I 

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 


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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. 

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 2011’’ 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 disVerDate Mar 15 2010 03:39 Jun 15, 2011 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2159.IH H2159

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1 ease, and when prostate cancer appears in early 

2 middle age it frequently takes on a more aggressive 

3 form. 

4 (5) There are significant racial and ethnic dis5 parities that demand attention, namely African6 Americans have prostate cancer mortality rates that 

7 are more than double those in the White population. 

8 (6) Underserved rural populations have higher 

9 rates of mortality compared to their urban counter10 parts, and innovative and cost-efficient methods to 

11 improve rural access to high quality care should take 

12 advantage of advances in telehealth to diagnose and 

13 treat prostate cancer when appropriate. 

14 (7) Certain veterans populations may have 

15 nearly twice the incidence of prostate cancer as the 

16 general population of the United States. 

17 (8) Urologists may constitute the specialists 

18 who diagnose and treat the vast majority of prostate 

19 cancer patients. 

20 (9) Although much basic and translational re21 search has been completed and much is currently 

22 known, there are still many unanswered questions. 

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

24 known disparities are attributable to disease etiVerDate Mar 15 2010 03:39 Jun 15, 2011 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2159.IH H2159

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1 ology, access to care, or education and awareness in 

2 the community. 

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

4 There is not good information regarding how to dif5 ferentiate accurately, early on, between aggressive 

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

7 is significant overtreatment in prostate cancer. 

8 There are no treatments that can durably arrest 

9 growth or cure prostate cancer once it has metasta10 sized. 

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

12 percent) of cases may be clinically indolent and 

13 ‘‘overdiagnosed’’, resulting in significant overtreat14 ment. More accurate tests will allow men and their 

15 families to face less physical, psychological, financial, 

16 and emotional trauma and billions of dollars could 

17 be saved in private and public health care systems 

18 in an area that has been identified by the Medicare 

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

20 in the Resource Utilization Report program author21 ized by Congress under the Medicare Improvements 

22 for Patients and Providers Act of 2008. 

23 (12) Prostate cancer research and health care 

24 programs across Federal agencies should be coordi25 nated to improve accountability and actively encourVerDate Mar 15 2010 03:39 Jun 15, 2011 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2159.IH H2159

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1 age the translation of research into practice, to iden2 tify and implement best practices, in order to foster 

3 an integrated and consistent focus on effective pre4 vention, diagnosis, and treatment of this disease. 

5 SEC. 3. PROSTATE CANCER COORDINATION AND EDU6 CATION. 

7 (a) INTERAGENCY PROSTATE CANCER COORDINA8 TION AND EDUCATION TASK FORCE.—Not later than 180 

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

10 Secretary of Veterans Affairs, in cooperation with the Sec11 retary of Defense and the Secretary of Health and Human 

12 Services, shall establish an Interagency Prostate Cancer 

13 Coordination and Education Task Force (in this section 

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

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

16 shall— 

17 (1) develop a summary of advances in prostate 

18 cancer research supported or conducted by Federal 

19 agencies relevant to the diagnosis, prevention, and 

20 treatment of prostate cancer, including psychosocial 

21 impairments related to prostate cancer treatment, 

22 and compile a list of best practices that warrant 

23 broader adoption in health care programs; 

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

25 guidance to enable physicians to allow screening of 


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

2 taking into account quality of life and family history 

3 of prostate cancer; 

4 (3) share and coordinate information on Fed5 eral research and health care program activities, in6 cluding activities related to— 

7 (A) determining how to improve research 

8 and health care programs, including psycho9 social impairments related to prostate cancer 

10 treatment; 

11 (B) identifying any gaps in the overall re12 search inventory and in health care programs; 

13 (C) identifying opportunities to promote 

14 translation of research into practice; and 

15 (D) maximizing the effects of Federal ef16 forts by identifying opportunities for collabora17 tion and leveraging of resources in research and 

18 health care programs that serve those suscep19 tible to or diagnosed with prostate cancer; 

20 (4) develop a comprehensive interagency strat21 egy and advise relevant Federal agencies in the solic22 itation of proposals for collaborative, multidisci23 plinary research and health care programs, including 

24 proposals to evaluate factors that may be related to 

25 the etiology of prostate cancer, that would— 


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1 (A) result in innovative approaches to 

2 study emerging scientific opportunities or elimi3 nate knowledge gaps in research to improve the 

4 prostate cancer research portfolio of the Fed5 eral Government; 

