Prostate Research, Outreach, Screening, Testing, Access, and Treatment Effectiveness Act of 2011 or the PROSTATE Act - Requires the Secretary of Veterans Affairs (VA) to establish the Interagency Prostate Cancer Coordination and Education Task Force, with duties to include: (1) developing a summary of advances in federal prostate cancer research and compile a list of best practices that warrant broader adoption in health care programs; (2) considering establishing guidance to enable physicians to allow screening of men over age 74; (3) coordinating information on federal research and health care program activities relating to prostate cancer; and (4) submitting recommendations regarding federal research and health care programs.
Directs the Secretary to establish and carry out a program to coordinate and intensify prostate cancer research, including by developing advances in diagnostic and prognostic methods and tests, better understanding the etiology of the disease, and establishing clinical registries for prostate cancer and awarding research grants.
Establishes in the Office of the Chief Scientist of the Food and Drug Administration (FDA) a Prostate Cancer Scientific Advisory Board to be responsible for accelerating real-time sharing of the latest research data and accelerating movement of new medicines to patients.
Directs the Secretary of VA, the Secretary of Defense (DOD) and the Secretary of Health and Human Services (HHS) to establish four-year telehealth pilot projects to analyze the clinical outcomes and cost effectiveness associated with telehealth services in a variety of geographic areas that contain high proportions of medically underserved populations and those in rural areas.
Requires the Secretary of VA to develop a national education campaign for prostate cancer.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2159 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 2159
To reduce disparities and improve access to effective and cost
efficient diagnosis and treatment of prostate cancer through advances
in testing, research, and education, including through telehealth,
comparative effectiveness research, and identification of best
practices in patient education and outreach particularly with respect
to underserved racial, ethnic and rural populations and men with a
family history of prostate cancer, to establish a directive on what
constitutes clinically appropriate prostate cancer imaging, and to
create a prostate cancer scientific advisory board for the Office of
the Chief Scientist at the Food and Drug Administration to accelerate
real-time sharing of the latest research and accelerate movement of new
medicines to patients.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 14, 2011
Mr. Towns (for himself, Mr. Broun of Georgia, Ms. Fudge, Ms.
Richardson, Mr. Gerlach, Ms. Moore, Mr. McIntyre, Mr. Rangel, Ms. Eddie
Bernice Johnson of Texas, Ms. Wilson of Florida, Ms. Norton, Mr.
Thompson of Mississippi, Mr. Carson of Indiana, Ms. Lee of California,
Mr. Israel, and Mr. King of New York) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committees on Veterans' Affairs and Armed Services, for
a period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To reduce disparities and improve access to effective and cost
efficient diagnosis and treatment of prostate cancer through advances
in testing, research, and education, including through telehealth,
comparative effectiveness research, and identification of best
practices in patient education and outreach particularly with respect
to underserved racial, ethnic and rural populations and men with a
family history of prostate cancer, to establish a directive on what
constitutes clinically appropriate prostate cancer imaging, and to
create a prostate cancer scientific advisory board for the Office of
the Chief Scientist at the Food and Drug Administration to accelerate
real-time sharing of the latest research and accelerate movement of new
medicines to patients.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Prostate Research, Outreach,
Screening, Testing, Access, and Treatment Effectiveness Act of 2011''
or the ``PROSTATE Act''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Prostate cancer is the second leading cause of cancer
death among men.
(2) In 2010, more than 217,730 new patients were diagnosed
with prostate cancer and more than 32,000 men died from this
disease.
(3) Roughly 2,000,000 Americans are living with a diagnosis
of prostate cancer and its consequences.
(4) While prostate cancer generally affects older
individuals, younger men are also at risk for the disease, and
when prostate cancer appears in early middle age it frequently
takes on a more aggressive form.
(5) There are significant racial and ethnic disparities
that demand attention, namely 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 counterparts, 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 veterans populations 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 research has been
completed and much is currently known, there are still many
unanswered questions. For example, it is not fully understood
how much of known disparities are attributable to disease
etiology, access to care, or education and awareness in the
community.
