STATE OF NEW YORK
________________________________________________________________________
1196
2023-2024 Regular Sessions
IN SENATE
January 10, 2023
___________
Introduced by Sens. PERSAUD, BROUK, CLEARE, GOUNARDES, HOYLMAN-SIGAL,
MANNION, MAY, MYRIE, THOMAS -- read twice and ordered printed, and
when printed to be committed to the Committee on Insurance
AN ACT to amend the insurance law and the social services law, in
relation to requiring health insurance policies and medicaid to cover
biomarker testing for certain purposes
The People of the State of New York, represented in Senate and Assem-
bly, do enact as follows:
1 Section 1. Subsection (i) of section 3216 of the insurance law is
2 amended by adding a new paragraph 11-c to read as follows:
3 (11-c) (A) Every policy which provides medical, major medical, or
4 similar comprehensive-type coverage shall provide coverage for biomarker
5 testing for the purposes of diagnosis, treatment, appropriate manage-
6 ment, or ongoing monitoring of a covered person's disease or condition
7 when the test is supported by medical and scientific evidence, includ-
8 ing, but not limited to:
9 (i) labeled indications for a test approved or cleared by the food and
10 drug administration of the United States government or indicated tests
11 for a food and drug administration approved drug;
12 (ii) centers for medicare and medicaid services national coverage
13 determinations and medicare administrative contractor local coverage
14 determinations; or
15 (iii) nationally recognized clinical practice guidelines and consensus
16 statements.
17 (B) Such coverage shall be provided in a manner that shall limit
18 disruptions in care including the need for multiple biopsies or biospe-
19 cimen samples.
20 (C) The covered person and prescribing practitioner shall have access
21 to a clear, readily accessible, and convenient process to request an
22 exception to a coverage policy provided pursuant to the provisions of
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD02625-01-3
S. 1196 2
1 this paragraph. Such process shall be made readily accessible on the
2 website of the insurer.
3 (D) As used in this paragraph, the following terms shall have the
4 following meanings:
5 (i) "Biomarker" means a characteristic that is objectively measured
6 and evaluated as an indicator of normal biological processes, pathogenic
7 processes, or pharmacologic responses to a specific therapeutic inter-
8 vention. Biomarkers include but are not limited to gene mutations or
9 protein expression.
10 (ii) "Biomarker testing" means the analysis of a patient's tissue,
11 blood, or other biospecimen for the presence of a biomarker. Biomarker
12 testing includes but is not limited to single-analyte tests, multi-plex
13 panel tests, and whole genome sequencing.
14 (iii) "Consensus statements" means statements developed by an inde-
15 pendent, multidisciplinary panel of experts utilizing a transparent
16 methodology and reporting structure and with a conflict of interest
17 policy. Such statements are aimed at specific clinical circumstances and
18 base the statements on the best available evidence for the purpose of
19 optimizing the outcomes of clinical care.
20 (iv) "Nationally recognized clinical practice guidelines" means
21 evidence-based clinical practice guidelines developed by independent
22 organizations or medical professional societies utilizing a transparent
23 methodology and reporting structure and with a conflict of interest
24 policy. Clinical practice guidelines establish standards of care
25 informed by a systematic review of evidence and an assessment of the
26 benefits and costs of alternative care options and include recommenda-
27 tions intended to optimize patient care.
28 § 2. Subsection (l) of section 3221 of the insurance law is amended by
29 adding a new paragraph 11-c to read as follows:
30 (11-c) (A) Every insurer delivering a group or blanket policy or issu-
31 ing a group or blanket policy for delivery in this state that provides
32 coverage for medical, major medical, or similar comprehensive-type
33 coverage shall provide coverage for biomarker testing for the purposes
34 of diagnosis, treatment, appropriate management, or ongoing monitoring
35 of a covered person's disease or condition when the test is supported by
36 medical and scientific evidence, including, but not limited to:
37 (i) labeled indications for a test approved or cleared by the food and
38 drug administration of the United States government or indicated tests
39 for a food and drug administration approved drug;
40 (ii) centers for medicare and medicaid services national coverage
41 determinations and medicare administrative contractor local coverage
42 determinations; or
43 (iii) nationally recognized clinical practice guidelines and consensus
44 statements.
45 (B) Such coverage shall be provided in a manner that shall limit
46 disruptions in care including the need for multiple biopsies or biospe-
47 cimen samples.
48 (C) The covered person and prescribing practitioner shall have access
49 to a clear, readily accessible, and convenient process to request an
50 exception to a coverage policy provided pursuant to the provisions of
51 this paragraph. Such process shall be made readily accessible on the
52 website of the insurer.
53 (D) As used in this paragraph, the following terms shall have the
54 following meanings:
55 (i) "Biomarker" means a characteristic that is objectively measured
56 and evaluated as an indicator of normal biological processes, pathogenic
S. 1196 3
1 processes, or pharmacologic responses to a specific therapeutic inter-
2 vention. Biomarkers include but are not limited to gene mutations or
3 protein expression.
4 (ii) "Biomarker testing" means the analysis of a patient's tissue,
5 blood, or other biospecimen for the presence of a biomarker. Biomarker
6 testing includes but is not limited to single-analyte tests, multi-plex
7 panel tests, and whole genome sequencing.
8 (iii) "Consensus statements" means statements developed by an inde-
9 pendent, multidisciplinary panel of experts utilizing a transparent
10 methodology and reporting structure and with a conflict of interest
11 policy. Such statements are aimed at specific clinical circumstances and
12 base the statements on the best available evidence for the purpose of
13 optimizing the outcomes of clinical care.
