I 

118TH CONGRESS 

1ST SESSION H. R. 6790 

To amend the Public Health Service Act with respect to preventing endstage kidney disease, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 14, 2023 

Mr. BILIRAKIS (for himself and Ms. SEWELL) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on Ways and Means, 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 

A BILL 

To amend the Public Health Service Act with respect to 

preventing end-stage 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 ‘‘New Era of Preventing 

5 End-Stage Kidney Disease Act’’. 


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1 SEC. 2. CENTERS OF EXCELLENCE ON RARE KIDNEY DIS2 EASE RESEARCH IN NATIONAL INSTITUTE OF 

3 DIABETES AND DIGESTIVE AND KIDNEY DIS4 EASES. 

5 Subpart 3 of part C of title IV of the Public Health 

6 Service Act (42 U.S.C. 281 et seq.) is amended by insert7 ing after section 426 (42 U.S.C. 285c) the following new 

8 section: 

9 ‘‘SEC. 426A. CENTERS OF EXCELLENCE ON RARE KIDNEY 

10 DISEASE RESEARCH IN NATIONAL INSTITUTE 

11 OF DIABETES AND DIGESTIVE AND KIDNEY 

12 DISEASES. 

13 ‘‘(a) COOPERATIVE AGREEMENTS AND GRANTS.— 

14 ‘‘(1) IN GENERAL.—The Director of the Insti15 tute may enter into cooperative agreements with, 

16 and make grants to, public and private nonprofit en17 tities to pay all or part of the cost of planning, es18 tablishing, or strengthening, and providing basic op19 erating support for, regional centers of excellence for 

20 rare kidney diseases, including primary glomerular 

21 disease. Such centers of excellence shall be known as 

22 NIDDK Centers of Excellence on Rare Kidney Dis23 ease Research (referred to in this section as ‘Centers 

24 of Excellence’). 


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1 ‘‘(2) PURPOSES OF CENTERS.—The purposes of 

2 the Centers of Excellence funded pursuant to para3 graph (1) shall be— 

4 ‘‘(A) to conduct research on the causes, 

5 etiology, symptoms, diagnosis, progression, and 

6 treatment of rare kidney diseases, including glo7 merular diseases; 

8 ‘‘(B) to increase public awareness of rare 

9 kidney diseases, particularly in rural and under10 served communities; and 

11 ‘‘(C) to develop resources for clinical re12 search into, training in, and demonstration of 

13 diagnostic, prevention, control, and treatment 

14 methods for, rare kidney diseases. 

15 ‘‘(3) POLICIES.—A cooperative agreement or 

16 grant under paragraph (1) shall be entered into in 

17 accordance with policies established by the Director 

18 of the National Institutes of Health. 

19 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.— 

20 The Director of the Institute shall coordinate the activities 

21 under this section with similar activities that are related 

22 to rare kidney disease and conducted by other national 

23 research institutes, centers, and agencies of the National 

24 Institutes of Health and by the Food and Drug Adminis25 tration. 


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1 ‘‘(c) USE OF FUNDS.—An entity that enters into a 

2 cooperative agreement or receives a grant under sub3 section (a) may use funds received through such agree4 ment or grant— 

5 ‘‘(1) to cover patient care costs required to con6 duct research described in subsection (a)(2)(A); 

7 ‘‘(2) to provide, for the purpose described in 

8 subsection (a)(2)(B)— 

9 ‘‘(A) clinical training and continuing edu10 cation for health professionals and related per11 sonnel with respect to rare kidney diseases; and 

12 ‘‘(B) information programs for the public, 

13 with respect to rare kidney diseases; and 

14 ‘‘(3) to provide, for the purpose described in 

15 subsection (a)(2)(B)— 

16 ‘‘(A) for education of members of the pub17 lic, particularly through outreach to rural and 

18 underserved communities, on the diagnosis (in19 cluding through routine urinalysis and through 

20 genetic testing), prevention, control, and treat21 ment of rare kidney diseases; and 

22 ‘‘(B) for education of individuals diagnosed 

23 with rare kidney diseases on renal diet and life24 style, genetic testing, and programs to promote 

25 urinalysis, and on mental and emotional health 


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1 resources for families of rare kidney disease pa2 tients. 

