II 

118TH CONGRESS 

2D SESSION S. 4469 

To improve the understanding of, and promote access to treatment for, 

chronic kidney disease, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 5, 2024 

Mr. CARDIN (for himself and Mrs. BLACKBURN) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

A BILL 

To improve the understanding of, and promote access to 

treatment for, chronic kidney disease, 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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Chronic Kidney Disease Improvement in Research and 

6 Treatment Act of 2024’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—PREVENTING KIDNEY DISEASE BY EXPANDING 

EDUCATION AND AWARENESS 


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Sec. 101. Expanding Medicare annual wellness benefit to include kidney disease 

screening. 

Sec. 102. Increasing access to Medicare kidney disease education benefit. 

Sec. 103. Understanding the progression of kidney disease and treatment of 

kidney failure in minority populations. 

TITLE II—INCENTIVIZING KIDNEY CARE INNOVATION 

Sec. 201. Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies. 

Sec. 202. Ensuring Medicare Advantage supports kidney care innovative therapies. 

Sec. 203. Improving patient lives and quality of care through research and innovation. 

TITLE III—ADDRESSING THE KIDNEY CARE WORKFORCE CRISIS. 

Sec. 301. Improving patient decision making and transparency by consolidating 

and modernizing quality programs. 

Sec. 302. Ensuring accuracy and stability in kidney care payment. 

TITLE IV—EXPANDING PATIENT CHOICE OF COVERAGE 

Sec. 401. Medigap coverage for beneficiaries with end-stage renal disease. 

1 TITLE I—PREVENTING KIDNEY 

2 DISEASE BY EXPANDING EDU3 CATION AND AWARENESS 

4 SEC. 101. EXPANDING MEDICARE ANNUAL WELLNESS BEN5 EFIT TO INCLUDE KIDNEY DISEASE SCREEN6 ING. 

7 (a) IN GENERAL.—Section 1861(ww)(2) of the Social 

8 Security Act (42 U.S.C. 1395x(ww)(2)) is amended— 

9 (1) by moving subparagraph (N) 2 ems to the 

10 left; 

11 (2) by redesignating subparagraph (O) as sub12 paragraph (P); and 

13 (3) by inserting after subparagraph (N) the fol14 lowing new subparagraph: 


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1 ‘‘(O) Chronic kidney disease screening as de2 fined by the Secretary.’’. 

3 (b) EFFECTIVE DATE.—The amendments made by 

4 this section apply to items and services furnished on or 

5 after January 1, 2025. 

6 SEC. 102. INCREASING ACCESS TO MEDICARE KIDNEY DIS7 EASE EDUCATION BENEFIT. 

8 (a) IN GENERAL.—Section 1861(ggg) of the Social 

9 Security Act (42 U.S.C. 1395x(ggg)) is amended— 

10 (1) in paragraph (1)— 

11 (A) in subparagraph (A), by inserting ‘‘or 

12 stage V’’ after ‘‘stage IV’’; and 

13 (B) in subparagraph (B), by inserting ‘‘or 

14 of a physician assistant, nurse practitioner, or 

15 clinical nurse specialist (as defined in section 

16 1861(aa)(5)) assisting in the treatment of the 

17 individual’s kidney condition’’ after ‘‘kidney 

18 condition’’; and 

19 (2) in paragraph (2)— 

20 (A) by striking subparagraph (B); and 

21 (B) in subparagraph (A)— 

22 (i) by striking ‘‘(A)’’ after ‘‘(2)’’; 

23 (ii) by striking ‘‘and’’ at the end of 

24 clause (i); 


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1 (iii) by striking the period at the end 

2 of clause (ii) and inserting ‘‘; and’’; 

3 (iv) by redesignating clauses (i) and 

4 (ii) as subparagraphs (A) and (B), respec5 tively, and indenting appropriately; and 

6 (v) by adding at the end the following: 

7 ‘‘(C) a renal dialysis facility subject to the 

8 requirements of section 1881(b)(1) with per9 sonnel who— 

10 ‘‘(i) provide the services described in 

11 paragraph (1); and 

12 ‘‘(ii) is a physician (as defined in sub13 section (r)(1)) or a physician assistant, 

14 nurse practitioner, or clinical nurse spe15 cialist (as defined in subsection (aa)(5)).’’. 

