1185 
an investigational drug, as compared to the risk of 
morbidity and death from the disease, indicates that 
a patient may obtain more benefit than risk if treat-
ed with the drug’’. 
(4) CDC.—Title XV of the Public Health Serv-
ice Act (42 U.S.C. 300k et seq.) is amended by add-
ing at the end the following: 
‘‘SEC. 1511. EARLY DISEASE RESEARCH AND MANAGEMENT 
PROGRAM. 
‘‘The Secretary shall establish and implement an 
early disease research and management program targeted 
at the high incidence and mortality rates of lung cancer 
among minority and low-income populations.’’. 
(d) DEPARTMENT OF DEFENSE AND THE DEPART-
MENT OF VETERANS AFFAIRS.—The Secretary of Defense 
and the Secretary of Veterans Affairs, each in coordina-
tion with the Secretary of Health and Human Services, 
shall engage— 
(1) in the implementation within the Depart-
ment of Defense and the Department of Veterans 
Affairs of an early detection and disease manage-
ment research program for military personnel and 
veterans whose smoking history and exposure to car-
cinogens during active duty service has increased 
their risk for lung cancer; and 
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1186 
(2) in the implementation of coordinated care 
programs for military personnel and veterans diag-
nosed with lung cancer. 
(e) LUNG CANCER ADVISORY BOARD.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall convene a Lung Cancer Advi-
sory Board (referred to in this section as the 
‘‘Board’’)— 
(A) to monitor the programs established 
under this section (and the amendments made 
by this section); and 
(B) to provide annual reports to the Con-
gress concerning benchmarks, expenditures, 
lung cancer statistics, and the public health im-
pact of such programs. 
(2) COMPOSITION.—The Board shall be com-
prised of— 
(A) the Secretary of Health and Human 
Services; 
(B) the Secretary of Defense; 
(C) the Secretary of Veterans Affairs; and 
(D) 2 representatives each from the fields 
of clinical medicine focused on lung cancer, 
lung cancer research, imaging, drug develop-
ment, and lung cancer advocacy, to be ap-
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pointed by the Secretary of Health and Human 
Services. 
(f) AUTHORIZATION OF APPROPRIATIONS.— 
(1) IN
GENERAL.—To carry out this section 
(and the amendments made by this section), there 
are authorized to be appropriated $75,000,000 for 
fiscal year 2023 and such sums as may be necessary 
for each of fiscal years 2024 through 2026. 
(2) LUNG CANCER MORTALITY REDUCTION PRO-
GRAM.—The amounts appropriated under paragraph 
(1) shall be allocated as follows: 
(A) $25,000,000 for fiscal year 2023, and 
such sums as may be necessary for each of fis-
cal years 2024 through 2026, for the activities 
described in section 417H(b)(1)(B) of the Pub-
lic Health Service Act, as added by subsection 
(d); 
(B) $25,000,000 for fiscal year 2023, and 
such sums as may be necessary for each of fis-
cal years 2024 through 2026, for the activities 
described in section 417H(b)(1)(C) of the Pub-
lic Health Service Act; 
(C) $10,000,000 for fiscal year 2023, and 
such sums as may be necessary for each of fis-
cal years 2024 through 2026, for the activities 
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described in section 417H(b)(1)(D) of the Pub-
lic Health Service Act; and 
(D) $15,000,000 for fiscal year 2023, and 
such sums as may be necessary for each of fis-
cal years 2024 through 2026, for the activities 
described in section 417H(b)(3) of the Public 
Health Service Act. 
SEC. 7002. EXPANDING PROSTATE CANCER RESEARCH, 
OUTREACH, SCREENING, TESTING, ACCESS, 
AND TREATMENT EFFECTIVENESS. 
(a) FINDINGS.—Congress makes the following find-
ings: 
(1) Prostate cancer is the second leading cause 
of cancer death among men. 
(2) In 2020, an estimated 191,930 individuals 
in the United States will be diagnosed with prostate 
cancer and approximately 33,330 will die from the 
disease. 
(3) Roughly 2,000,000 to 3,000,000 people in 
the United States are living with a diagnosis of pros-
tate cancer and its consequences. 
(4) Although prostate cancer generally affects 
older individuals, younger men are also at risk for 
the disease, and when prostate cancer appears in 
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early middle age, it frequently takes on a more ag-
gressive form. 
(5) There are significant racial and ethnic dis-
parities that demand attention, for example, African 
Americans have prostate cancer mortality rates that 
are more than double those in the White population. 
