[Congressional Record (Bound Edition), Volume 162 (2016), Part 12]
[House]
[Pages 15829-15834]
[From the U.S. Government Publishing Office, www.gpo.gov]




 CHILDHOOD CANCER SURVIVORSHIP, TREATMENT, ACCESS, AND RESEARCH ACT OF 
                                  2016

  Mr. BURGESS. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 3381) to maximize discovery, and accelerate development and 
availability, of promising childhood cancer treatments, and for other 
purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 3381

       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 
     2016'' 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. Children's cancer biorepositories and biospecimen research.
Sec. 102. Improving Childhood Cancer Surveillance.

                 Subtitle B--Pediatric Expertise at NIH

Sec. 111. Inclusion of at least one pediatric oncologist on the 
              National Cancer Advisory Board.
Sec. 112. Sense of Congress regarding pediatric expertise at the 
              National Cancer Institute.

         Subtitle C--NIH Report on Childhood Cancer Activities

Sec. 121. Reporting on childhood cancer research projects.

TITLE II--MAXIMIZING DELIVERY: CARE, QUALITY OF LIFE, SURVIVORSHIP, AND 
                           CAREGIVER SUPPORT

      Subtitle A--Childhood Cancer Survivors' Quality of Life Act

Sec. 201. Cancer survivorship programs.
Sec. 202. Grants to improve care for pediatric cancer survivors.
Sec. 203. Comprehensive long-term follow-up services for pediatric 
              cancer survivors.
Sec. 204. Survivorship demonstration project.

         Subtitle B--Coverage and Payment of High Quality Care

Sec. 211. Report by the Comptroller General.

     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 children and adolescents with cancer in the 
     United States is necessary to improve childhood and 
     adolescent 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) 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.
       (10) 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.
       (11) 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.

[[Page 15830]]

       (12) 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.
       (13) 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.
       (14) 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, the Children's Oncology Group (part of 
     the National Clinical Trials Network of the National Cancer 
     Institute), the Pediatric Preclinical Testing Consortium, 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 (including the Pediatric MATCH 
     Precision Medicine trial), 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. CHILDREN'S CANCER BIOREPOSITORIES AND BIOSPECIMEN 
                   RESEARCH.

       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) Children's Cancer Biorepositories.--
       ``(1) Award.--The Secretary, acting through the Director of 
     NIH, may make awards to an entity or entities described in 
     paragraph (4) to build upon existing initiatives to collect 
     biospecimens and clinical and demographic information with a 
     goal of collection for the vast majority of all children, 
     adolescents, and young adults with selected cancer subtypes 
     (and their recurrences) for which current treatments are 
     least effective, through one or more biospecimen research 
     efforts designed to achieve a better understanding of the 
     cause of such cancers (and their recurrences) and the effects 
     of treatments for such cancers.
       ``(2) Use of funds.--Amounts received under an award under 
     paragraph (1) may be used to carry out the following:
       ``(A) 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, focusing on 
     children and adolescents enrolled in clinical trials for whom 
     current treatments are least effective. Activities under this 
     subparagraph may include storage of biospecimens and 
     associated clinical and demographic data at biorepositories 
     supported by the National Cancer Institute, such as the 
     Children's Oncology Group Biorepository and the Pediatric 
     Cooperative Human Tissue Network as well as through 
     biorepositories established as appropriate to support the 
     scientific needs of future research efforts.
       ``(B) Make such information publicly available, including 
     the repositories described in subparagraph (A).
       ``(C) 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.
       ``(D) Establish procedures for evaluating applications for 
     access to such biospecimens and clinical and demographic data 
     from researchers and other qualified health care 
     professionals.
       ``(E) 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 and adolescents 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 2016, the Secretary shall submit 
     to Congress a report on--
       ``(A) the number of biospecimens and corresponding clinical 
     demographic data collected through the biospecimen research 
     efforts 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 
     biospecimen and biorepository research efforts under this 
     subsection.
       ``(10) Definitions.--For purposes of this subsection:
       ``(A) Award.--The term `award' includes a grant, contract, 
     cooperative agreement, or other transaction 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) the patient's gender, race, ethnicity, and 
     environmental exposures;
       ``(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 ``2017 
     through 2021''; 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:

[[Page 15831]]

       ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention, 
     may make awards to State cancer registries to enhance and 
     expand infrastructure to track the epidemiology of cancer in 
     children, adolescents, and young adults. Such registries may 
     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) as 
     appropriate.''.

