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 provide reimbursement for the Gentamicin-Sodium Chloride Compound. The Plan did not grant this request. We received this case to conduct an independent review.Gentamicin IngredientWe asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Gentamicin 40 mg via bladder irrigation. The drug is requested to treat chronic urinary tract infection, 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 drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is 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 drug is 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 Gentamicin ingredient of the Gentamicin-Sodium Chloride Compound 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 or reimbursement for the Gentamicin-Sodium Chloride Compound.Sodium Chloride IngredientFor 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. The Sodium Chloride ingredient of the Gentamicin-Sodium Chloride Compound is used as a vehicle in the reconstitution of Gentamicin-Sodium Chloride Compound Sodium Chloride's use in this instance is not therapeutic. Thus, he Sodium Chloride ingredient of the Gentamicin-Sodium Chloride Compound does not meet the definition of a Part D drug. Therefore, the Plan is not required to provide coverage or reimbursement for the Gentamicin-Sodium Chloride Compound.This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.