1342 
‘‘(V) monitoring barriers to ac-
cessing TB services; and 
‘‘(VI) increasing support for pa-
tient-led and community-led TB out-
reach efforts; 
‘‘(ix) support for country-level, sus-
tainable accountability mechanisms and ca-
pacity to measure progress and ensure that 
commitments made by governments and 
relevant stakeholders are met; and 
‘‘(x) support for the integration of TB 
diagnosis, treatment, and prevention activi-
ties into primary health care, as appro-
priate. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) APPROPRIATE
CONGRESSIONAL
COMMIT-
TEES.—The term ‘appropriate congressional com-
mittees’ means the Committee on Foreign Relations 
of the Senate and the Committee on Foreign Affairs 
of the House of Representatives. 
‘‘(2) END TB STRATEGY.—The term ‘End TB 
Strategy’ means the strategy to eliminate TB that 
was approved by the World Health Assembly in May 
2014, and is described in ‘The End TB Strategy: 
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Global Strategy and Targets for Tuberculosis Pre-
vention, Care and Control After 2015’. 
‘‘(3) GLOBAL
ALLIANCE
FOR
TUBERCULOSIS 
DRUG
DEVELOPMENT.—The term ‘Global Alliance 
for Tuberculosis Drug Development’ means the pub-
lic-private partnership that bring together leaders in 
health, science, philanthropy, and private industry to 
devise new approaches to TB. 
‘‘(4) GLOBAL
TUBERCULOSIS
DRUG
FACIL-
ITY.—The term ‘Global Tuberculosis Drug Facility’ 
means the initiative of the Stop Tuberculosis Part-
nership to increase access to the most advanced, af-
fordable, quality-assured TB drugs and diagnostics. 
‘‘(5) MDR–TB.—The term ‘MDR–TB’ means 
multi-drug-resistant TB. 
‘‘(6) STOP TUBERCULOSIS PARTNERSHIP.—The 
term ‘Stop Tuberculosis Partnership’ means the 
partnership of 1,600 organizations (including inter-
national and technical organizations, government 
programs, research and funding agencies, founda-
tions, nongovernmental organizations, civil society 
and community groups, and the private sector), do-
nors, including the United States, high TB burden 
countries, multilateral agencies, and nongovern-
mental and technical agencies, which is governed by 
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1344 
the Stop TB Partnership Coordinating Board and 
hosted by a United Nations entity, committed to 
short- and long-term measures required to control 
and eventually eliminate TB as a public health prob-
lem in the world. 
‘‘(7) XDR–TB.—The term ‘XDR–TB’ means 
extensively drug-resistant TB. 
‘‘(c) AUTHORIZATION.—To carry out this section, the 
President is authorized, consistent with section 104(c), to 
furnish assistance, on such terms and conditions as the 
President may determine, for the prevention, treatment, 
control, and elimination of TB. 
‘‘(d) GOALS.—In consultation with the appropriate 
congressional committees, the President shall establish 
goals, based on the policy and indicators described in sub-
section (a), for— 
‘‘(1) United States TB programs to detect, 
cure, and prevent all forms of TB globally for the 
period between 2023 and 2030 that are aligned with 
the End TB Strategy’s 2030 targets and the 
USAID’s Global Tuberculosis (TB) Strategy 2023– 
2030; and 
‘‘(2) updating the National Action Plan for 
Combating Multidrug-Resistant Tuberculosis. 
‘‘(e) COORDINATION.— 
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‘‘(1) IN GENERAL.—In carrying out this sec-
tion, the President shall coordinate with the World 
Health Organization, the Stop TB Partnership, the 
Global Fund to Fight AIDS, Tuberculosis, and Ma-
laria, and other organizations with respect to the de-
velopment and implementation of a comprehensive 
global TB response program. 
‘‘(2) BILATERAL ASSISTANCE.—In providing bi-
lateral assistance under this section, the President, 
acting through the Administrator of the United 
States 
Agency 
for 
International 
Development, 
shall— 
‘‘(A) catalyze support for research and de-
velopment of new tools to prevent, diagnose, 
treat, and control TB worldwide, particularly to 
reduce the incidence of, and mortality from, all 
forms of drug-resistant TB; 
‘‘(B) ensure United States programs and 
activities focus on finding individuals with ac-
tive TB disease and provide quality diagnosis 
and treatment, including through digital health 
solutions, and reaching those at high risk with 
preventive therapy; and 
‘‘(C) ensure coordination among relevant 
United States Government agencies, including 
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the Department of State, the Centers for Dis-
ease Control and Prevention, the National In-
stitutes of Health, the Biomedical Advanced 
Research and Development Authority, the Food 
and Drug Administration, the National Science 
Foundation, 
the 
Department 
of 
Defense 
(through its Congressionally Directed Medical 
Research Programs), and other relevant Fed-
eral departments and agencies that engage in 
international TB activities— 
‘‘(i) to ensure accountability and 
transparency; 
‘‘(ii) to reduce duplication of efforts; 
and 
‘‘(iii) to ensure appropriate integra-
tion and coordination of TB services into 
other United States-supported health pro-
grams. 
‘‘(f) PRIORITY TO END TB STRATEGY.—In fur-
nishing assistance under subsection (c), the President 
shall prioritize— 
‘‘(1) building and strengthening TB pro-
grams— 
‘‘(A) to increase the diagnosis and treat-
ment of everyone who is sick with TB; and 
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‘‘(B) to ensure that such individuals have 
access to quality diagnosis and treatment; 
‘‘(2) direct, high-quality integrated services for 
all forms of TB, as described by the World Health 
Organization, which call for the coordination of ac-
tive case finding, treatment of all forms of TB dis-
ease and infection, patient support, and TB preven-
tion; 
‘‘(3) treating individuals co-infected with HIV 
and other co-morbidities, and other individuals with 
TB who may be at risk of stigma; 
‘‘(4) strengthening the capacity of health sys-
tems to detect, prevent, and treat TB, including 
MDR–TB and XDR–TB, as described in the latest 
international guidance related to TB; 
‘‘(5) researching and developing innovative 
diagnostics, drug therapies, and vaccines, and pro-
gram-based research; 
‘‘(6) support for the Stop Tuberculosis Partner-
ship’s Global Drug Facility, the Global Alliance for 
Tuberculosis Drug Development, and other organiza-
tions promoting the development of new products 
and drugs for TB; and 
‘‘(7) ensuring that TB programs can serve as 
key platforms for supporting national respiratory 
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pandemic response against existing and new infec-
tious respiratory disease. 
‘‘(g) ASSISTANCE FOR THE WORLD HEALTH ORGA-
NIZATION
AND
THE STOP TUBERCULOSIS PARTNER-
SHIP.—In carrying out this section, the President, acting 
through the Administrator of the United States Agency 
for International Development, is authorized— 
‘‘(1) to provide resources to the World Health 
Organization and the Stop Tuberculosis Partnership 
to improve the capacity of countries with high bur-
dens or rates of TB and other affected countries to 
implement the End TB Strategy, the Stop TB Glob-
al Plan to End TB, their own national strategies 
and plans, other global efforts to control MDR–TB 
and XDR–TB; and 
‘‘(2) to leverage the contributions of other do-
nors for the activities described in paragraph (1). 
‘‘(h) ANNUAL REPORT
ON TB ACTIVITIES.—Not 
later than December 15 of each year until the earlier of 
the date on which the goals specified in subsection 
(a)(2)(A) are met or the last day of 2030, the President 
shall submit an annual report to the appropriate congres-
sional committees that describes United States foreign as-
sistance to control TB and the impact of such efforts, in-
cluding— 
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‘‘(1) the number of individuals with active TB 
disease that were diagnosed and treated, including 
the rate of treatment completion and the number re-
ceiving patient support; 
‘‘(2) the number of persons with MDR–TB and 
XDR–TB that were diagnosed and treated, includ-
ing the rate of completion, in countries receiving 
United States bilateral foreign assistance for TB 
control programs; 
‘‘(3) the number of people trained by the 
United States Government in TB surveillance and 
control; 
‘‘(4) the number of individuals with active TB 
disease identified as a result of engagement with the 
private sector and other nongovernmental partners 
in countries receiving United States bilateral foreign 
assistance for TB control programs; 
‘‘(5) a description of the collaboration and co-
ordination of United States anti-TB efforts with the 
World Health Organization, the Stop TB Partner-
ship, the Global Fund to Fight AIDS, Tuberculosis 
and Malaria, and other major public and private en-
tities; 
‘‘(6) a description of the collaboration and co-
ordination among the United States Agency for 
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International Development and other United States 
departments and agencies, including the Centers for 
Disease Control and Prevention and the Office of 
the Global AIDS Coordinator, for the purposes of 
combating TB and, as appropriate, its integration 
into primary care; 
‘‘(7) the constraints on implementation of pro-
grams posed by health workforce shortages, health 
system limitations, barriers to digital health imple-
mentation, other challenges to successful implemen-
tation, and strategies to address such constraints; 
‘‘(8) a breakdown of expenditures for patient 
services supporting TB diagnosis, treatment, and 
prevention, including procurement of drugs and 
other commodities, drug management, training in di-
agnosis and treatment, health systems strengthening 
that directly impacts the provision of TB services, 
and research; and 
‘‘(9) for each country, and when practicable, 
each project site receiving bilateral United States as-
sistance for the purpose of TB prevention, treat-
ment, and control— 
‘‘(A) a description of progress toward the 
adoption and implementation of the most recent 
World Health Organization guidelines to im-
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1351 
prove diagnosis, treatment, and prevention of 
TB for adults and children, disaggregated by 
sex, including the proportion of health facilities 
that have adopted the latest World Health Or-
ganization guidelines on strengthening moni-
toring systems and preventative, diagnostic, and 
therapeutic methods, including the use of rapid 
diagnostic tests and orally administered TB 
treatment regimens; 
‘‘(B) the number of individuals screened 
for TB disease and the number evaluated for 
TB infection using active case finding outside 
of health facilities; 
‘‘(C) the number of individuals with active 
TB disease that were diagnosed and treated, in-
cluding the rate of treatment completion and 
the number receiving patient support; 
‘‘(D) the number of adults and children, 
including people with HIV and close contacts, 
who are evaluated for TB infection, the number 
of adults and children started on treatment for 
TB infection, and the number of adults and 
children 
completing 
such 
treatment, 
disaggregated by sex and, as possible, income or 
wealth quintile; 
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‘‘(E) the establishment of effective TB in-
fection control in all relevant congregant set-
tings, including hospitals, clinics, and prisons; 
‘‘(F) a description of progress in imple-
menting measures to reduce TB incidence, in-
cluding actions— 
‘‘(i) to expand active case finding and 
contact tracing to reach vulnerable groups; 
and 
‘‘(ii) to expand TB preventive ther-
apy, engagement of the private sector, and 
diagnostic capacity; 
‘‘(G) a description of progress to expand 
diagnosis, prevention, and treatment for all 
forms of TB, including in pregnant women, 
children, and individuals and groups at greater 
risk of TB, including migrants, prisoners, min-
ers, people exposed to silica, and people living 
with HIV/AIDS, disaggregated by sex; 
‘‘(H) the rate of successful completion of 
TB 
treatment 
for 
adults 
and 
children, 
disaggregated by sex, and the number of indi-
viduals receiving support for treatment comple-
tion; 
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‘‘(I) the number of people, disaggregated 
by sex, receiving treatment for MDR–TB, the 
proportion of those treated with the latest regi-
mens endorsed by the World Health Organiza-
tion, factors impeding scale up of such treat-
ment, and a description of progress to expand 
community-based MDR–TB care; 
‘‘(J) a description of TB commodity pro-
curement 
challenges, 
including 
shortages, 
stockouts, or failed tenders for TB drugs or 
other commodities; 
‘‘(K) the proportion of health facilities 
with specimen referral linkages to quality diag-
nostic networks, including established testing 
sites and reference labs, to ensure maximum ac-
cess and referral for second line drug resistance 
testing, and a description of the turnaround 
time for test results; 
‘‘(L) the number of people trained by the 
United States Government to deliver high-qual-
ity TB diagnostic, preventative, monitoring, 
treatment, and care services; 
‘‘(M) a description of how supported activi-
ties are coordinated with— 
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1354 
‘‘(i) country national TB plans and 
strategies; and 
‘‘(ii) TB control efforts supported by 
the Global Fund to Fight AIDS, Tuber-
culosis, and Malaria, and other inter-
national assistance programs and funds, 
including in the areas of program develop-
ment and implementation; and 
‘‘(N) for the first 3 years of the report re-
quired under this subsection, a description of 
the progress in recovering from the negative im-
pact of COVID–19 on TB, including— 
‘‘(i) whether there has been the devel-
opment and implementation of a com-
prehensive plan to recover TB activities 
from diversion of resources; 
‘‘(ii) the continued use of bidirectional 
TB–COVID testing; and 
‘‘(iii) progress on increased diagnosis 
and treatment of active TB. 
