II 

118TH CONGRESS 

2D SESSION S. 4510 

To amend the American Taxpayer Relief Act of 2012 to delay implementation 

of the inclusion of oral-only ESRD-related drugs in the Medicare ESRD 

prospective payment system. 

IN THE SENATE OF THE UNITED STATES 

JUNE 11, 2024 

Mrs. BLACKBURN (for herself and Mr. LUJA ́N) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

A BILL 

To amend the American Taxpayer Relief Act of 2012 to 

delay implementation of the inclusion of oral-only ESRDrelated drugs in the Medicare ESRD prospective payment system. 

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 ‘‘Kidney Patient Access 

5 to Technologically Innovative and Essential Nephrology 

6 Treatments Act of 2024’’ or the ‘‘Kidney PATIENT Act 

7 of 2024’’. 


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1 SEC. 2. PROHIBITION OF IMPLEMENTATION OF ORAL-ONLY 

2 POLICY FOR CERTAIN DRUGS UNDER MEDI3 CARE ESRD PROSPECTIVE PAYMENT SYSTEM. 

4 (a) IN GENERAL.—Section 632(b) of the American 

5 Taxpayer Relief Act of 2012 (42 U.S.C. 1395rr note) is 

6 amended— 

7 (1) in the heading, by striking ‘‘TWO-YEAR

8 DELAY’’ and inserting ‘‘DELAY’’; and 

9 (2) in the first sentence of paragraph (1), by 

10 striking ‘‘may not implement’’ and all that follows 

11 through ‘‘January 1, 2025.’’ and inserting ‘‘may not 

12 implement the policy under section 413.174(f)(6) of 

13 title 42, Code of Federal Regulations (relating to 

14 oral-only ESRD-related drugs in the ESRD prospec15 tive payment system) with respect to such drugs in16 dicated for the reduction, management, or control of 

17 the serum phosphate of an individual before January 

18 1, 2027.’’. 

19 (b) STUDY.—Not later than 1 year after the date of 

20 the enactment of this Act, the Secretary of Health and 

21 Human Services shall submit to Congress and make avail22 able on the public website of the Centers for Medicare & 

23 Medicaid Services a report containing data from 2022 

24 through 2024 on— 

25 (1) the number of individuals entitled to bene26 fits under part A of title XVIII of the Social SecuVerDate Sep 11 2014 05:19 Jul 30, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4510.IS S4510

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•S 4510 IS

1 rity Act (42 U.S.C. 1395c et seq.) or enrolled under 

2 part B of such title (42 U.S.C. 1395j et seq.) with 

3 end-stage renal disease who are enrolled under a 

4 prescription drug plan under part D of such title (42 

5 U.S.C. 1395w–101 et seq.) or under an MA–PD 

6 plan under part C of such title (42 U.S.C. 1395w– 

7 21 et seq.), along with a specification of any gaps 

8 in coverage under such prescription drug plans or 

9 MA–PD plans; 

10 (2) the amount of expenditures under such part 

11 D attributable to oral-only drugs related to the 

12 treatment of end-stage renal disease and the amount 

13 of cost sharing incurred by such individuals for such 

14 drugs; 

15 (3) such individuals’ adherence to prescriptions 

16 for such drugs, including as measured by serum 

17 phosphate levels, reported through the end-stage 

18 renal disease quality reporting system; 

19 (4) adverse events of such individuals related to 

20 hyperphosphatemia and estimated costs attributable 

21 to such adverse events under such title; and 

22 (5) any recommended strategies or standards of 

23 practice to increase adherence to prescribed phos24 phate binders or lowering agents or other strategies 


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•S 4510 IS

1 to reduce costs to such individuals and expenditures 

2 under such program for such agents. 

Æ 


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