II 

114TH CONGRESS 

1ST SESSION S. 598 

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 

FEBRUARY 26, 2015 

Mr. CARDIN (for himself, Mr. CRAPO, and Mr. NELSON) 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. 

4 This Act may be cited as the ‘‘Chronic Kidney Dis5 ease Improvement in Research and Treatment Act of 

6 2015’’. 

7 SEC. 2. TABLE OF CONTENTS. 

8 The table of contents of this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—IMPROVING UNDERSTANDING OF CHRONIC KIDNEY 

DISEASE THROUGH EXPANDED RESEARCH AND COORDINATION 


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Sec. 101. Identifying gaps in chronic kidney disease research. 

Sec. 102. Coordinating research on chronic kidney disease. 

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

kidney failure in minority populations. 

Sec. 104. Identifying Medicare payment disincentives for transplant and posttransplant care. 

TITLE II—PROMOTING ACCESS TO CHRONIC KIDNEY DISEASE 

TREATMENTS 

Sec. 201. Increasing access to Medicare kidney disease education benefit. 

Sec. 202. Improving access to chronic kidney disease treatment in underserved 

rural and urban areas. 

Sec. 203. Promoting access to home dialysis treatments. 

Sec. 204. Expanding access for patients with acute kidney injury. 

TITLE III—CREATING ECONOMIC STABILITY FOR PROVIDERS 

CARING FOR INDIVIDUALS WITH CHRONIC KIDNEY DISEASE 

Sec. 301. Stabilizing Medicare payments for services provided to beneficiaries 

with stage V chronic kidney disease receiving dialysis services. 

Sec. 302. Providing individuals with kidney failure access to managed care and 

coordinated care programs. 

1 TITLE I—IMPROVING UNDER2 STANDING OF CHRONIC KID3 NEY DISEASE THROUGH EX4 PANDED RESEARCH AND CO5 ORDINATION 

6 SEC. 101. IDENTIFYING GAPS IN CHRONIC KIDNEY DISEASE 

7 RESEARCH. 

8 (a) REPORT.—Not later than one year after the date 

9 of enactment of this Act, the Comptroller General of the 

10 United States shall develop and submit to Congress a com11 prehensive report assessing the adequacy of Federal ex12 penditures in chronic kidney disease research relative to 

13 Federal expenditures for chronic kidney disease care. 

14 (b) CONTENTS.—The report required by this section 

15 shall— 


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1 (1) analyze the current chronic kidney disease 

2 research projects being funded by Federal agencies; 

3 (2) identify, including by surveying the kidney 

4 care community, areas of chronic kidney disease 

5 knowledge gaps that are not part of current Federal 

6 research efforts; 

7 (3) report on the level of Federal expenditures 

8 on kidney research as compared to the amount of 

9 Federal expenditures on treating individuals with 

10 chronic kidney disease; and 

11 (4) identify areas of kidney failure knowledge 

12 gaps in research to assess treatment patterns associ13 ated with providing care to minority populations 

14 that are disproportionately affected by kidney fail15 ure. 

16 SEC. 102. COORDINATING RESEARCH ON CHRONIC KIDNEY 

17 DISEASE. 

18 (a) INTERAGENCY COMMITTEE.—The Secretary of 

19 Health and Human Services shall establish and maintain 

20 an interagency committee for the purpose of improving the 

21 coordination of chronic kidney disease research. 

22 (b) REPORTS.—For the purpose described in sub23 section (a), the interagency committee established under 

24 such subsection shall issue public reports that— 


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1 (1) include a strategic plan, including rec2 ommendations for— 

3 (A) improving communication and coordi4 nation among Federal agencies; 

5 (B) procedures for monitoring Federal 

6 chronic kidney disease research activities; and 

7 (C) ways to maximize the efficiency of the 

8 Federal chronic kidney disease research invest9 ment and minimize the potential for unneces10 sary duplication; 

11 (2) include a portfolio analysis that provides in12 formation on chronic kidney disease research 

13 projects, organized by the strategic plan objectives; 

14 and 

15 (3) address such other topics as the interagency 

16 committee determines appropriate. 

