Persius/hicric huggingface dataset:
Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to cover Mycophenolate Sodium DR and Prednisone. The Plan did not grant this request. We received this case to conduct an independent review.The case record indicates that Mycophenolate Sodium DR is needed for a kidney transplant performed September 6, 2019. In this case, we sent a request for additional information to the Part D Plan. We requested the evidence that the Plan used to determine that Medicare paid for the transplant performed September 6, 2019. The Plan responded to our request, however the Plan failed to provide claims data that supports that Medicare paid for the transplant in question. Based on the available information we cannot verify that coverage would be available for the requested drug under Medicare Part B. Therefore we asked our Physician Reviewer to determine if other Medicare Part D coverage criteria are met.Mycophenolate Sodium DR:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Mycophenolate Sodium DR 360 mg. The drug is requested to treat rejection prophylaxis in a kidney transplant recipient. The enrollee has indicated that the transplant claim was paid by commercial insurance and the Plan has not provided evidence to the contrary. Therefore, the requested drug is eligible for Part D coverage. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Mycophenolate Sodium DR.Prednisone:We are dismissing the request for Prednisone. We received your letter asking for an appeal of the Plan's unfavorable determination for Prednisone. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination. You may wish to submit this request to the Plan at this time.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Trulicity. 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. Trulicity is a Tier 3 brand biologic. 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 Trulicity.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Jardiance. 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 Jardiance. The drug is requested to treat the enrollee's condition. The drug is abrand drug on tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan'sformulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. OurPhysician 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 in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharingtiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are notmet because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee'scondition. Therefore, our decision is the Plan is not required to provide a tiering exception for Jardiance.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Levalbuterol HCL. The Plan did not grant this request. We received this caseto conduct an independent review.We sent the case file to a Physician Reviewer. We asked this doctor to determine whether the Plan wascorrect in denying the request for Levalbuterol HCL.Our Physician Reviewer noted that Levalbuterol HCL was requested for an enrollee with a diagnosis ofICD-10-CM Diagnosis Code J44.1 - Chronic obstructive pulmonary disease with (acute) exacerbation(COPD). We asked our Physician Reviewer to determine whether the Part D Plan was correct in denyingthe request for Levalbuterol HCL 0.31 mg/3 mL nebulizer solution. The drug is requested to treat chronicobstructive pulmonary disease - J44.1. Based on the information provided, the drug would be eligible forcoverage under Part B for the enrollee's condition. Our Physician Reviewer's opinion is that the requesteddrug is not eligible for Part D coverage in this case.Medicare law specifically excludes coverage for any drug for which payment would be available under PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Levalbuterol HCL for the management of obstructive pulmonary disease.In this case, the record shows that Levalbuterol HCL is administered through a nebulizer in the home for adiagnosis of ICD-10-CM Diagnosis Code J44.1 - Chronic obstructive pulmonary disease with (acute)exacerbation (COPD). There is no indication that it is not administered through a small volume nebulizer. Itappears that this medication is eligible for coverage under Part B rather than Part D. Drugs which areeligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is ourdecision that the Part D Plan is not required to cover Levalbuterol HCL.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

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 Pyridostigmine Bromine. 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 Pyridostigmine Bromine 60mg tablet. The drug is requested to treat other idiopathic peripheralautonomic neuropathy, which is an off-label (non-FDA approved) use. The Medicare-approved compendiado not contain any citations to support the use of the requested drug, as prescribed, for treatment of thenoted condition. Therefore, the requested drug is not being prescribed for a medically accepted indicationas defined by Medicare law. As such, an exceptions request based on medical necessity cannot beconsidered 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 Pyridostigmine Bromine 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 Pyridostigmine Bromine.This decision does not concern the medical necessity
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Vyvanse 10 mg. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Vyvanse 10 mg. Vyvanse is requested for treatment of attention deficit disorder. The Plan has indicatedin its Redetermination Notice of Denial that Amphetamine-Dextroamphetamine ER, DextroamphetamineCR, Metadate ER, and Methylphenidate ER are on their formulary. The prescriber has indicated thatVyvanse is safer for this enrollee because of her history of substance abuse which is documented in themedical records. The prescriber has indicated why all alternatives required by the Plan would likely not beas effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or otherharm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. OurPhysician 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 Vyvanse 10 mg.
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 cover Sumatriptan . The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Sumatriptan, which is subject to prior approval. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, neither prior authorization criteria nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Sumatriptan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cosentyx. 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 Cosentyx 300 mg.The drug is requested to treat moderate to severe plaque psoriasis. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Cosentyx.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Entresto. 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 Entresto. The drug is requested to treat heart failure. The enrollee does not satisfy the Plan's coveragecriteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicatedwhy all alternatives required by the Plan would likely not be as effective for the enrollee as the requesteddrug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion isthat neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Entresto.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha SureClick. 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 Repatha SureClick. The drug is requested to treat hyperlipidemia in a patient with atherosclerotic cardiovascular disease (ASCVD), status post percutaneous coronary intervention/stents, and statin intolerance. The prescriber has not indicated why all alternatives required by the Plan (Praluent) would likely not be as effective for you as the requested drug; and/or would likely cause adverse reaction(s) or other harm to you. 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 exception criteria are not met. Therefore, the Plan is not required to cover Repatha SureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron ODT. 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 Ondansetron ODT 4 mg.The drug is requested to treat nausea and vomiting related to gastric bypass, 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 Ondansetron ODT 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 Ondansetron ODT. 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 Diclofenac Sodium 3% gel. 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 Diclofenac Sodium 3% gel.The drug is requested to treat chronic pain syndrome associated with spondylosis and radiculoapthy, 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 Diclofenac Sodium 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 Diclofenac Sodium. 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 L-Methylfolate Calcium. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. L-Methylfolate Calcium is one of those excluded drugs because it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicate that they provide supplemental coverage for L-Methylfolate Calcium. Therefore, the Plan is not required to cover L-Methylfolate Calcium. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil. The drug is requested to treat Churg-Strauss syndrome, eosinophilicpneumonia and eosinophilic gastritis, which is an off-label (non-FDA approved) use. Medical records fromdate of service February 3, 2020 were provided to support these diagnoses. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted conditions. 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 notedconditions.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 for the diagnosed conditions. 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 these conditions. 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 Mycophenolate Mofetil.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 Nucynta ER. 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 Nucynta ER 100 mg tablet. The drug is requested to treat chronic pain syndrome and cervical radiculopathy. The prescriber has not indicated why all alternatives required by the Plan (fentanyl transdermal patch, morphine ER tablet and Xtampza ER) 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 exception criteria are not met. Therefore, the Plan is not required to cover Nucynta ER.