I 

114TH CONGRESS 

1ST SESSION H. R. 3381 

To maximize discovery, and accelerate development and availability, of 

promising childhood cancer treatments, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 29, 2015 

Mr. MCCAUL (for himself, Mr. VAN HOLLEN, Ms. SPEIER, Mr. FLORES, Mr. 

FITZPATRICK, Mr. HINOJOSA, Mr. STIVERS, Mr. CAPUANO, Mr. KING of 

New York, Ms. EDWARDS, Mrs. COMSTOCK, Mr. HANNA, Mr. BEN RAY

LUJA ́N of New Mexico, Mr. HUNTER, Mr. PASCRELL, Mr. GARAMENDI, 

Ms. JACKSON LEE, Ms. WILSON of Florida, Mr. VEASEY, Mr. HIMES, 

Ms. CLARK of Massachusetts, Ms. CASTOR of Florida, Mr. SIRES, Ms. 

TITUS, Mr. NOLAN, Mr. DOGGETT, Mr. MCGOVERN, Mr. RANGEL, and 

Ms. FRANKEL of Florida) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

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, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

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


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1 Research Act of 2015’’ or the ‘‘Childhood Cancer STAR 

2 Act’’. 

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

4 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. Comprehensive children’s cancer biorepositories. 

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 malignancy projects. 

TITLE II—AVAILABILITY OF PROMISING TREATMENTS 

Sec. 201. Expanded access policy. 

Sec. 202. Finalizing draft guidance on expanded access. 

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

SURVIVORSHIP, AND CAREGIVER SUPPORT 

Subtitle A—Childhood Cancer Survivors’ Quality of Life Act 

Sec. 301. Cancer survivorship programs. 

Sec. 302. Grants to improve care for pediatric cancer survivors. 

Sec. 303. Comprehensive long-term follow-up services for pediatric cancer survivors. 

Sec. 304. Survivorship demonstration project. 

Subtitle B—Coverage and Payment of High Quality Care 

Sec. 311. Report by the Comptroller General. 

5 SEC. 2. FINDINGS. 

6 Congress makes the following findings: 

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

8 estimated 15,780 children between birth and the age 


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1 of 19 diagnosed with cancer. Approximately 1 in 285 

2 children in the United States will be diagnosed with 

3 cancer before their 20th birthday. 

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

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

6 rates have increased to over 80 percent for children 

7 and adolescents under age 20. 

8 (3) While the cure rates for some childhood 

9 cancers are now over 80 percent, the survival rates 

10 for many types of cancers in children remain ex11 tremely low. 

12 (4) According to the Centers for Disease Con13 trol and Prevention, cancer continues to be the lead14 ing cause of death by disease in children and adoles15 cents under the age of 14. 

16 (5) By 2020, the population of childhood can17 cers survivors is expected to be 500,000 individuals. 

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

19 survivors are likely to experience at least one late ef20 fect of treatment, with as many as one-fourth expe21 riencing a late effect that is serious or life-threat22 ening. Common late effects of childhood cancer are 

23 neurocognitive, psychological, cardiopulmonary, en24 docrine, and musculoskeletal effects, secondary ma25 lignancies, and early death. 


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

2 cancer care, minority, low-income, and other medi3 cally underserved children are more likely to be diag4 nosed with late stage disease, experience poorer 

5 treatment outcomes, have shorter survival time with 

6 less quality of life, and experience a substantially 

7 greater likelihood of cancer death. 

8 (8) Collection of biospecimens, along with clin9 ical and outcome data, on the maximum possible 

10 number of children with cancer in the United States 

11 is necessary to improve childhood cancer treatments 

12 and cures. Currently biospecimens, and clinical and 

13 outcome data, are collected for less than half of chil14 dren in the United States with cancer. 

15 (9) Despite the significant unmet medical need, 

16 pharmaceutical companies have been reluctant to de17 velop drugs appropriate for children with cancer be18 cause it requires making an investment in products 

19 that are unlikely to cover the high costs associated 

20 with their research, development, marketing, and 

21 distribution. Only 3 drugs have been approved by 

22 the Food and Drug Administration to treat any type 

23 of pediatric cancer since the 1980s, including 

24 Unituxin, the first-ever drug approved for high-risk 

25 neuroblastoma, for which the sponsor of the drug 


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1 was rewarded under the Food and Drug Administra2 tion’s priority review program to encourage treat3 ments for rare pediatric diseases. 

