Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Sensipar 60 mg as prescribed. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Medicare records document that Sensipar is being prescribed to an enrollee who is not on dialysis. Thus, in this case the requested drug is not eligible for coverage under the Part B ESRD payment bundle. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met.Our Physician Reviewer thoroughly reviewed the case record to determine whether the Part D Plan was correct in denying the request for Sensipar 60 mg.The drug is requested to treat secondary hyperparathyroidism of renal origin after transplant, with hypercalcemia, not on dialysis. Upon reconsideration, the prescribing physician has submitted additional documentation and laboratory reports, and has clarified the enrollee's diagnosis as noted.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 DrugDex, a Medicare-approved compendium, supports the use of the requested drug for the enrollee's condition:Cinacalcet treatment significantly decreased the mean corrected total serum calcium to less than 10.2 mg/dL in 78.9% of patients compared with 3.5% with placebo in a 26-week, randomized study of renal transplant recipients with hypercalcemia and persistent hyperparathyroidism.Therefore, the requested drug is being prescribed for a medically accepted indication. 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 Sensipar for the diagnosed condition. As a result, Sensipar 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 Sensipar.Please note that if the 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.