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

You asked the Plan to cover Bethkis. 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 Bethkis for the management of cystic fibrosis or bronchiectasis. We requested additional medical information to determine if criteria for Medicare Part D have been met. We requested the enrollee's diagnosis and ICD-10 code for which Bethkis has been prescribed, and confirmation of where this drug is being administered. A response to our request was not received in the timeframe required for review of this case. There is insufficient information to show that this drug is not eligible for Medicare Part B coverage. As a result, the record does not establish that Bethkis is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Bethkis. 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 provide a tiering exception for Edecrin. The Plan did not grant this request. Wereceived this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in thespecialty tier are not eligible for a tiering exception. Edecrin is in the specialty tier. The record indicates thePlan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is notrequired to provide a tiering exception for Edecrin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Intron A purchased at the pharmacy on March 17,2020 purchased on March 17, 2020 from your pharmacy. The Plan did not grant this request. We receivedthis case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrolleepays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof ofpayment to ask the Plan to pay its share of the cost. The Plan required a 50% copayment for up to a 30 daysupply of a Tier 5 drug purchased from a standard retail pharmacy in 2020. A request for reimbursementwas submitted to the Plan. In this case, the Plan provided documentation showing that this claim wascovered by the Plan at the time of purchase. The record shows that Intron A purchased at your pharmacy onMarch 17, 2020 was purchased for an amount that is less than or equal to the required copayment amount.The case record indicates that the Plan provided coverage in accordance with the Part D contract.Therefore, our decision is the Plan is not required to provide reimbursement for Intron A purchased at yourpharmacy on March 17, 2020.With regard to the March 3, 2020 purchase, the Plan has documented that this request had been processedunder Medicare Part B.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Compounded heparin powder, lidocaine powder, benzoyl alcohol, sodiumhydroxide, sterile water, and sodium phosphate dibasic anhydrous powder. The Plan did not grant thisrequest. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Compounded heparin powder, lidocaine powder, benzoyl alcohol, sodium hydroxide,sterile water, and sodium phosphate dibasic anhydrous powder is not FDA approved for both safety andeffectiveness by checking FDA sources. Therefore, the Plan is not required to cover Compounded heparinpowder, lidocaine powder, benzoyl alcohol, sodium hydroxide, sterile water, and sodium phosphate dibasicanhydrous powder.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Foltanx. The Plan did not grant this request. We received this case to conductan independent review.Medicare Part D does not cover medical foods. Foltanx is a medical food. Therefore, Foltanx is not eligiblefor 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 product. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Epogen. The Plan did not grant this request. We received this case to conduct an independent review.Please note, the Plan denied coverage for Epogen stating it would be covered under Medicare B; however the case file and records received indicate that the enrollee is not on dialysis. We therefore, sent this to our Physician Reviewer to see if criteria was met 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 Epogen 4000 unit/ml solution. The drug is requested to treat anemia in chronic kidney disease, not on dialysis. 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. On June 19, 2020 you sent additional information and medical records addressing the Plan's coverage criteria and clarifying that the enrollee is no longer on dialysis. Therefore, the requested drug is being prescribed for a medically accepted indication. You have 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. You did indicate that formulary alternative Procrit would be acceptable for the enrollee if the Plan would approve it.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 Epogen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Corlanor. 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 Corlanor 5mg. The drug is requested to treat inappropriate sinus tachycardia, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use ofthe requested drug, as prescribed, for treatment of the noted condition. 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. 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 Corlanor 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 Corlanor.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 Lyrica CR. 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 Lyrica CR. The drug is requested to treat neuropathic pain involving the lower extremities in anenrollee with multiple sclerosis, which is an off-label (non-FDA approved) use. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 CR 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 Lyrica CR.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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover and provide reimbursement for Prednisone Gati Ketor Ophthalmic Solution Compound purchased May 4, 2020 at the compounding pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Prednisone Gati Ketor Ophthalmic Solution Compound. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Prednisone Gati Ketor Ophthalmic Solution Compound purchased May 4, 2020 at the compounding pharmacy. This decision does not address the medical necessity or 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 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 10%. The drug is requested to treat D80.1 - Nonfamilial hypogammaglobulinemia. You sent a statement dated June 18, 2020 clarifying the medical history. You state that the enrollee tried Gamunex and had an allergic reaction. Privigen 10% is not on the Plan's formulary. Hizentra is on the Plan's formulary. You have 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 Privigen.
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 Cyclobenzaprine. 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 10 mg tab. Cyclobenzaprine 10 mg tab 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 Cyclobenzaprine 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. 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 provide reimbursement for Ursodiol 250 mg purchased on February 18, 2020 from the pharmacy. 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. In this case, documentation in the record shows that the enrollee was in the deductible stage when Ursodiol 250 mg was purchased on February 18, 2020 from the pharmacy. During the deductible stage, the Plan requires that the enrollee pay the full cost of Tier 3, Tier 4 and Tier 5 drugs purchased in 2020 before the Plan would pay a share of the cost. Ursodiol 250 mg was on the Plan's 2020 formulary and was classified as a Tier 3 drug. The Plan provided documentation showing that this claim was covered by the Plan at the time of purchase, and that the full cost of the purchase in dispute was applied to the required deductible amount. The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is not required to provide reimbursement for Ursodiol 250 mg purchased on February 18, 2020 from the pharmacy.
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 Lyrica 75 mg. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lyrica 75 mg. The drug is requested to treat G62.9 Polyneuropathy, unspecified. Lyrica 75 mg is not on the Plan's formulary. Pregabalin 75 mg capsule and Lyrica CR are on the Plan's formulary. You have 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 Lyrica.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Ozempic 2 mg/1.5 mL purchased May 15, 2020. The Plan did not grant this request. We received this case to conduct an independent review.In this case, the records show that when Ozempic 2 mg/1.5 mL was purchased on May 15, 2020, the claim straddled both the deductible stage and the initial coverage stage of the Part D benefit. An enrollee is responsible for the full cost of covered drugs until the deductible amount $200 is satisfied. The initial coverage phase requires a $47 copayment amount for this drug and day supply purchased. The Plan documentation shows that the total cost of the drug was $822.80 and that there was $200 remaining in the deductible phase of coverage. You paid $200 which was applied to the deductible stage of coverage. This amount is subtracted from the total cost of the drug. This remaining balance was subject to the initial coverage stage copayment amount of $47. The total of the two figures owed during each benefit phase (deductible and initial coverage) is $247. The record shows that the enrollee was charged an amount that is less than or equal to the required copayment for each phase the claim was processed in. The cost of Ozempic 2 mg/1.5 mL purchased May 15, 2020 was applied to your yearly true out-of-pocket (TrOOP) costs. The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, the Plan is not required to provide additional payment and/or reimbursement for Ozempic 2 mg/1.5 mL purchased May 15, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mekinist and Tafinlar. 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, 30 per 30 days and Tafinlar 50 mg, 120 per 30 days. The drugs are requested to treat pancreatic cancer which is an off-label (non-FDA approved) use. The enrollee is a 66 year old woman with metastatic pancreatic cancer involving peritoneum and nodes. She has been treated with 5FU, Leucovorin, Oxaliplatin, Irinotecan, Gemcitabine, and Abraxane. Caris testing identified a BRAFV600E mutation suggesting possible response to Mekinist and Tafinlar. You request the drugs to be used to treat her. You submitted a list of references in support of the request and these were 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 Mekinist and Tafinlar 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 and Tafinlar. 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.