Chapter 151
2022 -- S 2201 SUBSTITUTE A
Enacted 06/27/2022

A N   A C T
RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES -- BIOMARKER TESTING COVERAGE

Introduced By: Senators Goodwin, McCaffrey, Coyne, Miller, Pearson, Gallo, and Ruggerio

Date Introduced: February 08, 2022

It is enacted by the General Assembly as follows:
     SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness Insurance
Policies is hereby amended adding thereto the following section:
     27-18-89. Coverage for biomarker testing.
     (a) As used in this section:
     (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 intervention. 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) "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. The most appropriate test may include both information that is actionable and
some information that cannot be immediately used in the formulation of a clinical decision.
     (4) "Consensus statements" means statements developed by an independent,
multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and
with a conflict of interest policy. These 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.
     (5) "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
recommendations intended to optimize patient care.
     (b) Every individual or group health insurance contract, or every individual or group
hospital or medical expense insurance policy, plan, or group policy delivered, issued for delivery,
or renewed in this state on or after January 1, 2024, shall provide coverage for the services of
biomarker testing in accordance with each health insurer's respective principles and mechanisms
of reimbursement, credentialing, and contracting. Biomarker testing must be covered for the
purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's
disease or condition to guide treatment decisions, when the test provides clinical utility as
demonstrated by medical and scientific evidence, including, but not limited to:
     (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an FDA-
approved drug;
     (2) Centers for Medicare Services ("CMS") National Coverage Determinations national
coverage determinatons or Medicare Administrative Contractor ("MAC") Local Coverage
Determinations; or
     (3) Nationally recognized clinical practice guidelines and consensus statements.
     (c) Coverage as defined in subsection (b) of this section shall be provided in a manner that
limits disruptions in care including the need for multiple biopsies or biospecimen samples.
     (d) The patient and prescribing practitioner shall have access to clear, readily accessible,
and convenient processes to request an exception to a coverage policy of a health insurer, nonprofit
health service plan, and health maintenance organization. The process shall be made readily
accessible on the health insurers', nonprofit health service plans', or health maintenance
organizations' website.
     SECTION 2. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service
Corporations" is hereby amended by adding thereto the following section:
     27-19-81. Coverage for biomarker testing.
     (a) As used in this section:
     (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 intervention. Biomarkers include but are not limited to gene mutations or
protein expression.
     (2) "Biomarker testing" is 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) "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. The most appropriate test may include both information that is actionable and
some information that cannot be immediately used in the formulation of a clinical decision.
     (4) "Consensus statements" as used here are statements developed by an independent,
multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and
with a conflict of interest policy. These 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.
     (5) "Nationally recognized clinical practice guidelines" as used here are 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
recommendations intended to optimize patient care.
     (b) Every individual or group health insurance contract, or every individual or group
hospital or medical expense insurance policy, plan, or group policy delivered, issued for delivery,
or renewed in this state on or after January 1, 2024, shall provide coverage for the services of
biomarker testing in accordance with each health insurer's respective principles and mechanisms
of reimbursement, credentialing, and contracting. Biomarker testing must be covered for the
purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's
disease or condition to guide treatment decisions, when the test provides clinical utility as
demonstrated by medical and scientific evidence, including, but not limited to:
     (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an FDA-
approved drug;
     (2) Centers for Medicare Services ("CMS") National Coverage Determinations national
coverage determinations or Medicare Administrative Contractor ("MAC") Local Coverage
Determinations; or
     (3) Nationally recognized clinical practice guidelines and consensus statements.
     (c) Coverage as defined in subsection (b) is provided in a manner that limits disruptions in
care including the need for multiple biopsies or biospecimen samples.
     (d) The patient and prescribing practitioner shall have access to clear, readily accessible,
and convenient processes to request an exception to a coverage policy of a health insurer, nonprofit
health service plan, and health maintenance organization. The process shall be made readily
accessible on the health insurers', nonprofit health service plans', or health maintenance
organizations' website.
