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

You asked the Plan to cover Ondansetron HCL. 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 Ondansetron HCL. The drug is requested to treat post concussive nausea, 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 Ondansetron HCL for the diagnosed condition. As a result, thedrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forOndansetron HCL.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 Aimovig. 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 Aimovig 140 mg/ml injector. The drug is requested to treat migraine. The drug ison Tier 4 of the Plan's formulary. There are no available (equivalent) lower tier 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 the enrollee's condition.Therefore, our decision is the Plan is not required to provide a tiering exception for Aimovig.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lyrica. 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 Lyrica 75 mg capsule. The drug is requested to treat atypical facial pain, knee pain, osteoarthritis and cervicalgia, which are 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 conditions.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 Lyrica 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 Lyrica. 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 Ipratropium-Albuterol. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Ipratropium-Albuterol for the management of obstructive pulmonary disease.In this case, the record shows that Ipratropium-Albuterol is administered through a nebulizer in the home for a diagnosis of J44.9 chronic obstructive pulmonary disease, unspecified. There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Ipratropium-Albuterol. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes 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: Favorable

You asked the Plan to cover Ofev 150 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 Ofev 150mg capsule.Ofev 150mg capsule is requested for treatment of progressive interstitial lung disease in this enrollee with WHO group 1 pulmonary arterial hypertension related to previous use of anoexiants. You state that the enrollee has had a progressive worsening of symptoms, and decrease in pulmonary function. High resolution CT scan demonstrated findings consistent with a UIP (usual interstitial pneumonia) pattern of fibrosis. The Plan states in their denial letter that Ofev was denied because their coverage criteria require that the enrollee does not have WHO group 1 pulmonary arterial hypertension requiring parenteral therapy with Epoprostenol or Treprostinil. You discuss the medical rationale for Ofev, and state that there is no FDA indication that Treprostinil should not be used in combination with OFEV. Additionally the FDA label for OFEV updated March 2020, states that OFEV is indicated for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype; there are no limitations regarding the use of OFEV for this new indication. The enrollee does not satisfy the Plan's coverage criteria. You have 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. 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 Ofev 150 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hydrocodone Polistirex-Chlorpheniramine Polistirex ER. 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. Hydrocodone Polistirex-Chlorpheniramine Polistirex ER is one of those excluded drugs because it is a drug used for the symptomatic relief of coughs and colds. The record submitted by the Plan does not indicate that they provide supplemental coverage for Hydrocodone Polistirex-Chlorpheniramine Polistirex ER. Therefore, the Plan is not required to cover Hydrocodone Polistirex-Chlorpheniramine Polistirex ER. 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 Testosterone 1.62% gel packet. 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 Testosterone 1.62% gel packet. Testosterone 1.62% gel is requested for treatment of primary hypogonadism of unstated cause in this 70-year-old man, which is an off-label (non-FDA approved) use. The prescriber has submitted laboratory results which confirm the diagnosis of primary testicular hypogonadism; however as above, the prescriber did not clarify the etiology of the hypogonadism. 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 Testosterone 1.62% gel packet 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 Testosterone 1.62% gel packet. 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 Testosterone 30 mg/1.5 mg. 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 Testosterone 30 mg/1.5 mg.Testosterone 30 mg/1.5 ml was initially requested for treatment of the enrollee's condition. It is noted thatthe enrollee has trialed several topical formulations - changes were made because of insurance coverage.The prescriber has indicated that the enrollee does not wish to administer injections. The Plan processed thecase for the Testosterone 30 mg/1.5 mg formulation which is not on the Plan's formulary.With the request for reconsideration, the prescriber requested generic Androgel - Testosterone 20.25/1.25,1.62% gel which is on the Plan's formulary. The prescriber has not indicated why all alternatives requiredby the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likelycause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coveragecriteria cover coverage of Testosterone 30 mg/1.5 ml is not supported. Our Physician Reviewer's opinion isthat formulary exception criteria are not met.Please note, the subject of this medical review is Testosterone 30 mg/1.5 mg which was initially requestedby the prescriber and processed by the Plan. For coverage of generic Androgel - Testosterone 20.25/1.25,1.62% gel, a request needs to be made to the Plan.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 Testosterone 30 mg/1.5 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz. 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. Xeljanz is requested for ongoing treatment of Crohn's disease, which is an off-label (non-FDA approved) use. The prescriber states that the enrollee has failed all FDA approved medications for treatment of Crohn's disease and has cited medical literature supporting the use of Xeljanz for treatment of the enrollee's condition; however 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 Xeljanz 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. 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 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 140 mg/mL. Repatha SureClick 140 mg/mL is requested for treatment of severe mixed dyslipidemia in this enrollee with hypertension, family history of early coronary disease (less than age 60), nicotine abuse, and markedly elevated coronary calcium score of 1257.27 (93rd percentile - report was provided). It is noted that the enrollee had insufficient results with combination Zetia and Rosuvastatin 20 mg, and that the addition of Praluent resulted in marked improvement in lipid profile allowing discontinuation of fish oil and Zetia. It is noted that the enrollee is also being treated with Fenofibric 135 DR. Praluent is not on the plan's formulary. It is not clear if the enrollee satisfies the Plan's coverage criteria for Repatha. However, 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 prior authorization exception criteria are metMedicare 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 Repatha SureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Livalo, 2 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Livalo, 2 mg tablet is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Livalo, 2 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tagrisso. 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 Tagrisso 80 mg. Tagrisso 80 mg is requested for treatment of progressive glioblastoma, Epidermal Growth Factor Receptor Variant III (EGFRvIII) positive on Next Generation sequencing, which is an off-label (non-FDA approved) use. The prescriber states that the enrollee has received all standard treatment as well as a clinical trial for the noted condition. The prescriber has cited preclinical data suggesting that astrocytomas with the noted mutation are sensitive to the requested drug, and has also cited experience with his own patients with glioblastoma demonstrating an objective tumor response to the requested drug; however 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. 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 Tagrisso 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 Tagrisso. 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 provide a tiering exception for Breo Ellipta. 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 Breo-Ellipta. Breo-Ellipta is requested to treat the enrollee's condition. The requested drug is a brand drug on tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the requested 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 the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Breo Ellipta.