17 (c) MEETINGS.—The interagency committee estab18 lished under subsection (a) shall meet not less frequently 

19 than semi-annually. 

20 SEC. 103. UNDERSTANDING THE PROGRESSION OF KIDNEY 

21 DISEASE AND TREATMENT OF KIDNEY FAIL22 URE IN MINORITY POPULATIONS. 

23 Not later than one year after the date of enactment 

24 of this Act, the Secretary of Health and Human Services 

25 shall— 


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1 (1) complete a study on— 

2 (A) the social, behavioral, and biological 

3 factors leading to kidney disease; 

4 (B) efforts to slow the progression of kid5 ney disease in minority populations that are 

6 disproportionately affected by such disease; and 

7 (C) treatment patterns associated with 

8 providing care, under the Medicare program 

9 under title XVIII of the Social Security Act, the 

10 Medicaid program under title XIX of such Act, 

11 and through private health insurance, to minor12 ity populations that are disproportionately af13 fected by kidney failure; and 

14 (2) submit to Congress a report on the results 

15 of such study. 

16 SEC. 104. IDENTIFYING MEDICARE PAYMENT DISINCEN17 TIVES FOR TRANSPLANT AND POST-TRANS18 PLANT CARE. 

19 Not later than 2 years after the date of enactment 

20 of this Act, the Secretary of Health and Human Services 

21 shall submit to Congress a report on any disincentives in 

22 the payment systems under the Medicare program under 

23 title XVIII of the Social Security Act that create barriers 

24 to kidney transplants and post-transplant care for bene25 ficiaries with end-stage renal disease. 


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1 TITLE II—PROMOTING ACCESS 

2 TO CHRONIC KIDNEY DIS3 EASE TREATMENTS 

4 SEC. 201. INCREASING ACCESS TO MEDICARE KIDNEY DIS5 EASE EDUCATION BENEFIT. 

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

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

8 (1) in paragraph (1)— 

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

10 stage V’’ after ‘‘stage IV’’; and 

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

12 of a physician assistant, nurse practitioner, or 

13 clinical nurse specialist (as defined in section 

14 1861(aa)(5)) assisting in the treatment of the 

15 individual’s kidney condition’’ after ‘‘kidney 

16 condition’’; and 

17 (2) in paragraph (2)— 

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

19 (B) in subparagraph (A)— 

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

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

22 clause (i); 

23 (iii) by striking the period at the end 

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


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1 (iv) by redesignating clauses (i) and 

2 (ii) as subparagraphs (A) and (B), respec3 tively; and 

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

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

6 requirements of section 1881(b)(1) with per7 sonnel who— 

8 ‘‘(i) provide the services described in 

9 paragraph (1); and 

10 ‘‘(ii) is a physician (as defined in sub11 section (r)(1)) or a physician assistant, 

12 nurse practitioner, or clinical nurse spe13 cialist (as defined in subsection (aa)(5)).’’. 

14 (b) PAYMENT TO RENAL DIALYSIS FACILITIES.— 

15 Section 1881(b) of such Act (42 U.S.C. 1395rr(b)) is 

16 amended by adding at the end the following new para17 graph: 

18 ‘‘(15) For purposes of paragraph (14), the sin19 gle payment for renal dialysis services under such 

20 paragraph shall not take into account the amount of 

21 payment for kidney disease education services (as 

22 defined in section 1861(ggg)). Instead, payment for 

23 such services shall be made to the renal dialysis fa24 cility on an assignment-related basis under section 

25 1848.’’. 


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

2 this section apply to kidney disease education services fur3 nished on or after January 1, 2016. 