                 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 CANCER RESEARCH 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) childhood cancer research projects conducted or 
     supported by the National Institutes of Health.''.

TITLE II--MAXIMIZING DELIVERY: CARE, QUALITY OF LIFE, SURVIVORSHIP, AND 
                           CAREGIVER SUPPORT

      Subtitle A--Childhood Cancer Survivors' Quality of Life Act

     SEC. 201. CANCER SURVIVORSHIP PROGRAMS.

       (a) Cancer Survivorship Programs.--The Public Health 
     Service Act is amended by inserting after section 399N of 
     such Act (42 U.S.C. 280g-2) the following:

     ``SEC. 399N-1. 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 may make awards 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 an award under 
     this section to an eligible entity only if the entity 
     agrees--
       ``(1) to use the award 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 psychosocial interventions and support 
     programs to improve the quality of life of cancer survivors 
     and their families.
       ``(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. 399N-2. 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. 202. 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) Research awards.--The Director of NIH, in 
     coordination with ongoing research activities, may conduct or 
     support pediatric cancer survivorship research including any 
     of the following areas:
       ``(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.
       ``(iv) Familial, socioeconomic, and other environmental 
     factors and the impact of such factors on treatment outcomes 
     and survivorship.
       ``(B) Balanced approach.--In supporting research under 
     subparagraph (A)(i) on pediatric cancer survivors within 
     minority or

[[Page 15832]]

     other medically underserved populations, the Director of NIH 
     shall ensure that such research addresses both the physical 
     and the psychological needs of such survivors, as 
     appropriate.
       ``(2) Research on late effects and follow-up care for 
     pediatric cancer survivors.--The Director of NIH, in 
     coordination with ongoing research activities, may conduct or 
     support research on follow-up care for pediatric cancer 
     survivors, including any of the following areas:
       ``(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 adverse 
     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.
       ``(J) Examining the cost-effectiveness of the different 
     models of follow-up care.''.

     SEC. 203. 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 may 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. 204. 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'') 
     may 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 maximum number of sites 
     at which the demonstration project under subsection (a) is 
     carried out may not exceed 10.
       (2) Diversity of sites.--In selecting entities to 
     participate in the demonstration project, the Secretary may, 
     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 may use the following measures 
     to assess the performance of each site:
       (1) Patient care and patient/family satisfaction measures.
       (2) Resource utilization measures.
       (3) Adult survivorship measures, as appropriate.
       (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. 211. 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 across all stages of 
     illness 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 subsequent 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 and monitoring 25 
     hydroxyvitamin D levels;
       (G) dental coverage and necessary dental implants;
       (H) hearing aids and other prosthetic devices; and
       (I) screening for lung problems, such as pulmonary function 
     testing.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Texas (Mr. Burgess) and the gentlewoman from California (Ms. Matsui) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Texas.

