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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Congenital Heart Fu5 tures Reauthorization Act of 2017’’. 


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1 SEC. 2. NATIONAL CONGENITAL HEART DISEASE SURVEIL2 LANCE SYSTEM. 

3 Section 399V–2 of the Public Health Service Act (42 

4 U.S.C. 280g–13) is amended to read as follows: 

5 ‘‘SEC. 399V–2. NATIONAL CONGENITAL HEART DISEASE RE6 SEARCH, SURVEILLANCE, AND AWARENESS. 

7 ‘‘(a) IN GENERAL.—The Secretary shall— 

8 ‘‘(1) enhance and expand research and surveil9 lance infrastructure to study and track the epidemi10 ology of congenital heart disease (in this section re11 ferred to as ‘CHD’); and 

12 ‘‘(2) award grants to eligible entities to under13 take the activities described in this section. 

14 ‘‘(b) NATIONAL CONGENITAL HEART DISEASE

15 STUDY.— 

16 ‘‘(1) IN GENERAL.—The Secretary shall plan, 

17 develop, implement, and submit one or more reports 

18 to the Congress on a study to improve under19 standing of the epidemiology of CHD across the life20 span, from birth to adulthood, with particular inter21 est in the following: 

22 ‘‘(A) Health care utilization of those af23 fected by CHD. 

24 ‘‘(B) Demographic factors associated with 

25 CHD, such as age, race, ethnicity, gender, and 


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1 family history of individuals who are diagnosed 

2 with the disease. 

3 ‘‘(C) Outcome measures, such that analysis 

4 of the outcome measures will allow derivation of 

5 evidence-based best practices and guidelines for 

6 CHD patients. 

7 ‘‘(2) PERMISSIBLE CONSIDERATIONS.—The 

8 study under this subsection may— 

9 ‘‘(A) gather data on the health outcomes of 

10 a diverse population of those affected by CHD; 

11 ‘‘(B) consider health disparities among 

12 those affected by CHD, which may include the 

13 consideration of prenatal exposures; and 

14 ‘‘(C) incorporate behavioral, emotional, 

15 and educational outcomes of those affected by 

16 CHD. 

17 ‘‘(3) PUBLIC ACCESS.—Data generated from 

18 the study under this subsection shall be made avail19 able— 

20 ‘‘(A) for purposes of CHD research, sub21 ject to appropriate protections of personal pri22 vacy, including protections required by para23 graph (4); and 


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1 ‘‘(B) to the public, subject to paragraph 

2 (4) and with appropriate exceptions for protec3 tion of personal privacy. 

4 ‘‘(4) PATIENT PRIVACY.—The Secretary shall 

5 ensure that the study under this subsection is car6 ried out in a manner that complies with the require7 ments applicable to a covered entity under the regu8 lations promulgated pursuant to section 264(c) of 

9 the Health Insurance Portability and Accountability 

10 Act of 1996. 

11 ‘‘(c) ELIGIBILITY FOR GRANTS.—To be eligible to re12 ceive a grant under subsection (a)(2), an entity shall— 

13 ‘‘(1) be a public or private nonprofit entity with 

14 specialized experience in CHD; and 

15 ‘‘(2) submit to the Secretary an application at 

16 such time, in such manner, and containing such in17 formation as the Secretary may require. 

18 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To 

19 carry out this section, there is authorized to be appro20 priated $4,000,000 for each of fiscal years 2018 through 

21 2022.’’. 

22 SEC. 3. CONGENITAL HEART DISEASE RESEARCH. 

23 Section 425 of the Public Health Service Act (42 

24 U.S.C. 285b–8) is amended to read as follows: 


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1 ‘‘SEC. 425. CONGENITAL HEART DISEASE. 

2 ‘‘(a) IN GENERAL.—The Director of the Institute 

3 may expand, intensify, and coordinate research and re4 lated activities of the Institute with respect to congenital 

5 heart disease, which may include congenital heart disease 

6 research with respect to— 

7 ‘‘(1) causation of congenital heart disease, in8 cluding genetic causes; 

9 ‘‘(2) long-term outcomes in individuals with 

10 congenital heart disease, including infants, children, 

11 teenagers, adults, and elderly individuals; 

12 ‘‘(3) diagnosis, treatment, and prevention; 

13 ‘‘(4) studies using longitudinal data and retro14 spective analysis to identify effective treatments and 

15 outcomes for individuals with congenital heart dis16 ease; and 

17 ‘‘(5) identifying barriers to lifelong care for in18 dividuals with congenital heart disease. 

19 ‘‘(b) COORDINATION OF RESEARCH ACTIVITIES.— 

20 The Director of the Institute may coordinate research ef21 forts related to congenital heart disease among multiple 

22 research institutions and may develop research networks. 

23 ‘‘(c) MINORITY AND MEDICALLY UNDERSERVED

24 COMMUNITIES.—In carrying out the activities described in 

25 this section, the Director of the Institute shall consider 


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1 the application of such research and other activities to mi2 nority and medically underserved communities. 

3 ‘‘(d) REPORT FROM NIH.—Not later than 1 year 

4 after the date of the enactment of the Congenital Heart 

5 Futures Reauthorization Act of 2017, the Director of 

6 NIH, acting through the Director of the Institute, shall 

7 provide a report to Congress— 

8 ‘‘(1) outlining the ongoing research efforts of 

9 the National Institutes of Health regarding con10 genital heart disease; and 

11 ‘‘(2) identifying— 

12 ‘‘(A) future plans for research regarding 

13 congenital heart disease; and 

14 ‘‘(B) the areas of greatest need for such 

15 research.’’. 

