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

At issue is coverage for Qulipta 60 milligram tablet for the prophylaxis of migraine headache. The Part D plan auto-forwarded the case to us for review. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation. The 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 Nexletol180 milligram tablet to treat pure hypercholesterolemia. 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 Mounjaro 2.5 milligrams per 0.50 milliliter subcutaneous solution to treat type 2 diabetes mellitus without complications 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.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 Aformoterol 15 microgram per 2 milliliter solution for nebulization to treat the enrollee's condition. The Part D plan auto-forwarded the case to us for review. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.The documentation indicates that the requested drug is going to be used with a nebulizer in the enrollees home or home-like setting. Medicare classifies nebulizers 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 nebulizer drug is not eligible for 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. Please submit the request for coverage through Medicare Part B.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Xiidra 5 percent ophthalmic solution to treat bilateral dry eye syndrome. 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. 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: Unfavorable

At issue is coverage for Tremfya 100 milligram per milliliter injector to treat 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 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 are contraindicated. 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 Budesonide DR (delayed release) 3 milligram capsule to treat other chronic pancreatitis and autoimmune hepatitis. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation. In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. The noted conditions are off-label uses for the requested drug. The Medicare-approved compendia do not contain any citations to support the use of 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 a tiering exception request for Testosterone 50 milligram (1 percent) gel packet. The Part D plan auto-forwarded the case to us for review. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.Testosterone 50 milligram (1 percent) gel packet is a generic drug on Tier 4 of the plans formulary. There are no 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 Armour Thyroid 15 milligram tablet to treat hypothyroidism. The Part D plan auto-forwarded the case to us for review.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation. Armour Thyroid has not been found by the Food and Drug Administration (FDA) to be safe and effective, and the drug product labeling has not been approved by the FDA. Drugs that are not FDA-approved do not meet the definition of a Part D drug and are excluded from Part D coverage. Therefore, the requested drug is excluded from Medicare Part D coverage. This decision does not address the medical necessity of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Lenalidomide 10 milligram capsule. The Part D plan auto-forwarded the case to us for review.We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.Lenalidomide 10 milligram capsule 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 coverage for Trulicity 0.75 milligram per 0.5 milliliter pen to treat type 2 diabetes mellitus. The Part D plan auto-forwarded the case to us for review. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation. The plan has prior authorization requirements for this drug that must be met before coverage will be provided. The submitted documentation 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: Unfavorable

At issue is coverage for Lansoprazole DR (delayed release) 30 milligram oral disintegrating tablet to treat gastroesophageal reflux disease. The Part D plan auto-forwarded the case to us for review.We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.The plan has a step therapy requirement that must be met before coverage of this drug will be provided. The submitted documentation does not support that the plans step therapy requirement has been satisfied. Furthermore, the documentation does not support the medical necessity for an exception to the plans step therapy requirement.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Varubi 90 milligram oral tablet to treat severe nausea secondary to chronic autoimmune disease. The Part D plan denied the request for coverage.We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation. In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. The 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.We cannot consider a quantity limit exception for a drug for which the Medicare Part D plan is unable to provide coverage. Therefore, the plan is not required to cover Varubi or to grant a quantity limit exception for this drug.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 Ipratropium Bromide/Albuterol Sulfate 0.5/2.5 milligram per 3 milliliter inhalation solution to treat respiratory failure with hypercapnia. 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 documentation indicates that the requested drug is going to be used with a nebulizer in the enrollees home or home-like setting. Medicare classifies nebulizers 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 nebulizer drug is not eligible for 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. Please submit the request for coverage through Medicare Part B.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Farxiga 10 milligram tablet to treat type 2 diabetes mellitus in an enrollee with congestive heart failure. 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.Farxiga 10 milligram tablet is a brand drug on Tier 2 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 Sildenafil citrate 20 milligram tablet to treat esophageal spasm due to tracheostomy dependence and unspecified 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 Humalog Mix 75/25 Kwikpen, 93-day supply, to treat type 2 diabetes mellitus. The Part D plan approved coverage for the drug but denied the request for a 93-day supply.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 limited to a recurring 30-day or 90-day supply by the plan. The submitted documentation does not support the medical necessity for an exception to the plans quantity limit for this drug.A physician reviewed the appeal and determined that the plan is not required to cover more than a recurring 90-day supply of the requested drug.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Fulphila 6 milligram per 0.6 milliliter solution prefilled syringe for neutropenia prophylaxis in enrollee undergoing chemotherapy. The Part D plan auto-forwarded the case to us for review.We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.The 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 Topiramate 50 milligram tablet to treat anxiety, racing thoughts, trauma, and cravings. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. The noted conditions are off-label uses for the requested drug. The Medicare-approved compendia do not contain any citations to support the use of 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 Dupixent 300 milligram per 2 milliliter pen injector to treat chronic urticaria. 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 Vyvanse 20 milligram capsule to treat binge eating disorder and attention-deficit hyperactivity 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 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 all of the alternative drugs on the plans formulary to treat the enrollees condition(s) 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 Viibryd 10 milligram tablet to treat bipolar 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 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 bipolar disorder. 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 major depressive disorder 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 Orladeyo 110 milligram capsule prescribed for prophylaxis to prevent attacks of hereditary angioedema. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.The plan has prior authorization requirements for this drug that must be met before coverage will be provided. The submitted documentation does not support that all of the plans requirements for coverage have been satisfied. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Hydrocortisone Acetate 25mg vaginal suppository to treat vaginitis. 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.