119-hr4441

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4441 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 4441

 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.

_______________________________________________________________________

 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.
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