I 
114TH CONGRESS 
2D SESSION 
H. R. 5479 
To provide for programs under the Department of Health and Human Serv-
ices to improve newborn screening, evaluation, and intervention for crit-
ical congenital heart defect. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 14, 2016 
Ms. MCCOLLUM introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To provide for programs under the Department of Health 
and Human Services to improve newborn screening, eval-
uation, and intervention for critical congenital heart de-
fect. 
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 ‘‘Screening Hearts in 
Newborns for Early Detection of Congenital Heart Defect 
Act’’ or the ‘‘SHINE Act’’. 
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SEC. 2. PROGRAMS TO IMPROVE NEWBORN SCREENING, 
EVALUATION, AND INTERVENTION FOR CRIT-
ICAL CONGENITAL HEART DEFECT. 
(a) STATEWIDE NEWBORN SCREENING PROGRAMS, 
EVALUATION AND INTERVENTION PROGRAMS AND INFOR-
MATION SYSTEMS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall make awards of grants or co-
operative agreements to States to— 
(A) develop and improve, with respect to 
critical congenital heart defect, statewide new-
born CCHD screening, evaluation, diagnosis, 
results reporting, data collection and surveil-
lance, and intervention programs and systems; 
and 
(B) assist in the recruitment, retention, 
education, and training of qualified personnel; 
for the purposes described in paragraph (2). 
(2) PURPOSES.—For purposes of paragraph 
(1), the purposes described in this paragraph are the 
following: 
(A) To develop and monitor the efficacy of 
statewide programs and systems for CCHD 
screening of newborns, evaluate and diagnose 
newborns referred from screening programs, 
and provide for educational and medical inter-
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ventions for newborns identified with critical 
congenital heart defect (and other health condi-
tions associated with hypoxemia). 
(B) To provide for early intervention, in-
cluding— 
(i) referral to and delivery of informa-
tion and services, relating to CCHD 
screening, evaluation, and diagnosis, by en-
tities and agencies, including clinical, com-
munity, consumer, and parent-based agen-
cies and organizations; and 
(ii) other programs mandated by part 
C of the Individuals with Disabilities Edu-
cation Act (20 U.S.C. 1431 et seq.), which 
offer programs specifically designed to 
meet the unique needs of newborns with 
critical congenital heart defect and which 
establish and foster family-to-family sup-
port mechanisms critical in the first 
months after a newborn is identified with 
critical congenital heart defect. 
(C) To collect data on statewide newborn 
CCHD screening and screening of secondary 
conditions and evaluation and intervention pro-
grams and systems that can be applied for 
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quality improvement, research, program evalua-
tion, and policy development. 
(D) To encourage the adoption by State 
agencies of models described in subparagraph 
(E). 
(E) To provide for other activities, which 
may include the development of efficient models 
to ensure that newborns who are identified with 
critical congenital heart defect through screen-
ing receive follow-up by a qualified health care 
provider. 
(b) CCHD INFORMATION AND SURVEILLANCE SYS-
TEMS AND APPLIED RESEARCH.— 
(1) CENTERS FOR DISEASE CONTROL AND PRE-
VENTION.—In accordance with the recommendations 
described in paragraph (5), the Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall make awards of grants 
or cooperative agreements to provide technical as-
sistance to State agencies to complement intramural 
programs and to conduct applied research related to 
newborn CCHD screening, evaluation and interven-
tion programs, and data collection and information 
systems, such as— 
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(A) standardized procedures for data man-
agement and program effectiveness to ensure 
quality monitoring of newborn CCHD screen-
ing, evaluation, diagnosis, and intervention pro-
grams and systems; 
(B) evaluation of the current capacity of 
existing population-based State surveillance and 
tracking to monitor the effectiveness of new-
born CCHD screening to reduce infant mor-
tality and morbidity; 
(C) provision of technical assistance on 
data collection and management, including 
leveraging an electronic health record frame-
work for critical congenital heart defect data 
and reporting; 
(D) study of the costs and effectiveness of 
newborn CCHD screening and secondary tar-
gets and nontarget conditions associated with 
hypoxemia; 
(E) evaluation and intervention programs 
and systems conducted by State-based pro-
grams in order to answer issues of importance 
to State and national policymakers; 
(F) further study of the causes and risk 
factors for critical congenital heart defect; 
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(G) study of the effectiveness of newborn 
CCHDs screening, followup diagnostics, medical 
evaluations and intervention programs and sys-
tems by assessing the health, intellectual, and 
social 
developmental, 
cognitive, 
and 
neurodevelopmental status of such children as 
they grow and enter school age; and 
(H) data reporting by State agencies to 
the Department of Health and Human Services 
regarding CCHD screening conducted as part 
of State-based birth defects monitoring and 
long-term follow up programs for the purpose of 
providing appropriate services. 
(2) NATIONAL INSTITUTES OF HEALTH.—In ac-
cordance with the recommendations described in 
paragraph (5), the Director of the National Insti-
tutes of Health shall, for purposes of this section— 
(A) conduct a program of research and de-
velopment on the efficacy of new screening tech-
niques and technology, including clinical studies 
of screening methods, follow-up diagnostic tools, 
and studies on efficacy of intervention and re-
lated research; and 
(B) acting through the National Library of 
Medicine of the National Institutes of Health, 
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assist the Secretary with the development and 
deployment of expanded coding terminology for 
pulse oximetry screening for CCHD and follow- 
up diagnostic testing related to screening and 
integrating results into electronic medical 
records and as part of interoperability with 
public health information systems. 
