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    INSTITUTIONREPORT NOPUB DATENOTE

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    PS 031 223

    Toiv, Helene F.; Austin, Janina; Gardiner, Emily Gamble;Tynan, Ann; Hill, Ariel; Milne, Kevin; Moon, Cindy; Lawes,Susan

    Newborn Screening: Characteristics of State Programs.General Accounting Office, Washington, DC.GAO -03 -449

    2003-03-0050p.

    U.S. General Accounting Office, 441 G Street, NW, Room LM,Washington, DC 20548 (first copy, free; additional copies $2each). Tel: 202-512-6000; Fax: 202-512-6061; Web site:http://www.gao.gov/cgi-bin/ordtab.pl. For full text:http://www.gao.gov/cgi-bin/getrpt?GA0-03-449.Reports Research (143)EDRS Price MF01/PC03 Plus Postage.

    Child Health; *Neonates; Screening Tests; *State ProgramsDepartment of Health and Human Services; *ProgramCharacteristics; *Screening Programs

    Each year, state newborn screening programs test 4 millionnewborns for disorders that require early detection and treatment to preventserious illness or death. The U.S. General Accounting Office (GAO) was askedto provide Congress with information on variations among state newbornscreening programs. Based on surveys of such programs in all 50 states andthe District of Columbia, the GAO found the following: (1) while the numberof genetic and metabolic disorders included in state screening programsranges from 4 to 36, most states screen for 8 or fewer disorders; (2) indeciding which disorders to include, states generally consider similarcriteria, such as whether the disorder is treatable, and costs of screeningfor additional disorders; (3) most programs have similar practices foradministering and funding their programs, and almost all provide educationfor parents and providers, but fewer than one-fourth inform parents of theiroption to obtain tests for additional disorders not included in the state'sprogram; (4) state programs are primarily funded through fees collected fromhealth care, providers; (5) all newborn screening laboratories participate ina quality assurance program offered by Department of Health and HumanServices' Centers for Disease Control and Prevention; (6) all states requirenewborn screening, and state statutes usually do not require parentalconsent, but 33 states allow exemptions from screening for religious reasons,and 13 additional states allow exemptions for any reason; and (7) newbornscreening statutes and regulations in over half the states containconfidentiality provisions, but these provisions are often subject toexceptions. (Seven appendices include the scope and methodology of the GAOstudy, information on disorders most commonly included in state newbornscreening programs, a chart of newborn screening program fees andexpenditures per infant screened, and comments from the Department of Healthand Human Services.) (HTH)

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  • Highlights of GA0-03-449, a repoiftoCongressional Requesters,

    Why GAO Did This StudyEach year state newborn screeningprograms test 4 million newbornsfor 'disorders that require earlydetection and treatment to'preventserious illness or death. GAO was' ;asked to provide the Congress withinformation. on the variationsamong state newborn screeningprograms, including information oncriteria considered in selectingdisorders to include in state*Programs, education for parentsand providers about newborn ;screening programs, and programs'expenditures and funding sources.To collect this information, GAOsurveyed newborn screening ;programs for genetic and metabolicdisorders in all 50 states and theDistrict of Columbia. GAO wasalso asked to provide informationon efforts by the Department ofHealth and Human Services (HITS)and states to evaluate the quality ofnewborn screening programs, statelaws and regulations that addressparental consent for newbornscreening, and state laws andregulations that addressconfidentiality issues.

    www.gao.gov /cgi- bin /getrpt ?GAO -03 -449.

    To view the full report, including the scopeand methodology, click on the link above.For more information, contact Marjorie Kanofat (202) 512-7119.

    March 2003

    NEWBORN SCREENING

    Characteristics of State Programs

    What GAO Found

    While the number of genetic and metabolic disorders included in statenewborn screening programs ranges from 4 to 36, most states screen for 8 orfewer disorders. In deciding which disorders to include, states generallyconsider similar criteria, such as whether the disorder is treatable. States alsoconsider the cost of screening for additional disorders. HHS's HealthResources and Services Administration is funding an expert group to assist itin developing a recommended set of disorders for which all states shouldscreen and criteria for selecting disorders.

