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

At issue is coverage for Modafinil 100 milligram tablet to treat cancer-related fatigue. 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 a tiering exception request for Mounjaro 5 milligram per 0.5 milliliter pen injector. 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.Mounjaro 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 coverage for Lidocaine 5 percent patch to treat thoracic back pain. 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: Favorable

At issue is coverage for Topiramate 200 milligram tablet to treat alcohol dependence. 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 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 a Food and Drug Administration (FDA) non-FDA use and is a medically accepted indication for the drug as outlined in the Medicare approved compendium, Micromedex. Therefore, the drug is being prescribed for a medically accepted indication.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 medical records and the prescriber attests that the patient has benefitted from the use of Topiramate since 2019 and remains in maintenance of abstinence for alcohol dependence. 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 Spiriva Respimat 1.25 micrograms per actuation to treat pulmonary mycobacterial infection. 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 Hydrocortisone Acetate 25 milligram rectal suppository to treat hemorrhoids. 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.Hydrocortisone Acetate is currently classified by the Food and Drug Administration (FDA) Drug Efficacy Study Implementation (DESI) program as less than effective for its labeled indication. Some drugs currently on the market are FDA approved for safety only. These drugs were approved prior to the passing of current FDA law. The FDA reviews these drugs to determine which are less than effective for their labeled indications. This review process is known as the DESI program. This program has resulted in the FDA classifying some of these drugs as less than effective DESI program drugs. Medicare Part D does not pay for prescription drug products classified by the FDAs DESI program as less than effective for their labeled indications. 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 HYDROCORTISONE/PRAMOXINE 2.5 percent/1 percent perianal cream to treat Hemorrhoids. 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.HYDROCORTISONE/PRAMOXINE 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 a tiering exception request for Glyxambi 25/5 milligram tablet 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 available documentation. Glyxambi 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 coverage for Pimecrolimus 1 percent cream to treat hypertrophic scar/keloid skin disorder and hidradenitis axillaris. 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 Part D plan is responsible for determining whether the requested drug has been 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 the requested drug, as prescribed, for 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 Ingrezza 40 milligram capsule to treat Huntington's chorea. 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 Autologous Serum 9 milliliter ophthalmic solution to treat dry eye syndrome. 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.Autologous Serum 9 milliliter ophthalmic solution 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 Sodium Chloride 0.9 percent solution to treat dry eye syndrome. 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: Favorable

At issue is coverage for Ayvakit 25 milligram oral tablet to treat mastocytosis and myelodysplastic syndrome. 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 supports that all of the plans requirements for coverage have been satisfied. Specifically, the enrollee has a diagnosis of systemic mastocytosis and a platelet count greater than 50,000 per microliter. 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: Favorable

At issue is coverage for Enbrel Sureclick 50 milligram per milliliter solution auto injector to treat psoriatic arthritis and psoriasis of the skin. 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 supports that all of the plans requirements for coverage have been satisfied. Specifically, the enrollee has been taking this medication to treat psoriatic arthritis and psoriasis of the skin since 2014, with good results. The enrollee has been previously treated with this drug for psoriatic arthritis and medical records support this diagnosis. 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 Botox 200 unit reconstituted solution to treat migraine with aura, intractable, with status migrainosus. 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 Octreotide Acetate 50 micrograms per milliliter syringe to treat refractory diarrhea due to ileocecal resection for Meckels diverticulum. 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 Accrufer 30 milligram capsule to treat iron deficiency anemia. 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.Accrufer 30 milligram capsule is a prescription mineral. Prescription vitamin and mineral products are excluded from coverage under Medicare Part D. This is regardless of whether the vitamin or mineral product is being prescribed to correct a deficiency or to treat a disease process. 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 Forteo 600 micrograms per 2.4 milliliter injection to treat osteoporosis in a postmenopausal woman. 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. 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: Favorable

At issue is coverage for Xifaxan 550 milligram oral tablet, 42 per 14 days, to treat Irritable bowel syndrome with diarrhea. 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 plans quantity limit for the requested drug is 62 per 31 days. The prescriber has provided patient-specific clinical rationale as to why the amount allowed by the plan would likely be ineffective in treating the diagnosis and/or would be likely cause harm. Specifically, the drug compendium, Micromedex, states the usual dosage for this diagnosis is three times per day for 10 to 14 days. As such, the submitted documentation supports the medical necessity for an exception to the plans quantity limit for this drug. A physician reviewed the appeal and determined that the requested drug at the requested amount is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Tadalafil 20 milligram tablet to treat chronic thromboembolic pulmonary hypertension/World Health Organization (WHO) Group 4 pulmonary hypertension. 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 Skyrizi 360 milligram per 2.4 milliliter solution cartridge to treat ulcerative chronic rectosigmoiditis without complication. 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.At reconsideration, a new diagnosis of ulcerative colitis has been noted. 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 the requested drug, as prescribed, for 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 Humulin R (Regular) 500 units per milliliter vial to treat type 2 diabetes mellitus. 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 submitted documentation indicates that the requested drug is being administered via a durable insulin infusion pump. Medicare classifies durable insulin infusion pumps as durable medical equipment. Medicare rules state that Medicare Part B pays for the rental and purchase of durable medical equipment. Additionally, payment will be made under Medicare Part B for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals, which must be put directly into the equipment. Any drug available for coverage under Medicare Part B cannot be covered under Part D, per Medicare rules. Therefore, the requested drug is not eligible for Medicare Part D coverage.This decision does not address the medical necessity of the item. It only establishes that payment cannot be made under the Medicare Part D benefit. Please submit the request for coverage through Medicare Part B.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Darzalex Faspro 1800 milligrams/30000 units per 15 milliliters (to be used with Pomalyst/Dexamethasone) to treat newly diagnosed amyloid of the kidney. 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: Favorable

At issue is coverage for Venclexta 100 milligram tablet to treat acute myeloid leukemia. 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 a medically accepted indication for the drug as outlined in the Medicare approved compendium, DrugDex. Therefore, the drug is being prescribed for a medically accepted indication.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 Wegovy 0.25 milligram per 0.5 milliliter subcutaneous solution to treat prediabetes and obesity. 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.