Persius/hicric huggingface dataset:
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Clonazepam. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Clonazepam. The drug is requested to treat a neurodegenerative condition, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use ofthe requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. A request for medical records was sent to the prescriberas the diagnoses of panic disorder and dystonia were added at the reconsideration level with no supportingrecords. Despite the request no records were provided to support the diagnoses of panic disorder anddystonia. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Clonazepam for the diagnosed condition. As a result, the drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannotbe covered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Clonazepam.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hydrocortisone Acetate. The Plan did not grant this request. We received thiscase to conduct an independent review.Medicare Part D does not cover LTE DESI drugs. Hydrocortisone Acetate is identified as an LTE DESIdrug on the Centers for Medicare & Medicaid Services (CMS) website. Therefore, the Plan is not requiredto cover Hydrocortisone Acetate.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xifaxan, 550 mg tablet. 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 Xifaxan, 550 mg tablet.The drug is requested to treat hepatic encephalopathy, prophylaxis. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or 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. 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 Xifaxan, 550 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xifaxan, 550 mg tablet. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Xifaxan, 550 mg.Xifaxan, 550 mg is requested for use in this enrollee with primary sclerosing cholangitis who has hadrecent jaundice, pruritius and fever, which is an off-label (non-FDA approved) use. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Xifaxan, 550 mg tablet for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Xifaxan, 550 mg tablet.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolic Acid. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Mycophenolic Acid 360 mg tablet.The drug is requested to treat interstitial lung disease and autoimmune hepatitis, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use ofthe requested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare Part D for the noted conditions.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Mycophenolic Acid for the diagnosed conditions. As a result,the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for these conditions. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forMycophenolic Acid.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Budesonide for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide is administered through a nebulizer in the home for a diagnosis of J45.909 Unspecified asthma, uncomplicated. There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage 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 Budesonide. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Desvenlafaxine Succinate ER. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Desvenlafaxine Succinate ER. The drug is requested to treat schizoaffective disorder, which is an offlabel(non-FDA approved) use. This is the diagnosis supported by the provided medical records datedJune 23, 2020. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Desvenlafaxine Succinate ER for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Desvenlafaxine Succinate ER.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Alprazolam 1 mg. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Alprazolam 1 mg.Alprazolam 1 mg is requested for treatment of anxiety in this enrollee with the following additionaldiagnoses: panic attacks, grief reaction, and right breast cancer. You state that the enrollee has recentstressors including recent loss of her husband, recent diagnosis of breast cancer, and need for chemotherapyin the near future. You further state that the use of Xanax is warranted, appropriate, and medicallynecessary at this time for this enrollee. The enrollee satisfies the Plan's coverage criteria. Our PhysicianReviewer's opinion is that prior authorization criteria are 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 aremet. Therefore, our decision is the Plan is required to cover Alprazolam 1 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Bystolic . The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor a tiering exception for Bystolic. The drug is requested to treat hypertension. The drug is on Tier 3 of thePlan's formulary. There are no available (branded, equivalent) lower tier drugs on the Plan's formulary totreat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our PhysicianReviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere 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 Bystolic.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Jatenzo. The Plan did not grant this request. We received this case to conduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the Medicare Coverage Gap discount agreement. Jatenzo is a brand name drug, and its manufacturer is not on this list. Therefore, the Part D Plan is not required to cover Jatenzo.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Aimovig 70 mg/mL autoinjector. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Aimovig 70 mg/mL.The drug is requested to treat migraine. The enrollee does not satisfy the Plan's coverage criteria (nodesignation from the prescriber as to the number of migraines experienced per month or that the enrolleehas tried and failed at least two standard prophylactic pharmacologic therapies). The prescriber has notsufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required bythe Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely causeadverse reaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorizationnor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Aimovig 70 mg/mL autoinjector.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Omega-3-Acid Ethyl Esters. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Omega-3-Acid Ethyl Esters. The drug is requested to treat hypertriglyceridemia. The enrollee does notsatisfy the Plan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria and/orhave not indicated why all alternatives required by the Plan would likely not be as effective for the enrolleeas the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. OurPhysician'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. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Omega-3-Acid Ethyl Esters.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Memantine HCL ER. The Plan did not grant this request. We received thiscase to conduct an independent review.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer needed additional information from the prescriber to determine whether theenrollee is using Memantine HCL ER for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot beconsidered 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 Memantine HCL ER.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otezla. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Otezla. The drug is requested to treat psoriasis. You have not indicated why all alternatives required bythe Plan (including Humira and Enbrel) would likely not be as effective for the enrollee as the requesteddrug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exceptionto the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formularyexception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Otezla.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 5% Patch. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Lidocaine 5% Patch.The drug is requested to treat compression fractures of L1, L3, L4 lumbar vertebrae, which is an off-label(non-FDA approved) use. The prescriber clarified the diagnosis in the request for reconsideration dated7/6/2020. Relevant medical records were not provided. The Medicare-approved compendia do not containany 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 byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Lidocaine 5% Patch 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, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forLidocaine 5% Patch.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Pregabalin, 50 mg capsule. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Pregabalin, 50 mg capsule.The drug is requested to treat probable small fiber polyneuropathy. The enrollee does not satisfy the Plan'scoverage criteria (the drug is not being used for partial onset seizures, fibromyalgia, neuropathic painassociated with spinal cord injury, postherpetic neuralgia, neuropathic pain associated with diabeticperipheral neuropathy, cancer-related neuropathic pain or cancer treatment related neuropathic pain). Theprescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why allalternatives 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 thatneither 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. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Pregabalin, 50 mg capsule.