I 115th CONGRESS 1st Session H. R. 3880 IN THE HOUSE OF REPRESENTATIVES September 28, 2017 Mr. Pallone introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to authorize and support the creation and dissemination of cardiomyopathy education, awareness, and risk assessment materials and resources to identify more at-risk families, to authorize research and surveillance activities relating to cardiomyopathy, and for other purposes.

1. Short title This Act may be cited as the Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools Act of 2017 or the HEARTS Act of 2017 . 2. Materials and resources to increase education and awareness of car­di­o­my­op­a­thy among school administrators, educators, and families Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.) is amended by adding at the end the following new section: 399V–7. Materials and resources to increase education and awareness of cardiomyopathy among school administrators, educators, and families (a) Materials and resources Not later than 18 months after the date of the enactment of this section, the Secretary, in conjunction with the Director of the Centers for Disease Control and Prevention (in this section referred to as the Director ) shall develop public education materials and resources to be disseminated to school administrators, educators, school health professionals, coaches, families, guardians, caregivers, and other appropriate individuals. The materials and resources shall include— (1) background information to increase education and awareness of cardiomyopathy among school administrators, educators, and families; (2) guidelines regarding the placement of automated external defibrillators in schools, early childhood education programs, and child care centers; (3) training information on automated external defibrillators and cardiopulmonary resuscitation; and (4) recommendations for how schools, early childhood education programs, and child care centers can develop and implement a cardiac emergency response plan. (b) Dissemination of materials and resources Not later than 30 months after the date of the enactment of this section, the Secretary, through the Director, shall disseminate the materials and resources developed under subsection (a) in accordance with the following: (1) Distribution by State educational agencies The Secretary shall make available such materials and resources to State educational agencies to distribute— (A) to school administrators, educators, school health professionals, coaches, families, guardians, caregivers, and other appropriate individuals, the cardiomyopathy education and awareness materials and resources developed under subsection (a)(1); (B) to parents, guardians, or other caregivers, the risk assessment for individuals with or at risk for cardiomyopathy developed pursuant to section 399V–8(b)(1); and (C) to school administrators, educators, school health professionals, and coaches— (i) the guidelines described in subsection (a)(2); (ii) the training information described in subsection (a)(3); and (iii) the recommendations described in subsection (a)(4). (2) Dissemination to health departments and professionals The Secretary shall make available the materials and resources developed under subsection (a) to State and local health departments, pediatricians, hospitals, and other health professionals, such as nurses and first responders. (3) Posting on website (A) CDC (i) In general The Secretary, through the Director, shall post the materials and resources developed under subsection (a) on the public Internet website of the Centers for Disease Control and Prevention. (ii) Additional information The Director is encouraged to maintain on such public Internet website such additional information regarding cardiomyopathy as deemed appropriate by the Director. (B) State educational agencies State educational agencies are encouraged to create public Internet webpages dedicated to cardiomyopathy and post the materials and resources developed under subsection (a) on such webpages. (c) Definitions In this section: (1) The term school administrator means a principal, director, manager, or other supervisor or leader within an elementary school, secondary school, State-based early childhood education program, or child care center. (2) The term school health professional means a health professional serving at an elementary school, secondary school, State-based early childhood education program, or child care center. (3) The terms early childhood education program , elementary school , and secondary school have the meanings given to those terms in section 8101 of the Elementary and Secondary Education Act of 1965. (d) Authorization of appropriations For carrying out this section and section 399V–8, there is authorized to be appropriated $1,000,000 for each of fiscal years 2018 through 2022. . 