16 (b) PAYMENT TO RENAL DIALYSIS FACILITIES.— 

17 Section 1881(b) of the Social Security Act (42 U.S.C. 

18 1395rr(b)) is amended by adding at the end the following 

19 new paragraph: 

20 ‘‘(15) For purposes of paragraph (14), the single pay21 ment for renal dialysis services under such paragraph shall 

22 not take into account the amount of payment for kidney 

23 disease education services (as defined in section 

24 1861(ggg)). Instead, payment for such services shall be 


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1 made to the renal dialysis facility on an assignment-re2 lated basis under section 1848.’’. 

3 (c) EFFECTIVE DATE.—The amendments made by 

4 this section apply to kidney disease education services fur5 nished on or after January 1, 2025. 

6 SEC. 103. UNDERSTANDING THE PROGRESSION OF KIDNEY 

7 DISEASE AND TREATMENT OF KIDNEY FAIL8 URE IN MINORITY POPULATIONS. 

9 (a) STUDY.—The Secretary of Health and Human 

10 Services (in this section referred to as the ‘‘Secretary’’) 

11 shall conduct a study on— 

12 (1) the social, behavioral, and biological factors 

13 associated with kidney disease onset and progres14 sion; 

15 (2) efforts to slow the progression of kidney dis16 ease in minority populations that are disproportion17 ately affected by such disease; and 

18 (3) treatment patterns associated with pro19 viding care, under the Medicare program under title 

20 XVIII of the Social Security Act, the Medicaid pro21 gram under title XIX of such Act, and through pri22 vate health insurance, to minority populations that 

23 are disproportionately affected by kidney disease. 

24 (b) REPORT.—Not later than 1 year after the date 

25 of the enactment of this Act, the Secretary shall submit 


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1 to Congress a report on the study conducted under sub2 section (a), together with such recommendations as the 

3 Secretary determines to be appropriate. 

4 TITLE II—INCENTIVIZING 

5 KIDNEY CARE INNOVATION 

6 SEC. 201. REFINING THE END-STAGE RENAL DISEASE PAY7 MENT SYSTEM TO IMPROVE ACCURACY IN 

8 PAYMENT AND SUPPORT THERAPIES. 

9 (a) IN GENERAL.—Section 1881(b)(14) of the Social 

10 Security Act (42 U.S.C. 1395rr(b)(14)) is amended by 

11 adding at the end the following new subparagraph: 

12 ‘‘(J) PAYMENT FOR NEW AND INNOVATIVE DRUGS, 

13 BIOLOGICALS, AND DEVICES THAT ARE RENAL DIALYSIS

14 SERVICES.— 

15 ‘‘(i) IN GENERAL.—For any new renal dialysis 

16 drug or biological product that is used to treat or 

17 manage a condition for which there is a functional 

18 category as defined in section 413.234(a) of title 42, 

19 Code of Federal Regulations that received a transi20 tional drug add-on adjustment (referred to in this 

21 subparagraph as ‘TDAPA’) under section 

22 413.234(c)(2) of such title, and was furnished on or 

23 after January 1, 2024, the Secretary shall establish 

24 a permanent add-on adjustment to the base rate for 

25 claims submitted on or after January 1, 2025, that 


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1 includes the administration of such drugs or 

2 biologicals. 

