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 Cyclobenzaprine. 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 Cyclobenzaprine 10mg tablet. The drug is requested to treat jaw pain, 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 Cyclobenzaprine 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 Cyclobenzaprine.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.You asked the Plan to cover Jardiance. The Plan did not grant this request. We received this case to conduct an independent review.In this case, the records show that when Jardiance was purchased on September 6, 2019, the claim straddled both the initial coverage stage and the coverage gap stage of the Part D benefit. An enrollee is responsible for the applicable copayment/coinsurance amount for each phase a claim straddles. Documentation provided by the Plan shows that the total cost for Jardiance was $1508.11. The initial coverage phase requires a $141 copayment for this drug and day supply purchased. The Plan documentation appears to show that there was $764.23 remaining in the initial coverage phase which is subtracted from the total cost of the drug. This left a remaining total drug cost owed of $743.88. This remaining balance was subject to the coverage gap copayment/coinsurance amount of 25%. 25% of the remaining balance is $185.97. The total of the two figures owed during each benefit phase (initial coverage stage and coverage gap stage) is $326.97. The record shows that the enrollee was charged an amount that is less than or equal to the required copayment for each phase the claim was processed in. The cost of Jardiance was applied to your yearly true out-of-pocket (TrOOP) costs.