1393 
striking ‘‘In the case’’ and inserting 
‘‘Subject to section 1860D–2(b)(8), in 
the case’’. 
(6) COVERAGE
OF
HIV
PREVENTION
TREAT-
MENT BY DEPARTMENT OF VETERANS AFFAIRS.— 
(A) ELIMINATION OF MEDICATION COPAY-
MENTS.—Section 1722A(a) of title 38, United 
States Code, is amended by adding at the end 
the following new paragraph: 
‘‘(5) Paragraph (1) does not apply to a medica-
tion for the prevention of HIV.’’. 
(B) ELIMINATION OF HOSPITAL CARE AND 
MEDICAL
SERVICES
COPAYMENTS.—Section 
1710 of such title is amended— 
(i) in subsection (f)— 
(I) by redesignating paragraph 
(5) as paragraph (6); and 
(II) by inserting after paragraph 
(4) the following new paragraph (5): 
‘‘(5) A veteran shall not be liable to the United 
States under this subsection for any amounts for 
laboratory and other diagnostic procedures associ-
ated with the use of any prescription drug approved 
by the Food and Drug Administration for the pre-
vention of HIV, administrative fees for such drugs, 
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1394 
or for laboratory or other diagnostic procedures as-
sociated with the use of such drugs, or clinical follow 
up and monitoring, including any related services 
recommended in current United States Public 
Health Service clinical practice guidelines, without 
limitation.’’; and 
(ii) in subsection (g)(3), by adding at 
the end the following new subparagraph: 
‘‘(C) Any prescription drug approved by 
the Food and Drug Administration for the pre-
vention of HIV, administrative fees for such 
drugs, laboratory and other diagnostic proce-
dures associated with the use of such drugs, 
and clinical follow up and monitoring, including 
any related services recommended in current 
United States Public Health Service clinical 
practice guidelines, without limitation.’’. 
(C) INCLUSION
AS
PREVENTIVE
HEALTH 
SERVICE.—Section 1701(9) of such title is 
amended— 
(i) in subparagraph (K), by striking ‘‘; 
and’’ and inserting a semicolon; 
(ii) by redesignating subparagraph 
(L) as subparagraph (M); and 
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1395 
(iii) by inserting after subparagraph 
(K) the following new subparagraph (L): 
‘‘(L) any prescription drug approved by 
the Food and Drug Administration for the pre-
vention of HIV, administrative fees for such 
drugs, laboratory and other diagnostic proce-
dures associated with the use of such drugs, 
and clinical follow up and monitoring, including 
any related services recommended in current 
United States Public Health Service clinical 
practice guidelines, without limitation; and’’. 
(7) COVERAGE
OF
HIV
PREVENTION
TREAT-
MENT BY DEPARTMENT OF DEFENSE.— 
(A) IN GENERAL.—Chapter 55 of title 10, 
United States Code, is amended by inserting 
after section 1079c the following new section: 
‘‘§ 1079d. Coverage of HIV prevention treatment 
‘‘(a) IN GENERAL.—The Secretary of Defense shall 
ensure coverage under the TRICARE program of HIV 
prevention treatment described in subsection (b) for any 
beneficiary under section 1074(a) of this title. 
‘‘(b) HIV PREVENTION TREATMENT DESCRIBED.— 
HIV prevention treatment described in this subsection in-
cludes any prescription drug approved by the Food and 
Drug Administration for the prevention of HIV, adminis-
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1396 
trative fees for such drugs, laboratory and other diagnostic 
procedures associated with the use of such drugs, and clin-
ical follow up and monitoring, including any related serv-
ices recommended in current United States Public Health 
Service clinical practice guidelines, without limitation. 
‘‘(c) NO COST-SHARING.—Notwithstanding section 
1075, 1075a, or 1074g(a)(6) of this title or any other pro-
vision of law, there is no cost-sharing requirement for HIV 
prevention treatment covered under this section.’’. 
(B) CLERICAL AMENDMENT.—The table of 
sections at the beginning of such chapter is 
amended by inserting after the item relating to 
section 1079c the following new item: 
‘‘1079d. Coverage of HIV prevention treatment.’’. 
(8) INDIAN HEALTH SERVICE TESTING, MONI-
TORING, AND PRESCRIPTION DRUGS FOR THE PRE-
VENTION
OF
HIV.—The Indian Health Care Im-
provement Act is amended by inserting after section 
223 (25 U.S.C. 1621v) the following: 
‘‘SEC. 224. TESTING, MONITORING, AND PRESCRIPTION 
DRUGS FOR THE PREVENTION OF HIV. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Service, Indian tribes, and Tribal organizations, shall 
provide funding for any prescription drug approved by the 
Food and Drug Administration for the prevention of 
human immunodeficiency virus (commonly known as 
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1397 
‘HIV’), administrative fees for such a drug, laboratory and 
other diagnostic procedures associated with the use of 
such a drug, and clinical follow up and monitoring, includ-
ing any related services recommended in current United 
States Public Health Service clinical practice guidelines, 
without limitation. 
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section.’’. 
(9) EFFECTIVE DATE.—The amendments made 
by paragraphs (1), (2), (5), (6), (7), and (8) shall 
take effect with respect to plan years beginning on 
or after January 1, 2023. 
(b) PROHIBITION ON DENIAL OF COVERAGE OR IN-
CREASE IN PREMIUMS OF LIFE, DISABILITY, OR LONG- 
TERM
CARE
INSURANCE
FOR
INDIVIDUALS
TAKING 
MEDICATION FOR THE PREVENTION OF HIV ACQUISI-
TION.— 
(1) PROHIBITION.—Notwithstanding any other 
provision of law, it shall be unlawful to— 
(A) decline or limit coverage of a person 
under any life insurance policy, disability insur-
ance policy, or long-term care insurance policy, 
on account of the individual taking medication 
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1398 
for the purpose of preventing the acquisition of 
HIV; 
(B) preclude an individual from taking 
medication for the purpose of preventing the ac-
quisition of HIV as a condition of receiving a 
life insurance policy, disability insurance policy, 
or long-term care insurance policy; 
(C) consider whether an individual is tak-
ing medication for the purpose of preventing 
the acquisition of HIV in determining the pre-
mium rate for coverage of such individual under 
a life insurance policy, disability insurance pol-
icy, or long-term care insurance policy; or 
(D) otherwise discriminate in the offering, 
issuance, cancellation, amount of such coverage, 
price, or any other condition of a life insurance 
policy, disability insurance policy, or long-term 
care insurance policy for an individual, based 
solely and without any additional actuarial risks 
upon whether the individual is taking medica-
tion for the purpose of preventing the acquisi-
tion of HIV. 
(2) ENFORCEMENT.—A State insurance regu-
lator may take such actions to enforce paragraph (1) 
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1399 
as are specifically authorized under the laws of such 
State. 
(3) DEFINITIONS.—In this subsection: 
(A) DISABILITY INSURANCE POLICY.—The 
term ‘‘disability insurance policy’’ means a con-
tract under which an entity promises to pay a 
person a sum of money in the event that an ill-
ness or injury resulting in a disability prevents 
such person from working. 
(B) LIFE INSURANCE POLICY.—The term 
‘‘life insurance policy’’ means a contract under 
which an entity promises to pay a designated 
beneficiary a sum of money upon the death of 
the insured. 
(C) LONG-TERM
CARE
INSURANCE
POL-
ICY.—The term ‘‘long-term care insurance pol-
icy’’ means a contract for which the only insur-
ance protection provided under the contract is 
coverage of qualified long-term care services (as 
defined in section 7702B(c) of the Internal 
Revenue Code of 1986). 
(c) PATIENT CONFIDENTIALITY.—The Secretary of 
Health and Human Services shall amend the regulations 
promulgated under section 264(c) of the Health Insurance 
Portability and Accountability Act of 1996 (42 U.S.C. 
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1400 
1320d–2 note), as necessary, to ensure that individuals 
are able to access the benefits described in section 
2713(a)(6) under a family plan without any other indi-
vidual enrolled in such family plan, including a primary 
subscriber of or policyholder, being informed of such use 
of such benefits. 
(d) PRE-EXPOSURE PROPHYLAXIS AND POST-EXPO-
SURE PROPHYLAXIS FUNDING.—Part P of title III of the 
Public Health Service Act (42 U.S.C. 280g et seq.), as 
amended by section 7153, is further amended by adding 
at the end the following: 
‘‘SEC. 399V–8. PRE-EXPOSURE PROPHYLAXIS AND POST-EX-
POSURE PROPHYLAXIS FUNDING. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this Act, the Secretary shall establish 
a program that awards grants to States, territories, In-
dian Tribes, and directly eligible entities for the establish-
ment and support of pre-exposure prophylaxis (referred to 
in this section as ‘PrEP’) and post-exposure prophylaxis 
(referred to in this section as ‘PEP’) programs. 
‘‘(b) APPLICATIONS.—To be eligible to receive a 
grant under subsection (a), a State, territory, Indian 
Tribe, or directly eligible entity shall— 
‘‘(1) submit an application to the Secretary at 
such time, in such manner, and containing such in-
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1401 
formation as the Secretary may require, including a 
plan describing how any funds awarded will be used 
to increase access to PrEP for uninsured and under-
insured individuals and reduce disparities in access 
to PrEP and PEP for uninsured and underinsured 
individuals and reduce disparities in access to PrEP 
and PEP; and 
‘‘(2) appoint a PrEP and PEP grant adminis-
trator to manage the program. 
‘‘(c) DIRECTLY ELIGIBLE ENTITY.—For purposes of 
this section, the term ‘directly eligible entity’— 
‘‘(1) means a Federally qualified health center 
or other nonprofit entity engaged in providing PrEP 
and PEP information and services; and 
‘‘(2) may include— 
‘‘(A) a Federally qualified health center 
(as defined in section 1861(aa)(4) of the Social 
Security Act (42 U.S.C. 1395x(aa)(4))); 
‘‘(B) a family planning grantee (other than 
States) funded under section 1001 of the Public 
Health Service Act (42 U.S.C. 300); 
‘‘(C) a rural health clinic (as defined in 
section 1861(aa)(2) of the Social Security Act 
(42 U.S.C. 1395x(aa)(2)); 
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1402 
‘‘(D) a health facility operated by or pur-
suant to a contract with the Indian Health 
Service; 
‘‘(E) a community-based organization, clin-
ic, hospital, or other health facility that pro-
vides services to individuals at risk for or living 
with HIV; and 
‘‘(F) a nonprofit private entity providing 
comprehensive primary care to populations at 
risk of HIV, including faith-based and commu-
nity-based organizations. 
‘‘(d) AWARDS.—In determining whether to award a 
grant, and the grant amount for each grant awarded, the 
Secretary shall consider the grant application and the 
need for PrEP and PEP services in the area, the number 
of uninsured and underinsured individuals in the area, and 
how the State, territory, or Indian Tribe coordinates 
PrEP and PEP activities with the directly funded entity, 
if the State, territory, or Indian Tribe applies for the 
funds. 
‘‘(e) USE OF FUNDS.— 
‘‘(1) IN GENERAL.—Any State, territory, Indian 
Tribe, or directly eligible entity that is awarded 
funds under subsection (a) shall use such funds for 
eligible PrEP and PEP expenses. 
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1403 
‘‘(2) ELIGIBLE
PREP
EXPENSES.—The Sec-
retary shall publish a list of expenses that qualify as 
eligible PrEP and PEP expenses for purposes of this 
section, which shall include— 
‘‘(A) any prescription drug approved by 
the Food and Drug Administration for the pre-
vention of HIV, administrative fees for such 
drugs, laboratory and other diagnostic proce-
dures associated with the use of such drugs, 
and clinical follow up and monitoring, including 
any related services recommended in current 
United States Public Health Service clinical 
practice guidelines, without limitation; 
‘‘(B) outreach and public education activi-
ties directed toward populations overrepresented 
in the domestic HIV epidemic that increase 
awareness about the existence of PrEP and 
PEP, provide education about access to and 
health care coverage of PrEP and PEP, PrEP 
and PEP adherence programs, and counter 
stigma associated with the use of PrEP and 
PEP; and 
‘‘(C) outreach activities directed toward 
physicians and other providers that provide 
education about PrEP and PEP. 
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1404 
‘‘(f) REPORT TO CONGRESS.—The Secretary shall, in 
each of the first 5 years beginning one year after the date 
of the enactment of this section, submit to Congress, and 
make public on the internet website of Department of 
Health and Human Services, a report on the impact of 
any grants provided to States, territories, and Indian 
Tribes and directly eligible entities for the establishment 
and support of pre-exposure prophylaxis programs under 
this section. 
‘‘(g) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated such sums as may be necessary for each of fiscal 
years 2023 through 2028.’’. 
(e) CLARIFICATION.—This section, including the 
amendments made by this section, shall apply notwith-
standing any other provision of law, including Public Law 
103–141. 
(f) PRIVATE RIGHT OF ACTION.—Any person ag-
grieved by a violation of this section, including the amend-
ments made by this section, may commence a civil action 
in an appropriate United States District Court or other 
court of competent jurisdiction to obtain relief as allowed 
by law as either an individual or member of a class. If 
the plaintiff is the prevailing party in such an action, the 
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1405 
court shall order the defendant to pay the costs and rea-
sonable attorney fees of the plaintiff. 
Subtitle F—Diabetes 
SEC. 7251. RESEARCH, TREATMENT, AND EDUCATION. 
