Persius/hicric huggingface dataset:
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 Potassium Chloride 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 Potassium Chloride ER. Potassium Chloride 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 reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Potassium Chloride ER 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 Potassium Chloride 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.Please note: the request for a tiering exception (lower copayment) for Potassium Chloride ER was not reviewed. We cannot consider a tiering exception for Potassium Chloride ER if it cannot be confirmed that it meets the definition of a Medicare Part D drug.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lynparza 150 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 Lynparza 150 mg tablet. The drug is requested to treat metastatic bladder cancer in an enrollee status post (s/p) radical cystectomy with pelvic lymph node dissection LND), history of coronary artery disease, s/p CABG, AVR, and HTN, which is an off-label (non-FDA approved) use. The enrollee is an 80 year old male who received 4 cycles of neoadjuvant split dose Cisplatin and Gemcitabine. He underwent a radical cystectomy with pelvic LND. The enrollee continued with chemotherapy and received concurrent radiation therapy. The enrollee was diagnosed with liver metastases and maintained on Docetaxel. In June 2020, there was disease progression with enlarged liver lesions and therapy was changed to Enforumab Vendotin. Genetic testing revealed a small allele fraction of pathogenic ATM mutation. Per the prescriber, the enrollee has exhausted all of the treatment options and stated that multiple studies have shown benefits from PARP inhibitors (Olaparib). The prescriber has requested the off-label use of Lynparza (Olaparib). 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. 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 Lynparza 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 Lynparza.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 Mekinist 2 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 Mekinist 2 mg tablet. The drug is requested to treat NRAS mutated thyroid cancer in combination with Votrient, 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. 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 Mekinist 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 Mekinist.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 Gralise 600 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 Gralise 600mg tablet. The drug is requested to treat peripheral neuropathy and chronic pain syndrome, 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. 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 Gralise 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 Gralise. 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 provide reimbursement for Acetaminophen 325 mg, Diltiazem 120 mg, Losartan 50 mg, Metoprolol Tartrate 100 mg, Oxycodone 5 mg, Sertraline 50 mg and 100 mg, Tramadol 50 mg and Amoxicillin-Clavulanate 875-125 mg. The Plan did not grant this request. We received this case to conduct an independent review.Diltiazem, Losartan, Metoprolol Tartrate, Oxycodone, Sertraline, Tramadol and Amoxicillin-ClavulanateThe Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you received Diltiazem 120 mg, Losartan 50 mg, Metoprolol Tartrate 100 mg, Oxycodone 5 mg, Sertraline 50 mg and 100 mg, Tramadol 50 mg and Amoxicillin-Clavulanate 875-125 mg for an emergency or urgent care situation. You requested reimbursement from the part D Plan and submitted an itemized statement from the hospital. Proof of payment for the self-administered drug portion of the bill has been verified. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for Diltiazem 120 mg, Losartan 50 mg, Metoprolol Tartrate 100 mg, Oxycodone 5 mg, Sertraline 50 mg and 100 mg, Tramadol 50 mg and Amoxicillin-Clavulanate 875-125 mg.AcetaminophenMedicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Acetaminophen 325 mg received is not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for it 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: 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 provide reimbursement for Acetaminophen 500 mg and Monurol (Fosfomycin Tromethamine) 3 gm. The Plan did not grant this request. We received this case to conduct an independent review.Monurol (Fosfomycin Tromethamine)The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstance. .In this case, you received Monurol (Fosfomycin Tromethamine) 3 gm while at the hospital for an emergency or urgent care situation. You requested reimbursement from the Part D Plan and submitted an itemized statement which shows proof of payment for Monurol (Fosfomycin Tromethamine). The Plan did not process the request on the basis that Monurol (Fosfomycin Tromethamine) is not on the Plan's 2020 Formulary. Monurol (Fosfomycin Tromethamine) is an FDA approved, prescription only, Part D eligible drug. Because this was a hospital stay, you were not in a position to obtain the drugs that had been previously filled at a network pharmacy, nor were they able to obtain prior authorization or off-formulary exception review. Since this was a one-time emergency stay, the Plan should provide an exception to their normal coverage rules. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for Monurol (Fosfomycin Tromethamine) 3 gm.AcetaminophenMedicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Acetaminophen 500 mg received is not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for it 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 Insulin Aspart (NovoRapid) purchased while outside the United States and its territories. The Plan did not grant this request. We received this case to conduct an independent review.Insulin Aspart (NovoRapid) is not covered by Medicare because it was purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Insulin Aspart (NovoRapid). This decision does not concern the medical 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 Cyclobenzaprine 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 Cyclobenzaprine HCL 5mg Tablet. The drug is requested to treat muscle cramps due to end stage renal disease requiring dialysis, 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 Cyclobenzaprine HCL 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 Cyclobenzaprine HCL. 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 Tremfya 100 mg/ml syringe. 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 Tremfya 100 mg/ml syringe. The drug is requested to treat psoriasis vulgaris. The prescriber has not indicated why all alternatives required by the Plan (Cosentyx) 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. The prescriber has stated that the formulary alternative Cosentyx is contraindicated for the enrollee due to a history of skin cancer and irritable bowel syndrome; neither of the Medicare-approved drug compendia report these conditions as contraindications to the use of Cosentyx. 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 Tremfya.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil 500 mg tablet. The drug is requested to treat undifferentiated connective tissue 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil.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 Envarsus XR. 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 Envarsus XR is needed for a kidney transplant performed June 4, 2020. 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 Envarsus XR 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 Envarsus XR. 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 Taltz 80 mg/ml auto-injector. 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 Taltz 80 mg/ml auto-injector. The drug is requested to treat psoriatic arthritis. The prescriber states the enrollee has tried and failed Enbrel. Taltz is not on the Plan's formulary. 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 Taltz.