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

You asked the Plan to cover Epidiolex. 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 Epidiolox 100 mg/ml. The drug is requested to treat Primary generalized epilepsy consisting of absence, myoclonic and generalized tonic clonic seizures, which is an off-label (non-FDA approved) use. This is the diagnosis supported by the provided medical records. 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 Dronabinol. 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 Dronabinol 10 mg.The drug is requested to treat abdominal pain and nausea due to Behcet's disease and medication treatment of Behcet's disease, 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 Dronabinol 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 Dronabinol. 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 Jardiance. 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 Jardiance. The drug is requested to treat blood sugar. The drug is 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 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 Jardiance.
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 Jublia 10%. 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 Jublia 10%.Jublia 10% is requested to treat onychomycosis. Additional information was requested from the prescriber; however no additional information was provided. 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 Jublia 10%.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Levetiracetam powder compound. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Levetiracetam powder compound. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Levetiracetam powder compound. This decision does not address the medical necessity or appropriateness 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 Nourianz. 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 Nourianz 40 mg tablet. Nourianz 40 mg tablet is requested for treatment of off periods in this enrollee with Parkinson's disease. The prescriber indicates that the enrollee has tried and failed and/or had adverse effects to various dosing regimens and preparations of Levodopa/Carbidopa. The plan's coverage criteria for the requested drug require failure of, or intolerance/contraindication to Selegiline and Entacapone. The prescriber has indicated that the enrollee does not meet the noted coverage criteria. It is noted that enrollee was initially treated with Carbidopa/Levodopa, Sinemet CR was later added at bedtime, and that a trial of Neupro patch resulted in side effects. The prescriber cites efficacy data for the requested drug, and states that it is the only adenosine receptor antagonist indicated to reduce off episodes; however 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 Nourianz.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Armodafinil 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 Armodafinil 200 mg tablet. Armodafinil 200 mg tablet is requested to treat bipolar I disorder, depressed phase. The prescriber clarified the medical history and diagnosis in statements dated 4/8/2020 and 3/30/2020. Medical records were provided which document the diagnosis of F31.32 Bipolar disorder, current episode depressed, moderate. 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.The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Adjunctive armodafinil was associated with a significant reduction in least squares mean Inventory of Depressive Symptomatology Clinician-Rated (IDS-C30) scores compared with placebo in a randomized trial in patients with bipolar I disorder currently experiencing a major depressive episode. In a meta-analysis, dopaminergic agents, including armodafinil, significantly improved clinical response and remission compared with alternative active treatment or placebo in patients with bipolar disorder. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee does not satisfy the Plan's coverage criteria. 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 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 Armodafinil 200 mg.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 Cinqair 100 mg/10 mL solution. 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 Cinqair 100 mg/10 mL solution.The drug is requested to treat hypereosinophilic syndrome, which is an off-label (non-FDA approved) use. Medical records from date of service 3/5/2020 were provided which support this diagnosis. 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 Cinqair 100 mg/10 mL solution 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 Cinqair 100 mg/10 mL solution. 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 Shingrix vaccine and its administration fee received May 17, 2019 and July 16, 2019 at your provider's office. The Plan did not grant this request. We received this case to conduct an independent review.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If you pay the full cost of a prescription drug out-of-pocket you can ask the Plan to pay you back. When submitting a request for reimbursement, the Plan requires that you submit your receipt documenting the payment you have made along with your reimbursement request. In this case, you submitted a request for reimbursement to the Plan for Shingrix vaccine and its administration fee received May 17, 2019 and July 16, 2019 at your provider's office. The case record includes include proof of payment. The Plan denied reimbursement on the basis that the NDC 58160-828-03 provided was invalid. MAXIMUS verified using FDA sources that NDC 58160-828-03 is a valid NDC eligible for coverage under Medicare Part D. Medicare rules allow a Part D Plan to manage its formulary by requiring prior authorization, step therapy or quantity limits. Shingrix is on the Plan's formulary and is not subject to any of these restrictions. Therefore, our decision is the Plan is required to cover and provide any applicable reimbursement for Shingrix vaccine and its administration fee received May 17, 2019 and July 16, 2019 at your provider's office.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 Eucrisa. 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 Eucrisa 2% Ointment. The drug is requested to treat dermatitis. 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 Eucrisa.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Raloxifene HCL. 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 Raloxifene HCL 60 mg. The drug is requested to treat postmenopausal osteoporosis. The drug is a generic drug on Tier 3 of the Plan's formulary. There are no available lower tier drugs (in same drug class with similar action) 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 the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Raloxifene HCL.
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 packet is requested to treat male hypogonadism. 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.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 Reviewer'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 Testosterone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Butalbital/Acetaminophen/Caffeine/Codeine. 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 Butalbital/Acetaminophen/Caffeine/Codeine 50-325-40-30 mg capsule. The drug is requested to treat migraine headache. Butalbital/Acetaminophen/Caffeine/Codeine 50-325-40-30 mg capsule is not on the Plan's formulary. Butalbital/Acetaminophen/Caffeine/Codeine 50-300-40-30 mg capsule; Butalbital/Acetaminophen/Caffeine 50-300-40 mg capsule and Codeine sulfate 30 mg are on the Plan's formulary. 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 Butalbital/Acetaminophen/Caffeine/Codeine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Calcitrol. 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 0.5 mcg capsule. The drug is requested to treat vitamin D deficiency, hypocalcemia and hypoparathyroidism. The enrollee does not satisfy the Plan's coverage criteria. A request was sent to the prescriber to clarify the diagnosis and to provide medical records to support the diagnosis - no medical records were provided. You have not sufficiently addressed the Plan's coverage criteria and/or 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. 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 Calcitrol.