‘‘(i) ANNUAL REPORT ON TB RESEARCH AND DE-
VELOPMENT.—The President, acting through the Admin-
istrator of the United States Agency for International De-
velopment, and in coordination with the National Insti-
tutes of Health, the Centers for Disease Control and Pre-
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1355 
vention, the Biomedical Advanced Research and Develop-
ment Authority, the Food and Drug Administration, the 
National Science Foundation, and the Office of the Global 
AIDS Coordinator, shall submit to the appropriate con-
gressional committees until 2030 an annual report that— 
‘‘(1) describes the current progress and chal-
lenges to the development of new tools for the pur-
pose of TB prevention, treatment, and control; 
‘‘(2) identifies critical gaps and emerging prior-
ities for research and development, including for 
rapid and point-of-care diagnostics, shortened treat-
ments and prevention methods, telehealth solutions 
for prevention and treatment, and vaccines; and 
‘‘(3) describes research investments by type, 
funded entities, and level of investment. 
‘‘(j) EVALUATION REPORT.—Not later than 3 years 
after the date of the enactment of the Health Equity and 
Accountability Act of 2024, and 5 years thereafter, the 
Comptroller General of the United States shall submit a 
report to the appropriate congressional committees that 
evaluates the performance and impact on TB prevention, 
diagnosis, treatment, and care efforts that are supported 
by United States bilateral assistance funding, including 
recommendations for improving such programs.’’. 
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Subtitle I—Osteoarthritis and 
Musculoskeletal Diseases 
SEC. 
7801. 
OSTEOARTHRITIS 
AND 
OTHER 
MUSCULO-
SKELETAL HEALTH-RELATED ACTIVITIES OF 
THE CENTERS FOR DISEASE CONTROL AND 
PREVENTION. 
(a) EDUCATION AND AWARENESS ACTIVITIES.—The 
Secretary of Health and Human Services, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall direct the National Center for Chronic Dis-
ease Prevention and Health Promotion to conduct and ex-
pand the Health Community Program and Arthritis Pro-
gram to educate the public on— 
(1) the causes of, preventive health actions for, 
and effects of arthritis, lupus, and other musculo-
skeletal conditions in minority patient populations; 
and 
(2) the effects of such conditions on other 
comorbidities including obesity, hypertension, and 
cardiovascular disease. 
(b) PROGRAMS
ON
ARTHRITIS
AND
MUSCULO-
SKELETAL CONDITIONS.—Education and awareness pro-
grams of the Centers for Disease Control and Prevention 
on arthritis and other musculoskeletal conditions in minor-
ity communities shall— 
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(1) be culturally and linguistically appropriate 
to minority patients, targeting musculoskeletal 
health promotion and prevention programs of each 
major ethnic group, including— 
(A) Native Americans and Alaska Natives; 
(B) Asian Americans; 
(C) African Americans and Blacks; 
(D) Hispanic and Latino Americans; and 
(E) Native Hawaiians and Pacific Island-
ers; and 
(2) include public awareness campaigns directed 
toward these patient populations that emphasize the 
importance of musculoskeletal health, physical activ-
ity, diet and healthy lifestyle, and weight reduction 
for overweight and obese patients. 
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as are necessary for fiscal year 2025 and each 
subsequent fiscal year. 
SEC. 
7802. 
GRANTS 
FOR 
COMPREHENSIVE 
OSTEO-
ARTHRITIS 
AND 
MUSCULOSKELETAL 
DIS-
EASE HEALTH EDUCATION WITHIN HEALTH 
PROFESSIONS SCHOOLS. 
(a) PROGRAM
AUTHORIZED.—The Secretary of 
Health and Human Services (in this section referred to 
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as the ‘‘Secretary’’), in coordination with the Secretary of 
Education, shall award grants, on a competitive basis, to 
academic health science centers, health professions 
schools, and institutions of higher education to enable 
such centers, schools, and institutions to provide people 
with comprehensive education on arthritis and musculo-
skeletal health, particularly— 
(1) obesity-related musculoskeletal diseases; 
(2) arthritis and osteoarthritis; 
(3) arthritis and musculoskeletal health dispari-
ties; and 
(4) the relationship between arthritis and mus-
culoskeletal diseases and metabolic activity, psycho-
logical health, and comorbidities such as diabetes, 
cardiovascular disease, lupus, and hypertension. 
(b) DURATION.—Grants awarded under this section 
shall be for a period of 5 years. 
(c) APPLICATIONS.—An academic health science cen-
ter, health professions school, or institution of higher edu-
cation seeking a grant under this section shall submit an 
application to the Secretary at such time, in such manner, 
and containing such information as the Secretary may re-
quire. 
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1359 
(d) PRIORITY.—In awarding grants under this sec-
tion, the Secretary shall give priority to an institution of 
higher education that— 
(1) has an enrollment of needy students, as de-
fined in section 318(b) of the Higher Education Act 
of 1965 (20 U.S.C. 1059e(b)); 
(2) is a Hispanic-serving institution, as defined 
in section 502(a) of such Act (20 U.S.C. 1101a(a)); 
(3) is a Tribal College or University, as defined 
in section 316(b) of such Act (20 U.S.C. 1059c(b)); 
(4) is an Alaska Native-serving institution, as 
defined in section 317(b) of such Act (20 U.S.C. 
1059d(b)); 
(5) is a Native Hawaiian-serving institution, as 
defined in section 317(b) of such Act (20 U.S.C. 
1059d(b)); 
(6) is a Predominately Black Institution, as de-
fined in section 318(b) of such Act (20 U.S.C. 
1059e(b)); 
(7) is a Native American-serving, nontribal in-
stitution, as defined in section 319(b) of such Act 
(20 U.S.C. 1059f(b)); 
(8) is an Asian American and Native American 
Pacific Islander-serving institution, as defined in 
section 320(b) of such Act (20 U.S.C. 1059g(b)); or 
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1360 
(9) is a minority institution, as defined in sec-
tion 365 of such Act (20 U.S.C. 1067k), with an en-
rollment of needy students, as defined in section 312 
of such Act (20 U.S.C. 1058). 
(e) USES OF FUNDS.—An academic health science 
center, health professions school, or institution of higher 
education receiving a grant under this section may use the 
grant funds to integrate issues relating to comprehensive 
arthritis and musculoskeletal health into the academic or 
support sectors of the center, school, or institution in 
order to reach a large number of students, by carrying 
out 1 or more of the following activities: 
(1) Developing educational content for issues 
relating to comprehensive arthritis and musculo-
skeletal health education that will be incorporated 
into first-year orientation or core courses. 
(2) Creating innovative technology-based ap-
proaches to deliver arthritis and musculoskeletal 
health education to students, faculty, and staff. 
(3) Developing and employing peer-outreach 
and education programs to generate discussion, edu-
cate, and raise awareness among students about 
issues relating to arthritis and musculoskeletal 
health disorders, and their relationship to diabetes, 
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1361 
hypertension, cardiovascular disease, psychological 
health, and other comorbid conditions. 
(f) REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this Act, and annually 
thereafter for a period of 5 years, the Secretary shall 
prepare and submit to the appropriate committees of 
Congress a report on the activities to provide health 
professions students with comprehensive arthritis 
and musculoskeletal health education funded under 
this section. 
(2) REPORT ELEMENTS.—The report described 
in paragraph (1) shall include information about— 
(A) the number of entities that are receiv-
ing a grant under this section; 
(B) the specific activities supported by 
grants under this section; 
(C) the number of students served by pro-
grams supported by grants under this section; 
and 
(D) the status of evaluations of such pro-
grams. 
(g) DEFINITION OF INSTITUTION OF HIGHER EDU-
CATION.—In this section, the term ‘‘institution of higher 
education’’ has the meaning given such term in section 
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1362 
101 of the Higher Education Act of 1965 (20 U.S.C. 
1001). 
Subtitle J—Sleep and Circadian 
Rhythm Disorders 
SEC. 7901. SLEEP AND CIRCADIAN RHYTHM DISORDERS RE-
SEARCH ACTIVITIES OF THE NATIONAL IN-
STITUTES OF HEALTH. 
(a) IN GENERAL.—The Director of the National In-
stitutes of Health, acting through the Director of the Na-
tional Heart, Lung, and Blood Institute, shall— 
(1) continue to expand research activities ad-
dressing sleep health disparities; and 
(2) continue implementation of the NIH Sleep 
Disorders Research Plan across all institutes and 
centers of the National Institutes of Health to im-
prove treatment and prevention of sleep health dis-
parities. 
(b) REQUIRED
RESEARCH
ACTIVITIES.—In con-
ducting or supporting research relating to sleep and circa-
dian rhythm, the Director of the National Heart, Lung, 
and Blood Institute shall— 
(1) advance epidemiology and clinical research 
to achieve a more complete understanding of dispari-
ties in domains of sleep health and across population 
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1363 
subgroups for which cardiovascular and metabolic 
health disparities exist, including— 
(A) prevalence and severity of sleep apnea; 
(B) habitual sleep duration; 
(C) sleep timing and regularity; and 
(D) insomnia; 
(2) develop study designs and analytical ap-
proaches to explain and predict multilevel and life- 
course determinants of sleep health and to elucidate 
the sleep-related causes of cardiovascular and meta-
bolic health disparities across the age spectrum, in-
cluding such determinants and causes that are— 
(A) environmental; 
(B) biological or genetic; 
(C) psychosocial; 
(D) societal; 
(E) political; or 
(F) economic; 
(3) determine the contribution of sleep impair-
ments such as sleep apnea, insufficient sleep dura-
tion, irregular sleep schedules, and insomnia to un-
explained disparities in cardiovascular and metabolic 
risk and disease outcomes; 
(4) develop study designs, data sampling and 
collection tools, and analytical approaches to opti-
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mize understanding of mediating and moderating 
factors, and feedback mechanisms coupling sleep to 
cardiovascular and metabolic health disparities; 
(5) advance research to understand cultural 
and linguistic barriers (on the person, provider, or 
system level) to access to care, medical diagnosis, 
and treatment of sleep disorders in diverse popu-
lation groups; 
(6) develop and test multilevel interventions (in-
cluding sleep health education in diverse commu-
nities) to reduce disparities in sleep health that will 
impact the ability to improve disparities in cardio-
vascular and metabolic risk or disease; 
(7) create opportunities to integrate sleep and 
health disparity science by strategically utilizing re-
sources (involving existing or anticipated cohorts) 
and exchanging scientific data and ideas (including 
through cross-over into scientific meetings); and 
(8) enhance the diversity and foster career de-
velopment of young investigators involved in sleep 
and health disparities science. 
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary for fiscal year 2025 and 
each subsequent fiscal year. 
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SEC. 7902. SLEEP AND CIRCADIAN RHYTHM HEALTH DIS-
PARITIES-RELATED ACTIVITIES OF THE CEN-
TERS FOR DISEASE CONTROL AND PREVEN-
TION. 
(a) IN GENERAL.—The Director of the Centers for 
Disease Control and Prevention shall conduct, support, 
and expand public health strategies and prevention, diag-
nosis, surveillance, and public and professional awareness 
activities regarding sleep and circadian rhythm disorders. 
(b) REQUIRED
SURVEILLANCE
AND
EDUCATION 
AWARENESS ACTIVITIES.—In conducting or supporting 
research relating to sleep and circadian rhythm disorders 
surveillance and education awareness activities, the Direc-
tor of the Centers for Disease Control and Prevention 
shall— 
(1) ensure that such activities are culturally 
and linguistically appropriate to minority patients, 
targeting sleep and circadian rhythm health pro-
motion and prevention programs of each major eth-
nic group, including— 
(A) Native Americans and Alaska Natives; 
(B) Asian Americans; 
(C) African Americans and Blacks; 
(D) Hispanic and Latino-Americans; and 
(E) Native Hawaiians and Pacific Island-
ers; 
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(2) collect and compile national and State sur-
veillance data on sleep disorders health disparities; 
(3) continue to develop and implement new 
sleep questions in public health surveillance systems 
to increase public awareness of sleep health and 
sleep disorders and their impact on health; 
(4) publish monthly reports highlighting geo-
graphic, racial, and ethnic disparities in sleep health, 
as well as relationships between insufficient sleep 
and chronic disease, health risk behaviors, and other 
outcomes as determined necessary by the Director; 
and 
(5) include public awareness campaigns that in-
form patient populations from major ethnic groups 
about the prevalence of sleep and circadian rhythm 
disorders and emphasize the importance of sleep 
health. 
