I 
118TH CONGRESS 
1ST SESSION H. R. 6790 
To amend the Public Health Service Act with respect to preventing end- 
stage 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 subse-
quently 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘New Era of Preventing 
End-Stage Kidney Disease Act’’. 
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SEC. 2. CENTERS OF EXCELLENCE ON RARE KIDNEY DIS-
EASE RESEARCH IN NATIONAL INSTITUTE OF 
DIABETES AND DIGESTIVE AND KIDNEY DIS-
EASES. 
Subpart 3 of part C of title IV of the Public Health 
Service Act (42 U.S.C. 281 et seq.) is amended by insert-
ing after section 426 (42 U.S.C. 285c) the following new 
section: 
‘‘SEC. 426A. CENTERS OF EXCELLENCE ON RARE KIDNEY 
DISEASE RESEARCH IN NATIONAL INSTITUTE 
OF DIABETES AND DIGESTIVE AND KIDNEY 
DISEASES. 
‘‘(a) COOPERATIVE AGREEMENTS AND GRANTS.— 
‘‘(1) IN GENERAL.—The Director of the Insti-
tute may enter into cooperative agreements with, 
and make grants to, public and private nonprofit en-
tities to pay all or part of the cost of planning, es-
tablishing, or strengthening, and providing basic op-
erating support for, regional centers of excellence for 
rare kidney diseases, including primary glomerular 
disease. Such centers of excellence shall be known as 
NIDDK Centers of Excellence on Rare Kidney Dis-
ease Research (referred to in this section as ‘Centers 
of Excellence’). 
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‘‘(2) PURPOSES OF CENTERS.—The purposes of 
the Centers of Excellence funded pursuant to para-
graph (1) shall be— 
‘‘(A) to conduct research on the causes, 
etiology, symptoms, diagnosis, progression, and 
treatment of rare kidney diseases, including glo-
merular diseases; 
‘‘(B) to increase public awareness of rare 
kidney diseases, particularly in rural and under-
served communities; and 
‘‘(C) to develop resources for clinical re-
search into, training in, and demonstration of 
diagnostic, prevention, control, and treatment 
methods for, rare kidney diseases. 
‘‘(3) POLICIES.—A cooperative agreement or 
grant under paragraph (1) shall be entered into in 
accordance with policies established by the Director 
of the National Institutes of Health. 
‘‘(b) COORDINATION WITH OTHER INSTITUTES.— 
The Director of the Institute shall coordinate the activities 
under this section with similar activities that are related 
to rare kidney disease and conducted by other national 
research institutes, centers, and agencies of the National 
Institutes of Health and by the Food and Drug Adminis-
tration. 
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‘‘(c) USE OF FUNDS.—An entity that enters into a 
cooperative agreement or receives a grant under sub-
section (a) may use funds received through such agree-
ment or grant— 
‘‘(1) to cover patient care costs required to con-
duct research described in subsection (a)(2)(A); 
‘‘(2) to provide, for the purpose described in 
subsection (a)(2)(B)— 
‘‘(A) clinical training and continuing edu-
cation for health professionals and related per-
sonnel with respect to rare kidney diseases; and 
‘‘(B) information programs for the public, 
with respect to rare kidney diseases; and 
‘‘(3) to provide, for the purpose described in 
subsection (a)(2)(B)— 
‘‘(A) for education of members of the pub-
lic, particularly through outreach to rural and 
underserved communities, on the diagnosis (in-
cluding through routine urinalysis and through 
genetic testing), prevention, control, and treat-
ment of rare kidney diseases; and 
‘‘(B) for education of individuals diagnosed 
with rare kidney diseases on renal diet and life-
style, genetic testing, and programs to promote 
urinalysis, and on mental and emotional health 
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resources for families of rare kidney disease pa-
tients. 
‘‘(d) RESEARCH
FUNDED.—Research conducted 
using funds awarded through a cooperative agreement or 
grant under this section— 
‘‘(1) shall include study of genotype-phenotype 
relation to disease progression; and 
‘‘(2) with respect the populations studied in 
such research, may not include any consideration of 
quality-adjusted life years or disability adjusted life 
years, or other similar mechanisms that discriminate 
against individuals with disabilities in value and 
cost-effectiveness assessments. 
‘‘(e) PERIOD OF SUPPORT; ADDITIONAL PERIODS.— 
The period of support for a center of excellence under sub-
section (a) may not exceed 5 years, except that such period 
may be extended by the Director of the Institute for addi-
tional periods of not more than 5 years for each center 
if— 
‘‘(1) the operations of such center have been re-
viewed by an appropriate technical and scientific 
peer review group established by the Director of the 
Institute; and 
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‘‘(2) such group has recommended to the Direc-
tor of the Institute that such period should be ex-
tended. 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated $6,000,000 for each of fiscal years 2024 through 
2028.’’. 
SEC. 3. UNDERSTANDING AND SLOWING THE PROGRES-
SION OF RARE KIDNEY DISEASE THROUGH 
EARLY INTERVENTION, TESTING, AND TREAT-
MENT. 
