I 

111TH CONGRESS 

2D SESSION H. R. 6224 

To modernize cancer research, increase access to preventative cancer services, 

provide cancer treatment and survivorship initiatives, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 28, 2010 

Mrs. CAPPS (for herself and Mr. PALLONE) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on Ways and Means, 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 modernize cancer research, increase access to preventative 

cancer services, provide cancer treatment and survivorship initiatives, and for other purposes. 

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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘21st Century Cancer ALERT (Access to Life-Saving 

6 Early detection, Research and Treatment) Act’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 


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Sec. 1. Short title; table of contents. 

Sec. 2. Findings and purpose. 

Sec. 3. Advancement of the National Cancer Program. 

Sec. 4. Comprehensive and Responsible Access to Research, Data, and Outcomes. 

Sec. 5. Enhanced focus and reporting on cancer research. 

Sec. 6. Continuing access to care for prevention and early detection. 

Sec. 7. Early recognition and treatment of cancer through use of biomarkers. 

Sec. 8. Extending coverage under Medicaid of counseling and pharmacotherapy 

for cessation of tobacco use. 

Sec. 9. Comprehensive cancer care and coverage under Medicare. 

Sec. 10. Targeted Cancers program. 

Sec. 11. Activities of the Food and Drug Administration. 

Sec. 12. CDC Cancer Control Programs. 

Sec. 13. NIH cancer survivorship programs. 

Sec. 14. Clinics for comprehensive long-term follow-up services for childhood 

cancer survivors. 

Sec. 15. Grants to improve access to care for childhood cancer survivors. 

1 SEC. 2. FINDINGS AND PURPOSE. 

2 (a) FINDINGS.—Congress makes the following find3 ings: 

4 (1) One in 2 men and one in 3 women are ex5 pected to develop cancer in their lifetimes. 

6 (2) Cancer is the leading cause of death for 

7 people under the age of 85 and is expected to claim 

8 more than 1,500 lives per day in 2008. 

9 (3) At least 30 percent of all cancer deaths and 

10 87 percent of lung cancer deaths are attributed to 

11 smoking. 

12 (4) The National Institutes of Health estimates 

13 that in 2007 alone, the overall cost of cancer to the 

14 United States was more than $219,000,000,000. 

15 (5) In recent decades, the biomedical research 

16 enterprise has made considerable advances in the 

17 knowledge required to understand, prevent, diagVerDate Mar 15 2010 02:37 Oct 05, 2010 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6224.IH H6224

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1 nose, and treat cancer; however, it still takes 17 

2 years, on average, to translate these discoveries into 

3 viable treatment options. 

4 (6) While clinical trials are vital to the dis5 covery and implementation of new preventative, di6 agnostic, and treatment options, only 3 to 5 percent 

7 of the more than 10,000,000 adults with cancer in 

8 the United States participate in cancer clinical 

9 trials. 

10 (7) Where people reside should not determine 

11 whether they live, yet women in rural areas are less 

12 likely to obtain preventative cancer screenings than 

13 those residing in urban areas. 

14 (8) Two-thirds of childhood cancer survivors are 

15 likely to experience at least one late effect from 

16 treatment and one-fourth are expected to experience 

17 a late effect that is life threatening. 

18 (9) In 1971, there were only 3,000,000 cancer 

19 survivors. Today, cancer survivors account for 3 per20 cent of the United States population, approximately 

21 12,000,000. 

22 (10) The National Cancer Act of 1971 (Public 

23 Law 92–218) advanced the ability of the United 

24 States to develop new scientific leads and help in25 crease the rate of cancer survivorship. 


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1 (11) Yet in the 37 years since the national dec2 laration of the War on Cancer, the age adjusted 

3 mortality rate for cancer is still extraordinarily high. 

4 Eight forms of cancer have a 5-year survival rate of 

5 less than 50 percent (pancreatic, liver, lung, esopha6 geal, stomach, brain, multiple myeloma, and ovar7 ian). 

8 (12) While there have been substantial achieve9 ments since the crusade began, we are far from win10 ning the war on cancer. 

11 (13) Many obstacles have hindered our progress 

12 in cancer prevention, research, and treatment. 

13 (b) PURPOSES.—The purposes of this Act are as fol14 lows: 

15 (1) To reauthorize the National Cancer Pro16 gram in order to benefit cancer patients by enhanc17 ing and improving the cancer research conducted 

18 and supported by the National Cancer Institute and 

19 the National Cancer Program. 

20 (2) To recognize that with an increased under21 standing of cancer as more than 200 different dis22 eases with genetic and molecular variations, there is 

23 a need for increased coordination and greater flexi24 bility in how cancer research is conducted and co25 ordinated in order to maximize the return the 


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1 United States receives on its investment in such re2 search. 

3 (3) To prepare for the looming impact of an 

4 aging population of the United States and the an5 ticipated financial burden associated with medical 

6 treatment and lost productivity, along with the toll 

7 of human suffering that accompanies a cancer diag8 nosis. 

9 (4) To support the National Cancer Institute in 

10 establishing relationships and scientific consortia 

11 with an emphasis on public-private partnership de12 velopment, which will further the development of ad13 vanced technologies that will improve the prevention, 

14 diagnosis, and treatment of cancer. 

15 SEC. 3. ADVANCEMENT OF THE NATIONAL CANCER PRO16 GRAM. 

17 Section 411 of the Public Health Service Act (42 

18 U.S.C. 285a) is amended to read as follows: 

19 ‘‘SEC. 411. NATIONAL CANCER PROGRAM. 

20 ‘‘(a) IN GENERAL.—There shall be established a Na21 tional Cancer Program (referred to in this section as the 

22 ‘Program’) that shall consist of— 

23 ‘‘(1) an expanded, intensified, and coordinated 

24 cancer research program encompassing the research 

25 programs conducted and supported by the Institute 


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1 and the related research programs of the other na2 tional research institutes, including an expanded and 

3 intensified research program for the prevention of 

4 cancer caused by occupational or environmental ex5 posure to carcinogens; and 

6 ‘‘(2) the other programs and activities of the 

7 Institute. 

8 ‘‘(b) COLLABORATION.—In carrying out the Pro9 gram— 

10 ‘‘(1) the Secretary and the Director of the In11 stitute shall identify relevant Federal agencies that 

12 shall collaborate with respect to activities conducted 

13 under the Program (including the Institute, the 

14 other Institutes and Centers of the National Insti15 tutes of Health, the Office of the Director of the Na16 tional Institutes of Health, the Food and Drug Ad17 ministration, the Centers for Medicare & Medicaid 

18 Services, the Centers for Disease Control and Pre19 vention, the Department of Defense, the Department 

20 of Energy, the Agency for Healthcare Research and 

21 Quality, the Office for Human Research Protections, 

22 the Health Resources and Services Administration, 

23 and the Office for Human Research Protections); 

24 and 


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1 ‘‘(2) the Secretary shall ensure that the policies 

2 related to the promotion of cancer research of all 

3 agencies within the Department of Health and 

4 Human Services (including the Institute, the Food 

5 and Drug Administration, and the Centers for Medi6 care & Medicaid Services) are harmonized, and shall 

7 ensure that such agencies collaborate with regard to 

8 cancer research and development. 

9 ‘‘(c) TRANSPARENCY AND EFFICIENCY.— 

10 ‘‘(1) BUDGETING.—In carrying out the Pro11 gram, the Director of the Institute shall, in pre12 paring and submitting to the President the annual 

13 budget estimate for the Program— 

14 ‘‘(A) develop the budgetary needs of the 

15 entire Program and submit the budget estimate 

16 relating to such needs to the National Cancer 

17 Advisory Board for review prior to submitting 

18 such estimate to the President; and 

19 ‘‘(B) submit such budget estimate to the 

20 Committee on the Budget and the Committee 

21 on Appropriations of the Senate and the Com22 mittee on the Budget and Committee on Appro23 priations of the House of Representatives at the 

24 same time that such estimate is submitted to 

25 the President. 


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1 ‘‘(2) NATIONAL CANCER ADVISORY BOARD.—In 

2 establishing the priorities of the Program, the Na3 tional Cancer Advisory Board shall provide for in4 creased coordination by increasing the participation 

5 of representatives (to the extent practicable, rep6 resentatives who have appropriate decision making 

7 authority) of appropriate Federal agencies, includ8 ing— 

9 ‘‘(A) the Centers for Medicare & Medicaid 

10 Services; 

11 ‘‘(B) the Health Resources and Services 

12 Administration; 

13 ‘‘(C) the Centers for Disease Control and 

14 Prevention; and 

15 ‘‘(D) the Agency for Healthcare Research 

16 and Quality. 

17 ‘‘(d) PROGRAMS TO ENCOURAGE EARLY DETECTION

18 RESEARCH.—The Director of the Institute shall develop 

19 a standard process through which Federal agencies, in20 cluding the Department of Defense, and administrators of 

21 federally funded programs may engage in early cancer de22 tection research. 

23 ‘‘(e) IDENTIFICATION OF PROMISING

24 TRANSLATIONAL RESEARCH OPPORTUNITIES.— 


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1 ‘‘(1) IN GENERAL.—The Director of the Insti2 tute, acting through the Program and in accordance 

3 with the NIH Reform Act of 2007, shall continue to 

4 identify promising translational research opportuni5 ties across all disease sites, populations, and path6 ways to clinical goals through a transparent, inclu7 sive process by— 

8 ‘‘(A) continuing to support efforts to de9 velop a robust number of public or nonprofit 

10 entities to carry out early translational research 

11 activities; 

12 ‘‘(B) emphasizing the role of the young re13 searcher in the program under this section; and 

14 ‘‘(C) modifying guidelines for multiproject, 

15 collaborative, early translational research 

16 awards to focus research and reward collabo17 rative team science. 

18 ‘‘(2) MATCHING FUNDS FOR RESEARCH.— 

19 ‘‘(A) IN GENERAL.—The Secretary may 

20 provide assistance to eligible entities to match 

21 the amount of non-Federal funds made avail22 able by such entity for translational research of 

23 the type described in paragraph (1) relating to 

24 cancer. 


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1 ‘‘(B) ELIGIBILITY.—To be eligible to re2 ceive assistance under subparagraph (A), an en3 tity shall submit to the Secretary an application 

4 at such time, in such manner, and containing 

5 such information as the Secretary may require. 

6 ‘‘(C) RECOMMENDATIONS AND

7 PRIORITIZATION.—In providing assistance 

8 under subparagraph (A), the Secretary shall— 

9 ‘‘(i) select entities based on the rec10 ommendations of— 

11 ‘‘(I) the Director of NIH; and 

12 ‘‘(II) a peer review process; and 

13 ‘‘(ii) give priority to those entities 

14 submitting applications under subpara15 graph (B) that demonstrate that the re16 search involved is high risk or translational 

17 research (as determined by the Secretary). 

18 ‘‘(D) AMOUNT.—The amount of assistance 

19 to be provided to an entity under subparagraph 

20 (A) shall be at the discretion of the Secretary 

21 but shall not exceed an amount equal to 100 

22 percent of the amount of non-Federal funds ($1 

23 for each $2 of non-Federal funds) made avail24 able for research described in subparagraph 

25 (A). 


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1 ‘‘(E) DETERMINATION OF AMOUNT OF

2 NON-FEDERAL CONTRIBUTION.—Non-Federal 

3 funds to be matched under subparagraph (A) 

4 may be in cash or in kind, fairly evaluated, in5 cluding plant, equipment, or services. Amounts 

6 provided by the Federal Government, and any 

7 portion of any service subsidized by the Federal 

8 Government, may not be included in deter9 mining the amount of such non-Federal funds. 

10 ‘‘(f) BIOLOGICAL RESOURCE COORDINATION AND

11 ADVANCEMENT OF TECHNOLOGIES FOR CANCER RE12 SEARCH.— 

13 ‘‘(1) ESTABLISHMENT.—The Director of the 

14 Institute, acting through the Program, shall estab15 lish an entity within the Institute to augment ongo16 ing efforts to advance new technologies in cancer re17 search, support the national collection of tissues for 

18 cancer research purposes, and ensure the quality of 

19 tissue collection. 

20 ‘‘(2) GOALS.—The entity established under 

21 paragraph (1) shall— 

22 ‘‘(A) be designed to expand the access of 

23 researchers to biospecimens for cancer research 

24 purposes; 


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1 ‘‘(B) establish uniform standards for the 

2 handling and preservation of patient tissue 

3 specimens by entities participating in the net4 work established under paragraph (3); 

5 ‘‘(C) require adequate annotation of all rel6 evant clinical data while assuring patient pri7 vacy; 

8 ‘‘(D) facilitate the linkage of public and 

9 private entities into the national network under 

10 paragraph (3); 

11 ‘‘(E) provide for the linkage of cancer reg12 istries to other administrative Federal Govern13 ment data sources, including the Centers for 

14 Medicare & Medicaid Services, the Social Secu15 rity Administration, and the Centers for Dis16 ease Control and Prevention, with the goal of 

17 understanding the determinants of cancer treat18 ment, care, and outcomes by allowing economic, 

19 social, genetic, and other factors to be analyzed 

20 in an independent manner; and 

21 ‘‘(F) develop strategies to ensure patient 

22 rights and privacy, including an assessment of 

23 the regulations promulgated pursuant to 

24 HIPAA privacy and security law (as defined in 


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1 section 3009(a)(2)), while facilitating advances 

2 in medical research. 

