Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Buprenorphine HCL 8 mg SL tablet. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Buprenorphine HCL 8 mg SL tablet. Buprenorphine HCL 8 mg SL tablet is requested for ongoingtreatment of the enrollee's condition. The diagnosis being treated was initially stated to be chronic pain,which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain anycitations to support the use of the requested drug, as prescribed, for treatment of the noted condition.On the request for reconsideration, the prescriber states that Buprenorphine HCL 8 mg SL is indeed beingprescribed for opioid dependence. The prescriber states that the enrollee has been treated by painmanagement since October 2016, and that symptoms of chronic pain had been tolerable on a combinationof long and short acting opioids. The prescriber states that Buprenorphine HCL was started in December2019 because the enrollee reported over taking his medications due to increased pain - Buprenorphine HCLwas prescribed to eliminate the risk of overtaking medications ever again. It is noted in the medical recordat the time of a patient encounter November 15, 2019 that the enrollee was seen for follow up - it was notedthat the enrollee had been hospitalized since his prior visit for a fall followed by rehabilitation for over amonth - it was noted that the enrollee maintained on Morphine extended release, MS Contin, and Norco -specific questions asked to assess opioid dependence were all negative at that time. It is stated in themedical record at the time of a patient encounter December 16, 2019, that the enrollee was overtakingmedications 2 weeks prior to the visit because of increased foot pain from a recent foot surgery. It wasnoted that the enrollee had no cravings and that he did not take medication for any purpose other than pain.The enrollee's treatment regimen was changed from a combination of extended release and immediaterelease opioids to Buprenorphine. The diagnosis of opioid dependence was not noted in the prescriber'sassessment, and the Plan did not include any counseling, etc for treatment of opioid dependence. Insummary, there is insufficient documentation that the requested drug is being used to treat opioiddependence. Therefore there is insufficient documentation that the requested drug is being used to treat amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare Part D based on the available documentation.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Buprenorphine HCL 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, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forBuprenorphine HCL.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.