4 (10) The late effects of cancer treatment may 

5 change as therapies evolve, which means that the 

6 monitoring and care of cancer survivors may need to 

7 be modified on a routine basis. 

8 (11) Despite the intense stress caused by child9 hood cancer, there is a lack of standardized and co10 ordinated psychosocial care for the children and 

11 their families, from the date of diagnosis through 

12 treatment and survivorship. 

13 (12) The Institute of Medicine, in its report on 

14 cancer survivorship entitled ‘‘Childhood Cancer Sur15 vivorship: Improving Care and Quality of Life’’, 

16 states that an organized system of care and a meth17 od of care for pediatric cancer survivors is needed. 

18 (13) Focused and well-designed research and 

19 pilot health delivery programs can answer questions 

20 about the optimal ways to provide health care, fol21 low-up monitoring services, and survivorship care to 

22 those diagnosed with childhood cancer and con23 tribute to improvements in the quality of care and 

24 quality of life of those individuals through adult25 hood. 


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1 (14) The National Institutes of Health, includ2 ing the National Cancer Institute, invest approxi3 mately half of their annual appropriations to support 

4 basic research that serves as the foundation for 

5 translational and clinical research for all diseases 

6 and conditions, with the potential to lead to break7 throughs for children with cancer. Virtually all 

8 progress against cancer—in both children and 

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

10 areas not directly related to the disease. 

11 (15) The National Cancer Institute supports a 

12 number of key research programs specifically to ad13 vance childhood cancer care, including precision 

14 medicine clinical trials for children with cancer, in15 cluding the Children’s Oncology Group (part of the 

16 National Clinical Trials Network of the National 

17 Cancer Institute), the Pediatric Preclinical Testing 

18 Program, the Pediatric Brain Tumor Consortium, 

19 the Childhood Cancer Survivor Study, the Thera20 peutically Applicable Research to Generate Effective 

21 Treatments program and related pediatric cancer 

22 genomics research, and the Pediatric Oncology 

23 Branch (part of the intramural program of the Na24 tional Cancer Institute, whose mission is to develop 

25 new treatments for pediatric cancer). 


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1 TITLE I—MAXIMIZING RE2 SEARCH THROUGH DIS3 COVERY 

4 Subtitle A—Caroline Pryce Walker 

5 Conquer Childhood Cancer Re6 authorization Act 

7 SEC. 101. COMPREHENSIVE CHILDREN’S CANCER BIO8 REPOSITORIES. 

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

10 U.S.C. 285a–11) is amended— 

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

12 following: 

13 ‘‘(a) COMPREHENSIVE CHILDREN’S CANCER BIO14 REPOSITORIES.— 

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

16 the Director of NIH, may make an award for a du17 ration of at least 5 years to an entity or entities de18 scribed in paragraph (4) to build upon existing ini19 tiatives to collect biospecimens and clinical and de20 mographic information for at least 90 percent of all 

21 children, adolescents, and young adults with cancer 

22 in 1 or more Comprehensive Children’s Cancer Bio23 repositories to achieve a better understanding of the 

24 cause of such cancers and the effects of treatments 

25 for such cancers. 


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

2 the award under paragraph (1) may be used to carry 

3 out the following: 

4 ‘‘(A) Prospectively acquire, preserve, and 

5 store high-quality, donated biospecimens and 

6 associated clinical and demographic information 

7 on children, adolescents, and young adults diag8 nosed with cancer in the United States. 

9 ‘‘(B) Maintain a secure searchable data10 base on stored biospecimens and associated 

11 clinical and demographic data from children, 

12 adolescents, and young adults with cancer for 

13 the conduct of research by scientists and quali14 fied health care professionals. 

15 ‘‘(C) Establish procedures for evaluating 

16 applications for access to such biospecimens 

17 and clinical and demographic data from re18 searchers and other qualified health care pro19 fessionals. 

20 ‘‘(D) Make available and distribute bio21 specimens and clinical and demographic data 

22 from children, adolescents, and young adults 

23 with cancer to researchers and qualified health 

24 care professionals for peer-reviewed research at 

25 a minimal cost. 


