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

You asked the Plan to cover Cyclophosphamide. The Plan did not grant this request. We received this caseto conduct an independent review.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Medicare Part B coverage includes oral anti-cancer drugs thatare prescribed as anti-cancer chemotherapeutic agents providing they have the same active ingredients andare used for the same indications as anti-cancer chemotherapeutic agents which would be covered if theywere not self-administered and they were furnished incident to a physician's service as drugs andbiologicals. This coverage includes FDA approved prodrugs used as anti-cancer drugs. The oral anti-cancerdrug must be used for the same anti-cancer chemotherapeutic indications, including unlabeled or offlabeluses, as the non-self-administrable form of the drug. A claim denied for the reason that the diagnosisdoes not fall in the covered diagnosis section of the Policy Article, titled ICD-10 Codes that are Covered,will receive a statutory denial as non-covered, but may be covered at appeal if used for a medicallyaccepted indication, as defined by Medicare law for oral anti-cancer chemotherapeutic agents.In this case the record shows that Cyclophosphamide is being prescribed for a diagnosis of C56.9Malignant neoplasm of unspecified ovary. Medicare Part B provides coverage for oral anti-cancer drugswhen used as anti-cancer chemotherapeutic agents. It appears Cyclophosphamide may be eligible forcoverage under Medicare Part B for the diagnosis provided in this case. Drugs which are eligible for Part Bcoverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that the Part DPlan is not required to cover Cyclophosphamide.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes 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 Nubeqa. 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 Nubeqa. The drug is requested to treat metastatic castration naive prostate cancer, which is an off-label(non-FDA approved) use.The enrollee is a 67 year old man with metastatic prostate cancer involving bones and probably lymphnodes. He has been treated with surgery. He started initial androgen deprivation therapy (ADT) withDegarelix in April 2020. You request Nubeqa to be given with the Degarelix. You state the drug hasprohibitive drug-drug interactions with Abiraterone and Enzalutamide. Journal articles were submitted andreviewed.Nubeqa is indicated for non-metastatic, castration resistant prostate cancer. The enrollee has metastaticdisease and is castration naive, having just begun ADT. Therefore he does not meet either of the criteria fora medically accepted use. The Medicare-approved compendia do not contain any citations to support theuse 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 requesteddrug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drugis 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. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically acceptedindication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals orpublications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia and there was no peer-reviewed literature from an approved journal submitted tosupport the use of Nubeqa for the diagnosed condition. As a result, the drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit for this condition. An exceptions request based on medical necessity cannot beconsidered 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 Nubeqa.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

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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide a tiering exception for Propranolol. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor a tiering exception for Propranolol 10 mg. The drug is requested to treat atrial fibrillation. Propranolol10 mg is a generic drug on Tier 2 of the Plan's formulary. You did not state why all available lower tieralternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for theenrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, anexception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exceptioncriteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that thehigher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistentwith the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are notmet. Therefore, our decision is the Plan is not required to provide a tiering exception for Propranolol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Magic Mouthwash compound. 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 Store-brand Antacid/Anti-Gas Oral Suspension and Store-brand Allergy Relief Childrens Oral Liquid, parts of Magic Mouthwash compound are non-prescription or OTC drugs. Therefore, Store-brand Antacid/Anti-Gas Oral Suspension and Store-brand Allergy Relief Childrens Oral Liquid, parts of Magic Mouthwash compound are not eligible for Part D coverage, and the Plan is not required to cover them under the Part D benefit. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Prolia. 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. The drug is requested to treat osteoporosis. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. The drug is on Tier 4 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 Prolia.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Auryxia, 210 mg tablet. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Auryxia, 210 mg tablet.The drug is requested to treat iron deficiency anemia in chronic kidney disease (not on dialysis), which isan off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations tosupport the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, therequested drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, an exceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 Auryxia, 210 mg tablet for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Auryxia, 210 mg tablet.Medicare law excludes certain drugs from Part D coverage. Auryxia, 210 mg tablet is one of thoseexcluded drugs because it is a prescription vitamin and mineral product. The record submitted by the Plandoes not indicate that they provide supplemental coverage for Auryxia, 210 mg tablet. Therefore, the Planis not required to cover Auryxia, 210 mg tablet.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 Ubrelvy. 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 Ubrelvy. The drug is requested to treat chronic migraine without aura intractable. You state the enrolleehas tried and failed Sumatriptan and Frovatriptan. Ubrelvy is not on the Plan's formulary. You have notindicated why all alternatives required by the Plan would likely not be as effective for the enrollee as therequested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, anexception to the Plan's coverage criteria is not supported. 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 Ubrelvy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha 140 mg/mL. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Repatha 140 mg/mL.The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. 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 Repatha 140 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lyrica. 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 Lyrica 75 mg capsules. The drug is requested to treat lower extremity pain, which is an off-label (non-FDA approved) use. With the Reconsideration appeal dated 5/12/2020 relevant medical records wererequested and were not provided. The Medicare-approved compendia do not contain any citations tosupport the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, therequested drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, an exceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 Lyrica for the diagnosed condition. As a result, the drug is notbeing 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 Lyrica.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: 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 Repatha SureClick 140 mg/mL as prescribed. 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 Repatha SureClick.Repatha SureClick is requested for treatment of clinical atherosclerotic cardiovascular disease with persistent LDL elevation of 145 on January 28, 2020 who has had intolerance to Lipitor, Crestor, and Simvastatin. The prescriber is a cardiologist. It is unclear if the Plan's coverage criteria have been met.The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. 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 Repatha SureClick 140 mg/mL as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lynparza. 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. The drug is requested to treat lung cancer, which is an off-label (non-FDA approved) use. The enrollee is a 70 year old woman with metastatic adenocarcinoma of the lung involving lung, nodes, liver, bones and soft tissue of the left upper extremity. She has been treated with Carboplatin, Pemetrexed, and Bevacizumab. Her tumor does not have a molecular target such as EGFR, ALK, ROS, BRAF and the PDL1 level is 0%. Omniseq testing identified BRCA2 copy loss suggesting possible response to Lynparza. The prescriber requests Lynparza to treat her.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 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 Balversa. 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 Balversa. The drug is requested to treat tonsil cancer, which is an off-label (non-FDA approved) use.The enrollee is a 56 year old man with metastatic tonsil cancer involving lungs, liver and bones. He hasbeen treated with Cisplatin, Keytruda and Paclitaxel. Imaging on April 20, 2020 showed progression of thecancer. Guardant360 testing identified an FGFR rearrangement suggesting possible response to Balversa.The prescriber requests Balversa to treat him.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medicalliterature from an approved journal submitted to support this appeal. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically acceptedindication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals orpublications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia and there was no peer-reviewed literature from an approved journal submitted tosupport the use of Balversa for the diagnosed condition. As a result, the drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit for this condition. An exceptions request based on medical necessity cannot beconsidered 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 Balversa.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.