S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8040
 
                             I N  S E N A T E
 
                              January 5, 2024
                                ___________
 
 Introduced  by  Sen. PERSAUD -- read twice and ordered printed, and when
   printed to be committed to the Committee on Rules
 
 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:
 
   Section  1.  Paragraph  11-c  of subsection (i) of section 3216 of the
 insurance law, as added by 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, is amended to read as follows:
   (11-c) (A) Every policy which  provides  medical,  major  medical,  or
 similar comprehensive-type coverage shall provide coverage for biomarker
 PRECISION  MEDICAL  testing for the purposes of diagnosis, treatment, OR
 appropriate management OF, or ongoing monitoring [of a covered person's]
 TO GUIDE TREATMENT DECISIONS FOR, AN INSURED'S disease or condition when
 [the test provides clinical utility to the patient  as  demonstrated  by
 medical  and  scientific evidence, including, but not limited to] ONE OR
 MORE OF THE FOLLOWING RECOGNIZES THE  EFFICACY  AND  APPROPRIATENESS  OF
 BIOMARKER  PRECISION MEDICAL TESTING FOR DIAGNOSIS, TREATMENT, APPROPRI-
 ATE MANAGEMENT, OR GUIDING TREATMENT DECISIONS FOR AN INSURED'S  DISEASE
 OR CONDITION:
   (i)  labeled indications for a test approved or cleared by the federal
 food and drug administration or indicated tests  for  a  food  and  drug
 administration approved drug;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD02625-08-4
 S. 8040                             2
              

 
   (ii)  centers  for  medicare  and  medicaid services national coverage
 determinations [and] OR medicare administrative contractor local  cover-
 age determinations; [or]
   (iii) nationally recognized clinical practice guidelines [such as, but
 not  limited  to,  those of the national comprehensive cancer network or
 the American society of clinical oncology.]; OR
   (IV) PEER-REVIEWED LITERATURE  AND  PEER-REVIEWED  SCIENTIFIC  STUDIES
 PUBLISHED  IN  OR ACCEPTED FOR PUBLICATION BY MEDICAL JOURNALS THAT MEET
 NATIONALLY RECOGNIZED REQUIREMENTS FOR SCIENTIFIC MANUSCRIPTS  AND  THAT
 SUBMIT  MOST  OF  THEIR PUBLISHED ARTICLES FOR REVIEW BY EXPERTS WHO ARE
 NOT PART OF THE EDITORIAL STAFF.
   (B) Such coverage shall be provided  in  a  manner  that  shall  limit
 disruptions  in care including the need for multiple biopsies or biospe-
 cimen samples.
   (C) [The covered person and prescribing practitioner shall have access
 to a clear, readily accessible, and convenient  process  to  request  an
 exception  to  a  coverage policy provided pursuant to the provisions of
 this paragraph. Such process shall be made  readily  accessible  on  the
 website of the insurer.
   (D)]  As  used  in  this paragraph, the following terms shall have the
 following meanings:
   (i) "Biomarker" means a [defined] characteristic that is  measured  as
 an  indicator  of  normal biological processes, pathogenic processes, or
 responses to an exposure or intervention, including  therapeutic  inter-
 ventions.  [Molecular,  histologic, radiographic, or physiologic charac-
 teristics are types of biomarkers. A biomarker is not an  assessment  of
 how a patient feels, functions, or survives.]
   (ii)  "Biomarker  PRECISION  MEDICAL  testing" means the analysis of a
 patient's tissue, blood, or other biospecimen  for  the  presence  of  a
 biomarker.  Biomarker testing includes but is not limited to single-ana-
 lyte tests and multi-plex  panel  tests  performed  at  a  participating
 in-network  laboratory  facility  that  is either CLIA certified or CLIA
 waived by the federal food and drug administration.
   (iii) ["Clinical utility" means the test result  provides  information
 that  is  used  in the formulation of a treatment or monitoring strategy
 that informs a patient's outcome and impacts the clinical decision.
   (iv)]  "Nationally  recognized  clinical  practice  guidelines"  means
 evidence-based  clinical  practice  guidelines  informed by a systematic
 review of evidence and an assessment  of  the  benefits,  and  risks  of
 alternative  care options intended to optimize patient care developed by
 independent organizations or medical professional societies utilizing  a
 transparent  methodology  and reporting structure and with a conflict of
 interest policy.
   § 2. Paragraph 11-c of subsection (l) of section 3221 of the insurance
 law, as added by 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, is
 amended to read as follows:
   (11-c) (A) Every insurer delivering a group or blanket policy or issu-
 ing a group or blanket policy for delivery in this state  that  provides
 coverage  for  medical,  major  medical,  or  similar comprehensive-type
 coverage shall provide coverage for biomarker PRECISION MEDICAL  testing
 for  the purposes of diagnosis, treatment, OR appropriate management OF,
 or ongoing monitoring [of a covered person's] TO GUIDE  TREATMENT  DECI-
 SIONS  FOR,  AN  INSURED'S  disease or condition when [the test provides
 S. 8040                             3

