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

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 Ibrance. 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 Ibrance 125 mg; 21/28. The drug is requested to treat metastatic breast cancer. The enrollee is a 79 year old woman with hormone receptor positive, HER2 negative metastatic breast cancer involving bones, liver and nodes. She has a distant history of stage III left cancer treated with surgery, adjuvant chemotherapy and Tamoxifen. She then had stage III right breast cancer treated with surgery, adjuvant Cytoxan/Taxotere and Anastrozole. She was diagnosed with hypercalcemia, and metastatic breast cancer. The prescriber requests Ibrance to be given with Exemestane to treat her. Per the FDA website, Ibrance is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: - an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men. The enrollee has HR-positive, HER2 negative metastatic breast cancer. The requested treatment will be first line treatment of metastatic cancer. Therefore she meets the FDA approved use. She has not been treated with a prior CDK inhibitor. Therefore she meets the plan's prior authorization criteria. 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 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 Ibrance.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 provide a tiering exception for Rytary 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 Rytary ER 36.25 mg-145 mcg capsule.The drug is requested to treat Parkinson's disease. The drug is on tier four of the Plan's formulary. There are no available (branded) 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 Rytary ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Qvar Redihaler. 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 Qvar 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 Qvar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Travatan Z. 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. Travatan Z 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 Travatan Z.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Aristada. 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 Aristada 1064 mg/3.9 ml injection (once monthly). The drug is requested to treat F25.9, Schizoaffective disorder, unspecified. The Plan limits the amount of Aristada 1064 mg/3.9 ml injection, to 1 injection every 56 days. Please note that the product label, available at drugs@fda, states that the recommended dose is: 1064 mg every 2 months. You are asking for an amount well above the maximum recommended amount. Finally, it is noted that your office notes state, Client is aware that this (dose) exceeds the FDA's recommended frequency of once monthly.You have not indicated that the number of doses of the requested drug allowed by the Plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not 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 no citations in the Medicare approved compendia that support the use of Aristada 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 Aristada.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 Buprenorphine HCL, 2 mg SL 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 Buprenorphine HCL, 2 mg sublingual tablet.The drug is requested to treat opioid dependence maintenance therapy and chronic pain. 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.Also note the following citation in DrugDex, a Medicare approved compendium which states:Buprenorphine hydrochloride sublingual tablets are not appropriate as an analgesic (off-label usage) [17]. 17. Product Information: buprenorphine HCl sublingual tablets, buprenorphine HCl sublingual tablets. Roxane Laboratories, Inc. (per DailyMed), Columbus, OH, 2015.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 Buprenorphine HCL, 2 mg SL tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cresemba, 186 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 Cresemba, 186 mg.The drug is requested for the prophylaxis of invasive fungal infection in an enrollee with acute myeloblastic leukemia, not having achieved remission, 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 Cresemba, 186 mg capsule for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Cresemba, 186 mg capsule. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Menactra. 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. Menactra is a Tier 3 brand biologic drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Menactra.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Dayvigo 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 Dayvigo 10mg tablet. The drug is requested to treat insomnia in an enrollee with obstructive sleep apnea. You have indicated why all alternatives required by the Plan (Belsomra, Silenor, Trazadone, Zolpidem) 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 Dayvigo 10 mg tablet.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 Tobramycin 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 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 Tobramycin Solution for the management of obstructive pulmonary disease.In this case, the record shows that Tobramycin Solution is administered through a nebulizer in the home for a diagnosis of J47.1 Bronchiectasis with (acute) exacerbation. 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 Tobramycin Solution. 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 Belbuca. 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 Belbuca.Belbuca is requested to treat chronic pain in an enrollee with mast cell activation syndrome. 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. 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 Belbuca.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cresemba, 186 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 Cresemba, 186 mg capsule.The drug is requested for the prophylaxis of fungal infection in an enrollee with aggressive acute myeloid leukemia, 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 Cresemba, 186 mg capsule for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Cresemba, 186 mg capsule.This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Rytary 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 Rytary ER 23.75 mg/95 mg capsule. The drug is requested to treat Parkinson's disease. The drug is on tier four of the Plan's formulary. There are no available (branded) 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 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 Rytary ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Skyrizi 75 mg/0.83 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 Skyrizi 75 mg/0.83 mL - (150 mg dose).The drug is requested to treat Crohn's disease of both small and large intestine, 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 Skyrizi 75 mg/0.83 mL 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 Skyrizi 75 mg/0.83 mL.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.