3 ‘‘(3) ADVANCEMENT OF NEW TECHNOLOGIES

4 FOR CANCER RESEARCH AND EXPANSION OF CANCER

5 BIOREPOSITORY NETWORKS.— 

6 ‘‘(A) IN GENERAL.—As part of the entity 

7 established under paragraph (1), the Director 

8 of the Institute shall build upon existing initia9 tives to establish an interconnected network of 

10 biorepositories (referred to in this subsection as 

11 the ‘Network’) with consistent, interoperable 

12 systems for the collection and storage of tissues 

13 and information, the annotation of such infor14 mation, and the sharing of such information 

15 through an interoperable information system. 

16 ‘‘(B) GUIDELINES.—A biorepository in the 

17 Network that receives Federal funds shall adopt 

18 the Institute’s Best Practices for Biospecimen 

19 Resources for Institute-supported biospecimen 

20 resources (as published by the Institute and in21 cluding any successor guidelines) for the collec22 tion of biospecimens and any accompanying 

23 data. 

24 ‘‘(C) REPRESENTATION.—The composition 

25 of any leadership entity of the Network shall be 


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1 determined by the Director of the Institute and 

2 shall, at a minimum, include a representative 

3 of— 

4 ‘‘(i) private sector entities and individ5 uals, including cancer researchers and 

6 health care providers; 

7 ‘‘(ii) the Centers for Disease Control 

8 and Prevention; 

9 ‘‘(iii) the Agency for Healthcare Re10 search and Quality; 

11 ‘‘(iv) the Office of National Coordina12 tion of Health Information Technology; 

13 ‘‘(v) the National Library of Medicine; 

14 ‘‘(vi) the Office for the Protection of 

15 Research Subjects; and 

16 ‘‘(vii) the National Science Founda17 tion. 

18 ‘‘(D) PARTNERSHIPS WITH TISSUE SOURCE

19 SITES.—The Director of the Institute may 

20 enter into contracts with tissue source sites to 

21 acquire data from such sites. Any such data 

22 shall be acquired through the use of protocols 

23 and closely monitored, transparent procedures 

24 within appropriate ethical and legal frame25 works. 


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1 ‘‘(4) COLLECTION OF DATA.— 

2 ‘‘(A) HOSPITALS.—A hospital or ambula3 tory cancer center that receives Federal funds 

4 shall offer patients the opportunity to con5 tribute their biospecimens and clinical data to 

6 the entity established under paragraph (1). 

7 ‘‘(B) CLINICAL TRIAL DATA.—Clinical trial 

8 data relating to cancer care and treatment shall 

9 be provided to the entity established under 

10 paragraph (1).’’. 

11 SEC. 4. COMPREHENSIVE AND RESPONSIBLE ACCESS TO 

12 RESEARCH, DATA, AND OUTCOMES. 

13 (a) IN GENERAL.—Not later than 180 days after the 

14 date of the enactment of this Act, the Director of the Of15 fice for Human Research Protections shall issue guidance 

16 to National Institutes of Health grantees concerning use 

17 of the facilitated review process in conjunction with the 

18 central institutional review board of the National Cancer 

19 Institute as the preferred mechanism to satisfy regulatory 

20 requirements to review ethical or scientific issues for all 

21 National Cancer Institute-supported translational and 

22 clinical research. 

23 (b) IMPROVED PRIVACY STANDARDS IN CLINICAL

24 RESEARCH.— 


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1 (1) PERMITTED DISCLOSURE UNDER THE PRI2 VACY RULE.—For purposes of HIPAA privacy and 

3 security law (as referred to in section 411(f)(2)(F) 

4 of the Public Health Service Act, as amended by 

5 section 3), a covered entity (as defined for purposes 

6 of such law) shall be in compliance with such law re7 lating to the disclosure of de-identified patient infor8 mation if such disclosure is— 

9 (A) pursuant to a waiver that had been 

10 granted by an institutional review board or pri11 vacy board relating to such disclosure; and 

12 (B) in the case that such entity is a re13 search institution, the entity informs patients 

14 when they make first patient contact with the 

15 entity that the entity is a research institution 

16 that may conduct research using their de-identi17 fied medical records. 

18 (2) SYNCHRONIZATION OF STANDARDS.— 

19 (A) IN GENERAL.—The Secretary of 

20 Health and Human Services shall study the ad21 vantages and disadvantages of the synchroni22 zation of the standards for research under the 

23 Common Rule (under part 46 of title 45, Code 

24 of Federal Regulations) and the HIPAA privacy 

25 and security law (as described in section 


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1 411(f)(2)(F) of the Public Health Service Act, 

2 as amended by section 3) in order to determine 

3 the appropriate data elements that should be 

4 omitted under the strict de-identification stand5 ards relating to personal information. 

6 (B) REVIEW OF RECOMMENDATIONS.—In 

7 carrying out subparagraph (A), the Secretary of 

8 Health and Human Services shall conduct a re9 view of recommendations made by the Advisory 

10 Committee on Human Research Protections as 

11 well as recommendations from the appropriate 

12 leadership of the National Committee on Vital 

13 and Health Statistics. 

14 (C) ADDITIONAL AREAS.—In carrying out 

15 subparagraph (A), the Secretary of Health and 

16 Human Services shall— 

17 (i) make recommendations concerning 

18 the conduct of international research to de19 termine the boundaries and applications of 

20 extraterritoriality under such HIPAA pri21 vacy and security law; and 

22 (ii) include biorepository storage infor23 mation when obtaining patient consent. 

24 (D) REPORT.—Not later than 180 days 

25 after the date of the enactment of this Act, the 


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1 Secretary of Health and Human Services shall 

2 submit to the appropriate committee of Con3 gress, a report concerning the recommendations 

4 made under this paragraph. 

5 (3) APPLICATION OF HIPAA PRIVACY AND SECU6 RITY LAW TO EXTERNAL RESEARCHERS.— 

7 (A) IN GENERAL.—Notwithstanding any 

8 other provision of law, the HIPAA privacy and 

9 security law (as described in section 

10 411(f)(2)(F) of the Public Health Service Act, 

11 as amended by section 3) shall apply to external 

12 researchers. 

13 (B) DEFINITION.— 

14 (i) IN GENERAL.—In this paragraph, 

15 the term ‘‘external researcher’’ means a re16 searcher who is on the staff of a covered 

17 entity (as defined for purposes of the 

18 HIPAA privacy and security law) but who 

19 is not actually employed by such covered 

20 entity. 

21 (ii) INTERNAL AND EXTERNAL RE22 SEARCHERS.—With respect to determining 

23 the distinction of whether or not a re24 searcher has the ability to use protected 

25 health information under the provisions of 


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1 this paragraph, such determination shall 

2 be based on whether the covered entity in3 volved exercises effective control over that 

4 researcher’s activities. For purposes of the 

5 preceding sentence, effective control may 

6 include membership and privileges of staff 

7 or the ability to terminate staff member8 ship or discipline staff. 

9 (c) LIABILITY.—The Director of the Office of Human 

10 Research Protection, the Director of the National Insti11 tutes of Health, and the Director of the National Cancer 

12 Institute shall issue guidance for entities awarded grants 

13 by such Federal agencies to provide instruction on how 

14 such entities may best address concerns or issues relating 

15 to the liability that institutions or researchers may incur 

16 as a result of using the facilitated review process of the 

17 Central Institutional Review Board Initiative, as spon18 sored by the National Cancer Institute. 

19 SEC. 5. ENHANCED FOCUS AND REPORTING ON CANCER 

20 RESEARCH. 

21 Part C of title IV of the Public Health Service Act 

22 (42 U.S.C. 285 et seq.) is amended by inserting after sec23 tion 417A the following: 


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1 ‘‘SEC. 417B. ENHANCED FOCUS AND REPORTING ON CAN2 CER RESEARCH. 

3 ‘‘(a) ANNUAL INDEPENDENT REPORT.— 

4 ‘‘(1) IN GENERAL.—The Director of the Insti5 tute shall complete an annual independent report 

6 that shall be submitted to Congress on the same 

7 date that the annual budget estimate described in 

8 section 413(b)(9) is submitted to the President. 

9 ‘‘(2) CONTENTS OF REPORT.— 

10 ‘‘(A) CANCER CATEGORIES.—The report 

11 required under paragraph (1) shall address the 

12 following categories of cancer: 

13 ‘‘(i) Cancers that result in a 5-year 

14 survival rate of less than 50 percent. 

15 ‘‘(ii) Cancers in which the incidence 

16 rate is fewer than 15 cases per 100,000 

17 people, or fewer than 40,000 new cases per 

18 year. 

19 ‘‘(B) INFORMATION.—With regard to each 

20 of the categories of cancer described in sub21 paragraph (A), the report shall contain infor22 mation regarding— 

23 ‘‘(i) a strategic plan for reducing the 

24 mortality rate for the annual year, includ25 ing specific research areas of interest and 

26 budget amounts; 


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1 ‘‘(ii) identification of any barriers to 

2 implementing the strategic plan described 

3 in clause (i) for the annual year; 

4 ‘‘(iii) if the report for the prior year 

5 contained a strategic plan described in 

6 clause (i), an assessment of the success of 

7 such plan; 

8 ‘‘(iv) the total amount of grant fund9 ing, including the total dollar amount 

10 awarded per grant and per funding year, 

11 under— 

12 ‘‘(I) the National Cancer Insti13 tute; and 

14 ‘‘(II) the National Institutes of 

15 Health; 

16 ‘‘(v) the percentage of grant applica17 tions favorably reviewed by the Institute 

18 that the Institute funded in the previous 

19 annual year; 

20 ‘‘(vi) the total number of grant appli21 cations, with greater than 50 percent rel22 evance to each of the categories of cancer 

23 described in subparagraph (A), received by 

24 the Institute for awards in the previous an25 nual year; 


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1 ‘‘(vii) the total number of grants 

2 awarded, with greater than 50 percent rel3 evance to each of the categories of cancer 

4 described in subparagraph (A), for the pre5 vious annual year and the number of 

6 awards per grant type, including the Com7 mon Scientific Outline designation specific 

8 to each such grant; and 

9 ‘‘(viii) the total number of primary in10 vestigators that received grants from the 

11 Institute for projects with greater than 50 

12 percent relevance to each of the categories 

13 of cancer described in paragraph (1), in14 cluding the total number of awards grant15 ed to experienced investigators and the 

16 total number of awards granted to inves17 tigators receiving their first grant from the 

18 National Institutes of Health. 

19 ‘‘(3) DEFINITION.—In this section, the term 

20 ‘annual year’ means the year for which the strategic 

21 plan described in paragraph (2)(B)(i) applies, which 

22 shall be the same fiscal year for which the Director 

23 of the Institute submits the annual budget estimate 

24 described in section 413(b)(9) for that year. 

25 ‘‘(b) GRANT PROGRAM.— 


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1 ‘‘(1) IN GENERAL.—The Director of the Insti2 tute, in cooperation with the Director of the Fogarty 

3 International Center for Advanced Study in the 

4 Health Sciences and the Directors of other Insti5 tutes, as appropriate, shall award grants to re6 searchers to conduct research regarding cancers for 

7 which— 

8 ‘‘(A) the incidence is fewer than 40,000 

9 new cases per year; and 

10 ‘‘(B) the 5-year survival rate is less than 

11 50 percent. 

12 ‘‘(2) PRIORITIZATION.—In awarding grants for 

13 research regarding cancers described in paragraph 

14 (1)(A), the Director of the Institute shall give pri15 ority to collaborative research projects between adult 

16 and pediatric cancer research, with preference for 

17 projects building upon existing multi-institutional re18 search infrastructures. 

19 ‘‘(3) TISSUE SAMPLES.— 

20 ‘‘(A) IN GENERAL.—Except as provided in 

21 subparagraph (B), the Director of the Institute 

22 shall require each recipient receiving a grant 

23 under this subsection to submit tissue samples 

24 to designated tumor banks. 


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1 ‘‘(B) WAIVER.—The Director of the Insti2 tute may grant a waiver of the requirement de3 scribed in subparagraph (A) to a recipient who 

4 receives a grant for research described in para5 graph (1)(B) and who submits an application 

6 for such waiver to the Director of the Institute, 

7 in the manner in which such Director may re8 quire.’’. 