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

2 or young adult with cancer shall be required under 

3 this subsection to contribute a specimen to a Bio4 repository or share clinical or demographic data. 

5 ‘‘(4) APPLICATION; CONSIDERATIONS.— 

6 ‘‘(A) APPLICATION.—To be eligible to re7 ceive an award under paragraph (1) an entity 

8 shall submit an application to the Secretary at 

9 such a time, in such manner, and containing 

10 such information as the Secretary may reason11 ably require. 

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

13 applications in subparagraph (A), the Secretary 

14 shall consider the existing infrastructure of the 

15 entity that would allow for the timely capture of 

16 biospecimens and related clinical and demo17 graphic information for children, adolescents, 

18 and young adults with cancer. 

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

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

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

22 entity unless the Secretary ensures that such 

23 entity— 

24 ‘‘(i) collects biospecimens and associ25 ated clinical and demographic information 


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1 from children with appropriate permission 

2 from parents or legal guardians in accord3 ance with Federal and State law; and 

4 ‘‘(ii) adheres to strict confidentiality 

5 to protect the identity and privacy of pa6 tients in accordance with Federal and 

7 State law. 

8 ‘‘(B) CONSENT.—The Secretary shall es9 tablish an appropriate process for achieving 

10 consent from the patient, parent, or legal 

11 guardian. 

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

13 DATA; GUIDELINES AND OVERSIGHT.— 

14 ‘‘(A) SINGLE POINT OF ACCESS.—The Sec15 retary shall ensure that each Biorepository sup16 ported under paragraph (1) has electronically 

17 searchable data for use by researchers and 

18 other qualified health care professionals in the 

19 manner and to the extent defined by the Sec20 retary. 

21 ‘‘(B) STANDARD DATA.—The Secretary 

22 shall require all recipients of an award under 

23 this section to make available a standard 

24 dataset for the purposes of subparagraph (A) in 

25 a standard electronic format that enables reVerDate Sep 11 2014 05:32 Aug 06, 2015 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3381.IH H3381

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1 searchers and qualified health care professionals 

2 to search. 

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

4 Secretary shall develop and disseminate appro5 priate guidelines for the development and main6 tenance of the biorepositories supported under 

7 this section, including appropriate oversight. 

8 ‘‘(7) COORDINATION.—The Secretary shall en9 sure that clinical and demographic information col10 lected in accordance with this section is collected in 

11 coordination with the information collected under 

12 section 399E–1. 

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

14 made available to carry out this subsection shall not 

15 be used to acquire, preserve, or maintain a biospeci16 men collected from a patient if such activity is al17 ready covered by funds available from the National 

18 Cancer Institute for such purpose. 

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

20 date of enactment of the Childhood Cancer Survivor21 ship, Treatment, Access, and Research Act of 2015, 

22 the Secretary shall submit to Congress a report on— 

23 ‘‘(A) the number of biospecimens and cor24 responding clinical demographic data collected 


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1 through the Comprehensive Children’s Cancer 

2 Biorepositories supported under paragraph (1); 

3 ‘‘(B) the number of biospecimens and cor4 responding clinical demographic data requested 

5 for use by researchers; 

6 ‘‘(C) any barriers to the collection of bio7 specimens and corresponding clinical demo8 graphic data; 

9 ‘‘(D) any barriers experienced by research10 ers or health care professionals in accessing the 

11 biospecimens and corresponding clinical demo12 graphic data necessary for use in research; and 

13 ‘‘(E) any recommendations with respect to 

14 improving the Comprehensive Children’s Cancer 

15 Biorepository program under this subsection. 

16 ‘‘(10) DEFINITIONS.—For purposes of this sub17 section: 

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

19 a grant, contract, cooperative agreement, or 

20 other mechanism determined by the Secretary. 

