Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nortriptyline. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Nortriptyline.Nortriptyline is requested for treatment of the enrollee's condition. The diagnosis being treated withNortriptyline has changed over the course of the request for coverage/appeal process. The initial diagnosiswas stated to be functional dyspepsia; you stated in the letter of appeal (redetermination) that the wrongdiagnosis was submitted initially, and the actual diagnosis is Barrett's esophagus. Upon denial of theappeal, you stated with the request for Reconsideration that the diagnoses submitted previously wereincorrect, and that the actual diagnosis is chronic depression. Additional information was requested fromyou to clarify which diagnosis is being treated with Nortriptyline and to send supportive medical records.Records of phone conversations, and internal conversations were submitted. There were no records frompatient encounters with you. It was cited that per an office visit note from the provider from October 9,2019 that the patient likely has functional dyspepsia with anxiety as a major contributor. It is specificallystated if the increase in Pantoprazole is not helpful, consider an additional pain modulating agent such asNortriptyline. It was noted on December 21, 2019 that gastrointestinal symptoms worsened; a subsequentnote a few minutes later specifically stated to start Nortriptyline for worsening symptomatology. There wasno mention of depression or anxiety at that time. Subsequent to the Plan's denial, there are notes fromphone calls with the enrollee, and internal notes entered by you that the condition being treated withNortriptyline is depression. There were no medical records sent from patient encounters.In summary, the limited records submitted do not support that Nortriptyline was prescribed for treatment ofdepression. The gastrointestinal diagnoses noted are not medically accepted indications for the use ofNortriptyline. Based on the available information, there is insufficient documentation that Nortriptyline isbeing prescribed for a medically accepted indication. As such, an exceptions request based on medicalnecessity cannot be considered because the requested drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part Dbased on the information submitted.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 Nortriptyline for the diagnosed condition. As a result, the drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannotbe covered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Nortriptyline.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.