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

At issue is coverage for Brukinsa 80 milligram capsule to treat marginal zone lymphoma with Rituxan. The Part D plan denied the request for coverage.We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Per the Federal Drug Administration and compendia, Brukinsa is not indicated in marginal zone lymphoma with Rituxan. There are no supporting studies submitted to show it can be used in this case. The submitted documentation does not include any clinically relevant, peer-reviewed medical literature from a Medicare approved journal to support this appeal. Therefore, the available documentation supports that the requested drug is not being prescribed for a medically accepted indication, as defined by Medicare.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Octreotide Acetate 50 microgram per milliliter vial to treat chronic gastrointestinal bleeding from small bowel arteriovenous malformation. 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 Ipratropium/Albuterol 0.5/3 milligrams per 3 milliliter ampule/nebulizer to treat chronic obstructive pulmonary 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 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 Nuzyra 150 milligram oral tablet to treat community acquired pneumonia due to mycobacterium abscessus. 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 Ztlido 1.8 percent patch to treat other spondylosis with radiculopathy, lumbar region. 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 other spondylosis with radiculopathy, lumbar region. 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. An additional diagnosis of post herpetic neuralgia has been noted. However, the medical records supplied dated 11/6/2023 do not contain the diagnosis of post herpetic neuralgia. Due to lack of supporting medical records, it cannot be established that the requested drug has been prescribed for a 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. 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 Hydrocortisone Acetate 25 milligram suppository to treat hemorrhoids. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.Hydrocortisone Acetate 25 milligram suppository is currently classified by the Food and Drug Administration (FDA) Drug Efficacy Study Implementation (DESI) program as less than effective for its labeled indication. Some drugs currently on the market are FDA approved for safety only. These drugs were approved prior to the passing of current FDA law. The FDA reviews these drugs to determine which are less than effective for their labeled indications. This review process is known as the DESI program. This program has resulted in the FDA classifying some of these drugs as less than effective DESI program drugs. Medicare Part D does not pay for prescription drug products classified by the FDAs DESI program as less than effective for their labeled indications. Therefore, the requested drug is excluded from Medicare Part D coverage. This decision does not address the medical necessity of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Fanapt 1 milligram tablet to treat severe autism spectrum disorder, agitation, and generalized anxiety 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 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 Tagrisso 80 milligram tablet, to be used in combination with Tabrecta, to treat metastatic lung cancer with EGFR and MET exon 14 mutations. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. The submitted documentation does not include any clinically relevant, peer-reviewed medical literature from a Medicare approved journal to support this appeal. Therefore, the available documentation supports that the requested drug is not being prescribed for a medically accepted indication, as defined by Medicare.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Humulin R U-500 Kwikpen 500 unit per milliliter solution pen-injector to treat type 2 diabetes mellitus. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.The 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 drug on the plans formulary, Novolin R, is contraindicated. Additionally, the submitted documentation does not support that the enrollee has tried and failed the formulary alternative drug. 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 5 milligram/0.5 milliliter solution pen injector to treat unspecified. 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 submitted documentation does not include medical records or evidence of a prescribed diagnosis. This information was requested by the Part D plan with no response from the prescriber/prescribers office. The documentation submitted at reconsideration also does not include medical records or evidence of a prescribed diagnosis. As such, there is insufficient documentation available to establish 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 Diclofenac Sodium 3 percent gel to treat osteoarthritis. 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. As this drug is not being prescribed for a medically accepted indication, it is not eligible for consideration for a formulary exception.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 Mycophenolate Sodium 360 milligram delayed release tablet to treat anti-PCA1/anti-Yo associated paraneoplastic cerebellar degeneration syndrome. The Part D plan denied the request for coverage.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation. In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. The use of the requested drug to treat the noted condition is an off-label use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this condition. Therefore, the drug is being prescribed for a non-medically accepted indication. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Cresemba 186 milligram oral capsule for prophylaxis against aspergillosis status post lung transplant. 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 Sirturo 100 milligram tablet to treat non tuberculous mycobacterial lung 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. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Mounjaro 7.5 milligram per 0.5 milliliter solution pen injector # 16 pens (8 milliliter) per 28 days to treat type 2 diabetes mellitus. The Part D plan denied the request 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.Mounjaro is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type to treat the same condition on the lower tiers of the plans formulary. If there are no drugs of the same type on a lower tier, the drug is not eligible for a tiering exception.Additionally, the plans quantity limit for the requested drug is 4 pens (2 milliliters) per 28 days. The prescriber has not provided patient-specific clinical rational as to why the amount allowed by the plan would be ineffective in treating the diagnosis and/or would be contraindicated. Furthermore, the submitted documentation does not support the medical necessity for an exception to the plans quantity limit for the drug.A physician reviewed the appeal and determined that the requested drug is not eligible for a tiering exception, or a quantity limit exception.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Relpax 40 milligram tablet to treat migraines. 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 include any medical records to confirm 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 Dabigatran Etexilate Mesylate 150 milligram capsule to treat atrial fibrillation, prophylaxis against embolic event. 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.Dabigatran Etexilate Mesylate is a generic drug on Tier 3 of the plans formulary. The prescriber has not provided patient-specific clinical rationale as to why all of the lower-tiered alternative drugs on the plans formulary to treat the enrollees condition are contraindicated. Therefore, the tiering exception requirements have not been met. 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 prescribed to promote weight loss. 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 promote weight loss are excluded from the Part D coverage, even when there are weight-related comorbidities present. 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 Opzelura 1.5 percent cream to treat discoid 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. 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 Dronabinol 2.5 milligram capsule to treat weight loss associated with Parkinsons disease. The Part D plan denied the request for coverage and then auto-forwarded the case to us for review.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation. In order for a drug to be covered by Medicare Part D, it must be prescribed for a medically accepted indication outlined in the Medicare approved compendia. The use of the requested drug to treat the noted condition is 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 Evenity 210 milligram dose, 2 syringes, to treat age related osteoporosis. 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 confirm 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 Ztlido 1.8 % topical patch to treat sciatica. 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 Lidocaine/Prilocaine 2.5/2.5 percent to use for topical anesthesia for dialysis services. 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. Additionally, we researched Medicare systems.Medicare systems show that the enrollee has end stage renal disease (ESRD) coverage and is currently receiving dialysis. Drugs used for dialysis-related purposes for enrollees with end stage renal disease coverage who are receiving dialysis would be covered under Medicare Part B. Medicare rules state that any drug available for coverage under Medicare Part B cannot be covered under Part D. Therefore, the requested 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.