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

At issue is Hetlioz 20 milligram capsule to treat circadian rhythm sleep disorder, free-running type (Non-24).We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The plan has prior authorization requirements for this drug. These requirements must be met before coverage can be extended. The submitted documentation does not satisfy the plans coverage criteria. In addition, the documentation in the case file from the plan shows the enrollee does not have a valid prescription for Hetlioz 20 milligram capsule. Also, the case file from the Plan shows that the enrollee does not want Vanda to pursue this appeal on their behalf. As such, there cannot be a valid appointment of representation as required by Title XVIII of the Social Security Act.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: At-Risk Determination
Decision: Unfavorable

Medicare rules require that if a Part D sponsor affirms an at-risk determination on appeal, the case must be automatically forwarded to the Part D Independent Review Entity (IRE) for review and resolution. The plan forwarded this case to us as required by Medicare rules.We received an auto-forwarded reconsideration request from the plan to review the at-risk determination. The plan imposed a 90 morphine milligram equivalent (MME) restriction/limitation per day effective December 3, 2021.We performed 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 enrollees daily MME from March 20, 2021, through September 20, 2021, was 158. The prescriptions for opioid drugs were provided by five different providers and filled at one pharmacy. Therefore, the plan determined a safety edit is necessary and the enrollee has been placed in the Part D plans Drug Management Program (DMP) as of October 27, 2021.In addition, the submitted documentation shows the enrollee obtained Oxycodone-APAP, 5-325 milligrams, 15 tablets per 3 day supply on December 7, 2021, from CVS pharmacy, under a new prescriber (Linda Soldavini ).A physician determined the plans restriction/limitation, through a DMP, is appropriate as there is a risk of obtaining an unsafe quantity of frequently abused drugs (i.e., opioids and benzodiazepines) when receiving prescriptions from multiple prescribers and pharmacies.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Atovaquone 750-milligram per milliliter oral suspension prescribed for the prevention of pneumocystis jirovecii pneumonia (PCP) infection in an enrollee on immunosuppressive therapy following a kidney transplant who did not tolerate treatment with Sulfamethoxazole-Trimethoprim. The Part D plan denied the request for coverage because the plans prior authorization requirements were not met.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 that the enrollee does not have a human immunodeficiency virus (HIV) infection. As outlined in the Food and Drug Administration (FDA) product label and the Medicare approved compendia, the use of Atovaquone forPCP prophylaxis/prevention is indicated for HIV-infected individuals only. As such, the requested drug is being prescribed for a non-medically accepted indication and is not eligible for coverage under Medicare Part D. Since the drug is not eligible for coverage, the plans prior authorization requirements are not relevant in this case. 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 Humulin R 100-milliliter vial. The case was auto-forwarded by the plan.We received the 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 submitted documentation shows the enrollee received Humulin R as a self-administered drug in the hospital. According to the plan's Evidence of Coverage, if the 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 enrollee provided a hospital statement including the amount charged for the self-administered drug and a payment receipt. However, the statement indicates that a discount was provided for the self administered drugs, but did not provide the discount amount for each individual drug. Therefore, reimbursement amounts cannot be determined and criteria have not been met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Gamunex-C 20-grams per 200-milliliter solution to treat autonomic neuropathy. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Albuterol Sulfate 2.5-milligram/3-milliliter vial prescribed for the treatment of chronic obstructive pulmonary disease. The Part D plan denied the request.We received the 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 submitted documentation shows the requested drug is being administered through a nebulizer in the home setting. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. We determined that the Part D plan is not required to cover the requested drug.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Atorvastatin Calcium 40-milligram tablet. The case was auto-forwarded by the plan.We received the 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 submitted documentation shows the enrollee received Atorvastatin Calcium as a self-administered drug in the hospital. According to the plan's Evidence of Coverage, if the 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 enrollee provided a hospital statement including the amount charged for the self-administered drug and a payment receipt. However, the statement indicates that a discount was provided for the self administered drugs, but did not provide the discount amount for each individual drug. Therefore, reimbursement amounts cannot be determined and criteria have not been met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Wegovy 0.25-milligram/0.5-milliliter pen to treat unknown diagnosis. 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, 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 Amitriptyline Hydrochloride powder for compounded drug prescribed for arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.We determined that the plan is not required to cover the requested drug. According to Medicare rules, drugs that fall into the category of bulk powders do not meet the definition of a Part D drug. The requested drug is considered a bulk powder and is excluded from coverage under Part D. 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 Baclofen powder for compounded drug prescribed for arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.We determined that the plan is not required to cover the requested drug. According to Medicare rules, drugs that fall into the category of bulk powders do not meet the definition of a Part D drug. The requested drug is considered a bulk powder and is excluded from coverage under Part D. 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 Clonidine Hydrochloride powder for compounded drug prescribed for arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.We determined that the plan is not required to cover the requested drug. According to Medicare rules, drugs that fall into the category of bulk powders do not meet the definition of a Part D drug. The requested drug is considered a bulk powder and is excluded from coverage under Part D. 