Subpart 3 of part C of title IV of the Public Health 
Service Act (42 U.S.C. 285c et seq.) is amended by adding 
at the end the following new section: 
‘‘SEC. 434B. DIABETES IN MINORITY POPULATIONS. 
‘‘(a) IN GENERAL.—The Director of NIH shall ex-
pand, intensify, and support ongoing research and other 
activities with respect to prediabetes and diabetes, particu-
larly type 2, in minority populations. 
‘‘(b) RESEARCH.— 
‘‘(1) DESCRIPTION.—Research under subsection 
(a) shall include investigation into— 
‘‘(A) the causes of diabetes, including so-
cioeconomic, geographic, clinical, environmental, 
genetic, and other factors that may contribute 
to increased rates of diabetes in minority popu-
lations; and 
‘‘(B) the causes of increased incidence of 
diabetes complications in minority populations, 
and possible interventions to decrease such inci-
dence. 
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1406 
‘‘(2) INCLUSION OF MINORITY PARTICIPANTS.— 
In conducting and supporting research described in 
subsection (a), the Director of NIH shall seek to in-
clude minority participants as study subjects in clin-
ical trials. 
‘‘(c) REPORT; COMPREHENSIVE PLAN.— 
‘‘(1) IN
GENERAL.—The Diabetes Mellitus 
Interagency Coordinating Committee shall— 
‘‘(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 prediabetes and diabetes in minority popu-
lations; and 
‘‘(B) develop and submit to Congress, not 
later than 1 year after the date of enactment of 
this section, an effective and comprehensive 
Federal plan (including all appropriate Federal 
health programs) to address prediabetes and di-
abetes in minority populations. 
‘‘(2) CONTENTS.—The report under paragraph 
(1)(A) shall at minimum address each of the fol-
lowing: 
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1407 
‘‘(A) Research on diabetes and prediabetes 
in minority populations, including such research 
on— 
‘‘(i) 
genetic, 
behavioral, 
socio-
economic, and environmental factors; 
‘‘(ii) prevention of diabetes within 
these populations and who have individuals 
at increased risk of developing diabetes; 
‘‘(iii) 
prevention 
of 
complications 
among individuals in these populations who 
have already developed diabetes; and 
‘‘(iv) barriers to health care access 
and diabetes treatment within populations 
at increased risk of developing diabetes. 
‘‘(B) Surveillance and data collection on 
diabetes and prediabetes in minority popu-
lations, including with respect to— 
‘‘(i) efforts to better determine the 
prevalence of diabetes among Asian-Amer-
ican and Pacific Islander subgroups; and 
‘‘(ii) efforts to coordinate data collec-
tion on the American Indian population. 
‘‘(C) Community-based interventions to ad-
dress diabetes and prediabetes targeting minor-
ity populations, including— 
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1408 
‘‘(i) the evidence base for such inter-
ventions; 
‘‘(ii) the cultural appropriateness of 
such interventions; and 
‘‘(iii) efforts to educate the public on 
the causes and consequences of diabetes. 
‘‘(D) Education and training programs for 
health 
professionals 
(including 
community 
health workers) on the prevention and manage-
ment of diabetes and its related complications 
that is supported by the Health Resources and 
Services Administration, including such pro-
grams supported by— 
‘‘(i) the National Health Service 
Corps; or 
‘‘(ii) the community health centers 
program under section 330. 
‘‘(d) EDUCATION.—The Director of NIH shall— 
‘‘(1) through the National Institute on Minority 
Health and Health Disparities and the National Di-
abetes Education Program— 
‘‘(A) make grants to programs funded 
under section 464z–4 for the purpose of estab-
lishing a medical education program for health 
care professionals to be more involved in weight 
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1409 
counseling, obesity research, nutrition, and 
shared decision-making; and 
‘‘(B) provide for the participation of mi-
nority health professionals in diabetes-focused 
research programs; and 
‘‘(2) make grants to programs that establish a 
professional pipeline that will increase the participa-
tion of minority individuals in diabetes-focused 
health fields by expanding Minority Access to Re-
search Careers program internships and mentoring 
opportunities for the purposes of recruitment. 
‘‘(e) DEFINITIONS.—For purposes of this section: 
‘‘(1) DIABETES
MELLITUS
INTERAGENCY
CO-
ORDINATING
COMMITTEE.—The ‘Diabetes Mellitus 
Interagency Coordinating Committee’ means the Di-
abetes Mellitus Interagency Coordinating Committee 
established under section 429. 
‘‘(2) MINORITY POPULATION.—The term ‘mi-
nority population’ means a racial and ethnic minor-
ity group, as defined in section 1707.’’. 
SEC. 7252. RESEARCH, EDUCATION, AND OTHER ACTIVI-
TIES. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.), as amended by section 7101, is 
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1410 
further amended by inserting after section 317V the fol-
lowing section: 
‘‘SEC. 317W. DIABETES IN MINORITY POPULATIONS. 
‘‘(a) RESEARCH AND OTHER ACTIVITIES.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall conduct and support 
research and public health activities with respect to 
diabetes in minority populations. 
‘‘(2) CERTAIN
ACTIVITIES.—Activities under 
paragraph (1) regarding diabetes in minority popu-
lations shall include the following: 
‘‘(A) Further enhancing the National 
Health and Nutrition Examination Survey by 
oversampling Asian Americans, Native Hawai-
ians, and Pacific Islanders in appropriate geo-
graphic areas to better determine the preva-
lence of diabetes in such populations as well as 
to improve the data collection of diabetes pene-
tration disaggregated into major ethnic groups 
within such populations. The Secretary shall en-
sure that any such oversampling does not re-
duce the oversampling of other minority popu-
lations including African-American and Latino 
populations. 
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1411 
‘‘(B) Through the Division of Diabetes 
Translation— 
‘‘(i) providing for prevention research 
to better understand how to influence 
health care systems changes to improve 
quality of care being delivered to such pop-
ulations; 
‘‘(ii) carrying out model demonstra-
tion projects to design, implement, and 
evaluate effective diabetes prevention and 
control interventions for minority popu-
lations, including culturally appropriate 
community-based interventions; 
‘‘(iii) developing and implementing a 
strategic plan to reduce diabetes in minor-
ity populations through applied research to 
reduce disparities and culturally and lin-
guistically appropriate community-based 
interventions; 
‘‘(iv) supporting, through the national 
diabetes prevention program under section 
399V–3, diabetes prevention program sites 
in underserved regions highly impacted by 
diabetes; and 
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1412 
‘‘(v) implementing, through the na-
tional diabetes prevention program under 
section 399V–3, a demonstration program 
developing new metrics measuring health 
outcomes related to diabetes that can be 
stratified by specific minority populations. 
‘‘(b) EDUCATION.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall direct the Division of Diabetes Translation 
to conduct and support both programs to educate the pub-
lic on diabetes in minority populations and programs to 
educate minority populations about the causes and effects 
of diabetes. 
‘‘(c) DIABETES; HEALTH PROMOTION, PREVENTION 
INITIATIVES, 
AND
ACCESS.—The 
Secretary, 
acting 
through the Director of the Centers for Disease Control 
and Prevention and the National Diabetes Education Pro-
gram, shall conduct and support programs to educate spe-
cific minority populations through culturally appropriate 
and linguistically appropriate information campaigns and 
initiatives about prevention of, and managing, diabetes. 
‘‘(d) DEFINITION.—For purposes of this section, the 
term ‘minority population’ means a racial and ethnic mi-
nority group, as defined in section 1707.’’. 
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1413 
SEC. 7253. PROGRAMS TO EDUCATE HEALTH PROVIDERS 
ON THE CAUSES AND EFFECTS OF DIABETES 
IN MINORITY POPULATIONS. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.), as amended by section 7220, 
is further amended by adding at the end the following new 
section: 
‘‘SEC. 399V–9. PROGRAMS TO EDUCATE HEALTH PRO-
VIDERS ON THE CAUSES AND EFFECTS OF DI-
ABETES IN MINORITY POPULATIONS. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Health Resources and Services Admin-
istration, shall conduct and support programs described 
in subsection (b) to educate health professionals on the 
causes and effects of diabetes in minority populations. 
‘‘(b) PROGRAMS.—Programs described in this sub-
section, with respect to education on diabetes in minority 
populations, shall include the following: 
‘‘(1) Giving priority, under the primary care 
training and enhancement program under section 
747— 
‘‘(A) to awarding grants to focus on or ad-
dress diabetes; and 
‘‘(B) to adding minority populations to the 
list of vulnerable populations that should be 
served by such grants. 
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‘‘(2) Providing additional funds for the Health 
Careers Opportunity Program, the Centers for Ex-
cellence, and the Minority Faculty Fellowship Pro-
gram to partner with the Office of Minority Health 
under section 1707 and the National Institutes of 
Health to strengthen programs for career opportuni-
ties focused on diabetes treatment and care within 
underserved regions highly impacted by diabetes. 
‘‘(3) Developing a diabetes focus within, and 
providing additional funds for, the National Health 
Service Corps scholarship program— 
‘‘(A) to place individuals in areas that are 
disproportionately affected by diabetes and to 
provide diabetes treatment and care in such 
areas; and 
‘‘(B) to provide such individuals continuing 
medical education specific to diabetes care.’’. 
SEC. 7254. RESEARCH, EDUCATION, AND OTHER ACTIVITIES 
REGARDING DIABETES IN AMERICAN INDIAN 
POPULATIONS. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.), as amended by section 7253, 
is further amended by adding at the end the following sec-
tion: 
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‘‘SEC. 399V–10. RESEARCH, EDUCATION, AND OTHER ACTIVI-
TIES REGARDING DIABETES IN AMERICAN IN-
DIAN POPULATIONS. 
‘‘In addition to activities under sections 317W, 
399V–9, and 434B, the Secretary, acting through the In-
dian Health Service and in collaboration with other appro-
priate Federal agencies, shall— 
‘‘(1) conduct and support research and other 
activities with respect to diabetes; and 
‘‘(2) coordinate the collection of data on clini-
cally and culturally appropriate diabetes treatment, 
care, prevention, and services by health care profes-
sionals to the American Indian population.’’. 
SEC. 7255. UPDATED REPORT ON HEALTH DISPARITIES. 
The Secretary of Health and Human Services shall 
seek to enter into an arrangement with the National Acad-
emy of Medicine under which the National Academy will— 
(1) not later than 1 year after the date of en-
actment of this Act, submit to Congress an updated 
version of the 2003 report entitled ‘‘Unequal Treat-
ment: Confronting Racial and Ethnic Disparities in 
Health Care’’; and 
(2) in such updated version, address how racial 
and ethnic health disparities have changed since the 
publication of the original report. 
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Subtitle G—Lung Disease 
SEC. 7301. NATIONAL ASTHMA BURDEN. 
Congress finds as follows: 
(1) The prevalence of asthma has increased 
since 1980 and affects more than 26,000,000 people 
in the United States. 
(2) Significant disparities in asthma morbidity 
and mortality exist for both adults and children par-
ticularly for low-income and minority populations, 
particularly African Americans and Puerto Ricans. 
(3) African-American children are twice as like-
ly to have asthma as White children. 
(4) In 2016, almost 4,500,000 non-Hispanic 
African Americans reported having asthma. African 
Americans with asthma are 3 times as likely to visit 
the emergency department and twice as likely to get 
hospitalized as White patients with asthma. 
(5) Puerto Ricans are 3.4 times as likely to die 
from asthma compared with all other Hispanic or 
Latino groups. Overall Hispanic Americans are 30 
percent more likely to be hospitalized for asthma 
than non-Hispanic Whites. 
(6) The majority of adults with asthma are 
women. 
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SEC. 7302. ASTHMA-RELATED ACTIVITIES OF THE CENTERS 
FOR DISEASE CONTROL AND PREVENTION. 
Section 317I of the Public Health Service Act (42 
U.S.C. 247b–10) is amended to read as follows: 
‘‘SEC. 317I. ASTHMA-RELATED ACTIVITIES OF THE CENTERS 
FOR DISEASE CONTROL AND PREVENTION. 
‘‘(a) PROGRAM FOR PROVIDING INFORMATION AND 
EDUCATION
TO
THE PUBLIC.—The Secretary, acting 
through the Director of the Centers for Disease Control 
and Prevention, shall collaborate with State and local 
health departments to conduct activities, including the 
provision of information and education to the public re-
garding asthma including— 
‘‘(1) deterring the harmful consequences of un-
controlled asthma; and 
‘‘(2) disseminating health education and infor-
mation regarding prevention of asthma episodes and 
strategies for managing asthma. 
‘‘(b) DEVELOPMENT OF STATE ASTHMA PLANS.— 
The Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall collaborate with 
State and local health departments to develop State plans 
incorporating public health responses to reduce the burden 
of asthma, particularly regarding disproportionately af-
fected populations. 
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‘‘(c) COMPILATION OF DATA.—The Secretary, acting 
through the Director of the Centers for Disease Control 
and Prevention, shall, in cooperation with State and local 
public health officials— 
‘‘(1) conduct asthma surveillance activities to 
collect data on the prevalence and severity of asth-
ma, the effectiveness of public health asthma inter-
ventions, and the quality of asthma management, in-
cluding— 
‘‘(A) collection of data among people with 
asthma to monitor the impact on health and 
quality of life; 
‘‘(B) surveillance of health care facilities; 
and 
‘‘(C) collection of data not containing indi-
vidually identifiable information from electronic 
health records or other electronic communica-
tions; 
‘‘(2) compile and annually publish data regard-
ing the prevalence and incidence of childhood asth-
ma, the child mortality rate, and the number of hos-
pital admissions and emergency department visits by 
children associated with asthma nationally and in 
each State and at the county level by age, sex, race, 
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and ethnicity, as well as lifetime and current preva-
lence; and 
‘‘(3) compile and annually publish data regard-
ing the prevalence and incidence of adult asthma, 
the adult mortality rate, and the number of hospital 
admissions and emergency department visits by 
adults associated with asthma nationally and in each 
State and at the county level by age, sex, race, eth-
nicity, industry, and occupation, as well as lifetime 
and current prevalence. 
