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 re-
ferred to the Committee on Energy and Commerce 
A BILL 
To maximize discovery, and accelerate development and avail-
ability, of promising childhood cancer treatments, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Childhood Cancer Survivorship, Treatment, Access, and 
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Research Act of 2015’’ or the ‘‘Childhood Cancer STAR 
Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
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 Can-
cer 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 Finalizing draft guidance on expanded access.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 sur-
vivors. 
Sec. 304. Survivorship demonstration project. 
Subtitle B—Coverage and Payment of High Quality Care 
Sec. 311. Report by the Comptroller General. 
SEC. 2. FINDINGS. 
Congress makes the following findings: 
(1) Each year in the United States there are an 
estimated 15,780 children between birth and the age 
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of 19 diagnosed with cancer. Approximately 1 in 285 
children in the United States will be diagnosed with 
cancer before their 20th birthday. 
(2) In 1960, only 4 percent of children with 
cancer survived more than 5 years, but today, cure 
rates have increased to over 80 percent for children 
and adolescents under age 20. 
(3) While the cure rates for some childhood 
cancers are now over 80 percent, the survival rates 
for many types of cancers in children remain ex-
tremely low. 
(4) According to the Centers for Disease Con-
trol and Prevention, cancer continues to be the lead-
ing cause of death by disease in children and adoles-
cents under the age of 14. 
(5) By 2020, the population of childhood can-
cers survivors is expected to be 500,000 individuals. 
(6) As many as two-thirds of childhood cancer 
survivors are likely to experience at least one late ef-
fect of treatment, with as many as one-fourth expe-
riencing a late effect that is serious or life-threat-
ening. Common late effects of childhood cancer are 
neurocognitive, psychological, cardiopulmonary, en-
docrine, and musculoskeletal effects, secondary ma-
lignancies, and early death. 
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(7) As a result of disparities in the delivery of 
cancer care, minority, low-income, and other medi-
cally underserved children are more likely to be diag-
nosed with late stage disease, experience poorer 
treatment outcomes, have shorter survival time with 
less quality of life, and experience a substantially 
greater likelihood of cancer death. 
(8) Collection of biospecimens, along with clin-
ical and outcome data, on the maximum possible 
number of children with cancer in the United States 
is necessary to improve childhood cancer treatments 
and cures. Currently biospecimens, and clinical and 
outcome data, are collected for less than half of chil-
dren in the United States with cancer. 
(9) Despite the significant unmet medical need, 
pharmaceutical companies have been reluctant to de-
velop drugs appropriate for children with cancer be-
cause it requires making an investment in products 
that are unlikely to cover the high costs associated 
with their research, development, marketing, and 
distribution. Only 3 drugs have been approved by 
the Food and Drug Administration to treat any type 
of pediatric cancer since the 1980s, including 
Unituxin, the first-ever drug approved for high-risk 
neuroblastoma, for which the sponsor of the drug 
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was rewarded under the Food and Drug Administra-
tion’s priority review program to encourage treat-
ments for rare pediatric diseases. 
(10) The late effects of cancer treatment may 
change as therapies evolve, which means that the 
monitoring and care of cancer survivors may need to 
be modified on a routine basis. 
(11) Despite the intense stress caused by child-
hood cancer, there is a lack of standardized and co-
ordinated psychosocial care for the children and 
their families, from the date of diagnosis through 
treatment and survivorship. 
(12) The Institute of Medicine, in its report on 
cancer survivorship entitled ‘‘Childhood Cancer Sur-
vivorship: Improving Care and Quality of Life’’, 
states that an organized system of care and a meth-
od of care for pediatric cancer survivors is needed. 
(13) Focused and well-designed research and 
pilot health delivery programs can answer questions 
about the optimal ways to provide health care, fol-
low-up monitoring services, and survivorship care to 
those diagnosed with childhood cancer and con-
tribute to improvements in the quality of care and 
quality of life of those individuals through adult-
hood. 
