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

At issue is a tiering exception request for Xifaxan 550 milligram tablets to treat hepatic encephalopathy. The Part D auto-forwarded the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.Xifaxan is included on Tier 5 of the plans formulary. Tier 5 of the formulary is the tier reserved for specialty drugs. The Specialty tier is exempt from tiered cost-sharing expectations, per Medicare rules. Therefore, this drug is not eligible for a tiering exception. A physician reviewed the appeal and determined that the requested drug is not eligible for a tiering exception.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Pregabalin 75 milligram capsules to treat diabetic neuropathy. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.The plan has prior authorization requirements for this drug that must be met before coverage will be provided. The submitted documentation does not validate that all of the plans requirements for coverage have been satisfied. Furthermore, the documentation does not support the medical necessity for an exception to the plans prior authorization requirements.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 NP Thyroid 30 milligram tablets to treat autoimmune thyroiditis. The Part D plan 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 available documentation.NP Thyroid has not been found by the Food and Drug Administration (FDA) to be safe and effective, and the drug product labeling has not been approved by the FDA. Drugs that are not FDA-approved do not meet the definition of a Part D drug and are excluded from Part D coverage. Therefore, the requested drug is excluded from Medicare Part D coverage.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 coverage for Octagam 5 milligram per 50 milliliter solution to treat onfamilial hypogammaglobinemia. 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 available documentation. In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. 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 formulary exception cannot be granted for a drug that has not been approved for coverage.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 Modafinil 200 milligram tablet, 30 tablets per 30 days. The Part D plan denied the request for coverage due to a lack of information/response from the prescriber in order to establish that the plans coverage requirements for the drug were met. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.The plan has prior authorization requirements for this drug that must be met before coverage will be provided. The documentation submitted at reconsideration supports that the plans requirements for coverage of this drug have been satisfied. Specifically, the submitted progress notes indicate that the requested drug has been prescribed to treat excessive somnolence associated with the presence of obstructive sleep apnea. This is a medically accepted indication for the drug as outlined in the Medicare approved compendia. In addition, the documentation submitted at reconsideration includes sleep study results confirming the diagnosis of obstructive sleep apnea. Therefore, the plans prior authorization requirements have been met and 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 Buprenorphine Hydrochloride 2 milligram sublingual tablet to treat an unknown condition. 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 available documentation.In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. The submitted documentation does not include medical records or evidence of a prescribed diagnosis. This information was requested by the Part D plan with no response from the prescriber/prescribers office. The documentation submitted at reconsideration also does not include medical records or evidence of a prescribed diagnosis. As such, there is insufficient documentation available to establish that the requested drug has been prescribed for a medically accepted indication.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Promethazine 6.25 milligram per 5 milliliter syrup to treat chronic cough. 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 available documentation.Drugs prescribed for the symptomatic relief of coughs are excluded from the Part D coverage. Therefore, the requested drug is excluded from Medicare Part D coverage.This decision does not address the medical necessity 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 Xifaxan 550 milligram tablets to treat Irritable bowel syndrome with diarrhea. The Part D plan 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 available documentation.The plan has prior authorization requirements for this drug that must be met before coverage will be provided. The submitted documentation supports that all of the plans requirements for coverage have been satisfied. Specifically, the drug has been prescribed to treat irritable bowel syndrome with diarrhea and the enrollee has not been previously treated with the drug. Therefore, the plans prior authorization requirements have been met and 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 Praluent 75 milligram per milliliter solution auto-injector. 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 available documentation.In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. The medical records submitted at reconsideration indicate that the requested drug has been prescribed to treat dyslipidemia in the absence of established cardiovascular disease, primary hyperlipidemia (including heterozygous familial hypercholesterolemia), or homozygous familial hypercholesterolemia. However, the use of the requested drug to treat the noted condition is an off-label use. The Medicare-approved compendia do not contain any citations to support the use of the requested when the enrollee does not have established cardiovascular disease, primary hyperlipidemia, and/or homozygous familial hypercholesterolemia. 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 coverage for Kisqali 400 milligram tablets to treat metastatic HR positive, HER2 negative breast cancer as second line treatment after previous exposure to CDK 4/6 inhibitor. 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 available documentation.In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. 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. The submitted documentation does not include any clinically relevant, peer-reviewed medical literature from a Medicare approved journal to support this appeal. Therefore, the available documentation supports that 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 coverage for Nubeqa 300 milligram tablets to treat node positive hormone sensitive prostate cancer. 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 available documentation.In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. 