3 ‘‘(d) RESEARCH FUNDED.—Research conducted 

4 using funds awarded through a cooperative agreement or 

5 grant under this section— 

6 ‘‘(1) shall include study of genotype-phenotype 

7 relation to disease progression; and 

8 ‘‘(2) with respect the populations studied in 

9 such research, may not include any consideration of 

10 quality-adjusted life years or disability adjusted life 

11 years, or other similar mechanisms that discriminate 

12 against individuals with disabilities in value and 

13 cost-effectiveness assessments. 

14 ‘‘(e) PERIOD OF SUPPORT; ADDITIONAL PERIODS.— 

15 The period of support for a center of excellence under sub16 section (a) may not exceed 5 years, except that such period 

17 may be extended by the Director of the Institute for addi18 tional periods of not more than 5 years for each center 

19 if— 

20 ‘‘(1) the operations of such center have been re21 viewed by an appropriate technical and scientific 

22 peer review group established by the Director of the 

23 Institute; and 


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1 ‘‘(2) such group has recommended to the Direc2 tor of the Institute that such period should be ex3 tended. 

4 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To 

5 carry out this section, there are authorized to be appro6 priated $6,000,000 for each of fiscal years 2024 through 

7 2028.’’. 

8 SEC. 3. UNDERSTANDING AND SLOWING THE PROGRES9 SION OF RARE KIDNEY DISEASE THROUGH 

10 EARLY INTERVENTION, TESTING, AND TREAT11 MENT. 

12 (a) IN GENERAL.—The Secretary shall conduct a 

13 study on testing, preventative care, precision medicine, 

14 and treatment, with respect to rare kidney disease. Such 

15 study shall review— 

16 (1) the impact of routine urinalysis on the time17 ly diagnosis of rare kidney disease and on the qual18 ity of patient care following a diagnosis of such dis19 ease; 

20 (2) the quality and reliability of kidney biopsy 

21 in the diagnosis of rare kidney disease; 

22 (3) the utility and appropriate use of genetic 

23 and genomic tests in detecting kidney disease, in24 cluding— 


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1 (A) advances in genetic and genomic test2 ing, and in particular testing of the APOL1 

3 gene, and whether such testing may improve 

4 the diagnosis and treatment of rare kidney dis5 ease; 

6 (B) barriers to genetic and genomic test7 ing, such as diagnostic, predictive, presymp8 tomatic testing, and DNA sequencing clinical 

9 services, including an analysis of any existing 

10 barriers related to health insurance coverage of 

11 such testing and access to genetic counselors, 

12 pathologists, and other relevant professions; 

13 and 

14 (C) strategies to increase routine urinalysis 

15 and other diagnostic testing and to improve 

16 technologies to diagnose such disease, including 

17 genetic testing, and to improve access to health 

18 insurance coverage of such diagnostic testing 

19 and technologies; 

20 (4) the social, behavioral, and biological factors 

21 leading to rare kidney disease; 

22 (5) treatment patterns associated with pro23 viding care, under the Medicare program under title 

24 XVIII of the Social Security Act (42 U.S.C. 1395 et 

25 seq.), the Medicaid program under title XIX of such 


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1 Act (42 U.S.C. 1396 et seq.), and through private 

2 health insurance, to populations that are dispropor3 tionately affected by such disease; 

4 (6) access to nephrologists among populations 

5 that are disproportionately affected by such disease; 

6 (7) ongoing efforts and recommendations to 

7 slow the progression of end-stage kidney disease in 

8 populations that are disproportionately affected by 

9 rare kidney disease; and 

10 (8) patient trust of treating providers among 

11 populations that are disproportionately affected by 

12 such disease. 

