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

You asked the Plan to cover Nulojix. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part B local policy states that immunosuppressive drugs are covered only for the specific labeled indications and approval for marketing by the FDA (bp 102 c15, ?50.5.1). Parenteral Belatacept (Nulojix) is not proven to be safe when administered in the home setting and therefore will be denied as not medically necessary when provided in that setting. CGS Administrators, LLC, Local Coverage Determination for Immunosuppressive Drugs (L33824). The case record indicates that Nulojix will be administered in the home. Nulojix would therefore not be eligible for coverage under Medicare Part B in this case. Thus, Nulojix is eligible for coverage under Medicare Part D.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Nulojix 250 mg.The drug is requested to prevent Kidney transplant rejection. 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 Nulojix.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lupron Depot 11.25 mg IM inj. 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 Lupron Depot, 11.25 mg.The drug is requested to treat anemia due to heavy menstruation/menorrhagia in a 37 year old quadriplegic woman, 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 Lupron Depot 11.25 mg IM inj 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 Lupron Depot 11.25 mg IM inj.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

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 Hydrocodone/Acetaminophen 10/325 mg tablet, 90 per 30 days. 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 Hydrocodone-Acetaminophen 10-325 mg, 90 per 30 days.The drug is requested to treat chronic pain. The Plan limits the amount of the drug to 370 per 30 days. The requested quantity is within the number of doses allowed by the Plan. Our Physician Reviewer's opinion is that quantity limit criteria are met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. Based on a review of the available documentation, our Physician Reviewer's opinion is that the dose requested is within the allowed quantity limit. Therefore, the Plan is required to cover the requested quantity of Hydrocodone/Acetaminophen 10/325 mg tablet, 90 per 30 days.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 Ipratropium/Albuterol 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 Ipratropium/Albuterol Solution for the management of obstructive pulmonary disease.  In this case, the record shows that Ipratropium/Albuterol Solution is administered through a nebulizer in the home for a diagnosis of J44.9 chronic obstructive pulmonary disease. 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 Ipratropium/Albuterol 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 Auryxia. 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 Auryxia.    Auryxia is requested to treat iron deficiency anemia in this patient with stage 4 chronic kidney disease, not on dialysis. Prescription vitamins/minerals are excluded from coverage under Medicare Part D. Our Physician Reviewer's opinion is that Auryxia is excluded from coverage under Medicare Part D.  Medicare law excludes certain drugs from Part D coverage. Auryxia is one of those excluded drugs because it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicate that they provide supplemental coverage for Auryxia. Therefore, the Plan is not required to cover Auryxia.   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 provide a tiering exception for Buprenorphine-Naloxone. 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 Buprenorphine-Naloxone 8-2 mg Film. The drug is requested to treat opioid dependence. The drug is a GENERIC drug on Tier 4 of the Plan's formulary. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.  Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Buprenorphine-Naloxone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Privigen. 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 Privigen. The drug is requested to treat antibody mediated rejection of lung transplant due to donor-specific antibodies, 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 Privigen 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 Privigen.  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 Lidocaine 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 chest wall pain due to thoracentesis, 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 Lidocaine 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 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz XR, 11 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 Xeljanz XR, 11 mg.The drug is requested to treat rheumatoid arthritis. Upon reconsideration, the prescribing physician states that the enrollee has needle phobia. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan's prior authorization criteria, and to submit documentation supporting that the enrollee has needle phobia to the degree that the enrollee has previously refused any injectable therapy or medical procedure. The requested documentation was not submitted. 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.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 Xeljanz XR, 11 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cresemba. 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. The drug is requested fungal/mold prophylaxis, which is an off-label (non-FDA approved) use.The enrollee is a 47 year old man with multiple myeloma who has had an allogeneic bone marrow transplant. He developed graft vs host disease and has biopsy demonstrated bile duct injury. His ALT is elevated. There is no submitted documentation indicating fungal infection. He has been on Micafungin which requires daily infusions which are not feasible long term. Other drugs such as Voriconazole, Posaconazole and Fluconazole would cause further liver injury. You request Cresemba to treat him. Medical literature was cited in support of the request.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 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.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

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 Farxiga 5 mg, Pantoprazole DR 40 mg, Amlodipine Besylate 5 mg, Ciprofloxacin HCL 500 mg, Alendronate Sodium 70 mg, Janumet 50-1,000 mg, Atorvastatin 40 mg and Enalapril Maleate 10 mg. 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. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. Farxiga 5 mg, Pantoprazole DR 40 mg, Amlodipine Besylate 5 mg, Ciprofloxacin HCL 500 mg, Alendronate Sodium 70 mg, Janumet 50-1,000 mg, Atorvastatin 40 mg and Enalapril Maleate 10 mg are Part D eligible drugs. The documentation provided by the Plan shows the pharmacy used is an in-network pharmacy. Proof of payment for these drugs has been provided. The documentation shows the pharmacy would not use the Part D benefit to submit these claims despite you providing insurance information. The Plan has not provided any documentation that these claims have been paid by the Plan, nor has the Plan provided any reason why these claims should not be paid at this time.The case record indicates that the Plan did not provide coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is required to process and provide any reimbursement for Farxiga 5 mg, Pantoprazole DR 40 mg, Amlodipine Besylate 5 mg, Ciprofloxacin HCL 500 mg, Alendronate Sodium 70 mg, Janumet 50-1,000 mg, Atorvastatin 40 mg and Enalapril Maleate 10 mg.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xalkori. 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 Xalkori 250 mg; 60/30. The drug is requested to treat alveolar soft part sarcoma, which is an off-label (non-FDA approved) use. The enrollee is a 36 year old woman with metastatic alveolar soft part sarcoma involving lung, brain, liver and bone. She has been treated with surgery, Sorafenib, Temsirolimus, Afinitor, Pazopanib, Sutent, Nivolumab, Vandetanib, Axitinib, radiation, radiofrequency ablation, RGX104 on a clinical trial, radioembolization, Anlotinib on a clinical trial, and Cabozantinib. Recent scans show new liver and bone lesions. The prescriber requests Xalkori to treat her. Medical literature was submitted in support of the request and was reviewed.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 Xalkori 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 Xalkori. 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.