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Union Calendar No. 801 

118TH CONGRESS 

2D SESSION H. R. 1691 

[Report No. 118–952, Part I] 

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 HOUSE OF REPRESENTATIVES 

MARCH 22, 2023 

Mr. WENSTRUP (for himself, Ms. DELBENE, Mr. BILIRAKIS, Mr. CA ́RDENAS, 

Mr. MOORE of Utah, Ms. SEWELL, Mr. GUTHRIE, and Ms. ESHOO) 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 

DECEMBER 24, 2024 

Additional sponsors: Mr. JOYCE of Pennsylvania, Ms. KUSTER, Mr. CRENSHAW, Mr. KILMER, Mrs. MILLER of West Virginia, Ms. CRAIG, Mrs. 

STEEL, Ms. DEAN of Pennsylvania, Mr. BACON, Mr. PETERS, Mr. 

BALDERSON, Mr. AUCHINCLOSS, Mr. CURTIS, Ms. HOULAHAN, Mr. 

BUCSHON, Mr. FITZPATRICK, Mr. YAKYM, Ms. LOFGREN, Ms. SCHRIER, 

Mrs. TRAHAN, Mr. LIEU, Mr. MCGOVERN, Mr. BOYLE of Pennsylvania, 

Ms. WILD, Mr. BERA, Mr. CORREA, Ms. PORTER, Mr. SWALWELL, Mr. 

CISCOMANI, Mr. FERGUSON, Mr. CAREY, Mr. SIMPSON, Mrs. KIM of California, Mr. PAPPAS, Mr. BURGESS, Mrs. MILLER-MEEKS, Ms. SCANLON, 

Mr. PANETTA, Mr. DUNN of Florida, Mr. MULLIN, Ms. ROSS, Mr. 

KELLY of Pennsylvania, Ms. DEGETTE, Ms. LEE of Florida, Mr. 

GOTTHEIMER, Mr. PHILLIPS, Ms. TENNEY, Mr. BARR, Mr. KEAN of New 

Jersey, Mr. NEGUSE, Mr. PENCE, Mrs. FISCHBACH, Mr. MAST, Mr. 

JOHNSON of Ohio, Mr. LANGWORTHY, Ms. VAN DUYNE, Ms. 

PETTERSEN, Mr. FINSTAD, Mr. LAHOOD, Mr. SCHNEIDER, Mr. OWENS, 

Mr. SMUCKER, Mr. THOMPSON of Pennsylvania, Ms. CARAVEO, Mr. 

RUTHERFORD, Mr. CROW, Mr. WESTERMAN, Mr. ARMSTRONG, Mr. 

COHEN, Mr. SOTO, Mr. CARTER of Georgia, Mr. NICKEL, Mr. 

OBERNOLTE, Mr. SMITH of Nebraska, Mr. JAMES, Ms. MALOY, Ms. 


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BARRAGA ́N, Mr. DAVIS of North Carolina, Ms. SLOTKIN, Mr. DAVIS of 

Illinois, Ms. STRICKLAND, and Ms. STEVENS

DECEMBER 24, 2024 

Reported from the Committee on Ways and Means with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

DECEMBER 24, 2024 

Committee on Energy and Commerce discharged; committed to the Committee 

of the Whole House on the State of the Union and ordered to be printed 

[For text of introduced bill, see copy of bill as introduced on March 22, 2023] 

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. 


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•HR 1691 RH

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 Access 

5 to Critical Breakthrough Products Act of 2024’’. 

6 SEC. 2. ENSURING PROMPT COVERAGE OF BREAKTHROUGH 

7 DEVICES UNDER THE MEDICARE PROGRAM. 

8 (a) ENSURING COVERAGE THROUGH A TRANSITIONAL

9 COVERAGE PERIOD.— 

10 (1) IN GENERAL.—Section 1862(a)(1) of the So11 cial Security Act (42 U.S.C. 1395y(a)(1)) is amend12 ed— 

13 (A) in subparagraph (O), by striking ‘‘and’’ 

14 at the end; 

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

16 at the end; and 

17 (C) by inserting after subparagraph (P) the 

18 following new subparagraph: 

19 ‘‘(Q) in the case of a breakthrough device (as de20 fined in section 1861(nnn)) furnished during the 

21 transitional coverage period (as so defined) with re22 spect to such device, which is not furnished in accord23 ance with the Food and Drug Administration-ap24 proved labeling for such device or that the Secretary 

25 determines, based on a review of clinical data, preVerDate Sep 11 2014 00:09 Dec 27, 2024 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6203 E:\BILLS\H1691.RH H1691

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1 sents an undue risk of harm that outweighs the poten2 tial clinical benefits for individuals entitled to bene3 fits under part A or enrolled under part B;’’. 

