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

You asked the Plan to cover Humira. 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 Humira. The drug is requested to treat sarcoidosis, 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 Humira 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 Humira.  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 Rituxan, 500 mg/50 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 Rituxan, 500 mg/50 mL solution.   The drug is requested to treat chronic inflammatory demyelinating polyneuropathy, 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 Rituxan 500 mg/50 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 Rituxan 500 mg/50 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.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Pregabalin 50 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 Pregabalin 50 mg. Pregabalin 50 mg is requested to treat generalized anxiety disorder. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. This diagnosis was provided by you in the Reconsideration appeal dated September 1, 2020.     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 also stated that the enrollee tried and failed Gabapentin.  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. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Planis required to cover Pregabalin 50 mg.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Dulera 200-5 mcg inhaler. 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 Dulera 200-5 mcg/inhaler. The drug is requested to treat asthma/chronic obstructive pulmonary disease. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for you, and/or would likely cause adverse reaction(s) or other harm to you. The prescriber sent additional information and medical records on September 2, 2020 addressing the formulary alternatives and coverage criteria. The prescriber provided a statement and medical records documenting prior trial and intolerance to Symbicort, Advair and Alvesco. 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 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 met. Therefore,the Plan is required to cover Dulera 200-5 mcg inhaler.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Promacta, 25 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 Promacta, 25 mg tablet.   The drug is requested to treat thrombocytopenia. The enrollee does not satisfy the Plan's coverage criteria - (At any point prior to the initiation of the requested medication, did the patient meet ONE of the following criteria: A) untransfused platelet count less than 30,000 per microliter, OR B) untransfused platelet count 30,000 to 50,000 per microliter with symptomatic bleeding or risk factor(s) for bleeding?). 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 Promacta, 25 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Levofloxacin Hemihydrate Compound purchased August 13, 2020. 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 when compounding the prescription for Levofloxacin Hemihydrate Compound purchased August 13, 2020. 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 or provide reimbursement for Levofloxacin Hemihydrate Compound purchased August 13, 2020.  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 Testosterone. 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%. The drug is requested to treat testicular hypofunction. 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 prescriber was asked to clarify the enrollee's diagnosis, because it was unclear from the case file what the underlying etiology was of the enrollee's testicular hypofunction. The prescriber was also asked to address the Plan's prior authorization criteria and to provide supporting medical records.  A response from the prescriber was not received. The prescriber has not sufficiently addressed the Plan's coverage criteria.  Therefore, based on the current record, 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. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Testosterone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Northera. 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 Northera. The drug is requested to treat autonomic orthostatic hypotension (ICD-10 I95.1) and dizziness, status post falls, 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. Additional medical information was requested by the Part D QIC. You were asked to address a diagnosis of neurogenic orthostatic hypotension (ICD-10 G90.3), the etiology of the enrollee's condition, and prior authorization coverage criteria.  The prescriber statement was returned.  The diagnosis provided was autonomic orthostatic hypotension (ICD-10 I95.1).  You documented that the enrollee is currently symptomatic while taking Midodrine and Fludrocortisone.  According to the documentation, however, there is no evidence of Parkinson's disease, multiple system atrophy, or other neurological conditions associated with primary autonomic failure, nor dopamine beta-hydroxylase deficiency, or nondiabetic autonomic neuropathy. 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 Northera for the diagnosed conditions. 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 these conditions. 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 Northera.  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: Partially 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 reimbursement for Vitamin A 10,000 units, Zinc 220 mg, Vitamin D3 2,000 units, Humalog, Rosuvastatin 40 mg, Lantus Solostar, Tamsulosin 0.4 mg, Metoprolol Tartrate 25 mg, Pantoprazole 40 mg, Xifaxan 550 mg and Furosemide 40 mg received December 9, 2019 and December 10, 2019. The Plan did not grant this request. We received this case to conduct an independent review.   Humalog, Rosuvastatin, Lantus Solostar, Tamsulosin, Metoprolol Tartrate, Pantoprazole, Xifaxan and Furosemide  The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you received Humalog, Rosuvastatin 40 mg, Lantus Solostar, Tamsulosin 0.4 mg, Metoprolol Tartrate 25 mg, Pantoprazole 40 mg, Xifaxan 550 mg and Furosemide 40 mg while at the hospital. This was an emergency or urgent care situation. You requested reimbursement from the Part D Plan. The Plan denied the request on the basis the proof of payment had not been provided. Humalog, Rosuvastatin 40 mg, Lantus Solostar, Tamsulosin 0.4 mg, Metoprolol Tartrate 25 mg, Pantoprazole 40 mg, Xifaxan 550 mg and Furosemide 40 mg are Part D eligible drugs and proof of payment has been established. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for Humalog, Rosuvastatin 40 mg, Lantus Solostar, Tamsulosin 0.4 mg, Metoprolol Tartrate 25 mg, Pantoprazole 40 mg, Xifaxan 550 mg and Furosemide 40 mg mg received December 9, 2019 and December 10, 2019.  Vitamin A, Zinc, Vitamin D3  Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drugs' classification or determined from other available resources that the drugs are non-prescription or OTC drugs. Therefore, Vitamin A 10,000 units, Zinc 220 mg and Vitamin D3 2,000 units mg received December 9, 2019 and December 10, 2019 are not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for them under the Part D benefit. 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

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 Hydroxyzine HCL, 25 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 Hydroxyzine HCL, 25 mg tablet.  Hydroxyzine HCL, 25 mg tablet is requested to treat an unknown diagnosis. The prescriber was asked to state the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, an exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.  For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia.   Our Physician Reviewer needed additional information from the prescriber to determine whether the enrollee is using Hydroxyzine HCL, 25 mg tablet for an FDA-approved use, or a use listed in the Medicare-approved compendia. The requested information was not received. As a result, we could not confirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Hydroxyzine HCL, 25 mg tablet.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

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 Morphine Sulfate 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 Morphine Sulfate ER.  Morphine Sulfate ER is requested to treat an unknown diagnosis. The prescriber was asked to state the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, an exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.   For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia.   Our Physician Reviewer needed additional information from the prescriber to determine whether the enrollee is using Morphine Sulfate ER for an FDA-approved use, or a use listed in the Medicare-approved compendia. The requested information was not received. As a result, we could not confirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Morphine Sulfate ER.  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 reimbursement for Metronidazole 0.75% Gel purchased January 30, 2020. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. In this case, documentation in the record shows that the enrollee was in the deductible stage when Metronidazole 0.75% Gel was purchased on January 30, 2020. During the deductible stage, the Plan requires that the enrollee pay the full cost of Tier 3, Tier 4 and Tier 5 drugs purchased in 2020 before the Plan would pay a share of the cost. Metronidazole 0.75% Gel is on the Plan's 2020 formulary and classified as a Tier 3 drug. The Plan provided documentation showing that this claim was covered by the Plan at the time of purchase, and that the full cost of the purchase in dispute was applied to the required deductible amount.  The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is not required to provide reimbursement for Metronidazole 0.75% Gel purchased January 30, 2020.