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

At issue is coverage for Mounjaro 5 milligram per 0.5 milliliter pen-injector to treat type 2 diabetes mellitus with diabetic neuropathy. 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. To grant an exception for a drug not that is not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why all of the formulary alternative drugs listed by the plan 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 Fasenra 30 milligram per milliliter syringe to treat eosinophilic 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 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 coverage for Oxycontin 15 milligram extended-release tablet to treat cancer-related pain. 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. To grant an exception for a drug not that is not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why all of the formulary alternative drugs listed by the plan 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 Lynparza 150 milligram tablet to treat breast cancer (BRCA) gene mutated hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. 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. The Medicare approved journal article submitted does not 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 Cyclophosphamide 50 milligram capsule to treat multiple myeloma. 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 states that coverage has been approved under the enhanced coverage. 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 Quinine Sulfate 324 milligram capsule, 240 capsules per 30 days, to treat Babesiosis infection and leg cramps. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we read the case file carefully. We reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level. The prescriber stated on 10/14/2022 that the medication was prescribed for the treatment of leg cramps.At reconsideration the prescriber clarified the diagnosis as Babesiosis infection. Laboratory reports from 2017, 2018, and 2020 were provided which documented positive IgG titers to Babesia duncani. Relevant medical records were requested but not provided.  The plan limits the amount of Quinine Sulfate 324 milligram capsules to 42 capsules per 7 days. The prescriber has not indicated that the number of doses of the requested drug allowed by the plan would likely be ineffective in treating the diagnosis or would be likely to cause harm. Therefore, an exception to the plans coverage criteria is not supported.  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 Doptelet 20 milligram tablet to treat thrombocytopenia, unspecified, and nonalcoholic steatohepatitis. 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 Posaconazole 100 milligram delayed release tablet to treat paecilomyces lilacinus infection. 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 Qvar Redihaler 80 microgram per actuation 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 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 Metaxalone 800 milligram tablet to treat cervical disc disease with myelopathy. 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 coverage for Trintellix 10 milligram tablet. 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 diagnosis initially provided to the plan for the requested drug is generalized anxiety disorder. However, the use of the requested drug to treat the noted condition 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 condition. At reconsideration, the diagnosis for the requested drug has been changed to major depressive disorder. However, no medical records have been submitted to confirm this newly added diagnosis. The previously submitted physician progress notes indicate the drug was prescribed to treat generalized anxiety disorder. The progress notes do not list major depressive disorder as one of the enrollees conditions. Due to the conflicting information provided and a lack of supporting medical records to confirm the newly added diagnosis, it cannot be determined if the requested drug has been prescribed for a medically accepted indication.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 Atovaquone 750 milligram per 5 milliliter suspension for secondary prophylaxis of toxoplasmosis. 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 product label, available at drugs@fda, states: Mepron (brand name of Atovaquone) oral suspension is a quinone antimicrobial drug indicated for: Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate Trimethoprim-Sulfamethoxazole (TMP-SMX). The prescriber has stated that the Atovaquone is being used as secondary prophylaxis of toxoplasmosis for this patient who has had a bone marrow transplant for acute myelocytic leukemia and will start chemotherapy. Additionally, there is no evidence of intolerance to Trimethoprim-Sulfamethoxazole. Therefore, 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.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. The patient does not have a CD4 cell count less than 200 cells per cubic millimeter within the past 3 months. However, this PA criteria is not relevant to the enrollee's diagnosis. 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 Restasis Droperette 0.05% opthalmic emulsion to treat keratoconjunctivitis sicca. 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 Besremi 500 microgram per milliliter syringe to treat thrombocythemia. 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 Taltz auto-injector 80 milligrams per milliliter subcutaneous to treat psoriasis. The Part D plan auto-forwarded 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 Nuedexta 20/10/milligram capsule to treat an enrollee with Alzheimers 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 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 Gabapentin 800 milligram tablet to treat schizoaffective disorder, bipolar type. 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 Xeljanz 5 milligram tablet to treat dermatopolymyositis. 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 a tiering exception request for Eliquis 5 milligram tablet to prevent pulmonary embolism. 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. Eliquis 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 Epogen 4000 units per milliliter vial to treat anemia following chemotherapy. 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 alternative, Retacrit, 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 coverage for Tremfya 100 milligram per milliliter solution pen-injector. The Part D plan denied the request for coverage because the provided diagnosis of guttate psoriasis was not a medically accepted indication for the drug. 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 prescriber statement and medical records submitted at reconsideration indicate that the enrollees guttate psoriasis has evolved into plaque psoriasis. The use of Tremfya for the treatment of plaque psoriasis is a medically accepted indication for the drug as outlined in the Medicare approved compendia. However, Tremfya is not on the plans formulary. To grant an exception for a drug not that is not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the formulary alternative drugs listed by the plan 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 Pregabalin 75 milligram capsules to treat an unknown 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.At reconsideration, a diagnosis of neuropathic pain associated with diabetic peripheral neuropathy was given. However, the medical record dated May 19, 2022, does not define the etiology of the patients stated, neuropathy issue is unchanged and does not further address the physicians treatment of the neuropathy or location of pain. 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 Prolia 60 milligram per milliliter for 3 milliliter per 365 days to treat osteoporosis. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we read the case file carefully. We reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level. The plan limits the amount of Prolia 60 milligram per milliliter prefilled syringe to 1 milliliter per 180 days. The prescriber has not indicated that the number of doses of the requested drug allowed by the plan would likely be ineffective in treating the diagnosis or would be likely to cause harm. Therefore, an exception to the plans coverage criteria is not supported.  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 Opdivo 240 milligrams per 24 milliliter vial to treat metastatic non-small cell lung cancer (adenocarcinoma). 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.