2015 -- S 0895

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LC002579

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2015

____________

A N   A C T

RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES

     Introduced By: Senators Coyne, Conley, Nesselbush, Morgan, and Goldin

     Date Introduced: May 07, 2015

     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:

     27-18-82. Step therapy protocol. – (a) Legislative findings and declaration. The general

assembly makes the following findings:

     (1) Health insurance plans are increasingly making use of step therapy policies under

which health plan members are required to try one or more prescription drugs before coverage is

provided for a drug recommended by the patient's health care provider.

     (2) Such step therapy policies, where they are based on well-developed scientific

standards and administered in a flexible manner that takes into account the individual needs of

patients, can play an important role in controlling health care costs.

     (3) In some cases, requiring a patient to follow a step therapy policy may have adverse

and even dangerous consequences for the patient who may either not realize a benefit from taking

a prescription drug or may suffer harm from taking the wrong drug.

     (4) Without uniform policies across the state on step therapy, patients may not receive the

best and most appropriate treatment.

     (5) It is imperative that step therapy policies throughout the state preserve physicians'

rights to make treatment decisions in the best interest of their patients.

     (6) Based on these findings, the general assembly declares it a matter of public interest

that it require health plans to base step therapy requirements on appropriate clinical practice

guidelines developed by professional medical societies with expertise in the condition or

conditions under consideration; that patients be exempt from step therapy requirements when

impracticable or otherwise not in the best interest of the patients; and that patients and prescribers

have access to a transparent and independent process for requesting an exception of step therapy

requirements when appropriate.

     (b) Definitions. As used in this section:

     (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 or health plan 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 and medically appropriate

for a particular patient are to be prescribed and paid for by a 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.

     (c) Clinical review criteria, requirements and restrictions. Clinical review criteria used to

establish step therapy protocols shall be based on clinical practice guidelines:

     (1) Independently developed by a professional medical society with expertise in the

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

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

protocol.

     (d) Exceptions process transparency.

     (1) Exceptions process. 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

LC002579 - Page 2 of 14

documenting and making it easily accessible on the insurer's or health plan's website.

     (2) Exceptions. An exception request shall be expeditiously granted if:

     (i) The required drug is contraindicated or will likely cause an adverse reaction or

physical or mental harm to the patient;

     (ii) The required drug is expected to be ineffective based on the known relevant physical

or mental characteristics of the insured/patient and the known characteristics of the drug regimen;

     (iii) 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; or

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

medical condition under consideration, based on, but not limited to, a trial with medication

samples or a prescription filled at a pharmacy.

     (3) Effect of exception. Upon the granting of an exception request, the insurer, health

plan, utilization review organization, or other entity shall authorize dispensation of and coverage

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

covered drug under such policy or contract.

     (4) Limitations. This section shall not be construed to prevent:

     (i) 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;

     (ii) A health care provider from prescribing a drug he or she determines is medically

appropriate.

     (e) Regulations. Notwithstanding any general or special law to the contrary, the division

of insurance shall promulgate any regulations necessary to enforce this section.

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

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

     27-19-73. Step therapy drug protocol. -- (a) Legislative findings and declaration. The

general assembly makes the following findings:

     (1) Health insurance plans are increasingly making use of step therapy policies under

which health plan members are required to try one or more prescription drugs before coverage is

provided for a drug recommended by the patient's health care provider.

     (2) Such step therapy policies, where they are based on well-developed scientific

standards and administered in a flexible manner that takes into account the individual needs of

LC002579 - Page 3 of 14

patients, can play an important role in controlling health care costs.

     (3) In some cases, requiring a patient to follow a step therapy policy may have adverse

and even dangerous consequences for the patient who may either not realize a benefit from taking

a prescription drug or may suffer harm from taking the wrong drug.

     (4) Without uniform policies across the state on step therapy, patients may not receive the

best and most appropriate treatment.

     (5) It is imperative that step therapy policies throughout the state preserve physicians'

rights to make treatment decisions in the best interest of their patients.

     (6) Based on these findings, the general assembly declares it a matter of public interest

that it require health plans to base step therapy requirements on appropriate clinical practice

guidelines developed by professional medical societies with expertise in the condition or

conditions under consideration; that patients be exempt from step therapy requirements when

impracticable or otherwise not in the best interest of the patients; and that patients and prescribers

have access to a transparent and independent process for requesting an exception of step therapy

requirements when appropriate.

     (b) Definitions. As used in this section:

     (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 or health plan 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 and medically appropriate

for a particular patient are to be prescribed and paid for by a 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.

     (c) Clinical review criteria. Requirements and restrictions. Clinical review criteria used to

establish step therapy protocols shall be based on clinical practice guidelines:

     (1) Independently developed by a professional medical society with expertise in the

LC002579 - Page 4 of 14

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

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

protocol.

     (d) Exceptions process transparency.

     (1) Exceptions process. 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 it easily accessible on the insurer's or health plan's website.

