II 

114TH CONGRESS 

2D SESSION H. R. 3381 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 7, 2016 

Received 

AN ACT 

To maximize discovery, and accelerate development and availability, of promising childhood cancer treatments, 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, 


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

3 ‘‘Childhood Cancer Survivorship, Treatment, Access, and 

4 Research Act of 2016’’ or the ‘‘Childhood Cancer STAR 

5 Act’’. 

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

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

TITLE I—MAXIMIZING RESEARCH THROUGH DISCOVERY 

Subtitle A—Caroline Pryce Walker Conquer Childhood Cancer 

Reauthorization Act 

Sec. 101. Children’s cancer biorepositories and biospecimen research. 

Sec. 102. Improving Childhood Cancer Surveillance. 

Subtitle B—Pediatric Expertise at NIH 

Sec. 111. Inclusion of at least one pediatric oncologist on the National Cancer 

Advisory Board. 

Sec. 112. Sense of Congress regarding pediatric expertise at the National Cancer Institute. 

Subtitle C—NIH Report on Childhood Cancer Activities 

Sec. 121. Reporting on childhood cancer research projects. 

TITLE II—MAXIMIZING DELIVERY: CARE, QUALITY OF LIFE, 

SURVIVORSHIP, AND CAREGIVER SUPPORT 

Subtitle A—Childhood Cancer Survivors’ Quality of Life Act 

Sec. 201. Cancer survivorship programs. 

Sec. 202. Grants to improve care for pediatric cancer survivors. 

Sec. 203. Comprehensive long-term follow-up services for pediatric cancer survivors. 

Sec. 204. Survivorship demonstration project. 

Subtitle B—Coverage and Payment of High Quality Care 

Sec. 211. Report by the Comptroller General. 

8 SEC. 2. FINDINGS. 

9 Congress makes the following findings: 


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1 (1) Each year in the United States there are an 

2 estimated 15,780 children between birth and the age 

3 of 19 diagnosed with cancer. Approximately 1 in 285 

4 children in the United States will be diagnosed with 

5 cancer before their 20th birthday. 

6 (2) In 1960, only 4 percent of children with 

7 cancer survived more than 5 years, but today, cure 

8 rates have increased to over 80 percent for children 

9 and adolescents under age 20. 

10 (3) While the cure rates for some childhood 

11 cancers are now over 80 percent, the survival rates 

12 for many types of cancers in children remain ex13 tremely low. 

14 (4) According to the Centers for Disease Con15 trol and Prevention, cancer continues to be the lead16 ing cause of death by disease in children and adoles17 cents under the age of 14. 

18 (5) By 2020, the population of childhood can19 cers survivors is expected to be 500,000 individuals. 

20 (6) As many as two-thirds of childhood cancer 

21 survivors are likely to experience at least one late ef22 fect of treatment, with as many as one-fourth expe23 riencing a late effect that is serious or life-threat24 ening. Common late effects of childhood cancer are 

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1 docrine, and musculoskeletal effects, secondary ma2 lignancies, and early death. 

3 (7) As a result of disparities in the delivery of 

4 cancer care, minority, low-income, and other medi5 cally underserved children are more likely to be diag6 nosed with late stage disease, experience poorer 

7 treatment outcomes, have shorter survival time with 

8 less quality of life, and experience a substantially 

9 greater likelihood of cancer death. 

10 (8) Collection of biospecimens, along with clin11 ical and outcome data, on children and adolescents 

12 with cancer in the United States is necessary to im13 prove childhood and adolescent cancer treatments 

14 and cures. Currently biospecimens, and clinical and 

15 outcome data, are collected for less than half of chil16 dren in the United States with cancer. 

17 (9) The late effects of cancer treatment may 

18 change as therapies evolve, which means that the 

19 monitoring and care of cancer survivors may need to 

20 be modified on a routine basis. 

21 (10) Despite the intense stress caused by child22 hood cancer, there is a lack of standardized and co23 ordinated psychosocial care for the children and 

24 their families, from the date of diagnosis through 

25 treatment and survivorship. 


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1 (11) The Institute of Medicine, in its report on 

2 cancer survivorship entitled ‘‘Childhood Cancer Sur3 vivorship: Improving Care and Quality of Life’’, 

4 states that an organized system of care and a meth5 od of care for pediatric cancer survivors is needed. 

