BILL NUMBER: S11
SPONSOR: SKOUFIS
 
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 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 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, outlinin g 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 in empowering 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 85-9O', yet on product brochures before 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 tests 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 non-invasive prenatal screening (NIPS) is intended sole-
ly for screening purposes and that any positive result should be
followed by confirmatory diagnostic testing. 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
2021-2022: 58286, Referred to Health
2023-2024: S1159B, Passed Senate Assembly
2021-2022: A9413, Referred to Health
2023-2024: A9152A, Amend and Recommit 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 it
shall have become a law. Effective immediately, the addition, amendment,
and/or repeal of any rule or regulation necessary for the implementation
of this act on its effective date are authorized to be made and
completed on or before such effective date.

Statutes affected:
S11: 266 public health law