(a) A healthcare insurer, health benefit plan, or utilization review organization shall expeditiously grant a step therapy protocol exception if:

1. (1) A required prescription drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the patient;
2. (2) 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 regimen;

3. (3) A patient has tried the required prescription drug while under the patient's current or previous health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action and the prescription drug was discontinued due to:

   1. (A) Lack of efficacy or effectiveness;
   2. (B) Diminished effect; or
   3. (C) An adverse event;
4. (4) A required prescription drug is not in the best interest of the patient, based on medical necessity; or
5. (5) A patient is stable on a prescription drug selected by the patient's healthcare provider for the medical condition under consideration while on a current or previous health benefit plan.

(b)

1. (1) The healthcare insurer, health benefit plan, or utilization review organization shall grant or deny a request for a step therapy protocol exception within seventy-two (72) hours of receiving the request.
2. (2) However, in cases in which exigent circumstances exist, the healthcare insurer, health benefit plan, or utilization review organization shall grant or deny the request within twenty-four (24) hours of receiving the request.

(d)

1. (1) If a request for a step therapy protocol exception is incomplete or additional clinically relevant information is required, a healthcare insurer, health benefit plan, or utilization review organization shall notify the prescribing healthcare provider within seventy-two (72) hours of submission, or twenty-four (24) hours in exigent circumstances, of the additional or clinically relevant information that is required in order to approve or deny the step therapy protocol exception request.
2. (2) Once the requested information is submitted, the applicable time period to grant or deny a step therapy protocol exception request shall apply.
3. (3) If a determination or notice of incomplete or clinically relevant information by a healthcare insurer, health benefit plan, or utilization review organization is not received by the prescribing healthcare provider within the time allotted, the step therapy protocol exception shall be deemed granted.

(g) This section shall not be construed to prevent:

1. (1) A healthcare insurer, a health benefit plan, or a utilization review organization from requiring:

   1. (A) A patient to try a generic equivalent or interchangeable biological product unless such a requirement meets Arkansas Code § 23-79-2104(b) pursuant to a step therapy protocol exception request submitted under Arkansas Code § 23-79-2104(b); or
   2. (B) A pharmacist to effect substitutions of prescription drugs consistent with Arkansas Code § 17-92-503; or
2. (2) A healthcare provider from prescribing a prescription drug that is determined to be medically necessary.