Appeal type: Prescription Drug
Decision: Partially 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 provide reimbursement for Aspirin, Sertraline, Zolpidem, Oxybutynin ER 5 mg, Metoprolol Succinate 50 mg, Humalog 100 unit/mL, Tamsulosin 0.4 mg, Losartan Potassium 50 mg, and Atorvastatin 20 mg. The Plan did not grant this request. We received this case to conduct an independent review.Favorable DecisionThe Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you received several self-administered drugs for an emergency or urgent care situation. You requested reimbursement from the Part D Plan. Proof of payment for the self-administered drug portion of the bill has been established. The Plan did not process the request. The record shows Oxybutynin ER 5 mg, Metoprolol Succinate 50 mg, Humalog 100 unit/mL, Tamsulosin 0.4 mg, Losartan Potassium 50 mg, and Atorvastatin 20 mg. Oxybutynin ER 5 mg, Metoprolol Succinate 50 mg, Humalog 100 unit/mL, Tamsulosin 0.4 mg, Losartan Potassium 50 mg, and Atorvastatin 20 mg received are Part D eligible drugs. Of note, Oxybutynin ER and Tamsulosin were provided from re-packaged products. It is reasonable that a hospital would provide self-administered drugs that have been discontinued and/or repackaged. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for Oxybutynin ER 5 mg, Metoprolol Succinate 50 mg, Humalog 100 unit/mL, Tamsulosin 0.4 mg, Losartan Potassium 50 mg, and Atorvastatin 20 mg.Unfavorable DecisionMedicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Aspirin received while at the hospital is not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for it under the Part D benefit.Additionally, Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. The record also shows you were administered Sertraline (National Drug Code (NDC) 68084018201) and Zolpidem (NDC 68084020001). The NDC for Sertraline has a market end date of January 31, 2019 and the NDC Zolpidem has a market end date of December 31, 2018. Because these two drugs were administered after the market end dates, they are considered not FDA approved for both safety and effectiveness at the time of administration. Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Therefore, the Plan is not required to cover or provide reimbursement for Sertraline and Zolpidem received while at the hospital.This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.