2022 -- H 7587

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LC004725

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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) "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.

     (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 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, 2023, 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 when the test is supported 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 and Medicaid 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

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

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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" 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.

     (4) "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, 2023, 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 when the test is supported 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 and Medicaid 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.

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     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) "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.

     (4) "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, 2023, 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 when the test is supported 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 and Medicaid Services ("CMS") National Coverage

Determinations or Medicare Administrative Contractor ("MAC") Local Coverage Determinations;

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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) "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.

     (4) "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, 2023, shall provide coverage for the services of

LC004725 - Page 5 of 8

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 when the test is supported 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 and Medicaid 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. Chapter 40-8.4 of the General Laws entitled "Health Care for Families" is

hereby amended by adding thereto the following section:

     40-8.4-21. Coverage for biomarker testing.

     (a) No later than January 1, 2023, the executive office of health and human services

(EOHHS) shall apply for the appropriate federal approval to provide Medicaid beneficiaries

coverage for biomarker testing, as defined and described pursuant to the provisions of §§ 27-18-

89, 27-19-81, 27-20-77 and 27-41-94, for inclusion in the Rhode Island medical assistance program

(Medicaid program).

     (b) Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate

management, or ongoing monitoring of an enrollee’s disease or condition when the test is supported

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 and Medicaid Services ("CMS") National Coverage

Determinations or Medicare Administrative Contractor ("MAC") Local Coverage Determinations;

or

LC004725 - Page 6 of 8

     (3) Nationally recognized clinical practice guidelines and consensus statements.

     (c) Risk-bearing entities contracted to the Rhode Island medical assistance program

("Medicaid program") to deliver services to beneficiaries shall provide biomarker testing at the

same scope, duration and frequency as the Medicaid program otherwise provides to enrollees.

     (d) The enrollee and participating provider shall have access to clear, readily accessible,

and convenient processes to request an exception to a coverage policy of the Rhode Island medical

assistance program ("Medicaid program") or by risk-bearing entities contracted to the Rhode Island

medical assistance program ("Medicaid program"). The process shall be made readily accessible to

all participating providers and enrollees online.

     SECTION 6. This act shall take effect upon passage.

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LC004725

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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, 2023, and would require the Rhode Island

medical assistance program to provide similar coverage as well.

     This act would take effect upon passage.

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LC004725

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