6 (12) Focused and well-designed research and 

7 pilot health delivery programs can answer questions 

8 about the optimal ways to provide health care, fol9 low-up monitoring services, and survivorship care to 

10 those diagnosed with childhood cancer and con11 tribute to improvements in the quality of care and 

12 quality of life of those individuals through adult13 hood. 

14 (13) The National Institutes of Health, includ15 ing the National Cancer Institute, invest approxi16 mately half of their annual appropriations to support 

17 basic research that serves as the foundation for 

18 translational and clinical research for all diseases 

19 and conditions, with the potential to lead to break20 throughs for children with cancer. Virtually all 

21 progress against cancer—in both children and 

22 adults—has been founded in basic research, often in 

23 areas not directly related to the disease. 

24 (14) The National Cancer Institute supports a 

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1 vance childhood cancer care, including precision 

2 medicine clinical trials for children with cancer, the 

3 Children’s Oncology Group (part of the National 

4 Clinical Trials Network of the National Cancer In5 stitute), the Pediatric Preclinical Testing Consor6 tium, the Pediatric Brain Tumor Consortium, the 

7 Childhood Cancer Survivor Study, the Therapeuti8 cally Applicable Research to Generate Effective 

9 Treatments program and related pediatric cancer 

10 genomics research (including the Pediatric MATCH 

11 Precision Medicine trial), and the Pediatric Oncology 

12 Branch (part of the intramural program of the Na13 tional Cancer Institute, whose mission is to develop 

14 new treatments for pediatric cancer). 

15 TITLE I—MAXIMIZING RE16 SEARCH THROUGH DIS17 COVERY 

18 Subtitle A—Caroline Pryce Walker 

19 Conquer Childhood Cancer Re20 authorization Act 

21 SEC. 101. CHILDREN’S CANCER BIOREPOSITORIES AND BIO22 SPECIMEN RESEARCH. 

23 Section 417E of the Public Health Service Act (42 

24 U.S.C. 285a–11) is amended— 


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1 (1) by striking subsection (a) and inserting the 

2 following: 

3 ‘‘(a) CHILDREN’S CANCER BIOREPOSITORIES.— 

4 ‘‘(1) AWARD.—The Secretary, acting through 

5 the Director of NIH, may make awards to an entity 

6 or entities described in paragraph (4) to build upon 

7 existing initiatives to collect biospecimens and clin8 ical and demographic information with a goal of col9 lection for the vast majority of all children, adoles10 cents, and young adults with selected cancer 

11 subtypes (and their recurrences) for which current 

12 treatments are least effective, through one or more 

13 biospecimen research efforts designed to achieve a 

14 better understanding of the cause of such cancers 

15 (and their recurrences) and the effects of treatments 

16 for such cancers. 

17 ‘‘(2) USE OF FUNDS.—Amounts received under 

18 an award under paragraph (1) may be used to carry 

19 out the following: 

20 ‘‘(A) Acquire, preserve, and store high21 quality, donated biospecimens and associated 

22 clinical and demographic information on chil23 dren, adolescents, and young adults diagnosed 

24 with cancer in the United States, focusing on 

25 children and adolescents enrolled in clinical 


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1 trials for whom current treatments are least ef2 fective. Activities under this subparagraph may 

3 include storage of biospecimens and associated 

4 clinical and demographic data at biorepositories 

5 supported by the National Cancer Institute, 

6 such as the Children’s Oncology Group Bio7 repository and the Pediatric Cooperative 

8 Human Tissue Network as well as through bio9 repositories established as appropriate to sup10 port the scientific needs of future research ef11 forts. 

12 ‘‘(B) Make such information publicly avail13 able, including the repositories described in sub14 paragraph (A). 

15 ‘‘(C) Maintain a secure searchable data16 base on stored biospecimens and associated 

17 clinical and demographic data from children, 

18 adolescents, and young adults with cancer for 

19 the conduct of research by scientists and quali20 fied health care professionals. 

21 ‘‘(D) Establish procedures for evaluating 

22 applications for access to such biospecimens 

23 and clinical and demographic data from re24 searchers and other qualified health care pro25 fessionals. 


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1 ‘‘(E) Make available and distribute bio2 specimens and clinical and demographic data 

3 from children, adolescents, and young adults 

4 with cancer to researchers and qualified health 

5 care professionals for peer-reviewed research at 

6 a minimal cost. 