‘‘(d) COORDINATION OF DATA COLLECTION.—The 
Director of the Centers for Disease Control and Preven-
tion, in conjunction with State and local health depart-
ments, shall coordinate data collection activities under 
paragraphs (2) and (3) of subsection (c) so as to maximize 
comparability of results. 
‘‘(e) COLLABORATION.— 
‘‘(1) IN GENERAL.—The Centers for Disease 
Control and Prevention may collaborate with na-
tional, State, and local nonprofit organizations to 
provide information and education about asthma, 
and to strengthen such collaborations when possible. 
‘‘(2) SPECIFIC
ACTIVITIES.—The Director of 
the Centers for Disease Control and Prevention, act-
ing through the Division of Population Health of the 
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Centers, may expand activities relating to asthma 
with non-Federal partners, especially State-level en-
tities. 
‘‘(f) REPORTS TO CONGRESS.— 
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of the enactment of the Health Equity 
and Accountability Act of 2022, and once 2 years 
thereafter, the Secretary shall, in consultation with 
patient groups, nonprofit organizations, medical so-
cieties, and other relevant governmental and non-
governmental entities, submit to Congress a report 
that— 
‘‘(A) catalogs, with respect to asthma pre-
vention, management, and surveillance— 
‘‘(i) the activities of the Federal Gov-
ernment, including an assessment of the 
progress of the Federal Government and 
States, with respect to achieving the goals 
of the Healthy People 2030 initiative; and 
‘‘(ii) the activities of other entities 
that participate in the program under this 
section, including nonprofit organizations, 
patient advocacy groups, and medical soci-
eties; and 
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1421 
‘‘(B) makes recommendations for the fu-
ture direction of asthma activities, in consulta-
tion with researchers from the National Insti-
tutes of Health and other member bodies of the 
Asthma Disparities Subcommittee, including— 
‘‘(i) a description of how the Federal 
Government may improve its response to 
asthma, including identifying any barriers 
that may exist; 
‘‘(ii) a description of how the Federal 
Government may continue, expand, and 
improve its private-public partnerships 
with respect to asthma including identi-
fying any barriers that may exist; 
‘‘(iii) identification of steps that may 
be taken to reduce the— 
‘‘(I) morbidity, mortality, and 
overall prevalence of asthma; 
‘‘(II) financial burden of asthma 
on society; 
‘‘(III) burden of asthma on dis-
proportionately affected areas, par-
ticularly those in medically under-
served populations (as defined in sec-
tion 330(b)(3)); and 
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1422 
‘‘(IV) burden of asthma as a 
chronic disease that can be worsened 
by environmental exposures; 
‘‘(iv) the identification of programs 
and policies that have achieved the steps 
described under clause (iii), and steps that 
may be taken to expand such programs 
and policies to benefit larger populations; 
and 
‘‘(v) recommendations for future re-
search and interventions. 
‘‘(2) SUBSEQUENT REPORTS.— 
‘‘(A) CONGRESSIONAL REQUEST.—During 
the 5-year period following the submission of 
the second report under paragraph (1), the Sec-
retary shall submit updates and revisions of the 
report upon the request of the Congress. 
‘‘(B) FIVE-YEAR REEVALUATION.—At the 
end of the 5-year period referred to in subpara-
graph (A), the Secretary shall— 
‘‘(i) evaluate the analyses and rec-
ommendations made in previous reports; 
and 
‘‘(ii) determine whether an additional 
report is needed and if so submit such an 
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1423 
updated report to the Congress, including 
appropriate recommendations. 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS FUND-
ING.—In addition to any other authorization of appropria-
tions that is available to the Centers for Disease Control 
and Prevention for the purpose of carrying out this sec-
tion, there is authorized to be appropriated to such Cen-
ters $65,000,000 for the period of fiscal years 2023 
through 2027 for the purpose of carrying out this sec-
tion.’’. 
SEC. 7303. INFLUENZA AND PNEUMONIA VACCINATION 
CAMPAIGN. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall— 
(1) enhance the annual campaign by the De-
partment of Health and Human Services to increase 
the number of people vaccinated each year for influ-
enza and pneumonia; and 
(2) include in such campaign the use of written 
educational materials, public service announcements, 
physician education, and any other means which the 
Secretary deems effective. 
(b) MATERIALS AND ANNOUNCEMENTS.—In carrying 
out the annual campaign described in subsection (a), the 
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1424 
Secretary of Health and Human Services shall ensure 
that— 
(1) educational materials and public service an-
nouncements are readily and widely available in 
communities experiencing disparities in the incidence 
and mortality rates of influenza and pneumonia; and 
(2) the campaign uses targeted, culturally ap-
propriate messages and messengers to reach under-
served communities. 
(c) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
such sums as may be necessary for each of fiscal years 
2023 through 2027. 
SEC. 7304. CHRONIC OBSTRUCTIVE PULMONARY DISEASE. 
(a) FINDINGS.—Congress finds as follows: 
(1) Chronic obstructive pulmonary disease (re-
ferred to in this subsection as ‘‘COPD’’) refers to 
chronic bronchitis and emphysema, incurable dis-
eases that make it difficult to exhale all the air from 
one’s lungs, and that can cause persistent coughing, 
shortness of breath, and sputum. 
(2) COPD exacerbations—episodes of acute dif-
ficulty breathing and moderate to severe fatigue— 
are dangerous, and their treatment often requires 
hospitalization. 
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1425 
(3) While smoking is the primary risk factor for 
COPD, other risk factors include air pollution, occu-
pational exposures, heredity, a history of childhood 
respiratory infections, and socioeconomic status. 
(4) It is estimated that over 16,000,000 adults 
in the United States have COPD. 
(5) COPD is a leading cause of death in the 
United States, claiming over 156,000 lives in 2019. 
(6) Since 2000, deaths for women with COPD 
have exceeded deaths in men. 
(7) Although African Americans have a lower 
prevalence of COPD in the United States, research-
ers have shown that African Americans may be 
underdiagnosed. Furthermore, research has shown 
that African Americans develop COPD with less cu-
mulative smoke exposure and at a younger age. 
(b) 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 chronic obstructive pulmonary disease. 
(c) CHRONIC DISEASE PREVENTION PROGRAMS.— 
The Director of the National Heart, Lung, and Blood In-
stitute shall carry out the following: 
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1426 
(1) Conduct public education and awareness ac-
tivities with patient and professional organizations 
to stimulate earlier diagnosis and improve patient 
outcomes from treatment of chronic obstructive pul-
monary disease. To the extent known and relevant, 
such public education and awareness activities shall 
reflect differences in chronic obstructive pulmonary 
disease by cause (tobacco, environmental, occupa-
tional, biological, and genetic) and include a focus 
on outreach to undiagnosed and, as appropriate, mi-
nority populations. 
(2) Supplement and expand upon the activities 
of the National Heart, Lung, and Blood Institute by 
making grants to nonprofit organizations, State and 
local jurisdictions, and Indian Tribes for the purpose 
of reducing the burden of chronic obstructive pul-
monary disease, especially in disproportionately im-
pacted communities, through public health interven-
tions and related activities. 
(3) Coordinate with the Centers for Disease 
Control and Prevention, the Indian Health Service, 
the Health Resources and Services Administration, 
and the Department of Veterans Affairs to develop 
pilot programs to demonstrate best practices for the 
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1427 
diagnosis and management of chronic obstructive 
pulmonary disease. 
(4) Develop improved techniques and identify 
best practices, in coordination with the Secretary of 
Veterans Affairs, for assisting chronic obstructive 
pulmonary disease patients to successfully stop 
smoking, including identification of subpopulations 
with different needs. Initiatives under this para-
graph may include research to determine whether 
successful smoking cessation strategies are different 
for chronic obstructive pulmonary disease patients 
compared to such strategies for patients with other 
chronic diseases. 
(d) ENVIRONMENTAL AND OCCUPATIONAL HEALTH 
PROGRAMS.—The Director of the Centers for Disease 
Control and Prevention shall— 
(1) support research into the environmental and 
occupational causes and biological mechanisms that 
contribute to chronic obstructive pulmonary disease; 
and 
(2) develop and disseminate public health inter-
ventions that will lessen the impact of environmental 
and occupational causes of chronic obstructive pul-
monary disease. 
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1428 
(e) DATA COLLECTION.—Not later than 180 days 
after the enactment of this Act, the Director of the Na-
tional Heart, Lung, and Blood Institute and the Director 
of the Centers for Disease Control and Prevention, acting 
jointly, shall assess the depth and quality of information 
on chronic obstructive pulmonary disease that is collected 
in surveys and population studies conducted by the Cen-
ters for Disease Control and Prevention, including wheth-
er there are additional opportunities for information to be 
collected in the National Health and Nutrition Examina-
tion Survey, the National Health Interview Survey, and 
the Behavioral Risk Factors Surveillance System surveys. 
(f) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
such sums as may be necessary for each of fiscal years 
2023 through 2027. 
Subtitle H—Tuberculosis 
SEC. 7351. ELIMINATION OF ALL FORMS OF TUBERCULOSIS. 
(a) SHORT TITLE.—This subtitle may be cited as the 
‘‘End Tuberculosis Act’’. 
(b) FINDINGS.—Congress makes the following find-
ings: 
(1) In the United States, 7,174 people were di-
agnosed with tuberculosis (referred to in this section 
as ‘‘TB’’) in 2020. 
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1429 
(2) Disparities in TB exist and significantly im-
pact minority communities in the United States. The 
Centers for Disease Control and Prevention (re-
ferred to in this section as ‘‘CDC’’) finds that 89 
percent of people diagnosed with TB disease in 2020 
self-identified as racial and ethnic minorities. 
(3) African Americans comprised 19.6 percent 
of people diagnosed with TB disease during 2020. 
The population-adjusted rate of TB among African 
Americans is 1.5 times higher than the national 
total, and 8.0 times higher than among Whites. 
(4) Asian Americans, Native Hawaiians, and 
other Pacific Islanders comprised 37.4 percent of 
people diagnosed with TB disease during 2020. The 
population-adjusted rate of TB among Asian Ameri-
cans is 6 times higher than the national total, and 
33.25 times higher than among Whites. The popu-
lation-adjusted rate of TB among Native Hawaiians 
and other Pacific Islanders is 8.5 times higher than 
the national total, and 46.75 times higher than 
among Whites. 
(5) Hispanics and Latinos comprised 29.7 per-
cent of people diagnosed with TB disease during 
2020. The population-adjusted rate of TB among 
Hispanics and Latinos is 1.6 times higher than the 
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1430 
national total, and 8.75 times higher than among 
Whites. 
(6) TB is both preventable and curable, but the 
current rate of decline of TB in the United States 
remains too slow to achieve TB elimination in this 
century. 
(7) TB is transmitted through the air when a 
person who has TB disease in their lungs coughs or 
sneezes. People who are in close proximity to the 
person with TB can breathe in the TB bacteria, and 
the bacteria will initially settle in their lungs. Living 
conditions related to poverty, such as crowded hous-
ing and poor ventilation, can greatly increase the 
risk of transmission. Without proper and timely di-
agnosis and access to treatment, the TB bacteria 
may grow and spread to other parts of their body. 
(8) As many as 13,000,000 people in the 
United States may have latent TB infection (re-
ferred to in this section as ‘‘LTBI’’). People with 
LTBI have TB bacteria in their bodies, but their 
immune system is containing the bacteria, and they 
are not sick, nor do they have any current risk of 
spreading TB to others. LTBI can activate into in-
fectious, life-threatening TB if not treated. Modeling 
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1431 
has shown that eliminating TB is not possible with-
out addressing LTBI. 
(9) Comorbidities associated with TB include 
cancer, diabetes mellitus, and HIV. People with 
these medical conditions and compromised immune 
systems are more likely to develop active TB disease 
and to have worse outcomes from TB. Many of the 
communities placed at highest risk of other adverse 
health outcomes and injustices are also dispropor-
tionately impacted by TB, and these include people 
experiencing homelessness and housing instability, 
people in congregate living and carceral settings, and 
people born outside of the United States. 
(10) Forms of active TB that do not show drug 
resistance are classified as drug-susceptible TB (re-
ferred to in this section as ‘‘DS–TB’’). Drug-resist-
ant TB (referred to in this section as ‘‘DR–TB’’) is 
a rising threat to the public health of the United 
States. DR–TB that exhibits resistance to two or 
more first-line drugs is referred to as multi-drug re-
sistant TB (referred to in this section as ‘‘MDR– 
TB’’). MDR–TB that also is resistant to at least 
one fluoroquinolone, and at least one additional 
group A second-line medicine is classified as exten-
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sively drug-resistant TB (referred to in this section 
as ‘‘XDR–TB’’). 
(11) Approximately 56 people in the United 
States were diagnosed with MDR–TB in 2020. One 
person was diagnosed with XDR–TB in the same 
year. 
