Bill Text: NY A01673 | 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 56-10)

Status: (Introduced) 2023-06-08 - substituted by s1196a [A01673 Detail]

Download: New_York-2023-A01673-Amended.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                         1673--A

                               2023-2024 Regular Sessions

                   IN ASSEMBLY

                                    January 17, 2023
                                       ___________

        Introduced by M. of A. HUNTER, DINOWITZ, BRONSON, RAGA, LAVINE, ALVAREZ,
          McDONALD,   PAULIN,  GUNTHER,  SEAWRIGHT,  SEPTIMO,  THIELE,  SHIMSKY,
          DE LOS SANTOS, STECK, DAVILA,  L. ROSENTHAL,  SANTABARBARA,  WILLIAMS,
          BICHOTTE HERMELYN, FAHY, BUTTENSCHON, BURDICK, SIMONE, JACOBSON, BENE-
          DETTO, AUBRY, CRUZ, CLARK, SIMON, ARDILA, ZEBROWSKI, DICKENS, CUNNING-
          HAM,  BURGOS,  DURSO,  MAHER,  BRABENEC, SLATER, MANKTELOW, DeSTEFANO,
          BARCLAY,  EACHUS,  MAGNARELLI,  NOVAKHOV,  LEVENBERG,  WEPRIN,  MEEKS,
          ROZIC,  PRETLOW,  REYES,  PHEFFER AMATO,  WALKER,  KIM, TAYLOR, BURKE,
          HYNDMAN, RAMOS, WALLACE -- read once and referred to the Committee  on
          Insurance  -- reported and referred to the Committee on Ways and Means
          -- 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

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02625-07-3

        A. 1673--A                          2

     1    (iii)  nationally recognized clinical practice guidelines such as, but
     2  not limited to, those of the national comprehensive  cancer  network  or
     3  the American society of clinical oncology.
     4    (B)  Such  coverage  shall  be  provided  in a manner that shall limit
     5  disruptions in care including the need for multiple biopsies or  biospe-
     6  cimen samples.
     7    (C)  The covered person and prescribing practitioner shall have access
     8  to a clear, readily accessible, and convenient  process  to  request  an
     9  exception  to  a  coverage policy provided pursuant to the provisions of
    10  this paragraph. Such process shall be made  readily  accessible  on  the
    11  website of the insurer.
    12    (D)  As  used  in  this  paragraph, the following terms shall have the
    13  following meanings:
    14    (i) "Biomarker" means a defined characteristic that is measured as  an
    15  indicator  of  normal  biological  processes,  pathogenic  processes, or
    16  responses to an exposure or intervention, including  therapeutic  inter-
    17  ventions. Molecular, histologic, radiographic, or physiologic character-
    18  istics  are types of biomarkers. A biomarker is not an assessment of how
    19  a patient feels, functions, or survives.
    20    (ii) "Biomarker testing" means the analysis  of  a  patient's  tissue,
    21  blood,  or  other biospecimen for the presence of a biomarker. Biomarker
    22  testing includes but is not limited to single-analyte tests  and  multi-
    23  plex  panel  tests  performed  at  a participating in-network laboratory
    24  facility that is either CLIA certified or CLIA  waived  by  the  federal
    25  food and drug administration.
    26    (iii)  "Clinical  utility"  means the test result provides information
    27  that is used in the formulation of a treatment  or  monitoring  strategy
    28  that informs a patient's outcome and impacts the clinical decision.
    29    (iv)   "Nationally  recognized  clinical  practice  guidelines"  means
    30  evidence-based clinical practice guidelines  informed  by  a  systematic
    31  review  of  evidence  and  an  assessment  of the benefits, and risks of
    32  alternative care options intended to optimize patient care developed  by
    33  independent  organizations or medical professional societies utilizing a
    34  transparent methodology and reporting structure and with a  conflict  of
    35  interest policy.
    36    § 2. Subsection (l) of section 3221 of the insurance law is amended by
    37  adding a new paragraph 11-c to read as follows:
    38    (11-c) (A) Every insurer delivering a group or blanket policy or issu-
    39  ing  a  group or blanket policy for delivery in this state that provides
    40  coverage for  medical,  major  medical,  or  similar  comprehensive-type
    41  coverage  shall  provide coverage for biomarker testing for the purposes
    42  of diagnosis, treatment, appropriate management, or  ongoing  monitoring
    43  of  a covered person's disease or condition when the test provides clin-
    44  ical utility to the patient as demonstrated by  medical  and  scientific
    45  evidence, including, but not limited to:
    46    (i)  labeled indications for a test approved or cleared by the federal
    47  food and drug administration or indicated tests  for  a  food  and  drug
    48  administration approved drug;
    49    (ii)  centers  for  medicare  and  medicaid services national coverage
    50  determinations and medicare  administrative  contractor  local  coverage
    51  determinations; or
    52    (iii)  nationally  recognized  clinical practice guidelines including,
    53  but not limited to, those of the national comprehensive  cancer  network
    54  or the American society of clinical oncology.

