2021 -- S 0302

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LC001210

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2021

____________

A N   A C T

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

STEP THERAPY PROTOCOLS

     Introduced By: Senators Gallo, and Lombardo

     Date Introduced: February 18, 2021

     Referred To: Senate Health & Human Services

     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 by adding thereto the following section:

     27-18-85. Step therapy protocol.

     (a) As used in this section the following words shall, unless the context clearly requires

otherwise, have the following meanings:

     (1) "Clinical practice guidelines" means a systematically developed statement to assist

practitioner and patient decisions about appropriate health care for specific clinical circumstances.

     (2) "Clinical review criteria" means the written screening procedures, decision abstracts,

clinical protocols and practice guidelines used by an insurer, health plan, or utilization review

organization to determine the medical necessity and appropriateness of health care services.

     (3) "Step therapy exception" means a process that provides that a step therapy protocol

should be overridden in favor of immediate coverage of the health care provider's selected

prescription drug.

     (4) "Step therapy protocol" means a protocol or program that establishes the specific

sequence in which prescription drugs for a specified medical condition that are medically

appropriate for a particular patient and are covered as a pharmacy or medical benefit, including

self-administered and physician-administered drugs, are covered by an insurer or health plan.

     (5) "Utilization review organization" means an entity that conducts utilization review, other

than a health carrier performing utilization review for its own health benefit plans.

     (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or

renewed within the state that provides coverage for prescription drugs and uses step therapy

protocols shall have the following requirements and restrictions:

     (1) Clinical review criteria used to establish step therapy protocols shall be based on

clinical practice guidelines:

     (i) Independently developed by a multidisciplinary panel with expertise in the medical

condition, or conditions, for which coverage decisions said criteria will be applied; and

     (ii) That recommend drugs be taken in the specific sequence required by the step therapy

protocol.

     (c) When coverage of medications for the treatment of any medical condition are restricted

for use by an insurer, health plan, or utilization review organization via a step therapy protocol, the

patient and prescribing practitioner shall have access to a clear and convenient process to request a

step therapy exception. An insurer, health plan, or utilization review organization shall use its

existing medical exceptions process to satisfy this requirement. The process shall be disclosed to

the patient and health care providers, including documenting and making easily accessible on the

insurer's, health plan's or utilization review organization's website.

     (d) A step therapy override exception shall be expeditiously granted if:

     (1) The required drug is contraindicated or will likely cause an adverse reaction, or physical

or mental harm to the patient;

     (2) The required prescription drug is expected to be ineffective based on the known clinical

characteristics of the patient and the known characteristics of the prescription drug regimen;

     (3) The enrollee has tried the step therapy-required drug while under their current health

plan, or another drug in the same pharmacologic class or with the same mechanism of action and

such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an

adverse event;

     (4) The patient is stable on a drug recommended by their health care provider for the

medical condition under consideration while on a current or previous health insurance or health

benefit plan and no generic substitution is available. This subsection shall not be construed to allow

the use of a pharmaceutical sample to meet the requirements for a step therapy override exception.

     (e) Upon the granting of a step therapy override exception request, the insurer, health plan,

utilization review organization, or other entity shall authorize coverage for the drug prescribed by

the enrollee's treating health care provider, provided such drug is a covered drug under such terms

of policy or contract.

LC001210 - Page 2 of 10

     (f) The insurer, health plan, or utilization review organization shall grant or deny a step

therapy exception request or an appeal within seventy-two (72) hours of receipt. In cases where

exigent circumstances exist an insurer, health plan, or utilization review organization shall grant or

deny a step therapy exception request or an appeal within twenty-four (24) hours of receipt. Should

a grant or denial by an insurer, health plan, or utilization review organization not be received within

the time allotted, the exception or appeal shall be deemed granted.

     (g) Any step therapy exception as defined by this subsection shall be eligible for appeal by

an insured.

     (h) This section shall not be construed to prevent:

     (1) An insurer, health plan, or utilization review organization from requiring an enrollee to

try an AB-rated generic equivalent prior to providing reimbursement for the equivalent branded

drug;

     (2) A health care provider from prescribing a drug they determine is medically appropriate.

     (i) The health insurance commissioner may promulgate such rules and regulations,

including rules and regulations under chapter 18.9 of title 27, the benefit determination and

utilization review act, as are necessary and proper to effectuate the purpose and for the efficient

administration and enforcement of this section entitled "step therapy protocol", as well as to

effectuate the coordination of the efficient administration and enforcement of this section with the

act.

     SECTION 2. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service

Corporations" is hereby amended by adding thereto the following section:

     27-19-77. Step therapy protocol.

