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 Fed-
eral congenital heart disease research efforts and to im-
prove public education and awareness of congenital heart 
disease, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Congenital Heart Fu-
tures Reauthorization Act of 2017’’. 
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SEC. 2. NATIONAL CONGENITAL HEART DISEASE SURVEIL-
LANCE SYSTEM. 
Section 399V–2 of the Public Health Service Act (42 
U.S.C. 280g–13) is amended to read as follows: 
‘‘SEC. 399V–2. NATIONAL CONGENITAL HEART DISEASE RE-
SEARCH, SURVEILLANCE, AND AWARENESS. 
‘‘(a) IN GENERAL.—The Secretary shall— 
‘‘(1) enhance and expand research and surveil-
lance infrastructure to study and track the epidemi-
ology of congenital heart disease (in this section re-
ferred to as ‘CHD’); and 
‘‘(2) award grants to eligible entities to under-
take 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 under-
standing of the epidemiology of CHD across the life-
span, from birth to adulthood, with particular inter-
est in the following: 
‘‘(A) Health care utilization of those af-
fected by CHD. 
‘‘(B) Demographic factors associated with 
CHD, such as age, race, ethnicity, gender, and 
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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 avail-
able— 
‘‘(A) for purposes of CHD research, sub-
ject to appropriate protections of personal pri-
vacy, including protections required by para-
graph (4); and 
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‘‘(B) to the public, subject to paragraph 
(4) and with appropriate exceptions for protec-
tion of personal privacy. 
‘‘(4) PATIENT PRIVACY.—The Secretary shall 
ensure that the study under this subsection is car-
ried out in a manner that complies with the require-
ments applicable to a covered entity under the regu-
lations promulgated pursuant to section 264(c) of 
the Health Insurance Portability and Accountability 
Act of 1996. 
‘‘(c) ELIGIBILITY FOR GRANTS.—To be eligible to re-
ceive 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 in-
formation as the Secretary may require. 
‘‘(d)
AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $4,000,000 for each of fiscal years 2018 through 
2022.’’. 
SEC. 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: 
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‘‘SEC. 425. CONGENITAL HEART DISEASE. 
‘‘(a) IN GENERAL.—The Director of the Institute 
may expand, intensify, and coordinate research and re-
lated 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, in-
cluding 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 retro-
spective analysis to identify effective treatments and 
outcomes for individuals with congenital heart dis-
ease; and 
‘‘(5) identifying barriers to lifelong care for in-
dividuals with congenital heart disease. 
‘‘(b) COORDINATION OF RESEARCH ACTIVITIES.— 
The Director of the Institute may coordinate research ef-
forts 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 
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the application of such research and other activities to mi-
nority 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 con-
genital heart disease; and 
‘‘(2) identifying— 
‘‘(A) future plans for research regarding 
congenital heart disease; and 
‘‘(B) the areas of greatest need for such 
research.’’. 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Congenital Heart Fu-
tures Reauthorization Act of 2017’’. 
SEC. 2. NATIONAL CONGENITAL HEART DISEASE RE-
SEARCH, SURVEILLANCE, AND AWARENESS. 
Section 399V–2 of the Public Health Service Act (42 
U.S.C. 280g–13) is amended to read as follows: 
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‘‘SEC. 399V–2. NATIONAL CONGENITAL HEART DISEASE RE-
SEARCH, SURVEILLANCE, AND AWARENESS. 
‘‘(a) IN GENERAL.—The Secretary shall, as appro-
priate— 
‘‘(1) enhance and expand research and data col-
lection efforts related to congenital heart disease, in-
cluding to study and track the epidemiology of con-
genital heart disease to understand health outcomes 
for individuals with congenital heart disease across 
all ages; 
‘‘(2) conduct activities to improve public aware-
ness of, and education related to, congenital heart dis-
ease, 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 con-
genital heart disease in the United States; 
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‘‘(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, eth-
nicity, 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 car-
rying out the activities under this section, the Sec-
retary may, as appropriate— 
‘‘(A) collect data on the health outcomes, in-
cluding 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 prac-
tices for individuals with congenital heart dis-
ease; and 
‘‘(B) consider health disparities among in-
dividuals with congenital heart disease, which 
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may include the consideration of prenatal expo-
sures. 
‘‘(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, pro-
tects personal privacy to the extent required by applicable 
Federal and State law. 
‘‘(f) ELIGIBILITY FOR GRANTS.—To be eligible to re-
ceive 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 
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‘‘(2) submit to the Secretary an application at 
such time, in such manner, and containing such in-
formation 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.’’. 
SEC. 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 Pen-
sions of the Senate and the Committee on Energy and Com-
merce 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 re-
search findings and ongoing research efforts, gaps, and 
areas of greatest need within the Department of Health and 
Human Services regarding congenital heart disease in pa-
tients of all ages. 
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