New York State Assembly

 
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A08502 Summary:

A08502 Actions:

A08502 Committee Votes:

Committee:INSURANCE   Chair:Weprin      
DATE:01/08/2024AYE/NAY:23/0  Action: Favorable refer to committee Ways and Means        
Weprin
Aye
Blankenbush
Aye
Cook
Aye
Hawley
Aye
Pretlow
Aye
Palmesano
Aye
Lavine
Aye
Gandolfo
Aye
Steck
Aye
Curran
Aye
Dilan
Aye
Jensen
Aye
Hunter
Aye
Blumencranz
Aye
Stern
Aye
Bendett
Aye
Jacobson
Aye
Meeks
Excused
Forrest
Aye
Anderson
Aye
Cruz
Aye
Bores
Aye
Lunsford
Aye
Berger
Aye

Committee:RULES   Chair:Pretlow      
DATE:01/22/2024AYE/NAY:26/0  Action: Favorable         
Heastie
Excused
Barclay
Aye
Weinstein
Excused
Hawley
Aye
Pretlow
Aye
Giglio
Aye
Cook
Aye
Blankenbush
Aye
Glick
Aye
Norris
Aye
Aubry
Aye
Ra
Aye
Dinowitz
Aye
Brabenec
Aye
Colton
Aye
Palmesano
Aye
Magnarelli
Aye
Reilly
Aye
Paulin
Aye
Peoples-Stokes
Aye
Benedetto
Aye
Lavine
Aye
Lupardo
Aye
Zebrowski
Aye
Thiele
Aye
Braunstein
Aye
Dickens
Excused
Davila
Aye
Hyndman
Excused
Rozic
Excused
Bronson
Aye

Committee:WAYS AND MEANS   Chair:Weinstein      
DATE:01/22/2024AYE/NAY:31/0  Action: Favorable refer to committee Rules        
Weinstein
Excused
Ra
Aye
Glick
Aye
Fitzpatrick
Excused
Pretlow
Aye
Hawley
Aye
Colton
Aye
Blankenbush
Aye
Cook
Aye
Norris
Aye
Aubry
Aye
Brabenec
Aye
Benedetto
Aye
Palmesano
Aye
Weprin
Aye
Walsh
Aye
Ramos
Aye
DeStefano
Aye
Braunstein
Aye
Manktelow
Aye
McDonald
Aye
Smullen
Aye
Cunningham
Aye
Dinowitz
Aye
Magnarelli
Aye
Zebrowski
Aye
Bronson
Aye
Dilan
Aye
Seawright
Aye
Hyndman
Excused
Walker
Excused
Bichotte Hermel
Aye
Simon
Aye
Cruz
Aye
Fahy
Aye

A08502 Floor Votes:

A08502 Text:

 
                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.