Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to Plan to provide coverage of Lidocaine HCL 2% Viscous Solution, part of a compound, Almacone, part of a compound and Phenohytro Elixir, part of a compound (GI Cocktail). We denied coverage of GI Cocktail on the basis that we needed additional information, including all ingredients and the National Drug Code (NDC) for each ingredient. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.Lidocaine HCL 2% Viscous Solution, part of a compound:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lidocaine HCL 2% Viscous Solution (ingredient in a GI cocktail/compounded drug). Lidocaine HCL 2% Viscous Solution (ingredient in a GI cocktail/compounded drug) is requested to treat your condition, which is an off-label (non-FDA approved) use. A reopening has been requested. 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. According to DrugDex, a Medicare-approved compendium, Lidocaine 2% viscous solution is indicated for production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. 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, Lidocaine HCL 2% Viscous Solution, part of a compound 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 Lidocaine HCL 2% Viscous Solution, part of a 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 Lidocaine HCL 2% Viscous Solution, part of a compound.Almacone, part 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, Almacone, part of a compound is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit.Phenohytro Elixir, part of a compound:Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Phenohytro Elixir, part of a compound is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Phenohytro Elixir, part of a compound.We, therefore, have decided that Lidocaine HCL 2% Viscous Solution, part of a compound, Almacone, part of a compound and Phenohytro Elixir, part of a compound (GI Cocktail) are not covered under Medicare Part D rules. Therefore, the Plan does not have to provide coverage or provide reimbursement for Lidocaine HCL 2% Viscous Solution, part of a compound, Almacone, part of a compound and Phenolytro Elixir, part of a compound (GI Cocktail).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.This decision affirms our previous unfavorable decision.