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary for fiscal year 2025 and 
each subsequent fiscal year. 
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SEC. 7903. GRANTS FOR COMPREHENSIVE SLEEP AND CIR-
CADIAN 
HEALTH 
EDUCATION 
WITHIN 
HEALTH PROFESSIONS SCHOOLS. 
(a) PROGRAM
AUTHORIZED.—The Secretary of 
Health and Human Services (referred to in this section 
as the ‘‘Secretary’’), in coordination with the Secretary of 
Education, shall award grants, on a competitive basis, to 
academic health science centers, health professions 
schools, and institutions of higher education to enable 
such centers, schools, and institutions to provide people 
with comprehensive education on sleep and circadian 
health, particularly— 
(1) poor sleep health; 
(2) sleep disorders; 
(3) sleep health disparities; and 
(4) the relationship between sleep and circadian 
health on metabolic activity, neurological activity, 
comorbidities, and other diseases. 
(b) DURATION.—Grants awarded under this section 
shall be for a period of 5 years. 
(c) APPLICATIONS.—An academic health science cen-
ter, health professions school, or institution of higher edu-
cation seeking a grant under this section shall submit an 
application to the Secretary at such time, in such manner, 
and containing such information as the Secretary may re-
quire. 
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(d) PRIORITY.—In awarding grants under this sec-
tion, the Secretary shall give priority to an institution of 
higher education that— 
(1) has an enrollment of needy students, as de-
fined in section 318(b) of the Higher Education Act 
of 1965 (20 U.S.C. 1059e(b)); 
(2) is a Hispanic-serving institution, as defined 
in section 502(a) of such Act (20 U.S.C. 1101a(a)); 
(3) is a Tribal College or University, as defined 
in section 316(b) of such Act (20 U.S.C. 1059c(b)); 
(4) is an Alaska Native-serving institution, as 
defined in section 317(b) of such Act (20 U.S.C. 
1059d(b)); 
(5) is a Native Hawaiian-serving institution, as 
defined in section 317(b) of such Act (20 U.S.C. 
1059d(b)); 
(6) is a Predominately Black Institution, as de-
fined in section 318(b) of such Act (20 U.S.C. 
1059e(b)); 
(7) is a Native American-serving, nontribal in-
stitution, as defined in section 319(b) of such Act 
(20 U.S.C. 1059f(b)); 
(8) is an Asian American and Native American 
Pacific Islander-serving institution, as defined in 
section 320(b) of such Act (20 U.S.C. 1059g(b)); or 
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(9) is a minority institution, as defined in sec-
tion 365 of such Act (20 U.S.C. 1067k), with an en-
rollment of needy students, as defined in section 312 
of such Act (20 U.S.C. 1058). 
(e) USES OF FUNDS.—An academic health science 
center, health professions school, or institution of higher 
education receiving a grant under this section may use the 
grant funds to integrate issues relating to comprehensive 
sleep and circadian health into the academic or support 
sectors of the center, school, or institution, in order to 
reach a large number of students, by carrying out 1 or 
more of the following activities: 
(1) Developing educational content for issues 
relating to comprehensive sleep and circadian health 
education that will be incorporated into first-year 
orientation or core courses. 
(2) Creating innovative technology-based ap-
proaches to deliver sleep health education to stu-
dents, faculty, and staff. 
(3) Developing and employing peer-outreach 
and education programs to generate discussion, edu-
cate, and raise awareness among students about 
issues relating to poor quality sleep, sleep and circa-
dian disorders, and the role sleep health plays in 
other diseases and comorbidities. 
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(f) REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this Act, and annually 
thereafter for a period of 5 years, the Secretary shall 
prepare and submit to the appropriate committees of 
Congress a report on the activities to provide health 
professions students with comprehensive sleep and 
circadian health education funded under this section. 
(2) REPORT ELEMENTS.—The report described 
in paragraph (1) shall include information about— 
(A) the number of entities that are receiv-
ing a grant under this section; 
(B) the specific activities supported by 
grants under this section; 
(C) the number of students served by pro-
grams supported by grants under this section; 
and 
(D) the status of evaluations of programs 
supported by such grants. 
(g) DEFINITION OF INSTITUTION OF HIGHER EDU-
CATION.—In this section, the term ‘‘institution of higher 
education’’ has the meaning given such term in section 
101 of the Higher Education Act of 1965 (20 U.S.C. 
1001). 
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SEC. 7904. REPORT ON IMPACT OF SLEEP AND CIRCADIAN 
HEALTH DISORDERS IN VULNERABLE AND 
RACIAL/ETHNIC POPULATIONS. 
(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall submit to Congress and the Presi-
dent a report on the impact of sleep and circadian health 
disorders for racial and ethnic minority communities and 
other vulnerable populations. 
(b) CONTENTS.—The report under subsection (a) 
shall include information on the— 
(1) progress that has been made in reducing 
the impact of sleep and circadian health disorders in 
such communities and populations; 
(2) opportunities that exist to make additional 
progress in reducing the impact of sleep and circa-
dian health disorders in such communities and popu-
lations; 
(3) challenges that may impede such additional 
progress; and 
(4) Federal funding necessary to achieve sub-
stantial reductions in sleep and circadian health dis-
orders in racial and ethnic minority communities. 
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Subtitle 
K—Kidney 
Disease 
Re-
search, 
Surveillance, 
Preven-
tion, and Treatment 
SEC. 7901A. KIDNEY DISEASE RESEARCH IN MINORITY POP-
ULATIONS. 
(a) IN GENERAL.— 
(1) RESEARCH AND TRAINING CENTERS.—Sec-
tion 431(c)(3) of the Public Health Service Act (42 
U.S.C. 285c–5(c)(3)) is amended— 
(A) in subparagraph (B), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (C), by striking 
‘‘and’’ at the end; and 
(C) by adding at the end the following: 
‘‘(D) improving data science through im-
provement in bioinformatics, data integration, 
and data sharing; 
‘‘(E) defining the chronic kidney disease 
mechanism and identifying new therapeutic tar-
gets for chronic kidney disease using specific 
tools, including mapping the genetic architec-
ture of kidney function and disease and trans-
lating genetic maps to disease-causing genes 
and mechanisms, especially among minority 
populations; 
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‘‘(F) improving models of human disease 
including better humanized animal models, im-
proved reproducibility, and functional character-
ization of kidney organoids, and accelerating 
the development of in vivo imaging technologies; 
and 
‘‘(G) developing cell-specific drug delivery 
systems and gene editing, including targeted 
systems for the delivery of therapeutic com-
pounds to specific kidney compartments or cell 
types and accelerating the implementation of 
gene editing and gene therapy for the treatment 
of kidney diseases in vivo; and’’. 
(2) INCLUSION OF MINORITY PARTICIPANTS.— 
In conducting and supporting research described in 
the amendment made by paragraph (1), the Director 
of the National Institutes of Health shall work with 
the Director of the National Institute on Minority 
Health and Health Disparities to improve the num-
ber of minority participants as study subjects in 
clinical trials. Such work may include— 
(A) developing and sustaining clinical trial 
consortia that can recruit patients with chronic 
kidney disease to ensure adequate capacity for 
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assessment of kidney outcomes and increase the 
enrollment of underrepresented populations; 
(B) encouraging the use of novel designs in 
clinical trials to enhance the recruitment and 
retention of underrepresented populations which 
will enhance the generalizability of study find-
ings; 
(C) supporting outreach initiatives that in-
corporate acknowledgment of both historical 
and current grounds for participation reluc-
tance, and that prioritize demonstrating trust-
worthiness, in order to enhance the ability to 
promote and effectively convey the benefits of 
clinical research participation; 
(D) completing clinical trials that test 
interventions to improve patient quality of life 
and address patient-reported outcomes; and 
(E) encouraging inclusion of persons with 
chronic kidney disease in clinical trials of treat-
ments for nonkidney diseases. 
(b) REPORT; COMPREHENSIVE PLAN.—Section 429 
of the Public Health Services Act (42 U.S.C. 285c–3) is 
amended by adding at the end the following: 
‘‘(c) REPORT BY KIDNEY, UROLOGIC, AND HEMATO-
LOGIC DISEASES COORDINATING COMMITTEE.— 
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‘‘(1) IN GENERAL.—The Kidney, Urologic, and 
Hematologic Diseases Coordinating Committee, in 
coordination with the Chronic Kidney Disease Initia-
tive at the Centers for Disease Control and Preven-
tion, shall— 
‘‘(A) prepare and submit to the Congress, 
not later than 6 months after the date of enact-
ment of this subsection, a report on Federal re-
search and public health activities with respect 
to kidney disease in minority populations; and 
‘‘(B) develop and submit to the Congress, 
the Secretary, the Director of the National In-
stitutes of Health, and the Advisory Board es-
tablished under section 430 for the diseases for 
which the Committee was established, not later 
than 1 year after the date of enactment of this 
subsection, an effective and comprehensive Fed-
eral plan (including all appropriate Federal 
health programs) to address kidney disease in 
minority populations. 
‘‘(2) CONTENTS.—The report under paragraph 
(1)(A) shall at minimum address each of the fol-
lowing: 
‘‘(A) Research on kidney disease in minor-
ity populations, including such research on— 
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‘‘(i) genetic, behavioral, and environ-
mental factors; 
‘‘(ii) prevention and complications 
among individuals within these populations 
who have already developed kidney disease; 
‘‘(iii) the delivery of evidenced-based 
care for all chronic kidney disease stages, 
especially in underrepresented and under-
served populations; 
‘‘(iv) expanding support for a root- 
cause analysis approach to disparities, in-
cluding causes, detection, and management 
of chronic kidney disease for underserved 
populations; 
‘‘(v) developing research teams that 
engage with community organizations to 
develop and implement interventions which 
halt or delay development and progression 
of chronic kidney disease; and 
‘‘(vi) continued support of observa-
tional studies of kidney disease measures 
and outcomes. 
‘‘(B) Surveillance and data collection on 
kidney disease in minority populations, includ-
ing with respect to— 
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‘‘(i) efforts to better determine the 
prevalence of kidney disease among Asian- 
American and Pacific Islander subgroups; 
and 
‘‘(ii) efforts to coordinate data collec-
tion on the American Indian population. 
‘‘(C) Community-based interventions to ad-
dress kidney disease targeting minority popu-
lations, including— 
‘‘(i) the evidence bases for such inter-
ventions; 
‘‘(ii) the cultural appropriateness of 
such interventions; and 
‘‘(iii) efforts to educate the public on 
the causes and consequences of kidney dis-
ease. 
‘‘(D) Education and training programs for 
health 
professionals 
(including 
community 
health workers) on the prevention and manage-
ment of kidney disease and its related complica-
tions that are supported by the Health Re-
sources and Services Administration, including 
such programs supported by the Bureau of 
Health Workforce, the Bureau of Primary 
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Health Care, and the Health Systems Bureau. 
This shall include— 
‘‘(i) identification of effective strate-
gies to increase implementation of proven 
therapies to slow chronic kidney disease in-
cidence and progression, especially in high- 
risk underrepresented populations; and 
‘‘(ii) identification of effective practice 
improvement strategies in large and small 
health systems to reduce chronic kidney 
disease incidence and progression.’’. 
SEC. 7901A–1. KIDNEY DISEASE ACTION PLAN. 
(a) IN GENERAL.—The Director of the Centers for 
Disease Control and Prevention shall conduct, support, 
and expand public health strategies, prevention, diagnosis, 
surveillance, and public and professional awareness activi-
ties regarding kidney disease. 
(b) NATIONAL ACTION PLAN.— 
(1) DEVELOPMENT.—Pursuant to section 426 
of the Public Health Service Act (42 U.S.C. 285c), 
not later than 2 years after the date of the enact-
ment of this Act, the Director of the National Insti-
tute of Diabetes and Digestive and Kidney Diseases, 
in consultation with the Director of the National In-
stitute on Minority Health and Health Disparities 
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and the Director of the Centers for Disease Control 
and Prevention, shall develop a national action plan 
to address kidney disease in the United States with 
participation from patients, caregivers, health pro-
fessionals, patient advocacy organizations, research-
ers, providers, public health professionals, and other 
stakeholders. 