7 ‘‘(3) NO REQUIREMENT.—No child, adolescent, 

8 or young adult with cancer shall be required under 

9 this subsection to contribute a specimen to a bio10 repository or share clinical or demographic data. 

11 ‘‘(4) APPLICATION; CONSIDERATIONS.— 

12 ‘‘(A) APPLICATION.—To be eligible to re13 ceive an award under paragraph (1) an entity 

14 shall submit an application to the Secretary at 

15 such a time, in such manner, and containing 

16 such information as the Secretary may reason17 ably require. 

18 ‘‘(B) CONSIDERATIONS.—In evaluating the 

19 applications in subparagraph (A), the Secretary 

20 shall consider the existing infrastructure of the 

21 entity that would allow for the timely capture of 

22 biospecimens and related clinical and demo23 graphic information for children, adolescents, 

24 and young adults with cancer. 

25 ‘‘(5) PRIVACY PROTECTIONS; CONSENT.— 


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

2 not make an award under paragraph (1) to an 

3 entity unless the Secretary ensures that such 

4 entity— 

5 ‘‘(i) collects biospecimens and associ6 ated clinical and demographic information 

7 from children and adolescents with appro8 priate permission from parents or legal 

9 guardians in accordance with Federal and 

10 State law; and 

11 ‘‘(ii) adheres to strict confidentiality 

12 to protect the identity and privacy of pa13 tients in accordance with Federal and 

14 State law. 

15 ‘‘(B) CONSENT.—The Secretary shall es16 tablish an appropriate process for achieving 

17 consent from the patient, parent, or legal 

18 guardian. 

19 ‘‘(6) SINGLE POINT OF ACCESS; STANDARD

20 DATA; GUIDELINES AND OVERSIGHT.— 

21 ‘‘(A) SINGLE POINT OF ACCESS.—The Sec22 retary shall ensure that each biorepository sup23 ported under paragraph (1) has electronically 

24 searchable data for use by researchers and 

25 other qualified health care professionals in the 


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1 manner and to the extent defined by the Sec2 retary. 

3 ‘‘(B) STANDARD DATA.—The Secretary 

4 shall require all recipients of an award under 

5 this section to make available a standard 

6 dataset for the purposes of subparagraph (A) in 

7 a standard electronic format that enables re8 searchers and qualified health care professionals 

9 to search. 

10 ‘‘(C) GUIDELINES AND OVERSIGHT.—The 

11 Secretary shall develop and disseminate appro12 priate guidelines for the development and main13 tenance of the biorepositories supported under 

14 this section, including appropriate oversight. 

15 ‘‘(7) COORDINATION.—The Secretary shall en16 sure that clinical and demographic information col17 lected in accordance with this section is collected in 

18 coordination with the information collected under 

19 section 399E–1. 

20 ‘‘(8) PROHIBITION ON USE OF FUNDS.—Funds 

21 made available to carry out this subsection shall not 

22 be used to acquire, preserve, or maintain a biospeci23 men collected from a patient if such activity is al24 ready covered by funds available from the National 

25 Cancer Institute for such purpose. 


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1 ‘‘(9) REPORT.—Not later than 4 years after the 

2 date of enactment of the Childhood Cancer Survivor3 ship, Treatment, Access, and Research Act of 2016, 

4 the Secretary shall submit to Congress a report on— 

5 ‘‘(A) the number of biospecimens and cor6 responding clinical demographic data collected 

7 through the biospecimen research efforts sup8 ported under paragraph (1); 

9 ‘‘(B) the number of biospecimens and cor10 responding clinical demographic data requested 

11 for use by researchers; 

12 ‘‘(C) any barriers to the collection of bio13 specimens and corresponding clinical demo14 graphic data; 

15 ‘‘(D) any barriers experienced by research16 ers or health care professionals in accessing the 

17 biospecimens and corresponding clinical demo18 graphic data necessary for use in research; and 

19 ‘‘(E) any recommendations with respect to 

20 improving the biospecimen and biorepository re21 search efforts under this subsection. 

22 ‘‘(10) DEFINITIONS.—For purposes of this sub23 section: 


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1 ‘‘(A) AWARD.—The term ‘award’ includes 

2 a grant, contract, cooperative agreement, or 

3 other transaction determined by the Secretary. 