(6) Underserved rural populations have higher 
rates of mortality compared to their urban counter-
parts, and innovative and cost-efficient methods to 
improve rural access to high-quality care should take 
advantage of advances in telehealth to diagnose and 
treat prostate cancer when appropriate. 
(7) Certain populations of veterans may have 
nearly twice the incidence of prostate cancer as the 
general population of the United States. 
(8) Urologists may constitute the specialists 
who diagnose and treat the vast majority of prostate 
cancer patients. 
(9) Although much basic and translational re-
search has been completed and much is currently 
known, there are still many unanswered questions, 
such as the extent to which known disparities are at-
tributable to disease etiology, access to care, or edu-
cation and awareness in the community. 
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(10) Causes of prostate cancer are not known. 
There is not good information regarding how to dif-
ferentiate accurately, early on, between aggressive 
and indolent forms of the disease. As a result, there 
is significant overtreatment in prostate cancer. 
There are no treatments that can durably arrest 
growth or cure prostate cancer once it has metasta-
sized. 
(11) A significant proportion of cases may be 
clinically indolent and ‘‘overdiagnosed’’, resulting in 
significant overtreatment. More accurate tests will 
allow men and their families to face less physical, 
psychological, financial, and emotional trauma, and 
billions of dollars could be saved in private and pub-
lic health care systems. 
(12) Prostate cancer research and health care 
programs across Federal agencies should be coordi-
nated to improve accountability and actively encour-
age the translation of research into practice and to 
identify and implement best practices in order to 
foster an integrated and consistent focus on effective 
prevention, diagnosis, and treatment of the disease. 
(b) PROSTATE CANCER COORDINATION AND EDU-
CATION.— 
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1191 
(1) INTERAGENCY PROSTATE CANCER COORDI-
NATION AND EDUCATION TASK FORCE.—Not later 
than 180 days after the date of the enactment of 
this Act, the Secretary of Veterans Affairs, in co-
operation with the Secretary of Defense and the Sec-
retary of Health and Human Services, shall estab-
lish an Interagency Prostate Cancer Coordination 
and Education Task Force (in this section referred 
to as the ‘‘Prostate Cancer Task Force’’). 
(2) DUTIES.—The Prostate Cancer Task Force 
shall— 
(A) develop a summary of advances in 
prostate cancer research supported or con-
ducted by Federal agencies relevant to the diag-
nosis, prevention, and treatment of prostate 
cancer, including psychosocial impairments re-
lated to prostate cancer treatment, and compile 
a list of best practices that warrant broader 
adoption in health care programs; 
(B) consider establishing, and advocating 
for, a guidance to enable physicians to allow 
screening of men who are age 74 or older, on 
a case-by-case basis, taking into account quality 
of life and family history of prostate cancer; 
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(C) share and coordinate information on 
research and health care program activities by 
the Federal Government, including activities re-
lated to— 
(i) determining how to improve re-
search and health care programs, including 
psychosocial impairments related to pros-
tate cancer treatment; 
(ii) identifying any gaps in the overall 
research inventory and in health care pro-
grams; 
(iii) identifying opportunities to pro-
mote translation of research into practice; 
and 
(iv) maximizing the effects of Federal 
Government efforts by identifying opportu-
nities for collaboration and leveraging of 
resources in research and health care pro-
grams that serve individuals who are sus-
ceptible to or diagnosed with prostate can-
cer; 
(D) develop a comprehensive interagency 
strategy and advise relevant Federal agencies in 
the solicitation of proposals for collaborative, 
multidisciplinary research and health care pro-
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grams, including proposals to evaluate factors 
that may be related to the etiology of prostate 
cancer, that would— 
(i) result in innovative approaches to 
study emerging scientific opportunities or 
eliminate knowledge gaps in research to 
improve the prostate cancer research port-
folio of the Federal Government; and 
(ii) outline key research questions, 
methodologies, and knowledge gaps; 
(E) develop a coordinated message related 
to screening and treatment for prostate cancer 
to be reflected in educational and beneficiary 
materials for Federal health programs as such 
materials are updated; and 
(F) not later than 2 years after the date 
of the establishment of the Prostate Cancer 
Task Force, submit to the expert advisory pan-
els appointed under paragraph (4) to be re-
viewed and returned within 30 days, and then 
within 90 days submitted to Congress, rec-
ommendations— 
(i) regarding any appropriate changes 
to research and health care programs, in-
cluding recommendations to improve the 
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research portfolio of the Department of 
Veterans Affairs, the Department of De-
fense, the National Institutes of Health, 
and other Federal agencies to ensure that 
scientifically based strategic planning is 
implemented in support of research and 
health care program priorities; 
(ii) designed to ensure that the re-
search and health care programs and ac-
tivities of the Department of Veterans Af-
fairs, the Department of Defense, the De-
partment of Health and Human Services, 
and other Federal agencies are free of un-
necessary duplication; 
(iii) regarding public participation in 
decisions relating to prostate cancer re-
search and health care programs to in-
crease the involvement of patient advo-
cates, community organizations, and med-
ical associations representing a broad geo-
graphical area; 
(iv) on how to best disseminate infor-
mation on prostate cancer research and 
progress achieved by health care programs; 
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(v) about how to expand partnerships 
between public entities, including Federal 
agencies, and private entities to encourage 
collaborative, cross-cutting research and 
health care delivery; 
(vi) assessing any cost savings and ef-
ficiencies realized through the efforts iden-
tified in, and supported through, this sub-
section and recommending expansion of 
those efforts that have proved most prom-
ising while also ensuring against any con-
flicts in directives in law; 
(vii) identifying key priority action 
items from among the recommendations; 
and 
(viii) with respect to the level of fund-
ing needed by each agency to implement 
the recommendations contained in the re-
port. 
