Amd 3216, 3221 & 4303, Ins L; amd 365-a, Soc Serv L
Requires health insurance policies and medicaid to cover biomarker testing for diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person's disease or condition when the test is supported by medical and scientific evidence.
STATE OF NEW YORK
________________________________________________________________________
1673--A
2023-2024 Regular Sessions
IN ASSEMBLY
January 17, 2023
___________
Introduced by M. of A. HUNTER, DINOWITZ, BRONSON, RAGA, LAVINE, ALVAREZ,
McDONALD, PAULIN, GUNTHER, SEAWRIGHT, SEPTIMO, THIELE, SHIMSKY,
DE LOS SANTOS, STECK, DAVILA, L. ROSENTHAL, SANTABARBARA, WILLIAMS,
BICHOTTE HERMELYN, FAHY, BUTTENSCHON, BURDICK, SIMONE, JACOBSON, BENE-
DETTO, AUBRY, CRUZ, CLARK, SIMON, ARDILA, ZEBROWSKI, DICKENS, CUNNING-
HAM, BURGOS, DURSO, MAHER, BRABENEC, SLATER, MANKTELOW, DeSTEFANO,
BARCLAY, EACHUS, MAGNARELLI, NOVAKHOV, LEVENBERG, WEPRIN, MEEKS,
ROZIC, PRETLOW, REYES, PHEFFER AMATO, WALKER, KIM, TAYLOR, BURKE,
HYNDMAN, RAMOS, WALLACE -- read once and referred to the Committee on
Insurance -- reported and referred to the Committee on Ways and Means
-- committee discharged, bill amended, ordered reprinted as amended
and recommitted to said committee
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 provides clinical utility to the patient as demonstrated
8 by medical and scientific evidence, including, but not limited to:
9 (i) labeled indications for a test approved or cleared by the federal
10 food and drug administration or indicated tests for a food and drug
11 administration approved drug;
12 (ii) centers for medicare and medicaid services national coverage
13 determinations and medicare administrative contractor local coverage
14 determinations; or
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD02625-07-3
A. 1673--A 2
1 (iii) nationally recognized clinical practice guidelines such as, but
2 not limited to, those of the national comprehensive cancer network or
3 the American society of clinical oncology.
4 (B) Such coverage shall be provided in a manner that shall limit
5 disruptions in care including the need for multiple biopsies or biospe-
6 cimen samples.
7 (C) The covered person and prescribing practitioner shall have access
8 to a clear, readily accessible, and convenient process to request an
9 exception to a coverage policy provided pursuant to the provisions of
10 this paragraph. Such process shall be made readily accessible on the
11 website of the insurer.
12 (D) As used in this paragraph, the following terms shall have the
13 following meanings:
14 (i) "Biomarker" means a defined characteristic that is measured as an
15 indicator of normal biological processes, pathogenic processes, or
16 responses to an exposure or intervention, including therapeutic inter-
17 ventions. Molecular, histologic, radiographic, or physiologic character-
18 istics are types of biomarkers. A biomarker is not an assessment of how
19 a patient feels, functions, or survives.
20 (ii) "Biomarker testing" means the analysis of a patient's tissue,
21 blood, or other biospecimen for the presence of a biomarker. Biomarker
22 testing includes but is not limited to single-analyte tests and multi-
23 plex panel tests performed at a participating in-network laboratory
24 facility that is either CLIA certified or CLIA waived by the federal
25 food and drug administration.
26 (iii) "Clinical utility" means the test result provides information
27 that is used in the formulation of a treatment or monitoring strategy
28 that informs a patient's outcome and impacts the clinical decision.
29 (iv) "Nationally recognized clinical practice guidelines" means
30 evidence-based clinical practice guidelines informed by a systematic
31 review of evidence and an assessment of the benefits, and risks of
32 alternative care options intended to optimize patient care developed by
33 independent organizations or medical professional societies utilizing a
34 transparent methodology and reporting structure and with a conflict of
35 interest policy.