     (a) As used in this section the following words shall, unless the context clearly requires

otherwise, have the following meanings:

     (1) "Clinical practice guidelines" means a systematically developed statement to assist

practitioner and patient decisions about appropriate health care for specific clinical circumstances.

     (2) "Clinical review criteria" means the written screening procedures, decision abstracts,

clinical protocols and practice guidelines used by an insurer, health plan, or utilization review

organization to determine the medical necessity and appropriateness of health care services.

     (3) "Step therapy exception" means a process that provides that a step therapy protocol

should be overridden in favor of immediate coverage of the health care provider's selected

prescription drug.

     (4) "Step therapy protocol" means a protocol or program that establishes the specific

sequence in which prescription drugs for a specified medical condition that are medically

LC001210 - Page 3 of 10

appropriate for a particular patient and are covered as a pharmacy or medical benefit, including

self-administered and physician-administered drugs, are covered by an insurer or health plan.

     (5) "Utilization review organization" means an entity that conducts utilization review, other

than a health carrier performing utilization review for its own health benefit plans.

     (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or

renewed within the state that provides coverage for prescription drugs and uses step therapy

protocols shall have the following requirements and restrictions:

     (1) Clinical review criteria used to establish step therapy protocols shall be based on

clinical practice guidelines:

     (i) Independently developed by a multidisciplinary panel with expertise in the medical

condition, or conditions, for which coverage decisions said criteria will be applied; and

     (ii) That recommend drugs be taken in the specific sequence required by the step therapy

protocol.

     (c) When coverage of medications for the treatment of any medical condition are restricted

for use by an insurer, health plan, or utilization review organization via a step therapy protocol, the

patient and prescribing practitioner shall have access to a clear and convenient process to request a

step therapy exception. An insurer, health plan, or utilization review organization shall use its

existing medical exceptions process to satisfy this requirement. The process shall be disclosed to

the patient and health care providers, including documenting and making easily accessible on the

insurer's, health plan's or utilization review organization's website.

     (d) A step therapy override exception shall be expeditiously granted if:

     (1) The required drug is contraindicated or will likely cause an adverse reaction, or physical

or mental harm to the patient;

     (2) The required prescription drug is expected to be ineffective based on the known clinical

characteristics of the patient and the known characteristics of the prescription drug regimen;

     (3) The enrollee has tried the step therapy-required drug while under their current health

plan, or another drug in the same pharmacologic class or with the same mechanism of action and

such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an

adverse event;

     (4) The patient is stable on a drug recommended by their health care provider for the

medical condition under consideration while on a current or previous health insurance or health

benefit plan and no generic substitution is available. This subsection shall not be construed to allow

the use of a pharmaceutical sample to meet the requirements for a step therapy override exception.

     (e) Upon the granting of a step therapy override exception request, the insurer, health plan,

LC001210 - Page 4 of 10

utilization review organization, or other entity shall authorize coverage for the drug prescribed by

the enrollee's treating health care provider, provided such drug is a covered drug under such terms

of policy or contract.

     (f) The insurer, health plan, or utilization review organization shall grant or deny a step

therapy exception request or an appeal within seventy-two (72) hours of receipt. In cases where

exigent circumstances exist an insurer, health plan, or utilization review organization shall grant or

deny a step therapy exception request or an appeal within twenty-four (24) hours of receipt. Should

a grant or denial by an insurer, health plan, or utilization review organization not be received within

the time allotted, the exception or appeal shall be deemed granted.

     (g) Any step therapy exception as defined by this subsection shall be eligible for appeal by

an insured.

     (h) This section shall not be construed to prevent:

     (1) An insurer, health plan, or utilization review organization from requiring an enrollee to

try an AB-rated generic equivalent prior to providing reimbursement for the equivalent branded

drug;

     (2) A health care provider from prescribing a drug they determine is medically appropriate.

     (i) The health insurance commissioner may promulgate such rules and regulations,

including rules and regulations under chapter 18.9 of title 27, the benefit determination and

utilization review act, as are necessary and proper to effectuate the purpose and for the efficient

administration and enforcement of this section entitled "step therapy protocol", as well as to

effectuate the coordination of the efficient administration and enforcement of this section with the

act.

     SECTION 3. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service

Corporations" is hereby amended by adding thereto the following section:

     27-20-73. Step therapy protocol.

     (a) As used in this section the following words shall, unless the context clearly requires

otherwise, have the following meanings:

     (1) "Clinical practice guidelines" means a systematically developed statement to assist

practitioner and patient decisions about appropriate health care for specific clinical circumstances.