(10) Causes of prostate cancer are not known. There is not
good information regarding how to differentiate 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 metastasized.
(11) A significant proportion (roughly 23 to 54 percent) 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 public health care
systems in an area that has been identified by the Medicare
program as one of eight high volume, high cost areas in the
Resource Utilization Report program authorized by Congress
under the Medicare Improvements for Patients and Providers Act
of 2008.
(12) Prostate cancer research and health care programs
across Federal agencies should be coordinated to improve
accountability and actively encourage the translation of
research into practice, to identify and implement best
practices, in order to foster an integrated and consistent
focus on effective prevention, diagnosis, and treatment of this
disease.
SEC. 3. PROSTATE CANCER COORDINATION AND EDUCATION.
(a) Interagency Prostate Cancer Coordination and Education Task
Force.--Not later than 180 days after the date of the enactment of this
section, the Secretary of Veterans Affairs, in cooperation with the
Secretary of Defense and the Secretary of Health and Human Services,
shall establish an Interagency Prostate Cancer Coordination and
Education Task Force (in this section referred to as the ``Prostate
Cancer Task Force'').
(b) Duties.--The Prostate Cancer Task Force shall--
(1) develop a summary of advances in prostate cancer
research supported or conducted by Federal agencies relevant to
the diagnosis, prevention, and treatment of prostate cancer,
including psychosocial impairments related to prostate cancer
treatment, and compile a list of best practices that warrant
broader adoption in health care programs;
(2) consider establishing, and advocating for, a guidance
to enable physicians to allow screening of men who are over age
74, on a case-by-case basis, taking into account quality of
life and family history of prostate cancer;
(3) share and coordinate information on Federal research
and health care program activities, including activities
related to--
(A) determining how to improve research and health
care programs, including psychosocial impairments
related to prostate cancer treatment;
(B) identifying any gaps in the overall research
inventory and in health care programs;
(C) identifying opportunities to promote
translation of research into practice; and
(D) maximizing the effects of Federal efforts by
identifying opportunities for collaboration and
leveraging of resources in research and health care
programs that serve those susceptible to or diagnosed
with prostate cancer;
(4) develop a comprehensive interagency strategy and advise
relevant Federal agencies in the solicitation of proposals for
collaborative, multidisciplinary research and health care
programs, including proposals to evaluate factors that may be
related to the etiology of prostate cancer, that would--
(A) result in innovative approaches to study
emerging scientific opportunities or eliminate
knowledge gaps in research to improve the prostate
cancer research portfolio of the Federal Government;
(B) outline key research questions, methodologies,
and knowledge gaps; and
(C) ensure consistent action, as outlined by
section 402(b) of the Public Health Service Act;
(5) 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
documents are updated; and
(6) not later than two years after the date of the
establishment of the Prostate Cancer Task Force, submit to the
Expert Advisory Panel to be reviewed and returned within 30
days, and then within 90 days submitted to Congress
recommendations--
(A) regarding any appropriate changes to research
and health care programs, including recommendations to
improve the research portfolio of the Department of
Veterans Affairs, Department of Defense, 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;
(B) designed to ensure that the research and health
care programs and activities of the Department of
Veterans Affairs, the Department of Defense, the
Department of Health and Human Services, and other
Federal agencies are free of unnecessary duplication;
(C) regarding public participation in decisions
relating to prostate cancer research and health care
programs to increase the involvement of patient
advocates, community organizations, and medical
associations representing a broad geographical area;
(D) on how to best disseminate information on
prostate cancer research and progress achieved by
health care programs;
(E) about how to expand partnerships between public
entities, including Federal agencies, and private
entities to encourage collaborative, cross-cutting
research and health care delivery;
(F) assessing any cost savings and efficiencies
realized through the efforts identified and supported
in this Act and recommending expansion of those efforts
that have proved most promising while also ensuring
against any conflicts in directives from other
congressional or statutory mandates or enabling
statutes;
(G) identifying key priority action items from
among the recommendations; and
(H) with respect to the level of funding needed by
each agency to implement the recommendations contained
in the report.
