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

At issue is coverage for Lynparza 150 milligram tablet to treat recurrent, progressed uterine leiomyosarcoma with ATM mutation, but without BRCA mutation. 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 Center for Medicare Management (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, 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 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 clinically relevant and applicable peer-reviewed medical literature from an approved journal submitted 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 Myrbetriq extended release 25 milligram tablets to treat overactive bladder. 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 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, it 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 Chenodal 250 milligram tablets to treat cerebrotendinous xanthomatosis. 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 coverage criteria that must be met prior to approval. 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. The Food and Drug Administration has designated the drug at issue an orphan drug for the treatment of the enrollee's 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 Zolpidem Tartrate 5 milligram tablets to treat 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 plan has prior authorization requirements for this drug. These requirements must be met before coverage can be approved. 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 coverage for Praluent 150 milligram per milliliter subcutaneous injection pen to treat primary hypercholesterolemia. 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 that is not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the prescriber of the drug has not provided patient-specific clinical rationale with supporting documentation as to why the formulary alternative drug required by the plan would likely not be as effective as the requested drug; would likely cause adverse reactions or other harm; and/or has been tried and failed. 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: Favorable

At issue is Ursodiol 300 milligram capsule for the prevention of gallstone formation in an obese enrollee undergoing rapid weight loss. 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. Please note that the plan suggested that the enrollee try the formulary drug Ursodiol tablets. However Ursodiol tablets are not equivalent to Ursodiol capsules. Only the capsules are indicated to treat the provided diagnosis.The following citation in American Hospital Formulary Service - Drug Information (AHFS-DI), a Medicare approved compendium, supports the use of the requested drug for the enrollees condition: Ursodiol capsules are used for prevention of gallstone formation in obese patients undergoing rapid weight loss. Allergan. Actigall (ursodiol) capsules prescribing information. Madison, NJ; 2018 May.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 Cyclobenzaprine Hydrochloride 5 milligram tablets prescribed for chronic muscle spasms. 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 coverage for Humira CF (citrate-free) 40 milligram per 0.4 milliliter subcutaneous pen-injector kit to treat psoriasis vulgaris. 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 plan has prior authorization requirements for this drug that must be met before coverage can be approved. The submitted documentation does not confirm that all of the plans requirements for coverage have 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 Tresiba Flextouch 200 unit per milliliter insulin pen to treat type 2 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.Tresiba Flextouch is a biologic on Tier 3 of the plans formulary. The prescriber has not indicated if all alternatives required by the plan have been tried and failed or why the plans lower tiered biologics would likely not be as effective as the requested drug. Therefore, this biologic is 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 Repatha Pushtronex System 420 milligrams per 3 milliliter solution cartridge to treat hyperlipidemia. 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 statement and medical records indicate the enrollee was placed on Repatha in September 2019 and achieved stable within normal limit results. The enrollee was switched to Praluent in April 2022. The laboratory reports submitted show an increase to an abnormal high while taking Praluent. 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 Belbuca 450 microgram buccal film to treat chronic 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.The plan has prior authorization requirements for this drug. These requirements must be met before coverage can be approved. 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 Lidocaine 5 percent ointment prescribed for drug induced neuropathy, the diagnosis provided at initial determinations. 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, diagnosis of vulvodynia was given. However, no documentation by the prescriber to support this new diagnosis is provided in the form of medical records. Relevant medical records were requested, but no information was received. We are not able to determine whether the requested drug was prescribed for a medically accepted indication. Therefore, the 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 Nucala 100 milligram per milliliter subcutaneous solution auto-injector to treat severe persistent asthma, eosinophilic phenotype. 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 and 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 Mucinex D extended release 600-60 milligram tablet. 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: Unfavorable

At issue is Sildenafil citrate 25 milligrams prescribed for benign prostatic hyperplasia with urinary tract symptoms. 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 First-Mouthwash BLM (equivalent to Benadryl, Lidocaine, and Maalox) 200-25-400-40 milligram per 30 milliliter to treat mouth lesions caused by treatment of malignant neoplasm of left kidney. 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 that are not approved by the Food and Drug Administration (FDA) are excluded from Medicare Part D coverage. This drug has not been found by the FDA to be safe and effective, and the drug product labeling has not been approved by the FDA. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Trospium 20 milligram oral tablet to treat urge incontinence. 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: Favorable

At issue is Botox 100 units per milliliter solution to treat spastic hemiparesis of left non-dominant side as late effect of cerebral infarction and spasticity. 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 Medicare approved compendia contain a citation to support the use of the drug for the enrollees noted diagnosis. Furthermore, 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 statement and medical records indicate the enrollee is not a candidate for oral anti-spasticity medications due to seizure disorder. Additionally, the plan does not offer a formulary alternative to the biologic drug Botox to treat the same condition. 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 Crestor 5 milligram tablet to treat hyperlipidemia. 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 Qelbree extended release 200 milligram 24 hour capsule to treat attention-deficit hyperactivity disorder, predominantly inattentive 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 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 Diclofenac Epolamine 1.3 percent patch to treat acute pain due to lumbar radiculopathy, unspecified low back strain, sacroiliitis, spinal stenosis, facet arthropathy, anterolisthesis, perineural fibrosis and herniated disc. 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 diagnoses are off-label uses. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of these diagnoses. 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 Repatha Sureclick 140 milligram per milliliter solution auto-injector to treat mixed hyperlipidemia. 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 Promacta 25 milligram tablets to treat thrombocytopenia due to 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 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.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 Bystolic 5 milligram tablet to treat hypertensive heart disease without 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.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.