     SECTION 3. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service
Corporations" is hereby amended by adding thereto the following section:
     27-20-77. Coverage for biomarker testing.
     (a) As used in this section:
     (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 intervention. Biomarkers include, but are not limited to, gene mutations or
protein expression.
     (2) "Biomarker testing" is 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) "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. The most appropriate test may include both information that is actionable and
some information that cannot be immediately used in the formulation of a clinical decision.
     (4) "Consensus statements" as used here are statements developed by an independent,
multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and
with a conflict of interest policy. These 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.
     (5) "Nationally recognized clinical practice guidelines" as used here are 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
recommendations intended to optimize patient care.
     (b) Every individual or group health insurance contract, or every individual or group
hospital or medical expense insurance policy, plan, or group policy delivered, issued for delivery,
or renewed in this state on or after January 1, 2024, shall provide coverage for the services of
biomarker testing in accordance with each health insurer's respective principles and mechanisms
of reimbursement, credentialing, and contracting. Biomarker testing must be covered for the
purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's
disease or condition to guide treatment decisions, when the test provides clinical utility as
demonstrated by medical and scientific evidence, including, but not limited to:
     (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an FDA-
approved drug;
     (2) Centers for Medicare Services ("CMS") National Coverage Determinations national
coverage determinations or Medicare Administrative Contractor ("MAC") Local Coverage
Determinations; or
     (3) Nationally recognized clinical practice guidelines and consensus statements.
     (c) Coverage as defined in subsection (b) is provided in a manner that limits disruptions in
care including the need for multiple biopsies or biospecimen samples.
     (d) The patient and prescribing practitioner shall have access to clear, readily accessible,
and convenient processes to request an exception to a coverage policy of a health insurer, nonprofit
health service plan, and health maintenance organization. The process shall be made readily
accessible on the health insurers', nonprofit health service plans', or health maintenance
organizations' website.
     SECTION 4. Chapter 27-41 of the General Laws entitled "Health Maintenance
Organizations" is hereby amended by adding thereto the following section:
     27-41-94. Coverage for biomarker testing.
     (a) As used in this section:
     (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 intervention. Biomarkers include but are not limited to gene mutations or
protein expression.
     (2) "Biomarker testing" is 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) "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. The most appropriate test may include both information that is actionable and
some information that cannot be immediately used in the formulation of a clinical decision.
     (4) "Consensus statements" as used here are statements developed by an independent,
multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and
with a conflict of interest policy. These 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.
     (5) "Nationally recognized clinical practice guidelines" as used here are 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
recommendations intended to optimize patient care.
     (b) Every individual or group health insurance contract, or every individual or group
hospital or medical expense insurance policy, plan, or group policy delivered, issued for delivery,
or renewed in this state on or after January 1, 2024, shall provide coverage for the services of
biomarker testing in accordance with each health insurer's respective principles and mechanisms
of reimbursement, credentialing, and contracting. Biomarker testing must be covered for the
purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee’s
disease or condition to guide treatment decisions, when the test provides clinical utility as
demonstrated by medical and scientific evidence, including, but not limited to:
     (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an FDA-
approved drug;
     (2) Centers for Medicare Services ("CMS") National Coverage Determinations national
coverage determinations or Medicare Administrative Contractor ("MAC") Local Coverage
Determinations; or
     (3) Nationally recognized clinical practice guidelines and consensus statements.
     (c) Coverage as defined in subsection (b) is provided in a manner that limits disruptions in
care including the need for multiple biopsies or biospecimen samples.
     (d) The patient and prescribing practitioner shall have access to clear, readily accessible,
and convenient processes to request an exception to a coverage policy of a health insurer, nonprofit
health service plan, and health maintenance organization. The process shall be made readily
accessible on the health insurers', nonprofit health service plans', or health maintenance
organizations' website.
     SECTION 5. This act shall take effect upon passage.
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LC004362/SUB A/3
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