Appeal type: Prescription Drug
Decision: Partially Favorable

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 Lidocaine-Diphenhydramine-Prednisolone-Antacid Compound purchased December 5, 2019. The Plan did not grant this request. We received this case to conduct an independent review.Lidocaine IngredientWe asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lidocaine Viscous HCl Mouth/Throat Solution 2 % as part of a compound. The drug is requested to treat K12.1, Other forms of stomatitis. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of this drug for this condition. The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Lidocaine 2% viscous solution is indicated for production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx [44] 44. Product Information: Xylocaine(R) Viscous topical solution, lidocaine HCl 2% topical solution. Fresenius Kabi USA, LLC (per FDA), Lake Zurich, IL, 2014. There are no applicable utilization management criteria identified for coverage of the requested drug. Our Physician Reviewer's opinion is that Medicare Part D criteria for coverage of the requested drug have been met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior authorization, step therapy or quantity limits. The Lidocaine ingredient is on the Plan's formulary and is not subject to any of these restrictions. Therefore, our decision is the Plan is required to cover and provide reimbursement for the Lidocaine ingredient of the provide reimbursement for the Lidocaine-Diphenhydramine-Prednisolone-Antacid Compound purchased December 5, 2019.Diphenhydramine and Antacid ingredientsMedicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drugs' classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, the Diphenhydramine and Antacid ingredients are not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for them 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.Prednisolone ingredientMedicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that the Prednisolone ingredient is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover or provide reimbursement for the Prednisolone ingredient.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.