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. The submitted documentation does not include any clinically relevant, peer-reviewed medical literature from a Medicare approved journal to support this appeal. Therefore, the available documentation supports that 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 coverage for Wegovy 0.5 milligram per 0.5 milliliter solution auto-injector prescribed to promote weight loss in an enrollee with a body mass index (BMI) of 38.0 to 38.9 and chronic medical conditions. 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 available documentation.Drugs prescribed to treat obesity and/or to promote weight loss are excluded from the Part D coverage. Therefore, the requested drug is excluded from Medicare Part D coverage. This decision does not address the medical necessity 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 Loteprednol Etabonate 0.5 percent ophthalmic suspension to treat keratoconjunctivitis sicca (dry eye disease) and meibomian gland 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 available documentation. In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. 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 Loteprednol Etabonate in 0.5 percent strength form the treatment of these conditions. Therefore, the drug is being prescribed for non-medically accepted indications.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 Kisqali 600 milligram daily dose (three 200 milligram tablets), to be used as initial endocrine therapy (as it has been more than 3 years since enrollee has been on endocrine therapy) to treat metastatic, HR positive, HER2 negative breast cancer in an enrollee who has not experienced an intolerable adverse event to Ibrance and Verzenio and who does not have a contraindication to Ibrance and/or Verzenio. 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 available documentation.The plan has prior authorization requirements for this drug that must be met before coverage will be provided. The submitted documentation does not support that all of the plans requirements for coverage have been satisfied. 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 Tacrolimus 0.1 percent ointment to treat progressive immune-related leg ulcerations associated with systemic sclerosis. 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 available documentation. In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. 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 coverage for Budesonide DR (delayed release) 3 milligram capsule to treat ulcerative colitis with diarrhea and rectal bleeding. 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 available documentation.In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. 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 coverage for Mesalamine DR (delayed release) 800 milligram tablet to treat ulcerative colitis. 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 available documentation.The plan has a step therapy requirement that must be met before coverage of this drug will be provided. The submitted documentation does not indicate that the plans step therapy requirement has been satisfied. Furthermore, the documentation does not support the medical necessity for an exception to the plans step therapy requirement.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 Cimzia 2 X 200 milligrams per milliliter (X3) starter kit to treat Crohn's 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 available documentation.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 must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements 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 coverage for Lynparza 150 milligram tablets to treat BRCA mutated colon cancer. 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 available documentation.In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. 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. The submitted documentation does not include any clinically relevant, peer-reviewed medical literature from a Medicare approved journal to support this appeal. Therefore, the available documentation supports that 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 Trelegy Ellipta 100/62.5/25 micrograms per actuation aerosol powder breath activated to treat asthma. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.Trelegy Ellipta is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type to treat the same 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 reviewed the appeal and determined that the requested drug is not eligible for a tiering exception.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Spravato 84 milligram dose pack prescribed for 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 read the case file carefully. We reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.The record shows Spravato is being prescribed to the enrollee for treatment of major depressive disorder. Medicare law specifically excludes coverage for any drug for which payment would be available under Medicare Parts A or B for that individual. Medicare Part B pays for services and supplies incident to the service of a physician (or other practitioner).Spravato is a type of drug that must be administered under direct observation of a health care provider and monitored for at least two hours after administration. The Food and Drug Administration has mandated a Risk Evaluation and Mitigation Strategy for Spravato. This strategy requires that Spravato be only dispensed and administered to patients in a medically supervised healthcare setting that monitors the enrollee. We determined that the drug is eligible under Medicare Part B. Therefore, the Part D plan is not required to cover Spravato.This decision does not address medical necessity of the drug. It only indicates that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Levalbuterol Tartrate 45 microgram per actuation aerosol inhaler to treat shortness of breath due to a lung mass. 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 available documentation. In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. 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 coverage for Humalog 100 unit per milliliter kwikpen to treat type II diabetes mellitus with hyperglycemia. 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 available documentation.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 must be deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the alternative drugs on the plans formulary to treat the enrollees condition would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Additionally, the submitted documentation does not support that the enrollee has tried and failed all of the formulary alternative drugs. Therefore, the formulary exception requirements 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 a tiering exception request for Hydroxyzine Hydrochloride 25 milligram tablet to treat insomnia and anxiety 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 available documentation.Hydroxyzine Hydrochloride 25 milligram tablet is a generic drug on Tier 2 of the plans formulary. There are no generic drugs of the same type to treat the same 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 reviewed the appeal and determined that the requested drug is not eligible for a tiering exception.