1464 
rector of the National Institutes of Health, the Com-
missioner of Food and Drugs, the Administrator of 
the Centers for Medicare & Medicaid Services, and 
the Director of the Centers for Disease Control and 
Prevention, shall conduct a study over a 5-year pe-
riod of the barriers that prevent the development 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-
pital Antibiotic Stewardship Programs, as 
outlined by the Centers for Disease Control 
and Prevention; 
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(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 
paragraph (1), together with recommendations for 
such legislation and administrative action as the 
Comptroller General determines appropriate. 
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SEC. 7901C–5. TREAT AND REDUCE OBESITY ACT. 
(a) AUTHORITY TO EXPAND HEALTH CARE PRO-
VIDERS QUALIFIED TO FURNISH INTENSIVE BEHAVIORAL 
THERAPY.—Section 1861(ddd) of the Social Security Act 
(42 U.S.C. 1395x(ddd)) is amended by adding at the end 
the following new paragraph: 
‘‘(4)(A) Subject to subparagraph (B), the Sec-
retary may, in addition to qualified primary care 
physicians and other primary care practitioners, 
cover intensive behavioral therapy for obesity fur-
nished by any of the following: 
‘‘(i) A physician (as defined in subsection 
(r)(1)) who is not a qualified primary care phy-
sician. 
‘‘(ii) Any other appropriate health care 
provider (including a physician assistant, nurse 
practitioner, or clinical nurse specialist (as 
those terms are defined in subsection (aa)(5)), 
a clinical psychologist, a registered dietitian or 
nutrition professional (as defined in subsection 
(vv))). 
‘‘(iii) An evidence-based, community-based 
lifestyle counseling program approved by the 
Secretary. 
‘‘(B) In the case of intensive behavioral therapy 
for obesity furnished by a provider described in 
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clause (ii) or (iii) of subparagraph (A), the Secretary 
may only cover such therapy if such therapy is fur-
nished— 
‘‘(i) upon referral from, and in coordina-
tion with, a physician or primary care practi-
tioner operating in a primary care setting or 
any other setting specified by the Secretary; 
and 
‘‘(ii) in an office setting, a hospital out-
patient department, a community-based site 
that complies with the Federal regulations con-
cerning the privacy of individually identifiable 
health information promulgated under section 
264(c) of the Health Insurance Portability and 
Accountability Act of 1996, or another setting 
specified by the Secretary. 
‘‘(C) In order to ensure a collaborative effort, 
the coordination described in subparagraph (B)(i) 
shall include the health care provider or lifestyle 
counseling program communicating to the referring 
physician or primary care practitioner any rec-
ommendations or treatment plans made regarding 
the therapy.’’. 
(b) MEDICARE PART D COVERAGE
OF OBESITY 
MEDICATION.— 
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(1) IN
GENERAL.—Section 1860D–2(e)(2)(A) 
of the Social Security Act (42 U.S.C. 1395w– 
102(e)(2)(A)) is amended, in the first sentence— 
(A) by striking ‘‘and other than’’ and in-
serting ‘‘other than’’; and 
(B) by inserting after ‘‘benzodiazepines),’’ 
the following: ‘‘and other than subparagraph 
(A) of such section if the drug is used for the 
treatment of obesity (as defined in section 
1861(yy)(2)(C)) or for weight loss management 
for an individual who is overweight (as defined 
in section 1861(yy)(2)(F)(i)) and has 1 or more 
related comorbidities,’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall apply to plan years beginning 
on or after the date that is 2 years after the date 
of the enactment of this section. 
(c) REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than the date that 
is 1 year after the date of the enactment of this sec-
tion, and every 2 years thereafter, the Secretary of 
Health and Human Services shall submit a report to 
Congress describing the steps the Secretary has 
taken to implement the provisions of, and amend-
ments made by, this section. 
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(2) RECOMMENDATIONS.—Such report shall 
also include recommendations for better coordination 
and leveraging of programs within the Department 
of Health and Human Services and other Federal 
agencies that relate in any way to supporting appro-
priate research and clinical care (such as any inter-
actions between physicians and other health care 
providers and their patients) to treat, reduce, and 
prevent obesity in the adult population. 
SEC. 7901C–6. INCENTIVES, IMPROVEMENTS, AND OUT-
REACH TO INCREASE DIVERSITY IN ALZ-
HEIMER’S DISEASE RESEARCH. 