(c) Members of the Prostate Cancer Task Force.--The Prostate Cancer
Task Force described in subsection (a) shall be composed of
representatives from such Federal agencies, as each Secretary
determines necessary, to coordinate a uniform message relating to
prostate cancer screening and treatment where appropriate, including
representatives of the following:
(1) The Department of Veterans Affairs, including
representatives of each relevant program areas of the
Department of Veterans Affairs.
(2) The Prostate Cancer Research Program of the
Congressionally Directed Medical Research Program of the
Department of Defense.
(3) The Department of Health and Human Services, including
at a minimum representatives of the following:
(A) The National Institutes of Health.
(B) National research institutes and centers,
including the National Cancer Institute, the National
Institute of Allergy and Infectious Diseases, and the
Office of Minority Health.
(C) The Centers for Medicare & Medicaid Services.
(D) The Food and Drug Administration.
(E) The Centers for Disease Control and Prevention.
(F) The Agency for Healthcare Research and Quality.
(G) The Health Resources and Services
Administration.
(d) Appointing Expert Advisory Panels.--The Prostate Cancer Task
Force shall appoint expert advisory panels, as determined appropriate,
to provide input and concurrence from individuals and organizations
from the medical, prostate cancer patient and advocate, research, and
delivery communities with expertise in prostate cancer diagnosis,
treatment, and research, including practicing urologists, primary care
providers, and others and individuals with expertise in education and
outreach to underserved populations affected by prostate cancer.
(e) Meetings.--The Prostate Cancer Task Force shall convene not
less than twice a year, or more frequently as the Secretary determines
to be appropriate.
(f) Submittal of Recommendations to Congress.--The Secretary of
Veterans Affairs shall submit to Congress any recommendations submitted
to the Secretary under subsection (b)(5).
(g) Federal Advisory Committee Act.--
(1) In general.--Except as provided in paragraph (2), the
Federal Advisory Committee Act (5 U.S.C. App.) shall apply to
the Prostate Cancer Task Force.
(2) Exception.--Section 14(a)(2)(B) of such Act (relating
to the termination of advisory committees) shall not apply to
the Prostate Cancer Task Force.
(h) Sunset Date.--The Prostate Cancer Task Force shall terminate at
the end of fiscal year 2016.
SEC. 4. PROSTATE CANCER RESEARCH.
(a) Research Coordination.--The Secretary of Veterans Affairs, in
coordination with the Secretaries of Defense and of Health and Human
Services, shall establish and carry out a program to coordinate and
intensify prostate cancer research as needed. Specifically, such
research program shall--
(1) develop advances in diagnostic and prognostic methods
and tests, including biomarkers and an improved prostate cancer
screening blood test, including improvements or alternatives to
the prostate specific antigen test and additional tests to
distinguish indolent from aggressive disease;
(2) better understand the etiology of the disease
(including an analysis of lifestyle factors proven to be
involved in higher rates of prostate cancer, such as obesity
and diet, and in different ethnic, racial, and socioeconomic
groups, such as the African-American, Latin-American, and
American Indian populations and men with a family history of
prostate cancer) to improve prevention efforts;
(3) expand basic research into prostate cancer, including
studies of fundamental molecular and cellular mechanisms;
(4) identify and provide clinical testing of novel agents
for the prevention and treatment of prostate cancer;
(5) establish clinical registries for prostate cancer;
(6) use the National Institute of Biomedical Imaging and
Bioengineering and the National Cancer Institute for assessment
of appropriate imaging modalities; and
(7) address such other matters relating to prostate cancer
research as may be identified by the Federal agencies
participating in the program under this section.
(b) Prostate Cancer Advisory Board.--There is established in the
Office of the Chief Scientist of the Food and Drug Administration a
Prostate Cancer Scientific Advisory Board. Such board shall be
responsible for accelerating real-time sharing of the latest research
data and accelerating movement of new medicines to patients.