3 ‘‘(ii) CALCULATION OF THE POST-TDAPA ADD4 ON ADJUSTMENT.—In calculating the add-on adjust5 ment described in clause (i), the Secretary shall— 

6 ‘‘(I) base the calculation on— 

7 ‘‘(aa) except as provided in items (bb) 

8 and (cc), the most recent 12-month period 

9 of utilization for the new renal dialysis 

10 drug or biological product and the most re11 cent available full calendar quarter of aver12 age sales price data for such drug or prod13 uct; 

14 ‘‘(bb) if the most recent available full 

15 calendar quarter of average sales price 

16 data reflects 0 or negative sales, 100 per17 cent of the wholesale acquisition cost (as 

18 defined in section 1847A(c)(6)) of such 

19 drug or product; or 

20 ‘‘(cc) if the wholesale acquisition cost 

21 is not available, the drug manufacturer’s 

22 invoice; 

23 ‘‘(II) calculate the post-TDAPA add-on 

24 payment adjustment as the expenditures for the 

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1 vided by the total number of renal dialysis serv2 ices during which such drug or biological was 

3 administered during the same period; 

4 ‘‘(III) set the amount of the add-on adjust5 ment as an amount equal to 65 percent of the 

6 amount calculated under subclause (II); 

7 ‘‘(IV) update the add-on adjustment annu8 ally to account for inflationary changes; and 

9 ‘‘(V) apply the add-on adjustment amount 

10 immediately upon the expiration of the TDAPA 

11 period and availability of the post-TDAPA add12 on adjustment. 

13 ‘‘(iii) IMPLEMENTATION.—This subparagraph 

14 shall not be implemented in a budget neutral man15 ner and shall not be adjusted by any applicable pa16 tient-level case-mix adjustments described in section 

17 413.235 of title 42, Code of Federal Regulations (or 

18 any successor regulation).’’. 

19 (b) EXTENSION OF TRANSITIONAL DRUG ADD-ON

20 ADJUSTMENT UNDER THE DRUG DESIGNATION POL21 ICY.—The Secretary shall pay the transitional drug add22 on adjustment under paragraph (c) of section 413.234 of 

23 title 42, Code of Federal Regulations (or a successor regu24 lation) for a total of 3 years for any new renal dialysis 

25 drug or biological product that— 


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1 (1) is used to treat or manage a condition for 

2 which there is a functional category as defined in 

3 paragraph (a) of such section; 

4 (2) qualifies for such adjustment under para5 graph (c)(2) of such section; and 

6 (3) is furnished on or after January 1, 2024. 

7 (c) NEW DEVICES AND OTHER TECHNOLOGIES.— 

8 (1) IN GENERAL.—As part of the promulgation 

9 of the annual rule for the Medicare end-stage renal 

10 disease prospective payment system under section 

11 1881(b)(14) of the Social Security Act (42 U.S.C. 

12 1395rr(b)(14)) for calendar year 2026, and in con13 sultation with stakeholders, the Secretary of Health 

14 and Human Services (referred to in this subsection 

15 as the ‘‘Secretary’’) shall— 

16 (A) ensure that the single payment amount 

17 is adequate to cover the cost of any new innova18 tive device or other technology with substantial 

19 clinical improvement; and 

20 (B) increase the single payment amount if 

21 the Secretary determines such payment amount 

22 is not adequate to cover such cost. 

23 (2) COST AND UTILIZATION DATA.—In carrying 

24 out paragraph (1), the Secretary shall use the cost 

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1 tional payment period, as described in the final regu2 lation published on November 9, 2020 (85 Fed. Reg. 

3 71398). 

4 SEC. 202. ENSURING MEDICARE ADVANTAGE SUPPORTS 

5 KIDNEY CARE INNOVATIVE THERAPIES. 

6 Section 1853(c) of the Social Security Act (42 U.S.C. 

7 1395w–23(c)) is amended by adding at the end the fol8 lowing new paragraph: 

9 ‘‘(8) TREATMENT OF INNOVATIVE PRODUCTS

10 FOR ENROLLEES WITH END STAGE RENAL DIS11 EASE.— 

12 ‘‘(A) IN GENERAL.—The Secretary shall 

13 make direct payment adjustments to providers 

14 of services or renal dialysis facilities for— 

15 ‘‘(i) any new renal dialysis drug or bi16 ological product that receives a transitional 

17 drug add-on adjustment under section 

18 413.234(c) of title 42, Code of Federal 

19 Regulations; or 

20 ‘‘(ii) an item or service that receives a 

21 transitional add-on payment adjustment 

22 for new and innovative equipment and sup23 plies under section 413.236 of such title. 