(12) In the United States, $503,000,000 was 
spent in 2020 to treat TB; direct treatment costs 
average $20,211 to treat a patient with DS–TB, 
$182,186 to treat a patient with MDR–TB, and 
$567,708 to treat a patient with XDR–TB. When 
factoring in productivity losses during treatment, 
DS–TB averages $24,661, MDR–TB averages 
$347,324, and XDR–TB averages $729,039. Treat-
ment is often difficult, with daily complex multi-pill 
regimens, with side-effects ranging from hearing and 
vision loss to mental health issues. 
(13) Recognizing the public health, economic, 
and societal costs to the threat of MDR–TB, the 
National Action Plan to Combat MDR–TB was de-
veloped by the White House to provide the United 
States with a comprehensive three-pronged strategy 
to address MDR–TB by strengthening domestic ca-
pacity to combat MDR–TB; improve international 
capacity and cooperation to combat MDR–TB; and 
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1433 
accelerate basic and applied research and develop-
ment for new therapies, diagnostics, and prevention 
strategies to combat MDR–TB. 
(14) Additional Federal support is necessary to 
expand TB control efforts in case finding and treat-
ment to address LTBI in a national prevention ini-
tiative. Key policy and research breakthroughs in-
crease the success of a TB prevention initiative: the 
U.S. Preventative Services Task Force recommenda-
tion’s ‘‘B’’ rating, screening for LTBI among high- 
risk adults as a covered service increases the likeli-
hood that impacted racial and ethnic minority 
groups can get tested for TB; a new, shorter course 
treatment regimen reduces the length of treatment 
for LTBI from every day for 6 to 9 months to one 
dose per week for 12 weeks, increasing the likelihood 
of treatment completion; and the use of blood-based 
diagnostic tests, Interferon-gamma release assays or 
IGRAs, increases the ability to detect LTBI among 
patients in affected communities. 
(15) The right to health, and the right to 
science as a necessary human right to help achieve 
the right to health, is enshrined in Articles 25 and 
27 of the Universal Declaration of Human Rights. 
These fundamental human rights cannot be achieved 
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1434 
when anyone lacks access to TB prevention or treat-
ment, and when the benefits of scientific innovation 
are not extended to people with all forms of TB. 
SEC. 7352. ADDITIONAL FUNDING FOR STATES IN COM-
BATING AND ELIMINATING TUBERCULOSIS. 
Section 317E(h) of the Public Health Act (42 U.S.C. 
247b–6(h)) is amended by adding at the end the following: 
‘‘(3) ADDITIONAL
FUNDING
FOR
STATES
IN 
COMBATING AND ELIMINATING TUBERCULOSIS.—In 
addition to amounts otherwise authorized to be ap-
propriated to carry out this section, there are au-
thorized to be appropriated such sums as may be 
necessary to carry out this section for each of fiscal 
years 2023 through 2024.’’. 
SEC. 7353. STRENGTHENING CLINICAL RESEARCH FUND-
ING FOR TUBERCULOSIS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall expand and intensify support for 
current and prospective research activities of the National 
Institutes of Health, the Biomedical Advanced Research 
and Development Authority, and the Centers for Disease 
Control and Prevention Division of Tuberculosis Elimi-
nation to develop new therapeutics, diagnostics, vaccines, 
and other prevention modalities in addressing all forms 
of tuberculosis (referred to in this section as ‘‘TB’’). 
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(b) INCLUDED RESEARCH ACTIVITIES.—Research 
activities under subsection (a) shall include— 
(1) research and development, and pathways to 
approval, for novel, safe drugs and drug regimens 
for the treatment of TB, including in adolescent and 
pediatric populations and in pregnant and lactating 
people; 
(2) research to develop rapid diagnostic tests 
for all forms of TB, including diagnostics that can 
be used for pediatric populations and people living 
with HIV, diagnostics that can detect extra pul-
monary TB and drug resistance, and diagnostics 
that can be used at the point of care; 
(3) research to advance basic knowledge of the 
pathogenesis of TB and its major comorbidities, in-
cluding HIV and diabetes mellitus; 
(4) research to improve knowledge and under-
standings of the role of latency in TB and the fac-
tors that increase the risk of latent TB infection 
progressing to active, symptomatic TB disease; 
(5) awarding grants and contracts to specifi-
cally develop new and needed vaccines to address 
TB; 
(6) awarding grants and contracts to support 
the training and development of clinical researchers 
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1436 
whose research improves the landscape of tools to 
combat TB; and 
(7) awarding grants and contracts to support 
capacity-building and develop clinical trial site infra-
structure in the United States and in TB endemic 
countries to support the aforementioned research ac-
tivities. 
Subtitle I—Osteoarthritis and 
Musculoskeletal Diseases 
SEC. 7401. FINDINGS. 
Congress finds as follows: 
(1) Eighty percent of African-American women 
and nearly 74 percent of Hispanic men are either 
overweight or obese, speeding the onset and progres-
sion of knee arthritis. 
(2) Arthritis affects 58,500,000 people in the 
United States, and that number will rise to 
78,000,000 by the year 2040. 
(3) 32,500,000 people in the United States suf-
fer from osteoarthritis, the most common form of ar-
thritis, making it the leading cause of disability in 
the United States. Osteoarthritis is sometimes re-
ferred to as degenerative joint disease. 
(4) Obesity accelerates the onset of arthritis: 70 
percent of obese adults with mild osteoarthritis of 
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1437 
the knee at age 60 will develop advanced end-stage 
disease by age 80. In contrast, just 43 percent of 
non-obese adults will have end-stage disease over the 
same time period. 
(5) Arthritis affects 1 in 4 people in the United 
States and is the single greatest cause of chronic 
pain and disability in the United States. 
(6) Women, Black Americans, and Hispanics 
have more severe arthritis and functional limitations. 
These same individuals are more likely to be obese 
and diabetic, and have a higher incidence of heart 
diseases. 
(7) Arthritis costs $304,000,000,000 a year, in-
cluding $140,000,000,000 in direct costs (medical) 
and $164,000,000,000 in indirect costs (lost earn-
ings). 
(8) Obesity and other chronic health conditions 
exacerbate the debilitating impact of arthritis, lead-
ing to inactivity, loss of independence, and a per-
petual cycle of comorbid chronic conditions. 
(9) Sixty-one percent of arthritis sufferers are 
women, and women represent 64 percent of an esti-
mated 43,000,000 annual visits to physicians’ offices 
and outpatient clinics where arthritis was the pri-
mary diagnosis. Women also represented 60 percent 
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1438 
of approximately 1,000,000 hospitalizations that oc-
curred in 2003 for which arthritis was the primary 
diagnosis. 
(10) Women ages 65 and older have up to 21⁄2 
times more disabilities than men of the same age. 
Higher rates of obesity and arthritis among this 
group explained up to 48 percent of the gender gap 
in disability, above all other common chronic health 
conditions. 
(11) The primary indication for total knee 
arthroplasty (referred to in this section as ‘‘TKA’’), 
also known as knee replacement, is relief of signifi-
cant, disabling pain caused by severe arthritis. 
(12) Knee replacement is surgery for people 
with severe knee damage. Knee replacement can re-
lieve pain and allow an individual to be more active. 
The process for a total knee replacement involves 
the surgeon removing damaged cartilage and bone 
from the surface of the knee joint and replacing the 
cartilage and bone with a man-made surface of 
metal and plastic. In a partial knee replacement, the 
surgeon only replaces part of the knee joint. 
(13) Total hip replacement, also called total hip 
arthroplasty (referred to in this section as ‘‘THA’’), 
is used if hip pain interferes with daily activities and 
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1439 
more conservative treatments have not helped. Ar-
thritis damage is the most common reason to need 
hip replacement. 
(14) The odds of a family practice physician 
recommending TKA to a male patient with moderate 
arthritis are twice that of a female patient, while the 
odds of an orthopedic surgeon recommending TKA 
to a male patient with moderate arthritis are 22 
times that of a female patient. 
(15) Black Americans with doctor-diagnosed ar-
thritis have a higher prevalence of severe pain attrib-
utable to arthritis, compared with White Americans 
(34.0 percent versus 22.6 percent). Black Ameri-
cans, compared to White Americans, report a higher 
proportion of work limitations (39.5 percent versus 
28.0 percent) and a higher prevalence of arthritis-at-
tributable work limitation (6.6 percent versus 4.6 
percent). 
(16) Hispanics are 50 percent more likely than 
non-Hispanic Whites to report needing assistance 
with at least one instrumental activity of daily living 
and to have difficulty walking. 
(17) Black Americans and Hispanics were 1.3 
times more likely to have activity limitation, 1.6 
times more likely to have work limitations, and 1.9 
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1440 
times more likely to have severe joint pain than 
Whites. 
(18) In 2003, the National Academy of Medi-
cine reported that the rates of TKA and THA 
among Black American and Hispanic patients are 
significantly lower than for Whites—even for those 
with equitable health care coverage such as through 
Medicare or the Department of Veterans Affairs. 
(19) According to the Centers for Disease Con-
trol and Prevention, in 2000, Black American Medi-
care enrollees were 37 percent less likely than White 
Medicare enrollees to undergo total knee replace-
ments. In 2006, the disparity increased to 39 per-
cent. 
(20) Even after adjusting for insurance and 
health access, Hispanics and Black Americans are 
almost 50 percent less likely to undergo total knee 
replacement than Whites. 
SEC. 
7402. 
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-
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1441 
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— 
(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 
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1442 
(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 2023 and each 
subsequent fiscal year. 
SEC. 
7403. 
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 
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; 
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1443 
(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. 
(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)); 
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1444 
(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, non-Tribal 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 
(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 
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 
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1445 
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, 
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. 
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1446 
(2) REPORT ELEMENTS.—The report described 
in paragraph (1) shall include information about— 
(A) the number of entities that are receiv-
ing grant funds; 
(B) the specific activities supported by 
grant funds; 
(C) the number of students served by 
grant programs; and 
(D) the status of program evaluations. 
(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(b) of the Higher Education Act of 1965 (20 U.S.C. 
1001(b)). 
Subtitle J—Sleep and Circadian 
Rhythm Disorders 
SEC. 7451. SHORT TITLE; FINDINGS. 
(a) SHORT TITLE.—This subtitle may be cited as the 
‘‘Sleep and Circadian Rhythm Disorders Health Dispari-
ties Act’’. 
(b) FINDINGS.—Congress finds the following: 
(1) Decrements in sleep health such as sleep 
apnea, insufficient sleep time, and insomnia, affect 
50,000,000 to 70,000,000 adults in the United 
States. An estimated 25,000,000 adults in the 
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1447 
United States have sleep apnea, a chronic disorder 
characterized by one or more pauses in breathing 
which can last from a few seconds to minutes. They 
may occur 30 times or more an hour, disrupting 
sleep and resulting in excessive daytime sleepiness 
and loss in productivity. 
(2) Seventy percent of high school students are 
not getting enough sleep on school nights, while 35 
percent of people in the United States get fewer 
than 7 hours of sleep per night, and roughly 1,550 
fatal motor vehicle crashes are caused by drowsy 
drivers. 
(3) Insufficient sleep and insomnia are more 
prevalent in women. Women who are pregnant and 
have sleep apnea are at an increased risk of cardio-
vascular complications during pregnancy. The im-
pact of disparities in sleep health is associated with 
a growing number of health problems, including the 
following: 
(A) Hypertension. 
(B) Cancer. 
(C) Stroke. 
(D) Cardiac arrhythmia. 
(E) Chronic heart failure and heart dis-
ease. 
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1448 
(F) Diabetes. 
(G) Cognitive functioning and behavior. 
(H) Depression and bipolar disorder. 
(I) Substance abuse. 
(4) A sleep disparity exists in that poor sleep 
quality is strongly associated with poverty, race, and 
social determinants of health. Factors such as em-
ployment, education, and health status, amongst 
others, significantly mediated this effect only in poor 
subjects, suggesting a differential vulnerability to 
these factors in poor relative to nonpoor individuals 
in the context of sleep quality. 
(5) Black Americans sleep worse than White 
Americans. Black Americans take longer to fall 
asleep, report poorer sleep quality, have more light 
and less deep sleep, and nap more often and longer. 
(6) Black Americans and individuals in lower 
socioeconomic status groups may be at an increased 
risk for sleep disturbances and associated health 
consequences. 
(7) Among young Black Americans, the likeli-
hood of having sleep disordered breathing and exhib-
iting risk factors for poor sleep is twice that in 
young White Americans. Frequent snoring is more 
common among Black American and Hispanic 
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1449 
women and Hispanic men compared to non-Hispanic 
White Americans, independent of other factors in-
cluding obesity. 
(8) Black Americans with sleep-disordered 
breathing develop symptoms at a younger age than 
Caucasians but appear less likely to be diagnosed 
and treated in a timely manner. This delay may at 
least in part be due to reduced access to care. 
(9) Sleep loss contributes to increased risk for 
chronic conditions such as obesity, diabetes, and hy-
pertension, all of which have increased prevalence in 
underserved, underrepresented minorities. Racial 
and ethnic disparities related to obesity may also 
contribute to disparities in health outcomes related 
to sleep-disordered breathing. 
(10) Underrepresented minorities in the United 
States report an insomnia rate of 12.9 percent com-
pared to only 6.6 percent for White Americans. 
(11) Black women have a higher incidence of 
insomnia than Black men, perhaps related in part to 
higher risk for chronic persisting symptoms. 
