2019 -- S 0772 | |
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LC002065 | |
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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 10 |
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 | SECTION 2. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service |
19 | Corporations" is hereby amended by adding thereto the following section: |
20 | 27-19-77. Step therapy protocol. |
21 | (a) As used in this section the following words shall, unless the context clearly requires |
22 | otherwise, have the following meanings: |
23 | (1) "Clinical practice guidelines" means a systematically developed statement to assist |
24 | practitioner and patient decisions about appropriate health care for specific clinical circumstances. |
25 | (2) "Clinical review criteria" means the written screening procedures, decision abstracts, |
26 | clinical protocols and practice guidelines used by an insurer, health plan, or utilization review |
27 | organization to determine the medical necessity and appropriateness of health care services. |
28 | (3) "Step therapy exception" means a process that provides that a step therapy protocol |
29 | should be overridden in favor of immediate coverage of the health care provider's selected |
30 | prescription drug. |
31 | (4) "Step therapy protocol" means a protocol or program that establishes the specific |
32 | sequence in which prescription drugs for a specified medical condition that are medically |
33 | appropriate for a particular patient and are covered as a pharmacy or medical benefit, including |
34 | self-administered and physician-administered drugs, are covered by an insurer or health plan. |
| LC002065 - Page 3 of 10 |
1 | (5) "Utilization review organization" means an entity that conducts utilization review, |
2 | other than a health carrier performing utilization review for its own health benefit plans. |
3 | (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or |
4 | renewed within the state that provides coverage for prescription drugs and uses step therapy |
5 | protocols shall have the following requirements and restrictions: |
6 | (1) Clinical review criteria used to establish step therapy protocols shall be based on |
7 | clinical practice guidelines: |
8 | (i) Independently developed by a multidisciplinary panel with expertise in the medical |
9 | condition, or conditions, for which coverage decisions said criteria will be applied; and |
10 | (ii) That recommend drugs be taken in the specific sequence required by the step therapy |
11 | protocol. |
12 | (c) When coverage of medications for the treatment of any medical condition are |
13 | restricted for use by an insurer, health plan, or utilization review organization via a step therapy |
14 | protocol, the patient and prescribing practitioner shall have access to a clear and convenient |
15 | process to request a step therapy exception. An insurer, health plan, or utilization review |
16 | organization shall use its existing medical exceptions process to satisfy this requirement. The |
17 | process shall be disclosed to the patient and health care providers, including documenting and |
18 | making easily accessible on the insurer's, health plan's or utilization review organization's |
19 | website. |
20 | (d) A step therapy override exception shall be expeditiously granted if: |
21 | (1) The required drug is contraindicated or will likely cause an adverse reaction, or |
22 | physical or mental harm to the patient; |
23 | (2) The required prescription drug is expected to be ineffective based on the known |
24 | clinical characteristics of the patient and the known characteristics of the prescription drug |
25 | regimen; |
26 | (3) The enrollee has tried the step therapy-required drug while under their current health |
27 | plan, or another drug in the same pharmacologic class or with the same mechanism of action and |
28 | such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an |
29 | adverse event; |
30 | (4) The patient is stable on a drug recommended by their health care provider for the |
31 | medical condition under consideration while on a current or previous health insurance or health |
32 | benefit plan and no generic substitution is available. This subsection shall not be construed to |
33 | allow the use of a pharmaceutical sample to meet the requirements for a step therapy override |
34 | exception. |
| LC002065 - Page 4 of 10 |
1 | (e) Upon the granting of a step therapy override exception request, the insurer, health |
2 | plan, utilization review organization, or other entity shall authorize coverage for the drug |
3 | prescribed by the enrollee's treating health care provider, provided such drug is a covered drug |
4 | under such terms of policy or contract. |
5 | (f) The insurer, health plan, or utilization review organization shall grant or deny a step |
6 | therapy exception request or an appeal within seventy-two (72) hours of receipt. In cases where |
7 | exigent circumstances exist an insurer, health plan, or utilization review organization shall grant |
8 | or deny a step therapy exception request or an appeal within twenty-four (24) hours of receipt. |
9 | Should a grant or denial by an insurer, health plan, or utilization review organization not be |
10 | received within the time allotted, the exception or appeal shall be deemed granted. |
11 | (g) Any step therapy exception as defined by this subsection shall be eligible for appeal |
12 | by an insured. |
