NY State Senate Bill 2023-S1159A

Senate Bill S1159A

2023-2024 Legislative Session

Requires disclosure of information concerning non-invasive prenatal screening for chromosomal abnormalities

download bill text pdf

Current Bill Status - On Floor Calendar

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

View Actions

	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Feb 27, 2024	amended on third reading 1159b
Feb 12, 2024	advanced to third reading
Feb 07, 2024	2nd report cal.
Feb 06, 2024	1st report cal.381
Feb 01, 2024	print number 1159a
Feb 01, 2024	amend (t) and recommit to health
Jan 03, 2024	referred to health
Jun 10, 2023	committed to rules
Feb 06, 2023	advanced to third reading
Feb 01, 2023	2nd report cal.
Jan 31, 2023	1st report cal.244
Jan 10, 2023	referred to health

Votes

- Feb 6, 2024 - Health Committee Vote
  S1159A
  
  15
  
  Aye
  
  0
  
  Nay
  
  0
  
  Aye with Reservations
  
  0
  
  Absent
  
  0
  
  Excused
  
  0
  
  Abstained
  - - Health Committee Vote: Feb 6, 2024
      
      aye (15)
      
      Ashby
      
      Brouk
      
      Felder
      
      Gallivan
      
      Hoylman-Sigal
      
      Mannion
      
      Martins
      
      May
      
      Myrie
      
      Rhoads
      
      Rivera
      
      Salazar
      
      Stec
      
      Thomas
      
      Webb
  Jan 31, 2023 - Health Committee Vote
  S1159A
  
  14
  
  Aye
  
  0
  
  Nay
  
  1
  
  Aye with Reservations
  
  0
  
  Absent
  
  0
  
  Excused
  
  0
  
  Abstained
  - - Health Committee Vote: Jan 31, 2023
      
      aye (14)
      
      Ashby
      
      Brouk
      
      Felder
      
      Gallivan
      
      Hoylman-Sigal
      
      Mannion
      
      Martins
      
      May
      
      Myrie
      
      Rivera
      
      Salazar
      
      Stec
      
      Thomas
      
      Webb
      
      aye wr (1)
      
      Rhoads

Bill Amendments

Original

B (Active)

co-Sponsors

2023-S1159 - Details

See Assembly Version of this Bill:: A9152
Law Section:: Public Health Law
Laws Affected:: Add §2533, amd §266, Pub Health L
Versions Introduced in 2021-2022 Legislative Session:: S8286

2023-S1159 - Summary

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).

2023-S1159 - Sponsor Memo

                                 
BILL NUMBER: S1159

SPONSOR: SKOUFIS
 
TITLE OF BILL:

An act to amend the public health law, in relation to requiring a writ-
ten notice on the occurrence of a false-positive result for any condi-
tion tested during a prenatal test

 
PURPOSE:

Requires a written notice on the occurrence of a false-positive result
for any condition tested during a prenatal test.

 
SUMMARY OF PROVISIONS:

Section 1: Amends the public health law by adding a new section 2533,
which requires that every prenatal test must include a written notice of
the occurrence of false-positive results for any condition tested,
provided by the entity that created the test or advertises performing
prenatal testing services. The written notice must be provided to the
patient or potential parent prior to any prenatal test, with the test

results, and with any advertisement, promotional brochure, website, or
documentation provided by the entity. The written notice will be devel-
oped by the Department of Health and include all data used by a labora-
tory to determine false-positive results.

In addition, requires that hospitals or health care providers offering
prenatal testing services provide a written notice of the occurrence of
false positive results should the patient or potential parent not have
received such materials from the entity which manufactured, supplied, or
otherwise created such test or which advertised performing prenatal
tests.

If data cannot be obtained for a condition tested by a prenatal test to
be used in the written notice, then the condition cannot be offered to a
patient or potential parent for prenatal testing services.

Section 2: Sets effective date.

 
JUSTIFICATION:

Knowledge is essential to empower patients to make informed decisions
about their treatment. The proliferation of prenatal genetic testing has
provided healthcare providers and prospective parents with an ever-ex-
panding 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 the data they
already possess regarding false positive test rates to the commissioner
of the department of health. The department would be tasked with using
this data to draft written notice for healthcare providers to provide to
prospective parents both prior to and at the receipt of testing results.
Such language would be required by this bill to be understandable and
easily visible when provided. In no way is this bill intending to
contradict the advice of a healthcare provider to a patient, but rather
to make sure commercial vendors are sharing information they already
possess to better inform New York State healthcare professionals and
especially prospective parents.

 
LEGISLATIVE HISTORY:

Senate

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 thirtieth 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.