6 (B) outline key research questions, meth7 odologies, and knowledge gaps; and 

8 (C) ensure consistent action, as outlined by 

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

10 (5) develop a coordinated message related to 

11 screening and treatment for prostate cancer to be 

12 reflected in educational and beneficiary materials for 

13 Federal health programs as such documents are up14 dated; and 

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

16 the establishment of the Prostate Cancer Task 

17 Force, submit to the Expert Advisory Panel to be re18 viewed and returned within 30 days, and then within 

19 90 days submitted to Congress recommendations— 

20 (A) regarding any appropriate changes to 

21 research and health care programs, including 

22 recommendations to improve the research port23 folio of the Department of Veterans Affairs, 

24 Department of Defense, National Institutes of 

25 Health, and other Federal agencies to ensure 


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1 that scientifically based strategic planning is 

2 implemented in support of research and health 

3 care program priorities; 

4 (B) designed to ensure that the research 

5 and health care programs and activities of the 

6 Department of Veterans Affairs, the Depart7 ment of Defense, the Department of Health and 

8 Human Services, and other Federal agencies 

9 are free of unnecessary duplication; 

10 (C) regarding public participation in deci11 sions relating to prostate cancer research and 

12 health care programs to increase the involve13 ment of patient advocates, community organiza14 tions, and medical associations representing a 

15 broad geographical area; 

16 (D) on how to best disseminate informa17 tion on prostate cancer research and progress 

18 achieved by health care programs; 

19 (E) about how to expand partnerships be20 tween public entities, including Federal agen21 cies, and private entities to encourage collabo22 rative, cross-cutting research and health care 

23 delivery; 

24 (F) assessing any cost savings and effi25 ciencies realized through the efforts identified 


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1 and supported in this Act and recommending 

2 expansion of those efforts that have proved 

3 most promising while also ensuring against any 

4 conflicts in directives from other congressional 

5 or statutory mandates or enabling statutes; 

6 (G) identifying key priority action items 

7 from among the recommendations; and 

8 (H) with respect to the level of funding 

9 needed by each agency to implement the rec10 ommendations contained in the report. 

11 (c) MEMBERS OF THE PROSTATE CANCER TASK

12 FORCE.—The Prostate Cancer Task Force described in 

13 subsection (a) shall be composed of representatives from 

14 such Federal agencies, as each Secretary determines nec15 essary, to coordinate a uniform message relating to pros16 tate cancer screening and treatment where appropriate, 

17 including representatives of the following: 

18 (1) The Department of Veterans Affairs, in19 cluding representatives of each relevant program 

20 areas of the Department of Veterans Affairs. 

21 (2) The Prostate Cancer Research Program of 

22 the Congressionally Directed Medical Research Pro23 gram of the Department of Defense. 


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1 (3) The Department of Health and Human 

2 Services, including at a minimum representatives of 

3 the following: 

4 (A) The National Institutes of Health. 

5 (B) National research institutes and cen6 ters, including the National Cancer Institute, 

7 the National Institute of Allergy and Infectious 

8 Diseases, and the Office of Minority Health. 

9 (C) The Centers for Medicare & Medicaid 

10 Services. 

11 (D) The Food and Drug Administration. 

12 (E) The Centers for Disease Control and 

13 Prevention. 

14 (F) The Agency for Healthcare Research 

15 and Quality. 

16 (G) The Health Resources and Services 

17 Administration. 

18 (d) APPOINTING EXPERT ADVISORY PANELS.—The 

19 Prostate Cancer Task Force shall appoint expert advisory 

20 panels, as determined appropriate, to provide input and 

21 concurrence from individuals and organizations from the 

22 medical, prostate cancer patient and advocate, research, 

23 and delivery communities with expertise in prostate cancer 

24 diagnosis, treatment, and research, including practicing 

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1 uals with expertise in education and outreach to under2 served populations affected by prostate cancer. 

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

4 shall convene not less than twice a year, or more fre5 quently as the Secretary determines to be appropriate. 

6 (f) SUBMITTAL OF RECOMMENDATIONS TO CON7 GRESS.—The Secretary of Veterans Affairs shall submit 

8 to Congress any recommendations submitted to the Sec9 retary under subsection (b)(5). 

10 (g) FEDERAL ADVISORY COMMITTEE ACT.— 

11 (1) IN GENERAL.—Except as provided in para12 graph (2), the Federal Advisory Committee Act (5 

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

14 Task Force. 

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

16 Act (relating to the termination of advisory commit17 tees) shall not apply to the Prostate Cancer Task 

18 Force. 

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

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

21 SEC. 4. PROSTATE CANCER RESEARCH. 

22 (a) RESEARCH COORDINATION.—The Secretary of 

23 Veterans Affairs, in coordination with the Secretaries of 

24 Defense and of Health and Human Services, shall estab25 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 lifestyle 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; 


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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; and 

5 (7) address such other matters relating to pros6 tate cancer research as may be identified by the 

7 Federal agencies participating in the program under 

8 this section. 