     (2) Exceptions. An exception request shall be expeditiously granted if:

     (i) The required drug is contraindicated or will likely cause an adverse reaction or

physical or mental harm to the patient;

     (ii) The required drug is expected to be ineffective based on the known relevant physical

or mental characteristics of the insured/patient and the known characteristics of the drug regimen;

     (iii) 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; or

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

medical condition under consideration, based on, but not limited to, a trial with medication

samples or a prescription filled at a pharmacy.

     (3) Effect of exception. Upon the granting of an exception request, the insurer, health

plan, utilization review organization, or other entity shall authorize dispensation of and coverage

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

covered drug under such policy or contract.

     (4) Limitations. This section shall not be construed to prevent:

     (i) 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;

     (ii) A health care provider from prescribing a drug he or she determines is medically

appropriate.

     (e) Regulations. Notwithstanding any general or special law to the contrary, the division

LC002579 - Page 5 of 14

of insurance shall promulgate any regulations necessary to enforce this section.

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

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

     27-20-69. Step therapy protocol. -- (a) Legislative findings and declaration. The general

assembly makes the following findings:

     (1) Health insurance plans are increasingly making use of step therapy policies under

which health plan members are required to try one or more prescription drugs before coverage is

provided for a drug recommended by the patient's health care provider.

     (2) Such step therapy policies, where they are based on well-developed scientific

standards and administered in a flexible manner that takes into account the individual needs of

patients, can play an important role in controlling health care costs.

     (3) In some cases, requiring a patient to follow a step therapy policy may have adverse

and even dangerous consequences for the patient who may either not realize a benefit from taking

a prescription drug or may suffer harm from taking the wrong drug.

     (4) Without uniform policies across the state on step therapy, patients may not receive the

best and most appropriate treatment.

     (5) It is imperative that step therapy policies throughout the state preserve physicians'

rights to make treatment decisions in the best interest of their patients.

     (6) Based on these findings, the general assembly declares it a matter of public interest

that it require health plans to base step therapy requirements on appropriate clinical practice

guidelines developed by professional medical societies with expertise in the condition or

conditions under consideration; that patients be exempt from step therapy requirements when

impracticable or otherwise not in the best interest of the patients; and that patients and prescribers

have access to a transparent and independent process for requesting an exception of step therapy

requirements when appropriate.

     (b) Definitions. As used in this section:

     (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 or health plan 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 and medically appropriate

for a particular patient are to be prescribed and paid for by a health plan.

LC002579 - Page 6 of 14

     (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.

     (c) Clinical review criteria. Requirements and restrictions. Clinical review criteria used to

establish step therapy protocols shall be based on clinical practice guidelines:

     (1) Independently developed by a professional medical society with expertise in the

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

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

protocol.

     (d) Exceptions process transparency.

     (1) Exceptions process. 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 it easily accessible on the insurer's or health plan's website.

     (2) Exceptions. An exception request shall be expeditiously granted if:

     (i) The required drug is contraindicated or will likely cause an adverse reaction or

physical or mental harm to the patient;

     (ii) The required drug is expected to be ineffective based on the known relevant physical

or mental characteristics of the insured/patient and the known characteristics of the drug regimen;

     (iii) 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; or

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

medical condition under consideration, based on, but not limited to, a trial with medication

samples or a prescription filled at a pharmacy.

     (3) Effect of exception. Upon the granting of an exception request, the insurer, health

LC002579 - Page 7 of 14

plan, utilization review organization, or other entity shall authorize dispensation of and coverage

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

covered drug under such policy or contract.

     (4) Limitations. This section shall not be construed to prevent:

     (i) 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;

     (ii) A health care provider from prescribing a drug he or she determines is medically

appropriate.

     (e) Regulations. Notwithstanding any general or special law to the contrary, the division

of insurance shall promulgate any regulations necessary to enforce this section.

     SECTION 4. Chapter 27-20.1 of the General Laws entitled "Nonprofit Dental Service

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

     27-20.1-23. Step therapy protocol. – (a) Legislative findings and declaration. The

general assembly makes the following findings:

     (1) Health insurance plans are increasingly making use of step therapy policies under

which health plan members are required to try one or more prescription drugs before coverage is

provided for a drug recommended by the patient's health care provider.

     (2) Such step therapy policies, where they are based on well-developed scientific

standards and administered in a flexible manner that takes into account the individual needs of

patients, can play an important role in controlling health care costs.

     (3) In some cases, requiring a patient to follow a step therapy policy may have adverse

and even dangerous consequences for the patient who may either not realize a benefit from taking

a prescription drug or may suffer harm from taking the wrong drug.

     (4) Without uniform policies across the state on step therapy, patients may not receive the

best and most appropriate treatment.

     (5) It is imperative that step therapy policies throughout the state preserve physicians'

rights to make treatment decisions in the best interest of their patients.

     (6) Based on these findings, the general assembly declares it a matter of public interest

that it require health plans to base step therapy requirements on appropriate clinical practice

guidelines developed by professional medical societies with expertise in the condition or

conditions under consideration; that patients be exempt from step therapy requirements when

impracticable or otherwise not in the best interest of the patients; and that patients and prescribers

have access to a transparent and independent process for requesting an exception of step therapy

LC002579 - Page 8 of 14

requirements when appropriate.

