II Calendar No. 555 115th CONGRESS 2d Session H. R. 1222 IN THE SENATE OF THE UNITED STATES February 27, 2018 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions August 15, 2018 Reported by Mr. Alexander , with an amendment Strike out all after the enacting clause and insert the part printed in italic AN ACT To amend the Public Health Service Act to coordinate Federal congenital heart disease research efforts and to improve public education and awareness of congenital heart disease, and for other purposes.

1. Short title This Act may be cited as the Congenital Heart Futures Reauthorization Act of 2017 . 2. National congenital heart disease surveillance system Section 399V–2 of the Public Health Service Act ( 42 U.S.C. 280g–13 ) is amended to read as follows: 399V–2. National congenital heart disease research, surveillance, and awareness (a) In general The Secretary shall— (1) enhance and expand research and surveillance infrastructure to study and track the epidemiology of congenital heart disease (in this section referred to as CHD ); and (2) award grants to eligible entities to undertake the activities described in this section. (b) National congenital heart disease study (1) In general The Secretary shall plan, develop, implement, and submit one or more reports to the Congress on a study to improve understanding of the epidemiology of CHD across the lifespan, from birth to adulthood, with particular interest in the following: (A) Health care utilization of those affected by CHD. (B) Demographic factors associated with CHD, such as age, race, ethnicity, gender, and family history of individuals who are diagnosed with the disease. (C) Outcome measures, such that analysis of the outcome measures will allow derivation of evidence-based best practices and guidelines for CHD patients. (2) Permissible considerations The study under this subsection may— (A) gather data on the health outcomes of a diverse population of those affected by CHD; (B) consider health disparities among those affected by CHD, which may include the consideration of prenatal exposures; and (C) incorporate behavioral, emotional, and educational outcomes of those affected by CHD. (3) Public access Data generated from the study under this subsection shall be made available— (A) for purposes of CHD research, subject to appropriate protections of personal privacy, including protections required by paragraph (4); and (B) to the public, subject to paragraph (4) and with appropriate exceptions for protection of personal privacy. (4) Patient privacy The Secretary shall ensure that the study under 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. (c) Eligibility for grants To be eligible to receive a grant under subsection (a)(2), an entity shall— (1) be a public or private nonprofit entity with specialized experience in CHD; and (2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (d) Authorization of appropriations To carry out this section, there is authorized to be appropriated $4,000,000 for each of fiscal years 2018 through 2022. . 3. Congenital heart disease research Section 425 of the Public Health Service Act ( 42 U.S.C. 285b–8 ) is amended to read as follows: 425. Congenital heart disease (a) In general The Director of the Institute may expand, intensify, and coordinate research and related activities of the Institute with respect to congenital heart disease, which may include congenital heart disease research with respect to— (1) causation of congenital heart disease, including genetic causes; (2) long-term outcomes in individuals with congenital heart disease, including infants, children, teenagers, adults, and elderly individuals; (3) diagnosis, treatment, and prevention; (4) studies using longitudinal data and retrospective analysis to identify effective treatments and outcomes for individuals with congenital heart disease; and (5) identifying barriers to lifelong care for individuals with congenital heart disease. (b) Coordination of research activities The Director of the Institute may coordinate research efforts related to congenital heart disease among multiple research institutions and may develop research networks. (c) Minority and medically underserved communities In carrying out the activities described in this section, the Director of the Institute shall consider the application of such research and other activities to minority and medically underserved communities. (d) Report from NIH Not later than 1 year after the date of the enactment of the Congenital Heart Futures Reauthorization Act of 2017 , the Director of NIH, acting through the Director of the Institute, shall provide a report to Congress— (1) outlining the ongoing research efforts of the National Institutes of Health regarding congenital heart disease; and (2) identifying— (A) future plans for research regarding congenital heart disease; and (B) the areas of greatest need for such research. .

1. Short title This Act may be cited as the Congenital Heart Futures Reauthorization Act of 2017 . 2. National congenital heart disease research, surveillance, and awareness Section 399V–2 of the Public Health Service Act ( 42 U.S.C. 280g–13 ) is amended to read as follows: 399V–2. National congenital heart disease research, surveillance, and awareness (a) In general The Secretary shall, as appropriate— (1) enhance and expand research and data collection efforts related to congenital heart disease, including to study and track the epidemiology of congenital heart disease to understand health outcomes for individuals with congenital heart disease across all ages; (2) conduct activities to improve public awareness of, and education related to, congenital heart disease, including care of individuals with such disease; and (3) award grants to entities to undertake the activities described in this section. (b) Activities (1) In general The Secretary shall carry out activities, including, as appropriate, through a national cohort study and a nationally-representative, population-based surveillance system, to improve the understanding of the epidemiology of congenital heart disease in all age groups, with particular attention to— (A) the incidence and prevalence of congenital heart disease in the United States; (B) causation and risk factors associated with, and natural history of, congenital heart disease; (C) health care utilization by individuals with congenital heart disease; (D) demographic factors associated with congenital heart disease, such as age, race, ethnicity, sex, and family history of individuals who are diagnosed with the disease; and (E) evidence-based practices related to care and treatment for individuals with congenital heart disease. (2) Permissible considerations In carrying out the activities under this section, the Secretary may, as appropriate— (A) collect data on the health outcomes, including behavioral and mental health outcomes, of a diverse population of individuals of all ages with congenital heart disease, such that analysis of the outcomes will inform evidence-based practices for individuals with congenital heart disease; and (B) consider health disparities among individuals with congenital heart disease, which may include the consideration of prenatal exposures. (c) Awareness campaign The Secretary may carry out awareness and educational activities related to congenital heart disease in individuals of all ages, which may include information for patients, family members, and health care providers, on topics such as the prevalence of such disease, the effect of such disease on individuals of all ages, and the importance of long-term, specialized care for individuals with such disease. (d) Public access The Secretary shall ensure that, subject to subsection (e), information collected under this section is made available, as appropriate, to the public, including researchers. (e) Patient privacy The Secretary shall ensure that the data and information collected under this section are made available in a manner that, at a minimum, protects personal privacy to the extent required by applicable Federal and State law. (f) Eligibility for grants To be eligible to receive a grant under subsection (a)(3), an entity shall— (1) be a public or private nonprofit entity with specialized experience in congenital heart disease; and (2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (g) Authorization of appropriations To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2019 through 2023. . 3. Report Not later than 3 years after the date of enactment of the Congenital Heart Futures Reauthorization Act of 2017 , the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report summarizing any activities carried out pursuant to section 399V–2 of the Public Health Service Act (as amended by section 2), including planned activities, and a summary of any research findings and ongoing research efforts, gaps, and areas of greatest need within the Department of Health and Human Services regarding congenital heart disease in patients of all ages.

August 15, 2018 Reported with an amendment