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 Durezol. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Durezol.Durezol is requested for ongoing use for you, status post corneal transplant, and stated to have secondarycorneal edema. It is indicated that Durezol is requested for continuation of therapy; however it is not clearwhen the requested drug was started. Additionally it is noted that you have a corneal graft in your sightedeye, the prescriber states that your other eye is blind, Prednisolone Acetate 1% is not effective enough,brand Pred Forte could be used as an alternative, and that the requested drug and brand Pred Forte are theonly two options to keep the only sighted eye with the least risk for transplant rejection. Medical recordswere requested to document the indication that is being treated with the requested drug; however medicalrecords were not provided. Based on the information provided, it appears that continuation of Durezol isrequested for ongoing prevention of corneal transplant rejection, which is an off-label (non-FDA approved)use. There is insufficient documentation that the requested drug is being used in the immediate postsurgicalperiod to treat post-operative pain and inflammation related to ocular surgery. In summary, there isinsufficient documentation that the requested drug is being prescribed for a medically accepted indicationas defined by Medicare law. As such, an exceptions request based on medical necessity cannot beconsidered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D based on thedocumentation provided.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 reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Durezol for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Durezol.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.