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

At issue is coverage for Menostar 14 microgram patch to treat prophylaxis for osteoporosis and postmenopausal symptoms. 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 Xanax 0.5 milligram tablet to treat 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.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 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 validate 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 Doxepin Hydrochloride 3 milligram tablet to treat insomnia 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.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 a tiering exception request for Cinacalcet Hydrochloride 60 milligram tablet to treat hyperparathyroidism. 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.This drug is included on Tier 5 of the plans formulary. Tier 5 of the formulary is the tier reserved for specialty drugs. The Specialty tier is exempt from tiered cost-sharing expectations, per Medicare rules. Therefore, this 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 Humira 40 milligram per 0.4 milliliter injection pen to treat inflammatory 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. 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 Buprenorphine Hydrochloride 2 milligram sublingual tablet prescribed for chronic pain management. 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 Buprenorphine Hydrochloride in sublingual tablet form for the treatment of pain. As outlined in the Food and Drug Administration (FDA) product label for the drug and in the Medicare-approved compendia, the only indication for the use of Buprenorphine Hydrochloride by the sublingual route is for the treatment of opioid dependence/opioid use disorder. 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 Jakafi 5 milligram tablet to treat refractory large granular lymphocytic (LGL) leukemia. 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.At reconsideration, the prescriber/prescribers office has requested a peer-to-peer review for this case. However, while the Part D plans may do peer-to-peer reviews, we (C2C Innovative Solutions, Inc.) have not been contracted by Medicare to conduct peer-to-peer reviews at the second level (independent review level) of appeal. Therefore, a peer-to-peer review is not possible at this level and the case will be reviewed, as contracted.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 Nucala 100 milligram per milliliter auto-injector. The Part D plan denied the request for coverage because the provided diagnosis of severe persistent asthma, uncomplicated was not a medically accepted indication for the drug.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. At reconsideration, the prescriber has clarified that the requested drug has been prescribed to treat severe asthma with an eosinophilic phenotype. The use of the requested drug to treat severe asthma with an eosinophilic phenotype is a medically accepted indication for the drug.However, the plan has prior authorization requirements for this drug that must be met before coverage will be provided. The submitted documentation does not validate 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 Imatinib Mesylate 100 milligram (mg) tablet to treat chronic myeloid leukemia after Tasigna as second line 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 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 Dupixent 300 milligram per 2 milliliter solution pen-injector, being prescribed as single-agent therapy, to treat chronic rhinosinusitis with nasal polyps. 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 medical records/progress notes do not indicate that 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 Sirolimus 2 milligram tablet to treat immune thrombocytopenia; large granular lymphocyte disorder; other lymphoid leukemia; and/or local emotes. 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 Pulmicort Flexhaler Inhalation Aerosol Powder Breath Activated 180 microgram per actuation to treat bronchial asthma. 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 indicate 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 a tiering exception request for Humira 40 milligram (mg) per 0.4 milliliter (ml) prefilled syringe kit to treat the enrollees condition. 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.Humira is included on Tier 5 of the plans formulary. Tier 5 of the formulary is the tier reserved for specialty drugs. The Specialty tier is exempt from tiered cost-sharing expectations, per Medicare rules. Therefore, this 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 Sodium Bicarbonate 650 milligram tablet. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.Sodium Bicarbonate 650 milligram tablet is available over the counter without a prescription. Drugs available without a prescription, even when a prescription has been written, are excluded from coverage under Medicare Part D. 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 Hydroxyzine Hydrochloride 10 milligram per 5 milliliter syrup to treat burning and itching (pruritus) due to multiple chemical sensitivity. 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 a tiering exception request for Entresto 49 milligram (mg)-51 mg tablet to treat congestive heart failure, cardiomyopathy. 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.Entresto 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 a tiering exception request for Jardiance 10 milligram (mg) tablet to treat heart failure, nonishcemic dilated cardiomyopathy. 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.Jardiance 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 a tiering exception request for OmniPod 5 G6 pods cartridge to treat the enrollees condition. 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.OmniPod 5 G6 is a biologic drug on Tier 3 of the plans formulary. There are no biologic 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 Nuplazid 34 milligram (mg) capsule to treat hallucinations, unspecified and Parkinsons disease. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.Nuplazid is included on Tier 5 of the plans formulary. Tier 5 of the formulary is the tier reserved for specialty drugs. The Specialty tier is exempt from tiered cost-sharing expectations, per Medicare rules. Therefore, this 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 Otezla 28-Day Starter Pack (10, 20, and 30 milligram tablets) 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 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 Rituxan 500 milligram per 50 milliliter vial, which is not being given in combination with Methotrexate, 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. 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 for the treatment of rheumatoid arthritis when the drug is not being used in combination with Methotrexate. Therefore, the requested drug, as prescribed, is being used 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 Nexletol 180 milligram tablet. The Part D plan denied the request for coverage because the provided diagnosis of dyslipidemia was not sufficient to support that the drug was prescribed for a medically accepted indication. 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. At reconsideration, the prescriber has clarified that the requested drug has been prescribed, along with Ezetimibe, to treat dyslipidemia in an enrollee with established atherosclerotic cardiovascular disease. The use of the requested drug as an adjunct for the treatment of adults with established atherosclerotic cardiovascular disease who require additional lowering of lipids is a medically accepted indication for the drug.However, 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 the plans requirements for coverage have been satisfied, as no medical records have been submitted for review. Therefore, it is not possible to establish that these requirements have been met. 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 Otezla 30 milligram tablet to treat psoriasis vulgaris. 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.During this review, we requested additional information from the prescriber. Specifically, we requested medical records and a prescriber statement to support that the enrollee has satisfied the plans prior authorization coverage criteria. We received additional documentation and included it in the review.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 Gammagard Liquid 10 percent vial to treat unspecified combined immunodeficiency and other combined immunodeficiencies. The Part D plan denied the request for coverage because the drug would be available for coverage under Medicare Part B. We received the case to perform an independent and de novo review. To make our decision, we reviewed all available documentation.At reconsideration, the prescriber has indicated that the requested drug is not being infused in the enrollees home. The prescriber has indicated that the requested drug is being shipped from the pharmacy and infused in the prescribers office. As such, the drug is being provided incident to a physicians service. Drug furnished incident to a physicians service are excluded from Medicare Part D coverage. However, some drugs that are provided incident to a physicians service are covered under Medicare Part B. 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 contact Medicare Part B.