(3) HEALTH
RESOURCES
SERVICES
ADMINIS-
TRATION.—In accordance with the recommendations 
described in paragraph (5), the Administrator of the 
Health Resources and Services Administration shall, 
in coordination with the Director of the Centers for 
Disease Control and Prevention— 
(A) guide the assessment and improvement 
of screening standards and infrastructure need-
ed for the implementation of a public health ap-
proach to point of care screening for congenital 
heart defects; and 
(B) coordinate and collaborate in assisting 
States to establish newborn CCHD screening 
and other secondary conditions associated with 
hypoxemia, evaluation, diagnosis, and interven-
tion programs and systems under paragraph (1) 
and to develop a data collection system under 
paragraph (2). 
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(4) FDA CENTER FOR DEVICES AND RADIO-
LOGICAL
HEALTH.—In accordance with the rec-
ommendations described in paragraph (5), the Cen-
ter for Devices and Radiological Health of the Food 
and Drug Administration shall provide guidance to 
health care providers, industry, and staff of the 
Food and Drug Administration on pulse oximeters 
and the unique role of pulse oximetry in screening 
neonatal patients. 
(5) RECOMMENDATIONS.—The recommenda-
tions described in this paragraph are the following 
recommendations contained in the plan of action of 
the Interagency Coordinating Committee on New-
born and Child Screening established under section 
114 of the Public Health Service Act (42 U.S.C. 
300b–13): 
(A) The recommendation for the Centers 
for Disease Control and Prevention to fund sur-
veillance activities to monitor the CCHD link to 
infant mortality and other health outcomes. 
(B) The recommendation for the National 
Institutes of Health to fund research activities 
to determine the relationships among the 
screening technology, diagnostic processes, care 
provided, and health outcomes of affected 
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newborns with CCHD as a result of prospective 
newborn screening. 
(C) The recommendation for the Health 
Resources and Services Administration to guide 
the development of screening standards and in-
frastructure needed for the implementation of a 
public health approach to point of service 
screening for critical congenital cyanotic heart 
defect. 
(D) The recommendation for the Health 
Resources and Services Administration to fund 
the development of, in collaboration with public 
health and health care professional organiza-
tions and families, appropriate education and 
training materials for families and public health 
and health care professionals relevant to the 
screening and treatment of CCHD. 
(6) CONSULTATION.—In carrying out programs 
under this subsection, the Administrator of the 
Health Resources and Services Administration, the 
Director of the Centers for Disease Control and Pre-
vention, and the Director of the National Institutes 
of Health shall collaborate and consult with other 
Federal agencies; State and local agencies, including 
those responsible for newborn screening and early 
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intervention services under the Medicaid program 
under title XIX of the Social Security Act (42 
U.S.C. 1396 et seq.), under the Children’s Health 
Insurance Program under title XXI of the Social Se-
curity Act (42 U.S.C. 1397aa et seq.) (State Chil-
dren’s Health Insurance Program), under the Ma-
ternal and Child Health Block Grant Program under 
title V of the Social Security Act (42 U.S.C. 701 et 
seq.), and under part C of the Individuals with Dis-
abilities Education Act (20 U.S.C. 1431 et seq.); 
consumer groups of, and those that serve, individ-
uals with congenital heart defect and families of 
such individuals; appropriate national medical and 
other health and education specialty organizations; 
persons living with critical congenital heart defect 
and families of such persons; other qualified profes-
sional personnel who are proficient in congenital 
heart defect, CCHD, and related conditions, and 
who possess the specialized knowledge, skills, and at-
tributes needed to serve newborns, infants, toddlers, 
and children diagnosed with congenital heart defect 
and families of such newborns, infants, toddlers, and 
children; third-party payers and managed care orga-
nizations; and related commercial industries. 
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(7) POLICY
DEVELOPMENT.—The Adminis-
trator of the Health Resources and Services Admin-
istration, the Director of the Centers for Disease 
Control and Prevention, and the Director of the Na-
tional Institutes of Health shall coordinate and col-
laborate to develop and update recommendations for 
policy development at the Federal and State levels 
and with the private sector, including consumer, 
medical, and other health and education profes-
sional-based organizations, with respect to newborn 
screening, evaluation, diagnosis, and intervention 
programs and systems. Such recommendations and 
updates shall be made available on the public Web 
site of the Department of Health and Human Serv-
ices. 
(c) DEFINITIONS.—For purposes of this section: 
(1) The term ‘‘CCHD’’ means critical con-
genital heart defect. 
(2) The term ‘‘newborn CCHD screening’’ 
means objective physiologic procedures to detect pos-
sible congenital heart problems and to identify 
newborns and infants who require further medical 
evaluations or interventions. 
(d) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated such sums as may be nec-
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essary to carry out this section for each of fiscal years 
2017 through 2021. 
Æ 
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