Appeal type: Prescription Drug
Decision: Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Lidocaine 5% Patch, 30 per 30 days. 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% Patches.Lidocaine 5% Patch is requested to treat chronic low back pain/neuropathic pain in the lumbar region status post lumbar spine surgery. It is noted that the enrollee has tried several drugs including topical Celebrex, Tylenol, and Gabapentin; stated that enrollee cannot use NSAIDs (nonsteroidal anti-inflammatory drugs) due to GERD and because of a history of hypertension, can no longer use Cox-2 NSAID.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 nonopioid 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 nonopioid medications did not result in significantly better pain-related function over 12 months, and that opioids caused significantly more medication-related adverse symptoms than nonopioid medications. The noted reference states that topical Lidocaine was included in the nonopioid prescribing strategy. 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.