Appeal type: Prescription Drug
Decision: Partially Favorable

We previously issued a partially favorable reconsideration decision, finding that the Plan was required to provide coverage of Lidocaine 5% Patch and was not required to provide a tiering exception for Lidocaine 5% Patch. Our Physician Reviewer determined that prior authorization criteria were met. After we issued our decision, we received new information from the prescriber and the Plan requested a reopening on the basis that there was an error in our first review. Specially, the Plan stated that Lidocaine 5% Patch was not prescribed for a medically accepted indication. We reopened this appeal to conduct a second 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 to treat osteoarthritis of knee and low back pain. 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.The following citation in the comparative section of DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Opioids did not significantly improve pain-related function compared with nonopioids (3.4 vs 3.3 points on the 11-point Brief Pain Inventory (BPI) interference scale), nonopioids significantly improved pain intensity (mean BPI, 4 vs 3.5), and opioids were associated with significantly more adverse effects (mean symptoms, 1.8 vs 0.9) over 12 months in a randomized trial in patients with either chronic back (65%) or hip or knee osteoarthritis (35%) pain despite analgesic use (N=240). In addition, the reference cited in DrugDex states: 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. Nonopioid treatment was associated with significantly better pain intensity. Therefore, the requested drug is being prescribed for a medically accepted indication. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan's prior authorization criteria. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.The drug is a generic drug on tier 4 of the Plan's formulary. There are no available lower tier transdermal drugs/patches on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.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.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Lidocaine 5% Patch.This decision affirms our previous partially favorable decision.