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(14) The National Institutes of Health, includ-
ing the National Cancer Institute, invest approxi-
mately half of their annual appropriations to support 
basic research that serves as the foundation for 
translational and clinical research for all diseases 
and conditions, with the potential to lead to break-
throughs for children with cancer. Virtually all 
progress against cancer—in both children and 
adults—has been founded in basic research, often in 
areas not directly related to the disease. 
(15) The National Cancer Institute supports a 
number of key research programs specifically to ad-
vance childhood cancer care, including precision 
medicine clinical trials for children with cancer, in-
cluding the Children’s Oncology Group (part of the 
National Clinical Trials Network of the National 
Cancer Institute), the Pediatric Preclinical Testing 
Program, the Pediatric Brain Tumor Consortium, 
the Childhood Cancer Survivor Study, the Thera-
peutically Applicable Research to Generate Effective 
Treatments program and related pediatric cancer 
genomics research, and the Pediatric Oncology 
Branch (part of the intramural program of the Na-
tional Cancer Institute, whose mission is to develop 
new treatments for pediatric cancer). 
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TITLE 
I—MAXIMIZING 
RE-
SEARCH 
THROUGH 
DIS-
COVERY 
Subtitle A—Caroline Pryce Walker 
Conquer Childhood Cancer Re-
authorization Act 
SEC. 101. COMPREHENSIVE CHILDREN’S CANCER BIO-
REPOSITORIES. 
Section 417E of the Public Health Service Act (42 
U.S.C. 285a–11) is amended— 
(1) by striking subsection (a) and inserting the 
following: 
‘‘(a) COMPREHENSIVE CHILDREN’S CANCER BIO-
REPOSITORIES.— 
‘‘(1) AWARD.—The Secretary, acting through 
the Director of NIH, may make an award for a du-
ration of at least 5 years to an entity or entities de-
scribed in paragraph (4) to build upon existing ini-
tiatives to collect biospecimens and clinical and de-
mographic information for at least 90 percent of all 
children, adolescents, and young adults with cancer 
in 1 or more Comprehensive Children’s Cancer Bio-
repositories to achieve a better understanding of the 
cause of such cancers and the effects of treatments 
for such cancers. 
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‘‘(2) USE OF FUNDS.—Amounts received under 
the award under paragraph (1) may be used to carry 
out the following: 
‘‘(A) Prospectively acquire, preserve, and 
store high-quality, donated biospecimens and 
associated clinical and demographic information 
on children, adolescents, and young adults diag-
nosed with cancer in the United States. 
‘‘(B) Maintain a secure searchable data-
base on stored biospecimens and associated 
clinical and demographic data from children, 
adolescents, and young adults with cancer for 
the conduct of research by scientists and quali-
fied health care professionals. 
‘‘(C) Establish procedures for evaluating 
applications for access to such biospecimens 
and clinical and demographic data from re-
searchers and other qualified health care pro-
fessionals. 
‘‘(D) Make available and distribute bio-
specimens and clinical and demographic data 
from children, adolescents, and young adults 
with cancer to researchers and qualified health 
care professionals for peer-reviewed research at 
a minimal cost. 
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from children with appropriate permission 
from parents or legal guardians in accord-
ance with Federal and State law; and 
‘‘(ii) adheres to strict confidentiality 
to protect the identity and privacy of pa-
tients in accordance with Federal and 
State law. 
‘‘(B) CONSENT.—The Secretary shall es-
tablish an appropriate process for achieving 
consent from the patient, parent, or legal 
guardian. 
‘‘(6) SINGLE
POINT
OF
ACCESS; STANDARD 
DATA; GUIDELINES AND OVERSIGHT.— 
‘‘(A) SINGLE POINT OF ACCESS.—The Sec-
retary shall ensure that each Biorepository sup-
ported under paragraph (1) has electronically 
searchable data for use by researchers and 
other qualified health care professionals in the 
manner and to the extent defined by the Sec-
retary. 
