Bill Text: NY S01159 | 2023-2024 | General Assembly | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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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 3-0)

Status: (Engrossed) 2024-05-29 - referred to health [S01159 Detail]

Download: New_York-2023-S01159-Amended.html

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                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.