 clinical utility to the patient as demonstrated by medical and scientif-
 ic evidence, including, but not limited to] ONE OR MORE OF THE FOLLOWING
 RECOGNIZES THE  EFFICACY  AND  APPROPRIATENESS  OF  BIOMARKER  PRECISION
 MEDICAL  TESTING  FOR  DIAGNOSIS,  TREATMENT, APPROPRIATE MANAGEMENT, OR
 GUIDING TREATMENT DECISIONS FOR AN INSURED'S DISEASE OR CONDITION:
   (i) labeled indications for a test approved or cleared by the  federal
 food  and  drug  administration  or  indicated tests for a food and drug
 administration approved drug;
   (ii) centers for medicare  and  medicaid  services  national  coverage
 determinations  [and] OR medicare administrative contractor local cover-
 age determinations; [or]
   (iii) nationally recognized clinical practice  guidelines  [including,
 but  not  limited to, those of the national comprehensive cancer network
 or the American society of clinical oncology.]; OR
   (IV) PEER-REVIEWED LITERATURE  AND  PEER-REVIEWED  SCIENTIFIC  STUDIES
 PUBLISHED  IN  OR ACCEPTED FOR PUBLICATION BY MEDICAL JOURNALS THAT MEET
 NATIONALLY RECOGNIZED REQUIREMENTS FOR SCIENTIFIC MANUSCRIPTS  AND  THAT
 SUBMIT  MOST  OF  THEIR PUBLISHED ARTICLES FOR REVIEW BY EXPERTS WHO ARE
 NOT PART OF THE EDITORIAL STAFF.
   (B) Such coverage shall be provided  in  a  manner  that  shall  limit
 disruptions  in care including the need for multiple biopsies or biospe-
 cimen samples.
   (C) [The covered person and prescribing practitioner shall have access
 to a clear, readily accessible, and convenient  process  to  request  an
 exception  to  a  coverage policy provided pursuant to the provisions of
 this paragraph. Such process shall be made  readily  accessible  on  the
 website of the insurer.
   (D)]  As  used  in  this paragraph, the following terms shall have the
 following meanings:
   (i) "Biomarker" means a [defined] characteristic that is  measured  as
 an  indicator  of  normal biological processes, pathogenic processes, or
 responses to an exposure or intervention, including  therapeutic  inter-
 ventions.  [Molecular,  histologic, radiographic, or physiologic charac-
 teristics are types of biomarkers. A biomarker is not an  assessment  of
 how a patient feels, functions, or survives.]
   (ii)  "Biomarker  PRECISION  MEDICAL  testing" means the analysis of a
 patient's tissue, blood, or other biospecimen  for  the  presence  of  a
 biomarker.  Biomarker testing includes but is not limited to single-ana-
 lyte tests and multi-plex  panel  tests  performed  at  a  participating
 in-network  laboratory  facility  that  is either CLIA certified or CLIA
 waived by the federal food and drug administration.
   (iii) ["Clinical utility" means the test result  provides  information
 that  is  used  in the formulation of a treatment or monitoring strategy
 that informs a patient's outcome and impacts the clinical decision.
   (iv)]  "Nationally  recognized  clinical  practice  guidelines"  means
 evidence-based  clinical  practice  guidelines  informed by a systematic
 review of evidence and an assessment  of  the  benefits,  and  risks  of
 alternative  care options intended to optimize patient care developed by
 independent organizations or medical professional societies utilizing  a
 transparent  methodology  and reporting structure and with a conflict of
 interest policy.
   § 3. Subsection (p-1) of section 4303 of the insurance law,  as  added
 by  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
 S. 8040                             4
 