[[Page 15833]]




                             General Leave

  Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and insert extraneous materials into the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
  I rise today in support of H.R. 3381, the Childhood Cancer 
Survivorship, Treatment, Access, and Research Act of 2016, also known 
as the Childhood Cancer STAR Act. This bill was introduced by my Texas 
colleague, Representative Mike McCaul; Representative Chris Van Hollen; 
and Representative Jackie Speier.
  The legislation we are considering today is important for many young 
Americans, as it is intended to help the most vulnerable among us: 
children who have been diagnosed with cancer.
  We have made progress in combating childhood cancer. In 1960, only 4 
percent of children with cancer survived more than 5 years. Today, 80 
percent of children with cancer survive, but there is work left to do.
  H.R. 3381 will expand the opportunities for childhood cancer 
research, improve childhood cancer surveillance, help improve the 
quality of life for childhood cancer survivors, and help ensure that 
there is proper pediatric cancer research within the National 
Institutes of Health.
  This legislation enjoys broad bipartisan support. It has 270 
cosponsors, representing over 60 percent of the House of 
Representatives.
  Mr. Speaker, I urge my colleagues to vote ``yes'' on H.R. 3381.
  I reserve the balance of my time.
  Ms. MATSUI. Mr. Speaker, I yield myself such time as I may consume.
  I rise today in support of H.R. 3381, the Childhood Cancer 
Survivorship, Treatment, Access, and Research Act.
  Nearly 16,000 children are diagnosed with cancer in the United States 
each year. These children bravely battle disease and carry burdens that 
no one their age should. The Childhood Cancer STAR Act gives those 
children and their families hope by encouraging improved research, 
development of treatments, and survivorship programs for children with 
cancer.
  This legislation urges the National Institutes of Health to find new 
opportunities to expand research into pediatric cancer and 
survivorship, including research on the causes of health disparities in 
pediatric cancer survivors.
  This legislation would also allow the Centers for Disease Control and 
Prevention to award funding to help States better track pediatric 
cancer. Improved information about childhood cancer will help guide 
public health decisions and strategies as well as research.
  Expanding research that leads to treatments and cures is only part of 
the solution for children diagnosed with cancer. This bill recognizes 
that these children often require different care for the remainder of 
their lives.
  As many as two-thirds of pediatric cancer survivors suffer from the 
effects of their disease and treatments long term, including secondary 
cancers and organ damage.
  To help children after they have beat pediatric cancer, this bill 
would create a pilot program to explore model systems of care for 
pediatric cancer survivors and to study barriers to adequate medical 
care for survivors of childhood cancer.
  I urge my colleagues to support this bill.
  Mr. Speaker, I reserve the balance of my time.

