Amd §§3216, 3221 & 4303, Ins L; amd §365-a, Soc Serv L; amd §5, Chap of 2023 (as proposed in S.1196-A &
A.1673-A)
Requires health insurance policies and medicaid to cover biomarker precision medical testing for diagnosis, treatment, or appropriate management of, or ongoing monitoring to guide treatment decisions for, a covered person's disease or condition when the test has recognized efficacy and appropriateness for such purposes.
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A8502
SPONSOR: Hunter TITLE OF BILL:
An act to amend the insurance law and the social services law, in
relation to requiring health insurance policies and medicaid to cover
biomarker precision medical testing for certain purposes; and to amend a
chapter of the laws of 2023 amending the insurance law and the social
services law relating to requiring health insurance policies and medi-
caid to cover biomarker testing for certain purposes, as proposed in
legislative bills numbers S. 1196-A and A. 1673-A, in relation to the
effectiveness thereof
PURPOSE OR GENERAL IDEA OF BILL:
The purpose of this bill is to make amendments to Chapter 754 of the
Laws of 2023 relating to health insurance coverage for biomarker testing
for certain purposes.
SUMMARY OF PROVISIONS:
Sections 1-4 provides technical amendments to Chapter 754 of the Laws of
2023 and ensures coverage of biomarker precision medical tests whose
efficacy and appropriateness in the diagnosis, treatment, appropriate
management, or guiding treatment decisions for an insured's disease or
condition are recognized by peer-reviewed literature and peer-reviewed
scientific studies published in or accepted for publication by medical
journals that meet nationally recognized requirements.
Section 5 extends the effective date of Chapter 754 of the Laws of 2023
from April 1, 2024, to January 1, 2025.
Section 6 provides the effective date.
JUSTIFICATION:
Progress in improving cancer outcomes increasingly involves the use of
precision medicine. Biomarker testing is an important step for accessing
precision medicine, including targeted therapies that can improve survi-
vorship and better cancer patients' quality of life. Biomarker testing
is increasingly important for cancer care and for the treatment of other
diseases. Thirty-seven of the sixty-two oncology drugs launched in the
past five years require or recommend biomarker testing before use.
Chapter 754 of the Laws of 2023 required that individual, group or blan-
ket, and Article 43 licensed accident and health insurance policies that
provides coverage for medical, major ' '- medical, or similar comprehen-
sive-type coverage, and Medicaid policies provide coverage for biomarker
testing for the purposes of diagnosis, treatment, appropriate manage-
ment, or ongoing monitoring of a covered person's disease or condition
when the test provides clinical utility to an insured as demonstrated by
medical and scientific evidence. This Chapter amendment provides tech-
nical amendments to this law, extends the effective date to January 1,
2025, and ensures coverage of biomarker precision medical tests whose
efficacy and appropriateness is recognized by peer-reviewed literature
and peer-reviewed scientific studies published in or accepted for publi-
cation by medical journals that meet nationally recognized requirements.
PRIOR LEGISLATIVE HISTORY:
This is a new bill.
FISCAL IMPLICATIONS FOR STATE AND LOCAL GOVERNMENTS:
To be determined.
EFFECTIVE DATE:
This act shall take effect immediately; provided however that sections
one, two, three and four of this act shall take effect on the same date
and in the same manner as a chapter of the laws of 2023 amending the
insurance law and the social services law relating to requiring health
insurance policies and medicaid to cover biomarker testing for certain
purposes, as proposed in legislative bills numbers S. 1196-A and A.
1673-A, takes effect.
STATE OF NEW YORK
________________________________________________________________________
8502
IN ASSEMBLY
January 4, 2024
___________
Introduced by M. of A. HUNTER -- read once and referred 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 precision medical testing for certain purposes; and to amend
a chapter of the laws of 2023 amending the insurance law and the
social services law relating to requiring health insurance policies
and medicaid to cover biomarker testing for certain purposes, as
proposed in legislative bills numbers S. 1196-A and A. 1673-A, in
relation to the effectiveness thereof
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Paragraph 11-c of subsection (i) of section 3216 of the
2 insurance law, as added by a chapter of the laws of 2023 amending the
3 insurance law and the social services law relating to requiring health
4 insurance policies and medicaid to cover biomarker testing for certain
5 purposes, as proposed in legislative bills numbers S. 1196-A and A.