(2) CONTENTS.—At a minimum, such plan 
shall include recommendations for— 
(A) public health interventions for the pur-
pose of implementation of the national plan; 
(B) biomedical, health services, and public 
health research on kidney disease; and 
(C) inclusion of kidney disease in the 
health data collections of all Federal agencies. 
(c) KIDNEY DISEASE PREVENTION PROGRAMS.—The 
Director of the Centers for Disease Control and Preven-
tion, through the Chronic Kidney Disease Initiative, shall 
carry out the following: 
(1) Conduct public education and awareness ac-
tivities with patient and professional organizations 
to stimulate earlier diagnosis and improve patient 
outcomes from treatment of kidney disease. To the 
extent known and relevant, such public education 
and awareness activities shall reflect differences in 
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kidney disease by cause (such as hypertension, dia-
betes, lupus nephritis, COVID–19, and polycystic 
kidney disease) and include a focus on outreach to 
undiagnosed and, as appropriate, minority popu-
lations. 
(2) Supplement and expand upon the activities 
of the Centers for Disease Control and Prevention 
by making grants to nonprofit organizations, State 
and local jurisdictions, and Indian Tribes for the 
purpose of reducing the burden of kidney disease, 
especially in disproportionately impacted commu-
nities, through public health interventions and re-
lated activities. 
(3) Coordinate with the National Institute of 
Diabetes and Digestive and Kidney Diseases, the In-
dian Health Service, the Health Resources and Serv-
ices Administration, and the Department of Vet-
erans Affairs to develop pilot programs to dem-
onstrate best practices for the diagnosis and man-
agement of kidney disease. 
(4) Develop improved techniques and identify 
best practices, in coordination with the Secretary of 
Veterans Affairs, for assisting kidney disease pa-
tients. 
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(d) DATA COLLECTION.—Not later than 180 days 
after the date of enactment of this Act, the Director of 
the National Institute of Diabetes and Digestive and Kid-
ney Diseases and the Director of the Centers for Disease 
Control and Prevention, acting jointly, shall assess the 
depth and quality of information on kidney disease that 
is collected in surveys and population studies conducted 
by the Centers for Disease Control and Prevention, includ-
ing whether there are additional opportunities for informa-
tion to be collected in the National Health and Nutrition 
Examination Survey, the National Health Interview Sur-
vey, and the Behavioral Risk Factor Surveillance System 
surveys. The Director of the National Institute of Diabetes 
and Digestive and Kidney Diseases shall include the re-
sults of such assessment in the national action plan under 
subsection (b). 
(e) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$1,000,000 for fiscal year 2025, $1,000,000 for fiscal year 
2026, $1,000,000 for fiscal year 2027, $1,000,000 for fis-
cal year 2028, and $1,000,000 for fiscal year 2029. 
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SEC. 7901A–2. PROVIDING FOR STAFF-ASSISTED HOME DI-
ALYSIS FOR CERTAIN HEMODIALYSIS AND 
PERITONEAL DIALYSIS PATIENTS. 
(a) IN GENERAL.—Section 1881(b)(14) of the Social 
Security Act (42 U.S.C. 1395rr(b)(14)) is amended by 
adding at the end the following new subparagraph: 
‘‘(J)(i) With respect to staff-assisted home 
dialysis (as defined in clause (iv)(IV)) furnished 
on or after the date that is 1 year after the 
date of the enactment of this subparagraph, 
subject to the succeeding provisions of this sub-
paragraph, the Secretary shall increase the sin-
gle payment that would otherwise apply under 
this paragraph for renal dialysis services by the 
add-on payment amount established pursuant 
to clause (iii). 
‘‘(ii)(I) Subject to subclause (II), staff-as-
sisted home dialysis may only be furnished— 
‘‘(aa) with respect to an initializing 
patient (as defined in clause (iv)(I)) or a 
returning patient (as defined in clause 
(iv)(III)), for a period of up to 90 days, re-
ferred to as the ‘initial period’, which may 
be extended as determined necessary by 
the care team of the individual in not more 
than 2 intervals of up to 30 days each, 
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each of which is referred to as an ‘ex-
tended interval’; and 
‘‘(bb) with respect to a temporary as-
sistance patient (as defined in clause 
(iv)(V)), for any 30-day period as deter-
mined necessary by the care team of the 
individual, notwithstanding whether such 
an individual receives any routine dialysis 
respite care during such period. 
‘‘(II) Notwithstanding subclause (I), staff- 
assisted home dialysis may be furnished for as 
long as the Secretary determines appropriate to 
an individual who— 
‘‘(aa) is blind; 
‘‘(bb) has a cognitive or neurological 
impairment 
(including 
a 
stroke, 
Alz-
heimer’s Disease, dementia, amyotrophic 
lateral sclerosis, or any other impairment 
determined by the Secretary); or 
‘‘(cc) has any other illness or injury 
that reduces mobility (including cerebral 
palsy, spinal cord injuries, an injury or ill-
ness that requires the individual to be on 
a ventilator, or any other illness or injury 
determined by the Secretary). 
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‘‘(iii) The Secretary shall, by regulation, 
establish an add-on payment amount for staff- 
assisted 
home 
dialysis 
to 
determine 
the 
amounts payable to a qualified provider (as de-
fined in clause (iv)(II)) for assisting in the fur-
nishing of staff-assisted home dialysis on a fre-
quency as determined by the Secretary and in 
consultation with clinicians, patients, and care 
partners to ensure maximum patient choice, ac-
cess, and flexibility. In establishing the add-on 
payment under this clause, the Secretary shall 
consult with stakeholders, including providers of 
renal dialysis services, individuals receiving 
home dialysis, qualified providers, private insur-
ance payers, and Medicare Advantage plans 
under part C. 
‘‘(iv) In this subparagraph: 
‘‘(I) The term ‘initializing patient’ 
means an individual who initiates a home 
dialysis modality, including home hemo-
dialysis and peritoneal dialysis. 
‘‘(II) The term ‘qualified provider’ 
means a trained professional (as deter-
mined by the Secretary, including a reg-
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istered or licensed practical nurse and a 
certified patient care technician) who— 
‘‘(aa) furnishes renal dialysis 
services; 
‘‘(bb) meets requirements (as de-
termined by the Secretary) that en-
sure competency in patient care and 
modality usage; and 
‘‘(cc) during a period described 
in clause (ii)(I), provides in-person as-
sistance to an individual for an appro-
priate number of dialysis sessions, as 
determined by the care team of the in-
dividual based on the needs of the in-
dividual, caregiver availability, pre-
scription, and mode of home dialysis. 
‘‘(III) The term ‘returning patient’ 
means an individual who is returning to 
home dialysis after a period of hospitaliza-
tion or other non-home dialysis modality. 
‘‘(IV)(aa) The term ‘staff-assisted 
home dialysis’ means dialysis furnished by 
the individual in a home, residence, or 
other approved setting with the assistance 
of a qualified provider, the frequency of 
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which is determined by the qualified pro-
vider in coordination with the individual, 
the care partner, and the care team of the 
individual and outlined in a patient plan of 
care. 
‘‘(bb) In this subclause, the term ‘care 
partner’ means a friend or family member 
who is designated by the individual who is 
trained to assist the individual with the 
furnishing of home dialysis. 
‘‘(cc) In this subclause, the term ‘pa-
tient plan of care’ has the meaning given 
such term in section 494.90 of title 42, 
Code of Federal Regulations (or any suc-
cessor regulations). 
‘‘(V) The term ‘temporary assistance 
patient’ means an individual who is receiv-
ing home dialysis and is temporarily un-
able to perform functions necessary to self- 
furnish unassisted home dialysis due to ill-
ness, injury, caregiver unavailability, or 
other temporary circumstances not to ex-
ceed 30 days.’’. 
(b) PATIENT EDUCATION AND TRAINING RELATING 
TO STAFF-ASSISTED HOME DIALYSIS.— 
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(1) IN GENERAL.—Section 1881(b)(5) of the 
Social Security Act (42 U.S.C. 1395rr(b)(5)) is 
amended— 
(A) in subparagraph (C), by striking at the 
end ‘‘and’’; 
(B) in subparagraph (D), by striking the 
period at the end and inserting a semicolon; 
and 
(C) by adding at the end the following new 
subparagraphs: 
‘‘(E) educate individuals on the oppor-
tunity to receive staff-assisted home dialysis (as 
defined in paragraph (14)(J)(iv)(IV)) during 
the periods described in paragraph (14)(J)(ii); 
and 
‘‘(F) provide for registered or licensed 
nurses, certified patient care technicians, or 
other qualified providers (as determined by a 
physician) to train individuals and their care 
partners in skills and procedures needed to fur-
nish staff-assisted home dialysis, including— 
‘‘(i) in a group-training environment 
with other individuals and their care part-
ners when appropriate and in accordance 
with Federal regulations (concerning the 
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privacy of individually identifiable health 
information) promulgated under section 
264(c) of the Health Insurance Portability 
and Accountability Act of 1996; 
‘‘(ii) via telehealth (following an initial 
period of in-person competency training, in 
accordance with standards specified by the 
Secretary); 
‘‘(iii) through interdisciplinary team 
training (as described in the interpretive 
guidance relating to tag number V590 of 
‘Advance Copy—End Stage Renal Disease 
(ESRD) Program Interpretive Guidance 
Version 1.1’ (published on October 3, 
2008)); and 
‘‘(iv) in the home or residence of an 
individual, in a dialysis facility, in a stand- 
alone training facility, or the place in 
which the individual has been approved to 
perform home dialysis by the care team.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date that 
is 1 year after the date of the enactment of this Act. 
(c) OTHER PROVISIONS.— 
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(1) 
ANTI-KICKBACK
STATUTE.—Section 
1128B(b)(3) of the Social Security Act (42 U.S.C. 
1320a–7b(b)(3)) is amended— 
(A) by moving subparagraphs (J) and (K) 
2 ems to the left; 
(B) in subparagraph (K), by striking 
‘‘and’’ at the end; 
(C) in subparagraph (L), by striking the 
period at the end and inserting ‘‘; and’’; and 
(D) by adding at the end the following new 
subparagraph: 
‘‘(M) any remuneration relating to the fur-
nishing of staff-assisted home dialysis (as defined in 
section 1881(b)(14)(J)(iv)(IV)).’’. 
(2) STUDY.—Not later than 2 years after the 
date of the enactment of this Act, the Secretary of 
Health and Human Services (in this section referred 
to as the ‘‘Secretary’’) shall submit, to the Com-
mittee on Finance of the Senate and the Committees 
on Energy and Commerce and Ways and Means of 
the House of Representatives, a report that— 
(A) examines racial disparities in the utili-
zation of home dialysis (as defined in section 
1881(b)(14)(J)(iv)(IV) of the Social Security 
Act (42 U.S.C. 1395rr(b)(14)(J)(iv)(IV)), as 
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added by subsection (a)), and makes rec-
ommendations on how to improve access to 
home dialysis for communities of color; 
(B) examines coverage for, and utilization 
of, home dialysis in rural communities, and 
makes recommendations on how to improve ac-
cess to home dialysis for such rural commu-
nities; and 
(C) analyzes clinical and quality of life out-
comes for patients, disaggregated by geographic 
and demographic indicators, who receive dif-
ferent dialysis modalities, including staff-as-
sisted home dialysis, unassisted home dialysis, 
and dialysis furnished in a facility. 
(3) PATIENT DECISION TOOL.—Not later than 
December 31, 2025, for the purposes of section 
1881(b)(14)(J) of the Social Security Act (42 
U.S.C. 1395rr(b)(14)(J)), as added by subsection 
(a), the Secretary shall convene a patient panel to 
develop a patient-centered decision tool to assist di-
alysis patients in evaluating their lifestyle and goals 
and in choosing the dialysis setting and modality. 
Such tool shall include an acknowledgment that the 
patient is capable of home dialysis and wants home 
dialysis, if that is the modality such patient chooses. 