9 SEC. 6. CONTINUING ACCESS TO CARE FOR PREVENTION 

10 AND EARLY DETECTION. 

11 (a) PREVENTIVE HEALTH MEASURES WITH RE12 SPECT TO COLORECTAL CANCER.—Part B of title III of 

13 the Public Health Service Act (42 U.S.C. 243 et seq.) is 

14 amended by inserting after section 317T the following new 

15 section: 

16 ‘‘SEC. 317U. PREVENTIVE HEALTH MEASURES WITH RE17 SPECT TO COLORECTAL CANCER. 

18 ‘‘(a) GRANT PROGRAM AUTHORIZATION.— 

19 ‘‘(1) IN GENERAL.—The Secretary, acting 

20 through the Director of the Centers for Disease 

21 Control and Prevention, may make grants to eligible 

22 entities for the purpose of carrying out a program 

23 described in subsection (b). An eligible entity that is 

24 a recipient of a grant under this subsection may use 

25 such grant to carry out such programs directly or 


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1 through grants to, or contracts with, public and not2 for-profit private entities. 

3 ‘‘(2) ELIGIBLE ENTITY DEFINED.—For pur4 poses of this section, the term ‘eligible entity’ in5 cludes the following: 

6 ‘‘(A) A State, including, in addition to the 

7 several States, the District of Columbia, Guam, 

8 the Commonwealth of Puerto Rico, the North9 ern Mariana Islands, the Virgin Islands, Amer10 ican Samoa, and the Trust Territory of the Pa11 cific Islands. 

12 ‘‘(B) An Indian tribe or tribal organiza13 tion, as such terms are defined in section 4 of 

14 the Indian Self-Determination and Education 

15 Assistance Act. 

16 ‘‘(b) PROGRAMS DESCRIBED.— 

17 ‘‘(1) IN GENERAL.—Subject to paragraph (2), a 

18 program described in this subsection is a program 

19 for planning or implementing each of the following: 

20 ‘‘(A) Providing screenings for colorectal 

21 cancer to individuals who— 

22 ‘‘(i) are 50 years of age or older; or 

23 ‘‘(ii)(I) are under 50 years of age; and 


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1 ‘‘(II) are at high risk for such cancer, 

2 as determined in accordance with sub3 section (e)(2). 

4 ‘‘(B) Providing appropriate case manage5 ment and referrals for medical treatment of in6 dividuals screened pursuant to subparagraph 

7 (A). 

8 ‘‘(C) Ensuring (directly or through coordi9 nation or an arrangement with health care pro10 viders or programs) the full continuum of fol11 low-up and cancer care for individuals so 

12 screened, including appropriate follow-up for 

13 abnormal tests, diagnostic services, therapeutic 

14 services, and treatment of detected cancers and 

15 management of unanticipated medical complica16 tions. 

17 ‘‘(D) Carrying out activities to improve the 

18 education, training, and skills of health profes19 sionals (including allied health professionals) in 

20 the detection and control of colorectal cancer, 

21 which activities are carried out pursuant to the 

22 participation of the health professionals in the 

23 program. 

24 ‘‘(E) Establishing mechanisms through 

25 which the eligible entity involved can monitor 


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1 the quality of screening and diagnostic follow2 up procedures for colorectal cancer, including 

3 the interpretation of such procedures. 

4 ‘‘(F) Evaluating the activities described in 

5 this subsection through appropriate surveillance 

6 and program monitoring activities. 

7 ‘‘(G) Developing and disseminating find8 ings derived through such evaluations and the 

9 collection of data on outcomes. 

10 ‘‘(H) Developing and disseminating public 

11 information and education programs for the de12 tection and control of colorectal cancer and pro13 moting the benefits of receiving screenings 

14 through this program. 

15 ‘‘(2) SUPPLEMENT NOT SUPPLANT.—In the 

16 case of an eligible entity that implements a universal 

17 colorectal screening program under which the eligi18 ble entity makes available funds for activities de19 scribed in subparagraph (A), (B), or (C) of para20 graph (1), such entity shall be able to receive grant 

21 funds under subsection (a) only for purposes of— 

22 ‘‘(A) carrying out those activities under 

23 this subsection that are not so funded; or 


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1 ‘‘(B) supplementing (and not supplanting) 

2 funds made available by the entity for such 

3 funded program. 

4 ‘‘(c) PRIORITY FOR LOW-INCOME, UNINSURED, AND

5 UNDERINSURED INDIVIDUALS.—A grant may be made 

6 under subsection (a) to an eligible entity only if the eligible 

7 entity agrees that, in providing screenings under sub8 section (b)(1)(A), the eligible entity will give priority to 

9 low-income individuals who lack adequate coverage, as de10 termined by the Secretary, under health insurance and 

11 health plans with respect to screenings for colorectal can12 cer. 

13 ‘‘(d) SPECIAL CONSIDERATION FOR CERTAIN APPLI14 CANTS.—In making grants under subsection (a) for a fis15 cal year, the Secretary shall give special consideration to 

16 the following eligible entities: 

17 ‘‘(1) In the case of services under such sub18 section for women, to such entities that, for such 

19 year, are grantees under title XV. 

20 ‘‘(2) In the case of services under such sub21 section for men, to such entities that, for such year, 

22 are grantees under section 317D. 

23 ‘‘(3) To such entities that coordinate with other 

24 Federal, State, and local colorectal cancer programs. 


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1 ‘‘(4) To such entities with an existing program 

2 to provide cancer screening to individuals. 

3 ‘‘(e) USE OF CERTAIN STANDARDS UNDER MEDI4 CARE PROGRAM.—A grant may be made under subsection 

5 (a) to an eligible entity only if the eligible entity provides, 

6 as applicable, assurances as follows: 

7 ‘‘(1) Screenings under subsection (b)(1)(A) will 

8 be carried out as preventive health measures in ac9 cordance with evidence-based screening guidelines 

10 and procedures and in accordance with the standard 

11 of care required for purposes of title XVIII of the 

12 Social Security Act to carry out colorectal screening 

13 tests defined in section 1861(pp)(1) of such Act. 

14 ‘‘(2) An individual will be considered high risk 

15 for purposes of subsection (b)(1)(A)(ii) only if the 

16 individual is high risk within the meaning of section 

17 1861(pp)(2) of such Act. 

18 ‘‘(3) The payment made from the grant for a 

19 screening procedure under subsection (b)(1)(A) will 

20 not exceed the amount that would be paid under 

21 part B of title XVIII of such Act if payment were 

22 made under such part for furnishing the procedure 

23 to an individual enrolled under such part. 

24 ‘‘(f) RELATIONSHIP TO ITEMS AND SERVICES UNDER

25 OTHER PROGRAMS.—A grant under subsection (a) may 


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1 be made to an eligible entity only if the eligible entity, 

2 as applicable, provides assurances that the grant will not 

3 be expended to make payment for any item or service to 

4 the extent that payment has been made, or can reasonably 

5 be expected to be made, with respect to such item or serv6 ice— 

7 ‘‘(1) under any State compensation program, 

8 under an insurance policy, or under any Federal or 

9 State health benefits program; or 

10 ‘‘(2) by an entity that provides health services 

11 on a prepaid basis. 

12 ‘‘(g) RECORDS AND AUDITS.—A grant under sub13 section (a) may be made to an eligible entity only if the 

14 eligible entity provides assurances that the eligible entity 

15 will— 

16 ‘‘(1) establish such fiscal control and fund ac17 counting procedures as may be necessary to ensure 

18 proper disbursal of, and accounting for, amounts re19 ceived under subsection (a); and 

20 ‘‘(2) upon request, provide records maintained 

21 pursuant to paragraph (1) to the Secretary or the 

22 Comptroller General of the United States for pur23 poses of auditing the expenditures of the grant by 

24 the eligible entity. 

25 ‘‘(h) REQUIREMENT OF MATCHING FUNDS.— 


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1 ‘‘(1) IN GENERAL.—The Secretary may not 

2 make a grant under subsection (a) to an eligible en3 tity for a fiscal year unless the eligible entity agrees, 

4 with respect to the costs to be incurred by the eligi5 ble entity for such fiscal year in carrying out the ac6 tivities described in subsection (b), to make available 

7 non-Federal contributions (in cash or in kind under 

8 paragraph (2)) toward such costs in an amount 

9 equal to not less than $1 for each $3 of Federal 

10 funds provided in the grant for such fiscal year. 

11 Such contributions may be made directly or through 

12 donations from public or private entities. 

13 ‘‘(2) DETERMINATION OF AMOUNT OF NON14 FEDERAL CONTRIBUTION.— 

15 ‘‘(A) IN GENERAL.—Non-Federal contribu16 tions required in paragraph (1) may be in cash 

17 or in kind, fairly evaluated, including equipment 

18 or services (and excluding indirect or overhead 

19 costs). Amounts provided by the Federal Gov20 ernment, or services assisted or subsidized to 

21 any significant extent by the Federal Govern22 ment, may not be included in determining the 

23 amount of such non-Federal contributions. 

24 ‘‘(B) MAINTENANCE OF EFFORT.—In 

25 making a determination of the amount of nonVerDate Mar 15 2010 02:37 Oct 05, 2010 Jkt 099200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\H6224.IH H6224

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1 Federal contributions for purposes of paragraph 

2 (1), the Secretary may include only non-Federal 

3 contributions in excess of the average amount 

4 of non-Federal contributions made by the eligi5 ble entity involved toward the activities de6 scribed in subsection (b) for the 2-year period 

7 preceding the first fiscal year for which the eli8 gible entity is applying to receive a grant under 

9 subsection (a). 

10 ‘‘(C) INCLUSION OF RELEVANT NON-FED11 ERAL CONTRIBUTIONS FOR MEDICAID.—In 

12 making a determination of the amount of non13 Federal contributions for purposes of paragraph 

14 (1), the Secretary shall, subject to subpara15 graphs (A) and (B) of this paragraph, include 

16 any non-Federal amounts expended pursuant to 

17 title XIX of the Social Security Act by the eligi18 ble entity involved toward the activities de19 scribed in subparagraphs (A) and (B) of sub20 section (b)(1). 

21 ‘‘(i) ADDITIONAL REQUIREMENTS.— 

22 ‘‘(1) LIMITATION ON ADMINISTRATIVE EX23 PENSES.—The Secretary may not make a grant to 

24 an eligible entity under subsection (a) unless the eli25 gible entity provides assurances that not more than 


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1 10 percent of the grant will be expended for admin2 istrative expenses with respect to the activities fund3 ed by the grant. 

4 ‘‘(2) STATEWIDE PROVISION OF SERVICES.— 

5 ‘‘(A) IN GENERAL.—Subject to subpara6 graph (B), the Secretary may not make a grant 

7 under subsection (a) to an eligible entity unless 

8 the eligible entity provides assurances that any 

9 program funded by such grant will be made 

10 available throughout the State, including avail11 ability to members of an Indian tribe or tribal 

12 organization (as such terms are defined in sec13 tion 4 of the Indian Self-Determination and 

14 Education Assistance Act). 

15 ‘‘(B) WAIVER.—The Secretary may waive 

16 the requirement under subparagraph (A) for an 

17 eligible entity if the Secretary determines that 

18 compliance by the eligible entity with the re19 quirement would result in an inefficient alloca20 tion of resources with respect to carrying out 

21 the purposes described in subsection (a). 

22 ‘‘(j) TECHNICAL ASSISTANCE AND PROVISION OF

23 SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.— 

24 ‘‘(1) TECHNICAL ASSISTANCE.—The Secretary 

25 may provide training and technical assistance with 


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1 respect to the planning, development, and operation 

2 of any program funded by a grant under subsection 

3 (a). The Secretary may provide such technical as4 sistance directly to eligible entities or through grants 

5 to, or contracts with, public and private entities. 

6 ‘‘(2) PROVISION OF SUPPLIES AND SERVICES IN

7 LIEU OF GRANT FUNDS.— 

8 ‘‘(A) IN GENERAL.—Subject to subpara9 graph (B), upon the request of an eligible entity 

10 receiving a grant under subsection (a), the Sec11 retary for the purpose of aiding the eligible en12 tity to carry out a program under subsection 

13 (b)— 

14 ‘‘(i) may provide supplies, equipment, 

15 and services to the eligible entity; and 

16 ‘‘(ii) may detail to the eligible entity 

17 any officer or employee of the Department 

18 of Health and Human Services. 

19 ‘‘(B) CORRESPONDING REDUCTION IN PAY20 MENTS.—With respect to a request made by an 

21 eligible entity under subparagraph (A), the Sec22 retary shall reduce the amount of payments 

23 made under the grant under subsection (a) to 

24 the eligible entity by an amount equal to the 

25 fair market value of any supplies, equipment, or 


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1 services provided by the Secretary and the costs 

2 of detailing personnel (including pay, allow3 ances, and travel expenses) under subparagraph 

4 (A). The Secretary shall, for the payment of ex5 penses incurred in complying with such request, 

6 expend the amounts withheld. 

