I 

111TH CONGRESS 

2D SESSION H. R. 6389 

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 

SEPTEMBER 29, 2010 

Mr. TOWNS introduced the following bill; which was referred to the Committee 

on Energy and Commerce, and in addition to the Committees on Armed 

Services and Veterans’ Affairs, 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 


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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. 

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 2010’’ 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 2009, more than 190,000 new patients 

12 were diagnosed with prostate cancer and more than 

13 27,000 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 


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1 middle age it frequently takes on a more aggressive 

2 form. 

3 (5) There are significant racial and ethnic dis4 parities that demand attention, namely African5 Americans have prostate cancer mortality rates that 

6 are more than double those in the White population. 

7 (6) Underserved rural populations have higher 

8 rates of mortality compared to their urban counter9 parts, and innovative and cost-efficient methods to 

10 improve rural access to high quality care should take 

11 advantage of advances in telehealth to diagnose and 

12 treat prostate cancer when appropriate. 

13 (7) Urologists may constitute the specialists 

14 who diagnose and treat the vast majority of prostate 

15 cancer patients. 

16 (8) Although much basic and translational re17 search has been completed and much is currently 

18 known, there are still many unanswered questions. 

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

20 known disparities are attributable to disease eti21 ology, access to care, or education and awareness in 

22 the community. 

23 (9) Causes of prostate cancer are not known. 

24 There is not good information regarding how to dif25 ferentiate accurately, early on, between aggressive 


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

2 is significant overtreatment in prostate cancer. 

3 There are no treatments that can durably arrest 

4 growth or cure prostate cancer once it has metasta5 sized. 

6 (10) A significant proportion (roughly 23 to 54 

7 percent) of cases may be clinically indolent and 

8 ‘‘overdiagnosed’’, resulting in significant overtreat9 ment. More accurate tests will allow men and their 

10 families to face less physical, psychological, financial, 

11 and emotional trauma and billions of dollars could 

12 be saved in private and public health care systems 

13 in an area that has been identified by the Medicare 

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

15 in the Resource Utilization Report program author16 ized by Congress under the Medicare Improvements 

17 for Patients and Providers Act of 2008. 

18 (11) Prostate cancer research and health care 

19 programs across Federal agencies should be coordi20 nated to improve accountability and actively encour21 age the translation of research into practice, to iden22 tify and implement best practices, in order to foster 

23 an integrated and consistent focus on effective pre24 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 and compile a list of 

17 best practices that warrant broader adoption in 

18 health care programs; 

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

20 guidance to enable physicians to allow screening of 

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

22 taking into account quality of life and family history 

23 of prostate cancer; 

24 (3) share and coordinate information on Fed25 eral research and health care program activities, in26 cluding activities related to— 


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1 (A) determining how to improve research 

2 and health care programs; 

3 (B) identifying any gaps in the overall re4 search inventory and in health care programs; 

5 (C) identifying opportunities to promote 

6 translation of research into practice; and 

7 (D) maximizing the effects of Federal ef8 forts by identifying opportunities for collabora9 tion and leveraging of resources in research and 

10 health care programs that serve those suscep11 tible to or diagnosed with prostate cancer; 

12 (4) develop a comprehensive interagency strat13 egy and advise relevant Federal agencies in the solic14 itation of proposals for collaborative, multidisci15 plinary research and health care programs, including 

16 proposals to evaluate factors that may be related to 

17 the etiology of prostate cancer, that would— 

18 (A) result in innovative approaches to 

19 study emerging scientific opportunities or elimi20 nate knowledge gaps in research; 

21 (B) outline key research questions, meth22 odologies, and knowledge gaps; 

23 (C) ensure consistent action, as outlined by 

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


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1 (5) develop a coordinated message related to 

2 screening and treatment for prostate cancer to be 

3 reflected in educational and beneficiary materials for 

4 Federal health programs as such documents are up5 dated; and 

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

7 the establishment of the Prostate Cancer Task 

8 Force, submit to the Secretary of Veterans Affairs 

9 recommendations— 

10 (A) regarding any appropriate changes to 

11 research and health care programs, including 

12 recommendations to improve the research port13 folio of the Department of Veterans Affairs, 

14 Department of Defense, National Institutes of 

15 Health, and other Federal agencies to ensure 

16 that scientifically based strategic planning is 

17 implemented in support of research and health 

18 care program priorities; 