(a) IN GENERAL.—The Secretary shall conduct a 
study on testing, preventative care, precision medicine, 
and treatment, with respect to rare kidney disease. Such 
study shall review— 
(1) the impact of routine urinalysis on the time-
ly diagnosis of rare kidney disease and on the qual-
ity of patient care following a diagnosis of such dis-
ease; 
(2) the quality and reliability of kidney biopsy 
in the diagnosis of rare kidney disease; 
(3) the utility and appropriate use of genetic 
and genomic tests in detecting kidney disease, in-
cluding— 
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(A) advances in genetic and genomic test-
ing, and in particular testing of the APOL1 
gene, and whether such testing may improve 
the diagnosis and treatment of rare kidney dis-
ease; 
(B) barriers to genetic and genomic test-
ing, such as diagnostic, predictive, presymp-
tomatic testing, and DNA sequencing clinical 
services, including an analysis of any existing 
barriers related to health insurance coverage of 
such testing and access to genetic counselors, 
pathologists, and other relevant professions; 
and 
(C) strategies to increase routine urinalysis 
and other diagnostic testing and to improve 
technologies to diagnose such disease, including 
genetic testing, and to improve access to health 
insurance coverage of such diagnostic testing 
and technologies; 
(4) the social, behavioral, and biological factors 
leading to rare kidney disease; 
(5) treatment patterns associated with pro-
viding care, under the Medicare program under title 
XVIII of the Social Security Act (42 U.S.C. 1395 et 
seq.), the Medicaid program under title XIX of such 
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Act (42 U.S.C. 1396 et seq.), and through private 
health insurance, to populations that are dispropor-
tionately affected by such disease; 
(6) access to nephrologists among populations 
that are disproportionately affected by such disease; 
(7) ongoing efforts and recommendations to 
slow the progression of end-stage kidney disease in 
populations that are disproportionately affected by 
rare kidney disease; and 
(8) patient trust of treating providers among 
populations that are disproportionately affected by 
such disease. 
(b) REPORT.— 
(1) IN GENERAL.—Not later than 18 months 
after the date of the enactment of this Act, the Sec-
retary shall submit to the Congress a report on the 
results of the study under subsection (a), together 
with such recommendations as the Secretary deter-
mines to be appropriate. 
(2) CONSULTATION.—In conducting the study 
under subsection (a) and developing the report re-
quired by paragraph (1), the Secretary shall consult 
with relevant stakeholders, including health care 
providers, medical professional societies, State-based 
societies, public health experts, health educators, 
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health professional organizations, drug and device 
manufacturers, patient organizations, pharmacists, 
payors, State and local public health departments, 
State medical boards, and other entities with experi-
ence in health care, public health, nephrology, and 
rare disease, as appropriate. 
(c) COORDINATION.—In carrying out the activities 
under subsections (a) and (b), the Secretary shall coordi-
nate with the Director of NIH, the Administrator of the 
Center for Medicare & Medicaid Services, the Adminis-
trator of the Health Resources and Services Administra-
tion, and the Director of the Center for Medicare and 
Medicaid Innovation. 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$1,000,000 for each of fiscal years 2024 through 2028. 
SEC. 4. PROVIDER EDUCATION. 
(a) 
PRIMARY
CARE
TRAINING.—Section 
747(b)(3)(E) of the Public Health Service Act (42 U.S.C. 
293k(b)(3)(E)) is amended— 
(1) by striking ‘‘and individuals’’ and inserting 
‘‘, individuals’’; and 
(2) by inserting ‘‘, and individuals with kidney 
disease (including rare kidney disease)’’ after ‘‘dis-
abilities’’. 
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(b) NEPHROLOGY FELLOWSHIPS.—Section 736(b) of 
the Public Health Service Act (42 U.S.C. 293) is amend-
ed— 
(1) by redesignating paragraph (7) as para-
graph (8); 
(2) in paragraph (6)(B), by striking ‘‘; and’’ 
and inserting a semicolon; and 
(3) by inserting after paragraph (6) the fol-
lowing: 
‘‘(7) to award fellowships, which may include 
stipends, for postgraduate training in the field of ne-
phrology, for the purposes of— 
‘‘(A) increasing providers’ knowledge of 
issues related to prevention, diagnosis, and 
treatment of rare kidney disease for populations 
disproportionately impacted by the disease, in-
cluding the prevalence of the gene APOL1; 
‘‘(B) improving the quality of rare kidney 
disease prevention, diagnosis, and treatment de-
livered to racial and ethnic minorities; and 
‘‘(C) 
increasing 
the 
number 
of 
nephrologists trained to provide care to such 
populations; and’’. 
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SEC. 5. DELAYING KIDNEY DISEASE IMPACT. 
Section 1881(f) of the Social Security Act (42 U.S.C. 
1395rr(f)) is amended by adding at the end the following 
new paragraph: 
‘‘(9)(A) The Secretary shall conduct experiments to 
evaluate methods for treating rare kidney disease, giving 
particular attention to treatments that would delay or 
eliminate the need for dialysis and transplant. 
‘‘(B) The Secretary shall conduct a comprehensive 
study of methods to increase public awareness of rare kid-
ney disease. 
‘‘(C) The Secretary shall submit to Congress, not 
later than 24 months after the date of the enactment of 
the New Era of Preventing End-Stage Kidney Disease 
Act, a report on the experiments and study conducted 
under subparagraphs (A) and (B). Such report shall in-
clude recommendations for legislative changes that the 
Secretary finds necessary or desirable as a result of such 
experiments and study.’’. 
Æ 
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