(1) As used in this section, step therapy means a drug protocol in which the cost of a prescribed drug is reimbursed only if the patient has first tried a specified drug or series of drugs. (2) A coordinated care organization that requires step therapy shall make easily accessible to any provider who is reimbursed by the organization, directly or through a risk-bearing entity, to provide health services to members of the organization, clear explanations of: (a) The clinical criteria for each step therapy protocol; (b) The procedure by which a provider may submit to the organization or risk-bearing entity, the providers medical rationale for determining that a particular step therapy protocol is not appropriate for a particular patient based on the patients medical condition and history; and (c) The documentation, if any, that a provider must submit to the organization or risk-bearing entity for the organization or entity to determine the appropriateness of step therapy for a specific patient. [Formerly 414.637]
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