6 1673-A, is amended to read as follows:
7 (11-c) (A) Every policy which provides medical, major medical, or
8 similar comprehensive-type coverage shall provide coverage for biomarker
9 precision medical testing for the purposes of diagnosis, treatment, or
10 appropriate management of, or ongoing monitoring [of a covered person's]
11 to guide treatment decisions for, an insured's disease or condition when
12 [the test provides clinical utility to the patient as demonstrated by
13 medical and scientific evidence, including, but not limited to] one or
14 more of the following recognizes the efficacy and appropriateness of
15 biomarker precision medical testing for diagnosis, treatment, appropri-
16 ate management, or guiding treatment decisions for an insured's disease
17 or condition:
18 (i) labeled indications for a test approved or cleared by the federal
19 food and drug administration or indicated tests for a food and drug
20 administration approved drug;
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD02625-08-4
A. 8502 2
1 (ii) centers for medicare and medicaid services national coverage
2 determinations [and] or medicare administrative contractor local cover-
3 age determinations; [or]
4 (iii) nationally recognized clinical practice guidelines [such as, but
5 not limited to, those of the national comprehensive cancer network or
6 the American society of clinical oncology.]; or
7 (iv) peer-reviewed literature and peer-reviewed scientific studies
8 published in or accepted for publication by medical journals that meet
9 nationally recognized requirements for scientific manuscripts and that
10 submit most of their published articles for review by experts who are
11 not part of the editorial staff.
12 (B) Such coverage shall be provided in a manner that shall limit
13 disruptions in care including the need for multiple biopsies or biospe-
14 cimen samples.
15 (C) [The covered person and prescribing practitioner shall have access
16 to a clear, readily accessible, and convenient process to request an
17 exception to a coverage policy provided pursuant to the provisions of
18 this paragraph. Such process shall be made readily accessible on the
19 website of the insurer.
20 (D)] As used in this paragraph, the following terms shall have the
21 following meanings:
22 (i) "Biomarker" means a [defined] characteristic that is measured as
23 an indicator of normal biological processes, pathogenic processes, or
24 responses to an exposure or intervention, including therapeutic inter-
25 ventions. [Molecular, histologic, radiographic, or physiologic charac-
26 teristics are types of biomarkers. A biomarker is not an assessment of
27 how a patient feels, functions, or survives.]
28 (ii) "Biomarker precision medical testing" means the analysis of a
29 patient's tissue, blood, or other biospecimen for the presence of a
30 biomarker. Biomarker testing includes but is not limited to single-ana-
31 lyte tests and multi-plex panel tests performed at a participating
32 in-network laboratory facility that is either CLIA certified or CLIA
33 waived by the federal food and drug administration.
34 (iii) ["Clinical utility" means the test result provides information
35 that is used in the formulation of a treatment or monitoring strategy
36 that informs a patient's outcome and impacts the clinical decision.
37 (iv)] "Nationally recognized clinical practice guidelines" means
38 evidence-based clinical practice guidelines informed by a systematic
39 review of evidence and an assessment of the benefits, and risks of
40 alternative care options intended to optimize patient care developed by
41 independent organizations or medical professional societies utilizing a
42 transparent methodology and reporting structure and with a conflict of
43 interest policy.
44 § 2. Paragraph 11-c of subsection (l) of section 3221 of the insurance
45 law, as added by a chapter of the laws of 2023 amending the insurance
46 law and the social services law relating to requiring health insurance
47 policies and medicaid to cover biomarker testing for certain purposes,
48 as proposed in legislative bills numbers S. 1196-A and A. 1673-A, is
49 amended to read as follows:
50 (11-c) (A) Every insurer delivering a group or blanket policy or issu-
51 ing a group or blanket policy for delivery in this state that provides
52 coverage for medical, major medical, or similar comprehensive-type
53 coverage shall provide coverage for biomarker precision medical testing
54 for the purposes of diagnosis, treatment, or appropriate management of,
55 or ongoing monitoring [of a covered person's] to guide treatment deci-
56 sions for, an insured's disease or condition when [the test provides
A. 8502 3
1 clinical utility to the patient as demonstrated by medical and scientif-
2 ic evidence, including, but not limited to] one or more of the following
3 recognizes the efficacy and appropriateness of biomarker precision
4 medical testing for diagnosis, treatment, appropriate management, or
5 guiding treatment decisions for an insured's disease or condition:
6 (i) labeled indications for a test approved or cleared by the federal
7 food and drug administration or indicated tests for a food and drug
8 administration approved drug;
9 (ii) centers for medicare and medicaid services national coverage
10 determinations [and] or medicare administrative contractor local cover-
11 age determinations; [or]
12 (iii) nationally recognized clinical practice guidelines [including,
13 but not limited to, those of the national comprehensive cancer network
14 or the American society of clinical oncology.]; or
15 (iv) peer-reviewed literature and peer-reviewed scientific studies
16 published in or accepted for publication by medical journals that meet
17 nationally recognized requirements for scientific manuscripts and that
18 submit most of their published articles for review by experts who are
19 not part of the editorial staff.
20 (B) Such coverage shall be provided in a manner that shall limit
21 disruptions in care including the need for multiple biopsies or biospe-
22 cimen samples.