21 ‘‘(B) BIOSPECIMEN.—The term ‘biospeci22 men’ includes— 

23 ‘‘(i) solid tumor tissue or bone mar24 row; 

25 ‘‘(ii) normal or control tissue; 


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1 ‘‘(iii) blood and plasma; 

2 ‘‘(iv) DNA and RNA extractions; 

3 ‘‘(v) familial DNA; and 

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

5 Secretary. 

6 ‘‘(C) CLINICAL AND DEMOGRAPHIC INFOR7 MATION.—The term ‘clinical and demographic 

8 information’ includes— 

9 ‘‘(i) date of diagnosis; 

10 ‘‘(ii) age at diagnosis; 

11 ‘‘(iii) patient’s gender, race, and eth12 nicity; 

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

14 ‘‘(v) site of metastases; 

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

16 ‘‘(vii) histologic diagnosis; 

17 ‘‘(viii) tumor marker data when avail18 able; 

19 ‘‘(ix) treatment and outcome data; 

20 ‘‘(x) information related to specimen 

21 quality; and 

22 ‘‘(xi) any other information required 

23 by the Secretary.’’; and 

24 (2) in subsection (d)— 


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

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

3 and 417H–1’’; 

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

5 inserting ‘‘2016 through 2020’’; and 

6 (C) by striking ‘‘such purpose’’ and insert7 ing ‘‘such purposes’’. 

8 SEC. 102. IMPROVING CHILDHOOD CANCER SURVEIL9 LANCE. 

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

11 U.S.C. 280e–3a) is amended— 

12 (1) by redesignating subsection (b) as sub13 section (d); and 

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

15 following: 

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

17 the Director of the Centers for Disease Control and Pre18 vention, shall award grants to State cancer registries to 

19 enhance and expand infrastructure to track the epidemi20 ology of cancer in children, adolescents, and young adults. 

21 Such registries shall be updated to include each occurrence 

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

23 Secretary. 

24 ‘‘(b) ACTIVITIES.—The grants described in sub25 section (a) may be used for— 


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1 ‘‘(1) identifying, recruiting, and training all po2 tential sources for reporting childhood, adolescent, 

3 and young adult cancer cases; 

4 ‘‘(2) developing procedures to implement early 

5 inclusion of childhood, adolescent, and young adult 

6 cancer cases on State cancer registries through the 

7 use of electronic reporting; 

8 ‘‘(3) purchasing infrastructure to support the 

9 early inclusion of childhood, adolescent, and young 

10 adult cancer cases on such registries; 

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

12 for Disease Control and Prevention for inclusion in 

13 a national database of childhood, adolescent, and 

14 young adult cancers; and 

15 ‘‘(5) tracking the late effects of childhood, ado16 lescent, and young adult cancers. 

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

18 that information collected through State cancer registries 

19 under this section is collected in coordination with clinical 

20 and demographic information collected under section 

21 417E(a).’’. 


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1 Subtitle B—Pediatric Expertise at 

2 NIH 

3 SEC. 111. INCLUSION OF AT LEAST ONE PEDIATRIC 

4 ONCOLOGIST ON THE NATIONAL CANCER AD5 VISORY BOARD. 

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

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

8 amended to read as follows: 

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

10 ‘‘(I) not less than 5 members shall be indi11 viduals knowledgeable in environmental carcino12 genesis (including carcinogenesis involving occu13 pational and dietary factors); and 

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

15 individual knowledgeable in pediatric oncol16 ogy;’’. 

17 SEC. 112. SENSE OF CONGRESS REGARDING PEDIATRIC EX18 PERTISE AT THE NATIONAL CANCER INSTI19 TUTE. 

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

21 National Cancer Institute should ensure that all applicable 

22 study sections, committees, advisory groups, and panels 

23 at the National Cancer Institute include one or more 

24 qualified pediatric oncologists, as appropriate. 


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1 Subtitle C—NIH Report on 

2 Childhood Cancer Activities 

3 SEC. 121. REPORTING ON CHILDHOOD MALIGNANCY 

4 PROJECTS. 

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

6 (42 U.S.C. 284h(c)(3)) is amended by— 

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

8 on— 

9 ‘‘(A)’’; 

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

11 ‘‘; and’’; and 

12 (3) inserting at the end the following: 

13 ‘‘(B) the childhood malignancy projects 

14 conducted under section 399N.’’. 

15 TITLE II—AVAILABILITY OF 

16 PROMISING TREATMENTS 

17 SEC. 201. EXPANDED ACCESS POLICY. 

18 Chapter V of the Federal Food, Drug, and Cosmetic 

19 Act is amended by inserting after section 561 (21 U.S.C. 

20 360bbb) the following: 

21 ‘‘SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR IN22 VESTIGATIONAL DRUGS. 

