1| SENATE FLOOR VERSION | | February 24, 2025 | 2| AS AMENDED | | | 3|SENATE BILL NO. 1064 By: Rosino of the Senate | | | 4| and | | | 5| Stinson of the House | | | 6| | | | 7| | | | 8| [ health insurance - step therapy protocol - | | guidelines - effective date ] | 9| | | | 10| | | | 11|BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: | | | 12| SECTION 1. AMENDATORY 63 O.S. 2021, Section 7310, is | | | 13|amended to read as follows: | | | 14| Section 7310. A. As used in this section: | | | 15| 1. "Clinical practice guidelines" means a systematically | | | 16|developed statement to assist decision-making by healthcare | | | 17|providers and patients about appropriate healthcare or specific | | | 18|clinical circumstances and conditions; | | | 19| 2. "Health insurance plan" means any individual or group health | | | 20|insurance policy, medical service plan, contract, hospital service | | | 21|corporation contract, hospital and medical service corporation | | | 22|contract, fraternal benefit society or health maintenance | | | 23|organization, municipal group-funded pool, the Oklahoma Medicaid | | | 24|Program and the state health care benefits plan that provides | | | arsid544147 SENATE FLOOR VERSION - SB1064 SFLR Page 1 ___________________________________________________________________________
1|medical, surgical or hospital expense coverage. For purposes of | | | 2|this section, "health insurance plan" also includes any utilization | | | 3|review organization that contracts with a health insurance plan | | | 4|provider; | | | 5| 3. "Medical necessity" means that, under the applicable | | | 6|standard of care, a health service or supply is appropriate to | | | 7|improve or preserve health, life or function, to slow the | | | 8|deterioration of health, life or function or for the early | | | 9|screening, prevention, evaluation, diagnosis or treatment of a | | | 10|disease, condition, illness or injury; | | | 11| 4. "Step therapy protocol" means a protocol or program that | | | 12|establishes a specific sequence in which prescription drugs for a | | | 13|specified medical condition that are medically appropriate for a | | | 14|particular patient are covered by a health insurance plan; | | | 15| 5. "Step therapy exception" means a process by which a step | | | 16|therapy protocol is overridden in favor of immediate coverage of the | | | 17|healthcare provider's selected prescription drug; | | | 18| 6. "Utilization review organization" means an entity that | | | 19|conducts utilization review, not including a health insurance plan | | | 20|provider performing utilization review for the provider's own health | | | 21|insurance plan; and | | | 22| 7. "Pharmaceutical sample" means a unit of a prescription drug | | | 23|that is not intended to be sold and is intended to promote the sale | | | 24|of the drug. | | | arsid544147 SENATE FLOOR VERSION - SB1064 SFLR Page 2 ___________________________________________________________________________
1| B. For any health insurance plan that is delivered, issued for | | | 2|delivery, amended or renewed on or after January 1, 2020, and that | | | 3|utilizes a step therapy protocol, a health carrier, health benefit | | | 4|plan or utilization review organization shall use recognized, | | | 5|evidence-based and peer-reviewed clinical practice guidelines when | | | 6|establishing any step therapy protocol, when such guidelines are | | | 7|available. When peer-reviewed clinical guidelines are not | | | 8|available, decisions shall default to the United States Food and | | | 9|Drug Administration label as the authoritative reference. | | | 10| C. 1. For any health insurance plan that is delivered, issued | | | 11|for delivery, amended or renewed on or after January 1, 2020, and | | | 12|that restricts coverage of a prescription drug for the treatment of | | | 13|any medical condition pursuant to a step therapy protocol, the | | | 14|health insurance plan provider shall provide to the prescribing | | | 15|healthcare provider and patient access to a clear, convenient and | | | 16|readily accessible process to request a step therapy exception. Any | | | 17|health insurance plan provider that utilizes a step therapy protocol | | | 18|shall make such process to request a step therapy exception | | | 19|accessible on the health insurance plan provider's website. | | | 20| 2. A health insurance plan shall grant a requested step therapy | | | 21|exception if the submitted justification of the prescribing provider | | | 22|and supporting clinical documentation, if needed, is completed and | | | 23|supports the statement of the provider that: | | | 24| | | | arsid544147 SENATE FLOOR VERSION - SB1064 SFLR Page 3 ___________________________________________________________________________
