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.