Health Equity and Rare Disease Act of 2025 or the HEARD Act of 2025
This bill establishes Department of Health and Human Services (HHS) grants and other initiatives to address rare diseases or conditions (e.g., those affecting less than 200,000 people in the United States) in racial and ethnic minority populations.
For example, to advance such purposes, the bill establishes within HHS
Also, the bill requires HHS to submit various reports to Congress on topics including (1) the federal government’s research and public health activities regarding rare diseases or conditions in minority populations, (2) regulatory barriers to treating rare diseases in Medicare beneficiaries of color, and (3) strategies for research and development of treatments for rare diseases or conditions that disproportionately impact minority populations.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1750 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1750
To amend the Public Health Service Act to provide for greater
investments in research on rare diseases and conditions
disproportionately affecting minority populations, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 27, 2025
Ms. Strickland introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
Ways and Means, and Natural Resources, 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 to provide for greater
investments in research on rare diseases and conditions
disproportionately affecting minority populations, 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 ``Health Equity and Rare Disease Act
of 2025'' or the ``HEARD Act of 2025''.
SEC. 2. NIH EXPANSION, INTENSIFICATION, AND COORDINATION OF RESEARCH ON
RARE DISEASES HEALTH EQUITY.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.) is amended by adding at the end the following:
``SEC. 409K. RARE DISEASES HEALTH EQUITY.
``(a) Expansion, Intensification, and Coordination of Activities.--
``(1) In general.--The Director of NIH shall expand,
intensify, and coordinate research and other activities of the
National Institutes of Health with respect to rare diseases
health equity.
``(2) Allocations by director of nih.--With respect to
amounts appropriated to carry out this section for a fiscal
year, the Director of NIH shall allocate the amounts among the
national research institutes that are carrying out paragraph
(1).
``(b) Coordinating Committee.--
``(1) In general.--The Secretary shall maintain a
coordinating committee with respect to rare diseases health
equity (referred to in this section as the `Coordinating
Committee') to coordinate activities across the National
Institutes and with other Federal health programs and
activities relating to rare diseases health equity.
``(2) Composition.--The Coordinating Committee shall be
composed of--
``(A) the directors (or their designees) of each of
the national research institutes involved in research
with respect to rare diseases and minority health or
health equity; and
``(B) representatives of all other Federal
departments and agencies whose programs involve health
functions or responsibilities relevant to such rare
diseases, including the Centers for Disease Control and
Prevention and the Food and Drug Administration.
``(3) Chair.--
``(A) In general.--With respect to rare diseases
health equity, the Chair of the Coordinating Committee
shall serve as the principal advisor to the Secretary,
the Assistant Secretary for Health, and the Director of
NIH, and shall provide advice to the Director of the
Centers for Disease Control and Prevention, the
Commissioner of Food and Drugs, and other relevant
agencies.
``(B) Director of nih.--The Chair of the
Coordinating Committee shall be directly responsible to
the Director of NIH.
``(c) Plan for NIH Activities.--
``(1) In general.--Not later than 1 year after the date of
the enactment of this section, the Coordinating Committee shall
develop a plan for conducting and supporting research and
education on rare diseases health equity, and rare diseases or
conditions in minority populations, through the national
research institutes. The Coordinating Committee shall
periodically review and revise the plan. The plan shall--
``(A) provide for a broad range of research and
education activities relating to biomedical,
psychosocial, and rehabilitative issues, including
studies of the disproportionate impact of such diseases
or conditions on minority populations;
``(B) identify priorities among the programs and
activities of the National Institutes of Health
regarding such diseases or conditions; and
``(C) reflect input from a broad range of
scientists, patients, and advocacy groups.
``(2) Certain elements of plan.--The plan under paragraph
(1) shall, with respect to rare diseases or conditions in
minority populations, provide for the following as appropriate:
``(A) Research to determine the reasons underlying
the incidence and prevalence of the diseases or
conditions, including among subpopulations.
``(B) Basic research concerning the etiology and
causes of the diseases or conditions.
``(C) Epidemiological studies to address the
frequency and natural history of the diseases or
conditions, including any differences among the sexes
and among racial and ethnic groups.
``(D) The development of improved screening
techniques.
``(E) Clinical research for the development and
evaluation of new treatments, including new biological
agents.
``(F) Information and education programs for health
care professionals and the public.
