Bill Text: NY A09152 | 2023-2024 | General Assembly | Amended
Bill Title: 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).
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced) 2024-04-04 - print number 9152a [A09152 Detail]
Download: New_York-2023-A09152-Amended.html
STATE OF NEW YORK ________________________________________________________________________ 9152--A IN ASSEMBLY February 8, 2024 ___________ Introduced by M. of A. PAULIN -- read once and referred to the Committee on Health -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee 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 24 or facilitating the prenatal testing. Such written notice shall be 25 reviewed and approved by the department. Such written notice shall be EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD04085-05-4A. 9152--A 2 1 plainly worded and prominently displayed in any material presented to a 2 patient or a potential parent about prenatal testing services. 3 c. Nothing contained in this section shall be construed to limit a 4 health care practitioner licensed, certified, or authorized under title 5 eight of the education law from recommending certain prenatal testing 6 services according to the practitioner's reasonable and good faith 7 professional judgment based on the facts of a patient's case. 8 § 2. Section 266 of the public health law is amended by adding a new 9 subdivision 7 to read as follows: 10 7. Non-invasive prenatal testing. In addition to the information 11 provided pursuant to this section, the commissioner shall also develop 12 comprehensive informational materials regarding the benefits and limita- 13 tions of non-invasive prenatal testing, including the difference between 14 non-invasive prenatal testing and prenatal diagnostic testing. Such 15 information shall be posted on the website in a printable format, in 16 multiple languages in accordance with section two hundred two-a of the 17 executive law to allow all general hospitals, diagnostic and treatment 18 centers, obstetricians, primary care providers, midwives, and other 19 health care programs providing women's wellness services to provide the 20 information to their patients as part of their prenatal care activities. 21 The informational materials shall also include: 22 (a) the current recommendations on non-invasive prenatal testing made 23 by the American College of Obstetricians and Gynecologists (ACOG), and 24 the Society for Maternal Fetal Medicine, and the American College of 25 Medical Genetics and Genomics (ACMG); 26 (b) a statement informing individuals that non-invasive prenatal test- 27 ing is used for screening purposes to determine the potential for possi- 28 ble fetal genetic abnormalities and is not intended to determine whether 29 or not such abnormalities exist; 30 (c) a statement informing individuals that non-invasive prenatal test- 31 ing carries a risk of false-positive results and that any positive 32 result should be followed up with prenatal diagnostic testing; and 33 (d) a list of the non-invasive screening tests that have been approved 34 or cleared by the federal Food and Drug Administration (FDA), the New 35 York State Clinical Laboratory Evaluation Program (CLEP), or both, and a 36 summary of the known performance characteristics of these tests when 37 available. 38 § 3. This act shall take effect on the one hundred eightieth day after 39 it shall have become a law. Effective immediately, the addition, amend- 40 ment and/or repeal of any rule or regulation necessary for the implemen- 41 tation of this act on its effective date are authorized to be made and 42 completed on or before such effective date.
