New York Senate Bill S01159 Latest Draft

   
  STATE OF NEW YORK ________________________________________________________________________ 1159--A 2023-2024 Regular Sessions  IN SENATE January 10, 2023 ___________ Introduced by Sens. SKOUFIS, THOMAS, WEBB -- read twice and ordered printed, and when printed to be committed to the Committee on Health -- recommitted to the Committee on Health in accordance with Senate Rule 6, sec. 8 -- 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 following terms shall mean the following: 6 (a) "Laboratory" shall have the same meaning as is set forth in 7 section five hundred seventy-one of this chapter. 8 (b) "Non-invasive prenatal screening" shall mean any non-invasive 9 prenatal screening or cell free fetal DNA screening used to ascertain 10 whether a fetus is at risk for certain chromosomal abnormalities. 11 2. Non-invasive prenatal screenings shall be accompanied by a written 12 notice, provided by the entity which manufactured, supplied, or other- 13 wise created such test or which advertised performing these prenatal 14 screening tests, about the use of such test for screening purposes, the 15 fact that not all high risk occurrences correspond to a positive result, 16 the fact that not all low risk results correspond to a negative result, 17 a clear statement indicating that non-invasive prenatal screenings are 18 intended solely for screening purposes to assess risk of possible fetal 19 genetic abnormalities and is not intended to be used for diagnostic 20 purposes to determine whether such abnormalities actually exist and that 21 any positive result should be followed by confirmatory diagnostic test- EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD04085-02-4 
 S. 1159--A 2 1 ing, and that additional follow up is recommended for all high risk 2 screening. Such written notice shall be provided to a patient or a 3 potential parent: (a) prior to any prenatal test; (b) with such test 4 results; and (c) with any materials provided by the entity providing 5 or facilitating the prenatal testing. Such written notice shall be 6 reviewed and approved by the department. Such written notice shall be 7 plainly worded and prominently displayed in any material presented to a 8 patient or a potential parent about prenatal testing services. 9 c. Nothing contained in this section shall be construed to limit a 10 health care practitioner licensed, certified, or authorized under title 11 eight of the education law from recommending certain prenatal testing 12 services according to the practitioner's reasonable and good faith 13 professional judgment based on the facts of a patient's case. 14 § 2. Section 266 of the public health law is amended by adding a new 15 subdivision 7 to read as follows: 16 7. Non-invasive prenatal testing. In addition to the information 17 provided pursuant to this section, the commissioner shall also develop 18 comprehensive informational materials regarding the benefits and limita- 19 tions of non-invasive prenatal testing, including the difference between 20 non-invasive prenatal testing and prenatal diagnostic testing. Such 21 information shall be posted on the website in a printable format, in 22 each of the top six languages spoken in the state, other than English, 23 according to the latest available data from the United States Census 24 Bureau, to allow all general hospitals, diagnostic and treatment 25 centers, obstetricians, primary care providers, midwives, and other 26 health care programs providing women's wellness services to provide the 27 information to their patients as part of their prenatal care activities. 28 The informational materials shall also include: 29 (a) the current recommendations on non-invasive prenatal testing made 30 by the American College of Obstetricians and Gynecologists (ACOG) and 31 the Society for Maternal Fetal Medicine; 32 (b) a statement informing individuals that non-invasive prenatal test- 33 ing is used for screening purposes to determine the potential for possi- 34 ble fetal genetic abnormalities and is not intended to determine whether 35 or not such abnormalities exist; 36 (c) a statement informing individuals that non-invasive prenatal test- 37 ing carries a risk of false-positive results and that any positive 38 result should be followed up with prenatal diagnostic testing; and 39 (d) a list of the non-invasive screening tests that have been approved 40 or cleared by the federal Food and Drug Administration (FDA), the New 41 York State Clinical Laboratory Evaluation Program (CLEP), or both, and a 42 summary of the known performance characteristics of these tests when 43 available. 44 § 3. This act shall take effect on the one hundred eightieth day after 45 it shall have become a law. Effective immediately, the addition, amend- 46 ment and/or repeal of any rule or regulation necessary for the implemen- 47 tation of this act on its effective date are authorized to be made and 48 completed on or before such effective date.