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

At issue is coverage for Hyoscyamine Sulfate 0.125 milligram sublingual tablet to treat irritable bowel 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. Hyoscyamine Sulfate 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 Fentanyl 50 microgram per hour patch 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 available documentation.Fentanyl 50 microgram per hour patch is a generic drug on Tier 4 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.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Zoryve 0.30 percent topical cream 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 available documentation.Zoryve 0.30 percent topical cream 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 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 topical patch to treat opioid abuse uncomplicated and chronic pain 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 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: Favorable

At issue is coverage for Benlysta 200 milligram per milliliter auto injector, 4 milliliters (auto injectors) per 28 days, to treat systemic lupus erythematosus. 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, at reconsideration, the prescriber has provided results showing a positive antinuclear antibodies titer of 1:320. Additionally, the available documentation supports that the enrollee has had a trial of hydroxychloroquine with inadequate response; the enrollee is on concomitant therapy with Plaquenil and Sulfasalazine; and the drug has been prescribed by a rheumatologist. 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 a tiering exception request for Trelegy Ellipta 200/62.5/25 microgram per actuation aerosol powder breath activation to treat mild intermittent asthma, uncomplicated. 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 200/62.5/25 microgram per actuation aerosol powder breath activation 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 Wegovy 0.25 milligram per 0.5 milliliter solution auto injector to treat morbid 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.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Humalog mix 50/50 Kwikpen 50/50 units per milliliter insulin pen to treat type 2 diabetes mellitus without complication, with long term current use of insulin. 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 Simponi 50 milligram per 0.5 milliliter solution prefilled syringe 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 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 Hydroxychloroquine Sulfate 200 milligram oral tablet to treat Sjogren's 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 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 Temazepam 7.5 milligram capsule to treat insomnia, long term. 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 Modafinil 200 milligram tablet to treat excessive fatigue due to multiple 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.  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 Ozempic 0.25 or 0.50 milligram subcutaneous solution to treat type 2 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 documentationOzempic 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 Nexlizet 180/10 milligram tablet to treat mixed dyslipidemia. 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 diagnosis initially provided to the plan for the requested drug was mixed hyperlipidemia. 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. At reconsideration, a new diagnosis of familial combined hyperlipidemia has been noted. However, this diagnosis was not initially provided to the plan. Furthermore, no medical records have been submitted to validate this additional diagnosis. As such, due to the conflicting information provided and a lack of supporting medical records, it cannot be established that the requested drug has been prescribed for a medically accepted indication. Of note, formulary exception has not been addressed as drug has not been approved.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 Cyclobenzaprine Hydrochloride 10 milligram tablet to treat lumbar degenerative disc disease with associated spinal stenosis and lumbar spondylosis. 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 suppositories prescribed for the treatment of recurrent prolapsing 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 suppositories are 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 a tiering exception request for Ozempic 2 milligram per 3 milliliter (0.25 or 0.5 milligram per dose) solution pen-injector to treat type 1 diabetes. 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.Ozempic 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 Wegovy 0.25 milligram per 0.5 milliliter solution auto injector to treat overweight with hypertension, nonalcoholic fatty liver disease, hyperinsulinemia, dyslipidemia. 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 Xyrem 500 milligram per milliliter oral solution to treat narcolepsy with cataplexy. 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 indicate 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 Fluvastatin Extended Release 80 milligram tablet to treat dyslipidemia. 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 Estradiol 1 milligram tablet to treat hormone replacement therapy. 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 diagnosis initially provided to the plan for the requested drug was hormone replacement therapy. 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. At reconsideration, a new diagnosis of vaginal atrophy has been noted. However, this diagnosis was not initially provided to the plan. Furthermore, no medical records have been submitted to validate this additional diagnosis. As such, due to the conflicting information provided and a lack of supporting medical records, it cannot be established 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 Acthar gel 400 units per 5 milliliter vial to treat rheumatoid arthritis with rheumatoid factor, unspecified, for long term use. 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.Additionally, 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. 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 Cyclobenzaprine Hydrochloride 10 milligram tablet to treat acute muscle spasms associated with chronic degenerative lumbar disc 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 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 Relion Prime blood glucose test strips. The Part D plan denied the request for coverage. Medicare classifies home blood glucose monitors 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 the supplies necessary for the effective use of the durable medical equipment (home blood glucose monitor), including test strips. Any drug/item available for coverage under Medicare Part B cannot be covered under Part D, per Medicare rules. As such, the requested item 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 Diclofenac Sodium 3 percent gel to treat unspecified polyosteoarthritis, ankylosing spondylitis, and calcium pyrophosphate deposition. 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.