 legislative bills numbers S. 1196-A and A. 1673-A, is amended to read as
 follows:
   (p-1)  (1) A medical expense indemnity corporation, a hospital service
 corporation or a health service corporation that provides  coverage  for
 medical,  major  medical,  or  similar comprehensive-type coverage shall
 provide  coverage  for  biomarker  PRECISION  MEDICAL  testing  for  the
 purposes of diagnosis, treatment, OR appropriate management OF, or ongo-
 ing monitoring [of a covered person's] TO GUIDE TREATMENT DECISIONS FOR,
 AN INSURED'S disease or condition when [the test provides clinical util-
 ity  to  the patient as demonstrated by medical and scientific evidence,
 including, but not limited to] ONE OR MORE OF THE  FOLLOWING  RECOGNIZES
 THE  EFFICACY AND APPROPRIATENESS OF BIOMARKER PRECISION MEDICAL TESTING
 FOR DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT, OR  GUIDING  TREATMENT
 DECISIONS FOR AN INSURED'S DISEASE OR CONDITION:
   (A)  labeled indications for a test approved or cleared by the federal
 food and drug administration or indicated tests  for  a  food  and  drug
 administration approved drug;
   (B)  centers  for  medicare  and  medicaid  services national coverage
 determinations [and] OR medicare administrative contractor local  cover-
 age determinations; [or]
   (C)  nationally  recognized clinical practice guidelines [such as, but
 not limited to, those of the national comprehensive  cancer  network  or
 the American society of clinical oncology.]; OR
   (D)  PEER-REVIEWED  LITERATURE  AND  PEER-REVIEWED  SCIENTIFIC STUDIES
 PUBLISHED IN OR ACCEPTED FOR PUBLICATION BY MEDICAL JOURNALS  THAT  MEET
 NATIONALLY  RECOGNIZED  REQUIREMENTS FOR SCIENTIFIC MANUSCRIPTS AND THAT
 SUBMIT MOST OF THEIR PUBLISHED ARTICLES FOR REVIEW BY  EXPERTS  WHO  ARE
 NOT PART OF THE EDITORIAL STAFF.
   (2)  Such  coverage  shall  be  provided  in a manner that shall limit
 disruptions in care including the need for multiple biopsies or  biospe-
 cimen samples.
   (3) [The covered person and prescribing practitioner shall have access
 to  a  clear,  readily  accessible, and convenient process to request an
 exception to a coverage policy provided pursuant to  the  provisions  of
 this  subsection.  Such  process shall be made readily accessible on the
 website of the insurer.
   (4)] As used in this subsection, the following terms  shall  have  the
 following meanings:
   (A)  "Biomarker"  means a [defined] characteristic that is measured as
 an indicator of normal biological processes,  pathogenic  processes,  or
 responses  to  an exposure or intervention, including therapeutic inter-
 ventions. [Molecular, histologic, radiographic, or  physiologic  charac-
 teristics  are  types of biomarkers. A biomarker is not an assessment of
 how a patient feels, functions, or survives.]
   (B) "Biomarker PRECISION MEDICAL testing"  means  the  analysis  of  a
 patient's  tissue,  blood,  or  other  biospecimen for the presence of a
 biomarker. Biomarker testing includes but is not limited to  single-ana-
 lyte  tests  and  multi-plex  panel  tests  performed at a participating
 in-network laboratory facility that is either  CLIA  certified  or  CLIA
 waived by the federal food and drug administration.
   (C)  ["Clinical  utility"  means  the test result provides information
 that is used in the formulation of a treatment  or  monitoring  strategy
 that informs a patient's outcome and impacts the clinical decision.
   (D)]   "Nationally  recognized  clinical  practice  guidelines"  means
 evidence-based clinical practice guidelines  informed  by  a  systematic
 review  of  evidence  and  an  assessment  of the benefits, and risks of
 S. 8040                             5

