(a)(1) Clinical review criteria used to establish a step therapy protocol shall be based on clinical practice guidelines that:(A) 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: (i)(a) Requiring members to disclose any potential conflicts of interest with entities, including healthcare insurers, health benefit plans, and pharmaceutical manufacturers.(b) A member shall recuse himself or herself from voting if the member has a conflict of interest;(ii) 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(iii) Offering opportunities for public review and comments;(B) Are based on high-quality studies, research, and medical practice;(C) Are created by an explicit and transparent process that: (i) Minimizes biases and conflicts of interest;(ii) Explains the relationship between treatment options and outcomes;(iii) Rates the quality of the evidence supporting recommendations; and(iv) Considers relevant patient subgroups and preferences; and(D) plains the relationship between treatment options and outcomes;(iii) Rates the quality of the evidence supporting recommendations; and(iv) Considers relevant patient subgroups and preferences; and(D) Are continually updated through a review of new evidence, research, and newly developed treatments.(2) Peer-reviewed published medical literature may be substituted for clinical practice guidelines to establish clinical review criteria if the peer-reviewed published medical literature meets the requirements of subdivisions (a)(1)(B) and (C) of this section, when those requirements apply to the available peer-reviewed published medical literature.(3) 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.(4) A healthcare insurer, pharmacy benefit manager, or utilization review organization shall: (A) Upon written request, provide all specific written clinical review criteria relating to the particular condition or disease, including clinical review criteria relating to a step therapy protocol override determination; and(B) Make available such clinical cal review criteria relating to the particular condition or disease, including clinical review criteria relating to a step therapy protocol override determination; and(B) Make available such clinical review criteria and other clinical information on its website and to a healthcare professional on behalf of an insured upon written request.(b) This section does not require healthcare insurers, health benefit plans, or the state to set up a new entity to develop clinical review criteria used for step therapy protocols.Added by Act 2021, No. 97,§ 2, eff. 1/1/2022.
Arkansas Legal Code