4 SEC. 202. IMPROVING ACCESS TO CHRONIC KIDNEY DIS5 EASE TREATMENT IN UNDERSERVED RURAL 

6 AND URBAN AREAS. 

7 (a) DEFINITION OF PRIMARY CARE SERVICES.—Sec8 tion 331(a)(3)(D) of the Public Health Service Act (42 

9 U.S.C. 254d(a)(3)(D)) is amended by inserting ‘‘and in10 cludes renal dialysis services’’ before the period at the end. 

11 (b) NATIONAL HEALTH SERVICE CORPS SCHOLAR12 SHIP PROGRAM.—Section 338A(a)(2) of the Public Health 

13 Service Act (42 U.S.C. 254l(a)(2)) is amended by insert14 ing ‘‘, including nephrologists and non-physician practi15 tioners providing renal dialysis services’’ before the period 

16 at the end. 

17 (c) NATIONAL HEALTH SERVICE CORPS LOAN RE18 PAYMENT PROGRAM.—Section 338B(a)(2) of the Public 

19 Health Service Act (42 U.S.C. 254l–1(a)(2)) is amended 

20 by inserting ‘‘, including nephrologists and non-physician 

21 practitioners providing renal dialysis services’’ before the 

22 period at the end. 


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1 SEC. 203. PROMOTING ACCESS TO HOME DIALYSIS TREAT2 MENTS. 

3 Section 1834(m)(4)(C)(ii) of the Social Security Act 

4 (42 U.S.C. 1395m(m)(4)(C)(ii)) is amended by adding at 

5 the end the following new subclause: 

6 ‘‘(IX) A renal dialysis facility (as 

7 defined in section 1881).’’. 

8 SEC. 204. EXPANDING ACCESS FOR PATIENTS WITH ACUTE 

9 KIDNEY INJURY. 

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

11 1395rr(b)) is amended— 

12 (1) in paragraph (1), by inserting ‘‘or acute 

13 kidney injury’’ after ‘‘individuals who have been de14 termined to have end stage renal disease’’; 

15 (2) in paragraph (2)(A), by inserting ‘‘or acute 

16 kidney injury’’ after ‘‘end stage renal disease’’; 

17 (3) in paragraph (2)(B), by inserting ‘‘or acute 

18 kidney injury’’ after ‘‘end stage renal disease’’; 

19 (4) in paragraph (3), in the matter preceding 

20 subparagraph (A), by inserting ‘‘or acute kidney in21 jury’’ after ‘‘end stage renal disease’’; 

22 (5) in paragraph (11)(A), by inserting ‘‘or 

23 acute kidney injury’’ after ‘‘end stage renal disease’’; 

24 (6) in paragraph (11)(B), by inserting ‘‘or 

25 acute kidney injury’’ after ‘‘end stage renal disease’’; 

26 (7) in paragraph (14)(B)— 


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1 (A) in clause (ii), by inserting ‘‘or acute 

2 kidney injury’’ after ‘‘end stage renal disease’’; 

3 (B) in clause (iii), by inserting ‘‘or acute 

4 kidney injury’’ after ‘‘end stage renal disease’’; 

5 and 

6 (C) in clause (iv), by inserting ‘‘or acute 

7 kidney injury’’ after ‘‘end stage renal disease’’; 

8 and 

9 (8) in paragraph (14)(H)(i), by inserting ‘‘or 

10 acute kidney injury’’ after ‘‘end stage renal disease’’. 

11 TITLE III—CREATING ECONOMIC 

12 STABILITY FOR PROVIDERS 

13 CARING FOR INDIVIDUALS 

14 WITH CHRONIC KIDNEY DIS15 EASE 

16 SEC. 301. STABILIZING MEDICARE PAYMENTS FOR SERV17 ICES PROVIDED TO BENEFICIARIES WITH 

18 STAGE V CHRONIC KIDNEY DISEASE RECEIV19 ING DIALYSIS SERVICES. 

20 Section 1881(b)(14) of the Social Security Act (42 

21 U.S.C. 1395rr(b)(14)) is amended— 

22 (1) in subparagraph (D), in the matter pre23 ceding clause (i), by striking ‘‘Such system’’ and in24 serting ‘‘Subject to subparagraph (J), such system’’; 

