II 

113TH CONGRESS 

1ST SESSION S. 516 

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 

MARCH 11, 2013 

Mr. TESTER (for himself and Mr. BLUNT) 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 


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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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prostate Research, 

5 Outreach, Screening, Testing, Access, and Treatment Ef6 fectiveness Act of 2013’’ or the ‘‘PROSTATE Act’’. 

7 SEC. 2. FINDINGS. 

8 Congress makes the following findings: 

9 (1) Prostate cancer is the second leading cause 

10 of cancer death among men. 

11 (2) In 2010, more than 217,730 new patients 

12 were diagnosed with prostate cancer and more than 

13 32,000 men died from this disease. 

14 (3) Roughly 2,000,000 Americans are living 

15 with a diagnosis of prostate cancer and its con16 sequences. 

17 (4) While prostate cancer generally affects older 

18 individuals, younger men are also at risk for the dis19 ease, and when prostate cancer appears in early 

20 middle age it frequently takes on a more aggressive 

21 form. 


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1 (5) There are significant racial and ethnic dis2 parities that demand attention, namely African3 Americans have prostate cancer mortality rates that 

4 are more than double those in the White population. 

5 (6) Underserved rural populations have higher 

6 rates of mortality compared to their urban counter7 parts, and innovative and cost-efficient methods to 

8 improve rural access to high quality care should take 

9 advantage of advances in telehealth to diagnose and 

10 treat prostate cancer when appropriate. 

11 (7) Certain veterans populations may have 

12 nearly twice the incidence of prostate cancer as the 

13 general population of the United States. 

14 (8) Urologists may constitute the specialists 

15 who diagnose and treat the vast majority of prostate 

16 cancer patients. 

17 (9) Although much basic and translational re18 search has been completed and much is currently 

19 known, there are still many unanswered questions. 

20 For example, it is not fully understood how much of 

21 known disparities are attributable to disease eti22 ology, access to care, or education and awareness in 

23 the community. 

24 (10) Causes of prostate cancer are not known. 

25 There is not good information regarding how to difVerDate Mar 15 2010 00:55 Mar 13, 2013 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S516.IS S516

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1 ferentiate accurately, early on, between aggressive 

2 and indolent forms of the disease. As a result, there 

3 is significant overtreatment in prostate cancer. 

4 There are no treatments that can durably arrest 

5 growth or cure prostate cancer once it has metasta6 sized. 

7 (11) A significant proportion (roughly 23 to 54 

8 percent) of cases may be clinically indolent and 

9 ‘‘overdiagnosed’’, resulting in significant overtreat10 ment. More accurate tests will allow men and their 

11 families to face less physical, psychological, financial, 

12 and emotional trauma and billions of dollars could 

13 be saved in private and public health care systems 

14 in an area that has been identified by the Medicare 

15 program as one of eight high volume, high cost areas 

16 in the Resource Utilization Report program author17 ized by Congress under the Medicare Improvements 

18 for Patients and Providers Act of 2008. 

19 (12) Prostate cancer research and health care 

20 programs across Federal agencies should be coordi21 nated to improve accountability and actively encour22 age the translation of research into practice, to iden23 tify and implement best practices, in order to foster 

24 an integrated and consistent focus on effective pre25 vention, diagnosis, and treatment of this disease. 


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1 SEC. 3. PROSTATE CANCER COORDINATION AND EDU2 CATION. 

3 (a) INTERAGENCY PROSTATE CANCER COORDINA4 TION AND EDUCATION TASK FORCE.—Not later than 180 

5 days after the date of the enactment of this section, the 

6 Secretary of Veterans Affairs, in cooperation with the Sec7 retary of Defense and the Secretary of Health and Human 

8 Services, shall establish an Interagency Prostate Cancer 

9 Coordination and Education Task Force (in this section 

10 referred to as the ‘‘Prostate Cancer Task Force’’). 