(a) IMPROVING ACCESS
FOR
AND OUTREACH
TO 
UNDERREPRESENTED POPULATIONS.— 
(1) EXPANDING ACCESS TO ALZHEIMER’S RE-
SEARCH CENTERS.— 
(A) IN
GENERAL.—Section 445(a)(1) of 
the Public Health Service Act (42 U.S.C. 285e– 
2(a)(1)) is amended— 
(i) by striking ‘‘(a)(1) The Director of 
the Institute may’’ and inserting the fol-
lowing: 
‘‘(a)(1) The Director of the Institute— 
‘‘(A) may’’; 
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(ii) by striking ‘‘disease.’’ and insert-
ing ‘‘disease; and’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(B) beginning January 1, 2024, shall enter 
into cooperative agreements and make grants to 
public or private nonprofit entities under this sub-
section for the planning, establishment, and oper-
ation of new such centers that are located in areas 
with a higher concentration of minority groups (as 
determined under section 444(d)(3)(D)), such as en-
tities that are historically Black colleges and univer-
sities, Hispanic-serving institutions, Tribal colleges 
and universities, or centers of excellence for other 
minority populations.’’. 
(B) USE OF FUNDING FOR CLINICS TO OP-
ERATE
CLINICAL
TRIALS.—Section 445(b) of 
the Public Health Service Act (42 U.S.C. 285e– 
2(b)) is amended by adding at the end the fol-
lowing: 
‘‘(3) Federal payments made under a cooperative 
agreement or grant under subsection (a) from funds made 
available under section 7901C–6(g) of the Health Equity 
and Accountability Act of 2024 shall, with respect to Alz-
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1471 
heimer’s disease, be used in part to establish and operate 
diagnostic and treatment clinics designed— 
‘‘(A) to meet the special needs of minority and 
rural populations and other underserved populations; 
and 
‘‘(B) to operate clinical trials.’’. 
(2) OUTREACH.— 
(A) ALZHEIMER’S
DISEASE
CENTERS.— 
Section 445(b) of the Public Health Service Act 
(42 U.S.C. 285e–2(b)), as amended by para-
graph (1)(B), is amended by adding at the end 
the following: 
‘‘(4) Federal payments made under a cooperative 
agreement or grant under subsection (a) shall be used to 
establish engagement centers to carry out public outreach, 
education efforts, and dissemination of information for 
members of minority groups about clinical trial participa-
tion. Activities funded pursuant to the preceding sentence 
shall include— 
‘‘(A) using established mechanisms to encour-
age members of minority groups to participate in 
clinical trials on Alzheimer’s disease; 
‘‘(B) expanding education efforts to make mem-
bers of minority groups aware of ongoing clinical 
trials; 
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‘‘(C) working with trial sponsors to increase the 
number of recruitment events for members of minor-
ity groups; 
‘‘(D) conducting outreach to national, State, 
and local physician professional organizations, espe-
cially for members of such organizations who are 
primary care physicians or physicians who specialize 
in dementia, to increase awareness of clinical re-
search opportunities for members of minority 
groups; and 
‘‘(E) using community-based participatory re-
search methodologies to engage with minority popu-
lations.’’. 
(B) RESOURCE
CENTERS
FOR
MINORITY 
AGING RESEARCH.—Section 444(c) of the Pub-
lic Health Service Act (42 U.S.C. 285e–1(c)) is 
amended— 
(i) by striking ‘‘(c) The Director’’ and 
inserting ‘‘(c)(1) The Director’’; and 
(ii) by adding at the end the following 
new paragraph: 
‘‘(2) The Director of the Institute, acting through the 
Resource Centers for Minority Aging Research of the In-
stitute, shall carry out public outreach, education efforts, 
and dissemination of information for members of minority 
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groups about participation in clinical research on Alz-
heimer’s disease carried out or supported under this sub-
part.’’. 
(b) INCENTIVES TO INCREASE DIVERSITY IN ALZ-
HEIMER’S DISEASE RESEARCH THROUGH PRINCIPAL IN-
VESTIGATORS
AND
RESEARCHERS
FROM
UNDERREP-
RESENTED POPULATIONS.— 
(1) ALZHEIMER’S
CLINICAL
RESEARCH
AND 
TRAINING
AWARDS.—Section 445I of the Public 
Health Service Act (42 U.S.C. 285e–10a) is amend-
ed by adding at the end the following: 
‘‘(d) ENHANCING THE PARTICIPATION OF PRINCIPAL 
INVESTIGATORS AND RESEARCHERS WHO ARE MEMBERS 
OF UNDERREPRESENTED POPULATIONS.— 
‘‘(1) IN GENERAL.—The Director of the Insti-
tute shall enhance diversity in the conduct or sup-
port of clinical research on Alzheimer’s disease 
under this subpart by encouraging the participation 
of individuals from groups that are underrepresented 
in the biomedical, clinical, behavioral, and social 
sciences as principal investigators of such clinical re-
search, as researchers for such clinical research, or 
both. 
