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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide reimbursement for Phytonadione 5 mg purchased April 6, 2020 andDesmopressin 0.2 mg purchased May 7, 2020. The Plan did not grant this request. We received this case toconduct an independent review.PhytonadioneWe asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Phytonadione 5 mg.Phytonadione 5 mg is requested to treat an unknown diagnosis. The prescriber was asked to state theenrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file.The prescriber was also asked to address medical necessity for the requested drug. A response from theprescriber was not received. Therefore, based on the current record, there is insufficient documentation thatthe requested medication is being prescribed for a medically accepted indication as defined by Medicarelaw. In addition, an exceptions request based on medical necessity cannot be considered because it cannotbe 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer needed additional information from the prescriber to determine whether theenrollee is using Phytonadione 5 mg for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot beconsidered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.Therefore, our decision is that the Plan is not required to provide coverage or reimbursement for forPhytonadione 5 mg purchased April 6, 2020.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.DesmopressinMedicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrolleepays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof ofpayment to ask the Plan to pay its share of the cost. The Plan required a $47 copayment amount for up to a30 day supply of a Tier 3 drug purchased in 2020 from an in-network retail pharmacy. Desmopressin 0.2mg was on the Plan's 2020 formulary and was classified as a Tier 3 drug. A request for reimbursement wassubmitted to the Plan. In this case, the Plan provided documentation showing that this claim was coveredby the Plan at the time of purchase. The record shows that Desmopressin 0.2 mg purchased May 7, 2020was purchased for an amount that is less than or equal to the required copayment amount.The case record indicates that the Plan provided coverage in accordance with the Part D contract.Therefore, our decision is the Plan is not required to provide reimbursement for Desmopressin 0.2 mgpurchased May 7, 2020.