11 (b) DUTIES.—The Prostate Cancer Task Force 

12 shall— 

13 (1) develop a summary of advances in prostate 

14 cancer research supported or conducted by Federal 

15 agencies relevant to the diagnosis, prevention, and 

16 treatment of prostate cancer, including psychosocial 

17 impairments related to prostate cancer treatment, 

18 and compile a list of best practices that warrant 

19 broader adoption in health care programs; 

20 (2) consider establishing, and advocating for, a 

21 guidance to enable physicians to allow screening of 

22 men who are over age 74, on a case-by-case basis, 

23 taking into account quality of life and family history 

24 of prostate cancer; 


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1 (3) share and coordinate information on Fed2 eral research and health care program activities, in3 cluding activities related to— 

4 (A) determining how to improve research 

5 and health care programs, including psycho6 social impairments related to prostate cancer 

7 treatment; 

8 (B) identifying any gaps in the overall re9 search inventory and in health care programs; 

10 (C) identifying opportunities to promote 

11 translation of research into practice; and 

12 (D) maximizing the effects of Federal ef13 forts by identifying opportunities for collabora14 tion and leveraging of resources in research and 

15 health care programs that serve those suscep16 tible to or diagnosed with prostate cancer; 

17 (4) develop a comprehensive interagency strat18 egy and advise relevant Federal agencies in the solic19 itation of proposals for collaborative, multidisci20 plinary research and health care programs, including 

21 proposals to evaluate factors that may be related to 

22 the etiology of prostate cancer, that would— 

23 (A) result in innovative approaches to 

24 study emerging scientific opportunities or elimi25 nate knowledge gaps in research to improve the 


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1 prostate cancer research portfolio of the Fed2 eral Government; 

3 (B) outline key research questions, meth4 odologies, and knowledge gaps; and 

5 (C) ensure consistent action, as outlined by 

6 section 402(b) of the Public Health Service Act; 

7 (5) develop a coordinated message related to 

8 screening and treatment for prostate cancer to be 

9 reflected in educational and beneficiary materials for 

10 Federal health programs as such documents are up11 dated; and 

12 (6) not later than two years after the date of 

13 the establishment of the Prostate Cancer Task 

14 Force, submit to the Expert Advisory Panel to be re15 viewed and returned within 30 days, and then within 

16 90 days submitted to Congress recommendations— 

17 (A) regarding any appropriate changes to 

18 research and health care programs, including 

19 recommendations to improve the research port20 folio of the Department of Veterans Affairs, 

21 Department of Defense, National Institutes of 

22 Health, and other Federal agencies to ensure 

23 that scientifically based strategic planning is 

24 implemented in support of research and health 

25 care program priorities; 


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1 (B) designed to ensure that the research 

2 and health care programs and activities of the 

3 Department of Veterans Affairs, the Depart4 ment of Defense, the Department of Health and 

5 Human Services, and other Federal agencies 

6 are free of unnecessary duplication; 

7 (C) regarding public participation in deci8 sions relating to prostate cancer research and 

9 health care programs to increase the involve10 ment of patient advocates, community organiza11 tions, and medical associations representing a 

12 broad geographical area; 

13 (D) on how to best disseminate informa14 tion on prostate cancer research and progress 

15 achieved by health care programs; 

16 (E) about how to expand partnerships be17 tween public entities, including Federal agen18 cies, and private entities to encourage collabo19 rative, cross-cutting research and health care 

20 delivery; 

21 (F) assessing any cost savings and effi22 ciencies realized through the efforts identified 

23 and supported in this Act and recommending 

24 expansion of those efforts that have proved 

25 most promising while also ensuring against any 


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1 conflicts in directives from other congressional 

2 or statutory mandates or enabling statutes; 

3 (G) identifying key priority action items 

4 from among the recommendations; and 

5 (H) with respect to the level of funding 

6 needed by each agency to implement the rec7 ommendations contained in the report. 

8 (c) MEMBERS OF THE PROSTATE CANCER TASK

9 FORCE.—The Prostate Cancer Task Force described in 

10 subsection (a) shall be composed of representatives from 

11 such Federal agencies, as each Secretary determines nec12 essary, to coordinate a uniform message relating to pros13 tate cancer screening and treatment where appropriate, 

14 including representatives of the following: 

15 (1) The Department of Veterans Affairs, in16 cluding representatives of each relevant program 

17 areas of the Department of Veterans Affairs. 

18 (2) The Prostate Cancer Research Program of 

19 the Congressionally Directed Medical Research Pro20 gram of the Department of Defense. 

21 (3) The Department of Health and Human 

22 Services, including at a minimum representatives of 

23 the following: 

24 (A) The National Institutes of Health. 


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1 (B) National research institutes and cen2 ters, including the National Cancer Institute, 

3 the National Institute of Allergy and Infectious 

4 Diseases, and the Office of Minority Health. 

5 (C) The Centers for Medicare & Medicaid 

6 Services. 

7 (D) The Food and Drug Administration. 