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

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

11 and Drug Administration a Prostate Cancer Scientific Ad12 visory Board. Such board shall be responsible for accel13 erating real-time sharing of the latest research data and 

14 accelerating movement of new medicines to patients. 

15 (c) UNDERSERVED MINORITY GRANT PROGRAM.—In 

16 carrying out such program, the Secretary shall— 

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

18 components of the research outlined in subsection 

19 (a); 

20 (2) integrate and build upon existing knowledge 

21 gained from comparative effectiveness research; and 

22 (3) recognize and address— 

23 (A) the racial and ethnic disparities in the 

24 incidence and mortality rates of prostate cancer 


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

3 (B) any barriers in access to care and par4 ticipation in clinical trials that are specific to 

5 racial, ethnic, and other underserved minorities 

6 and men with a family history of prostate can7 cer; 

8 (C) needed outreach and educational ef9 forts to raise awareness in these communities; 

10 and 

11 (D) appropriate access and utilization of 

12 imaging modalities. 

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

14 (a) IN GENERAL.—The Secretary of Veterans Af15 fairs, the Secretary of Defense, and the Secretary of 

16 Health and Human Services (in this section referred to 

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

18 projects for the purpose of analyzing the clinical outcomes 

19 and cost effectiveness associated with telehealth services 

20 in a variety of geographic areas that contain high propor21 tions of medically underserved populations, including Afri22 can-Americans, Latin-Americans, American Indians, and 

23 those in rural areas. Such projects shall promote efficient 

24 use of specialist care through better coordination of pri25 mary care and physician extender teams in underserved 


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1 areas and more effectively employ tumor boards to better 

2 counsel patients. 

3 (b) ELIGIBLE ENTITIES.— 

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

5 eligible entities to participate in the pilot projects 

6 under this section. 

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

8 participate in the pilot projects under this section, 

9 the Secretaries shall give priority to such entities lo10 cated in medically underserved areas, particularly 

11 those that include African-Americans, Latin-Ameri12 cans, and facilities of the Indian Health Service, and 

13 those in rural areas. 

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

15 pilot projects, evaluate— 

16 (1) the effective and economic delivery of care 

17 in diagnosing and treating prostate cancer with the 

18 use of telehealth services in medically underserved 

19 and tribal areas including collaborative uses of 

20 health professionals and integration of the range of 

21 telehealth and other technologies; 

22 (2) the effectiveness of improving the capacity 

23 of nonmedical providers and nonspecialized medical 

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1 cluding the exploration of innovative medical home 

2 models with collaboration between urologists, other 

3 relevant medical specialists, including oncologists, 

4 radiologists, and primary care teams and coordina5 tion of care through the efficient use of primary care 

6 teams and physician extenders; and 

7 (3) the effectiveness of using telehealth services 

8 to provide prostate cancer treatment in medically 

9 underserved areas, including the use of tumor 

10 boards to facilitate better patient counseling. 

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

12 completion of the pilot projects under this subsection, the 

13 Secretaries shall submit to Congress a report describing 

14 the outcomes of such pilot projects, including any cost sav15 ings and efficiencies realized, and providing recommenda16 tions, if any, for expanding the use of telehealth services. 

17 SEC. 6. EDUCATION AND AWARENESS. 

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

19 shall develop a national education campaign for prostate 

20 cancer. Such campaign shall involve the use of written 

21 educational materials and public service announcements 

22 consistent with the findings of the Prostate Cancer Task 

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

24 to seek prostate cancer screening when appropriate. 


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1 (b) RACIAL DISPARITIES AND THE POPULATION OF

2 MEN WITH A FAMILY HISTORY OF PROSTATE CANCER.— 

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

4 the Secretary shall ensure that such educational materials 

5 and public service announcements are more readily avail6 able in communities experiencing racial disparities in the 

7 incidence and mortality rates of prostate cancer and by 

8 men of any race classification with a family history of 

9 prostate cancer. 

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

11 under this section, the Secretary shall award grants to 

12 nonprofit private entities to enable such entities to test 

13 alternative outreach and education strategies. 

14 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

15 (a) IN GENERAL.—There is authorized to be appro16 priated to carry out this Act for the period of fiscal years 

17 2012 through 2016 an amount equal to the savings de18 scribed in subsection (b). 

19 (b) CORRESPONDING REDUCTION.—The amount au20 thorized to be appropriated by provisions of law other than 

21 this Act for the period of fiscal years 2012 through 2016 

22 for Federal research and health care program activities 

23 related to prostate cancer is reduced by the amount of 


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1 Federal savings projected to be achieved over such period 

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

Æ 


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