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(4) PATIENT QUALITY OF LIFE METRIC.—Sec-
tion 1881(h)(2)(A)(iv) of the Social Security Act (42 
U.S.C. 1395rr(h)(2)(A)(iv)) is amended— 
(A) in subclause (II), by striking ‘‘and’’ at 
the end; 
(B) in subclause (III), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(C) by adding at the end the following new 
subclause: 
‘‘(IV) patient quality of life for 
all individuals utilizing dialysis re-
gardless of modality, with the intent 
of measuring and improving patient 
quality of life on dialysis.’’. 
SEC. 7901A–3. INCREASING KIDNEY TRANSPLANTS IN MI-
NORITY POPULATIONS. 
(a) IN GENERAL.—The Director of the National In-
stitutes of Health shall expand, intensify, and support on-
going research and other activities with respect to kidney 
transplants in minority populations. 
(b) CMS DATA COLLECTION AND REPORTING.—The 
Centers for Medicare & Medicaid Services shall collect and 
report annual data on dialysis facility and nephrologist 
performance on transplant referral, with an emphasis on 
data relating to patients of color. 
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(c) OPTN DATA COLLECTION AND REPORTING.— 
The Organ Procurement and Transplantation Network 
shall collect and the Scientific Registry of Transplant Re-
cipients shall report annual data, broken down by demo-
graphic and socioeconomic characteristics, on individual 
transplant center performance as it relates to patients re-
ferred, evaluated, waitlisted, and successfully trans-
planted. 
(d) TRANSPLANT CENTER DATA.—Each organ trans-
plant center shall report on the percent of appropriate 
waitlisted patients (including socioeconomic and demo-
graphic data) giving and receiving annual informed con-
sent for offers for suboptimal kidneys (such as kidneys 
with a kidney donor profile index of greater than 85 per-
cent or kidney age 50 with diabetes, or age greater than 
60). 
(e) ORGAN PROCUREMENT ORGANIZATION DATA.— 
Each organ procurement organization shall report annual 
data on referrals, refusals (patient or doctor), and accept-
ance of organs by hospital, ZIP Code, race, ethnicity, and 
age strata except as prohibited by need for confidentiality. 
(f) DATA TRANSPARENCY
FOR PATIENTS.—Each 
organ transplant center shall provide to each patient of 
such center, on an annual basis— 
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(1) the number of times an organ was offered 
to the patient, declined, and transplanted into an-
other patient from organs within a 500-mile radius; 
and 
(2) the number of times an organ was offered 
to and declined for the patient from a low-risk donor 
which was subsequently transplanted into another 
patient. 
(g) IMPROVED TRANSPLANTATION EDUCATION.— 
The Centers for Medicare & Medicaid Services shall certify 
a nonbiased, third-party organization to accredit organ 
transplant education. 
(h) RESEARCH.—Research under subsection (a) shall 
include investigation into— 
(1) the causes of lower rates of kidney trans-
plants in minority populations, including socio-
economic, geographic, clinical, environmental, ge-
netic, and other factors that may contribute to lower 
rates of kidney transplants in minority populations; 
and 
(2) possible interventions to increase kidney 
transplants. 
(i) REPORT; COMPREHENSIVE PLAN.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall— 
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(A) prepare and submit to the Congress, 
not later than 6 months after the date of enact-
ment of this section, a report on Federal re-
search and public health activities with respect 
to kidney transplants as a treatment for end- 
stage renal disease in minority populations; and 
(B) develop and submit to the Congress, 
not later than 1 year after the date of enact-
ment of this section, an effective and com-
prehensive Federal plan (including all appro-
priate Federal health programs) to increase the 
number of kidney transplants in minority popu-
lations. 
(2) CONTENTS.—The report under paragraph 
(1)(A) shall at a minimum address each of the fol-
lowing: 
(A) Research on kidney transplants in mi-
nority populations, including such research on 
financial, insurance coverage, genetic, behav-
ioral, and environmental factors. 
(B) Surveillance and data collection on 
kidney transplants in minority populations, in-
cluding with respect to— 
(i) efforts to increase kidney trans-
plants among Asian-American and Pacific 
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Islander subgroups with end-stage renal 
disease; and 
(ii) efforts to increase kidney trans-
plants in the American Indian population. 
(C) Community-based efforts to increase 
kidney transplants targeting minority popu-
lations, including— 
(i) the evidence base for such in-
creases; 
(ii) the cultural appropriateness of 
such increases; and 
(iii) efforts to educate the public on 
kidney transplants. 
(D) Education and training programs for 
health 
professionals 
(including 
community 
health workers) on the kidney transplants that 
are supported by the Health Resources and 
Services Administration, including such pro-
grams supported by the Bureau of Health 
Workforce, the Bureau of Primary Health Care, 
and the Health Systems Bureau. 
SEC. 
7901A–4. 
ENVIRONMENTAL 
AND 
OCCUPATIONAL 
HEALTH PROGRAMS. 
The Director of the Centers for Disease Control and 
Prevention shall— 
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(1) support research into the environmental and 
occupational causes and biological mechanisms that 
contribute to kidney disease; and 
(2) develop and disseminate public health inter-
ventions that will lessen the impact of environmental 
and occupational causes of kidney disease. 
SEC. 7901A–5. UNDERSTANDING THE TREATMENT PAT-
TERNS ASSOCIATED WITH PROVIDING CARE 
AND TREATMENT OF KIDNEY FAILURE IN MI-
NORITY POPULATIONS. 
(a) STUDY.—The Secretary of Health and Human 
Services (in this section referred to as the ‘‘Secretary’’) 
shall conduct a study on 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.), under the Medicaid program under title XIX of 
such Act (42 U.S.C. 1396 et seq.), and through private 
health insurance, to minority populations that are dis-
proportionately affected by kidney failure. 
(b) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary shall submit 
to Congress a report on the study conducted under sub-
section (a), together with such recommendations as the 
Secretary determines to be appropriate. 
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SEC. 7901A–6. ENCOURAGING KIDNEY CARE WORKFORCE IN 
UNDERSERVED AREAS. 
(a) DEFINITION OF PRIMARY HEALTH SERVICES.— 
Section 331(a)(3)(D) of the Public Health Service Act (42 
U.S.C. 254d(a)(3)(D)) is amended by inserting ‘‘nephrol-
ogy,’’ after ‘‘dentistry,’’. 
(b) NATIONAL HEALTH SERVICE CORPS SCHOLAR-
SHIP PROGRAM.—Section 338A(a)(2) of the Public Health 
Service Act (42 U.S.C. 254l(a)(2)) is amended by insert-
ing ‘‘, which may include kidney health professionals’’ be-
fore the period at the end. 
(c) NATIONAL HEALTH SERVICE CORPS LOAN RE-
PAYMENT PROGRAM.—Section 338B(a)(2) of the Public 
Health Service Act (42 U.S.C. 254l–1(a)(2)) is amended 
by inserting ‘‘, which may include kidney health profes-
sionals’’ before the period at the end. 
SEC. 7901A–7. THE JACK REYNOLDS MEMORIAL MEDIGAP 
EXPANSION ACT; MEDIGAP COVERAGE FOR 
BENEFICIARIES WITH END-STAGE RENAL DIS-
EASE. 
(a) GUARANTEED AVAILABILITY OF MEDIGAP POLI-
CIES TO ALL ESRD MEDICARE BENEFICIARIES.— 
(1) IN GENERAL.—Section 1882(s) of the So-
cial Security Act (42 U.S.C. 1395ss(s)) is amend-
ed— 
(A) in paragraph (2)— 
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(i) in subparagraph (A), by striking 
‘‘is 65’’ and all that follows through the 
period at the end and inserting the fol-
lowing: ‘‘is— 
‘‘(i) 65 years of age or older and is en-
rolled for benefits under part B; or 
‘‘(ii) is entitled to benefits under 226A(b) 
and is enrolled for benefits under part B.’’; and 
(ii) in subparagraph (D), in the mat-
ter preceding clause (i), by inserting ‘‘(or 
is entitled to benefits under 226A(b))’’ 
after ‘‘is 65 years of age or older’’; and 
(B) in paragraph (3)(B)— 
(i) in clause (ii), by inserting ‘‘(or is 
entitled to benefits under 226A(b))’’ after 
‘‘is 65 years of age or older’’; and 
(ii) in clause (vi), by inserting ‘‘(or 
under 226A(b))’’ after ‘‘at age 65’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall apply to Medicare supple-
mental policies effective on or after January 1, 
2025. 
(b) ADDITIONAL ENROLLMENT PERIOD FOR CER-
TAIN INDIVIDUALS.— 
(1) ONE-TIME ENROLLMENT PERIOD.— 
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(A) IN GENERAL.—In the case of an indi-
vidual described in paragraph (2), the Secretary 
of Health and Human Services shall establish a 
one-time enrollment period during which such 
an individual may enroll in any Medicare sup-
plemental policy under section 1882 of the So-
cial Security Act (42 U.S.C. 1395ss) of the in-
dividual’s choosing. 
(B) ENROLLMENT
PERIOD.—The enroll-
ment period established under subparagraph 
(A) shall begin on January 1, 2025, and shall 
end June 30, 2025. 
(2) INDIVIDUAL DESCRIBED.—An individual de-
scribed in this paragraph is an individual who— 
(A) is entitled to hospital insurance bene-
fits under part A of title XVIII of the Social 
Security Act (42 U.S.C. 1395c et seq.) or under 
section 226A(b) of such Act (42 U.S.C. 426– 
1(b)); 
(B) is enrolled for benefits under part B of 
such title XVIII (42 U.S.C. 1395j et seq.); and 
(C) would not, but for the provisions of, 
and amendments made by, subsection (a) be eli-
gible for the guaranteed issue of a Medicare 
supplemental policy under paragraph (2) or (3) 
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of section 1882(s) of such Act (42 U.S.C. 
1395ss(s)). 
Subtitle L—Diversity in Clinical 
Trials 
SEC. 7901B. FDA REVIEW OF CLINICAL TRIAL BEST PRAC-
TICES. 
The Commissioner of Food and Drugs shall— 
(1) aggregate information on the accumulated 
experience of sponsors of drugs that develop and 
execute clinical trial diversity plans during drug de-
velopment; 
(2) include in such aggregated information an 
analysis from the perspectives of the Food and Drug 
Administration and such sponsors of which actions 
worked or which did not work to enhance clinical 
trial diversity; 
(3) not later than September 30, 2025, convene 
a public meeting, including representatives from the 
regulated industry and patient organizations, to dis-
cuss findings and recommendations for specific ac-
tions that have led to measurable improvements in 
the representation of racial and ethnic populations 
in clinical research; and 
(4) not later than September 30, 2026, update 
the guidance of the Food and Drug Administration 
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titled ‘‘Enhancing the Diversity of Clinical Trial 
Populations—Eligibility Criteria, Enrollment Prac-
tices, and Trial Designs’’ to align such guidance 
with findings and recommendations that were dis-
cussed at the meeting under paragraph (3). 
SEC. 7901B–1. DIVERSIFYING INVESTIGATIONS VIA EQUI-
TABLE RESEARCH STUDIES FOR EVERYONE 
TRIALS ACT. 
(a) ENCOURAGEMENT OF CLINICAL TRIAL ENROLL-
MENT BY RACIALLY AND ETHNICALLY DIVERSE POPU-
LATIONS.— 
(1) NO COST PROVISION OF DIGITAL HEALTH 
TECHNOLOGIES.—The free provision of digital 
health technologies by drug or device manufacturers 
to their clinical trial participants shall not be consid-
ered a violation of section 1128A of the Social Secu-
rity Act (commonly known as the ‘‘Civil Monetary 
Penalties Law’’) (42 U.S.C. 1320a–7a), section 
1128B of the Social Security Act (42 U.S.C. 1320a– 
7b), or sections 3729 through 3733 of title 31, 
United States Code (commonly known as the ‘‘False 
Claims Act’’), provided that— 
(A) the use of digital health technologies 
will facilitate in any phase of clinical develop-
ment the inclusion of diversity of patient popu-
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lations, such as underrepresented racial and 
ethnic minorities, low-income populations, and 
the elderly; 
(B) the digital health technologies will fa-
cilitate individuals’ participation, or are nec-
essary to such participation; 
(C) all features of the digital health tech-
nologies that are unrelated to use in the clinical 
trial are disabled or only allowed to remain acti-
vated to model real-world usage of the digital 
technology; and 
(D) the clinical trial sponsor requires par-
ticipants to return, purchase, or disable the dig-
ital health technologies by the conclusion of the 
trial. 
