Bill Text: NY S01196 | 2023-2024 | General Assembly | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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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-Introduced.html

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                STATE OF NEW YORK
        ________________________________________________________________________

                                          1196

                               2023-2024 Regular Sessions

                    IN SENATE

                                    January 10, 2023
                                       ___________

        Introduced  by  Sens.  PERSAUD, BROUK, CLEARE, GOUNARDES, HOYLMAN-SIGAL,
          MANNION, MAY, MYRIE, THOMAS -- 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-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

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02625-01-3
        S. 1196                             2

     1  this  paragraph.  Such  process  shall be made readily accessible on the
     2  website of the insurer.
     3    (D)  As  used  in  this  paragraph, the following terms shall have the
     4  following meanings:
     5    (i) "Biomarker" means a characteristic that  is  objectively  measured
     6  and evaluated as an indicator of normal biological processes, pathogenic
     7  processes,  or  pharmacologic responses to a specific therapeutic inter-
     8  vention. Biomarkers include but are not limited  to  gene  mutations  or
     9  protein expression.
    10    (ii)  "Biomarker  testing"  means  the analysis of a patient's tissue,
    11  blood, or other biospecimen for the presence of a  biomarker.  Biomarker
    12  testing  includes but is not limited to single-analyte tests, multi-plex
    13  panel tests, and whole genome sequencing.
    14    (iii) "Consensus statements" means statements developed  by  an  inde-
    15  pendent,  multidisciplinary  panel  of  experts  utilizing a transparent
    16  methodology and reporting structure and  with  a  conflict  of  interest
    17  policy. Such statements are aimed at specific clinical circumstances and
    18  base  the  statements  on the best available evidence for the purpose of
    19  optimizing the outcomes of clinical care.
    20    (iv)  "Nationally  recognized  clinical  practice  guidelines"   means
    21  evidence-based  clinical  practice  guidelines  developed by independent
    22  organizations or medical professional societies utilizing a  transparent
    23  methodology  and  reporting  structure  and  with a conflict of interest
    24  policy.  Clinical  practice  guidelines  establish  standards  of   care
    25  informed  by  a  systematic  review of evidence and an assessment of the
    26  benefits and costs of alternative care options and  include  recommenda-
    27  tions intended to optimize patient care.
    28    § 2. Subsection (l) of section 3221 of the insurance law is amended by
    29  adding a new paragraph 11-c to read as follows:
    30    (11-c) (A) Every insurer delivering a group or blanket policy or issu-
    31  ing  a  group or blanket policy for delivery in this state that provides
    32  coverage for  medical,  major  medical,  or  similar  comprehensive-type
    33  coverage  shall  provide coverage for biomarker testing for the purposes
    34  of diagnosis, treatment, appropriate management, or  ongoing  monitoring
    35  of a covered person's disease or condition when the test is supported by
    36  medical and scientific evidence, including, but not limited to:
    37    (i) labeled indications for a test approved or cleared by the food and
    38  drug  administration  of the United States government or indicated tests
    39  for a food and drug administration approved drug;
    40    (ii) centers for medicare  and  medicaid  services  national  coverage
    41  determinations  and  medicare  administrative  contractor local coverage
    42  determinations; or
    43    (iii) nationally recognized clinical practice guidelines and consensus
    44  statements.
    45    (B) Such coverage shall be provided  in  a  manner  that  shall  limit
    46  disruptions  in care including the need for multiple biopsies or biospe-
    47  cimen samples.
    48    (C) The covered person and prescribing practitioner shall have  access
    49  to  a  clear,  readily  accessible, and convenient process to request an
    50  exception to a coverage policy provided pursuant to  the  provisions  of
    51  this  paragraph.  Such  process  shall be made readily accessible on the
    52  website of the insurer.
    53    (D) As used in this paragraph, the  following  terms  shall  have  the
    54  following meanings:
    55    (i)  "Biomarker"  means  a characteristic that is objectively measured
    56  and evaluated as an indicator of normal biological processes, pathogenic
        S. 1196                             3

