Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Clobetasol Shampoo, Tacrolimus Ointment and provide a tiering exception for Combigan. The Plan did not grant this request. We received this case to conduct an independent review.Clobetasol Propionate Shampoo:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Clobetasol Propionate Shampoo 0.05%. Clobetasol Propionate Shampoo 0.05% is requested to treat an unknown diagnosis. The prescriber was asked to state your diagnosis, because there was no prescriber statement of your diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, an exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.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.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Clobetasol Shampoo.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.Tacrolimus Ointment:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Tacrolimus 0.1% ointment. Tacrolimus 0.1% ointment is requested to treat an unknown diagnosis. The prescriber was asked to state your diagnosis, because there was no prescriber statement of your diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, an exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Tacrolimus 0.1% Ointment.Combigan:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Combigan 0.2/0.5%. The drug is requested to treat your condition. The drug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs of the same type on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Combigan.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Clobetasol Shampoo.