23 ‘‘(a) IN GENERAL.—The manufacturer or distributor 

24 of one or more investigational drugs for the diagnosis, 

25 monitoring, or treatment of one or more serious diseases 


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1 or conditions shall make publicly available the policy of 

2 the manufacturer or distributor on evaluating and re3 sponding to requests submitted under section 561(b) for 

4 provision of such a drug. A manufacturer or distributor 

5 may satisfy the requirement of the preceding sentence by 

6 posting such policy as generally applicable to all of such 

7 manufacturer’s of distributor’s investigational drugs. 

8 ‘‘(b) CONTENT OF POLICY.—A policy described in 

9 subsection (a) shall include making publicly available— 

10 ‘‘(1) contact information for the manufacturer 

11 or distributor to facilitate communication about re12 quests described in subsection (a); 

13 ‘‘(2) procedures for making such requests; 

14 ‘‘(3) the general criteria the manufacturer or 

15 distributor will consider or use to approve such re16 quests; and 

17 ‘‘(4) the length of time the manufacturer or dis18 tributor anticipates will be necessary to acknowledge 

19 receipt of such requests. 

20 ‘‘(c) NO GUARANTEE OF ACCESS.—The posting of 

21 policies by manufacturers and distributors under sub22 section (a) shall not serve as a guarantee of access to any 

23 specific investigational drug by any individual patient. 


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1 ‘‘(d) REVISED POLICY.—A manufacturer or dis2 tributor that has made a policy publicly available as re3 quired by this section may revise the policy at any time. 

4 ‘‘(e) APPLICATION.—This section shall apply to a 

5 manufacturer or distributor with respect to an investiga6 tional drug beginning on the later of— 

7 ‘‘(1) the date that is 60 days after the date of 

8 enactment of the Childhood Cancer Survivorship, 

9 Treatment, Access, and Research Act of 2015; or 

10 ‘‘(2) the first initiation of a phase 2 or phase 

11 3 study (as such terms are defined in section 

12 312.21(b) and (c) of title 21, Code of Federal Regu13 lations (or any successor regulations)) with respect 

14 to such investigational new drug.’’. 

15 SEC. 202. FINALIZING DRAFT GUIDANCE ON EXPANDED AC16 CESS. 

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

18 date of enactment of this Act, the Secretary of Health and 

19 Human Services shall finalize the draft guidance entitled 

20 ‘‘Expanded Access to Investigational Drugs for Treatment 

21 Use—Qs & As’’, dated May 2013. 

22 (b) CONTENTS.—The final guidance referred to in 

23 subsection (a) shall clearly define how the Secretary of 

24 Health and Human Services interprets and uses adverse 

25 drug event data reported by investigators in the case of 


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1 data reported from use under a request submitted under 

2 section 561(b) of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 360bbb(b)). 

4 TITLE III—MAXIMIZING DELIV5 ERY: CARE, QUALITY OF LIFE, 

6 SURVIVORSHIP, AND CARE7 GIVER SUPPORT 

8 Subtitle A—Childhood Cancer 

9 Survivors’ Quality of Life Act 

10 SEC. 301. CANCER SURVIVORSHIP PROGRAMS. 

11 (a) CANCER SURVIVORSHIP PROGRAMS.—Subpart 1 

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

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

14 following: 

15 ‘‘SEC. 417H. PILOT PROGRAMS TO EXPLORE MODEL SYS16 TEMS OF CARE FOR PEDIATRIC CANCER SUR17 VIVORS. 

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

19 date of enactment of this section, the Secretary shall make 

20 grants to eligible entities to establish pilot programs to 

21 develop, study, or evaluate model systems for monitoring 

22 and caring for childhood cancer survivors throughout their 

23 lifespan, including evaluation of shared care and medical 

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


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

2 ‘eligible entity’ means— 

3 ‘‘(1) a medical school; 

4 ‘‘(2) a children’s hospital; 

5 ‘‘(3) a cancer center; 

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

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

8 and expertise in treating survivors of childhood can9 cers. 