13 | (h) This section shall not be construed to prevent: |
14 | (1) An insurer, health plan, or utilization review organization from requiring an enrollee |
15 | to try an AB-rated generic equivalent prior to providing reimbursement for the equivalent |
16 | branded drug; |
17 | (2) A health care provider from prescribing a drug they determine is medically |
18 | appropriate. |
19 | SECTION 3. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service |
20 | Corporations" is hereby amended by adding thereto the following section: |
21 | 27-20-73. Step therapy protocol. |
22 | (a) As used in this section the following words shall, unless the context clearly requires |
23 | otherwise, have the following meanings: |
24 | (1) "Clinical practice guidelines" means a systematically developed statement to assist |
25 | practitioner and patient decisions about appropriate health care for specific clinical circumstances. |
26 | (2) "Clinical review criteria" means the written screening procedures, decision abstracts, |
27 | clinical protocols and practice guidelines used by an insurer, health plan, or utilization review |
28 | organization to determine the medical necessity and appropriateness of health care services. |
29 | (3) "Step therapy exception" means a process that provides that a step therapy protocol |
30 | should be overridden in favor of immediate coverage of the health care provider's selected |
31 | prescription drug. |
32 | (4) "Step therapy protocol" means a protocol or program that establishes the specific |
33 | sequence in which prescription drugs for a specified medical condition that are medically |
34 | appropriate for a particular patient and are covered as a pharmacy or medical benefit, including |
| LC002065 - Page 5 of 10 |
1 | self-administered and physician-administered drugs, are covered by an insurer or health plan. |
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. An insurer, health plan, or utilization review |
17 | organization shall use its existing medical exceptions process to satisfy this requirement. The |
18 | process shall be disclosed to the patient and health care providers, including documenting and |
19 | making easily accessible on the insurer's, health plan's or utilization review organization's |
20 | website. |
21 | (d) A step therapy override exception shall be expeditiously granted if: |
22 | (1) The required drug is contraindicated or will likely cause an adverse reaction, or |
23 | physical or mental harm to the patient; |
24 | (2) The required prescription drug is expected to be ineffective based on the known |
25 | clinical characteristics of the patient and the known characteristics of the prescription drug |
26 | regimen; |
27 | (3) The enrollee has tried the step therapy-required drug while under their current health |
28 | plan, or another drug in the same pharmacologic class or with the same mechanism of action and |
29 | such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an |
30 | adverse event; |
31 | (4) The patient is stable on a drug recommended by their health care provider for the |
32 | medical condition under consideration while on a current or previous health insurance or health |
33 | benefit plan and no generic substitution is available. This subsection shall not be construed to |
34 | allow the use of a pharmaceutical sample to meet the requirements for a step therapy override |
| LC002065 - Page 6 of 10 |
1 | exception. |
2 | (e) Upon the granting of a step therapy override exception request, the insurer, health |
3 | plan, utilization review organization, or other entity shall authorize coverage for the drug |
4 | prescribed by the enrollee's treating health care provider, provided such drug is a covered drug |
5 | under such terms of policy or contract. |
6 | (f) The insurer, health plan, or utilization review organization shall grant or deny a step |
7 | therapy exception request or an appeal within seventy-two (72) hours of receipt. In cases where |
8 | exigent circumstances exist an insurer, health plan, or utilization review organization shall grant |
9 | or deny a step therapy exception request or an appeal within twenty-four (24) hours of receipt. |
10 | Should a grant or denial by an insurer, health plan, or utilization review organization not be |
11 | received within the time allotted, the exception or appeal shall be deemed granted. |
12 | (g) Any step therapy exception as defined by this subsection shall be eligible for appeal |
13 | by an insured. |
14 | (h) This section shall not be construed to prevent: |
15 | (1) An insurer, health plan, or utilization review organization from requiring an enrollee |
16 | to try an AB-rated generic equivalent prior to providing reimbursement for the equivalent |
17 | branded drug; |
18 | (2) A health care provider from prescribing a drug they determine is medically |
19 | appropriate. |
20 | SECTION 4. Chapter 27-41 of the General Laws entitled "Health Maintenance |
21 | Organizations" is hereby amended by adding thereto the following section: |
22 | 27-41-90. Step therapy protocol. |
23 | (a) As used in this section the following words shall, unless the context clearly requires |
24 | otherwise, have the following meanings: |
25 | (1) "Clinical practice guidelines" means a systematically developed statement to assist |
26 | practitioner and patient decisions about appropriate health care for specific clinical circumstances. |
27 | (2) "Clinical review criteria" means the written screening procedures, decision abstracts, |
