I 
119TH CONGRESS 
1ST SESSION H. R. 4441 
To amend title XVIII of the Social Security Act to improve Medicare bene-
ficiary access to new medical technologies that improve health care qual-
ity 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. 
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 con-
cerned 
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 ensur-
ing 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 Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Patient Access to Inno-
vative New Technologies Act of 2025’’. 
SEC. 2. INCREASING ADOPTION OF AND ACCESS TO BREAK-
THROUGH DEVICES. 
(a) IN GENERAL.—Section 1886(d)(5)(K) of the So-
cial Security Act (42 U.S.C. 1395ww(d)(5)(K)) is amend-
ed 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 pay-
ment under this subparagraph for a particular fiscal year, 
effective for discharges beginning in the first quarter after 
receiving such approval, clearance, or authorization, pro-
vided that the approval, clearance, or authorization is 
granted before July 1 of the fiscal year for which the ap-
plicant applied for new technology add-on payments. 
‘‘(II) For purposes of this clause, the term ‘break-
through device’ means a medical device that— 
‘‘(aa) is designated for expedited development 
and priority review under section 515B of the Fed-
eral Food, Drug, and Cosmetic Act; and 
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‘‘(bb) has been approved, cleared, or authorized 
under section 510(k), 513(f)(2), or 515 of the Fed-
eral Food, Drug, and Cosmetic Act for the indica-
tion for which the designation described in item (aa) 
was made. 
‘‘(III) This clause shall not be considered an adjust-
ment and shall be implemented in a budget neutral man-
ner.’’. 
(b) EFFECTIVE DATE.—This section, and the amend-
ments made by this section, shall take effect on the enact-
ment 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. 
Æ 
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