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

You asked the Plan to cover Paliperidone 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 Paliperidone ER. The drug is requested to treat F70 Mild intellectual disability, F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type and F39 Unspecified mood [affective] disorder, which is are off-label (non-FDA approved) uses. Medical records were provided which support these diagnoses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted conditions.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Paliperidone ER 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 Paliperidone 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 cover Alprazolam. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules state that for prescription drugs to be covered under Part D when the enrollee has elected hospice, the drug must be for treatment of a condition that is completely unrelated to the terminal condition(s) or related conditions for which hospice coverage is being provided. In this case, the prescribing physician has indicated the enrollee is receiving hospice benefits and Alprazolam is being used for treatment of a condition that is related to the terminal condition(s). Additionally, Medicare records show you are currently enrolled in hospice. Thus, Alprazolam appears to be eligible for Part A coverage in this case. Drugs which are eligible for Part A coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to provide coverage for Alprazolam. 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 enrollee's hospice benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 5% Patch. 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 Lidocaine 5% Patch. The drug is requested to treat chronic shoulder pain, 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. Note that the coverage determination level, you, via electronic prior authorization (PA), listed the diagnosis as chronic shoulder pain. Via fax you changed the diagnosis to chronic back pain. Due to this change in diagnosis you were told that you, MUST submit medical records which clearly show the diagnosis being treated with the requested drug. You stated that the diagnosis was both shoulder pain and back pain, however you did not submit any medical records. 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 Lidocaine 5% Patch 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 Lidocaine 5% Patch.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.Please note, the Plan has indicated that the enrollee has coverage of Lidocaine 5% Patch under the enhanced benefit. Please contact the Plan for further information on this.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Buspirone HCL 5 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 Buspirone HCL 5 mg tablet. Buspirone HCL is requested for ongoing treatment of anxiety and depression. The Plan denied coverage of the requested drug because they concluded that the enrollee is on hospice; however, the prescriber clarified that the enrollee was discharged from hospice. There are no applicable utilization management criteria identified for coverage of the drug. Our Physician Reviewer's opinion is that Medicare Part D criteria for coverage of the requested drug have been met.For prescription drugs to be covered under Part D when the enrollee has elected hospice, the drug must be for treatment of a condition that is completely unrelated to the terminal condition(s) or related conditions. In this case, the enrollee is not currently enrolled in hospice. Therefore, this request is not eligible for coverage under Medicare Part A or B and we reviewed the request under the Part D benefit.Medicare rules allow a Part D Plan to manage its formulary by requiring prior authorization, step therapy or quantity limits. Buspirone HCL 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 Buspirone HCL.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 Prevymis. 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 Prevymis. The drug is requested for Cytomegaloviral prophylaxis in a lung transplant enrollee, 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 Prevymis 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 Prevymis. 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 Prednisone, Cyclosporine and Azathioprine. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant. The case record indicates that Prednisone, Cyclosporine and Azathioprine is needed for a kidney transplant. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant and Prednisone, Cyclosporine and Azathioprine is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is not required to cover Prednisone, Cyclosporine and Azathioprine. 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 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 40 mg/0.4 ml subcutaneous solution. The drug is requested to treat pyoderma gangrenosum, 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: Favorable

We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Xifaxan 550 mg tablet (42 per 14 days). Xifaxan 550 mg tablet is requested for treatment of recurrent symptoms associated with irritable bowel syndrome with diarrhea (IBS D). A reopening was requested challenging Maximus' decision. You stated that the enrollee was previously treated with Xifaxan for the noted condition with improvement. However, after three months, you stated that the enrollee is needing another round of treatment with Xifaxan. The enrollee does not satisfy the Plan's coverage criteria. Xifaxan is being prescribed for treatment of a medically accepted indication. 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.We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Xifaxan. Our Physician Reviewer determined that prior authorization exception criteria was met. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that prior authorization criteria was not met. We reopened this case to address the Plan's argument.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 Xifaxan.This decision affirms our previous favorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Rabeprazole Sodium DR 20 mg tablet. Rabeprazole Sodium DR 20 mg tablet is requested to treat gastroesophageal reflux disease. Upon the reopening request, additional information was submitted. The letter submitted documents that the higher dose formulary option of Dexilant (60 mg capsule) was tried and failed. However, the letter was dated one day after the original review was done. The progress notes submitted do not support that Dexilant 60 mg capsule was tried and failed. You have not indicated why this alternative 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.We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Rabeprazole Sodium DR. Our Physician Reviewer determined that formulary exception criteria was met. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.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 Rabeprazole Sodium DR.This decision affirms our previous unfavorable decision.
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 or provide reimbursement for Atorvastatin 80 mg, Metoprolol Tartrate 50 mg and 25 mg, Zolpidem 5 mg, Alprazolam 0.25 mg, Carboxymethycellulose 0.5%, Pantoprazole 40 mg DR, Potassium Chloride 20 MEQ and Ticagrelor 90 mg you received while you were a patient in the hospital. The Plan did not grant this request. We received this case to conduct an independent review.The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to pay the full cost when the prescription is filled. The enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost.In this case, the record shows that you were a patient at the hospital. You received Atorvastatin 80 mg, Metoprolol Tartrate 50 mg and 25 mg, Zolpidem 5 mg, Alprazolam 0.25 mg, Carboxymethycellulose 0.5%, Pantoprazole 40 mg DR, Potassium Chloride 20 MEQ and Ticagrelor 90 mg for a medical emergency or urgent care. You submitted a request for reimbursement with a copy of an itemized hospital bill. However, the record does not include proof of payment in full of the self-administered drug portion of the bill. In addition, the Plan denied because the bill did not show the National Drug Code (NDC) for each drug. The Plan's criteria for out-of-network coverage and reimbursement have not been met. Therefore, our decision is the Plan is not required to cover or provide reimbursement for Atorvastatin 80 mg, Metoprolol Tartrate 50 mg and 25 mg, Zolpidem 5 mg, Alprazolam 0.25 mg, Carboxymethycellulose 0.5%, Pantoprazole 40 mg DR, Potassium Chloride 20 MEQ and Ticagrelor 90 mg received while you were a patient in the hospital.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tadalafil. 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 Tadalafil 5 mg tablet. The drug is requested to treat erectile dysfunction and benign prostatic hyperplasia. Sexual/erectile dysfunction drugs prescribed to treat sexual/erectile dysfunction or other conditions for which the drug is not FDA approved, are excluded from coverage under Medicare Part D. Therefore the requested drug is excluded from coverage.Medicare law excludes certain drugs from Part D coverage. Tadalafil is one of those excluded drugs because it is a drug used to treat sexual or erectile dysfunction. The record submitted by the Plan does not indicate that they provide supplemental coverage for Tadalafil. Therefore, the Plan is not required to cover Tadalafil. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zytiga. 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 Zytiga. The drug is requested to treat non-metastatic prostate cancer, which is an off-label (non-FDA approved) use.The enrollee is a 78-year-old man with prostate cancer. He has been treated with radiation and castration and Casodex. He has rising PSA and scan shows tumor in the prostate bed. The prescriber requests Zytiga to be given with Prednisone to treat him. There is nothing in the submitted documentation to indicate the enrollee has metastatic prostate cancer. Zytiga is indicated for metastatic prostate cancer.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 Zytiga 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 Zytiga. 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.