Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe.If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Fluorouracil-Calcipotriene Compound. The Plan did not grant this request. Wereceived this case to conduct an independent review.CalcipotrieneWe asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Fluorouracil-Calcipotriene Compound.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Calcipotriene 0.05% in a compound.Calcipotriene 0.05% in a compound is requested to treat an unknown diagnosis. The prescriber was askedto state the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in thecase file. The prescriber was also asked to address medical necessity for the requested drug. A responsefrom the prescriber was not received. Therefore, based on the current record, there is insufficientdocumentation that the requested medication is being prescribed for a medically accepted indication asdefined by Medicare law. In addition, an exceptions request based on medical necessity cannot beconsidered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer needed additional information from the prescriber to determine whether theenrollee is using Fluorouracil-Calcipotriene Compound for an FDA-approved use, or a use listed in theMedicare-approved compendia. The requested information was not received. As a result, we could notconfirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law.As such, it cannot be covered under the Medicare Part D benefit. An exceptions request based on medicalnecessity cannot be considered because it cannot be confirmed that the drug meets the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forFluorouracil-Calcipotriene Compound.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.FluorouracilMedicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy statedthat bulk powder was used or would be used when compounding the compound ingredient Fluoroucacil.Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by theFDA. Therefore, the Plan is not required to cover the Fluorouracil ingredient of the compound.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.