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

At issue is a tiering exception request for Xarelto 20 milligram tablet prescribed for anticoagulation therapy in an enrollee with atrial fibrillation. 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.Xarelto is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type to treat the noted condition on the lower tiers of the plans formulary. If there are no brand drugs of the same type on a lower tier, the drug is not eligible for a tiering exception. A physician reviewer determined that tiering exception criteria have not been met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Spravato 28 milligram per 0.2 milliliter (56 milligram per dose) nasal spray prescribed for severe treatment-resistant major depressive disorder. 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.As outlined in the drugs product labeling, SPRAVATO is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. SPRAVATO must never be dispensed directly to a patient for home use. Drugs that cannot be dispensed directly to a patient for home use and require physician supervision with administration are excluded from Part D coverage. However, the drug may be available for coverage under Medicare Part B. 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 Xeljanz 5 milligram tablet to treat rheumatoid arthritis. 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. 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 the formulary alternative drug required by the plan to treat the enrollees condition and provided patient specific clinical rationale as to why this 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 Hizentra 10 gram per 50 milliliter solution 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.The use of the requested biologic 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 biologic, as prescribed, for the treatment of this diagnosis. Therefore, the requested biologic is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested biologic is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Carbidopa-Levodopa 25 milligram/100 milligram tablets (1620 tablets per 30 days) to treat Parkinson's 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 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 plan limits the amount of Carbidopa-Levodopa to 1620 tablets per 90 days. The prescriber has not indicated that the number of doses of the requested drug allowed by the plan would likely be ineffective in treating the diagnosis or would be likely to cause harm. 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: Unfavorable