8 (E) The Centers for Disease Control and 

9 Prevention. 

10 (F) The Agency for Healthcare Research 

11 and Quality. 

12 (G) The Health Resources and Services 

13 Administration. 

14 (d) APPOINTING EXPERT ADVISORY PANELS.—The 

15 Prostate Cancer Task Force shall appoint expert advisory 

16 panels, as determined appropriate, to provide input and 

17 concurrence from individuals and organizations from the 

18 medical, prostate cancer patient and advocate, research, 

19 and delivery communities with expertise in prostate cancer 

20 diagnosis, treatment, and research, including practicing 

21 urologists, primary care providers, and others and individ22 uals with expertise in education and outreach to under23 served populations affected by prostate cancer. 


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1 (e) MEETINGS.—The Prostate Cancer Task Force 

2 shall convene not less than twice a year, or more fre3 quently as the Secretary determines to be appropriate. 

4 (f) SUBMITTAL OF RECOMMENDATIONS TO CON5 GRESS.—The Secretary of Veterans Affairs shall submit 

6 to Congress any recommendations submitted to the Sec7 retary under subsection (b)(5). 

8 (g) FEDERAL ADVISORY COMMITTEE ACT.— 

9 (1) IN GENERAL.—Except as provided in para10 graph (2), the Federal Advisory Committee Act (5 

11 U.S.C. App.) shall apply to the Prostate Cancer 

12 Task Force. 

13 (2) EXCEPTION.—Section 14(a)(2)(B) of such 

14 Act (relating to the termination of advisory commit15 tees) shall not apply to the Prostate Cancer Task 

16 Force. 

17 (h) SUNSET DATE.—The Prostate Cancer Task 

18 Force shall terminate at the end of fiscal year 2016. 

19 SEC. 4. PROSTATE CANCER RESEARCH. 

20 (a) RESEARCH COORDINATION.—The Secretary of 

21 Veterans Affairs, in coordination with the Secretaries of 

22 Defense and of Health and Human Services, shall estab23 lish and carry out a program to coordinate and intensify 

24 prostate cancer research as needed. Specifically, such re25 search program shall— 


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1 (1) develop advances in diagnostic and prog2 nostic methods and tests, including biomarkers and 

3 an improved prostate cancer screening blood test, in4 cluding improvements or alternatives to the prostate 

5 specific antigen test and additional tests to distin6 guish indolent from aggressive disease; 

7 (2) better understand the etiology of the disease 

8 (including an analysis of life style factors proven to 

9 be involved in higher rates of prostate cancer, such 

10 as obesity and diet, and in different ethnic, racial, 

11 and socioeconomic groups, such as the African12 American, Latin American, and American Indian 

13 populations and men with a family history of pros14 tate cancer) to improve prevention efforts; 

15 (3) expand basic research into prostate cancer, 

16 including studies of fundamental molecular and cel17 lular mechanisms; 

18 (4) identify and provide clinical testing of novel 

19 agents for the prevention and treatment of prostate 

20 cancer; 

21 (5) establish clinical registries for prostate can22 cer; 

23 (6) use the National Institute of Biomedical 

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1 cer Institute for assessment of appropriate imaging 

2 modalities; and 

3 (7) address such other matters relating to pros4 tate cancer research as may be identified by the 

5 Federal agencies participating in the program under 

6 this section. 

7 (b) PROSTATE CANCER ADVISORY BOARD.—There is 

8 established in the Office of the Chief Scientist of the Food 

9 and Drug Administration a Prostate Cancer Scientific Ad10 visory Board. Such board shall be responsible for accel11 erating real-time sharing of the latest research data and 

12 accelerating movement of new medicines to patients. 

13 (c) UNDERSERVED MINORITY GRANT PROGRAM.—In 

14 carrying out such program, the Secretary shall— 

15 (1) award grants to eligible entities to carry out 

16 components of the research outlined in subsection 

17 (a); 

18 (2) integrate and build upon existing knowledge 

19 gained from comparative effectiveness research; and 

20 (3) recognize and address— 

21 (A) the racial and ethnic disparities in the 

22 incidence and mortality rates of prostate cancer 

23 and men with a family history of prostate can24 cer; 


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1 (B) any barriers in access to care and par2 ticipation in clinical trials that are specific to 

3 racial, ethnic, and other underserved minorities 

4 and men with a family history of prostate can5 cer; 

6 (C) needed outreach and educational ef7 forts to raise awareness in these communities; 

8 and 

9 (D) appropriate access and utilization of 

10 imaging modalities. 

