I 

114TH CONGRESS 

2D SESSION H. R. 5479 

To provide for programs under the Department of Health and Human Services to improve newborn screening, evaluation, and intervention for critical 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, evaluation, and intervention for critical congenital heart defect. 

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 ‘‘Screening Hearts in 

5 Newborns for Early Detection of Congenital Heart Defect 

6 Act’’ or the ‘‘SHINE Act’’. 


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1 SEC. 2. PROGRAMS TO IMPROVE NEWBORN SCREENING, 

2 EVALUATION, AND INTERVENTION FOR CRIT3 ICAL CONGENITAL HEART DEFECT. 

4 (a) STATEWIDE NEWBORN SCREENING PROGRAMS, 

5 EVALUATION AND INTERVENTION PROGRAMS AND INFOR6 MATION SYSTEMS.— 

7 (1) IN GENERAL.—The Secretary of Health and 

8 Human Services shall make awards of grants or co9 operative agreements to States to— 

10 (A) develop and improve, with respect to 

11 critical congenital heart defect, statewide new12 born CCHD screening, evaluation, diagnosis, 

13 results reporting, data collection and surveil14 lance, and intervention programs and systems; 

15 and 

16 (B) assist in the recruitment, retention, 

17 education, and training of qualified personnel; 

18 for the purposes described in paragraph (2). 

19 (2) PURPOSES.—For purposes of paragraph 

20 (1), the purposes described in this paragraph are the 

21 following: 

22 (A) To develop and monitor the efficacy of 

23 statewide programs and systems for CCHD 

24 screening of newborns, evaluate and diagnose 

25 newborns referred from screening programs, 

26 and provide for educational and medical interVerDate Sep 11 2014 02:38 Jun 15, 2016 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5479.IH H5479

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1 ventions for newborns identified with critical 

2 congenital heart defect (and other health condi3 tions associated with hypoxemia). 

4 (B) To provide for early intervention, in5 cluding— 

6 (i) referral to and delivery of informa7 tion and services, relating to CCHD 

8 screening, evaluation, and diagnosis, by en9 tities and agencies, including clinical, com10 munity, consumer, and parent-based agen11 cies and organizations; and 

12 (ii) other programs mandated by part 

13 C of the Individuals with Disabilities Edu14 cation Act (20 U.S.C. 1431 et seq.), which 

15 offer programs specifically designed to 

16 meet the unique needs of newborns with 

17 critical congenital heart defect and which 

18 establish and foster family-to-family sup19 port mechanisms critical in the first 

20 months after a newborn is identified with 

21 critical congenital heart defect. 

22 (C) To collect data on statewide newborn 

23 CCHD screening and screening of secondary 

24 conditions and evaluation and intervention pro25 grams and systems that can be applied for 


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1 quality improvement, research, program evalua2 tion, and policy development. 

3 (D) To encourage the adoption by State 

4 agencies of models described in subparagraph 

5 (E). 

6 (E) To provide for other activities, which 

7 may include the development of efficient models 

8 to ensure that newborns who are identified with 

9 critical congenital heart defect through screen10 ing receive follow-up by a qualified health care 

11 provider. 

12 (b) CCHD INFORMATION AND SURVEILLANCE SYS13 TEMS AND APPLIED RESEARCH.— 

14 (1) CENTERS FOR DISEASE CONTROL AND PRE15 VENTION.—In accordance with the recommendations 

16 described in paragraph (5), the Secretary, acting 

17 through the Director of the Centers for Disease 

18 Control and Prevention, shall make awards of grants 

19 or cooperative agreements to provide technical as20 sistance to State agencies to complement intramural 

21 programs and to conduct applied research related to 

22 newborn CCHD screening, evaluation and interven23 tion programs, and data collection and information 

24 systems, such as— 


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1 (A) standardized procedures for data man2 agement and program effectiveness to ensure 

3 quality monitoring of newborn CCHD screen4 ing, evaluation, diagnosis, and intervention pro5 grams and systems; 

6 (B) evaluation of the current capacity of 

7 existing population-based State surveillance and 

8 tracking to monitor the effectiveness of new9 born CCHD screening to reduce infant mor10 tality and morbidity; 

11 (C) provision of technical assistance on 

12 data collection and management, including 

13 leveraging an electronic health record frame14 work for critical congenital heart defect data 

15 and reporting; 

16 (D) study of the costs and effectiveness of 

17 newborn CCHD screening and secondary tar18 gets and nontarget conditions associated with 

19 hypoxemia; 

20 (E) evaluation and intervention programs 

21 and systems conducted by State-based pro22 grams in order to answer issues of importance 

23 to State and national policymakers; 

24 (F) further study of the causes and risk 

25 factors for critical congenital heart defect; 


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1 (G) study of the effectiveness of newborn 

2 CCHDs screening, followup diagnostics, medical 

3 evaluations and intervention programs and sys4 tems by assessing the health, intellectual, and 

5 social developmental, cognitive, and 

6 neurodevelopmental status of such children as 

7 they grow and enter school age; and 

8 (H) data reporting by State agencies to 

9 the Department of Health and Human Services 

10 regarding CCHD screening conducted as part 

11 of State-based birth defects monitoring and 

12 long-term follow up programs for the purpose of 

13 providing appropriate services. 

14 (2) NATIONAL INSTITUTES OF HEALTH.—In ac15 cordance with the recommendations described in 

16 paragraph (5), the Director of the National Insti17 tutes of Health shall, for purposes of this section— 

18 (A) conduct a program of research and de19 velopment on the efficacy of new screening tech20 niques and technology, including clinical studies 

21 of screening methods, follow-up diagnostic tools, 

22 and studies on efficacy of intervention and re23 lated research; and 

24 (B) acting through the National Library of 

25 Medicine of the National Institutes of Health, 


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1 assist the Secretary with the development and 

2 deployment of expanded coding terminology for 

3 pulse oximetry screening for CCHD and follow4 up diagnostic testing related to screening and 

5 integrating results into electronic medical 

6 records and as part of interoperability with 

7 public health information systems. 

