§460.34. Step therapy; fail first protocols; requirements
A. Each managed care organization that utilizes step therapy or fail first protocols shall comply with the provisions of this Section.
B. When medications for the treatment of any medical condition are restricted for use by a managed care organization by a step therapy or fail first protocol, the prescribing physician shall be provided with and have access to a clear and convenient process to expeditiously request an override of such restriction from the managed care organization. The managed care organization shall expeditiously grant an override of such restriction under any of the following circumstances:
(1) The prescribing physician can demonstrate to the managed care organization, based on sound clinical evidence, that the preferred treatment required under step therapy or fail first protocol has been ineffective in the treatment of the Medicaid enrollee's disease or medical condition.
(2) The prescribing physician can demonstrate to the managed care organization, based on sound clinical evidence, that the preferred treatment required under the step therapy or fail first protocol will be expected to be ineffective based on the known relevant physical or mental characteristics and medical history of the Medicaid enrollee and known characteristics of the drug regimen.
(3) The prescribing physician can demonstrate to the managed care organization, based on sound clinical evidence, that the preferred treatment required under the step therapy or fail first protocol will cause or will likely cause an adverse reaction or other physical harm to the Medicaid enrollee.
C. The duration of any step therapy or fail first protocol shall not be longer than the duration of action for the medication as described in the pharmacokinetics section of the package insert approved by the United States Food and Drug Administration when such treatment is demonstrated by the prescribing physician to be clinically ineffective.
Acts 2013, No. 312, §1, eff. Jan. 1, 2014.
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