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1450 
SEC. 7452. 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 
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; 
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1451 
(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-
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, 
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1452 
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 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 (existing or anticipated cohorts), exchanging 
scientific data and ideas (cross-over into scientific 
meetings), and develop multidisciplinary investi-
gator-initiated grant applications; 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 2023 and 
each subsequent fiscal year. 
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1453 
SEC. 7453. 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) FINDINGS.—Congress finds as follows: 
(1) Sleep disorders and sleep deficiency unre-
lated to a primary sleep disorder are underdiagnosed 
and are increasingly detrimental to health status. 
(2) The consequences to society include addi-
tional diseases, motor vehicle accidents, decreased 
longevity, elevated direct medical costs, and indirect 
costs related to work absenteeism and property dam-
age. 
(c) 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, 
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1454 
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; 
(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 
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1455 
disorders and emphasize the importance of sleep 
health. 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary for fiscal year 2023 and 
each subsequent fiscal year. 
SEC. 7454. 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. 
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1456 
(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. 
(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)); 
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1457 
(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 
(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. 
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1458 
(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. 
(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 grant funds; 
(B) the specific activities supported by 
grant funds; 
(C) the number of students served by 
grant programs; and 
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1459 
(D) the status of program evaluations. 
(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(b) of the Higher Education Act of 1965 (20 U.S.C. 
1001(b)). 
SEC. 7455. 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; 
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1460 
(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. 
Subtitle 
K—Kidney 
Disease 
Re-
search, 
Surveillance, 
Preven-
tion, and Treatment 
SEC. 7501. KIDNEY DISEASE, RESEARCH, SURVEILLANCE, 
PREVENTION, AND TREATMENT. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Kidney Disease Research, Surveillance, Prevention and 
Treatment Improvement Act of 2022’’. 
(b) FINDINGS.—Congress makes the following find-
ings: 
(1) Kidney diseases impact 37,000,000 individ-
uals in the United States. 
(2) Black Americans comprise just 13 percent 
of the United States population, but 33 percent of 
the United States dialysis patient population. Com-
pared to White Americans, kidney failure prevalence 
is about 3.7 times greater in Black Americans, 1.4 
times greater in Native Americans, and 1.5 times 
greater in Asian Americans. 
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1461 
(3) Peritoneal dialysis and home hemodialysis 
use is 40–50 percent lower among Black Americans 
and Hispanics. 
(4) Every racial and ethnic minority group in 
the United States is significantly less likely to be 
treated with home dialysis than Whites, and demo-
graphic and clinical characteristics are insufficient to 
explain this differential use. 
(5) Black Americans on dialysis, irrespective of 
dialysis modality, and Hispanics undergoing PD or 
in-center HD, are significantly less likely than their 
White counterparts to receive a kidney transplant. 
(6) Black Americans, Hispanics, and Asian 
Americans are less likely to receive living donor kid-
ney transplants than Whites. Efforts to reduce dis-
parities in live donor kidney transplantation for 
Black American, Hispanic, and Asian patients with 
kidney failure have been largely unsuccessful. 
(7) Medicare and Medicaid patients are less 
likely to receive a preemptive transplant from a de-
ceased donor compared to private insurance patients 
(5 percent and 11 percent versus 24 percent), and 
Black and Hispanic patients are less likely to receive 
a preemptive transplant from a deceased donor com-
pared with White patients even after changes to the 
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1462 
kidney allocation system (5 percent of Black patients 
and 5 percent of Hispanic patients compared with 
18 percent of White patients). 
(8) Low-income populations are significantly 
more likely to progress to kidney failure. 
(9) Low socioeconomic status is associated with 
increased incidence of chronic kidney disease, pro-
gression to kidney failure, inadequate dialysis treat-
ment, and reduced access to kidney transplantation. 
(10) The 3 goals of Executive Order 13879 of 
July 10, 2019 (84 Fed. Reg. 33817; relating to Ad-
vancing American Kidney Health), recognize the 
need for more transplants, better prevention and 
education, and improved access to treatment modali-
ties. 
SEC. 7502. KIDNEY DISEASE RESEARCH IN MINORITY POPU-
LATIONS. 
(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 
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1463 
(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; 
‘‘(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’’. 
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1464 
(2) INCLUSION OF MINORITY PARTICIPANTS.— 
In conducting and supporting research described in 
the amendment made by subsection (a), 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 
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; 
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(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.— 
‘‘(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 
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1466 
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— 
‘‘(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; 
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1467 
‘‘(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— 
‘‘(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 
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1468 
‘‘(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 
Health Care, and the Healthcare Systems Bu-
reau. This should 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. 7503. KIDNEY DISEASE ACTION PLAN. 
(a) IN GENERAL.—The Director of the Centers for 
Disease Control and Prevention shall conduct, support, 
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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 
464z–3 of the Public Health Service Act (42 U.S.C. 
285t), not later than 2 years after the date of the 
enactment of this Act, the Director of the National 
Institute of Diabetes and Digestive and Kidney Dis-
eases, in consultation with the Director of the Na-
tional Institute on Minority Health and Health Dis-
parities and the Director of the Centers for Disease 
Control and Prevention, shall develop a national ac-
tion plan to address kidney disease in the United 
States with participation from patients, caregivers, 
health professionals, patient advocacy organizations, 
researchers, 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 
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1470 
(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 
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. 
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1471 
(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. 
(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-
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1472 
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 2023, $1,000,000 for fiscal year 
2024, $1,000,000 for fiscal year 2025, $1,000,000 for fis-
cal year 2026, and $1,000,000 for fiscal year 2027. 
SEC. 7504. HOME DIALYSIS AND INCREASING END-STAGE 
RENAL DISEASE TREATMENT MODALITIES IN 
MINORITY COMMUNITIES ACTION PLAN. 
(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) For services furnished on or after the 
date which is 1 year after the date of the enactment 
of this subparagraph which are staff-assisted home 
dialysis (as defined in clause (iv)(III)), the Secretary 
shall increase the single payment that would other-
wise apply under this paragraph for renal dialysis 
services furnished to new and respite individuals in 
accordance with the payment system established 
under clause (iii) by qualified providers. 
‘‘(ii)(I) Subject to subclause (II), staff-assisted 
home dialysis may only be furnished during— 
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‘‘(aa) with respect to an individual de-
scribed in subclause (iv)(I)(aa), one 90-day pe-
riod which may be renewed up to two 30-day 
periods; and 
‘‘(bb) with respect to an individual de-
scribed in subclause (iv)(I)(bb) and notwith-
standing whether such an individual receives 
any respite care under part A, any 30-day pe-
riod. 
‘‘(II) Notwithstanding the limits described in 
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 im-
pairment (including a stroke, Alzheimer’s, de-
mentia, 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, spi-
nal cord injuries, or any other illness or injury 
determined by the Secretary). 
‘‘(iii) The Secretary shall establish an add-on to 
the single payment under this paragraph through 
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1474 
regulations to determine the amounts payable to 
qualified providers for staff-assisted home dialysis. 
In establishing such system add-on payment, the 
Secretary may consider— 
‘‘(I) the costs of furnishing staff-assisted 
home dialysis; 
‘‘(II) consultations with dialysis providers, 
dialysis patients, private payers, and Medicare 
Advantage plans; 
‘‘(III) payment amounts for similar items 
and services under parts A and B; and 
‘‘(IV) payment amounts established by 
Medicare Advantage plans under part C, group 
health plans, and health insurance coverage of-
fered by health insurance issuers. 
‘‘(iv) In this subparagraph: 
‘‘(I) The term ‘new and respite individual’ 
means an individual described in subsection (a) 
who is— 
‘‘(aa) initiating either peritoneal or 
home hemodialysis; 
‘‘(bb) receiving home dialysis and is 
unable to self-dialyze due to illness, injury, 
caregiver issues, or other temporary cir-
cumstances; or 
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1475 
‘‘(cc) returning to home dialysis after 
a period of hospitalization. 
‘‘(II) The term ‘qualified provider’ means 
a trained professional (as determined by the 
Secretary, including nurses and certified patient 
technicians) who furnishes renal dialysis serv-
ices and— 
‘‘(aa) meets requirements (as deter-
mined by the Secretary) that ensures com-
petency in patient care and modality 
usage; and 
‘‘(bb) provides in-person assistance to 
a patient for an appropriate number of di-
alysis sessions (as determined by the Sec-
retary) at least 75 percent of staff-assisted 
home dialysis sessions during a period de-
scribed in clause (ii)(I). 
‘‘(III)(aa) The term ‘staff-assisted home 
dialysis’ means home dialysis using trained pro-
fessionals to assist individuals who have been 
determined to have end stage renal disease, and 
the frequency of such home dialysis is deter-
mined by such professionals in coordination 
with the patient and his or her care partner, 
and outlined in a patient plan of care. 
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1476 
‘‘(bb) The term ‘care partner’ means any-
one who is designated by the patient who as-
sists the individual with the furnishing of home 
dialysis. 
‘‘(cc) The term ‘patient plan of care’ has 
the meaning given such term in section 494.90 
of title 42, Code of Federal Regulations.’’. 
(b) PATIENT EDUCATION AND TRAINING RELATING 
TO
STAFF-ASSISTED
HOME
DIALYSIS.—Section 
1881(b)(5) of the Social Security Act (42 U.S.C. 
1395rr(b)(5)) is amended— 
(1) in subparagraph (C), by striking at the end 
‘‘and’’; 
(2) in subparagraph (D), by striking the period 
at the end and inserting a semicolon; and 
(3) by adding at the end the following: 
‘‘(E) educate patients of the opportunity to 
receive staff-assisted home dialysis (as defined 
in paragraph (14)(J)(iv)(III)) during the period 
beginning 30 days after the first day such facil-
ity furnishes renal dialysis services to an indi-
vidual and ending 60 days after such day; and 
‘‘(F) provide for nurses, certified patient 
technicians, social workers and or other profes-
sionals to train patients and their care partners 
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in skills and procedures needed to perform 
home 
dialysis 
(as 
defined 
in 
paragraph 
(14)(J)(iv)(III)) treatment— 
‘‘(i) regularly and independently; 
‘‘(ii) through telehealth services or 
through group training (as described in the 
interpretive guidance relating to tag num-
ber V590 of ‘Advance Copy–End Stage 
Renal Disease (ESRD) Program Interpre-
tive Guidance Version 1.1’ (published on 
October 3, 2008)) in accordance with the 
Federal regulations (concerning the privacy 
of individually identifiable health informa-
tion) promulgated under section 264(c) of 
the Health Insurance Portability and Ac-
countability Act of 1996; and 
‘‘(iii) in the home or residence of a 
patient, in a dialysis facility, or in the 
place in which the patient intends to re-
ceive staff-assisted home dialysis.’’. 
(c) NATIONAL ACTION PLAN.— 
(1) DEVELOPMENT.—Not later than 2 years 
after the date of the enactment of this Act, the Di-
rector of the National Institute of Diabetes and Di-
gestive and Kidney Diseases, in consultation with 
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1478 
the Director of the Centers for Disease Control and 
Prevention, shall develop a national action plan to 
increase the number of home dialyzers and choice in 
dialysis treatment modality in the United States 
with participation from patients, caregivers, health 
professionals, patient advocacy organizations, re-
searchers, providers, public health professionals, and 
other stakeholders in minority communities. 
(2) CONTENTS.—At a minimum, such plan 
shall include recommendations for— 
(A) public health officials for the purpose 
of implementation of the national plan; 
(B) biomedical, health services, and public 
health research on home dialysis and modalities 
in minority communities; and 
(C) inclusion of dialysis location and mo-
dality in the health data collections of all Fed-
eral agencies. 
(d) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$1,000,000 for fiscal year 2023, $1,000,000 for fiscal year 
2024, $1,000,000 for fiscal year 2025, $1,000,000 for fis-
cal year 2026, and $1,000,000 for fiscal year 2027. 
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1479 
SEC. 7505. INCREASING KIDNEY TRANSPLANTS IN MINOR-
ITY 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. 
(c) OPTN DATA COLLECTION AND REPORTING.— 
The Organ Procurement and Transplantation Network 
shall collect and the Scientific Registry of Transplant Re-
cipients report annual data, broken down by demographic 
and socioeconomic characteristics, on individual transplant 
center performance as it relates to patients referred, eval-
uated, waitlisted, and successfully transplanted. 
(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). 
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1480 
(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— 
(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-
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1481 
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— 
(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: 
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1482 
(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 
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 
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1483 
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 Healthcare Systems Bureau. 
SEC. 7506. ENVIRONMENTAL AND OCCUPATIONAL HEALTH 
PROGRAMS. 
The Director of the Centers for Disease Control and 
Prevention shall— 
(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. 7507. UNDERSTANDING THE TREATMENT PATTERNS 
ASSOCIATED WITH PROVIDING CARE AND 
TREATMENT OF KIDNEY FAILURE IN MINOR-
ITY 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.), the Medicaid program under title XIX of such 
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1484 
Act (42 U.S.C. 1396 et seq.), and through private health 
insurance, to minority populations that are disproportion-
ately 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. 
SEC. 7508. IMPROVING ACCESS IN UNDERSERVED AREAS. 
(a) DEFINITION OF PRIMARY CARE SERVICES.—Sec-
tion 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. 
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1485 
SEC. 7509. THE JACK REYNOLDS MEMORIAL MEDIGAP EX-
PANSION 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)— 
(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 
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1486 
(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, 
2023. 
