Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dextroamphetamine ER. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Dextroamphetamine ER. The drug is requested to treat idiopathic edema, which is an off-label (non-FDA approved) use.On 3/6/2020, the prescriber attested that the requested drug is being used to treat idiopathic edema. In the request for reconsideration dated 3/16/2020, the prescriber attested that the diagnosis was ADHD. Relevant medical records were requested but not provided with the request for reconsideration.Due to the discrepancy in the diagnoses, the prescriber was asked to clarify the diagnosis and to provide relevant medical records to support the diagnosis. In a statement dated 3/20/20, the prescriber states the enrollee has the following: P91.60 Hypoxic ischemic encephalopathy [HIE], unspecified F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type, and I36.1 Nonrheumatic tricuspid (valve) insufficiency. The prescriber states that the enrollee has Behcet's and hypoxic encephalopathy that at times prone to hyperactivity-significant decreased attention with deficits in concentration. The prescriber sent a letter which stated in regard to the idiopathic edema she should be able to respond to 10 mg extended release Dextroamphetamine 2 in the morning. I will attempt to get this for her and then her family doctor can continue to provide it.Relevant medical records were requested to support the diagnoses provided. Relevant medical records were not provided.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 Dextroamphetamine ER 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 Dextroamphetamine ER. 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.