2017 -- S 0862 SUBSTITUTE A AS AMENDED

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LC002482/SUB A/2

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2017

____________

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:

1

     SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness

2

Insurance Policies" is hereby amended by adding thereto the following section:

3

     27-18-83. Step therapy protocol.

4

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

5

otherwise, have the following meanings:

6

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

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

 

1

along with supporting rationale and documentation.

2

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

3

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

4

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

5

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

6

protocols shall have the following requirements and restrictions:

7

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

8

clinical practice guidelines:

9

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

10

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

11

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

12

protocol.

13

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

14

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

15

protocol, the patient and prescribing practitioner shall have access to a clear and convenient

16

process to request a step therapy exception determination. An insurer, health plan, or utilization

17

review organization may use its existing medical exceptions process to satisfy this requirement.

18

The process shall be disclosed to the patient and health care providers, including documenting

19

and making easily accessible on the insurer's, health plan's or utilization review organization's

20

website.

21

     (d) A step therapy override exception determination request shall be expeditiously

22

considered if:

23

     (1) The required drug is contraindicated;

24

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

25

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

26

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

27

adverse event;

28

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

29

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

30

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

31

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

32

exception.

33

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

34

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

 

LC002482/SUB A/2 - Page 2 of 9

1

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

2

under such terms of policy or contract.

3

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

4

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

5

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

6

drug;

7

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

8

appropriate.

9

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

10

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

11

     27-19-74. Step therapy protocol.

12

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

13

otherwise, have the following meanings:

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

along with supporting rationale and documentation.

28

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

29

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

30

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

31

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

32

protocols shall have the following requirements and restrictions:

33

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

34

clinical practice guidelines:

 

LC002482/SUB A/2 - Page 3 of 9

1

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

2

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

3

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

4

protocol.

5

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

6

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

7

protocol, the patient and prescribing practitioner shall have access to a clear and convenient

8

process to request a step therapy exception determination. An insurer, health plan, or utilization

9

review organization may use its existing medical exceptions process to satisfy this requirement.

10

The process shall be disclosed to the patient and health care providers, including documenting

11

and making easily accessible on the insurer's, health plan's or utilization review organization's

12

website.

13

     (d) A step therapy override exception determination request shall be expeditiously

14

considered if:

15

     (1) The required drug is contraindicated;

16

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

17

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

18

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

19

adverse event;

20

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

21

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

22

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

23

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

24

exception.

25

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

26

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

27

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

28

under such terms of policy or contract.

29

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

30

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

31

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

32

drug;

33

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

34

appropriate.

 

LC002482/SUB A/2 - Page 4 of 9

1

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

2

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

3

     27-20-70. Step therapy protocol.

4

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

5

otherwise, have the following meanings:

6

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

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

along with supporting rationale and documentation.

20

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

21

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

22

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

23

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

24

protocols shall have the following requirements and restrictions:

25

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

26

clinical practice guidelines:

27

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

28

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

29

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

30

protocol.

31

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

32

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

33

protocol, the patient and prescribing practitioner shall have access to a clear and convenient

34

process to request a step therapy exception determination. An insurer, health plan, or utilization

 

LC002482/SUB A/2 - Page 5 of 9

1

review organization may use its existing medical exceptions process to satisfy this requirement.

2

The process shall be disclosed to the patient and health care providers, including documenting

3

and making easily accessible on the insurer's, health plan's or utilization review organization's

4

website.

5

     (d) A step therapy override exception determination request shall be expeditiously

6

considered if:

7

     (1) The required drug is contraindicated;

8

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

9

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

10

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

11

adverse event;

12

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

13

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

14

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

15

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

16

exception.

17

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

18

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

19

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

20

under such terms of policy or contract.

21

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

22

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

23

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

24

drug;

25

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

26

appropriate.

27

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

28

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

29

     27-41-87. Step therapy protocol.

30

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

31

otherwise, have the following meanings:

32

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

33

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

34

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

 

LC002482/SUB A/2 - Page 6 of 9

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

along with supporting rationale and documentation.

12

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

13

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

14

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

15

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

16

protocols shall have the following requirements and restrictions:

17

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

18

clinical practice guidelines:

19

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

20

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

21

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

22

protocol.

23

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

24

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

25

protocol, the patient and prescribing practitioner shall have access to a clear and convenient

26

process to request a step therapy exception determination. An insurer, health plan, or utilization

27

review organization may use its existing medical exceptions process to satisfy this requirement.

28

The process shall be disclosed to the patient and health care providers, including documenting

29

and making easily accessible on the insurer's, health plan's or utilization review organization's

30

website.

31

     (d) A step therapy override exception determination request shall be expeditiously

32

considered if:

33

     (1) The required drug is contraindicated;

34

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

 

LC002482/SUB A/2 - Page 7 of 9

1

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

2

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

3

adverse event;

4

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

5

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

6

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

7

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

8

exception.

9

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

10

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

11

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

12

under such terms of policy or contract.

13

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

14

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

15

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

16

drug;

17

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

18

appropriate.

19

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

20

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

21

2018.

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LC002482/SUB A/2 - Page 8 of 9

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -

STEP THERAPY PROTOCOL

***

1

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

2

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

3

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

4

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

5

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

6

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

7

transparent and independent process for requesting an exception to a step therapy protocol when

8

the patients physician deems appropriate.

9

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

10

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

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LC002482/SUB A/2 - Page 9 of 9