Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2016 or the Childhood Cancer STAR Act
TITLE I--MAXIMIZING RESEARCH THROUGH DISCOVERY
Subtitle A--Caroline Pryce Walker Conquer Childhood Cancer Reauthorization Act
(Sec. 101) This bill amends the Public Health Service Act to authorize the National Institutes of Health (NIH) to provide support for the collection of the medical specimens and information of children, adolescents, and young adults with selected cancers that have the least effective treatments in order to achieve a better understanding of these cancers and the effects of treatment.
The national childhood cancer registry is reauthorized through FY2021 and revised to authorize the Centers for Disease Control and Prevention to award grants to state cancer registries to improve tracking of childhood cancers.
Subtitle B--Pediatric Expertise at NIH
(Sec. 111) The National Cancer Advisory Board must include an individual knowledgable in pediatric oncology.
Subtitle C--NIH Report on Childhood Cancer Activities
(Sec. 121) The Pediatric Research Initiative must annually report on childhood cancer research projects conducted or supported by the NIH.
TITLE II--MAXIMIZING DELIVERY: CARE, QUALITY OF LIFE, SURVIVORSHIP, AND CAREGIVER SUPPORT
Subtitle A--Childhood Cancer Survivors' Quality of Life Act
(Sec. 201) The Department of Health and Human Services (HHS) may support pilot programs to develop or study models for monitoring and caring for childhood cancer survivors throughout their lives.
HHS must convene a Workforce Development Collaborative on Medical and Psychosocial Care for Pediatric Cancer Survivors.
(Sec. 202) The NIH may support research on: (1) outcomes for, and barriers faced by, pediatric cancer survivors within minority or medically underserved populations; and (2) follow-up care for pediatric cancer survivors, including research on the late effects of cancer treatment and long-term complications.
(Sec. 203) HHS may establish a task force on standards for high-quality childhood cancer survivorship care.
(Sec. 204) HHS may carry out a demonstration project to improve care coordination as childhood cancer survivors transition to adult care.
Subtitle B--Coverage and Payment of High Quality Care
(Sec. 211) The Government Accountability Office must make recommendations to address barriers to childhood cancer survivors obtaining and paying for adequate medical care.
[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3381 Introduced in House (IH)]
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 Lujan 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.
Be it enacted by the Senate and House of Representatives 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 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 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.
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 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 extremely low.
(4) According to the Centers for Disease Control and
Prevention, cancer continues to be the leading cause of death
by disease in children and adolescents under the age of 14.
(5) By 2020, the population of childhood cancers 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 effect of treatment,
with as many as one-fourth experiencing a late effect that is
serious or life-threatening. Common late effects of childhood
cancer are neurocognitive, psychological, cardiopulmonary,
endocrine, and musculoskeletal effects, secondary malignancies,
and early death.
(7) As a result of disparities in the delivery of cancer
care, minority, low-income, and other medically underserved
children are more likely to be diagnosed 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 clinical 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
children in the United States with cancer.
(9) Despite the significant unmet medical need,
pharmaceutical companies have been reluctant to develop drugs
appropriate for children with cancer because 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 was rewarded under the Food and Drug Administration's
priority review program to encourage treatments 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 childhood cancer,
there is a lack of standardized and coordinated 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 Survivorship:
Improving Care and Quality of Life'', states that an organized
system of care and a method 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, follow-up monitoring services, and
survivorship care to those diagnosed with childhood cancer and
contribute to improvements in the quality of care and quality
of life of those individuals through adulthood.
(14) The National Institutes of Health, including the
National Cancer Institute, invest approximately 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
breakthroughs 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 advance childhood cancer
care, including precision medicine clinical trials for children
with cancer, including 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 Therapeutically 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 National Cancer Institute, whose
mission is to develop new treatments for pediatric cancer).
TITLE I--MAXIMIZING RESEARCH THROUGH DISCOVERY
Subtitle A--Caroline Pryce Walker Conquer Childhood Cancer
Reauthorization Act
SEC. 101. COMPREHENSIVE CHILDREN'S CANCER BIOREPOSITORIES.
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 Biorepositories.--
``(1) Award.--The Secretary, acting through the Director of
NIH, may make an award for a duration of at least 5 years to an
entity or entities described in paragraph (4) to build upon
existing initiatives to collect biospecimens and clinical and
demographic information for at least 90 percent of all
children, adolescents, and young adults with cancer in 1 or
more Comprehensive Children's Cancer Biorepositories to achieve
a better understanding of the cause of such cancers and the
effects of treatments for such cancers.
``(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 diagnosed with cancer in
the United States.
``(B) Maintain a secure searchable database 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 qualified health care professionals.
``(C) Establish procedures for evaluating
applications for access to such biospecimens and
clinical and demographic data from researchers and
other qualified health care professionals.
``(D) Make available and distribute biospecimens
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.
``(3) No requirement.--No child, adolescent, or young adult
with cancer shall be required under this subsection to
contribute a specimen to a Biorepository or share clinical or
demographic data.
