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

At issue is Sucraid 8500-unit/milliliter oral solution to treat unspecified sucrase-isomaltase deficiency. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. A request for information to clarify the diagnosis was sent to the prescriber; however, no further documentation has been received. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Verzenio 150-milligram tablets to treat high-grade glioma with CDKN2A/B loss. The Part D plan denied the request for coverage.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. 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. The prescriber did not submit any clinically relevant, peer-reviewed medical literature from a Medicare approved journal to support this appeal. As such, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Ciprofloxacin-Dexamethasone 0.3-0.1-percent otic suspension prescribed for treatment-resistant otitis externa and chronic myringitis of the left ear. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The noted conditions are off-label uses for the requested drug. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of these conditions. Therefore, the drug is being prescribed for non-medically accepted indications.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Aubagio 14-milligram tablets to treat multiple sclerosis. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, all alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the prescriber has not addressed all formulary alternatives required by the plan to treat the enrollees condition and provided sufficient patient specific clinical rationale as to why each formulary alternative would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Therefore, the formulary exception criteria have not been met.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Gamunex-C 20-gram/200-milliliter vial. The case was auto-forwarded by the plan.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Gamunex-C is a biologic on Tier 4 of the plans formulary. There are no biologics of the same type on the lower tiers of the plans formulary. Therefore, this biologic is not eligible for a tiering exception.A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Dulera 200-5-microgram hydrofluoroalkane (HFA) aerosol with adapter to treat mild persistent asthma, uncomplicated. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.This drug is being provided by the plan under a formulary exception. It is not on the plans formulary but they have agreed to provide it at a cost sharing level assigned to all formulary exceptions. Per Medicare rules, non-formulary drugs are not eligible for a tiering exception.A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Auryxia 210-milligram tablet prescribed to treat secondary hyperphosphatemia in an enrollee with chronic kidney disease who is currently receiving dialysis. The Part D plan denied the request for coverage because the drug was not on the plans formulary and the submitted documentation did not support a formulary exception. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. We also researched Medicare systems and reviewed the enrollment data available.Medicare systems show the enrollee currently has end stage renal disease coverage while receiving dialysis. Drugs used for enrollees with end stage renal disease coverage who are receiving dialysis would be covered under Medicare Part B, as these drugs are included in the Medicare Part B bundled payment to an end stage renal disease dialysis facility. Drugs covered under Medicare Part B are not available for coverage under Medicare Part D. It should also be noted that Auryxia, which is ferric citrate, is a mineral product. Prescription vitamin and mineral products are excluded from coverage under Medicare Part D. Therefore, the requested drug is not available for coverage under Medicare Part D, as the drug is available for coverage under Medicare Part B and the drug is a prescription mineral product. Since the drug is not eligible for coverage under the Part D plan, a formulary exception is not relevant to this review.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Xifaxan 550 milligram tablet for the treatment of Crohn's disease and irritable bowel syndrome with diarrhea. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The plan has prior authorization requirements for this drug. These requirements must be met before coverage can be extended. The submitted documentation does not satisfy the plans coverage criteria. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Vemlidy 25-milligram tablet to treat Hepatitis B. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The plan has prior authorization requirements for this drug. These requirements must be met before coverage can be extended. The submitted documentation does not satisfy the plans coverage criteria.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Diclofenac Sodium 3 percent gel for the treatment of pain in knee, radiculopathy, and pain in shoulder. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Anoro Ellipta 62.5-25 microgram blisters with device to treat cough variant asthma. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The following citation in DrugDex, a Medicare approved compendium, does not support the use of the requested drug for the enrollees condition: 'Umeclidinium bromide/vilanterol trifenatate is not indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and efficacy of umeclidinium bromide/vilanterol trifenatate in asthma have not been established.' The use of the requested drug to treat the provided diagnosis is an off-label use.  The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Xarelto 20-milligram tablet to treat blood clots. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. Xarelto is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception. A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Gengraf 25-milligram capsule prescribed daily for kidney transplant. