A step therapy override exception shall be approved by a health carrier, health benefit plan, or utilization review organization if any of the following circumstances apply:

1. (1) The prescription drug required under the step therapy protocol is contraindicated pursuant to the drug manufacturer's prescribing information for the drug or, due to a documented adverse event with a previous use or a documented medical condition, including a comorbid condition, is likely to do any of the following:

   1. (a) Cause an adverse reaction to a covered person;
   2. (b) Decrease the ability of a covered person to achieve or maintain reasonable functional ability in performing daily activities;
   3. (c) Cause physical or mental harm to a covered person;

2. (2) The prescription drug required under the step therapy protocol is expected to be ineffective based on the known clinical characteristics of the covered person, such as the covered person's adherence to or compliance with the covered person's individual plan of care, and any of the following:

   1. (a) The known characteristics of the prescription drug regimen as described in peer-reviewed literature or in the manufacturer's prescribing information for the drug;
   2. (b) The health care professional's medical judgment based on clinical practice guidelines or peer-reviewed journals;
   3. (c) The covered person's documented experience with the prescription drug regimen;
3. (3) The covered person has had a trial of a therapeutically equivalent dose of the prescription drug under the step therapy protocol while under the covered person's current or previous health benefit plan for a period of time to allow for a positive treatment outcome, and such prescription drug was discontinued by the covered person's health care professional due to lack of effectiveness;
4. (4) The covered person is currently receiving a positive therapeutic outcome on a prescription drug selected by the covered person's health care professional for the medical condition under consideration while under the covered person's current or previous health benefit plan. This subdivision may not be construed to encourage the use of a pharmaceutical sample for the sole purpose of meeting the requirements for a step therapy override exception.

Upon approval of a step therapy override exception, the health carrier, health benefit plan, or utilization review organization shall authorize coverage for the prescription drug selected by the covered person's prescribing health care professional if the prescription drug is a covered prescription drug under the covered person's health benefit plan.

Except in the case of an urgent care request, a health carrier, health benefit plan, or utilization review organization shall make a determination to approve or deny a request for a step therapy override exception within five calendar days after receipt of complete, clinically relevant written documentation supporting a step therapy override exception under subdivisions (1) through (4) of this section. In the case of an urgent care request, a health carrier, health benefit plan, or utilization review organization shall approve or deny a request for a step therapy override exception within seventy-two hours after receipt of such documentation. If a request for a step therapy override exception is incomplete or additional clinically relevant information is required, the health carrier, health benefit plan, or utilization review organization may request such information within the applicable time period provided in this section. Once the information is submitted, the applicable time period for approval or denial shall begin again. If a health carrier, health plan, or utilization review organization fails to respond to the request for a step override exception within the applicable time, the step therapy override exception shall be deemed granted.

If a nonurgent care request for a step therapy override exception is denied, the denial is an adverse determination and the health carrier, health benefit plan, or utilization review organization shall provide notification of adverse determination pursuant to § 58-17H-32 . If an urgent care request is denied, the health carrier, health benefit plan, or utilization review organization shall provide notification of adverse determination pursuant to § 58-17H-48 . Any denial of a request for a step therapy override exception is subject to the grievance procedures under chapter 58-17I .

Source: SL 2020, ch 209 , § 4.