     1  processes, or pharmacologic responses to a specific  therapeutic  inter-
     2  vention.  Biomarkers  include  but  are not limited to gene mutations or
     3  protein expression.
     4    (ii)  "Biomarker  testing"  means  the analysis of a patient's tissue,
     5  blood, or other biospecimen for the presence of a  biomarker.  Biomarker
     6  testing  includes but is not limited to single-analyte tests, multi-plex
     7  panel tests, and whole genome sequencing.
     8    (iii) "Consensus statements" means statements developed  by  an  inde-
     9  pendent,  multidisciplinary  panel  of  experts  utilizing a transparent
    10  methodology and reporting structure and  with  a  conflict  of  interest
    11  policy. Such statements are aimed at specific clinical circumstances and
    12  base  the  statements  on the best available evidence for the purpose of
    13  optimizing the outcomes of clinical care.
    14    (iv)  "Nationally  recognized  clinical  practice  guidelines"   means
    15  evidence-based  clinical  practice  guidelines  developed by independent
    16  organizations or medical professional societies utilizing a  transparent
    17  methodology  and  reporting  structure  and  with a conflict of interest
    18  policy.  Clinical  practice  guidelines  establish  standards  of   care
    19  informed  by  a  systematic  review of evidence and an assessment of the
    20  benefits and costs of alternative care options and  include  recommenda-
    21  tions intended to optimize patient care.
    22    §  3.  Section  4303  of  the insurance law is amended by adding a new
    23  subsection (p-1) to read as follows:
    24    (p-1) (1) A medical expense indemnity corporation, a hospital  service
    25  corporation  or  a health service corporation that provides coverage for
    26  medical, major medical, or  similar  comprehensive-type  coverage  shall
    27  provide  coverage  for  biomarker testing for the purposes of diagnosis,
    28  treatment, appropriate management, or ongoing monitoring  of  a  covered
    29  person's  disease or condition when the test is supported by medical and
    30  scientific evidence, including, but not limited to:
    31    (A) labeled indications for a test approved or cleared by the food and
    32  drug administration of the United States government or  indicated  tests
    33  for a food and drug administration approved drug;
    34    (B)  centers  for  medicare  and  medicaid  services national coverage
    35  determinations and medicare  administrative  contractor  local  coverage
    36  determinations; or
    37    (C)  nationally  recognized clinical practice guidelines and consensus
    38  statements.
    39    (2) Such coverage shall be provided  in  a  manner  that  shall  limit
    40  disruptions  in care including the need for multiple biopsies or biospe-
    41  cimen samples.
    42    (3) The covered person and prescribing practitioner shall have  access
    43  to  a  clear,  readily  accessible, and convenient process to request an
    44  exception to a coverage policy provided pursuant to  the  provisions  of
    45  this  subsection.  Such  process shall be made readily accessible on the
    46  website of the insurer.
    47    (4) As used in this subsection, the following  terms  shall  have  the
    48  following meanings:
    49    (A)  "Biomarker"  means  a characteristic that is objectively measured
    50  and evaluated as an indicator of normal biological processes, pathogenic
    51  processes, or pharmacologic responses to a specific  therapeutic  inter-
    52  vention.  Biomarkers  include  but  are not limited to gene mutations or
    53  protein expression.
    54    (B) "Biomarker testing" means the  analysis  of  a  patient's  tissue,
    55  blood,  or  other biospecimen for the presence of a biomarker. Biomarker
        S. 1196                             4