1| a. the required prescription drug is contraindicated or | | | 2| will likely cause an adverse reaction or physical or | | | 3| mental harm to the patient, | | | 4| b. the required prescription drug is expected to be | | | 5| ineffective based on the known clinical | | | 6| characteristics of the patient and the known | | | 7| characteristics of the prescription drug, | | | 8| c. the patient has tried the required prescription drug | | | 9| while under the patient's current or a previous health | | | 10| insurance plan and such prescription drug was | | | 11| discontinued due to lack of efficacy or effectiveness, | | | 12| diminished effect or an adverse event, | | | 13| d. the required prescription drug is not in the best | | | 14| interest of the patient, based on medical necessity, | | | 15| or | | | 16| e. the patient is stable on a prescription drug selected | | | 17| by the patient's healthcare provider for the medical | | | 18| condition under consideration while on the patient's | | | 19| current or a previous health insurance plan. | | | 20| 3. A health insurance plan provider shall permit a patient to | | | 21|appeal any decision rendered on a request for a step therapy | | | 22|exception. | | | 23| D. A health insurance plan provider shall respond to a request | | | 24|for a step therapy exception, or any appeal therefor, within | | | arsid544147 SENATE FLOOR VERSION - SB1064 SFLR Page 4 ___________________________________________________________________________
1|seventy-two (72) hours of receipt of the request or appeal. If a | | | 2|patient's prescribing healthcare provider indicates that exigent | | | 3|circumstances exist, the health insurance plan provider shall | | | 4|respond to such a request or appeal within twenty-four (24) hours of | | | 5|receipt of the request or appeal. If the health insurance plan | | | 6|provider fails to respond within the required time, the step therapy | | | 7|exception or appeal shall be deemed granted. Upon granting a step | | | 8|therapy exception, the health insurance plan provider shall | | | 9|authorize coverage for and dispensation of the prescription drug | | | 10|prescribed by the patient's healthcare provider. | | | 11| E. This section shall not be construed to prevent a healthcare | | | 12|provider from prescribing a prescription drug that is determined to | | | 13|be medically appropriate. | | | 14| F. Nothing in this section shall be construed to authorize the | | | 15|use of a pharmaceutical sample for the sole purpose of meeting the | | | 16|requirements for a step therapy exception. | | | 17| G. Nothing in this section shall be construed to prevent the | | | 18|substitution of a drug in accordance with current statutes and | | | 19|regulations of this state. | | | 20| H. If the prescription drug that is subject to step therapy | | | 21|protocol is approved by the FDA for the treatment of a rare disease | | | 22|pursuant to Section 360bb of Title 21 of the United States Code, and | | | 23|no clinical practice guidelines are available for the rare disease, | | | 24|any restrictions imposed by the step therapy protocol shall not be | | | arsid544147 SENATE FLOOR VERSION - SB1064 SFLR Page 5 ___________________________________________________________________________
1|any more restrictive than in accordance with the conditions of use | | | 2|included in the FDA required labeling for the prescription drug. | | | 3| I. The Oklahoma Insurance Department and the Oklahoma Health | | | 4|Care Authority shall adopt rules necessary to implement and | | | 5|administer this act prior to January 1, 2020. | | | 6| SECTION 2. This act shall become effective November 1, 2025. | | | 7|COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES | |February 24, 2025 - DO PASS AS AMENDED | 8| | | | 9| | | | 10| | | | 11| | | | 12| | | | 13| | | | 14| | | | 15| | | | 16| | | | 17| | | | 18| | | | 19| | | | 20| | | | 21| | | | 22| | | | 23| | | | 24| | | | arsid544147 SENATE FLOOR VERSION - SB1064 SFLR Page 6