HR
2159
112th CONGRESS
1st Session
H. R. 2159To 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 REPRESENTATIVESJune 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
BILLTo 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.
(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.
END
