Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lidocaine 5% patch, 30 per 30 days 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.Lidocaine 5% patch is requested for ongoing treatment of chronic diabetic neuropathy which is well documented in the medical records. The prescriber notes that the enrollee has been treated with Lidocaine patches since at least 2017 and has responded well. The patient is also being treated with Ibuprofen 200 mg, and Diclofenac sodium 1% gel. The prescriber has indicated that the enrollee is stable on the requested drug, and has a high risk of a significant adverse clinical outcome with medication change. Medical records indicate that the enrollee is a complex patient with multiple medical problems being treated with many medications.Coverage of Lidocaine patches was denied by the Plan because they determined that the diagnosis of diabetic neuropathy is not a medically accepted indication for the use of Lidocaine patches. 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 states in its off-label uses section in the discussion regarding the use of the requested drug for treatment of diabetic neuropathy, 5% Lidocaine patches were well tolerated and reduced pain in patients with diabetic neuropathy. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee does not satisfy the Plan's coverage criteria. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Plan is required to cover Lidocaine 5% patch, 30 per 30 days as prescribed.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.