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Patient Access to Innovative New Technologies Act of 2025
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.
Summary
The Patient Access to Innovative New Technologies Act of 2025 amends Medicare law to accelerate patient access to breakthrough medical devices through the Medicare New Technology Add-On Payment (NTAP) Program. The bill allows breakthrough devices—defined as those designated by the FDA for expedited development and priority review—to receive conditional NTAP approval if FDA approval, clearance, or authorization is granted before July 1 of the fiscal year in which the application was submitted, even if it missed the normal deadline. This conditional approval becomes effective beginning the first quarter after FDA approval is obtained. The provision is implemented in a budget-neutral manner and applies to devices approved or authorized by the FDA on or after July 1, 2023. The law aims to reduce delays in providing innovative medical devices to Medicare beneficiaries.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Rep. Carey, Mike [R-OH-15] (R-OH)
2 cosponsors
Actions (2)
- Jul 16, 2025 Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. · house
- Jul 16, 2025 Introduced in House
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Text versions (1)
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Full text
IN THE HOUSE OF REPRESENTATIVES
July 16, 2025
Mr. Carey (for himself and Mr. Davis of Illinois) introduced the following bill; which was referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
A BILL
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.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “Patient Access to Innovative New Technologies Act of 2025”.
SEC. 2. INCREASING ADOPTION OF AND ACCESS TO BREAKTHROUGH DEVICES.
(a) In General.—Section 1886(d)(5)(K) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(K)) is amended by adding at the end the following new clause:
“(x)(I) A breakthrough device that is not approved, cleared, or authorized under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act by the deadline specified in section 412.87(f)(2) of title 42, Code of Federal Regulations (or a successor regulation) may be conditionally approved for the new technology add-on payment under this subparagraph for a particular fiscal year, effective for discharges beginning in the first quarter after receiving such approval, clearance, or authorization, provided that the approval, clearance, or authorization is granted before July 1 of the fiscal year for which the applicant applied for new technology add-on payments.
“(II) For purposes of this clause, the term ‘breakthrough device’ means a medical device that— “(aa) is designated for expedited development and priority review under section 515B of the Federal Food, Drug, and Cosmetic Act; and “(bb) has been approved, cleared, or authorized under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act for the indication for which the designation described in item (aa) was made.
“(III) This clause shall not be considered an adjustment and shall be implemented in a budget neutral manner.”.
(b) Effective Date.—This section, and the amendments made by this section, shall take effect on the enactment of this Act and shall apply to a breakthrough device (as defined in section 1886(d)(5)(K)(x)(II) of the Social Security Act, as added by subsection (a)) that is approved, cleared, or authorized under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2), 360e) on or after July 1, 2023. <all>
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