2023-S1159 - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1159
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                             January 10, 2023
                                ___________
 
 Introduced  by  Sens. SKOUFIS, THOMAS -- read twice and ordered printed,
   and when printed to be committed to the Committee on Health
 
 AN ACT to amend the public health law, in relation to requiring a  writ-
   ten notice on the occurrence of a false-positive result for any condi-
   tion tested during a prenatal test

   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 PRENATAL TESTING. A. THE
 FOLLOWING TERMS AS USED IN THIS SECTION SHALL MEAN THE FOLLOWING:
   1. "LABORATORY" SHALL HAVE THE SAME MEANING AS IS SET FORTH IN SECTION
 FIVE HUNDRED SEVENTY-ONE OF THIS CHAPTER.
   2. "PRENATAL TESTING SERVICES" MEANS ANY SERVICE PROVIDED BY A  HOSPI-
 TAL  TO  IDENTIFY  POTENTIAL  PROBLEMS  WITH A PREGNANCY OR THE RELATIVE
 LIKELIHOOD OF ABNORMALITIES IN A FETUS. SUCH SERVICES SHALL INCLUDE  BUT
 NOT  BE LIMITED TO SERVICES THAT TEST PLACENTAL TISSUE OR THE BLOOD OF A
 PREGNANT PATIENT.
   3. "MATERIAL" MEANS ANY ADVERTISEMENT, PROMOTIONAL  BROCHURE,  WEBSITE
 OR  DOCUMENTATION  THAT  MAY  BE  PRESENTED  TO A PATIENT OR A POTENTIAL
 PARENT TO RECOMMEND PRENATAL TESTING SERVICES OFFERED BY A HOSPITAL.
   4. "PERCENTAGE OF POSITIVES BEING A FALSE-POSITIVE" MEANS THE RATIO OF
 THE NUMBER OF FALSE-POSITIVE RESULTS DIVIDED BY THE SUM OF THE NUMBER OF
 FALSE-POSITIVE RESULTS AND THE NUMBER OF TRUE POSITIVES.
   B. EVERY PRENATAL TEST SHALL INCLUDE A WRITTEN NOTICE, PROVIDED BY THE
 ENTITY WHICH MANUFACTURED, SUPPLIED, OR OTHERWISE CREATED SUCH  TEST  OR
 WHICH  ADVERTISED  PERFORMING  PRENATAL TESTS, ABOUT THE OCCURRENCE OF A
 FALSE-POSITIVE RESULT, INCLUDING BUT NOT LIMITED TO  THE  PERCENTAGE  OF
 POSITIVES  BEING  A FALSE-POSITIVE, FOR ANY CONDITION TESTED DURING SUCH
 PRENATAL TEST. SUCH WRITTEN NOTICE SHALL BE PROVIDED TO A PATIENT  OR  A
 POTENTIAL  PARENT:  (I)  PRIOR TO ANY PRENATAL TEST; (II) WITH SUCH TEST
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD04085-01-3