19 (B) designed to ensure that the research 

20 and health care programs and activities of the 

21 Department of Veterans Affairs, the Depart22 ment of Defense, the Department of Health and 

23 Human Services, and other Federal agencies 

24 are free of unnecessary duplication; 


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1 (C) regarding public participation in deci2 sions relating to prostate cancer research and 

3 health care programs to increase the involve4 ment of patient advocates, community organiza5 tions, and medical associations representing a 

6 broad geographical area; 

7 (D) on how to best disseminate informa8 tion on prostate cancer research and progress 

9 achieved by health care programs; 

10 (E) about how to expand partnerships be11 tween public entities, including Federal agen12 cies, and private entities to encourage collabo13 rative, cross-cutting research and health care 

14 delivery; 

15 (F) assessing any cost savings and effi16 ciencies realized through the efforts identified 

17 and supported in this Act and recommending 

18 expansion of those efforts that have proved 

19 most promising while also ensuring against any 

20 conflicts in directives from other congressional 

21 or statutory mandates or enabling statutes; 

22 (G) identifying key priority action items 

23 from among the recommendations; and 


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1 (H) with respect to the level of funding 

2 needed by each agency to implement the rec3 ommendations contained in the report. 

4 (c) MEMBERS OF THE PROSTATE CANCER TASK

5 FORCE.—The Prostate Cancer Task Force described in 

6 subsection (a) shall be composed of representatives from 

7 such Federal agencies, as each Secretary determines nec8 essary, to coordinate a uniform message relating to pros9 tate cancer screening and treatment where appropriate, 

10 including representatives of the following: 

11 (1) The Department of Veterans Affairs, in12 cluding representatives of each relevant program 

13 areas of the Department of Veterans Affairs. 

14 (2) The Prostate Cancer Research Program of 

15 the Congressionally Directed Medical Research Pro16 gram of the Department of Defense. 

17 (3) The Department of Health and Human 

18 Services. 

19 (d) APPOINTING EXPERT ADVISORY PANELS.—The 

20 Prostate Cancer Task Force shall appoint expert advisory 

21 panels, as determined appropriate, to provide input and 

22 concurrence from individuals and organizations from the 

23 medical, research, and delivery communities with expertise 

24 in prostate cancer diagnosis, treatment, and research, in25 cluding practicing urologists, primary care providers, and 


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1 others and individuals with expertise in education and out2 reach to underserved populations affected by prostate can3 cer. 

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

5 shall convene not less than twice a year, or more fre6 quently as the Secretary determines to be appropriate. 

7 (f) SUBMITTAL OF RECOMMENDATIONS TO CON8 GRESS.—The Secretary of Veterans Affairs shall submit 

9 to Congress any recommendations submitted to the Sec10 retary under subsection (b)(5). 

11 (g) FEDERAL ADVISORY COMMITTEE ACT.— 

12 (1) IN GENERAL.—Except as provided in para13 graph (2), the Federal Advisory Committee Act (5 

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

15 Task Force. 

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

17 Act (relating to the termination of advisory commit18 tees) shall not apply to the Prostate Cancer Task 

19 Force. 

20 SEC. 4. PROSTATE CANCER RESEARCH. 

21 (a) RESEARCH COORDINATION.—The Secretary of 

22 Veterans Affairs, in coordination with the Secretaries of 

23 Defense and of Health and Human Services, shall estab24 lish and carry out a program to coordinate and intensify 


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1 prostate cancer research as needed. Specifically, such re2 search program shall— 

3 (1) develop advances in diagnostic and prog4 nostic methods and tests, including biomarkers and 

5 an improved prostate cancer screening blood test, in6 cluding improvements or alternatives to the prostate 

7 specific antigen test and additional tests to distin8 guish indolent from aggressive disease; 

9 (2) better understand the etiology of the disease 

10 (including an analysis of life style factors proven to 

11 be involved in higher rates of prostate cancer, such 

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

13 and socioeconomic groups, such as the African14 American, Latin-American, and American Indian 

15 populations and men with a family history of pros16 tate cancer) to improve prevention efforts; 

17 (3) expand basic research into prostate cancer, 

18 including studies of fundamental molecular and cel19 lular mechanisms; 

20 (4) identify and provide clinical testing of novel 

21 agents for the prevention and treatment of prostate 

22 cancer; 

23 (5) establish clinical registries for prostate can24 cer; and 


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1 (6) use the National Institute of Biomedical 

2 Imaging and Bioengineering and the National Can3 cer Institute for assessment of appropriate imaging 

4 modalities. 