        A. 1673--A                          3

     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    §  3.  Section  4303  of  the insurance law is amended by adding a new
    34  subsection (p-1) to read as follows:
    35    (p-1) (1) A medical expense indemnity corporation, a hospital  service
    36  corporation  or  a health service corporation that provides coverage for
    37  medical, major medical, or  similar  comprehensive-type  coverage  shall
    38  provide  coverage  for  biomarker testing for the purposes of diagnosis,
    39  treatment, appropriate management, or ongoing monitoring  of  a  covered
    40  person's disease or condition when the test provides clinical utility to
    41  the  patient as demonstrated by medical and scientific evidence, includ-
    42  ing, but not limited to:
    43    (A) 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    (B) centers for  medicare  and  medicaid  services  national  coverage
    47  determinations  and  medicare  administrative  contractor local coverage
    48  determinations; or
    49    (C) nationally recognized clinical practice guidelines  such  as,  but
    50  not  limited  to,  those of the national comprehensive cancer network or
    51  the American society of clinical oncology.
    52    (2) 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    (3) The covered person and prescribing practitioner shall have  access
    56  to  a  clear,  readily  accessible, and convenient process to request an

        A. 1673--A                          4

     1  exception to a coverage policy provided pursuant to  the  provisions  of
     2  this  subsection.  Such  process shall be made readily accessible on the
     3  website of the insurer.
     4    (4)  As  used  in  this subsection, the following terms shall have the
     5  following meanings:
     6    (A) "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    (B) "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    (C) "Clinical utility" means the test result provides information that
    19  is  used  in  the formulation of a treatment or monitoring strategy that
    20  informs a patient's outcome and impacts the clinical decision.
    21    (D)  "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    § 4. Subdivision 2 of section 365-a of  the  social  services  law  is
    29  amended by adding a new paragraph (mm) to read as follows:
    30    (mm)  (i)  biomarker testing for the purposes of diagnosis, treatment,
    31  appropriate management, or ongoing monitoring of a  recipient's  disease
    32  or  condition  when the test provides clinical utility to the patient as
    33  demonstrated by medical and  scientific  evidence,  including,  but  not
    34  limited to:
    35    (1)  labeled indications for a test approved or cleared by the federal
    36  food and drug administration or indicated tests  for  a  food  and  drug
    37  administration approved drug;
    38    (2)  centers  for  medicare  and  medicaid  services national coverage
    39  determinations and medicare  administrative  contractor  local  coverage
    40  determinations; or
    41    (3)  nationally  recognized  clinical practice guidelines such as, but
    42  not limited to, those of the national comprehensive  cancer  network  or
    43  the American society of clinical oncology.
    44    (ii)  Risk-bearing  entities  contracted  to  the  medicaid program to
    45  deliver services to recipients shall provide biomarker  testing  at  the
    46  same  scope,  duration  and  frequency as the medicaid program otherwise
    47  provides to enrollees.
    48    (iii) The recipient and participating provider shall have access to  a
    49  clear,  readily  accessible, and convenient process to request an excep-
    50  tion to a coverage policy of the medicaid  program  or  by  risk-bearing
    51  entities  contracted to the medicaid program. Such process shall be made
    52  readily accessible to all participating providers and enrollees online.
    53    (iv) As used in this paragraph, the following  terms  shall  have  the
    54  following meanings:
    55    (1)  "Biomarker" means a defined characteristic that is measured as an
    56  indicator of  normal  biological  processes,  pathogenic  processes,  or

        A. 1673--A                          5

     1  responses  to  an exposure or intervention, including therapeutic inter-
     2  ventions. Molecular, histologic, radiographic, or physiologic character-
     3  istics are types of biomarkers. A biomarker is not an assessment of  how
     4  a patient feels, functions, or survives.
     5    (2)  "Biomarker  testing"  means  the  analysis of a patient's tissue,
     6  blood, or other biospecimen for the presence of a  biomarker.  Biomarker
     7  testing  includes  but is not limited to single-analyte tests and multi-
     8  plex panel tests performed  at  a  participating  in-network  laboratory
     9  facility  that  is  either  CLIA certified or CLIA waived by the federal
    10  food and drug administration.
    11    (3) "Clinical utility" means the test result provides information that
    12  is used in the formulation of a treatment or  monitoring  strategy  that
    13  informs a patient's outcome and impacts the clinical decision.
    14    (4)   "Nationally   recognized  clinical  practice  guidelines"  means
    15  evidence-based clinical practice guidelines  informed  by  a  systematic
    16  review  of  evidence  and  an  assessment  of the benefits, and risks of
    17  alternative care options intended to optimize patient care developed  by
    18  independent  organizations or medical professional societies utilizing a
    19  transparent methodology and reporting structure and with a  conflict  of
    20  interest policy.
    21    §  5.  This act shall take effect April 1, 2024 and shall apply to all
    22  policies and contracts issued, renewed, modified, altered or amended  on
    23  or after such date.
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