(b) ADDITIONAL ENROLLMENT PERIOD FOR CER-
TAIN INDIVIDUALS.— 
(1) ONE-TIME ENROLLMENT PERIOD.— 
(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, 2023, and shall 
end June 30, 2023. 
(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 
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1487 
Security Act 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; 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) 
of section 1882(s) of such Act (42 U.S.C. 
1395ss(s)). 
(c) ALLOWING INDIVIDUALS WITH KIDNEY FAILURE 
TO RETAIN ACCESS TO PRIVATE INSURANCE.— 
(1) IN GENERAL.—Section 1862(b)(1)(C) of the 
Social Security Act (42 U.S.C. 1395y(b)(1)(C)) is 
amended— 
(A) in the last sentence, by inserting ‘‘and 
before January 1, 2023’’ after ‘‘prior to such 
date’’; and 
(B) by adding at the end the following new 
sentence: ‘‘Effective for items and services fur-
nished on or after January 1, 2023 (with re-
spect to periods beginning on or after the date 
that is 42 months prior to such date), clauses 
(i) and (ii) shall be applied by substituting ‘42- 
month’ for ‘12-month’ each place it appears.’’. 
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1488 
(2) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date of en-
actment of this Act. For purposes of determining an 
individual’s status under section 1862(b)(1)(C) of 
the Social Security Act (42 U.S.C. 1395y(b)(1)(C)), 
as amended by paragraph (1), an individual who is 
within the coordinating period as of the date of en-
actment of this Act shall have that period extended 
to the full 42 months described in the last sentence 
of such section, as added by the amendment made 
by paragraph (1)(B). 
Subtitle L—Diversity in Clinical 
Trials 
SEC. 7551. 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; 
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1489 
(3) not later than September 30, 2024, 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, 2025, update 
the guidance of the Food and Drug Administration 
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. 7552. DIVERSIFYING INVESTIGATIONS VIA EQUITABLE 
RESEARCH STUDIES FOR EVERYONE TRIALS 
ACT. 
(a) 
GUIDANCE
ON
DECENTRALIZED
CLINICAL 
TRIALS.— 
(1) DEFINITION.—In this subsection, the term 
‘‘decentralized clinical trials’’ includes clinical trials 
that are executed through a broad spectrum of op-
tions, such as telemedicine or other mobile or digital 
technologies, to allow for the remote collection and 
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1490 
assessment of clinical trial data from participants, 
including in the home or office setting. 
(2) GUIDANCE.—Not later than 6 months after 
the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this sec-
tion as the ‘‘Secretary’’), acting through the Com-
missioner of Food and Drugs (referred to in this 
section as the ‘‘Commissioner’’), shall issue a draft 
guidance that addresses how to conduct decentral-
ized clinical trials with meaningful demographic di-
versity, including racial, ethnic, age, gender, and ge-
ographic diversity in patient engagement, enroll-
ment, and participation, including how to appro-
priately use digital health technologies or other re-
mote assessment options, such as telemedicine, to 
support such trials. Not later than 6 months after 
the date the public comment period for the draft 
guidance ends, the Secretary shall issue a final guid-
ance. 
(3) CONTENT
OF
GUIDANCE.—The guidance 
under paragraph (2) shall address the following: 
(A) Strategies to engage with prospective 
clinical trial participants and community part-
ners, such as patient advocacy groups with di-
verse representation, to incorporate input of 
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1491 
such patients and partners into the design of 
decentralized clinical trials. 
(B) Recommendations for— 
(i) protocol design approaches; 
(ii) appropriate clinical endpoints; 
(iii) institutional review board com-
position and ensuring that such boards in-
clude members with expertise in decentral-
ized clinical trials; 
(iv) delegation of clinical research or-
ganization responsibilities and suitable 
proxies for clinical research organizations; 
and 
(v) simplifying informed consent. 
(C) Recommendations for how digital 
health technology or other remote assessment 
options, such as telemedicine, could support de-
centralized clinical trials, including guidance on 
appropriate technological platforms and medi-
ums, data collection and use, data integrity, 
and 
communication 
to 
study 
participants 
through digital technology. 
(D) 
Recommendations 
for 
appropriate 
methods of patient recruitment and retention, 
including institutional review board oversight, 
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1492 
patient communication, and the role of study 
participants and community partners as advo-
cates to facilitate clinical trial recruitment, par-
ticularly with respect to underrepresented popu-
lations. 
(E) Information regarding when and how a 
study sponsor may solicit a meeting with the 
Secretary regarding the issues described in sub-
paragraphs (A) through (D). 
(4) INTERNATIONAL
HARMONIZATION.—After 
issuing the final guidance under paragraph (2), the 
Secretary, acting through the Commissioner, may 
work with foreign regulators pursuant to existing 
memoranda of understanding governing exchange of 
information to facilitate international harmonization 
of the regulation of decentralized clinical trials and 
use of digital health technology or other remote as-
sessment options. 
(b) 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-
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1493 
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-
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. 
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1494 
(2) GRANTS AND CONTRACTS.— 
(A) IN
GENERAL.—The Secretary may 
issue grants to, and enter into contracts with, 
entities to support community education, out-
reach, and recruitment activities for clinical 
trials with respect to drugs, including vaccines 
for diseases or conditions which have a dis-
proportionate impact on underrepresented pop-
ulations (including on racial and ethnic minor-
ity populations), including for the diagnosis, 
prevention, or treatment of COVID–19. Such 
activities may include— 
(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, 
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1495 
especially in underrepresented racial and 
ethnic minority communities; and 
(iv) fostering partnerships with com-
munity-based organizations serving under-
represented racial and ethnical minority 
populations, including employee unions and 
frontline health care workers. 
(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 2023 and 2024 such sums as 
may be necessary to carry out this paragraph. 
(c) CLARIFICATION THAT CERTAIN REMUNERATION 
RELATED TO PARTICIPATION IN CLINICAL TRIALS DOES 
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1496 
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 
trial, as defined in subsection (d) of the first section 
2709 of the Public Health Service 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. 
(d) NATIONAL ACADEMY OF MEDICINE STUDY.— 
(1) IN
GENERAL.—The Secretary shall enter 
into an arrangement with the National Academy of 
Medicine under which the National Academy agrees 
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1497 
to study and propose a design for a national inter-
operable data platform to improve access to health 
data, and other relevant data needs, during public 
health emergencies. 
(2) REPORT.—The arrangement under para-
graph (1) shall provide for submission by the Na-
tional Academy of Medicine to the Secretary and 
Congress, not later than 120 days after the date of 
enactment of this Act, of a report on the results of 
the study under paragraph (1) and the design pro-
posed based on such study. 
SEC. 7553. 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 et seq.)) or biological product 
(as defined in section 351(i) of the Public Health 
Service Act (42 U.S.C. 262(i))), and funded by the 
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1498 
National Institutes of Health and conducted at any 
national research institute or national center, submit 
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; 
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1499 
(C) a detailed plan for how the clinical 
trial will achieve the goals specified under sub-
paragraph (A) that specifies— 
(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 
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1500 
(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 
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; 
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(v) allowing for weekend hours for re-
quired follow-up visits; 
(vi) allowing virtual or telemedicine 
visits; 
(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 Director 
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. 
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(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. 
(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, 
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1503 
primary written and spoken language, 
disability status, sexual orientation, 
socioeconomic status, occupation, and 
other relevant factors; and 
(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 to complete 
education and training programs on diver-
sity in clinical trials; and 
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(iv) at the conclusion of the trial, the 
sponsor submits to the Secretary the num-
ber 
of 
participants 
in 
the 
trial, 
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 sub-
section, 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— 
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(i) a summary of the disease being 
targeted in the clinical trial that is the 
subject of the application and the preva-
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 under subparagraph 
(A), the design of the study involved is not dis-
closed. 
(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— 
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(i) to develop, in consultation with the 
Secretary and advocacy and community- 
based organizations representing individ-
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 
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1507 
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 
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 
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1508 
subparagraph (A) that, after the close of 
the 60-day period referred to in subpara-
graph (A), continues to fail to meet the 
condition referred to in such subpara-
graph, the sponsor of such clinical trial 
may submit an application to the relevant 
program officer and grants specialist re-
questing a waiver of such condition. Such 
an application shall specify reasoning for 
why the recruitment of each of the popu-
lation 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. 
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1509 
(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). 
(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 after the 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 
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1510 
receiving funding through the National Insti-
tutes of Health— 
(i) that requested and received waiv-
ers under this subsection; or 
(ii) with respect to which funding has 
been terminated pursuant to this sub-
section. 
(8) STUDY.— 
(A) IN GENERAL.—The Comptroller Gen-
eral of the United States shall conduct a study 
that— 
(i) examines which actions Federal 
agencies have taken to address barriers to 
participation in federally funded clinical 
trials by the demographic groups specified 
in paragraph (1)(A); and 
(ii) identifies challenges, if any, in im-
plementing such actions. 
(B) REPORT.—Not later than 1 year after 
the date of the enactment of this Act, the 
Comptroller General of the United States shall 
submit to Congress a report on the findings of 
the study conducted under subparagraph (A). 
(9) NONDISCRIMINATION.—Section 1557 of the 
Patient Protection and Affordable Care Act (42 
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1511 
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 
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 
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1512 
(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 et seq.)) or 
biological product (as defined in section 351(i) of the 
Public Health Service Act (42 U.S.C. 262(i))) the 
Secretary shall require that the sponsor of such clin-
ical trial— 
(A) works with institutional review boards 
and program officers of the National Institutes 
of Health to determine when reimbursement for 
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-
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1513 
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, 
may require that, in order to receive pay-
ment or reimbursement as described in 
such paragraph, a participant complete an 
application and share with the sponsor 
such documentation of expenses described 
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1514 
in such paragraph, as the sponsor may re-
quire. 
(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 payment or reim-
bursements made to clinical trial participants 
under subparagraph (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 
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1515 
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 
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-
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1516 
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 
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 
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1517 
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, 
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). 
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1518 
(5) STAKEHOLDERS
SPECIFIED.—The stake-
holders specified in this paragraph are the following: 
(A) Representatives of the Health Re-
sources Services Administration, the Office on 
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 paragraph $10,000,000 for each of fiscal years 
2023 through 2026. 
(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 
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). 
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1519 
SEC. 7554. 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 new subsection: 
‘‘(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; 
‘‘(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 
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1520 
‘‘(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 2022, 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 2022.’’. 
(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of Health 
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. 
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1521 
Subtitle M—Additional Provisions 
Addressing High Impact Minor-
ity Diseases 
SEC. 7601. MEDICARE COVERAGE OF MULTI-CANCER EARLY 
DETECTION SCREENING TESTS. 
(a) COVERAGE.—Section 1861 of the Social Security 
Act (42 U.S.C. 1395x) is amended— 
(1) in subsection (s)(2)— 
(A) by striking ‘‘and’’ at the end of sub-
paragraph (GG); 
(B) by striking the period at the end of 
subparagraph (HH) and inserting ‘‘; and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(II) multi-cancer early detection screening 
tests (as defined in subsection (lll));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(lll) MULTI-CANCER EARLY DETECTION SCREEN-
ING
TESTS.—The term ‘multi-cancer early detection 
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 
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1522 
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 other 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(lll) 
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(lll)) for an individual if 
such a test was furnished to the individual during 
the previous 11 months.’’. 
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1523 
(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 de-
tection screening tests (as defined in section 
1861(lll)), 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-
fect coverage under part B for other cancer screen-
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1524 
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. 7602. 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.) is amended by adding at 
the end the following new section: 
‘‘SEC. 399V–7. 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 
that inform health care professionals and the public about 
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1525 
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 
2022 through 2026.’’. 
(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) is amended— 
(A) in subsection (s)(2)— 
(i) in subparagraph (GG), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (HH), by strik-
ing the period at the end and inserting ‘‘; 
and’’; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(II) peripheral artery disease screening 
tests furnished to at-risk beneficiaries (as such 
terms are defined in subsection (lll)).’’; and 
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1526 
(B) by adding at the end the following new 
subsection: 
‘‘(lll) 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 
smoking, hyperlipidemia, and hypertension) or a 
family history of peripheral artery disease; 
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1527 
‘‘(C) who is younger than 50 years of age with 
diabetes mellitus and one 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)(II) 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 
(C) by inserting after subparagraph (N) 
the following new subparagraph: 
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1528 
‘‘(O) Peripheral artery disease screening 
tests furnished to at risk-beneficiaries (as such 
terms are defined in subsection (lll)).’’. 
(3) PAYMENT.— 
(A) IN GENERAL.—Section 1833(a) of the 
Social Security Act (42 U.S.C. 1395l(a)) 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(lll))’’ after 
‘‘other than personalized prevention 
plan services (as defined in section 
1861(hhh)(1))’’; 
(II) by striking ‘‘and’’ before 
‘‘(DD)’’; and 
(III) by striking ‘‘such service,;’’ 
at the end and inserting the following: 
‘‘, and (EE) with respect to peripheral 
artery disease screening tests fur-
nished to at-risk beneficiaries (as such 
terms are defined in section 1861(lll)), 
the amount paid shall be 100 percent 
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1529 
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 
striking the comma at the end and in-
serting ‘‘; and’’; 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(lll)) 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)) is 
amended, in the first sentence— 
(i) by striking ‘‘and’’ before ‘‘(12)’’; 
and 
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1530 
(ii) by inserting ‘‘, and (13) 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(lll))’’ be-
fore 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(lll))’’ after ‘‘personal-
ized prevention plan services (as defined in 
section 1861(hhh)(1))’’. 