                              {time}  1245

  Mr. BURGESS. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Texas (Mr. McCaul), the chairman of the Committee on 
Homeland Security, a true champion for all things pediatric.
  Mr. McCAUL. Mr. Speaker, I want to also thank the gentleman from 
Texas (Mr. Burgess) for his work on this effort as well. I chair the 
Committee on Homeland Security, but I also chair the Congressional 
Childhood Cancer Caucus. It is one of the biggest threats to our 
children. It is the number one killer of our children.
  Therefore, I rise in support of H.R. 3381, the Childhood Cancer STAR 
Act, because it will address four major concerns facing the pediatric 
cancer community: survivorship, treatment, access, and research. I 
introduced this bill with my colleagues on the other side of the aisle, 
Chris Van Hollen of Maryland and Ms. Jackie Speier of California, to be 
the most comprehensive childhood cancer bill ever considered before 
this House.
  I cofounded, as I said, the Congressional Childhood Cancer Caucus 7 
years ago as a platform to give children a voice, children who don't 
have lobbyists, children who are dying, who have been impacted by this 
life-altering diagnosis.
  To better fight childhood cancer, we must know more about it, and 
that is what the STAR Act does. It authorizes NIH to expand their 
efforts to collect data on childhood cancer so we can better understand 
its causes and the effects of treatment. It also builds on previous 
work from cancer research groups to provide doctors with the resources 
necessary to identify children who may be at risk for developing 
cancer, preventing the worst outcomes from becoming a reality.
  Finally, we must address the needs of two-thirds of childhood cancer 
survivors facing serious lifelong medical conditions. Our bill will 
improve collaboration among providers so doctors are better able to 
care for survivors as they age.
  I am pleased this bill has the strong support of the patient advocacy 
community. I especially want to thank the St. Baldrick's Foundation for 
their continued support and help and work on this important bill. Their 
CEO, Kathleen Ruddy, as well as Kevin Mathis and Danielle Leach, have 
been relentless advocates of this bill to make a difference in kids' 
lives. I look forward to working with them in the future as we look to 
further address the needs of the childhood cancer community.
  Mr. Speaker, I close by stating that we are also very excited that 
the Cures Act bill passed the House of Representatives, a very 
important bill about curing not just childhood cancer, but all 
diseases. We urge the Senate to pass that legislation as well. In that 
bill was the Advancing Hope Act, which will make a difference in the 
number of drugs that can be developed to cure childhood cancer.
  In fact, it reauthorizes a bill that I introduced to the year 2020, a 
bill that has already produced a childhood cancer drug, the first since 
the 1980s, to cure neuroblastoma in children. When I went to meet with 
Rex Ryan at Dell Children's Medical Center in Austin, Texas, in this 
clinical trial, the idea, Mr. Speaker, that you can actually pass a 
bill in this Congress and see that tangible result, a bill passed in 
this great body that transforms into saving the life of a child, is 
truly a tremendous and extraordinary experience.
  Ms. MATSUI. Mr. Speaker, I yield 5 minutes to the gentlewoman from 
California (Ms. Speier).
  Ms. SPEIER. Mr. Speaker, let me first say what a joy it has been to 
work with my colleague Mike McCaul on this issue, and with Chris Van 
Hollen as well. Their passion, compassion, and commitment to this issue 
is one that I have not seen replicated many times.
  Let me comment by talking about the letter I received from Sylvia 
DeCourcey in my district. Her son Tyler has been battling stage 4 
neuroblastoma for about a year. She had written to me the following: 
``As a parent of a pediatric cancer patient, I wanted to say thank you 
for introducing the Childhood Cancer STAR Act. This has the potential 
to make a huge difference for my son Tyler and his fellow warriors. In 
August we lost two little buddies to the neuroblastoma monster. To 
think that if this act was already in place, that may not have 
happened, and the heartaches of their families and friends could be 
prevented. I hope and pray that my son will beat this. Thank you again 
for sponsoring the STAR Act. . . .''
  On Friday I received a follow-up email from Sylvia, and it still 
sends

[[Page 15834]]

