Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Carvediol, part of a compound, Sorbitol 70% Solution, part of a compound and Sterile Water, part of a compound. The Plan did not grant this request. We received this case to conduct an independent review.   Carvediol, part of a compound:  We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Carvedilol 6.25 mg tablet as part of a compound. The drug is requested to treat hypertension status post failed kidney transplant in a child (date of birth - January 3, 2016), which is an off-label (non-FDA approved) use. 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 Carvediol, 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 for Carvediol, part of a compound.  Sorbitol 70% Solution, part of a compound:  Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Sorbitol 70% Solution, part of a compound. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Sorbitol 70% Solution, part of a compound.  Sterile Water, part of a compound:  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. Sterile Water, part of a compound is used as a dilutant in the reconstitution of the Carvediol compound. Sterile Water, part of a compound use in this instance is not therapeutic. Thus, Sterile Water, part of a compound does not meet the definition of a Part D drug. Therefore, the Plan is not required to cover Sterile Water, part of a 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.