‘‘(B) STANDARD
DATA.—The Secretary 
shall require all recipients of an award under 
this section to make available a standard 
dataset for the purposes of subparagraph (A) in 
a standard electronic format that enables re-
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searchers and qualified health care professionals 
to search. 
‘‘(C) GUIDELINES AND OVERSIGHT.—The 
Secretary shall develop and disseminate appro-
priate guidelines for the development and main-
tenance of the biorepositories supported under 
this section, including appropriate oversight. 
‘‘(7) COORDINATION.—The Secretary shall en-
sure that clinical and demographic information col-
lected in accordance with this section is collected in 
coordination with the information collected under 
section 399E–1. 
‘‘(8) PROHIBITION ON USE OF FUNDS.—Funds 
made available to carry out this subsection shall not 
be used to acquire, preserve, or maintain a biospeci-
men collected from a patient if such activity is al-
ready covered by funds available from the National 
Cancer Institute for such purpose. 
‘‘(9) REPORT.—Not later than 4 years after the 
date of enactment of the Childhood Cancer Survivor-
ship, Treatment, Access, and Research Act of 2015, 
the Secretary shall submit to Congress a report on— 
‘‘(A) the number of biospecimens and cor-
responding clinical demographic data collected 
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through the Comprehensive Children’s Cancer 
Biorepositories supported under paragraph (1); 
‘‘(B) the number of biospecimens and cor-
responding clinical demographic data requested 
for use by researchers; 
‘‘(C) any barriers to the collection of bio-
specimens and corresponding clinical demo-
graphic data; 
‘‘(D) any barriers experienced by research-
ers or health care professionals in accessing the 
biospecimens and corresponding clinical demo-
graphic data necessary for use in research; and 
‘‘(E) any recommendations with respect to 
improving the Comprehensive Children’s Cancer 
Biorepository program under this subsection. 
‘‘(10) DEFINITIONS.—For purposes of this sub-
section: 
‘‘(A) AWARD.—The term ‘award’ includes 
a grant, contract, cooperative agreement, or 
other mechanism determined by the Secretary. 
‘‘(B) BIOSPECIMEN.—The term ‘biospeci-
men’ includes— 
‘‘(i) solid tumor tissue or bone mar-
row; 
‘‘(ii) normal or control tissue; 
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‘‘(iii) blood and plasma; 
‘‘(iv) DNA and RNA extractions; 
‘‘(v) familial DNA; and 
‘‘(vi) any other sample required by the 
Secretary. 
‘‘(C) CLINICAL AND DEMOGRAPHIC INFOR-
MATION.—The term ‘clinical and demographic 
information’ includes— 
‘‘(i) date of diagnosis; 
‘‘(ii) age at diagnosis; 
‘‘(iii) patient’s gender, race, and eth-
nicity; 
‘‘(iv) extent of disease at enrollment; 
‘‘(v) site of metastases; 
‘‘(vi) location of primary tumor coded; 
‘‘(vii) histologic diagnosis; 
‘‘(viii) tumor marker data when avail-
able; 
‘‘(ix) treatment and outcome data; 
‘‘(x) information related to specimen 
quality; and 
‘‘(xi) any other information required 
by the Secretary.’’; and 
(2) in subsection (d)— 
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(A) by striking ‘‘and section 399E–1’’ and 
inserting ‘‘and sections 317U, 399E–1, 417H, 
and 417H–1’’; 
(B) by striking ‘‘2009 through 2013’’ and 
inserting ‘‘2016 through 2020’’; and 
(C) by striking ‘‘such purpose’’ and insert-
ing ‘‘such purposes’’. 
SEC. 102. IMPROVING CHILDHOOD CANCER SURVEIL-
LANCE. 
Section 399E–1 of the Public Health Service Act (42 
U.S.C. 280e–3a) is amended— 
(1) by redesignating subsection (b) as sub-
section (d); and 
(2) by striking subsection (a) and inserting the 
following: 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall award grants to State cancer registries to 
enhance and expand infrastructure to track the epidemi-
ology of cancer in children, adolescents, and young adults. 
