Bill Text: NY S01196 | 2023-2024 | General Assembly | Amended
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 27-7)
Status: (Passed) 2023-12-22 - APPROVAL MEMO.76 [S01196 Detail]
Download: New_York-2023-S01196-Amended.html
STATE OF NEW YORK ________________________________________________________________________ 1196--A 2023-2024 Regular Sessions IN SENATE January 10, 2023 ___________ Introduced by Sens. PERSAUD, ADDABBO, BROUK, CHU, CLEARE, COMRIE, COONEY, GALLIVAN, GIANARIS, GONZALEZ, GOUNARDES, GRIFFO, HARCKHAM, HELMING, HOYLMAN-SIGAL, KENNEDY, KRUEGER, MANNION, MATTERA, MAY, MYRIE, PALUMBO, PARKER, RIVERA, SALAZAR, SCARCELLA-SPANTON, SERRANO, SKOUFIS, STAVISKY, THOMAS, WEIK -- read twice and ordered printed, and when printed to be committed to the Committee on Insurance -- reported favorably from said committee and committed to the Committee on Finance -- 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 15 (iii) nationally recognized clinical practice guidelines such as, but 16 not limited to, those of the national comprehensive cancer network or 17 the American society of clinical oncology. EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD02625-06-3S. 1196--A 2 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 § 2. Subsection (l) of section 3221 of the insurance law is amended by 34 adding a new paragraph 11-c to read as follows: 35 (11-c) (A) Every insurer delivering a group or blanket policy or issu- 36 ing a group or blanket policy for delivery in this state that provides 37 coverage for medical, major medical, or similar comprehensive-type 38 coverage shall provide coverage for biomarker testing for the purposes 39 of diagnosis, treatment, appropriate management, or ongoing monitoring 40 of a covered person's disease or condition when the test provides clin- 41 ical utility to the patient as demonstrated by medical and scientific 42 evidence, including, but not limited to: 43 (i) 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 (ii) centers for medicare and medicaid services national coverage 47 determinations and medicare administrative contractor local coverage 48 determinations; or 49 (iii) nationally recognized clinical practice guidelines including, 50 but not limited to, those of the national comprehensive cancer network 51 or the American society of clinical oncology. 52 (B) 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 (C) The covered person and prescribing practitioner shall have access 56 to a clear, readily accessible, and convenient process to request anS. 1196--A 3 1 exception to a coverage policy provided pursuant to the provisions of 2 this paragraph. Such process shall be made readily accessible on the 3 website of the insurer. 4 (D) As used in this paragraph, the following terms shall have the 5 following meanings: 6 (i) "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 (ii) "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 (iii) "Clinical utility" means the test result provides information 19 that is used in the formulation of a treatment or monitoring strategy 20 that informs a patient's outcome and impacts the clinical decision. 21 (iv) "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 § 3. Section 4303 of the insurance law is amended by adding a new 29 subsection (p-1) to read as follows: 30 (p-1) (1) A medical expense indemnity corporation, a hospital service 31 corporation or a health service corporation that provides coverage for 32 medical, major medical, or similar comprehensive-type coverage shall 33 provide coverage for biomarker testing for the purposes of diagnosis, 34 treatment, appropriate management, or ongoing monitoring of a covered 35 person's disease or condition when the test provides clinical utility to 36 the patient as demonstrated by medical and scientific evidence, includ- 37 ing, but not limited to: 38 (A) labeled indications for a test approved or cleared by the federal 39 food and drug administration or indicated tests for a food and drug 40 administration approved drug; 41 (B) centers for medicare and medicaid services national coverage 42 determinations and medicare administrative contractor local coverage 43 determinations; or 44 (C) nationally recognized clinical practice guidelines such as, but 45 not limited to, those of the national comprehensive cancer network or 46 the American society of clinical oncology. 47 (2) Such coverage shall be provided in a manner that shall limit 48 disruptions in care including the need for multiple biopsies or biospe- 49 cimen samples. 50 (3) The covered person and prescribing practitioner shall have access 51 to a clear, readily accessible, and convenient process to request an 52 exception to a coverage policy provided pursuant to the provisions of 53 this subsection. Such process shall be made readily accessible on the 54 website of the insurer. 