     (2) "Clinical review criteria" means the written screening procedures, decision abstracts,

clinical protocols and practice guidelines used by an insurer, health plan, or utilization review

organization to determine the medical necessity and appropriateness of health care services.

     (3) "Step therapy exception" means a process that provides that a step therapy protocol

should be overridden in favor of immediate coverage of the health care provider's selected

LC001210 - Page 5 of 10

prescription drug.

     (4) "Step therapy protocol" means a protocol or program that establishes the specific

sequence in which prescription drugs for a specified medical condition that are medically

appropriate for a particular patient and are covered as a pharmacy or medical benefit, including

self-administered and physician-administered drugs, are covered by an insurer or health plan.

     (5) "Utilization review organization" means an entity that conducts utilization review, other

than a health carrier performing utilization review for its own health benefit plans.

     (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or

renewed within the state that provides coverage for prescription drugs and uses step therapy

protocols shall have the following requirements and restrictions:

     (1) Clinical review criteria used to establish step therapy protocols shall be based on

clinical practice guidelines:

     (i) Independently developed by a multidisciplinary panel with expertise in the medical

condition, or conditions, for which coverage decisions said criteria will be applied; and

     (ii) That recommend drugs be taken in the specific sequence required by the step therapy

protocol.

     (c) When coverage of medications for the treatment of any medical condition are restricted

for use by an insurer, health plan, or utilization review organization via a step therapy protocol, the

patient and prescribing practitioner shall have access to a clear and convenient process to request a

step therapy exception. An insurer, health plan, or utilization review organization shall use its

existing medical exceptions process to satisfy this requirement. The process shall be disclosed to

the patient and health care providers, including documenting and making easily accessible on the

insurer's, health plan's or utilization review organization's website.

     (d) A step therapy override exception shall be expeditiously granted if:

     (1) The required drug is contraindicated or will likely cause an adverse reaction, or physical

or mental harm to the patient;

     (2) The required prescription drug is expected to be ineffective based on the known clinical

characteristics of the patient and the known characteristics of the prescription drug regimen;

     (3) The enrollee has tried the step therapy-required drug while under their current health

plan, or another drug in the same pharmacologic class or with the same mechanism of action and

such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an

adverse event;

     (4) The patient is stable on a drug recommended by their health care provider for the

medical condition under consideration while on a current or previous health insurance or health

LC001210 - Page 6 of 10

benefit plan and no generic substitution is available. This subsection shall not be construed to allow

the use of a pharmaceutical sample to meet the requirements for a step therapy override exception.

     (e) Upon the granting of a step therapy override exception request, the insurer, health plan,

utilization review organization, or other entity shall authorize coverage for the drug prescribed by

the enrollee's treating health care provider, provided such drug is a covered drug under such terms

of policy or contract.

     (f) The insurer, health plan, or utilization review organization shall grant or deny a step

therapy exception request or an appeal within seventy-two (72) hours of receipt. In cases where

exigent circumstances exist an insurer, health plan, or utilization review organization shall grant or

deny a step therapy exception request or an appeal within twenty-four (24) hours of receipt. Should

a grant or denial by an insurer, health plan, or utilization review organization not be received within

the time allotted, the exception or appeal shall be deemed granted.

     (g) Any step therapy exception as defined by this subsection shall be eligible for appeal by

an insured.

     (h) This section shall not be construed to prevent:

     (1) An insurer, health plan, or utilization review organization from requiring an enrollee to

try an AB-rated generic equivalent prior to providing reimbursement for the equivalent branded

drug;

     (2) A health care provider from prescribing a drug they determine is medically appropriate.

     (i) The health insurance commissioner may promulgate such rules and regulations,

including rules and regulations under chapter 18.9 of title 27, the benefit determination and

utilization review act, as are necessary and proper to effectuate the purpose and for the efficient

administration and enforcement of this section entitled "step therapy protocol", as well as to

effectuate the coordination of the efficient administration and enforcement of this section with the

act.

     SECTION 4. Chapter 27-41 of the General Laws entitled "Health Maintenance

Organizations" is hereby amended by adding thereto the following section:

     27-41-90. Step therapy protocol.

     (a) As used in this section the following words shall, unless the context clearly requires

otherwise, have the following meanings:

     (1) "Clinical practice guidelines" means a systematically developed statement to assist

practitioner and patient decisions about appropriate health care for specific clinical circumstances.

     (2) "Clinical review criteria" means the written screening procedures, decision abstracts,

clinical protocols and practice guidelines used by an insurer, health plan, or utilization review

LC001210 - Page 7 of 10

organization to determine the medical necessity and appropriateness of health care services.

