[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1518 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 1518
To amend the Public Health Service Act with respect to preventing end-
stage kidney disease, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 24, 2025
Mr. Bilirakis (for himself, Ms. Sewell, Mrs. Miller of West Virginia,
Mr. Peters, Mr. Balderson, Mr. Tonko, Mr. Schneider, and Mr. Davis of
Illinois) 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.
Be it enacted by the Senate and House of Representatives 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''.
SEC. 2. CENTERS OF EXCELLENCE ON RARE KIDNEY DISEASE RESEARCH IN THE
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY
DISEASES.
Subpart 3 of part C of title IV of the Public Health Service Act
(42 U.S.C. 281 et seq.) is amended by inserting after section 426 (42
U.S.C. 285c) the following new section:
``SEC. 426A. CENTERS OF EXCELLENCE ON RARE KIDNEY DISEASE RESEARCH IN
THE NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND
KIDNEY DISEASES.
``(a) Cooperative Agreements and Grants.--
``(1) In general.--The Director of the Institute may enter
into cooperative agreements with, and make grants to, public
and private nonprofit entities to pay all or part of the cost
of planning, establishing, or strengthening, and providing
basic operating 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 Disease Research (referred to in this
section as `Centers of Excellence').
``(2) Purposes of centers.--The purposes of the Centers of
Excellence funded pursuant to paragraph (1) shall be--
``(A) to conduct research on the causes, etiology,
symptoms, diagnosis, progression, and treatment of rare
kidney diseases, including glomerular diseases;
``(B) to increase public awareness of rare kidney
diseases, particularly in rural and underserved
communities; and
``(C) to develop resources for clinical research
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
Administration.
``(c) Use of Funds.--An entity that enters into a cooperative
agreement or receives a grant under subsection (a) may use funds
received through such agreement or grant--
``(1) to cover patient care costs required to conduct
research described in subsection (a)(2)(A);
``(2) to provide, for the purpose described in subsection
(a)(2)(B)--
``(A) clinical training and continuing education
for health professionals and related personnel 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 public,
particularly through outreach to rural and underserved
communities, on the diagnosis (including through
routine urinalysis and through genetic testing),
prevention, control, and treatment of rare kidney
diseases; and
``(B) for education of individuals diagnosed with
rare kidney diseases on renal diet and lifestyle,
genetic testing, and programs to promote urinalysis,
and on mental and emotional health resources for
families of rare kidney disease patients.
``(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 subsection (a) may not exceed 5 years,
except that such period may be extended by the Director of the
Institute for additional periods of not more than 5 years for each
center if--
``(1) the operations of such center have been reviewed by
an appropriate technical and scientific peer review group
established by the Director of the Institute; and
``(2) such group has recommended to the Director of the
Institute that such period should be extended.
``(f) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $6,000,000 for each of fiscal
years 2026 through 2030.''.
SEC. 3. UNDERSTANDING AND SLOWING THE PROGRESSION OF RARE KIDNEY
DISEASE THROUGH EARLY INTERVENTION, TESTING, AND
TREATMENT.
(a) In General.--The Secretary of Health and Human Services (in
this section referred to as 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 timely
diagnosis of rare kidney disease and on the quality of patient
care following a diagnosis of such disease;
(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, including--
(A) advances in genetic and genomic testing, and in
particular testing of the APOL1 gene, and whether such
testing may improve the diagnosis and treatment of rare
kidney disease;
(B) barriers to genetic and genomic testing, such
as diagnostic, predictive, presymptomatic 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 providing 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 Act (42 U.S.C. 1396 et seq.), and
through private health insurance, to populations that are
disproportionately 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 Secretary shall submit to the
Congress a report on the results of the study under subsection
(a), together with such recommendations as the Secretary
determines to be appropriate.
(2) Consultation.--In conducting the study under subsection
(a) and developing the report required 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,
health professional organizations, drug and device
manufacturers, patient organizations, pharmacists, payors,
State and local public health departments, State medical
boards, and other entities with experience 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 coordinate with the Director of NIH,
the Administrator of the Center for Medicare & Medicaid Services, the
Administrator of the Health Resources and Services Administration, 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 2026 through 2030.
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 ``disabilities''.
(b) Nephrology Fellowships.--Section 736(b) of the Public Health
Service Act (42 U.S.C. 293) is amended--
(1) by redesignating paragraph (7) as paragraph (8);
(2) in paragraph (6)(B), by striking ``; and'' and
inserting a semicolon; and
(3) by inserting after paragraph (6) the following:
``(7) to award fellowships, which may include stipends, for
postgraduate training in the field of nephrology, 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, including the prevalence of
the gene APOL1;
``(B) improving the quality of rare kidney disease
prevention, diagnosis, and treatment delivered to
racial and ethnic minorities; and
``(C) increasing the number of nephrologists
trained to provide care to such populations; and''.
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 kidney 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 include
recommendations for legislative changes that the Secretary finds
necessary or desirable as a result of such experiments and study.''.
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