Appeal type: Prescription Drug
Decision: Unfavorable

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 Bromsite Ophthalmic drops, Tamsulosin 0.4 mg, Clopidogrel 75 mg, Pantoprazole 40 mg, Amlodipine 5 mg, Atorvastatin 40 mg Eye Drops, EO Counter Cards, Refresh Optiv Drops, CVS 81 mg ORNG Tabs, Biotene Lozenges, Biotene Mister Spray, Aspirin 81 mg, Collagen Hydrolysate, Protein 40, Optivida Silver So gel, Activac Therapy System, LDR Bandage, Cardinal Health BFM 44RR, Nivolumab (Opdivo), office visit, laboratory and other provider copays, and several unknown items purchased in 2019. The Plan did not grant this request. We received this case to conduct an independent review.Bromsite Ophthalmic DropsYou submitted receipts for Bromsite Ophthalmic drops purchased March 8, 2019 and March 19, 2019. We contacted the pharmacy to determine if these prescriptions were covered by insurance at the time of purchase. The pharmacist verified that you chose to use chose to use the BromSite discount program instead of your Part D insurance when purchasing this drug. Patients that have prescription drug coverage under Medicare Part D may take advantage of this offer, provided that they acknowledge that by doing so they will not seek any prescription coverage or reimbursement from their insurer for the cost of BromSite?, or report any amounts paid for BromSite? as part of their true out of pocket expenses under Medicare Part D. When you use this card, you are certifying that you understand the program rules, regulations and terms and conditions, and that you have responded truthfully to questions when activating the card. When you decided to use this discount program you acknowledged and agreed that the Bromsite coupon would be treated as the primary payer with respect to medications that you have selected to purchase through the Bromisite discount program. Thus, Bromsite ophthalmic drops are not eligible for coverage or reimbursement by Part D. Therefore, it is our decision that the Plan is not required to cover or provide reimbursement for Bromsite ophthalmic drops purchased March 8, 2019 and March 19, 2019.Tamsulosin, Clopidogrel, Pantoprazole, Amlodipine and AtorvastatinYou asked the Plan to provide reimbursement for Tamsulosin 0.4 mg purchased November 14, 2019 and Clopidogrel 75 mg, Pantoprazole 40 mg, Amlodipine 5 mg and Atorvastatin 40 mg purchased March 12, 2019. Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. The Plan required a $15 copayment for up to a 30 day supply of a Tier 1 drug purchased in 2019 from a standard retail pharmacy. Clopidogrel 75 mg, Pantoprazole 40 mg, Amlodipine 5 mg and Atorvastatin 40 mg were on the Plan's 2019 formulary and were classified as a Tier 1 drugs. The Plan required a $30 copayment for up to a 90 day supply of a Tier 2 drug purchased in 2019 from a preferred retail pharmacy. Tamsulosin was on the Plan's 2019 formulary and classified as a Tier 2 drug. A request for reimbursement was submitted to the Plan. In this case, the Plan provided documentation showing that this claim was covered by the Plan at the time of purchase. The record shows that Tamsulosin 0.4 mg, Clopidogrel 75 mg, Pantoprazole 40 mg, Amlodipine 5 mg and Atorvastatin 40 mg were purchased for an amount that is less than or equal to the required copayment amounts.The case record indicates that the Plan provided coverage in accordance with the Part D contract. Therefore, our decision is the Plan is not required to provide reimbursement for Tamsulosin 0.4 mg purchased November 14, 2019 and Clopidogrel 75 mg, Pantoprazole 40 mg, Amlodipine 5 mg and Atorvastatin 40 mg purchased March 12, 2019.Over-the-Counter DrugsWe reviewed your request for coverage of Eye Drops, EO Counter Cards, Refresh Optiv Drops, CVS 81 mg ORNG Tabs, Biotene Lozenges, Biotene Mister Spray, Aspirin 81 mg, Collagen Hydrolysate, Protein 40 and Optivida Silver So gel. Medicare 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 these drugs are non-prescription or OTC drugs. Therefore, Eye Drops, EO Counter Cards, Refresh Optiv Drops, CVS 81 mg ORNG Tabs, Biotene Lozenges, Biotene Mister Spray, Aspirin 81 mg, Collagen Hydrolysate, Protein 40 and Optivida Silver So gel are not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for them under the Part D benefit. Activac Therapy SystemMedicare Part D does not cover devices. Activac Therapy System has been classified by the FDA as a device, not as a drug. Therefore, our decision is the Part D Plan is not required to cover Activac Therapy System.Non-DrugsMedicare Part D only covers items that meet the definition of a Part D drug. LDR Bandage and Cardinal Health BFM 44RR do not meet the definition of a Part D drug because it either does not require a prescription, it is not approved by the FDA for safety and effectiveness, or it is otherwise excluded. LDR Bandage and Cardinal Health BFM 44RR are medical supplies, not drugs. Therefore, our decision is the Plan is not required to cover LDR Bandage and Cardinal Health BFM 44RR.Paid under Part BYou included receipts for payments made to your provider on April 12, 2019, July 1, 2019, July 15, 2019, July 29, 2019 and August 21, 2019. The Part D Plan contacted the provider on February 5, 2020. The provider stated that these payments were for Nivolumab (Opdivo) and that this drug has already been covered under your Medicare Part B benefits. Drugs which are covered under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Nivolumab (Opdivo) purchased April 12, 2019, July 1, 2019, July 15, 2019, July 29, 2019 and August 21, 2019 from your provider.Office CopaysYour request for reimbursement you included several receipts with office visit, laboratory or other provider copays. These medical services are not covered under Medicare Part D and therefore have not been reviewed for reimbursement.Unknown PaymentsFinally, the receipts submitted also included statements showing payments for unknown items or items denoted as Other. The Part D Plan reached out to the provider on February 5, 2020 and was unable to determine what these payments were for. There is insufficient information to review these payments to determine if any reimbursement is due under Medicare Part D.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.