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

At issue is Prednisone 5 milligram tablets to treat chronic obstructive pulmonary 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 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 Linzess 290 microgram capsules to treat irritable bowel syndrome without 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.Linzess is a brand drug on Tier 4 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 a tiering exception request for Praluent 75 milligram per milliliter pen injector 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.This biologic 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 biologics 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 Neupogen 480 microgram per 1.6 milliliter vial to treat neutropenia secondary to immunosuppressive therapy status post liver transplantation. 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 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.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Nuedexta 20 milligram-10 milligram capsules. 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 initial determination, the prescriber submitted a diagnosis of anxiety disorder, unspecified. At redetermination, the prescriber indicated a diagnosis of major depressive disorder. At reconsideration, a diagnosis of pseudobulbar affect was given. However, no documentation was provided by the prescriber to support this diagnosis. The plan requested information from the prescriber 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 Fluorometholone 0.1 percent eye drops to treat dry eye disease related to Sjogren's syndrome. 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 Entresto 24 milligram-26 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.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 Zolpidem Tartrate 10-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 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 a tiering exception request for Entresto 24 milligram-26 milligram tablets to treat the enrollee's condition. 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.Entresto 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 a tiering exception request for Farxiga 10 milligram tablets to treat congestive heart failure and cardiomyopathy. 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.Farxiga 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 Xifaxan 550 milligram tablets to reduce the risk of overt hepatic encephalopathy recurrence. 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 satisfies the plans coverage criteria. The submitted medical records support the enrollee was prescribed the drug at issue to reduce the risk of overt hepatic encephalopathy recurrence.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 Gimoti SPR 15 milligram per actuation nasal spray to treat gastroparesis due to diabetes mellitus, greater than 12 weeks of therapy. 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 Gralise ER 600 milligram extended-release tablet prescribed for chronic pain syndrome. 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 coverage for Zolpidem Tartrate 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 submitted documentation does not include evidence of a prescribed diagnosis for the requested drug. While a physician progress note from an office visit for the date of April 28, 2022, has been submitted for review, the progress note does not list Zolpidem Tartrate as one of the enrollees medications. Furthermore, the diagnoses included in the progress note, which are low back pain; essential (primary) hypertension; polyosteoarthritis; hyperlipidemia; and lumbar radiculopathy, 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 for the treatment of these conditions. Therefore, the available documentation supports that the drug is being prescribed for non-medically accepted indication(s).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 Buprenorphine Hydrochloride 2 milligram sublingual tablets 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, 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 Binosto 70 milligram tablets to treat age-related osteoporosis without current pathological fracture. 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 Prevymis 480 milligram tablet prescribed for the prevention of cytomegalovirus (CMV) viremia in an at-risk solid organ transplant recipient. 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 compendium, American Hospital Formulary Service Drug Information (AHFS-DI), contains a citation to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. As outlined in AHFS-DI, The drug [Prevymis] has been designated an orphan drug by the US Food and Drug Administration (FDA) for prevention of CMV viremia and disease in at-risk populations. This enrollee has had multiple episodes of CMV viremia after solid organ transplant, which has been resistant to other drugs. Therefore, it is considered a medically accepted indication. An exception is granted for any prior authorization criteria. A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Prolia 60 milligram per milliliter injection solution to treat age-related 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 reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The documentation satisfies the plans coverage criteria. The submitted documentation supports the enrollee has a diagnosis of age-related osteoporosis. The enrollee has a very low T-score of -3.2 and is at a very high fracture risk. The enrollee is not taking any other therapy for treatment of osteoporosis and does not have a contraindication to Prolia. Finally, the record now contains laboratory results to show the enrollee has a calcium level within the laboratory's normal reference range.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 Trulicity 5 milligram per 0.5 milliliter pen injector 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.Trulicity is a biologic on Tier 3 of the plans formulary. There are no biologics of the same type on the lower tiers of the plans formulary to treat the same diagnosis. 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 Veltassa 8.4 gram powder packet to treat hypokalemia. 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 Tobramycin nebulizer solution. 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: Favorable

At issue is coverage for Cabometyx 60 milligram tablet, 30 tablets per 30 days, to treat metastatic renal cell carcinoma. The Part D plan denied the request for coverage because the drug was not being used 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.The medical records indicate that the enrollee has metastatic renal cell carcinoma, which progressed after treatment with Axitinib and Keytruda. The prescriber indicates the enrollee will now be part of Clinical Trial 2020-0258A: Phase 1b/2 Randomized Study of AVG S6 500 in Combination with Cabozantinib versus Cabozantinib Alone in Patients with Advanced Clear Cell Renal Cell Carcinoma who have Received Front Line Treatment. The documentation supports that the study meets the requirements for an approved Medicare study. These requirements are: the principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes; the trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use; the trial does not unjustifiably duplicate existing studies; the trial design is appropriate to answer the research question being asked in the trial; the trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully; the trial is in compliance with federal regulations relating to the protection of human subjects; and all aspects of the trial are conducted according to the appropriate standards of scientific integrity.As outlined in the Food and Drug Administration (FDA) product guidelines, Cabometyx is indicated as monotherapy for second line treatment of renal cell carcinoma. The documentation supports this, as Carbometyx is being prescribed as monotherapy in this setting (there will just be a study drug added because of the study). As such, the documentation supports the drug is being used for a medically accepted indication in a study that meets the Medicare requirements for an acceptable study. Furthermore, the documentation supports that the plans prior authorization requirements for this drug have been met. Finally, the quantity requested does not exceed the plans quantity limit for the drug.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 Humira CF 40 milligram per 0.4 milliliter prefilled subcutaneous syringe prescribed for sarcoidosis of other sites (neurosarcoidosis). 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; rather, it speaks to whether the Part D drug plan is responsible for payment under 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 Cibinqo 100 milligram tablets to treat atopic dermatitis. 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 Diclofenac Sodium 1 percent topical gel to treat chronic neck and back pain with myalgia due to cervical and lumbosacral radiculopathies. 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 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.