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NY A00044
Bill
Status
1/8/2025
Primary Sponsor
Amy Paulin
Click for details
AI Summary
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Requires manufacturers and suppliers of non-invasive prenatal screening tests to provide written notice explaining that these tests are for screening purposes only, not diagnostic, and that positive results should be followed by confirmatory diagnostic testing
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Mandates written notice be provided to patients at three points: prior to testing, with test results, and with any materials about prenatal testing services, with all notices reviewed and approved by the Department of Health
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Directs the Health Commissioner to develop comprehensive informational materials on benefits and limitations of non-invasive prenatal testing, to be posted online in printable format and multiple languages for distribution by healthcare providers
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Requires informational materials to include current recommendations from ACOG, Society for Maternal Fetal Medicine, and ACMG, plus a list of FDA and NYS Clinical Laboratory Evaluation Program approved tests with known performance characteristics
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Takes effect 180 days after becoming law, with immediate authorization for necessary regulatory rule-making
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
1/7/2026