10 ‘‘(c) USE OF FUNDS.—The Secretary may make a 

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

12 entity agrees— 

13 ‘‘(1) to use the grant to establish a pilot pro14 gram to develop, study, or evaluate one or more 

15 model systems for monitoring and caring for cancer 

16 survivors; and 

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

18 such systems, to give special emphasis to the fol19 lowing: 

20 ‘‘(A) Design of protocols for different mod21 els of follow-up care, monitoring, and other sur22 vivorship programs (including peer support and 

23 mentoring programs). 

24 ‘‘(B) Development of various models for 

25 providing multidisciplinary care. 


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1 ‘‘(C) Dissemination of information and the 

2 provision of training to health care providers 

3 about how to provide linguistically and cul4 turally competent follow-up care and monitoring 

5 to cancer survivors and their families. 

6 ‘‘(D) Development of support programs to 

7 improve the quality of life of cancer survivors. 

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

9 transfer of treatment information and care 

10 summaries from cancer care providers to other 

11 health care providers (including risk factors and 

12 a plan for recommended follow-up care). 

13 ‘‘(F) Dissemination of the information and 

14 programs described in subparagraphs (A) 

15 through (E) to other health care providers (in16 cluding primary care physicians and internists) 

17 and to cancer survivors and their families, 

18 where appropriate. 

19 ‘‘(G) Development of initiatives that pro20 mote the coordination and effective transition of 

21 care between cancer care providers, primary 

22 care physicians, and mental health profes23 sionals. 


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1 ‘‘SEC. 417H–1. WORKFORCE DEVELOPMENT COLLABO2 RATIVE ON MEDICAL AND PSYCHOSOCIAL 

3 CARE FOR CHILDHOOD CANCER SURVIVORS. 

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

5 than 1 year after the date of enactment of this Act, con6 vene a Workforce Development Collaborative on Medical 

7 and Psychosocial Care for Pediatric Cancer Survivors (re8 ferred to in this paragraph as the ‘Collaborative’). The 

9 Collaborative shall be a cross-specialty, multidisciplinary 

10 group composed of educators, consumer and family advo11 cates, and providers of psychosocial and biomedical health 

12 services. 

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

14 submit to the Secretary a report establishing a plan to 

15 meet the following objectives for medical and psychosocial 

16 care workforce development: 

17 ‘‘(1) Identifying, refining, and broadly dissemi18 nating to health care educators information about 

19 workforce competencies, models, and curricula rel20 evant to providing medical and psychosocial services 

21 to persons surviving pediatric cancers. 

22 ‘‘(2) Adapting curricula for continuing edu23 cation of the existing workforce using efficient work24 place-based learning approaches. 


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

2 trainers in teaching psychosocial health care using 

3 evidence-based teaching strategies. 

4 ‘‘(4) Strengthening the emphasis on psycho5 social health care in educational accreditation stand6 ards and professional licensing and certification 

7 exams by recommending revisions to the relevant 

8 oversight organizations. 

9 ‘‘(5) Evaluating the effectiveness of patient 

10 navigators in pediatric cancer survivorship care. 

11 ‘‘(6) Evaluating the effectiveness of peer sup12 port programs in the psychosocial care of pediatric 

13 cancer patients and survivors.’’. 

14 (b) TECHNICAL AMENDMENT.— 

15 (1) IN GENERAL.—Section 3 of the 

16 Hematological Cancer Research Investment and 

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

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

19 and inserting ‘‘section 417C’’. 

20 (2) EFFECTIVE DATE.—The amendment made 

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

22 section 3 of the Hematological Cancer Research In23 vestment and Education Act of 2002 (Public Law 

24 107–172; 116 Stat. 541). 


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1 SEC. 302. GRANTS TO IMPROVE CARE FOR PEDIATRIC CAN2 CER SURVIVORS. 