Such registries shall be updated to include each occurrence 
of such cancers within a period of time designated by the 
Secretary. 
‘‘(b) ACTIVITIES.—The grants described in sub-
section (a) may be used for— 
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‘‘(1) identifying, recruiting, and training all po-
tential sources for reporting childhood, adolescent, 
and young adult cancer cases; 
‘‘(2) developing procedures to implement early 
inclusion of childhood, adolescent, and young adult 
cancer cases on State cancer registries through the 
use of electronic reporting; 
‘‘(3) purchasing infrastructure to support the 
early inclusion of childhood, adolescent, and young 
adult cancer cases on such registries; 
‘‘(4) submitting deidentified data to the Centers 
for Disease Control and Prevention for inclusion in 
a national database of childhood, adolescent, and 
young adult cancers; and 
‘‘(5) tracking the late effects of childhood, ado-
lescent, and young adult cancers. 
‘‘(c) COORDINATION.—The Secretary shall ensure 
that information collected through State cancer registries 
under this section is collected in coordination with clinical 
and demographic information collected under section 
417E(a).’’. 
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Subtitle B—Pediatric Expertise at 
NIH 
SEC. 111. INCLUSION OF AT LEAST ONE PEDIATRIC 
ONCOLOGIST ON THE NATIONAL CANCER AD-
VISORY BOARD. 
Clause (iii) of section 406(h)(2)(A) of the Public 
Health and Service Act (42 U.S.C. 284a(h)(2)(A)) is 
amended to read as follows: 
‘‘(iii) of the members appointed to the Board— 
‘‘(I) not less than 5 members shall be indi-
viduals knowledgeable in environmental carcino-
genesis (including carcinogenesis involving occu-
pational and dietary factors); and 
‘‘(II) not less than one member shall be an 
individual knowledgeable in pediatric oncol-
ogy;’’. 
SEC. 112. SENSE OF CONGRESS REGARDING PEDIATRIC EX-
PERTISE AT THE NATIONAL CANCER INSTI-
TUTE. 
It is the sense of Congress that the Director of the 
National Cancer Institute should ensure that all applicable 
study sections, committees, advisory groups, and panels 
at the National Cancer Institute include one or more 
qualified pediatric oncologists, as appropriate. 
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Subtitle C—NIH Report on 
Childhood Cancer Activities 
SEC. 
121. 
REPORTING 
ON 
CHILDHOOD 
MALIGNANCY 
PROJECTS. 
Section 409D(c)(3) of the Public Health Service Act 
(42 U.S.C. 284h(c)(3)) is amended by— 
(1) striking ‘‘public on’’ and inserting ‘‘public 
on— 
‘‘(A)’’; 
(2) striking the period at the end and inserting 
‘‘; and’’; and 
(3) inserting at the end the following: 
‘‘(B) the childhood malignancy projects 
conducted under section 399N.’’. 
TITLE II—AVAILABILITY OF 
PROMISING TREATMENTS 
SEC. 201. EXPANDED ACCESS POLICY. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 561 (21 U.S.C. 
360bbb) the following: 
‘‘SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR IN-
VESTIGATIONAL DRUGS. 
‘‘(a) IN GENERAL.—The manufacturer or distributor 
of one or more investigational drugs for the diagnosis, 
monitoring, or treatment of one or more serious diseases 
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or conditions shall make publicly available the policy of 
the manufacturer or distributor on evaluating and re-
sponding to requests submitted under section 561(b) for 
provision of such a drug. A manufacturer or distributor 
may satisfy the requirement of the preceding sentence by 
posting such policy as generally applicable to all of such 
manufacturer’s of distributor’s investigational drugs. 
‘‘(b) CONTENT OF POLICY.—A policy described in 
subsection (a) shall include making publicly available— 
‘‘(1) contact information for the manufacturer 
or distributor to facilitate communication about re-
quests described in subsection (a); 
‘‘(2) procedures for making such requests; 
‘‘(3) the general criteria the manufacturer or 
distributor will consider or use to approve such re-
quests; and 
‘‘(4) the length of time the manufacturer or dis-
tributor anticipates will be necessary to acknowledge 
receipt of such requests. 
