A 44: 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).

  
  STATE OF NEW YORK ________________________________________________________________________ 44 2025-2026 Regular Sessions  IN ASSEMBLY (Prefiled) January 8, 2025 ___________ Introduced by M. of A. PAULIN -- read once and referred to the Committee on Health AN ACT to amend the public health law, in relation to requiring disclo- sure of information concerning non-invasive prenatal screening for chromosomal abnormalities The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. The public health law is amended by adding a new section 2 2533 to read as follows: 3 § 2533. Disclosure of information concerning non-invasive prenatal 4 screening for chromosomal abnormalities. 1. For the purposes of this 5 section, the term "non-invasive prenatal screening" shall mean any non- 6 invasive prenatal screening or cell free fetal DNA screening used to 7 ascertain whether a fetus is at risk for certain chromosomal abnor- 8 malities. 9 2. Non-invasive prenatal screenings shall be accompanied by a written 10 notice, provided by the entity which manufactured, supplied, or other- 11 wise created such test or which advertised performing these prenatal 12 screening tests, about the use of such test for screening purposes, the 13 fact that not all high risk occurrences correspond to a positive result, 14 the fact that not all low risk results correspond to a negative result, 15 a clear statement indicating that non-invasive prenatal screenings are 16 intended solely for screening purposes to assess risk of possible fetal 17 genetic abnormalities and is not intended to be used for diagnostic 18 purposes to determine whether such abnormalities actually exist and that 19 any positive result should be followed by confirmatory diagnostic test- 20 ing, and that additional follow up is recommended for all high risk 21 screening. Such written notice shall be provided to a patient or a 22 potential parent: (a) prior to any prenatal test; (b) with such test 23 results; and (c) with any materials provided by the entity providing EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD00009-01-5 
 A. 44 2 1 or facilitating the prenatal testing. Such written notice shall be 2 reviewed and approved by the department. Such written notice shall be 3 plainly worded and prominently displayed in any material presented to a 4 patient or a potential parent about prenatal testing services. 5 c. Nothing contained in this section shall be construed to limit a 6 health care practitioner licensed, certified, or authorized under title 7 eight of the education law from recommending certain prenatal testing 8 services according to the practitioner's reasonable and good faith 9 professional judgment based on the facts of a patient's case. 10 § 2. Section 266 of the public health law is amended by adding a new 11 subdivision 7 to read as follows: 12 7. Non-invasive prenatal testing. In addition to the information 13 provided pursuant to this section, the commissioner shall also develop 14 comprehensive informational materials regarding the benefits and limita- 15 tions of non-invasive prenatal testing, including the difference between 16 non-invasive prenatal testing and prenatal diagnostic testing. Such 17 information shall be posted on the website in a printable format, in 18 multiple languages in accordance with section two hundred two-a of the 19 executive law to allow all general hospitals, diagnostic and treatment 20 centers, obstetricians, primary care providers, midwives, and other 21 health care programs providing women's wellness services to provide the 22 information to their patients as part of their prenatal care activities. 23 The informational materials shall also include: 24 (a) the current recommendations on non-invasive prenatal testing made 25 by the American College of Obstetricians and Gynecologists (ACOG), and 26 the Society for Maternal Fetal Medicine, and the American College of 27 Medical Genetics and Genomics (ACMG); 28 (b) a statement informing individuals that non-invasive prenatal test- 29 ing is used for screening purposes to determine the potential for possi- 30 ble fetal genetic abnormalities and is not intended to determine whether 31 or not such abnormalities exist; 32 (c) a statement informing individuals that non-invasive prenatal test- 33 ing carries a risk of false-positive results and that any positive 34 result should be followed up with prenatal diagnostic testing; and 35 (d) a list of the non-invasive screening tests that have been approved 36 or cleared by the federal Food and Drug Administration (FDA), the New 37 York State Clinical Laboratory Evaluation Program (CLEP), or both, and a 38 summary of the known performance characteristics of these tests when 39 available. 40 § 3. This act shall take effect on the one hundred eightieth day after 41 it shall have become a law. Effective immediately, the addition, amend- 42 ment and/or repeal of any rule or regulation necessary for the implemen- 43 tation of this act on its effective date are authorized to be made and 44 completed on or before such effective date.