24 ‘‘(B) AMOUNT OF DIRECT PAYMENT.—The 

25 amount of the adjustment shall equal the 


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1 amount determined under the end stage renal 

2 disease prospective payment system described in 

3 section 1881(b)(14). 

4 ‘‘(C) DURATION OF DIRECT PAYMENT.— 

5 The Secretary shall make payments under sub6 paragraph (A) for the duration of the transi7 tional payment under the end stage renal dis8 ease prospective payment system described in 

9 such section.’’. 

10 SEC. 203. IMPROVING PATIENT LIVES AND QUALITY OF 

11 CARE THROUGH RESEARCH AND INNOVA12 TION. 

13 (a) STUDY.—The Secretary of Health and Human 

14 Services (referred to in this section as the ‘‘Secretary’’) 

15 shall conduct a study on increasing kidney transplantation 

16 rates. Such study shall include an analysis of each of the 

17 following: 

18 (1) Any disincentives in the payment systems 

19 under the Medicare program under title XVIII of 

20 the Social Security Act (42 U.S.C. 1395 et seq.) 

21 that create barriers to kidney transplants and post22 transplant care for beneficiaries with end-stage renal 

23 disease. 

24 (2) The practices used by donation service 

25 areas with higher than average donation rates and 


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1 whether those practices and policies could be suc2 cessfully utilized in other donation service areas. 

3 (3) Practices and policies that could increase 

4 donation rates among minority populations. 

5 (4) Whether cultural and policy barriers exist to 

6 increasing living donation rates, including an exam7 ination of how to better facilitate kidney paired do8 nations. 

9 (5) Criteria for transplant recipients for refer10 ral and for getting on the waitlist to receive a kid11 ney. 

12 (6) Other areas determined appropriate by the 

13 Secretary. 

14 (b) REPORT.—Not later than 18 months after the 

15 date of enactment of this Act, the Secretary shall submit 

16 to Congress a report on the study conducted pursuant to 

17 subsection (a), together with such recommendations as the 

18 Secretary determines to be appropriate. 


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1 TITLE III—INCREASING PATIENT 

2 ACCESS TO QUALITY PER3 FORMANCE BY IMPROVING 

4 THE ACCURACY AND TRANS5 PARENCY OF END-STAGE 

6 RENAL DISEASE QUALITY 

7 PROGRAMS 

8 SEC. 301. IMPROVING PATIENT DECISION MAKING AND 

9 TRANSPARENCY BY CONSOLIDATING AND 

10 MODERNIZING QUALITY PROGRAMS. 

11 (a) MEASURES.—Section 1881(h)(2) of the Social 

12 Security Act (42 U.S.C. 1395rr(h)(2)) is amended— 

13 (1) by striking subparagraph (A) and inserting 

14 the following: 

15 ‘‘(A) The measures specified under this 

16 paragraph with respect to the year involved 

17 shall be selected by the Secretary in consulta18 tion with stakeholders to promote improvement 

19 in beneficiary outcomes and shared decision20 making with beneficiaries and their caregivers. 

21 When selecting measures specified under this 

22 paragraph, the Secretary shall take into ac23 count clinical gaps in care, underutilization that 

24 may lead to beneficiary harm, patient safety, 

25 and outcomes.’’; 


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1 (2) in subparagraph (B)(i), by striking ‘‘sub2 paragraph (A)(iv)’’ and inserting ‘‘subparagraph 

3 (A)’’; 

4 (3) by striking subparagraph (E); and 

5 (4) by adding at the end the following new sub6 paragraphs: 

7 ‘‘(E) WEIGHTING LIMITATION.—No single 

8 measure specified by the Secretary or individual 

9 measure within a composite measure so speci10 fied may be weighted less than 10 percent of 

11 the total performance score. 

