Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Rivastigmine Patch. 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 Rivastigmine Patch.Rivastigmine Patch is requested for treatment of this 92 year old woman with mild cognitive impairment, 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. Of note, at the time of the initial request, you specifically indicated that the enrollee does not have Alzheimer's dementia; however on the request for reconsideration, you have added a note to the medical record as to why you feel the enrollee does indeed have Alzheimer's type of dementia. Records from a patient encounter the same date - February 17, 2020 - indicate the 92 year old enrollee still drives locally, has always been a good driver, she had a mini-mental state exam score of 23/30, but did remarkably well with many other tests, and you concluded the enrollee has mild cognitive impairment functioning at a high level. It is noted in the available medical records that the enrollee has had issues with anxiety, depression, and adjustment reactions, and that there has been no significant decline in the enrollee's condition over the last few years - mini mental status test was 24/30 in August 2019, which was noted not to be significantly different from October 2017. Based on the information provided, there is insufficient documentation that the requested drug is being prescribed for treatment of Alzheimer's dementia; therefore there is insufficient documentation that the requested drug is 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 based on the available documentation.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 Rivastigmine Patch 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 Rivastigmine Patch. 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.