Appeal type: Prescription Drug
Decision: Unfavorable

 You asked the Plan to cover Diclofenac Sodium. 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 Diclofenac Sodium 1.5% solution. The drug is requested to treat cervical pain due to spondylosis without myelopathy or radiculopathy, which is an off-label (non-FDA approved) use. 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 Diclofenac Sodium 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 Diclofenac Sodium.  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 are dismissing the request for Diclofenac 1%. You requested an appeal of the Plan's unfavorable determination for coverage of Diclofenac 1%. Medicare rules do not allow us to review this case until you have completed all levels of appeal with the Plan. Medicare rules set forth the steps you must take when appealing a Part D plan's denial of coverage. If you do not agree with a coverage decision from the Plan, you must request that the Plan review this decision, and the Plan must issue a Coverage Determination. If you do not agree with the Plan's Coverage Determination, the next step is for you to request a Redetermination appeal from the Plan. The request for a Redetermination asks the Plan to reconsider the initial Coverage Determination. Both levels of appeal with the Plan must be completed before you can appeal to us. You may request a Reconsideration appeal with us after the Plan issues an unfavorableRedetermination for Diclofenac 1%. 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.