New Era of Preventing End-Stage Kidney Disease Act
This bill addresses rare kidney diseases through research, training for health professionals, and other means. It also modifies requirements for Medicare drug plan formularies that include drugs for rare diseases or conditions.
The Department of Health and Human Services (HHS) must
HHS may award grants to educate and train health professionals about kidney disease and nephrology. Additionally, health professional schools that receive certain HHS funding for educating underrepresented minority individuals must support postgraduate nephrology training.
The National Institutes of Health (NIH) must report on diversity in its kidney disease research. The NIH may also (1) support research on rare kidney diseases that, among other requirements, includes persons of color in study populations; and (2) establish regional centers of excellence for rare kidney diseases.
The Centers for Medicare & Medicaid Services must evaluate methods for (1) treating rare kidney diseases, with a focus on delaying dialysis and transplant; and (2) raising awareness about rare kidney diseases, including in communities of color.
Furthermore, if a Medicare drug plan formulary includes a drug to treat a rare disease or condition, at least two members of the committee that develops or reviews the formulary must have expertise in the field of medicine related to that drug.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7506 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 7506
To amend the Public Health Service Act with respect to preventing end-
stage kidney disease, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 14, 2022
Mr. Butterfield (for himself and Mr. Bilirakis) 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. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Findings.
Sec. 4. Definitions.
TITLE I--CENTERS OF EXCELLENCE AND RARE KIDNEY DISEASE RESEARCH
Sec. 101. NIDDK Centers on Rare Kidney Disease Research.
Sec. 102. Rare kidney disease progression research.
TITLE II--DIAGNOSTICS
Sec. 201. Diagnostic issues relating to rare kidney disease.
TITLE III--COMMUNITIES OF COLOR
Sec. 301. Understanding and slowing the progression of rare kidney
disease and treatment in certain
populations.
Sec. 302. Communities of color service program.
Sec. 303. NIH report on NIH research programs.
Sec. 304. Partnerships with organizations and agencies.
TITLE IV--PROVIDER EDUCATION
Sec. 401. Primary care provider training grant program.
Sec. 402. Grant program for development and implementation of curricula
for continuing education on kidney disease.
TITLE V--COVERAGE AND EXPERIMENTS TO REDUCE DIALYSIS AND TRANSPLANT
COSTS
Sec. 501. Medical expertise in pharmacy and therapeutic committees.
Sec. 502. Reducing dialysis and transplant costs related to rare kidney
disease.
SEC. 3. FINDINGS.
Congress finds the following:
(1) Approximately 37,000,000 adults in the United States
have a chronic kidney disease, and kidney diseases are the
ninth leading cause of death in the United States.
(2) Each day in the United States, on average, 340 people
begin dialysis and 13 people die waiting for a kidney
transplant.
(3) Rare kidney diseases like focal segmental
glomerulosclerosis and immunoglobulin A nephropathy are
particularly difficult to treat, and there are no approved
treatments for these diseases.
(4) In the absence of approved treatment options, more than
100,000 people live with rare glomerular kidney disease and
face dialysis, transplant, or death.
(5) Focal segmental glomerulosclerosis is associated with a
50 percent risk of end-stage kidney disease within 5 years of
diagnosis if partial or complete remission is not achieved.
(6) Between 20 and 40 percent of individuals with
immunoglobulin A nephropathy are expected to develop end-stage
kidney disease within 20 years.
(7) Rare kidney diseases disproportionately affect Black
Americans, who are 3.5 times more likely to develop end-stage
kidney disease, and 5 times more likely than the general
population to have focal segmental glomerulosclerosis.
(8) Because approximately one-third of Black Americans with
focal segmental glomerulosclerosis cases are associated with a
particular gene, communities of color would benefit from
additional resources to support earlier detection, including
genetic and genomic testing and referrals to high-quality
providers.
(9) The prevalence of end-stage kidney disease is
exacerbated by diagnostic challenges, barriers to high-quality
care, and lack of awareness of disease risks.
(10) Federal spending on end-stage kidney disease currently
accounts for approximately 7 percent of Federal Medicare
spending.
(11) The total Medicare spending on both chronic kidney
disease and end-stage kidney disease patients exceeded
$120,000,000,000 per year in recent years.
(12) A focus on renal health and the prevention of end-
stage kidney disease would improve patient outcomes, extend
lives, mitigate racial health care disparities, and reduce
government spending.
(13) Due in large part to the 21st Century Cures Act, new
regulatory paradigms have unleashed a wave of clinical
innovation in the rare kidney disease space.
(14) In 2020, the first-ever Rare Kidney Disease Roundtable
outlined urgent needs in the areas of diagnosis, education,
communities of color, and patient support for rare kidney
disease patients and their families in the United States.
