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1 STATE OF OKLAHOMA
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2 1st Session of the 60th Legislature (2025)
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3 SENATE BILL 1064 By: Rosino
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6 AS INTRODUCED
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7 An Act relating to health insurance; amending 63 O.S.
7 2021, Section 7310, which relates to step therapy
8 protocol; establishing guidelines for step therapy
8 protocol; and providing an effective date.
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12 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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13 SECTION 1. AMENDATORY 63 O.S. 2021, Section 7310, is
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14 amended to read as follows:
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15 Section 7310. A. As used in this section:
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16 1. "Clinical practice guidelines" means a systematically
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17 developed statement to assist decision-making by healthcare
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18 providers and patients about appropriate healthcare or specific
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19 clinical circumstances and conditions;
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20 2. "Health insurance plan" means any individual or group health
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21 insurance policy, medical service plan, contract, hospital service
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22 corporation contract, hospital and medical service corporation
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23 contract, fraternal benefit society or health maintenance
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24 organization, municipal group-funded pool, the Oklahoma Medicaid
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Req. No. 760 Page 1
1 Program and the state health care benefits plan that provides
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2 medical, surgical or hospital expense coverage. For purposes of
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3 this section, "health insurance plan" also includes any utilization
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4 review organization that contracts with a health insurance plan
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5 provider;
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6 3. "Medical necessity" means that, under the applicable
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7 standard of care, a health service or supply is appropriate to
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8 improve or preserve health, life or function, to slow the
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9 deterioration of health, life or function or for the early
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10 screening, prevention, evaluation, diagnosis or treatment of a
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11 disease, condition, illness or injury;
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12 4. "Step therapy protocol" means a protocol or program that
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13 establishes a specific sequence in which prescription drugs for a
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14 specified medical condition that are medically appropriate for a
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15 particular patient are covered by a health insurance plan;
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16 5. "Step therapy exception" means a process by which a step
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17 therapy protocol is overridden in favor of immediate coverage of the
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18 healthcare provider's selected prescription drug;
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19 6. "Utilization review organization" means an entity that
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20 conducts utilization review, not including a health insurance plan
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21 provider performing utilization review for the provider's own health
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22 insurance plan; and
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1 7. "Pharmaceutical sample" means a unit of a prescription drug
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2 that is not intended to be sold and is intended to promote the sale
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3 of the drug.
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4 B. For any health insurance plan that is delivered, issued for
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5 delivery, amended or renewed on or after January 1, 2020, and that
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6 utilizes a step therapy protocol, a health carrier, health benefit
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7 plan or utilization review organization shall use recognized,
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8 evidence-based and peer-reviewed clinical practice guidelines when
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9 establishing any step therapy protocol, when such guidelines are
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10 available. When peer-reviewed clinical guidelines are not
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11 available, decisions shall default to the United States Food and
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12 Drug Administration label as the authoritative reference.
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13 C. 1. For any health insurance plan that is delivered, issued
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14 for delivery, amended or renewed on or after January 1, 2020, and
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15 that restricts coverage of a prescription drug for the treatment of
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16 any medical condition pursuant to a step therapy protocol, the
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17 health insurance plan provider shall provide to the prescribing
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18 healthcare provider and patient access to a clear, convenient and
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19 readily accessible process to request a step therapy exception. Any
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20 health insurance plan provider that utilizes a step therapy protocol
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21 shall make such process to request a step therapy exception
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22 accessible on the health insurance plan provider's website.
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23 2. A health insurance plan shall grant a requested step therapy
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24 exception if the submitted justification of the prescribing provider
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Req. No. 760 Page 3
1 and supporting clinical documentation, if needed, is completed and
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2 supports the statement of the provider that:
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3 a. the required prescription drug is contraindicated or
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4 will likely cause an adverse reaction or physical or
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5 mental harm to the patient,
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6 b. the required prescription drug is expected to be
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7 ineffective based on the known clinical
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8 characteristics of the patient and the known
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9 characteristics of the prescription drug,
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10 c. the patient has tried the required prescription drug
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11 while under the patient's current or a previous health
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12 insurance plan and such prescription drug was
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13 discontinued due to lack of efficacy or effectiveness,
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14 diminished effect or an adverse event,
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15 d. the required prescription drug is not in the best
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16 interest of the patient, based on medical necessity,
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17 or
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18 e. the patient is stable on a prescription drug selected
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19 by the patient's healthcare provider for the medical
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20 condition under consideration while on the patient's
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21 current or a previous health insurance plan.
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22 3. A health insurance plan provider shall permit a patient to
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23 appeal any decision rendered on a request for a step therapy
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24 exception.
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1 D. A health insurance plan provider shall respond to a request
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2 for a step therapy exception, or any appeal therefor, within
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3 seventy-two (72) hours of receipt of the request or appeal. If a
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4 patient's prescribing healthcare provider indicates that exigent
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5 circumstances exist, the health insurance plan provider shall
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6 respond to such a request or appeal within twenty-four (24) hours of
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7 receipt of the request or appeal. If the health insurance plan
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8 provider fails to respond within the required time, the step therapy
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9 exception or appeal shall be deemed granted. Upon granting a step
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10 therapy exception, the health insurance plan provider shall
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11 authorize coverage for and dispensation of the prescription drug
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12 prescribed by the patient's healthcare provider.
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13 E. This section shall not be construed to prevent a healthcare
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14 provider from prescribing a prescription drug that is determined to
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15 be medically appropriate.
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16 F. Nothing in this section shall be construed to authorize the
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17 use of a pharmaceutical sample for the sole purpose of meeting the
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18 requirements for a step therapy exception.
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19 G. Nothing in this section shall be construed to prevent the
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20 substitution of a drug in accordance with current statutes and
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21 regulations of this state.
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22 H. If the prescription drug that is subject to step therapy
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23 protocol is approved by the FDA for the treatment of a rare disease
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24 pursuant to Section 360bb of Title 21 of the United States Code, and
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Req. No. 760 Page 5
1 no clinical practice guidelines are available for the rare disease,
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2 any restrictions imposed by the step therapy protocol shall not be
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3 any more restrictive than in accordance with the conditions of use
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4 included in the FDA required labeling for the prescription drug.
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5 I. The Oklahoma Insurance Department and the Oklahoma Health
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6 Care Authority shall adopt rules necessary to implement and
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7 administer this act prior to January 1, 2020.
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8 SECTION 2. This act shall become effective November 1, 2025.
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Req. No. 760 Page 6Every fact on this page links to its source, starting with the official bill record.