New Era of Preventing End-Stage Kidney Disease Act

[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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