25 and 


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1 (2) by adding at the end the following new sub2 paragraph: 

3 ‘‘(J)(i) For payment for renal dialysis services fur4 nished on or after January 1, 2016, under the system 

5 under this paragraph— 

6 ‘‘(I) the payment adjustment described in 

7 clause (i) of subparagraph (D) shall not take into 

8 account comorbidities; 

9 ‘‘(II) the payment adjustment described in 

10 clause (ii) of such subparagraph shall not be in11 cluded; 

12 ‘‘(III) the standardization factor described in 

13 the final rule published in the Federal Register on 

14 November 8, 2012 (77 Fed. Reg. 67470), shall be 

15 established using the most currently available data 

16 (and not historical data) and adjusted on an annual 

17 basis, based on such available data, to account for 

18 any change in utilization of drugs and any modifica19 tion in adjustors applied under this paragraph; and 

20 ‘‘(IV) the Secretary shall take into account rea21 sonable costs consistent with paragraph (2)(B) when 

22 calculating such payments. 

23 ‘‘(ii) Not later than January 1, 2016, the Secretary 

24 shall amend the ESRD facility cost report to— 


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1 ‘‘(I) include the per treatment network fee (as 

2 described in paragraph (7)) as an allowable cost; 

3 and 

4 ‘‘(II) eliminate the limitation for reporting med5 ical director fees on such reports in order to take 

6 into account the wages of a board-certified 

7 nephrologist.’’. 

8 SEC. 302. PROVIDING INDIVIDUALS WITH KIDNEY FAILURE 

9 ACCESS TO MANAGED CARE AND COORDI10 NATED CARE PROGRAMS. 

11 (a) EXPANDING ACCESS TO MEDICARE ADVAN12 TAGE.— 

13 (1) ELIGIBILITY UNDER MEDICARE ADVAN14 TAGE.— 

15 (A) IN GENERAL.—Section 1851(a)(3) of 

16 the Social Security Act (42 U.S.C. 1395w– 

17 21(a)(3)) is amended— 

18 (i) by striking subparagraph (B); and 

19 (ii) by striking ‘‘ELIGIBLE INDI20 VIDUAL.—’’ and all that follows through 

21 ‘‘In this title’’ and inserting ‘‘ELIGIBLE IN22 DIVIDUAL.—In this title’’. 

23 (B) CONFORMING AMENDMENT.—Section 

24 1852(b)(1) of the Social Security Act (42 

25 U.S.C. 1395w–22(b)(1)) is amended— 


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1 (i) by striking subparagraph (B); and 

2 (ii) by striking ‘‘BENEFICIARIES.—’’ 

3 and all that follows through ‘‘A 

4 Medicare+Choice organization’’ and in5 serting ‘‘BENEFICIARIES.—A Medicare Ad6 vantage organization’’. 

7 (C) EFFECTIVE DATE.—The amendments 

8 made by this paragraph shall apply with respect 

9 to plan years beginning on or after January 1, 

10 2016. 

11 (2) EDUCATION.—Section 1851(d)(2)(A)(iii) of 

12 the Social Security Act (42 U.S.C. 1395w– 

13 21(d)(2)(A)(iii)) is amended by inserting before the 

14 period at the end the following ‘‘, including any ad15 ditional information that individuals determined to 

16 have end stage renal disease may need to make in17 formed decisions with respect to such an election’’. 