4 ‘‘(B) BIOSPECIMEN.—The term ‘biospeci5 men’ includes— 

6 ‘‘(i) solid tumor tissue or bone mar7 row; 

8 ‘‘(ii) normal or control tissue; 

9 ‘‘(iii) blood and plasma; 

10 ‘‘(iv) DNA and RNA extractions; 

11 ‘‘(v) familial DNA; and 

12 ‘‘(vi) any other sample required by the 

13 Secretary. 

14 ‘‘(C) CLINICAL AND DEMOGRAPHIC INFOR15 MATION.—The term ‘clinical and demographic 

16 information’ includes— 

17 ‘‘(i) date of diagnosis; 

18 ‘‘(ii) age at diagnosis; 

19 ‘‘(iii) the patient’s gender, race, eth20 nicity, and environmental exposures; 

21 ‘‘(iv) extent of disease at enrollment; 

22 ‘‘(v) site of metastases; 

23 ‘‘(vi) location of primary tumor coded; 

24 ‘‘(vii) histologic diagnosis; 


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1 ‘‘(viii) tumor marker data when avail2 able; 

3 ‘‘(ix) treatment and outcome data; 

4 ‘‘(x) information related to specimen 

5 quality; and 

6 ‘‘(xi) any other information required 

7 by the Secretary.’’; and 

8 (2) in subsection (d)— 

9 (A) by striking ‘‘and section 399E–1’’ and 

10 inserting ‘‘and sections 317U, 399E–1, 417H, 

11 and 417H–1’’; 

12 (B) by striking ‘‘2009 through 2013’’ and 

13 inserting ‘‘2017 through 2021’’; and 

14 (C) by striking ‘‘such purpose’’ and insert15 ing ‘‘such purposes’’. 

16 SEC. 102. IMPROVING CHILDHOOD CANCER SURVEIL17 LANCE. 

18 Section 399E–1 of the Public Health Service Act (42 

19 U.S.C. 280e–3a) is amended— 

20 (1) by redesignating subsection (b) as sub21 section (d); and 

22 (2) by striking subsection (a) and inserting the 

23 following: 

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

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1 vention, may make awards to State cancer registries to 

2 enhance and expand infrastructure to track the epidemi3 ology of cancer in children, adolescents, and young adults. 

4 Such registries may be updated to include each occurrence 

5 of such cancers within a period of time designated by the 

6 Secretary. 

7 ‘‘(b) ACTIVITIES.—The grants described in sub8 section (a) may be used for— 

9 ‘‘(1) identifying, recruiting, and training all po10 tential sources for reporting childhood, adolescent, 

11 and young adult cancer cases; 

12 ‘‘(2) developing procedures to implement early 

13 inclusion of childhood, adolescent, and young adult 

14 cancer cases on State cancer registries through the 

15 use of electronic reporting; 

16 ‘‘(3) purchasing infrastructure to support the 

17 early inclusion of childhood, adolescent, and young 

18 adult cancer cases on such registries; 

19 ‘‘(4) submitting deidentified data to the Centers 

20 for Disease Control and Prevention for inclusion in 

21 a national database of childhood, adolescent, and 

22 young adult cancers; and 

23 ‘‘(5) tracking the late effects of childhood, ado24 lescent, and young adult cancers. 


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1 ‘‘(c) COORDINATION.—The Secretary shall ensure 

2 that information collected through State cancer registries 

3 under this section is collected in coordination with clinical 

4 and demographic information collected under section 

5 417E(a) as appropriate.’’. 

6 Subtitle B—Pediatric Expertise at 

7 NIH 

8 SEC. 111. INCLUSION OF AT LEAST ONE PEDIATRIC 

9 ONCOLOGIST ON THE NATIONAL CANCER AD10 VISORY BOARD. 

11 Clause (iii) of section 406(h)(2)(A) of the Public 

12 Health and Service Act (42 U.S.C. 284a(h)(2)(A)) is 

13 amended to read as follows: 

14 ‘‘(iii) of the members appointed to the Board— 

15 ‘‘(I) not less than five members shall be in16 dividuals knowledgeable in environmental car17 cinogenesis (including carcinogenesis involving 

18 occupational and dietary factors); and 

19 ‘‘(II) not less than one member shall be an 

20 individual knowledgeable in pediatric oncol21 ogy;’’. 


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1 SEC. 112. SENSE OF CONGRESS REGARDING PEDIATRIC EX2 PERTISE AT THE NATIONAL CANCER INSTI3 TUTE. 