8 (3) HEALTH RESOURCES SERVICES ADMINIS9 TRATION.—In accordance with the recommendations 

10 described in paragraph (5), the Administrator of the 

11 Health Resources and Services Administration shall, 

12 in coordination with the Director of the Centers for 

13 Disease Control and Prevention— 

14 (A) guide the assessment and improvement 

15 of screening standards and infrastructure need16 ed for the implementation of a public health ap17 proach to point of care screening for congenital 

18 heart defects; and 

19 (B) coordinate and collaborate in assisting 

20 States to establish newborn CCHD screening 

21 and other secondary conditions associated with 

22 hypoxemia, evaluation, diagnosis, and interven23 tion programs and systems under paragraph (1) 

24 and to develop a data collection system under 

25 paragraph (2). 


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1 (4) FDA CENTER FOR DEVICES AND RADIO2 LOGICAL HEALTH.—In accordance with the rec3 ommendations described in paragraph (5), the Cen4 ter for Devices and Radiological Health of the Food 

5 and Drug Administration shall provide guidance to 

6 health care providers, industry, and staff of the 

7 Food and Drug Administration on pulse oximeters 

8 and the unique role of pulse oximetry in screening 

9 neonatal patients. 

10 (5) RECOMMENDATIONS.—The recommenda11 tions described in this paragraph are the following 

12 recommendations contained in the plan of action of 

13 the Interagency Coordinating Committee on New14 born and Child Screening established under section 

15 114 of the Public Health Service Act (42 U.S.C. 

16 300b–13): 

17 (A) The recommendation for the Centers 

18 for Disease Control and Prevention to fund sur19 veillance activities to monitor the CCHD link to 

20 infant mortality and other health outcomes. 

21 (B) The recommendation for the National 

22 Institutes of Health to fund research activities 

23 to determine the relationships among the 

24 screening technology, diagnostic processes, care 

25 provided, and health outcomes of affected 


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1 newborns with CCHD as a result of prospective 

2 newborn screening. 

3 (C) The recommendation for the Health 

4 Resources and Services Administration to guide 

5 the development of screening standards and in6 frastructure needed for the implementation of a 

7 public health approach to point of service 

8 screening for critical congenital cyanotic heart 

9 defect. 

10 (D) The recommendation for the Health 

11 Resources and Services Administration to fund 

12 the development of, in collaboration with public 

13 health and health care professional organiza14 tions and families, appropriate education and 

15 training materials for families and public health 

16 and health care professionals relevant to the 

17 screening and treatment of CCHD. 

18 (6) CONSULTATION.—In carrying out programs 

19 under this subsection, the Administrator of the 

20 Health Resources and Services Administration, the 

21 Director of the Centers for Disease Control and Pre22 vention, and the Director of the National Institutes 

23 of Health shall collaborate and consult with other 

24 Federal agencies; State and local agencies, including 

25 those responsible for newborn screening and early 


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1 intervention services under the Medicaid program 

2 under title XIX of the Social Security Act (42 

3 U.S.C. 1396 et seq.), under the Children’s Health 

4 Insurance Program under title XXI of the Social Se5 curity Act (42 U.S.C. 1397aa et seq.) (State Chil6 dren’s Health Insurance Program), under the Ma7 ternal and Child Health Block Grant Program under 

8 title V of the Social Security Act (42 U.S.C. 701 et 

9 seq.), and under part C of the Individuals with Dis10 abilities Education Act (20 U.S.C. 1431 et seq.); 

11 consumer groups of, and those that serve, individ12 uals with congenital heart defect and families of 

13 such individuals; appropriate national medical and 

14 other health and education specialty organizations; 

15 persons living with critical congenital heart defect 

16 and families of such persons; other qualified profes17 sional personnel who are proficient in congenital 

18 heart defect, CCHD, and related conditions, and 

19 who possess the specialized knowledge, skills, and at20 tributes needed to serve newborns, infants, toddlers, 

21 and children diagnosed with congenital heart defect 

22 and families of such newborns, infants, toddlers, and 

23 children; third-party payers and managed care orga24 nizations; and related commercial industries. 


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1 (7) POLICY DEVELOPMENT.—The Adminis2 trator of the Health Resources and Services Admin3 istration, the Director of the Centers for Disease 

4 Control and Prevention, and the Director of the Na5 tional Institutes of Health shall coordinate and col6 laborate to develop and update recommendations for 

7 policy development at the Federal and State levels 

8 and with the private sector, including consumer, 

9 medical, and other health and education profes10 sional-based organizations, with respect to newborn 

11 screening, evaluation, diagnosis, and intervention 

12 programs and systems. Such recommendations and 

13 updates shall be made available on the public Web 

14 site of the Department of Health and Human Serv15 ices. 

16 (c) DEFINITIONS.—For purposes of this section: 

17 (1) The term ‘‘CCHD’’ means critical con18 genital heart defect. 

19 (2) The term ‘‘newborn CCHD screening’’ 

20 means objective physiologic procedures to detect pos21 sible congenital heart problems and to identify 

22 newborns and infants who require further medical 

23 evaluations or interventions. 

24 (d) AUTHORIZATION OF APPROPRIATIONS.—There is 

25 authorized to be appropriated such sums as may be necVerDate Sep 11 2014 02:38 Jun 15, 2016 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5479.IH H5479

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1 essary to carry out this section for each of fiscal years 

2 2017 through 2021. 

Æ 


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