HEARTS Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 6166 To amend the Public Health Service Act to authorize and support the creation and dissemination of cardiomyopathy education, awareness, and risk as- sessment materials and resources to identify more at-risk families, to authorize research and surveillance activities relating to cardiomyopathy, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 10, 2020 Mr. KIM (for himself and Mr. BARR) 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 cardio- myopathy education, awareness, and risk assessment ma- terials and resources to identify more at-risk families, to authorize research and surveillance activities relating to cardiomyopathy, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Cardiomyopathy 4 Health Education, Awareness, Research, and Training in 5 the Schools Act of 2020’’ or the ‘‘HEARTS Act of 2020’’. 6 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 6166 IH SEC. 2. MATERIALS AND RESOURCES TO INCREASE EDU- 1 CATION AND AWARENESS OF CARDIO- 2 MYOPATHY AMONG SCHOOL ADMINISTRA- 3 TORS, EDUCATORS, AND FAMILIES. 4 Part P of title III of the Public Health Service Act 5 (42 U.S.C. 280g et seq.) is amended by adding at the end 6 the following new section: 7 ‘‘SEC. 399V–7. MATERIALS AND RESOURCES TO INCREASE 8 EDUCATION AND AWARENESS OF CARDIO- 9 MYOPATHY AMONG SCHOOL ADMINISTRA- 10 TORS, EDUCATORS, AND FAMILIES. 11 ‘‘(a) MATERIALS AND RESOURCES.—Not later than 12 18 months after the date of the enactment of this section, 13 the Secretary, in conjunction with the Director of the Cen- 14 ters for Disease Control and Prevention (in this section 15 referred to as the ‘Director’) shall develop public education 16 materials and resources to be disseminated to school ad- 17 ministrators, educators, school health professionals, coach- 18 es, families, guardians, caregivers, and other appropriate 19 individuals. The materials and resources shall include— 20 ‘‘(1) background information to increase edu- 21 cation and awareness of cardiomyopathy among 22 school administrators, educators, and families; 23 ‘‘(2) guidelines regarding the placement of 24 automated external defibrillators in schools, early 25 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 6166 IH childhood education programs, and child care cen- 1 ters; 2 ‘‘(3) training information on automated exter- 3 nal defibrillators and cardiopulmonary resuscitation; 4 and 5 ‘‘(4) recommendations for how schools, early 6 childhood education programs, and child care centers 7 can develop and implement a cardiac emergency re- 8 sponse plan. 9 ‘‘(b) DISSEMINATION OF MATERIALS AND RE- 10 SOURCES.—Not later than 30 months after the date of 11 the enactment of this section, the Secretary, through the 12 Director, shall disseminate the materials and resources de- 13 veloped under subsection (a) in accordance with the fol- 14 lowing: 15 ‘‘(1) DISTRIBUTION BY STATE EDUCATIONAL 16 AGENCIES.—The Secretary shall make available such 17 materials and resources to State educational agen- 18 cies to distribute— 19 ‘‘(A) to school administrators, educators, 20 school health professionals, coaches, families, 21 guardians, caregivers, and other appropriate in- 22 dividuals, the cardiomyopathy education and 23 awareness materials and resources developed 24 under subsection (a)(1); 25 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 6166 IH ‘‘(B) to parents, guardians, or other care- 1 givers, the risk assessment for individuals with 2 or at risk for cardiomyopathy developed pursu- 3 ant to section 399V–8(b)(1); and 4 ‘‘(C) to school administrators, educators, 5 school health professionals, and coaches— 6 ‘‘(i) the guidelines described in sub- 7 section (a)(2); 8 ‘‘(ii) the training information de- 9 scribed in subsection (a)(3); and 10 ‘‘(iii) the recommendations described 11 in subsection (a)(4). 12 ‘‘(2) DISSEMINATION TO HEALTH DEPART- 13 MENTS AND PROFESSIONALS.—The Secretary shall 14 make available the materials and resources devel- 15 oped under subsection (a) to State and local health 16 departments, pediatricians, hospitals, and other 17 health professionals, such as nurses and first re- 18 sponders. 19 ‘‘(3) POSTING ON WEBSITE.— 20 ‘‘(A) CDC.— 21 ‘‘(i) IN GENERAL.—The Secretary, 22 through the Director, shall post the mate- 23 rials and resources developed under sub- 24 section (a) on the public internet website 25 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 6166 IH of the Centers for Disease Control and 1 Prevention. 