S. 292 — what changed

Section 417E of the Public Health Service Act (42 U.S.C. 285a–11) is amended—

“(a) Children's cancer biorepositories

added “(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 research efforts to collect biospecimens and clinical and demographic information of children, adolescents, and young adults with selected cancer subtypes (and their recurrences) for which current treatments are least effective, in order to achieve a better understanding of the causes of such cancer subtypes (and their recurrences), and the effects and outcomes of treatments for such cancers.

removed “(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:

added “(A) Collect 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, adolescents, and young adults with cancer 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 existing biorepositories supported by the National Cancer Institute.

added “(B) Maintain an interoperable, secure, and searchable database on stored biospecimens and associated clinical and demographic data from children, adolescents, and young adults with cancer for the purposes of research by scientists and qualified health care professionals.

added “(C) Establish and implement procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals.

added “(D) Provide access to 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—

added “(i) consistent with the procedures established pursuant to subparagraph (C);

added “(ii) only to the extent permitted by applicable Federal and State law; and

added “(iii) in a manner that protects personal privacy to the extent required by applicable Federal and State privacy law, at minimum.

removed “(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.

removed “(B) Make such information publicly available, including the repositories described in subparagraph (A).

removed “(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.

removed “(D) Establish procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals.

removed “(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.

added “(B) Considerations—In evaluating applications submitted under 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 for whom current treatments are least effective.

added “(5) Privacy protections and informed consent

removed “(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.

removed “(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—

added “(i) collects biospecimens and associated clinical and demographic information only from participants who have given their informed consent in accordance with Federal and State law; and

added “(ii) protects personal privacy to the extent required by applicable Federal and State law, at minimum.

added “(B) Informed consent—The Secretary shall ensure biospecimens and associated clinical and demographic information are collected with informed consent, as described in subparagraph (A)(i).

added “(6) Guidelines and oversight—The Secretary shall develop and disseminate appropriate guidelines for the development and maintenance of the biorepositories supported under this subsection, including appropriate oversight, to facilitate further research on select cancer subtypes (and their recurrences) in children, adolescents, and young adults with such cancers (and their recurrences).

added “(7) Coordination—To encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect to the activities described in this subsection, the Secretary shall ensure the appropriate coordination of programs supported under this section with existing federally supported cancer registry programs and the activities under section 399E–1, as appropriate.

added “(8) Supplement not supplant—Funds provided under this subsection shall be used to supplement, and not supplant, Federal and non-Federal funds available for carrying out the activities described in this subsection.

added “(9) Report—Not later than 4 years after the date of enactment of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018, the Secretary shall submit to Congress a report on—

removed “(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

removed “(ii) adheres to strict confidentiality to protect the identity and privacy of patients in accordance with Federal and State law.

removed “(B) Consent—The Secretary shall establish an appropriate process for achieving consent from the patient, parent, or legal guardian.

removed “(6) Single point of access; standard data; guidelines and oversight

removed “(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.

removed “(B) Standard data—The Secretary shall require all recipients of an award under paragraph (1) 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.

removed “(C) Guidelines and oversight—The Secretary shall develop and disseminate appropriate guidelines for the development and maintenance of the biorepositories supported under this subsection, including appropriate oversight.

removed “(7) Coordination—The Secretary shall ensure that clinical and demographic information collected in accordance with this subsection is collected in coordination with the information collected under section 399E–1.

removed “(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.

removed “(9) Report—Not later than 4 years after the date of enactment of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2017, 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;

added “(C) barriers to the collection of biospecimens and corresponding clinical demographic data;

added “(D) barriers experienced by researchers or health care professionals in accessing the biospecimens and corresponding clinical demographic data necessary for use in research; and

added “(E) recommendations with respect to improving the biospecimen and biorepository research efforts under this subsection.

removed “(C) any barriers to the collection of biospecimens and corresponding clinical demographic data;

removed “(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

removed “(E) any recommendations with respect to improving the biospecimen and biorepository research efforts under this subsection.