23 (C) [The covered person and prescribing practitioner shall have access
24 to a clear, readily accessible, and convenient process to request an
25 exception to a coverage policy provided pursuant to the provisions of
26 this paragraph. Such process shall be made readily accessible on the
27 website of the insurer.
28 (D)] As used in this paragraph, the following terms shall have the
29 following meanings:
30 (i) "Biomarker" means a [defined] characteristic that is measured as
31 an indicator of normal biological processes, pathogenic processes, or
32 responses to an exposure or intervention, including therapeutic inter-
33 ventions. [Molecular, histologic, radiographic, or physiologic charac-
34 teristics are types of biomarkers. A biomarker is not an assessment of
35 how a patient feels, functions, or survives.]
36 (ii) "Biomarker precision medical testing" means the analysis of a
37 patient's tissue, blood, or other biospecimen for the presence of a
38 biomarker. Biomarker testing includes but is not limited to single-ana-
39 lyte tests and multi-plex panel tests performed at a participating
40 in-network laboratory facility that is either CLIA certified or CLIA
41 waived by the federal food and drug administration.
42 (iii) ["Clinical utility" means the test result provides information
43 that is used in the formulation of a treatment or monitoring strategy
44 that informs a patient's outcome and impacts the clinical decision.
45 (iv)] "Nationally recognized clinical practice guidelines" means
46 evidence-based clinical practice guidelines informed by a systematic
47 review of evidence and an assessment of the benefits, and risks of
48 alternative care options intended to optimize patient care developed by
49 independent organizations or medical professional societies utilizing a
50 transparent methodology and reporting structure and with a conflict of
51 interest policy.
52 § 3. Subsection (p-1) of section 4303 of the insurance law, as added
53 by a chapter of the laws of 2023 amending the insurance law and the
54 social services law relating to requiring health insurance policies and
55 medicaid to cover biomarker testing for certain purposes, as proposed in
A. 8502 4
1 legislative bills numbers S. 1196-A and A. 1673-A, is amended to read as
2 follows:
3 (p-1) (1) A medical expense indemnity corporation, a hospital service
4 corporation or a health service corporation that provides coverage for
5 medical, major medical, or similar comprehensive-type coverage shall
6 provide coverage for biomarker precision medical testing for the
7 purposes of diagnosis, treatment, or appropriate management of, or ongo-
8 ing monitoring [of a covered person's] to guide treatment decisions for,
9 an insured's disease or condition when [the test provides clinical util-
10 ity to the patient as demonstrated by medical and scientific evidence,
11 including, but not limited to] one or more of the following recognizes
12 the efficacy and appropriateness of biomarker precision medical testing
13 for diagnosis, treatment, appropriate management, or guiding treatment
14 decisions for an insured's disease or condition:
15 (A) labeled indications for a test approved or cleared by the federal
16 food and drug administration or indicated tests for a food and drug
17 administration approved drug;
18 (B) centers for medicare and medicaid services national coverage
19 determinations [and] or medicare administrative contractor local cover-
20 age determinations; [or]
21 (C) nationally recognized clinical practice guidelines [such as, but
22 not limited to, those of the national comprehensive cancer network or
23 the American society of clinical oncology.]; or
24 (D) peer-reviewed literature and peer-reviewed scientific studies
25 published in or accepted for publication by medical journals that meet
26 nationally recognized requirements for scientific manuscripts and that
27 submit most of their published articles for review by experts who are
28 not part of the editorial staff.
29 (2) Such coverage shall be provided in a manner that shall limit
30 disruptions in care including the need for multiple biopsies or biospe-
31 cimen samples.
32 (3) [The covered person and prescribing practitioner shall have access
33 to a clear, readily accessible, and convenient process to request an
34 exception to a coverage policy provided pursuant to the provisions of
35 this subsection. Such process shall be made readily accessible on the
36 website of the insurer.
37 (4)] As used in this subsection, the following terms shall have the
38 following meanings:
39 (A) "Biomarker" means a [defined] characteristic that is measured as
40 an indicator of normal biological processes, pathogenic processes, or
41 responses to an exposure or intervention, including therapeutic inter-
42 ventions. [Molecular, histologic, radiographic, or physiologic charac-
43 teristics are types of biomarkers. A biomarker is not an assessment of
44 how a patient feels, functions, or survives.]
45 (B) "Biomarker precision medical testing" means the analysis of a
46 patient's tissue, blood, or other biospecimen for the presence of a
47 biomarker. Biomarker testing includes but is not limited to single-ana-
48 lyte tests and multi-plex panel tests performed at a participating
49 in-network laboratory facility that is either CLIA certified or CLIA
50 waived by the federal food and drug administration.
51 (C) ["Clinical utility" means the test result provides information
52 that is used in the formulation of a treatment or monitoring strategy
53 that informs a patient's outcome and impacts the clinical decision.