     (b) Definitions. As used in this section:

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

practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.

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

clinical protocols and practice guidelines used by an insurer or health plan to determine the

medical necessity and appropriateness of healthcare services.

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

sequence in which prescription drugs for a specified medical condition and medically appropriate

for a particular patient are to be prescribed and paid for by a 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.

     (c) Clinical review criteria. Requirements and restrictions. Clinical review criteria used to

establish step therapy protocols shall be based on clinical practice guidelines:

     (1) Independently developed by a professional medical society with expertise in the

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

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

protocol.

     (d) Exceptions process transparency.

     (1) Exceptions process. 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 it easily accessible on the insurer's or health plan's website.

     (2) Exceptions. An exception request shall be expeditiously granted if:

     (i) The required drug is contraindicated or will likely cause an adverse reaction or

physical or mental harm to the patient;

LC002579 - Page 9 of 14

     (ii) The required drug is expected to be ineffective based on the known relevant physical

or mental characteristics of the insured/patient and the known characteristics of the drug regimen;

     (iii) 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; or

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

medical condition under consideration, based on, but not limited to, a trial with medication

samples or a prescription filled at a pharmacy.

     (3) Effect of exception. Upon the granting of an exception request, the insurer, health

plan, utilization review organization, or other entity shall authorize dispensation of and coverage

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

covered drug under such policy or contract.

     (4) Limitations. This section shall not be construed to prevent:

     (i) 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;

     (ii) A health care provider from prescribing a drug he or she determines is medically

appropriate.

     (e) Regulations. Notwithstanding any general or special law to the contrary, the division

of insurance shall promulgate any regulations necessary to enforce this section.

     SECTION 5. Chapter 27-41 of the General Laws entitled "Health Maintenance

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

     27-41-86. Step therapy protocol. -- (a) Legislative findings and declaration. The general

assembly makes the following findings:

     (1) Health insurance plans are increasingly making use of step therapy policies under

which health plan members are required to try one or more prescription drugs before coverage is

provided for a drug recommended by the patient's health care provider.

     (2) Such step therapy policies, where they are based on well-developed scientific

standards and administered in a flexible manner that takes into account the individual needs of

patients, can play an important role in controlling health care costs.

     (3) In some cases, requiring a patient to follow a step therapy policy may have adverse

and even dangerous consequences for the patient who may either not realize a benefit from taking

a prescription drug or may suffer harm from taking the wrong drug.

LC002579 - Page 10 of 14

     (4) Without uniform policies across the state on step therapy, patients may not receive the

best and most appropriate treatment.

     (5) It is imperative that step therapy policies throughout the state preserve physicians'

rights to make treatment decisions in the best interest of their patients.

     (6) Based on these findings, the general assembly declares it a matter of public interest

that it require health plans to base step therapy requirements on appropriate clinical practice

guidelines developed by professional medical societies with expertise in the condition or

conditions under consideration; that patients be exempt from step therapy requirements when

impracticable or otherwise not in the best interest of the patients; and that patients and prescribers

have access to a transparent and independent process for requesting an exception of step therapy

requirements when appropriate.

     (b) Definitions. As used in this section:

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

practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.

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

clinical protocols and practice guidelines used by an insurer or health plan to determine the

medical necessity and appropriateness of healthcare services.

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

sequence in which prescription drugs for a specified medical condition and medically appropriate

for a particular patient are to be prescribed and paid for by a 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.

     (c) Clinical review criteria. Requirements and restrictions. Clinical review criteria used to

establish step therapy protocols shall be based on clinical practice guidelines:

     (1) Independently developed by a professional medical society with expertise in the

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

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

protocol.

     (d) Exceptions process transparency.

LC002579 - Page 11 of 14

     (1) Exceptions process. 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 it easily accessible on the insurer's or health plan's website.

     (2) Exceptions. An exception request shall be expeditiously granted if:

     (i) The required drug is contraindicated or will likely cause an adverse reaction or

physical or mental harm to the patient;

     (ii) The required drug is expected to be ineffective based on the known relevant physical

or mental characteristics of the insured/patient and the known characteristics of the drug regimen;

     (iii) 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; or

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

medical condition under consideration, based on, but not limited to, a trial with medication

samples or a prescription filled at a pharmacy.

     (3) Effect of exception. Upon the granting of an exception request, the insurer, health

plan, utilization review organization, or other entity shall authorize dispensation of and coverage

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

covered drug under such policy or contract.

     (4) Limitations. This section shall not be construed to prevent:

     (i) 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;

     (ii) A health care provider from prescribing a drug he or she determines is medically

appropriate.

     (e) Regulations. Notwithstanding any general or special law to the contrary, the division

of insurance shall promulgate any regulations necessary to enforce this section.

     SECTION 6. This act shall take effect upon passage and shall apply to health insurance

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

2016.

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LC002579

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE -- ACCIDENT AND SICKNESS INSURANCE POLICIES

***

     This act would require that a step therapy protocol be included in all health care

insurance policies and health insurance plans.

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

health benefit plans delivered, issued for delivery, or renewed on or after January 1, 2016.

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LC002579

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LC002579 - Page 14 of 14