‘‘(c) NO GUARANTEE OF ACCESS.—The posting of 
policies by manufacturers and distributors under sub-
section (a) shall not serve as a guarantee of access to any 
specific investigational drug by any individual patient. 
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‘‘(d) REVISED POLICY.—A manufacturer or dis-
tributor that has made a policy publicly available as re-
quired by this section may revise the policy at any time. 
‘‘(e) APPLICATION.—This section shall apply to a 
manufacturer or distributor with respect to an investiga-
tional drug beginning on the later of— 
‘‘(1) the date that is 60 days after the date of 
enactment of the Childhood Cancer Survivorship, 
Treatment, Access, and Research Act of 2015; or 
‘‘(2) the first initiation of a phase 2 or phase 
3 study (as such terms are defined in section 
312.21(b) and (c) of title 21, Code of Federal Regu-
lations (or any successor regulations)) with respect 
to such investigational new drug.’’. 
SEC. 202. FINALIZING DRAFT GUIDANCE ON EXPANDED AC-
CESS. 
(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall finalize the draft guidance entitled 
‘‘Expanded Access to Investigational Drugs for Treatment 
Use—Qs & As’’, dated May 2013. 
(b) CONTENTS.—The final guidance referred to in 
subsection (a) shall clearly define how the Secretary of 
Health and Human Services interprets and uses adverse 
drug event data reported by investigators in the case of 
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data reported from use under a request submitted under 
section 561(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb(b)). 
TITLE III—MAXIMIZING DELIV-
ERY: CARE, QUALITY OF LIFE, 
SURVIVORSHIP, 
AND 
CARE-
GIVER SUPPORT 
Subtitle A—Childhood Cancer 
Survivors’ Quality of Life Act 
SEC. 301. CANCER SURVIVORSHIP PROGRAMS. 
(a) CANCER SURVIVORSHIP PROGRAMS.—Subpart 1 
of part C of title IV of the Public Health Service Act (42 
U.S.C. 285 et seq.) is amended by adding at the end the 
following: 
‘‘SEC. 417H. PILOT PROGRAMS TO EXPLORE MODEL SYS-
TEMS OF CARE FOR PEDIATRIC CANCER SUR-
VIVORS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this section, the Secretary shall make 
grants to eligible entities to establish pilot programs to 
develop, study, or evaluate model systems for monitoring 
and caring for childhood cancer survivors throughout their 
lifespan, including evaluation of shared care and medical 
home and clinic based models for transition to adult care. 
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‘‘(b) ELIGIBLE ENTITIES.—In this section, the term 
‘eligible entity’ means— 
‘‘(1) a medical school; 
‘‘(2) a children’s hospital; 
‘‘(3) a cancer center; 
‘‘(4) a community-based medical facility; or 
‘‘(5) any other entity with significant experience 
and expertise in treating survivors of childhood can-
cers. 
‘‘(c) USE OF FUNDS.—The Secretary may make a 
grant under this section to an eligible entity only if the 
entity agrees— 
‘‘(1) to use the grant to establish a pilot pro-
gram to develop, study, or evaluate one or more 
model systems for monitoring and caring for cancer 
survivors; and 
‘‘(2) in developing, studying, and evaluating 
such systems, to give special emphasis to the fol-
lowing: 
‘‘(A) Design of protocols for different mod-
els of follow-up care, monitoring, and other sur-
vivorship programs (including peer support and 
mentoring programs). 
‘‘(B) Development of various models for 
providing multidisciplinary care. 
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‘‘(C) Dissemination of information and the 
provision of training to health care providers 
about how to provide linguistically and cul-
turally competent follow-up care and monitoring 
to cancer survivors and their families. 
‘‘(D) Development of support programs to 
improve the quality of life of cancer survivors. 
‘‘(E) Design of systems for the effective 
transfer of treatment information and care 
summaries from cancer care providers to other 
health care providers (including risk factors and 
a plan for recommended follow-up care). 