 S. 1159                             2
 
 RESULTS; AND (III) WITH ANY MATERIALS PROVIDED BY THE  ENTITY  PROVIDING
 OR  FACILITATING  THE  PRENATAL  TESTING.  SUCH  WRITTEN NOTICE SHALL BE
 DEVELOPED BY THE DEPARTMENT AND SHALL INCLUDE ALL DATA USED BY A LABORA-
 TORY  TO  DETERMINE  SUCH FALSE-POSITIVE RESULTS. IF SUCH DATA CANNOT BE
 OBTAINED FOR A CONDITION TESTED DURING A PRENATAL TEST FROM THE  LABORA-
 TORY,  SUCH  CONDITION  SHALL NOT BE OFFERED TO A PATIENT OR A POTENTIAL
 PARENT TO BE INCLUDED IN THE PRENATAL  TESTING  SERVICES.  SUCH  WRITTEN
 NOTICE SHALL BE PLAINLY WORDED AND PROMINENTLY DISPLAYED IN ANY MATERIAL
 PRESENTED  TO  A  PATIENT  OR  A POTENTIAL PARENT ABOUT PRENATAL TESTING
 SERVICES.
   C. EVERY HOSPITAL OR HEALTH CARE PROVIDER  OFFERING  PRENATAL  TESTING
 SERVICES SHALL PROVIDE A WRITTEN NOTICE ABOUT THE OCCURRENCE OF A FALSE-
 POSITIVE  RESULT,  WHICH MAY INCLUDE THE PERCENTAGE OF POSITIVES BEING A
 FALSE-POSITIVE AS REQUIRED UNDER SUBDIVISION B OF THIS SECTION, FOR  ANY
 CONDITION  TESTED  DURING  SUCH  PRENATAL  TEST; PROVIDED, HOWEVER, SUCH
 NOTICE SHALL NOT BE REQUIRED IF SUCH NOTICE IS PROVIDED TO  THE  PATIENT
 OR  POTENTIAL  PARENT  BY  THE  ENTITY  WHICH MANUFACTURED, SUPPLIED, OR
 OTHERWISE CREATED SUCH TEST  OR  WHICH  ADVERTISED  PERFORMING  PRENATAL
 TESTS UNDER SUBDIVISION B OF THIS SECTION.  SUCH WRITTEN NOTICE SHALL BE
 PROVIDED  TO  A PATIENT OR A POTENTIAL PARENT PRIOR TO ANY PRENATAL TEST
 AND WHEN A PATIENT OR A POTENTIAL PARENT  RECEIVES  SUCH  TEST  RESULTS.
 SUCH  WRITTEN  NOTICE  SHALL  BE  DEVELOPED  BY THE DEPARTMENT AND SHALL
 INCLUDE ALL DATA USED BY A LABORATORY TO DETERMINE  SUCH  FALSE-POSITIVE
 RESULTS. IF SUCH DATA CANNOT BE OBTAINED FOR A CONDITION TESTED DURING A
 PRENATAL  TEST  FROM THE LABORATORY, SUCH CONDITION SHALL NOT BE OFFERED
 TO A PATIENT OR A POTENTIAL PARENT TO BE INCLUDED IN THE PRENATAL  TEST-
 ING SERVICES. SUCH WRITTEN NOTICE SHALL BE PLAINLY WORDED AND PROMINENT-
 LY  DISPLAYED  IN  ANY  MATERIAL  PRESENTED  TO A PATIENT OR A POTENTIAL
 PARENT ABOUT PRENATAL TESTING SERVICES.
   D. NOTWITHSTANDING THE  PROVISION  OF  SUBDIVISION  B  OR  C  OF  THIS
 SECTION,  IF  PRIOR  TO RECEIVING MATERIAL FROM AN ENTITY OR HOSPITAL ON
 THE PRENATAL TESTING SERVICES OFFERED  BY  SUCH  ENTITY  OR  HOSPITAL  A
 PATIENT  REQUESTS  A  CERTAIN CONDITION TO BE TESTED DURING THE PRENATAL
 TEST, SUCH CONDITION SHALL BE TESTED FOR  IF  SUCH  TEST  IS  AVAILABLE.
 WHEN  A  PATIENT RECEIVES THE RESULTS OF SUCH PRENATAL TEST, IF THERE IS
 DATA ON ANY CONDITION TESTED SUCH DATA SHALL BE PROVIDED TO THE  PATIENT
 PURSUANT TO SUBDIVISION B OR C OF THIS SECTION.
   E.  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.  This  act shall take effect on the thirtieth 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.

co-Sponsors

2023-S1159A - Details

See Assembly Version of this Bill:: A9152
Law Section:: Public Health Law
Laws Affected:: Add §2533, amd §266, Pub Health L
Versions Introduced in 2021-2022 Legislative Session:: S8286

2023-S1159A - Summary

2023-S1159A - Sponsor Memo

                                 
BILL NUMBER: S1159A

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 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 "laboratory" and "non-invasive prenatal screening."
States that Non-invasive prenatal screenings must be accompanied by a

written notice, provided by the entity responsible for the test, outlin-
ing 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. The information should be avail-
able on the website in printable format and in the top six languages
spoken in the state, other than English.

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.

2023-S1159A - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  1159--A
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                             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:
 
   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-
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD04085-02-4

 S. 1159--A                          2
 
 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
 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.

co-Sponsors

2023-S1159B (ACTIVE) - Details

See Assembly Version of this Bill:: A9152
Law Section:: Public Health Law
Laws Affected:: Add §2533, amd §266, Pub Health L
Versions Introduced in 2021-2022 Legislative Session:: S8286

2023-S1159B (ACTIVE) - Summary

2023-S1159B (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S1159B

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 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.

2023-S1159B (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  1159--B
     Cal. No. 381
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                             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 -- reported
   favorably from said committee, ordered to  first  and  second  report,
   ordered  to  a third reading, amended and ordered reprinted, retaining
   its place in the order of third reading
 
 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
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.

                                                            LBD04085-04-4
 S. 1159--B                          2
 
 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
 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.

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Senate Bill S1159A

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Sponsored By

James Skoufis

Current Bill Status - On Floor Calendar

Bill Amendments

co-Sponsors

Kevin Thomas

Lea Webb

2023-S1159 - Details

2023-S1159 - Summary

2023-S1159 - Sponsor Memo

2023-S1159 - Bill Text download pdf

co-Sponsors

Kevin Thomas

Lea Webb

2023-S1159A - Details

2023-S1159A - Summary

2023-S1159A - Sponsor Memo

2023-S1159A - Bill Text download pdf

co-Sponsors

Kevin Thomas

Lea Webb

2023-S1159B (ACTIVE) - Details

2023-S1159B (ACTIVE) - Summary

2023-S1159B (ACTIVE) - Sponsor Memo

2023-S1159B (ACTIVE) - Bill Text download pdf

Comments