7 ‘‘(k) REPORTS.—A grant under subsection (a) may 

8 be made only if the applicant involved agrees to submit 

9 to the Secretary such reports as the Secretary may require 

10 with respect to the grant. 

11 ‘‘(l) AUTHORIZATION OF APPROPRIATIONS.— 

12 ‘‘(1) IN GENERAL.—For the purpose of car13 rying out this section, there are authorized to be ap14 propriated— 

15 ‘‘(A) for fiscal year 2012, $50,000,000; 

16 ‘‘(B) for fiscal year 2013, $75,000,000; 

17 ‘‘(C) for fiscal year 2014, $150,000,000; 

18 ‘‘(D) for fiscal year 2015, $200,000,000; 

19 and 

20 ‘‘(E) for fiscal year 2016, $250,000,000. 

21 ‘‘(2) SET-ASIDE FOR TECHNICAL ASSISTANCE

22 AND PROVISION OF SUPPLIES AND SERVICES.—Of 

23 the amount appropriated under paragraph (1) for a 

24 fiscal year, the Secretary shall reserve not to exceed 

25 20 percent for carrying out subsection (j).’’. 


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1 (b) OPTIONAL MEDICAID COVERAGE OF CERTAIN

2 PERSONS SCREENED AND FOUND TO HAVE COLORECTAL

3 CANCER.— 

4 (1) COVERAGE AS OPTIONAL CATEGORICALLY

5 NEEDY GROUP.— 

6 (A) IN GENERAL.—Section 

7 1902(a)(10)(A)(ii) of the Social Security Act 

8 (42 U.S.C. 1396a(a)(10)(A)(ii)), as amended by 

9 section 2402(d)(1) of the Patient Protection 

10 and Affordable Care Act (Public Law 111–148) 

11 is further amended— 

12 (i) in subclause (XXI), by striking 

13 ‘‘or’’ at the end; 

14 (ii) in subclause (XXII), by adding 

15 ‘‘or’’ at the end; and 

16 (iii) by adding at the end the fol17 lowing: 

18 ‘‘(XXIII) who are described in 

19 subsection (kk) (relating to certain 

20 persons screened and found to need 

21 treatment from complications from 

22 screening or have colorectal cancer);’’. 

23 (B) GROUP DESCRIBED.—Section 1902 of 

24 the Social Security Act (42 U.S.C. 1396a), as 

25 amended by section 211(a)(1)(A)(ii) of Public 


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1 Law 111–3, section 5006(b)(1) of division B of 

2 Public Law 111–5, and section 1202 of the Pa3 tient Protection and Affordable Care Act (Pub4 lic Law 111–148), is further amended by add5 ing at the end the following: 

6 ‘‘(kk) Individuals described in this subsection are in7 dividuals who— 

8 ‘‘(1) are not described in subsection 

9 (a)(10)(A)(i); 

10 ‘‘(2) have not attained age 65; 

11 ‘‘(3) have been screened for colorectal cancer 

12 and need treatment for complications due to screen13 ing or colorectal cancer; and 

14 ‘‘(4) are not otherwise covered under creditable 

15 coverage, as defined in section 2704(c) of the Public 

16 Health Service Act.’’. 

17 (C) LIMITATION ON BENEFITS.—Section 

18 1902(a)(10) of the Social Security Act (42 

19 U.S.C. 1396a(a)(10)) is amended in the matter 

20 following subparagraph (G)— 

21 (i) by striking ‘‘(XV)’’ and inserting 

22 ‘‘, (XV)’’; 

23 (ii) by striking ‘‘and (XVI) the med24 ical assistance’’ and inserting ‘‘, (XVI) the 

25 medical assistance’’; 


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1 (iii) by striking ‘‘and (XVI) if an indi2 vidual’’ and inserting ‘‘, (XVII) if an indi3 vidual’’; and 

4 (iv) by inserting ‘‘, and (XVIII) the 

5 medical assistance made available to an in6 dividual described in subsection (kk) who 

7 is eligible for medical assistance only be8 cause of subparagraph (A)(10)(ii)(XXIII) 

9 shall be limited to medical assistance pro10 vided during the period in which such an 

11 individual requires treatment for complica12 tions due to screening or colorectal cancer’’ 

13 before the semicolon. 

14 (D) CONFORMING AMENDMENTS.—Section 

15 1905(a) of the Social Security Act (42 U.S.C. 

16 1396d(a)), as amended by section 

17 2402(d)(2)(B) of the Patient Protection and 

18 Affordable Care Act (Public Law 111–148) is 

19 further amended in the matter preceding para20 graph (1)— 

21 (i) in clause (xvi), by striking ‘‘or’’ at 

22 the end; 

23 (ii) in clause (xvii), by adding ‘‘or’’ at 

24 the end; and 


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1 (iii) by inserting after clause (xvii) the 

2 following: 

3 ‘‘(xviii) individuals described in sec4 tion 1902(kk),’’. 

5 (2) PRESUMPTIVE ELIGIBILITY.— 

6 (A) IN GENERAL.—Title XIX of the Social 

7 Security Act (42 U.S.C. 1396 et seq.) is 

8 amended by inserting after section 1920C, as 

9 inserted by section 2303(b) of the Patient Pro10 tection and Affordable Care Act (Public Law 

11 111–148), the following: 

12 ‘‘OPTIONAL APPLICATION OF PRESUMPTIVE ELIGIBILITY

13 PROVISIONS FOR CERTAIN PERSONS WITH

14 COLORECTAL CANCER

15 ‘‘SEC. 1920D. A State may elect to apply the provi16 sions of section 1920B to individuals described in section 

17 1902(kk) (relating to certain colorectal cancer patients) 

18 in the same manner as such section applies to individuals 

19 described in section 1902(aa) (relating to certain breast 

20 or cervical cancer patients).’’. 

21 (B) CONFORMING AMENDMENTS.— 

22 (i) Section 1902(a)(47) of the Social 

23 Security Act (42 U.S.C. 1396a(a)(47)), as 

24 amended by section 2303(b)(2) of the Pa25 tient Protection and Affordable Care Act 

26 (Public Law 111–148), is amended— 


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1 (I) in subparagraph (A)— 

2 (aa) by striking ‘‘and’’ after 

3 ‘‘section 1920’’ and inserting a 

4 comma; 

5 (bb) by striking ‘‘and’’ after 

6 ‘‘with such section’’ each place it 

7 occurs and inserting a comma 

8 each such place; and 

9 (cc) by inserting before the 

10 semicolon at the end the fol11 lowing: ‘‘, and provide for making 

12 medical assistance available to in13 dividuals described in section 

14 1920D during a presumptive eli15 gibility period in accordance with 

16 such section’’; and 

17 (II) in subparagraph (B), by 

18 striking ‘‘or 1920C’’ and inserting 

19 ‘‘1920C, or 1920D’’. 

20 (ii) Section 1903(u)(1)(d)(v) of such 

21 Act (42 U.S.C. 1396b(u)(1)(d)(v)), as 

22 amended by section 2202(b) of the Patient 

23 Protection and Affordable Care Act (Public 

24 Law 111–148), is further amended— 


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1 (I) by striking ‘‘or for’’ and in2 serting ‘‘, for’’; and 

3 (II) by inserting before the pe4 riod the following: ‘‘, or for medical 

5 assistance provided to an individual 

6 described in section 1920D during a 

7 presumptive eligibility period under 

8 such section’’. 

9 (3) ENHANCED MATCH.—The first sentence of 

10 section 1905(b) of the Social Security Act (42 

11 U.S.C. 1396d(b)) is amended— 

12 (A) by striking ‘‘and’’ before ‘‘(4)’’; and 

13 (B) by inserting before the period at the 

14 end the following: ‘‘, and (5) the Federal med15 ical assistance percentage shall be equal to the 

16 enhanced FMAP described in section 2105(b) 

17 with respect to medical assistance provided to 

18 individuals who are eligible for such assistance 

19 only on the basis of section 

20 1902(a)(10)(A)(ii)(XXIII)’’. 

21 (4) EFFECTIVE DATE.—The amendments made 

22 by this section apply to medical assistance for items 

23 and services furnished on or after October 1, 2011, 

24 without regard to whether final regulations to carry 


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1 out such amendments have been promulgated by 

2 such date. 

3 (c) MOBILE MEDICAL VAN GRANT PROGRAM.— 

4 (1) IN GENERAL.—The Secretary of Health and 

5 Human Services (referred to in this subsection as 

6 the ‘‘Secretary’’), acting through the Administrator 

7 of the Health Resources and Services Administra8 tion, shall award grants to eligible entities for the 

9 development and implementation of a mobile medical 

10 van program that shall provide cancer screening 

11 services that are recommended with a grade of A or 

12 B by the United States Preventative Services Task 

13 Force of the Agency for Healthcare Research and 

14 Quality to communities that are underserved and 

15 suffer from barriers to access to high quality cancer 

16 prevention care. 

17 (2) ELIGIBLE ENTITIES.—To be eligible to re18 ceive a grant under paragraph (1), and entity 

19 shall— 

20 (A) be a consortium of public and private 

21 entities (such as academic medical centers, uni22 versities, hospitals, and non profit organiza23 tions); 

24 (B) submit to the Secretary an application 

25 at such time, in such manner, and containing 


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1 such information as the Secretary shall require, 

2 including— 

3 (i) a description of the manner in 

4 which the applicant intends to use funds 

5 received under the grant; 

6 (ii) a description of the manner in 

7 which the applicant will evaluate the im8 pact and effectiveness of the health care 

9 services provided under the program car10 ried out under the grant; 

11 (iii) a plan for sustaining activities 

12 and services funded under the grant after 

13 Federal support for the program has 

14 ended; 

15 (iv) a plan for the referral of patients 

16 to other health care facilities if additional 

17 services are needed; 

18 (v) a protocol for the transfer of pa19 tients in the event of a medical emergency; 

20 (vi) a plan for advertising the services 

21 of the mobile medical van to the commu22 nities targeted for health care services; and 

23 (vii) a plan to educate patients about 

24 the availability of federally funded medical 


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1 insurance programs for which such pa2 tients, or their children, may qualify; and 

3 (C) agree that amounts under the grant 

4 will be used to supplement, and not supplant, 

5 other funds (including in-kind contributions) 

6 used by the entity to carry out activities for 

7 which the grant is awarded. 

8 (3) USE OF FUNDS.—An entity shall use 

9 amounts received under a grant under this sub10 section to do any of the following: 

11 (A) Purchase or lease a mobile medical 

12 van. 

13 (B) Make repairs and provide maintenance 

14 for a mobile medical van. 

15 (C) Purchase or lease telemedicine equip16 ment that is reasonable and necessary to oper17 ate the mobile medical van. 

18 (D) Purchase medical supplies and medica19 tion that are necessary to provide health care 

20 services on the mobile medical van. 

21 (E) Retain medical professionals with ex22 pertise and experience in providing cancer 

23 screening services to underserved communities 

24 to provide health care services on the mobile 

25 medical van. 


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1 (4) MATCHING REQUIREMENTS.— 

2 (A) IN GENERAL.—With respect to the 

3 costs of a mobile medical van program to be 

4 carried out under a grant under this subsection, 

5 the grantee shall make available (directly or 

6 through donations from public or private enti7 ties) non-Federal contributions toward such 

8 costs in an amount that is not less than the 

9 amount of the Federal funds provided under 

10 this grant. 

11 (B) DETERMINATION OF AMOUNT CON12 TRIBUTED.—Non-Federal contributions re13 quired under subparagraph (A) may be in cash 

14 or in-kind, fairly evaluated, including plant, 

15 equipment, or services. Amounts provided by 

16 the Federal Government, or services assisted or 

17 subsidized to any significant extent by the Fed18 eral Government, may not be included in deter19 mining the amount of such non-Federal con20 tributions. 

21 (C) WAIVER.—The Secretary may waive 

22 the requirement established in subparagraph 

23 (A) if— 

24 (i) the Secretary determines that such 

25 waiver is justified; and 


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1 (ii) the Secretary publishes the ration2 ale for such waiver in the Federal Register. 

3 (D) RETURN OF FUNDS.—An entity that 

4 receives a grant under this section that fails to 

5 comply with subparagraph (A) shall return to 

6 the Secretary an amount equal to the difference 

7 between— 

8 (i) the amount provided under the 

9 grant; and 

10 (ii) the amount of matching funds ac11 tually provided by the grantee. 