‘‘(F) Dissemination of the information and 
programs described in subparagraphs (A) 
through (E) to other health care providers (in-
cluding primary care physicians and internists) 
and to cancer survivors and their families, 
where appropriate. 
‘‘(G) Development of initiatives that pro-
mote the coordination and effective transition of 
care between cancer care providers, primary 
care physicians, and mental health profes-
sionals. 
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‘‘SEC. 
417H–1. 
WORKFORCE 
DEVELOPMENT 
COLLABO-
RATIVE ON MEDICAL AND PSYCHOSOCIAL 
CARE FOR CHILDHOOD CANCER SURVIVORS. 
‘‘(a) IN GENERAL.—The Secretary shall, not later 
than 1 year after the date of enactment of this Act, con-
vene a Workforce Development Collaborative on Medical 
and Psychosocial Care for Pediatric Cancer Survivors (re-
ferred to in this paragraph as the ‘Collaborative’). The 
Collaborative shall be a cross-specialty, multidisciplinary 
group composed of educators, consumer and family advo-
cates, and providers of psychosocial and biomedical health 
services. 
‘‘(b) GOALS AND REPORTS.—The Collaborative shall 
submit to the Secretary a report establishing a plan to 
meet the following objectives for medical and psychosocial 
care workforce development: 
‘‘(1) Identifying, refining, and broadly dissemi-
nating to health care educators information about 
workforce competencies, models, and curricula rel-
evant to providing medical and psychosocial services 
to persons surviving pediatric cancers. 
‘‘(2) Adapting curricula for continuing edu-
cation of the existing workforce using efficient work-
place-based learning approaches. 
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‘‘(3) Developing the skills of faculty and other 
trainers in teaching psychosocial health care using 
evidence-based teaching strategies. 
‘‘(4) Strengthening the emphasis on psycho-
social health care in educational accreditation stand-
ards and professional licensing and certification 
exams by recommending revisions to the relevant 
oversight organizations. 
‘‘(5) Evaluating the effectiveness of patient 
navigators in pediatric cancer survivorship care. 
‘‘(6) Evaluating the effectiveness of peer sup-
port programs in the psychosocial care of pediatric 
cancer patients and survivors.’’. 
(b) TECHNICAL AMENDMENT.— 
(1) 
IN
GENERAL.—Section 
of 
the 
Hematological Cancer Research Investment and 
Education Act of 2002 (Public Law 107–172; 116 
Stat. 541) is amended by striking ‘‘section 419C’’ 
and inserting ‘‘section 417C’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall take effect as if included in 
section 3 of the Hematological Cancer Research In-
vestment and Education Act of 2002 (Public Law 
107–172; 116 Stat. 541). 
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SEC. 302. GRANTS TO IMPROVE CARE FOR PEDIATRIC CAN-
CER SURVIVORS. 
(a) IN GENERAL.—Section 417E of the Public 
Health Service Act (42 U.S.C. 285a–11), as amended by 
section 101, is further amended— 
(1) in the section heading, by striking ‘‘RE-
SEARCH AND AWARENESS’’ and inserting ‘‘RE-
SEARCH, AWARENESS, AND
SURVIVORSHIP’’; 
and 
(2) by striking subsection (b) and inserting the 
following: 
‘‘(b) IMPROVING CARE FOR PEDIATRIC CANCER SUR-
VIVORS.— 
‘‘(1) RESEARCH ON CAUSES OF HEALTH DIS-
PARITIES IN PEDIATRIC CANCER SURVIVORSHIP.— 
‘‘(A) GRANTS.—The Director of NIH, with 
guidance from the Director of the Institute, in 
coordination with ongoing research activities, 
shall make grants to entities to conduct re-
search relating to— 
‘‘(i) needs and outcomes of pediatric 
cancer survivors within minority or other 
medically underserved populations; 
‘‘(ii) health disparities in pediatric 
cancer survivorship outcomes within minor-
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ity or other medically underserved popu-
lations; 
‘‘(iii) barriers that pediatric cancer 
survivors within minority or other medi-
cally underserved populations face in re-
ceiving follow-up care; and 
‘‘(iv) 
familial, 
socioeconomic, 
and 
other environmental factors and the impact 
of such factors on treatment outcomes and 
survivorship. 