36 § 2. Subsection (l) of section 3221 of the insurance law is amended by
37 adding a new paragraph 11-c to read as follows:
38 (11-c) (A) Every insurer delivering a group or blanket policy or issu-
39 ing a group or blanket policy for delivery in this state that provides
40 coverage for medical, major medical, or similar comprehensive-type
41 coverage shall provide coverage for biomarker testing for the purposes
42 of diagnosis, treatment, appropriate management, or ongoing monitoring
43 of a covered person's disease or condition when the test provides clin-
44 ical utility to the patient as demonstrated by medical and scientific
45 evidence, including, but not limited to:
46 (i) labeled indications for a test approved or cleared by the federal
47 food and drug administration or indicated tests for a food and drug
48 administration approved drug;
49 (ii) centers for medicare and medicaid services national coverage
50 determinations and medicare administrative contractor local coverage
51 determinations; or
52 (iii) nationally recognized clinical practice guidelines including,
53 but not limited to, those of the national comprehensive cancer network
54 or the American society of clinical oncology.
A. 1673--A 3
1 (B) Such coverage shall be provided in a manner that shall limit
2 disruptions in care including the need for multiple biopsies or biospe-
3 cimen samples.
4 (C) The covered person and prescribing practitioner shall have access
5 to a clear, readily accessible, and convenient process to request an
6 exception to a coverage policy provided pursuant to the provisions of
7 this paragraph. Such process shall be made readily accessible on the
8 website of the insurer.
9 (D) As used in this paragraph, the following terms shall have the
10 following meanings:
11 (i) "Biomarker" means a defined characteristic that is measured as an
12 indicator of normal biological processes, pathogenic processes, or
13 responses to an exposure or intervention, including therapeutic inter-
14 ventions. Molecular, histologic, radiographic, or physiologic character-
15 istics are types of biomarkers. A biomarker is not an assessment of how
16 a patient feels, functions, or survives.
17 (ii) "Biomarker testing" means the analysis of a patient's tissue,
18 blood, or other biospecimen for the presence of a biomarker. Biomarker
19 testing includes but is not limited to single-analyte tests and multi-
20 plex panel tests performed at a participating in-network laboratory
21 facility that is either CLIA certified or CLIA waived by the federal
22 food and drug administration.
23 (iii) "Clinical utility" means the test result provides information
24 that is used in the formulation of a treatment or monitoring strategy
25 that informs a patient's outcome and impacts the clinical decision.
26 (iv) "Nationally recognized clinical practice guidelines" means
27 evidence-based clinical practice guidelines informed by a systematic
28 review of evidence and an assessment of the benefits, and risks of
29 alternative care options intended to optimize patient care developed by
30 independent organizations or medical professional societies utilizing a
31 transparent methodology and reporting structure and with a conflict of
32 interest policy.
33 § 3. Section 4303 of the insurance law is amended by adding a new
34 subsection (p-1) to read as follows:
35 (p-1) (1) A medical expense indemnity corporation, a hospital service
36 corporation or a health service corporation that provides coverage for
37 medical, major medical, or similar comprehensive-type coverage shall
38 provide coverage for biomarker testing for the purposes of diagnosis,
39 treatment, appropriate management, or ongoing monitoring of a covered
40 person's disease or condition when the test provides clinical utility to
41 the patient as demonstrated by medical and scientific evidence, includ-
42 ing, but not limited to:
43 (A) labeled indications for a test approved or cleared by the federal
44 food and drug administration or indicated tests for a food and drug
45 administration approved drug;
46 (B) centers for medicare and medicaid services national coverage
47 determinations and medicare administrative contractor local coverage
48 determinations; or
49 (C) nationally recognized clinical practice guidelines such as, but
50 not limited to, those of the national comprehensive cancer network or
51 the American society of clinical oncology.
52 (2) Such coverage shall be provided in a manner that shall limit
53 disruptions in care including the need for multiple biopsies or biospe-
54 cimen samples.
55 (3) The covered person and prescribing practitioner shall have access
56 to a clear, readily accessible, and convenient process to request an
A. 1673--A 4
1 exception to a coverage policy provided pursuant to the provisions of
2 this subsection. Such process shall be made readily accessible on the
3 website of the insurer.
