STATE OF NEW YORK ________________________________________________________________________ 8147 IN SENATE January 26, 2022 ___________ Introduced by Sen. PERSAUD -- 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-b to read as follows: 3 (11-b) (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 23 this paragraph. Such process shall be made readily accessible on the 24 website of the insurer. 25 (D) As used in this paragraph, the following terms shall have the 26 following meanings: EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD13311-02-2S. 8147 2 1 (i) "Biomarker" means a characteristic that is objectively measured 2 and evaluated as an indicator of normal biological processes, pathogenic 3 processes, or pharmacologic responses to a specific therapeutic inter- 4 vention. Biomarkers include but are not limited to gene mutations or 5 protein expression. 6 (ii) "Biomarker testing" means the analysis of a patient's tissue, 7 blood, or other biospecimen for the presence of a biomarker. Biomarker 8 testing includes but is not limited to single-analyte tests, multi-plex 9 panel tests, and whole genome sequencing. 10 (iii) "Consensus statements" means statements developed by an inde- 11 pendent, multidisciplinary panel of experts utilizing a transparent 12 methodology and reporting structure and with a conflict of interest 13 policy. Such statements are aimed at specific clinical circumstances and 14 base the statements on the best available evidence for the purpose of 15 optimizing the outcomes of clinical care. 16 (iv) "Nationally recognized clinical practice guidelines" means 17 evidence-based clinical practice guidelines developed by independent 18 organizations or medical professional societies utilizing a transparent 19 methodology and reporting structure and with a conflict of interest 20 policy. Clinical practice guidelines establish standards of care 21 informed by a systematic review of evidence and an assessment of the 22 benefits and costs of alternative care options and include recommenda- 23 tions intended to optimize patient care. 24 § 2. Subsection (l) of section 3221 of the insurance law is amended by 25 adding a new paragraph 11-b to read as follows: 26 (11-b) (A) Every insurer delivering a group or blanket policy or issu- 27 ing a group or blanket policy for delivery in this state that provides 28 coverage for medical, major medical, or similar comprehensive-type 29 coverage shall provide coverage for biomarker testing for the purposes 30 of diagnosis, treatment, appropriate management, or ongoing monitoring 31 of a covered person's disease or condition when the test is supported by 32 medical and scientific evidence, including, but not limited to: 33 (i) labeled indications for a test approved or cleared by the food and 34 drug administration of the United States government or indicated tests 35 for a food and drug administration approved drug; 36 (ii) centers for medicare and medicaid services national coverage 37 determinations and medicare administrative contractor local coverage 38 determinations; or 39 (iii) nationally recognized clinical practice guidelines and consensus 40 statements. 41 (B) Such coverage shall be provided in a manner that shall limit 42 disruptions in care including the need for multiple biopsies or biospe- 43 cimen samples. 44 (C) The covered person and prescribing practitioner shall have access 45 to a clear, readily accessible, and convenient process to request an 46 exception to a coverage policy provided pursuant to the provisions of 47 this paragraph. Such process shall be made readily accessible on the 48 website of the insurer. 49 (D) As used in this paragraph, the following terms shall have the 50 following meanings: 51 (i) "Biomarker" means a characteristic that is objectively measured 52 and evaluated as an indicator of normal biological processes, pathogenic 53 processes, or pharmacologic responses to a specific therapeutic inter- 54 vention. Biomarkers include but are not limited to gene mutations or 55 protein expression.S. 8147 3 1 (ii) "Biomarker testing" means the analysis of a patient's tissue, 2 blood, or other biospecimen for the presence of a biomarker. Biomarker 3 testing includes but is not limited to single-analyte tests, multi-plex 4 panel tests, and whole genome sequencing. 5 (iii) "Consensus statements" means statements developed by an inde- 6 pendent, multidisciplinary panel of experts utilizing a transparent 7 methodology and reporting structure and with a conflict of interest 8 policy. Such statements are aimed at specific clinical circumstances and 9 base the statements on the best available evidence for the purpose of 10 optimizing the outcomes of clinical care. 11 (iv) "Nationally recognized clinical practice guidelines" means 12 evidence-based clinical practice guidelines developed by independent 13 organizations or medical professional societies utilizing a transparent 14 methodology and reporting structure and with a conflict of interest 15 policy. Clinical practice guidelines establish standards of care 16 informed by a systematic review of evidence and an assessment of the 17 benefits and costs of alternative care options and include recommenda- 18 tions intended to optimize patient care. 19 § 3. Section 4303 of the insurance law is amended by adding a new 20 subsection (p-1) to read as follows: 21 (p-1) (1) A medical expense indemnity corporation, a hospital service 22 corporation or a health service corporation that provides coverage for 23 medical, major medical, or similar comprehensive-type coverage shall 24 provide coverage for biomarker testing for the purposes of diagnosis, 25 treatment, appropriate management, or ongoing monitoring of a covered 26 person's disease or condition when the test is supported by medical and 27 scientific evidence, including, but not limited to: 28 (A) labeled indications for a test approved or cleared by the food and 29 drug administration of the United States government or indicated tests 30 for a food and drug administration approved drug; 31 (B) centers for medicare and medicaid services national coverage 32 determinations and medicare administrative contractor local coverage 33 determinations; or 34 (C) nationally recognized clinical practice guidelines and consensus 35 statements. 