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

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil 250 mg. Mycophenolate Mofetil 250 mg is requested for treatment of interstitial lung disease/pulmonary fibrosis associated with polymyositis with some features of Sjogren's, 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Ondansetron ODT. 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 Ondansetron ODT 8 mg. Ondansetron ODT 8 mg is requested to treat an unknown diagnosis. You wereasked to state the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosisin the case file. You were also asked to address medical necessity for the requested drug. A response fromyou was not received. Therefore, based on the current record, there is insufficient documentation that therequested medication is being prescribed for a medically accepted indication as defined by Medicare law.In addition, an exceptions request based on medical necessity cannot be considered because it cannot beconfirmed that the drug meets the definition of a Medicare Part D drug.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 Ondansetron ODT for the diagnosed condition. As a result, thedrug 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 forOndansetron ODT.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 Atrovent HFA. 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 requestfor a tiering exception for Atrovent HFA. The drug is requested to treat J44.9 Chronic obstructivepulmonary disease, unspecified. The prescriber sent a statement dated 6/12/2020 clarifying the medicalhistory. The prescriber states the enrollee has tried and failed Spiriva. Atrovent HFA is a brand drug onTier 4 of the Plan's formulary. The prescriber does not state why all available lower tier alternatives on thePlan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as therequested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to thesecriteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that thehigher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistentwith the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are notmet. Therefore, our decision is the Plan is not required to provide a tiering exception for Atrovent HFA.
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 a tiering exception for Nystatin-Triamcinolone cream. 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 a tiering exception for Nystatin/Triamcinolone cream. The drug is requested to treat the enrollee's condition. The drug is a GENERIC drug on Tier 4 of the Plan's formulary. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Nystatin-Triamcinolone cream.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycontin ER, 15 mg tablet, 60 per 30 days. The Plan did not grant thisrequest. 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 Oxycontin ER, 15 mg tablet.The drug is requested to treat chronic low back pain. 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 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 Oxycontin ER, 15 mg tablet, 60 per 30 days.
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 cover Acetylcysteine Bruistablet and Acetylcyst Apo purchased January 29, 2020and February 5, 2020. The Plan did not grant this request. We received this case to conduct an independentreview.Acetylcysteine Bruistablet and Acetylcyst Apo is not covered by Medicare because it was purchasedoutside the United States.Therefore, our decision is that the Part D Plan is not required to pay forAcetylcysteine Bruistablet and Acetylcyst Apo.This decision does not concern the medical appropriateness of the requested drug. It only establishes ifpayment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zolpidem Tartrate. 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 Zolpidem Tartrate 10 mg tab. Zolpidem Tartrate 10 mg tab is requested to treat an unknown diagnosis.The prescriber was asked to state the enrollee's diagnosis, because there was no prescriber statement of theenrollee's diagnosis in the case file. The prescriber was also asked to address medical necessity for therequested drug. A response from the prescriber was not received. Therefore, based on the current record,there is insufficient documentation that the requested medication is being prescribed for a medicallyaccepted indication as defined by Medicare law. In addition, an exceptions request based on medicalnecessity cannot be considered because it cannot be confirmed that the drug meets the definition of aMedicare Part D drug.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 Zolpidem Tartrate for the diagnosed condition. As a result, thedrug 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 forZolpidem Tartrate.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 Nurtec ODT. 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 Nurtec ODT. The drug is requested to treat migraines. Nurtec ODT is not on the Plan's formulary. Youhave 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.Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinionis 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 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 Nurtec ODT.
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 Shingrix Vaccine purchased October 8, 2019 from 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. In this case, documentation in the record shows that the enrollee was in the deductible stage when Shingrix Vaccine was purchased on October 8, 2019 from the pharmacy. 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 2019 before the Plan would pay a share of the cost. Shingrix Vaccine was on the Plan's 2019 formulary and was 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 Shingrix Vaccine purchased on October 8, 2019 from the pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover NitroMist. 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 NitroMist Aerosol 400mcg/spray. The drug is requested to treat angina. Additional medical informationwas requested by the Part D QIC. You were asked to address the formulary alternative genericNitroglycerin 0.4 mg/act spray. You have not indicated why this alternative required by the Plan wouldlikely not be as effective for the enrollee as the requested drug; and/or would likely cause adversereaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is notsupported. 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 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 NitroMist.Sincerely,
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Flector 1.3% patch. 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 Flector 1.3% patch.The drug is requested to treat acute strain of muscle, fascia and tendon of lower back. 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.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
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Pregabalin. 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 Pregabalin.Pregabalin is requested to treat idiopathic peripheral neuropathy. For coverage under the prescription drugbenefit, Medicare requires that the drug prescribed be used for a medically accepted indication. OurPhysician Reviewer found that the Medicare-approved resources do contain citations to support the use ofthe requested drug for treatment of the noted condition. DRUGDEX cites results from the followingreference in the FDA USE section Neuropathic pain - spinal cord injury: Finnerup NB, Attal N,Haroutounian S, et al: Pharmacotherapy for neuropathic pain in adults: a systematic review and metaanalysis.Lancet Neurol 2015; 14(2):162-173 which concluded that the requested drug is one of severaldrugs proposed as first line treatment of neuropathic pain in general. It is noted that your condition isincluded in the patient population of studies cited.. Therefore, the requested drug is being prescribed for amedically accepted indication. Additional medical information was requested by the Part D QIC. Theprescribing physician was asked to address the Plan's prior authorization criteria. A response from theprescribing physician was not received. You do not satisfy the Plan's coverage criteria. The prescriber hasnot sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives requiredby the Plan would likely not be as effective for you as the requested drug, and/or would likely causeadverse reaction(s) or other harm to you. Our Physician's opinion is that neither prior authorization norprior 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha Pushtronex 420 mg/3.5 mL. 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 Repatha Pushtronex.The drug is requested to treat hyperlipidemia in an enrollee with atherosclerotic cardiovascular disease. Theenrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan'scoverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be aseffective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harmto the enrollee. Our Physician's opinion is that neither prior authorization nor prior authorization exceptioncriteria 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 Repatha Pushtronex 420 mg/3.5 mL.
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 Shingrix Vaccine purchased October 15, 2019 and December 14, 2019 from 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 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 $37 for up to a 30 day supply of a Tier 3 drug purchased from a preferred retail in 2019. 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 Shingrix Vaccine was purchased for an amount that is less than or equal to the required copayment amount. 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 Shingrix Vaccine purchased on October 15, 2019 and December 14, 2019 from the pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Calcium Acetate. 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 for both safety and effectiveness. We determined that Calcium Acetate is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Calcium Acetate. 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.