(D) CONFORMING
AMENDMENT.—Section 
1848(j)(3) of the Social Security Act (42 
U.S.C. 1395w–4(j)(3)) is amended by striking 
‘‘(2)(FF) (including administration of the 
health risk assessment) ,’’ and inserting 
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1531 
‘‘(2)(FF) (including administration of the 
health risk assessment), (2)(II)’’. 
(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)) is amended— 
(A) in subparagraph (O), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (P), by striking the 
semicolon at the end and inserting ‘‘, and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(Q) in the case of peripheral artery dis-
ease screening tests furnished to at-risk bene-
ficiaries (as such terms are defined in section 
1861(lll)), which are performed more frequently 
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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1532 
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, 2022. 
(c) MEDICAID COVERAGE OF PERIPHERAL ARTERY 
DISEASE SCREENING TESTS FURNISHED
TO AT-RISK 
BENEFICIARIES WITHOUT IMPOSITION OF COST SHARING 
REQUIREMENTS.— 
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1533 
(1) IN GENERAL.—Section 1905 of the Social 
Security Act (42 U.S.C. 1396d) is amended— 
(A) in subsection (a)— 
(i) in paragraph (30), by striking 
‘‘and’’ at the end; 
(ii) by redesignating paragraph (31) 
as paragraph (32); and 
(iii) by inserting after paragraph (30) 
the following new paragraph: 
‘‘(31) peripheral artery disease screening tests 
furnished to at-risk beneficiaries (as such terms are 
defined in subsection (hh)); and’’; and 
(B) by adding at the end the following new 
subsection: 
‘‘(hh) PERIPHERAL ARTERY DISEASE SCREENING 
TEST; AT-RISK BENEFICIARY.— 
‘‘(1) PERIPHERAL ARTERY DISEASE SCREENING 
TEST.—The term ‘peripheral artery disease screen-
ing test’ means— 
‘‘(A) noninvasive physiologic studies of ex-
tremity arteries (commonly referred to as ankle- 
brachial index testing); 
‘‘(B) arterial duplex scans of lower extrem-
ity arteries vascular; and 
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1534 
‘‘(C) such other items and services as the 
Secretary determines, in consultation with rel-
evant stakeholders, to be appropriate for 
screening for peripheral artery disease for at- 
risk beneficiaries. 
‘‘(2) AT-RISK BENEFICIARY.—The term ‘at-risk 
beneficiary’ means an individual enrolled under a 
State plan (or a waiver of such plan)— 
‘‘(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 atherosclerosis (such as diabetes mellitus, a 
history of smoking, hyperlipidemia, and hyper-
tension) or a family history of peripheral artery 
disease; 
‘‘(C) who is younger than 50 years of age 
with diabetes mellitus and one additional risk 
factor for atherosclerosis; or 
‘‘(D) with a known atherosclerotic disease 
in another vascular bed such as coronary, ca-
rotid, subclavian, renal, or mesenteric artery 
stenosis, or abdominal aortic aneurysm. 
‘‘(3) FREQUENCY.—The Secretary shall, in con-
sultation with appropriate organizations, establish 
standards regarding the frequency for peripheral ar-
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1535 
tery disease screening tests described in subsection 
(a)(31) for purposes of coverage under a State plan 
under this title.’’. 
(2) NO COST SHARING.— 
(A) IN GENERAL.—Subsections (a)(2) and 
(b)(2) of section 1916 of the Social Security 
Act (42 U.S.C. 1396o) are each amended— 
(i) in subparagraph (F), by striking 
‘‘or’’ at the end; 
(ii) in subparagraph (G), by striking 
‘‘; and’’ and inserting ‘‘, or’’; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(H) peripheral artery disease screening 
tests furnished to at-risk beneficiaries (as such 
terms are defined in section 1905(hh)); and’’. 
(B) APPLICATION TO ALTERNATIVE COST 
SHARING.—Section 1916A(b)(3)(B) of the So-
cial Security Act (42 U.S.C. 1396o–1(b)(3)(B)) 
is amended by adding at the end the following 
new clause: 
‘‘(xii) 
Peripheral 
artery 
disease 
screening tests furnished to at-risk bene-
ficiaries (as such terms are defined in sec-
tion 1905(hh)).’’. 
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1536 
(3) 
MANDATORY
COVERAGE.—Section 
1902(a)(10)(A) of the Social Security Act (42 
U.S.C. 1396a(a)(10)(A)) is amended by striking 
‘‘and (30)’’ and inserting ‘‘(30), and (31)’’. 
(4) CONFORMING AMENDMENTS.— 
(A) Section 1902(nn)(3) of the Social Se-
curity Act (42 U.S.C. 1396a(nn)(3)) is amend-
ed by striking ‘‘following paragraph (30)’’ and 
inserting ‘‘following paragraph (32)’’. 
(B) Section 1905(a) of the Social Security 
Act (42 U.S.C. 1396d(a)) is amended by strik-
ing ‘‘following paragraph (30)’’ and inserting 
‘‘following paragraph (32)’’. 
(d) REQUIREMENT FOR GROUP HEALTH PLANS AND 
HEALTH INSURANCE ISSUERS OFFERING GROUP OR IN-
DIVIDUAL HEALTH INSURANCE COVERAGE TO PROVIDE 
COVERAGE FOR PERIPHERAL ARTERY DISEASE SCREEN-
ING TESTS FURNISHED TO AT-RISK ENROLLEES WITH-
OUT IMPOSITION OF COST SHARING REQUIREMENTS.— 
(1) IN
GENERAL.—Subsection (a) of section 
2713 of the Public Health Service Act (42 U.S.C. 
300gg–13) is amended to read as follows: 
‘‘(a) COVERAGE
OF PREVENTIVE HEALTH SERV-
ICES.— 
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1537 
‘‘(1) IN GENERAL.—A group health plan and a 
health insurance issuer offering group or individual 
health insurance coverage shall, at a minimum, pro-
vide coverage for and shall not impose any cost shar-
ing requirements for— 
‘‘(A) evidence-based items or services that 
have in effect a rating of ‘A’ or ‘B’ in the cur-
rent recommendations of the United States Pre-
ventive Services Task Force; 
‘‘(B) immunizations that have in effect a 
recommendation from the Advisory Committee 
on Immunization Practices of the Centers for 
Disease Control and Prevention with respect to 
the individual involved; 
‘‘(C) with respect to infants, children, and 
adolescents, evidence-informed preventive care 
and screenings provided for in the comprehen-
sive guidelines supported by the Health Re-
sources and Services Administration; 
‘‘(D) with respect to women, such addi-
tional preventive care and screenings not de-
scribed in subparagraph (A) as provided for in 
comprehensive guidelines supported by the 
Health Resources and Services Administration 
for purposes of this subparagraph; and 
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1538 
‘‘(E) with respect to at-risk enrollees, pe-
ripheral artery disease screening tests. 
‘‘(2) PERIPHERAL ARTERY DISEASE SCREENING 
TEST; AT-RISK ENROLLEE.—For purposes of para-
graph (1)(E): 
‘‘(A) 
PERIPHERAL
ARTERY
DISEASE 
SCREENING TEST.—The term ‘peripheral artery 
disease screening test’ means— 
‘‘(i) noninvasive physiologic studies of 
extremity arteries (commonly referred to 
as ankle-brachial index testing); 
‘‘(ii) arterial duplex scans of lower ex-
tremity arteries vascular; and 
‘‘(iii) such other items and services as 
the Secretary determines, in consultation 
with relevant stakeholders, to be appro-
priate for screening for peripheral artery 
disease for at-risk enrollees. 
‘‘(B) AT-RISK ENROLLEE.—The term ‘at- 
risk enrollee’ means an individual enrolled in a 
group health plan or group or individual health 
insurance coverage— 
‘‘(i) who is 65 years of age or older; 
‘‘(ii) who is at least 50 years of age 
but not older than 64 years of age with 
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1539 
risk factors for atherosclerosis (such as di-
abetes mellitus, a history of smoking, 
hyperlipidemia, and hypertension) or a 
family history of peripheral artery disease; 
‘‘(iii) who is younger than 50 years of 
age with diabetes mellitus and one addi-
tional risk factor for atherosclerosis; or 
‘‘(iv) with a known atherosclerotic dis-
ease in another vascular bed such as coro-
nary, carotid, subclavian, renal, or mesen-
teric artery stenosis, or abdominal aortic 
aneurysm. 
‘‘(C) FREQUENCY.—The Secretary shall, 
in consultation with appropriate organizations, 
establish standards regarding the frequency for 
peripheral artery disease screening tests de-
scribed in paragraph (1)(E) for purposes of 
coverage under this section. 
‘‘(3) CLARIFICATION REGARDING BREAST CAN-
CER SCREENING, MAMMOGRAPHY, AND PREVENTION 
RECOMMENDATIONS.—For the purposes of this Act, 
and for the purposes of any other provision of law, 
the current recommendations of the United States 
Preventive Service Task Force regarding breast can-
cer screening, mammography, and prevention shall 
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1540 
be considered the most current other than those 
issued in or around November 2009. 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to prohibit a plan 
or issuer from providing coverage for services in ad-
dition to those recommended by the United States 
Preventive Services Task Force or to deny coverage 
for services that are not recommended by such Task 
Force.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply with respect to plan 
years beginning on or after January 1, 2022. 
(e) DISALLOWANCE
OF PAYMENT
FOR NONTRAU-
MATIC AMPUTATION SERVICES FURNISHED WITHOUT 
ANATOMICAL TESTING SERVICES.—Section 1834 of the 
Social Security Act (42 U.S.C. 1395m) is amended by 
adding at the end the following new subsection: 
‘‘(z) DISALLOWANCE OF PAYMENT FOR NONTRAU-
MATIC AMPUTATION SERVICES FURNISHED WITHOUT 
ANATOMICAL TESTING SERVICES.— 
‘‘(1) IN
GENERAL.—In the case of nontrau-
matic amputation services furnished by a supplier on 
or after January 1, 2022, to an individual entitled 
to, or enrolled for, benefits under part A and en-
rolled for benefits under this part, for which pay-
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1541 
ment is made under this part, payment may only be 
made under this part if— 
‘‘(A) such supplier furnishes anatomical 
testing services to such individual during the 3- 
month period preceding the date on which such 
nontraumatic amputation services is furnished; 
or 
‘‘(B) such individual has a pre-existing 
dysfunctional or unsalvageable limb, life-threat-
ening sepsis, intractable infection, extensive 
gangrene or necrotic tissue loss beyond salvage, 
a poor functional status, severe dementia, or a 
short life expectancy after shared decision-mak-
ing with a health care team and patient, family, 
or caregiver. 
‘‘(2) DEFINITIONS.—In this subsection: 
‘‘(A) ANATOMICAL
TESTING
SERVICES.— 
The term ‘anatomical testing services’ means 
arterial duplex scanning, computed tomography 
angiography, 
and 
magnetic 
resonance 
angiography. 
‘‘(B) NONTRAUMATIC AMPUTATION SERV-
ICES.—The term ‘nontraumatic amputation 
services’ means amputations as a result of ath-
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1542 
erosclerotic vascular disease or a related comor-
bidity of such disease (including diabetes).’’. 
(f) DEVELOPMENT AND IMPLEMENTATION OF QUAL-
ITY MEASURES.— 
(1) DEVELOPMENT.—The Secretary of Health 
and Human Services (referred to in this subsection 
as the ‘‘Secretary’’) shall, in consultation with rel-
evant stakeholders, develop quality measures for 
nontraumatic, lower-limb, major amputation that 
utilize appropriate diagnostic screening (including 
peripheral artery disease screening) in order to en-
courage 
alternative 
treatments 
(including 
revascularization) in lieu of such an amputation. 
(2) IMPLEMENTATION.—After appropriate test-
ing and validation of the measures developed under 
paragraph (1), the Secretary shall incorporate such 
measures in quality reporting programs for appro-
priate providers of services and suppliers under the 
Medicare program under title XVIII of the Social 
Security Act (42 U.S.C. 1395 et seq.), including for 
purposes of— 
(A) the merit-based incentive payment sys-
tem under section 1848(q) of such Act (42 
U.S.C. 1395w–4(q)); 
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1543 
(B) incentive payments for participation in 
eligible alternative payment models under sec-
tion 1833(z) of such Act (42 U.S.C. 1395l(z)); 
(C) the shared savings program under sec-
tion 1899 of such Act (42 U.S.C. 1395jjj); 
(D) models under section 1115A of such 
Act (42 U.S.C. 1315a); and 
(E) such other payment systems or models 
as the Secretary may specify. 
SEC. 7603. ELIMINATING THE COINSURANCE REQUIRE-
MENT FOR CERTAIN COLORECTAL CANCER 
SCREENING TESTS FURNISHED UNDER THE 
MEDICARE PROGRAM. 
Section 1833(dd) of the Social Security Act (42 
U.S.C. 1395l(dd)) is amended— 
(1) in paragraph (1), by striking ‘‘and before 
January 1, 2030,’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A), by adding ‘‘and’’ 
at the end; 
(B) in subparagraph (B), by striking 
‘‘through 2026, 85 percent; and’’ and inserting 
‘‘and each subsequent year, 100 percent.’’; and 
(C) by striking subparagraph (C). 
