Okla. Stat. tit. 63, § 63-7310: Health insurance plans – Step therapy protocol -

Requirements.

A. As used in this section:

1. "Clinical practice guidelines" means a systematically

developed statement to assist decision-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 service

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

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 applicable

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 appropriate 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 sold and is intended to promote the sale

of the drug.

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.

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 patient 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:

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 known

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,

expected to be

ineffective based on the known clinical

characteristics of the patient and the known

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 medical

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 for a step therapy

exception.

D. A health insurance plan provider shall respond to a request

for a step therapy exception, or any appeal therefor, within

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 meeting 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. The Oklahoma Insurance Department and the Oklahoma Health

Care Authority shall adopt rules necessary to implement and

administer this act prior to January 1, 2020.