Bill Text: NY A01673 | 2023-2024 | General Assembly | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: 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.
Spectrum: Moderate Partisan Bill (Democrat 56-10)
Status: (Introduced) 2023-06-08 - substituted by s1196a [A01673 Detail]
Download: New_York-2023-A01673-Introduced.html
Bill Title: 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.
Spectrum: Moderate Partisan Bill (Democrat 56-10)
Status: (Introduced) 2023-06-08 - substituted by s1196a [A01673 Detail]
Download: New_York-2023-A01673-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 1673 2023-2024 Regular Sessions IN ASSEMBLY January 17, 2023 ___________ Introduced by M. of A. HUNTER, DINOWITZ, BRONSON -- 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 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 23 this paragraph. Such process shall be made readily accessible on the 24 website of the insurer. EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD02625-01-3A. 1673 2 1 (D) As used in this paragraph, the following terms shall have the 2 following meanings: 3 (i) "Biomarker" means a characteristic that is objectively measured 4 and evaluated as an indicator of normal biological processes, pathogenic 5 processes, or pharmacologic responses to a specific therapeutic inter- 6 vention. Biomarkers include but are not limited to gene mutations or 7 protein expression. 8 (ii) "Biomarker testing" means the analysis of a patient's tissue, 9 blood, or other biospecimen for the presence of a biomarker. Biomarker 10 testing includes but is not limited to single-analyte tests, multi-plex 11 panel tests, and whole genome sequencing. 12 (iii) "Consensus statements" means statements developed by an inde- 13 pendent, multidisciplinary panel of experts utilizing a transparent 14 methodology and reporting structure and with a conflict of interest 15 policy. Such statements are aimed at specific clinical circumstances and 16 base the statements on the best available evidence for the purpose of 17 optimizing the outcomes of clinical care. 18 (iv) "Nationally recognized clinical practice guidelines" means 19 evidence-based clinical practice guidelines developed by independent 20 organizations or medical professional societies utilizing a transparent 21 methodology and reporting structure and with a conflict of interest 22 policy. Clinical practice guidelines establish standards of care 23 informed by a systematic review of evidence and an assessment of the 24 benefits and costs of alternative care options and include recommenda- 25 tions intended to optimize patient care. 26 § 2. Subsection (l) of section 3221 of the insurance law is amended by 27 adding a new paragraph 11-c to read as follows: 28 (11-c) (A) Every insurer delivering a group or blanket policy or issu- 29 ing a group or blanket policy for delivery in this state that provides 30 coverage for medical, major medical, or similar comprehensive-type 31 coverage shall provide coverage for biomarker testing for the purposes 32 of diagnosis, treatment, appropriate management, or ongoing monitoring 33 of a covered person's disease or condition when the test is supported by 34 medical and scientific evidence, including, but not limited to: 35 (i) labeled indications for a test approved or cleared by the food and 36 drug administration of the United States government or indicated tests 37 for a food and drug administration approved drug; 38 (ii) centers for medicare and medicaid services national coverage 39 determinations and medicare administrative contractor local coverage 40 determinations; or 41 (iii) nationally recognized clinical practice guidelines and consensus 42 statements. 43 (B) Such coverage shall be provided in a manner that shall limit 44 disruptions in care including the need for multiple biopsies or biospe- 45 cimen samples. 46 (C) The covered person and prescribing practitioner shall have access 47 to a clear, readily accessible, and convenient process to request an 48 exception to a coverage policy provided pursuant to the provisions of 49 this paragraph. Such process shall be made readily accessible on the 50 website of the insurer. 51 (D) As used in this paragraph, the following terms shall have the 52 following meanings: 53 (i) "Biomarker" means a characteristic that is objectively measured 54 and evaluated as an indicator of normal biological processes, pathogenic 55 processes, or pharmacologic responses to a specific therapeutic inter-A. 1673 3 1 vention. Biomarkers include but are not limited to gene mutations or 2 protein expression. 3 (ii) "Biomarker testing" means the analysis of a patient's tissue, 4 blood, or other biospecimen for the presence of a biomarker. Biomarker 5 testing includes but is not limited to single-analyte tests, multi-plex 6 panel tests, and whole genome sequencing. 7 (iii) "Consensus statements" means statements developed by an inde- 8 pendent, multidisciplinary panel of experts utilizing a transparent 9 methodology and reporting structure and with a conflict of interest 10 policy. Such statements are aimed at specific clinical circumstances and 11 base the statements on the best available evidence for the purpose of 12 optimizing the outcomes of clinical care. 13 (iv) "Nationally recognized clinical practice guidelines" means 14 evidence-based clinical practice guidelines developed by independent 15 organizations or medical professional societies utilizing a transparent 16 methodology and reporting structure and with a conflict of interest 17 policy. Clinical practice guidelines establish standards of care 18 informed by a systematic review of evidence and an assessment of the 19 benefits and costs of alternative care options and include recommenda- 20 tions intended to optimize patient care. 21 § 3. Section 4303 of the insurance law is amended by adding a new 22 subsection (p-1) to read as follows: 23 (p-1) (1) A medical expense indemnity corporation, a hospital service 24 corporation or a health service corporation that provides coverage for 25 medical, major medical, or similar comprehensive-type coverage shall 26 provide coverage for biomarker testing for the purposes of diagnosis, 27 treatment, appropriate management, or ongoing monitoring of a covered 28 person's disease or condition when the test is supported by medical and 29 scientific evidence, including, but not limited to: 30 (A) labeled indications for a test approved or cleared by the food and 31 drug administration of the United States government or indicated tests 32 for a food and drug administration approved drug; 33 (B) centers for medicare and medicaid services national coverage 34 determinations and medicare administrative contractor local coverage 35 determinations; or 36 (C) nationally recognized clinical practice guidelines and consensus 37 statements. 