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 Oral Suspending Compound Plus or Suspension. The Plan did not grant this request. We received this case to conduct an independent review.Lidocaine Viscous HCL and Nystatin, parts of a compound:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lidocaine 2% Viscous HCL & Nystatin 100,000 units/ml Mouth/Throat Suspension as part of a compound. The drugs are requested to treat B00.1 - Herpesviral vesicular dermatitis, 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 drugs, as prescribed, do 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 Lidocaine Viscous HCL and Nystatin parts of a compound for the diagnosed condition. As a result, the drugs are not being prescribed for a medically accepted indication as defined by Medicare law. As such, they cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because these drugs, as prescribed, do not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Lidocaine Viscous HCL and Nystatin parts of a compound. Antacid Oral Suspension and M-Dryl Oral Liquid, parts of a compound:Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Antacid Oral Suspension and M-Dryl Oral Liquid, parts of a compound are not eligible for Part D coverage, and the Plan is not required to cover them under the Part D benefit.Purified Water, part of a compound (non-therapeutic): Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Purified Water, part of a compound (non-therapeutic) is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Purified Water, part of a 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.