14 (iv) "Nationally recognized clinical practice guidelines" means
15 evidence-based clinical practice guidelines developed by independent
16 organizations or medical professional societies utilizing a transparent
17 methodology and reporting structure and with a conflict of interest
18 policy. Clinical practice guidelines establish standards of care
19 informed by a systematic review of evidence and an assessment of the
20 benefits and costs of alternative care options and include recommenda-
21 tions intended to optimize patient care.
22 § 3. Section 4303 of the insurance law is amended by adding a new
23 subsection (p-1) to read as follows:
24 (p-1) (1) A medical expense indemnity corporation, a hospital service
25 corporation or a health service corporation that provides coverage for
26 medical, major medical, or similar comprehensive-type coverage shall
27 provide coverage for biomarker testing for the purposes of diagnosis,
28 treatment, appropriate management, or ongoing monitoring of a covered
29 person's disease or condition when the test is supported by medical and
30 scientific evidence, including, but not limited to:
31 (A) labeled indications for a test approved or cleared by the food and
32 drug administration of the United States government or indicated tests
33 for a food and drug administration approved drug;
34 (B) centers for medicare and medicaid services national coverage
35 determinations and medicare administrative contractor local coverage
36 determinations; or
37 (C) nationally recognized clinical practice guidelines and consensus
38 statements.
39 (2) Such coverage shall be provided in a manner that shall limit
40 disruptions in care including the need for multiple biopsies or biospe-
41 cimen samples.
42 (3) The covered person and prescribing practitioner shall have access
43 to a clear, readily accessible, and convenient process to request an
44 exception to a coverage policy provided pursuant to the provisions of
45 this subsection. Such process shall be made readily accessible on the
46 website of the insurer.
47 (4) As used in this subsection, the following terms shall have the
48 following meanings:
49 (A) "Biomarker" means a characteristic that is objectively measured
50 and evaluated as an indicator of normal biological processes, pathogenic
51 processes, or pharmacologic responses to a specific therapeutic inter-
52 vention. Biomarkers include but are not limited to gene mutations or
53 protein expression.
54 (B) "Biomarker testing" means the analysis of a patient's tissue,
55 blood, or other biospecimen for the presence of a biomarker. Biomarker
S. 1196 4
1 testing includes but is not limited to single-analyte tests, multi-plex
2 panel tests, and whole genome sequencing.
3 (C) "Consensus statements" means statements developed by an independ-
4 ent, multidisciplinary panel of experts utilizing a transparent method-
5 ology and reporting structure and with a conflict of interest policy.
6 Such statements are aimed at specific clinical circumstances and base
7 the statements on the best available evidence for the purpose of opti-
8 mizing the outcomes of clinical care.
9 (D) "Nationally recognized clinical practice guidelines" means
10 evidence-based clinical practice guidelines developed by independent
11 organizations or medical professional societies utilizing a transparent
12 methodology and reporting structure and with a conflict of interest
13 policy. Clinical practice guidelines establish standards of care
14 informed by a systematic review of evidence and an assessment of the
15 benefits and costs of alternative care options and include recommenda-
16 tions intended to optimize patient care.
17 § 4. Subdivision 2 of section 365-a of the social services law is
18 amended by adding a new paragraph (kk) to read as follows:
19 (kk) (i) biomarker testing for the purposes of diagnosis, treatment,
20 appropriate management, or ongoing monitoring of a recipient's disease
21 or condition when the test is supported by medical and scientific
22 evidence, including, but not limited to:
23 (1) labeled indications for a test approved or cleared by the food and
24 drug administration of the United States government or indicated tests
25 for a food and drug administration approved drug;
26 (2) centers for medicare and medicaid services national coverage
27 determinations and medicare administrative contractor local coverage
28 determinations; or
29 (3) nationally recognized clinical practice guidelines and consensus
30 statements.
31 (ii) Risk-bearing entities contracted to the medicaid program to
32 deliver services to recipients shall provide biomarker testing at the
33 same scope, duration and frequency as the medicaid program otherwise
34 provides to enrollees.
35 (iii) The recipient and participating provider shall have access to a
36 clear, readily accessible, and convenient process to request an excep-
37 tion to a coverage policy of the medicaid program or by risk-bearing
38 entities contracted to the medicaid program. Such process shall be made
39 readily accessible to all participating providers and enrollees online.
40 (iv) As used in this paragraph, the following terms shall have the
41 following meanings:
42 (1) "Biomarker" means a characteristic that is objectively measured
43 and evaluated as an indicator of normal biological processes, pathogenic
44 processes, or pharmacologic responses to a specific therapeutic inter-
45 vention. Biomarkers include but are not limited to gene mutations or
46 protein expression.
47 (2) "Biomarker testing" means the analysis of a patient's tissue,
48 blood, or other biospecimen for the presence of a biomarker. Biomarker
49 testing includes but is not limited to single-analyte tests, multi-plex
50 panel tests, and whole genome sequencing.
51 (3) "Consensus statements" means statements developed by an independ-
52 ent, multidisciplinary panel of experts utilizing a transparent method-
53 ology and reporting structure and with a conflict of interest policy.
54 Such statements are aimed at specific clinical circumstances and base
55 the statements on the best available evidence for the purpose of opti-
56 mizing the outcomes of clinical care.
S. 1196 5
1 (4) "Nationally recognized clinical practice guidelines" means
2 evidence-based clinical practice guidelines developed by independent
3 organizations or medical professional societies utilizing a transparent
4 methodology and reporting structure and with a conflict of interest
5 policy. Clinical practice guidelines establish standards of care
6 informed by a systematic review of evidence and an assessment of the
7 benefits and costs of alternative care options and include recommenda-
8 tions intended to optimize patient care.
9 § 5. This act shall take effect January 1, 2024 and shall apply to all
10 policies and contracts issued, renewed, modified, altered or amended on
11 or after such date.