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1544 
SEC. 7604. EXPANDING THE AVAILABILITY OF MEDICAL NU-
TRITION THERAPY SERVICES UNDER THE 
MEDICARE PROGRAM. 
(a) IN GENERAL.—Section 1861 of the Social Secu-
rity Act (42 U.S.C. 1395x) is amended— 
(1) in subsection (s)(2)(V), by striking ‘‘in the 
case of’’ and all that follows through ‘‘organiza-
tions’’; and 
(2) in subsection (vv)— 
(A) in paragraph (1)— 
(i) by striking ‘‘disease management’’ 
and inserting ‘‘the prevention, manage-
ment, or treatment of a disease or condi-
tion specified in paragraph (4)’’; and 
(ii) by striking ‘‘by a physician’’ and 
all that follows through the period at the 
end and inserting the following: ‘‘by a— 
‘‘(A) physician (as defined in subsection 
(r)(1)); 
‘‘(B) physician assistant; 
‘‘(C) nurse practitioner; 
‘‘(D) clinical nurse specialist (as defined in 
subsection (aa)(5)(B)); or 
‘‘(E) in the case of such services furnished 
to manage such a disease or condition that is 
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1545 
an eating disorder, a clinical psychologist (as 
defined by the Secretary). 
Such term shall not include any services furnished 
to an individual for the prevention, management, or 
treatment of a renal disease if such individual is re-
ceiving maintenance dialysis for which payment is 
made under section 1881.’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(4) For purposes of paragraph (1), the diseases and 
conditions specified in this paragraph are the following: 
‘‘(A) Diabetes and prediabetes. 
‘‘(B) A renal disease. 
‘‘(C) Obesity (as defined for purposes of sub-
section (yy)(2)(C) or as otherwise defined by the 
Secretary). 
‘‘(D) Hypertension. 
‘‘(E) Dyslipidemia. 
‘‘(F) Malnutrition. 
‘‘(G) Eating disorders. 
‘‘(H) Cancer. 
‘‘(I) Gastrointestinal diseases, including celiac 
disease. 
‘‘(J) HIV. 
‘‘(K) AIDS. 
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1546 
‘‘(L) Cardiovascular disease. 
‘‘(M) Any other disease or condition— 
‘‘(i) specified by the Secretary relating to 
unintentional weight loss; 
‘‘(ii) for which the Secretary determines 
the services described in paragraph (1) to be 
medically necessary and appropriate for the 
prevention, management, or treatment of such 
disease or condition, consistent with any appli-
cable recommendations of the United States 
Preventive Services Task Force; or 
‘‘(iii) for which the Secretary determines 
the services described in paragraph (1) are 
medically necessary, consistent with either pro-
tocols established by registered dietitians or nu-
trition professional organizations or with ac-
cepted clinical guidelines identified by the Sec-
retary.’’. 
(b) EXCLUSION MODIFICATION.—Section 1862(a)(1) 
is amended— 
(1) in subparagraph (O), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (P), by striking the semi-
colon at the end and inserting ‘‘, and’’; and 
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1547 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(Q) in the case of medical nutrition therapy 
services (as defined in section 1861(vv)), which are 
not furnished for the prevention, management, or 
treatment of a disease or condition specified in para-
graph (4) of such section;’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply with respect to items and services 
furnished on or after January 1, 2023. 
SEC. 7605. ENCOURAGING THE DEVELOPMENT AND USE OF 
DISARM ANTIMICROBIAL DRUGS. 
(a) ADDITIONAL PAYMENT
FOR DISARM ANTI-
MICROBIAL DRUGS UNDER MEDICARE.— 
(1) IN GENERAL.—Section 1886(d)(5) of the 
Social Security Act (42 U.S.C. 1395ww(d)(5)) is 
amended by adding at the end the following new 
subparagraph: 
‘‘(N)(i)(I) Effective for discharges beginning on or 
after October 1, 2021, or such sooner date as specified 
by the Secretary, subject to subclause (II), the Secretary 
shall, after notice and opportunity for public comment (in 
the publications required by subsection (e)(5) for a fiscal 
year or otherwise), provide for an additional payment 
under a mechanism (separate from the mechanism estab-
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1548 
lished under subparagraph (K)), with respect to such dis-
charges involving any DISARM antimicrobial drug, in an 
amount equal to— 
‘‘(aa) the amount payable under section 1847A 
for such drug during the calendar quarter in which 
the discharge occurred; or 
‘‘(bb) if no amount for such drug is determined 
under section 1847A, an amount to be determined 
by the Secretary in a manner similar to the manner 
in which payment amounts are determined under 
section 1847A based on information submitted by 
the manufacturer or sponsor of such drug (as re-
quired under clause (v)). 
‘‘(II) In determining the amount payable under sec-
tion 1847A for purposes of items (aa) and (bb) of sub-
clause (I), subparagraphs (A) and (B) of subsection (b)(1) 
of such section shall be applied by substituting ‘102 per-
cent’ for ‘106 percent’ each place it appears and para-
graph (8)(B) of such section shall be applied by sub-
stituting ‘2 percent’ for ‘6 percent’. 
‘‘(ii) For purposes of this subparagraph, a DISARM 
antimicrobial drug is— 
‘‘(I) a drug— 
‘‘(aa) that— 
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1549 
‘‘(AA) is approved by the Food and 
Drug Administration; 
‘‘(BB) is designated by the Food and 
Drug Administration as a qualified infec-
tious disease product under subsection (d) 
of section 505E of the Federal Food, 
Drug, and Cosmetic Act; and 
‘‘(CC) has received an extension of its 
exclusivity period pursuant to subsection 
(a) of such section; and 
‘‘(bb) that has been designated by the Sec-
retary pursuant to the process established 
under clause (iv)(I)(bb); or 
‘‘(II) an antibacterial or antifungal biological 
product— 
‘‘(aa) that is licensed for use, or an anti-
bacterial or antifungal biological product for 
which an indication is first licensed for use, by 
the Food and Drug Administration on or after 
June 5, 2014, under section 351(a) of the Pub-
lic Health Service Act for human use to treat 
serious or life-threatening infections, as deter-
mined by the Food and Drug Administration, 
including those caused by, or likely to be caused 
by— 
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1550 
‘‘(AA) an antibacterial or antifungal 
resistant pathogen, including novel or 
emerging infectious pathogens; or 
‘‘(BB) a qualifying pathogen (as de-
fined under section 505E(f) of the Federal 
Food, Drug, and Cosmetic Act); and 
‘‘(bb) has been designated by the Secretary 
pursuant to the process established under 
clause (iv)(I)(bb). 
‘‘(iii) The mechanism established pursuant to clause 
(i) shall provide that the additional payment under clause 
(i) shall— 
‘‘(I) with respect to a discharge, only be made 
to a subsection (d) hospital that, as determined by 
the Secretary— 
‘‘(aa) is participating in the National 
Healthcare Safety Network Antimicrobial Use 
and Resistance Module of the Centers for Dis-
ease Control and Prevention; and 
‘‘(bb) has an antimicrobial stewardship 
program that aligns with the Core Elements of 
Hospital Antibiotic Stewardship Programs of 
the Centers for Disease Control and Prevention 
or the Antimicrobial Stewardship Standard set 
by the Joint Commission; and 
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1551 
‘‘(II) apply to discharges occurring on or after 
October 1 of the year in which the drug or biological 
product is designated by the Secretary as a DIS-
ARM antimicrobial drug. 
For purposes of this clause, in the case of a similar report-
ing program described in item (aa), a subsection (d) hos-
pital shall be treated as participating in such a program 
if the entity maintaining such program identifies to the 
Secretary such hospital as so participating. 
‘‘(iv)(I) The mechanism established pursuant to 
clause (i) shall provide for a process for— 
‘‘(aa) a manufacturer or sponsor of a drug or 
biological product to request the Secretary to des-
ignate the drug or biological product as a DISARM 
antimicrobial drug; and 
‘‘(bb) the designation (and removal of such des-
ignation) by the Secretary of drugs and biological 
products as DISARM antimicrobial drugs. 
‘‘(II) A designation of a drug or biological product 
as a DISARM antimicrobial drug may be revoked by the 
Secretary if the Secretary determines that— 
‘‘(aa) the drug or biological product no longer 
meets the requirements for a DISARM antimicrobial 
drug under clause (ii); 
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1552 
‘‘(bb) the request for such designation con-
tained an untrue statement of material fact; or 
‘‘(cc) clinical or other information that was not 
available to the Secretary at the time such designa-
tion was made shows that— 
‘‘(AA) such drug or biological product is 
unsafe for use or not shown to be safe for use 
for individuals who are entitled to benefits 
under part A; or 
‘‘(BB) an alternative to such drug or bio-
logical product is an advance that substantially 
improves the diagnosis or treatment of such in-
dividuals. 
‘‘(III) Not later than October 1, 2021, the Secretary 
shall publish in the Federal Register a list of the DISARM 
antimicrobial drugs designated under this subparagraph 
pursuant to the process established under subclause 
(I)(bb). The Secretary shall annually update such list. 
‘‘(v)(I) For purposes of determining additional pay-
ment amounts under clause (i), a manufacturer or sponsor 
of a drug or biological product that submits a request de-
scribed in clause (iv)(I)(aa) shall submit to the Secretary 
information described in section 1927(b)(3)(A)(iii). 
‘‘(II) The penalties for failure to provide timely infor-
mation under clause (i) of subparagraph (C) section 
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1553 
1927(b)(3) and for providing false information under 
clause (ii) of such subparagraph shall apply to manufac-
turers and sponsors of a drug or biological product under 
this section with respect to information under subclause 
(I) in the same manner as such penalties apply to manu-
facturers under such clauses with respect to information 
under subparagraph (A) of such section. 
‘‘(vi)(I) The mechanism established pursuant to 
clause (i) shall provide that— 
‘‘(aa) except as provided in item (bb), no addi-
tional payment shall be made under this subpara-
graph for discharges involving a DISARM anti-
microbial drug if any additional payments have been 
made for discharges involving such drug as a new 
medical service or technology under subparagraph 
(K); 
‘‘(bb) additional payments may be made under 
this subparagraph for discharges involving a DIS-
ARM antimicrobial drug if any additional payments 
have been made for discharges occurring prior to the 
date of enactment of this subparagraph involving 
such drug as a new medical service or technology 
under subparagraph (K); and 
‘‘(cc) no additional payment shall be made 
under subparagraph (K) for discharges involving a 
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1554 
DISARM antimicrobial drug as a new medical serv-
ice or technology if any additional payments for dis-
charges involving such drug have been made under 
this subparagraph.’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
1886(d)(5)(K)(ii)(III) of the Social Security Act (42 
U.S.C. 1395ww(d)(5)(K)(ii)(III)) is amended by 
striking ‘‘provide’’ and inserting ‘‘subject to sub-
paragraph (N)(vii), provide’’. 
(b) AUTHORIZATION OF APPROPRIATIONS FOR THE 
CENTERS FOR DISEASE CONTROL AND PREVENTION.— 
There is authorized to be appropriated to the Centers for 
Disease Control and Prevention $500,000,000, to remain 
available until expended, to support establishment and im-
plementation of antimicrobial stewardship programs and 
data reporting capabilities to the Antimicrobial Use and 
Resistance option of the CDC National Healthcare Safety 
Network, especially in critical access hospitals, rural hos-
pitals, and community hospitals, to support detection, sur-
veillance, containment, and prevention of resistant patho-
gens in the United States and overseas. 
(c) STUDY AND REPORTS ON REMOVING BARRIERS 
TO
THE DEVELOPMENT
OF DISARM ANTIMICROBIAL 
DRUGS.— 
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1555 
(1) STUDY.—The Comptroller General of the 
United States (in this subsection referred to as the 
‘‘Comptroller General’’) shall, in consultation with 
the Director of the National Institutes of Health, 
the Commissioner of Food and Drugs, the Adminis-
trator of the Centers for Medicare & Medicaid Serv-
ices, and the Director of the Centers for Disease 
Control and Prevention, conduct a study over a 5- 
year period of the barriers that prevent the develop-
ment of DISARM antimicrobial drugs (as defined in 
section 1886(d)(5)(N)(ii) of the Social Security Act, 
as added by subsection (a)), including— 
(A) patient outcomes in conjunction with 
the use of DISARM drugs, including— 
(i) duration of stay in the intensive 
care unit; 
(ii) recidivism within 30 days; and 
(iii) measures of additional follow up 
care; 
(B) the effectiveness of antimicrobial stew-
ardship and surveillance programs, including— 
(i) changes in the percentage of hos-
pitals in the United States with an anti-
microbial stewardship program in place 
that aligns with the Core Elements of Hos-
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1556 
pital Antibiotic Stewardship Programs, as 
outlined by the Centers for Disease Control 
and Prevention; 
(ii) changes in inpatient care of 
clostridioides difficile infection; and 
(iii) changes in inpatient rates of re-
sistance to key pathogens; and 
(C) considerations relating to Medicare 
payment reform, including— 
(i) changes in the number of qualified 
antimicrobial products approved; 
(ii) changes in wholesale acquisition 
cost of individual qualified antimicrobial 
products over time; 
(iii) changes in year-over-year volume 
of individual qualified antimicrobial prod-
ucts sold; and 
(iv) the overall cost of qualified anti-
microbial products to the Medicare pro-
gram as a proportion of total Medicare 
part A spending. 
(2) REPORT.—Not later than 5 years after the 
date of the enactment of this section, the Comp-
troller General shall submit to Congress a report 
containing the results of the study conducted under 
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