Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to cover Lidocaine 5% Patch as prescribed. 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 Lidocaine 5% Patch.The drug is requested to treat pain due to bilateral hip osteoarthritis. The enrollee was scheduled to have a right hip replacement, however, was cancelled due to the Covid-19 pandemic. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. DrugDex cites the following medical reference in the Comparative Efficacy section of their Lidocaine monograph in the discussion of chronic back pain, and chronic osteoarthritis of the hip and knee, for multiple drugs: Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs non-opioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA 2018; 319(9):872-882.The study demonstrated that among patients with chronic back pain or hip or knee osteoarthritis pain, treatment with opioids compared with non-opioid medications did not result in significantly better pain-related function over 12 months, and that opioids caused significantly more medication-related adverse symptoms than non-opioid medications. The noted reference states that topical Lidocaine was included in the non-opioid prescribing strategy. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 citations in the Medicare approved compendia that support the use of Lidocaine 5% Patch as prescribed for the diagnosed condition. As a result, Lidocaine 5% Patch as prescribed is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Lidocaine 5% Patch as prescribed.We are dismissing the request for Olmesartan Medoxomil-HCTZ. You requested an appeal of the Plan's unfavorable determination for coverage of Olmesartan Medoxomil-HCTZ. 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 unfavorable Redetermination for Olmesartan Medoxomil-HCTZ.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.