     1  testing includes but is not limited to single-analyte tests,  multi-plex
     2  panel tests, and whole genome sequencing.
     3    (C)  "Consensus statements" means statements developed by an independ-
     4  ent, multidisciplinary panel of experts utilizing a transparent  method-
     5  ology  and  reporting  structure and with a conflict of interest policy.
     6  Such statements are aimed at specific clinical  circumstances  and  base
     7  the  statements  on the best available evidence for the purpose of opti-
     8  mizing the outcomes of clinical care.
     9    (D)  "Nationally  recognized  clinical  practice   guidelines"   means
    10  evidence-based  clinical  practice  guidelines  developed by independent
    11  organizations or medical professional societies utilizing a  transparent
    12  methodology  and  reporting  structure  and  with a conflict of interest
    13  policy.  Clinical  practice  guidelines  establish  standards  of   care
    14  informed  by  a  systematic  review of evidence and an assessment of the
    15  benefits and costs of alternative care options and  include  recommenda-
    16  tions intended to optimize patient care.
    17    §  4.  Subdivision  2  of  section 365-a of the social services law is
    18  amended by adding a new paragraph (kk) to read as follows:
    19    (kk) (i) biomarker testing for the purposes of  diagnosis,  treatment,
    20  appropriate  management,  or ongoing monitoring of a recipient's disease
    21  or condition when the  test  is  supported  by  medical  and  scientific
    22  evidence, including, but not limited to:
    23    (1) labeled indications for a test approved or cleared by the food and
    24  drug  administration  of the United States government or indicated tests
    25  for a food and drug administration approved drug;
    26    (2) centers for  medicare  and  medicaid  services  national  coverage
    27  determinations  and  medicare  administrative  contractor local coverage
    28  determinations; or
    29    (3) nationally recognized clinical practice guidelines  and  consensus
    30  statements.
    31    (ii)  Risk-bearing  entities  contracted  to  the  medicaid program to
    32  deliver services to recipients shall provide biomarker  testing  at  the
    33  same  scope,  duration  and  frequency as the medicaid program otherwise
    34  provides to enrollees.
    35    (iii) The recipient and participating provider shall have access to  a
    36  clear,  readily  accessible, and convenient process to request an excep-
    37  tion to a coverage policy of the medicaid  program  or  by  risk-bearing
    38  entities  contracted to the medicaid program. Such process shall be made
    39  readily accessible to all participating providers and enrollees online.
    40    (iv) As used in this paragraph, the following  terms  shall  have  the
    41  following meanings:
    42    (1)  "Biomarker"  means  a characteristic that is objectively measured
    43  and evaluated as an indicator of normal biological processes, pathogenic
    44  processes, or pharmacologic responses to a specific  therapeutic  inter-
    45  vention.  Biomarkers  include  but  are not limited to gene mutations or
    46  protein expression.
    47    (2) "Biomarker testing" means the  analysis  of  a  patient's  tissue,
    48  blood,  or  other biospecimen for the presence of a biomarker. Biomarker
    49  testing includes but is not limited to single-analyte tests,  multi-plex
    50  panel tests, and whole genome sequencing.
    51    (3)  "Consensus statements" means statements developed by an independ-
    52  ent, multidisciplinary panel of experts utilizing a transparent  method-
    53  ology  and  reporting  structure and with a conflict of interest policy.
    54  Such statements are aimed at specific clinical  circumstances  and  base
    55  the  statements  on the best available evidence for the purpose of opti-
    56  mizing the outcomes of clinical care.
        S. 1196                             5

     1    (4)  "Nationally  recognized  clinical  practice   guidelines"   means
     2  evidence-based  clinical  practice  guidelines  developed by independent
     3  organizations or medical professional societies utilizing a  transparent
     4  methodology  and  reporting  structure  and  with a conflict of interest
     5  policy.   Clinical  practice  guidelines  establish  standards  of  care
     6  informed by a systematic review of evidence and  an  assessment  of  the
     7  benefits  and  costs of alternative care options and include recommenda-
     8  tions intended to optimize patient care.
     9    § 5. This act shall take effect January 1, 2024 and shall apply to all
    10  policies and contracts issued, renewed, modified, altered or amended  on
    11  or after such date.