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

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

5 section 101, is further amended— 

6 (1) in the section heading, by striking ‘‘RE7 SEARCH AND AWARENESS’’ and inserting ‘‘RE8 SEARCH, AWARENESS, AND SURVIVORSHIP’’; 

9 and 

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

11 following: 

12 ‘‘(b) IMPROVING CARE FOR PEDIATRIC CANCER SUR13 VIVORS.— 

14 ‘‘(1) RESEARCH ON CAUSES OF HEALTH DIS15 PARITIES IN PEDIATRIC CANCER SURVIVORSHIP.— 

16 ‘‘(A) GRANTS.—The Director of NIH, with 

17 guidance from the Director of the Institute, in 

18 coordination with ongoing research activities, 

19 shall make grants to entities to conduct re20 search relating to— 

21 ‘‘(i) needs and outcomes of pediatric 

22 cancer survivors within minority or other 

23 medically underserved populations; 

24 ‘‘(ii) health disparities in pediatric 

25 cancer survivorship outcomes within minorVerDate Sep 11 2014 05:32 Aug 06, 2015 Jkt 049200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\H3381.IH H3381

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1 ity or other medically underserved popu2 lations; 

3 ‘‘(iii) barriers that pediatric cancer 

4 survivors within minority or other medi5 cally underserved populations face in re6 ceiving follow-up care; and 

7 ‘‘(iv) familial, socioeconomic, and 

8 other environmental factors and the impact 

9 of such factors on treatment outcomes and 

10 survivorship. 

11 ‘‘(B) BALANCED APPROACH.—In making 

12 grants for research under subparagraph (A)(i) 

13 on pediatric cancer survivors within minority or 

14 other medically underserved populations, the 

15 Director of NIH shall ensure that such research 

16 addresses both the physical and the psycho17 logical needs of such survivors. 

18 ‘‘(2) RESEARCH ON LATE EFFECTS AND FOL19 LOW-UP CARE FOR PEDIATRIC CANCER SUR20 VIVORS.—The Director of NIH, in coordination with 

21 ongoing research activities, shall conduct or support 

22 research on follow-up care for pediatric cancer sur23 vivors, with special emphasis given to— 

24 ‘‘(A) the development of indicators used 

25 for long-term patient tracking and analysis of 


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1 the late effects of cancer treatment for pediatric 

2 cancer survivors; 

3 ‘‘(B) the identification of risk factors asso4 ciated with the late effects of cancer treatment; 

5 ‘‘(C) the identification of predictors of 

6 neurocognitive and psychosocial outcomes; 

7 ‘‘(D) the identification of the molecular 

8 underpinnings of long-term complications; 

9 ‘‘(E) the development of risk prediction 

10 models to identify those at highest risk of long11 term complications; 

12 ‘‘(F) initiatives to protect cancer survivors 

13 from the late effects of cancer treatment, by de14 veloping targeted interventions to reduce the 

15 burden of morbidity borne by cancer survivors; 

16 ‘‘(G) transitions in care for pediatric can17 cer survivors; 

18 ‘‘(H) training of professionals to provide 

19 linguistically and culturally competent follow-up 

20 care to pediatric cancer survivors; 

21 ‘‘(I) different models of follow-up care; and 

22 ‘‘(J) examining the cost-effectiveness of the 

23 different models of follow-up care.’’. 


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1 SEC. 303. COMPREHENSIVE LONG-TERM FOLLOW-UP SERV2 ICES FOR PEDIATRIC CANCER SURVIVORS. 

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

4 (42 U.S.C. 243 et seq.) is amended by inserting after sec5 tion 317T the following: 

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

7 CARE FOR PEDIATRIC CANCER SURVIVORS 

8 THROUGH THE LIFESPAN. 

9 ‘‘The Secretary shall establish a task force to develop 

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

11 childhood cancer survivorship care in consultation with a 

12 full spectrum of representation of experts in late effects 

13 of disease and treatment of childhood cancers, including— 

14 ‘‘(1) oncologists who treat children and adoles15 cents; 

16 ‘‘(2) oncologists who treat adults; 

17 ‘‘(3) primary care providers engaged in survi18 vorship care; 

19 ‘‘(4) survivors of childhood cancer; 

20 ‘‘(5) parents of children who have been diag21 nosed with and treated for cancer and parents of 

22 long-term survivors; 

23 ‘‘(6) professionals who are engaged in the devel24 opment of clinical practice guidelines; 

25 ‘‘(7) nurses and social workers; 

26 ‘‘(8) mental health professionals; 


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1 ‘‘(9) allied health professionals, including phys2 ical therapists and occupational therapists; 

3 ‘‘(10) experts in health care quality measure4 ment and improvement; and 

5 ‘‘(11) others, as the Secretary determines ap6 propriate.’’. 

