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

You asked the Plan to cover Buprenorphine HCL 2 mg tablet sublingual, 120 per 30 days. The Plan did notgrant 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 requestfor Buprenorphine HCL 2 mg sublingual tablet.The drug is requested to treat pain related to thoracic radiculitis, which is an off-label (non-FDA approved)use. The Medicare-approved compendia do not contain any citations to support the use of the requesteddrug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions requestbased on medical necessity cannot be considered because the requested drug, as prescribed, does not meetthe definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare 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 Buprenorphine HCL 2 mg tablet sublingual, 120 per 30 daysfor the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indicationas defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for thiscondition. An exceptions request based on medical necessity cannot be considered because this drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Planis not required to provide coverage for Buprenorphine HCL 2 mg tablet sublingual, 120 per 30 days.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 Northera. 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 Northera. The drug is requested to treat postural tachycardia syndrome/neurogenic orthostatic hypotension (not related to primary autonomic failure - Parkinson's disease, multiple system atrophy or pure autonomic failure or dopamine betahydroxylase deficiency or non-diabetic neuropathy), which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 conditions.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 Northera 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, it cannot be covered under the Medicare Part D benefit for these conditions. 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 Northera. 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 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 30 mg.The drug is requested to treat dyshidrotic eczema, which is an off-label (non-FDA approved) use. TheMedicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. The initial request indicated a diagnosis of dyshidroticeczema. The prescribing physician subsequently submitted diagnoses of pustular palmar psoriasis andpsoriasis vulgaris; however, chart notes do not support the change in diagnosis. Therefore, the requesteddrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 Otezla for the diagnosed condition. As a result, the drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered 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 Otezla.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 Suboxone 8-2 mg Film. 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 Suboxone 8-2 mg Film.The drug is requested to treat opioid dependence and chronic pain syndrome. The prescriber changed thediagnosis to include opioid dependence on 6/24/2020. Medical records from date of service 6/16/2020 wereprovided which document that the prescriber amended the diagnosis on 6/24/2020 to include opioiddependence. For coverage under the prescription drug benefit, Medicare requires that the drug prescribedbe used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approvedresources 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.Suboxone 8-2 mg Film is not on the Plan's formulary. The prescriber has not indicated why all alternativesrequired by the Plan would likely not be as effective for the enrollee as the requested drug; and/or wouldlikely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan'scoverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria arenot metA 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 Suboxone 8-2 mg Film.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Humira. 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 Humira. The drug is requested to treat polymyalgia rheumatica, giant cell arteritis and persistentinflammatory arthritis, which is an off-label (non-FDA approved) use. Although you changed the diagnosisto rheumatoid arthritis on the request for reconsideration dated June 25, 2020, the medical records provideddo not substantiate the diagnosis of rheumatoid arthritis. Medical records from date of serviceJune 23, 2020 were provided which document that for the diagnosis of polymyalgia rheumatica, possiblegiant cell arteritis and persistent inflammatory arthritis, will add Humira. 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 Humira for the diagnosed condition. As a result, the drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered 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 Humira.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 provide a tiering exception for Tacrolimus. 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 Tacrolimus. The drug is requested to treat liver transplant. The drug is a genericdrug on Tier 4 of the Plan's formulary. There are no available lower tier drugs of the same type on thePlan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception.Our Physician Reviewer'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 Tacrolimus.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Mirena. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being coveredthrough a formulary exception. The documentation in the record shows that Mirena is currently beingcovered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not requiredto provide a tiering exception for Mirena.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine-Prilocaine 2.5-2.5% Cream. 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 Lidocaine-Prilocaine 2.5-2.5% Cream.The drug is requested to treat painful peripheral neuropathy, which is an off-label (non-FDA approved) use.The prescriber clarified the diagnosis in a letter dated 6/29/2020. The Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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 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-Prilocaine 2.5-2.5% Cream for the diagnosedcondition. As a result, the drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. Anexceptions request based on medical necessity cannot be considered because this drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required toprovide coverage for Lidocaine-Prilocaine 2.5-2.5% Cream.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

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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide a tiering exception for Ozempic. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Ozempic is a Tier 6 branddrug. Tiers 1 and 2 only contain generic drugs - therefore, a tiering exception to Tier 1 or 2 would not beallowed. Tiers 3 through 6 contain both brand and generic drugs. The higher the Tier placement, the higherthe copayment or coinsurance will be. Tier 3 drugs have a $42-$47 copayment for up to a 30 day supplyand $126-$141 copayment for up to a 90 day supply. Tier 4 drugs have a $95-$100 copayment for up to a30 day supply and $285-$300 payment for up to a 90 day supply. Tier 5 drugs have a 33% coinsuranceamount for up to a 30 day supply. A 90 day supply is not allowed for Tier 5 drugs. Tier 6 drugs have a $5copayment for up to a 30 day supply and a $10 copayment for up to a 90 day supply. A tiering exception,allowing coverage of Ozempic at the Tier 3, 4 or 5 copayment/coinsurance amount would result in anincrease in price. Therefore, our decision is the Plan is not required to provide a tiering exception forOzempic.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Calquence. 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 Calquence. The drug is requested to treat Mantle cell lymphoma, in a previously-untreated enrollee(first line therapy), which is an off-label (non-FDA approved) use. The Medicare-approved compendia donot contain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. There was no peer-reviewed, clinically relevant, medical literature from an approved journalsubmitted to support this appeal. Therefore, the requested drug is not being prescribed for a medicallyaccepted indication as defined by Medicare law. As such, an exceptions request based on medical necessitycannot be considered because the requested drug, as prescribed, does not meet the definition of a MedicarePart D drug. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically acceptedindication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals orpublications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia and there was no peer-reviewed literature from an approved journal submitted tosupport the use of Calquence for the diagnosed condition. As a result, the drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit for this condition. An exceptions request based on medical necessity cannot beconsidered 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 Calquence.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 Dronabinol. 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 Dronabinol. The drug is requested to treat nausea and vomiting associated with gastroparesis, which isan off-label (non-FDA approved) use. Medical records from date of service June 24, 2020 were providedwhich support these diagnosis. The Medicare-approved compendia do not contain any citations to supportthe use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requesteddrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 Dronabinol for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered 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 Dronabinol.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 Lidocaine-Prilocaine 2.5-2.5% Cream. 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 Lidocaine-Prilocaine 2.5-2.5% Cream. The drug is requested to treat severe knee pain, which is an offlabel(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to supportthe use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requesteddrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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-Prilocaine 2.5-2.5% Cream for the diagnosedcondition. As a result, the drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. Anexceptions request based on medical necessity cannot be considered because this drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required toprovide coverage for Lidocaine-Prilocaine 2.5-2.5% Cream.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.