20-3653. Clinical review criteria
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. Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol.
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:
(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.
(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. Are based on high quality studies, research and medical practice.
4. Are created by an explicit and transparent process that does all of the following:
(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.
(d) Considers relevant patient subgroups and preferences.
5. Are regularly updated at least once a year through a review of new evidence and research and newly developed treatments.
B. If no clinical practice guidelines exist that meet the requirements prescribed in subsection A, paragraph 2 of this section, peer reviewed publications may be used.
C. When considering clinical review criteria to establish a step therapy protocol, a utilization review agent shall also consider the needs of atypical patient populations and diagnoses.
D. Each health care insurer, pharmacy benefit manager and utilization review agent shall annually certify to the department that the clinical review criteria used in the insurer's, manager's or agent's step therapy protocol for prescription drugs meet the requirements prescribed by this article. On the department's request, the health care insurer, pharmacy benefit manager or utilization review agent shall submit the insurer's, manager's or agent's clinical review criteria for approval. The department may require a health care insurer to submit an annual certification or clinical review criteria submission for a pharmacy benefit manager or utilization review agent that acts on behalf of the health care insurer, and the health care insurer and the pharmacy benefit manager or utilization review agent shall be held jointly responsible for any errors, omissions, misstatements or misrepresentations in that annual certification or submission. A health care insurer that submits an annual certification or clinical review criteria submission on behalf of the health care insurer's pharmacy benefit manager or utilization review agent shall provide the pharmacy benefit manager or utilization review agent at least fifteen days' advance notice of the certification or submission, and the pharmacy benefit manager or utilization review agent may submit an independent certification or submission, in lieu of having the health care insurer make the certification or submission on the pharmacy benefit manager's or utilization review agent's behalf.
E. This section does not require a health care insurer to establish a new entity to develop clinical review criteria used for a step therapy protocol.