12 ‘‘(F) STATISTICALLY VALID AND RELI13 ABLE.—In specifying measures under subpara14 graph (A), the Secretary shall only specify 

15 measures that have been shown to be statis16 tically valid and reliable through testing.’’. 

17 (b) ENDORSEMENT.—Section 1881(h)(2)(B)(ii) of 

18 the Social Security Act (42 U.S.C. 1395rr(h)(2)(B)(ii)) is 

19 amended by adding at the end the following new sentence: 

20 ‘‘The exception under the preceding sentence shall not 

21 apply to a measure that the entity with a contract under 

22 section 1890(a) (or a similar entity) considered but failed 

23 to endorse.’’. 


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1 (e) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to items and services furnished on 

3 or after January 1, 2025. 

4 TITLE IV—EMPOWERING 

5 PATIENTS 

6 SEC. 401. MEDIGAP COVERAGE FOR BENEFICIARIES WITH 

7 END-STAGE RENAL DISEASE. 

8 (a) GUARANTEED AVAILABILITY OF MEDIGAP POLI9 CIES TO ALL ESRD MEDICARE BENEFICIARIES.— 

10 (1) IN GENERAL.—Section 1882(s) of the So11 cial Security Act (42 U.S.C. 1395ss(s)) is amend12 ed— 

13 (A) in paragraph (2)— 

14 (i) in subparagraph (A), by striking 

15 ‘‘is 65’’ and all that follows through the 

16 period and inserting the following: ‘‘is— 

17 ‘‘(i) 65 years of age or older and is enrolled for 

18 benefits under part B; or 

19 ‘‘(ii) entitled to benefits under 226A(b) and is 

20 enrolled for benefits under part B.’’; and 

21 (ii) in subparagraph (D), in the mat22 ter preceding clause (i), by inserting ‘‘(or 

23 is entitled to benefits under 226A(b))’’ 

24 after ‘‘is 65 years of age or older’’; and 

25 (B) in paragraph (3)(B)— 


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1 (i) in clause (ii), by inserting ‘‘(or is 

2 entitled to benefits under 226A(b))’’ after 

3 ‘‘is 65 years of age or older’’; and 

4 (ii) in clause (vi), by inserting ‘‘(or 

5 under 226A(b))’’ after ‘‘at age 65’’. 

6 (2) EFFECTIVE DATE.—The amendments made 

7 by paragraph (1) shall apply to Medicare supple8 mental policies effective on or after January 1, 

9 2026. 

10 (b) ADDITIONAL ENROLLMENT PERIOD FOR CER11 TAIN INDIVIDUALS.— 

12 (1) ONE-TIME ENROLLMENT PERIOD.— 

13 (A) IN GENERAL.—In the case of an indi14 vidual described in subparagraph (B), the Sec15 retary of Health and Human Services shall es16 tablish a one-time enrollment period during 

17 which such an individual may enroll in any 

18 Medicare supplemental policy under section 

19 1882 of the Social Security Act (42 U.S.C. 

20 1395ss) of the individual’s choosing. 

21 (B) ENROLLMENT PERIOD.—The enroll22 ment period established under subparagraph 

23 (A) shall begin on January 1, 2026, and shall 

24 end June 30, 2026. 


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1 (2) INDIVIDUAL DESCRIBED.—An individual de2 scribed in this paragraph is an individual who— 

3 (A) is entitled to hospital insurance bene4 fits under part A of title XVIII of the Social 

5 Security Act under section 226A(b) of such Act 

6 (42 U.S.C. 426–1); 

7 (B) is enrolled for benefits under part B of 

8 such title XVIII; and 

9 (C) would not, but for the provisions of, 

10 and amendments made by, subsection (a) be eli11 gible for the guaranteed issue of a Medicare 

12 supplemental policy under paragraph (2) or (3) 

13 of section 1882(s) of such Act (42 U.S.C. 

14 1395ss(s)). 

Æ 


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