2017 -- S 0862 SUBSTITUTE A

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LC002482/SUB A/2

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2017

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A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -

STEP THERAPY PROTOCOL

     Introduced By: Senators Gallo, Goodwin, Miller, and Satchell

     Date Introduced: May 04, 2017

     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:

     27-18-83. 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 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.

     (4) "Step therapy override determination" means a determination as to whether step

therapy should apply in a particular situation, or whether the step therapy protocol should be

overridden in favor of immediate coverage of the patient's and/or prescriber's preferred drug. This

determination is based on a review of the patient's and/or prescriber's request for an override,

along with supporting rationale and documentation.

     (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 determination. An insurer, health plan, or utilization

review organization may 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 determination request shall be expeditiously

considered if:

     (1) The required drug is contraindicated;

     (2) The enrollee has tried the step therapy-required drug while under their current or a

previous 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;

     (3) 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

LC002482/SUB A/2 - Page 2 of 8

prescribed by the enrollee's treating health care provider, provided such drug is a covered drug

under such terms of policy or contract.

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

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

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.

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

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

     27-19-74. 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 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.

     (4) "Step therapy override determination" means a determination as to whether step

therapy should apply in a particular situation, or whether the step therapy protocol should be

overridden in favor of immediate coverage of the patient's and/or prescriber's preferred drug. This

determination is based on a review of the patient's and/or prescriber's request for an override,

along with supporting rationale and documentation.

     (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:

LC002482/SUB A/2 - Page 3 of 8

     (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 determination. An insurer, health plan, or utilization

review organization may 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 determination request shall be expeditiously

considered if:

     (1) The required drug is contraindicated;

     (2) The enrollee has tried the step therapy-required drug while under their current or a

previous 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;

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

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

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.

LC002482/SUB A/2 - Page 4 of 8

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

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

     27-20-70. 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 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.

     (4) "Step therapy override determination" means a determination as to whether step

therapy should apply in a particular situation, or whether the step therapy protocol should be

overridden in favor of immediate coverage of the patient's and/or prescriber's preferred drug. This

determination is based on a review of the patient's and/or prescriber's request for an override,

along with supporting rationale and documentation.

     (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 determination. An insurer, health plan, or utilization

LC002482/SUB A/2 - Page 5 of 8

review organization may 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 determination request shall be expeditiously

considered if:

     (1) The required drug is contraindicated;

     (2) The enrollee has tried the step therapy-required drug while under their current or a

previous 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;

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

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

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.

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

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

     27-41-87. 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,

LC002482/SUB A/2 - Page 6 of 8

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 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.

     (4) "Step therapy override determination" means a determination as to whether step

therapy should apply in a particular situation, or whether the step therapy protocol should be

overridden in favor of immediate coverage of the patient's and/or prescriber's preferred drug. This

determination is based on a review of the patient's and/or prescriber's request for an override,

along with supporting rationale and documentation.

     (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 determination. An insurer, health plan, or utilization

review organization may 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 determination request shall be expeditiously

considered if:

     (1) The required drug is contraindicated;

     (2) The enrollee has tried the step therapy-required drug while under their current or a

LC002482/SUB A/2 - Page 7 of 8

previous 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;

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

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

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.

     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,

2018.

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LC002482/SUB A/2

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LC002482/SUB A/2 - Page 8 of 8

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -

STEP THERAPY PROTOCOL

***

     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 patients physician deems appropriate.

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

health benefit plans delivered, issued for delivery, or renewed on or after January 1, 2018.

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LC002482/SUB A/2

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LC002482/SUB A/2 - Page 9 of 8