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 and provide reimbursement for Tobramycin Ophthalmic Compound and Vancomycin HCL Ophthalmic Compound purchased August 11, 2020 from the pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.   Tobramycin and Vancomycin HCL, parts of a compound:  We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Tobramycin and Vancomycin HCL. Tobramycin and Vancomycin HCL are requested to treat an unknown diagnosis. The prescriber was asked to state your diagnosis because there was no prescriber statement of your diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, an exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.  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 Tobramycin and Vancomycin HCL, parts of a compound purchased August 11, 2020 from the pharmacy 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, it 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 or reimbursement for Tobramycin and Vancomycin HCL, parts of a compound purchased August 11, 2020 from the pharmacy.  Sodium Chloride and Sterile Water:  For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. If a drug is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. Sodium Chloride and Sterile Water, parts of compounds are used as a dilutant in the reconstitution of the Tobramycin and Vancomycin Ophthalmic Solutions. Sodium Chloride and Sterile Water, parts of compounds used in this instance are not therapeutic. Thus, Sodium Chloride and Sterile Water, parts of compounds do not meet the definition of a Part D drug. Therefore, the Plan is not required to cover or provide reimbursement for Sodium Chloride and Sterile Water, parts of compounds.  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.