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

You asked the Plan to cover Ipratropium-Albuterol nebulizer solution. 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 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 Ipratropium-Albuterol nebulizer solution for the management of obstructivepulmonary disease.In this case, the record shows that Ipratropium-Albuterol nebulizer solution is administered through anebulizer in the home for a diagnosis of unspecified asthma with status asthmaticus (ICD-10 J45.902) andsevere persistent asthma, uncomplicated (J45.50). There is no indication that it is not administered througha small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather thanPart D. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicarelaw. Therefore, it is our decision that the Part D Plan is not required to cover Ipratropium-Albuterolnebulizer solution.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

You asked the Plan to provide a tiering exception for Toviaz 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 a tiering exception for Toviaz ER 8 mg tablets.The drug is requested to treat neurogenic bladder. 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 the enrollee's 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 the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Toviaz ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Invokana 100 mg. 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 if thelower tiers on the formulary only contain generic alternative drugs. Invokana is a Tier 3 brand drug. Thelower cost-sharing tiers only contain generic alternative drugs. Therefore, our decision is the Plan is notrequired to provide a tiering exception for Invokana.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sodium Chloride 7%. The Plan did not grant this request. We received thiscase to conduct an independent review.Medicare Part D does not cover devices. Sodium Chloride has been classified by the FDA as a device, notas a drug. Therefore, our decision is the Part D Plan is not required to cover Sodium Chloride.This decision does not address the medical necessity or appropriateness of the requested item. It onlyestablishes 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 Belsomra. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Belsomra is a Tier3 brand drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, ourdecision is the Plan is not required to provide a tiering exception for Belsomra.
Appeal type: Prescription Drug
Decision: Unfavorable

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

You asked the Plan to provide reimbursement for Aminocaproic Acid 500 mg purchased March 28, 2019. The Plan did not grant this request. We received this case to conduct an independent review.In this case, the records show that when Aminocaproic Acid 500 mg purchased on March 28, 2019 the claim straddled the deductible stage, the initial coverage stage and coverage gap stage of the Part D benefit.An enrollee is responsible for the full cost of covered drugs until the deductible amount $415 is satisfied. The initial coverage phase requires a 25% coinsurance amount for this drug and day supply purchased. While in the coverage gap you pay 37% of the price for generic drugs. Aminocaproic Acid 500 mg was on Tier 5 of the Plan's 2019 Formulary. The Plan provided documentation showing Aminocaproic Acid 500 mg was covered by the Plan at the time of purchase. The Plan's claim information shows that the total cost of the drug at the pharmacy was $4,032.93. You paid $1,331.38. The amount applied to each stage of coverage was $393.33 (deductible), $851.25 (initial coverage limit) and $86.90 (coverage gap).The record shows that the enrollee was charged an amount that is less than or equal to the required copayment for each phase the claim was processed in. The cost of Aminocaproic Acid 500 mg purchased March 28, 2019 was applied to your yearly true out-of-pocket (TrOOP) costs.The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, the Plan is not required to provide additional payment and/or reimbursement for Aminocaproic Acid 500 mg purchased March 28, 2019.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Calcitriol. 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 Calcitriol. The drug is requested to treat Hypocalcemia - Hypoparathyroidism, Postsurgical. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. You state the enrollee is not receiving dialysis. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Calcitriol for the diagnosed condition. As a result, Calcitriol is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Calcitriol.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 Verzenio. 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 Verzenio 200 mg. The drug is requested to treat lung cancer, which is an off-label (non-FDA approved) use.The enrollee is a 69 year old man with squamous cell lung cancer involving lung and nodes. He has been treated with radiation, multiple debulking surgeries, Carboplatin, Taxol, Gemcitabine, Nivolumab, Taxotere, and Pembrolizumab/VSV-IFNbeta-NIS, on a clinical trial. Tumor genetics showed a loss of CDKN2a/b suggesting possible response to CDK4/6 inhibitors. The lung mass continues to grow. The prescriber requests Verzenio to treat him. The prescriber noted there are clinical trials with the drug. This reviewer did not find any supporting citations in a PubMed search.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 in Medicare 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 Verzenio 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 Verzenio. 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 Epidiolex 100 mg/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 Epidiolex 100 mg/ml. The drug is requested to treat localization related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, not intractable without status epilepticus, 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 Epidiolex 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 Epidiolex. 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 Acetylcysteine. 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 Acetylcysteine for the management of obstructive pulmonary disease and for persistent thick or tenacious pulmonary secretions. In this case, the record shows that Acetylcysteine is administered through a nebulizer in the home for a diagnosis of J44.9 Chronic obstructive pulmonary disease and J69.0 Pneumonitis due to inhalation of food and vomit. 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 Acetylcysteine.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: Unfavorable

You asked the Plan to cover Lyrica 200 mg. 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 200 mg. The drug is requested to treat migraine, 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 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 provide a tiering exception for Timoptic Ocudose. 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 Timoptic Ocudose 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 Timoptic Ocudose.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lokelma 10 gm powder packet, 90 per 90 days. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lokelma 10 gm powder packet, 90 per 90 days. The drug is requested to treat hyperkalemia. Upon reconsideration, you have submitted a sufficiently strong statement as to why the formulary alternatives are inappropriate for the enrollee. 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 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 Lokelma 10 gm powder packet, 90 per 90 days.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 Grastek. 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 Grastek.The drug is requested to treat ICD-10 diagnosis code J30.1, Allergic rhinitis due to pollen in an enrollee who is over age 65, which is an off-label (non-FDA approved) use. The enrollee's date of birth is 04/14/1951. 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 Grastek 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 Grastek. 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.