§ 20-3654 — Exceptions; process

A. Notwithstanding any other law, if coverage of a prescription drug for the treatment of any medical condition is restricted for use by a health care insurer, pharmacy benefit manager or utilization review agent through the use of a step therapy protocol, the patient and prescribing provider shall have access to a clear and convenient process to request a step therapy exception determination. A health care insurer, pharmacy benefit manager or utilization review agent may use its existing medical exceptions process to satisfy this requirement if that process is consistent with the requirements prescribed in section 20-3653 and this section. The process shall be made easily accessible on the health care insurer's, health benefit plan's, pharmacy benefit manager's or utilization review agent's website and shall include a list of the information and documentation the health care insurer, pharmacy benefit manager or utilization review agent requires and where and to whom the patient and prescribing provider must send the step therapy exception request.

B. A step therapy exception request shall be granted if sufficient justification and any necessary supporting clinical documentation are submitted to establish that any of the following applies:

1. The prescription drug required by the step therapy protocol is contraindicated or will likely cause a serious adverse reaction by or physical or mental harm to the patient.

2. The prescription drug required by the step therapy protocol is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen.

3. The patient has tried the prescription drug required by the step therapy protocol while under the patient's current or previous health care plan, or another prescription drug in the same pharmacologic class with a similar efficacy and side effect profile or with the same mechanism of action, the patient's adherence during the trial was for a period of time sufficient to allow for a positive treatment outcome and the prescription drug was discontinued due to lack of efficacy or effectiveness, an adverse event or contraindication.

4. The prescription drug required by the step therapy protocol is not in the best interest of the patient based on medical necessity because the patient's use of the prescription drug is expected to cause any of the following:

(a) A barrier to the patient's adherence to or compliance with the patient's plan of care.

(b) A negative impact on the patient's comorbid conditions.

(c) A clinically predictable negative drug interaction.

(d) A decrease in the patient's ability to achieve or maintain a reasonably functional ability in performing daily activities for which the patient has experienced a positive therapeutic outcome.

5. The patient has experienced a positive therapeutic outcome on a prescribed drug selected by the patient's health care provider for the medical condition under consideration while on the patient's current or previous health care plan. A health care provider may not use a pharmaceutical sample for the purpose of qualifying for an exception to step therapy under this paragraph.

C. On granting a step therapy exception determination, the health care insurer, pharmacy benefit manager or utilization review agent shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider if the prescription drug is covered by the patient's health care plan.

D. The health care insurer, pharmacy benefit manager or utilization review agent shall grant or deny a step therapy exception request within seventy-two hours after receiving the request. In a case in which an exigent circumstance exists, the health care insurer, pharmacy benefit manager or utilization review agent shall grant or deny the step therapy exception request within twenty-four hours after receiving the request. If the step therapy exception request is incomplete or additional clinically relevant information is required, the health care insurer, pharmacy benefit manager or utilization review agent shall notify the prescribing provider within seventy-two hours after receiving the request, or within twenty-four hours if an exigent circumstance exists, that additional or clinically relevant information is required in order to approve or deny the step therapy exception request pursuant to the requirements outlined in subsection A of this section. The health care insurer, pharmacy benefit manager or utilization review agent shall grant or deny the step therapy exception request within seventy-two hours after receiving the requested additional or clinically relevant information, or within twenty-four hours if an exigent circumstance exists. If the prescribing provider does not receive a determination or request for additional or clinically relevant information from the health care insurer, pharmacy benefit manager or utilization review agent within the time period prescribed by this subsection, the exception is deemed granted.

E. An insured, enrollee or subscriber may appeal an adverse step therapy exception determination as prescribed in chapter 15, article 2 of this title.

F. This section does not prevent either of the following:

1. A health care insurer, pharmacy benefit manager or utilization review agent from requiring a patient to try an AB-rated generic equivalent before providing coverage for the equivalent branded prescription drug.

2. A health care provider from prescribing a prescription drug that is determined to be medically necessary.