(3) MEMBERS OF THE PROSTATE CANCER TASK 
FORCE.—The Prostate Cancer Task Force shall be 
comprised of representatives from such Federal 
agencies as the head of each such applicable agency 
determines necessary, so as to coordinate a uniform 
message relating to prostate cancer screening and 
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1196 
treatment where appropriate, including representa-
tives of each of the following: 
(A) The Department of Veterans Affairs, 
including representatives of each relevant pro-
gram area of the Department of Veterans Af-
fairs. 
(B) The Prostate Cancer Research Pro-
gram of the Congressionally Directed Medical 
Research Program of the Department of De-
fense. 
(C) The Department of Health and 
Human Services, including, at a minimum, rep-
resentatives of each of the following: 
(i) The National Institutes of Health. 
(ii) National research institutes and 
centers, including the National Cancer In-
stitute, the National Institute of Allergy 
and Infectious Diseases, and the Office of 
Minority Health. 
(iii) The Centers for Medicare & Med-
icaid Services. 
(iv) The Food and Drug Administra-
tion. 
(v) The Centers for Disease Control 
and Prevention. 
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(vi) The Agency for Healthcare Re-
search and Quality. 
(vii) The Health Resources and Serv-
ices Administration. 
(4) APPOINTING EXPERT ADVISORY PANELS.— 
The Prostate Cancer Task Force shall appoint ex-
pert advisory panels, as the task force determines 
appropriate, to provide input and concurrence 
from— 
(A) individuals and organizations from the 
medical, prostate cancer patient and advocate, 
research, and delivery communities with exper-
tise in prostate cancer diagnosis, treatment, 
and research, including practicing urologists, 
primary care providers, and others; and 
(B) individuals with expertise in education 
and outreach to underserved populations af-
fected by prostate cancer. 
(5) MEETINGS.—The Prostate Cancer Task 
Force shall convene not less frequently than twice 
each year, or more frequently as the Secretary of 
Veterans Affairs determines to be appropriate. 
(6) FEDERAL ADVISORY COMMITTEE ACT.—The 
Federal Advisory Committee Act (5 U.S.C. App.) 
shall apply to the Prostate Cancer Task Force. 
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(7) SUNSET DATE.—The Prostate Cancer Task 
Force shall terminate on September 30, 2025. 
(c) PROSTATE CANCER RESEARCH.— 
(1) RESEARCH COORDINATION PROGRAM.— 
(A) IN GENERAL.—The Secretary of Vet-
erans Affairs, in coordination with the Sec-
retary of Defense and the Secretary of Health 
and Human Services, shall establish and carry 
out a program to coordinate and intensify pros-
tate cancer research. 