(15) In 2021, there are over 30 ongoing clinical trials
underway for treatments for a range of rare kidney diseases,
offering the first hope for novel therapies for patients living
with rare kidney diseases, a new era of preventing end-stage
kidney disease and related Federal costs, and the possibility
of improving chronic kidney care writ large.
SEC. 4. DEFINITIONS.
In this Act:
(1) Director of nih.--The term ``Director of NIH'' means
the Director of the National Institutes of Health.
(2) NIH.--The term ``NIH'' means the National Institutes of
Health.
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
TITLE I--CENTERS OF EXCELLENCE AND RARE KIDNEY DISEASE RESEARCH
SEC. 101. NIDDK CENTERS ON RARE KIDNEY DISEASE RESEARCH.
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. NIDDK CENTERS ON RARE KIDNEY DISEASE RESEARCH.
``(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 on
Rare Kidney Disease Research.
``(2) Purposes of centers.--The purposes of the centers of
excellence funded pursuant to paragraph (1) shall be--
``(A) to increase public awareness of rare kidney
diseases, particularly in communities of color; and
``(B) 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) Uses for Federal Payments Under Cooperative Agreements or
Grants.--Federal payments made under a cooperative agreement or grant
under subsection (a) may be used for--
``(1) basic operating costs, including such patient care
costs as are required for research;
``(2) clinical training, including training for allied
health professionals, continuing education for health
professionals and allied health professions personnel, and
information programs for the public with respect to rare kidney
diseases;
``(3) clinical research and demonstration programs;
``(4) education of members of the public, particularly
through outreach to communities of color, on the diagnosis
(including through routine urinalysis and through genetic
testing), prevention, control, and treatment of rare kidney
diseases; and
``(5) 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) 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.
``(e) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $4,000,000 for each of fiscal
years 2023 through 2027.''.
SEC. 102. RARE KIDNEY DISEASE PROGRESSION RESEARCH.
(a) NIH Research on Rare Kidney Diseases.--The Director of NIH may
award grants or contracts to public and nonprofit private entities to
conduct research on the causes, etiology, symptoms, diagnosis,
progression, and treatment of rare kidney diseases, including
glomerular diseases.
(b) Application.--To seek a grant under this section, an eligible
entity shall submit an application in such form, in such manner, and
containing such agreements, assurances, and information as the Director
of NIH determines to be necessary.
(c) Research Funded.--Research funded through a grant under this
section--
(1) may not include any consideration of quality-adjusted
life years or disability-adjusted life years, or other similar
mechanisms that discriminate against people with disabilities
in value and cost-effectiveness assessments;
(2) shall include persons of color in populations studied
in the research; and
(3) shall include study of genotype-phenotype relation to
disease progression.
(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $1,000,000 for each of fiscal
years 2023 through 2027.
TITLE II--DIAGNOSTICS
SEC. 201. DIAGNOSTIC ISSUES RELATING TO RARE KIDNEY DISEASE.
(a) Conference.--
(1) In general.--The Secretary shall, not later than 12
months after the date of the enactment of this Act, convene a
conference to--
(A) analyze the impact of the decline of routine
urinalysis on the timely diagnosis of rare kidney
disease and on the quality of patient care following a
diagnosis of such disease;
(B) analyze the quality and reliability of kidney
biopsy in the diagnosis of rare kidney disease;
(C) analyze the impact of genetic and genomic
testing on preventative care and precision medicine
with respect to rare kidney disease;
(D) recommend strategies to reduce disparities in
the occurrence and treatment of rare kidney disease
among different groups, including communities of color;
and
(E) recommend strategies to increase routine
urinalysis and to improve technologies to diagnose such
disease, including genetic testing.
(2) Consultation.--In carrying out paragraph (1), the
Secretary shall consult with relevant stakeholders, including
health care providers, medical professional societies, State-
based societies, public health experts, State and local public
health departments, State medical boards, patient groups, drug
manufacturers, pharmacists, insurers, and other entities with
experience in health care, public health, and rare disease, as
appropriate.
(b) Early Intervention on Genetic Screening.--
(1) Study.--The Secretary shall conduct a study on--
(A) whether genetic and genomic testing may improve
preventative care and precision medicine with respect
to rare kidney disease;
(B) whether genetic and genomic testing, and in
particular testing of the APOL1 gene, may reduce
disparities in the occurrence and treatment of rare
kidney disease among different groups, including
communities of color;
(C) whether the Federal Government may help to
reduce barriers to genetic and genomic testing for rare
kidney disease, including by--
(i) encouraging the expansion of health
insurance coverage of genetic and genomic
testing, including diagnostic, predictive, and
presymptomatic testing, and DNA sequencing
clinical services;
(ii) supporting the collection of evidence
for the clinical utility and appropriate use of
genetic and genomic tests; and
(iii) improving access to genetic
counselors, pathologists, and other relevant
professions, including strengthening related
workforce education and training efforts;
(D) the extent to which coverage provisions in the
Medicare and Medicaid programs under titles XVIII and
XIX of the Social Security Act (42 U.S.C. 1395 et seq.,
1396 et seq.) may restrain the use of genetic and
genomic testing for rare kidney disease that may
improve clinical outcomes for beneficiaries;
(E) whether the Centers for Medicare & Medicaid
Services may make coverage determinations that better
suit a precision medicine approach to treatment; and
(F) whether genetic and genomic testing may improve
health outcomes for individuals with rare kidney
disease.
