(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 re
Free access — add to your briefcase to read the full text and ask questions with AI
(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) 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 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.