Appeal type: Prescription Drug
Decision: Favorable

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 Mycophenolate. 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. The drug is requested to treat systemic sclerosis-related interstitial lung disease. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. The following citation in AHFS-DI, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Mycophenolate mofetil and mycophenolate sodium have been used in the management of systemic sclerosis (often called scleroderma). Systemic sclerosis is a rare and heterogeneous autoimmune connective tissue disease and fibrosing disorder; the disease most commonly affects women and often develops during middle age. Ref Systemic sclerosis is characterized by immune dysregulation, microvascular disease, and excess collagen deposition. The disease can impair organ function, reduce physical function, decrease quality of life, and result in premature mortality. Although sclerosis of the skin (i.e., fibrosis and thickening) is a hallmark of the diffuse cutaneous form of the disease and skin involvement is usually extensive, progressive, and debilitating, cardiopulmonary involvement, particularly interstitial lung disease (ILD) and pulmonary arterial hypertension (PAH), accounts for most of the increased mortality in patients with this condition. Therefore, the requested drug is being prescribed for a medically accepted indication. The requested drug is subject to B versus D prior authorization criteria. The requested drug is not eligible for coverage under Part B rules. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 citations in the Medicare approved compendia that support the use of Mycophenolate for the diagnosed condition. As a result, Mycophenolate is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Mycophenolate.Please note that if CareMore Health Plan of Arizona does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.