     (3) "Step therapy exception" means a process that provides that a step therapy protocol

should be overridden in favor of immediate coverage of the health care provider's selected

prescription drug.

     (4) "Step therapy protocol" means a protocol or program that establishes the specific

sequence in which prescription drugs for a specified medical condition that are medically

appropriate for a particular patient and are covered as a pharmacy or medical benefit, including

self-administered and physician-administered drugs, are covered by an insurer or health plan.

     (5) "Utilization review organization" means an entity that conducts utilization review, other

than a health carrier performing utilization review for its own health benefit plans.

     (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or

renewed within the state that provides coverage for prescription drugs and uses step therapy

protocols shall have the following requirements and restrictions:

     (1) Clinical review criteria used to establish step therapy protocols shall be based on

clinical practice guidelines:

     (i) Independently developed by a multidisciplinary panel with expertise in the medical

condition, or conditions, for which coverage decisions said criteria will be applied; and

     (ii) That recommend drugs be taken in the specific sequence required by the step therapy

protocol.

     (c) When coverage of medications for the treatment of any medical condition are restricted

for use by an insurer, health plan, or utilization review organization via a step therapy protocol, the

patient and prescribing practitioner shall have access to a clear and convenient process to request a

step therapy exception. An insurer, health plan, or utilization review organization shall use its

existing medical exceptions process to satisfy this requirement. The process shall be disclosed to

the patient and health care providers, including documenting and making easily accessible on the

insurer's, health plan's or utilization review organization's website.

     (d) A step therapy override exception shall be expeditiously granted if:

     (1) The required drug is contraindicated or will likely cause an adverse reaction, or physical

or mental harm to the patient;

     (2) The required prescription drug is expected to be ineffective based on the known clinical

characteristics of the patient and the known characteristics of the prescription drug regimen;

     (3) The enrollee has tried the step therapy-required drug while under their current health

plan, or another drug in the same pharmacologic class or with the same mechanism of action and

such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an

LC001210 - Page 8 of 10

adverse event;

     (4) The patient is stable on a drug recommended by their health care provider for the

medical condition under consideration while on a current or previous health insurance or health

benefit plan and no generic substitution is available. This subsection shall not be construed to allow

the use of a pharmaceutical sample to meet the requirements for a step therapy override exception.

     (e) Upon the granting of a step therapy override exception request, the insurer, health plan,

utilization review organization, or other entity shall authorize coverage for the drug prescribed by

the enrollee's treating health care provider, provided such drug is a covered drug under such terms

of policy or contract.

     (f) The insurer, health plan, or utilization review organization shall grant or deny a step

therapy exception request or an appeal within seventy-two (72) hours of receipt. In cases where

exigent circumstances exist an insurer, health plan, or utilization review organization shall grant or

deny a step therapy exception request or an appeal within twenty-four (24) hours of receipt. Should

a grant or denial by an insurer, health plan, or utilization review organization not be received within

the time allotted, the exception or appeal shall be deemed granted.

     (g) Any step therapy exception as defined by this subsection shall be eligible for appeal by

an insured.

     (h) This section shall not be construed to prevent:

     (1) An insurer, health plan, or utilization review organization from requiring an enrollee to

try an AB-rated generic equivalent prior to providing reimbursement for the equivalent branded

drug;

     (2) A health care provider from prescribing a drug they determine is medically appropriate.

     (i) The health insurance commissioner may promulgate such rules and regulations,

including rules and regulations under chapter 18.9 of title 27, the benefit determination and

utilization review act, as are necessary and proper to effectuate the purpose and for the efficient

administration and enforcement of this section entitled "step therapy protocol", as well as to

effectuate the coordination of the efficient administration and enforcement of this section with the

act.

     SECTION 5. This act shall take effect upon passage and shall apply only to health

insurance and health benefit plans delivered, issued for delivery, or renewed on or after January 1,

2022.

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LC001210

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

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

STEP THERAPY PROTOCOLS

***

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

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

coverage for prescription drugs and use step therapy protocols, to base step therapy protocols on

appropriate clinical practice guidelines or published peer review data developed by independent

experts with knowledge of the condition or conditions under consideration; that patients be exempt

from step therapy protocols when inappropriate; and that patients have access to a fair, transparent

and independent process for requesting an exception to a step therapy protocol when the patient's

physician deems appropriate.

     This act would take effect upon passage and shall apply only to health insurance and health

benefit plans delivered, issued for delivery, or renewed on or after January 1, 2022.

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LC001210

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