“(10) Definitions—For purposes of this subsection:

added “(A) Award—The term award includes a grant, contract, or cooperative agreement determined by the Secretary.

removed “(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

added “(vi) any other sample relevant to cancer research, as required by the Secretary.

removed “(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;

added “(iii) the patient’s sex, race, ethnicity, and environmental exposures;

removed “(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

added “(xi) any other applicable information required by the Secretary.”

removed “(xi) any other information required by the Secretary.”

removed Section 399E–1 of the Public Health Service Act (42 U.S.C. 280e–3a) is amended—

removed “(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—

added “(1) identifying, recruiting, and training potential sources for reporting childhood, adolescent, and young adult cancer cases;

added “(2) developing practices to ensure early inclusion of childhood, adolescent, and young adult cancer cases in State cancer registries through the use of electronic reporting;

added “(3) collecting and submitting deidentified data to the Centers for Disease Control and Prevention for inclusion in a national database that includes information on childhood, adolescent, and young adult cancers; and

added “(4) improving State cancer registries and the database described in paragraph (3), as appropriate, including to support the early inclusion of childhood, adolescent, and young adult cancer cases.

added “(c) Coordination—To encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect to the activities described in this section, the Secretary shall ensure the appropriate coordination of programs supported under this section with other federally supported cancer registry programs and the activities under section 417E(a), as appropriate.”

removed “(1) identifying, recruiting, and training all potential sources for reporting childhood, adolescent, and young adult cancer cases;

removed “(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;

removed “(3) purchasing infrastructure to support the early inclusion of childhood, adolescent, and young adult cancer cases on such registries;

removed “(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

removed “(5) tracking the late effects of childhood, adolescent, and young adult cancers.

removed “(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.”

changed Clause (iii) of section 406(h)(2)(A) of the Public Health Service Act (42 U.S.C. 284a(h)(2)(A)) is amended to read as follows:amended—

added “(I) not less than 5”

added “(II) not less than one member shall be an individual knowledgeable in pediatric oncology;”

removed “(iii) of the members appointed to the Board—

removed “(I) not less than 5 members shall be individuals knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors); and

removed “(II) not less than one member shall be an individual knowledgeable in pediatric oncology;”

changed Section 409D(c)(3) The Director of the Public National Institutes of Health Service Act (42 U.S.C. 284h(c)(3)) is amended by—shall ensure that childhood cancer research projects conducted or supported by the National Institutes of Health are included in appropriate reports to Congress, which may include the Pediatric Research Initiative report.

removed “(A)”

removed “(B) childhood cancer research projects conducted or supported by the National Institutes of Health.”

removed “399N–1. Pilot programs to explore model systems of care for pediatric cancer survivors

removed “(a) In general—Not later than 1 year after the date of enactment of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2017, 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.

removed “(b) Eligible entities—In this section, the term eligible entity means—

removed “(1) a medical school;

removed “(2) a children’s hospital;

removed “(3) a cancer center;

removed “(4) a community-based medical facility; or

removed “(5) any other entity with significant experience and expertise in treating survivors of childhood cancers.

removed “(c) Use of funds—The Secretary may make an award under this section to an eligible entity only if the entity agrees—

removed “(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

removed “(2) in developing, studying, and evaluating such systems, to give special emphasis to—

removed “(A) design of protocols for different models of follow-up care, monitoring, and other survivorship programs (including peer support and mentoring programs);

removed “(B) development of various models for providing multidisciplinary care;

removed “(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;

removed “(D) development of psychosocial interventions and support programs to improve the quality of life of cancer survivors and their families;

removed “(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);

removed “(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; and

removed “(G) development of initiatives that promote the coordination and effective transition of care between cancer care providers, primary care physicians, and mental health professionals.

removed “399N–2. Workforce development collaborative on medical and psychosocial care for childhood cancer survivors

removed “(a) In general—The Secretary shall, not later than 1 year after the date of enactment of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2017, convene a Workforce Development Collaborative on Medical and Psychosocial Care for Pediatric Cancer Survivors (referred to in this section 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.

removed “(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:

removed “(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.

removed “(2) Adapting curricula for continuing education of the existing workforce using efficient workplace-based learning approaches.

removed “(3) Developing the skills of faculty and other trainers in teaching psychosocial health care using evidence-based teaching strategies.

removed “(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.

removed “(5) Evaluating the effectiveness of patient navigators in pediatric cancer survivorship care.

removed “(6) Evaluating the effectiveness of peer support programs in the psychosocial care of pediatric cancer patients and survivors.”