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 Diclofenac powder for compounded drug prescribed for arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.We determined that the plan is not required to cover the requested drug. According to Medicare rules, drugs that fall into the category of bulk powders do not meet the definition of a Part D drug. The requested drug is considered a bulk powder and is excluded from coverage under Part D. 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 Gabapentin powder for compounded drug prescribed for arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.We determined that the plan is not required to cover the requested drug. According to Medicare rules, drugs that fall into the category of bulk powders do not meet the definition of a Part D drug. The requested drug is considered a bulk powder and is excluded from coverage under Part D. 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 Lidocaine powder for compounded drug prescribed for unknown diagnosis. 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.We determined that the plan is not required to cover the requested drug. According to Medicare rules, drugs that fall into the category of bulk powders do not meet the definition of a Part D drug. The requested drug is considered a bulk powder and is excluded from coverage under Part D. 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 Menthol Crystals for compounded drug prescribed for arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.According to Medicare rules, drugs that are not approved by the Food and Drug Administration are excluded from coverage under Part D. The requested drug is an ingredient in a compound that has not been approved by the Food and Drug Administration to be safe and effective. Therefore, the drug excluded from coverage under Part D. This decision does not address the medical necessity or appropriateness of the drug/product. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Propylene Glycol liquid for compounded drug prescribed for arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.According to Medicare rules, drugs that are not approved by the Food and Drug Administration are excluded from coverage under Part D. The requested drug is an ingredient in a compound that has not been approved by the Food and Drug Administration to be safe and effective. Therefore, the drug excluded from coverage under Part D. This decision does not address the medical necessity or appropriateness of the drug/product. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Sepineo P 600 liquid for compounded drug prescribed for arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.According to Medicare rules, drugs that are not approved by the Food and Drug Administration are excluded from coverage under Part D. The requested drug is an ingredient in a compound that has not been approved by the Food and Drug Administration to be safe and effective. Therefore, the drug excluded from coverage under Part D. This decision does not address the medical necessity or appropriateness of the drug/product. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Versapro cream for compounded drug prescribed for arthritis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.According to Medicare rules, drugs that are not approved by the Food and Drug Administration are excluded from coverage under Part D. The requested drug is an ingredient in a compound that has not been approved by the Food and Drug Administration to be safe and effective. Therefore, the drug excluded from coverage under Part D. This decision does not address the medical necessity or appropriateness of the drug/product. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Cinacalcet Hydrochloride 30-milligram tablet to treat hypercalcemia associated with persistent hyperparathyroidism in a renal transplant recipient not on dialysis.  The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The documentation satisfies the plans coverage criteria. In the reconsideration appeal the prescriber submitted medical records.  The records show that the enrollee has tertiary hyperparathyroidism status post renal transplant, is not receiving dialysis, and that the enrollee's calcium levels are above the lower limit of normal.   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 Hetlioz 20-milligram capsule to treat circadian rhythm sleep disorder, free-running type. 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.During this review, we requested medical records and a prescriber statement from the prescriber to validate that the plans coverage requirements for the requested drug were met. However, we did not receive a response from the prescriber.The plan has prior authorization requirements for this drug. These requirements must be met before coverage can be approved. The submitted documentation does not satisfy the plans coverage criteria.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Myophenolate Mofetil 250-milligram capsule prescribed daily for kidney transplant. 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 also researched Medicare systems and reviewed the enrollment data available. We determined that the plan is not required to cover the drug. Medicare records indicate the enrollee received a (ORGAN) transplant, which was covered by Medicare Part A. Therefore, the transplant is considered a Medicare covered transplant and the requested drug is eligible under Medicare Part B. Medicare rules state that a drug covered under Part B cannot be covered under Part D. 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 Prednisone 5-milligram capsule prescribed daily for kidney transplant. 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 also researched Medicare systems and reviewed the enrollment data available. We determined that the plan is not required to cover the drug. Medicare records indicate the enrollee received a (ORGAN) transplant, which was covered by Medicare Part A. Therefore, the transplant is considered a Medicare covered transplant and the requested drug is eligible under Medicare Part B. Medicare rules state that a drug covered under Part B cannot be covered under Part D. 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 Tacrolimus 1-milligram capsule prescribed daily for kidney transplant. 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 also researched Medicare systems and reviewed the enrollment data available. We determined that the plan is not required to cover the drug. Medicare records indicate the enrollee received a (ORGAN) transplant, which was covered by Medicare Part A. Therefore, the transplant is considered a Medicare covered transplant and the requested drug is eligible under Medicare Part B. Medicare rules state that a drug covered under Part B cannot be covered under Part D. 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 a tiering exception request for Eliquis 5-milligrams tablet to reduce the risk of a stroke and blood clots prescribed to an enrollee with the diagnosis of 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.Eliquis is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Eliquis 5-milligram tablets as anti-coagulation therapy in an enrollee with supraventricular tachycardia and unspecified atrial flutter. 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.Eliquis is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that the tiering exception criteria are not met.