Forrest, Simon, Reyes, Mitaynes, Epstein, Solages, Clark, Gallagher, Cunningham, De Los Santos
MLTSPNSR
Add §2533, Pub Health L
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.
STATE OF NEW YORK
________________________________________________________________________
9413
IN ASSEMBLY
March 3, 2022
___________
Introduced by M. of A. GRIFFIN -- read once and referred to the Commit-
tee 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:
1 Section 1. The public health law is amended by adding a new section
2 2533 to read as follows:
3 § 2533. Disclosure of information concerning prenatal testing. a. The
4 following terms as used in this section shall mean the following:
5 1. "Laboratory" shall have the same meaning as is set forth in section
6 five hundred seventy-one of this chapter.
7 2. "Prenatal testing services" means any service provided by a hospi-
8 tal to identify potential problems with a pregnancy or the relative
9 likelihood of abnormalities in a fetus. Such services shall include but
10 not be limited to services that test placental tissue or the blood of a
11 pregnant patient.
12 3. "Material" means any advertisement, promotional brochure, website
13 or documentation that may be presented to a patient or a potential
14 parent to recommend prenatal testing services offered by a hospital.
15 4. "Percentage of positives being a false-positive" means the ratio of
16 the number of false-positive results divided by the sum of the number of
17 false-positive results and the number of true positives.
18 b. Every prenatal test shall include a written notice, provided by the
19 entity which manufactured, supplied, or otherwise created such test or
20 which advertised performing prenatal tests, about the occurrence of a
21 false-positive result, including but not limited to the percentage of
22 positives being a false-positive, for any condition tested during such
23 prenatal test. Such written notice shall be provided to a patient or a
24 potential parent: (i) prior to any prenatal test; (ii) with such test
25 results; and (iii) with any materials provided by the entity providing
26 or facilitating the prenatal testing. Such written notice shall be
27 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
A. 9413 2
1 tory to determine such false-positive results. If such data cannot be
2 obtained for a condition tested during a prenatal test from the labora-
3 tory, such condition shall not be offered to a patient or a potential
4 parent to be included in the prenatal testing services. Such written
5 notice shall be plainly worded and prominently displayed in any material
6 presented to a patient or a potential parent about prenatal testing
7 services.
8 c. Every hospital or health care provider offering prenatal testing
9 services shall provide a written notice about the occurrence of a false-
10 positive result, which may include the percentage of positives being a
11 false-positive as required under subdivision b of this section, for any
12 condition tested during such prenatal test; provided, however, such
13 notice shall not be required if such notice is provided to the patient
14 or potential parent by the entity which manufactured, supplied, or
15 otherwise created such test or which advertised performing prenatal
16 tests under subdivision b of this section. Such written notice shall be
17 provided to a patient or a potential parent prior to any prenatal test
18 and when a patient or a potential parent receives such test results.
19 Such written notice shall be developed by the department and shall
20 include all data used by a laboratory to determine such false-positive
21 results. If such data cannot be obtained for a condition tested during a
22 prenatal test from the laboratory, such condition shall not be offered
23 to a patient or a potential parent to be included in the prenatal test-
24 ing services. Such written notice shall be plainly worded and prominent-
25 ly displayed in any material presented to a patient or a potential
26 parent about prenatal testing services.
27 d. Notwithstanding the provision of subdivision b or c of this
28 section, if prior to receiving material from an entity or hospital on
29 the prenatal testing services offered by such entity or hospital a
30 patient requests a certain condition to be tested during the prenatal
31 test, such condition shall be tested for if such test is available.
32 When a patient receives the results of such prenatal test, if there is
33 data on any condition tested such data shall be provided to the patient
34 pursuant to subdivision b or c of this section.
35 e. Nothing contained in this section shall be construed to limit a
36 health care practitioner licensed, certified, or authorized under title
37 eight of the education law from recommending certain prenatal testing
38 services according to the practitioner's reasonable and good faith
39 professional judgment based on the facts of a patient's case.
40 § 2. This act shall take effect on the thirtieth day after it shall
41 have become a law. Effective immediately, the addition, amendment and/or
42 repeal of any rule or regulation necessary for the implementation of
43 this act on its effective date are authorized to be made and completed
44 on or before such effective date.