54 (D)] "Nationally recognized clinical practice guidelines" means
55 evidence-based clinical practice guidelines informed by a systematic
56 review of evidence and an assessment of the benefits, and risks of
A. 8502 5
1 alternative care options intended to optimize patient care developed by
2 independent organizations or medical professional societies utilizing a
3 transparent methodology and reporting structure and with a conflict of
4 interest policy.
5 § 4. Paragraph (mm) of subdivision 2 of section 365-a of the social
6 services law, as added by a chapter of the laws of 2023 amending the
7 insurance law and the social services law relating to requiring health
8 insurance policies and medicaid to cover biomarker testing for certain
9 purposes, as proposed in legislative bills numbers S. 1196-A and A.
10 1673-A, is amended to read as follows:
11 (mm) (i) biomarker precision medical testing for the purposes of diag-
12 nosis, treatment, or appropriate management of, or ongoing monitoring
13 [of] to guide treatment decisions for, a recipient's disease or condi-
14 tion when [the test provides clinical utility to the patient as demon-
15 strated by medical and scientific evidence, including, but not limited
16 to] one or more of the following recognizes the efficacy and appropri-
17 ateness of biomarker precision medical testing for diagnosis, treatment,
18 appropriate management, or guiding treatment decisions for a recipient's
19 disease or condition:
20 (1) labeled indications for a test approved or cleared by the federal
21 food and drug administration or indicated tests for a food and drug
22 administration approved drug;
23 (2) centers for medicare and medicaid services national coverage
24 determinations [and] or medicare administrative contractor local cover-
25 age determinations; [or]
26 (3) nationally recognized clinical practice guidelines [such as, but
27 not limited to, those of the national comprehensive cancer network or
28 the American society of clinical oncology.]; or
29 (4) peer-reviewed literature and peer-reviewed scientific studies
30 published in or accepted for publication by medical journals that meet
31 nationally recognized requirements for scientific manuscripts and that
32 submit most of their published articles for review by experts who are
33 not part of the editorial staff.
34 (ii) [Risk-bearing entities contracted to the medicaid program to
35 deliver services to recipients shall provide biomarker testing at the
36 same scope, duration and frequency as the medicaid program otherwise
37 provides to enrollees.
38 (iii) The recipient and participating provider shall have access to a
39 clear, readily accessible, and convenient process to request an excep-
40 tion to a coverage policy of the medicaid program or by risk-bearing
41 entities contracted to the medicaid program. Such process shall be made
42 readily accessible to all participating providers and enrollees online.
43 (iv)] As used in this paragraph, the following terms shall have the
44 following meanings:
45 (1) "Biomarker" means a [defined] characteristic that is measured as
46 an indicator of normal biological processes, pathogenic processes, or
47 responses to an exposure or intervention, including therapeutic inter-
48 ventions. [Molecular, histologic, radiographic, or physiologic charac-
49 teristics are types of biomarkers. A biomarker is not an assessment of
50 how a patient feels, functions, or survives.]
51 (2) "Biomarker precision medical testing" means the analysis of a
52 patient's tissue, blood, or other biospecimen for the presence of a
53 biomarker. Biomarker testing includes but is not limited to single-ana-
54 lyte tests and multi-plex panel tests performed at a participating
55 in-network laboratory facility that is either CLIA certified or CLIA
56 waived by the federal food and drug administration.
A. 8502 6
1 (3) ["Clinical utility" means the test result provides information
2 that is used in the formulation of a treatment or monitoring strategy
3 that informs a patient's outcome and impacts the clinical decision.
4 (4)] "Nationally recognized clinical practice guidelines" means
5 evidence-based clinical practice guidelines informed by a systematic
6 review of evidence and an assessment of the benefits, and risks of
7 alternative care options intended to optimize patient care developed by
8 independent organizations or medical professional societies utilizing a
9 transparent methodology and reporting structure and with a conflict of
10 interest policy.
11 § 5. Section 5 of a chapter of the laws of 2023 amending the insurance
12 law and the social services law relating to requiring health insurance
13 policies and medicaid to cover biomarker testing for certain purposes,
14 as proposed in legislative bills numbers S. 1196-A and A. 1673-A, is
15 amended to read as follows:
16 § 5. This act shall take effect [April 1, 2024] January 1, 2025 and
17 shall apply to all policies and contracts issued, renewed, modified,
18 altered or amended on or after such date.
19 § 6. This act shall take effect immediately; provided however that
20 sections one, two, three and four of this act shall take effect on the
21 same date and in the same manner as a chapter of the laws of 2023 amend-
22 ing the insurance law and the social services law relating to requiring
23 health insurance policies and medicaid to cover biomarker testing for
24 certain purposes, as proposed in legislative bills numbers S. 1196-A
25 and A. 1673-A, takes effect.
