[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1190 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                S. 1190

    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 SENATE OF THE UNITED STATES

                             June 14, 2011

   Mr. Tester (for himself, Mr. Blunt, Mr. Wyden, Mr. Sessions, Mr. 
  Chambliss, and Mr. Inouye) introduced the following bill; which was 
 read twice and referred to the Committee on Health, Education, Labor, 
                              and Pensions

_______________________________________________________________________

                                 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 life style 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.
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