Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Temazepam, 15 mg capsule, 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 Temazepam, 15 mg.Temazepam, 15 mg is requested for treatment of primary insomnia in this enrollee with Parkinson's disease and major depression. The prescriber has indicated that the enrollee has tried and failed, and/or had adverse effects to one of the Plan's required non-HRM (high risk management) drugs, and that the benefits of therapy with the requested drug outweighs the potential risk of treatment in this elderly man. The Plan has indicated in the case file that they only cover Temazepam 15 mg for short term treatment of insomnia. 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 the following in section on insomnia in the FDA approved uses section for the requested drug: The American Academy of Sleep Medicine makes the following statements for the treatment of primary chronic insomnia in adults based on a systematic review and metaanalysis of 46 studies (3 randomized trials with Temazepam 15 mg): In a dosage of 15 mg, Temazepam is suggested for the treatment of sleep onset and sleep maintenance insomnia compared with no treatment in adults based on its efficacy and side effect profile. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria as stated in HPMS (Health Plan Management System - CMS's official database for Plan formularies). 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 Temazepam, 15 mg capsule, 30 per 30 days for the diagnosed condition. As a result, Temazepam, 15 mg capsule, 30 per 30 days 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 Temazepam, 15 mg capsule, 30 per 30 days.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.