2 ‘‘(ii) ADDITIONAL INFORMATION.— 3 The Director is encouraged to maintain on 4 such public internet website such addi- 5 tional information regarding cardio- 6 myopathy as deemed appropriate by the 7 Director. 8 ‘‘(B) STATE EDUCATIONAL AGENCIES.— 9 State educational agencies are encouraged to 10 create public internet webpages dedicated to 11 cardiomyopathy and post the materials and re- 12 sources developed under subsection (a) on such 13 webpages. 14 ‘‘(c) DEFINITIONS.—In this section: 15 ‘‘(1) The term ‘school administrator’ means a 16 principal, director, manager, or other supervisor or 17 leader within an elementary school, secondary 18 school, State-based early childhood education pro- 19 gram, or child care center. 20 ‘‘(2) The term ‘school health professional’ 21 means a health professional serving at an elemen- 22 tary school, secondary school, State-based early 23 childhood education program, or child care center. 24 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 6166 IH ‘‘(3) The terms ‘early childhood education pro- 1 gram’, ‘elementary school’, and ‘secondary school’ 2 have the meanings given to those terms in section 3 8101 of the Elementary and Secondary Education 4 Act of 1965. 5 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For 6 carrying out this section and section 399V–8, there is au- 7 thorized to be appropriated $1,000,000 for each of fiscal 8 years 2021 through 2025.’’. 9 SEC. 3. RESEARCH AND SURVEILLANCE ACTIVITIES RELAT- 10 ING TO CARDIOMYOPATHY. 11 (a) CDC RESEARCH AND SURVEILLANCE.—Part P 12 of title III of the Public Health Service Act (42 U.S.C. 13 280g et seq.), as amended by section 2, is further amended 14 by adding at the end the following new section: 15 ‘‘SEC. 399V–8. RESEARCH AND SURVEILLANCE ACTIVITIES 16 RELATING TO CARDIOMYOPATHY. 17 ‘‘(a) REPORTS ON CDC NATIONAL CARDIO- 18 MYOPATHY SURVEILLANCE RESEARCH ACTIVITIES.— 19 ‘‘(1) INITIAL REPORT.—Not later than June 1, 20 2021, the Secretary, acting through the Director of 21 the Centers for Disease Control and Prevention, 22 shall submit to Congress an initial report on find- 23 ings and data generated from surveillance and re- 24 search activities conducted by the Centers for Dis- 25 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 6166 IH ease Control and Prevention to improve the under- 1 standing of the prevalence and epidemiology of car- 2 diomyopathy across the lifespan, from birth to adult- 3 hood, with particular interest in the following: 4 ‘‘(A) The health care costs, utilization, and 5 natural history of individuals with cardio- 6 myopathy, in both the pediatric and adult popu- 7 lation. 8 ‘‘(B) The number of adults and children 9 affected by cardiomyopathy, as well as age-spe- 10 cific mortality. 11 ‘‘(2) FINAL REPORT.—Not later than January 12 1, 2026, the Secretary, acting through the Director 13 of the Centers for Disease Control and Prevention, 14 shall submit to Congress a final report on the con- 15 tent described in paragraph (1). 16 ‘‘(3) PUBLIC ACCESS.—Subject to paragraph 17 (4), the reports submitted under this subsection 18 shall be made available to the public. 19 ‘‘(4) PATIENT PRIVACY.—The Secretary shall 20 ensure that this subsection is carried out in a man- 21 ner that complies with the requirements applicable 22 to a covered entity under the regulations promul- 23 gated pursuant to section 264(c) of the Health In- 24 surance Portability and Accountability Act of 1996. 25 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 6166 IH ‘‘(b) IMPROVING RISK ASSESSMENTS FOR INDIVID- 1 UALS WITH CARDIOMYOPATHY.— 2 ‘‘(1) IN GENERAL.—The Secretary, acting 3 through the Director of the Centers for Disease 4 Control and Prevention, shall develop and make pub- 5 licly available a risk assessment for individuals with 6 or at risk for cardiomyopathy. Such risk assessment 7 shall, at a minimum, include the following: 8 ‘‘(A) Background information of the preva- 9 lence, incidence, and health impact of cardio- 10 myopathy, including all forms of cardio- 11 myopathy and their effects on pediatric, adoles- 12 cent, and adult individuals. 13 ‘‘(B) A worksheet with variables and con- 14 ditions for an individual or health care provider 15 to use in assessing whether the individual is at 16 risk for cardiomyopathy. 17 ‘‘(C) A worksheet with variables and 18 stages of progression for an individual or health 19 care provider to use in assessing whether and to 20 what extent cardiomyopathy has progressed in 21 the individual. 