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

You asked the Plan to cover Toprol XL. 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 Toprol XL 50 mg. The drug is requested to treat inappropriate sinus tachycardia. 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. The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Beta-blockers are effective treatment, alone or in combination with other antiarrhythmic agents, for a variety of ventricular and supraventricular arrhythmias including ventricular tachycardia, premature ventricular contractions (PVCs), ventricular fibrillation, sinus tachycardia, atrial fibrillation, atrial flutter, and atrial tachycardia. Therefore, the requested drug is being prescribed for a medically accepted indication. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the formulary alternatives. 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 metA 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 Toprol XL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Lokelma. 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 Lokelma 10 gram powder packet. The drug is requested to treat hyperkalemia. The drug is on tier three of the Plan's formulary. There are no available lower tier drugs on the Plan'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 the same type in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there 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 Lokelma.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xifaxan. 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 recurrent small intestinal bacterial overgrowth, 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 Xifaxan 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 Xifaxan. 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 Cayston 75 mg/mL. 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 Cayston 75 mg/mL inhalation powder for solution.The drug is requested to treat non-cystic fibrosis bronchiectasis, 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 Cayston 75 mg/mL 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 forCayston 75 mg/mL.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 Mycophenolate Mofetil, 500 mg tablet. 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 Mycophenolate Mofetil, 500 mg tablet.The drug is requested to treat lung transplant, 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. Therefore, the requested drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition 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 Mycophenolate Mofetil, 500 mg tablet 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 Mycophenolate Mofetil, 500 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 provide a tiering exception for Lantus Solostar. The Plan did not grant this request. We received 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 the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Lantus Solostar is a Tier 3 brand drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Lantus Solostar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover NP Thyroid. The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that NP Thyroid is not FDA approved for both safety and effectiveness by checking FDAsources. Therefore, the Plan is not required to cover NP Thyroid.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.We also received your letter asking for an appeal of the Plan's unfavorable determination for ArmourThyroid.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Acthar gel 400 units/5 mL vial. 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 Acthar gel 400 unist/5 mL vial.The drug is requested to treat membranous nephropathy, 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 Acthar gel 400 units/5 mL vial 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 Acthar gel 400 units/5 mL vial. 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 Chlorzoxazone-Diclofenac-Doxepin-Lidocaine compound cream. The Plan didnot grant this request. We received this case to conduct an independent review. You also requested weconsider coverage for Medrol.Medicare Part D does not cover drugs that are not FDA approved. We reached out to the prescribingphysician's office but were unable to obtain contact information for the compounding pharmacy within thetimeframe required for review of this case. There is insufficient evidence in the case record that bulkpowder was not used or would not be used when compounding the prescription for Chlorzoxazone-Diclofenac-Doxepin-Lidocaine. Bulk powders used in pharmacy compounding are not reviewed andapproved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Chlorzoxazone-Diclofenac-Doxepin-Lidocaine.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.We are dismissing the request for Medrol. We received your letter asking for an appeal of the Plan'sunfavorable determination for Medrol. Medicare rules do not allow us to review this request until you havecompleted the appeal process with the Plan. You may request a Reconsideration appeal with us after thePlan issues an unfavorable Redetermination for Medrol. You may wish to submit the request for Medrolto the Plan at this time.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Tivicay. The Plan did not grant this request. Wereceived this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in thespecialty tier are not eligible for a tiering exception. Tivicay is in the specialty tier. The record indicates thePlan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is notrequired to provide a tiering exception for Tivicay.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Butalbital APAP Caffeine. 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 Butalbital APAP Caffeine. The drug is requested to treat migraine, unspecified, intractable. Forcoverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. Our Physician Reviewer found that the Medicare-approved resources docontain 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 (includingDihydroergotamine Mesylate, Caffeine Ergotamine Tartrate, Aimovig, and Emgality) would likely not beas effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or otherharm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our PhysicianReviewer'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 Butalbital APAP Caffeine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lonsurf. 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 Lonsurf.Lonsurf is requested to treat an unclear or incomplete diagnosis. The prescriber was asked to clarify the enrollee's diagnosis. The prescriber was also asked to address medical necessity for the requested 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 medically accepted indication as defined by Medicare law. In addition, 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.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 the enrollee is using Lonsurf 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 Lonsurf. 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 Lorazepam, 0.5 mg tablet, 30 per 7 days. 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 Lorazepam, 0.5 mg tablet, 30 per 7 days.Lorazepam, 0.5 mg tablet, 30 per 7 days is requested to treat an unknown diagnosis. The prescriber wasasked to state the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosisin the case file. The prescriber was also asked to address medical necessity for the requested drug. Aresponse from the prescriber was not received. Therefore, based on the current record, there is insufficientdocumentation that the requested medication is being prescribed for a medically accepted indication asdefined by Medicare law. In addition, 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.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 Lorazepam, 0.5 mg tablet, 30 per 7 days for an FDA-approved use, or a use listed in theMedicare-approved compendia. The requested information was not received. As a result, we could notconfirm 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 medicalnecessity cannot be considered because it cannot be confirmed that the drug meets the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forLorazepam, 0.5 mg tablet, 30 per 7 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 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 vitiligo, which is an off-label (non-FDA approved) use. The Medicareapprovedcompendia do not contain any citations to support the use of the requested drug, as prescribed, fortreatment of the noted condition. 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. 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.