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

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

7 and Drug Administration a Prostate Cancer Scientific Ad8 visory Board. Such board shall be responsible for accel9 erating real-time sharing of the latest research data and 

10 accelerating movement of new medicines to patients. 

11 (c) UNDERSERVED MINORITY GRANT PROGRAM.—In 

12 carrying out such program, the Secretary shall— 

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

14 components of the research outlined in subsection 

15 (a); 

16 (2) integrate and build upon existing knowledge 

17 gained from comparative effectiveness research; and 

18 (3) recognize and address— 

19 (A) the racial and ethnic disparities in the 

20 incidence and mortality rates of prostate cancer 

21 and men with a family history of prostate can22 cer; 

23 (B) any barriers in access to care and par24 ticipation in clinical trials that are specific to 

25 racial, ethnic, and other underserved minorities 


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1 and men with a family history of prostate can2 cer; 

3 (C) needed outreach and educational ef4 forts to raise awareness in these communities; 

5 and 

6 (D) appropriate access and utilization of 

7 imaging modalities. 

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

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

10 shall establish four-year telehealth pilot projects for the 

11 purpose of analyzing the clinical outcomes and cost effec12 tiveness associated with telehealth services in a variety of 

13 geographic areas that contain high proportions of medi14 cally underserved populations, including African-Ameri15 cans, Latin-Americans, American Indians, and those in 

16 rural areas. Such projects shall promote efficient use of 

17 specialist care through better coordination of primary care 

18 and physician extender teams in underserved areas and 

19 more effectively employ tumor boards to better counsel pa20 tients. 

21 (b) ELIGIBLE ENTITIES.— 

22 (1) IN GENERAL.—The Secretary shall select el23 igible entities to participate in the pilot projects 

24 under this section. 


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

2 participate in the pilot projects under this section, 

3 the Secretary shall give priority to such entities lo4 cated in medically underserved areas, particularly 

5 those that include African-Americans, Latin-Ameri6 cans, and facilities of the Indian Health Service, and 

7 those in rural areas. 

8 (c) EVALUATION.—The Secretary shall, through the 

9 pilot projects, evaluate— 

10 (1) the effective and economic delivery of care 

11 in diagnosing and treating prostate cancer with the 

12 use of telehealth services in medically underserved 

13 and tribal areas including collaborative uses of 

14 health professionals and integration of the range of 

15 telehealth and other technologies; 

16 (2) the effectiveness of improving the capacity 

17 of nonmedical providers and nonspecialized medical 

18 providers to provide health services for prostate can19 cer in medically underserved and tribal areas, in20 cluding the exploration of innovative medical home 

21 models with collaboration between urologists, other 

22 relevant medical specialists, including oncologists, 

23 radiologists, and primary care teams and coordina24 tion of care through the efficient use of primary care 

25 teams and physician extenders; and 


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1 (3) the effectiveness of using telehealth services 

2 to provide prostate cancer treatment in medically 

3 underserved areas, including the use of tumor 

4 boards to facilitate better patient counseling. 

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

6 completion of the pilot projects under this subsection, the 

7 Secretary shall submit to Congress a report describing the 

8 outcomes of such pilot projects, including any cost savings 

9 and efficiencies realized, and providing recommendations, 

10 if any, for expanding the use of telehealth services. 

11 SEC. 6. EDUCATION AND AWARENESS. 

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

13 shall develop a national education campaign for prostate 

14 cancer. Such campaign shall involve the use of written 

15 educational materials and public service announcements 

16 consistent with the findings of the Prostate Cancer Task 

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

18 to seek prostate cancer screening when appropriate. 

19 (b) RACIAL DISPARITIES AND THE POPULATION OF

20 MEN WITH A FAMILY HISTORY OF PROSTATE CANCER.— 

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

22 the Secretary shall ensure that such educational materials 

23 and public service announcements are more readily avail24 able in communities experiencing racial disparities in the 

25 incidence and mortality rates of prostate cancer and by 


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1 men of any race classification with a family history of 

2 prostate cancer. 

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

4 under this section, the Secretary shall award grants to 

5 nonprofit private entities to enable such entities to test 

6 alternative outreach and education strategies. 

7 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

8 There is authorized to be appropriated to carry out 

9 this Act such sums as may be necessary for each of fiscal 

10 years 2011 through 2015. 

Æ 


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