4 It is the sense of Congress that the Director of the 

5 National Cancer Institute should ensure that all applicable 

6 study sections, committees, advisory groups, and panels 

7 at the National Cancer Institute include one or more 

8 qualified pediatric oncologists, as appropriate. 

9 Subtitle C—NIH Report on 

10 Childhood Cancer Activities 

11 SEC. 121. REPORTING ON CHILDHOOD CANCER RESEARCH 

12 PROJECTS. 

13 Section 409D(c)(3) of the Public Health Service Act 

14 (42 U.S.C. 284h(c)(3)) is amended by— 

15 (1) striking ‘‘public on’’ and inserting ‘‘public 

16 on— 

17 ‘‘(A)’’; 

18 (2) striking the period at the end and inserting 

19 ‘‘; and’’; and 

20 (3) inserting at the end the following: 

21 ‘‘(B) childhood cancer research projects 

22 conducted or supported by the National Insti23 tutes of Health.’’. 


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1 TITLE II—MAXIMIZING DELIV2 ERY: CARE, QUALITY OF LIFE, 

3 SURVIVORSHIP, AND CARE4 GIVER SUPPORT 

5 Subtitle A—Childhood Cancer 

6 Survivors’ Quality of Life Act 

7 SEC. 201. CANCER SURVIVORSHIP PROGRAMS. 

8 (a) CANCER SURVIVORSHIP PROGRAMS.—The Public 

9 Health Service Act is amended by inserting after section 

10 399N of such Act (42 U.S.C. 280g–2) the following: 

11 ‘‘SEC. 399N–1. PILOT PROGRAMS TO EXPLORE MODEL SYS12 TEMS OF CARE FOR PEDIATRIC CANCER SUR13 VIVORS. 

14 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

15 date of enactment of this section, the Secretary may make 

16 awards to eligible entities to establish pilot programs to 

17 develop, study, or evaluate model systems for monitoring 

18 and caring for childhood cancer survivors throughout their 

19 lifespan, including evaluation of shared care and medical 

20 home and clinic based models for transition to adult care. 

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

22 ‘eligible entity’ means— 

23 ‘‘(1) a medical school; 

24 ‘‘(2) a children’s hospital; 

25 ‘‘(3) a cancer center; 


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1 ‘‘(4) a community-based medical facility; or 

2 ‘‘(5) any other entity with significant experience 

3 and expertise in treating survivors of childhood can4 cers. 

5 ‘‘(c) USE OF FUNDS.—The Secretary may make an 

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

7 entity agrees— 

8 ‘‘(1) to use the award to establish a pilot pro9 gram to develop, study, or evaluate one or more 

10 model systems for monitoring and caring for cancer 

11 survivors; and 

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

13 such systems, to give special emphasis to the fol14 lowing: 

15 ‘‘(A) Design of protocols for different mod16 els of follow-up care, monitoring, and other sur17 vivorship programs (including peer support and 

18 mentoring programs). 

19 ‘‘(B) Development of various models for 

20 providing multidisciplinary care. 

21 ‘‘(C) Dissemination of information and the 

22 provision of training to health care providers 

23 about how to provide linguistically and cul24 turally competent follow-up care and monitoring 

25 to cancer survivors and their families. 


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1 ‘‘(D) Development of psychosocial inter2 ventions and support programs to improve the 

3 quality of life of cancer survivors and their fam4 ilies. 

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

6 transfer of treatment information and care 

7 summaries from cancer care providers to other 

8 health care providers (including risk factors and 

9 a plan for recommended follow-up care). 

10 ‘‘(F) Dissemination of the information and 

11 programs described in subparagraphs (A) 

12 through (E) to other health care providers (in13 cluding primary care physicians and internists) 

14 and to cancer survivors and their families, 

15 where appropriate. 

16 ‘‘(G) Development of initiatives that pro17 mote the coordination and effective transition of 

18 care between cancer care providers, primary 

19 care physicians, and mental health profes20 sionals. 

21 ‘‘SEC. 399N–2. WORKFORCE DEVELOPMENT COLLABO22 RATIVE ON MEDICAL AND PSYCHOSOCIAL 

23 CARE FOR CHILDHOOD CANCER SURVIVORS. 

24 ‘‘(a) IN GENERAL.—The Secretary shall, not later 

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1 vene a Workforce Development Collaborative on Medical 

2 and Psychosocial Care for Pediatric Cancer Survivors (re3 ferred to in this paragraph as the ‘Collaborative’). The 

4 Collaborative shall be a cross-specialty, multidisciplinary 

5 group composed of educators, consumer and family advo6 cates, and providers of psychosocial and biomedical health 

7 services. 

