S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9149
 
                           I N  A S S E M B L Y
 
                             January 31, 2022
                                ___________
 
 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 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-b to read as follows:
   (11-B)  (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 IS SUPPORTED BY MEDICAL AND SCIENTIFIC  EVIDENCE,  INCLUD-
 ING, BUT NOT LIMITED TO:
   (I) LABELED INDICATIONS FOR A TEST APPROVED OR CLEARED BY THE FOOD AND
 DRUG  ADMINISTRATION  OF THE UNITED STATES GOVERNMENT 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 AND CONSENSUS
 STATEMENTS.
   (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:
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD13311-02-2
              

 A. 9149                             2
 
   (I)  "BIOMARKER"  MEANS  A CHARACTERISTIC THAT IS OBJECTIVELY MEASURED
 AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL PROCESSES, PATHOGENIC
 PROCESSES, OR PHARMACOLOGIC RESPONSES TO A SPECIFIC  THERAPEUTIC  INTER-
 VENTION.  BIOMARKERS  INCLUDE  BUT  ARE NOT LIMITED TO GENE MUTATIONS OR
 PROTEIN EXPRESSION.
   (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, MULTI-PLEX
 PANEL TESTS, AND WHOLE GENOME SEQUENCING.
   (III) "CONSENSUS STATEMENTS" MEANS STATEMENTS DEVELOPED  BY  AN  INDE-
 PENDENT,  MULTIDISCIPLINARY  PANEL  OF  EXPERTS  UTILIZING A TRANSPARENT
 METHODOLOGY AND REPORTING STRUCTURE AND  WITH  A  CONFLICT  OF  INTEREST
 POLICY. SUCH STATEMENTS ARE AIMED AT SPECIFIC CLINICAL CIRCUMSTANCES AND
 BASE  THE  STATEMENTS  ON THE BEST AVAILABLE EVIDENCE FOR THE PURPOSE OF
 OPTIMIZING THE OUTCOMES OF CLINICAL CARE.
   (IV)  "NATIONALLY  RECOGNIZED  CLINICAL  PRACTICE  GUIDELINES"   MEANS
 EVIDENCE-BASED  CLINICAL  PRACTICE  GUIDELINES  DEVELOPED BY INDEPENDENT
 ORGANIZATIONS OR MEDICAL PROFESSIONAL SOCIETIES UTILIZING A  TRANSPARENT
 METHODOLOGY  AND  REPORTING  STRUCTURE  AND  WITH A CONFLICT OF INTEREST
 POLICY.  CLINICAL  PRACTICE  GUIDELINES  ESTABLISH  STANDARDS  OF   CARE
 INFORMED  BY  A  SYSTEMATIC  REVIEW OF EVIDENCE AND AN ASSESSMENT OF THE
 BENEFITS AND COSTS OF ALTERNATIVE CARE OPTIONS AND  INCLUDE  RECOMMENDA-
 TIONS INTENDED TO OPTIMIZE PATIENT CARE.
   § 2. Subsection (l) of section 3221 of the insurance law is amended by
 adding a new paragraph 11-b to read as follows:
   (11-B) (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 IS SUPPORTED BY
 MEDICAL AND SCIENTIFIC EVIDENCE, INCLUDING, BUT NOT LIMITED TO:
   (I) LABELED INDICATIONS FOR A TEST APPROVED OR CLEARED BY THE FOOD AND
 DRUG  ADMINISTRATION  OF THE UNITED STATES GOVERNMENT 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 AND CONSENSUS
 STATEMENTS.
   (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 CHARACTERISTIC THAT IS OBJECTIVELY MEASURED
 AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL PROCESSES, PATHOGENIC
 PROCESSES, OR PHARMACOLOGIC RESPONSES TO A SPECIFIC  THERAPEUTIC  INTER-
 VENTION.  BIOMARKERS  INCLUDE  BUT  ARE NOT LIMITED TO GENE MUTATIONS OR
 PROTEIN EXPRESSION.
 A. 9149                             3
 