(B) ELEMENTS.—The program established 
under subparagraph (A) shall— 
(i) develop advances in diagnostic and 
prognostic methods and tests, including 
biomarkers and an improved prostate can-
cer screening blood test, including improve-
ments or alternatives to the prostate spe-
cific antigen test and additional tests to 
distinguish indolent from aggressive dis-
ease; 
(ii) develop a better understanding of 
the etiology of the disease (including an 
analysis of lifestyle factors proven to be in-
volved in higher rates of prostate cancer, 
such as obesity and diet, and in different 
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1199 
ethnic, racial, and socioeconomic groups, 
such as the African-American, Latino or 
Hispanic, and American Indian popu-
lations and men with a family history of 
prostate cancer) to improve prevention ef-
forts; 
(iii) expand basic research into pros-
tate cancer, including studies of funda-
mental molecular and cellular mechanisms; 
(iv) identify and provide clinical test-
ing of novel agents for the prevention and 
treatment of prostate cancer; 
(v) establish clinical registries for 
prostate cancer; 
(vi) use the National Institute of Bio-
medical Imaging and Bioengineering and 
the National Cancer Institute for assess-
ment of appropriate imaging modalities; 
and 
(vii) address such other matters relat-
ing to prostate cancer research as may be 
identified by the Federal agencies partici-
pating in the program under this sub-
section. 
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(C) UNDERSERVED MINORITY GRANT PRO-
GRAM.—In carrying out the program estab-
lished under subparagraph (A), the Secretary 
shall— 
(i) award grants to eligible entities to 
carry out components of the research out-
lined in subparagraph (B); 
(ii) integrate and build upon existing 
knowledge gained from comparative effec-
tiveness research; and 
(iii) recognize and address— 
(I) the racial and ethnic dispari-
ties in the incidence and mortality 
rates of prostate cancer and men with 
a family history of prostate cancer; 
(II) any barriers in access to care 
and participation in clinical trials that 
are specific to racial, ethnic, and other 
underserved minorities and men with 
a family history of prostate cancer; 
(III) outreach and educational ef-
forts to raise awareness among the 
populations described in subclause 
(II); and 
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(IV) appropriate access and utili-
zation of imaging modalities. 
(2) PROSTATE CANCER ADVISORY BOARD.— 
(A) IN GENERAL.—There is established in 
the Office of the Chief Scientist of the Food 
and Drug Administration a Prostate Cancer 
Scientific Advisory Board. 
(B) DUTIES.—The board established under 
subparagraph (A) shall be responsible for accel-
erating real-time sharing of the latest research 
data and accelerating movement of new medi-
cines for the treatment of prostate cancer to 
patients. 
(d) TELEHEALTH
AND
RURAL
ACCESS
PILOT 
PROJECTS.— 
(1) ESTABLISHMENT OF PILOT PROJECTS.— 
(A) IN GENERAL.—The Secretary of Vet-
erans Affairs, in cooperation with the Secretary 
of Defense and the Secretary of Health and 
Human Services (referred to in this subsection 
collectively as the ‘‘Secretaries’’) shall establish 
4-year telehealth pilot projects for the purpose 
of analyzing the clinical outcomes and cost-ef-
fectiveness associated with telehealth services in 
a variety of geographic areas that contain high 
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proportions of medically underserved popu-
lations, including African Americans, Latinos or 
Hispanics, American Indians or Alaska Natives, 
and those in rural areas. 
(B) EFFICIENT AND EFFECTIVE CARE.— 
Pilot projects established under subparagraph 
(A) shall promote efficient use of specialist care 
through better coordination of primary care and 
physician extender teams in underserved areas 
and more effectively employ tumor boards to 
better counsel patients. 
(2) ELIGIBLE ENTITIES.— 
(A) IN
GENERAL.—The Secretaries shall 
select eligible entities to participate in the pilot 
projects established under this subsection. 
(B) PRIORITY.—In selecting eligible enti-
ties to participate in the pilot projects under 
this subsection, the Secretaries shall give pri-
ority to entities located in medically under-
served areas, particularly those that include Af-
rican Americans, Latinos and Hispanics, and 
facilities of the Indian Health Service, including 
facilities operated by the Indian Health Service, 
tribally operated facilities, and Urban Indian 
Clinics, and those in rural areas. 
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(4) REPORT.—Not later than 1 year after the 
completion of the pilot projects under this sub-
section, the Secretaries shall submit to Congress a 
report describing the outcomes of such pilot projects, 
including any cost savings and efficiencies realized, 
and providing recommendations, if any, for expand-
ing the use of telehealth services. 
(e) EDUCATION AND AWARENESS.— 
(1) CAMPAIGN.— 
(A) IN GENERAL.—The Secretary of Vet-
erans Affairs shall develop a national education 
campaign for prostate cancer. 
(B) ELEMENTS.—The campaign developed 
under subparagraph (A) shall involve the use of 
written educational materials and public service 
announcements consistent with the findings of 
the Prostate Cancer Task Force under sub-
section (c) that are intended to encourage men 
to seek prostate cancer screening when appro-
priate. 
