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

You asked the Plan to cover Fentanyl. The Plan did not grant this request. We received this case to conduct an independent review.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 you are using Fentanyl 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 Fentanyl. 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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Dexilant. The Plan did not grant this request. We received this case to conduct an independent review.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 you to determine whether the enrollee is using Dexilant 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 Dexilant. 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 Nexlizet. 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 Nexlizet 180mg-10mg Tablet. Nexlizet 180mg-10mg Tablet is requested for treatment of hyperlipidemia which the prescriber has clarified is heterozygous familial hypercholesterolemia. The prescriber has consistently indicated that baseline LDL has been over 200; the prescriber has additionally added that LDL has been over 200 for 20 years, the enrollee has xanthelasma, and that the enrollee has failed many statins including one high intensity statin. 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 Nexlizet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ubrelvy. 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 Ubrelvy. The drug is requested to treat migraines. You have not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Ubrelvy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Anoro Ellipta, 62.5-25 mcg for the 2021 Plan benefit year. 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 Anoro Ellipta 62.5-25 mcg.The drug is requested to treat chronic obstructive pulmonary disease. 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 Anoro Ellipta, 62.5-25 mcg for the 2021 Plan benefit year.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz, 5 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 Xeljanz 5 mg; 30/30.The drug is requested to treat T-cell large granular lymphocytic leukemia (LGL), which is an off-label (non-FDA approved) use. The enrollee is a 65 year old man with LGL. He has been treated with Methotrexate, Dexamethasone, Cytoxan and transfusions. He cannot tolerate the Cytoxan due to cytopenias. Cyclosporine is contraindicated due to multiple skin cancers. The prescriber requests Xeljanz to treat him. A 2015 letter to the editor in Leukemia (Leukemia (2015) 29: 2427-2429) and a 2020 article in Leukemia (Leukemia (2020) 34:1118-1124) were submitted in support of the request. The letter is case reports of 9 patients, 8 of whom had rheumatoid arthritis for which the drug is FDA approved. The conclusion of the letter was that clinical trials were warranted. Therefore the use is investigational. The article does not report on clinical treatment with the drug.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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals or publications. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Xeljanz, 5 mg tablet 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 Xeljanz, 5 mg tablet. 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 Oxycontin, 30 mg tablet 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 Oxycontin ER 30 mg tablet.The drug is requested to treat chronic pain. The prescriber has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Oxycontin, 30 mg tablet ER.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Xiidra 5% eye drops 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 Xiidra 5% eye drops.The drug is requested to treat dry eye syndrome. In the Reconsideration appeal dated December 22, 2020 the prescriber stated that the enrollee tried and failed Restasis. The Plan noted that the enrollee had a paid claim for Restasis on October 30, 2020. The prescriber has 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 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 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 met. Therefore, the Plan is required to cover Xiidra 5% eye drops as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dupixent 300 mg/2 mL. 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 Dupixent 300 mg/2 mL.The drug is requested to treat atopic dermatitis. Medical records were provided which documented that the enrollee has tried and failed Triamcinolone, urea, and Vaseline. Methotrexate was started in October 2020 but discontinued due to COVID-19 and not restarted. Dupixent is not on the Plan's formulary. The prescriber has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Dupixent 300 mg/2 mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Fluorouracil 5% Cream. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Fluorouracil 5% cream. The drug is requested to treat actinic keratosis. The drug is on Tier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat your 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 (such as brand or biologic drugs when considering an exception for a brand or biologic drug) 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 your condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Fluorouracil 5% Cream for the 2021 Plan year.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclobenzaprine HCL, 10 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 Cyclobenzaprine HCL, 10 mg tablet.The drug is requested to treat skeletal muscle spasm related to chronic conditions including chronic neck and back pain, spinal stenosis, osteoarthritis, and scoliosis, 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 Cyclobenzaprine HCL, 10 mg tablet 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 Cyclobenzaprine HCL, 10 mg tablet. 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 Vraylar, 1.5 mg capsule 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 Vraylar, 1.5 mg capsule.The drug is requested to treat Bipolar disorder. In the Reconsideration appeal the prescriber clarified the drugs which the enrollee has already tried and failed. The enrollee has tried and failed Seroquel (Quetiapine). 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 Vraylar, 1.5 mg capsule as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 5% Patch. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lidocaine 5% Patch.The drug is requested to treat post-thoracotomy neuralgia, 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 Lidocaine 5% Patch 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 Lidocaine 5% Patch. 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 Fycompa. 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 Fycompa 2 mg. The drug is requested to treat orthostatic tremor, 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 Fycompa 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 Fycompa. 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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Tretinoin 0.025% Cream. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Tretinoin 0.025% cream.The drug is requested to treat solar aging of skin. Drugs prescribed for cosmetic purposes are excluded from coverage under Medicare Part D. Therefore the requested drug is excluded from coverage.Medicare law excludes certain drugs from Part D coverage. Tretinoin 0.025% Cream is one of those excluded drugs because it is a drug used for cosmetic purposes. The record submitted by the Plan does not indicate that they provide supplemental coverage for Tretinoin 0.025% Cream. Therefore, the Plan is not required to cover Tretinoin 0.025% Cream. 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 provide a tiering exception for Entresto, 97-103 mg tablet. 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. Entresto, 97-103 mg tablet 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 Entresto, 97-103 mg tablet