18 (3) QUALITY METRICS.—Section 1852(e)(3)(A) 

19 of the Social Security Act (42 U.S.C. 1395w– 

20 22(e)(3)(A)) is amended by adding at the end the 

21 following new clause: 

22 ‘‘(v) REQUIREMENTS WITH RESPECT

23 TO INDIVIDUALS WITH ESRD.—In addition 

24 to the data required to be collected, ana25 lyzed, and reported under clause (i) and 


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1 notwithstanding the limitations under sub2 paragraph (B), as part of the quality im3 provement program under paragraph (1), 

4 each MA organization shall provide for the 

5 collection, analysis, and reporting of data, 

6 determined in consultation with the kidney 

7 care community, that permits the measure8 ment of health outcomes and other indices 

9 of quality with respect to individuals deter10 mined to have end stage renal disease.’’. 

11 (b) PERMANENT EXTENSION OF MEDICARE ADVAN12 TAGE ESRD SPECIAL NEEDS PLANS AUTHORITY.—Sec13 tion 1859(f)(1) of the Social Security Act (42 U.S.C. 

14 1395w–28(f)(1)) is amended by inserting ‘‘, in the case 

15 of a specialized MA plan for special needs individuals who 

16 have not been determined to have end stage renal dis17 ease,’’ before ‘‘for periods before January 1, 2017’’. 

18 (c) VOLUNTARY ESRD COORDINATED CARE

19 GAINSHARING PROGRAM.— 

20 (1) IN GENERAL.—Section 1881(b) of the So21 cial Security Act (42 U.S.C. 1395rr(b)) is amended 

22 by adding at the end the following new paragraph: 

23 ‘‘(15)(A) Not later than January 1, 2017, the Sec24 retary shall, in accordance with this paragraph, establish 

25 an ESRD Care Coordination gainsharing program for 


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1 nephrologists, renal dialysis facilities, and providers of 

2 services that develop coordinated care organizations to 

3 provide a full range of clinical and supportive services (as 

4 described in subparagraph (D)) to individuals determined 

5 to have end stage renal disease. 

6 ‘‘(B) Under such program, subject to subparagraph 

7 (C), the payment amounts renal dialysis facilities and pro8 viders of services described in subparagraph (A) would 

9 otherwise receive under paragraph (14) and nephrologists 

10 described in subparagraph (A) would otherwise receive 

11 under section 1848 with respect to dialysis services fur12 nished by such a facility, provider, or nephrologist during 

13 a year, shall be increased by a portion of the amount (as 

14 determined by the Secretary) of actual reductions in ex15 penditures under this title attributable to the coordinated 

16 care organization developed by such facility, provider, or 

17 nephrologist involved, taking into account non-dialysis ex18 penditures under parts A and B, during the preceding cal19 endar year. The payment amount under this subparagraph 

20 shall be provided to a nephrologist, renal dialysis facility, 

21 and provider of services that developed the coordinated 

22 care organization not later than March 31 of the year 

23 after the year during which such services are provided by 

24 such nephrologist, facility, or provider. 


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1 ‘‘(C) The aggregate incentive payment amounts pro2 vided under such program for a year may not exceed the 

3 amount equal to 2 percent less than the estimated total 

4 amount of non-dialysis expenditures under parts A and 

5 B for 2017 for items and services that are not related 

6 to dialysis or transplant services. 

7 ‘‘(D) For purposes of subparagraph (A), the full 

8 range of clinical and supportive services includes at least 

9 the following: 

10 ‘‘(i) Primary care and other preventative serv11 ices. 

12 ‘‘(ii) Specialty care for co-morbidities or non13 renal acute conditions, including at least podiatry, 

14 cardiology, and orthopedics. 

15 ‘‘(iii) Vascular access. 

16 ‘‘(iv) Laboratory testing and diagnostic imag17 ing. 

18 ‘‘(v) Pharmacy care management. 

19 ‘‘(vi) Patient, family, and caregiver education. 

20 ‘‘(vii) Psychiatric, behavioral therapy, and coun21 seling services. 

22 ‘‘(E) In providing payment incentive amounts under 

23 such program, the Secretary shall apply a risk adjustment 

24 methodology that— 


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1 ‘‘(i) uses risk adjuster factors applied under 

2 part C; and 

3 ‘‘(ii) adjusts such payments to exclude the top 

4 2 percent of outliers. 