‘‘(B) BALANCED
APPROACH.—In making 
grants for research under subparagraph (A)(i) 
on pediatric cancer survivors within minority or 
other medically underserved populations, the 
Director of NIH shall ensure that such research 
addresses both the physical and the psycho-
logical needs of such survivors. 
‘‘(2) RESEARCH ON LATE EFFECTS AND FOL-
LOW-UP
CARE
FOR
PEDIATRIC
CANCER
SUR-
VIVORS.—The Director of NIH, in coordination with 
ongoing research activities, shall conduct or support 
research on follow-up care for pediatric cancer sur-
vivors, with special emphasis given to— 
‘‘(A) the development of indicators used 
for long-term patient tracking and analysis of 
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the late effects of cancer treatment for pediatric 
cancer survivors; 
‘‘(B) the identification of risk factors asso-
ciated with the late effects of cancer treatment; 
‘‘(C) the identification of predictors of 
neurocognitive and psychosocial outcomes; 
‘‘(D) the identification of the molecular 
underpinnings of long-term complications; 
‘‘(E) the development of risk prediction 
models to identify those at highest risk of long- 
term complications; 
‘‘(F) initiatives to protect cancer survivors 
from the late effects of cancer treatment, by de-
veloping targeted interventions to reduce the 
burden of morbidity borne by cancer survivors; 
‘‘(G) transitions in care for pediatric can-
cer survivors; 
‘‘(H) training of professionals to provide 
linguistically and culturally competent follow-up 
care to pediatric cancer survivors; 
‘‘(I) different models of follow-up care; and 
‘‘(J) examining the cost-effectiveness of the 
different models of follow-up care.’’. 
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SEC. 303. COMPREHENSIVE LONG-TERM FOLLOW-UP SERV-
ICES FOR PEDIATRIC CANCER SURVIVORS. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 317T the following: 
‘‘SEC. 317U. STANDARDS FOR COMPREHENSIVE LONG-TERM 
CARE FOR PEDIATRIC CANCER SURVIVORS 
THROUGH THE LIFESPAN. 
‘‘The Secretary shall establish a task force to develop 
and test standards, outcomes, and metrics for high-quality 
childhood cancer survivorship care in consultation with a 
full spectrum of representation of experts in late effects 
of disease and treatment of childhood cancers, including— 
‘‘(1) oncologists who treat children and adoles-
cents; 
‘‘(2) oncologists who treat adults; 
‘‘(3) primary care providers engaged in survi-
vorship care; 
‘‘(4) survivors of childhood cancer; 
‘‘(5) parents of children who have been diag-
nosed with and treated for cancer and parents of 
long-term survivors; 
‘‘(6) professionals who are engaged in the devel-
opment of clinical practice guidelines; 
‘‘(7) nurses and social workers; 
‘‘(8) mental health professionals; 
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‘‘(9) allied health professionals, including phys-
ical therapists and occupational therapists; 
‘‘(10) experts in health care quality measure-
ment and improvement; and 
‘‘(11) others, as the Secretary determines ap-
propriate.’’. 
SEC. 304. SURVIVORSHIP DEMONSTRATION PROJECT. 
(a) IN GENERAL.—Not later than one year after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services (referred to in this section as the 
‘‘Secretary’’) shall carry out a demonstration project over 
a 3-year period, designed to improve the quality and effi-
ciency of care provided to childhood cancer survivors 
throughout their lifespan, through improved care coordi-
nation as survivors transitions to adult care. 
(b) SELECTION OF DEMONSTRATION SITES.— 
(1) MAXIMUM NUMBER OF SITES.—The Sec-
retary shall ensure that the maximum number of 
sites does not exceed 10. 