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

5 Security Act (42 U.S.C. 1395x) is amended by adding 

6 at the end the following new subsection: 

7 ‘‘(nnn) BREAKTHROUGH DEVICE.— 

8 ‘‘(1) IN GENERAL.—The term ‘breakthrough de9 vice’ means a device so designated by the Secretary 

10 under section 1899C. 

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

12 term ‘transitional coverage period’ means, with re13 spect to a breakthrough device, the 4-year period that 

14 begins on the date that such device is so designated 

15 by the Secretary under section 1899C.’’. 

16 (3) BREAKTHROUGH DEVICE DETERMINA17 TIONS.—Part E of title XVIII of the Social Security 

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

19 at the end the following new section: 

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

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

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

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

24 the Federal Food, Drug, and Cosmetic Act) that is cleared, 

25 classified, or approved under section 510(k), 513(f)(2), or 


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1 515 of such Act on or after the date of the enactment of 

2 this section, the Secretary shall designate such device as a 

3 breakthrough device if the Secretary determines that such 

4 device meets the criteria specified in subsection (b). 

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

6 criteria specified in this subsection are, with respect to a 

7 device, the following: 

8 ‘‘(1) The device is provided with priority review 

9 pursuant to section 515B of the Federal Food, Drug, 

10 and Cosmetic Act. 

11 ‘‘(2) In the case such device is cleared under sec12 tion 510(k) of such Act, such device is so cleared based 

13 on clinical trial information from an applicable de14 vice clinical trial (as such terms are defined in sec15 tion 402(j) of such Act) that enrolled individuals enti16 tled to benefits under part A or enrolled under part 

17 B. 

18 ‘‘(3) The device is not a clinical diagnostic lab19 oratory test. 

20 ‘‘(c) DETERMINATION PROCESS.— 

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

22 determination with respect to a device that is the sub23 ject of an application described in subsection (a) not 

24 later than 6 months after such application is sub25 mitted to the Secretary. 


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1 ‘‘(2) EXPLANATION REQUIRED IN CASE OF DE2 TERMINATION THAT DEVICE DOES NOT MEET CRI3 TERIA FOR DESIGNATION.—In the case that the Sec4 retary determines that a device that is the subject of 

5 an application described in subsection (a) does not 

6 meet the criteria specified in subsection (b), the Sec7 retary shall notify the manufacturer of such device of 

8 such determination and include in such notification 

9 an explanation identifying the specific criterion or 

10 criteria that such device failed to meet. 

11 ‘‘(d) REPORTS.—The Secretary shall submit to Con12 gress on an annual basis a report specifying— 

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

14 this section during such year; 

15 ‘‘(2) the number of devices designated as break16 through devices under this section during such year; 

17 and 

18 ‘‘(3) the number of applications for a designa19 tion for a device under this section with respect to 

20 which the Secretary determined that such device did 

21 not meet the criteria specified in subsection (b) dur22 ing such year.’’. 

23 (b) ENSURING ISSUANCE OF NATIONAL COVERAGE DE24 TERMINATION DURING TRANSITION PERIOD.—Section 

25 1862(l)(2) of the Social Security Act (42 U.S.C. 


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1 1395y(l)(2)) is amended by adding at the end the following 

2 new flush sentence: 

3 ‘‘In the case of a request for a national coverage de4 termination with respect to a breakthrough device (as 

5 defined in section 1861(nnn)), the Secretary shall en6 sure that a final decision is made on such request 

7 prior to the end of the transitional coverage period 

8 (as so defined) for such device if such request was sub9 mitted to the Secretary before the date that is 9 

10 months (or 12 months, in the case such request is a 

11 request to which subparagraph (B) applies) before the 

12 last day of such period.’’. 

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

14 available, there are appropriated to the Centers for Medi15 care & Medicaid Services Program Management Account, 

16 out of any monies in the Treasury not otherwise appro17 priated, $10,000,000 for each of fiscal years 2025 through 

18 2030, to remain available until expended, to carry out the 

19 amendments made by this section. 


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Union Calendar No. 801 

118TH CONGRESS 

2D SESSION H. R. 1691 

[Report No. 118–952, Part I] 

A BILL 

To amend title XVIII of the Social Security Act to 

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

DECEMBER 24, 2024 

Reported from the Committee on Ways and Means with 

an amendment 

DECEMBER 24, 2024 

Committee on Energy and Commerce discharged; comState of the Union and ordered to be printed mitted to the Committee of the Whole House on the 


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