4 (4) As used in this subsection, the following terms shall have the
5 following meanings:
6 (A) "Biomarker" means a defined characteristic that is measured as an
7 indicator of normal biological processes, pathogenic processes, or
8 responses to an exposure or intervention, including therapeutic inter-
9 ventions. Molecular, histologic, radiographic, or physiologic character-
10 istics are types of biomarkers. A biomarker is not an assessment of how
11 a patient feels, functions, or survives.
12 (B) "Biomarker testing" means the analysis of a patient's tissue,
13 blood, or other biospecimen for the presence of a biomarker. Biomarker
14 testing includes but is not limited to single-analyte tests and multi-
15 plex panel tests performed at a participating in-network laboratory
16 facility that is either CLIA certified or CLIA waived by the federal
17 food and drug administration.
18 (C) "Clinical utility" means the test result provides information that
19 is used in the formulation of a treatment or monitoring strategy that
20 informs a patient's outcome and impacts the clinical decision.
21 (D) "Nationally recognized clinical practice guidelines" means
22 evidence-based clinical practice guidelines informed by a systematic
23 review of evidence and an assessment of the benefits, and risks of
24 alternative care options intended to optimize patient care developed by
25 independent organizations or medical professional societies utilizing a
26 transparent methodology and reporting structure and with a conflict of
27 interest policy.
28 § 4. Subdivision 2 of section 365-a of the social services law is
29 amended by adding a new paragraph (mm) to read as follows:
30 (mm) (i) biomarker testing for the purposes of diagnosis, treatment,
31 appropriate management, or ongoing monitoring of a recipient's disease
32 or condition when the test provides clinical utility to the patient as
33 demonstrated by medical and scientific evidence, including, but not
34 limited to:
35 (1) labeled indications for a test approved or cleared by the federal
36 food and drug administration or indicated tests for a food and drug
37 administration approved drug;
38 (2) centers for medicare and medicaid services national coverage
39 determinations and medicare administrative contractor local coverage
40 determinations; or
41 (3) nationally recognized clinical practice guidelines such as, but
42 not limited to, those of the national comprehensive cancer network or
43 the American society of clinical oncology.
44 (ii) Risk-bearing entities contracted to the medicaid program to
45 deliver services to recipients shall provide biomarker testing at the
46 same scope, duration and frequency as the medicaid program otherwise
47 provides to enrollees.
48 (iii) The recipient and participating provider shall have access to a
49 clear, readily accessible, and convenient process to request an excep-
50 tion to a coverage policy of the medicaid program or by risk-bearing
51 entities contracted to the medicaid program. Such process shall be made
52 readily accessible to all participating providers and enrollees online.
53 (iv) As used in this paragraph, the following terms shall have the
54 following meanings:
55 (1) "Biomarker" means a defined characteristic that is measured as an
56 indicator of normal biological processes, pathogenic processes, or
A. 1673--A 5
1 responses to an exposure or intervention, including therapeutic inter-
2 ventions. Molecular, histologic, radiographic, or physiologic character-
3 istics are types of biomarkers. A biomarker is not an assessment of how
4 a patient feels, functions, or survives.
5 (2) "Biomarker testing" means the analysis of a patient's tissue,
6 blood, or other biospecimen for the presence of a biomarker. Biomarker
7 testing includes but is not limited to single-analyte tests and multi-
8 plex panel tests performed at a participating in-network laboratory
9 facility that is either CLIA certified or CLIA waived by the federal
10 food and drug administration.
11 (3) "Clinical utility" means the test result provides information that
12 is used in the formulation of a treatment or monitoring strategy that
13 informs a patient's outcome and impacts the clinical decision.
14 (4) "Nationally recognized clinical practice guidelines" means
15 evidence-based clinical practice guidelines informed by a systematic
16 review of evidence and an assessment of the benefits, and risks of
17 alternative care options intended to optimize patient care developed by
18 independent organizations or medical professional societies utilizing a
19 transparent methodology and reporting structure and with a conflict of
20 interest policy.
21 § 5. This act shall take effect April 1, 2024 and shall apply to all
22 policies and contracts issued, renewed, modified, altered or amended on
23 or after such date.
