S T A T E O F N E W Y O R K
________________________________________________________________________
1673--A
2023-2024 Regular Sessions
I N A S S E M B L Y
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:
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
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD02625-07-3
A. 1673--A 2
(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.
(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.
A. 1673--A 3
(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.
§ 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
A. 1673--A 4
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 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
A. 1673--A 5
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.
(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.