chills up and down my spine. Tyler has officially been in remission for 
2 weeks. It is only fitting that today we are taking up the STAR Act.
  The STAR Act would not have been possible without the perseverance of 
families like Sylvia and Tyler and of the young people who are living 
with the cancers. There have been more than 50 organizations that have 
worked on this issue. Together they have managed to push even a 
gridlocked Congress into action.
  I would like to take a moment to highlight the personal importance of 
the survivorship provisions of the STAR Act, which I have been working 
on since 2011. Fifty years ago, only 4 percent of children with cancer 
survived more than 5 years beyond their diagnosis. Today the cure rate 
has increased to over 80 percent. It is a remarkable accomplishment. 
Now we have some 500,000 young people who have survived childhood 
cancer.
  But, as many families know, the fight against childhood cancer 
doesn't end with remission. As many as two-thirds of childhood cancer 
survivors experience secondary cancers, and that is why this particular 
provision of the bill is so important. It is imperative that the STAR 
Act has a strategy to improve their care and quality of life, and it 
would not have happened without the guidance of Susan Weiner and Sue 
Emmer of Children's Cause for Cancer Advocacy. I would also like to 
thank the staff of all of our offices who worked so hard on this 
measure: Thomas Rice, Jessica Nalepa, Austin Carson, Kelly Cotner, and 
Andy Taylor with Congressman McCaul; Ziky Ababiya and Erika Appel with 
Congressman Van Hollen; Jill Brimmer with Senator Reed; Dana Richter 
with Senator Moore Capito; Adrianna Simonelli with Chairman Upton; 
Waverly Gordon with Ranking Member Pallone; Kelly Dixon with Majority 
Leader McCarthy; Charlene MacDonald with Democratic Whip Hoyer; Holly 
Gibbons and her team at the NIH; and Molly Fishman on my staff as well.
  I want to thank my colleagues for the time, the leadership, and for 
giving us an opportunity to do something to improve the lives of these 
children living with cancer and their parents who are advocating for 
them.
  Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from 
Georgia (Mr. Carter).
  Mr. CARTER of Georgia. Mr. Speaker, I rise today in support of H.R. 
3381, the Childhood Cancer STAR Act, which would allow the National 
Institutes of Health and the Department of Health and Human Services to 
expand their efforts to research treatments and care for childhood 
cancer patients.
  Each year, thousands of children are diagnosed with cancer, and far 
too many children are lost to this horrible disease. Childhood cancer 
survivors and their families still face an uphill battle after 
remission, as the chances for recurrence can be higher for children.
  Advances in treatment have greatly improved outcomes, but more must 
be done to support patients, survivors, and their families. The bill 
would help expand efforts to improve the lives of childhood cancer 
survivors, develop new treatments, increase access to care, and 
accelerate lifesaving research for those impacted by childhood cancer.
  Childhood cancer patients and survivors have unique needs, and this 
bill will ensure that those needs are addressed through continued 
child-focused research. We must continue the fight until no child is 
lost to cancer. I urge my colleagues to support childhood cancer 
patients, survivors, and families by supporting the Childhood Cancer 
STAR Act.
  Ms. MATSUI. Mr. Speaker, I urge my colleagues to support the 
Childhood Cancer STAR Act.
  I yield back the balance of my time.
  Mr. BURGESS. Mr. Speaker, I urge all Members to vote in favor of H.R. 
3381.
  I yield back the balance of my time.
  Mr. VAN HOLLEN. Mr. Speaker, I rise in strong support of the 
Survivorship, Treatment, Access, and Research (STAR) Act. As the most 
comprehensive way to address childhood cancer, the bill advances 
research, treatment, and quality of life for pediatric cancer survivors 
here in Maryland and across the nation.
  Each year, nearly 16,000 children in the United States are diagnosed 
with cancer. While there have been advances made in childhood cancer 
research, too many young people and their families continue to suffer. 
And for the kids who survive, the battle is not over. Ninety-five 
percent of survivors will suffer serious health complications as they 
age.
  To give pediatric cancer patients and their families hope, I 
spearheaded the STAR Act with Congressman Mike McCaul and Congresswoman 
Jackie Speier. By the bill's several provisions, including improving 
efforts to identify and track childhood cancer incidence and 
establishing a pilot program to explore innovative models of care to 
enhance the quality of life for survivors, the STAR Act will provide 
our researchers with the necessary resources to work towards cures and 
less toxic treatments that will help our children live longer, 
healthier lives.
  With the majority of this chamber as co-sponsors, this bill shows 
that Congress can come together to make progress for the most 
vulnerable in our society--the thousands of children and families 
impacted by cancer. It is also a testament of passionate advocacy--
those who fight hard so another child's life is not robbed too early 
from cancer or so survivors do not have to live with physical and 
psychological effects of harmful treatments. I want to thank all the 
advocates who have been working tirelessly behind the scenes and who 
have helped us get this vital bill to the House floor today.
  Lastly, it has been an honor serving as the Co-Chair of the Childhood 
Cancer Caucus with Congressman Mike McCaul and want to welcome the new 
Co-Chairs for next Congress: Congresswoman Jackie Speier, Congressman 
G. K. Butterfield, and Congressman Mike Kelly.
  I strongly support passage of the STAR Act and urge my colleagues to 
vote in favor of the bill.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Texas (Mr. Burgess) that the House suspend the rules and 
pass the bill, H.R. 3381, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________