28 | clinical protocols and practice guidelines used by an insurer, health plan, or utilization review |
29 | organization to determine the medical necessity and appropriateness of health care services. |
30 | (3) "Step therapy exception" means a process that provides that a step therapy protocol |
31 | should be overridden in favor of immediate coverage of the health care provider's selected |
32 | prescription drug. |
33 | (4) "Step therapy protocol" means a protocol or program that establishes the specific |
34 | sequence in which prescription drugs for a specified medical condition that are medically |
| LC002065 - Page 7 of 10 |
1 | appropriate for a particular patient and are covered as a pharmacy or medical benefit, including |
2 | self-administered and physician-administered drugs, are covered by an insurer or health plan. |
3 | (5) "Utilization review organization" means an entity that conducts utilization review, |
4 | other than a health carrier performing utilization review for its own health benefit plans. |
5 | (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or |
6 | renewed within the state that provides coverage for prescription drugs and uses step therapy |
7 | protocols shall have the following requirements and restrictions: |
8 | (1) Clinical review criteria used to establish step therapy protocols shall be based on |
9 | clinical practice guidelines: |
10 | (i) Independently developed by a multidisciplinary panel with expertise in the medical |
11 | condition, or conditions, for which coverage decisions said criteria will be applied; and |
12 | (ii) That recommend drugs be taken in the specific sequence required by the step therapy |
13 | protocol. |
14 | (c) When coverage of medications for the treatment of any medical condition are |
15 | restricted for use by an insurer, health plan, or utilization review organization via a step therapy |
16 | protocol, the patient and prescribing practitioner shall have access to a clear and convenient |
17 | process to request a step therapy exception. An insurer, health plan, or utilization review |
18 | organization shall use its existing medical exceptions process to satisfy this requirement. The |
19 | process shall be disclosed to the patient and health care providers, including documenting and |
20 | making easily accessible on the insurer's, health plan's or utilization review organization's |
21 | website. |
22 | (d) A step therapy override exception shall be expeditiously granted if: |
23 | (1) The required drug is contraindicated or will likely cause an adverse reaction, or |
24 | physical or mental harm to the patient; |
25 | (2) The required prescription drug is expected to be ineffective based on the known |
26 | clinical characteristics of the patient and the known characteristics of the prescription drug |
27 | regimen; |
28 | (3) The enrollee has tried the step therapy-required drug while under their current health |
29 | plan, or another drug in the same pharmacologic class or with the same mechanism of action and |
30 | such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an |
31 | adverse event; |
32 | (4) The patient is stable on a drug recommended by their health care provider for the |
33 | medical condition under consideration while on a current or previous health insurance or health |
34 | benefit plan and no generic substitution is available. This subsection shall not be construed to |
| LC002065 - Page 8 of 10 |
1 | allow the use of a pharmaceutical sample to meet the requirements for a step therapy override |
2 | exception. |
3 | (e) Upon the granting of a step therapy override exception request, the insurer, health |
4 | plan, utilization review organization, or other entity shall authorize coverage for the drug |
5 | prescribed by the enrollee's treating health care provider, provided such drug is a covered drug |
6 | under such terms of policy or contract. |
7 | (f) The insurer, health plan, or utilization review organization shall grant or deny a step |
8 | therapy exception request or an appeal within seventy-two (72) hours of receipt. In cases where |
9 | exigent circumstances exist an insurer, health plan, or utilization review organization shall grant |
10 | or deny a step therapy exception request or an appeal within twenty-four (24) hours of receipt. |
11 | Should a grant or denial by an insurer, health plan, or utilization review organization not be |
12 | received within the time allotted, the exception or appeal shall be deemed granted. |
13 | (g) Any step therapy exception as defined by this subsection shall be eligible for appeal |
14 | by an insured. |
15 | (h) This section shall not be construed to prevent: |
16 | (1) An insurer, health plan, or utilization review organization from requiring an enrollee |
17 | to try an AB-rated generic equivalent prior to providing reimbursement for the equivalent |
18 | branded drug; |
19 | (2) A health care provider from prescribing a drug they determine is medically |
20 | appropriate. |
21 | SECTION 5. This act shall take effect upon passage and shall apply only to health |
22 | insurance and health benefit plans delivered, issued for delivery, or renewed on or after January 1, |
23 | 2020. |
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LC002065 | |
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| LC002065 - Page 9 of 10 |
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. |
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LC002065 | |
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| LC002065 - Page 10 of 10 |