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