S T A T E O F N E W Y O R K
________________________________________________________________________
9152--A
I N A S S E M B L Y
February 8, 2024
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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:
Section 1. The public health law is amended by adding a new section
2533 to read as follows:
§ 2533. DISCLOSURE OF INFORMATION CONCERNING NON-INVASIVE PRENATAL
SCREENING FOR CHROMOSOMAL ABNORMALITIES. 1. FOR THE PURPOSES OF THIS
SECTION, THE TERM "NON-INVASIVE PRENATAL SCREENING" SHALL MEAN ANY NON-
INVASIVE PRENATAL SCREENING OR CELL FREE FETAL DNA SCREENING USED TO
ASCERTAIN WHETHER A FETUS IS AT RISK FOR CERTAIN CHROMOSOMAL ABNOR-
MALITIES.
2. NON-INVASIVE PRENATAL SCREENINGS SHALL BE ACCOMPANIED BY A WRITTEN
NOTICE, PROVIDED BY THE ENTITY WHICH MANUFACTURED, SUPPLIED, OR OTHER-
WISE CREATED SUCH TEST OR WHICH ADVERTISED PERFORMING THESE PRENATAL
SCREENING TESTS, 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 NON-INVASIVE PRENATAL SCREENINGS ARE
INTENDED SOLELY FOR SCREENING PURPOSES TO ASSESS RISK OF POSSIBLE FETAL
GENETIC ABNORMALITIES AND IS NOT INTENDED TO BE USED FOR DIAGNOSTIC
PURPOSES TO DETERMINE WHETHER SUCH ABNORMALITIES ACTUALLY EXIST AND THAT
ANY POSITIVE RESULT SHOULD BE FOLLOWED BY CONFIRMATORY DIAGNOSTIC TEST-
ING, AND THAT ADDITIONAL FOLLOW UP IS RECOMMENDED FOR ALL HIGH RISK
SCREENING. SUCH WRITTEN NOTICE SHALL BE PROVIDED TO A PATIENT OR A
POTENTIAL PARENT: (A) PRIOR TO ANY PRENATAL TEST; (B) WITH SUCH TEST
RESULTS; AND (C) WITH ANY MATERIALS PROVIDED BY THE ENTITY PROVIDING
OR FACILITATING THE PRENATAL TESTING. SUCH WRITTEN NOTICE SHALL BE
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
PLAINLY WORDED AND PROMINENTLY DISPLAYED IN ANY MATERIAL PRESENTED TO A
PATIENT OR A POTENTIAL PARENT ABOUT PRENATAL TESTING SERVICES.
C. NOTHING CONTAINED IN THIS SECTION SHALL BE CONSTRUED TO LIMIT A
HEALTH CARE PRACTITIONER LICENSED, CERTIFIED, OR AUTHORIZED UNDER TITLE
EIGHT OF THE EDUCATION LAW FROM RECOMMENDING CERTAIN PRENATAL TESTING
SERVICES ACCORDING TO THE PRACTITIONER'S REASONABLE AND GOOD FAITH
PROFESSIONAL JUDGMENT BASED ON THE FACTS OF A PATIENT'S CASE.
§ 2. Section 266 of the public health law is amended by adding a new
subdivision 7 to read as follows:
7. NON-INVASIVE PRENATAL TESTING. IN ADDITION TO THE INFORMATION
PROVIDED PURSUANT TO THIS SECTION, THE COMMISSIONER SHALL ALSO DEVELOP
COMPREHENSIVE INFORMATIONAL MATERIALS REGARDING THE BENEFITS AND LIMITA-
TIONS OF NON-INVASIVE PRENATAL TESTING, INCLUDING THE DIFFERENCE BETWEEN
NON-INVASIVE PRENATAL TESTING AND PRENATAL DIAGNOSTIC TESTING. SUCH
INFORMATION SHALL BE POSTED ON THE WEBSITE IN A PRINTABLE FORMAT, IN
MULTIPLE LANGUAGES IN ACCORDANCE WITH SECTION TWO HUNDRED TWO-A OF THE
EXECUTIVE LAW TO ALLOW ALL GENERAL HOSPITALS, DIAGNOSTIC AND TREATMENT
CENTERS, OBSTETRICIANS, PRIMARY CARE PROVIDERS, MIDWIVES, AND OTHER
HEALTH CARE PROGRAMS PROVIDING WOMEN'S WELLNESS SERVICES TO PROVIDE THE
INFORMATION TO THEIR PATIENTS AS PART OF THEIR PRENATAL CARE ACTIVITIES.
THE INFORMATIONAL MATERIALS SHALL ALSO INCLUDE:
(A) THE CURRENT RECOMMENDATIONS ON NON-INVASIVE PRENATAL TESTING MADE
BY THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS (ACOG), AND
THE SOCIETY FOR MATERNAL FETAL MEDICINE, AND THE AMERICAN COLLEGE OF
MEDICAL GENETICS AND GENOMICS (ACMG);
(B) A STATEMENT INFORMING INDIVIDUALS THAT NON-INVASIVE PRENATAL TEST-
ING IS USED FOR SCREENING PURPOSES TO DETERMINE THE POTENTIAL FOR POSSI-
BLE FETAL GENETIC ABNORMALITIES AND IS NOT INTENDED TO DETERMINE WHETHER
OR NOT SUCH ABNORMALITIES EXIST;
(C) A STATEMENT INFORMING INDIVIDUALS THAT NON-INVASIVE PRENATAL TEST-
ING CARRIES A RISK OF FALSE-POSITIVE RESULTS AND THAT ANY POSITIVE
RESULT SHOULD BE FOLLOWED UP WITH PRENATAL DIAGNOSTIC TESTING; AND
(D) A LIST OF THE NON-INVASIVE SCREENING TESTS THAT HAVE BEEN APPROVED
OR CLEARED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION (FDA), THE NEW
YORK STATE CLINICAL LABORATORY EVALUATION PROGRAM (CLEP), OR BOTH, AND A
SUMMARY OF THE KNOWN PERFORMANCE CHARACTERISTICS OF THESE TESTS WHEN
AVAILABLE.
§ 3. This act shall take effect on the one hundred eightieth day after
it shall have become a law. Effective immediately, the addition, amend-
ment and/or repeal of any rule or regulation necessary for the implemen-
tation of this act on its effective date are authorized to be made and
completed on or before such effective date.