Sponsors (3)
The bill speeds Medicare payment and gives clearer payment certainty for certain FDA-designated breakthrough devices—potentially improving patient access and encouraging manufacturer investment—while restricting eligibility, limiting new spending through budget neutrality, and adding administrative complexity that may delay or exclude some innovations.
Medicare beneficiaries and patients with chronic conditions may get earlier access to FDA-designated breakthrough medical devices because CMS can grant conditional NTAP sooner, potentially improving treatment options and outcomes.
Hospitals and health systems can receive NTAP payments earlier for eligible breakthrough devices, improving near-term revenue timing and support for adopting new technologies.
Device manufacturers, including small businesses, gain clearer assurance of a Medicare payment pathway when FDA authorizations occur close to CMS deadlines, which can encourage investment in innovative devices.
Patients (including Medicare beneficiaries) may still face delayed access because eligibility is narrowly limited to FDA breakthrough devices cleared via specified pathways by the July 1 cutoff, excluding some innovations.
Hospitals, providers, and taxpayers may see limited additional financial support because the program is implemented budget-neutral, which could constrain Medicare spending for these devices.
Hospitals, providers, and state CMS administrators could face administrative burden and payment delays because conditional NTAP tied to post-deadline FDA actions requires CMS to verify timing and implement new processes.
Based on analysis of 2 sections of legislative text.
Allows conditional Medicare NTAP for eligible FDA-designated breakthrough devices that receive FDA action before July 1 of a fiscal year, effective the first quarter after FDA action.
Official title: To amend title XVIII of the Social Security Act to improve Medicare beneficiary access to new medical technologies that improve health care quality and outcomes by ensuring that breakthrough devices are eligible for conditional approval under the Medicare New Technology Add-On Payment (NTAP) Program, enabling these medical breakthroughs to be provided to Medicare beneficiaries without unnecessary delay.
Introduced July 16, 2025 by Mike Carey · Last progress July 16, 2025
Allows certain FDA-designated breakthrough medical devices that lack final FDA clearance/approval by CMS’s regular regulatory deadline to receive a conditional Medicare New Technology Add-On Payment (NTAP) for a fiscal year if the device obtains FDA clearance, approval, or authorization before July 1 of that fiscal year. The conditional NTAP applies beginning with discharges in the first quarter after the FDA action, must be budget-neutral, and the rule takes effect upon enactment (applying to breakthrough devices cleared/approved on or after July 1, 2023).