II 

118TH CONGRESS 

2D SESSION S. 5349 

To amend title XVIII of the Social Security Act to ensure prompt coverage 

of breakthrough devices under the Medicare program, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 20, 2024 

Mr. YOUNG (for himself and Mr. PADILLA) introduced the following bill; which 

was read twice and referred to the Committee on Finance 

A BILL 

To amend title XVIII of the Social Security Act to ensure 

prompt coverage of breakthrough devices under the Medicare program, and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ensuring Patient Ac5 cess to Critical Breakthrough Products Act of 2024’’. 

6 SEC. 2. ENSURING PROMPT COVERAGE OF BREAK7 THROUGH DEVICES UNDER THE MEDICARE 

8 PROGRAM. 

9 (a) ENSURING COVERAGE THROUGH A TRANSI10 TIONAL COVERAGE PERIOD.— 


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1 (1) IN GENERAL.—Section 1862(a)(1) of the 

2 Social Security Act (42 U.S.C. 1395y(a)(1)) is 

3 amended— 

4 (A) in subparagraph (O), by striking 

5 ‘‘and’’ at the end; 

6 (B) in subparagraph (P), by adding ‘‘and’’ 

7 at the end; and 

8 (C) by inserting after subparagraph (P) 

9 the following new subparagraph: 

10 ‘‘(Q) in the case of a breakthrough device (as 

11 defined in section 1861(nnn)) furnished during the 

12 transitional coverage period (as so defined) with re13 spect to such device, which is not furnished in ac14 cordance with the Food and Drug Administration15 approved labeling for such device or that the Sec16 retary determines, based on a review of clinical data, 

17 presents an undue risk of harm that outweighs the 

18 potential clinical benefits for individuals entitled to 

19 benefits under part A or enrolled under part B;’’. 

20 (2) DEFINITIONS.—Section 1861 of the Social 

21 Security Act (42 U.S.C. 1395x) is amended by add22 ing at the end the following new subsection: 

23 ‘‘(nnn) BREAKTHROUGH DEVICE.— 


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1 ‘‘(1) IN GENERAL.—The term ‘breakthrough 

2 device’ means a device so designated by the Sec3 retary under section 1899C. 

4 ‘‘(2) TRANSITIONAL COVERAGE PERIOD.—The 

5 term ‘transitional coverage period’ means, with re6 spect to a breakthrough device, the 4-year period 

7 that begins on the date that such device is so des8 ignated by the Secretary under section 1899C.’’. 

9 (3) BREAKTHROUGH DEVICE DETERMINA10 TIONS.—Part E of title XVIII of the Social Security 

11 Act (42 U.S.C. 1395x et seq.) is amended by adding 

12 at the end the following new section: 

13 ‘‘SEC. 1899C. DESIGNATION OF BREAKTHROUGH DEVICES. 

14 ‘‘(a) IN GENERAL.—Beginning 18 months after the 

15 date of the enactment of this section, upon application of 

16 a manufacturer of a device (as defined in section 201 of 

17 the Federal Food, Drug, and Cosmetic Act) that is 

18 cleared, classified, or approved under section 510(k), 

19 513(f)(2), or 515 of such Act on or after the date of the 

20 enactment of this section, the Secretary shall designate 

21 such device as a breakthrough device if the Secretary de22 termines that such device meets the criteria specified in 

23 subsection (b). 

24 ‘‘(b) CRITERIA.—For purposes of subsection (a), the 

25 criteria specified in this subsection is, with respect to a 


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1 device, that the device is provided with priority review pur2 suant to section 515B of the Federal Food, Drug, and 

3 Cosmetic Act. 

4 ‘‘(c) DETERMINATION PROCESS.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall make a 

6 determination with respect to a device that is the 

7 subject of an application described in subsection (a) 

8 not later than 6 months after such application is 

9 submitted to the Secretary. 

10 ‘‘(2) EXPLANATION REQUIRED IN CASE OF DE11 TERMINATION THAT DEVICE DOES NOT MEET CRI12 TERIA FOR DESIGNATION.—In the case that the Sec13 retary determines that a device that is the subject 

14 of an application described in subsection (a) does 

15 not meet the criteria specified in subsection (b), the 

16 Secretary shall notify the manufacturer of such de17 vice of such determination and include in such noti18 fication an explanation identifying the specific cri19 terion or criteria that such device failed to meet. 

20 ‘‘(d) REPORTS.—The Secretary shall submit to Con21 gress on an annual basis a report specifying— 

22 ‘‘(1) the number of applications received under 

23 this section during such year; 


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1 ‘‘(2) the number of devices designated as break2 through devices under this section during such year; 

3 and 

4 ‘‘(3) the number of applications for a designa5 tion for a device under this section with respect to 

6 which the Secretary determined that such device did 

7 not meet the criteria specified in subsection (b) dur8 ing such year.’’. 

9 (b) ENSURING ISSUANCE OF NATIONAL COVERAGE

10 DETERMINATION DURING TRANSITION PERIOD.—Section 

11 1862(l)(2) of the Social Security Act (42 U.S.C. 

12 1395y(l)(2)) is amended by adding at the end the fol13 lowing new flush sentence: 

14 ‘‘In the case of a request for a national coverage de15 termination with respect to a breakthrough device 

16 (as defined in section 1861(nnn)), the Secretary 

17 shall ensure that a final decision is made on such re18 quest prior to the end of the transitional coverage 

19 period (as so defined) for such device if such request 

20 was submitted to the Secretary before the date that 

21 is 9 months (or 12 months, in the case such request 

22 is a request to which subparagraph (B) applies) be23 fore the last day of such period.’’. 

24 (c) FUNDING.—In addition to amounts otherwise 

25 available, there are appropriated to the Centers for MediVerDate Sep 11 2014 18:01 Nov 25, 2024 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S5349.IS S5349

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1 care & Medicaid Services Program Management Account, 

2 out of any monies in the Treasury not otherwise appro3 priated, $10,000,000 for each of fiscal years 2025 through 

4 2030, to remain available until expended, to carry out the 

5 amendments made by this section. 

Æ 


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