Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tacrolimus 0.1% Ointment. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Tacrolimus 0.1% Ointment.Tacrolimus 0.1% Ointment is requested for treatment of the enrollee's condition. There has been discrepantinformation provided by the prescriber with regards to the diagnosis being treated with the requested drug,and area of involvement. The prescriber indicated on February 4, 2020 that the condition(s) being treatedwith the requested drug are diagnoses other than atopic dermatitis - the prescriber specifically indicated thatthe diagnoses being treated with Tacrolimus ointment are Grover's disease, and contact allergic dermatitis.The Plan denied coverage of the requested drug because they concluded that the submitted diagnoses arenot medically accepted indications for the requested drug.On the request for reconsideration dated February 24, 2020, the prescriber states that the enrollee uses themedication on the genital area. Medical records submitted include a progress note from a single visit onFebruary 12, 2020 which was amended on February 21, 2020. It was noted that the enrollee was seen onthe noted date for follow up of dermatitis, and that the enrollee complained of itching on the upper body. Itwas stated that the enrollee had seen multiple dermatologists, and ultimately went to WVU. It was notedthat he was started on tacrolimus topical which was helpful. Physical exam was notable for scatteredpustules on the chest and abdomen. Diagnoses noted for the noted visit date included: follicular disorder,unspecified which was treated with Doxycycline. Although the diagnosis of atopic dermatitis was listed, itwas not stated that Protopic/Tacrolimus was being prescribed for treatment of atopic dermatitis, nor wasthere evidence of atopic dermatitis based on the physical exam in the medical records providedIn summary, discrepant information has been provided regarding the diagnosis being treated with therequested drug; there is insufficient documentation that Tacrolimus ointment is being prescribed fortreatment of a medically accepted indication. As such, an exceptions request based on medical necessitycannot be considered because the requested drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Tacrolimus 0.1% Ointment for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Tacrolimus 0.1% Ointment.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.