Persius/hicric huggingface dataset:
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 Gralise, 600 mg tablet. 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 Gralise, 600 mg tablet.Gralise, 600 mg tablet is requested to treat an unknown diagnosis. The prescriber was asked to state theenrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file.The prescriber was also asked to address medical necessity for the requested drug. A response from theprescriber was not received. Therefore, based on the current record, there is insufficient documentation thatthe requested medication is being prescribed for a medically accepted indication as defined by Medicarelaw. In addition, an exceptions request based on medical necessity cannot be considered because it cannotbe 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 Gralise, 600 mg tablet for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. 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.Therefore, our decision is that the Plan is not required to provide coverage for Gralise, 600 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 Amitiza, 8 mcg capsule. The Plan did not grant thisrequest. 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 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. Amitiza, 8 mcg capsule is aTier 3 brand [biologic] 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 Amitiza, 8 mcg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Levitra. The Plan did not grant this request. We received this case to conductan independent review.Medicare law excludes certain drugs from Part D coverage. Levitra is one of those excluded drugs becauseit is a drug used to treat sexual or erectile dysfunction. The record submitted by the Plan does not indicatethat they provide supplemental coverage for Levitra. Therefore, the Plan is not required to cover Levitra.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.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe.If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide a tiering exception for Novolog FlexPen. 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 Novolog FlexPen. The drug is requested to treat type 2 diabetes mellitus. Thedrug is on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan'sformulary to treat your condition. Therefore, the drug is not eligible for a tiering exception. Our PhysicianReviewer'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 your condition. Therefore, ourdecision is the Plan is not required to provide a tiering exception for Novolog FlexPen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron ODT, 8 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 Ondansetron ODT, 8 mg tablet.The drug is requested to treat nausea and vomiting due to gastroparesis, which is an off-label (non-FDAapproved) use. The prescriber clarified the diagnosis in a statement. 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 Ondansetron ODT, 8 mg tablet for the diagnosed condition. Asa 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 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 Ondansetron ODT, 8 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

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 Stelara. 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 Stelara. The drug is requested to treat ulcerative colitis. The enrollee does not satisfy the Plan's coveragecriteria. You have not sufficiently addressed the Plan's coverage criteria (no documentation of aninadequate response, intolerance, or contraindication to Humira or Xeljanz) and/or have not indicated whyall 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 thatneither 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 Stelara.
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 Lotemax 0.5%. 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 Lotemax 0.5%.Lotemax 0.5% is requested to treat an unknown diagnosis. The prescriber was asked to state the enrollee'sdiagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file. Theprescriber was also asked to address medical necessity for the requested drug. A response from theprescriber was not received. Therefore, based on the current record, there is insufficient documentation thatthe requested medication is being prescribed for a medically accepted indication as defined by Medicarelaw. In addition, an exceptions request based on medical necessity cannot be considered because it cannotbe 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 Lotemax 0.5% for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. 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.Therefore, our decision is that the Plan is not required to provide coverage for Lotemax 0.5%.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 or provide reimbursement for Aspirin, Rosuvastatin and Valsartan received while a patient at the local hospital. You also requested additional reimbursement for Carvedilol, Clopidogrel, Clopidogrel Bisulf, Fenofibrate, Levothyroxine, Nitroglycerin, and Nitrostat received while a patient at the local Hospital. The Plan did not grant this request. We received this case to conduct an independent review.Regarding the request for reimbursement for Rosuvastatin and Valsartan: the Part D Plan coversprescriptions filled at an out-of-network pharmacy only in certain limited circumstances. If an enrolleemust use an out-of-network pharmacy, the enrollee will generally have to pay the full cost when theprescription is filled. The enrollee may submit a request for reimbursement with proof of payment to askthe Plan to pay its share of the cost.In this case, the record shows that you were a