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

You asked the Plan to cover Olopatadine. 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 Olopatadine. The drug is requested to treat allergic rhinitis. You have 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 Olopatadine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz XR, 11 mg tablet. 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 Xeljanz XR, 11 mg tablet.The drug is requested to treat rheumatoid arthritis. Xeljanz XR, 11 mg is not on the Plan's formulary. Theprescriber has not indicated why all alternatives required by the Plan would likely not be as effective for theenrollee 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 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 Xeljanz XR, 11 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Myrbetriq ER. 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 Myrbetriq ER. The drug is requested to treat N32.81 Overactive bladder. Medicalrecords from date of service May 26, 2020 were provided which support this diagnosis. Myrbetriq ER is abrand drug on Tier 2 of the Plan's formulary. There are no available lower tier brand drugs of the same typeon the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tieringexception. 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 Myrbetriq ER.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Auryxia, 210 mg tablet, 270 per 90 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 Auryxia, 210 mg, 90 per 30 days.The drug is requested to treat hyperphosphatemia related to end stage renal disease on dialysis. Theprescribing physician has submitted laboratory reports which support the presence of hyperphosphatemia.The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization criteria are met.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 citations in the Medicare approved compendia that support the use ofAuryxia, 210 mg tablet, 270 per 90 days for the diagnosed condition. As a result, Auryxia, 210 mg tablet, 270 per 90 days is being prescribed for a medically accepted indication as defined by Medicare law.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 are met. Therefore, our decision is the Plan is required to cover Auryxia, 210 mg tablet, 270 per 90 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Xtandi. 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. Xtandi 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 Xtandi.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Azopt. 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. Azopt is a Tier 3 brand drug.The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Planis not required to provide a tiering exception for Azopt.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Rayaldee. 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 Rayaldee. The drug is requested to treat secondary hyperparathyroidism with chronic kidney disease,Stage 3 and with serum total 25-hydroxyvitamin D level greater than 30 nanograms/mL, 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 Rayaldee 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 Rayaldee.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 Forteo . 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 Forteo. The drug is requested to treat osteopenia, 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 Forteo 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 Forteo. 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 Armodafinil. 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 Armodafinil 250 mg. The drug is requested to improve wakefulness in an enrollee with post -concussionsyndrome and traumatic brain injury, 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 Armodafinil 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 Armodafinil.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 due to anxiety and chronic pain, whichare off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations tosupport the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, therequested drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, an exceptions 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 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 Dronabinol for the diagnosed conditions. 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 these conditions. 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 Rituxan, 100 mg/10 mL. 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 Rituxan, 100 mg.The drug is requested to treat chronic inflammatory demyelinating polyneuritis, 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. 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 Rituxan, 100 mg/10 mL 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 Rituxan, 100 mg/10 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

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 on July 12, 2019 and October 12, 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 $30 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 July 12, 2019 and October 12, 2019 from the pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac 3% Gel. 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 Diclofenac 3% Gel.The drug is requested to treat knee pain, bursitis, diabetic neuropathy and tendonitis which are off-label(non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support theuse of the requested drug, as prescribed, for treatment of the noted conditions. A request for prescriberstatement was sent and returned indicating the noted diagnoses. 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 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 Diclofenac 3% Gel 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 forDiclofenac 3% Gel.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 Tegsedi 284 mg/1.5 ml. 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 Tegsedi 284 mg/1.5 mL. The drug is requested to treat polyneuropathy of ATTR amyloidosis. 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. The productlabel, available at drugs@fda, states that TEGSEDI is a transthyretin-directed antisense oligonucleotideindicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTR) inadult. Therefore, the requested drug is being prescribed for a medically accepted indication.Upon reconsideration, you have submitted an additional statement and chart notes indicating that theenrollee has a polyneuropathy disability score of I. Chart notes indicate that the enrollee has sensorydisturbances and preserved walking capacity. There are no formulary alternates available for the treatmentof the enrollee's condition. Therefore, an exception to the Plan's coverage criteria is medically necessary.Our Physician Reviewer's opinion is that formulary exception criteria are 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 met. Therefore,the Plan is required to cover Tegsedi 284 mg/1.5 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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Hydrocortisone Acetate Suppository. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare Part D does not cover LTE DESI drugs. Hydrocortisone Acetate Suppository is identified as anLTE DESI drug on the Centers for Medicare & Medicaid Services (CMS) website. Therefore, the Plan isnot required to cover Hydrocortisone Acetate Suppository.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.