8 ‘‘(b) GOALS AND REPORTS.—The Collaborative shall 

9 submit to the Secretary a report establishing a plan to 

10 meet the following objectives for medical and psychosocial 

11 care workforce development: 

12 ‘‘(1) Identifying, refining, and broadly dissemi13 nating to health care educators information about 

14 workforce competencies, models, and curricula rel15 evant to providing medical and psychosocial services 

16 to persons surviving pediatric cancers. 

17 ‘‘(2) Adapting curricula for continuing edu18 cation of the existing workforce using efficient work19 place-based learning approaches. 

20 ‘‘(3) Developing the skills of faculty and other 

21 trainers in teaching psychosocial health care using 

22 evidence-based teaching strategies. 

23 ‘‘(4) Strengthening the emphasis on psycho24 social health care in educational accreditation stand25 ards and professional licensing and certification 


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1 exams by recommending revisions to the relevant 

2 oversight organizations. 

3 ‘‘(5) Evaluating the effectiveness of patient 

4 navigators in pediatric cancer survivorship care. 

5 ‘‘(6) Evaluating the effectiveness of peer sup6 port programs in the psychosocial care of pediatric 

7 cancer patients and survivors.’’. 

8 (b) TECHNICAL AMENDMENT.— 

9 (1) IN GENERAL.—Section 3 of the 

10 Hematological Cancer Research Investment and 

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

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

13 and inserting ‘‘section 417C’’. 

14 (2) EFFECTIVE DATE.—The amendment made 

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

16 section 3 of the Hematological Cancer Research In17 vestment and Education Act of 2002 (Public Law 

18 107–172; 116 Stat. 541). 

19 SEC. 202. GRANTS TO IMPROVE CARE FOR PEDIATRIC CAN20 CER SURVIVORS. 

21 (a) IN GENERAL.—Section 417E of the Public 

22 Health Service Act (42 U.S.C. 285a–11), as amended by 

23 section 101, is further amended— 

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1 SEARCH, AWARENESS, AND SURVIVORSHIP’’; 

2 and 

3 (2) by striking subsection (b) and inserting the 

4 following: 

5 ‘‘(b) IMPROVING CARE FOR PEDIATRIC CANCER SUR6 VIVORS.— 

7 ‘‘(1) RESEARCH ON CAUSES OF HEALTH DIS8 PARITIES IN PEDIATRIC CANCER SURVIVORSHIP.— 

9 ‘‘(A) RESEARCH AWARDS.—The Director 

10 of NIH, in coordination with ongoing research 

11 activities, may conduct or support pediatric 

12 cancer survivorship research including any of 

13 the following areas: 

14 ‘‘(i) Needs and outcomes of pediatric 

15 cancer survivors within minority or other 

16 medically underserved populations. 

17 ‘‘(ii) Health disparities in pediatric 

18 cancer survivorship outcomes within minor19 ity or other medically underserved popu20 lations. 

21 ‘‘(iii) Barriers that pediatric cancer 

22 survivors within minority or other medi23 cally underserved populations face in re24 ceiving follow-up care. 


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1 ‘‘(iv) Familial, socioeconomic, and 

2 other environmental factors and the impact 

3 of such factors on treatment outcomes and 

4 survivorship. 

5 ‘‘(B) BALANCED APPROACH.—In sup6 porting research under subparagraph (A)(i) on 

7 pediatric cancer survivors within minority or 

8 other medically underserved populations, the 

9 Director of NIH shall ensure that such research 

10 addresses both the physical and the psycho11 logical needs of such survivors, as appropriate. 

12 ‘‘(2) RESEARCH ON LATE EFFECTS AND FOL13 LOW-UP CARE FOR PEDIATRIC CANCER SUR14 VIVORS.—The Director of NIH, in coordination with 

15 ongoing research activities, may conduct or support 

16 research on follow-up care for pediatric cancer sur17 vivors, including any of the following areas: 

18 ‘‘(A) The development of indicators used 

19 for long-term patient tracking and analysis of 

20 the late effects of cancer treatment for pediatric 

21 cancer survivors. 

22 ‘‘(B) The identification of risk factors as23 sociated with the late effects of cancer treat24 ment. 