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. We also researched Medicare systems and reviewed the enrollment data available. We determined that the plan is not required to cover the drug. Medicare records indicate the enrollee received a kidney transplant, which was covered by Medicare Part A. Therefore, the transplant is considered a Medicare covered transplant and the requested drug is eligible under Medicare Part B. Medicare rules state that a drug covered under Part B cannot be covered under Part D. This decision does not address the medical necessity or appropriateness of the drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Betamethasone Sodium Phosphate powder to treat chronic allergic fungal sinusitis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The record shows Betamethasone Sodium Phosphate powder is an ingredient for a compounded drug, which includes Gentamicin Sulfate powder and Sodium Chloride 0.9%. None of the ingredients satisfies the definition of a Part D drug. In addition, the requested product is not an approved drug by the Food and Drug Administration (FDA). Products not approved as drugs by the Food and Drug Administration are excluded from coverage under the Medicare Part D drug benefit. Therefore, this drug is not eligible for coverage under Medicare Part D.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Esomeprazole Magnesium Delayed Release 40 milligram capsule to treat gastroesophageal reflux disease. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried, failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives, required by the plan would likely not be as effective for this diagnosis, and/or would likely cause adverse reaction(s) or other harm. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Amitiza 24 microgram capsule. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. This drug is being provided by the plan under a formulary exception. It is not on the plans formulary but they have agreed to provide it at a cost sharing level assigned to all formulary exceptions. Per Medicare rules, non-formulary drugs are not eligible for a tiering exception. A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Qsymia 3.75-milligram-23-milligram to treat obesity. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Drugs prescribed to treat weight gain (promote weight loss) are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Verzenio 150-milligram tablets to treat retroperitoneal sarcoma. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. Medicare-approved compendia do not contain any citations to support the use of the requested drug as prescribed, for treatment of the noted diagnosis. 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.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Jakafi 200-milligram tablets to treat alopecia universalis and monoclonal gammopathy. The Part D plan denied the request for coverage.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. 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. The prescriber did not submit any clinically relevant, peer-reviewed medical literature from a Medicare approved journal to support this appeal. As such, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Copaxone 40-milligrams/milliliter to treat multiple sclerosis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.This drug is being provided by the plan at the cost sharing level of the Specialty tier. Specialty tier drugs are not available for a tiering exception per Medicare rules. A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Droxidopa 300-milligram capsule to treat neurogenic orthostatic hypotension. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The drug at issue is not on the plans formulary. The prescriber provided patient specific clinical rationale supported by documentation, indicating why the formulary alternatives, required by the plan, would likely not be as effective as the requested drug for this diagnosis, and/or would likely cause adverse reaction(s) or other harm. Specifically, the prescriber submitted medical records that show the enrollee has tried and failed Midodrine and Florinef. Therefore, an exception to the plans formulary coverage criteria is medically necessary.A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Xiidra 5 percent eye drops to treat an unspecified diagnosis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.This drug is being provided by the plan under a formulary exception. It is not on the plans formulary but they have agreed to provide it at a cost sharing level assigned to all formulary exceptions. Per Medicare rules, non-formulary drugs are not eligible for a tiering exception.A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Levothyroxine 125-microgram tablet to treat hypothyroidism. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The request was initially for capsules of Levothyroxine which are not on formulary. However, the enrollee has sent in supporting evidence that the form of Levothyroxine requested is tablets and capsule was a mistake on the request form. The use of the requested drug to treat the provided diagnosis is supported in Medicare approved compendia. There are no prior authorization requirements and Levothyroxine tablets are on formulary. Therefore, the requested drug(s) is eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a direct member reimbursement request for Prolia 60-milligram/milliliter syringe. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. Based on the information provided, we determined the drug may be eligible for coverage under Part B under Medicare rules.The plan does not offer supplemental (additional) coverage for this drug. If the enrollee purchased drugs that are excluded, the enrollee must pay for them. This decision does not address the medical necessity or appropriateness of the drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Intrarosa 6.5 milligram vaginal insert prescribed for unknown diagnosis. The Part D plan denied the request.We received the case to perform an independent and de novo review of this request for coverage. We reviewed all documentation submitted for review, including the case file from the plan, and any information submitted at the reconsideration level. The plan submitted documentation showing the requested drug was previously denied for a tier exception. Therefore, the dates of fill for the requested drug are not eligible for reimbursement consideration.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Elmiron 100 milligram capsule to treat interstitial cystitis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. Elmiron is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Lidoderm 5-percent patch to treat chronic back pain. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.We requested additional information from the prescriber. Specifically, we requested medical records and a prescriber statement to support the enrollee has satisfied the plans prior authorization coverage criteria. We received additional documentation and included it in the review.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.