S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9152
 
                           I N  A S S E M B L Y
 
                             February 8, 2024
                                ___________
 
 Introduced by M. of A. PAULIN -- read once and referred to the Committee
   on Health
 
 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 FOLLOWING TERMS SHALL MEAN THE FOLLOWING:
   (A)  "LABORATORY"  SHALL  HAVE  THE  SAME  MEANING  AS IS SET FORTH IN
 SECTION FIVE HUNDRED SEVENTY-ONE OF THIS CHAPTER.
   (B) "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 ABNORMALITIES.
   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.
              

                                                            LBD04085-03-4
 A. 9152                             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
 EACH OF THE TOP SIX LANGUAGES SPOKEN IN THE STATE, OTHER  THAN  ENGLISH,
 ACCORDING  TO  THE  LATEST  AVAILABLE DATA FROM THE UNITED STATES CENSUS
 BUREAU,  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;
   (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.