12 (5) CONSIDERATIONS IN MAKING GRANTS.—In 

13 awarding grants under this subsection, the Secretary 

14 shall give preference to eligible entities— 

15 (A) that will provide cancer screening serv16 ices in underserved areas; and 

17 (B) that on the date on which the grant is 

18 awarded, have a mobile medical van that is non19 functioning due to the need for necessary me20 chanical repairs. 

21 (6) LIMITATION ON DURATION AND AMOUNT OF

22 GRANT.—A grant under this subsection shall be for 

23 a 2-year period, except that the Secretary may waive 

24 such limitation and extend the grant period by an 

25 additional year. The amount awarded to an entity 


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1 under such grant for a fiscal year shall not exceed 

2 $200,000. 

3 (7) EVALUATION.—Not later than 1 year after 

4 the date on which a grant awarded to an entity 

5 under this subsection expires, the entity shall submit 

6 to the Secretary the results of an evaluation to be 

7 conducted by the entity concerning the effectiveness 

8 of the program carried out under the grant. 

9 (8) REPORT.—Not later than 18 months after 

10 grants are first awarded under this subsection, the 

11 Secretary shall submit to the Committee on Appro12 priations of the Senate and the Committee on Ap13 propriations of the House of Representatives a re14 port on the results of activities carried out with 

15 amounts received under such grants. 

16 (9) DEFINITIONS.—In this section: 

17 (A) MOBILE MEDICAL VAN.—The term 

18 ‘‘mobile medical van’’ means a mobile vehicle 

19 that is equipped to provide non-urgent medical 

20 services and health care counseling to patients 

21 in underserved areas. 

22 (B) UNDERSERVED AREA.—The term ‘‘un23 derserved area’’, with respect to the location of 

24 patients receiving medical treatment, means a 

25 ‘‘medically underserved community’’ as defined 


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1 in section 799B(6) of the Public Health Service 

2 Act (42 U.S.C. 295p(6)). 

3 SEC. 7. EARLY RECOGNITION AND TREATMENT OF CANCER 

4 THROUGH USE OF BIOMARKERS. 

5 (a) PROMOTION OF THE DISCOVERY AND DEVELOP6 MENT OF BIOMARKERS.— 

7 (1) IN GENERAL.—The Secretary of Health and 

8 Human Services (referred to in this section as the 

9 ‘‘Secretary’’), in consultation with appropriate Fed10 eral agencies including the National Institutes of 

11 Health, the National Cancer Institute, the Food and 

12 Drug Administration, and the National Institute of 

13 Standards and Technology, and extramural experts 

14 as appropriate, shall establish and coordinate a pro15 gram to award contracts to eligible entities to sup16 port the development of innovative biomarker dis17 covery technologies. All activities under this section 

18 shall be consistent with and complement the ongoing 

19 efforts of the Oncology Biomarker Qualification Ini20 tiative and the Reagan-Udall Foundation of the 

21 Food and Drug Administration. 

22 (2) LEAD AGENCY.—Not later than 2 years 

23 after the date of enactment of this Act, the Sec24 retary shall designate a lead Federal agency to adVerDate Mar 15 2010 02:37 Oct 05, 2010 Jkt 099200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6201 E:\BILLS\H6224.IH H6224

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1 minister and coordinate the program established 

2 under paragraph (1). 

3 (3) ELIGIBILITY.—To be eligible to enter into a 

4 contract under paragraph (1), an entity shall submit 

5 to the Secretary an application at such time, in such 

6 manner, and containing such information as the Sec7 retary may require. Such information shall be suffi8 cient to enable the Secretary to— 

9 (A) promote the scientific review of such 

10 contracts in a timely fashion; and 

11 (B) contain the capacity to perform the 

12 necessary analysis of contract applications, in13 cluding determinations as to the intellectual ex14 pertise of applicants. 

15 (4) REQUIREMENT.—In awarding contracts 

16 under this subsection, the lead agency shall consider 

17 whether the research involved will result in the de18 velopment of quantifiable biomarkers of cell sig19 naling pathways that will have the broadest applica20 bility across different tumor types or different dis21 eases. 

22 (5) INTERNATIONAL CONSORTIA.—The Sec23 retary shall designate one of the Federal entities de24 scribed in paragraph (1) to establish an inter25 national private-public consortia to develop and 


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1 share methods and precompetitive data on the vali2 dation and qualification of cancer biomarkers for 

3 specific uses. 

4 (b) CLINICAL STUDY GUIDELINES.—Not later than 

5 1 year after the date of enactment of this Act, the Com6 missioner of Food and Drugs, the Administrator of the 

7 Centers for Medicare & Medicaid Services, and the Direc8 tor of the National Cancer Institute shall jointly develop 

9 guidelines for the conduct of clinical studies designed to 

10 generate clinical data relating to cancer care and treat11 ment biomarkers that is adequate for review by each such 

12 Federal entity. Such guidelines shall be designed to assist 

13 in optimizing clinical study design and to strengthen the 

14 evidence base for evaluations of studies related to cancer 

15 biomarkers. 

16 (c) DEMONSTRATION PROJECT.— 

17 (1) IN GENERAL.—The Secretary, in consulta18 tion with the Commissioner of Food and Drugs and 

19 the Administrator of the Agency for Healthcare Re20 search and Quality, shall carry out a demonstration 

21 project that provides for a limited regional assess22 ment of biomarker tests to facilitate the controlled 

23 and limited use of a risk assessment measure with 

24 an intervention that may consist of a biomarker test. 


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1 (2) PROCEDURES.—As a component of the 

2 demonstration project under paragraph (1), the 

3 Commissioner of Food and Drugs, in consultation 

4 with other relevant agencies, shall establish proce5 dures that independent research entities shall follow 

6 in conducting high quality assessments of efficacy of 

7 biomarker tests. 

8 (d) POSTMARKET SURVEILLANCE.—The Food and 

9 Drug Administration and the Centers for Medicare & 

10 Medicaid Services shall assess quality and accuracy of bio11 marker tests through appropriate postmarket surveillance 

12 and other means, as necessary and appropriate to the mis13 sion of each such agency. 

14 (e) ESTABLISHMENT AND OPERATION OF RESEARCH

15 CENTERS FOR THE STUDY OF BIOMARKERS FOR RISK

16 STRATIFICATION AND EARLY DETECTION OF CANCERS

17 WITH SURVIVAL RATES OF LESS THAN 50 PERCENT.— 

18 (1) IN GENERAL.—The Director of the National 

19 Cancer Institute, in consultation with the directors 

20 of other relevant institutes and centers of the Na21 tional Institutes of Health and the Department of 

22 Defense, shall enter into cooperative agreements 

23 with, or make grants to, public or nonprofit entities 

24 to establish and operate centers to conduct research 

25 on biomarkers for use in risk stratification for, and 


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1 the early detection and screening of, cancer with a 

2 five year survival rate of less than 50 percent. Each 

3 center shall be known as an Early Detection Bio4 marker Center of Excellence. 

5 (2) RESEARCH FUNDED.—Federal payments 

6 made under a cooperative agreement or grant under 

7 paragraph (1) may be used for research on any of 

8 the following: 

9 (A) The development and characterization 

10 of new biomarkers, and the refinement of exist11 ing biomarkers, for cancers with a five-year sur12 vival rate of less than 50 percent. 

13 (B) The clinical and laboratory validation 

14 of such biomarkers, including technical develop15 ment, standardization of assay methods, sample 

16 preparation, reagents, reproducibility, port17 ability, and other refinements. 

18 (C) The development and implementation 

19 of clinical and epidemiological research on the 

20 utilization of biomarkers for the early detection 

21 and screening of cancers with a five-year sur22 vival rate of less than 50 percent. 

23 (D) The development and implementation 

24 of new repositories for additional tissue, urine, 


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1 serum, and other biological specimens (such as 

2 ascites and pleural fluids). 

3 (E) Other areas identified by the Director, 

4 in consultation with the research community. 

5 (3) COLLABORATION.—Any center funded 

6 under paragraph (1) shall demonstrate their intent 

7 to collaborate with current National Cancer Institute 

8 funded, sponsored, or funded and sponsored initia9 tives regarding risk stratification, early detection, 

10 and screening of cancer, including but not limited to 

11 the early detection research networks, the Cancer 

12 Genomic Atlas, and therapeutic biomarker initia13 tives, where applicable. 

14 (4) AVAILABILITY OF BANKED SPECIMENS.— 

15 The Director of the Institute shall make available 

16 for research conducted under this section banked 

17 serum and tissue specimens from clinical research 

18 regarding these cancers that was funded by the De19 partment of Health and Human Services. 

20 (5) REPORT.—Not later than the end of fiscal 

21 year 2011, and annually thereafter, the Director of 

22 the Institute shall submit a report to the Congress 

23 on the cooperative agreements entered into and the 

24 grants made under this subsection, the progress of 


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1 these grants, and recommendations for any program 

2 improvements that would speed discovery. 

3 (6) BIOMARKER CLINICAL TRIAL COMMITTEE.— 

4 The Director of the Institute shall establish an Bio5 marker Clinical Trial Committee (in this section re6 ferred to as the ‘‘Committee’’), for each cancer with 

7 biomarker centers of excellence, to assist the Direc8 tor to design and implement one or more national 

9 clinical trial, in accordance with this subsection, to 

10 determine the utility of using biomarkers validated 

11 pursuant to the research conducted under this sub12 section for risk stratification for, and early detection 

13 and screening of, cancers with a five-year survival 

14 rate of less than 50 percent. 

15 (7) AUTHORIZATION OF APPROPRIATIONS.—For 

16 the purpose of carrying out this subsection, there 

17 are authorized to be appropriated $25,000,000 for 

18 each of the fiscal years 2011 through 2013, and 

19 such sums as may be necessary for each of the fiscal 

20 years 2014 through 2020. If for two consecutive 

21 years funds are not appropriated to carry out this 

22 subsection, this subsection will automatically sunset. 

23 Such authorization of appropriations is in addition 

24 to any other authorization of appropriations that is 

25 available for such purpose. 


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1 (f) SENSE OF THE HOUSE OF REPRESENTATIVES.— 

2 It is the sense of the House of Representatives that the 

3 Commissioner of Food and Drugs and the Director of the 

4 National Cancer Institute should continue to place high 

5 priority upon the identification and use of biomarkers to— 

6 (1) determine the role of genetic polymorphisms 

7 on drug activity and toxicity; 

8 (2) establish effective strategies for selecting 

9 patients for treatment with specific drugs; and 

10 (3) identify early biomarkers of clinical benefit. 

11 (g) DEFINITION.—In this section, the term ‘‘bio12 marker’’ means any characteristic that can be objectively 

13 measured and evaluated as an indicator of normal biologic 

14 processes, pathogenic processes, or pharmacological re15 sponses to therapeutic interventions. 

16 SEC. 8. EXTENDING COVERAGE UNDER MEDICAID OF 

17 COUNSELING AND PHARMACOTHERAPY FOR 

18 CESSATION OF TOBACCO USE. 

19 (a) SERVICES DESCRIBED.—Section 1905 of the So20 cial Security Act (42 U.S.C. 1396d) is amended— 

21 (1) in subsection (a)(4)(D), as inserted by sec22 tion 4107(a)(1)(B) of the Patient Protection and Af23 fordable Care Act (Public Law 111–148), by strik24 ing ‘‘by pregnant women’’; and 


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1 (2) in subsection (bb), as added by section 

2 4107(a)(2) of the Patient Protection and Affordable 

3 Care Act (Public Law 111–148)— 

4 (A) in paragraph (1)— 

5 (i) by striking ‘‘the term ‘counseling 

6 and pharmacotherapy for cessation of to7 bacco use by pregnant women’ ’’ and in8 serting ‘‘the term ‘counseling and 

9 pharmacotherapy for cessation of tobacco 

10 use’ ’’; and 

11 (ii) by striking ‘‘by pregnant women 

12 who use tobacco products’’ and inserting 

13 ‘‘by individuals who use tobacco products’’; 

14 and 

15 (B) in paragraph (2)— 

16 (i) in subparagraph (A), by striking 

17 ‘‘with respect to pregnant women’’; and 

18 (ii) in subparagraph (B), by striking 

19 ‘‘by pregnant women’’. 

20 (b) DROPPING EXCEPTION FROM MEDICAID PRE21 SCRIPTION DRUG COVERAGE FOR TOBACCO CESSATION

22 MEDICATIONS.—Section 1927(d)(2)(F) of the Social Se23 curity Act (42 U.S.C. 1396r–8(d)(2)(F)), as amended by 

24 section 4107(b) of the Patient Protection and Affordable 


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1 Care Act (Public Law 111–148), is further amended by 

2 striking ‘‘in the case of pregnant women’’. 

3 (c) EFFECTIVE DATE.—The amendments made by 

4 this section shall take effect 1 year after the date of enact5 ment of this Act and apply to medical assistance provided 

6 under a State Medicaid program on or after such date. 