(2) GRANTS AND CONTRACTS.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services (in this section re-
ferred to as the ‘‘Secretary’’) may issue grants 
to, and enter into contracts with, entities to 
support community education, outreach, and re-
cruitment activities for clinical trials with re-
spect to drugs, including vaccines for diseases 
or conditions which have a disproportionate im-
pact on underrepresented populations (including 
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on racial and ethnic minority populations), in-
cluding for the diagnosis, prevention, or treat-
ment of COVID–19. Such activities may in-
clude— 
(i) working with community clinical 
trial sites, including community health cen-
ters, academic health centers, and other fa-
cilities; 
(ii) training health care personnel in-
cluding potential clinical trial investigators, 
with a focus on significantly increasing the 
number of underrepresented racial and 
ethnic minority health care personnel who 
are clinical trial investigators at the com-
munity sites for ongoing clinical trials; 
(iii) engaging community stakeholders 
to encourage participation in clinical trials, 
especially in underrepresented racial and 
ethnic minority communities; and 
(iv) fostering partnerships with com-
munity-based organizations serving under-
represented racial and ethnic minority pop-
ulations, including labor organizations and 
frontline health care workers. 
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(B) PRIORITY FOR GRANT AND CONTRACT 
AWARDS.—In awarding grants and contracts 
under this paragraph, the Secretary shall 
prioritize entities that— 
(i) develop educational, recruitment, 
and training materials in multiple lan-
guages; or 
(ii) undertake clinical trial outreach 
efforts in more diverse racial and ethnic 
communities that are traditionally under-
represented in clinical trials, such as Trib-
al areas. 
(C) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—There is authorized to be appropriated 
for fiscal years 2025 and 2026 such sums as 
may be necessary to carry out this paragraph. 
(b) CLARIFICATION THAT CERTAIN REMUNERATION 
RELATED TO PARTICIPATION IN CLINICAL TRIALS DOES 
NOT CONSTITUTE REMUNERATION UNDER
THE FED-
ERAL CIVIL MONEY PENALTIES LAW.— 
(1) IN
GENERAL.—Section 1128A(i)(6)(F) of 
the Social Security Act (42 U.S.C. 1320a– 
7a(i)(6)(F)) is amended by inserting ‘‘(including re-
muneration offered or transferred to an individual to 
promote the participation in an approved clinical 
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trial, as defined in subsection (d) of the first section 
2709 of the Public Health Service Act (42 U.S.C. 
300gg–8) (relating to coverage for individuals par-
ticipating in approved clinical trials), as so des-
ignated by section 1563(c)(10)(C) of the Patient 
Protection and Affordable Care Act, that is reg-
istered with the database of clinical trials main-
tained by the National Library of Medicine (or any 
successor database), so long as such remuneration 
facilitates equitable inclusion of patients from all rel-
evant demographic and socioeconomic populations 
and is related to patient participation in the ap-
proved clinical trial)’’ after ‘‘promotes access to 
care’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply to remuneration pro-
vided on or after the date of the enactment of this 
Act. 
(c) NATIONAL ACADEMY OF MEDICINE STUDY.— 
(1) IN GENERAL.—The Secretary shall seek to 
enter into an arrangement with the National Acad-
emy of Medicine under which the National Academy 
agrees to study and propose a design for a national 
interoperable data platform to improve access to 
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health data, and other relevant data needs, during 
public health emergencies. 
(2) REPORT.—The arrangement under para-
graph (1) shall provide that the National Academy 
of Medicine, not later than 180 days after the date 
of enactment of this Act, shall submit a report to 
the Secretary and Congress on the results of the 
study under paragraph (1) and the design proposed 
based on such study. 
SEC. 7901B–2. CLINICAL TRIAL DIVERSITY. 
(a) DIVERSITY REQUIREMENTS FOR APPLICATIONS 
FOR FEDERAL FUNDING FOR CLINICAL TRIALS.— 
(1) APPLICATIONS.—Beginning on the date of 
the enactment of this Act, the Secretary of Health 
and Human Services, acting through the Director of 
the National Institutes of Health (in this subsection 
referred to as the ‘‘Secretary’’), shall require that an 
entity seeking to conduct a clinical trial investigating 
a drug or device (as those terms are defined in sec-
tion 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321)) or biological product (as de-
fined in section 351(i) of the Public Health Service 
Act (42 U.S.C. 262(i))) that is funded by the Na-
tional Institutes of Health and conducted at any na-
tional research institute or national center, submit 
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an application (or renewal thereof) for such funding 
that includes— 
(A) clear and measurable goals for the re-
cruitment and retention of participants that re-
flect— 
(i) the race, ethnicity, age, and gender 
or sex of patients with the disease or con-
dition being investigated; or 
(ii) the race, ethnicity, age, and gen-
der or sex of the general population of the 
United States if the prevalence of the dis-
ease or condition is not known; 
(B) a rationale for the goals specified 
under subparagraph (A) that specifies— 
(i) how investigators will calculate the 
number of participants for each population 
category that reflect the population groups 
specified in subparagraph (A); and 
(ii) strategies that will be used to en-
roll and retain participants across the dif-
ferent racial, ethnic, age, and gender or 
sex categories; 
(C) a detailed plan for how the clinical 
trial will achieve the goals specified under sub-
paragraph (A) that specifies— 
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(i) the requirements for researchers, 
in conducting the trial to analyze the popu-
lation groups specified in subparagraph 
(A) separately; 
(ii) the role of community partners or 
community institutional review boards in 
reviewing the plans; and 
(iii) how the trial will recruit a study 
population that is— 
(I) in proportion to the preva-
lence of the disease or condition in 
such groups relative to the prevalence 
of the disease or condition in the over-
all population of the United States; 
(II) in sufficient numbers to ob-
tain clinically and statistically mean-
ingful determinations of the safety 
and effectiveness of the drug being 
studied in the respective race, eth-
nicity, age, and gender or sex groups; 
and 
(III) consistent with the guidance 
under section 505(b)(1) of the Fed-
eral Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(b)(1)) and guidance 
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issued by the National Institutes of 
Health on the inclusion of women and 
minorities in clinical trials; 
(D) the entity’s plan for implementing, or 
an explanation of why the entity cannot imple-
ment, alternative clinical trial follow-up require-
ments that are less burdensome for trial partici-
pants, such as— 
(i) requiring fewer follow-up visits; 
(ii) allowing phone follow-up or home 
visits by nurse trial coordinators (in lieu of 
in-person visits by patients); 
(iii) allowing for online follow-up op-
tions; 
(iv) permitting the patient’s primary 
care provider to perform some of the fol-
low-up visit requirements and to reimburse 
the patient for any out-of-pocket costs in-
curred by the patient for such follow-up 
visits; 
(v) allowing for weekend hours for re-
quired follow-up visits; 
(vi) allowing virtual or telemedicine 
visits; 
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(vii) use of wearable technology to 
record key health parameters; and 
(viii) use of alternate labs or imaging 
centers, which may be closer to the resi-
dence of the patients participating in the 
trial; and 
(E) the entity’s education and training re-
quirements for researchers and other individ-
uals conducting or supporting the clinical trial 
with respect to diversity and health inequities in 
underrepresented populations, including a re-
quirement to consult with, and review materials 
made available by, such committees, task forces, 
and working groups other entities the Secretary 
determines are appropriate, including the fol-
lowing: 
(i) The Equity Committee of the Na-
tional Institutes of Health. 
(ii) The National Advisory Council on 
Minority Health and Health Disparities. 
(iii) The Advisory Committee on Re-
search on Women’s Health. 
(iv) The Sexual & Gender Minority 
Research Coordinating Committee of the 
National Institutes of Health. 
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(v) The Tribal Health Research Co-
ordinating Committee of the National In-
stitutes of Health. 
(2) TERMS.— 
(A) IN GENERAL.—As a condition on the 
receipt of funding through the National Insti-
tutes of Health, as described in paragraph (1), 
with respect to a clinical trial, the sponsor of 
the clinical trial shall agree to terms requiring 
that— 
(i) the aggregate demographic infor-
mation of trial participants be shared on 
an annual basis with the Secretary while 
participant recruitment and data collection 
in such trial is ongoing, and that such in-
formation is provided with respect to— 
(I) underrepresented populations, 
including populations grouped by race, 
ethnicity, age, sex, gender identity 
and expression, geographic region, 
primary written and spoken language, 
disability status, sexual orientation, 
socioeconomic status, occupation, and 
other relevant factors; and 
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(II) such populations that reflect 
the prevalence of the disease or condi-
tion that is the subject of the clinical 
trial involved (as available and as ap-
propriate to the scientific objective for 
the study, as determined by the Direc-
tor of the National Institutes of 
Health); 
(ii) the sponsor submits to the pro-
gram officer and grants management spe-
cialist of the specific National Institutes of 
Health national research institute or na-
tional center, as frequently as such officer 
or specialist determines necessary, the re-
tention rate of participants in the clinical 
trial, disaggregated by race, ethnicity, gen-
der or sex, and age; 
(iii) both the clinical trial researchers 
and the applicant reviewers complete edu-
cation and training programs on diversity 
in clinical trials; and 
(iv) at the conclusion of the trial, the 
sponsor submits to the Secretary the num-
ber 
of 
participants 
in 
the 
trial, 
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disaggregated by race, ethnicity, age, and 
gender or sex. 
(B) PRIVACY
PROTECTIONS.—Any data 
shared under subparagraph (A) may not in-
clude any individually identifiable information 
or protected health information with respect to 
clinical trial participants and shall only be dis-
closed to the extent allowed under Federal pri-
vacy laws. 
(3) EXCEPTION.—In lieu of submitting an ap-
plication under paragraph (1) and documentation of 
goals as required by subparagraph (A) of such para-
graph, an applicant may provide reasoning (other 
than cost) for why the recruitment of each of the 
population groups specified in subparagraph (A) of 
paragraph (1) is not necessary and why such re-
cruitment is not scientifically justified or possible. 
(4) PUBLICATION.—The Secretary shall— 
(A) publish on a public website of the Na-
tional Institutes of Health, upon receipt of an 
application to which paragraph (1) applies or 
reasoning under paragraph (3)— 
(i) a summary of the disease being 
targeted in the clinical trial that is the 
subject of the application and the preva-
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lence of such disease across race, ethnicity, 
gender or sex, age, and clinical trial rep-
resentation in each such category; 
(ii) the goals specified in such applica-
tion, as required by paragraph (1)(A); or 
(iii) the reasoning described in para-
graph (3); and 
(B) ensure that, in publishing information 
relating to an application or reasoning under 
subparagraph (A), the design of the study in-
volved is not disclosed. 
(5) REMEDIATION.— 
(A) IN GENERAL.—In the case of a clinical 
trial subject to paragraph (1) that fails to meet 
the condition specified pursuant to paragraph 
(1) by such date as may be agreed upon by the 
sponsor of the trial and the program officer and 
grants management specialist of the specific 
National Institutes of Health national research 
institute or national center, the Secretary shall 
require the sponsor of that clinical trial, not 
later than 60 days after such date occurs— 
(i) to develop, in consultation with the 
Secretary and advocacy and community- 
based organizations representing individ-
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uals who are members of relevant demo-
graphic groups specified in paragraph 
(1)(A), a strategic plan to increase partici-
pation in such clinical trial of such individ-
uals; and 
(ii) to submit to the Secretary, such 
strategic plan. 
(B) PUBLICATION.—The Secretary shall 
make publicly available on the website of the 
National Institutes of Health, the strategic plan 
received under subparagraph (A) as soon as 
possible after receipt. The Secretary shall en-
sure that, in publishing such plan under the 
preceding sentence, the design of the study in-
volved is not disclosed. 
(C) IMPLEMENTATION.—The sponsor of 
the clinical trial that is the subject of the stra-
tegic plan published under subparagraph (B), 
shall, not later than 60 days after such date as 
may be agreed upon by the sponsor of the trial 
and the appropriate program officer and grants 
management specialist of the National Insti-
tutes of Health, implement the strategic plan. 
(D) TECHNICAL
ASSISTANCE.—The Sec-
retary may provide technical assistance to a 
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sponsor of a clinical trial, as necessary for the 
sponsor to meet the requirements of subpara-
graph (C). 
(6) PENALTIES IN CASE OF FAILURE OF REME-
DIATION.— 
(A) IN GENERAL.—In the case of a clinical 
trial subject to paragraph (1) that, after the 
close of the 60-day period specified in para-
graph (5)(C), continues to fail to meet the con-
dition specified pursuant to paragraph (1)(A), 
the Secretary shall— 
(i) hold the noncompeting continu-
ation of funding received through the grant 
involved; 
(ii) apply specific conditions on the 
award of funds to such sponsor to conduct 
such clinical trial; or 
(iii) terminate such funding. 
