S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  1196--A
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                             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:
 
   Section 1. Subsection (i) of section 3216  of  the  insurance  law  is
 amended by adding a new paragraph 11-c to read as follows:
   (11-C)  (A)  EVERY  POLICY  WHICH  PROVIDES MEDICAL, MAJOR MEDICAL, OR
 SIMILAR COMPREHENSIVE-TYPE COVERAGE SHALL PROVIDE COVERAGE FOR BIOMARKER
 TESTING FOR THE PURPOSES OF DIAGNOSIS,  TREATMENT,  APPROPRIATE  MANAGE-
 MENT,  OR  ONGOING MONITORING OF A COVERED PERSON'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:
   (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 MEDICARE  ADMINISTRATIVE  CONTRACTOR  LOCAL  COVERAGE
 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.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD02625-06-3
              

 S. 1196--A                          2
 
   (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 CHARACTER-
 ISTICS  ARE TYPES OF BIOMARKERS. A BIOMARKER IS NOT AN ASSESSMENT OF HOW
 A PATIENT FEELS, FUNCTIONS, OR SURVIVES.
   (II) "BIOMARKER 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-ANALYTE 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. Subsection (l) of section 3221 of the insurance law is amended by
 adding a new paragraph 11-c 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 TESTING FOR THE PURPOSES
 OF DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT, OR  ONGOING  MONITORING
 OF  A COVERED PERSON'S DISEASE OR CONDITION WHEN THE TEST PROVIDES CLIN-
 ICAL UTILITY TO THE PATIENT AS DEMONSTRATED BY  MEDICAL  AND  SCIENTIFIC
 EVIDENCE, INCLUDING, BUT NOT LIMITED TO:
   (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 MEDICARE  ADMINISTRATIVE  CONTRACTOR  LOCAL  COVERAGE
 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.
   (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
 S. 1196--A                          3
 
 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 CHARACTER-
 ISTICS  ARE TYPES OF BIOMARKERS. A BIOMARKER IS NOT AN ASSESSMENT OF HOW
 A PATIENT FEELS, FUNCTIONS, OR SURVIVES.
   (II) "BIOMARKER 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-ANALYTE 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.  Section  4303  of  the insurance law is amended by adding a new
 subsection (p-1) 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 TESTING FOR THE PURPOSES OF DIAGNOSIS,
 TREATMENT, APPROPRIATE MANAGEMENT, OR ONGOING MONITORING  OF  A  COVERED
 PERSON'S DISEASE OR CONDITION WHEN THE TEST PROVIDES CLINICAL UTILITY TO
 THE  PATIENT AS DEMONSTRATED BY MEDICAL AND SCIENTIFIC EVIDENCE, INCLUD-
 ING, BUT NOT LIMITED TO:
   (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  MEDICARE  ADMINISTRATIVE  CONTRACTOR LOCAL COVERAGE
 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.
   (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:
 S. 1196--A                          4
 
   (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 CHARACTER-
 ISTICS  ARE TYPES OF BIOMARKERS. A BIOMARKER IS NOT AN ASSESSMENT OF HOW
 A PATIENT FEELS, FUNCTIONS, OR SURVIVES.
   (B) "BIOMARKER 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-ANALYTE 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
 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. Subdivision 2 of section 365-a of  the  social  services  law  is
 amended by adding a new paragraph (mm) to read as follows:
   (MM)  (I)  BIOMARKER TESTING FOR THE PURPOSES OF DIAGNOSIS, TREATMENT,
 APPROPRIATE MANAGEMENT, OR ONGOING MONITORING OF A  RECIPIENT'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:
   (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 MEDICARE  ADMINISTRATIVE  CONTRACTOR  LOCAL  COVERAGE
 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.
   (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 CHARACTER-
 ISTICS ARE TYPES OF BIOMARKERS. A BIOMARKER IS NOT AN ASSESSMENT OF  HOW
 A PATIENT FEELS, FUNCTIONS, OR SURVIVES.
 S. 1196--A                          5
 
   (2)  "BIOMARKER  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-ANALYTE 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.
   (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.  This act shall take effect April 1, 2024 and shall apply to all
 policies and contracts issued, renewed, modified, altered or amended  on
 or after such date.