‘‘(2) TRAINING
FOR
PRINCIPAL
INVESTIGA-
TORS.—The Director of the Institute shall provide 
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training for principal investigators who are members 
of a minority group with respect to skills for— 
‘‘(A) the design and conduct of clinical re-
search and clinical protocols; 
‘‘(B) applying for grants for clinical re-
search; and 
‘‘(C) such other areas as the Director of 
the Institute determines to be appropriate.’’. 
(2) SENIOR
RESEARCHER
AWARDS.—Section 
445B(a) of the Public Health Service Act (42 
U.S.C. 285e–4(a)) is amended by inserting ‘‘, in-
cluding senior researchers who are members of a mi-
nority group’’ before the period at the end of the 
first sentence. 
(c) INCENTIVES TO INCREASE DIVERSITY IN ALZ-
HEIMER’S DISEASE RESEARCH THROUGH TRIAL SITES.— 
Section 444(d) of the Public Health Service Act (42 
U.S.C. 285e–1(d)) is amended— 
(1) by striking ‘‘(d) The Director’’ and insert-
ing ‘‘(d)(1) The Director’’; and 
(2) by adding at the end the following: 
‘‘(2) In conducting or supporting clinical research on 
Alzheimer’s disease for purposes of this subpart, in addi-
tion to requirements otherwise imposed under this title, 
including under section 492B, the Director of the Institute 
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shall increase the participation of members of minority 
groups in such clinical research through one or more of 
the activities described in paragraph (3). 
‘‘(3)(A) The Director of the Institute shall provide 
incentives for the support of clinical research on Alz-
heimer’s disease with clinical trial sites established in 
areas with a higher concentration of minority groups, in-
cluding rural areas if practicable. 
‘‘(B) In determining whether to conduct or support 
clinical research on Alzheimer’s disease, the Director of 
the Institute shall encourage the conduct of clinical re-
search with clinical trial sites in areas described in sub-
paragraph (A) as a higher-level priority criterion among 
the criteria established to evaluate whether to conduct or 
support clinical research. 
‘‘(C) In determining the amount of funding to be pro-
vided for the conduct or support of such clinical research, 
the Director of the Institute shall provide additional fund-
ing for the conduct of such clinical research with clinical 
trial sites in areas described in subparagraph (A). 
‘‘(D) In determining whether an area is an area with 
a higher concentration of minority groups, the Director 
of the Institute— 
‘‘(i) shall consider the most recent data col-
lected by the Bureau of the Census; and 
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‘‘(ii) may also consider— 
‘‘(I) data from the Centers for Medicare & 
Medicaid Services on the incidence of Alz-
heimer’s disease in the United States by region; 
and 
‘‘(II) such other data as the Director de-
termines appropriate. 
‘‘(4) In order to facilitate the participation of mem-
bers of minority groups in clinical research supported 
under this subpart, in addition to activities described in 
paragraph (3), the Director of the Institute shall— 
‘‘(A) ensure that such clinical research uses 
community-based participatory research methodolo-
gies; and 
‘‘(B) encourage the use of remote health tech-
nologies, including telehealth, remote patient moni-
toring, and mobile technologies, that reduce or elimi-
nate barriers to participation of members of minor-
ity groups in such clinical research. 
‘‘(5)(A) Clinical research on Alzheimer’s disease con-
ducted or supported under this subpart shall ensure that 
such research includes outreach activities designed to in-
crease the participation of members of minority groups in 
such research. 
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‘‘(B)(i) Each applicant for a grant under this subpart 
for clinical research on Alzheimer’s disease shall submit 
to the Director of the Institute in the application for such 
grant— 
‘‘(I) a budget for outreach activities to members 
of minority populations with respect to participation 
in such clinical research; and 
‘‘(II) a description of the plan to conduct such 
outreach. 
‘‘(ii) The Director of the Institute shall encourage ap-
plicants for, and recipients of, grants under this subpart 
to conduct clinical research on Alzheimer’s disease to en-
gage with community-based organizations to increase par-
ticipation of minority populations in such research. 
‘‘(6) For purposes of this subpart: 
‘‘(A) The term ‘clinical research’ includes a 
clinical trial. 
‘‘(B) The term ‘minority group’ has the mean-
ing given such term under section 492B(g).’’. 