``(3) Implementation of plan.--The Director of NIH shall
ensure that programs and activities of the National Institutes
of Health regarding rare diseases or conditions in minority
populations are implemented in accordance with the plan under
paragraph (1).
``(d) Definitions.--In this section:
``(1) The term `minority' has the meaning given such term
in section 464z-3.
``(2) The term `rare disease or condition' has the meaning
given such term in section 526 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bb).''.
SEC. 3. COLLABORATIVE COMPREHENSIVE PLAN TO ADDRESS RARE DISEASES AND
CONDITIONS IN MINORITY POPULATIONS.
Subpart 20 of part C of title IV of the Public Health Service Act
(42 U.S.C. 285t et seq.) is amended by adding at the end the following:
``SEC. 464Z-7. COLLABORATIVE COMPREHENSIVE PLAN TO ADDRESS RARE
DISEASES AND CONDITIONS IN MINORITY POPULATIONS.
``Not later than 180 days after the date of enactment of this
section, the Director of NIH, the Director of the Institute, the
Director of the National Center for Advancing Translational Sciences,
the Director of the National Heart, Lung, and Blood Institute, and the
directors of the other agencies of the National Institutes of Health in
collaboration (and in consultation with the advisory council for the
Institute) shall--
``(1) develop a comprehensive Federal plan to address rare
diseases and conditions in minority populations (as those terms
are defined in section 409K), including a strategy to increase
diversity in genetic programs at the program for Therapeutics
for Rare and Neglected Diseases at the National Institutes of
Health;
``(2) conduct or support through grants or cooperative
agreements basic, clinical, and translational research on rare
diseases and conditions in minority populations, including
research on--
``(A) early detection, diagnosis, and treatment of
such diseases and conditions in such populations; and
``(B) improving the quality of life for individuals
with rare diseases or conditions and their families;
``(3) conduct or support clinical training programs for
physicians and other health care practitioners with respect to
detecting, diagnosing, and treating such diseases and
conditions in such populations; and
``(4) develop guidance for increasing participation of
health professionals who are members of minority groups (as
defined in section 464z-3) in research conducted or supported
by the National Institutes of Health on such diseases and
conditions in such populations.''.
SEC. 4. GRANTS TO COLLECT AND ANALYZE DATA ON RARE DISEASES AND
CONDITIONS IN MINORITY POPULATIONS.
Section 1707(b) of the Public Health Service Act (42 U.S.C. 300u-
6(b)) is amended by adding at the end the following:
``(11) In coordination with the Director of the Centers for
Disease Control and Prevention, award grants to public and
private nonprofit entities to--
``(A) collect, analyze, and report data on rare
diseases and conditions in minority populations,
including on epidemiological data with respect to
incidence of such diseases and conditions in such
populations;
``(B) conduct outreach and engagement activities
with the minority populations impacted by such rare
diseases and conditions by--
``(i) improving health literacy with
respect to rare diseases and conditions;
``(ii) disseminating information on health
and community services related to rare diseases
and conditions; and
``(iii) providing information regarding the
maintenance of rare diseases and conditions.
``(12) Submit to Congress, on a biannual basis (beginning
not later than 2 years after the date of the enactment of the
HEARD Act of 2025), a report describing the activities carried
out pursuant to paragraph (11).''.
SEC. 5. PHYSICIAN TRAINING PROGRAMS WITH RESPECT TO RARE DISEASES.
Subpart II of part C of title VII of the Public Health Service Act
is amended by adding at the end the following:
``SEC. 749C. PHYSICIAN TRAINING PROGRAMS WITH RESPECT TO RARE DISEASES.
``(a) In General.--The Secretary shall establish a program to award
grants to accredited schools of allopathic medicine, osteopathic
medicine, and nursing, and other health professional training programs
for the training of health care professionals--
``(1) to improve the provision of care to individuals who
have rare diseases or conditions (as defined in section 526 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb));
``(2) to improve the provision of care to such individuals
via telehealth; and
``(3) to conduct research relevant to rare diseases and
conditions.
``(b) Eligibility.--To be eligible for a grant under subsection
(a), an entity described in such subsection shall submit to the
Secretary an application at such time, in such manner, and containing
such information as the Secretary may require.
``(c) Reporting Requirements.--
``(1) Periodic reports.--Each entity awarded a grant under
this section shall periodically submit to the Secretary a
report on the status of activities conducted using the grant,
including a description of the impact of such training on
patient outcomes, as applicable.