5 ‘‘(F) In establishing such program, the Secretary 

6 shall ensure that each of the following is satisfied: 

7 ‘‘(i) The program allows for all types and sizes 

8 of renal dialysis facilities and providers of services 

9 described in subparagraph (A), including profit and 

10 not-for-profit, urban and rural, as well as all other 

11 types and sizes of such facilities and providers, to 

12 participate. 

13 ‘‘(ii) The program rewards high quality, effi14 cient facilities and providers through gain-sharing. 

15 ‘‘(iii) For purposes of determining the actual 

16 reductions in expenditures under this title attrib17 utable to a coordinated care organization described 

18 in subparagraph (A), the program includes a mar19 ket-based benchmark system that will not be rebased 

20 against which such expenditures shall be compared. 

21 ‘‘(iv) The program results in reductions of ex22 penditures under parts A and B for services that are 

23 not dialysis-related services. 


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1 ‘‘(v) The program allows new applicants to par2 ticipate in the program after the initial implementa3 tion period. 

4 ‘‘(vi) The program establishes clear quality 

5 metrics in consultation with the kidney care commu6 nity. 

7 ‘‘(vii) The program provides for waivers of Fed8 eral laws or requirements, in consultation with inter9 ested stakeholders. 

10 ‘‘(viii) Under such program the Secretary at11 tributes individuals described in subparagraph (A) 

12 who receive treatment through a care coordination 

13 organization described in such subparagraph to such 

14 organization rather than to any other payment 

15 model that requires beneficiary attribution. 

16 ‘‘(ix) Under such program the Secretary pro17 vides quarterly Medicare parts A and B claims data 

18 to facilities and providers described in subparagraph 

19 (A) participating in such program. 

20 ‘‘(G) Not later than 3 years after the date of the im21 plementation of the ESRD Care Coordination gainsharing 

22 program, the Secretary shall submit to Congress a report 

23 on the waivers granted under subparagraph (F)(vii) and 

24 the effectiveness of such waivers in allowing the coordina25 tion of care.’’. 


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1 (2) CONFORMING AMENDMENTS.— 

2 (A) SECTION 1881.—Section 1881(b) of the 

3 Social Security Act (42 U.S.C. 1395rr(b)) is 

4 amended— 

5 (i) in each of paragraphs (12)(A) and 

6 (13)(A), by striking ‘‘paragraph (14)’’ and 

7 inserting ‘‘paragraphs (14) and (15)’’; and 

8 (ii) in paragraph (14)(A)(i), by insert9 ing ‘‘and paragraph (15)’’ after ‘‘Subject 

10 to subparagraph (E)’’. 

11 (B) SECTION 1848.—Section 1848 of the 

12 Social Security Act (42 U.S.C. 1395w–4) is 

13 amended by adding at the end the following 

14 new subsection: 

15 ‘‘(q) VOLUNTARY ESRD COORDINATED CARE PRO16 GRAM.—For provisions related to incentive payment 

17 amounts to nephrologists under the ESRD Care Coordina18 tion gainsharing program, see section 1881(b)(15).’’. 

19 (d) PATIENT INFORMATION REQUIREMENT.—The 

20 Secretary of Health and Human Services shall require 

21 hospitals that furnish items and services to individuals en22 titled to benefits under part A of title XVIII of the Social 

23 Security Act or eligible for benefits under part B of such 

24 title and who subsequently receive dialysis services at a 

25 renal dialysis facility (as defined in section 1881 of such 


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1 Act (42 U.S.C. 1395rr)) to provide to such facility health 

2 information with respect to such individual, including a 

3 discharge summary and co-morbidity information, upon 

4 request of the facility, not later than 7 days after notifica5 tion by the hospital of the provision of such services to 

6 such individual or of the determination that such indi7 vidual has end stage renal disease, as applicable. 

Æ 


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