11 SEC. 5. TELEHEALTH AND RURAL ACCESS PILOT PROJECT. 

12 (a) IN GENERAL.—The Secretary of Veterans Af13 fairs, the Secretary of Defense, and the Secretary of 

14 Health and Human Services (in this section referred to 

15 as the ‘‘Secretaries’’) shall establish 4-year telehealth pilot 

16 projects for the purpose of analyzing the clinical outcomes 

17 and cost effectiveness associated with telehealth services 

18 in a variety of geographic areas that contain high propor19 tions of medically underserved populations, including Afri20 can-Americans, Latin Americans, American Indians, and 

21 those in rural areas. Such projects shall promote efficient 

22 use of specialist care through better coordination of pri23 mary care and physician extender teams in underserved 

24 areas and more effectively employ tumor boards to better 

25 counsel patients. 


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1 (b) ELIGIBLE ENTITIES.— 

2 (1) IN GENERAL.—The Secretaries shall select 

3 eligible entities to participate in the pilot projects 

4 under this section. 

5 (2) PRIORITY.—In selecting eligible entities to 

6 participate in the pilot projects under this section, 

7 the Secretaries shall give priority to such entities lo8 cated in medically underserved areas, particularly 

9 those that include African-Americans, Latin Ameri10 cans, and facilities of the Indian Health Service, and 

11 those in rural areas. 

12 (c) EVALUATION.—The Secretaries shall, through the 

13 pilot projects, evaluate— 

14 (1) the effective and economic delivery of care 

15 in diagnosing and treating prostate cancer with the 

16 use of telehealth services in medically underserved 

17 and tribal areas including collaborative uses of 

18 health professionals and integration of the range of 

19 telehealth and other technologies; 

20 (2) the effectiveness of improving the capacity 

21 of nonmedical providers and nonspecialized medical 

22 providers to provide health services for prostate can23 cer in medically underserved and tribal areas, in24 cluding the exploration of innovative medical home 

25 models with collaboration between urologists, other 


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1 relevant medical specialists, including oncologists, 

2 radiologists, and primary care teams and coordina3 tion of care through the efficient use of primary care 

4 teams and physician extenders; and 

5 (3) the effectiveness of using telehealth services 

6 to provide prostate cancer treatment in medically 

7 underserved areas, including the use of tumor 

8 boards to facilitate better patient counseling. 

9 (d) REPORT.—Not later than 12 months after the 

10 completion of the pilot projects under this subsection, the 

11 Secretaries shall submit to Congress a report describing 

12 the outcomes of such pilot projects, including any cost sav13 ings and efficiencies realized, and providing recommenda14 tions, if any, for expanding the use of telehealth services. 

15 SEC. 6. EDUCATION AND AWARENESS. 

16 (a) IN GENERAL.—The Secretary of Veterans Affairs 

17 shall develop a national education campaign for prostate 

18 cancer. Such campaign shall involve the use of written 

19 educational materials and public service announcements 

20 consistent with the findings of the Prostate Cancer Task 

21 Force under section 3, that are intended to encourage men 

22 to seek prostate cancer screening when appropriate. 

23 (b) RACIAL DISPARITIES AND THE POPULATION OF

24 MEN WITH A FAMILY HISTORY OF PROSTATE CANCER.— 

25 In developing the national campaign under subsection (a), 


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1 the Secretary shall ensure that such educational materials 

2 and public service announcements are more readily avail3 able in communities experiencing racial disparities in the 

4 incidence and mortality rates of prostate cancer and by 

5 men of any race classification with a family history of 

6 prostate cancer. 

7 (c) GRANTS.—In carrying out the national campaign 

8 under this section, the Secretary shall award grants to 

9 nonprofit private entities to enable such entities to test 

10 alternative outreach and education strategies. 

11 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

12 (a) IN GENERAL.—There is authorized to be appro13 priated to carry out this Act for the period of fiscal years 

14 2014 through 2018 an amount equal to the savings de15 scribed in subsection (b). 

16 (b) CORRESPONDING REDUCTION.—The amount au17 thorized to be appropriated by provisions of law other than 

18 this Act for the period of fiscal years 2014 through 2018 

19 for Federal research and health care program activities 

20 related to prostate cancer is reduced by the amount of 

21 Federal savings projected to be achieved over such period 

22 by implementation of section 3(b)(3) of this Act. 

Æ 


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