(b) For step therapy protocols based on clinical practice guidelines, such guidelines shall be:

1. (1) Developed and endorsed by a multidisciplinary panel of experts who manage conflicts of interest among the members of the writing and review groups by:

   1. (A) Requiring members to disclose any potential conflicts of interest with entities, including healthcare insurers, health benefit plans, and pharmaceutical manufacturers, and to recuse from voting if the member has 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 the preparation of evidence tables and facilitating consensus; and
   3. (C) Offering opportunities for public review and comments;
2. (2) Based on high-quality studies, research, and medical practices;

3. (3) Created by an explicit and transparent process that:

   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; and
   4. (D) Considers relevant patient subgroups and preferences; and
4. (4) Continually updated through a review of new evidence, research, and newly developed treatments.

(c) For step therapy protocols based on peer-reviewed published medical literature, such materials, when applicable, shall be:

1. (1) Based on high-quality studies, research, and medical practices; and

2. (2) Created by an explicit and transparent process that:

   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; and
   4. (D) Considers relevant patient subgroups and preferences.