7 SEC. 9. COMPREHENSIVE CANCER CARE AND COVERAGE 

8 UNDER MEDICARE. 

9 (a) COVERAGE OF ROUTINE COSTS ASSOCIATED

10 WITH CLINICAL TRIALS UNDER MEDICARE.— 

11 (1) COVERAGE UNDER PART A.—Section 1814 

12 of the Social Security Act (42 U.S.C. 1395f) is 

13 amended by adding at the end the following new 

14 subsection: 

15 ‘‘(m) COVERAGE OF ROUTINE COSTS ASSOCIATED

16 WITH CLINICAL TRIALS.—The Secretary shall not exclude 

17 from payment for items and services provided under a 

18 clinical trial payment for coverage of routine costs of care 

19 (as defined by the Secretary) furnished to an individual 

20 entitled to benefits under this part who participates in 

21 such a trial to the extent the Secretary provides payment 

22 for such costs as of the date of enactment of this sub23 section.’’. 

24 (2) COVERAGE UNDER PART B.—Section 

25 1833(w) of the Social Security Act (42 U.S.C. 


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1 1395l(w)), as added by section 184 of the Medicare 

2 Improvements for Patients and Providers Act of 

3 2008 (Public Law 110–275), is amended— 

4 (A) by striking ‘‘PAYMENT.—The Sec5 retary’’ and inserting ‘‘PAYMENT AND COV6 ERAGE OF ROUTINE COSTS ASSOCIATED WITH

7 CLINICAL TRIALS.— 

8 ‘‘(1) METHODS OF PAYMENT.—Subject to para9 graph (2), the Secretary’’; and 

10 (B) by adding at the end the following new 

11 paragraph: 

12 ‘‘(2) COVERAGE OF ROUTINE COSTS ASSOCI13 ATED WITH CLINICAL TRIALS.—The Secretary shall 

14 not exclude from payment for items and services 

15 provided under a clinical trial payment for coverage 

16 of routine costs of care (as defined by the Secretary) 

17 furnished to an individual enrolled under this part 

18 who participates in such a trial to the extent the 

19 Secretary provides payment for such costs as of the 

20 date of enactment of this subsection.’’. 

21 (3) PROVIDER OUTREACH.—The Secretary of 

22 Health and Human Services, acting through the Ad23 ministrator of the Centers for Medicare & Medicaid 

24 Services, shall conduct an outreach campaign to pro25 viders of services and suppliers under the Medicare 


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1 program under title XVIII of the Social Security Act 

2 regarding coverage of routine costs of care furnished 

3 to Medicare beneficiaries participating in clinical 

4 trials in accordance with sections 1814(m) and 

5 1833(w)(2) of the Social Security Act (as added by 

6 paragraphs (1) and (2), respectively). 

7 (b) COVERAGE OF CANCER CARE PLANNING SERV8 ICES.— 

9 (1) IN GENERAL.—Section 1861 of the Social 

10 Security Act, as amended by section 4103 of the Pa11 tient Protection and Affordable Care Act (Public 

12 Law 111–148), is amended— 

13 (A) in subsection (s)(2)— 

14 (i) by striking ‘‘and’’ at the end of 

15 subparagraph (EE); 

16 (ii) by adding ‘‘and’’ at the end of 

17 subparagraph (FF); and 

18 (iii) by adding at the end the fol19 lowing new subparagraph: 

20 ‘‘(GG) comprehensive cancer care planning 

21 services (as defined in subsection (iii));’’; and 

22 (B) by adding at the end the following new 

23 subsection: 


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1 ‘‘Comprehensive Cancer Care Planning Services 

2 ‘‘(iii)(1) The term ‘comprehensive cancer care plan3 ning services’ means— 

4 ‘‘(A) with respect to an individual who is 

5 diagnosed with cancer, the development of a 

6 plan of care that— 

7 ‘‘(i) details, to the greatest extent 

8 practicable, all aspects of the care to be 

9 provided to the individual, with respect to 

10 the treatment of such cancer, including 

11 any curative treatment and comprehensive 

12 symptom management (such as palliative 

13 care) involved; 

14 ‘‘(ii) is furnished in written form to 

15 the individual in person within a period 

16 specified by the Secretary that is as soon 

17 as practicable after the date on which the 

18 individual is so diagnosed; 

19 ‘‘(iii) is furnished, to the greatest ex20 tent practicable, in a form that appro21 priately takes into account cultural and 

22 linguistic needs of the individual in order 

23 to make the plan accessible to the indi24 vidual; and 


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1 ‘‘(iv) is in accordance with standards 

2 determined by the Secretary to be appro3 priate; 

4 ‘‘(B) with respect to an individual for 

5 whom a plan of care has been developed under 

6 subparagraph (A), the revision of such plan of 

7 care as necessary to account for any substantial 

8 change in the condition of the individual, if 

9 such revision— 

10 ‘‘(i) is in accordance with clauses (i) 

11 and (iii) of such subparagraph; and 

12 ‘‘(ii) is furnished in written form to 

13 the individual within a period specified by 

14 the Secretary that is as soon as practicable 

15 after the date of such revision; 

16 ‘‘(C) with respect to an individual who has 

17 completed the primary treatment for cancer, as 

18 defined by the Secretary (such as completion of 

19 chemotherapy or radiation treatment), the de20 velopment of a follow-up cancer care plan 

21 that— 

22 ‘‘(i) describes the elements of the pri23 mary treatment, including symptom man24 agement, furnished to such individual; 


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1 ‘‘(ii) provides recommendations for 

2 the subsequent care of the individual with 

3 respect to the cancer involved; 

4 ‘‘(iii) is furnished in written form to 

5 the individual in person within a period 

6 specified by the Secretary that is as soon 

7 as practicable after the completion of such 

8 primary treatment; 

9 ‘‘(iv) is furnished, to the greatest ex10 tent practicable, in a form that appro11 priately takes into account cultural and 

12 linguistic needs of the individual in order 

13 to make the plan accessible to the indi14 vidual; and 

15 ‘‘(v) is in accordance with standards 

16 determined by the Secretary to be appro17 priate; and 

18 ‘‘(D) with respect to an individual for 

19 whom a follow-up cancer care plan has been de20 veloped under subparagraph (C), the revision of 

21 such plan as necessary to account for any sub22 stantial change in the condition of the indi23 vidual, if such revision— 

24 ‘‘(i) is in accordance with clauses (i), 

25 (ii), and (iv) of such subparagraph; and 


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1 ‘‘(ii) is furnished in written form to 

2 the individual within a period specified by 

3 the Secretary that is as soon as practicable 

4 after the date of such revision. 

5 ‘‘(2) The Secretary shall establish standards to carry 

6 out paragraph (1) in consultation with appropriate organi7 zations representing providers of services related to cancer 

8 treatment and organizations representing survivors of can9 cer. Such standards shall include standards for deter10 mining the need and frequency for revisions of the plans 

11 of care and follow-up plans based on changes in the condi12 tion of the individual and standards for the communica13 tion of the plan to the patient.’’. 

14 (2) PAYMENT.—Section 1833(a)(1) of the So15 cial Security Act (42 U.S.C. 1395l(a)(1)), as amend16 ed by section 10501(g)(3)(B) of the Patient Protec17 tion and Affordable Care Act (Public Law 111–148), 

18 is amended by striking ‘‘and’’ before ‘‘(Z)’’ and in19 serting before the semicolon at the end the following: 

20 ‘‘, and (AA) with respect to comprehensive cancer 

21 care planning services described in any of subpara22 graphs (A) through (D) of section 1861(iii)(1), the 

23 amount paid shall be an amount equal to the sum 

24 of (i) the national average amount under the physi25 cian fee schedule established under section 1848 for 


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1 a new patient office consultation of the highest level 

2 of service in the non-facility setting, and (ii) the na3 tional average amount under such fee schedule for a 

4 physician certification described in section 

5 1814(a)(2) for home health services furnished to an 

6 individual by a home health agency under a home 

7 health plan of care’’. 

8 (3) EFFECTIVE DATE.—The amendments made 

9 by this section shall apply to services furnished on 

10 or after the first day of the first calendar year that 

11 begins after the date of the enactment of this Act. 

12 (c) MEDICARE COVERAGE OF COMPREHENSIVE CAN13 CER PATIENT TREATMENT EDUCATION SERVICES.— 

14 (1) IN GENERAL.—Section 1861 of the Social 

15 Security Act (42 U.S.C. 1395x), as amended by sub16 section (b)(1), is further amended— 

17 (A) in subsection (s)(2)— 

18 (i) by striking ‘‘and’’ at the end of 

19 subparagraph (FF); 

20 (ii) by adding ‘‘and’’ at the end of 

21 subparagraph (GG); and 

22 (iii) by adding at the end the fol23 lowing new subparagraph: 


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1 ‘‘(HH) comprehensive cancer patient treatment 

2 education services (as defined in subsection 

3 (jjj)(1));’’; and 

4 (B) by adding at the end the following new 

5 subsection: 

6 ‘‘Comprehensive Cancer Patient Treatment Education 

7 Services 

8 ‘‘(jjj)(1) The term ‘comprehensive cancer patient 

9 treatment education services’ means— 

10 ‘‘(A) in the case of an individual who is diag11 nosed with cancer, the provision of a one-hour pa12 tient treatment education session delivered by a reg13 istered nurse that— 

14 ‘‘(i) is furnished to the individual and the 

15 caregiver (or caregivers) of the individual in ad16 vance of the onset of treatment and to the ex17 tent practicable, is not furnished on the day of 

18 diagnosis or on the first day of treatment; 

19 ‘‘(ii) educates the individual and such care20 giver (or caregivers) to the greatest extent prac21 ticable, about all aspects of the care to be fur22 nished to the individual, informs the individual 

23 regarding any potential symptoms, side-effects, 

24 or adverse events, and explains ways in which 

25 side effects and adverse events can be miniVerDate Mar 15 2010 02:37 Oct 05, 2010 Jkt 099200 PO 00000 Frm 00065 Fmt 6652 Sfmt 6201 E:\BILLS\H6224.IH H6224

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1 mized and health and well-being maximized, 

2 and provides guidance regarding those side ef3 fects to be reported and to which health care 

4 provider the side effects should be reported; 

5 ‘‘(iii) includes the provision, in written 

6 form, of information about the course of treat7 ment, any responsibilities of the individual with 

8 respect to self-dosing, and ways in which to ad9 dress symptoms and side-effects; and 

10 ‘‘(iv) is furnished, to the greatest extent 

11 practicable, in an oral, written, or electronic 

12 form that appropriately takes into account cul13 tural and linguistic needs of the individual in 

14 order to make the information comprehensible 

15 to the individual and such caregiver (or care16 givers); and 

17 ‘‘(B) with respect to an individual for whom a 

18 course of cancer treatment or therapy is materially 

19 modified, a one-hour patient treatment education 

20 session described in subparagraph (A), including up21 dated information on the matters described in such 

22 subparagraph should the individual’s oncologic 

23 health care professional deem it appropriate and 

24 necessary. 


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1 ‘‘(2) In establishing standards to carry out paragraph 

2 (1), the Secretary shall consult with appropriate organiza3 tions representing providers of oncology patient treatment 

4 education services and organizations representing people 

5 with cancer.’’. 

6 (2) PAYMENT.—Section 1833(a)(1) of such Act 

7 (42 U.S.C. 1395l(a)(1)), as amended by subsection 

8 (b)(2), is further amended— 

9 (A) by striking ‘‘and’’ before ‘‘(AA)’’; and 

10 (B) by inserting before the semicolon at 

11 the end the following: ‘‘, and (BB) with respect 

12 to comprehensive cancer patient treatment edu13 cation service (as defined in section 

14 1861(jjj)(1)), 150 percent of the payment rate 

15 established under section 1848 for diabetes out16 patient self-management training services (as 

17 defined in section 1861(qq)), determined and 

18 applied without regard to any coinsurance’’. 

19 (3) COVERAGE.—Section 1862(a)(1) of such 

20 Act (42 U.S.C. 1395y(a)(1)), as amended by section 

21 4103(d)(1) of the Patient Protection and Affordable 

22 Care Act (Public Law 111–148), is amended— 

23 (A) in subparagraph (O), by striking 

24 ‘‘and’’ at the end; 


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1 (B) in subparagraph (P), by striking the 

2 semicolon at the end and inserting ‘‘, and’’; and 

3 (C) by adding at the end the following new 

4 subparagraph: 

5 ‘‘(Q) in the case of comprehensive cancer pa6 tient treatment education services (as defined in 

7 subsection (jjj)(1)) which are performed more fre8 quently than is covered under such section;’’. 