   (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,  MULTI-PLEX
 PANEL TESTS, AND WHOLE GENOME SEQUENCING.
   (III)  "CONSENSUS  STATEMENTS"  MEANS STATEMENTS DEVELOPED BY AN INDE-
 PENDENT, MULTIDISCIPLINARY PANEL  OF  EXPERTS  UTILIZING  A  TRANSPARENT
 METHODOLOGY  AND  REPORTING  STRUCTURE  AND  WITH A CONFLICT OF INTEREST
 POLICY. SUCH STATEMENTS ARE AIMED AT SPECIFIC CLINICAL CIRCUMSTANCES AND
 BASE THE STATEMENTS ON THE BEST AVAILABLE EVIDENCE FOR  THE  PURPOSE  OF
 OPTIMIZING THE OUTCOMES OF CLINICAL CARE.
   (IV)   "NATIONALLY  RECOGNIZED  CLINICAL  PRACTICE  GUIDELINES"  MEANS
 EVIDENCE-BASED CLINICAL PRACTICE  GUIDELINES  DEVELOPED  BY  INDEPENDENT
 ORGANIZATIONS  OR MEDICAL PROFESSIONAL SOCIETIES UTILIZING A TRANSPARENT
 METHODOLOGY AND REPORTING STRUCTURE AND  WITH  A  CONFLICT  OF  INTEREST
 POLICY.   CLINICAL  PRACTICE  GUIDELINES  ESTABLISH  STANDARDS  OF  CARE
 INFORMED BY A SYSTEMATIC REVIEW OF EVIDENCE AND  AN  ASSESSMENT  OF  THE
 BENEFITS  AND  COSTS OF ALTERNATIVE CARE OPTIONS AND INCLUDE RECOMMENDA-
 TIONS INTENDED TO OPTIMIZE PATIENT CARE.
   § 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 IS SUPPORTED BY MEDICAL  AND
 SCIENTIFIC EVIDENCE, INCLUDING, BUT NOT LIMITED TO:
   (A) LABELED INDICATIONS FOR A TEST APPROVED OR CLEARED BY THE FOOD AND
 DRUG  ADMINISTRATION  OF THE UNITED STATES GOVERNMENT 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  AND  CONSENSUS
 STATEMENTS.
   (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 CHARACTERISTIC THAT  IS  OBJECTIVELY  MEASURED
 AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL PROCESSES, PATHOGENIC
 PROCESSES,  OR  PHARMACOLOGIC RESPONSES TO A SPECIFIC THERAPEUTIC INTER-
 VENTION. BIOMARKERS INCLUDE BUT ARE NOT LIMITED  TO  GENE  MUTATIONS  OR
 PROTEIN EXPRESSION.
   (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, MULTI-PLEX
 PANEL TESTS, AND WHOLE GENOME SEQUENCING.
   (C) "CONSENSUS STATEMENTS" MEANS STATEMENTS DEVELOPED BY AN  INDEPEND-
 ENT,  MULTIDISCIPLINARY PANEL OF EXPERTS UTILIZING A TRANSPARENT METHOD-
 A. 9149                             4
 