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1 ‘‘(C) The identification of predictors of ad2 verse neurocognitive and psychosocial outcomes. 

3 ‘‘(D) The identification of the molecular 

4 underpinnings of long-term complications. 

5 ‘‘(E) The development of risk prediction 

6 models to identify those at highest risk of long7 term complications. 

8 ‘‘(F) Initiatives to protect cancer survivors 

9 from the late effects of cancer treatment, by de10 veloping targeted interventions to reduce the 

11 burden of morbidity borne by cancer survivors. 

12 ‘‘(G) Transitions in care for pediatric can13 cer survivors. 

14 ‘‘(H) Training of professionals to provide 

15 linguistically and culturally competent follow-up 

16 care to pediatric cancer survivors. 

17 ‘‘(I) Different models of follow-up care. 

18 ‘‘(J) Examining the cost-effectiveness of 

19 the different models of follow-up care.’’. 

20 SEC. 203. COMPREHENSIVE LONG-TERM FOLLOW-UP SERV21 ICES FOR PEDIATRIC CANCER SURVIVORS. 

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

23 (42 U.S.C. 243 et seq.) is amended by inserting after sec24 tion 317T the following: 


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1 ‘‘SEC. 317U. STANDARDS FOR COMPREHENSIVE LONG-TERM 

2 CARE FOR PEDIATRIC CANCER SURVIVORS 

3 THROUGH THE LIFESPAN. 

4 ‘‘The Secretary may establish a task force to develop 

5 and test standards, outcomes, and metrics for high-quality 

6 childhood cancer survivorship care in consultation with a 

7 full spectrum of representation of experts in late effects 

8 of disease and treatment of childhood cancers, including— 

9 ‘‘(1) oncologists who treat children and adoles10 cents; 

11 ‘‘(2) oncologists who treat adults; 

12 ‘‘(3) primary care providers engaged in survi13 vorship care; 

14 ‘‘(4) survivors of childhood cancer; 

15 ‘‘(5) parents of children who have been diag16 nosed with and treated for cancer and parents of 

17 long-term survivors; 

18 ‘‘(6) professionals who are engaged in the devel19 opment of clinical practice guidelines; 

20 ‘‘(7) nurses and social workers; 

21 ‘‘(8) mental health professionals; 

22 ‘‘(9) allied health professionals, including phys23 ical therapists and occupational therapists; 

24 ‘‘(10) experts in health care quality measure25 ment and improvement; and 


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1 ‘‘(11) others, as the Secretary determines ap2 propriate.’’. 

3 SEC. 204. SURVIVORSHIP DEMONSTRATION PROJECT. 

4 (a) IN GENERAL.—Not later than 1 year after the 

5 date of the enactment of this Act, the Secretary of Health 

6 and Human Services (referred to in this section as the 

7 ‘‘Secretary’’) may carry out a demonstration project over 

8 a 3-year period, designed to improve the quality and effi9 ciency of care provided to childhood cancer survivors 

10 throughout their lifespan, through improved care coordi11 nation as survivors transitions to adult care. 

12 (b) SELECTION OF DEMONSTRATION SITES.— 

13 (1) MAXIMUM NUMBER OF SITES.—The max14 imum number of sites at which the demonstration 

15 project under subsection (a) is carried out may not 

16 exceed 10. 

17 (2) DIVERSITY OF SITES.—In selecting entities 

18 to participate in the demonstration project, the Sec19 retary may, to the extent practicable, include in such 

20 selection— 

21 (A) small-, medium-, and large-sized sites; 

22 and 

23 (B) sites located in different geographic 

24 areas. 


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1 (c) ACTIVITIES UNDER DEMONSTRATION

2 PROJECT.—The activities conducted under the demonstra3 tion project under subsection (a) may, in addition to any 

4 other activity specified by the Secretary, include activities 

5 that seek to develop different models of care coordination, 

6 including transitions of care, follow-up care, monitoring, 

7 and other survivorship related programs that utilize a 

8 multidisciplinary, team based approach to care, including 

9 any of the following activities: 

10 (1) Coordination of care and transitions of care 

11 between cancer care providers, primary care physi12 cians, mental health professionals and any other rel13 evant providers. 

14 (2) Dissemination of information to, and train15 ing of, health care providers about linguistically and 

16 culturally competent follow-up care specific to cancer 

17 survivors. 

18 (3) Development of monitoring programs for 

19 cancer survivors and their families. 

