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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Sterile Water, Tobramycin and Vancomycin being used as ingredients in a compound drug. The Plan did not grant this request. We received this case to conduct an independent review. The request for coverage also involves Sodium Chloride.Regarding the request for Tobramycin and Vancomycin being used as ingredients in a compound drug: we asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Vancomycin 1 gm and Tobramycin 80 mg/2 mL topically in compound.The drugs are requested to treat osteomyelitis and complicated cellulitis, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drugs, as prescribed, for treatment of the noted condition. Therefore, the requested drugs are not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drugs are not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Tobramycin and Vancomycin for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Tobramycin and Vancomycin being used as ingredients in a compound drug. Regarding the request for Sterile Water being used as an ingredient in a compound: for coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. If a drug is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. Sterile Water is used as a diluent in the reconstitution of the Tobramycin-Vancomycin compound. Sterile Water's use in this instance is not therapeutic. Thus, Sterile Water does not meet the definition of a Part D drug. Therefore, the Plan is not required to cover Sterile Water. This decision does not concern the medical necessity of the requested compound drug nor of its ingredients. It only establishes if payment can be made under the Medicare Part D benefit.