9 (4) NO IMPACT ON PAYMENT FOR OTHER SERV10 ICES.—Nothing in this section shall be construed to 

11 affect or otherwise authorize any reduction or modi12 fication, in the Medicare payment amounts otherwise 

13 established for chemotherapy infusion or injection 

14 codes with respect to the calculation and payment of 

15 minutes for chemotherapy teaching or related serv16 ices. 

17 (5) EFFECTIVE DATE.—The amendments made 

18 by this section shall apply to services furnished on 

19 or after the first day of the first calendar year that 

20 begins after the date of the enactment of this Act. 

21 SEC. 10. TARGETED CANCERS PROGRAM. 

22 Subpart 1 of part C of title IV of the Public Health 

23 Service Act (42 U.S.C. 285 et seq.), as amended by section 

24 14, is further amended by adding at the end the following: 


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1 ‘‘SEC. 417H. TARGETED CANCERS PROGRAM. 

2 ‘‘(a) ESTABLISHMENT.—The Director of the Insti3 tute shall establish a targeted cancers program under 

4 which the Director may enter into agreements and make 

5 grants to conduct and coordinate research activities, with 

6 respect to cancers that result in a 5-year survival rate of 

7 less than 50 percent, for purposes of increasing such sur8 vival rate for such cancers. Such program shall include 

9 each of the elements described in subsections (b) through 

10 (i). 

11 ‘‘(b) STRATEGIC PLAN FOR PROGRESS.— 

12 ‘‘(1) IN GENERAL.—Under the targeted cancers 

13 program, the Director of the Institute, in coordina14 tion with relevant stakeholders and other appro15 priate Federal agencies, shall develop a comprehen16 sive plan, including budget amounts, for the imple17 mentation of the research activities described in this 

18 subsection (a) as well as the identification of addi19 tional research activities that will be necessary to in20 crease the survival for patients diagnosed with a 

21 cancer described in such subsection. 

22 ‘‘(2) REPORT.—Not later than 6 months after 

23 the date of the enactment of this section, the Direc24 tor of the Institute shall submit to Congress and 

25 make publicly available the comprehensive plan de26 scribed in paragraph (1). 


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1 ‘‘(c) DEDICATED FUNDING FOR BASIC RESEARCH.— 

2 Under the targeted cancers program, the Director of the 

3 Institute shall establish a separate funding mechanism 

4 that can be used to fund basic research grants for inves5 tigators with a primary interest in one of the cancers de6 scribed in subsection (a). 

7 ‘‘(d) IMAGING RESEARCH.—Under the targeted can8 cers program, the Director of the Institute shall provide 

9 for research to expand and advance the potential of imag10 ing to assist in early detection, disease management, and 

11 drug development. 

12 ‘‘(e) INCUBATOR GRANT PROGRAM.—Under the tar13 geted cancers program, the Director of the Institute shall 

14 establish a high-risk, high-reward incubator grant pro15 gram for each cancer described in subsection (a) to allow 

16 investigators with a primary interest in such cancer an 

17 opportunity to build data for future grants provided by 

18 the Institute or the National Institutes of Health. 

19 ‘‘(f) GRANT REVIEW BY SCIENTIFIC EXPERTS.— 

20 Under the targeted cancers program, the Director of the 

21 Institute shall provide for a peer-review process of applica22 tions submitted for a grant under this section. Such proc23 ess shall be conducted by grant peer-review teams that in24 clude scientific experts in the specific disease area in25 volved, as well as patient advocates. 


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1 ‘‘(g) SPECIALIZED TRAINING PROGRAMS.—Under 

2 the targeted cancers program, the Director of the Institute 

3 shall provide for advanced specialized training and edu4 cation programs for early career PhD and clinician sci5 entists that ensure sufficient time of such scientists is re6 served for research in order to attract and retain a broader 

7 pool of investigators for the cancers specified in subsection 

8 (a). 

9 ‘‘(h) SURVEILLANCE AND SCREENING.—Under the 

10 targeted cancers program, the Director of the Institute 

11 shall, as prevention, early detection, and treatments are 

12 identified for cancers described in subsection (a), develop 

13 pilot programs for the surveillance and treatment of such 

14 conditions that are precursors to such cancers. 

15 ‘‘(i) COOPERATIVE RESEARCH AGREEMENTS.— 

16 Under the targeted cancers program, the Director of the 

17 Institute may enter into cooperative research agreements 

18 with other Federal agencies on programs targeting cancers 

19 specified in subsection (a), including other Institutes at 

20 the National Institutes of Health, other agencies within 

21 the Department of Health and Human Services, the De22 partment of Defense, and the Department of Veterans Af23 fairs. 

24 ‘‘(j) IOM REPORT.— 


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1 ‘‘(1) IN GENERAL.—The Secretary of Health 

2 and Human Services shall enter into an arrange3 ment with the Institute of Medicine of the National 

4 Academies to provide an independent assessment, 

5 with respect to cancers described in subsection (a), 

6 of funding of the National Cancer Institute, progress 

7 of such Institute, and the additional improvements 

8 that should be implemented by the Department of 

9 Health and Human Services, by the National Insti10 tutes of Health, and by the National Cancer Insti11 tute to make sufficient progress on research related 

12 to such cancers. 

13 ‘‘(2) REPORT.—The agreement entered into 

14 under paragraph (1) shall provide for the Institute 

15 of Medicine to submit to the Secretary and the Con16 gress, not later than 1 year after the date of the en17 actment of this section, a report containing a de18 scription of the results of the study conducted under 

19 such paragraph and the conclusions and rec20 ommendations of the Institute of Medicine regarding 

21 the issues described in such paragraph.’’. 

22 SEC. 11. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRA23 TION. 

24 (a) REVIEW, IMPROVEMENT, AND COORDINATION.— 

25 The Commissioner of Food and Drugs shall— 


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1 (1) conduct a review of the policies, programs, 

2 and activities of the Food and Drug Administration 

3 relating to oncology products; and 

4 (2) based on the results of such review, improve 

5 and coordinate such policies, programs, and activi6 ties, including by— 

7 (A) integrating policies, programs, activi8 ties, and, if appropriate, organizational units of 

9 the Administration to facilitate the concurrent 

10 development of oncology products; 

11 (B) considering alternatives or surrogates 

12 to traditional clinical trial endpoints (for exam13 ple, other than survival) that are acceptable for 

14 regulatory approval as evidence of clinical ben15 efit to patients; and 

16 (C) modernizing the Office of Oncology 

17 Drug Products by examining and addressing in18 ternal barriers that exist within the Office’s or19 ganizational structure. 

20 (b) DEFINITIONS.—In this section: 

21 (1) The term ‘‘biological product’’ has the 

22 meaning given to that term in section 351 of the 

23 Public Health Service Act (42 U.S.C. 262). 

24 (2) The terms ‘‘device’’ and ‘‘drug’’ have the 

25 meanings given to those terms in section 201 of the 


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1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 321). 

3 (3) The term ‘‘oncology product’’ means— 

4 (A) any biological product, drug, or device 

5 for cancer diagnosis, prevention, or treatment; 

6 or 

7 (B) any other product that is regulated by 

8 the Food and Drug Administration and is de9 termined by the Commissioner of Food and 

10 Drugs to be relevant to cancer diagnosis, pre11 vention, or treatment. 

12 SEC. 12. CDC CANCER CONTROL PROGRAMS. 

13 Part B of title III of the Public Health Service Act 

14 (42 U.S.C. 243 et seq.), as amended by section 6, is fur15 ther amended by inserting after section 317U the fol16 lowing: 

17 ‘‘SEC. 317V. CANCER CONTROL PROGRAMS. 

18 ‘‘(a) IN GENERAL.—The Secretary, acting through 

19 the Director of the Centers for Disease Control and Pre20 vention, shall expand and intensify the cancer control pro21 grams of the Centers, including programs for conducting 

22 surveillance activities or supporting State comprehensive 

23 cancer control plans. 

24 ‘‘(b) CERTAIN ACTIVITIES.—In carrying out sub25 section (a), the Secretary shall— 


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1 ‘‘(1) in collaboration with the Director of the 

2 National Cancer Institute, provide guidance to 

3 States on projects and interventions that may be in4 corporated into State comprehensive cancer control 

5 programs to improve the long-term health status of 

6 childhood cancer survivors, including childhood can7 cer survivors in minority and other medically under8 served populations; 

9 ‘‘(2) encourage States to incorporate strategies 

10 for improving systems of care for childhood cancer 

11 survivors and their families into State comprehensive 

12 cancer plans; and 

13 ‘‘(3) collaborate with the Director of the Na14 tional Cancer Institute to improve existing surveil15 lance systems or develop appropriate new systems 

16 for tracking cancer survivors and assessing their 

17 health status and risk for other chronic and dis18 abling conditions. 

19 ‘‘(c) CHILDHOOD CANCER SURVIVORSHIP.— 

20 ‘‘(1) FOCUS ON CHILDHOOD CANCER SURVIVOR21 SHIP.—In conducting or supporting national, State, 

22 and local comprehensive cancer control programs 

23 through the Centers for Disease Control and Preven24 tion, the Secretary shall enhance such programs— 


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1 ‘‘(A) to include a focus on childhood cancer 

2 survivorship, including survivorship in minority 

3 and other medically underserved populations; 

4 and 

5 ‘‘(B) to include childhood cancer survivor6 ship initiatives for improving— 

7 ‘‘(i) the monitoring of survivors of all 

8 forms of cancer; and 

9 ‘‘(ii) follow-up treatment for childhood 

10 cancer survivors. 

11 ‘‘(2) RELIANCE ON GUIDELINES.—In carrying 

12 out this subsection, the Secretary shall rely, where 

13 appropriate, on existing guidelines for care of child14 hood cancer survivors.’’. 

15 SEC. 13. NIH CANCER SURVIVORSHIP PROGRAMS. 

16 (a) TECHNICAL AMENDMENT.— 

17 (1) IN GENERAL.—Section 3 of the 

18 Hematological Cancer Research Investment and 

19 Education Act of 2002 (Public Law 107–172; 116 

20 Stat. 541) is amended by striking ‘‘section 419C’’ 

21 and inserting ‘‘section 417C’’. 

22 (2) EFFECTIVE DATE.—The amendment made 

23 by paragraph (1) shall take effect as if included in 

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1 vestment and Education Act of 2002 (Public Law 

2 107–172; 116 Stat. 541). 

3 (b) CANCER SURVIVORSHIP PROGRAMS.—Subpart 1 

4 of part C of title IV of the Public Health Service Act (42 

5 U.S.C. 285 et seq.), is amended by adding at the end the 

6 following: 

7 ‘‘SEC. 417G. EXPANSION OF CANCER SURVIVORSHIP ACTIVI8 TIES. 

9 ‘‘(a) EXPANSION OF ACTIVITIES.—The Director of 

10 the Institute shall coordinate the activities of the National 

11 Institutes of Health with respect to cancer survivorship, 

12 including childhood cancer survivorship. 

13 ‘‘(b) PRIORITY AREAS.—In carrying out subsection 

14 (a), the Director of the Institute shall give priority to the 

15 following: 

16 ‘‘(1) Comprehensive assessment of the preva17 lence and etiology of late effects of cancer and its 

18 treatment, including physical, neu-rocognitive, and 

19 psychosocial late effects. Such assessment shall in20 clude— 

21 ‘‘(A) development of a system for patient 

22 tracking and analysis; 

23 ‘‘(B) establishment of a system of tissue 

24 collection, banking, and analysis for childhood 


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1 cancers, using guidelines from the Office of 

2 Biorepositories and Biospecimen Research; and 

3 ‘‘(C) coordination of, and resources for, as4 sessment and data collection. 

5 ‘‘(2) Identification of risk and protective factors 

6 related to the development of late effects of cancer. 

7 ‘‘(3) Identification of predictors of neu8 rocognitive and psychosocial outcomes, including 

9 quality of life, in cancer survivors and identification 

10 of qualify of life and other outcomes in family mem11 bers. 

12 ‘‘(4) Development and implementation of inter13 vention studies for patients and families, including 

14 studies focusing on— 

15 ‘‘(A) preventive interventions during treat16 ment; 

17 ‘‘(B) interventions to lessen the impact of 

18 late effects; 

19 ‘‘(C) rehabilitative or remediative interven20 tions; 

21 ‘‘(D) interventions to promote health be22 haviors in long-term survivors; and 

23 ‘‘(E) interventions to improve health care 

24 utilization and access to linguistically and cul25 turally competent long-term follow-up care for 


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1 childhood cancer survivors in minority and 

2 other medically underserved populations. 

3 ‘‘(c) GRANTS FOR RESEARCH ON CAUSES OF

4 HEALTH DISPARITIES IN CHILDHOOD CANCER SURVI5 VORSHIP.— 

6 ‘‘(1) GRANTS.—The Director of NIH, acting 

7 through the Director of the Institute, shall make 

8 grants to entities to conduct research relating to— 

9 ‘‘(A) childhood cancer survivors within mi10 nority populations; and 

11 ‘‘(B) health disparities in cancer survivor12 ship outcomes within minority or other medi13 cally underserved populations. 

