary extra Medicare payment for some "breakthrough" medical devices. The device would need an FDA breakthrough designation and then receive approval, clearance, or authorization. To qualify for a fiscal year, the FDA action would need to happen before July 1 of that year. Payments would start for hospital stays in the first quarter after that FDA action. This could apply even if the device missed a Medicare timing deadline. It would take effect on enactment and cover devices approved on or after July 1, 2023. Payments would be budget neutral and not treated as a general rate change.
Sponsors & CoSponsors
Sponsor
Carey
OH • R
Cosponsors
Davis (IL)
IL • D
Sponsored 7/16/2025
Vindman
VA • D
Sponsored 9/15/2025
Roll Call Votes
No roll call votes available for this bill.
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