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

At issue is Dupixent 300 milligram per 2 milliliter solution to treat eczema. 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 Mavenclad 10 milligram tablet 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.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 Clinimix E/Dextrose 8/14 percent solution to treat malignant neoplasm of oropharynx, unspecified. 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 Rexulti 0.5 milligram tablet to treat depression. 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 Epolamine 1.3 percent patch to treat low back pain, muscle spasm. 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 Xyrem 500 milligram per milliliter solution to treat chronic insomnia. 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 Promacta 50 milligram tablet to treat immune thrombocytopenia purpura. 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 Wegovy 0.5 milligram per 0.5 milliliter injection 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 anorexia and/or promote weight loss, unrelated to AIDS wasting or cachexia due to certain chronic diseases, 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 Elmiron 100 milligram capsule to treat bladder hypersensitivity. 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 interstitial cystitis was given. However, no documentation was provided by the prescriber to support this diagnosis. We are not able to determine whether the requested drug(s) was prescribed for a medically accepted indication. Therefore, the 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 deep vein thrombosis. 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 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 a tiering exception request for Trileptal 300 milligram tablet to treat seizure disorder. 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.Trileptal is a brand drug on Tier 3 of the plans formulary. There are no 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 Cincalcet hydrochloride 30 milligram tablet prescribed for secondary hyperparathyroidism after kidney transplant, not on dialysis. 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 is not eligible for coverage under Medicare Part D. This decision does not speak to the medical necessity of this drug; it speaks to whether the Part D drug plan is responsible for payment under the Centers for Medicare and Medicaid Services (CMS) rules.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 2.5 milligram tablets for treatment of a personal history of other venous thrombosis and embolism (DVT). 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: Favorable

At issue is Rubraca 300 milligram tablets to treat advanced pancreatic cancer, BRCA2 mutated. 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 documentation indicates the prescriber ordered the drug at issue for the enrollees diagnosis. The Medicare approved compendia contain a citation to support the use of the drug for the noted diagnosis. The National Comprehensive Cancer Network supports a 2A recommendation for the use of the drug at issue as maintenance therapy as a single agent in patients with germline or somatic BRCA1/2 or PALB2 mutations, if good performance status and no disease progression after at least four to six months of platinum-based chemotherapy. The enrollee has advanced pancreatic cancer with celiac plexus involvement, and received platinum-based chemotherapy. As such, the submitted documentation supports the drug was prescribed for a medically accepted indication. The plan has prior authorization coverage criteria that must be met prior to approval. The enrollee satisfies the Plans coverage criteria. The criteria indicates the enrollee must have a Food and Drug Administration approved indication. The Medicare approved compendia contain a citation to support the use of the drug for the enrollees noted diagnosis. Therefore, an exception to the plans 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 Rybelsus 3 milligram tablets to treat type II diabetes mellitus. 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 Reguloid Original (Metamucil Smooth Texture) 58.6 percent powder. 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 that are available Over the Counter are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is coverage for Tagrisso 80 milligram tablet to treat non-small cell lung cancer with S768 exon 20 mutation. The Part D plan denied the request for coverage because the drug was not being prescribed for a medically accepted indication. 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.As outlined in the plans prior authorization criteria, which are consistent with the Food and Drug Administration (FDA) indications, Tagrisso is not indicated for exon 20 mutated non-small cell lung cancer, except for when there is presence of T790M mutation. However, as outlined in the National Comprehensive Cancer Network (NCCN) guidelines, it is a 2A recommendation for Tagrisso to used as single-agent therapy for recurrent, advanced, or metastatic disease with EGFR S768I, L861Q, and/or G719X mutation positive tumors as first-line therapy. In this case, S768 mutations are included, which the enrollee does have. In addition, the documentation supports the enrollee has advanced disease, as the records show that the enrollee had two large lesions, which were both confirmed to be lung cancer and also the enrollee has bone lesions and subcentimeter (subcm) nodules in the lung. Furthermore, the documentation supports Tagrisso will be used as first-line therapy. As such, the documentation supports that the requested drug is being prescribed for a medically accepted indication, as outlined in the NCCN guidelines. Since the enrollee is being treated for a medically accepted indication outlined in the NCCN guidelines, an exception to the plans diagnosis-specific prior authorization requirements is supported. 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 2023 coverage year tiering exception request for Tranylcypromine Sulfate 10 milligram tablet to treat major depressive disorder. 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.Tranylcypromine Sulfate 10 milligram tablet is a generic drug on Tier 4 of the plans 2023 formulary. There are no drugs of the same type to treat the noted condition on the lower tiers of the plans formulary. If there are no drugs of the same type on a lower tier, the drug is not eligible for a tiering exception. A physician reviewer determined that tiering exception criteria have not been met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Xeljanx XR (extended release) 11 milligram tablets to treat rheumatoid arthritis. 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 Eliquis 5 milligram tablets prescribed for prophylaxis of thromboembolism in patients with atrial fibrillation. 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 Tibsovo 250 milligram tablets to treat advanced cholangiocarcinoma with IDH1 mutation, as first-line treatment. 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: Favorable

At issue is coverage for Octreotide Acetate 100 microgram per milliliter injection solution to treat occult gastrointestinal blood loss due to amyloidosis with cardiac, renal, and gastrointestinal involvement. The Part D plan denied the request for coverage because the drug was not being prescribed for a medically accepted indication. 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.As outlined in one of the Medicare approved compendia for cancer cases, Clinical Pharmacology, Octreotide Acetate can be used for nonvariceal upper gastrointestinal bleeding in patients with amyloidosis, as amyloids can contribute to gastrointestinal bleeding through causing erosions, inflammation and ulcers. As such, the documentation supports the drug is being used for a medically accepted indication outlined in the Medicare approved compendium, Clinical Pharmacology. The plans prior authorization requirements for this drug are diagnosis-specific and not related to the condition being treated. Since the drug is being prescribed for a medically accepted indication outlined in Clinical Pharmacology, an exception to the diagnosis-specific prior authorization requirements is supported. As such, coverage for the drug is supported.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 coverage for Testosterone 25 milligram per 2.5 gram (1 percent) gel packet. 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 submitted medical records indicate that the requested drug has been prescribed to treat male erectile dysfunction due to testosterone deficiency. Drugs used for the treatment of sexual or erectile dysfunction are excluded from coverage under Medicare Part D. This is regardless of the underlying condition. Therefore, the requested drug is not eligible for coverage under Medicare Part D. This decision does not address the medical necessity of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Jardiance 10 milligram tablets to treat chronic heart failure. 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.Jardiance 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. The drug will continue to be covered at the Tier 3 copay.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Erythromycin 200 milligram per 5 milliliter suspension to treat gastroparesis related to prior surgery, in an adult enrollee who did not tolerate Reglan. 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.At reconsideration, the prescriber has requested a peer-to-peer review for this case. However, C2C is a qualified independent review organization that has been contracted by the Centers for Medicare & Medicaid Services (CMS) to do independent second-level appeal reviews for Part D drugs that have been denied by the Part D plans. While the Part D plans do peer-to-peer reviews with the prescribers of drugs, C2C has not been contracted by CMS to conduct peer-to-peer reviews. Therefore, a peer-to-peer review is not possible at this level and the case will be reviewed, as contracted. 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. Therefore, the drug is being prescribed for a non-medically accepted indication.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.