2022 -- H 7587 SUBSTITUTE A

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LC004725/SUB A/3

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2022

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A N   A C T

RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES --

BIOMARKER TESTING COVERAGE

     Introduced By: Representatives Ackerman, McNamara, Serpa, Chippendale, Bennett,
Baginski, Filippi, Diaz, and Amore

     Date Introduced: February 18, 2022

     Referred To: House Finance

     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 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

LC004725/SUB A/3 - Page 2 of 7

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 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

LC004725/SUB A/3 - Page 3 of 7

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,

LC004725/SUB A/3 - Page 4 of 7

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 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,

LC004725/SUB A/3 - Page 5 of 7

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 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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LC004725/SUB A/3

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES --

BIOMARKER TESTING COVERAGE

***

     This act would require health insurers, nonprofit hospital service corporations, nonprofit

medical service corporations and health maintenance organizations to issue policies that provide

coverage for biomarker testing, on or after January 1, 2024.

     This act would take effect upon passage.

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