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).
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A9152A
SPONSOR: Paulin TITLE OF BILL:
An act to amend the public health law, in relation to requiring disclo-
sure of information concerning non-invasive prenatal screening for chro-
mosomal abnormalities
PURPOSE:
Requires that entities resting providing non-invasive prenatal screening
for chromosomal abnormalities disclose information about the screening
and what the results could mean to patients
SUMMARY OF PROVISIONS:
Section 1: Amends the public health law by adding a new section 2533,
requiring a disclosure of information regarding non-invasive prenatal
screening for chromosomal abnormalities. It provides definitions for
terms such as "non-invasive prenatal screening." States that Non-inva-
sive prenatal screenings must be accompanied by a written notice,
provided by the entity responsible for the test, outlining information
about the purpose of the test, the limitations of results, and the
recommendation for confirmatory diagnostic testing in case of a positive
result. The written notice is required before the prenatal test, with
test results, and with any materials related to the prenatal testing.
Section 2: Amends Section 266 of the public health law to include a new
subdivision 7, mandating the commissioner of the DOH develop comprehen-
sive informational materials about non-invasive prenatal testing,
including its benefits and limitations.
Section 3: Sets effective date.
JUSTIFICATION:
Knowledge is essential to empower patients to make informed decisions
about their pregnancies. The proliferation of prenatal genetic testing
has provided healthcare providers and prospective parents with an ever-
expanding list of conditions for which a fetus can be tested early in
pregnancy.
Unfortunately, recent media reports have found that testing companies
are not providing doctors and patients with relevant information on the
high rate of false positive outcomes when testing for statistically rare
developmental conditions. In some cases, these tests have false positive
rates as high as 85-90%, yet on product brochures prior to testing, and
even on the test result sheets, companies describe the test results as
near certain in accuracy (language such as "reliable)" "highly accu-
rate," "total confidence," and "peace of mind" are included in promo-
tional advertising and documentation provided by testing companies.
This bill would require testing companies to provide information about
the use of such test for screening purposes, the fact that not all high
risk occurrences correspond to a positive result, the fact that not all
low risk results correspond to a negative result, a clear statement
indicating that NIPS are intended solely for screening purposes and that
any positive result should be followed by confirmatory diagnostic test-
ing. Such language would be required by this bill to be understandable
and easily visible when provided.
Additionally, the bill addresses the need for widespread dissemination
of information about non-invasive prenatal testing. By requiring the
commissioner to develop informational materials in multiple languages to
post on the DOH website, the bill aims to allow a diverse population to
easily access crucial information about the benefits and limitations of
NIPS with a simple search online.
LEGISLATIVE HISTORY:
Senate
2023: S8286, Referred to Health
2021-2022: S8286, Referred to Health Assembly
2021-2022: A9413, Referred to Health
FISCAL IMPLICATIONS:
Minimal costs to the Department of Health to be determined.
EFFECTIVE DATE:
This act shall take effect on the one hundred eightieth day after 39 it
shall have become a law.
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.
LBD04085-05-4
A. 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.