 alternative care options intended to optimize patient care developed  by
 independent  organizations or medical professional societies utilizing a
 transparent methodology and reporting structure and with a  conflict  of
 interest policy.
   §  4.  Paragraph  (mm) of subdivision 2 of section 365-a of the social
 services law, as added by 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, is amended to read as follows:
   (mm) (i) biomarker PRECISION MEDICAL testing for the purposes of diag-
 nosis, treatment, OR appropriate management OF,  or  ongoing  monitoring
 [of]  TO  GUIDE TREATMENT DECISIONS FOR, a recipient's disease or condi-
 tion when [the test provides clinical utility to the patient  as  demon-
 strated  by  medical and scientific evidence, including, but not limited
 to] ONE OR MORE OF THE FOLLOWING RECOGNIZES THE EFFICACY  AND  APPROPRI-
 ATENESS OF BIOMARKER PRECISION MEDICAL TESTING FOR DIAGNOSIS, TREATMENT,
 APPROPRIATE MANAGEMENT, OR GUIDING TREATMENT DECISIONS FOR A RECIPIENT'S
 DISEASE OR CONDITION:
   (1)  labeled indications for a test approved or cleared by the federal
 food and drug administration or indicated tests  for  a  food  and  drug
 administration approved drug;
   (2)  centers  for  medicare  and  medicaid  services national coverage
 determinations [and] OR medicare administrative contractor local  cover-
 age determinations; [or]
   (3)  nationally  recognized clinical practice guidelines [such as, but
 not limited to, those of the national comprehensive  cancer  network  or
 the American society of clinical oncology.]; OR
   (4)  PEER-REVIEWED  LITERATURE  AND  PEER-REVIEWED  SCIENTIFIC STUDIES
 PUBLISHED IN OR ACCEPTED FOR PUBLICATION BY MEDICAL JOURNALS  THAT  MEET
 NATIONALLY  RECOGNIZED  REQUIREMENTS FOR SCIENTIFIC MANUSCRIPTS AND THAT
 SUBMIT MOST OF THEIR PUBLISHED ARTICLES FOR REVIEW BY  EXPERTS  WHO  ARE
 NOT PART OF THE EDITORIAL STAFF.
   (ii)  [Risk-bearing  entities  contracted  to  the medicaid program to
 deliver services to recipients shall provide biomarker  testing  at  the
 same  scope,  duration  and  frequency as the medicaid program otherwise
 provides to enrollees.
   (iii) The recipient and participating provider shall have access to  a
 clear,  readily  accessible, and convenient process to request an excep-
 tion to a coverage policy of the medicaid  program  or  by  risk-bearing
 entities  contracted to the medicaid program. Such process shall be made
 readily accessible to all participating providers and enrollees online.
   (iv)] As used in this paragraph, the following terms  shall  have  the
 following meanings:
   (1)  "Biomarker"  means a [defined] characteristic that is measured as
 an indicator of normal biological processes,  pathogenic  processes,  or
 responses  to  an exposure or intervention, including therapeutic inter-
 ventions. [Molecular, histologic, radiographic, or  physiologic  charac-
 teristics  are  types of biomarkers. A biomarker is not an assessment of
 how a patient feels, functions, or survives.]
   (2) "Biomarker PRECISION MEDICAL testing"  means  the  analysis  of  a
 patient's  tissue,  blood,  or  other  biospecimen for the presence of a
 biomarker. Biomarker testing includes but is not limited to  single-ana-
 lyte  tests  and  multi-plex  panel  tests  performed at a participating
 in-network laboratory facility that is either  CLIA  certified  or  CLIA
 waived by the federal food and drug administration.
 S. 8040                             6

   (3)  ["Clinical  utility"  means  the test result provides information
 that is used in the formulation of a treatment  or  monitoring  strategy
 that informs a patient's outcome and impacts the clinical decision.
   (4)]   "Nationally  recognized  clinical  practice  guidelines"  means
 evidence-based clinical practice guidelines  informed  by  a  systematic
 review  of  evidence  and  an  assessment  of the benefits, and risks of
 alternative care options intended to optimize patient care developed  by
 independent  organizations or medical professional societies utilizing a
 transparent methodology and reporting structure and with a  conflict  of
 interest policy.
   § 5. Section 5 of 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, is
 amended to read as follows:
   § 5. This act shall take effect [April 1, 2024] JANUARY  1,  2025  and
 shall  apply  to  all  policies and contracts issued, renewed, modified,
 altered or amended on or after such date.
   § 6. This act shall take effect  immediately;  provided  however  that
 sections  one,  two, three and four of this act shall take effect on the
 same date and in the same manner as a chapter of the laws of 2023 amend-
 ing 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, takes effect.