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 the Lidocaine-Antacid-M-Dryl-Sucralfate Compound. The Plan did not grant this request. We received this case to conduct an independent review.Sucralfate ingredientWe asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Sucralfate Suspension as part of a compound for oral administration. The drug is requested to treat C50.412 - Malignant neoplasm of upper-outer quadrant of left female breast, which is an off-label (non-FDA approved) use. Please note that this is the diagnosis submitted to the plan by the prescriber for the requested drug. 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 the Sucralfate ingredient of the Lidocaine-Antacid-M-Dryl-Sucralfate 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 for the Sucralfate ingredient of the Lidocaine-Antacid-M-Dryl-Sucralfate 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.Antacid and M-Dryl ingredientsMedicare 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, the Antacid and M-Dryl ingredients of the Lidocaine-Antacid-M-Dryl-Sucralfate Compound are not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit.This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.Lidocaine ingredientWe are dismissing the Lidocaine ingredient of the Lidocaine-Antacid-M-Dryl-Sucralfate Compound. The Part D Plan provided documentation that the request for coverage or payment for the Lidocaine ingredient of the Lidocaine-Antacid-M-Dryl-Sucralfate Compound was approved as requested. Since the Plan has agreed to provide coverage or payment, there is no need for a reconsideration review.Contact the Part D Plan to learn more about how and when coverage or payment will be provided for the Lidocaine ingredient of the Lidocaine-Antacid-M-Dryl-Sucralfate Compound.