38 (2) Such coverage shall be provided in a manner that shall limit 39 disruptions in care including the need for multiple biopsies or biospe- 40 cimen samples. 41 (3) The covered person and prescribing practitioner shall have access 42 to a clear, readily accessible, and convenient process to request an 43 exception to a coverage policy provided pursuant to the provisions of 44 this subsection. Such process shall be made readily accessible on the 45 website of the insurer. 46 (4) As used in this subsection, the following terms shall have the 47 following meanings: 48 (A) "Biomarker" means a characteristic that is objectively measured 49 and evaluated as an indicator of normal biological processes, pathogenic 50 processes, or pharmacologic responses to a specific therapeutic inter- 51 vention. Biomarkers include but are not limited to gene mutations or 52 protein expression. 53 (B) "Biomarker testing" means the analysis of a patient's tissue, 54 blood, or other biospecimen for the presence of a biomarker. Biomarker 55 testing includes but is not limited to single-analyte tests, multi-plex 56 panel tests, and whole genome sequencing.A. 1673 4 1 (C) "Consensus statements" means statements developed by an independ- 2 ent, multidisciplinary panel of experts utilizing a transparent method- 3 ology and reporting structure and with a conflict of interest policy. 4 Such statements are aimed at specific clinical circumstances and base 5 the statements on the best available evidence for the purpose of opti- 6 mizing the outcomes of clinical care. 7 (D) "Nationally recognized clinical practice guidelines" means 8 evidence-based clinical practice guidelines developed by independent 9 organizations or medical professional societies utilizing a transparent 10 methodology and reporting structure and with a conflict of interest 11 policy. Clinical practice guidelines establish standards of care 12 informed by a systematic review of evidence and an assessment of the 13 benefits and costs of alternative care options and include recommenda- 14 tions intended to optimize patient care. 15 § 4. Subdivision 2 of section 365-a of the social services law is 16 amended by adding a new paragraph (kk) to read as follows: 17 (kk) (i) biomarker testing for the purposes of diagnosis, treatment, 18 appropriate management, or ongoing monitoring of a recipient's disease 19 or condition when the test is supported by medical and scientific 20 evidence, including, but not limited to: 21 (1) labeled indications for a test approved or cleared by the food and 22 drug administration of the United States government or indicated tests 23 for a food and drug administration approved drug; 24 (2) centers for medicare and medicaid services national coverage 25 determinations and medicare administrative contractor local coverage 26 determinations; or 27 (3) nationally recognized clinical practice guidelines and consensus 28 statements. 29 (ii) Risk-bearing entities contracted to the medicaid program to 30 deliver services to recipients shall provide biomarker testing at the 31 same scope, duration and frequency as the medicaid program otherwise 32 provides to enrollees. 33 (iii) The recipient and participating provider shall have access to a 34 clear, readily accessible, and convenient process to request an excep- 35 tion to a coverage policy of the medicaid program or by risk-bearing 36 entities contracted to the medicaid program. Such process shall be made 37 readily accessible to all participating providers and enrollees online. 38 (iv) As used in this paragraph, the following terms shall have the 39 following meanings: 40 (1) "Biomarker" means a characteristic that is objectively measured 41 and evaluated as an indicator of normal biological processes, pathogenic 42 processes, or pharmacologic responses to a specific therapeutic inter- 43 vention. Biomarkers include but are not limited to gene mutations or 44 protein expression. 45 (2) "Biomarker testing" means the analysis of a patient's tissue, 46 blood, or other biospecimen for the presence of a biomarker. Biomarker 47 testing includes but is not limited to single-analyte tests, multi-plex 48 panel tests, and whole genome sequencing. 49 (3) "Consensus statements" means statements developed by an independ- 50 ent, multidisciplinary panel of experts utilizing a transparent method- 51 ology and reporting structure and with a conflict of interest policy. 52 Such statements are aimed at specific clinical circumstances and base 53 the statements on the best available evidence for the purpose of opti- 54 mizing the outcomes of clinical care. 55 (4) "Nationally recognized clinical practice guidelines" means 56 evidence-based clinical practice guidelines developed by independentA. 1673 5 1 organizations or medical professional societies utilizing a transparent 2 methodology and reporting structure and with a conflict of interest 3 policy. Clinical practice guidelines establish standards of care 4 informed by a systematic review of evidence and an assessment of the 5 benefits and costs of alternative care options and include recommenda- 6 tions intended to optimize patient care. 7 § 5. This act shall take effect January 1, 2024 and shall apply to all 8 policies and contracts issued, renewed, modified, altered or amended on 9 or after such date.