16 SECTION 1. SHORT TITLE. 

17 This Act may be cited as the ‘‘Congenital Heart Fu18 tures Reauthorization Act of 2017’’. 

19 SEC. 2. NATIONAL CONGENITAL HEART DISEASE RE20 SEARCH, SURVEILLANCE, AND AWARENESS. 

21 Section 399V–2 of the Public Health Service Act (42 

22 U.S.C. 280g–13) is amended to read as follows: 


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1 ‘‘SEC. 399V–2. NATIONAL CONGENITAL HEART DISEASE RE2 SEARCH, SURVEILLANCE, AND AWARENESS. 

3 ‘‘(a) IN GENERAL.—The Secretary shall, as appro4 priate— 

5 ‘‘(1) enhance and expand research and data col6 lection efforts related to congenital heart disease, in7 cluding to study and track the epidemiology of con8 genital heart disease to understand health outcomes 

9 for individuals with congenital heart disease across 

10 all ages; 

11 ‘‘(2) conduct activities to improve public aware12 ness of, and education related to, congenital heart dis13 ease, including care of individuals with such disease; 

14 and 

15 ‘‘(3) award grants to entities to undertake the 

16 activities described in this section. 

17 ‘‘(b) ACTIVITIES.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall carry 

19 out activities, including, as appropriate, through a 

20 national cohort study and a nationally-representative, 

21 population-based surveillance system, to improve the 

22 understanding of the epidemiology of congenital heart 

23 disease in all age groups, with particular attention 

24 to— 

25 ‘‘(A) the incidence and prevalence of con26 genital heart disease in the United States; 


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1 ‘‘(B) causation and risk factors associated 

2 with, and natural history of, congenital heart 

3 disease; 

4 ‘‘(C) health care utilization by individuals 

5 with congenital heart disease; 

6 ‘‘(D) demographic factors associated with 

7 congenital heart disease, such as age, race, eth8 nicity, sex, and family history of individuals 

9 who are diagnosed with the disease; and 

10 ‘‘(E) evidence-based practices related to care 

11 and treatment for individuals with congenital 

12 heart disease. 

13 ‘‘(2) PERMISSIBLE CONSIDERATIONS.—In car14 rying out the activities under this section, the Sec15 retary may, as appropriate— 

16 ‘‘(A) collect data on the health outcomes, in17 cluding behavioral and mental health outcomes, 

18 of a diverse population of individuals of all ages 

19 with congenital heart disease, such that analysis 

20 of the outcomes will inform evidence-based prac21 tices for individuals with congenital heart dis22 ease; and 

23 ‘‘(B) consider health disparities among in24 dividuals with congenital heart disease, which 


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1 may include the consideration of prenatal expo2 sures. 

3 ‘‘(c) AWARENESS CAMPAIGN.—The Secretary may 

4 carry out awareness and educational activities related to 

5 congenital heart disease in individuals of all ages, which 

6 may include information for patients, family members, and 

7 health care providers, on topics such as the prevalence of 

8 such disease, the effect of such disease on individuals of all 

9 ages, and the importance of long-term, specialized care for 

10 individuals with such disease. 

11 ‘‘(d) PUBLIC ACCESS.—The Secretary shall ensure 

12 that, subject to subsection (e), information collected under 

13 this section is made available, as appropriate, to the public, 

14 including researchers. 

15 ‘‘(e) PATIENT PRIVACY.—The Secretary shall ensure 

16 that the data and information collected under this section 

17 are made available in a manner that, at a minimum, pro18 tects personal privacy to the extent required by applicable 

19 Federal and State law. 

20 ‘‘(f) ELIGIBILITY FOR GRANTS.—To be eligible to re21 ceive a grant under subsection (a)(3), an entity shall— 

22 ‘‘(1) be a public or private nonprofit entity with 

23 specialized experience in congenital heart disease; and 


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1 ‘‘(2) submit to the Secretary an application at 

2 such time, in such manner, and containing such in3 formation as the Secretary may require. 

4 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

5 out this section, there are authorized to be appropriated 

6 such sums as may be necessary for each of fiscal years 2019 

7 through 2023.’’. 

8 SEC. 3. REPORT. 

9 Not later than 3 years after the date of enactment of 

10 the Congenital Heart Futures Reauthorization Act of 2017, 

11 the Secretary of Health and Human Services shall submit 

12 to the Committee on Health, Education, Labor, and Pen13 sions of the Senate and the Committee on Energy and Com14 merce of the House of Representatives a report summarizing 

15 any activities carried out pursuant to section 399V–2 of 

16 the Public Health Service Act (as amended by section 2), 

17 including planned activities, and a summary of any re18 search findings and ongoing research efforts, gaps, and 

19 areas of greatest need within the Department of Health and 

20 Human Services regarding congenital heart disease in pa21 tients of all ages. 


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Calendar No. 555 

115TH CONGRESS 

2D SESSION H. R. 1222 

AN ACT 

To amend the Public Health Service Act to coordipurposes. ness of congenital heart disease, and for other forts and to improve public education and aware- nate Federal congenital heart disease research efAUGUST 15, 2018 

Reported with an amendment 


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