(2) RACIAL DISPARITIES AND THE POPULATION 
OF
MEN
WITH
A
FAMILY
HISTORY
OF
PROSTATE 
CANCER.—In developing the campaign under para-
graph (1), the Secretary shall ensure that edu-
cational materials and public service announcements 
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used in the campaign are more readily available in 
communities experiencing racial disparities in the in-
cidence and mortality rates of prostate cancer and to 
men of any race classification with a family history 
of prostate cancer. 
(3) GRANTS.—In carrying out the campaign 
under this subsection, the Secretary shall award 
grants to nonprofit private entities to enable such 
entities to test alternative outreach and education 
strategies. 
(f) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated to carry out this section for 
the period of fiscal years 2023 through 2027 an amount 
equal to the amount of savings for the Federal Govern-
ment projected to be achieved over such period by imple-
mentation of this section. 
SEC. 7003. PROSTATE RESEARCH, IMAGING, AND MEN’S 
EDUCATION (PRIME). 
(a) FINDINGS.—Congress makes the following find-
ings: 
(1) Prostate cancer has reached epidemic pro-
portions, particularly among African-American men, 
and strikes and kills men in numbers comparable to 
the number of women who lose their lives from 
breast cancer. 
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(2) Life-saving breakthroughs in screening, di-
agnosis, and treatment of breast cancer resulted 
from the development of advanced imaging tech-
nologies led by the Federal Government. 
(3) Men should have accurate and affordable 
prostate cancer screening exams and minimally 
invasive treatment tools, similar to what women have 
for breast cancer. 
(4) While it is important for men to take ad-
vantage of current prostate cancer screening tech-
niques, a recent NCI-funded study demonstrated 
that the most common available methods of detect-
ing prostate cancer (PSA blood test and physical 
exams) are not foolproof, causing numerous false 
alarms and false reassurances. 
(5) The absence of advanced imaging tech-
nologies for prostate cancer causes the lack of accu-
rate information critical for clinical decisions, result-
ing in missed cancers and lost lives, as well as un-
necessary and costly medical procedures, with re-
lated complications. 
(6) With prostate imaging tools, men and their 
families would face less physical, psychological, fi-
nancial, and emotional trauma and billions of dollars 
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could be saved in private and public health care sys-
tems. 
(b) RESEARCH AND DEVELOPMENT OF PROSTATE 
CANCER IMAGING TECHNOLOGIES.— 
(1) EXPANSION OF RESEARCH.—The Secretary 
of Health and Human Services (referred to in this 
section as the ‘‘Secretary’’), acting through the Di-
rector of the National Institutes of Health and the 
Administrator of the Health Resources and Services 
Administration, and in consultation with the Sec-
retary of Defense, shall carry out a program to ex-
pand and intensify research to develop innovative 
advanced imaging technologies for prostate cancer 
detection, diagnosis, and treatment comparable to 
state-of-the-art mammography technologies. 
(2) 
EARLY
STAGE
RESEARCH.—In 
imple-
menting the program under paragraph (1), the Sec-
retary, acting through the Administrator of the 
Health Resources and Services Administration, shall 
carry out a grant program to encourage the early 
stages of research in prostate imaging to develop 
and implement new ideas, proof of concepts, and 
pilot studies for high-risk technologic innovation in 
prostate cancer imaging that would have a high po-
tential impact for improving patient care, including 
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individualized care, quality of life, and cost-effective-
ness. 
(3) LARGE SCALE LATER STAGE RESEARCH.— 
In implementing the program under paragraph (1), 
the Secretary, acting through the Director of the 
National Institutes of Health, shall utilize the Na-
tional Institute of Biomedical Imaging and Bio-
engineering and the National Cancer Institute for 
advanced stages of research in prostate imaging, in-
cluding technology development and clinical trials for 
projects determined by the Secretary to have dem-
onstrated promising preliminary results and proof of 
concept. 
(4) INTERDISCIPLINARY PRIVATE-PUBLIC PART-
NERSHIPS.—In developing the program under para-
graph (1), the Secretary, acting through the Admin-
istrator of the Health Resources and Services Ad-
ministration, shall establish interdisciplinary private- 
public partnerships to develop and implement re-
search strategies for expedited innovation in imaging 
and image-guided treatment and to conduct such re-
search. 
(5) RACIAL
DISPARITIES.—In developing the 
program under paragraph (1), the Secretary shall 
recognize and address— 
VerDate Sep 11 2014 
20:42 Jun 23, 2022
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pbinns on DSKJLVW7X2PROD with $$_JOB