SB 1064 — Health insurance; establishing guidelines for step therapy protocol. Effective date,

STATESENATE OFFLOOR OKLAHOMAVERSION 2February 1st24, Session2025 ofAS theAMENDED 60th Legislature (2025) 3 SENATE BILL 1064NO. By:

Rosino1064 4By: 5 AS INTRODUCED 7 An Act relating to health insurance;

amendingRosino 63of O.S.the Senate and Stinson of the House 7 [ health insurance - step therapy protocol - guidelines - effective date ] BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:

2021, Section 7310, which relates to step therapy protocol;

establishing guidelines for step therapy protocol;

and providing an effective date.

9 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:

“Health insurance plan” means any individual or group health insurance policy, medical service plan, contract, hospital service corporation contract, hospital and medical service corporation contract, fraternal benefit society or health maintenance organization, municipal group-funded pool, the Oklahoma Medicaid Req.Program and the state health care benefits plan that provides SENATE FLOOR VERSION - SB1064 SFLR Page 1 (Bold face denotes Committee Amendments) medical, surgical or hospital expense coverage.

No.For purposes of this section, “health insurance plan” also includes any utilization review organization that contracts with a health insurance plan provider;

7603. Page 1 Program and the state health care benefits plan that provides 2 medical, surgical or hospital expense coverage.

For“Medical purposesnecessity” means that, under the applicable standard of 3care, thisa section,health “healthservice insuranceor plan”supply alsois includesappropriate anyto utilizationimprove reviewor organizationpreserve thathealth, contractslife withor function, to slow the deterioration of health, life or function or for the early screening, prevention, evaluation, diagnosis or treatment of a healthdisease, insurancecondition, planillness 5or provider;injury;

6 3.

“Medical necessity” means that, under the applicable 7 standard of care, a health service or supply is appropriate to improve or preserve health, life or function, to slow the 9 deterioration of health, life or function or for the early screening, prevention, evaluation, diagnosis or treatment of a disease, condition, illness or injury;

and Req.7.

No.“Pharmaceutical sample” means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

760SENATE FLOOR VERSION - SB1064 SFLR Page 2 7.(Bold face denotes Committee Amendments) B.

“PharmaceuticalFor sample”any meanshealth insurance plan that is delivered, issued for delivery, amended or renewed on or after January 1, 2020, and that utilizes a unitstep oftherapy protocol, a prescriptionhealth drugcarrier, 2health thatbenefit isplan notor intendedutilization toreview beorganization soldshall use recognized, evidence-based and ispeer-reviewed intendedclinical topractice promoteguidelines thewhen saleestablishing 3any ofstep thetherapy drug.protocol, when such guidelines are available.

B.

For any health insurance plan that is delivered, issued for 5 delivery, amended or renewed on or after January 1, 2020, and that 6 utilizes a step therapy protocol, a health carrier, health benefit 7 plan or utilization review organization shall use recognized, evidence-based and peer-reviewed clinical practice guidelines when 9 establishing any step therapy protocol, when such guidelines are available.

A health insurance plan shall grant a requested step therapy exception if the submitted justification of the prescribing provider Req.and supporting clinical documentation, if needed, is completed and supports the statement of the provider that:

No.SENATE FLOOR VERSION - SB1064 SFLR Page 3 (Bold face denotes Committee Amendments) a.

760the Pagerequired 3prescription anddrug supportingis clinicalcontraindicated documentation,or ifwill needed,likely iscause completedan andadverse 2reaction supportsor thephysical statementor ofmental harm to the providerpatient, that:b.

3the a.required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug, c.

the required prescription drug is contraindicated or will likely cause an adverse reaction or physical or 5 mental harm to the patient, 6 b.

the required prescription drug is expected to be 7 ineffective based on the known clinical characteristics of the patient and the known 9 characteristics of the prescription drug, c.

Req.D.

No.A health insurance plan provider shall respond to a request for a step therapy exception, or any appeal therefor, within SENATE FLOOR VERSION - SB1064 SFLR Page 4 (Bold face denotes Committee Amendments) seventy-two (72) hours of receipt of the request or appeal.

760If Pagea 4patient’s D.prescribing healthcare provider indicates that exigent circumstances exist, the health insurance plan provider shall respond to such a request or appeal within twenty-four (24) hours of receipt of the request or appeal.

AIf the health insurance plan provider shallfails respond to arespond requestwithin 2the forrequired atime, the step therapy exception,exception or any appeal therefor,shall withinbe 3deemed seventy-twogranted. (72) hours of receipt of the request or appeal.

If a patient’s prescribing healthcare provider indicates that exigent 5 circumstances exist, the health insurance plan provider shall 6 respond to such a request or appeal within twenty-four (24) hours of 7 receipt of the request or appeal.

If the health insurance plan provider fails to respond within the required time, the step therapy 9 exception or appeal shall be deemed granted.

If the prescription drug that is subject to step therapy protocol is approved by the FDA for the treatment of a rare disease pursuant to Section 360bb of Title 21 of the United States Code, and Req.no clinical practice guidelines are available for the rare disease, any restrictions imposed by the step therapy protocol shall not be SENATE FLOOR VERSION - SB1064 SFLR Page 5 (Bold face denotes Committee Amendments) any more restrictive than in accordance with the conditions of use included in the FDA required labeling for the prescription drug.

No.I.

760The PageOklahoma 5Insurance noDepartment clinicaland practice guidelines are available for the rareOklahoma disease,Health 2Care anyAuthority restrictions imposed by the step therapy protocol shall notadopt berules 3necessary anyto moreimplement restrictiveand thanadminister inthis accordanceact withprior theto conditionsJanuary of1, use2020. included in the FDA required labeling for the prescription drug.

5 I.

The Oklahoma Insurance Department and the Oklahoma Health 6 Care Authority shall adopt rules necessary to implement and 7 administer this act prior to January 1, 2020.

9COMMITTEE 60-1-760REPORT CADBY: 1/16/2025 3:02:42 PM Req.

No.COMMITTEE ON HEALTH AND HUMAN SERVICES February 24, 2025 - DO PASS AS AMENDED 9 SENATE FLOOR VERSION - SB1064 SFLR Page 6 (Bold face denotes Committee Amendments)

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