[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1883 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1883

To maximize discovery, and accelerate development and availability, of 
     promising childhood cancer treatments, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 29, 2015

 Mr. Reed (for himself and Mrs. Capito) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 Finalizing draft guidance on expanded access.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.
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