(d) PARTICIPANT ELIGIBILITY CRITERIA.—Section 
445I of the Public Health Service Act (42 U.S.C. 285e– 
10a), as amended by subsection (b)(1), is amended by 
adding at the end the following: 
‘‘(e) PARTICIPANT ELIGIBILITY CRITERIA.—The Di-
rector of the Institute shall take such actions as are nec-
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essary to ensure that clinical research on Alzheimer’s dis-
ease conducted or supported under this subpart is de-
signed with eligibility criteria that ensure the clinical trial 
population reflects the diversity of the prospective patient 
population. Such actions may include the following: 
‘‘(1) EXAMINATION OF CRITERIA.— 
‘‘(A) IN
GENERAL.—An examination of 
each exclusion criterion to determine if the cri-
terion is necessary to ensure the safety of trial 
participants or to achieve the study objectives. 
‘‘(B) MODIFICATION OF CRITERIA.—In the 
case of an exclusion criterion that is not nec-
essary to ensure the safety of trial participants 
or to achieve the study objectives— 
‘‘(i) encouraging the modification or 
elimination of the criterion; or 
‘‘(ii) encouraging tailoring the cri-
terion as narrowly as possible to avoid un-
necessary limits to the population of the 
clinical study. 
‘‘(2) REQUIREMENT
FOR
STRONG
JUSTIFICA-
TION FOR EXCLUSION.—A review of each exclusion 
criterion to ensure that populations are included in 
clinical trials, such as older adults, individuals with 
a mild form of disease, individuals at the extremes 
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of the weight range, or children, unless there is a 
strong clinical or scientific justification to exclude 
them. 
‘‘(3) USE OF ADAPTIVE DESIGN.—Encouraging 
the use of an adaptive clinical trial design that— 
‘‘(A) starts with a defined population 
where there are concerns about safety; and 
‘‘(B) may expand to a broader population 
based on initial data from the trial and external 
data.’’. 
(e) RESOURCE CENTER FOR SUCCESSFUL STRATE-
GIES
TO
INCREASE
PARTICIPATION
OF
UNDERREP-
RESENTED
POPULATIONS
IN
ALZHEIMER’S
DISEASE 
CLINICAL RESEARCH.—Section 444 of the Public Health 
Service Act (42 U.S.C. 285e–1) is amended by adding at 
the end the following: 
‘‘(e)(1) The Director of the Institute, acting through 
the Office of Special Populations and in consultation with 
the Division of Extramural Activities, shall support re-
source information and technical assistance to grantees 
under section 445 (relating to Alzheimer’s disease cen-
ters), other grantees, and prospective grantees, designed 
to increase the participation of minority populations in 
clinical research on Alzheimer’s disease conducted or sup-
ported under this subpart. 
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(B) All recipients of such grants, con-
tracts, and cooperative agreements during such 
period. 
(C) All members of the peer review panels 
of such applicants and recipients, respectively. 
(2) REPORT.—Not later than 6 months after 
the date of enactment of this Act, the Comptroller 
General shall complete the study under paragraph 
(1) and submit to Congress a report containing the 
results of such study. 
(b) NIH REPORT ON CERTAIN AUTHORITY OF NA-
TIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH 
DISPARITIES.—Not later than 6 months after the date of 
enactment of this Act, and biennially thereafter, the Direc-
tor of the National Institutes of Health, in collaboration 
with the Director of the National Institute on Minority 
Health and Health Disparities, shall submit to Congress 
a report that details and evaluates— 
(1) the steps taken during the applicable report 
period by the Director of the National Institutes of 
Health to plan, coordinate, review, and evaluate all 
minority health and health disparity research that is 
conducted or supported by the institutes and centers 
at the National Institutes of Health; and 
(2) the outcomes of such steps. 
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(D) business, industry, and agriculture; 
and 
(E) land-use plans, projects, and policies 
that impact the physical or social characteris-
tics of a community, including access to services 
and amenities. 
(4) DETERMINANTS
OF
HEALTH.—The term 
‘‘determinants of health’’— 
(A) means the range of nonclinical factors 
inclusive of personal, social, economic, and envi-
ronmental factors that directly influence health 
status; and 
(B) includes social determinants of health. 
(5) ECONOMIC DETERMINANTS OF HEALTH.— 
The term ‘‘economic determinants of health’’ means 
income and social status. 
(6) 
ENVIRONMENTAL
DETERMINANTS
OF 
HEALTH.—The term ‘‘environmental determinants 
of health’’ means the broad physical (including man-
made and natural), psychological, social, spiritual, 
cultural, and aesthetic environment. 
(7) PERSONAL DETERMINANTS OF HEALTH.— 
The term ‘‘personal determinants of health’’ means 
an individual’s behavior, biology, and genetics. 
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