(2) Report.--
(A) In general.--Not later than 18 months after the
date of the enactment of this Act, the Secretary shall
submit a report to the Congress on the proceedings of
the conference under subsection (a) and the results of
the study under paragraph (1).
(B) Consultation.--In conducting the study under
paragraph (1) and developing the report required by
subparagraph (A), the Secretary shall consult with
physicians, other health professionals, health
educators, health professional organizations, relevant
companies, patients, patient organizations, the Health
Resources and Services Administration, the Director of
NIH, the National Institute of Diabetes and Digestive
and Kidney Diseases, and the Centers for Medicare &
Medicaid Services. Such consultation shall include
consultation activities conducted as part of the
conference under subsection (a).
(3) Definition.--In this subsection, the term ``DNA
sequencing clinical services'', with respect to an individual--
(A) means a determination of an exact sequence of
deoxyribonucleic acid bases in the genome of such
individual, and, if for the sole benefit of the
individual, a biological parent of such individual for
the purpose of determining whether one or more
potentially disease-causing genetic variants are
present in the genome of such individual or such
biological parent; and
(B) includes--
(i) sequencing of the entire genome, of the
exome, of a panel of genes, or other regions of
the genome; and
(ii) any analysis, interpretation, and data
report derived from such sequencing.
(c) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $5,000,000 for the period of
fiscal years 2023 through 2027.
TITLE III--COMMUNITIES OF COLOR
SEC. 301. UNDERSTANDING AND SLOWING THE PROGRESSION OF RARE KIDNEY
DISEASE AND TREATMENT IN CERTAIN POPULATIONS.
(a) Study.--The Secretary shall conduct a study on--
(1) the social, behavioral, and biological factors leading
to rare kidney disease;
(2) 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;
(3) access to nephrologists among populations that are
disproportionately affected by such disease;
(4) ongoing efforts and recommendations to slow the
progression of end-stage kidney disease in populations that are
disproportionately affected by rare kidney disease; and
(5) patient trust of treating providers among populations
that are disproportionately affected by such disease.
(b) Report.--Not later than 1 year after the date of the enactment
of this Act, the Secretary shall submit to the Congress a report on the
study conducted under subsection (a), together with such
recommendations as the Secretary determines to be 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) Consultation.--In carrying out the activities under subsections
(a) and (b), the Secretary shall consult with relevant stakeholders,
including health care providers, medical professional societies, State-
based societies, public health experts, State and local public health
departments, State medical boards, patient groups, drug manufacturers,
pharmacists, insurers, and other entities with experience in health
care, public health, health equity, and rare disease, as appropriate.
SEC. 302. COMMUNITIES OF COLOR SERVICE PROGRAM.
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 among racial and ethnic minority
populations, especially 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 culturally competent
nephrologists; and''.
SEC. 303. NIH REPORT ON NIH RESEARCH PROGRAMS.
The Director of NIH shall prepare and publish on the public website
of the agency a report on diversity within the programs of the NIH to
research kidney disease, including--
(1) the diversity of recipients of research grants; and
(2) the extent to which grants are awarded to research
kidney disease among communities of color, including
disparities in the prevention, diagnosis, and treatment of
kidney disease among racial and ethnic minority populations.
SEC. 304. PARTNERSHIPS WITH ORGANIZATIONS AND AGENCIES.
(a) HHS Program.--Under this section or other applicable provisions
of law, the Secretary shall establish a program to provide grants to
eligible entities to provide education and appropriate medical and
other referrals for patients in communities of color regarding kidney
disease, including rare kidney disease.
(b) Eligibility.--To be eligible to receive a grant under this
section, an entity shall--
(1) be--
(A) a nonprofit or community-based organization,
including any community health center; or
(B) a State or local governmental agency; and
(2) submit to the Secretary an application--
(A) at such time and in such manner as the
Secretary may require; and
(B) containing--
(i) a description of how the applicant
proposes to use the grant funds; and
(ii) such other information as the
Secretary may require.
(c) Reporting.--
(1) By grantee.--A recipient of a grant under this section
shall submit annually to the Secretary, and make publicly
available, a report on the activities conducted using funds
received through the grant.