    Most state newborn screening programs have similar practices foradministering and funding their programs. Almost all states provide educationon their newborn screening program for parents and providers, but fewer thanone-fourth inform parents of their option to obtain tests for additionaldisorders not included in the state's program. State programs are primarilyfunded through fees collected from health care providers, who may receivepayments from Medicaid and other third-party payers. Nationwide, feesfunded 64 percent of states' 2001 fiscal year program expenditures of over$120 million.

    All newborn screening laboratories participate in a quality assurance programoffered by HHS's Centers for Disease Control and Prevention, which assistsprograms in evaluating the quality of their laboratories. All states requirenewborn screening, and state statutes that govern screening usually do notrequire parental consent. However, 33 states' newborn screening statutes orregulations allow exemptions from screening for religious reasons, and 13additional states' newborn screening statutes or regulations allow exemptionsfor any reason. Newborn screening statutes and regulations inover half thestates contain confidentiality provisions, but these provisions are often subjectto exceptions.

    HHS said that the report presents a thorough summary of state newbornscreening programs' current practices.

    Disorders Most States Included in Their Newborn Screening Programs as of December2002

    Disorder

    Phenylketonuria

    Congenital hypothyroidism

    Galactosemia

    Sickle cell diseases

    Congenital adrenal hyperplasia

    Source: National Newborn Screening and Genetics Resource Center.

    Number of states

    51

    51

    50

    44

    32

    Note: This table does not include states that provide screening for the disorders to selectedpopulations, as part of pilot programs, or by request.

    '"States" refers to the 50 states and the District of Columbia.

    United States General Accounting Office

    3113) TO Will pilaw AVATR.A1TUR

  • Contents

    Letter1

    Results in Brief 2Background 4Disorders Included in State Newborn Screening Programs Vary,

    but Administration of Program Components Is Similar 8State Spending on Newborn Screening Varies, and Majority of State

    Programs Receive Most Funding from Fees 14Newborn Screening Quality Assurance Efforts Focus on

    Laboratory Testing and Performance Monitoring 17States Generally Do Not Require Consentfor Newborn Screening

    and Most Limit Disclosure of Screening Information 21Agency Comments 26

    Appendix I Scope and Methodology 28

    Appendix II Number of Disorders Included in State NewbornScreening Programs, December 2002 31

    Appendix III Information on Disorders Most CommonlyIncluded in State Newborn Screening Programs 33

    Appendix IV Selected Disorders States Screen for UsingMS/MS and Number of States That Screen forEach, December 2002 34

    Appendix V State Newborn Screening Program Fees andExpenditures Per Infant Screened 35

    Appendix VI Comments from the Department of Health andHuman Services 37

    Page i

    4GAO -03 -449 State Newborn Screening Programs

  • Appendix VII GAO Contact and Staff Acknowledgments 42GAO ContactAcknowledgments

    4242

    TablesTable 1: Disorders Most Commonly Included in State Newborn

    Screening Programs, December 2002 9Table 2: Categories of Individuals Represented on States' Newborn

    Screening Advisory Committees 12Table 3: Number of States Notifying Specific Parties of Newborn

    Screening Results 13Table 4: Funding Sources for State Newborn Screening Programs,

    as Percentage of Nationwide Program Expenditures, StateFiscal Year 2001 16

    Table 5: Basis on Which Newborn Screening Exemption IsGranted, by State 22

    Table 6: Exceptions to Confidentiality Requirements in States'Genetic Privacy Laws 25

    5Page ii GAO -03 -449 State Newborn Screening Programs

  • Abbreviations

    AAP American Academy of PediatricsAPHL Association of Public Health LaboratoriesCDC Centers for Disease Control and PreventionCLIA Clinical Laboratory Improvement Amendments of 1988CMS Centers for Medicare & Medicaid ServicesCORN Council of Regional Networks for Genetic ServicesHHS Departmen