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

At issue is Budesonide enteric coated 3 milligram capsule to treat collagenous colitis. 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 Gralise 600 milligram extended release tablet to treat polyneuropathy in an enrollee with spondylosis and myelopathy, cervical region. 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 Gemtesa 75 milligram tablet to treat unspecified urinary 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: Unfavorable

At issue is Dronabinol 2.5 milligram capsule to treat abnormal 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 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 Auryxia 210 milligram ferric iron tablet, equivalent to 1-gram ferric citrate, prescribed to treat anemia associated with chronic kidney disease. 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.Auryxia is a mineral product. Prescription vitamin and mineral products are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from 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 Adbry 150 milligram per milliliter injectable solution prescribed for 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 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 Prolia 60 milligram per milliliter syringe 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 reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Prolia is a biologic on Tier 4of the plans formulary. There are no biologic 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 Repatha Sureclick 140 milligram per milliliter injection solution to treat mixed hyperlipidemia and pure hyperglyceridemia. The Part D plan denied the request. The Part D plan further denied the request for a tiering exception.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.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. Furthermore, a tiering exception cannot be granted for a drug that has not been approved for coverage, or a drug that has been allowed as a non-formulary exception.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 Dextroamphetamine Sulfate ER (extended release) 15 milligram capsules. The Part D plan denied the request for coverage because the drug was being prescribed for non-medically accepted indications. 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 diagnoses initially provided to the plan for the requested drug were autistic disorder and pervasive developmental disorder, unspecified. However, the noted conditions are off-label uses for the requested drug. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of these conditions. At reconsideration, progress notes from an office visit dated October 26, 2016, have been submitted for review. The progress notes include the diagnoses of autism spectrum disorder and attention deficit hyperactivity disorder. However, while the notes list Dextroamphetamine Sulfate as one of the enrollees medications, there is no indication in the notes what condition the drug is being prescribed to treat, whether it be autism spectrum disorder or attention deficit hyperactivity disorder. Furthermore, it should be noted that the progress notes are dated 5 years ago and from a different practice with a different prescriber/provider. The enrollees current provider indicated to the plan that the drug was prescribed to treat autistic disorder and pervasive developmental disorder, unspecified. Moreover, there is no indication in the submitted progress notes from the current provider for the date of October 1, 2021, that the enrollee is still being treated for attention deficit hyperactivity disorder. As such, there is insufficient documentation to determine if the requested drug is being 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 Topiramate 200 milligram tablets 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.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 Humalog 100 unit per milliliter injection solution to treat 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 a tiering exception request for Welchol 625 milligram tablets to treat Irritable bowel syndrome with diarrhea. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.This drug is being provided by the plan under a formulary exception. It is not on the plans formulary but they have agreed to provide it at a cost sharing level assigned to all formulary exceptions. Per Medicare rules, non-formulary drugs are not eligible for a tiering exception.A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Belbuca 750 microgram film to treat 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 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 Simponi 50 milligram per 0.5 milliliter subcutaneous solution 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 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/or medical records indicate the enrollee has a contraindication to the formulary alternative Kevzara. Per the Medicare approved compendium DrugDex, 'Not recommended for use in active hepatic disease or hepatic impairment.' The enrollee has active hepatic cirrhosis. 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 Acetylcysteine 20 percent 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: Unfavorable

At issue is coverage for Ondansetron 4 milligram orally disintegrating tablet to treat nausea and vomiting due to gastroparesis. 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 Vyvanse 20 milligram capsules to treat multiple sclerosis related fatigue. 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: Favorable

At issue is coverage for Tibsovo 250 milligram tablet, 60 tablets per 30 days, to be used as monotherapy to treat relapsed/refractory acute myeloblastic leukemia with IDH1 mutation. The Part D plan denied the request for coverage because the medically accepted use of the drug required the enrollee to have newly diagnosed (or previously untreated) disease. 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 Food and Drug Administration (FDA) product label and the Medicare approved compendia do include citations to support the use of the requested drug to treat newly diagnosed acute myeloblastic leukemia. However, the FDA label and Medicare approved compendium also include citations to support the use of the requested drug to treat relapsed/refractory acute myeloblastic leukemia with IDH1 mutation. As such, the drug is being prescribed for a medically accepted indication outlined by the FDA and the Medicare approved compendia.Furthermore, it should be noted that the plans prior authorization requirements include both conditions, newly diagnosed acute myeloblastic leukemia and relapsed/refractory acute myeloblastic leukemia, as acceptable uses for the requested drug. The plans authorization requirements for the requested drug to treat relapsed/refractory acute myeloblastic leukemia are as follows: the enrollee has a diagnosis of acute myeloid leukemia; the enrollee has relapsed or refractory disease, and the member will be using Tibsovo as monotherapy. The prescriber has clarified at reconsideration that the enrollee will be using Tibsovo as monotherapy. As such, the submitted medical records support that the plans prior authorization requirements for the requested drug have been met. Therefore, the submitted documentation supports coverage for the requested drug. In addition, the amount 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: Favorable

At issue is Epclusa 400-100 milligram tablet to treat chronic viral hepatitis C. 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 provider has provided documentation showing that the patient did not complete 12-week course of Epclusa in the past. Therefore, the patient has met the coverage criteria.  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 Oxycontin ER 40 milligram tablets to treat 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 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 Simbrinza 1.0-0.2 percent eye drops to treat primary open-angle glaucoma. The Part D plan denied the request for coverage and then auto-forwarded the case to us for review. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted.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 prescriber has not addressed all formulary alternatives required by the plan to treat the enrollees condition and provided patient specific clinical rationale as to why each formulary alternative would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Therefore, the formulary exception criteria have not been met.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Sofosbuvir-Velpatasvir 400-100 milligram tablet to treat treatmentnaive chronic viral hepatitis C, genotype 3 with compensated cirrhosis. 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 Benztropine Mesylate 1 milligram tablets to treat schizoaffective 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.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.