23 CAR § 149-104. Development of clinical review criteria

(a) Health insurers shall base clinical review criteria used to establish step therapy protocols on appropriate clinical practice guidelines or peer-reviewed published medical literature. (b) For step therapy protocols based on clinical practice guidelines, such guidelines shall be: (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: (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; (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 (C) Offering opportunities for public review and comments; (2) Based on high-quality studies, research, and medical practices; (3) Created by an explicit and transparent process that: (A) Minimizes biases and conflicts of interest; (B) Explains the relationship between treatment options and outcomes; (C) Rates the quality of the evidence supporting recommendations; and (D) Considers relevant patient subgroups and preferences; and (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) Based on high-quality studies, research, and medical practices; and (2) Created by an explicit and transparent process that: (A) Minimizes biases and conflicts of interest; (B) Explains the relationship between treatment options and outcomes; (C) Rates the quality of the evidence supporting recommendations; and (D) Considers relevant patient subgroups and preferences. (d) If establishing a step therapy protocol, a utilization review agent shall take into account the needs of atypical patient populations and diagnoses when establishing clinical review criteria. (e) Healthcare insurers, health benefit plans, or the state are not required to set up a new entity to develop critical review criteria used for step therapy protocols.