7 SEC. 304. SURVIVORSHIP DEMONSTRATION PROJECT. 

8 (a) IN GENERAL.—Not later than one year after the 

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

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

11 ‘‘Secretary’’) shall carry out a demonstration project over 

12 a 3-year period, designed to improve the quality and effi13 ciency of care provided to childhood cancer survivors 

14 throughout their lifespan, through improved care coordi15 nation as survivors transitions to adult care. 

16 (b) SELECTION OF DEMONSTRATION SITES.— 

17 (1) MAXIMUM NUMBER OF SITES.—The Sec18 retary shall ensure that the maximum number of 

19 sites does not exceed 10. 

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

21 to participate in the demonstration project, the Sec22 retary shall, to the extent practicable, include in 

23 such selection— 

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

25 and 


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1 (B) sites located in different geographic 

2 areas. 

3 (c) ACTIVITIES UNDER DEMONSTRATION

4 PROJECT.—The activities conducted under the demonstra5 tion project under subsection (a) may, in addition to any 

6 other activity specified by the Secretary, include activities 

7 that seek to develop different models of care coordination, 

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

9 and other survivorship related programs that utilize a 

10 multidisciplinary, team based approach to care, including 

11 any of the following activities: 

12 (1) Coordination of care and transitions of care 

13 between cancer care providers, primary care physi14 cians, mental health professionals and any other rel15 evant providers. 

16 (2) Dissemination of information to, and train17 ing of, health care providers about linguistically and 

18 culturally competent follow-up care specific to cancer 

19 survivors. 

20 (3) Development of monitoring programs for 

21 cancer survivors and their families. 

22 (4) Incorporation of peer support and men23 toring programs to improve the quality of life of can24 cer survivors. 


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1 (5) Designing systems and models for the effec2 tive transfer of treatment information and care sum3 maries from cancer care providers to other health 

4 care providers (including risk factors and a care 

5 plan). 

6 (6) Evaluation of functional status and incorpo7 ration of specific functional needs into the care plan8 ning process. 

9 (7) Dissemination of the information on activi10 ties and programs conducted under this section to 

11 other health care providers (including primary care 

12 physicians) and to cancer survivors and their fami13 lies, where appropriate. 

14 (8) Other items determined by the Secretary. 

15 (d) MEASURES.—The Secretary shall use the fol16 lowing measures to assess the performance of each site: 

17 (1) Patient care and satisfaction measures. 

18 (2) Resource utilization measures. 

19 (3) Adult survivorship measures. 

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

21 United States shall submit a report to Congress evaluating 

22 the success of the demonstration project. Such report shall 

23 include an assessment of the impact of the project upon 

24 the quality and cost-efficiency of services furnished to indi25 viduals under this title, including an assessment of the satVerDate Sep 11 2014 05:32 Aug 06, 2015 Jkt 049200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\H3381.IH H3381

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1 isfaction of such individuals with respect to such services 

2 that were furnished under such project. Such report shall 

3 include recommendations regarding the possible expansion 

4 of the demonstration project. 

5 Subtitle B—Coverage and Payment 

6 of High Quality Care 

7 SEC. 311. REPORT BY THE COMPTROLLER GENERAL. 

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

9 United States shall conduct a review and submit rec10 ommendations to Congress on existing barriers to obtain11 ing and paying for adequate medical care for survivors of 

12 childhood cancer. 

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

14 and formulating recommendations under subsection (a), 

15 the Comptroller General shall— 

16 (1) identify existing barriers to the availability 

17 of complete and coordinated survivorship care for 

18 survivors of childhood cancer and to the availability 

19 of expert pediatric palliative care, including consider20 ation of— 

21 (A) understanding and education among 

22 patients, health care providers, regulators, and 

23 third-party payors; 

24 (B) adequacy of payment codes to cover 

25 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 and 

5 hospice services for patients approaching the 

6 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 second cancers), 

9 such as mammograms and magnetic resonance 

10 imaging testing to screen for possible breast 

11 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; 

17 (G) dental coverage and necessary dental 

18 implants; 

19 (H) hearing aids; and 

20 (I) screening for lung problems, such as 

21 pulmonary function testing. 

Æ 


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