(B) WAIVER.— 
(i) IN
GENERAL.—In the case of a 
clinical trial subject to the penalty under 
subparagraph (A) that fails to meet the 
condition referred to in such subpara-
graph, the sponsor of such clinical trial 
may, prior to the conclusion of the 60-day 
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period referred to in subparagraph (A), 
submit an application to the relevant pro-
gram officer and grants specialist request-
ing a waiver of such condition. Such an ap-
plication shall specify reasoning for why 
the recruitment of each of the population 
groups specified in subparagraph (A) of 
paragraph (1) is not necessary or why such 
recruitment is not scientifically justified or 
possible. 
(ii) REVIEW.—Not later than 30 days 
after a date agreed upon by the sponsor of 
the trial and the appropriate program offi-
cer and grants management specialist of 
the National Institutes of Health, the Sec-
retary shall— 
(I) complete the review of such 
application; and 
(II) make a determination to ap-
prove or deny the application. 
(iii) NO ADDITIONAL PENALTIES.—No 
additional penalties may be applied with 
respect to a sponsor of a clinical trial 
under subparagraph (A) during the 30-day 
period specified in clause (ii). 
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(C) TERMINATION OF FUNDING.—In the 
case of a clinical trial described in subpara-
graph (B)(i), the Secretary may elect to termi-
nate funding described in paragraph (1) for the 
clinical trial if no request for a waiver under 
subparagraph (B) is received by the conclusion 
60-day period referred to in subparagraph (A). 
(7) WAIVER FOR CERTAIN CLINICAL TRIALS.— 
(A) IN GENERAL.—In the case of a clinical 
trial that received funding through the National 
Institutes of Health and is ongoing as of the 
date of the enactment of this Act, the sponsor 
of such clinical trial is exempt from the require-
ments of (and associated penalties imposed by) 
this section. 
(B) REPORT.—The Secretary shall include 
in the triennial report required to be submitted 
under section 403 of the Public Health Service 
Act (42 U.S.C. 283), a list of all clinical trials 
receiving funding through the National Insti-
tutes of Health— 
(i) that requested and received waiv-
ers under this subsection; or 
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(ii) with respect to which funding has 
been terminated pursuant to this sub-
section. 
(8) NONDISCRIMINATION.—Section 1557 of the 
Patient Protection and Affordable Care Act (42 
U.S.C. 18116) shall apply with respect to a clinical 
trial subject to paragraph (1). 
(b) ELIMINATING COST BARRIERS.— 
(1) STUDY
ON
MODERNIZATION
OF
HUMAN 
SUBJECT
REGULATIONS.—Not later than 2 years 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services, acting 
through the Director of the National Institutes of 
Health (referred to in this subsection as the ‘‘Sec-
retary’’), shall conduct and complete a study on— 
(A) the need for review of human subject 
regulations specified in part 46 of title 45, Code 
of Federal Regulations (or successor regula-
tions), and related guidance; 
(B) the modernization of such regulations 
and guidance to establish updated guidelines for 
reimbursement of out-of-pocket expenses of 
human subjects, compensation of human sub-
jects for time spent participating in the clinical 
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trial, and incentives for recruitment of human 
subjects; and 
(C) the need for updated safe harbor rules 
under section 1001.952 of title 42, Code of 
Federal Regulations (or successor regulations) 
and section 1128B of the Social Security Act 
(commonly referred to as the Federal Anti- 
Kickback Statute (42 U.S.C. 1320a–7b)) with 
respect to the assistance provided under this 
subsection. 
(2) REIMBURSEMENT FOR COSTS ASSOCIATED 
WITH CLINICAL TRIAL PARTICIPATION.—As a condi-
tion on receipt of any funding provided through the 
National Institutes of Health to conduct a clinical 
trial investigating a drug or device (as those terms 
are defined in section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321)) or biologi-
cal product (as defined in section 351(i) of the Pub-
lic Health Service Act (42 U.S.C. 262(i))), the Sec-
retary shall require that the sponsor of such clinical 
trial— 
(A) works with institutional review boards 
and program officers of the National Institutes 
of Health to determine when reimbursement for 
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the costs associated with clinical trial participa-
tion is warranted; and 
(B) subject to paragraph (3), provides to 
clinical trial participants reimbursement for ex-
penses (using funds other than funds supplied 
through the National Institutes of Health) in-
curred as a result of that participation, which 
may include— 
(i) missed or forgone salary; 
(ii) language assistance, including in-
terpreter services; 
(iii) food expenses; 
(iv) childcare expenses; 
(v) lodging expenses; 
(vi) transportation expenses; or 
(vii) other expenses as identified by 
the participant, subject to review by the 
clinical trial sponsor, at its discretion, on a 
case-by-case basis. 
(3) PROVISION
OF
COSTS
ASSOCIATED
WITH 
CLINICAL TRIAL PARTICIPATION.— 
(A) 
APPLICATION
AND
DOCUMENTA-
TION.— 
(i) IN GENERAL.—A sponsor of a clin-
ical trial to which subsection (a)(1) applies, 
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may require that, in order to receive reim-
bursement as described in paragraph (2), a 
participant complete an application and 
share with the sponsor such documentation 
of expenses described in such paragraph, 
as the sponsor may require. 
(ii) TIMING.—Not later than 30 days 
after the date on which a sponsor of a clin-
ical trial receives an application under 
clause (i), the sponsor shall— 
(I) review the application; and 
(II) provide for reimbursement of 
eligible expenses documented in such 
application, as determined at the dis-
cretion of the clinical trial sponsor on 
a case-by-case basis. 
(B) ENFORCEMENT.—A sponsor of a clin-
ical trial to which subsection (a)(1) applies, 
shall submit on an annual basis, as part of the 
progress reports submitted to the Secretary 
pursuant to section 402(j) of the Public Health 
Service Act (42 U.S.C. 282(j)), during the data 
collection period of the clinical trial, to the Sec-
retary an accounting of the reimbursements 
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made to clinical trial participants under sub-
paragraph (A). Such data shall— 
(i) include relevant aggregate data 
with respect to each population group spec-
ified in subsection (a)(2)(A)(i) when such 
data will not compromise the identities of 
study participants and in a manner con-
sistent with applicable privacy protections; 
and 
(ii) not later than 6 months after re-
ceipt by the Secretary, be published on a 
public website of the National Institutes of 
Health. 
(c) PUBLIC AWARENESS
AND EDUCATION CAM-
PAIGN.— 
(1) NATIONAL
CAMPAIGN.—The Secretary of 
Health and Human Services, acting through the Di-
rector of the National Institutes of Health and the 
Commissioner of Food and Drugs (referred to in 
this subsection as the ‘‘Secretary’’), in consultation 
with the stakeholders specified in paragraph (5), 
shall carry out a national campaign to increase the 
awareness and knowledge of individuals in the 
United States with respect to the need for diverse 
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clinical trials among the demographic groups identi-
fied pursuant to subsection (a)(1)(A). 
(2) REQUIREMENTS.—The national campaign 
conducted shall include— 
(A) the development and distribution of 
written educational materials, and the develop-
ment and placing of public service announce-
ments, that are intended to encourage individ-
uals who are members of the demographic 
groups 
identified 
pursuant 
to 
subsection 
(a)(2)(A)(i)(I) to seek to participate in clinical 
trials; 
(B) such efforts as are reasonable and nec-
essary to ensure meaningful access by con-
sumers with limited English proficiency; 
(C) the development and distribution of 
best practices and training for recruiting under-
represented study populations, including a 
method for sharing such best practices among 
clinical trial sponsors, providers, community- 
based organizations who assist with recruit-
ment, and with the public; and 
(D) the conduct of focus groups to better 
understand the concerns and fears of certain 
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1425 
underrepresented groups who may be reluctant 
to participate in clinical trials. 
(3) HEALTH
INEQUITIES.—In developing the 
national campaign under paragraph (1), the Sec-
retary shall recognize and address— 
(A) health inequities among individuals 
who are members of the population groups 
specified in subsection (a)(2)(A)(i) with respect 
to access to care and participation in clinical 
trials; and 
(B) any barriers in access to care and par-
ticipation in clinical trials that are specific to 
individuals who are members of such groups. 
(4) GRANTS.—The Secretary shall establish a 
program to award grants to nonprofit private enti-
ties, including community-based organizations and 
faith communities, institutions of higher education 
eligible to receive funds under section 371 of the 
Higher Education Act of 1965 (20 U.S.C. 1067q) 
and national organizations that serve underrep-
resented populations and community pharmacies to 
enable such entities— 
(A) to test alternative outreach and edu-
cation strategies to increase the awareness and 
knowledge of individuals in the United States, 
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with respect to the need for diverse clinical 
trials that reflect the race, ethnicity, age, and 
gender or sex of patients with the disease or 
condition being investigated; and 
(B) to cover administrative costs of such 
entities in assisting in diversifying clinical trials 
subject to subsection (a). 
(5) STAKEHOLDERS
SPECIFIED.—The stake-
holders specified in this paragraph are the following: 
(A) Representatives of the Health Re-
sources Services Administration, the Office of 
Minority Health of the Department of Health 
and Human Services, the Centers for Disease 
Control and Prevention, and the National Insti-
tutes of Health. 
(B) Community-based resources and advo-
cates. 
(6) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this subsection $10,000,000 for each of fiscal years 
2025 through 2029. 
(d) DEFINITIONS.—In this section: 
(1) CLINICAL TRIAL.—The term ‘‘clinical trial’’ 
means a research study in which one or more human 
subjects are prospectively assigned to one or more 
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interventions (which may include placebo or other 
control) to evaluate the effects of those interventions 
on health-related biomedical or behavioral outcomes. 
(2) SPONSOR.—The term ‘‘sponsor’’ has the 
meaning given such term in section 50.3 of title 21, 
Code of Federal Regulations (or successor regula-
tions). 
SEC. 7901B–3. PATIENT EXPERIENCE DATA. 
(a) POLICY.—Section 569C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) is amend-
ed— 
(1) by redesignating subsections (b) and (c) as 
subsections (c) and (d), respectively; and 
(2) by inserting after subsection (a) the fol-
lowing: 
‘‘(b) COLLECTION, SUBMISSION, 
AND
USE
OF 
DATA.— 
‘‘(1) IN GENERAL.—The Secretary shall— 
‘‘(A) for any drug for which an exemption 
is granted for investigational use under section 
505(i) of this Act or section 351(a) of the Pub-
lic Health Service Act, require the sponsor of 
the drug to collect standardized patient experi-
ence data as part of the clinical trials conducted 
pursuant to such exemption; 
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‘‘(B) require any application for the ap-
proval or licensing of such drug under section 
505(b) of this Act or section 351(a) of the Pub-
lic Health Service Act to include— 
‘‘(i) the standardized patient experi-
ence data so collected; and 
‘‘(ii) such related information as the 
Secretary may require; and 
‘‘(C) consider patient experience data and 
related information that is submitted pursuant 
to subparagraph (B) in deciding whether to ap-
prove or license, as applicable, the drug in-
volved. 
‘‘(2) APPLICABILITY.—Paragraph (1) applies 
only with respect to drugs for which a request for 
an exemption described in paragraph (1)(A) is sub-
mitted on or after the date of the enactment of the 
Health Equity and Accountability Act of 2024, or an 
application under section 505(b) of this Act or sec-
tion 351(a) of the Public Health Service Act is filed, 
as applicable, on or after the day that is 2 years 
after the date of the enactment of the Health Equity 
and Accountability Act of 2024.’’. 
(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of Health 
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and Human Services, acting through the Commissioner of 
Food and Drugs, shall promulgate final regulations to im-
plement section 569C(b) of the Federal Food, Drug, and 
Cosmetic Act, as added by this section. 
Subtitle M—Additional Provisions 
Addressing High-Impact Minor-
ity Diseases 
SEC. 7901C. MEDICARE COVERAGE OF MULTI-CANCER 
EARLY DETECTION SCREENING TESTS. 
