SHINE Act

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''.

SEC. 2. PROGRAMS TO IMPROVE NEWBORN SCREENING, EVALUATION, AND 
              INTERVENTION FOR CRITICAL CONGENITAL HEART DEFECT.

    (a) Statewide Newborn Screening Programs, Evaluation and 
Intervention Programs and Information Systems.--
            (1) In general.--The Secretary of Health and Human Services 
        shall make awards of grants or cooperative agreements to States 
        to--
                    (A) develop and improve, with respect to critical 
                congenital heart defect, statewide newborn CCHD 
                screening, evaluation, diagnosis, results reporting, 
                data collection and surveillance, 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 interventions for newborns identified with 
                critical congenital heart defect (and other health 
                conditions associated with hypoxemia).
                    (B) To provide for early intervention, including--
                            (i) referral to and delivery of information 
                        and services, relating to CCHD screening, 
                        evaluation, and diagnosis, by entities and 
                        agencies, including clinical, community, 
                        consumer, and parent-based agencies and 
                        organizations; and
                            (ii) other programs mandated by part C of 
                        the Individuals with Disabilities Education 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 support 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 programs and systems that 
                can be applied for quality improvement, research, 
                program evaluation, 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 screening receive 
                follow-up by a qualified health care provider.
    (b) CCHD Information and Surveillance Systems and Applied 
Research.--
            (1) Centers for disease control and prevention.--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 assistance to State 
        agencies to complement intramural programs and to conduct 
        applied research related to newborn CCHD screening, evaluation 
        and intervention programs, and data collection and information 
        systems, such as--
                    (A) standardized procedures for data management and 
                program effectiveness to ensure quality monitoring of 
                newborn CCHD screening, evaluation, diagnosis, and 
                intervention programs and systems;
                    (B) evaluation of the current capacity of existing 
                population-based State surveillance and tracking to 
                monitor the effectiveness of newborn CCHD screening to 
                reduce infant mortality and morbidity;
                    (C) provision of technical assistance on data 
                collection and management, including leveraging an 
                electronic health record framework for critical 
                congenital heart defect data and reporting;
                    (D) study of the costs and effectiveness of newborn 
                CCHD screening and secondary targets and nontarget 
                conditions associated with hypoxemia;
                    (E) evaluation and intervention programs and 
                systems conducted by State-based programs 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;
                    (G) study of the effectiveness of newborn CCHDs 
                screening, followup diagnostics, medical evaluations 
                and intervention programs and systems 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 accordance with the 
        recommendations described in paragraph (5), the Director of the 
        National Institutes of Health shall, for purposes of this 
        section--
                    (A) conduct a program of research and development 
                on the efficacy of new screening techniques and 
                technology, including clinical studies of screening 
                methods, follow-up diagnostic tools, and studies on 
                efficacy of intervention and related research; and
                    (B) acting through the National Library of Medicine 
                of the National Institutes of Health, 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 administration.--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 needed for the 
                implementation of a public health approach 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 intervention programs and systems under 
                paragraph (1) and to develop a data collection system 
                under paragraph (2).
            (4) FDA center for devices and radiological health.--In 
        accordance with the recommendations described in paragraph (5), 
        the Center 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 recommendations described in this 
        paragraph are the following recommendations contained in the 
        plan of action of the Interagency Coordinating Committee on 
        Newborn 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 surveillance 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 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 infrastructure 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 organizations 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 Prevention, 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 
        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 Security Act (42 U.S.C. 1397aa et seq.) (State 
        Children's Health Insurance Program), under the Maternal 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 Disabilities Education Act (20 U.S.C. 1431 et 
        seq.); consumer groups of, and those that serve, individuals 
        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 professional personnel who are proficient in 
        congenital heart defect, CCHD, and related conditions, and who 
        possess the specialized knowledge, skills, and attributes 
        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 organizations; and related commercial 
        industries.
            (7) Policy development.--The Administrator of the Health 
        Resources and Services Administration, the Director of the 
        Centers for Disease Control and Prevention, and the Director of 
        the National Institutes of Health shall coordinate and 
        collaborate 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 professional-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 Services.
    (c) Definitions.--For purposes of this section:
            (1) The term ``CCHD'' means critical congenital heart 
        defect.
            (2) The term ``newborn CCHD screening'' means objective 
        physiologic procedures to detect possible 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 necessary to carry out this section 
for each of fiscal years 2017 through 2021.

Summary: Screening Hearts in Newborns for Early Detection of Congenital Heart Defect Act or the SHINE Act This bill requires the Department of Health and Human Services (HHS) to award grants or cooperative agreements to states for: (1) developing and improving statewide newborn critical congenital heart defect (CCHD) screening, evaluation, diagnosis, results reporting, data collection and surveillance, and intervention programs and systems; and (2) assisting in the recruitment, retention, education, and training of qualified personnel for related purposes. The Centers for Disease Control and Prevention must award grants or cooperative agreements to provide technical assistance to states in order to support programs and research concerning newborn CCHD screening, evaluation and intervention, and data collection and information systems. The National Institutes of Health must: (1) conduct a CCHD research and development program on the efficacy of new screening techniques and technology, and (2) assist HHS in developing and deploying expanded coding terminology for pulse oximetry screening for CCHD and related evaluation and data collection. The Health Resources and Services Administration must: (1) guide the assessment and improvement of screening standards and infrastructure needed for the implementation of a public health approach to point of care screening for congenital heart defects, and (2) develop a CCHD data collection system. The Center for Devices and Radiological Health must 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.