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

At issue is Hizentra 10 gram per 50 milliliter vial to treat non-familial hypogammaglobulinemia. The Part D plan denied the request but indicated coverage/payment for the drug has been approved under the enhanced coverage for one year. 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 Local Coverage Determination (LCD) for Intravenous Immune Globulin (L33610) and the related Policy Article (PA) (A52509) indicate the submitted diagnosis is not a diagnosis that is covered under Part B. Therefore, the drug at issue should be considered a Part D drug. However, 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 Tadalafil (pulmonary arterial hypertension) 20 milligram tablet to treat pulmonary arterial hypertension. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The Medicare approved compendia contain a citation to support the use of the drug for the enrollees noted diagnosis. When this drug is used for pulmonary arterial hypertension, it is not an excluded drug. For the drug Tadalafil (pulmonary arterial hypertension) the drug is on formulary and there is no quantity limit. Therefore, the requested drug is eligible for coverage.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 Suboxone 8 milligrams/2 milligrams sublingual film to treat opioid dependence. 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 Everolimus 10 milligram tablets. Also at issue is a request for reimbursement for the drug that was purchased on September 26, 2022. The Part D plan denied both requests. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. To grant an exception for a drug not that is not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the prescriber has not provided patient-specific medical rationale as to why the formulary alternative drug listed by the plan 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. Since the drug is not eligible for coverage, reimbursement is not eligible for the drug that has already been purchased.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Lubiprostone 24 microgram capsule to treat irritable bowel syndrome with constipation. 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.Lubiprostone is a generic drug on Tier 3 of the plans formulary. There are no drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, 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 Vyzulta 0.024 percent drops to treat glaucoma. 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 prescriber has indicated that you have not tried any of the alternative drugs to satisfy the step therapy requirements and that you will be switched to the preferred eye drop Lumigan. As such, Vyzulta cannot be approved.A physician reviewer determined that neither step therapy nor step therapy exception criteria are met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Dextroamphetamine Sulfate 10 milligram tablet to treat attention deficit hyperactivity 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 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 Orgovyx 120 milligram tablets to treat malignant neoplasm of prostate. 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/biologic is being provided by the plan at the cost sharing level of the Specialty tier. Specialty tier drugs/biologic are not available for a tiering exception per Medicare rules. A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Levalbuterol Hydrochloride 1.25 milligram per 3 milliliter 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.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Ultomiris 300 milligram per 3 milliliter vial to treat myasthenia gravis. 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. We requested additional information from the prescriber. Specifically, we requested documentation to support how the drug will be administered. However, we did not receive the requested information.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 a tiering exception request for Entresto 97-103 milligram tablet to treat heart 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 97-103 milligram tablet 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 Droxidopa 100 milligram capsule, 132 per 44 days. 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 limits the amount of Droxidopa 100 milligram capsule provided as a 30-day supply. Therefore, an exception to the plans coverage criteria is not supported. 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 Hydromorphone ER (extended release) 12 milligram 24 hour tablet, 30 per 30 days, to treat chronic pain. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The plan limits the amount of Hydromorphone ER (extended release) 12 milligram 24 hour tablet and the enrollees other opioid medications to 90 Morphine milligram equivalents (MME) per day. The records supports the enrollees MME is 56 per day. The requested quantity is within the plans allowed quantity limit. 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 Diclofenac Sodium 3 percent gel to treat chronic pain in an enrollee with primary osteoarthritis of unspecified hand and spondylosis without myelopathy or radiculopathy of the lumbosacral 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 Glatiramer 40 milligrams per milliliter syringe to treat multiple sclerosis. 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 Atovaquone 750-milligram/5-milliliter suspension as prophylaxis of pneumocystitis jiroveci pneumonia in an immunocompromised patient on high dose steroids. 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 product label, available at drugs@fda, states: MEPRON oral suspension is a quinone antimicrobial drug indicated for: Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). The prescriber has stated that the enrollee cannot tolerate trimethoprim-sulfamethoxazole due to allergy. The Medicare approved compendia contain citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug is eligible for coverage under Medicare Part D. 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. The patient does not have a CD4 cell count less than 200 cells per cubic millimeter within the past 3 months. This PA criteria is not relevant to the enrollee's diagnosis. Therefore, an exception to the Plan's 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 a tiering exception request for Dupixent 300 milligram per 2 milliliter solution pre-filled syringe 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.This biologic 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 biologic 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 Zolpidem Tartrate 10 milligram tablet to treat psychophysiologic 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 coverage for Taltz 80 milligram per milliliter injection pen to treat plaque psoriasis. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. To grant an exception for a drug not that is not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the prescriber has not provided patient-specific clinical rationale as to why the formulary alternative drugs listed by the plan 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 Oxycodone Hydrochloride extended-release (ER) 40 milligram tablet and 80 milligram tablet 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 Evenity 105 milligram per 1.17 milliliter syringe 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 documentation satisfies the plans coverage criteria. The records show the enrollee has a diagnosis of age related osteoporosis without current pathological fracture with a T-score of -2.6 standard deviation. The prescriber states the enrollee has not had a heart attack or a stroke within the preceding year and the medical records show the enrollee has not received previous treatment with the requested 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 Prevymis 480 milligram tablets for prophylaxis of cytomegalovirus (CMV) infection and 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 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 Cosentyx 300 milligram pen to treat psoriatic 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 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 Dupixent 300 milligram per 2 milliliter syringe to treat extreme pruritis. 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 Exelon 9.5 milligram (mg) per 24 hour5 (HR) patch to treat Alzheimer's disease and dementia. 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 Vraylar 1.5 milligram capsule to treat bipolar 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.This drug is being provided by the plan at the cost sharing level of the Specialty tier. Specialty tier drugs are not available for a tiering exception per Medicare rules. A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Valium 2 milligram (mg) tablet to treat muscle spasms. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The 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.