(2) DIVERSITY OF SITES.—In selecting entities 
to participate in the demonstration project, the Sec-
retary shall, to the extent practicable, include in 
such selection— 
(A) small-, medium-, and large-sized sites; 
and 
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(B) sites located in different geographic 
areas. 
(c) 
ACTIVITIES
UNDER
DEMONSTRATION 
PROJECT.—The activities conducted under the demonstra-
tion project under subsection (a) may, in addition to any 
other activity specified by the Secretary, include activities 
that seek to develop different models of care coordination, 
including transitions of care, follow-up care, monitoring, 
and other survivorship related programs that utilize a 
multidisciplinary, team based approach to care, including 
any of the following activities: 
(1) Coordination of care and transitions of care 
between cancer care providers, primary care physi-
cians, mental health professionals and any other rel-
evant providers. 
(2) Dissemination of information to, and train-
ing of, health care providers about linguistically and 
culturally competent follow-up care specific to cancer 
survivors. 
(3) Development of monitoring programs for 
cancer survivors and their families. 
(4) Incorporation of peer support and men-
toring programs to improve the quality of life of can-
cer survivors. 
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(5) Designing systems and models for the effec-
tive transfer of treatment information and care sum-
maries from cancer care providers to other health 
care providers (including risk factors and a care 
plan). 
(6) Evaluation of functional status and incorpo-
ration of specific functional needs into the care plan-
ning process. 
(7) Dissemination of the information on activi-
ties and programs conducted under this section to 
other health care providers (including primary care 
physicians) and to cancer survivors and their fami-
lies, where appropriate. 
(8) Other items determined by the Secretary. 
(d) MEASURES.—The Secretary shall use the fol-
lowing measures to assess the performance of each site: 
(1) Patient care and satisfaction measures. 
(2) Resource utilization measures. 
(3) Adult survivorship measures. 
(e) GAO REPORT.—The Comptroller General of the 
United States shall submit a report to Congress evaluating 
the success of the demonstration project. Such report shall 
include an assessment of the impact of the project upon 
the quality and cost-efficiency of services furnished to indi-
viduals under this title, including an assessment of the sat-
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isfaction of such individuals with respect to such services 
that were furnished under such project. Such report shall 
include recommendations regarding the possible expansion 
of the demonstration project. 
Subtitle B—Coverage and Payment 
of High Quality Care 
SEC. 311. REPORT BY THE COMPTROLLER GENERAL. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a review and submit rec-
ommendations to Congress on existing barriers to obtain-
ing and paying for adequate medical care for survivors of 
childhood cancer. 
(b) CONSIDERATIONS.—In carrying out the review 
and formulating recommendations under subsection (a), 
the Comptroller General shall— 
(1) identify existing barriers to the availability 
of complete and coordinated survivorship care for 
survivors of childhood cancer and to the availability 
of expert pediatric palliative care, including consider-
ation of— 
(A) understanding and education among 
patients, health care providers, regulators, and 
third-party payors; 
(B) adequacy of payment codes to cover 
necessary survivorship services; 
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(C) access to necessary medical and other 
services for such survivors, including the serv-
ices described in subsection (c); and 
(D) lack of pediatric palliative care and 
hospice services for patients approaching the 
end of life; and 
(2) make recommendations to provide improved 
access and payment plans for childhood cancer sur-
vivorship programs and palliative care, including 
psychosocial services and coverage of such services. 
(c) SERVICES DESCRIBED.—The services described in 
this subsection are the following: 
(1) Coordinated multidisciplinary long-term fol-
low-up care with access to appropriate pediatric sub-
specialists and adult subspecialists with specific ex-
pertise in survivorship, including subspecialists with 
expertise in oncology, radiation oncology, surgery, 
cardiology, psychiatry or psychology, endocrinology, 
pulmonology, nephrology, dermatology, gynecology, 
and urology. 
(2) Appropriate organ function testing (particu-
larly screening for potential problems at much 
younger ages than usually indicated in the general 
population) and treatment, including— 
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