 OLOGY AND REPORTING STRUCTURE AND WITH A CONFLICT  OF  INTEREST  POLICY.
 SUCH  STATEMENTS  ARE  AIMED AT SPECIFIC CLINICAL CIRCUMSTANCES AND BASE
 THE STATEMENTS ON THE BEST AVAILABLE EVIDENCE FOR THE PURPOSE  OF  OPTI-
 MIZING THE OUTCOMES OF CLINICAL CARE.
   (D)   "NATIONALLY   RECOGNIZED  CLINICAL  PRACTICE  GUIDELINES"  MEANS
 EVIDENCE-BASED CLINICAL PRACTICE  GUIDELINES  DEVELOPED  BY  INDEPENDENT
 ORGANIZATIONS  OR MEDICAL PROFESSIONAL SOCIETIES UTILIZING A TRANSPARENT
 METHODOLOGY AND REPORTING STRUCTURE AND  WITH  A  CONFLICT  OF  INTEREST
 POLICY.   CLINICAL  PRACTICE  GUIDELINES  ESTABLISH  STANDARDS  OF  CARE
 INFORMED BY A SYSTEMATIC REVIEW OF EVIDENCE AND  AN  ASSESSMENT  OF  THE
 BENEFITS  AND  COSTS OF ALTERNATIVE CARE OPTIONS AND INCLUDE RECOMMENDA-
 TIONS INTENDED TO OPTIMIZE PATIENT CARE.
   § 4. Subdivision 2 of section 365-a of  the  social  services  law  is
 amended by adding a new paragraph (jj) to read as follows:
   (JJ)  (I)  BIOMARKER TESTING FOR THE PURPOSES OF DIAGNOSIS, TREATMENT,
 APPROPRIATE MANAGEMENT, OR ONGOING MONITORING OF A  RECIPIENT'S  DISEASE
 OR  CONDITION  WHEN  THE  TEST  IS  SUPPORTED  BY MEDICAL AND SCIENTIFIC
 EVIDENCE, INCLUDING, BUT NOT LIMITED TO:
   (1) LABELED INDICATIONS FOR A TEST APPROVED OR CLEARED BY THE FOOD AND
 DRUG ADMINISTRATION OF THE UNITED STATES GOVERNMENT 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 AND CONSENSUS
 STATEMENTS.
   (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 CHARACTERISTIC THAT  IS  OBJECTIVELY  MEASURED
 AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL PROCESSES, PATHOGENIC
 PROCESSES,  OR  PHARMACOLOGIC RESPONSES TO A SPECIFIC THERAPEUTIC INTER-
 VENTION. BIOMARKERS INCLUDE BUT ARE NOT LIMITED  TO  GENE  MUTATIONS  OR
 PROTEIN EXPRESSION.
   (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, MULTI-PLEX
 PANEL TESTS, AND WHOLE GENOME SEQUENCING.
   (3) "CONSENSUS STATEMENTS" MEANS STATEMENTS DEVELOPED BY AN  INDEPEND-
 ENT,  MULTIDISCIPLINARY PANEL OF EXPERTS UTILIZING A TRANSPARENT METHOD-
 OLOGY AND REPORTING STRUCTURE AND WITH A CONFLICT  OF  INTEREST  POLICY.
 SUCH  STATEMENTS  ARE  AIMED AT SPECIFIC CLINICAL CIRCUMSTANCES AND BASE
 THE STATEMENTS ON THE BEST AVAILABLE EVIDENCE FOR THE PURPOSE  OF  OPTI-
 MIZING THE OUTCOMES OF CLINICAL CARE.
   (4)   "NATIONALLY   RECOGNIZED  CLINICAL  PRACTICE  GUIDELINES"  MEANS
 EVIDENCE-BASED CLINICAL PRACTICE  GUIDELINES  DEVELOPED  BY  INDEPENDENT
 ORGANIZATIONS  OR MEDICAL PROFESSIONAL SOCIETIES UTILIZING A TRANSPARENT
 METHODOLOGY AND REPORTING STRUCTURE AND  WITH  A  CONFLICT  OF  INTEREST
 A. 9149                             5
 
 POLICY.   CLINICAL  PRACTICE  GUIDELINES  ESTABLISH  STANDARDS  OF  CARE
 INFORMED BY A SYSTEMATIC REVIEW OF EVIDENCE AND  AN  ASSESSMENT  OF  THE
 BENEFITS  AND  COSTS OF ALTERNATIVE CARE OPTIONS AND INCLUDE RECOMMENDA-
 TIONS INTENDED TO OPTIMIZE PATIENT CARE.
   § 5. This act shall take effect January 1, 2023 and shall apply to all
 policies  and contracts issued, renewed, modified, altered or amended on
 or after such date.