``(2) Report to congress.--Not later than 2 years after the
date of enactment of this section, the Secretary shall submit a
report to Congress on the activities conducted using grants
under subsection (a) and any best practices identified and
disseminated under subsection (d).
``(d) Best Practices.--The Secretary may identify and disseminate
best practices for the training described in subsection (a).
``SEC. 749D. HEALTH PROFESSIONALS EDUCATION ON RARE DISEASES AND
CONDITIONS IN MINORITY POPULATIONS.
``(a) In General.--The Secretary may award grants, cooperative
agreements, and contracts to accredited schools of medicine and
nursing, and other health professional training programs, for the
development and implementation of programs to provide education and
training to health care professionals on the causes and effects of rare
diseases and conditions in minority populations.
``(b) Definitions.--In this section:
``(1) The term `minority' has the meaning given such term
in section 464z-3.
``(2) The term `rare disease or condition' has the meaning
given such term in section 526 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bb).
``SEC. 749E. MENTORING PROGRAM FOR HEALTH CARE PROFESSIONALS SEEKING TO
WORK IN RARE DISEASES AND CONDITIONS.
``The Secretary, acting through the Administrator of the Health
Resources and Services Administration, may award grants, contracts, or
cooperative agreements to public and nonprofit private entities
(including Tribal entities) for the establishment of a mentoring
program for health care professionals seeking to treat patients with
rare diseases and conditions.
``SEC. 749F. SCHOLARSHIP AND LOAN REPAYMENT PROGRAM FOR PHYSICIANS AND
GENETIC COUNSELORS SERVING POPULATIONS WITH RARE DISEASES
AND CONDITIONS.
``(a) Loan Repayment Program.--
``(1) In general.--The Secretary shall establish a program
of entering into contracts with eligible individuals under
which the individuals agree to serve as health care
professionals serving populations with rare diseases or
conditions in consideration of the Federal Government agreeing
to pay, for each year of such service, up to $50,000 (plus an
amount determined by the Secretary on an annual basis to
reflect inflation) of the principal and interest of the
educational loans of such individuals.
``(2) Determination of amount.--In making a determination
of the amount to pay for a year of such service by an
individual, the Secretary shall consider the extent to which
each such determination--
``(A) affects the ability of the Secretary to
maximize the number of contracts that can be provided
under the program from the amounts appropriated for
such contracts;
``(B) provides an incentive to serve as health care
professionals serving populations with rare diseases or
conditions; and
``(C) provides an incentive with respect to the
health professional involved to remain serving
populations with rare diseases or conditions, including
after the completion of the period of obligated service
under the program.
``(3) Eligible individuals.--In this subsection, the term
`eligible individual' means an individual who is enrolled or
accepted for enrollment as a full-time or part-time student in
a school of medicine.
``(4) Applicability of certain provisions.--With respect to
the National Health Service Corps Loan Repayment Program
established in subpart III of part D of title III of this Act,
the provisions of such subpart shall, except as inconsistent
with paragraph (1), apply to the program established in this
section in the same manner and to the same extent as such
provisions apply to the National Health Service Corps Loan
Repayment Program.
``(b) Scholarship Program.--
``(1) In general.--The Secretary shall carry out a program
of entering into contracts with eligible individuals under
which each such individual agrees to serve, for a period of not
less than 5 years, as a health care professional primarily
serving populations with rare diseases or conditions, in
consideration of the Federal Government agreeing to provide to
the individual a scholarship for attendance at a school of
medicine.
``(2) Eligible individuals.--In this subsection, the term
`eligible individual' means an individual who is enrolled or
accepted for enrollment as a full-time or part-time student in
a school of medicine.
``(3) Applicability of certain provisions.--The provisions
of subpart III of part D of title III shall, except as
inconsistent with this section, apply to the program
established in paragraph (1) in the same manner and to the same
extent as such provisions apply to the National Health Service
Corps Scholarship Program established in such subpart.''.
SEC. 6. INCREASING MINORITY REPRESENTATION IN RESEARCH ON RARE DISEASES
AND CONDITIONS.
Part G of title IV of the Public Health Service Act (42 U.S.C. 288
et seq.) is amended by adding at the end the following:
``SEC. 487E. INCREASING MINORITY REPRESENTATION IN RESEARCH ON RARE
DISEASES AND CONDITIONS.
``(a) Grant Program.--In carrying out section 487, the Secretary
may award grants to eligible entities involved in research on rare
diseases and minority health to establish programs to increase the
recruitment and retention of members of minority groups to conduct
research in matters relating to the cause, diagnosis, prevention, and
treatment of rare diseases or conditions, including by expanding the
number of internships and mentoring opportunities.