22 ‘‘(D) Guidelines on cardiomyopathy 23 screenings for individuals who are at risk for, 24 or have a family history of, cardiomyopathy. 25 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 6166 IH ‘‘(2) STAKEHOLDER INPUT.—In carrying out 1 paragraph (1), the Director of the Centers for Dis- 2 ease Control and Prevention shall seek input from 3 external stakeholders including— 4 ‘‘(A) representatives from national patient 5 advocacy organizations expert in all forms of 6 cardiomyopathy; 7 ‘‘(B) representatives from medical profes- 8 sional societies that specialize in the care of 9 adults and pediatrics with cardiomyopathy; and 10 ‘‘(C) representatives from other relevant 11 Federal agencies. 12 ‘‘(c) CARDIOMYOPATHY DEFINED.—For purposes of 13 this section, the term ‘cardiomyopathy’ means a heart dis- 14 ease that affects the heart’s muscle (myocardium)— 15 ‘‘(1) the symptoms of which may vary from 16 case to case, including— 17 ‘‘(A) cases in which no symptoms are 18 present (asymptomatic); and 19 ‘‘(B) cases in which there are symptoms of 20 a progressive condition that may result from an 21 impaired ability of the heart to pump blood, 22 such as fatigue, irregular heartbeats (arrhyth- 23 mia), heart failure, and, potentially, sudden car- 24 diac death; and 25 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 6166 IH ‘‘(2) the recognized types of which include di- 1 lated, hypertrophic, restrictive, arrhythmogenic right 2 ventricular dysplasia, and left ventricular non-com- 3 paction.’’. 4 (b) FEDERAL WORKING GROUP.— 5 (1) IN GENERAL.—Not later than one year 6 after the date of the enactment of this Act, the Sec- 7 retary of Health and Human Services shall convene 8 an interdisciplinary working group for the purpose 9 of expanding cardiomyopathy research. 10 (2) DUTIES.—The working group shall— 11 (A) develop a research strategy to address 12 the gaps in knowledge on the molecular and ge- 13 netic causes of cardiomyopathy in children; 14 (B) identify approaches that could result 15 in the development of preventive and disease-di- 16 rected therapies specific to pediatric cardiomy- 17 opathies and heart failure; and 18 (C) explore novel clinical trial methodolo- 19 gies and end points in an effort to optimize suc- 20 cessful completion of clinical trials in this rare 21 patient population. 22 (3) MEMBERSHIP.—The Secretary shall appoint 23 to the working group members representing a range 24 of stakeholders outside of the Federal Government 25 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 6166 IH with subject matter expertise relating to cardio- 1 myopathy, including— 2 (A) pediatric cardiologists with expertise in 3 the diagnosis and treatment of children with 4 cardiomyopathies and heart failure and clinical 5 trials related to the pediatric population; 6 (B) geneticists with expertise in pediatric 7 cardiomyopathy and heart failure; 8 (C) cardiovascular molecular biologists; 9 (D) pharmacologists; 10 (E) research scientists with expertise in 11 cardiomyopathy and heart failure; and 12 (F) other stakeholders with relevant exper- 13 tise, as determined by the Secretary. 14 (4) REPORT TO CONGRESS.—Not later than 2 15 years after the date of the enactment of this Act, the 16 Working Group shall publish and submit to Con- 17 gress a report that contains— 18 (A) a description of the activities of the 19 working group; 20 (B) the findings and recommendations of 21 the working group with respect to each of the 22 topics described in paragraph (2); and 23 (C) the recommendations of the working 24 group relating to actions that Federal agencies 25 VerDate Sep 11 2014 00:42 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H6166.IH H6166 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 6166 IH and Congress can take to implement the rec- 1 ommendations described in subparagraph (B). 2 (5) NO COMPENSATION.—A member of the 3 working group shall serve without compensation. 4 (6) TERMINATION.—The working group shall 5 terminate on the date on which the working group 6 submits the report under paragraph (4). 7 (7) CARDIOMYOPATHY DEFINED.—For pur- 8 poses of this subsection, the term ‘‘cardiomyopathy’’ 9 means a heart disease that affects the heart’s muscle 10 (myocardium)— 11 (A) the symptoms of which may vary from 12 case to case, including— 13 (i) cases in which no symptoms are 14 present (asymptomatic); and 15 (ii) cases in [Text truncated for display. 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