“(b) Improving care for pediatric cancer survivors

added “(1) Research on pediatric cancer survivorship—The Director of NIH, in coordination with ongoing research activities, may continue to conduct or support pediatric cancer survivorship research including in any of the following areas:

added “(A) Outcomes of pediatric cancer survivors, including within minority or other medically underserved populations and with respect to health disparities of such outcomes.

added “(B) Barriers to follow-up care for pediatric cancer survivors, including within minority or other medically underserved populations.

added “(C) The impact of relevant factors, which may include familial, socioeconomic, and other environmental factors, on treatment outcomes and survivorship.

added “(D) The development of indicators used for long-term follow-up and analysis of the late effects of cancer treatment for pediatric cancer survivors.

added “(E) The identification of, as applicable—

added “(i) risk factors associated with the late effects of cancer treatment;

added “(ii) predictors of adverse neurocognitive and psychosocial outcomes; and

added “(iii) the molecular basis of long-term complications.

added “(F) The development of targeted interventions to reduce the burden of morbidity borne by cancer survivors in order to protect such cancer survivors from the late effects of cancer.

added “(2) Balanced approach—In conducting or supporting research under paragraph (1)(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, as appropriate.”

removed “(1) Research on causes of health disparities in pediatric cancer survivorship

removed “(A) Research awards—The Director of NIH, in coordination with ongoing research activities, may conduct or support pediatric cancer survivorship research including in any of the following areas:

removed “(i) Needs and outcomes of pediatric cancer survivors within minority or other medically underserved populations.

removed “(ii) Health disparities in pediatric cancer survivorship outcomes within minority or other medically underserved populations.

removed “(iii) Barriers that pediatric cancer survivors within minority or other medically underserved populations face in receiving follow-up care.

removed “(iv) Familial, socioeconomic, and other environmental factors and the impact of such factors on treatment outcomes and survivorship.

removed “(B) Balanced approach—In conducting or supporting 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, as appropriate.

removed “(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 in any of the following areas:

removed “(A) The development of indicators used for long-term patient tracking and analysis of the late effects of cancer treatment for pediatric cancer survivors.

removed “(B) The identification of risk factors associated with the late effects of cancer treatment.

removed “(C) The identification of predictors of adverse neurocognitive and psychosocial outcomes.

removed “(D) The identification of the molecular underpinnings of long-term complications.

removed “(E) The development of risk prediction models to identify those at highest risk of long-term complications.

removed “(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.

removed “(G) Transitions in care for pediatric cancer survivors.

removed “(H) Training of professionals to provide linguistically and culturally competent follow-up care to pediatric cancer survivors.

removed “(I) Different models of follow-up care.

removed “(J) Examining the cost-effectiveness of the different models of follow-up care.”

changed Part B of title III The Secretary of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 317T and Human Services may facilitate the following:identification of best practices for childhood and adolescent cancer survivorship care, and, as appropriate, may consult with individuals who have expertise in late effects of disease and treatment of childhood and adolescent cancers, which may include—

removed “317U. Standards for comprehensive long-term care for pediatric cancer survivors through the lifespan

removed “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—

removed “(1) oncologists who treat children and adolescents;

removed “(2) oncologists who treat adults;

removed “(3) primary care providers engaged in survivorship care;

removed “(4) survivors of childhood cancer;

removed “(5) parents of children who have been diagnosed with and treated for cancer and parents of long-term survivors;

removed “(6) professionals who are engaged in the development of clinical practice guidelines;

removed “(7) nurses and social workers;

removed “(8) mental health professionals;

removed “(9) allied health professionals, including physical therapists and occupational therapists;

removed “(10) experts in health care quality measurement and improvement; and

removed “(11) others, as the Secretary determines appropriate.”