(c) Underserved Minority Grant Program.--In carrying out such
program, the Secretary shall--
(1) award grants to eligible entities to carry out
components of the research outlined in subsection (a);
(2) integrate and build upon existing knowledge gained from
comparative effectiveness research; and
(3) recognize and address--
(A) the racial and ethnic disparities in the
incidence and mortality rates of prostate cancer and
men with a family history of prostate cancer;
(B) 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;
(C) needed outreach and educational efforts to
raise awareness in these communities; and
(D) appropriate access and utilization of imaging
modalities.
SEC. 5. TELEHEALTH AND RURAL ACCESS PILOT PROJECT.
(a) In General.--The Secretary of Veterans Affairs, the Secretary
of Defense, and the Secretary of Health and Human Services (in this
section referred to as the ``Secretaries'') shall establish 4-year
telehealth pilot projects for the purpose of analyzing the clinical
outcomes and cost effectiveness associated with telehealth services in
a variety of geographic areas that contain high proportions of
medically underserved populations, including African-Americans, Latin-
Americans, American Indians, and those in rural areas. Such projects
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.
(b) Eligible Entities.--
(1) In general.--The Secretaries shall select eligible
entities to participate in the pilot projects under this
section.
(2) Priority.--In selecting eligible entities to
participate in the pilot projects under this section, the
Secretaries shall give priority to such entities located in
medically underserved areas, particularly those that include
African-Americans, Latin-Americans, and facilities of the
Indian Health Service, and those in rural areas.
(c) Evaluation.--The Secretaries shall, through the pilot projects,
evaluate--
(1) the effective and economic delivery of care in
diagnosing and treating prostate cancer with the use of
telehealth services in medically underserved and tribal areas
including collaborative uses of health professionals and
integration of the range of telehealth and other technologies;
(2) the effectiveness of improving the capacity of
nonmedical providers and nonspecialized medical providers to
provide health services for prostate cancer in medically
underserved and tribal areas, including the exploration of
innovative medical home models with collaboration between
urologists, other relevant medical specialists, including
oncologists, radiologists, and primary care teams and
coordination of care through the efficient use of primary care
teams and physician extenders; and
(3) the effectiveness of using telehealth services to
provide prostate cancer treatment in medically underserved
areas, including the use of tumor boards to facilitate better
patient counseling.
(d) Report.--Not later than 12 months after the completion of the
pilot projects under this subsection, 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 expanding the use of telehealth services.
SEC. 6. EDUCATION AND AWARENESS.
(a) In General.--The Secretary of Veterans Affairs shall develop a
national education campaign for prostate cancer. Such campaign shall
involve the use of written educational materials and public service
announcements consistent with the findings of the Prostate Cancer Task
Force under section 3, that are intended to encourage men to seek
prostate cancer screening when appropriate.
(b) Racial Disparities and the Population of Men With a Family
History of Prostate Cancer.--In developing the national campaign under
subsection (a), the Secretary shall ensure that such educational
materials and public service announcements are more readily available
in communities experiencing racial disparities in the incidence and
mortality rates of prostate cancer and by men of any race
classification with a family history of prostate cancer.
(c) Grants.--In carrying out the national campaign under this
section, the Secretary shall award grants to nonprofit private entities
to enable such entities to test alternative outreach and education
strategies.
SEC. 7. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--There is authorized to be appropriated to carry
out this Act for the period of fiscal years 2012 through 2016 an amount
equal to the savings described in subsection (b).
(b) Corresponding Reduction.--The amount authorized to be
appropriated by provisions of law other than this Act for the period of
fiscal years 2012 through 2016 for Federal research and health care
program activities related to prostate cancer is reduced by the amount
of Federal savings projected to be achieved over such period by
implementation of section 3(b)(3) of this Act.
<all>
Introduced in House
Introduced in House
Sponsor introductory remarks on measure. (CR E1082)
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Veterans' Affairs, and Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Veterans' Affairs, and Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Veterans' Affairs, and Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Military Personnel.
Referred to the Subcommittee on Health.
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