9981

The purpose of this chapter is to establish standards for the payment or reimbursement of costs associated with prescription drugs that, even though they have been approved by the U. S. Food and Drug Administration (FDA), are used for indications other than those stated in the labeling approved by the FDA (this use is hereinafter referred to as 'off-label use'). Denial of payment or reimbursement for off-label use can interrupt or effectively deny access to necessary and appropriate treatment for covered persons or enrollees.\nHistory —Aug. 29, 2011, No. 194, added as § 52.010 on Aug. 23, 2012, No. 203, § 8, eff. 90 days after Aug. 23, 2012.