(2) By secretary.--Not later than the end of fiscal year
2026, the Secretary shall submit to the Congress a report that
includes--
(A) a summary of the reports received under
paragraph (1);
(B) an evaluation of the effectiveness of grants
awarded under this section; and
(C) any recommendations the Secretary may have.
(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $2,000,000 for each of fiscal
years 2023 through 2027.
TITLE IV--PROVIDER EDUCATION
SEC. 401. PRIMARY CARE PROVIDER TRAINING GRANT PROGRAM.
Subpart I of part C of title VII of the Public Health Service Act
(42 U.S.C. 293k et seq.) is amended by inserting after section 747A (42
U.S.C. 293k-1) the following:
``SEC. 747B. RARE KIDNEY DISEASE TRAINING FOR PRIMARY CARE PROVIDERS.
``(a) In General.--The Secretary may make grants to an accredited
public or nonprofit private hospital, school of medicine, or
academically affiliated physician assistant training program, to a
public or private nonprofit entity that the Secretary has determined is
capable of carrying out such grant, or to any consortium of such
hospitals, schools, programs, or entities, to plan, develop, and
operate a professional training program in the field of nephrology for
primary care residents, physicians, physician assistants, or nurse
practitioners, on--
``(1) methods to detect and diagnose rare kidney disease,
including urinalysis and genetic testing;
``(2) implementing such diagnostic methods in their
practices;
``(3) establishing treatment protocols for individuals
diagnosed with rare kidney disease; and
``(4) implementing a collaborative care model to coordinate
care of patients diagnosed with rare kidney disease among
health care providers.
``(b) Priorities in Making Awards.--In awarding grants under this
section, the Secretary may give priority to qualified applicants that--
``(1) have a record of training primary care providers;
``(2) establish formal relationships and submit joint
applications with Federally qualified health centers, rural
health clinics, or clinics located in underserved areas or that
serve underserved populations; or
``(3) teach trainees the skills to provide
interprofessional, integrated care through collaboration among
health professionals, including specialists.
``(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $800,000 for each of fiscal
years 2023 through 2027.''.
SEC. 402. GRANT PROGRAM FOR DEVELOPMENT AND IMPLEMENTATION OF CURRICULA
FOR CONTINUING EDUCATION ON KIDNEY DISEASE.
Part C of title VII of the Public Health Service Act (42 U.S.C.
293k et seq.) is amended--
(1) in the part heading, by striking ``and pediatric
dentistry'' and inserting ``pediatric dentistry, and kidney
disease''; and
(2) by inserting after subpart II (42 U.S.C. 293m) the
following:
``Subpart III--Continuing Education in Kidney Disease
``SEC. 749C. CURRICULA FOR CONTINUING EDUCATION ON KIDNEY DISEASE.
``(a) Grants.--The Secretary may award grants to eligible entities
for the development and implementation of curricula for providing
continuing education and training to health care professionals on
identifying, referring, and treating individuals with kidney disease.
``(b) Eligible Entities.--To be eligible to seek a grant under this
section, an entity shall be a public or nonprofit entity that--
``(1) provides continuing education or training to health
care professionals; or
``(2) applies for the grant in partnership with another
entity that provides such education and training.
``(c) Preference.--In awarding grants under this section, the
Secretary shall give preference to eligible entities proposing to
develop and implement curricula for providing continuing education and
training to--
``(1) primary care providers; or
``(2) health care professionals who are required, as a
condition of State licensure, to participate in continuing
education or training.
``(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $1,600,000 for each of fiscal
years 2023 through 2027.''.
TITLE V--COVERAGE AND EXPERIMENTS TO REDUCE DIALYSIS AND TRANSPLANT
COSTS
SEC. 501. MEDICAL EXPERTISE IN PHARMACY AND THERAPEUTIC COMMITTEES.
Section 1860D-4(b)(3)(A) of the Social Security Act (42 U.S.C.
1395w-104(b)(3)(A)) is amended by striking clause (ii) and inserting
the following:
``(ii) Inclusion of independent experts.--
Such committee shall include--
``(I) at least one practicing
physician and at least one practicing
pharmacist, each of whom--
``(aa) is independent and
free of conflict with respect
to the sponsor and plan; and
``(bb) has expertise in the
care of elderly or disabled
persons; and
``(II) in the case of a drug
approved to treat a rare disease or
condition as defined in section 526 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bb), at least two
members that meet the requirements
described in items (aa) and (bb) of
subclause (I) and have expertise in the
field of medicine related to that
drug.''.
SEC. 502. REDUCING DIALYSIS AND TRANSPLANT COSTS RELATED TO RARE KIDNEY
DISEASE.
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, including in
communities of color.
``(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.''.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
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