Persius/hicric huggingface dataset:
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 cover Metformin ER. 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 Metformin ER Osmotic 1,000 mg 180/90. Metformin ER Osmotic 1,000 mg 180/90 is requested to treat diabetes. The prescriber was asked questions to clarify the diagnosis being treated and/or to provide documentation to support the noted diagnosis. The prescriber was also asked questions to address the Plan's coverage/exception criteria. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation to support an exception to the Plan's coverage criteria.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Metformin ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide additional reimbursement for Nystatin and Ketoconazole Cream  at the pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If you pay the full cost of a prescription drug out-of-pocket or if you find you have paid more than you expected to pay under the Plan's coverage rules, you can ask the Plan to pay you back. When submitting a request for reimbursement, the Plan requires that you submit your receipt documenting the payment you have made along with your reimbursement request. Pursuant to guidelines issued by the Centers for Medicare and Medicare Services (CMS), the Plan has enacted a policy in which an enrollee is responsible for the difference between the cash price paid and the Plan's contracted negotiated rate for a drug for any purchases made at an in-network pharmacy that are not submitted online electronically through the pharmacy.In this case, the Plan approved coverage for Nystatin Powder and Ketoconazole Cream. The Plan calculated reimbursement by using their contracted negotiated rate as the total cost for the drug and subtracting the required copayment amount due to the claim not being run electronically at the time of purchase. Thus, the Plan charged the enrollee the difference between the cash price paid and the Plan's contracted negotiated rate for this drug. The Plan is permitted to calculate reimbursement this way for in-network pharmacy purchases not run online electronically per Medicare rules.The case record indicates that the Plan provided coverage and calculated reimbursement in accordance with Medicare law and rules. Therefore, our decision is the Plan is not required to provide additional reimbursement for Nystatin  and Ketoconazole Cream at the pharmacy.Please note: whether the Plan should provide a one-time exception to their reimbursement rules given the circumstances of this case is a grievance. A grievance is any complaint or dispute, other than one that involves a coverage determination, expressing dissatisfaction with any aspect of the operations, activities, or behavior of a Part D plan. Grievance procedures are separate and distinct from appeal procedures.Each Part D Plan must provide meaningful procedures for timely hearing and resolving grievances between enrollees and the Part D Plan (or any other entity or individual through whom the Part D Plan provides covered benefits under any Part D Plan it offers). Since your complaint involves a grievance, the Part D Plan must review this part of your complaint under the Plan's grievance procedures. At this time, you should contact the Plan for information on how to proceed with having this part of your complaint reviewed under the Plan's grievance procedures.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testopel pellets. 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 Testopel pellets. Testopel pellets are requested to treat E29.1 Testicular hypofunction. 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. Therefore, the requested drug is being prescribed for a medically accepted indication.However, the prescriber has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Testopel pellets.
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 cover Omeprazole. The Plan did not grant this request. We received this case to conduct an independent review.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 needed additional information from the prescriber to determine whether you are using Omeprazole for an FDA-approved use, or a use listed in the Medicare-approved compendia. The requested information was not received. As a result, we could not confirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Omeprazole. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
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 cover Farxiga. 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 Farxiga 5 mg tablet. The drug is requested to treat type 2 diabetes mellitus. The prescriber has not indicated why all alternatives required by the Plan (including Jardiance and Invokana) would likely not be as effective for you as the requested drug; and/or would likely cause adverse reaction(s) or other harm to you. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Farxiga.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover and provide reimbursement for Fluzone Quad Vaccine received at the pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Fluzone Quad Vaccine:Medicare Part B pays for the influenza (flu) virus vaccine and its administration. This medication qualifies for coverage under Part B rather than Part D. As a result, Fluzone Quad Vaccine received at the pharmacy is not a Part D drug in this case. Therefore, our decision is the Part D Plan is not required to pay for Fluzone Quad Vaccine received at the pharmacy.You may wish to submit this request to the Medicare Part B carrier.Shingrix Vaccine:We are dismissing the request for reimbursement for Shingrix Vaccine. The Part D Plan provided documentation that the request for coverage or payment for Shingrix Vaccine received at the pharmacy was approved as requested. Since the Plan has agreed to provide coverage or payment, there is no need for a reconsideration review. Contact the Part D Plan to learn more about how and when coverage or payment will be provided for Shingrix Vaccine received at the pharmacy.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover and provide reimbursement for the Adacel Vaccine and its administration fee. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase.The case record indicates that the Plan did not provide coverage in accordance with the Part D Plan contract on the basis that the National Drug Code (NDC) number and prescriber's National Provided Identifier (NPI) number were not provided. The documentation received includes a valid and Part D eligible NDC (49281040020), NPI (1104242205) and proof of payment for the vaccine and administration fee. Additionally, the Plan's documentation indicates the vaccine was received at an in-network pharmacy and the Plan does not provide any indication that the claim paid at point of sale or has since been processed at the Plan level. Therefore, our decision is the Plan is required to provide coverage and reimbursement for the Adacel Vaccine and its administration fee.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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha Sureclick 140 mg/mL. 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 Repatha Sureclick 140 mg/mL.The drug is requested to treat hypercholesterolemia. The prescriber has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Repatha Sureclick 140 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclosporine Compound. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Cyclosporine Compound. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Cyclosporine Compound. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.Please note: since coverage cannot be approved the subsequent request for reimbursement cannot be considered.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Epclusa 400/100 mg tablet, 12 week treatment course. 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 Epclusa 400/100 mg tablet, 12 week treatment course. The drug is requested to treat chronic hepatitis C genotype 1a, treatment experienced, which is an off-label (non-FDA approved) use. The enrollee has received a prior 12 week course of Epclusa.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.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 no citations in the Medicare approved compendia that support the use of Epclusa 400/100 mg tablet, 12 week treatment course for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Epclusa 400/100 mg tablet, 12 week treatment course. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
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 the Shingrix vaccine. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. In this case, documentation in the record shows that the enrollee was in the deductible stage when the Shingrix vaccine was received. During the deductible stage, the Plan requires that the enrollee pay the full cost of Tier 3, Tier 4 and Tier 5 drugs purchased in 2020 before the Plan would pay a share of the cost. The Shingrix vaccine is on the Plan's 2020 formulary and classified as a Tier 3 drug. The Plan provided documentation showing that this claim was covered by the Plan at the time of purchase, and that the full cost of the purchase in dispute was applied to the required deductible amount. The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is not required to provide reimbursement for the Shingrix vaccine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Arikayce 590 mg/8.4 mL. 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 Arikayce 590 mg/8.4 ml inhalation suspension.The drug is requested to treat Mycobacterium abcessus cavitary pneumonia, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.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 no citations in the Medicare approved compendia that support the use of Arikayce 590 mg/8.4 mL for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Arikayce 590 mg/8.4 mL. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover the Magic Mouthwash (Antacid-Lidocaine-Diphenhydramine) Compound. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules require a Part D Plan to issue a coverage decision or a redetermination decision within the specified timeframes. If the Plan does not make a timely decision, this is considered a denial. In these circumstances, the Plan is required to forward the coverage request or the redetermination request to the Part D QIC. The case record indicates multiple requests were submitted to the Plan for the (Magic Mouthwash (Antacid-Lidocaine-Diphenhydramine) Compound. Maximus requested a case file for the Magic Mouthwash (Antacid-Lidocaine-Diphenhydramine) Compound. The Plan responded with a case file for a different drug. Multiple requests were made to the Plan to clarify if the Magic Mouthwash (Antacid-Lidocaine-Diphenhydramine) Compound was reviewed at the Plan level. The Plan did not respond in the timeframe required to make a decision. Based on the available documentation, it appears as though the Plan did not properly process these requests to move the case forward to the next appeal level. Therefore, the applicable time frames have been exceeded, and the Part D QIC has jurisdiction to process this case.Antacid and Diphenhydramine ingredientsMedicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drugs' classification or determined from other available resources that the drugs are non-prescription or OTC drugs. Therefore, the Antacid and Diphenhydramine ingredients of the Magic Mouthwash Compound are not eligible for Part D coverage, and the Plan is not required to cover them under the Part D benefit. 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.Lidocaine ingredientThe Part D Plan provided documentation that the request for coverage or payment for the Lidocaine ingredient of the Magic Mouthwash Compound was approved as requested. Since the Plan has agreed to provide coverage or payment, there is no need for a reconsideration review.Contact the Part D Plan to learn more about how and when coverage or payment will be provided for the Lidocaine ingredient of the Magic Mouthwash Compound.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Rexulti. 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 Rexulti. The drug is requested to treat bipolar disorder, current episode depressed, mild and bipolar II disorder. The enrollee does not satisfy the Plan's coverage criteria. A request for medical records was sent to you as there were multiple conflicting answers to prior authorization questions in the case file and appeal request with no supporting records. Despite the request, no supporting medical records were provided to clarify the prior authorization status. You have not sufficiently addressed the Plan's coverage criteria and/or have not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor 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 not met. Therefore, the Plan is not required to cover Rexulti.