A. Clinical review criteria that are used by a health care insurer, pharmacy benefit manager or utilization review agent to establish a step therapy protocol shall be based on clinical practice guidelines that:

1. 1. Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol.

2. 2. Except as provided in subsection B of this section, are developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by doing both of the following:

   1. (a) Requiring the members to disclose any potential conflict of interest with an entity, including a health care insurer or pharmaceutical manufacturer, and recuse themselves from voting if they have a conflict of interest.
   2. (b) Using a methodologist to work with writing groups to provide objectivity in data analysis and ranking of evidence through preparing evidence tables and facilitating consensus.
3. 3. Are based on high quality studies, research and medical practice.

4. 4. Are created by an explicit and transparent process that does all of the following:

   1. (a) Minimizes biases and conflicts of interest.
   2. (b) Explains the relationship between treatment options and outcomes.
   3. (c) Rates the quality of the evidence supporting recommendations.
   4. (d) Considers relevant patient subgroups and preferences.
5. 5. Are regularly updated at least once a year through a review of new evidence and research and newly developed treatments.