``(4) Application; considerations.--
``(A) Application.--To be eligible to receive an
award under paragraph (1) an entity shall submit an
application to the Secretary at such a time, in such
manner, and containing such information as the
Secretary may reasonably require.
``(B) Considerations.--In evaluating the
applications in subparagraph (A), the Secretary shall
consider the existing infrastructure of the entity that
would allow for the timely capture of biospecimens and
related clinical and demographic information for
children, adolescents, and young adults with cancer.
``(5) Privacy protections; consent.--
``(A) In general.--The Secretary may not make an
award under paragraph (1) to an entity unless the
Secretary ensures that such entity--
``(i) collects biospecimens and associated
clinical and demographic information from
children with appropriate permission from
parents or legal guardians in accordance with
Federal and State law; and
``(ii) adheres to strict confidentiality to
protect the identity and privacy of patients in
accordance with Federal and State law.
``(B) Consent.--The Secretary shall establish 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 Secretary shall
ensure that each Biorepository supported 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 Secretary.
``(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 researchers and qualified health care
professionals to search.
``(C) Guidelines and oversight.--The Secretary
shall develop and disseminate appropriate guidelines
for the development and maintenance of the
biorepositories supported under this section, including
appropriate oversight.
``(7) Coordination.--The Secretary shall ensure that
clinical and demographic information collected 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 biospecimen collected from a patient if
such activity is already 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 Survivorship, Treatment,
Access, and Research Act of 2015, the Secretary shall submit to
Congress a report on--
``(A) the number of biospecimens and corresponding
clinical demographic data collected through the
Comprehensive Children's Cancer Biorepositories
supported under paragraph (1);
``(B) the number of biospecimens and corresponding
clinical demographic data requested for use by
researchers;
``(C) any barriers to the collection of
biospecimens and corresponding clinical demographic
data;
``(D) any barriers experienced by researchers or
health care professionals in accessing the biospecimens
and corresponding clinical demographic 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 subsection:
``(A) Award.--The term `award' includes a grant,
contract, cooperative agreement, or other mechanism
determined by the Secretary.
``(B) Biospecimen.--The term `biospecimen'
includes--
``(i) solid tumor tissue or bone marrow;
``(ii) normal or control tissue;
``(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 information.--The
term `clinical and demographic information' includes--
``(i) date of diagnosis;
``(ii) age at diagnosis;
``(iii) patient's gender, race, and
ethnicity;
``(iv) extent of disease at enrollment;
``(v) site of metastases;
``(vi) location of primary tumor coded;
``(vii) histologic diagnosis;
``(viii) tumor marker data when available;
``(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)--
(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 inserting
``such purposes''.
SEC. 102. IMPROVING CHILDHOOD CANCER SURVEILLANCE.
Section 399E-1 of the Public Health Service Act (42 U.S.C. 280e-3a)
is amended--
(1) by redesignating subsection (b) as subsection (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 Prevention, shall award grants to
State cancer registries to enhance and expand infrastructure to track
the epidemiology 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 subsection (a) may be
used for--
``(1) identifying, recruiting, and training all potential
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, adolescent,
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).''.
Subtitle B--Pediatric Expertise at NIH
SEC. 111. INCLUSION OF AT LEAST ONE PEDIATRIC ONCOLOGIST ON THE
NATIONAL CANCER ADVISORY 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 individuals
knowledgeable in environmental carcinogenesis
(including carcinogenesis involving occupational and
dietary factors); and
``(II) not less than one member shall be an
individual knowledgeable in pediatric oncology;''.
SEC. 112. SENSE OF CONGRESS REGARDING PEDIATRIC EXPERTISE AT THE
NATIONAL CANCER INSTITUTE.
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.
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 INVESTIGATIONAL 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 or conditions shall make publicly
available the policy of the manufacturer or distributor on evaluating
and responding 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 requests
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 requests; and
``(4) the length of time the manufacturer or distributor
anticipates will be necessary to acknowledge receipt of such
requests.
``(c) No Guarantee of Access.--The posting of policies by
manufacturers and distributors under subsection (a) shall not serve as
a guarantee of access to any specific investigational drug by any
individual patient.
``(d) Revised Policy.--A manufacturer or distributor that has made
a policy publicly available as required 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 investigational 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 Regulations (or any successor
regulations)) with respect to such investigational new drug.''.
SEC. 202. FINALIZING DRAFT GUIDANCE ON EXPANDED ACCESS.
(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 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 DELIVERY: CARE, QUALITY OF LIFE, SURVIVORSHIP,
AND CAREGIVER 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 SYSTEMS OF CARE FOR
PEDIATRIC CANCER SURVIVORS.
``(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.
``(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 cancers.
``(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 program 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 following:
``(A) Design of protocols for different models of
follow-up care, monitoring, and other survivorship
programs (including peer support and mentoring
programs).
``(B) Development of various models for providing
multidisciplinary care.
``(C) Dissemination of information and the
provision of training to health care providers about
how to provide linguistically and culturally 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 (including primary care
physicians and internists) and to cancer survivors and
their families, where appropriate.
``(G) Development of initiatives that promote the
coordination and effective transition of care between
cancer care providers, primary care physicians, and
mental health professionals.
