Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Mycophenolate Mofetil200 mg/ml suspension. The Plan did not grant this request. We received this case to conduct an independent review. Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant.The case record indicates that Mycophenolate Mofetil is needed for a kidney transplant. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant. However, review of Medicare records show that the enrollee's Part B coverage was terminated and the enrollee is no longer entitled to Medicare Part B. Since the enrollee is not entitled to Medicare Part B coverage, Mycophenolate Mofetil is not eligible for coverage under Part B. We therefore asked our Physician Reviewer to review coverage under Medicare Part D.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Mycophenolate Mofetil 200 mg/ml suspension. The drug is requested to treat renal transplant rejection prophylaxis. 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. Therefore, the requested drug is being prescribed for a medically accepted indication. Medicare covered the transplant however the enrollee is no longer entitled to Part B (lost End Stage Renal Disease entitlement) therefore this drug is eligible for coverage under Medicare Part D. 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 Mofetil for the diagnosed condition. As a result, Mycophenolate Mofetil 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 Mofetil.Please note that if the Part D Plan 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