patient at the local hospital. You received Rosuvastatin and Valsartan for a medical emergency or urgent care. You submitted a request for reimbursement with a copy of an itemized hospital bill. However, the record does not include proof of payment in full of the self-administered drug portion of the bill. The Plan's criteria for out-of-network coverage and reimbursement have not been met. Therefore, our decision is the Plan is notrequired to cover or provide reimbursement for Rosuvastatin and Valsartan received as a patient at the local hospital.Regarding the request for additional reimbursement for Carvedilol, Clopidogrel, Clopidogrel Bisulf, Fenofibrate, Levothyroxine, Nitroglycerin, and Nitrostat: the Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. The case record contains documentation showing that the Plan approved coverage. The Plan calculated reimbursement based on the total cost of the drug, less your required copayment amount, and less the difference between what the Plan normally pays for the drug and what the out-of-network pharmacy (i.e., hospital or provider's office) charged you.The case record indicates that the Plan provided coverage and reimbursement in accordance with the Part DPlan rules for out-of-network reimbursement. Therefore, our decision is the Plan is not required to provideany additional reimbursement for Carvedilol, Clopidogrel, Clopidogrel Bisulf, Fenofibrate, Levothyroxine,Nitroglycerin, and Nitrostat received as a patient at the local hospital.Regarding the request for reimbursement for Aspirin EC: Medicare Part D does not cover non-prescriptiondrugs. We checked FDA approved sources for the drug's classification or determined from other availableresources that the drug is a non-prescription or OTC drug. Therefore, Aspirin EC is not eligible for Part Dcoverage, and the Plan is not required to cover it under the Part D benefit.This decision does not address the medical necessity or appropriateness of Aspirin EC. It only establishesthat payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Tymlos 3120 mcg/1.56 mL sol pen as prescribed. 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 Tymlos.Tymlos is requested for treatment of postmenopausal osteoporosis. The enrollee's medical history is notable for a history of rheumatoid arthritis, fractured ribs following a fall, and extensive spinal surgery including a L4-L5 posterior spinal fusion in the remote past, and a recent posterior spinal fusion from T10 - S1. Although bone mineral density T-score in the left femoral neck was -1.6. CT of the spine was notable for a vertebral body density of 100 Hounsfield units (HU) at L1 consistent with osteoporosis, and poor bone quality was noted on direct visualization during the recent spine surgery. The enrollee does not satisfy the Plan's coverage criteria.The prescriber has provided sufficient documentation that this enrollee does have osteoporosis despite her only mildly decreased bone mineral density T-score. Additionally, sufficient documentation has been provided which supports the prescriber's claim that treatment with the requested drug, an anabolic agent, is the best option for the enrollee at this time. The prescriber has sufficiently indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that 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 met. Therefore, our decision is the Plan is required to cover Tymlos 3120 mcg/1.56 mL sol pen as prescribed.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Quinine Sulfate, 324 mg capsule. 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 Quinine Sulfate, 324 mg capsule.The drug is requested for the treatment or prevention of nocturnal leg cramps, 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 Quinine Sulfate, 324 mg capsule 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 Quinine Sulfate, 324 mg capsule. 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. 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 left elbow, deltoid tendonitis, other specified disorders of synovium and tendon - multiple sites, which are an off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted 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 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. 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: Favorable

You asked the Plan to cover Venetoclax 100 mg tablet. 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 Venetoclax 100 mg tablet.Venetoclax 100 mg tablet is requested for use in combination with Vidaza for treatment of newly diagnosed acute myeloid leukemia in this 70 year old patient. The plan's Redetermination Denial letter states that their criteria for coverage of the requested drug requires an additional diagnosis which would prevent the use of intensive induction therapy. Medical records submitted with the request for reconsideration indicate that the enrollee has a history of recurrent pneumonia requiring recent hospitalization. It was noted that the enrollee had persistent symptoms following hospital discharge while on oral antibiotics. Follow up chest CT scan performed was notable for no significant change compared to the extensive consolidation throughout the right lower lobe and partially involving the inferior upper lobe consistent with pneumonia. Antibiotic regimen has been adjusted due to adverse effects - it is noted that the enrollee was most recently switched to oral Augmentin/Ceftin. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met. Of note, there was no case file for this medical reviewMedicare 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 Venetoclax.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.