``SEC. 417H-1. WORKFORCE DEVELOPMENT COLLABORATIVE 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, convene a Workforce Development
Collaborative on Medical and Psychosocial Care for Pediatric Cancer
Survivors (referred to in this paragraph as the `Collaborative'). The
Collaborative shall be a cross-specialty, multidisciplinary group
composed of educators, consumer and family advocates, 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 disseminating to
health care educators information about workforce competencies,
models, and curricula relevant to providing medical and
psychosocial services to persons surviving pediatric cancers.
``(2) Adapting curricula for continuing education of the
existing workforce using efficient workplace-based learning
approaches.
``(3) Developing the skills of faculty and other trainers
in teaching psychosocial health care using evidence-based
teaching strategies.
``(4) Strengthening the emphasis on psychosocial health
care in educational accreditation standards 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 support programs
in the psychosocial care of pediatric cancer patients and
survivors.''.
(b) Technical Amendment.--
(1) In general.--Section 3 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 Investment and Education Act of
2002 (Public Law 107-172; 116 Stat. 541).
SEC. 302. GRANTS TO IMPROVE CARE FOR PEDIATRIC CANCER 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 ``research and
awareness'' and inserting ``research, awareness, and
survivorship''; and
(2) by striking subsection (b) and inserting the following:
``(b) Improving Care for Pediatric Cancer Survivors.--
``(1) Research on causes of health disparities 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 research 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 minority or
other medically underserved populations;
``(iii) barriers that pediatric cancer
survivors within minority or other medically
underserved populations face in receiving
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 psychological needs of such survivors.
``(2) Research on late effects and follow-up care for
pediatric cancer survivors.--The Director of NIH, in
coordination with ongoing research activities, shall conduct or
support research on follow-up care for pediatric cancer
survivors, with special emphasis given to--
``(A) the development of indicators used for long-
term patient tracking and analysis of the late effects
of cancer treatment for pediatric cancer survivors;
``(B) the identification of risk factors associated
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 developing
targeted interventions to reduce the burden of
morbidity borne by cancer survivors;
``(G) transitions in care for pediatric cancer
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.''.
SEC. 303. COMPREHENSIVE LONG-TERM FOLLOW-UP SERVICES 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 section 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 adolescents;
``(2) oncologists who treat adults;
``(3) primary care providers engaged in survivorship care;
``(4) survivors of childhood cancer;
``(5) parents of children who have been diagnosed with and
treated for cancer and parents of long-term survivors;
``(6) professionals who are engaged in the development of
clinical practice guidelines;
``(7) nurses and social workers;
``(8) mental health professionals;
``(9) allied health professionals, including physical
therapists and occupational therapists;
``(10) experts in health care quality measurement and
improvement; and
``(11) others, as the Secretary determines appropriate.''.
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 efficiency of care provided to childhood cancer survivors
throughout their lifespan, through improved care coordination as
survivors transitions to adult care.
(b) Selection of Demonstration Sites.--
(1) Maximum number of sites.--The Secretary 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 Secretary shall,
to the extent practicable, include in such selection--
(A) small-, medium-, and large-sized sites; and
(B) sites located in different geographic areas.
(c) Activities Under Demonstration Project.--The activities
conducted under the demonstration 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 physicians, mental health
professionals and any other relevant providers.
(2) Dissemination of information to, and training 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 mentoring programs to
improve the quality of life of cancer survivors.
(5) Designing systems and models for the effective transfer
of treatment information and care summaries from cancer care
providers to other health care providers (including risk
factors and a care plan).
(6) Evaluation of functional status and incorporation of
specific functional needs into the care planning process.
(7) Dissemination of the information on activities and
programs conducted under this section to other health care
providers (including primary care physicians) and to cancer
survivors and their families, where appropriate.
(8) Other items determined by the Secretary.
(d) Measures.--The Secretary shall use the following 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
individuals under this title, including an assessment of the
satisfaction 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 recommendations to Congress on existing
barriers to obtaining 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 consideration 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;
(C) access to necessary medical and other services
for such survivors, including the services 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 survivorship 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 follow-up care
with access to appropriate pediatric subspecialists and adult
subspecialists with specific expertise 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 (particularly
screening for potential problems at much younger ages than
usually indicated in the general population) and treatment,
including--
(A) neuropsychological testing and mental health
services;
(B) fertility testing and treatment;
(C) evaluation and treatment for endocrine
disorders including growth hormone and testosterone
replacement;
(D) diagnostic imaging to screen for late effects
of treatment (including second cancers), such as
mammograms and magnetic resonance imaging testing to
screen for possible breast cancer;
(E) screening for cardiac problems, such as
echocardiograms;
(F) screening for osteoporosis with bone
densitometry, including duel x-ray absorptiometry;
(G) dental coverage and necessary dental implants;
(H) hearing aids; and
(I) screening for lung problems, such as pulmonary
function testing.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Mr. Burgess moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H7193-7198)
DEBATE - The House proceeded with forty minutes of debate on H.R. 3381.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H7193-7196)
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7193-7196)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate.
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