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

You asked the Plan to cover Mekinist. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Mekinist 0.5 mg (60/30). Mekinist is requested to treat C56.9 - Malignant neoplasm of unspecifiedovary (low grade serous ovarian cancer). The enrollee has low grade gynecological cancer and is status post2 cycles of Carboplatin/Taxol; you plan to continue Letrozole and add Trametinib (Mekinist) at half dose.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. NCCN (National Comprehensive Cancer Network) Drugs & BiologicsCompendium states for Mekinist: Ovarian Cancer, Useful in certain circumstances for persistent disease orrecurrence of low-grade serous carcinoma. For progression on primary, maintenance, or recurrencetherapy. Also note that the submitted ICD-10 code of C56.9 is listed in NCCN as a covered diagnosis. TheNCCN category of treatment is 2A.Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the useof the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribedfor a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. You havendicated why all alternatives required by the Plan would likely not be as effective as the requested drug forthe enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, anexception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is thatprior 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 Mekinist.
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 tibial neuropathy, 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 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolic Acid DR. 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 that Medicare Part A paid for the transplant in question.Mycophenolic Acid DR:The case record indicates that Mycophenolic Acid DR is needed for a kidney transplant performed May 22, 2011. According to the case record, the transplant in question was paid for by Medicare Part A. Thus, the transplant is considered a Medicare covered transplant and Mycophenolic Acid DR 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 Mycophenolic Acid DR, Tacrolimus and Prednisone. 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 Ure-na. The Plan did not grant this request. We received this case to conduct an independent review.Medicare 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, Ure-na is not eligible for Part D coverage, and the Plan is not required to cover 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

You asked the Plan to cover Modafinil. 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 Modafinil. The drug is requested to treat fatigue secondary to scleroderma, coronary artery disease, congestive heart failure and end-stage renal disease, 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 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 Modafinil 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 Modafinil. 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 Actemra. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Actemra 400 mg/20 ml sol. The drug is requested to treat antibody mediated rejection in a renaltransplant recipient, which is an off-label (non-FDA approved) use. The Medicare-approved compendia donot contain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Actemra for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Actemra.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Entresto. 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 Entresto 49/51 mg. The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Entresto.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Calquence. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Calquence 100 mg cap. The drug is requested to treat stage IV mantle cell lymphoma in an enrolleepreviously treated with the Nordic chemotherapy regimen. For coverage under the prescription drugbenefit, Medicare requires that the drug prescribed be used for a medically accepted indication. OurPhysician Reviewer found that the Medicare-approved resources do contain citations to support the use ofthe requested drug for treatment of the noted condition.The product label, available at drugs@fda, states:CALQUENCE is a kinase inhibitor indicated for the treatment of adult patients with: Mantle celllymphoma (MCL) who have received at least one prior therapy.Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee satisfiesthe Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofCalquence for the diagnosed condition. As a result, Calquence is being prescribed for a medically acceptedindication as defined by Medicare law.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs.Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria aremet. Therefore, our decision is the Plan is required to cover Calquence.
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 conductan independent review.Medicare Part B local policy states that immunosuppressive drugs are covered only for the specificlabeled indications and approval for marketing by the FDA. The Medicare Part B rules state thatparenteral Belatacept (Nulojix) is not proven to be safe when administered in the home setting, andtherefore will be denied under Medicare Part B as not medically necessary when provided in that setting.The case record indicates that Nulojix will be administered in the home. Nulojix would therefore not beeligible for coverage under Medicare Part B in this case. Thus, Nulojix may be eligible for coverageunder Medicare Part D. We therefore asked our Physician Reviewer to determine if Part D coveragecriteria have been met, including addressing safety concerns.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Nulojix 250 mg. The drug is requested for the prophylaxis of renal transplant rejection. The case recordindicates that Nulojix will be administered in the home. Nulojix would therefore not be eligible forcoverage under Medicare Part B in this case. Thus, Nulojix may be eligible for coverage under MedicarePart D. Nulojix 250 mg is not on the Plan's formulary. Medical records provided document that the enrolleehas been currently using Tacrolimus, Mycophenolate Mofetil and Prednisone for the treatment of theenrollee's condition. You have not indicated why all alternatives required by the Plan would likely not be aseffective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harmto the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our PhysicianReviewer'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 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 not met.Therefore, the Plan is not required to cover Nulojix.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron HCL. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ondansetron HCL 4 mg. The drug is requested to treat nausea/vomiting associated with chronicmigraines, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Ondansetron HCL for the diagnosed condition. As a result, thedrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forOndansetron HCL.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lansoprazole DR. The Plan did not grant this request. We received this case toconduct an independent review.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer needed additional information from you to determine whether the enrollee is usingLansoprazole DR for an FDA-approved use, or a use listed in the Medicare-approved compendia. Therequested information was not received. As a result, we could not confirm that the drug is being prescribedfor a medically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit. An exceptions request based on medical necessity cannot be considered because itcannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decisionis that the Plan is not required to provide coverage for Lansoprazole DR.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxymorphone HCL ER, 15 mg tablet. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forOxymorphone HCL ER, 15 mg tablet, which is not on the Plan's formulary. Our Physician Reviewerneeded additional information including medical records from the prescriber to make this determination.The prescriber was asked to address whether the drugs offered by the Plan would: (1) not be as effective asthe requested non-formulary drug; and/or (2) have adverse effects. The requested information was notreceived. Based on a review of the available documentation, our Physician Reviewer's opinion is thatformulary 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 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 not met.Therefore, the Plan is not required to cover Oxymorphone HCL ER, 15 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Cyclosporine. The Plan did not grant this request. We received this case toconduct an independent review.The case record indicates that Cyclosporine is needed for a stem cell transplant performed January 28,2020. In this case, we sent a request for additional information to the Part D Plan. We requested theevidence that the Plan used to determine that Medicare paid for the transplant performed January 28, 2020.The Plan did not respond to our request and failed to provide claims data that supports that Medicre paidfor the transplant in question. Based on the available information, we cannot verify that coverage would beavailable for the requested drug under Medicare Part B. Therefore, we asked our Physician Reviewer todetermine if other Medicare Part D coverage criteria are met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Cyclosporine 25 mg. The drug is requested to treat graft-versus-host disease. For coverage under theprescription drug benefit, Medicare requires that the drug prescribed be used for a medically acceptedindication. Our Physician Reviewer found that the Medicare-approved resources do contain citations tosupport the use of the requested drug for treatment of the noted condition.The following citation in DrugDex, a Medicare approved compendium, supports the use of the requesteddrug for the enrollee's condition:Orphan drug designation: Treatment and prevention of graft-versus-host diseaseTherefore, the requested drug is being prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofCyclosporine for the diagnosed condition. As a result, Cyclosporine is being prescribed for a medicallyaccepted indication as defined by Medicare law.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs.Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria aremet. Therefore, our decision is the Plan is required to cover Cyclosporine.