Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac 1% Gel. 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% Gel. Diclofenac Sodium 1% Gel is requested for treatment of the enrollee's condition. The diagnosis initially submitted was low back pain associated with lumbar disc disease, which is an off-label (non-FDA approved) use. The records submitted at that time included a patient encounter; the history of present illness discusses the enrollee's worsening low back pain which was stated to be referred down both legs to the feet. Review of systems was only notable for back pain, the details of the physical exam were not documented. The records also discussed results of a prior left shoulder x-ray. The diagnoses documented on the noted patient encounter were left shoulder pain, lumbar DDD, Lumbar radiculopathy right sided, myofascial pain syndrome, and chronic pain syndrome, which are off-label uses for the requested drug. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 conditions. Of note, on the request for reconsideration, you state that the enrollee would benefit from the use of Diclofenac gel for a diagnosis of primary osteoarthritis of multiple joints including the left shoulder, foot, and knee. The same documentation from the patient encounter; was submitted. The additional diagnosis of primary osteoarthritis involving multiple joints was added to the end of the note; however the history of present illness and review of systems only discusses the enrollee's complaint of back pain as noted above. In summary, there is insufficient documentation that Diclofenac gel is being prescribed specifically for treatment osteoarthritis of the knee or foot; therefore there is insufficient documentation that Diclofenac gel is being prescribed for a medically accepted indication as defined by Medicare law.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 1% Gel 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 1% Gel. 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.