20 (4) Incorporation of peer support and men21 toring programs to improve the quality of life of can22 cer survivors. 

23 (5) Designing systems and models for the effec24 tive transfer of treatment information and care sum25 maries from cancer care providers to other health 


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1 care providers (including risk factors and a care 

2 plan). 

3 (6) Evaluation of functional status and incorpo4 ration of specific functional needs into the care plan5 ning process. 

6 (7) Dissemination of the information on activi7 ties and programs conducted under this section to 

8 other health care providers (including primary care 

9 physicians) and to cancer survivors and their fami10 lies, where appropriate. 

11 (8) Other items determined by the Secretary. 

12 (d) MEASURES.—The Secretary may use the fol13 lowing measures to assess the performance of each site: 

14 (1) Patient care and patient/family satisfaction 

15 measures. 

16 (2) Resource utilization measures. 

17 (3) Adult survivorship measures, as appro18 priate. 

19 (e) GAO REPORT.—The Comptroller General of the 

20 United States shall submit a report to Congress evaluating 

21 the success of the demonstration project. Such report shall 

22 include an assessment of the impact of the project upon 

23 the quality and cost-efficiency of services furnished to indi24 viduals under this title, including an assessment of the sat25 isfaction of such individuals with respect to such services 


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1 that were furnished under such project. Such report shall 

2 include recommendations regarding the possible expansion 

3 of the demonstration project. 

4 Subtitle B—Coverage and Payment 

5 of High Quality Care 

6 SEC. 211. REPORT BY THE COMPTROLLER GENERAL. 

7 (a) IN GENERAL.—The Comptroller General of the 

8 United States shall conduct a review and submit rec9 ommendations to Congress on existing barriers to obtain10 ing and paying for adequate medical care for survivors of 

11 childhood cancer. 

12 (b) CONSIDERATIONS.—In carrying out the review 

13 and formulating recommendations under subsection (a), 

14 the Comptroller General shall— 

15 (1) identify existing barriers to the availability 

16 of complete and coordinated survivorship care for 

17 survivors of childhood cancer and to the availability 

18 of expert pediatric palliative care, including consider19 ation of— 

20 (A) understanding and education among 

21 patients, health care providers, regulators, and 

22 third-party payors; 

23 (B) adequacy of payment codes to cover 

24 necessary survivorship services; 


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1 (C) access to necessary medical and other 

2 services for such survivors, including the serv3 ices described in subsection (c); and 

4 (D) lack of pediatric palliative care across 

5 all stages of illness and hospice services for pa6 tients approaching the end of life; and 

7 (2) make recommendations to provide improved 

8 access and payment plans for childhood cancer sur9 vivorship programs and palliative care, including 

10 psychosocial services and coverage of such services. 

11 (c) SERVICES DESCRIBED.—The services described in 

12 this subsection are the following: 

13 (1) Coordinated multidisciplinary long-term fol14 low-up care with access to appropriate pediatric sub15 specialists and adult subspecialists with specific ex16 pertise in survivorship, including subspecialists with 

17 expertise in oncology, radiation oncology, surgery, 

18 cardiology, psychiatry or psychology, endocrinology, 

19 pulmonology, nephrology, dermatology, gynecology, 

20 and urology. 

21 (2) Appropriate organ function testing (particu22 larly screening for potential problems at much 

23 younger ages than usually indicated in the general 

24 population) and treatment, including— 


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1 (A) neuropsychological testing and mental 

2 health services; 

3 (B) fertility testing and treatment; 

4 (C) evaluation and treatment for endocrine 

5 disorders including growth hormone and testos6 terone replacement; 

7 (D) diagnostic imaging to screen for late 

8 effects of treatment (including subsequent can9 cers), such as mammograms and magnetic reso10 nance imaging testing to screen for possible 

11 breast cancer; 

12 (E) screening for cardiac problems, such 

13 as echocardiograms; 

14 (F) screening for osteoporosis with bone 

15 densitometry, including duel x-ray 

16 absorptiometry and monitoring 25 

17 hydroxyvitamin D levels; 

18 (G) dental coverage and necessary dental 

19 implants; 

20 (H) hearing aids and other prosthetic de21 vices; and 


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1 (I) screening for lung problems, such as 

2 pulmonary function testing. 

Passed the House of Representatives December 6, 

2016. 

Attest: KAREN L. HAAS, 

Clerk. 


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