``(b) Eligible Entities.--In subsection (a), the term `eligible
entities' means accredited schools of allopathic medicine, osteopathic
medicine, and nursing, and other health professional training
programs.''.
SEC. 7. REPORT TO CONGRESS ON FEDERAL EFFORTS ON RARE DISEASES AND
CONDITIONS IN MINORITY POPULATIONS.
Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services, acting through the Director of
the National Institutes of Health and in consultation with the Director
of the Centers for Disease Control and Prevention, shall submit to
Congress--
(1) a report on research and public health activities
carried out by the Federal Government with respect to rare
diseases or conditions in minority populations (as those terms
are defined in section 409K of the Public Health Service Act,
as added by section 2 of this Act);
(2) a comprehensive list of known rare diseases and
conditions that impact minority populations heavily or
disproportionately; and
(3) an analysis of data gaps with respect to rare diseases
and conditions and the effect of such diseases and conditions
on minority populations.
SEC. 8. RESEARCH AND AWARENESS CAMPAIGNS WITH RESPECT TO RARE DISEASES
AND CONDITIONS IN MINORITY POPULATIONS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 317V (42 U.S.C. 247b-24)
the following:
``SEC. 317W. RESEARCH AND AWARENESS CAMPAIGNS WITH RESPECT TO RARE
DISEASES AND CONDITIONS IN MINORITY POPULATIONS.
``(a) Research.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall conduct or support
research and carry out public health awareness campaigns with respect
to rare diseases and conditions in minority populations (as defined in
section 409K).
``(b) Awareness Campaign.--The Secretary shall, directly or through
grants or contracts, establish a public education program in
cooperation with existing national public awareness campaigns to
increase awareness about rare diseases and conditions in minority
populations through culturally and linguistically appropriate
information campaigns about prevention and management of rare diseases
and conditions.''.
SEC. 9. FDA SURVEY AND REPORT ON CLINICAL TRIAL DIVERSITY.
Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services, acting through the Commissioner
of Food and Drugs, shall--
(1) conduct a survey of policies and programs of the Food
and Drug Administration to support an increase the availability
of clinical trial data on minority populations, with an
emphasis on minority populations with rare diseases and
conditions; and
(2) submit to Congress a report containing--
(A) the findings of such survey;
(B) the Secretary's recommendations for statutory
or regulatory changes to increase the availability of
such data;
(C) the Secretary's recommendations for strategies
to encourage drug manufacturers to address racial
equity and inclusion in research and development of
treatments of rare diseases or conditions that
disproportionately impact minority populations; and
(D) the Secretary's recommendations for strategies
to address research and development of treatments of
rare diseases or conditions that disproportionately
impact minority populations.
SEC. 10. TRIBAL EPIDEMIOLOGY CENTER GRANT PROGRAM.
Title II of the Indian Health Care Improvement Act (25 U.S.C. 1621
et seq.) is amended by adding at the end the following:
``SEC. 227. TRIBAL EPIDEMIOLOGY CENTER GRANT PROGRAM.
``(a) In General.--The Secretary, acting through the Service, shall
award grants to Tribal Epidemiology Centers and Tribal and Urban Indian
Health Centers to support clinically and culturally appropriate
research and other activities with respect to rare diseases and
conditions in Native American or Tribal communities.
``(b) Permissible Activities.--The activities funded through a
grant under subsection (a) may include coordination of data collection
on the prevention, diagnosis, treatment, and care of rare diseases and
conditions by health care professionals serving American Indian and
Alaska Native populations.''.
SEC. 11. MEDICARE REVIEW AND REPORT.
Not later than 180 days after the date of enactment of this Act,
the Secretary of Health and Human Service shall conduct a review of and
submit to Congress a report on the following:
(1) Regulatory barriers under the Medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.)
that inhibit access to the treatment of rare diseases for
Medicare beneficiaries of color, including barriers that
inhibit health care providers from improving care related to
such diseases for such beneficiaries.
(2) Requirements relating to the furnishing of telehealth
services under such title insofar as such services relate to
the treatment of rare diseases.
Such report shall include any recommendations determined appropriate by
the Secretary based on such review.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Natural Resources, 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 Committees on Ways and Means, and Natural Resources, 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 Committees on Ways and Means, and Natural Resources, 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.
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