I 

118TH CONGRESS 

2D SESSION H. R. 7939 

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 

APRIL 11, 2024 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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•HR 7939 IH

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Patient Access to Inno3 vative New Technologies Act of 2024’’. 

4 SEC. 2. INCREASING ADOPTION OF AND ACCESS TO BREAK5 THROUGH DEVICES. 

6 (a) IN GENERAL.—Section 1886(d)(5)(K) of the So7 cial Security Act (42 U.S.C. 1395ww(d)(5)(K)) is amend8 ed by adding at the end the following new clause: 

9 ‘‘(x)(I) A breakthrough device that is not approved, 

10 cleared, or authorized under section 510(k), 513(f)(2), or 

11 515 of the Federal Food, Drug, and Cosmetic Act by the 

12 deadline specified in section 412.87(f)(2) of title 42, Code 

13 of Federal Regulations (or a successor regulation) may be 

14 conditionally approved for the new technology add-on pay15 ment under this subparagraph for a particular fiscal year, 

16 effective for discharges beginning in the first quarter after 

17 receiving such approval, clearance, or authorization, pro18 vided that the approval, clearance, or authorization is 

19 granted before July 1 of the fiscal year for which the ap20 plicant applied for new technology add-on payments. 

21 ‘‘(II) For purposes of this clause, the term ‘break22 through device’ means a medical device that— 

23 ‘‘(aa) is designated for expedited development 

24 and priority review under section 515B of the Fed25 eral Food, Drug, and Cosmetic Act; and 


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•HR 7939 IH

1 ‘‘(bb) has been approved, cleared, or authorized 

2 under section 510(k), 513(f)(2), or 515 of the Fed3 eral Food, Drug, and Cosmetic Act for the indica4 tion for which the designation described in item (aa) 

5 was made. 

6 ‘‘(III) This clause shall not be considered an adjust7 ment and shall be implemented in a budget neutral man8 ner.’’. 

9 (b) EFFECTIVE DATE.—This section, and the amend10 ments made by this section, shall take effect on the enact11 ment of this Act and shall apply to a breakthrough device 

12 (as defined in section 1886(d)(5)(K)(x)(II) of the Social 

13 Security Act, as added by subsection (a)) that is approved, 

14 cleared, or authorized under section 510(k), 513(f)(2), or 

15 515 of the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 360(k), 360c(f)(2), 360e) on or after July 1, 2023. 

Æ 


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