55 (4) As used in this subsection, the following terms shall have the 56 following meanings:S. 1196--A 4 1 (A) "Biomarker" means a defined characteristic that is measured as an 2 indicator of normal biological processes, pathogenic processes, or 3 responses to an exposure or intervention, including therapeutic inter- 4 ventions. Molecular, histologic, radiographic, or physiologic character- 5 istics are types of biomarkers. A biomarker is not an assessment of how 6 a patient feels, functions, or survives. 7 (B) "Biomarker testing" means the analysis of a patient's tissue, 8 blood, or other biospecimen for the presence of a biomarker. Biomarker 9 testing includes but is not limited to single-analyte tests and multi- 10 plex panel tests performed at a participating in-network laboratory 11 facility that is either CLIA certified or CLIA waived by the federal 12 food and drug administration. 13 (C) "Clinical utility" means the test result provides information that 14 is used in the formulation of a treatment or monitoring strategy that 15 informs a patient's outcome and impacts the clinical decision. 16 (D) "Nationally recognized clinical practice guidelines" means 17 evidence-based clinical practice guidelines informed by a systematic 18 review of evidence and an assessment of the benefits, and risks of 19 alternative care options intended to optimize patient care developed by 20 independent organizations or medical professional societies utilizing a 21 transparent methodology and reporting structure and with a conflict of 22 interest policy. 23 § 4. Subdivision 2 of section 365-a of the social services law is 24 amended by adding a new paragraph (mm) to read as follows: 25 (mm) (i) biomarker testing for the purposes of diagnosis, treatment, 26 appropriate management, or ongoing monitoring of a recipient's disease 27 or condition when the test provides clinical utility to the patient as 28 demonstrated by medical and scientific evidence, including, but not 29 limited to: 30 (1) labeled indications for a test approved or cleared by the federal 31 food and drug administration or indicated tests for a food and drug 32 administration approved drug; 33 (2) centers for medicare and medicaid services national coverage 34 determinations and medicare administrative contractor local coverage 35 determinations; or 36 (3) nationally recognized clinical practice guidelines such as, but 37 not limited to, those of the national comprehensive cancer network or 38 the American society of clinical oncology. 39 (ii) Risk-bearing entities contracted to the medicaid program to 40 deliver services to recipients shall provide biomarker testing at the 41 same scope, duration and frequency as the medicaid program otherwise 42 provides to enrollees. 43 (iii) The recipient and participating provider shall have access to a 44 clear, readily accessible, and convenient process to request an excep- 45 tion to a coverage policy of the medicaid program or by risk-bearing 46 entities contracted to the medicaid program. Such process shall be made 47 readily accessible to all participating providers and enrollees online. 48 (iv) As used in this paragraph, the following terms shall have the 49 following meanings: 50 (1) "Biomarker" means a defined characteristic that is measured as an 51 indicator of normal biological processes, pathogenic processes, or 52 responses to an exposure or intervention, including therapeutic inter- 53 ventions. Molecular, histologic, radiographic, or physiologic character- 54 istics are types of biomarkers. A biomarker is not an assessment of how 55 a patient feels, functions, or survives.S. 1196--A 5 1 (2) "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 and multi- 4 plex panel tests performed at a participating in-network laboratory 5 facility that is either CLIA certified or CLIA waived by the federal 6 food and drug administration. 7 (3) "Clinical utility" means the test result provides information that 8 is used in the formulation of a treatment or monitoring strategy that 9 informs a patient's outcome and impacts the clinical decision. 10 (4) "Nationally recognized clinical practice guidelines" means 11 evidence-based clinical practice guidelines informed by a systematic 12 review of evidence and an assessment of the benefits, and risks of 13 alternative care options intended to optimize patient care developed by 14 independent organizations or medical professional societies utilizing a 15 transparent methodology and reporting structure and with a conflict of 16 interest policy. 17 § 5. This act shall take effect April 1, 2024 and shall apply to all 18 policies and contracts issued, renewed, modified, altered or amended on 19 or after such date.
