Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Magic Mouthwash Compound (Carafate Liquid, Nystatin Suspension, Guaifensen Liquid, Allergy Relief (Ciphenydramine), SM Antacid (Maalox Suspension). The Plan did not grant this request. We received this case to conduct an independent review.   Carafate Liquid and Nystatin Suspension, parts of Magic Mouthwash Compound:  We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Carafate Liquid and Nystatin Suspension, as parts of a mouthwash compound. The drugs are requested to treat mucositis in an enrollee with chronic xerostomia and sicca syndrome associated with Sjogren's Disease, which is an off-label (non-FDA approved) use. You clarified the diagnosis and medical history in a letter dated September 8, 2020. 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 Carafate Liquid and Nystatin Suspension, parts of Magic Mouthwash 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 Carafate Liquid and Nystatin Suspension, parts of Magic Mouthwash 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.  Guaifensen Liquid, Allergy Relief (Ciphenydramine) and SM Antacid (Maalox Suspension), parts of Magic Mouthwash 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 drugs are non-prescription or OTC drugs. Therefore, Guaifensen Liquid, Allergy Relief (Ciphenydramine) and SM Antacid (Maalox Suspension), parts of Magic Mouthwash Compound are not eligible for Part D coverage, and the Plan is not required to cover 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.