36 (2) Such coverage shall be provided in a manner that shall limit 37 disruptions in care including the need for multiple biopsies or biospe- 38 cimen samples. 39 (3) The covered person and prescribing practitioner shall have access 40 to a clear, readily accessible, and convenient process to request an 41 exception to a coverage policy provided pursuant to the provisions of 42 this subsection. Such process shall be made readily accessible on the 43 website of the insurer. 44 (4) As used in this subsection, the following terms shall have the 45 following meanings: 46 (A) "Biomarker" means a characteristic that is objectively measured 47 and evaluated as an indicator of normal biological processes, pathogenic 48 processes, or pharmacologic responses to a specific therapeutic inter- 49 vention. Biomarkers include but are not limited to gene mutations or 50 protein expression. 51 (B) "Biomarker testing" means the analysis of a patient's tissue, 52 blood, or other biospecimen for the presence of a biomarker. Biomarker 53 testing includes but is not limited to single-analyte tests, multi-plex 54 panel tests, and whole genome sequencing. 55 (C) "Consensus statements" means statements developed by an independ- 56 ent, multidisciplinary panel of experts utilizing a transparent method-S. 8147 4 1 ology and reporting structure and with a conflict of interest policy. 2 Such statements are aimed at specific clinical circumstances and base 3 the statements on the best available evidence for the purpose of opti- 4 mizing the outcomes of clinical care. 5 (D) "Nationally recognized clinical practice guidelines" means 6 evidence-based clinical practice guidelines developed by independent 7 organizations or medical professional societies utilizing a transparent 8 methodology and reporting structure and with a conflict of interest 9 policy. Clinical practice guidelines establish standards of care 10 informed by a systematic review of evidence and an assessment of the 11 benefits and costs of alternative care options and include recommenda- 12 tions intended to optimize patient care. 13 § 4. Subdivision 2 of section 365-a of the social services law is 14 amended by adding a new paragraph (jj) to read as follows: 15 (jj) (i) biomarker testing for the purposes of diagnosis, treatment, 16 appropriate management, or ongoing monitoring of a recipient's disease 17 or condition when the test is supported by medical and scientific 18 evidence, including, but not limited to: 19 (1) labeled indications for a test approved or cleared by the food and 20 drug administration of the United States government or indicated tests 21 for a food and drug administration approved drug; 22 (2) centers for medicare and medicaid services national coverage 23 determinations and medicare administrative contractor local coverage 24 determinations; or 25 (3) nationally recognized clinical practice guidelines and consensus 26 statements. 27 (ii) Risk-bearing entities contracted to the medicaid program to 28 deliver services to recipients shall provide biomarker testing at the 29 same scope, duration and frequency as the medicaid program otherwise 30 provides to enrollees. 31 (iii) The recipient and participating provider shall have access to a 32 clear, readily accessible, and convenient process to request an excep- 33 tion to a coverage policy of the medicaid program or by risk-bearing 34 entities contracted to the medicaid program. Such process shall be made 35 readily accessible to all participating providers and enrollees online. 36 (iv) As used in this paragraph, the following terms shall have the 37 following meanings: 38 (1) "Biomarker" means a characteristic that is objectively measured 39 and evaluated as an indicator of normal biological processes, pathogenic 40 processes, or pharmacologic responses to a specific therapeutic inter- 41 vention. Biomarkers include but are not limited to gene mutations or 42 protein expression. 43 (2) "Biomarker testing" means the analysis of a patient's tissue, 44 blood, or other biospecimen for the presence of a biomarker. Biomarker 45 testing includes but is not limited to single-analyte tests, multi-plex 46 panel tests, and whole genome sequencing. 47 (3) "Consensus statements" means statements developed by an independ- 48 ent, multidisciplinary panel of experts utilizing a transparent method- 49 ology and reporting structure and with a conflict of interest policy. 50 Such statements are aimed at specific clinical circumstances and base 51 the statements on the best available evidence for the purpose of opti- 52 mizing the outcomes of clinical care. 53 (4) "Nationally recognized clinical practice guidelines" means 54 evidence-based clinical practice guidelines developed by independent 55 organizations or medical professional societies utilizing a transparent 56 methodology and reporting structure and with a conflict of interestS. 8147 5 1 policy. Clinical practice guidelines establish standards of care 2 informed by a systematic review of evidence and an assessment of the 3 benefits and costs of alternative care options and include recommenda- 4 tions intended to optimize patient care. 5 § 5. This act shall take effect January 1, 2023 and shall apply to all 6 policies and contracts issued, renewed, modified, altered or amended on 7 or after such date.