(a) COVERAGE.—Section 1861 of the Social Security 
Act (42 U.S.C. 1395x), as amended by sections 2007, 
4221, 4251, 6101, and 7419, is amended— 
(1) in subsection (s)(2)— 
(A) in subparagraph (LL), by striking 
‘‘and’’ at the end; 
(B) by inserting ‘‘and’’ at the end of sub-
paragraph (MM); and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(NN) multi-cancer early detection screen-
ing tests (as defined in subsection (sss));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(sss) MULTI-CANCER EARLY DETECTION SCREEN-
ING
TESTS.—The term ‘multi-cancer early detection 
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screening test’ means any of the following tests, approved 
or cleared by the Food and Drug Administration, fur-
nished to an individual for the purpose of early detection 
of cancer across many cancer types (as categorized in the 
Annual Report to the Nation on the Status of Cancer 
issued by the National Cancer Institute): 
‘‘(1) A genomic sequencing blood or blood prod-
uct test that includes the analysis of cell-free nucleic 
acids. 
‘‘(2) Such other equivalent tests (which are 
based on urine or another sample of biological mate-
rial) as the Secretary determines appropriate.’’. 
(b) PAYMENT AND FREQUENCY LIMIT.— 
(1) PAYMENT UNDER FEE SCHEDULE.—Section 
1833(h) of the Social Security Act (42 U.S.C. 
1395l(h)) is amended— 
(A) in paragraph (1)(A), by inserting after 
‘‘(including’’ the following: ‘‘multi-cancer early 
detection 
screening 
tests 
under 
section 
1861(sss) and including’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(10) No payment may be made under this 
part for a multi-cancer early detection screening test 
(as defined in section 1861(sss)) for an individual if 
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such a test was furnished to the individual during 
the previous 11 months.’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
1862(a) of the Social Security Act (42 U.S.C. 
1395y(a)) is amended— 
(A) in paragraph (1)— 
(i) in subparagraph (O), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (P), by striking 
the semicolon at the end and inserting ‘‘, 
and’’; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(Q) in the case of multi-cancer early detection 
screening tests (as defined in section 1861(sss)), 
which are performed more frequently than is covered 
under section 1833(h)(10);’’; and 
(B) in paragraph (7), by striking ‘‘or (P)’’ 
and inserting ‘‘(P), or (Q)’’. 
(c) RULE OF CONSTRUCTION RELATING TO OTHER 
CANCER SCREENING TESTS.—Nothing in this section, in-
cluding the amendments made by this section, shall be 
construed— 
(1) in the case of an individual who undergoes 
a multi-cancer early detection screening test, to af-
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fect coverage under part B for other cancer screen-
ing tests covered under this section, such as screen-
ing tests for breast, cervical, colorectal, lung, or 
prostate cancer; or 
(2) in the case of an individual who undergoes 
another cancer screening test, to affect coverage for 
a multi-cancer early detection screening test or the 
use of such a test as a diagnostic or confirmatory 
test for a result of the other cancer screening test. 
SEC. 7901C–1. AMPUTATION REDUCTION AND COMPASSION 
ACT. 
(a) PERIPHERAL ARTERY DISEASE EDUCATION PRO-
GRAM.—Part P of title III of the Public Health Service 
Act (42 U.S.C. 280g et seq.), as amended by section 7504, 
is amended by adding at the end the following: 
‘‘SEC. 399V–14. PERIPHERAL ARTERY DISEASE EDUCATION 
PROGRAM. 
‘‘(a) 
ESTABLISHMENT.—The 
Secretary, 
acting 
through the Director of the Centers for Disease Control 
and Prevention, in collaboration with the Administrator 
of the Centers for Medicare & Medicaid Services and the 
Administrator of the Health Resources and Services Ad-
ministration, shall establish and coordinate a peripheral 
artery disease education program to support, develop, and 
implement educational initiatives and outreach strategies 
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that inform health care professionals and the public about 
the existence of peripheral artery disease and methods to 
reduce amputations related to such disease, particularly 
with respect to at-risk populations. 
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
such sums as may be necessary for each of fiscal years 
2025 through 2029.’’. 
(b) MEDICARE COVERAGE OF PERIPHERAL ARTERY 
DISEASE SCREENING TESTS FURNISHED
TO AT-RISK 
BENEFICIARIES WITHOUT IMPOSITION OF COST SHARING 
REQUIREMENTS.— 
(1) IN GENERAL.—Section 1861 of the Social 
Security Act (42 U.S.C. 1395x), as amended by sec-
tions 2007, 4221, 4251, 6101, 7419, and 7901C, is 
amended— 
(A) in subsection (s)(2)— 
(i) in subparagraph (MM), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (NN), by striking 
the period at the end and inserting ‘‘; 
and’’; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
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‘‘(OO) peripheral artery disease screening 
tests furnished to at-risk beneficiaries (as such 
terms are defined in subsection (ttt)).’’; and 
(B) by adding at the end the following new 
subsection: 
‘‘(ttt) PERIPHERAL ARTERY DISEASE SCREENING 
TEST; AT-RISK BENEFICIARY.—(1) The term ‘peripheral 
artery disease screening test’ means— 
‘‘(A) noninvasive physiologic studies of extrem-
ity arteries (commonly referred to as ankle-brachial 
index testing); 
‘‘(B) arterial duplex scans of lower extremity 
arteries vascular; and 
‘‘(C) such other items and services as the Sec-
retary determines, in consultation with relevant 
stakeholders, to be appropriate for screening for pe-
ripheral artery disease for at-risk beneficiaries. 
‘‘(2) The term ‘at-risk beneficiary’ means an indi-
vidual entitled to, or enrolled for, benefits under part A 
and enrolled for benefits under part B— 
‘‘(A) who is 65 years of age or older; 
‘‘(B) who is at least 50 years of age but not 
older than 64 years of age with risk factors for ath-
erosclerosis (such as diabetes mellitus, a history of 
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smoking, hyperlipidemia, and hypertension) or a 
family history of peripheral artery disease; 
‘‘(C) who is younger than 50 years of age with 
diabetes mellitus and 1 additional risk factor for 
atherosclerosis; or 
‘‘(D) with a known atherosclerotic disease in 
another vascular bed such as coronary, carotid, sub-
clavian, renal, or mesenteric artery stenosis, or ab-
dominal aortic aneurysm. 
‘‘(3) The Secretary shall, in consultation with appro-
priate organizations, establish standards regarding the 
frequency for peripheral artery disease screening tests de-
scribed in subsection (s)(2)(OO) for purposes of coverage 
under this title.’’. 
(2) INCLUSION OF PERIPHERAL ARTERY DIS-
EASE
SCREENING
TESTS
IN
INITIAL
PREVENTIVE 
PHYSICAL
EXAMINATION.—Section 1861(ww)(2) of 
the Social Security Act (42 U.S.C. 1395x(ww)(2)) is 
amended— 
(A) in subparagraph (N), by moving the 
margins of such subparagraph 2 ems to the 
left; 
(B) by redesignating subparagraph (O) as 
subparagraph (P); and 
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(C) by inserting after subparagraph (N) 
the following new subparagraph: 
‘‘(O) Peripheral artery disease screening 
tests furnished to at-risk beneficiaries (as such 
terms are defined in subsection (ttt)).’’. 
(3) PAYMENT.— 
(A) IN GENERAL.—Section 1833(a) of the 
Social Security Act (42 U.S.C. 1395l(a)), as 
amended by sections 4251(c)(3), 6101(a)(4), 
and 7419, is amended— 
(i) in paragraph (1)— 
(I) in subparagraph (N), by in-
serting ‘‘and other than peripheral ar-
tery disease screening tests furnished 
to at-risk beneficiaries (as such terms 
are defined in section 1861(ttt))’’ 
after ‘‘other than personalized preven-
tion plan services (as defined in sec-
tion 1861(hhh)(1))’’; 
(II) by striking ‘‘and’’ before 
‘‘(KK)’’; and 
(III) by inserting before the 
semicolon at the end the following: ‘‘, 
and (LL) with respect to peripheral 
artery disease screening tests fur-
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nished to at-risk beneficiaries (as such 
terms 
are 
defined 
in 
section 
1861(ttt)), the amount paid shall be 
100 percent of the lesser of the actual 
charge for the services or the amount 
determined under the payment basis 
determined under section 1848’’; and 
(ii) in paragraph (2)— 
(I) in subparagraph (G), by 
striking ‘‘and’’ at the end; 
(II) in subparagraph (H), by in-
serting ‘‘ and’’ at the end; and 
(III) by inserting after subpara-
graph (H) the following new subpara-
graph: 
‘‘(I) with respect to peripheral artery disease 
screening tests (as defined in paragraph (1) of sec-
tion 1861(ttt)) furnished by an outpatient depart-
ment of a hospital to at-risk beneficiaries (as defined 
in paragraph (2) of such section), the amount deter-
mined under paragraph (1)(EE),’’. 
(B) NO DEDUCTIBLE.—Section 1833(b) of 
the Social Security Act (42 U.S.C. 1395l(b)), as 
amended 
by 
section 
7419(a)(5)(A)(iii), 
is 
amended, in the first sentence— 
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(i) by striking ‘‘and’’ before ‘‘(14)’’; 
and 
(ii) by inserting ‘‘, and (15) such de-
ductible shall not apply with respect to pe-
ripheral artery disease screening tests fur-
nished to at-risk beneficiaries (as such 
terms are defined in section 1861(ttt))’’ 
before the period at the end. 
(C) EXCLUSION FROM PROSPECTIVE PAY-
MENT SYSTEM FOR HOSPITAL OUTPATIENT DE-
PARTMENT
SERVICES.—Section 
1833(t)(1)(B)(iv) of the Social Security Act (42 
U.S.C. 1395l(t)(1)(B)(iv)) is amended— 
(i) by striking ‘‘, or personalized’’ and 
inserting ‘‘, personalized’’; and 
(ii) by inserting ‘‘, or peripheral ar-
tery disease screening tests furnished to 
at-risk beneficiaries (as such terms are de-
fined in section 1861(ttt))’’ after ‘‘person-
alized prevention plan services (as defined 
in section 1861(hhh)(1))’’. 
(D) PAYMENT
UNDER
PHYSICIAN
FEE 
SCHEDULE.—Section 1848(j)(3) of the Social 
Security Act (42 U.S.C. 1395w–4(j)(3)), as 
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amended by section 4251(c)(4), is amended by 
inserting ‘‘, (2)(OO),’’ after ‘‘(2)(KK)’’. 
(4) EXCLUSION
FROM
COVERAGE
AND
MEDI-
CARE AS SECONDARY PAYER FOR TESTS PERFORMED 
MORE
FREQUENTLY
THAN
ALLOWED.—Section 
1862(a)(1) of the Social Security Act (42 U.S.C. 
1395y(a)(1)), as amended by subsection (b)(2), is 
amended— 
(A) in subparagraph (P), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (Q), by striking the 
semicolon at the end and inserting ‘‘, and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(R) in the case of peripheral artery dis-
ease screening tests furnished to at-risk bene-
ficiaries (as such terms are defined in section 
1861(ttt)), which are performed more fre-
quently than is covered under such section;’’. 
(5) AUTHORITY TO MODIFY OR ELIMINATE COV-
ERAGE OF CERTAIN PREVENTIVE SERVICES.—Sec-
tion 1834(n) of the Social Security Act (42 U.S.C. 
1395m(n)) is amended— 
(A) by redesignating subparagraphs (A) 
and (B) of paragraph (1) as clauses (i) and (ii), 
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respectively, and moving the margins of such 
clauses, as so redesignated, 2 ems to the right; 
(B) by redesignating paragraphs (1) and 
(2) as subparagraphs (A) and (B), respectively, 
and moving the margins of such subparagraphs, 
as so redesignated, 2 ems to the right; 
(C) by striking ‘‘CERTAIN PREVENTIVE 
SERVICES’’ and all that follows through ‘‘any 
other provision of this title’’ and inserting: 
‘‘CERTAIN PREVENTIVE SERVICES.— 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of this title’’; and 
(D) by adding at the end the following new 
paragraph: 
‘‘(2) INAPPLICABILITY.—The Secretarial au-
thority described in paragraph (1) shall not apply 
with respect to preventive services described in sec-
tion 1861(ww)(2)(O).’’. 
(6) EFFECTIVE DATE.—The amendments made 
by this subsection shall apply with respect to items 
and services furnished on or after January 1, 2025. 
(c) MEDICAID COVERAGE OF PERIPHERAL ARTERY 
DISEASE SCREENING TESTS FURNISHED
TO AT-RISK 
BENEFICIARIES WITHOUT IMPOSITION OF COST SHARING 
REQUIREMENTS.— 
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