At issue is a tiering exception request for Linzess 72 microgram capsules to treat chronic idiopathic 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.Linzess is a brand drug on Tier 4 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Gemtesa 75 milligram tablets to treat overactive bladder. 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 coverage for Trospium Chloride 20 milligram tablet to treat overactive bladder. 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. 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 the formulary alternatives required by the plan to treat the enrollees condition and provided valid, sufficient patient specific clinical rationale with supporting documentation 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. At reconsideration, the prescriber has indicated that two of the formulary alternative drugs suggested by the plan (Darifenacin and Tolterodine) are both strongly recommended to avoid in patients over the age of 65 per the Beers criteria due to the anticholinergic properties of the medications. However, it should be noted that the requested drug, Trospium Chloride, is also an anticholinergic drug that has the same Beers criteria precaution. As such, this is not a valid reason to support a formulary exception in this case. 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 a tiering exception request for Alfuzosin Hydrochloride extended release 10 milligram tablets to treat benign localized prostatic hyperplasia with lower urinary tract symptoms and urinary obstruction. 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.Alfuzosin Hydrochloride is a generic drug on Tier 3 of the plans formulary. The prescriber has not indicated if all alternatives required by the plan have been tried and failed, or why the plans lower tiered drugs would likely not be as effective as the requested drug. Therefore, this drug is 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 a tiering exception request for Travatan Z 0.004 percent eye 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.Travatan Z is a brand drug on Tier 3 of the plans formulary. The prescriber has not indicated if all alternatives required by the plan have been tried and failed, or why the plans lower tiered drugs would likely not be as effective as the requested drug. Therefore, this drug is 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 Acetylcysteine 10 percent ophthalmic solution to treat dry eye syndrome of unspecified lacrimal gland. 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 Hydrocodone/Chlorpheniramine suspension to treat cough. 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.Drugs prescribed for the symptomatic treatment of cough and colds are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Cyclobenzaprine Hydrochloride 10 milligram tablet to treat skeletal muscle spasm associated with chronic musculoskeletal condition; other spondylosis, lumbar region; pain in unspecified knee; and diabetic polyneuropathy. 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 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 Orladeyo 150 milligram capsule prescribed for the prevention of hereditary angioedema attacks in an enrollee with type 3 hereditary angioedema with normal C1-esterase inhibitor (C1-INH) levels. 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 coverage for Corlanor 5 milligram tablet. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The submitted medical records indicate that the requested drug has been prescribed to treat palpitations and an elevated heart rate in an enrollee with paroxysmal atrial fibrillation status post ablation. 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 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 Ozempic 8 milligram per 3 milliliter pen injector to treat morbid obesity. 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.Drugs prescribed to treat weight gain (promote weight loss) are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Skyrizi 150 milligram per milliliter solution to treat psoriasis. 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 biologic is not on the plans formulary. In order to grant an exception for a biologic not on the plans formulary, formulary alternatives 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 biologic is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Cyclobenzaprine HCl 5 milligram tablets to treat bruxism and 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 use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a request for coverage of Ivermectin 3 milligram tablet to treat an unknown condition. The Part D plan denied the request for coverage due to a lack of information/response from the prescriber to support the medical necessity for the drug. The plan 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 submitted documentation does not include medical records or evidence of a prescribed diagnosis. During this review, a request was submitted to the prescriber to provide the condition being treated and supporting medical records. The prescriber did not respond to the request. Without a diagnosis, it cannot be determined if the 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 a tiering exception request for Rectiv 0.4 percent ointment. The Part D plan auto-forwarded the request 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. During this review, we requested a prescriber statement and supporting medical records from the prescriber to support that all lower-tier drugs to treat the enrollees condition were tried and failed or were contraindicated. The prescriber did not respond to the request.Rectiv is a brand drug on Tier 4 of the plans formulary. The prescriber has not addressed the brand drugs of the same type on the lower tiers of the plans formulary to treat the enrollees condition and provide patient specific clinical rationale as to why the lower-tiered brand drugs have been tried and failed, or are contraindicated. As such, the tiering exception requirements have not been met.A physician reviewer determined that tiering exception criteria have not been met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Mesalamine delayed release 800 milligram tablet to treat noninfective gastroenteritis and 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.We requested additional information from the prescriber. Specifically, we requested medical records and a prescriber statement to support all lower-tier drugs to treat the enrollees condition were tried and failed or were contraindicated. We received additional documentation and included it in the review.Mesalamine delayed is a generic drug on Tier 4 of the plans formulary. The prescriber has not indicated if all alternatives required by the plan have been tried and failed, or why the plans lower tiered drugs would likely not be as effective as the requested drug. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Lonsurf 15 milligram/6.14 milligram tablets to treat metastatic colorectal cancer, following multiple lines of treatment. 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 indicates the prescriber ordered the drug at issue for the enrollees diagnosis. The Medicare approved compendia contain a citation to support the use of the drug for the noted diagnosis. The National Comprehensive Cancer Network indicates the drug at issue has a 2A recommendation as subsequent therapy as a single agent for advanced or metastatic disease not previously treated with trifluridine/tipiracil in patients who have progressed through all available regimens besides regorafenib or trifluridine/tipiracil with or without bevacizumab. As such, the submitted documentation supports the drug was prescribed for a medically accepted indication. The plan has prior authorization coverage criteria that must be met prior to approval. The enrollee satisfies the Plans coverage criteria. The criteria indicates the enrollee must have a Food and Drug Administration approved indication. The Medicare approved compendia contain a citation to support the use of the drug for the enrollees noted diagnosis. Therefore, an exception to the plans 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: Favorable

At issue is Dicyclomine Hydrochloride 20 milligram tablet prescribed to treat an unspecified diagnosis. The Part D plan auto-forwarded the request.We received a case to perform an independent and de novo review of this request for coverage. We reviewed all documentation submitted for review, including the case file from the plan, and any information submitted at the reconsideration level. The plan provided documentation showing the drug is approved for coverage effective January 1, 2022 through December 31, 2022. The plan's Evidence of Coverage states, that if an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the plan to pay its share of the cost. The documentation includes proof of payment in the form of a receipt for the requested drug at a preferred pharmacy. Therefore, we determined that the reimbursement criteria have been met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Clonazepam 0.5 milligram powder compound prescribed to treat burning mouth 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. This includes the case file from the plan, and any information submitted at the reconsideration level.Drugs that fall into the category of bulk powders are excluded from coverage under Part D. In addition, over the counter drugs are excluded from coverage under Medicare Part D. The requested compounded drug includes both bulk powder ingredients and over the counter ingredients and is therefore, excluded from coverage and not eligible for reimbursement. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Clindamycin 300 milligram capsule prescribed to treat a rash. The case was auto-forwarded by the plan.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level. The submitted documentation shows the enrollee purchased drugs from a pharmacy outside of the United States. Drugs purchased outside of the United States are excluded from coverage. Therefore, the requested drug is excluded from coverage and not eligible for reimbursement.