3. Research and surveillance activities relating to cardiomyopathy (a) CDC research and surveillance Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.), as amended by section 2, is further amended by adding at the end the following new section: 399V–8. Research and surveillance activities relating to cardiomyopathy (a) Reports on CDC national cardiomyopathy surveillance research activities (1) Initial report Not later than January 1, 2020, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall submit to Congress an initial report on findings and data generated from surveillance and research activities conducted by the Centers for Disease Control and Prevention to improve the understanding of the prevalence and epidemiology of cardiomyopathy across the lifespan, from birth to adulthood, with particular interest in the following: (A) The health care costs, utilization, and natural history of individuals with cardiomyopathy, in both the pediatric and adult population. (B) The number of adults and children affected by cardiomyopathy, as well as age-specific mortality. (2) Final report Not later than January 1, 2025, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall submit to Congress a final report on the content described in paragraph (1). (3) Public access Subject to paragraph (4), the reports submitted under this subsection shall be made available to the public. (4) Patient privacy The Secretary shall ensure that this subsection is carried out in a manner that complies with the requirements applicable to a covered entity under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996. (b) Improving risk assessments for individuals with cardiomyopathy (1) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop and make publicly available a risk assessment for individuals with or at risk for cardiomyopathy. Such risk assessment shall, at a minimum, include the following: (A) Background information of the prevalence, incidence, and health impact of car­di­o­my­op­a­thy, including all forms of car­di­o­my­op­a­thy and their effects on pediatric, adolescent, and adult individuals. (B) A worksheet with variables and conditions for an individual or health care provider to use in assessing whether the individual is at risk for cardiomyopathy. (C) A worksheet with variables and stages of progression for an individual or health care provider to use in assessing whether and to what extent cardiomyopathy has progressed in the individual. (D) Guidelines on cardiomyopathy screenings for individuals who are at risk for, or have a family history of, cardiomyopathy. (2) Stakeholder Input In carrying out paragraph (1), the Director of the Centers for Disease Control and Prevention shall seek input from external stakeholders including— (A) representatives from national patient advocacy organizations expert in all forms of cardiomyopathy; (B) representatives from medical professional societies that specialize in the care of adults and pediatrics with cardiomyopathy; and (C) representatives from other relevant Federal agencies. (c) Cardiomyopathy defined For purposes of this section, the term cardiomyopathy means a heart disease that affects the heart’s muscle (myocardium)— (1) the symptoms of which may vary from case to case, including— (A) cases in which no symptoms are present (asymptomatic); and (B) cases in which there are symptoms of a progressive condition that may result from an impaired ability of the heart to pump blood, such as fatigue, irregular heartbeats (arrhythmia), heart failure, and, potentially, sudden cardiac death; and (2) the recognized types of which include dilated, hypertrophic, restrictive, arrhythmogenic right ventricular dysplasia, and left ventricular non-compaction. . (b) NIH research Part A of title IV of the Public Health Service Act ( 42 U.S.C. 281 et seq.) is amended by inserting after section 404E the following new section: 404F. Cardiomyopathy research (a) In general The Director of NIH may expand, intensify, and coordinate research and related activities of the National Institutes of Health with respect to cardiomyopathy, which may include research with respect to— (1) causation of cardiomyopathy, including genetic causes and molecular biomarkers; (2) long-term health outcomes in individuals with cardiomyopathy, including infants, children, teenagers, adults, and elderly individuals; and (3) studies using longitudinal data and retrospective analysis to identify effective treatments and outcomes for individuals with cardiomyopathy. (b) Cardiomyopathy defined For purposes of this section, the term cardiomyopathy means a heart disease that affects the heart’s muscle (myocardium)— (1) the symptoms of which may vary from case to case, including— (A) cases in which no symptoms are present (asymptomatic); and (B) cases in which there are symptoms of a progressive condition that may result from an impaired ability of the heart to pump blood, such as fatigue, irregular heartbeats (arrhythmia), heart failure, and, potentially, sudden cardiac death; and (2) the recognized types of which include dilated, hypertrophic, restrictive, arrhythmogenic right ventricular dysplasia, and left ventricular non-compaction. . (c) NIH report Not later than 18 months after the date of the enactment of this Act, the Director of the National Institutes of Health shall submit to Congress a report— (1) outlining the ongoing research efforts of the National Institutes of Health regarding cardiomyopathy; and (2) identifying— (A) a research agenda regarding adult forms of cardiomyopathy; (B) plans for researching cardiomyopathy affecting the pediatric population; and (C) the areas of greatest need for such research.