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NY S01159
Bill
Status
5/29/2024
Primary Sponsor
James Skoufis
Click for details
AI Summary
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Requires written notice from entities manufacturing, supplying, or performing non-invasive prenatal screening tests that clearly states these tests are for screening purposes only, not diagnosis, and that positive results require confirmatory diagnostic testing.
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Notice must be provided prior to testing, with results, and in all materials about prenatal testing services, must be plainly worded and prominently displayed, and subject to Department of Health review and approval.
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Directs the Department of Health to develop comprehensive informational materials on non-invasive prenatal testing benefits and limitations, posted online in printable format in the top six non-English languages spoken in New York.
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Informational materials must include current recommendations from ACOG and Society for Maternal Fetal Medicine, distinction between screening and diagnostic testing, risk of false-positive results, and list of FDA-approved or CLEP-cleared non-invasive screening tests with performance characteristics.
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Takes effect 180 days after enactment; authorizes regulatory implementation immediately.
Legislative Description
Requires disclosure of information concerning non-invasive prenatal screening for chromosomal abnormalities including the benefits and limitations of non-invasive prenatal testing, the difference between non-invasive prenatal testing and prenatal diagnostic testing, and current recommendations from the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal Fetal Medicine, and the American College of Medical Genetics and Genomics (ACMG).
Last Action
referred to health
5/29/2024