Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil. The drug is requested to treat the enrollee's condition which is an off-label (non-FDA approved) use.The enrollee is a 67 year old man with retroperitoneal fibrosis. He presented with right lower quadrant abdominal pain and was found to have right hydronephroureter with amorphous stranding extending around the right common artery. He was seen by an oncologist to rule out lymphoma or other possible neoplastic process. Diagnoses listed in the March 18, 2020 office note include follicular lymphoma grade 1 unspecified type and retroperitoneal tuberculosis. Exam did not reveal hepatosplenomegaly or enlarged lymph nodes. Additional CT scanning was ordered. You stated lymphoma is less likely and agree that retroperitoneal fibrosis and/or sclerosing mesenteritis are likely possibilities as are other autoimmune diseases and vasculitis. On the appeal dated April 30, 2020 the diagnosis is stated to be retroperitoneal fibrosis. You request the drug to be given with Prednisone to treat him.A journal article regarding retroperitoneal fibrosis treatment was submitted and reviewed. Journal articles cannot be used to determine medically accepted use for non-cancer treatments. The documentation indicates the diagnosis is retroperitoneal fibrosis, not lymphoma. Our reviewer completed this review as a non-cancer related treatment review. However, our reviewer did search each of the CMS approved compendia including the cancer related compendia. None of the compendia include support for use in either retroperitoneal fibrosis or for lymphoma.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 Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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.We also received your letter asking for an appeal of the Plan's unfavorable determination for Prednisone. We are dismissing this case. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination. You may wish to submit this request to the Plan at this time.