2019 -- S 0772 AS AMENDED

========

LC002065

========

     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2019

____________

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -

STEP THERAPY PROTOCOLS

     

     Introduced By: Senators Gallo, Conley, Goodwin, Lawson, and Pearson

     Date Introduced: April 04, 2019

     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

     27-18-85. 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 exception" means a process that provides that a step therapy protocol

12

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

13

prescription drug.

14

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

15

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

16

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

17

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

18

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

 

1

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

2

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

3

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

4

protocols shall have the following requirements and restrictions:

5

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

6

clinical practice guidelines:

7

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

8

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

9

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

10

protocol.

11

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

12

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

13

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

14

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

15

organization shall use its existing medical exceptions process to satisfy this requirement. The

16

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

17

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

18

website.

19

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

20

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

21

physical or mental harm to the patient;

22

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

23

clinical characteristics of the patient and the known characteristics of the prescription drug

24

regimen;

25

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

26

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

27

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

28

adverse event;

29

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

30

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

31

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

32

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

33

exception.

34

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

 

LC002065 - Page 2 of 11

1

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

2

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

3

under such terms of policy or contract.

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

by an insured.

12

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

13

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

14

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

15

branded drug;

16

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

17

appropriate.

18

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

19

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

20

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

21

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

22

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

23

act.

24

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

25

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

26

     27-19-77. Step therapy protocol.

27

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

28

otherwise, have the following meanings:

29

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

30

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

31

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

32

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

33

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

34

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

 

LC002065 - Page 3 of 11

1

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

2

prescription drug.

3

     (4) "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

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

8

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

9

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

10

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

11

protocols shall have the following requirements and restrictions:

12

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

13

clinical practice guidelines:

14

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

15

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

16

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

17

protocol.

18

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

19

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

20

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

21

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

22

organization shall use its existing medical exceptions process to satisfy this requirement. The

23

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

24

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

25

website.

26

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

27

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

28

physical or mental harm to the patient;

29

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

30

clinical characteristics of the patient and the known characteristics of the prescription drug

31

regimen;

32

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

33

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

34

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

 

LC002065 - Page 4 of 11

1

adverse event;

2

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

3

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

4

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

5

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

6

exception.

7

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

8

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

9

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

10

under such terms of policy or contract.

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

by an insured.

19

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

20

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

21

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

22

branded drug;

23

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

24

appropriate.

25

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

26

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

27

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

28

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

29

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

30

act.

31

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

32

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

33

     27-20-73. Step therapy protocol.

34

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

 

LC002065 - Page 5 of 11

1

otherwise, have the following meanings:

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

prescription drug.

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

protocols shall have the following requirements and restrictions:

19

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

20

clinical practice guidelines:

21

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

22

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

23

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

24

protocol.

25

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

26

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

27

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

28

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

29

organization shall use its existing medical exceptions process to satisfy this requirement. The

30

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

31

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

32

website.

33

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

34

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

 

LC002065 - Page 6 of 11

1

physical or mental harm to the patient;

2

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

3

clinical characteristics of the patient and the known characteristics of the prescription drug

4

regimen;

5

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

6

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

7

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

8

adverse event;

9

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

10

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

11

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

12

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

13

exception.

14

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

15

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

16

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

17

under such terms of policy or contract.

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

by an insured.

26

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

27

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

28

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

29

branded drug;

30

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

31

appropriate.

32

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

33

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

34

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

 

LC002065 - Page 7 of 11

1

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

2

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

3

act.

4

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

5

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

6

     27-41-90. Step therapy protocol.

7

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

8

otherwise, have the following meanings:

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

prescription drug.

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

protocols shall have the following requirements and restrictions:

26

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

27

clinical practice guidelines:

28

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

29

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

30

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

31

protocol.

32

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

33

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

34

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

 

LC002065 - Page 8 of 11

1

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

2

organization shall use its existing medical exceptions process to satisfy this requirement. The

3

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

4

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

5

website.

6

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

7

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

8

physical or mental harm to the patient;

9

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

10

clinical characteristics of the patient and the known characteristics of the prescription drug

11

regimen;

12

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

13

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

14

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

15

adverse event;

16

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

17

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

18

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

19

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

20

exception.

21

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

22

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

23

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

24

under such terms of policy or contract.

25

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

26

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

27

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

28

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

29

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

30

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

31

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

32

by an insured.

33

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

34

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

 

LC002065 - Page 9 of 11

1

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

2

branded drug;

3

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

4

appropriate.

5

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

6

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

7

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

8

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

9

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

10

act.

11

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

12

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

13

2020.

========

LC002065

========

 

LC002065 - Page 10 of 11

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -

STEP THERAPY PROTOCOLS

***

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 patient's physician deems appropriate.

9

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

10

health benefit plans delivered, issued for delivery, or renewed on or after January 1, 2020.

========

LC002065

========

 

LC002065 - Page 11 of 11