13 (b) REPORT.— 

14 (1) IN GENERAL.—Not later than 18 months 

15 after the date of the enactment of this Act, the Sec16 retary shall submit to the Congress a report on the 

17 results of the study under subsection (a), together 

18 with such recommendations as the Secretary deter19 mines to be appropriate. 

20 (2) CONSULTATION.—In conducting the study 

21 under subsection (a) and developing the report re22 quired by paragraph (1), the Secretary shall consult 

23 with relevant stakeholders, including health care 

24 providers, medical professional societies, State-based 

25 societies, public health experts, health educators, 


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1 health professional organizations, drug and device 

2 manufacturers, patient organizations, pharmacists, 

3 payors, State and local public health departments, 

4 State medical boards, and other entities with experi5 ence in health care, public health, nephrology, and 

6 rare disease, as appropriate. 

7 (c) COORDINATION.—In carrying out the activities 

8 under subsections (a) and (b), the Secretary shall coordi9 nate with the Director of NIH, the Administrator of the 

10 Center for Medicare & Medicaid Services, the Adminis11 trator of the Health Resources and Services Administra12 tion, and the Director of the Center for Medicare and 

13 Medicaid Innovation. 

14 (d) AUTHORIZATION OF APPROPRIATIONS.—To carry 

15 out this section, there is authorized to be appropriated 

16 $1,000,000 for each of fiscal years 2024 through 2028. 

17 SEC. 4. PROVIDER EDUCATION. 

18 (a) PRIMARY CARE TRAINING.—Section 

19 747(b)(3)(E) of the Public Health Service Act (42 U.S.C. 

20 293k(b)(3)(E)) is amended— 

21 (1) by striking ‘‘and individuals’’ and inserting 

22 ‘‘, individuals’’; and 

23 (2) by inserting ‘‘, and individuals with kidney 

24 disease (including rare kidney disease)’’ after ‘‘dis25 abilities’’. 


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1 (b) NEPHROLOGY FELLOWSHIPS.—Section 736(b) of 

2 the Public Health Service Act (42 U.S.C. 293) is amend3 ed— 

4 (1) by redesignating paragraph (7) as para5 graph (8); 

6 (2) in paragraph (6)(B), by striking ‘‘; and’’ 

7 and inserting a semicolon; and 

8 (3) by inserting after paragraph (6) the fol9 lowing: 

10 ‘‘(7) to award fellowships, which may include 

11 stipends, for postgraduate training in the field of ne12 phrology, for the purposes of— 

13 ‘‘(A) increasing providers’ knowledge of 

14 issues related to prevention, diagnosis, and 

15 treatment of rare kidney disease for populations 

16 disproportionately impacted by the disease, in17 cluding the prevalence of the gene APOL1; 

18 ‘‘(B) improving the quality of rare kidney 

19 disease prevention, diagnosis, and treatment de20 livered to racial and ethnic minorities; and 

21 ‘‘(C) increasing the number of 

22 nephrologists trained to provide care to such 

23 populations; and’’. 


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1 SEC. 5. DELAYING KIDNEY DISEASE IMPACT. 

2 Section 1881(f) of the Social Security Act (42 U.S.C. 

3 1395rr(f)) is amended by adding at the end the following 

4 new paragraph: 

5 ‘‘(9)(A) The Secretary shall conduct experiments to 

6 evaluate methods for treating rare kidney disease, giving 

7 particular attention to treatments that would delay or 

8 eliminate the need for dialysis and transplant. 

9 ‘‘(B) The Secretary shall conduct a comprehensive 

10 study of methods to increase public awareness of rare kid11 ney disease. 

12 ‘‘(C) The Secretary shall submit to Congress, not 

13 later than 24 months after the date of the enactment of 

14 the New Era of Preventing End-Stage Kidney Disease 

15 Act, a report on the experiments and study conducted 

16 under subparagraphs (A) and (B). Such report shall in17 clude recommendations for legislative changes that the 

18 Secretary finds necessary or desirable as a result of such 

19 experiments and study.’’. 

Æ 


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