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.