14 ‘‘(2) BALANCED APPROACH.—In making grants 

15 for research under paragraph (1)(A) on childhood 

16 cancer survivors within minority populations, the Di17 rector of NIH shall ensure that such research ad18 dresses both the physical and the psychosocial needs 

19 of such survivors. 

20 ‘‘(3) HEALTH DISPARITIES.—In making grants 

21 for research under paragraph (1)(B) on health dis22 parities in cancer survivorship outcomes within mi23 nority populations, the Director of NIH shall ensure 

24 that such research examines each of the following: 


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1 ‘‘(A) Key adverse events after childhood 

2 cancer. 

3 ‘‘(B) Assessment of health and quality of 

4 life in childhood cancer survivors. 

5 ‘‘(C) Barriers to follow-up care to child6 hood cancer survivors. 

7 ‘‘(d) RESEARCH TO EVALUATE FOLLOW-UP CARE

8 FOR CHILDHOOD CANCER SURVIVORS.—The Director of 

9 NIH shall conduct or support research to evaluate systems 

10 of follow-up care for childhood cancer survivors, with spe11 cial emphasis given to— 

12 ‘‘(1) transitions in care for childhood cancer 

13 survivors; 

14 ‘‘(2) those professionals who should be part of 

15 care teams for childhood cancer survivors; 

16 ‘‘(3) training of professionals to provide linguis17 tically and culturally competent follow-up care to 

18 childhood cancer survivors; and 

19 ‘‘(4) different models of follow-up care. 

20 ‘‘SEC. 417G–1. IMPROVING THE QUALITY OF FOLLOW-UP 

21 CARE FOR SURVIVORS OF CHILDHOOD CAN22 CERS AND THEIR FAMILIES. 

23 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

24 with the Director of NIH, shall make grants to eligible 

25 entities to establish or improve training programs for 


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1 health care professionals (including physicians, nurses, 

2 physician assistants, and mental health professionals)— 

3 ‘‘(1) to improve the quality of immediate and 

4 long-term follow-up care for survivors of childhood 

5 cancers and their families; and 

6 ‘‘(2) to ensure that such care is linguistically 

7 and culturally competent. 

8 ‘‘(b) ELIGIBLE ENTITIES.—In this section, the term 

9 ‘eligible entity’ means— 

10 ‘‘(1) a medical school; 

11 ‘‘(2) a children’s hospital; 

12 ‘‘(3) a cancer center; 

13 ‘‘(4) a hospital with one or more residency pro14 grams that serve a significant number of childhood 

15 cancer patients; 

16 ‘‘(5) a graduate training program for health 

17 professionals described in subsection (a) who will 

18 treat survivors of childhood cancers; or 

19 ‘‘(6) any other entity with significant experience 

20 and expertise in treating survivors of childhood can21 cers. 

22 ‘‘(c) DURATION.—Each grant under this section shall 

23 be for a period of 2 years. 

24 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To 

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1 priated $5,000,000 for each of fiscal years 2012 through 

2 2016. 

3 ‘‘SEC. 417G–2. STUDY OF PILOT PROGRAMS TO EXPLORE 

4 MODEL SYSTEMS OF CARE. 

5 ‘‘(a) IN GENERAL.—The Director of NIH, in con6 sultation with the Administrator of the Health Resources 

7 and Services Administration, shall make grants to eligible 

8 entities to establish pilot programs to develop, study, or 

9 evaluate model systems for monitoring and caring for 

10 childhood cancer survivors. 

11 ‘‘(b) ELIGIBLE ENTITIES.—In this section, the term 

12 ‘eligible entity’ means— 

13 ‘‘(1) a medical school; 

14 ‘‘(2) a children’s hospital; 

15 ‘‘(3) a cancer center; or 

16 ‘‘(4) any other entity with significant experience 

17 and expertise in treating survivors of childhood can18 cers. 

19 ‘‘(c) USE OF FUNDS.—The Director of NIH may 

20 make a grant under this section to an eligible entity only 

21 if the entity agrees— 

22 ‘‘(1) to use the grant to establish a pilot pro23 gram to develop, study, or evaluate one or more 

24 model systems for monitoring and caring for cancer 

25 survivors; and 


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1 ‘‘(2) in developing, studying, and evaluating 

2 such systems, to give special emphasis to the fol3 lowing: 

4 ‘‘(A) Design of protocols for follow-up 

5 care, monitoring, and other survivorship pro6 grams (including peer support and mentoring 

7 programs). 

8 ‘‘(B) Dissemination of information to 

9 health care providers about how to provide lin10 guistically and culturally competent follow-up 

11 care and monitoring to cancer survivors and 

12 their families. 

13 ‘‘(C) Dissemination of other information, 

14 as appropriate, to health care providers and to 

15 cancer survivors and their families. 

16 ‘‘(D) Development of support programs to 

17 improve the quality of life of cancer survivors. 

18 ‘‘(E) Design of systems for the effective 

19 transfer of treatment information from cancer 

20 care providers to other health care providers 

21 (including family practice physicians and inter22 nists) and to cancer survivors and their fami23 lies, where appropriate. 

24 ‘‘(F) Development of various models for 

25 providing multidisciplinary care. 


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1 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To 

2 carry out this section, there is authorized to be appro3 priated $10,000,000 for each of fiscal years 2012 through 

4 2016.’’. 

5 (c) COMPLETE RECOVERY CARE.— 

6 (1) DEFINITION.—In this subsection, the term 

7 ‘‘complete recovery care’’ means care intended to ad8 dress the secondary effects of cancer and its treat9 ment, including late, psychosocial, neurocognitive, 

10 psychiatric, psychological, physical, and other effects 

11 associated with cancer and cancer survivorship be12 yond the impairment of bodily function directly 

13 caused by the disease, as described in the report by 

14 the Institute of Medicine of the National Academies 

15 entitled ‘‘Cancer Care for the Whole Patient’’. 

16 (2) EXPANSION OF ACTIVITIES.—The Secretary 

17 of Health and Human Services (referred to in this 

18 subsection as the ‘‘Secretary’’) shall— 

19 (A) coordinate the activities of Federal 

20 agencies, including the National Institutes of 

21 Health, the National Cancer Institute, the Na22 tional Institute of Mental Health, the Centers 

23 for Medicare and Medicaid Services, the Vet24 erans Health Administration, the Centers for 

25 Disease Control and Prevention, the Food and 


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1 Drug Administration, the Agency for 

2 Healthcare Research and Quality, the Office for 

3 Human Research Protections, and the Health 

4 Resources and Services Administration to im5 prove the provision of complete recovery care in 

6 the treatment of cancer; and 

7 (B) solicit input from professional and pa8 tient organizations, payors, and other relevant 

9 institutions and organizations regarding the 

10 status of provision of complete recovery care in 

11 the treatment of cancer. 

12 (3) IMPROVING THE COMPLETE RECOVERY

13 CARE WORKFORCE.— 

14 (A) CHRONIC DISEASE WORKFORCE DE15 VELOPMENT COLLABORATIVE.—The Secretary 

16 shall, not later than 1 year after the date of en17 actment of this Act, convene a Workforce De18 velopment Collaborative on Psychosocial Care 

19 During Chronic Medical Illness (referred to in 

20 this paragraph as the ‘‘Collaborative’’). The 

21 Collaborative shall be a cross-specialty, multi22 disciplinary group composed of educators, con23 sumer and family advocates, and providers of 

24 psychosocial and biomedical health services. 


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1 (B) GOALS AND REPORT.—The Collabo2 rative shall submit to the Secretary a report es3 tablishing a plan to meet the following objec4 tives for psychosocial care workforce develop5 ment: 

6 (i) Identifying, refining, and broadly 

7 disseminating to healthcare educators in8 formation about workforce competencies, 

9 models, and preservices curricula relevant 

10 to providing psychosocial services to per11 sons with chronic medical illnesses and 

12 their families. 

13 (ii) Adapting curricula for continuing 

14 education of the existing workforce using 

15 efficient workplace-based learning ap16 proaches. 

17 (iii) Developing the skills of faculty 

18 and other trainers in teaching psychosocial 

19 health care using evidence-based teaching 

20 strategies. 

21 (iv) Strengthening the emphasis on 

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1 mending revisions to the relevant oversight 

2 organizations. 

3 SEC. 14. CLINICS FOR COMPREHENSIVE LONG-TERM FOL4 LOW-UP SERVICES FOR CHILDHOOD CANCER 

5 SURVIVORS. 

6 Part B of title III of the Public Health Service Act 

7 (42 U.S.C. 243 et seq.), as amended by sections 6 and 

8 13, is further amended by inserting after section 317V the 

9 following: 

10 ‘‘SEC. 317W. CLINICS FOR COMPREHENSIVE LONG-TERM 

11 FOLLOW-UP SERVICES FOR CHILDHOOD CAN12 CER SURVIVORS. 

13 ‘‘(a) IN GENERAL.—The Secretary shall make grants 

14 to eligible entities to pay all or a portion of the costs in15 curred during the first 4 years of establishing and oper16 ating a clinic for comprehensive long-term follow-up serv17 ices for childhood cancer survivors. 

18 ‘‘(b) ELIGIBLE ENTITIES.—In this section, the term 

19 ‘eligible entity’ means— 

20 ‘‘(1) a school of medicine; 

21 ‘‘(2) a children’s hospital; 

22 ‘‘(3) a cancer center; or 

23 ‘‘(4) any other entity with significant experience 

24 and expertise in treating survivors of childhood can25 cers. 


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1 ‘‘(c) PRIORITY.—In making grants under this sec2 tion, the Secretary shall give priority to any eligible entity 

3 that demonstrates an expertise in improving access to care 

4 for minority and other medically underserved populations. 

5 ‘‘(d) USE OF FUNDS.—The Secretary may make a 

6 grant under this section to an eligible entity only if the 

7 entity agrees to use the grant to pay costs incurred during 

8 the first 4 years of establishing and operating a clinic for 

9 comprehensive long-term follow-up services for childhood 

10 cancer survivors. Such costs may include the costs of— 

11 ‘‘(1) purchasing or leasing facilities; 

12 ‘‘(2) providing medical and psychosocial follow13 up services, including coordination with the patient’s 

14 primary care provider and oncologist in order to en15 sure that the unique medical needs of survivors are 

16 addressed; 

17 ‘‘(3) conducting research to improve care for 

18 childhood cancer survivors; 

19 ‘‘(4) providing linguistically and culturally com20 petent information to childhood cancer survivors and 

21 their families; and 

22 ‘‘(5) improving access by minority or other 

23 medically underserved populations to the best prac24 tices and care for childhood cancer survivors. 


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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

2 carry out this section, there is authorized to be appro3 priated $15,000,000 for each of fiscal years 2012 through 

4 2016.’’. 

5 SEC. 15. GRANTS TO IMPROVE ACCESS TO CARE FOR 

6 CHILDHOOD CANCER SURVIVORS. 

7 Part B of title III of the Public Health Service Act 

8 (42 U.S.C. 243 et seq.), as amended by sections 6, 13, 

9 and 15, is further amended by inserting after section 

10 317W the following: 

11 ‘‘SEC. 317X. GRANTS TO IMPROVE ACCESS TO CARE FOR 

12 CHILDHOOD CANCER SURVIVORS. 

13 ‘‘(a) GRANTS.—The Secretary shall make grants to 

14 recognized childhood cancer professional and advocacy or15 ganizations to improve physical and psychosocial care for 

16 childhood cancer survivors, especially childhood cancer 

17 survivors in minority or other medically underserved popu18 lations. 

19 ‘‘(b) USE OF FUNDS.—The Secretary may make a 

20 grant under this section to an organization only if the or21 ganization agrees to use the grant to improve physical and 

22 psychosocial care for childhood cancer survivors, especially 

23 childhood cancer survivors in minority or other medically 

24 underserved populations. Such care may include— 

25 ‘‘(1) patient navigator programs; 


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1 ‘‘(2) peer support programs; 

2 ‘‘(3) education and outreach for survivors and 

3 their families, including developing bilingual mate4 rials; 

5 ‘‘(4) follow-up care for uninsured and under6 insured survivors— 

7 ‘‘(A) to identify, prevent, or control side ef8 fects associated with cancer and its treatment; 

9 and 

10 ‘‘(B) to screen for cancer recurrence; and 

11 ‘‘(5) assistance with transportation necessary to 

12 receive medical care for survivors and their families 

13 who lack adequate transportation resources. 

14 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To 

15 carry out this section, there is authorized to be appro16 priated $10,000,000 for each of fiscal years 2012 through 

17 2016.’’. 

Æ 


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