NY State Senate Bill 2021-S8286

Senate Bill S8286

2021-2022 Legislative Session

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

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Archive: Last Bill Status - In Senate Committee Rules Committee

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
Jun 03, 2022	committed to rules
May 17, 2022	advanced to third reading
May 16, 2022	2nd report cal.
May 11, 2022	1st report cal.1342
Feb 09, 2022	referred to health

Votes

- May 9, 2022 - Health Committee Vote
  S8286
  
  13
  
  Aye
  
  0
  
  Nay
  
  1
  
  Aye with Reservations
  
  0
  
  Absent
  
  1
  
  Excused
  
  0
  
  Abstained
  - - Health Committee Vote: May 9, 2022
      
      aye (13)
      
      Biaggi
      
      Boyle
      
      Cleare
      
      Gallivan
      
      Hoylman-Sigal
      
      Kaminsky
      
      May
      
      Rath III
      
      Rivera
      
      Ryan
      
      Salazar
      
      Stec
      
      Thomas
      
      aye wr (1)
      
      Oberacker
      
      excused (1)
      
      Brouk

co-Sponsors

2021-S8286 (ACTIVE) - Details

See Assembly Version of this Bill:: A9413
Current Committee:: Senate Rules
Law Section:: Public Health Law
Laws Affected:: Add §2533, Pub Health L
Versions Introduced in 2023-2024 Legislative Session:: S1159

2021-S8286 (ACTIVE) - Summary

Requires a written notice on the occurrence of a false-positive result, including the percentage of positives being a false-positive, for any condition tested during a prenatal test to be prominently displayed on 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 an entity or hospital.

2021-S8286 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S8286

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:

New bill.

 
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.

2021-S8286 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8286
 
                             I N  S E N A T E
 
                             February 9, 2022
                                ___________
 
 Introduced  by  Sens. SKOUFIS, KAPLAN -- 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
 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-
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.

                                                            LBD14192-06-2
 S. 8286                             2

 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.

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Senate Bill S8286

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Sponsored By

James Skoufis